[go: up one dir, main page]

WO2025187842A1 - Dispositif d'injection de solution médicamenteuse - Google Patents

Dispositif d'injection de solution médicamenteuse

Info

Publication number
WO2025187842A1
WO2025187842A1 PCT/JP2025/008879 JP2025008879W WO2025187842A1 WO 2025187842 A1 WO2025187842 A1 WO 2025187842A1 JP 2025008879 W JP2025008879 W JP 2025008879W WO 2025187842 A1 WO2025187842 A1 WO 2025187842A1
Authority
WO
WIPO (PCT)
Prior art keywords
injection
phase
contrast agent
sec
rate
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Pending
Application number
PCT/JP2025/008879
Other languages
English (en)
Japanese (ja)
Other versions
WO2025187842A8 (fr
Inventor
茂 根本
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Nemoto Kyorindo Co Ltd
Original Assignee
Nemoto Kyorindo Co Ltd
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Nemoto Kyorindo Co Ltd filed Critical Nemoto Kyorindo Co Ltd
Publication of WO2025187842A1 publication Critical patent/WO2025187842A1/fr
Publication of WO2025187842A8 publication Critical patent/WO2025187842A8/fr
Pending legal-status Critical Current
Anticipated expiration legal-status Critical

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/14—Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
    • A61M5/142—Pressure infusion, e.g. using pumps
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/14—Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
    • A61M5/142—Pressure infusion, e.g. using pumps
    • A61M5/145—Pressure infusion, e.g. using pumps using pressurised reservoirs, e.g. pressurised by means of pistons
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/14—Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
    • A61M5/168—Means for controlling media flow to the body or for metering media to the body, e.g. drip meters, counters ; Monitoring media flow to the body
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/14—Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
    • A61M5/168—Means for controlling media flow to the body or for metering media to the body, e.g. drip meters, counters ; Monitoring media flow to the body
    • A61M5/172—Means for controlling media flow to the body or for metering media to the body, e.g. drip meters, counters ; Monitoring media flow to the body electrical or electronic

Definitions

  • the present invention relates to a drug solution injection device that injects a drug solution filled in a container into a subject.
  • CMOS complementary metal-oxide-semiconductor
  • CT Computer Tomography
  • MRI Magnetic Resonance Imaging
  • PET PET
  • ultrasound diagnostic devices and angiography imaging devices.
  • a contrast agent or saline solution (hereinafter referred to simply as “medicinal solution”) may be injected into the patient.
  • a known injection protocol for contrast agent injection is known as a variable injection protocol.
  • the injection rate of the contrast agent is set to gradually decrease over time, for example. It is known that this type of injection protocol results in a more rapid rise in CT value and a longer period of time during which the desired CT value is maintained, compared to a constant injection rate (single-phase injection).
  • Patent Document 1 discloses several examples of such variable injection protocols.
  • Patent Document 2 also discloses a cross injection protocol for an angiography injection device used in cardiac X-ray imaging diagnosis, in which contrast agent is injected at a constant injection rate in the first phase, and in the second phase, the injection rates of the contrast agent and saline are varied linearly so that the sum of the injection rates of the contrast agent and saline remains constant.
  • Patent Document 1 Japanese Patent No. 4620929
  • Patent Document 2 Japanese Patent No. 5117376
  • contrast examinations that use radiation. For example, prior to tumor removal surgery, a contrast examination is often performed using a CT scanner to determine the tumor's location and size, and anatomical structures such as blood vessels, solid organs, and tumors are extracted, and medical images such as tomographic images and 3D images are created.
  • CT values In imaging examinations using CT devices, the tendency for CT values to rise (maximum CT value, the time from the start of contrast agent injection until the maximum CT value is reached, and the time a certain CT value is maintained, etc.) varies depending on the blood vessels, solid organs, and tumor. Therefore, in order to properly image all blood vessels, solid organs, and tumors, multiple images are taken at different times. However, as the number of images taken increases, the subject's radiation exposure also increases. Methods for reducing radiation exposure include taking images at a lower tube voltage and shortening the imaging time, but the most effective method is to minimize the number of images taken.
  • the present invention aims to provide a liquid medicine injector that can set an injection protocol that reduces the physical burden on the subject while obtaining good medical images.
  • CT values are maintained for a long period of time in a variable pattern in which the injection rate of contrast agent decreases over time is because a relatively large amount of contrast agent is injected in the early stages of injection.
  • the initial injection rate tends to be high. Because a high injection rate increases the internal pressure of the blood vessels, caution is required when applying a variable pattern to elderly people and dialysis patients, whose blood vessels are considered to be fragile.
  • the inventors have investigated various injection protocols and found that, if appropriate injection conditions are given, it is possible to realize an injection protocol that can depict the desired anatomical structure in a single scan, and that can inject a relatively large amount of contrast agent in the early stages of injection while suppressing the initial injection rate. This is the result of their work, and this invention was conceived.
  • the liquid medicine injector of the present invention is a liquid medicine injector that injects a liquid medicine filled in a container into a subject, a control unit configured to set an injection protocol in which at least a contrast agent is injected as the medicinal liquid; the injection protocol has at least one phase including an injection phase in which the contrast agent is injected at a decreasing or increasing injection rate over time;
  • the control unit is configured to set the injection protocol using at least one of parameters including an injection amount of contrast agent, an injection time of contrast agent, an injection rate of contrast agent at the start of a phase, an injection rate of contrast agent at the end of a phase, and a variable constant expressed as injection rate of contrast agent at the end of a phase/injection rate of contrast agent at the start of a phase.
  • a medical imaging system comprising: a liquid medicine injector configured to inject a liquid medicine filled in a container into a subject; a medical imaging device that acquires medical images from a subject into whom a liquid has been injected by the liquid injector; a control unit configured to set an injection protocol in which at least a contrast agent is injected as the liquid medicine; and the injection protocol has at least one phase including an injection phase in which the contrast agent is injected at a decreasing or increasing injection rate over time;
  • the control unit is configured to set the injection protocol using at least one of parameters including an injection amount of contrast agent, an injection time of contrast agent, an injection rate of contrast agent at the start of a phase, an injection rate of contrast agent at the end of a phase, and a variable constant expressed as injection rate of contrast agent at the end of a phase/injection rate of contrast agent at the start of a phase.
  • a computer program for a liquid medicine injector that injects a liquid medicine filled in a container into a subject
  • the computer program comprising: Computer, a control unit configured to set an injection protocol in which at least a contrast agent is injected as the liquid medicine; the injection protocol has at least one phase including an injection phase in which the contrast agent is injected at a decreasing or increasing injection rate over time; the control unit is configured to set the injection protocol using at least one of parameters including an injection amount of contrast agent, an injection time of contrast agent, an injection rate of contrast agent at the start of a phase, an injection rate of contrast agent at the end of a phase, and a variable constant expressed as injection rate of contrast agent at the end of a phase/injection rate of contrast agent at the start of a phase;
  • a computer program is provided.
  • a computer program for a medical imaging system having a liquid medicine injector that injects a liquid medicine filled in a container into a subject, and a medical imaging device that acquires medical images of the subject into whom the liquid medicine has been injected by the liquid medicine injector
  • the computer program comprising: Computer, a control unit configured to set an injection protocol in which at least a contrast agent is injected as the liquid medicine; the injection protocol has at least one phase including an injection phase in which the contrast agent is injected at a decreasing or increasing injection rate over time; the control unit is configured to set the injection protocol using at least one of parameters including an injection amount of contrast agent, an injection time of contrast agent, an injection rate of contrast agent at the start of a phase, an injection rate of contrast agent at the end of a phase, and a variable constant expressed as injection rate of contrast agent at the end of a phase/injection rate of contrast agent at the start of a phase;
  • a computer program is provided.
  • Initial infusion rate means the infusion rate of the drug at the beginning of a phase
  • end infusion rate means the infusion rate of the drug at the end of a phase.
  • “Variable infusion phase” means a phase in which a drug solution is infused at a linearly decreasing infusion rate over time.
  • “Inverse variable infusion phase” means a phase in which a drug solution is infused at an infusion rate that increases linearly with time.
  • Constant rate infusion phase means a phase in which the drug solution is infused at a constant infusion rate.
  • “Anatomical structure” refers to recognizable objects within a subject (e.g., organs, bones, blood vessels, etc.), including fat and lesions such as tumors. Also, even if an anatomical structure is viewed as a whole, if it is divided into multiple units or has separate functions, it may be treated as a separate anatomical structure.
  • Medical imaging device refers to a CT device, an angiography device, an MRI device, an ultrasound imaging diagnostic device, etc.
  • a “medical imaging diagnostic device” is a device that captures medical images by irradiating electromagnetic waves
  • the “medical imaging device” has an "electromagnetic wave irradiator” that irradiates the electromagnetic waves.
  • CT devices and an angiography device have an X-ray tube as an "electromagnetic wave irradiator,” and an MRI device has a high-frequency pulse transmitter that irradiates high-frequency pulses as an "electromagnetic wave irradiator.”
  • the present invention makes it easy to set injection protocols that reduce the physical burden on the subject while still allowing for the acquisition of good medical images.
  • FIG. 1 is a schematic diagram of a medical imaging system according to an embodiment of the present invention
  • 1 is an example of a hypothetical TDC (time concentration curve) when contrast is injected with a variable injection protocol.
  • FIG. 10 is a diagram for explaining parameters of an injection protocol when the injection rate changes linearly.
  • FIG. 1 shows injection protocol form 1.
  • 5 is a time-density curve (TDC) showing an example of a simulation result when a contrast agent is injected using the injection protocol shown in FIG. 4.
  • TDC time-density curve
  • FIG. 10 shows injection protocol form 2.
  • FIG. 10 shows injection protocol form 3.
  • FIG. 10 shows injection protocol form 4.
  • FIG. 10 shows injection protocol form 5.
  • FIG. 6 shows injection protocol form 6.
  • FIG. 10 shows injection protocol form 7.
  • TDC time concentration curve
  • FIG. 10 is a diagram showing an example of a screen displayed on a display device of the liquid injector (injection protocol setting screen).
  • FIG. 10 is a diagram showing an example of a screen displayed on a display device of the liquid injector (enlarged thumbnails overlapping each other);
  • FIG. 10 is a diagram showing an example of a screen displayed on a display device of the liquid injector (enlarged thumbnail).
  • FIG. 10 is a diagram showing an example of a screen displayed on a display device of the chemical liquid injector (speed change of the first phase).
  • FIG. 10 is a diagram showing an example of a screen displayed on a display device of the chemical liquid injector (changing the initial velocity of the second phase);
  • FIG. 10 is a diagram showing an example of a screen displayed on a display device of the chemical liquid injector (setting confirmation screen).
  • FIG. 10 is a diagram showing an example of a screen displayed on a display device of the chemical liquid injector (injection screen).
  • FIG. 10 is a diagram showing an example of a screen displayed on a display device of the liquid injector (list of injection results);
  • FIG. 10 is a diagram showing an example of a screen displayed on a display device of the chemical liquid injector (injection result graph).
  • FIG. 10 is a diagram showing an example of a screen displayed on a display device of the liquid injector when editing an injection protocol (injection pattern selection).
  • FIG. 10 is a diagram showing an example of a screen displayed on a display device of the liquid injector when editing an injection protocol (injection pattern selection).
  • FIG. 10 is a diagram showing an example of a screen displayed on a display device of the liquid injector when editing an injection protocol (changing parameters).
  • FIG. 10 illustrates an example protocol selection screen that allows a user to select one of a number of injection protocols.
  • 10 is an example of an injection setting screen including an injection simulation button.
  • 10 is a time concentration curve (TDC) showing an example of a simulation result when injected according to a set injection protocol.
  • TDC time concentration curve
  • CT Computer Tomography
  • MRI Magnetic Resonance Imaging
  • PET PET
  • ultrasound imaging systems and the like.
  • FIG. 1 a schematic diagram of a medical imaging system according to one embodiment of the present invention is shown, which includes a liquid injector 10 that injects a liquid into a subject and a medical imaging device 50 that captures medical images of the subject.
  • Liquid injector 10 includes an injection head 10a and a console 10b. Typically, injection head 10a is located in an examination room, and console 10b is located in an operation room. Liquid injector 10 and 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.
  • 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 imaging operation unit 52 typically includes a subject bed and an electromagnetic wave irradiation unit that irradiates electromagnetic waves into a specified space above the bed.
  • the imaging control unit 51 controls the operation of the entire medical imaging device, such as by determining imaging conditions and controlling the operation of the imaging operation unit 52 in accordance with 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.
  • the ROM is loaded with a computer program for controlling the medical imaging device 50.
  • the CPU controls the operation of each part of the medical imaging device 50 by executing various functions in accordance with this computer program. Medical images, including tomographic images and/or three-dimensional images of the subject, can be generated using data obtained when the imaging operation unit 52 performs imaging operations under the control of the imaging control unit 51.
  • the medical imaging device 50 may further include a display device 54 such as an LCD display that can display 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, or 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 arranged as an input device on a display that is also a display device may also be used as the input device 53 and display device 54. Part 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 device.
  • the drug solution injection device 10 is used to inject a drug solution stored in a syringe 20, a container filled with the drug solution, into a subject's blood vessel.
  • the syringe 20 is detachably mounted on the injection head 10a.
  • the injection head 10a incorporates a drive mechanism 15 that operates the plunger (or piston) of the syringe 20.
  • the drive mechanism 15 may include a presser for at least advancing the plunger (or piston) of the syringe 20 and an actuator for operating the presser.
  • the injection head 10a is configured to accommodate two syringes 20 so that two types of drug solution, such as a contrast medium and saline, can be injected separately or simultaneously, and has two drive mechanisms 15 that operate each syringe 20 independently.
  • the injection head 10a may be configured to accommodate only a single syringe 20, or three or more syringes 20. If the injection head 10 is configured to be able to mount multiple syringes 20, the number of drive mechanisms 15 may be equal to or different from the number of mounted syringes 20.
  • the console 10b has an injection control unit 11, an input device 12, and a display device 13.
  • the injection control unit 11 controls the operation of the entire liquid injection device by determining injection conditions such as the injection amount and injection rate using at least a portion of the data input from the input device 12, controlling the operation of the injection head 10a so that the liquid is injected according to the determined injection conditions, and controlling the display on the display device 13.
  • the injection control unit 11 can be configured to include a so-called microcomputer, and can have a CPU, ROM, RAM, a storage device, and interfaces with other devices.
  • a computer program for controlling the liquid injection device 10 is installed in the ROM.
  • the CPU can control the operation of each part of the liquid injection device 10 by executing various functions in accordance with this computer program.
  • the input device 12 is a device used to input data used by the injection control unit 11 to determine the injection conditions for the medicinal liquid.
  • the input device 12 can be at least one of known input devices, such as various buttons, a keyboard, or a mouse. A portion of the input device 12 may be provided separately from the console 10b. Data input from the input device 12 is sent to the injection control unit 11, and data displayed on the display device 13 is sent from the injection control unit 11.
  • the display device 13 is controlled by the injection control unit 11 and displays data necessary for determining the injection conditions of the medicinal liquid, the injection protocol, the injection operation, various guidance messages, and various warnings.
  • the display device 13 may be provided in the injection head 10a instead of the console 10b, or in both the injection head 10a and the console 10b.
  • the display device 13 may be a known display device, such as a liquid crystal display device.
  • a touch panel with a touch screen arranged as an input device on a display that serves as a display device can be used as the input device 12 and the display device 13.
  • the input device 12 and display device 13 function as a user interface for receiving various data inputs from the user.
  • An injection protocol indicates what type of medicinal liquid should be injected, in what quantity, and at what speed.
  • the injection rate may be constant or may change over time.
  • the injection protocol also includes information such as the order in which these liquids should be injected.
  • the injection protocol set by the injection control unit 11 can also be modified by the user.
  • 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.
  • the liquid injector 10 and the medical imaging device 50 each have a separate injection control unit 11 and imaging control unit 51.
  • the medical imaging system may have a single control unit that integrates these control units.
  • the injection control unit 11 and the imaging control unit 51 may be included in a programmable computer device (not shown) separate from the liquid injector 10 and the medical imaging device 50, either separately or as an integrated single control unit. This simplifies the configuration of the entire system and enables good coordination between the liquid injector 10 and the medical imaging device 50.
  • injection protocols for injecting at least a contrast agent as a medicinal liquid are pre-set (registered) in the injection control unit 11.
  • the injection protocol pre-set (registered) in the injection control unit 11 may be a normal injection protocol.
  • an injection protocol having at least one phase including an injection phase in which the contrast agent is injected by decreasing or increasing the injection rate over time, is pre-set (registered) in the injection control unit 11.
  • the injection control unit 11 may be configured to be able to set (register) an injection protocol having at least one phase, including an injection phase in which the contrast agent is injected by decreasing or increasing the injection rate over time.
  • the tendency for the CT value of an anatomical structure to increase upon injection of a contrast agent varies depending on the anatomical structure. Therefore, in order to obtain the desired image, it is important to create an injection protocol that, at a certain timing, increases the CT value of each of the multiple anatomical structures to be imaged to a level sufficient for them to be imaged, and that obtains TDCs (time density curves) with CT values that differ enough to obtain a contrast ratio that allows each anatomical structure to be distinguished from one another.
  • TDCs time density curves
  • the CT value of the portal vein increases rapidly around the time of the aorta's peak CT value, particularly around 40 to 50 seconds after the start of contrast agent injection, and the CT value also increases to the extent that the liver and liver cancer can be visualized in the image. Furthermore, between 40 and 50 seconds after the start of injection, the aorta, portal vein, liver, and liver cancer all have significantly different CT values. Therefore, if imaging is performed between 40 and 50 seconds after the start of contrast agent injection, a single image can be obtained in which the aorta, portal vein, liver, and liver cancer can be distinguished based on differences in contrast ratio. Because the resulting images have a high contrast ratio for each anatomical structure, they are easy for users to interpret, and 3D images can also be easily created.
  • the injection phase of the injection protocol may be a variable injection phase in which the contrast agent is injected by linearly decreasing the injection rate over time, or an inverse variable injection phase in which the contrast agent is injected by linearly increasing the injection rate over time.
  • the medicinal liquid injected in the injection phase needs to contain at least the contrast agent. That is, in the injection phase, only the contrast agent may be injected, or the contrast agent diluted with saline may be injected by injecting saline simultaneously with the injection of the contrast agent.
  • the dilution of the contrast agent can be achieved by injecting the contrast agent and saline simultaneously, or by injecting the contrast agent and saline alternately in a time-division manner.
  • the injection phase has multiple phases
  • at least one of the multiple phases may be a variable injection phase or an inverse variable injection phase
  • the other phases may be constant-rate injection phases in which contrast agent or contrast agent diluted with saline is injected at a constant rate.
  • the multiple phases may also include a phase in which only contrast agent is injected and a phase in which contrast agent diluted with saline is injected.
  • the combination and order of phases in which only contrast agent is injected and phases in which contrast agent diluted with saline is injected are not particularly limited.
  • An injection protocol may further include a pre-injection before a phase in which only contrast agent, contrast agent diluted with saline, or only saline is injected.
  • an injection protocol may further include a post-injection after a phase in which only contrast agent, contrast agent diluted with saline, or only saline is injected.
  • An injection protocol may also include both a pre-injection and a post-injection. If an injection protocol has multiple phases, a pre-injection may occur before at least one phase. Similarly, a post-injection may occur after at least one phase.
  • the start of the contrast agent injection (the start of the subsequent phase) can be clearly determined and/or extravasation of the drug solution can be confirmed prior to the subsequent phase.
  • a contrast agent diluted with saline is injected in the pre-injection
  • the contrast agent diluted with saline may be injected in the same pattern as the subsequent phase or phases.
  • the drug solution in the pre-injection in the same pattern as the drug solution to be injected in one or more subsequent phases, but at a lower rate than the drug solution to be injected in the one or more subsequent phases, it is possible to determine in advance the TDC when the drug solution is injected in the one or more subsequent phases and determine the appropriate imaging timing.
  • the injection conditions for the pre-injection and/or post-injection may be set based on the injection volume and injection rate of the drug solution in the subsequent phase, or may be set to the same injection rate and injection time as the subsequent phase (the injection volume can be automatically calculated from the injection rate and injection time).
  • the injection protocol may have a hold or interval between the two phases. If the injection protocol has three or more phases, the injection protocol may have a hold or interval between any of the phases, and any number of holds or intervals.
  • An injection protocol has at least one phase, including an injection phase in which the contrast agent is injected by decreasing or increasing the injection rate over time.
  • General parameters that determine an injection protocol are the injection amount, injection time, and injection rate.
  • the initial injection rate F s can be calculated as follows:
  • the injection volume V can be set according to the subject's physical information.
  • the injection control unit 11 may be further configured to function as a user interface that accepts input of the subject's physical information by the user, allowing the injection control unit 11 to automatically set the injection volume V by accepting the subject's physical information.
  • the injection time T can be set appropriately for each imaging site based on past clinical data, etc.
  • the injection control unit 11 may be further configured to function as a user interface that accepts input of the imaging site by the user, allowing the injection control unit 11 to automatically set the injection time T by accepting input of the imaging site. Therefore, by calculating at least either the initial injection rate Fs or the final injection rate F e, each parameter of the injection protocol can be obtained, allowing the injection protocol to be set.
  • the set values may be configured so that the user can change them as needed.
  • the above concept can be applied to each phase.
  • the change in injection rate is not limited to a linear function change, but may be a stepwise change or an exponential change. Below, several forms of injection protocol are described for cases where the injection rate changes linearly.
  • FIG. 4 shows a first injection protocol set in the injection control unit 11.
  • This injection protocol has a first phase, which is a variable injection phase in which contrast agent is injected at an injection rate that linearly decreases over time, and a second phase, which is an inverse variable injection phase in which contrast agent is injected at an injection rate that linearly increases over time.
  • the first and second phases are continuous, and the final injection rate of the first phase is inherited as the initial injection rate of the second phase. That is, the final injection rate of the first phase is equal to the initial injection rate of the second phase.
  • the end injection rate of the first phase and the initial injection rate of the second phase be zero, and the end injection rate of the first phase and the initial injection rate of the second phase are preset in the injection control unit 11.
  • the end injection rate of the first phase and the initial injection rate of the second phase were set to completely zero in an actual injection operation, it may be impossible to maintain continuity of injection between the first and second phases, so it is preferable to set the end injection rate of the first phase and the initial injection rate of the second phase to values as close to zero as possible. This allows the contrast medium to be injected continuously, without interruption, from the start of the first phase to the end of the second phase.
  • T 1 injection time in the first phase (sec)
  • T2 injection time in the second phase (sec)
  • F 1s initial infusion rate of the first phase (mL/sec)
  • F 1e end infusion rate of the first phase (mL/sec)
  • F 2s initial infusion rate of the second phase (mL/sec);
  • F 2e end infusion rate of the second phase (mL/sec)
  • V 1 injection volume in the first phase (mL);
  • V2 injection volume in the second phase (mL);
  • V total injection volume of first and second phases (mL); is given by
  • f 1 variable constant in the first phase
  • f 2 variable constant in the second phase
  • I 1 iodine amount (mgI/kg) per body weight of the contrast medium injected in the first phase
  • I2 Body weight-specific iodine amount (mgI/kg) of contrast agent injected in the second phase
  • C Iodine concentration of the contrast agent (mgI/mL)
  • BW Subject's weight (kg) is used.
  • these values preset in the injection control unit 11 may be changed by the user as necessary.
  • the initial infusion rate F 1s of the first phase is given by the following formula (1-1) using the final infusion rate F 1e of the first phase, the injection volume V 1 and the injection time T 1 of the first phase.
  • the final infusion rate F 1e of the first phase is preset in the injection control unit 11.
  • the value of the final infusion rate F 1e of the first phase is set to 0.1 (mL/s) in the injection control unit 11.
  • the injection control unit 11 can calculate the initial infusion rate F 1s of the first phase by the following formula (1-1) using the injection volume V 1 of the first phase, the injection time T 1 of the first phase and the final infusion rate F 1e of the first phase.
  • the end infusion rate F 2e of the second phase is given by the following formula (1-2) using the initial infusion rate F 2s of the second phase, the injection volume V 2 in the second phase, and the injection time T 2.
  • the initial infusion rate F 2s of the second phase is equal to the end infusion rate F 1e of the first phase.
  • the value of the initial infusion rate F 2s of the second phase is set to 0.1 (mL/s) in the injection control unit 11.
  • the injection control unit 11 can calculate the end infusion rate F 2e of the second phase by the following formula (1-2) using the injection volume V 2 in the second phase, the injection time T 2 in the second phase, and the initial infusion rate F 2s of the second phase.
  • the parameters of the injection protocol shown in Figure 4 are calculated.
  • this injection protocol by executing a first phase in which the injection rate of the contrast agent decreases linearly and a second phase in which the injection rate of the contrast agent increases linearly so that the contrast agent is injected continuously in the first and second phases, it is possible to acquire image data in a single scan that allows the aorta, veins, and parenchymal organs to be extracted in a manner that allows them to be distinguished from one another. Furthermore, because the desired image data can be acquired in a single scan, the subject's radiation exposure and physical burden can be reduced.
  • Figure 5 shows an example of a simulation result, in the form of a time-concentration curve (TDC), when a contrast agent is injected using the injection protocol shown in Figure 4.
  • TDC time-concentration curve
  • the TDC shown in Figure 5 simulated the changes over time in CT values for the aorta (a blood vessel) and portal vein (a vein), as well as the pancreas and liver (solid organs).
  • Figure 5 shows that approximately 10 to 15 seconds after the end of the first and second phase injections (35 seconds + 10 seconds) (approximately 55 to 60 seconds after the start of injection), (1) the CT value of the aorta reaches its second peak, (2) the CT values of the aorta, portal vein, and solid organs differ enough to be distinguishable from one another, and (3) the CT values of the pancreas and liver increase to a level that allows them to be visualized.
  • a single imaging session approximately 55 to 60 seconds after the start of contrast agent injection can obtain image data that allows the aorta, portal vein, pancreas, and liver to be distinguished from one another.
  • a single imaging of the splenic vein, superior mesenteric vein, and inferior mesenteric vein, etc., at the above timing can also be performed to obtain image data that can be distinguished from other blood vessels.
  • the acquired image data can be used to create medical images (including cross-sectional and 3D images) that facilitate differentiation and diagnosis, as well as medical images (including cross-sectional and 3D images) that are useful for supporting procedures such as pancreatic tumor removal surgery.
  • the liver can be visualized simultaneously with the pancreas, tumors present in the liver as well as the pancreas can be visualized, allowing for confirmation of tumor metastasis to the liver.
  • a tumor is present in a solid organ, the tissue penetration of the contrast agent in the tumor differs from that of normal tissue, resulting in different CT values from normal tissue. Therefore, the presence and size of the tumor can be confirmed based on the differences in CT values within the solid organ.
  • the injection protocol of this embodiment has a first injection phase and a second injection phase, it may also have only the first injection phase, which is a variable injection phase.
  • the phases may be a phase in which contrast agent diluted with saline is injected. In this case, the dilution rate may be set between 0% and 100%.
  • the injection protocol may further have an additional phase after the last phase in which saline or contrast agent diluted with saline is injected, thereby boosting the drug solution injected in the previous phase.
  • the injection protocol of this embodiment has a continuous first and second phases, there may also be an interval between the first and second phases.
  • the subject's body weight is used as the subject's physical information to calculate the injection amount of contrast agent.
  • this is not limiting, and other conventionally known calculation methods may also be used.
  • lean body weight (LBW) calculation methods body surface area (BSA) calculation methods, circulating blood volume (BV) calculation methods, adjusted body weight (AdBW) calculation methods, etc.
  • the injection amount of contrast agent may be calculated using a value (fractional dose) obtained by dividing the amount of iodine per body weight by the injection time.
  • the injection amount may be calculated using a regression equation obtained by regression analysis of statistical data, or may be calculated based on other physical information, or may be calculated using machine learning.
  • the injection control unit 11 may notify the user of this by displaying it on the display device 13, for example, and prompt the user to replace the syringe.
  • the contrast effect of the contrast agent also differs depending on the magnitude of the energy of the electromagnetic waves emitted from the electromagnetic wave irradiator possessed by the imaging operation unit 52 of the medical imaging device 50. Therefore, the calculated injection amount of the contrast agent may be adjusted according to the operating conditions of the electromagnetic wave irradiator. For example, if the medical imaging device 50 is a CT device, the injection amount of the contrast agent can be adjusted according to the tube voltage and energy (two different values in the case of a dual-energy CT device) of the X-ray tube, which is the electromagnetic wave irradiator.
  • FIG. 6 shows injection protocol form 2.
  • This form is the same as the form shown in FIG. 4 in that it has a first phase that is a variable injection and a second phase that is an inverse variable injection. However, this form is intended to inject contrast agent at a certain injection rate at the end of the first phase. It also differs from the form shown in FIG. 4 in that the end injection rate F 1e of the first phase and the initial injection rate F 2s of the second phase are not set, but a variable constant f 1 of the first phase is set.
  • the other parameters can be calculated in the same manner as the form shown in FIG. 4.
  • the initial injection rate F 1s of the first phase is given by the following equation (2-1), and the end injection rate F 1e of the first phase is given by the following equation (2-2).
  • the injection control unit 11 calculates the initial injection rate F 1s and the final injection rate F 1e of the first phase using these equations (2-1) and (2-2).
  • the injection protocol may also include an additional phase in which saline is injected after the final phase, to boost the contrast agent with saline. There may also be intervals between phases.
  • the injection control unit 11 calculates the initial injection rate F 2s and the final injection rate F 2e of the second phase using these equations (3-1) and (3-2).
  • the phases may be a phase in which contrast agent diluted with saline is injected.
  • the dilution rate can be set between 0% and 100%.
  • the injection protocol may also include an additional phase after the last phase in which saline or contrast agent diluted with saline is injected, thereby boosting the medicinal liquid injected in the previous phase. There may also be an interval between phases.
  • FIG. 8 shows injection protocol form 4.
  • This form has a first phase, which is a constant-rate injection phase, a second phase, which is a variable injection phase, a third phase, which is an inverse-variable injection phase, and a fourth phase, which is a constant-rate injection phase.
  • the initial injection rate F2s of the second phase is equal to the injection rate F1 of the first phase
  • the initial injection rate F3s of the third phase is equal to the final injection rate F2e of the second phase
  • the injection rate F4 of the fourth phase is equal to the final injection rate F3e of the third phase.
  • Contrast medium is injected continuously from the first phase to the fourth phase.
  • the injection rate F1 of the first phase and the injection rate F4 of the fourth phase may be different from each other or may be the same.
  • the final injection rate F2e of the second phase and the initial injection rate F3s of the third phase may be injection rates intended to be zero, or may be injection rates intended to inject a certain amount of contrast medium.
  • the calculation formulas for each parameter are omitted.
  • the phases may be a phase in which contrast agent diluted with saline is injected.
  • the dilution rate can be set between 0% and 100%.
  • the injection protocol may also include an additional phase after the final phase in which saline or contrast agent diluted with saline is injected, thereby boosting the medicinal liquid injected in the previous phase.
  • There may also be an interval between at least one of the first and second phases, the second and third phases, and the third and fourth phases.
  • FIG. 9 shows infusion protocol form 5.
  • This form has a first phase, which is a variable infusion phase, and a second phase, which is also a variable infusion phase.
  • the initial infusion rate F2s of the second phase is higher than the final infusion rate F1e of the first phase.
  • the initial infusion rate F2s of the second phase may be higher, lower, or the same as the initial infusion rate F1s of the first phase.
  • the final infusion rate F2e of the second phase may be higher, lower, or the same as the final infusion rate F1e of the first phase.
  • the variable constant f1 of the first phase and the variable constant f2 of the second phase may be the same or different.
  • the calculation formulas for each parameter are omitted.
  • the phases may be a phase in which contrast agent diluted with saline is injected.
  • the dilution rate can be set between 0% and 100%.
  • the injection protocol may also include an additional phase after the last phase in which saline or contrast agent diluted with saline is injected, thereby boosting the medicinal liquid injected in the previous phase. There may also be an interval between phases.
  • FIG. 10 shows the sixth form of infusion protocol.
  • This form has a first phase, which is a variable infusion phase, and a second phase, which is a constant rate infusion phase.
  • the final infusion rate F1e of the first phase may be higher than, lower than, or the same as the infusion rate F2 of the second phase.
  • the calculation formulas for each parameter are omitted.
  • the second phase is a constant-rate injection phase, but the first phase may also be a constant-rate injection phase.
  • the second phase may be a variable injection phase or a reverse-variable injection phase.
  • only contrast agent is injected, but at least one of the phases may be a phase in which contrast agent diluted with saline is injected.
  • the dilution rate can be set between 0% and 100%.
  • the injection protocol may also have an additional phase after the last phase in which saline or contrast agent diluted with saline is injected, thereby boosting the drug solution injected in the previous phase. There may also be an interval between phases.
  • Injection protocol form 7 11 shows injection protocol type 7.
  • This injection protocol has a first phase in which the contrast agent is injected at a constant injection rate, and a second phase in which the contrast agent is injected at a linearly varying injection rate.
  • the injection rate at the start of the second phase i.e., the initial rate, is equal to the injection rate in the first phase.
  • T 1 injection time in the first phase (sec)
  • T2 injection time in the second phase (sec)
  • F 1 infusion rate in the first phase (mL/sec)
  • F2 terminal rate of injection in the second phase (mL/sec)
  • V 1 injection volume in the first phase (mL)
  • V2 injection volume in the second phase (mL)
  • V total injection volume of first and second phases (mL); is given by
  • C variable constant (final velocity in the second phase/initial velocity in the second phase)
  • I need required amount of iodine (mgI/kg)
  • I CM contrast agent concentration (mgI/mL)
  • W Subject's weight (kg), is used.
  • the total injection volume V is calculated using equation (7-1). Note that the injection time T1 in the first phase and the injection time T2 in the second phase are preset in the injection control unit 11, but can be changed by the user as needed.
  • the injection conditions for the first phase and the second phase are calculated so that the contrast medium is injected in the determined total injection volume V.
  • the injection rate F1 for the first phase is calculated using equation (7-2).
  • the injection protocol shown in Figure 11 is calculated.
  • a phase in which the contrast agent is injected at a constant injection rate is executed prior to a phase in which the injection rate of the contrast agent decreases linearly, making it possible to inject a relatively large amount of contrast agent in the early stages of injection while suppressing the initial injection rate.
  • an injection protocol is achieved that reduces the physical burden on the subject and improves the contrast effect.
  • the injection time T1 in the first phase is preferably within the range of 5 to 15 seconds. If the injection time T1 in the first phase is less than 5 seconds, the injection rate may not be sufficiently reduced. Conversely, if the injection time T1 in the first phase exceeds 15 seconds, a CT value suitable for imaging may not be maintained. Furthermore, the variable coefficient C is preferably within the range of 0.3 to 0.5.
  • the injection control unit 11 may be configured to display at least one screen for setting an injection protocol on the display device 13. Examples of the screen for setting an injection protocol include a screen for setting an imaging site and a screen for setting parameters of the injection protocol.
  • the user follows these screens to input the imaging area, subject weight, iodine concentration of the contrast agent, iodine amount relative to body weight of the contrast agent, injection time, variable constants (in the case of a variable injection phase or inverse variable injection phase), etc., and the injection control unit 11 calculates the remaining parameters and sets the resulting injection protocol.
  • the iodine amount relative to body weight of the contrast agent, injection time, and variable constants may be preset to specific values in the injection control unit 11, and the user may be able to change these values as needed.
  • the iodine concentration of the contrast agent may also be automatically obtained from the syringe 20. If the syringe 20 is equipped with a data carrier (RFID tag, barcode, etc.) on which various data including the contrast agent concentration is recorded, the various data recorded on the data carrier can be obtained by reading the data carrier with an appropriate reader.
  • FIG. 12 An example of a display screen is described in detail below with reference to Figures 12 to 18.
  • the following describes a liquid injector 10 having an injection head 10a equipped with two drive mechanisms 15 so that two syringes 20 can be mounted.
  • Each drive mechanism 15 is identified by "A” and "B,” and the syringe 20 operated by the drive mechanism 15 on side A is filled with contrast medium, while the syringe 20 operated by the drive mechanism 15 on side B is filled with saline. Therefore, "A” displayed on the screen shown below represents contrast medium, and "B" represents saline.
  • the imaging region selection screen When setting an injection protocol, the imaging region selection screen is first displayed.
  • the imaging region selection screen displays an image of a human body divided into multiple body segments, and the user specifies the imaging region by performing predetermined input operations according to the imaging region selection screen.
  • selecting an imaging region for example, the user selects one of multiple body segments, and multiple imaging regions included in the selected body segment are further displayed, from which the user can select an imaging region, allowing the imaging region to be specified in multiple stages, from larger segments to smaller regions.
  • the selected imaging region is set in the injection control unit 11.
  • the injection protocol setting screen displays a human body image 201 representing the imaging area, a contrast agent concentration button 202, a required iodine amount button 203, a pressure limit button 204, a volume of drug solution in the syringe 205, a weight button 206, an injection time button 207, a thumbnail 210 of the injection protocol, and the like.
  • the contrast agent concentration button 202 displays the concentration of the contrast agent filled in the syringe 20 mounted on the injection head 10a.
  • the data for the contrast agent concentration may be obtained automatically from the syringe 20, or may be input by the user. If the syringe 20 is equipped with a data carrier (RFID tag, barcode, etc.) on which various data including the contrast agent concentration is recorded, the various data recorded on the data carrier can be obtained by reading the data carrier with an appropriate reader. Furthermore, if the pressure resistance value of the syringe 20 and the concentration of the contrast agent filled in the syringe 20 are recorded on the data carrier, these values are displayed and set on the contrast agent concentration button 202 and pressure limit button 204, respectively.
  • the Required Iodine Amount button 203 displays the amount of iodine per subject's body weight required to achieve a contrast effect.
  • the value displayed on the Required Iodine Amount button 203 can be changed by the user via the input device 12. If the input device 12 is configured as part of a touch panel display, for example, when the user taps the Required Iodine Amount button 203, the injection control unit 11 displays a sub-screen for entering numerical values, overlapping the protocol setting screen. The user can change the required iodine amount by entering a numerical value on this sub-screen.
  • the pressure limit button 204 displays the limit value of the internal pressure that occurs during the injection of the medicinal liquid; if this limit value is exceeded, the injection control unit 11 controls the operation of the drive mechanism 15 so that the limit value is not exceeded (for example, by limiting the injection rate or stopping the injection), and issues an appropriate alarm to the user.
  • the weight button 206 displays the subject's weight
  • the injection time button 207 displays the injection time for the first phase.
  • the injection time for the first phase is one of the important parameters that affects the injection rate of the contrast agent in the injection protocol of this embodiment. Therefore, displaying the injection time for the first phase on the injection protocol setting screen is preferable for the user to determine whether the injection protocol is appropriate.
  • the values displayed on the pressure limit button 204, weight button 206, and injection time button 207 can be changed by the user, just like the required iodine amount button 203.
  • the required iodine amount, weight, and injection time are also stored in the memory device of the injection control unit 11 and are used to calculate the injection protocol.
  • Thumbnail 210 displays a protocol image that shows the change in the injection rate of the liquid drug over time for the set injection protocol as an injection rate-time graph, with time on the horizontal axis and injection rate on the vertical axis.
  • thumbnail 210 shows an injection protocol consisting of two phases, a first phase (0-10 seconds) and a second phase (10-30 seconds).
  • the thumbnail 211 also displays a back button 211a, and the user can hide the thumbnail 211 by operating the back button 211a.
  • the injection rate in the first phase and the initial rate in the second phase of the injection protocol displayed in the thumbnail 211 can be changed by the user.
  • a first phase rate button 212 and a second phase initial rate button 213 can be displayed in the thumbnail 211, as shown in FIG. 14A.
  • the thumbnail 211 may also display the total injection volume 214 of the medicinal fluid to be injected with this injection protocol.
  • the total injection volume 214 indicates that 80 mL of medicinal fluid, i.e., contrast medium, will be injected on side A.
  • the user can change the injection rate in the first phase by performing a predetermined input operation on the first phase speed button 212.
  • the initial rate in the second phase also changes accordingly, but the injection time in the first phase, the injection time in the second phase, and the variable constants do not change.
  • the injection rate in the first phase is changed to 2.4 mL/sec by operating the first phase speed button 212, and the initial rate in the second phase also changes accordingly to 2.4 mL/sec. Note that by changing the injection rate in the first phase and the initial rate in the second phase, the total injection volume in the first and second phases changes from 80 mL to 55 mL.
  • the user can also change the initial rate in the second phase by performing a specified input operation on the second phase initial rate button 213.
  • the injection time in the first phase, the injection time in the second phase, the rate in the first phase, and the variable constants remain unchanged.
  • the initial rate in the second phase is changed to 2.4 mL/sec, and accordingly the total injection volume in the first and second phases is changed to 65 mL.
  • the user can perform a specified input operation, which causes the injection control unit 11 to display a setting confirmation screen, such as that shown in FIG. 15, on the display device 13.
  • a specified input operation which causes the injection control unit 11 to display a setting confirmation screen, such as that shown in FIG. 15, on the display device 13.
  • Examples of appropriate input operations by the user at this time include operating a button provided on the injection head 10a, operating a hand switch connected to the injection head 10a, or operating the check button 215 displayed on the injection protocol setting screen shown in FIG. 12.
  • the settings confirmation screen can display an injection protocol that shows, for example, the imaging area, the subject's weight, the amount of iodine required, the injection time, the amount of medicinal liquid in the syringe, and the injection rate over time.
  • the settings confirmation screen also displays a start OK button 311 and a pressure limit button 312. In this state, the user can further perform a specified input operation to execute the medicinal liquid injection. Examples of specified user input operations include operating a button on the injection head 10a, operating a hand switch connected to the injection head 10a, or operating the start OK button 311 displayed on the settings confirmation screen shown in Figure 15.
  • the settings confirmation screen shown in Figure 15 displays the pressure limit button 312, which the user can use to change the pressure limit value.
  • the injection control unit 11 displays an injection screen such as that shown in Figure 16 on the display device 13.
  • the injection screen displays an injection graph in real time, which shows the change in injection pressure over time.
  • the injection graph is displayed approximately 20 seconds after the start of injection.
  • the injection graph displays a marker indicating the end of the first phase or the start of the second phase, as well as a marker indicating the current time.
  • the injection protocol performed in this test is saved in the memory device of the injection control unit 11 as the injection result along with the date.
  • the injection results can be displayed on the display device 13, for example, in the form of a list of previously performed injections as shown in FIG. 17 and/or in the form of an injection result graph as shown in FIG. 18.
  • the list may include, for example, the injection date and time, injection pattern, maximum injection rate, injection volume, and maximum injection pressure.
  • the injection pattern can be represented by an injection graph image 411, which pictograms the injection protocol as a rate-time graph, allowing the user to recognize at a glance the injection pattern in which the medicinal liquid was injected.
  • the default values of each parameter are those preset in the injection control unit 11.
  • Some of the displayed parameters can be changed on the injection protocol setting screen, and when a parameter required for calculating the injection protocol is changed, the injection control unit 11 recalculates the injection protocol using the changed parameter.
  • variable constants important for calculating the injection protocol and the injection time in the second phase cannot be changed on the injection protocol setting screen (in particular, the variable constants are not even displayed on the screen). This is to prevent the user from casually changing these parameters.
  • the screens displayed in Figures 19A and 19B can be called up, for example, from the home screen, separately from the normal series of steps from setting the injection protocol to executing the injection operation.
  • the injection pattern selection screen shown in Figure 19A is first displayed.
  • the injection pattern selection screen displays icons that schematically represent the injection patterns registered in the injection control unit 11.
  • the user selects from the displayed icons the icon that represents the injection pattern for which they wish to edit the injection protocol.
  • a protocol editing screen is displayed, displaying various parameters for the selected injection pattern, as shown in FIG. 19B.
  • the user can change the value of each parameter by performing a predetermined input operation on this protocol editing screen. After changing the parameter value, the user can confirm the value of each parameter by operating the "Next" button.
  • the protocol editing screen also allows the user to change not only the required iodine amount and the injection time for the first phase, but also the injection time and variable constants for the second phase, which cannot be changed by the user on the injection protocol setting screen shown in FIG. 12.
  • the injection control unit 11 may be configured to display a protocol selection screen on the display device 13 so that the user can select an injection protocol depending on the imaging site, imaging purpose, etc.
  • the liquid injector 10 may further include a sub-display 14 controllably connected to the control unit 11 as a second display device.
  • the sub-display 14 is located in the examination room and may be, for example, integrally provided with the injection head 10a.
  • the sub-display 14 may display the screens described with reference to FIGS. 12 to 18 .
  • the sub-display 14 allows the user to check and set the injection protocol while observing the subject's condition in the examination room.
  • the sub-display 14 is preferably a touch panel display.
  • the display device 13 may also be referred to as the main display.
  • the display contents on both may be the same or different.
  • the main display and sub-display 14 are touch panels, they may be configured to exclusively accept input operations, or to accept input operations simultaneously. If both are configured to exclusively accept input operations, input operations on one may be prohibited when one is in a state where it can accept input operations, or if both are configured to accept input operations simultaneously, input operations on the other may be prohibited when one is in a state where it is accepting input operations. Furthermore, they may be configured to display a screen prompting input operations on the other depending on the state.
  • the main display and sub-display 14 may be configured to allow the setting of injection conditions for different subjects. This allows, for example, the setting of injection conditions for the current subject on the sub-display 14 while the setting of injection conditions for the next subject on the main display, resulting in efficient injections for multiple subjects.
  • the container to be filled with the drug solution is syringe 20, and driving mechanism 15 is described as operating syringe 20.
  • the container may be a bag or a bottle, in which case a known mechanism such as a tube-type pump can be used as driving mechanism 15.
  • the injection control unit 11 may be configured to simulate the currently set injection protocol prior to the injection operation and display the results, for example, in a TDC.
  • an injection simulation button 250 may be displayed on the screen for setting the injection protocol, and the injection simulation may be executed by the user operating this injection simulation button 250.
  • the injection simulation may be executed using a known simulation algorithm.
  • the simulation may be performed only for the currently set injection protocol, and its TDC may be displayed. Alternatively, a simulation may be performed for the currently set injection protocol and at least one other injection protocol, and their TDCs may be displayed simultaneously, allowing the TDC of the currently set injection protocol to be compared with the TDC of another injection protocol.
  • the injection control unit 11 may also have an injection protocol optimization function that uses the results of the simulation to determine the optimal imaging timing for each blood vessel and each solid organ, for example, based on the magnitude of the CT number and the magnitude of the difference in CT numbers between other blood vessels and solid organs, and provides this to the user.
  • the other injection protocol to be compared may be any injection protocol, or, if the currently set injection protocol is an injection protocol whose parameters have been changed by the user on the injection setting screen as described using Figures 4, 5, and 6A-6C, it may be the injection protocol before the change, or it may be both the any injection protocol and the injection protocol before the change.
  • Figure 22 shows an example of a TDC that can be displayed as an injection simulation result.
  • the solid line represents the simulation results when the currently set injection protocol is the injection protocol described in Injection Protocol Form 7 (hereinafter referred to as the trapezoidal injection protocol), while the dashed line represents the simulation results when the other injection protocol is the variable injection protocol.
  • Figure 22 shows that the trapezoidal injection protocol produces a time-concentration curve equivalent to that of the variable injection protocol, while injecting at a lower initial rate than the variable injection protocol.
  • variable injection protocol used for comparison was simulated with the same variable constants as the trapezoidal injection protocol, but simulations may also be performed with variable constants determined separately from the trapezoidal injection protocol.
  • the simulation results can be displayed as a pop-up screen overlaid on the currently displayed screen.
  • the displayed simulation results can be configured to close with a specified user operation. This allows the user to adjust the injection conditions while checking the simulation results, optimizing the injection conditions so that the desired contrast ratios between multiple anatomical structures are achieved.
  • the TDC displayed as the simulation results may be configured to include the TDC of that tumor. In this case, the TDC may be calculated for a tumor modeled using a statistical method. In this way, displaying the tumor along with the anatomical structure on the TDC makes it easier to find the imaging timing that will increase the contrast ratio between the anatomical structure and the tumor.
  • the injection control unit 11 may be configured to automatically simulate injection conditions that will increase the contrast ratio between each anatomical structure and the tumor, and display the results as a TDC, for example.
  • the TDC displayed as a simulation result may reflect the subject's biometric information.
  • the subject's biometric information may be input by the user, or may be input from one or more appropriate sensors for detecting biometric information.
  • Biometric information includes heart rate information, blood oxygen saturation, blood pressure information, electrocardiogram information, pulse wave information, body temperature, respiratory rate, inhalation state, and exhalation state, and at least one of these can be reflected in the TDC.
  • injection control unit 11 of liquid injector 10 may be connected to medical network 70.
  • RIS Radiology Information System
  • PACS Physical Component Automation System
  • HIS Hospital Information System
  • external cloud server etc.
  • the configured injection protocol includes the injection rate, injection time, and injection volume (or, in the case of a multi-phase injection, the injection rate, injection time, injection volume, and injection pressure for each phase).
  • the data format may be text, graph, or image data.
  • the injection protocol may be saved as an image that visually represents the injection pattern, such as the injection rate-time graph shown in Figure 3. In this case, at least one of the injection conditions may be saved as part of the image, separately from the image, or both.
  • the injection results may include not only the injection rate, injection time, and injection volume of the actual injected drug (or, in the case of a multi-phase injection, the injection rate, injection time, and injection volume for each phase), but also injection result graphs (time-concentration curve, injection rate-time graph, injection pressure-time graph).
  • the injection result graph may be in a format that allows the user to freely switch between an injection rate-time graph and an injection pressure-time graph, for example by switching the vertical axis between injection rate and injection pressure.
  • Other examples of injection results include contrast images obtained by imaging and TDC. This makes it easier for the user to understand the relationship between the injection protocol and the injection results. Furthermore, the injection protocol and the injection results can be easily compared, which can be useful for adjusting the injection protocol or imaging protocol to obtain better contrast images during the next contrast examination.
  • the container into which the medicinal liquid is filled is equipped with a data carrier and data is acquired from that data carrier, the acquired data can also be stored in a RIS, PACS, HIS, etc. via the medical network 70.
  • Data recorded on the data carrier includes various data related to the medicinal liquid, such as the manufacturer, type of medicinal liquid, product number, contained ingredients (especially iodine concentration if the medicinal liquid is a contrast agent), amount of medicinal liquid contained, lot number, expiration date, etc.
  • various data related to the syringe can be included, such as unique identification numbers such as the manufacturer and product number, allowable pressure value, syringe capacity, piston stroke, necessary dimensions of each part, lot number, etc.
  • the saved injection data is used to manage injection history.
  • the injection amount can be recorded in the patient's medical record as used liquid medicine, or used for accounting purposes.
  • the subject's physical information such as weight, ID, name, examination area, and examination method can be obtained from RIS, PACS, HIS, etc. and displayed on the liquid medicine injector, allowing the appropriate injection to be carried out.
  • a liquid medicine injection device that injects a liquid medicine filled in a container into a subject, a control unit configured to set an injection protocol in which at least a contrast agent is injected as the medicinal liquid; the injection protocol has at least one phase including an injection phase in which the contrast agent is injected at a decreasing or increasing injection rate over time; the control unit is configured to set the injection protocol using at least one of parameters including an injection amount of contrast agent, an injection time of contrast agent, an injection rate of contrast agent at the start of a phase, an injection rate of contrast agent at the end of a phase, and a variable constant expressed as injection rate of contrast agent at the end of a phase/injection rate of contrast agent at the start of a phase; Chemical injection device.
  • A2 The drug solution injector described in A1, wherein the injection phase is a variable injection phase in which the contrast agent is injected by decreasing the injection rate linearly over time.
  • the injection amount of the contrast agent is V (mL)
  • the injection time of the contrast agent is T (sec)
  • the injection rate of the contrast agent at the start of the phase is F s (mL/sec)
  • the injection rate of the contrast agent at the end of the phase is F e (mL/sec)
  • T (sec) and F e (mL/sec) are set in the control unit, and the control unit calculates V (mL) using the subject's physical information and calculates V (mL) using the following formula:
  • the control unit calculates V (mL) using the subject's physical information and calculates V (mL) using the following formula:
  • F s (mL/sec) is calculated by:
  • the injection amount of the contrast agent in the first phase is V 1 (mL)
  • the injection amount of the contrast agent in the second phase is V 2 (mL)
  • the injection time of the contrast agent in the first phase is T 1 (sec)
  • the injection time of the contrast agent in the second phase is T 2 (sec)
  • the initial injection rate of the contrast agent in the first phase is F 1s (mL/sec)
  • the final injection rate of the contrast agent in the first phase is F 1e (mL/sec)
  • the initial injection rate of the contrast agent in the second phase is F 2s (mL/sec)
  • the final injection rate of the contrast agent in the second phase is F 2e (mL/sec)
  • the control unit calculates V 1 (mL) and V 2 (mL) using the subject's physical information, and calculates V 1 (
  • control unit is configured to set a final injection rate F1e of the contrast agent in the first phase and an initial injection rate F2s of the contrast agent in the second phase, both of which are 0.1 (mL/sec).
  • the injection amount of the contrast agent in the first phase is V 1 (mL)
  • the injection amount of the contrast agent in the second phase is V 2 (mL)
  • the injection time of the contrast agent in the first phase is T 1 (sec)
  • the injection time of the contrast agent in the second phase is T 2 (sec)
  • the initial injection rate of the contrast agent in the first phase is F 1s (mL/sec)
  • the final injection rate of the contrast agent in the first phase is F 1e (mL/sec)
  • the initial injection rate of the contrast agent in the second phase is F 2s (mL/sec)
  • the final injection rate of the contrast agent in the second phase is F 2e (mL/sec)
  • the variable constant of the first phase is f 1
  • f 1 is set in the control unit
  • F 1e (mL/sec) F 2s (mL/sec)
  • the control unit calculates V 1 (mL) and V 2 (mL) using the subject's physical information, and calculates V 1 (mL) and
  • the injection amount of the contrast agent in the first phase is V 1 (mL)
  • the injection amount of the contrast agent in the second phase is V 2 (mL)
  • the injection time of the contrast agent in the first phase is T 1 (sec)
  • the injection time of the contrast agent in the second phase is T 2 (sec)
  • the initial injection rate of the contrast agent in the first phase is F 1s (mL/sec)
  • the final injection rate of the contrast agent in the first phase is F 1e (mL/sec)
  • the initial injection rate of the contrast agent in the second phase is F 2s (mL/sec)
  • the final injection rate of the contrast agent in the second phase is F 2e (mL/sec)
  • the variable constant of the first phase is f 1
  • the variable constant of the second phase is f 2
  • f 1 and f 2 are set in the control unit, and the control unit calculates V 1 (mL) and V 2 (mL) using the subject's physical information, and calculates V 1 (mL) and V 2 (
  • a drug solution injector that injects a drug solution filled in a container into a subject; a medical imaging device that acquires medical images from a subject into whom a liquid has been injected by the liquid injector; a control unit configured to set an injection protocol in which at least a contrast agent is injected as the medicinal liquid; and the injection protocol has at least one phase including an injection phase in which the contrast agent is injected at a decreasing or increasing injection rate over time; the control unit is configured to set the injection protocol using at least one of parameters including an injection amount of contrast agent, an injection time of contrast agent, an injection rate of contrast agent at the start of a phase, an injection rate of contrast agent at the end of a phase, and a variable constant expressed as injection rate of contrast agent at the end of a phase/injection rate of contrast agent at the start of a phase; Medical imaging systems.
  • a computer program for a liquid medicine injector that injects a liquid medicine filled in a container into a subject, Computer, a control unit configured to set an injection protocol in which at least a contrast agent is injected as the liquid medicine; the injection protocol has at least one phase including an injection phase in which the contrast agent is injected at a decreasing or increasing injection rate over time; the control unit is configured to set the injection protocol using at least one of parameters including an injection amount of contrast agent, an injection time of contrast agent, an injection rate of contrast agent at the start of a phase, an injection rate of contrast agent at the end of a phase, and a variable constant expressed as injection rate of contrast agent at the end of a phase/injection rate of contrast agent at the start of a phase; Computer program.
  • a computer program for a medical imaging system having a liquid medicine injector that injects a liquid medicine filled in a container into a subject, and a medical imaging device that acquires medical images of the subject into whom the liquid medicine has been injected by the liquid medicine injector comprising: Computer, a control unit configured to set an injection protocol in which at least a contrast agent is injected as the liquid medicine; the injection protocol has at least one phase including an injection phase in which the contrast agent is injected at a decreasing or increasing injection rate over time; the control unit is configured to set the injection protocol using at least one of parameters including an injection amount of contrast agent, an injection time of contrast agent, an injection rate of contrast agent at the start of a phase, an injection rate of contrast agent at the end of a phase, and a variable constant expressed as injection rate of contrast agent at the end of a phase/injection rate of contrast agent at the start of a phase; Computer program.
  • a liquid medicine injection device for injecting a liquid medicine filled in a container into a subject, a control unit configured to set an injection protocol in which at least a contrast agent is injected as the medical solution in a plurality of injection phases including a first phase and a second phase subsequent to the first phase;
  • the control unit Calculating a total injection amount of the contrast agent to be injected in the injection protocol based on the subject's physical information; and calculating injection conditions for the contrast agent in the first phase and the second phase such that the contrast agent is injected at a constant injection rate in the first phase, and the contrast agent is injected at a variable injection rate in the second phase, and the total injection amount of the contrast agent is injected in the first phase and the second phase;
  • Chemical injection device for injecting a liquid medicine filled in a container into a subject, a control unit configured to set an injection protocol in which at least a contrast agent is injected as the medical solution in a plurality of injection phases including a first phase and a second phase subsequent to the first phase;
  • the drug solution injector described in B1 further comprising a user interface for accepting input of the subject's physical information, the duration of the first phase, and the duration of the second phase from the user.
  • the chemical liquid injector according to B1 wherein the injection conditions include an injection time in the first phase, an injection time in the second phase, an injection rate in the first phase, a terminal rate in the second phase, an injection amount in the first phase, and an injection amount in the second phase.
  • B6 The liquid injector according to B5, wherein the injection time in the first phase and the injection time in the second phase are preset in the control unit.
  • B7 When the total injection volume is V (mL), the required amount of iodine is I (mgI/kg), the contrast medium concentration is I (mgI/mL), and the subject's weight is W (kg), the total injection volume V is The chemical liquid injector according to B4,
  • the injection rate in the first phase is F 1 (mL/sec)
  • the injection time in the first phase is T 1 (sec)
  • the injection time in the second phase is T 2 (sec)
  • a variable constant represented by the final rate in the second phase/the initial rate in the second phase is C
  • the injection rate F 1 (mL/sec) in the first phase is The chemical liquid injector according to B5
  • a drug solution injector that injects a drug solution filled in a container into a subject; a medical imaging device that acquires medical images from a subject into whom a liquid has been injected by the liquid injector; a control unit configured to set an injection protocol in which at least a contrast agent is injected as the medical solution in a plurality of injection phases including a first phase and a second phase subsequent to the first phase; The control unit Calculating a total injection amount of the contrast agent to be injected in the injection protocol based on the subject's physical information; and calculating injection conditions for the contrast agent in the first phase and the second phase such that the contrast agent is injected at a constant injection rate in the first phase, and the contrast agent is injected at a variable injection rate in the second phase, and the total injection amount of the contrast agent is injected in the first phase and the second phase; Medical imaging systems.
  • a computer program for a liquid medicine injector that injects a liquid medicine filled in a container into a subject, Computer, a control unit configured to set an injection protocol in which at least a contrast agent is injected as the medical solution in a plurality of injection phases including a first phase and a second phase subsequent to the first phase;
  • the control unit Calculating a total injection amount of the contrast agent to be injected in the injection protocol based on the subject's physical information; and calculating injection conditions for the contrast agent in the first phase and the second phase such that the contrast agent is injected at a constant injection rate in the first phase, and the contrast agent is injected at a variable injection rate in the second phase, and the total injection amount of the contrast agent is injected in the first phase and the second phase;
  • a computer program for a medical imaging system having a liquid medicine injector that injects a liquid medicine filled in a container into a subject, and a medical imaging device that acquires medical images of the subject into whom the liquid medicine has been injected by the liquid medicine injector comprising: Computer, a control unit configured to set an injection protocol in which at least a contrast agent is injected as the medical solution in a plurality of injection phases including a first phase and a second phase subsequent to the first phase; The control unit Calculating a total injection amount of the contrast agent to be injected in the injection protocol based on the subject's physical information; and calculating injection conditions for the contrast agent in the first phase and the second phase such that the contrast agent is injected at a constant injection rate in the first phase, and the contrast agent is injected at a variable injection rate in the second phase, and the total injection amount of the contrast agent is injected in the first phase and the second phase; Computer program.

Landscapes

  • Health & Medical Sciences (AREA)
  • Vascular Medicine (AREA)
  • Engineering & Computer Science (AREA)
  • Anesthesiology (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Hematology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Infusion, Injection, And Reservoir Apparatuses (AREA)

Abstract

La présente invention concerne un dispositif d'injection de solution médicamenteuse ou similaire capable de régler un protocole d'injection qui permet l'acquisition d'une bonne image médicale avec moins de charge physique sur un sujet. Ce dispositif d'injection de solution médicamenteuse comprend une unité de commande configurée pour régler un protocole d'injection dans lequel au moins un agent de contraste est injecté en tant que solution médicamenteuse. Le protocole d'injection présente au moins une phase comprenant une phase d'injection dans laquelle l'agent de contraste est injecté alors que la vitesse d'injection est diminuée ou augmentée avec le passage du temps. L'unité de commande est configurée pour régler le protocole d'injection à l'aide d'au moins un des paramètres parmi une quantité d'injection V de l'agent de contraste, un temps d'injection T de l'agent de contraste, une vitesse d'injection Fs de l'agent de contraste au début de la phase, une vitesse d'injection Fe de l'agent de contraste à la fin de la phase, et une constante variable exprimée par la vitesse d'injection Fe de l'agent de contraste à la fin de la phase/la vitesse d'injection Fsde l'agent de contraste au début de la phase.
PCT/JP2025/008879 2024-03-08 2025-03-10 Dispositif d'injection de solution médicamenteuse Pending WO2025187842A1 (fr)

Applications Claiming Priority (4)

Application Number Priority Date Filing Date Title
JP2024-036124 2024-03-08
JP2024036124 2024-03-08
JP2024192522 2024-10-31
JP2024-192522 2024-10-31

Publications (2)

Publication Number Publication Date
WO2025187842A1 true WO2025187842A1 (fr) 2025-09-12
WO2025187842A8 WO2025187842A8 (fr) 2025-10-02

Family

ID=96990851

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/JP2025/008879 Pending WO2025187842A1 (fr) 2024-03-08 2025-03-10 Dispositif d'injection de solution médicamenteuse

Country Status (1)

Country Link
WO (1) WO2025187842A1 (fr)

Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2007116840A1 (fr) * 2006-04-04 2007-10-18 Nemoto Kyorindo Co., Ltd. Injecteur de solution de médicament
WO2014168210A1 (fr) * 2013-04-11 2014-10-16 株式会社根本杏林堂 Dispositif d'injection de produit chimique

Patent Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2007116840A1 (fr) * 2006-04-04 2007-10-18 Nemoto Kyorindo Co., Ltd. Injecteur de solution de médicament
WO2014168210A1 (fr) * 2013-04-11 2014-10-16 株式会社根本杏林堂 Dispositif d'injection de produit chimique

Also Published As

Publication number Publication date
WO2025187842A8 (fr) 2025-10-02

Similar Documents

Publication Publication Date Title
JP6208205B2 (ja) 医療用注入手順用に患者ベースのパラメータを生成するシステム
JP5232473B2 (ja) 注入処理中に生成される圧力をモデル化するためのシステム及び装置
US11398165B2 (en) Simulator, injection device or imaging system provided with simulator, and simulation program
JP7296654B2 (ja) 注入プロトコルの生成装置、該生成装置を備える注入装置及び撮像装置、注入プロトコル生成方法、及び注入プロトコル生成プログラム
CN111528872A (zh) 用于基于x射线管电压确定药用流体注射协议的系统和方法
US11565035B2 (en) Systems and methods for split bolus protocol generation
JP7646234B2 (ja) 薬液注入装置および注入プロトコル設定プログラム
US20220133982A1 (en) System and methods for delivering a test bolus for medical imaging
JP7202595B2 (ja) 血管画像処理システムおよび血管画像処理方法
JP6327632B2 (ja) 薬液注入装置
WO2025187842A1 (fr) Dispositif d'injection de solution médicamenteuse
JP2020124598A (ja) 薬液注入装置
JP7711910B2 (ja) 報知システム、報知システムの制御方法、及び報知プログラム
JP2024178457A (ja) 注入システム、制御方法、及び制御プログラム
WO2020012657A1 (fr) Simulateur, dispositif d'injection ou système d'imagerie comprenant ledit simulateur, et programme de simulation
JP2024133044A (ja) 医用画像品質評価装置、医用画像品質評価方法および医用画像品質評価プログラム
AU2023337897A1 (en) Systems and methods for generating protocols embodying contrast and radiation dose management techniques
JP2022048581A (ja) シミュレーター、シミュレーターの制御方法、及びシミュレーションプログラム

Legal Events

Date Code Title Description
121 Ep: the epo has been informed by wipo that ep was designated in this application

Ref document number: 25768469

Country of ref document: EP

Kind code of ref document: A1