Medical liquid injection device

JPWO2023199993A5Pending Publication Date: 2026-06-02
View PDF 0 Cites 0 Cited by

Patent Information

Authority / Receiving Office
JP · JP
Patent Type
Applications
Filing Date
2023-04-13
Publication Date
2026-06-02

AI Technical Summary

Technical Problem

Existing drug injection devices face challenges in effectively preventing backflow of blood during both injection and aspiration processes, particularly when refilling the syringe, which can lead to contamination and inefficiency in medicinal solution delivery.

Method used

A chemical liquid injection device with a detachable chemical liquid circuit, featuring a flow path opening/closing mechanism downstream of the branch point in the patient line and transducer line, incorporating one-way valves and a housing with a piston mechanism to control fluid flow, ensuring directional flow and preventing backflow.

Benefits of technology

The device satisfactorily controls the flow of medicinal solutions, preventing backflow and ensuring reliable injection and aspiration processes, enhancing the safety and efficiency of drug delivery systems.

✦ Generated by Eureka AI based on patent content.
Patent Text Reader

Abstract

The present invention provides a medical liquid injection device with which it is possible to satisfactorily control the flow of a medical liquid in a medical liquid circuit. The medical liquid injection device has a medical liquid circuit mounting part on which is mounted a medical liquid circuit 30 having a subject line 303 and a transducer line 304 branching from the subject line 303, as a flow path for the medical liquid. A squeezing mechanism 750 is provided at a position, of the medical liquid circuit mounting part, on the downstream side of a branching part at which the subject line 303 and the transducer line 304 branch from each other.
Need to check novelty before this filing date? Find Prior Art

Description

Chemical injection device

[0001] The present invention relates to a chemical liquid injector having a chemical liquid circuit including a plurality of tubes and the like.

[0002] A liquid injector is often used to inject a liquid medicine into a subject. To facilitate injection at a desired injection rate, many liquid injectors are configured to inject the liquid medicine filled in the syringe via a liquid medicine circuit that fluidly connects the syringe and the subject, with the aim of facilitating injection at a desired injection rate.

[0003] In principle, syringes are used only once, but they are often refilled with medicinal liquid from a bottle for multiple uses. In this case, the injection circuit includes a patient line connecting the syringe to the patient and a bottle line branching off from the patient line and leading to the bottle. When injecting medicinal liquid, the bottle line is closed, but when filling the medicinal liquid, the patient line is closed downstream of the branch point of the bottle line and then opened. In this case, it is important to prevent the patient's blood flowing backward through the patient line (backflow) from reaching the upstream side of the closed part of the patient line.

[0004] As an example of a drug solution circuit that can more reliably prevent such backflow of blood, Patent Document 1 (WO 2018 / 181270) discloses a drug solution circuit in which the closure section includes a first movable member having a flow path, a second movable member having a flow path and located downstream of the first movable member in the subject line, and a housing that slidably accommodates the first movable member and the second movable member, and is configured so that the flow path of the second movable member is opened after the flow path of the first movable member is opened.

[0005] Patent Document 1: International Publication No. 2018 / 181270

[0006] The liquid medicine circuit includes various components such as a flow path opening / closing valve in addition to the tube to control the flow of the liquid medicine in accordance with the operation of the liquid medicine injector. One of the objects of the present invention is to provide a liquid medicine injector that can effectively control the flow of the liquid medicine in the liquid medicine circuit having such various components.

[0007] According to one aspect of the present invention, there is provided a drug solution injection device having a drug solution circuit detachably mounted thereon, the drug solution circuit having a subject line and a transducer line branching from the subject line as a drug solution flow path, the drug solution injection device having a flow path opening and closing mechanism on the drug solution circuit mounting section downstream of the branch point of the subject line with the transducer line.

[0008] (Definition of Terms) In this specification, "upstream" and "downstream" mean "upstream" and "downstream" relative to the flow direction of the liquid medicine. However, in cases where the liquid medicine can flow in both directions, such as when the liquid medicine is injected and aspirated, unless otherwise specified, "upstream" and "downstream" mean "upstream" and "downstream" relative to the flow direction of the liquid medicine when it is injected.

[0009] According to the present invention, it is possible to provide a chemical liquid injector that can effectively control the flow of chemical liquid in a chemical liquid circuit.

[0010] 1 is a schematic diagram of a medical imaging system according to an embodiment of the present invention. FIG. 1 is a schematic diagram of a chemical liquid circuit shown in FIG. 1. FIG. 2 is an exploded perspective view of one embodiment of a syringe that can be used in the chemical liquid injector shown in FIG. 1. FIG. 3 is an exploded perspective view, seen from the rear, of another embodiment of the protective cover 21, together with a syringe that can be combined therewith. FIG. 4 is a plan view of the distal end portion of the protective cover shown in FIG. 3A. FIG. 3C is a cross-sectional view of the protective cover shown in FIG. 3B, taken along line 3C-3C. FIG. 3B is a front view of one embodiment of an anti-slip ring that can be provided on the inner surface of the protective cover. FIG. 4 is a perspective view, seen from the lower rear, of a syringe inserted into the protective cover. FIG. 2 is a perspective view of one embodiment of the flow path opening / closing valve shown in FIG. 2. FIG. 4 is a perspective view of the housing of the flow path opening / closing valve shown in FIG. 4. FIG. 5 is a cross-sectional perspective view of the housing shown in FIG. 5, taken along line 5A-5A. FIG. 6 is a cross-sectional perspective view of the piston of the flow path opening / closing valve shown in FIG. 4. FIG. 6 is a cross-sectional perspective view of the piston shown in FIG. 6, taken along line 6A-6A. FIG. 6 is a cross-sectional perspective view of the piston shown in FIG. 6, taken along line 6B-6B. FIG. 7A is a cross-sectional view of the flow path opening / closing valve shown in FIG. 4, taken along line 7A-7A, in the open position and the closed position. FIG. 7B is a cross-sectional view of the flow path opening / closing valve shown in FIG. 4, taken along line 7B-7B, in the open position and the closed position. 7B , showing an enlarged view of the stopper mechanism shown in FIG. 7B . FIG. 8C is a perspective view of a first form of one-way valve that can be used in a liquid chemical circuit. FIG. 9 is an exploded perspective view of the one-way valve shown in FIG. 8A . FIG. 10 is a perspective view of a second case of the one-way valve shown in FIG. 8A . FIG. 11 is a perspective view of a second one-way valve that can be used in a liquid chemical circuit, showing the closed state of a second one-way valve that can be used in a liquid chemical circuit. FIG. 12 is a cross-sectional view of a second one-way valve that can be used in a liquid chemical circuit, showing the open state of a second one-way valve that can be used in a liquid chemical circuit. FIG. 13 is an exploded perspective view of the one-way valve shown in FIG. 10A . FIG. 14 is a cross-sectional view of a fourth form of one-way valve that can be used in a liquid chemical circuit. FIG. 15 is an exploded perspective view of the one-way valve shown in FIG. 16A . FIG. 16 is a cross-sectional view of a fourth one-way valve that can be used in a liquid chemical circuit. FIG. 17 is an exploded perspective view of the one-way valve shown in FIG. 17A . FIG. 18 is a cross-sectional view of a fourth one-way valve that can be used in a liquid chemical circuit. FIG. 19 ... 12B is a perspective view of the spike of the suction tube unit shown in FIG. 12A, and FIG. 12C is a cross-sectional perspective view of the spike shown in FIG. 12A taken along line 12E-12E.A side view showing a part of a syringe connector and a modification of a syringe in cross section. A block diagram showing the configuration of an injection head of the medical imaging system shown in FIG. 1. A perspective view of the head body of the injection head shown in FIG. 14. A view showing the open position of the clamper shown in FIG. 15. A view showing the closed position of the clamper shown in FIG. 15. A perspective view of a presser showing the relationship with the plunger of the syringe. A perspective view of the presser as seen from the upper rear side (in the direction of the arrow in FIG. 15C to FIG. 15D). A plan view of the presser in a state where the convex portion of the syringe is engaged. A perspective view of one form of a syringe drive mechanism. A view schematically showing the arrangement of a side frame, a ram, and a linear guide when the syringe drive mechanism is viewed from the front. A perspective view of another form of the injection head. A perspective view of the injection head shown in FIG. 16, in which a bottle is held in the first chemical solution container holder and a large-capacity bag is held in the second chemical solution container holder. A perspective view of the injection head shown in FIG. 16, in which a bottle is held in the first chemical solution container holder and a small-capacity bag is held in the second chemical solution container holder. A perspective view of the injection head shown in FIG. 16 in an upward posture. A block diagram of one form of a chemical solution injection device having two consoles. A perspective view of one form of the variable hand switch shown in FIG. 17. A view showing one form of a screen displayed on a display device of the chemical solution injection device. A view showing one form of a screen displayed on a display device of the chemical solution injection device. A view showing one form of a screen displayed on a display device of the chemical solution injection device. A view showing one form of a screen displayed on a display device of the chemical solution injection device. A view showing one form of a screen displayed on a display device of the chemical solution injection device. A view showing one form of a screen displayed on a display device of the chemical solution injection device. A view showing one form of a screen displayed on a display device of the chemical solution injection device. A view showing one form of a screen displayed on a display device of the chemical solution injection device. A view showing one form of a screen displayed on a display device of the chemical solution injection device.

[0011] Hereinafter, an embodiment of the present invention will be described with reference to the drawings. Here, an angio imaging system that is preferably used for cardiac catheterization by coronary angiography will be described as an example, but the present invention is not limited to this and can also be applied to a CT (Computed Tomography) imaging system, an MRI (Magnetic Resonance Imaging) system, a PET (Positron Emission Tomography) system, etc.

[0012] [A] Overall Configuration Referring to FIG. 1, a schematic diagram of a medical imaging system according to one embodiment of the present invention is shown, including a liquid injector 10, a liquid injector circuit 30, and a medical imaging device 50. The liquid injector 10 includes an injection head 10a and a console 10b. The liquid injector circuit 30 fluidly connects the injection head 10a to a subject. The liquid injector 10 and the medical imaging device 50 can be connected to each other so that data can be transmitted and received between them. The connection between the two may be wired or wireless.

[0013] The medical imaging device 50 includes an imaging operation unit 52 that performs imaging operations and an imaging control unit 51 that controls the operation of the imaging operation unit 52. The medical imaging device 50 can acquire medical images, including tomographic images and / or three-dimensional images, of a subject into which a liquid has been injected by the liquid injector 10. The imaging operation unit 52 typically includes a patient bed and an electromagnetic wave irradiation unit that irradiates a predetermined space above the bed with electromagnetic waves. The imaging control unit 51 controls the overall operation of the medical imaging device, such as by determining imaging conditions and controlling the operation of the imaging operation unit 52 according to the determined imaging conditions. The imaging control unit 51 may include a so-called microcomputer and may have a CPU, ROM, RAM, and interfaces with other devices. A computer program for controlling the medical imaging device 50 is installed in the ROM. The CPU controls the operation of each component of the medical imaging device 50 by executing various functions in accordance with the computer program.

[0014] The medical imaging apparatus 50 may further include a display device 54 such as a liquid crystal display capable of displaying imaging conditions and acquired medical images, and an input device 53 for inputting imaging conditions, etc. The input device 53 may be at least one of known input devices such as various buttons, a keyboard, and a mouse. At least a portion of the data used to determine the imaging conditions is input from the input device 53 and transmitted to the imaging control unit 51. Data displayed on the display device 54 is transmitted from the imaging control unit 51. A touch panel having a touch screen disposed as an input device on a display serving as a display device may also be used as the input device 53 and the display device 54. A portion of the input device 53, the display device 54, and the imaging control unit 51 may be incorporated into a single housing as a console for the medical imaging apparatus.

[0015] Liquid injector 10 is used to inject a liquid drug filled in a syringe into a subject's blood vessel via liquid drug circuit 30. The syringe is detachably mounted on injection head 10a, which houses at least one syringe drive mechanism for operating the syringe plunger (or piston). In this embodiment, injection head 10a is configured to accommodate two syringes 20A, 20B so that two types of liquid drug, such as a contrast medium and a physiological saline solution, can be injected separately or simultaneously. It also has two syringe drive mechanisms for independently operating each syringe 20A, 20B. However, at least one of the syringe drive mechanisms for injecting one liquid drug and the syringe drive mechanism for injecting the other liquid drug may be provided in plural.

[0016] One form of syringe that can be used in this embodiment will now be described with reference to Figure 3. The syringe shown is generally called a rodless syringe and includes a cylinder 22 with a flange 22a and a nozzle portion 22b formed at the end and tip, respectively, and a plunger 23 inserted into the cylinder 22 so as to be movable back and forth. A flange-shaped protrusion (not shown) that engages with the syringe drive mechanism of the injection head 10a is integrally formed at the end of the plunger 23. The syringe may be a pre-filled type syringe provided by the manufacturer in a state filled with a medicinal solution, or a field-filled type syringe filled with a medicinal solution at a medical site.

[0017] The syringe is inserted into protective cover 21 and attached to injection head 10a. Protective cover 21 is a cylindrical component with dimensions that leave virtually no gap between the outer circumferential surface of cylinder 22 and the inner circumferential surface of protective cover 21 in order to suppress expansion due to an increase in internal pressure of cylinder 22 during injection of a chemical solution. In order for protective cover 21 to fulfill this role, protective cover 21 is formed with a thickness that provides sufficient mechanical strength to withstand the internal pressure acting on cylinder 22 during injection of a chemical solution.

[0018] An opening is formed at the tip of protective cover 21, and cylinder 22 is inserted into protective cover 21 with nozzle portion 22b protruding from this opening. A cover flange 21a is formed at the end of protective cover 21, with a ring-shaped recess formed to receive flange 22a of cylinder 22. In this embodiment, a syringe is inserted into protective cover 21 for use, but protective cover 21 is not essential to the present invention, and a syringe may be attached directly to injection head 10a.

[0019] 3A is an exploded perspective view showing another embodiment of the protective cover 21, together with the syringe (cylinder 22 and plunger 23) that can be combined with it. Note that in FIG. 3A, the portion protruding from the end of the plunger 23 is a flange-like protrusion 23a that engages with the syringe drive mechanism of the injection head 10a.

[0020] 3A includes an upside piece 211 and a ring member 212. The upside piece 211 is attached to a portion of the outer circumferential surface of the cover flange 21a that faces the upper surface of the injection head 10a when the protective cover 21 is attached to the injection head 10a. The ring member 212 is attached to cover the portion of the outer circumferential surface of the cover flange 21a where the upside piece 211 is not attached. The ring member 212 can be made of a metal such as stainless steel (e.g., SUS443J1).

[0021] The upside piece 211 may be attached to the protective cover 21 by any means, such as adhesive. However, from the viewpoint of preventing it from falling off the protective cover 21, this embodiment employs the structures shown in FIGS. 3B and 3C . (Slip-off prevention structure 1) Shoulders 211a extending laterally on both sides are formed at the base of the upside piece 211. Both circumferential ends of the ring member 212 are bent inward, and their tips press against the shoulders 211a of the upside piece 211. (Slip-off prevention structure 2) The protective cover 21 and the upside piece 211 are fixed together by a pin 213. The above-described slip-off prevention structures may be either structure 1 or 2, or both structures 1 and 2 may be employed. When both structures are employed, the bent portions of the ring member 212 also serve to prevent the pin 213 from falling off.

[0022] The inner surface of the protective cover 21 may be provided with an anti-slip structure for the cylinder 22 (syringe). FIG. 3D shows an example of an anti-slip structure, an anti-slip ring 214. The anti-slip ring 214 is made of an elastic material, such as silicone rubber, and has multiple protrusions 214a that protrude radially inward so as to partially contact the outer circumferential surface of the cylinder 22. The protrusions 214a are preferably arranged at equal intervals around the circumference. The number and protrusion height of the protrusions 214a can be appropriately designed so as to provide an anti-slip effect without interfering with the insertion and removal of the cylinder 22 into and from the protective cover 21.

[0023] The cover flange 21a of the protective cover 21 may have a recess 21b formed therein to make it easier for the user to hook his / her finger onto the flange 22a of the cylinder 22 inserted into the protective cover 21. This makes it easier to pull out the cylinder 22 inserted into the protective cover 21 from the protective cover 21.

[0024] Referring back to FIG. 1 , console 10b includes injection control unit 11, input device 12, and display device 13. Injection control unit 11 determines injection conditions, such as the injection volume and injection rate, using at least a portion of the data input from input device 12, controls the operation of injection head 10a so that the liquid is injected according to the determined injection conditions, and controls the display on display device 13, thereby controlling the operation of the entire liquid injector. Injection control unit 11 may include a so-called microcomputer and may have a CPU, ROM, RAM, and interfaces with other devices. The ROM is loaded with a computer program for controlling liquid injector 10. The CPU executes various functions in accordance with this computer program to control the operation of each component of liquid injector 10. A hand switch is also connected to console 10b to enable manual injection by the user in addition to automatic injection by injection control unit 11. The hand switch includes a start button, which the user operates to inject the liquid.

[0025] The input device 12 is a device used to input data used by the injection control unit 11 to determine the injection conditions of the medicinal liquid. The input device 12 may be at least one of known input devices such as various buttons, a keyboard, and a mouse. The data input from the input device 12 is transmitted to the injection control unit 11, and the data displayed on the display device 13 is transmitted from the injection control unit 11. The display device 13 is controlled by the injection control unit 11 to display data necessary for determining the injection conditions of the medicinal liquid, the injection protocol, the injection operation, various guidance messages, and various warnings.

[0026] An injection protocol indicates what type of medicinal liquid is to be injected, in what amount, and at what speed. The injection rate may be constant or may vary over time. Furthermore, when multiple types of medicinal liquids, such as a contrast medium and saline, are injected, the injection protocol also includes information on the order in which these medicinal liquids are to be injected. Any known injection protocol can be used as the injection protocol. The injection protocol can also be set using known procedures, or the user can change the set injection protocol as desired. The injection protocol may also include a maximum allowable injection pressure (pressure limit). If a pressure limit is set, the injection pressure is monitored during the injection operation, and the operation of the injection head 10a is controlled so that the injection pressure does not exceed the set pressure limit.

[0027] The display device 13 may be a known display device such as a liquid crystal display device. A touch panel having a touch screen as an input device arranged on a display as a display device may also be used as the input device 12 and the display device 13. A part of the input device 12 may be provided separately from the console.

[0028] The liquid medicine circuit 30 constitutes a liquid flow path that connects the syringe and the subject, and can have at least one tube, at least one connector, and at least one valve.

[0029] [B] Configuration of the Chemical Solution Circuit FIG. 2 shows one embodiment of a chemical solution circuit 30 suitable for use with the chemical solution injector 10 shown in FIG. 1 . The chemical solution circuit 30 shown in FIG. 2 is connected to syringes 20A and 20B and is used to inject the first and second chemical solutions contained in the syringes 20A and 20B into a subject. The chemical solution circuit 30 can also be connected to a first container 40A and a second container 40B containing the first and second chemical solutions, respectively, and can aspirate the first and second chemical solutions from the first container 40A and the second container 40B into the syringes 20A and 20B, respectively. The first and second chemical solutions are medical chemical solutions. The following description will be given assuming that the first chemical solution is a contrast medium and the second chemical solution is physiological saline.

[0030] The chemical liquid circuit 30 has a first main line 301a connected to a syringe 20A containing a contrast agent, a second main line 302a connected to a syringe 20B containing saline solution, a first sub-line 301b connected to a first container 40A containing a contrast agent, a second sub-line 302b connected to a second container 40B containing saline solution, a subject line 303 located downstream of the first main line 301a, and a transducer line 304 connected to a transducer.

[0031] Here, a "line" refers to a flow path through which a liquid flows, and includes various components through which the liquid flows (for example, various tubes, T-shaped pipes, various fluid connectors, various valves, mixing devices, etc.). Furthermore, in FIG. 2, the lines are depicted for the sake of convenience, and the relative lengths of the lines do not represent the relative lengths of the actual lines. Furthermore, the term "tube," which is one of the components constituting a "line," used in the following description may be composed of a single tube member, or may be composed of a tube assembly in which multiple tube members are connected.

[0032] First main line 301a includes, in order from upstream to downstream, a syringe connector 310a, a T-shaped tube 311a, a first tube 312a, a rotary high-pressure adapter 313a, a female luer lock connector 314a, and a second tube 315a. Syringe connector 310a is rotatably connected to T-shaped tube 311a via a rotary joint, and syringe 20A is detachably connected thereto. Rotary high-pressure adapter 313a and female luer lock connector 314a are detachably connected thereto. This allows first main line 301a to be separated into first tube 312a and second tube 315a.

[0033] First sub-line 301b connects first container 40A and first main line 301a. First sub-line 301b includes, in order from the first container 40A side, spike 310b, third tube 311b, drip chamber 312b, fourth tube 313b, and one-way valve 314b. Spike 310b is connected to first container 40A. One-way valve 314b is attached in an orientation that allows liquid to flow only in the direction from first container 40A to first main line 301a, and is connected to T-shaped tube 311a of first main line 301a. First container 40A is, for example, a bottle-shaped container. Contrast medium flowing from first container 40A drips into drip chamber 312b and is then supplied to first main line 301a.

[0034] As described above, by disposing the one-way valve 314b in the first sub-line 301b, the chemical liquid is prevented from flowing from the first main line 301a into the first sub-line 301b.

[0035] Second main line 302a includes, in order from upstream to downstream, a syringe connector 320a, a T-shaped tube 321a, a first tube 322a, a rotary high-pressure adapter 323a, a female luer lock connector 324a, and a second tube 325a. Syringe connector 320a is rotatably connected to T-shaped tube 321a via a rotary joint, and syringe 20B is detachably connected thereto. Rotary high-pressure adapter 323a and female luer lock connector 324a are detachably connected thereto. This allows second main line 302a to be separated into first tube 322a and second tube 325a.

[0036] The second sub-line 302b connects the second container 40B and the second main line 302a. The second sub-line 302b includes, in order from the second container 40B side, a spike 320b, a third tube 321b, a drip chamber 322b, a fourth tube 323b, and a one-way valve 324b. The spike 320b is connected to the second container 40B. The one-way valve 324b is oriented to allow liquid flow only from the second container 40B to the second main line 302a, and is connected to a T-shaped tube 321a of the second main line 302a. The second container 40B is, for example, a bag-shaped container. The saline solution flowing from the second container 40B drips into the drip chamber 322b and is then supplied to the second main line 302a.

[0037] As described above, by disposing the one-way valve 324b in the second sub-line 302b, the chemical liquid is prevented from flowing from the second main line 302a into the second sub-line 302b.

[0038] The subject line 303 includes, in order from upstream to downstream, a mixing device 330, a fifth tube 331, a flow path on-off valve 332, a one-way valve 333 connected to the flow path on-off valve 332 via a tube, a T-shaped tube 334, a sixth tube 335, and a connector 336. The mixing device 330 has two inlets and one outlet, and is configured to mix the liquids flowing in through the inlets and discharge the mixed liquid from the outlet. The inlets of the mixing device 330 are connected to the second tube 315a of the first main line 301a and the second tube 325a of the second main line 302a, respectively. The outlet of the mixing device 330 is connected to the fifth tube 331. For example, the "SPIRAL FLOW" (registered trademark) manufactured by Nemoto Kyorindo Co., Ltd. can be used as the mixing device 330. A T-shaped connector can also be used instead of the mixing device 330. A three-way stopcock (not shown) may be attached to the downstream side of the sixth tube 335. The position of the three-way stopcock may be either upstream or downstream of the connector 336. By having the three-way stopcock on the subject line 303 downstream of the sixth tube 335, it is possible to connect a hand-operated syringe to the three-way stopcock and manually inject various medicinal solutions as needed.

[0039] The flow path on-off valve 332 is a unit configured to be able to control the opening and closing of the flow path. The flow path on-off valve 332 will be described in detail later.

[0040] The one-way valve 333 is attached in an orientation that allows liquid to flow only in the upstream-to-downstream direction. The connector 336 is disposed at the downstream end of the patient line 303, and the patient line 303 is connected via the connector 336 to a patient tube, such as a catheter, that is punctured or inserted into the patient. Note that a reservoir cap 337 may be attached downstream of the connector 336 before the patient line 303 is connected to the patient tube. The reservoir cap 337 is a component that receives excess saline when the drug solution circuit 30 is filled with saline to bleed air from the drug solution circuit 30, thereby preventing the saline from leaking from the downstream end of the patient line 303. After air bleed-out is complete, the reservoir cap 337 is removed, and the connector 336 is connected to the patient tube.

[0041] The transducer line 304 is a line connected to a T-shaped tube 334 of the subject line 303 so as to branch off from the subject line 303, and includes, in order from the T-shaped tube 334 side, a tube assembly 340 consisting of a single tube or multiple tubes connected in series, and a connector 343. The tube assembly 340 is flexible enough that at least a portion thereof can be crushed by pinching it from the outside. A transducer 70 is connected to the connector 343 to detect the subject's blood pressure and monitor the pulse. A display (not shown) that displays the waveform of the subject's pulse is connected to the transducer 70.

[0042] The drug solution circuit 30 configured as described above can be divided into a downstream single-use section 300A and an upstream multiple-use section 300B. The single-use section 300A is a section that can be used only once, i.e., disposable. The multiple-use section 300B is a section that can be used repeatedly multiple times. Specifically, the single-use section 300A is composed of a downstream section of the first main line 301a separated by the female luer lock connector 314a, a downstream section of the second main line 302a separated by the female luer lock connector 324a, the subject line 303, and the transducer line 304. The multiple-use section 300B is composed of the parts of the chemical circuit 30 other than the single-use section 300A, i.e., the upstream section of the first main line 301a separated by the rotating high-pressure adapter 313a, the first sub-line 301b, the upstream section of the second main line 302a separated by the rotating high-pressure adapter 323a, and the second sub-line 302b.

[0043] As described above, the drug solution circuit 30 has multiple tubes. As will be described in detail later, some of the tubes are crushed by a crushing mechanism, and the multiple-use section 300B is used repeatedly multiple times. Therefore, to improve durability, it is preferable that at least some of these tubes be configured as braided tubes. Examples of tubes that are preferably configured as braided tubes are listed below. The multiple-use section 300B: - the first tube 312a of the first main line 301a; - the first tube 322a of the second main line 302a; The single-use section 300A: - the second tube 315a of the first main line 301a; - the second tube 325a of the second main line 302a; - at least the portion of the sixth tube 335 of the subject line 303 that is crushed by the crushing mechanism; and - at least the portion of the tube assembly 340 of the transducer line 304 that is crushed by the crushing mechanism.

[0044] The liquid medicine circuit 30 may further include an accessory circuit 350. The accessory circuit 350 includes a female luer lock connector 351 with a one-way valve, a tenth tube 352, a male luer lock connector 353 connected to the female luer lock connector 351 via the tenth tube 352, and a liquid reservoir cap 354 removably connected to the male luer connector 353. The one-way valve of the female luer lock connector 351 allows liquid to flow only in the direction from the female luer lock connector 351 to the male luer lock connector 353. After the multiple-use unit 300B is connected to the syringes 20A and 20B and the liquid medicine containers 40A and 40B, air is purged from the multi-use unit 300B. Until air purging is complete, the female luer lock connectors 351 of the accessory circuit 350 are connected to the rotary high-pressure adapters 313a of the first main line 301a and the rotary high-pressure adapters 323a of the second main line 302a, respectively. The liquid reservoir cap 354 is a member that receives excess physiological saline when air is removed, similar to the liquid reservoir cap 337 of the subject line 303 described above.

[0045] After the air has been removed, the auxiliary circuit 350 is removed from the first main line 301a and the second main line 302a, and the female luer lock connectors 314a, 324a of the single-use part 300A are connected to the rotary high-pressure connectors 313a, 323a, respectively.

[0046] After the test is completed, the single-use portion 300A is replaced with a new one, but at this time, air is still purged from the multiple-use portion 300B, requiring the auxiliary circuit 350. However, for the second and subsequent tests, the multiple-use portion 300B is already nearly filled with saline, and only a small amount of saline is required to purify the air. Therefore, the auxiliary circuit 350 used before the second and subsequent tests can be configured to have a luer connector 351 with a one-way valve and a liquid reservoir cap 354 directly connected to it.

[0047] The main components of the chemical liquid circuit 30 will be described in more detail below.

[0048] (B-a) Flow path on-off valve As shown in Fig. 4, the flow path on-off valve 332 has a housing 501 and a piston 502 inserted into the housing 501 so as to be slidable in the direction of arrow S so as to be able to take an open position and a closed position. The flow path on-off valve 332 shown in Fig. 4 will be described below with reference to Figs. 5, 5A, 6, 6A, and 6B.

[0049] The housing 501 can be molded, for example, by injection molding a resin, and has a cylinder portion 501c into which the piston 502 is slidably inserted. The cylinder portion 501c is configured as a through-hole formed along the axial direction of the housing 501. The housing 501 also has conduits 501a and 501b adjacent to the cylinder portion 501c and extending from the outer wall of the housing 501 in a direction perpendicular to the axial direction of the cylinder portion 501c. One of the conduits 501a is connected to the fifth tube 331 (see FIG. 2) of the subject line 303. The other conduit 501b is connected to the one-way valve 333 (see FIG. 2) of the subject line 303 via a tube. Therefore, in the illustrated embodiment, the conduit 501a serves as an inlet path, and the conduit 501b serves as an outlet path.

[0050] Furthermore, a communication flow path 501e that connects one conduit portion 501a and the cylinder portion 501c, and a communication flow path 501g that connects the other conduit portion 501b and the cylinder portion 501c are formed in the housing 501. These conduit portions 501a, 501b and communication flow paths 501e, 501g are aligned in a straight line.

[0051] The piston 502 is a columnar member molded, for example, by injection molding a resin, and has a flange-like head 502a at one end that extends radially outward. A flow path 502b is formed in the middle of the piston 502 in the longitudinal direction, traversing the piston 502 in a direction perpendicular to the longitudinal direction of the piston 502. Sealing rings 506, such as O-rings, are attached to the outer circumferential surface of the piston 502 on both sides of the flow path 502b in the longitudinal direction of the piston 502.

[0052] The flow path on-off valve 332 further includes a stopper structure 503 that limits the range of movement of the piston 502 relative to the housing 501. As shown in Fig. 7C, the stopper structure 503 includes a convex portion 503a formed on the housing 501 and a concave portion 503b formed on the piston 502. The concave portion 503b extends in the sliding direction of the piston 502 to receive the convex portion 503a. The length of the concave portion 503b in the sliding direction of the piston 502 is determined so that the concave portion 503b has a first end portion 503c with which the convex portion 503a abuts when the piston 502 is in the open position and a second end portion 503d with which the convex portion 503a abuts when the piston 502 is in the closed position.

[0053] The convex portion 503a can be formed as a part of the housing 501, and the concave portion 503b can be formed as a part of the piston 502. This allows the stopper structure 503 to be formed using only the housing 501 and the piston 502 without using any other parts, and the flow path on-off valve 332 can be formed with a smaller number of parts.

[0054] In this embodiment, two protrusions 503a are formed on the outer peripheral surface of the housing 501 at equal angular intervals in the circumferential direction of the housing 501. Correspondingly, two recesses 503b are also formed on the piston 502 at equal angular intervals in the circumferential direction of the piston 502. The number of protrusions 503a may be one, or may be three or more. The number of recesses 503b is the same as the number of protrusions 503a.

[0055] When the convex portion 503a is formed on the outer peripheral surface of the housing 501, it is preferable to form the concave portion 503b in a hook shape, as shown in the figure, extending from one end of the piston 502 (in the illustrated form, the concave portion 503b is formed on the end opposite the head 502a of the piston 502, but it may also be formed on the end on the head 502a side), beyond the peripheral wall of the housing 501, and wrapping around the outer peripheral surface of the housing 501.

[0056] This allows the convex portion 503a to be received in the concave portion 503b. Furthermore, by forming the concave portion 503b in a hook shape, the housing 501 and the piston 502 can be connected by a snap-fit ​​connection without using any other parts other than the housing 501 and the piston 502. Furthermore, as shown in Figure 5, by forming a notch 503e in the peripheral wall of the housing 501 and allowing the concave portion 503b to wrap around the outer peripheral surface of the housing 501 through this notch 503e, the flow path on-off valve 332 can be configured compactly.

[0057] In this embodiment, the protrusion 501a is formed on the housing 501 and the recess 503b is formed on the piston 502, but the reverse may also be true. That is, the recess may be formed on the housing 501 and the protrusion may be formed on the piston 502. In this case, the recess may be formed on the inner peripheral surface of the housing 501 and the protrusion may be formed on the outer peripheral surface of the piston 502.

[0058] The operation of the flow path opening / closing valve 332 will be described below with reference to FIG. 7A, which is a cross-sectional view of the flow path opening / closing valve 332 shown in FIG. 4 taken along line 7A-7A, and FIG. 7B, which is a cross-sectional view of the flow path opening / closing valve 332 shown in FIG. 4 taken along line 7B-7B.

[0059] In the open position (in the illustrated embodiment, a state in which piston 502 is pushed into housing 501), flow path 502b of piston 502 is positioned on the same straight line as communicating flow paths 501e and 501g of housing 501, and conduit portions 501a and 501b communicate with each other via flow path 502b. Also, in the open position, first end 503c of recess 503b of piston 502 abuts against protrusion 503a of housing 501, and the amount of movement of piston 502 in the pushing direction is limited so that piston 502 is not pushed any further into housing 501.

[0060] When piston 502 is pulled out from housing 501 in the open position, flow path 502b moves in accordance with the movement of piston 502. When piston 502 is pulled out a distance L from the closed position and positioned at the closed position, communicating flow paths 501e and 501g are completely blocked by piston 502, and the flow of fluid between conduit portions 501a and 501b is blocked.

[0061] Furthermore, as the piston 502 moves from the open position to the closed position, the recessed portion 503b of the piston 502 also moves in the direction of movement of the piston 502, and at the closed position, the protruding portion 503a comes into contact with the second end portion 503d of the recessed portion 503b. This limits the amount of movement of the piston 502 in the pulling direction so that the piston 502 is not pulled out any further from the housing 501.

[0062] By configuring the stopper structure 503, which limits the range of movement of the piston 502 relative to the housing 501, using a portion of the housing 501 and a portion of the piston 502, the flow path opening / closing valve 332 can be configured using at least four parts: the housing 501, the piston 502, and two sealing rings 506. Furthermore, since the stopper structure 503 is configured using the engagement between the convex portion 503a and the concave portion 503b, the flow path opening / closing valve 332 can be assembled without using adhesive by inserting the piston 502 into the housing 501 and then engaging the convex portion 503a with the concave portion 503b in a snap-fit ​​manner. Therefore, the flow path opening / closing valve 332 of this embodiment can be configured using a minimum number of parts and / or can reduce assembly man-hours, thereby enabling significant cost reductions.

[0063] To ensure that the communicating flow paths 501e and 501g and the flow path 502b are blocked reliably in the closed position, it is desirable that the inner circumferential surface of the housing 501 and the outer circumferential surface of the piston 502 be in contact with each other at least in the closed position. To achieve this, for example, a packing can be added to the outer circumferential surface of the piston 502. Alternatively, the piston 502 and the housing 501 can be made of materials with different elastic moduli. In this case, a packing is not necessary. When the housing 501 and the piston 502 are made of materials with different elastic moduli, for example, the housing can be made of polycarbonate (PC) and the piston can be made of high-density polyethylene (HDPE).

[0064] The piston can be pushed into and pulled out of the housing 501 using the head 502a. Specifically, while the housing 501 is fixed, an engaging member that engages with the head 502a and moves reciprocally in the direction of movement of the piston 502 can be engaged with the head 502a to move the piston 501 between the open and closed positions. To make it easier for the engaging member to engage with the head 502a and to move the piston 502 between the open and closed positions in this state, it is preferable that one end of the piston 502 in the direction of movement protrudes from the housing 501 within the range of movement of the piston 502 between the open and closed positions, and that the head 502a is formed on that protruding portion. Alternatively, both ends of the piston 502 in the direction of movement can protrude from the housing 501 within the range of movement of the piston 502 between the open and closed positions, or only one end of the piston 502 can protrude at the open position and only the other end of the piston 502 can protrude at the closed position. In this case, the piston 502 can be moved between the open position and the closed position by pushing the piston 502 from both sides, so a structure for engaging an engaging member, such as the head 502a, is not necessary. A rod-shaped pushing member can be used to push the piston 502. If a pushing member having a diameter equal to or smaller than the diameter of the cylinder portion 501c is used as the pushing member, the length of the piston 502 can be set to a length such that the piston 502 does not protrude from the housing 501 in both the open position and the closed position.

[0065] As described above, the flow path opening / closing valve 332 of this embodiment has a housing 501, a piston 502 inserted into the housing 501 so as to be able to slide freely, and a stopper structure 503 that limits the amount of sliding of the piston 502. By configuring this stopper structure 503 with the housing 501 and the piston 502, stable operation can be achieved without leakage of chemical solution even when operating under high pressure.

[0066] The flow path opening / closing valve 332 is not limited to the above-described configuration and may have other configurations. For example, instead of the flow path opening / closing valve 332, the opening / closing unit described in International Publication No. 2018 / 181270 may be used, or a squeezing mechanism described below may be used.

[0067] (B-b) One-Way Valve As described above, the first sub-line 301b, the second sub-line 302b, and the patient line 303 respectively have one-way valves 314b, 324b, and 333. Below, several forms of one-way valves suitable for use under high pressure such as in a drug solution circuit will be described.

[0068] [One-way Valve Configuration 1] Referring to Fig. 8A, there is shown a perspective view of one-way valve 610 according to Configuration 1. Also, Fig. 8B shows an exploded perspective view of one-way valve 610 shown in Fig. 8A, and Fig. 8C shows a cross-sectional view of one-way valve 610 taken along line 8C-8C in Fig. 8A.

[0069] One-way valve 610 according to form 1 has first case 611, second case 612, and valve body 613, and is configured to allow the flow of medicinal liquid only in the direction of arrow 8 A. Valve body 613 is a spherical member, and is movably disposed within valve chamber 610 a formed by first case 611 and second case 612 being joined together in a mating manner.

[0070] As shown in Figures 8B, 8C, and 8D, which is a perspective view from a different angle than Figure 8B, first case 611 has a receiving recess 611a, a downstream flow path 611b, and a valve element position restriction protrusion 611c. Receiving recess 611a has an overall concave spherical surface and receives a spherical valve element 613. Downstream flow path 611b communicates with receiving recess 611a and opens at the end of first case 611 opposite the joint with second case 612. Valve element position restriction protrusion 611c abuts against valve element 613 when valve element 613 moves downstream in the flow direction of the chemical solution within one-way valve 610 (direction of arrow 8A), restricting the position of valve element 613 so that valve element 613 does not block downstream flow path 611b.

[0071] To better ensure a flow path for the chemical solution within the one-way valve 610, grooves 611d and / or protrusions 611e may be formed on the surface of the receiving recess 611a of the first case 611. The grooves 611d are preferably formed over the entire receiving recess 611a in the direction of flow of the chemical solution within the one-way valve 610. The protrusions 611e may be formed over the entire receiving recess 611a in the direction of flow of the chemical solution within the one-way valve 610, or only on a portion of the receiving recess 611a, as long as they protrude from the surface of the receiving recess 611a. The number of grooves 611d and the number of protrusions 611e may be one or two or more. The number of grooves 611d and the number of protrusions 611e may be the same or different. When forming multiple grooves 611d, the multiple grooves 611d are preferably arranged at equal angular intervals in the circumferential direction of the one-way valve 610, which prevents uneven movement of the medicinal solution within the valve chamber 610a and allows the valve element 613 to move smoothly within the valve chamber 610a. The case of forming multiple convex portions 611e is similar to the case of forming multiple grooves 611d.

[0072] As shown in Fig. 8C and Fig. 8E, which is a perspective view taken along line 8C-8C in Fig. 8A, second case 612 has a valve seat 612a and an upstream flow path 612b. Valve seat 612a has a concave spherical surface. Upstream flow path 612b communicates with valve seat 612a and opens at the end of second case 612 opposite the joint with first case 611.

[0073] In the above-described configuration, when the pressure upstream in the direction of liquid flow in the one-way valve 610 becomes higher than the pressure downstream, such as when the valve chamber 610a becomes negative pressure, the valve element 613 moves from the second case 612 side to the first case 611 side within the valve chamber 610a, allowing fluid to flow through the one-way valve 610. That is, the one-way valve 610 opens. Conversely, when the pressure upstream in the direction of liquid flow in the one-way valve 610 becomes lower than the pressure downstream, such as when the valve chamber 610a becomes positive pressure, the valve element 613 moves from the first case 611 side to the second case 612 side within the valve chamber 610a, thereby blocking the valve chamber 610a. That is, the one-way valve 610 closes.

[0074] As described above, the receiving recess 611a of the first case 611 has an overall concave spherical surface, and the valve seat 612a of the second case 612 also has a concave spherical surface. Furthermore, the valve element 613 is a spherical member. Therefore, when the one-way valve 610 is open and fluid flows through the valve chamber 610a formed by the receiving recess 611a and the valve seat 612a, turbulence is unlikely to occur within the valve chamber 610a, and the generation of air bubbles can be suppressed. For example, when a liquid medicine container such as a liquid medicine bottle is connected to the upstream side of the one-way valve 610 and an empty syringe is connected to the downstream side, and liquid medicine is drawn into the syringe from the liquid medicine container, the inflow of air bubbles into the syringe can be suppressed.

[0075] Furthermore, in order to ensure that the valve element 613 moves smoothly in response to changes in fluid pressure between the upstream and downstream sides when the one-way valve 610 changes from an open state to a closed state, the valve element 613 is preferably made of a material with a specific gravity lower than that of the fluid flowing through the one-way valve 610. For example, when the one-way valve 610 is used in a liquid medicine circuit for contrast medium or saline, the valve element 613 can be made of polypropylene (PP), which can prevent backflow of the fluid.

[0076] A luer lock type connection structure is formed at the upstream end of second case 612. A luer lock type connector is also attached to the tube connected to second case 612, so that the user can attach and detach the tube to second case 612.

[0077] The method for joining the first case 611 and the second case 612 is not particularly limited, and examples thereof include bonding using an adhesive, and welding such as thermal welding and ultrasonic welding. When joining the first case 611 and the second case 612 with an adhesive, for example, a recess may be formed in either the first case 611 or the second case 612 to serve as an inlet for injecting adhesive into the joint between the two and a reservoir. In the first embodiment of the one-way valve 610, the joint between the first case 611 and the second case 612 is configured so that the outer peripheral surface of the first case 611 and the inner peripheral surface of the second case 612 are joined at the ends facing each other. Therefore, in the first embodiment, a recess 612d is formed in the second case 612 as shown in FIG. 8E .

[0078] When joining the first case 611 and the second case 612, first, the first case 611 is fitted into the second case 612 with the valve body 613 disposed between the first case 611 and the second case 612. Then, adhesive is poured into the recess 612d of the second case 612. The poured adhesive then penetrates the joining surface between the first case 611 and the second case 612 by capillary action. Furthermore, when the first case 611 is rotated in the circumferential direction of the one-way valve 610, the permeated adhesive spreads circumferentially, and ultimately the adhesive is applied to the joining surface between the first case 611 and the second case 612 over the entire circumference. The adhesive is then dried in this state, thereby joining the first case 611 and the second case 612. This allows the first case 611 and the second case 612 to be joined simply and reliably.

[0079] As described above, according to this embodiment, the first case 611 and the second case 612 are joined in an interlocking manner to ensure a larger joining area between the two, and by forming the valve body 613 from a spherical member, stable operation can be achieved without leakage of the chemical solution even when operating under high pressure.

[0080] In addition, in form 1, a luer lock type connecting structure is formed at the upstream end of second case 612 so that the tube can be attached and detached freely to second case 612, but this connecting structure is not essential, and second case 612 and the tube may be glued together.

[0081] [One-way Valve Configuration 2] Figures 9A and 9B show cross-sectional views of one-way valve Configuration 2 taken along the fluid flow direction. Figures 9A and 9B show the one-way valve in a closed state and an open state, respectively. Configuration 2 has the same basic configuration as Configuration 1, and includes a first case 611, a second case 612, and a valve body 613. However, Configuration 2 differs from Configuration 1 in terms of the size and material of valve body 613. Below, a description of the configuration that may be the same as Configuration 1 will be omitted, and the following description will mainly focus on valve body 613.

[0082] In form 2, the valve element 613 has a main body 613 a that is a spherical portion, and a protrusion 613 b that is a portion that protrudes from the main body 613 a. The protrusion 613 b is located in a communication hole that communicates between the valve chamber and the upstream flow path 612 b, and has a size and shape that allows fluid to flow between the valve chamber and the upstream flow path 612 b.

[0083] The protrusion 613b can be used to hold the valve element 613 in a fixed position when the first case 611 and the second case 612 are joined together to assemble the one-way valve 610. For example, the valve element 613 is positioned relative to the second case 612 in an orientation such that the protrusion 613b is positioned within the second communication hole when the valve element 613 is brought into contact with the valve seat 612a. In this state, a thin, rod-shaped valve element fixing jig (not shown) is inserted into the upstream flow path 612b from the side of the second case 612 opposite the valve seat 612a. The tip of the valve element fixing jig has a structure that can fix the protrusion 613b, and this structure is used to fix the valve element 613 to the inserted valve element fixing jig. This holds the valve element 613 in a fixed position relative to the second case 612, so that the valve element 610 can be more easily assembled by joining the second case 612 and the first case 611 in this state. After the valve body 610 is assembled, the valve body fixing jig is removed from the valve body 613 .

[0084] The main body 613a, which is the spherical portion of the valve disc 613, has a larger diameter than in Embodiment 1, and the valve disc occupancy rate, which is the ratio of the volume of the main body 613a to the volume of the valve chamber, is higher than in Embodiment 1. The valve disc occupancy rate can be expressed as Vb / Vc × 100 (%), where Vc is the volume of the valve chamber and Vb is the volume of the main body 613b of the valve disc 613. Increasing the valve disc occupancy rate suppresses air retention in the valve chamber and improves air release due to the flow of fluid within the one-way valve 610. To effectively suppress air retention in the valve chamber, the valve disc occupancy rate is preferably 80% or more, more preferably 85% or more, and even more preferably 90% or more. On the other hand, because a too high valve disc occupancy rate impedes fluid flow, the valve disc occupancy rate is preferably 95% or less.

[0085] When the valve element occupancy rate is maximized within a practical range, the valve element 613 can be sized so that it contacts the valve element position restricting protrusion 611c on the downstream side and the valve seat 612a on the upstream side. In this case, since it is difficult for the valve element 613 to move within the valve chamber, the valve element 613 is formed of an elastic material such as rubber, and is configured so that the one-way valve 610 opens when the valve element 613 elastically deforms as the pressure acting on the valve element 613 on the upstream side of the valve element 613 increases. The elastic deformation of the valve element 613 is specifically compression, and as shown in FIG. 9B , the valve element 613 is compressed toward the downstream side and moves away from the valve seat 612a, thereby opening the valve 613. On the other hand, when the pressure acting on the upstream side of the valve element 613 returns to its original shape, the valve element 613 returns to contact the valve seat 612a, thereby closing the one-way valve.

[0086] Silicone rubber can be used as the material for the valve disc 613. To allow elastic deformation of the valve disc 613 in response to pressure changes, the hardness of the valve disc 613 is preferably 70 degrees or less, and more preferably 50 degrees or less. On the other hand, if excessive elastic deformation of the valve disc 613 occurs in response to pressure changes, when the valve disc 613 is compressed in response to an increase in upstream pressure, the valve disc 613 may come into contact with the inner surface of the valve chamber over the entire circumferential direction of the one-way valve 610, blocking the valve chamber and causing an opening / closing malfunction. To prevent such opening / closing malfunction, the hardness of the valve disc 613 is preferably 30 degrees or more, and more preferably 40 degrees or more.

[0087] The above has described the second embodiment of the one-way valve 610, but in the above description, the protruding portion 613b of the valve body 613 is not essential, and the valve body 613 may have only a spherical portion, as in the first embodiment. Conversely, in the first embodiment, the valve body 613 may have the protruding portion 613b, as in the second embodiment.

[0088] [One-way Valve Configuration 3] Figure 10A shows a perspective view of a one-way valve Configuration 3, and Figure 10B shows an exploded perspective view thereof. Figure 10C shows a cross-sectional view of the one-way valve of Configuration 3 taken along the fluid flow direction. Configuration 3 has the same basic configuration as Configuration 2, and includes a first case 611, a second case 612, and a valve body 613. However, Configuration 3 differs from Configuration 2 in the structure of the first case 611. Below, a description of the configuration that may be the same as Configuration 2 will be omitted, and the first case 611 will be mainly described.

[0089] As shown in Fig. 10C, first case 611 is configured to have a structure that also functions as a luer lock connector. A luer lock connector that connects to this connector is also attached to the tube connected to first case 611, so that the user can attach and detach the tube to first case 611. As described in embodiment 1, second case 612 is also configured to allow the tube to be attached and detached, so according to embodiment 3, the user can freely remove one-way valve 610 from the tube. First case 611 having such a structure that functions as a connector can also be applied to embodiment 1.

[0090] [One-way Valve Configuration 4] Figure 11A shows a perspective view of one-way valve Configuration 4, and Figure 11B shows its exploded perspective view. Figure 11C shows a cross-sectional view of one-way valve Configuration 4 taken along the fluid flow direction. Like Configurations 1 to 3, one-way valve 620 of Configuration 4 has first case 621, second case 622, and valve body 623, and allows the flow of medicinal liquid only in the direction of arrow 11A. However, its shape and structure differ from those of Configurations 1 to 3, and Configuration 4 further has gasket 624 and biasing spring 625.

[0091] The first case 621 and the second case 622 have a downstream flow path 621b and an upstream flow path 622b, respectively, and are joined together to form a valve chamber. The joining method and structure of the first case 621 and the second case 622 may be the same as in embodiment 1. The valve body 623, the gasket 624, and the biasing spring 625 are disposed within the valve chamber.

[0092] The valve element 623 has a valve body 623a, legs 623b, and multiple first and second protrusions 623c and 623d, and is located within the valve chamber so as to be movable in the axial direction of the one-way valve 620. The valve body 623a is a portion of the valve body 623 whose downstream end is tapered. The legs 623a are a portion of the one-way valve 620 that extend from the downstream end face of the valve body 623a in the axial direction of the one-way valve 620. The first protrusions 623c are formed on the side surface of the valve body 623a and prevent movement of the valve body 623a in the radial direction of the one-way valve 620. The second protrusions 623d are formed on the upstream end face of the valve body 623a to hold the gasket 624.

[0093] The gasket 624 is a hemispherical member and is disposed with its spherical surface facing upstream so that it can close the opening of the upstream flow path 622b on the valve chamber side. A recess is formed in the downstream end face of the gasket 624, and the second protrusion 623d of the valve element 623 fits into this recess, thereby holding the gasket 624 to the valve body 623a. The hemispherical top of the gasket 624 may have a protrusion similar to the protrusion 613b of the valve element 613 described in embodiment 2 (see FIG. 9A ).

[0094] Any means can be used for biasing spring 625 as long as it can bias valve element 623 toward the upstream side of one-way valve 620, but in form 4, a coil spring is used, with legs 623b located inside this coil spring. The spring constant of biasing spring 625 is set according to the predetermined pressure at which one-way valve 620 is to open and close. By appropriately setting the spring constant of biasing spring 625, it can be used as one-way valve 620 that opens when the medicinal liquid is drawn from the medicinal liquid container into the syringe, or as a one-way valve that opens when the medicinal liquid is injected from the syringe.

[0095] The downstream flow path 621b of the first case 621 is stepped to include a first portion 621U, a second portion 621M, and a third portion 621L, each having a diameter that gradually decreases from the upstream side to the downstream side. The first portion 621U has a diameter that allows insertion of the biasing spring 625 but not of the valve body 623a. The second portion 621M has a diameter that allows insertion of the leg portion 623b but not of the biasing spring 625. The third portion 621L has a diameter that does not allow insertion of the leg portion 623b. Thus, the step between the first portion 621U and the second portion 621M functions as a stopper for the biasing spring 625, and the step between the second portion 621M and the third portion 621L functions as a stopper for the leg portion 623b. However, it is preferable to design the dimensions of leg portion 623b, biasing spring 625, etc. so that the radial dimensions of these steps are minimized in order to reduce pressure loss within one-way valve 620. Furthermore, it is preferable to make the spatial volume within one-way valve 620 as small as possible in order to prevent air from accumulating within one-way valve 620 and to facilitate the escape of air.

[0096] Based on the above-described configuration, when the pressure acting on the upstream side of one-way valve 620 is equal to or lower than a predetermined pressure, valve element 623a is urged upstream by biasing spring 625, and the opening of upstream flow path 622b on the valve chamber side is blocked by gasket 624. In other words, one-way valve 620 is closed. When the pressure acting on the upstream side of one-way valve 620 exceeds a predetermined pressure or the valve chamber becomes negative pressure, valve element 623 moves downstream against the biasing force of biasing spring 625. As a result, gasket 624 moves away from the opening of upstream flow path 622b on the valve chamber side, and one-way valve 620 opens.

[0097] (B-c) Additional Units The drug solution circuit 30 may further include additional units. An example of such additional units is a suction tube unit used to draw the drug solution from the drug solution containers (40A, 40B) into the syringes (20A, 20B). One embodiment of the suction tube unit will be described below with reference to FIG. 12, which is a perspective view thereof, and FIGS. 12A to 12E, which are perspective views of the components that make up the suction tube unit.

[0098] The suction tube unit 400 has a tube body 410, a suction valve 420 connected to one end of the tube body 410, a lidded open / close dust cap 430 removably attached to the open end of the suction valve 420, a spike 440 connected to the other end of the tube body 410, and a spike cap 450.

[0099] The suction valve 420 has a first case 421, a second case 422, a valve body 423, and a coil spring 424. The first case 421 and the second case 422 each have a flow path, and by joining the first case 421 and the second case 422 together, a valve chamber is formed between the flow paths of the first case 421 and the second case 422, which is in communication with these flow paths.

[0100] The valve element 423 and the coil spring 424 are disposed within the valve chamber. Within the valve chamber, the valve element 423 is biased by the coil spring 424 toward the flow path of the second case 422. The biasing force of the coil spring 424 causes the valve element 423 to close the opening of the flow path to the valve chamber of the second case 422. However, when a force that pushes the valve element 423 toward the first case 421 acts on the valve element 423, the valve element 423 moves toward the first case 421 against the biasing force of the coil spring 424, thereby opening the opening of the flow path of the second case 422 on the valve chamber side. The tip end of the valve element 423 (the end on the second case 422 side) is shaped so that when the tip of the nozzle portion of the syringe abuts against it, it does not block the opening of the nozzle portion and allows fluid communication between the interior of the syringe and the valve chamber.

[0101] The flow path of the second case 422 has a diameter large enough to allow the nozzle of a syringe to be inserted. A plurality of ribs 422a are formed on the inner surface of the flow path of the second case 422 at equal intervals in the circumferential direction of the flow path. These ribs 422a function as a stopper for the syringe and prevent the syringe from being inserted too far into the suction valve 420. Furthermore, these ribs 422a also function as a guide for the valve body 423 during operation, thereby enabling stable operation of the valve body 423.

[0102] The spike 440 is connected to the liquid medicine container and has a liquid medicine introduction channel 440a extending along the entire length. The tip of the spike 440 is formed as a sharp piercing portion 440b. By penetrating the piercing portion 440b into the stopper of the liquid medicine container, the liquid medicine container and the introduction channel 440a are fluidly connected. To enable the user to firmly hold the spike 440 during the piercing operation, a pair of grippers 440c are preferably integrally formed at the base of the piercing portion 440b. The grippers 440c may be provided with a non-slip surface. Furthermore, the piercing portion 440b is formed with an air vent 440d separate from the introduction channel 440a. A filter 441 (not shown in FIGS. 12D and 12E ) is attached to the end of the air vent 440d.

[0103] Here, a luer lock type connecting structure is formed at the end of the second case 422. Meanwhile, a luer lock type connecting structure that meshes with the connecting structure of the second case 422 is formed on the open-close dust cap 430. These connecting structures allow the open-close dust cap 430 to be detachably connected to the end of the second case 422. Furthermore, a spike cap 450 is detachably attached to the piercing portion 440b of the spike 440. When the suction tube unit 400 is not in use, the open-close dust cap 430 and the spike cap 450 remain attached to the suction valve 420 and the spike 440, respectively, thereby preventing foreign matter from entering the suction tube unit 400.

[0104] Next, the procedure for using the suction tube unit 400 described above will be described. First, the open-close dust cap 430 is opened and the spike cap 450 is removed. Next, the spike 440 is pierced into the stopper of the liquid container, and the nozzle of the syringe is inserted into the flow path of the suction valve 420. The syringe used is an empty syringe that is not filled with liquid and whose plunger is in its most forward position. Inserting the nozzle of the syringe into the suction valve 420 pushes the valve body 423, thereby opening the suction valve 420. After connecting the liquid container and the syringe via the suction tube unit 400 in this manner, the liquid is aspirated from the liquid container into the syringe by retracting the plunger of the syringe. After aspirating the liquid, the nozzle of the syringe is withdrawn from the suction valve 420, and the spike 440 is withdrawn from the stopper of the liquid container. When the nozzle of the syringe is pulled out of the suction valve 420, the valve body 423 is returned to its original position by the biasing force of the coil spring 424, and the suction valve 420 is closed.

[0105] (B-d) Syringe Connectors Syringe connectors 310a, 320a that connect the syringes to the liquid medicine circuit are not particularly limited in structure as long as there is no leakage of the liquid medicine during the injection and suction operations of the liquid medicine, but it is preferable that the syringe connectors have a function to prevent loosening.

[0106] Figure 13 shows a side view of a syringe connector with a loosening prevention function and a syringe compatible with the syringe connector. Note that in Figure 13, the lower half of the syringe is shown in cross section. Syringe connector 360 shown in Figure 13 is a cap-shaped member into which the nozzle portion of syringe 22 is inserted. The inner surface of syringe connector 360 is formed with a thread groove that engages with the thread formed on the nozzle portion of syringe 22. By screwing syringe connector 360 into the nozzle portion of syringe 22, syringe connector 360 and the syringe can be connected.

[0107] A connecting member (not shown in FIG. 13 ), such as a tube or a T-shaped tube, is connected via a rotary joint to the end of syringe connector 360 opposite the side where the nozzle portion of cylinder 22 is inserted. A plurality of connector protrusions 360 a are formed on the end of syringe connector 360 where the nozzle portion of cylinder 22 is inserted. Connector protrusions 360 a are arranged at equal intervals around the circumference of syringe connector 360 and extend in the longitudinal direction of syringe connector 360 so as to further extend syringe connector 360.

[0108] Corresponding to the connector protrusions 360a, a plurality of syringe protrusions 22c protruding from the outer surface of the nozzle portion of the syringe 22 are also formed. The syringe protrusions 22c are formed in positions, shapes, and dimensions such that they are positioned between the connector protrusions 360a when the syringe 22 and the syringe connector 360 are connected.

[0109] When connecting the syringe 22 and the syringe connector 360, as the syringe connector 360 is screwed into the nozzle portion of the syringe 22, the connector protrusion 360a comes into contact with the syringe protrusion 22c, and the syringe connector 360 is subjected to resistance from the syringe protrusion 22c. The syringe connector 360 is made of a material and has dimensions such that, when the syringe connector 360 is further rotated, the connector protrusion 360a elastically deforms and overcomes the syringe protrusion 22c. Thus, the user can apply a greater force to the syringe connector 360 and further rotate the syringe connector 360 to screw it into the nozzle portion of the syringe 22.

[0110] When syringe connector 360 is screwed all the way in and completely connected to syringe 22, connector protrusions 360a are positioned between syringe protrusions 22c. In this state, in order to rotate syringe 22 and syringe connector 360 relatively, it is necessary to apply a force that causes connector protrusions 360a to elastically deform and overcome syringe protrusions 22c, which ultimately acts as a function to prevent syringe 22 from loosening.

[0111] The user is given a clicking sensation when connector protrusion 360a moves over syringe protrusion 22c. The clicking sensation allows the user to intuitively understand that syringe connector 360 is screwed into the nozzle portion of syringe 22. The magnitude of the clicking sensation can be set arbitrarily by appropriately designing the material of syringe connector 360, the dimensions of connector protrusion 360a, and the dimensions of syringe protrusion 22c.

[0112] [C] Configuration of Injection Head Next, the injection head 10a shown in FIG. 1 will be described with reference to FIG. 14 and other figures. Injection head 10a includes a head main body 101 on which a syringe is mounted, a liquid chemical circuit operation unit 102 located in front of head main body 101 (the side on which the syringe is mounted), and a liquid chemical container holder 103 for holding liquid chemical containers 40A and 40B (see FIG. 1). Head main body 101, liquid chemical circuit operation unit 102, and liquid chemical container holder 103 are parts that may come into contact with liquid chemicals. Therefore, the exterior materials that make up these casings are preferably made of a resin with excellent chemical resistance, such as PETCARBO (registered trademark) or Iupilon (registered trademark).

[0113] (Ca) Head Main Body The main function of head main body 101 is to mount and operate syringes. To this end, head main body 101 has a clamper 111 that detachably fixes two syringes 20A and 20B (see FIG. 1), a presser 112, and an operation unit 113, as shown in FIG.

[0114] The clamper 111 can have a first holding structure 111a and two second holding structures 111b that cooperate with the first holding structure 111a to hold the syringes. The first holding structure 111a has two recesses that receive circumferential portions of the end portions of the two syringes (when the syringes are attached with the protective cover 21 as in the embodiment shown in FIG. 3, etc., the cover flanges 21a of the protective cover 21). The second holding structure 111b is arranged corresponding to each recess of the first holding structure 111a and is configured with recesses that can receive at least a portion of the remaining flange portions received in the respective recesses.

[0115] The second holding structure 111b is supported so as to be movable between an open position and a closed position relative to the first holding structure 111a, and in the closed position, cooperates with the first holding structure 111a to hold the distal end portion of the syringe so as to be immovable in the longitudinal direction of the syringe. Here, "immovable" does not only mean that the target structure does not move at all, but also includes movement within a clearance range caused by design dimensional tolerances, etc.

[0116] As shown in FIG. 15A , the second holding structure 111b is rotatably supported by the first holding structure 111a at its circumferentially intermediate portion. By rotating the second holding structure 111b to the closed position with the syringe (and protective cover 21) placed on it, the syringe (and protective cover 21) is held in place, as shown in FIG. 15B . By configuring the second holding structure 111b so that its circumferentially intermediate portion is supported by the first holding structure 111a, a compact head body 101 is achieved, with minimal lateral expansion when the second holding structure 111b is moved from the closed position to the open position. This allows the syringe to be attached and detached even in a limited space.

[0117] The presser 112 is movable forward and backward by a drive source such as a motor, and constitutes a part of the syringe drive mechanism. The tip of the presser 112 has an engagement portion that engages with the plunger (or piston) of the syringe. When this engagement portion engages with the plunger (or piston) and the presser 112 is moved forward and backward while the syringe is held by the clamper 111, the plunger (or piston) moves forward and backward relative to the cylinder. This allows the drug solution to be injected from the syringe or drawn into the syringe.

[0118] 15C to 15E, the presser 112 has a receiving recess 112a that is open at the top to receive the protrusion 23a of the plunger 23 of the syringe, and a hook portion 112b that extends inward to engage between the main body of the plunger 23 and the protrusion 23a. The front surface of the hook portion 112b acts to press the plunger 23 through surface contact when the presser 112 advances to push the plunger 23 into the cylinder 22 (see FIG. 3, etc.). The rear surface of the hook portion 112b acts on the protrusion 23a of the plunger 23 when the presser 112 retreats to pull the plunger 23 out of the cylinder 22. In the illustrated embodiment, one or more protrusions 112c are formed on the rear surface of the hook portion 112b so that the rear surface of the hook portion 112b makes point or line contact with the protrusion 23a of the plunger 23.

[0119] This reduces the frictional force generated between the rear surface of the hook portion 112b when the plunger 23 is inserted into or removed from the receiving recess 112a, while suppressing back and forth rattle of the protrusion 23a in the receiving recess 112a. As a result, the plunger 23 can be smoothly attached to and detached from the presser 112, and the operation of the presser 112 can be more reliably applied to the plunger 23.

[0120] The number and shape of the protrusions 112c provided on the rear surface of the hook portion 112b may be arbitrary. For example, from the viewpoint of smoothly attaching and detaching the plunger 23 to the presser 112, it is preferable that the protrusions 112c have a shape with a longitudinal direction that follows the attachment and detachment direction of the plunger 23. Furthermore, from the viewpoint of more reliably causing the operation of the presser 112 to act on the plunger 23, it is preferable to arrange the multiple protrusions 112c symmetrically.

[0121] The syringe drive mechanism may be any mechanism that can move the presser back and forth. Figure 15F shows one embodiment of the syringe drive mechanism.

[0122] The syringe drive mechanism 120 shown in FIG. 15F utilizes a ball screw mechanism and includes a front frame 121, a rear frame 122, a pair of left and right side frames 123, a pair of left and right ball screw mechanisms 124, a linear guide 125, a pair of left and right sliders 126, and a pair of left and right rams 127 that are moved in the front-to-rear direction by the operation of each ball screw mechanism 124. The linear guide 125 is a member that extends in the direction of movement of the ram 127 and is disposed between the pair of side frames 123. Each ball screw mechanism 124 is disposed between the linear guide 125 and the side frames 123 so as to be located on both the left and right sides of the linear guide 125. Each slider 126 is disposed on both the left and right sides of the linear guide 125, fixed to a nut of the ball screw mechanism 124, and supported by the linear guide 125 so as to be movable in the front-to-rear direction. Each ram 127 is fixed to the slider 126 and supported so as to be movable in the front-to-rear direction together with the slider 126. The presser 112 (see FIG. 15, etc.) is fixed to the front end of the ram 127. A motor is connected to each ball screw mechanism 124, and when the ball screw of the ball screw mechanism 124 is rotated by the motor, the ram 127 moves forward and backward by a distance corresponding to the amount of rotation.

[0123] According to syringe drive mechanism 120 of this embodiment, by supporting a pair of sliders 126 on a single common linear guide 125, the configuration of syringe drive mechanism 120 is simplified and the syringe drive mechanism can be made compact. Also, in this embodiment, as shown in FIG. 15G , side frame 123 is configured with recesses that allow clearance for sliders 126 and ram 127. This allows the lateral (left-right) dimension of syringe drive mechanism 120 to be reduced, resulting in a more compact syringe drive mechanism 120.

[0124] Furthermore, in the syringe drive mechanism 120 using the ball screw mechanism 124, a rotational force due to the rotation of the ball screw acts on the slider 126, so the linear guide 125 is required to have the mechanical strength to movably support the slider 126 and prevent the slider 126 from rotating. In this embodiment, a pair of sliders 126 is supported by a single linear guide 125 located between them. Therefore, when the ball screw mechanism 124 is operated so that both sliders 126 move in the same direction, as shown in FIG. 15G, a force that cancels out the rotational forces of both sliders 126 acts on the linear guide 125. Therefore, the mechanical strength required for the linear guide 125 is only the same as that required to support a single slider 125, and as a result, a compact and lightweight linear guide 125 can be used. This also contributes to the compactness of the syringe drive mechanism 120.

[0125] The operation unit 113 has multiple buttons, such as a forward button and a backward button, for operating the presser 112, and allows the user to operate the presser 112 as desired, regardless of the conditions set in the injection control unit 11 (see Figure 1).

[0126] Furthermore, head main body 101 can have a support shaft 114 extending in a direction perpendicular to the longitudinal direction of the syringe to be mounted. Head main body 101 can be supported via support shaft 114 on a stand (not shown) or a rotating arm (not shown) extending from the ceiling so as to be rotatable about support shaft 114. By supporting head main body 101 with support shaft 114 oriented in a substantially horizontal direction, head main body 101 can be supported so as to be rotatable between a position in which the tip of the syringe faces the ceiling (upward position) and a position in which the tip of the syringe faces the floor (downward position).

[0127] (C-b) Chemical Circuit Operation Unit The chemical circuit operation unit 102 is detachably fitted with the single-use section 300A (see FIG. 2) of the chemical circuit 30, and has a plurality of mechanisms that control each flow path of this single-use section 300A. These mechanisms are electrically driven, and to prevent the chemical solution from coming into contact with these mechanisms, these mechanisms are housed in a casing, except for the parts necessary for routing the chemical circuit 30.

[0128] The chemical liquid circuit operation unit 102 may be fixed to the head body 101. By fixing the chemical liquid circuit operation unit 102 to the head body 101, the chemical liquid circuit 30 can be arranged in an orderly manner without the tubes that make up the chemical liquid circuit 30 being bent.

[0129] The mechanisms included in chemical liquid circuit operating unit 102 include air sensors 710 and 780, squeezing mechanisms 720, 730, and 750, and flow path opening / closing valve driving mechanism 740. The operations of these are controlled by injection control unit 11 of console 10b (see FIG. 1). The positions of these mechanisms are shown in FIG. 2.

[0130] (C-b1) Air Sensors The air sensors detect air in the flow paths. Referring to FIG. 2, two air sensors 710 detect the presence of air in the second tubes 315a and 325b of the first and second main lines 301a and 302a of the chemical circuit 30, respectively. The air sensor 780 detects the presence of air in the eighth tube 340 of the transducer line 304 of the chemical circuit 30. Any known sensor capable of detecting air in a tube can be used as these air sensors 710 and 780. One example of an air sensor is an ultrasonic sensor having a transmitter and a receiver arranged opposite each other across a tube.

[0131] When using an ultrasonic sensor, the transmitter and receiver are positioned facing each other with a tube that forms part of the flow path between them. To more reliably detect air, it is important that the tube be tightly and securely sandwiched between the air sensor. Therefore, it is preferable to combine the part of the flow path sandwiched between the air sensor with a silicone tube, for example, by replacing it with a silicone tube or by covering the outside with a silicone tube.

[0132] The air sensors 710 and 780 may be equipped with a light-emitting module. In this case, the air sensors 710 and 780 are configured so that the light-emitting module lights up when air is detected and turns off when air is not detected. This allows the user to easily visually confirm that air has been detected.

[0133] (C-b2) Crushing Mechanism The crushing mechanisms 720, 730, and 750 control the opening and closing of the flow path by operating to crush and open the tube. The crushing mechanisms 720 and 730 can be disposed near the air sensors 710 and 780. As long as they are near the air sensors 710 and 780, the crushing mechanisms 720 and 730 may be disposed upstream or downstream of the air sensors 710 and 780. In the first main line 301a and the second main line 302a, it is preferable that the crushing mechanisms 720 and 730 be disposed closer to the subject (downstream) than the air sensors 710 and 780 in order to effectively perform a closing operation that prevents air from reaching the subject when air is detected by the air sensors 710 and 780. Additionally, in the transducer line 304, an air sensor 780 is preferably disposed downstream of the squeezing mechanism 730 303 to prevent unnecessary detection of air drawn into the transducer line 304. The squeezing mechanism 750 may be disposed in the sixth tube 335. The squeezing mechanisms 720, 730, and 750 may each include, for example, a base on which the tube is placed and a pushing member slidably supported on the base. With the tube disposed on the base, the pushing member can be moved toward the base to crush the tube with the base and pushing member, thereby closing the flow path.

[0134] (C-b3) Flow path opening / closing valve driving mechanism The flow path opening / closing valve driving mechanism 740 is a mechanism that is equipped with the flow path opening / closing valve 332 (see FIG. 4, etc.) and drives the flow path opening / closing valve 332 to open or close the flow path within the flow path opening / closing valve 332.

[0135] The flow path on-off valve drive mechanism 740 may have any configuration as long as it can control the opening and closing of the flow path. For example, the flow path on-off valve drive mechanism 740 may include a holder that detachably holds the flow path on-off valve 332, a hook that is an engaging portion that engages with the piston 502 (see FIG. 4 ) of the flow path on-off valve 332, and a mechanism for moving the hook. To prevent backflow of the drug solution when the flow path on-off valve 332 is opened, the flow path on-off valve drive mechanism 740 is preferably controlled to open the flow path on-off valve 332 after a predetermined time has elapsed since the start of injection, so that a pre-pressure is applied such that the pressure upstream of the flow path on-off valve 332 is higher than the pressure downstream of the flow path on-off valve 332. The flow path on-off valve drive mechanism 740 may further include a sensor that detects whether the flow path on-off valve 332 is attached to the flow path on-off valve drive mechanism 740. Such a sensor is not particularly limited, and any sensor that can detect whether the flow path on-off valve 332 attached to the flow path on-off valve drive mechanism 740 is attached can be used.

[0136] In the chemical liquid circuit 30 shown in FIG. 2, a crushing mechanism 730 is arranged in the transducer line 304, but instead, a flow path opening / closing valve 332 may be arranged in the transducer line 304, and the crushing mechanism 730 may be replaced with the flow path opening / closing valve 332.

[0137] (C-b4) Illumination of the Pathway Open / Close Valve The chemical liquid circuit operation unit 102 may have an illumination module that illuminates the pathway open / close valve 332 attached to the pathway open / close valve drive mechanism 740. This makes it easier to see the pathway open / close valve 332 attached to the chemical liquid circuit operation unit 102. The illumination module includes a light source, and any illumination method using the illumination module may be used. Any light source, such as a light-emitting diode, may be used as the light source. It is preferable that the illumination module illuminates the pathway open / close valve only when the pathway open / close valve is attached to the pathway open / close valve drive mechanism. This allows the user to easily visually recognize that the pathway open / close valve is attached to the pathway open / close valve drive mechanism.

[0138] Instead of the illumination module, a flow path opening / closing valve detection sensor equipped with a light emitting module can be used. The flow path opening / closing valve detection sensor is configured to detect the flow path opening / closing valve 332 that is maintained in an operable state by the flow path opening / closing valve drive mechanism 740, and to light up the light emitting module when the flow path opening / closing valve 332 is detected. Any sensor such as an optical sensor or a contact sensor can be used as the flow path opening / closing valve detection sensor.

[0139] When air sensors 710, 780 with light-emitting modules are used in combination with flow path opening / closing valve detection sensors with light-emitting modules, the light-emitting colors of the light-emitting modules of both sensors may be different from each other, for example, the light-emitting color of the light-emitting modules of air sensors 710, 780 may be red and the light-emitting color of the light-emitting module of the flow path opening / closing valve detection sensor may be green.

[0140] Furthermore, when the tube is removed from the air sensors 710, 780, the same detection result as when air is detected is obtained. Therefore, the detection results of both sensors can also be used to detect the removal of the single-use portion 300A of the chemical circuit 30. After the test is completed, the single-use portion 300A is removed from the chemical circuit operation unit 102 in preparation for the next test. When the single-use portion 300A is removed, the air sensors 710, 780 change from a non-air-detecting state to an air-detecting state, and the flow path on-off valve detection sensor changes from a flow path on-off valve detecting state to a non-detecting state, thereby detecting the removal of the single-use portion 3000A. When the removal of the single-use portion 300A is detected, a message indicating that the single-use portion 300A has been removed is displayed on the console display device. Furthermore, since the new single-use unit 300A has the flow path opening / closing valve 332 in an open state due to the sterilization process during manufacturing, the hook of the flow path opening / closing valve drive mechanism 740 is operated so that the flow path opening / closing valve 332 can be attached in an open state in preparation for attaching the new single-use unit 300A to the chemical circuit operating unit 102 during the next inspection.

[0141] (C-c) Liquid Medicinal Container Holder Liquid Medicinal Container Holder 103 detachably holds liquid medicament containers 40A and 40B and can be attached to injection head 10a or liquid medicament circuit operation unit 102 in a hanging manner. Liquid medicament container holder 103 may have air sensor 841 that detects air in first subline 301b and second subline 302b shown in FIG. 2. Any sensor, such as an ultrasonic air sensor, can be used as air sensor 841.

[0142] [D] Operation of the Liquid Injector Next, the operation of the liquid injector described above will be described, focusing on the operation of the flow path opening / closing valve 332 and the squeezing mechanisms 720, 730, and 750. These operations are controlled by the injection control unit 11. In the following description, the first main line 301a and the first sub-line 301b are lines for the contrast agent (A), and the second main line 302a and the second sub-line 302b are lines for the saline solution (B). For simplicity, the contrast agent will be referred to as "liquid solution A" and the saline solution will be referred to as "liquid solution B." In the following description, "opening the squeezing mechanism" means that the squeezing mechanism is driven to open the flow path between its upstream and downstream sides. Similarly, "closing the squeezing mechanism" means that the squeezing mechanism is driven to close the flow path between its upstream and downstream sides. Furthermore, in the transducer line 304, if the crushing mechanism 730 is replaced with a flow path opening / closing valve driving mechanism 740, the operation of the crushing mechanism 730 in the following description can be interpreted as the operation of the replaced flow path opening / closing valve driving mechanism 740.

[0143] (D-a) Self-check: In the self-check performed after the power is turned on, each of the squeezing mechanisms 720, 730, 750 and the flow path opening / closing valve 332 is opened and closed multiple times to check whether they are operating normally, and finally all of them are opened. In this state, multiple-use portion 300B and single-use portion 300A can be connected, and single-use portion 300A can be attached to chemical liquid circuit operating unit 102.

[0144] (D-b) During Operation Stoppage During operation stoppage after various operations are completed, the crushing mechanisms 720, 730, and 750 are all open, and the flow path opening / closing valve 332 is closed. However, during setup of the multiple use unit 300B, the crushing mechanisms 720, 730, and 750 and the flow path opening / closing valve 332 are all left open, and during setup of the single use unit 300A (after the tubes are attached), the flow path opening / closing valve 332, the crushing mechanism 730 of the transducer line 304, and the crushing mechanism 750 of the sixth tube 335 are open, but the A-side and B-side crushing mechanisms 720 may be closed.

[0145] (D-c) Forward movement of A-side and B-side When the syringe drive mechanism on side A moves forward, such as when injecting medicinal liquid A, the crushing mechanism 720 on side B and the crushing mechanism 730 of transducer line 304 are closed, and flow path opening / closing valve 332 is opened. When the syringe drive mechanism on side B moves forward, such as when flushing with medicinal liquid B, the crushing mechanism on side A and the crushing mechanism 730 of transducer line 304 are closed, and flow path opening / closing valve 332 is opened. When the syringe drive mechanism on side A and the syringe drive mechanism on side B are moved forward simultaneously, such as when injecting medicinal liquids A and B simultaneously, flow path opening / closing valve 332 is opened, and the crushing mechanism 730 of transducer line 304 is closed.

[0146] (D-d) Retraction Operation of Sides A and B When the syringe mechanism on side A is retracted, such as when medicinal liquid A is drawn from first container 40A into syringe 20A, the crushing mechanism 720 on side A is closed. When the syringe drive mechanism on side B is retracted, such as when medicinal liquid B is drawn from second container 40B into syringe 20B, the crushing mechanism 720 on side B is closed. When both the syringe drive mechanisms on sides A and B are retracted simultaneously, the crushing mechanisms 720 on both sides A and B are closed.

[0147] (De) Standby When on standby for injection of medicinal liquid A, the crushing mechanism 720 on the B side is closed.

[0148] (Df) During Priming of the Transducer During priming of the transducer, the A-side squeezing mechanism 720 and the squeezing mechanism 750 of the subject line 303 are closed, and the flow path opening / closing valve 332 is opened.

[0149] (D-g) When air is detected When air is detected, the flow path opening / closing valve 332 and the crushing mechanism 750 of the subject line 303 are closed. However, when air is detected during standby, only the crushing mechanism 750 of the subject line 303 may be closed. For the transducer line 304, the operation of the crushing mechanism 730 may be optional, but if an air sensor 780 is located downstream of the crushing mechanism 730, it is preferable that the crushing mechanism 730 be closed to prevent air from being drawn from the transducer line 304 into the subject line 303.

[0150] In this embodiment, the liquid medicine circuit 30 includes a mixing device 330 in the subject line 303. The mixing device 330 includes a chamber for mixing liquid medicine A and liquid medicine B. This chamber can temporarily trap air that flows downstream from the air sensors 710 on the A and B sides. As a result, the risk of air flowing into the subject is reduced. The risk of air flowing into the subject can also be reduced by increasing the length of the tubing from the air sensor 710 to the flow path opening / closing valve 332. However, if the length of the tubing is limited due to layout constraints of the liquid medicine circuit 30, a chamber capable of trapping air can be placed between the air sensor 710 and the flow path opening / closing valve 332, as in this embodiment, to achieve the same effect as using a long tubing.

[0151] (D-h) Others It is preferable that the timing of opening and closing of the crushing mechanism 730 of the transducer line 304 be within the pressure range that protects the transducer and that closes according to the injection timing. If there is residual pressure after injection, it may be opened after a predetermined time after injection (in the case of manual injection using a hand switch, after the start button on the hand switch is released) to prevent the residual pressure from affecting the transducer.

[0152] In addition, when various operations are completed and the single-use section 300A is removed, the A-side and B-side crushing mechanisms 720, the flow path opening / closing valve 332, the crushing mechanism 730 of the transducer line 304, and the crushing mechanism 750 of the sixth tube 335 may be opened.

[0153] (E) Other Forms Although several forms of the present invention have been described above, the present invention is not limited to the above-described forms. Other forms will be described below. Of course, the present invention is not limited to the forms described below, and appropriate modifications are possible within the scope of the technical concept of the present invention. Furthermore, the above-described forms and the forms described below can be combined as appropriate.

[0154] (E-a) Alternative Forms of Injection Heads Figure 16 shows a perspective view of another form of injection head. Similar to the previous embodiment, the injection head 10a shown in Figure 16 includes a head main body 101 on which a syringe is mounted and a liquid medicine circuit operation unit 102 located in front of the head main body 101. The head main body 101 is supported by a suitable stand or the like for rotation around a support shaft 114. However, this form differs from the previous embodiment in that two liquid medicine container holders 103a and 103b are supported by the liquid medicine circuit operation unit 102. The first liquid medicine container holder 103a is adapted to hold a bottle as a liquid medicine container and includes a bottle receptacle 105. An example of a liquid medicine that can be filled into a bottle is a contrast medium. The second liquid medicine container holder 103b is adapted to hold a bag as a liquid medicine container and includes multiple hooks 104 for hanging the bag. The multiple hooks 104 are arranged at different positions in the vertical direction, and each hook 104 is preferably a folding hook so that the lower hooks 104 do not get in the way when a bag is hung on an upper hook 104. An example of the medicinal liquid filled in the bag is physiological saline. Fig. 16A shows a state in which a first container 40A, which is a bottle filled with contrast medium, is held in a first medicinal liquid container holder 103a, and a second container 40B, which is a large-capacity bag, is held in a second medicinal liquid container holder 103b. Fig. 16B shows a state in which a first container 40A, which is a bottle filled with contrast medium, is held in a first medicinal liquid container holder 103a, and a second container 40B, which is a small-capacity bag, is held in a second medicinal liquid container holder 103b.

[0155] Furthermore, it is preferable that liquid container holders 103a, 103b be supported so as to be rotatable about an axis parallel to support shaft 114. This allows liquid container holders 103a, 103b to maintain their positions even when the position of injection head 10a is changed, such as when injection head 10a is placed in an upward position as shown in Figure 16C. In this case, the attachment interval of liquid container holders 103a, 103b to injection head 10a is designed so that liquid container holders 103a, 103b do not interfere with each other even when the position of injection head 10a is changed.

[0156] (E-b) Two-Console System The liquid injector can have multiple consoles. Figure 17 shows the system configuration of a liquid injector with two consoles. This liquid injector has an injection head 10a, a main unit 900, a main console 910, a sub-console 920, a variable hand switch 940, and a charging stand 950. The liquid injector also has an optional hand switch 930. This option can also be included in the system shown in Figure 1.

[0157] Main unit 900 includes a power supply unit that supplies power to injection head 10a, main console 910, and sub-console 920. Main console 910 and sub-console 920 each have the same configuration and function as console 10b shown in Figure 1. Injection head 10a and main console 910 are located in the examination room, sub-console 920 is located in the operation room, and main unit 900 is located in the machine room.

[0158] The hand switch 930 is one of the input devices externally connected to the sub-console 920 and has a start button for starting the liquid medicine injection operation. The liquid medicine is injected only while the start button is pressed. The variable hand switch 940 is one of the input devices wirelessly connected to the main console 910 so that the liquid medicine can be injected at will by the user in the examination room. The variable hand switch 940 has a built-in rechargeable battery, which can be charged using a charging stand 950. In this embodiment, two variable hand switches 940 are provided, including a spare for when the battery runs low. The communication standard between the variable hand switch 940 and the main console 910 is not particularly limited; for example, the Bluetooth (registered trademark) standard can be used.

[0159] The variable hand switch 940 will be described with reference to Fig. 18. The variable hand switch 940 has a hand switch body 941 with a grip, a first start button 942, a second start button 943, and an LED lamp 944 disposed on the side of the hand switch body 941. A power switch and a charging connector are also provided on the bottom of the variable hand switch 940.

[0160] The first start button 942 is a button for starting the injection of a first medicinal liquid (e.g., a contrast agent), and the medicinal liquid is injected only while the button is pressed. The term "first medicinal liquid" here includes the first medicinal liquid diluted with a second medicinal liquid (e.g., physiological saline). The first start button 942 can also change the injection rate of the medicinal liquid depending on the pressing depth, or can inject the medicinal liquid at a constant injection rate regardless of the pressing depth. For example, in a cardiac imaging mode (cardio mode), the medicinal liquid is injected at a higher injection rate the deeper the first start button 942 is pressed. In an angiography mode (angio mode), the medicinal liquid is injected at a constant injection rate regardless of the pressing depth of the first start button 942. The second start button 943 is a button for starting the injection of a second medicinal liquid. The second start button 943 can be operated in two injection modes: a first mode in which the second liquid medicine is injected only while the second start button 943 is pressed, and a second mode in which a predetermined amount of the second liquid medicine is injected when the second start button 943 is pressed. The user can preset which mode to use. The first start button 942 and the second start button 943 are located on the top surface of the hand switch body 941, and the user can operate the first start button 942 and the second start button 943 with, for example, their thumbs while gripping the hand switch body 941.

[0161] The light emitted by the LED lamp 944 is controlled according to the state of the variable hand switch 940. For example, it flashes orange while charging and lights up orange when charging is complete. It also flashes blue when communication is not connected and lights up blue when communication is connected.

[0162] The variable hand switch 940 and the main console 910 may be connected by wire, in which case the battery and charging configuration are not included.

[0163] The variable hand switch 940 may have a third start button in addition to the first start button 942 and the second start button 943. Currently, in angiography, after inserting a catheter into a subject, a foot switch is used to confirm the position of the inserted catheter tip, and a small amount of contrast medium is ejected to guide the catheter tip to the target position while checking the catheter tip position. However, because the foot switch is large and located on the floor, the foot switch itself can get in the way of catheter insertion, preventing the user from inserting the catheter at a desired position. Therefore, by providing the variable hand switch 940 with the function of ejecting contrast medium via the foot switch, the user can guide the catheter tip to the target position while checking the catheter tip position at a desired position.

[0164] (E-c) User Interface Here, we will explain the user interface, such as various screens displayed on the display devices of the consoles of the liquid injector (console 10b, main console 942, sub-console 943), and sounds used to alert the user or notify the user of the system status.

[0165] When the liquid injector is turned on, a predetermined initialization operation is performed, after which a home screen is displayed on the console display device. The home screen displays an injection mode selection key, an injection result key, and an environment setting key. The injection mode selection key is used to select an injection mode, the injection result key is used to display the injection results, and the environment setting key is used to set various environment settings.

[0166] By tapping the environment setting key, an environment setting screen is displayed. On this environment setting screen, a selection screen is displayed for setting items such as date and time, beep sound, filling operation, flush, priming operation, etc., and the user can select which item to set from this selection screen.

[0167] 19A , which shows a filling operation setting screen that is displayed when the filling operation is selected on the selection screen, will be described below. The filling operation setting screen 2000 allows the user to set the filling operation ON / OFF, the filling protocol ON / OFF, and the filling speed, remaining amount at the start of filling, and filling amount for each of the liquid A and the liquid B.

[0168] The filling protocol is a special protocol that reduces air adhesion to the inner surface of the cylinder when the plunger is retracted to fill the cylinder with the medicinal liquid. In this filling protocol, the medicinal liquid is filled by successively performing a first phase in which the medicinal liquid is filled at a first speed and a second phase in which the medicinal liquid is filled at a speed higher than the first speed. The filling speeds and filling times of the first and second phases are determined so that the total amount of the medicinal liquid filled in the first and second phases is equal to the set amount of medicinal liquid to be filled. The filling speeds in the first and second phases can be, for example, ±1.5 mL / sec relative to the filling speed when the filling operation is performed without changing the filling speed.

[0169] When the filling protocol is set to ON on the filling operation setting screen 2000, the filling operation is performed according to the above filling protocol. On the other hand, when the filling protocol is set to OFF, the filling operation is performed at a set constant injection rate.

[0170] Next, a user interface for injecting a medicinal liquid will be described.

[0171] When the liquid injector is used in an angio imaging system, the liquid injector can be configured to inject contrast agent and saline in two injection modes compatible with a cardiac imaging mode (cardio mode) and an angiography mode (angio mode). In these injection modes, the injection of contrast agent diluted with saline is also called a cardiodilution mode and an angiodilution mode, respectively.

[0172] 19B shows an injection condition setting screen 1000 in cardiodilution mode. At the top of this injection condition setting screen 1000, a bar displays an injection mode indicator 1001, a status indicator 1002, a memory key 1003, a priming key 1004, and an end-of-test key 1005. Below this, previous result information 1006, a metered injection rate indicator 1007, a flow path on-off valve status 1008 (shown when the valve is closed), a rate key 1009, a volume key 1010, and a dilution key 1011 are displayed. On the right side of the screen, a variable hand switch battery indicator 1012, a remaining amount indicator and fill key 1013, an integrated volume indicator 1014, and a pressure limit key 1015 are displayed. Near the injection rate indicator 1007, a previous result rate mark 1020 and a set rate mark 1021 are also displayed.

[0173] The priming key 1004 is used to perform priming, and the user transitions to a priming screen (not shown) by tapping the priming key 1004. After priming is complete, a predetermined operation allows the user to return from the priming screen to the injection condition setting screen 1000. Furthermore, for transducer priming, the priming conditions can be preset from the environment setting screen that is displayed after the console is powered on, with a delay time in the range of 0 to 10 seconds, an injection rate in the range of 0.1 to 10 mL / sec, and an injection volume in the range of 1 to 50 mL. The delay time refers to the grace period from the start operation of priming until the priming operation is performed, and can be set according to the time required for the user to move to the location of the transducer after performing the start operation.

[0174] The test end key 1005 is used for test end processing, and when the user taps the test end key 1005, a selection screen pops up to prompt the user to select whether to perform the next test or end the test, and the process proceeds to the next step depending on the user's selection. Note that this selection screen also pops up when removal of the single-use part is detected.

[0175] The dilution key 1101 is used to set the dilution rate of the contrast agent with saline. When the user taps the dilution key 1101, a dilution rate setting screen pops up, allowing the user to arbitrarily set the dilution rate on the dilution rate setting screen. The dilution rate setting screen may be set in any manner, such as by directly entering a value using a numeric keypad, by swiping a slider on a slide bar, or by sliding a slider using a key. The dilution rate may be expressed as a dilution ratio (e.g., "xx%"), a dilution ratio (e.g., "xx: △△"), or a multiplier (e.g., "xx times"), or the user may be able to arbitrarily select the manner in which the dilution rate is expressed.

[0176] The battery indicator 1012 displays the charge status (remaining charge) of the battery of the variable hand switch, and the remaining charge is displayed in increments of 10%, for example. Furthermore, when the remaining charge changes from 40% to 30%, from 30% to 20%, or from 20% to 10%, for example, a notification sound may be emitted from the console and the battery indicator 1012 may flash. Furthermore, when the remaining charge reaches, for example, 30%, the battery indicator 1012 may display a warning message saying "low battery charge" and / or change color to orange.

[0177] When the user completes the setting of the injection conditions and taps on the status display 1002, the injection condition setting screen 1000 transitions to the start OK screen 1100 shown in FIG. 19C , and the bar at the top of the screen displays the injection mode display 1001, the status display 1002, and the return key 1016. In this state, the user can press the start button on the hand switch to start the injection of contrast medium and saline. The user can also return to the injection condition setting screen 1000 by tapping on the return key 1016.

[0178] When injection begins, the screen transitions to an injection in progress screen 1200 shown in Fig. 19D. The injection in progress screen 1200 displays an injection mode display 1201, a status display 1202, previous result information 1203, a previous result rate mark 1204, an injection rate display 1205 designed like a meter, a set rate mark 1206, an injection rate display 1207, an injection amount display 1208, a battery display 1209, and a pressure display 1210. The injection rate display 1205 displays an animation of the current injection rate. The pressure display 1210 displays the set pressure limit value and the pressure during injection.

[0179] During the injection operation, the console may emit intermittent beeps to notify the user that an injection is in progress. The interval between beeps may be varied depending on the injection rate, including when the injection rate changes over time. The tone of the beep may also be changed depending on the type of liquid being injected (side A or side B). This also applies to the operation of the variable hand switch 940.

[0180] Furthermore, if the injection pressure reaches the set pressure limit during an injection operation, the pressure limiter is activated, and the user is notified of this by at least one of the following: the display of the pressure limit key 1015, a notification sound from the console, and other means. However, since the notification sound may be difficult to hear if another device that emits a notification sound is being used simultaneously with the liquid injector, the user can set the notification sound to ON or OFF as desired. The notification sound can be turned ON or OFF from the environment setting screen described above. However, in angiodilution mode, the notification sound will still be emitted even if it is set to OFF.

[0181] 19E is displayed during flushing with saline. The flushing screen 1300 displays an injection mode display 1301, a status display 1302, previous result information 1303, a previous result rate mark 1304, an injection rate display 1305 designed in a meter format, a set rate mark 1306, an injection rate display 1307, an injection volume display 1308, a battery display 1309, and an injection pressure display 1310.

[0182] The flush conditions can be preset on the environment setting screen, for example, with an injection rate in the range of 0.1 to 5 mL / sec and an injection amount in the range of 1 to 20 mL.

[0183] Next, the screen transitions in the angiodilution mode will be described. Figure 19F shows an injection condition setting screen 1400 in the angiodilution mode. At the top of this injection condition setting screen 1400, a bar is displayed that includes an injection mode display 1401, a status display 1402, a memory key 1403, a priming key 1404, and an examination end key 1405. Below this, a battery display 1406, a remaining amount display / fill key 1407, an accumulated amount display 1408, a rate key 1409, a volume key 1410, a contrast medium proportion key 1411, an injection time key 1412, a delay key 1413, a start key 1414, and a pressure limit key 1415 are displayed.

[0184] The rate keys 1409 and volume keys 1410 are used to set the injection rate and volume, respectively. The rate keys 1409 and volume keys 1410 also display the rate and volume of the contrast agent and saline, respectively. The contrast ratio key 1411 is used to set the ratio of the contrast agent to the injection volume. The contrast ratio key 1411 has the same function as the dilution key 1011 (see FIG. 10B ) described above, and therefore will not be described here. The injection time key 1412 displays the injection time. The delay key 1413 is used to set the delay type and delay time. The rise key 1414 is used to set the time required to reach the set injection rate. The pressure limit key 1415 is used to set the injection pressure limit.

[0185] When the user completes the setting of the injection conditions and taps on the status display 1402, the injection condition setting screen 1400 transitions to the start OK screen 1500 shown in FIG. 19G, and the bar at the top of the screen displays the injection mode display 1401, the status display 1402, and the return key 1416. In this state, the user can press the start button on the hand switch to start the injection of contrast medium and saline. The user can also return to the injection condition setting screen 1400 by tapping on the return key 1416.

[0186] When the injection starts, the screen transitions to an injection in progress screen 1600 shown in FIG. 19H. Injection in progress screen 1600 displays an injection mode display 1601, a status display 1602, a rate display 1603, a quantity display 1604, an injection time display 1605, a remaining amount display 1606, an integrated amount display 1607, a remaining amount animation display 1608, a delay display 1609, a rise display 1610, and an injection pressure display 1611. The rate display 1603 and the quantity display 1604 also display the respective rates and amounts of the contrast medium and saline. The remaining amount animation display 1608 displays an animation of the remaining amount of the liquid in the syringe and the state of the liquid being injected.

[0187] In both cardio and angio modes, injection results can be viewed on the injection results screen. The injection results include the date, start time, total injection volume, number of cardio injections, and number of angio injections. For the number of angio injections, in addition to the above, you can also view details such as the injection pattern, maximum speed, injection volume, injection time, maximum pressure, delay time, and rise time.

[0188] REFERENCE SIGNS LIST 10 Chemical liquid injector 10a Injection head 10b Console 22 Syringe 22a Flange 22b Nozzle portion 22c Syringe protrusion 30 Chemical liquid circuit 101 Head body 102 Chemical liquid circuit operating unit 103, 103a, 103b Chemical liquid container holder 111 Clamper 112 Presser 113 Operation unit 120 Syringe drive mechanism 121 Front frame 122 Rear frame 123 Side frame 124 Ball screw mechanism 125 Linear guide 126 Slider 127 Ram 301a First main line 301b First sub-line 302a Second main line 302b Second sub-line 303 Subject line 304 Transducer line 332 Flow path opening / closing valve 360 ​​Syringe connector 360a Connector protrusion 400 Suction tube unit 410 Tube body 420 Suction valve 421 First case 422 Second case 423 Valve body 424 Coil spring 430 Open / close dust cap 440 Spike 440a Introduction path 440b Piercing portion 440d Air vent 441 Filter 501 Housing 501a, 501b Conduit portion 502 Piston 502a Head 503 Stopper structure 503a Convex portion 503b Concave portion 506 Sealing ring 610, 620 One-way valve 610a Valve chamber 611, 621 First case 611a Receiving recess 611b, 621b Downstream flow path 611c Valve body position restricting protrusion 612, 622 Second case 612a Valve seat 612b, 622b Upstream flow path 613, 623 Valve body 624 Gasket 625 Biasing spring 710, 780 Air sensor 720, 730 Crushing mechanism 740 Flow path opening / closing valve drive mechanism 841 Air sensor 900 Main unit 910 Main console 920 Sub-console 930 Hand switch 930 Variable hand switch 950 Charging stand

Claims

1. A drug injection device in which a drug solution circuit is detachably mounted, The drug solution circuit operating unit is equipped with the drug solution circuit having a subject line as the flow path for the drug solution, The drug solution circuit operating unit is a drug solution injection device having a flow path opening / closing mechanism at a position where a tube upstream of the connector located at the downstream end of the subject line is positioned.

2. The drug injection device according to claim 1, wherein the drug circuit operating unit further comprises an air sensor.

3. The drug injection device according to claim 2, wherein the flow path opening / closing mechanism is closed when air is detected by the air sensor.

4. The drug injection device according to any one of claims 1 to 3, wherein the flow path opening / closing mechanism is a crushing mechanism for crushing the tube.

5. A drug solution circuit that is detachably mounted on the drug solution injection device described in Claim 1, It is equipped with a patient line as a flow path connected to the subject, The subject line is a drug solution circuit having a tube in which the flow path opening / closing mechanism is located upstream of the connector located at its downstream end.

6. A drug solution circuit that is detachably mounted on the drug solution injection device according to Claim 1, The subject line serves as a fluid path connected to the subject, The system includes a transducer line branched off from the subject line, The drug solution circuit has a tube in which the subject line has the flow path opening / closing mechanism located downstream of the branching point with the transducer line and upstream of the connector located at the downstream end of the subject line.

7. The drug solution circuit according to claim 6, wherein, during priming of the transducer line, the tube of the subject line is closed by the flow path opening / closing mechanism, and liquid is supplied to the transducer line from the upstream side of the subject line.