JP7789403B2 - Chemical injection device - Google Patents

Description

The present invention relates to a liquid injector that injects a contrast agent into a subject to obtain a good contrast effect when capturing fluoroscopic images of the subject using an imaging diagnostic device.

Medical imaging diagnostic devices include CT devices, MRI devices, PET devices, angiography devices, MRA devices, and ultrasound imaging diagnostic devices. When using these devices, a contrast agent or a medicinal liquid such as saline is often injected into the subject to enhance the contrast effect. Contrast agents contain contrast enhancing agents.

These medicinal liquids are typically filled into containers such as syringes or bottles, and a medicinal liquid injector is generally used to inject the medicinal liquid from the container. A medicinal liquid injector has a holding mechanism that holds the container and a drive mechanism that operates to release the medicinal liquid from the container. By operating the drive mechanism while the container is held by the holding mechanism, the medicinal liquid filled in the container can be injected into a subject.

When injecting a medicinal solution, the injection conditions are set so that optimal fluoroscopic images can be obtained for diagnostic imaging. For example, when taking CT images, the amount of contrast agent injected is set so that the CT value, which is proportional to the concentration of contrast agent in the blood, remains above a certain value for at least the duration of the imaging procedure.

On the other hand, for example, in a CT scanner, there is a proportional relationship between the CT number and the amount of contrast agent injected, and between the CT number and the injection speed of the contrast agent. The CT number also correlates with the intensity of the electromagnetic waves emitted from the fluoroscopic imaging device, specifically the tube voltage, which is the voltage applied to the X-ray tube of the CT scanner; the lower the tube voltage, the higher the resulting CT number. Therefore, by lowering the tube voltage setting, the optimal CT number can be obtained with a smaller amount of contrast agent. Utilizing this relationship, Patent Document 1 describes taking the tube voltage of the CT scanner into consideration when calculating the amount of contrast agent injected, and how the tube voltage can be changed in stages depending on the purpose of the imaging and the subject's symptoms, etc.

Patent No. 5416761

As mentioned above, capturing fluoroscopic images at a lower tube voltage allows for imaging with a smaller amount of contrast agent, which ultimately reduces the physical strain on the subject. However, because capturing fluoroscopic images at low tube voltages results in images with a lot of noise, imaging at low tube voltages has not traditionally been practiced. However, recent improvements in image processing technology have led to progress in reducing noise, and as a result, it is now possible to obtain images with less noise even when capturing images at lower tube voltages.

However, if the tube voltage is set to a low value and the amount of contrast agent injected is reduced, a new problem arises. Even if the amount of contrast agent injected is reduced, the injection time is often determined based on the imaging time, so the injection time is usually not changed. Therefore, reducing the amount of contrast agent injected results in a lower injection rate. If the injection rate and injection rate are too low, the contrast agent will not maintain its bolus properties by the time it reaches the target area, and will diffuse into the blood, resulting in insufficient CT values.

This phenomenon can occur, for example, in the following circumstances: When taking a CT image of the heart, contrast agent is injected, for example, through the basilic vein in the arm, and flows into the superior vena cava. The superior vena cava joins with the inferior vena cava just before reaching the right ventricle of the heart. If the amount of contrast agent injected is too small or the injection speed is too slow, the contrast agent will be unable to flow due to the blood flowing from the inferior vena cava and the blood flow of the superior vena cava itself, causing the contrast agent to diffuse into the bloodstream and losing its bolus effect.

In order to maintain good bolus properties even with a small amount of contrast agent, it is possible to dilute the contrast agent with saline. However, there are several types of contrast agents with different concentrations of contrast enhancers (e.g., iodine) that affect the contrast effect. Therefore, in order to obtain good contrast effects regardless of the type of contrast agent, it is necessary to determine a new dilution rate for the contrast agent depending on the type of contrast agent, particularly the contrast enhancer concentration, and set the injection protocol based on the new dilution rate.

One of the objectives of the present invention is to make it easy to set an appropriate amount of contrast agent while maintaining bolus properties, even when the type of contrast agent is changed.

According to one aspect of the present invention, there is provided a liquid injector that injects a contrast agent and a physiological saline solution into a subject prior to capturing a medical image of the subject using a fluoroscopic imaging device having an electromagnetic wave irradiator, the liquid injector comprising:
an injection head including a first drive mechanism that operates to cause a contrast medium to flow out of a first container filled with the contrast medium, and a second drive mechanism that operates to cause a saline solution to flow out of a second container filled with the saline solution;
at least one data input interface for accepting input of data;
an injection control unit configured to set an injection protocol for the contrast agent and the physiological saline using data input via the data input interface, and to control operations of the first drive mechanism and the second drive mechanism in accordance with the set injection protocol;
and
the injection control unit is configured to register the injection protocol including a mixed injection in which a contrast agent and a physiological saline solution are injected at a predetermined mixing ratio, the mixed injection protocol being set using a plurality of parameters;
A drug solution injection device is provided in which the injection control unit is configured to change the mixing ratio in accordance with the changed concentration when the concentration of the contrast enhancer of the contrast agent among the plurality of parameters used to set the registered injection protocol is changed, and to apply the changed mixing ratio to the injection protocol.

The present invention also provides a fluoroscopic imaging system, comprising:
a fluoroscopic imaging device having an electromagnetic wave irradiator;
a plurality of containers including a first container for a contrast medium and a second container for a saline solution;
an injection head including a first drive mechanism operative to cause the contrast agent to flow from the first container and a second drive mechanism operative to cause the saline to flow from the second container;
at least one data input interface for accepting input of data;
an injection control unit configured to set an injection protocol for the contrast agent and the physiological saline using data input via the data input interface, and to control operations of the first drive mechanism and the second drive mechanism in accordance with the set injection protocol;
and
the injection control unit is configured to register the injection protocol including a mixed injection in which a contrast agent and a physiological saline solution are injected at a predetermined mixing ratio, the mixed injection protocol being set using a plurality of parameters;
The injection control unit is configured to change the mixing ratio in accordance with the changed concentration when the concentration of the contrast enhancer of the contrast agent among the plurality of parameters used to set the registered injection protocol is changed, and apply the changed mixing ratio to the injection protocol.

According to yet another aspect of the present invention, there is provided a method for controlling a liquid injector having a first drive mechanism that operates to cause a contrast agent to flow out of a first container filled with the contrast agent, a second drive mechanism that operates to cause physiological saline to flow out of a second container filled with the physiological saline, and an injection control unit that sets an injection protocol for the contrast agent and the physiological saline and controls operations of the first drive mechanism and the second drive mechanism in accordance with the set injection protocol, the injection protocol being set using a plurality of parameters and including a mixed injection in which the contrast agent and the physiological saline are injected at a predetermined mixing ratio, the method comprising:
when a concentration of a contrast enhancing agent of the contrast agent among a plurality of parameters used to set a registered injection protocol is changed, the injection control unit changes the mixing ratio in accordance with the changed concentration;
the injection controller applying the changed mixing ratio to the injection protocol;
A method for controlling a chemical liquid injector is provided, comprising:

According to yet another aspect of the present invention, there is provided a method for calculating an injection protocol including a mixed injection in which a contrast medium and a physiological saline solution are injected at a predetermined mixing ratio in a chemical liquid injector having an injection control unit, the method comprising:
the injection control unit determining a reference injection amount, which is an injection amount when only the contrast agent is injected in the mixed injection;
the injection control unit calculating an actual mixing ratio, which is an actual mixing ratio, from a reference mixing ratio, which is a preset mixing ratio, and a concentration of a contrast enhancing agent in the contrast agent;
the injection control unit calculating the injection amount of the contrast agent and the injection amount of the physiological saline using the calculated reference injection amount and the calculated actual mixing ratio;
A method for calculating an infusion protocol having:

In the present invention, an "injection protocol" indicates what kind of medicinal liquid is to be injected and under what conditions (amount, speed, time, etc.). Furthermore, when multiple types of medicinal liquid are injected, such as a contrast medium and saline, the injection protocol also includes the order in which they are injected and the respective injection conditions.

In this invention, the term "fluoroscopic imaging device" refers to a device that captures fluoroscopic images by irradiating electromagnetic waves, such as a CT device, an angiography device, or an MRI device. A "fluoroscopic imaging device" has an "electromagnetic wave irradiator" that irradiates electromagnetic waves. CT devices and an angiography device have an X-ray tube as their "electromagnetic wave irradiator," and an MRI device has a high-frequency pulse transmitter that irradiates high-frequency pulses as their "electromagnetic wave irradiator."

In this invention, the term "contrast agent" refers to a medicinal liquid administered to a subject to add contrast to the image or to emphasize specific tissues when capturing fluoroscopic images of the subject using a fluoroscopic imaging device, and contains a "contrast enhancer." Examples of "contrast enhancers" include iodine (used when capturing images using CT devices and angiography devices), gadolinium (used when capturing images using MRI devices), barium, and carbon dioxide.

In the present invention, "mixing ratio" means the amount of contrast agent relative to the total amount of contrast agent and saline injected, expressed as (amount of contrast agent) / (amount of contrast agent + amount of saline).

According to the present invention, even when the type of contrast agent used is changed, the mixing ratio between the contrast agent and saline is changed according to the contrast enhancement agent concentration of the changed contrast agent, making it extremely easy to set an appropriate amount of contrast agent while maintaining bolus properties.

1 is a layout diagram of a fluoroscopic imaging system according to an embodiment of the present invention; FIG. 2 is a front view of the console shown in FIG. 1 . FIG. 2 is a perspective view of the injection head shown in FIG. 1 . 1. FIG. 4 is a diagram illustrating a procedure for attaching a syringe to the injection head shown in FIG. 1. FIG. 4 is a diagram illustrating a procedure for attaching a syringe to the injection head shown in FIG. FIG. 2 is a block diagram showing main functions of a control system in the fluoroscopic imaging system shown in FIG. 1 . 10 is a cross-sectional view showing the positional relationship between the RFID tag and the antenna of the RFID module when the cylinder is properly attached to the cylinder holding mechanism. FIG. 10A and 10B are diagrams showing one form of an extension tube connected to a syringe. FIG. 10 is a diagram showing an example of an injection condition call screen displayed on a display unit in one embodiment of the present invention. FIG. 10 is a diagram showing the next step of the injection condition call screen shown in FIG. 9 . FIG. 10 is a diagram showing an example of a protocol screen displayed on a display unit in one embodiment of the present invention. FIG. 10 is a diagram showing an example of a screen for selecting an injection pattern among protocol setting screens displayed on a display unit in one embodiment of the present invention. FIG. 10 is a diagram showing an example of a protocol setting screen displayed on a display unit in one embodiment of the present invention, for inputting some of the items necessary for setting an injection protocol. 1 is a perspective view showing one embodiment of the structure of a syringe that can be used in the present invention. FIG. 10 is a perspective view showing another form of syringe structure that can be used in the present invention. 10A and 10B are diagrams schematically showing other forms of extension tubes connected to syringes. FIG. 13B is a perspective view of a mixing device provided on the extension tube shown in FIG. 13A. 14B is a cross-sectional view of a mixing tube provided in the extension tube shown in FIG. 14A. FIG. 10 is a perspective view showing an example of the arrangement of a second display unit that can be provided in the fluoroscopic imaging system of the present invention. FIG. 10 is a perspective view showing another example of the arrangement of the second display unit that can be provided in the fluoroscopic imaging system of the present invention. FIG. 2 is a block diagram of a fluoroscopic imaging system in accordance with another aspect of the present invention.

Referring to FIG. 1, a fluoroscopic imaging system according to one embodiment of the present invention is shown, which includes a fluoroscopic imaging apparatus 200 and a liquid injector 100. The fluoroscopic imaging apparatus 200 and the liquid injector 100 can be connected to each other so that data can be transmitted and received between them. The connection between the fluoroscopic imaging apparatus 200 and the liquid injector 100 can be wired or wireless.

The fluoroscopic imaging device 200 has a scanner 201 that performs imaging operations and an imaging control unit (not shown) that controls the operation of the scanner 201, and is capable of acquiring medical images of a subject into which a medicinal liquid has been injected by the medicinal liquid injector 100. The scanner 201 has an electromagnetic wave irradiator 153 (see Figure 6) that irradiates electromagnetic waves, and the electromagnetic wave irradiator 153 has a variable electromagnetic wave irradiation intensity setting. The imaging control unit may include a display device such as an LCD display that can display imaging conditions and acquired tomographic images, and an input device such as a keyboard and/or mouse for inputting imaging conditions, etc. The display device may have a touch screen that also serves as an input device.

The liquid injector 100 includes, for example, an injection head 110 attached to the top of a stand 121 via a swivel arm 122 so as to be freely rotatable in the vertical direction, and a console 101 equipped with various functions for controlling the overall operation of the liquid injector 100. While the injection head 110 and console 101 can be configured in a single housing, in this embodiment they are configured as separate units. In this case, the injection head 110 can be placed in an examination room together with the scanner 201, and the console 101 can be placed in an operation room together with the imaging control unit of the fluoroscopic imaging device 200. The stand 121 can be equipped with casters to facilitate movement of the injection head 110.

The console 101 has a built-in AC/DC converter, and power converted from AC to DC is supplied to the console 101. As shown in Figure 2, the console 101 has a group of buttons 102 including a stop button 102a for forcibly stopping injection, a home button 102b for displaying the home screen, and a power button 102c for turning the power on and off, as well as a touch panel 103 that doubles as an input unit and display unit.

As shown in Figures 3 to 5, the injection head 110 can detachably mount two syringes 800, which are containers filled with a medicinal solution. For example, one syringe 800 can be a syringe for contrast medium, and the other a syringe for saline solution. The syringe 800 has a cylinder that contains the medicinal solution and has a conduit formed at the tip, and a piston inserted into the cylinder so that it can move back and forth. The injection head 110 has two cylinder holding mechanisms 111 that hold the cylinder, and two linear motion units that move in the axial direction of the syringe 800 to operate the piston of the syringe 800, whose cylinder is held by the cylinder holding mechanism 111 (e.g., pushing it into the cylinder).

The linear motion unit has a rod 113 that is moved back and forth by an appropriate rotational motion conversion mechanism, such as a lead screw mechanism or rack and pinion mechanism, which converts the rotational motion of the motor into linear motion, and a presser 112 fixed to the tip of the rod 113. The mechanism that includes the motor, rotational motion conversion mechanism, and linear motion unit (a unit that includes the rod 113 and presser 112 and moves linearly) for moving the piston back and forth is referred to here as the piston drive mechanism. In this embodiment, the injection head 110 is equipped with two piston drive mechanisms.

In this specification, the cylinder holding mechanism and piston driving mechanism for the contrast agent syringe are sometimes referred to as the first holding mechanism and first driving mechanism, respectively, and the cylinder holding mechanism and piston driving mechanism for saline are sometimes referred to as the second holding mechanism and second driving mechanism, respectively. In the illustrated example, there is one cylinder holding mechanism and one piston driving mechanism for contrast agent, but there may be more than one of each. Similarly, there may also be more than one cylinder holding mechanism and piston driving mechanism for saline.

A DC motor can be used as the motor that drives the piston drive mechanism, with DC brushless motors being particularly preferred. Brushless motors are quieter and more durable because they have no brushes. Furthermore, because brushless motors are capable of higher speeds, increasing the external gear ratio and reducing the torque applied to the motor can reduce the current required to inject the chemical solution at the desired injection pressure compared to a brush motor. Alternatively, an ultrasonic motor can be used as the drive source for the piston drive mechanism.

The injection head 110 is entirely enclosed in a synthetic resin housing 115, except for a portion of the piston drive mechanism (e.g., the presser 112). Several operation buttons 116 are located on the top surface of the housing 115 so that the piston drive mechanism can be operated by the user.

For example, in this embodiment, the injection head 110 has, as operation buttons 116, a check button 116a that is operated to make the injection possible, a start button 116b that is operated to start the injection, a forward button 116c that is operated to move the presser 112 forward a desired distance (for example, at a speed of 1.5 ml/sec), and an acceleration button 116c that is operated to accelerate the movement speed of the presser 112 (for example, to add an additional 8 ml/sec to the current speed. Both forward and backward movement is possible). The piston drive mechanism may include a pushbutton 116d, a retract button 116e that is operated to retract the presser 112 a desired distance (for example, at a speed of 1.5 ml/sec), an auto-return button 116f that is operated to retract the presser 112 to the initialized position, stop buttons 116g and 116h that are operated to manually stop or interrupt operation, and a route switch 116h that is operated to advance/retract the presser at a slow speed (for example, 0.7 ml/sec). In this embodiment, there are two each of the forward button 116c, acceleration button 116d, retract button 116e, and auto-return button 116f so that each piston drive mechanism can be operated independently.

The initialized position, which is the retracted end when the auto-return button 116f is operated, may be set to a different position for each size of syringe 800 and/or each type of medicinal liquid filled therein, if the cylinder holding mechanism 111 is configured to be able to accommodate syringes 800 of various sizes as described below. Furthermore, if the syringe 800 is configured to be attached via an adapter 600, the initialized position may be set for each type of adapter 600. This initialized position may be set arbitrarily by the operator depending on the type of syringe 800 and/or the type of adapter 600, or may be set automatically by the fluoroscopic imaging system.

If the initialization position can be set using a fluoroscopic imaging system, for example, RFID technology can be used to identify the type of syringe 800, as described in detail below, and the initialization position can be set based on the results. Furthermore, if the injection head has an appropriate adapter sensor (not shown) that can detect the type of adapter 600, the initialization position can also be set based on the detection results from this adapter sensor.

Like the initialized position, the most forward position of the presser 112 may be set to a different position for each size of syringe 800 and/or each type of medicinal liquid filled therein, and even each type of adapter 600. Like the initialized position, the most forward position of the presser 112 may be set arbitrarily by the operator, or it may be possible to identify the type of attached syringe 800 and/or adapter 600 using RFID technology or an appropriate detection sensor, and have the fluoroscopic imaging system automatically set the position according to the identified type of syringe 800 and/or adapter 600.

The cylinder holding mechanism 111 is configured so that the syringe 800 is attached via an adapter 600. Syringes 800 are available in various sizes depending on the volume of medicinal liquid that can be filled. An adapter 600 is provided for each size of syringe 800, and as shown in Figure 4, each adapter 600 is configured to hold the cylinder flange 801 formed at the end of the cylinder of the corresponding syringe 800. The adapter 600 is removably attached to the cylinder holding mechanism 111 of the injection head 110. In this embodiment, the syringe 800 is configured so that it is attached via an adapter 600, but the syringe 800 may also be configured so that it is attached directly to the injection head 110 without the adapter 600.

Attaching the syringe 800 to the injection head 110 can be achieved, for example, by attaching the adapter 600 to the cylinder holding mechanism 111 of the injection head 110 and then holding the cylinder flange 801 of the syringe 800 in the adapter 600. The adapter 600 has a groove that receives the cylinder flange 801, and the syringe 800 is held in the adapter 600 by inserting the cylinder flange 801 into the groove. The adapter 600 may also have a locking mechanism that locks the cylinder by rotating the syringe 800 a predetermined angle (e.g., 90 degrees) around its axis after the cylinder flange 801 is inserted into the groove of the adapter 600. In this way, by preparing adapters 600 according to the size of the syringe 800, syringes 800 of various sizes can be attached to the injection head 110.

The syringe 800 may be a pre-filled syringe provided by a pharmaceutical manufacturer already filled with a medicinal solution, or it may be a pre-filled syringe filled with a medicinal solution at a medical facility.

When injecting a liquid drug into a subject and capturing images, the scanner 201 and injection head 110 of the above-described configuration are installed in an examination room, while the imaging control unit of the fluoroscopic imaging device 200 and the console 101 of the liquid drug injector 100 are installed in an operation room separated from the examination room by a wall. Therefore, if signals and data are transmitted and received between the console 101 and the injection head 110 via wired communication, a cable passage is formed in the wall separating the examination room and the operation room, and the cable is routed through this passage. Signals and data can also be transmitted and received between the console 101 and the injection head 110 via wireless communication, which eliminates the need to form a cable passage in the wall. For wireless communication, the console 101 and the injection head 110 can each be equipped with a wireless communication unit (not shown), for example.

The flow of data and other information in the above-mentioned fluoroscopic imaging system will be explained below with reference to the block diagram shown in Figure 6. Note that Figure 6 only shows the main functions of the control system in this embodiment of the fluoroscopic imaging system, and the present invention is not limited to this.

The imaging control unit 152 can be incorporated into the imaging control unit of the fluoroscopic imaging apparatus 200, for example, and is configured to control the overall operation of the fluoroscopic imaging apparatus 200, including the scanner 201 and the display device of the imaging control unit. The imaging control unit 152 can be configured as a so-called microcomputer and can have a CPU, ROM, RAM, and interfaces with other devices. A computer program for controlling the fluoroscopic imaging apparatus 200 is implemented in the ROM. The CPU controls the operation of each part of the fluoroscopic imaging apparatus 200 by executing various functions in accordance with this computer program. The imaging control unit 152 can also receive data, signals, etc. from the injection control unit 150, and can use the data and signals received from the injection control unit 150 to control the operation of each part of the fluoroscopic imaging apparatus 200.

The electromagnetic wave irradiator 153 is a device provided in the fluoroscopic imaging device 200 (see Figure 1), and is configured to irradiate electromagnetic waves at an intensity corresponding to the applied voltage value when a voltage is applied. A fluoroscopic image of the subject can be captured by performing predetermined processing on the signals obtained when the electromagnetic waves are irradiated onto the subject.

The injection control unit 150 can be incorporated into the console 101, for example, and is configured to generally control the operation of the console 101 and the injection head 110. More specifically, the injection control unit 150 can control the screen and data displayed on the display unit 154 in response to input of data and information from the input unit 156 and data and information from the RFID module 166, determine an injection protocol including the injection amount and injection rate of the medicinal liquid using data input from the input unit 156, and control the operation of the piston drive mechanism 140 in accordance with the determined injection conditions.

The injection control unit 150 can be configured as a so-called microcomputer and can have a CPU, ROM, RAM, and interfaces with other devices. A computer program for controlling the liquid injector 100 is implemented in the ROM. The CPU controls the operation of each part of the liquid injector 100 by executing various functions in accordance with this computer program. The injection control unit 150 also has a timing function that uses the CPU's clock, and can count, for example, the current time and the elapsed time since the start of injection. The injection control unit 150 can also receive data and signals from the imaging control unit 152, and can use the data and signals received from the imaging control unit 152 to control the operation of each part of the liquid injector 100.

The display unit 154 can be the touch panel 103 of the console 101. The input unit 156 is a data input interface of the present invention that is configured to accept data input operations by an operator. The input unit 156 can include the touch panel 103, the buttons 102 of the console 101, and the buttons 116 of the injection head 110. The touch panel 103 is typically a modular combination of a display that functions as the display unit 154, a touch screen that functions as the input unit, and control circuits for these.

Any display can be used as the display, including a liquid crystal display and an organic electroluminescence display. Any touch screen can be used as the touch screen, including capacitive and pressure-sensitive types. The control circuit of the touch panel 103 displays a specified screen and data on the display based on signals transmitted from the injection control unit 150, and also transmits input information to the injection control unit 150 based on signals generated from the touch screen when an operator or other user touches the touch screen.

The RFID module 166 has an RFID control circuit 164 and an antenna 165. In this embodiment, the syringe 800 has an RFID tag 802, which is a data carrier, affixed to the outer circumferential surface of the cylinder (see Figure 4). The RFID module 166 reads information recorded on the RFID tag 802 from the RFID tag 802 using the antenna 165 and transmits the read information to the injection control unit 150. The RFID module 166 may also have the function of writing information transmitted from the injection control unit 150 to the RFID tag 802. The RFID control circuit 164 controls the information transmission and reception operations of the RFID module 166. In other words, the RFID module 166 functions as a reader that reads information from the RFID tag 802, or as a reader/writer that writes information to the RFID tag 802.

The fluoroscopic imaging system may further include a memory card reader/writer 158 connected to the injection control unit 150 so that data can be sent and received. The memory card reader/writer 158 may be built into the console 101 shown in FIG. 2, for example. In that case, a memory card slot 104 is provided in the housing of the console 101, as shown in FIG. 2. Of course, the fluoroscopic imaging system may also include the memory card reader/writer 158 as an independent unit.

The memory card reader/writer 158 writes data to a memory card (not shown) and reads data recorded on the memory card. For example, an injection protocol can be recorded as data on a memory card, and the recorded injection protocol can be read via the memory card reader/writer 158 and sent to the injection control unit 150. Conversely, an injection protocol set in the injection control unit 150 can also be written to a memory card via the memory card reader/writer 158. In this way, for example, an injection protocol set in one liquid injector can be transmitted to another liquid injector via the memory card.

When transmitting data via a memory card in this way, it is preferable to set a password or other security measures to prevent unauthorized sending and receiving of data. It is also possible to record the control program for the liquid medicine injector on a memory card, and install or update the control program in the injection control unit 150 via the memory card reader/writer 158.

The memory card may be any type of memory card, such as a CF memory card or an SD memory card, and the memory card reader/writer 158 may be any device compatible with reading and writing to a memory card. Note that while the data exchange between the memory card and the injection control unit 150 has been described here as involving both writing and reading data, a memory card reader or writer that only writes or reads data may also be connected to the injection control unit 150.

As described above, the RFID module 166 accepts data input from the RFID tag 802, and in that sense, the RFID module 166, together with the input unit 156, constitutes a data input interface in the present invention.

The information recorded on the RFID tag 802 includes information about the medicinal liquid filled in the syringe 800, such as the manufacturer, type of medicinal liquid, product name, product number, contained ingredients (particularly when the medicinal liquid is a contrast agent, the contrast agent contains iodine as a contrast enhancing agent, and the iodine concentration, which is the iodine content per unit amount of contrast agent), filled amount, lot number, expiration date, etc., as well as information about the syringe, such as unique identification numbers such as the manufacturer, product name, and product number, allowable pressure value, syringe capacity, piston stroke, necessary dimensions of each part, and lot number. At least some of this information can be transmitted to the fluoroscopic imaging device 200.

The RFID control circuit 164 can be installed in any position, but it is desirable for the antenna 165 to be installed in a position facing the RFID tag 802 when the syringe 800 is properly held in the cylinder holding mechanism 111.

In particular, in this embodiment, as shown in FIG. 4, the RFID tag 802 has a longitudinal shape and is affixed with its longitudinal direction aligned with the circumferential direction of the syringe 800. The syringe 800 is designed to be held properly by being inserted into the cylinder holding mechanism 111, or by being inserted and then rotated so that the syringe 800 is in a specific orientation, with the RFID tag 802 facing downward when held properly.

The antenna 165 of the RFID module 166 has an FPC (flexible printed circuit board) with a predetermined pattern (for example, one or more loop-shaped patterns) made of a conductor, and as shown in Figure 7, is bent into an arc so as to be concentric with the syringe 800, in a position facing the RFID tag 802 of the syringe 800 when the cylinder is properly held in the cylinder holding mechanism. This expands the detection range of the RFID tag 802 attached to the curved surface.

In addition, in this embodiment, the antenna 165 has a larger area than the RFID tag 802 so that the RFID tag 802 can reliably face the antenna 165 even if there is variation in the attachment position of the RFID tag 802. Therefore, it is preferable to design the size of the antenna 165 taking into account variation in the attachment position of the RFID tag 802 on the syringe 800.

On the other hand, by bending the antenna 165 into an arc, the smaller the radius of curvature of the antenna 165 and the longer the circumferential length of the antenna 165, the more likely it is that radio waves used for communication will interfere, and communication sensitivity will tend to decrease. Therefore, in order to suppress radio wave interference, it is preferable that the antenna 165 have a ferrite sheet 165a on the surface opposite to the surface facing the RFID tag 802 of the FPC.

The output of the RFID module 166 can be set to, for example, 200 mW. By setting the output to such a weak level, data can be read successfully from the RFID tag 802 when the syringe 800 is attached in the correct position, with the RFID tag 802 directly facing the antenna 165, but data cannot be read if the syringe 800 is not attached in the correct position. As a result, if data cannot be read from the RFID tag 802, the injection control unit 150 can alert the operator by displaying on the display unit 154 that the syringe 800 may not be attached correctly.

Next, the operation of the above-mentioned fluoroscopic imaging system will be explained in more detail, focusing on the operation of the liquid injector 100, using an example in which the fluoroscopic imaging device 200 is an X-ray CT device. Note that the following explanation is provided as merely one example, and the present invention is not limited to the example described below.

First, the liquid injector 100 and the fluoroscopic imaging device 200 are powered on, and the liquid injector 100 and the fluoroscopic imaging device 200 are started up. When the liquid injector 100 is started up, the injection control unit 150 displays an injection condition call screen 300, as shown in FIG. 9, on the display unit 154 (e.g., touch panel 103). The operator can use this injection condition call screen 300 to call up pre-set injection conditions.

The injection condition call screen 300 displays an imaging region icon 301 that resembles a human body. The imaging region icon 301 represents an image of a human body divided into multiple regions, such as the head, chest, abdomen, and legs. The operator selects one of these multiple regions by tapping on it. Once a region is selected, the injection condition call screen 300 then further displays multiple region detail icons 302 that have been pre-registered corresponding to the selected region, as shown in FIG. 9A, for example. The operator selects a region by tapping on one of these multiple region detail icons 302. The display of the selected region and region is changed, for example, by displaying the region in a different color from the other regions and regions so that it can be visually distinguished from the other regions and regions. Figures 9 and 9A show the abdomen selected as the region and the liver selected as the region.

When the area is selected in this manner, the injection control unit 150 calls up pre-registered parameters corresponding to the selected area, sets an injection protocol using the called-up parameters through calculations, etc., and displays the set injection protocol as a protocol screen on the display unit 154.

Figure 10 shows an example of a protocol screen. The protocol screen 310 shown in Figure 10 displays various data/information, including an imaging region icon 301 and an injection graph thumbnail 311. Note that the "A" and "B" displays on the protocol screen 310 represent contrast agent and saline, respectively.

The imaging site icon 301 is the same as the imaging site icon 301 displayed on the injection condition call screen 300 described above, and indicates which imaging site the displayed injection protocol is for.

In the illustrated example, the imaging region icon 301 is an image that illustrates a person lying on their back as seen from the side, but it may also be an image that illustrates a person lying on their back as seen from above, and the orientation of the human body image on the screen may be portrait or landscape. Furthermore, the imaging region icon 301 does not have to be an image that resembles a human body, and may be any icon, such as one that represents the imaging region using only images of organs, one that represents the imaging region using only text, or a combination of these. This also applies to imaging region icons 301 on other screens.

The weight icon 312 is used to display and input the subject's weight. For example, when the operator taps the weight icon 312, a numeric keypad is displayed near the weight icon 312, and the operator can tap the displayed numeric keypad, or when the operator taps the weight icon 312, an increase/decrease icon is displayed to increase or decrease the number displayed on the weight icon 312 by one, and the operator can tap the increase/decrease icon to input the subject's weight.

The injection time icon 313 is used to display and input the injection time of the contrast agent, and the reference iodine amount icon 314 is used to display and input the amount of iodine required per unit of the subject's weight. The injection time is often the same as the imaging time using the fluoroscopic imaging device. The operations for inputting the injection time and iodine amount can be similar to those for the weight icon 312. Note that predetermined values for the subject's weight, injection time, and reference iodine amount are stored in the memory of the injection control unit 150, and these values may be displayed as the respective icons by default. Alternatively, at least one of these pieces of data may be transmitted to the injection control unit 150 from a unit external to the liquid injector 100, and the transmitted data may be displayed as the corresponding icon. Examples of external units include the fluoroscopic imaging device 200, a RIS, PACS, and HIS, which will be described later.

The pressure limit icon 315 is used to display and input the pressure limit value of the syringe 800 being used. If the pressure limit data is recorded on the RFID tag 802, the data read by the RFID module 166 is displayed on the pressure limit icon 309. The pressure limit icon 309 allows the operator to input numerical values, similar to the weight icon 305. If this data is not recorded on the RFID tag 802, or if a syringe without an RFID tag 802 is attached, the operator can input the respective numerical values, similar to the weight icon 305. The syringe capacity icon 316 displays the remaining volume of medicinal liquid in the syringe 800, calculated by the injection control unit 150 in accordance with the position of the presser 112.

The actual iodine concentration icon 317 displays the iodine concentration of the contrast agent. There are several types of contrast agents with different iodine concentrations. The actual iodine concentration icon 317 displays the iodine concentration that was the basis for setting the injection protocol shown in the injection graph thumbnail 311. The iodine concentration value displayed in the actual iodine concentration icon 317 can be changed if it differs from the iodine concentration of the contrast agent actually used. For example, if iodine concentration data is recorded in the RFID tag 802, the iodine concentration value is changed by reading the data using the RFID module 166 and then changing it to the read value. Alternatively, like the weight icon 312, it can also be changed by the operator's operation.

The timing icon 318 is an icon for causing the liquid injector to perform a test injection. A test injection is an injection of contrast medium performed to determine the timing for starting medical imaging by the fluoroscopic imaging apparatus 200. When the operator taps the timing icon 318, the injection control unit 150 displays a screen for setting up the test injection on the display unit 154. The operator makes the specified settings for the test injection according to the displayed screen, and after making the settings, performs the specified operation to start the test injection. The injection control unit 150 then controls the operation of the liquid injector according to the settings, thereby performing the test injection.

The route icon 319 is an icon that is operated when the liquid injector is to perform a route test. A route test is a test to confirm whether the injection circuit from the syringe 800 to the subject is properly secured. Generally, a route test involves injecting saline into the subject while detecting the pressure acting on the syringe filled with the saline. If the detected pressure is within a predetermined range, the injection circuit is determined to be properly secured. On the other hand, if the pressure is lower than the predetermined range, there may be a leak in the injection circuit, and conversely, if it is higher, there may be a blockage in the injection circuit.

The injection graph thumbnail 311 represents the injection protocol in a time-series graph format. The injection protocol shown in the injection graph thumbnail 311 in Figure 10 consists of two phases: a first phase in which a contrast agent and saline mixture are injected, and a second phase in which only saline is injected. This type of injection protocol is typical when imaging is performed at a lower-than-normal tube voltage. Injecting only the intended contrast agent would result in an excessively large amount of iodine. Therefore, in the first phase, the contrast agent is diluted with saline, thereby reducing the amount of iodine injected while ensuring a sufficient overall injection volume and injection rate. In the second phase, the iodine injected in the first phase is boosted with saline.

For example purposes, in the injection protocol shown in FIG. 10, the ratio of contrast agent to saline in the first phase, i.e., contrast agent:saline, is 60:40, as shown by the vertical bar graph next to the time-lapse graph in the injection graph thumbnail 311. Also, in the first phase, the total injection rate and injection volume of contrast agent and saline combined are 4.0 mL/sec and 100 mL, respectively. The injection time in the first phase is 25 seconds. In the second phase, 20 mL of saline is injected at an injection rate of 4.0 mL/sec. The injection time in the second phase is 5 seconds.

The protocol screen 310 shown in FIG. 10 may also display an actual iodine amount icon 320. The actual iodine amount icon 320 displays the amount of iodine injected when the contrast agent is injected using the injection protocol displayed in the injection graph thumbnail 311.

The operator checks the protocol screen 310, and if the displayed content is acceptable, taps the check icon 321 or operates the check button 116a on the injection head 110. This temporarily stores the data required to set the injection protocol, such as the displayed injection volume and injection rate, in the memory of the injection control unit 150, and the injection protocol is finalized.

Next, the operator attaches syringe 800 filled with medicinal liquid to injection head 110 using a predetermined procedure. Once syringe 800 is attached, RFID module 166 reads the data/information recorded on RFID tag 802. Here, we will assume that two syringes 800, specifically a contrast agent syringe filled with contrast agent and a saline syringe filled with saline, are attached to injection head 110. In this specification, when distinguishing between syringes based on the type of medicinal liquid they contain, a syringe filled with contrast agent will be designated with the suffix C and referred to as syringe 800C, and a syringe filled with saline will be designated with the suffix P and referred to as syringe 800P.

After syringe 800C filled with contrast medium and syringe 800P filled with saline are attached to injection head 110, the operator connects extension tube 400, as shown in FIG. 8, to each syringe 800C and 800P. Extension tube 400 has three tubes connected via T-shaped connectors. Connectors 401 and 402 are attached to the ends of the tubes connected to each syringe 800C and 800P, and a separate connector 403 is attached to the end of the tube facing the subject. Each connector 401 and 402 has a cylindrical portion with a threaded portion at its tip, and may be connected to a conduit portion at the tip of syringe 800C and 800P via a luer lock system. Furthermore, of these connectors 401, 402, at least connector 402, which is connected to syringe 800P for saline, may function as a one-way valve, such as that described in International Publication WO2012/060365. An indwelling needle or catheter (not shown) is connected to connector 403. By using such an extension tube 400, contrast medium and saline can be injected into the subject simultaneously or separately.

When the contrast agent syringe 800 is attached, at least data regarding the iodine content per unit dose of contrast agent is read from its RFID tag 802 and temporarily stored in memory within the injection control unit 150. The injection control unit 150 displays at least a portion of the data/information read from the RFID tag 802 on the display unit 154 and moves the presser 112 to a standby position. The standby position is any position between the position where the presser 112 abuts against the end of the piston of the syringe 800 and the rearmost position. Movement to the standby position can be achieved by the injection control unit 150 determining the end position of the piston based on the information read from the RFID tag 802, determining the distance from the initial position, which is the rearmost position of the presser 112's range of motion, to the piston end position, and operating the piston drive mechanism 140 to move the presser 112 forward by that distance plus a predetermined offset value. This moves the presser 112 to the piston's standby position.

This completes the preparation for injection. After preparation for injection is complete, the operator operates the start button 116b on the injection head 110, which sends a corresponding signal to the injection control unit 150. The injection control unit 150 uses this signal as a trigger to read various data stored in memory and control the operation of the piston drive mechanism 140 so that it operates in accordance with the confirmed injection protocol. This allows the medicinal liquid filled in the syringe 800 to be injected into the subject.

The injection protocol displayed on the protocol screen 310 shown in Figure 10 is determined according to pre-registered parameters. We will now explain how to register the parameters required to set this injection protocol.

It is preferable to input parameters for setting the injection protocol using a menu separate from the series of steps described above, such as the series of steps using the protocol screen 310. This prevents registered parameters from being erased or changed due to an incorrect operation during the injection preparation stage.

For example, to register parameters, the protocol setting procedure can be called from the home screen. The home screen is displayed by operating the home button 102b of the console 101. When the protocol setting procedure is called from the home screen, for example, the home screen may include a protocol setting icon, and the operator may select the protocol setting by tapping the protocol setting icon, causing the injection control unit 150 to call the protocol setting procedure. The process of calling the protocol setting procedure from the home screen may involve several steps, such as selecting the protocol setting and then selecting the user who will perform the protocol setting.

In the protocol setting procedure, the site is first selected. Site selection may be similar to the procedure for calling up injection conditions described above. That is, the injection control unit 150 displays the imaging site icon 301 and site detail icon 302, as shown in Figures 9 and 9A, on the display unit 154, and the operator can determine the site for which the injection protocol is to be set by performing a predetermined operation.

Once the site for setting the injection protocol has been determined, the injection control unit 150 displays the injection protocol setting screen on the display unit 154. Before displaying the injection protocol setting screen, the operator may be prompted to assign a name to the injection protocol to be set. The operator can assign a name of their choice that will make it easy to identify when the operator later edits or deletes the registered injection protocol.

11A and 11B show an example of a protocol setting screen. As shown in FIGS. 11A and 11B, the protocol setting screen 350 may have a menu display area including multiple menu tabs, such as a detailed name tab 351, an injection pattern tab 352, a first item tab 353, and a second item tab 354, and a main display area 355. The main display area 355 displays content corresponding to the selected menu tab. Alternatively, a "next" icon 358 and a return icon 357 may be displayed in the main display area 355, and tapping these may switch between the menu tabs in sequence. The protocol setting screen 350 may also have a delete icon 356. Tapping the delete icon 356 deletes the displayed injection protocol.

When the detailed name tab 351 is selected, a list of the names of injection protocols that have already been registered is displayed in the main display area 355. By selecting one from this list, the operator can switch to displaying the injection protocol with the selected name, and the operator can edit or delete the displayed injection protocol.

When the injection pattern tab 352 is selected, several injection patterns are displayed in the main display area 355, as shown in Figure 11A. In the illustrated example, the injection patterns are represented by icons that schematically illustrate an injection graph, with the horizontal axis representing elapsed time and the vertical axis representing injection rate. The top row displays an injection pattern for injecting only contrast medium, while the bottom row displays an injection pattern for injecting contrast medium and saline. The operator can select an injection pattern by tapping one of the multiple injection pattern icons displayed.

In addition to the icons representing the injection pattern, the main display area 355 may also display an icon indicating whether the target site is the vascular system or the parenchymal system, and an icon indicating whether the injection is a mixed injection. These icons are displayed differently from other icons so that it is visually clear that they have been selected. In the example shown in Figure 11A, the liver has been selected as the site in advance, so the parenchymal system is automatically selected, and the selected injection pattern is a mixed injection consisting of a first phase in which contrast medium and saline are injected simultaneously, and a second phase in which only saline is injected.

The target areas are divided into the vascular system and the parenchymal system because the contrast effect differs depending on which one is used. Generally, the contrast effect in the vascular system is determined by the amount of iodine injected per unit time, so the total amount of iodine used is determined by multiplying the injection rate by the injection time. On the other hand, in the parenchymal system, the total amount of iodine injected is considered important, and the injection rate, etc. are determined based on the total amount of iodine used.

After determining the injection pattern, the operator taps the "Next" icon 358, which causes parameter input icons corresponding to the first item tab 353 to be displayed in the main display area 355. Although not shown, the subject's weight, which is the basis for calculating the injection volume and injection rate of the medicinal liquid, is displayed as one of the parameter input icons. The operator inputs appropriate numerical values into the parameter input icons displayed in the main display area 355. The input numerical values are temporarily stored in the memory of the injection control unit 150. The main display area 355 includes a "Next" icon 358 similar to that shown in FIG. 11A, and once input into the parameter input icons displayed in the main display area 355 is complete, the operator taps this "Next" icon 358.

As a result, as shown in FIG. 11B, parameter input icons corresponding to the second item tab 354 are displayed in the main display area 355. The operator inputs appropriate values and conditions into each parameter input icon displayed in the main display area 355. The input values and conditions are temporarily stored in the memory of the injection control unit 150.

In the example shown in FIG. 11B, the following parameters are specifically input as the second item:
Phase 1 (injection of a mixture of contrast medium and saline)
Standard injection time: 25 [sec]
Standard mixing ratio: 0.7 (amount of contrast medium: amount of saline = 70:30)
Reference iodine content: 500 [mgI/kg]
Reference iodine concentration: 300 [mgI/mL]
Phase 2 (saline injection only)
Injection speed: A follow-up (*1)
Injection volume: 20 [mL]
Injection time: Automatic setting Other: Pressure limit: 10.0 [kg/cm ² ]
(*1) Inject at the same injection rate as the overall injection rate in the first phase.

In this embodiment, the first item tab 353 and the second item tab 354 are configured to allow all parameters necessary for calculating the injection protocol to be entered. After entering numerical values and conditions into the parameter input icons in the first item tab 353 and the second item tab 354, when the operator taps the "Next" icon 358, the injection control unit 150 reads the parameters temporarily stored in memory and calculates the injection protocol, specifically, the injection amount and injection rate of the contrast agent and saline in the first phase, and the injection amount and injection rate of saline in the second phase, as described in detail below.

First, calculate the injection volume L [mL] and injection rate S [mL/sec] assuming that the injection in the first phase is not a mixed injection but is entirely a contrast agent injection. The injection volume L [mL] of contrast agent is calculated as follows, assuming that the subject's weight is W [kg], the standard amount of iodine required per unit of subject weight is I [mgI/kg], the standard iodine concentration per unit amount of contrast agent is C [mgI/mL], and the injection time of contrast agent is T [sec]:

The injection rate S [mL/sec] of the contrast agent is calculated as follows:
S [mL/sec] = L [mL] / T [sec] ... Formula (2)
It can be calculated as follows.

For example, if W = 60 kg, I = 500 mgI/kg, C = 300 mgI/mL, and T = 25 sec, then equation (1) calculates the contrast agent injection volume L = 100 mL, and equation (2) calculates the contrast agent injection rate S = 4.0 mL/sec.

Next, the injection volume and injection rate of the contrast agent and saline solution in the first phase are calculated by multiplying the calculated injection volume and injection rate by the mixing ratio. That is, the injection volume of the contrast agent in the first phase is 100 mL x 0.7 = 70 mL, and the injection rate is 100 mL x (1 - 0.7) = 30 mL.

Next, in the second phase, the injection rate is the same as in the first phase, so it is calculated as 4.0 [mL/sec]. Also, since the injection volume is 20 [mL], the injection time is calculated as 5 [sec].

In the above formula (1), the injection amount L of contrast agent is calculated using the amount of iodine I required per subject's body weight. However, in the vascular system, the injection amount is generally calculated using the standard amount of iodine I' [mgI/kg/sec] required per unit body weight of the subject and per unit injection time. In this case, the following formula (1') can be used to calculate the injection amount.

As mentioned above, if the injection volume of contrast agent is too small or the injection rate is too slow, the contrast agent may diffuse into the bloodstream or be absorbed by surrounding tissues before reaching the target site. Therefore, lower limits for the injection volume and injection rate of the contrast agent may be preset in the injection control unit 150. The injection control unit 150 compares these values with the calculated injection volume and injection rate, and issues a warning if at least one of the calculated injection volume and injection rate is smaller than the preset value. The lower limit for the injection volume of contrast agent set in the injection control unit 150 may be preferably 30 mL, and more preferably 50 mL. The lower limit for the injection rate of contrast agent set in the injection control unit 150 may be preferably 3 mL/sec, and more preferably 5 mL/sec. These lower limits may be set for each imaging site or may be adjustable by the operator. The warning may also be displayed as text or graphics on the display unit 154 (or at least one of the second display units, as described below), or may be an audio warning from a sound generator such as a buzzer or speaker.

The injection protocol obtained in this manner can be displayed in the main display area 355 of the protocol setting screen 350 as a preview screen having a configuration similar to that of the protocol screen 310 shown in FIG. 10, for example, so that the operator can check it. In addition, simultaneously with the preview screen, a "Save" icon (for new registration) or a "Save overwrite" icon (for editing registered injection conditions) can be displayed in the menu display area or main display area, and when the operator taps the "Save" icon or the "Save overwrite" icon, the parameters used to set one of the injection protocols for that specific site, etc. are registered in the memory of the injection control unit 150.

When the injection conditions are called up as described above, the injection protocol calculation (a series of calculations to determine the injection protocol) is performed by the injection control unit 150 using pre-registered parameters after the target site is determined and before the protocol screen 310 shown in FIG. 10 is displayed. At this stage, the results of the calculation using the pre-registered parameters are displayed in the injection graph thumbnail 311 on the protocol screen 310. Calculation of the injection protocol using pre-registered parameters may also be performed at any time.

Referring again to FIG. 10, as mentioned above, the injection protocol and parameters displayed on the protocol screen 310, except for the volume value displayed in the syringe volume icon 316 and the iodine amount value displayed in the actual iodine amount icon 320, can be changed either manually by the operator in accordance with actual conditions or automatically in accordance with data read from the RFID tag 802. For example, subject weights vary from subject to subject, and the reference iodine amount and reference iodine concentration vary depending on the type of contrast agent used.

Therefore, when the parameters displayed on the protocol screen 310 are changed in accordance with the subject's actual weight, the type of contrast agent actually used, etc., the injection control unit 150 sets the injection protocol according to the changed parameters and displays the newly set injection protocol on the protocol screen 310.

As an example, the following explains the calculations when a registered injection protocol calculates the injection amount and injection rate using a contrast agent with a reference iodine concentration of 300 mgI/mL, as shown in Figure 11B. However, as shown by the actual iodine concentration icon 317 in Figure 10, a contrast agent with an iodine concentration of 350 mgI/mL is used. Note that in this example, contrast agent is injected only in the first phase, so the following explanation focuses on the first phase.

First, the injection controller 150 calculates the actual iodine amount I _n , which is the amount of iodine in the contrast medium injected in this injection protocol, from the reference iodine amount I n — _base and the reference mixing ratio R _base using the following equation (2).
In=I _{n_base} ×R _base ...Formula (2)
The reference iodine amount is the amount of iodine used to calculate the registered injection protocol, and the reference mixing ratio is the mixing ratio used to calculate the registered injection protocol. In this example, the reference iodine amount I _{n — base} =500 [mgI/mL], and the reference mixing ratio R _base =0.7, so
Actual iodine amount I _n = 500 [mgI/mL] × 0.7 = 350 [mgI/mL]
That is, in the registered injection protocol, an iodine amount of 350 [mgI/mL] is injected.

Next, the injection control unit 150 calculates the reference injection amount V _total , which is the injection amount when the contrast agent is not diluted with saline, from the reference iodine amount I _{n — base} , the reference iodine concentration I _{c — base} and the subject's weight W, using the following equation (3).

The reference iodine concentration is the iodine concentration used to calculate the registered injection protocol, and the subject's weight is assumed to be the same as the weight used to calculate the registered injection protocol. That is, the subject's weight W=60 [kg], and the reference iodine concentration I _{c — base} =300 [mgI/mL]. Therefore, from equation (3),
V _total =100 [mL]
And it is required.

Furthermore, when the actual iodine concentration, which is the iodine concentration of the contrast agent used in the current examination, is _Ic , the injection control unit 150 calculates the actual mixing ratio R, which is the mixing ratio when injection is performed with the changed parameters (iodine concentration in this example), using the following formula (4): As a result, even if a contrast agent with a different iodine concentration is changed, the mixing ratio at which the contrast agent is injected with the same amount of iodine as that injected in the registered injection protocol can be calculated.

In this example, the actual iodine concentration Ic is 350 [mgI/mL], so from equation (4),
R = 0.6
As a result, the mixing ratio is changed from 0.7 to 0.6. The changed actual mixing ratio is displayed next to the time-lapse graph in the injection graph thumbnail 311 on the protocol screen 310 shown in Figure 10, as a contrast medium ratio of 60% and a saline ratio of 40%.

If the calculated actual mixing ratio R is greater than 1, the actual mixing ratio R = 1, and the injection protocol will inject only contrast agent. On the other hand, if the actual mixing ratio R = 0, this means that contrast agent will not be injected, so one of the changeable parameters is changed and the process will not proceed to the next step until an actual mixing ratio R greater than 0 is obtained.

In this way, by automatically changing the mixing ratio according to the iodine concentration of the contrast agent actually used for injection, the amount of iodine injected does not change even when the contrast agent is changed, and as a result, good contrast effects can be achieved with various contrast agents with different iodine concentrations. Furthermore, the actual mixing ratio can be calculated by multiplying the predetermined reference mixing ratio by the coefficient, which is the ratio between a predetermined reference iodine concentration and the actual iodine concentration of the contrast agent actually used. This gives an appropriate mixing ratio.

Once the actual mixing ratio R has been calculated as described above, the injection controller 150 calculates the injection volume V _A [mL] of the contrast agent and the injection volume V _B [mL] of the saline solution from the calculated actual mixing ratio R and the reference injection volume V _total , as given by the following equations (5) and (6).
_VA [mL]=V _total [mL]×R...Formula (5)
V _B [mL] = V _total [mL] × (1-R) ... Formula (6)

From the reference injection volume V _total [mL] and the injection time t [sec], the reference injection rate F _total [mL/sec], which is the injection rate when the contrast medium is not diluted with physiological saline, is calculated as follows:
F _total = V _total [mL]/t [sec] ... Formula (7)
From equation (7), the injection rate of the contrast medium, F _A [mL/sec], and the injection rate of the saline solution, F _B [mL/sec], can be calculated using the following equations (8) and (9).
F _A [mL/sec]=F _total [mL/sec]×R...Formula (8)
F _B [mL/sec] = F _total [mL/sec] × (1-R) ... Formula (9)

The injection control unit 150 applies the parameters determined as described above to the injection protocol and displays the modified injection protocol on the protocol screen 310. From then on, the injection operation is carried out in the same sequence of steps as described above. Note that the changes made here are only changes to the called injection protocol, and do not change the registered injection protocol itself. Injection protocols can only be created and edited from the protocol setting screen 350, which is called from the home screen.

As described above, in this embodiment, when the iodine concentration is changed, the injection control unit 150 calculates the mixing ratio so that the amount of iodine used remains unchanged, changes the mixing ratio to the calculated mixing ratio, and applies the changed mixing ratio to the injection protocol. However, the changed mixing ratio may be different from the calculated value as long as it does not affect the contrast effect. For example, if the mixing ratio is calculated to be 0.57 (amount of contrast agent:amount of saline = 57:43) when the iodine concentration is changed, rounding to the nearest tenth and injecting at a mixing ratio of 0.6 will not significantly affect the contrast effect. In this sense, the same results can be obtained by approximating the mixing ratio when the iodine concentration is changed, for example, to one decimal place, and changing the mixing ratio to the estimated mixing ratio.

Therefore, when the iodine concentration is changed, the injection control unit 150 can be said to be configured to change the mixing ratio in accordance with the changed iodine concentration and apply the changed mixing ratio to the injection protocol. Here, it is preferable that the mixing ratio be changed within a range that does not affect the contrast effect, and it is more preferable that it be changed so that the amount of iodine used does not change.

The above explanation was given using an example where a change in iodine concentration results in a change in the mixing ratio in the injection protocol. However, the injection protocol can also be changed when other parameters are changed. For example, if the base iodine amount is changed, the actual iodine amount, injection rate, and injection volume in the injection protocol will change; if the mixing ratio is changed, the actual iodine amount in the injection protocol will change; and if the subject's weight is changed, the injection rate and injection volume in the injection protocol will change. Furthermore, if the injection time is changed, the injection volume will change if the imaging target is the vascular system, and the injection rate will change if the imaging target is the parenchymal system.

The above explanation deals with the case where an injection protocol is set for each imaging region. However, injection protocols may also be registered for each manufacturer and/or specification of the fluoroscopic imaging device. Fluoroscopic imaging devices generally perform image processing using iterative approximation or image processing that utilizes iterative approximation when reconstructing images. This image processing differs depending on the manufacturer of the fluoroscopic imaging device, and may even differ depending on the specifications of the fluoroscopic imaging device even if the manufacturer is the same. The image quality of the image obtained when a medicinal solution is injected under the same injection conditions differs depending on the type of image processing performed. Therefore, injection protocols may be registered that correspond not only to the imaging region but also to the fluoroscopic imaging device being used.

When a contrast agent is injected as the medicinal liquid, the contrast effect of the contrast agent varies from subject to subject. In order to understand the degree of this individual difference in the contrast effect, a test injection is performed prior to the injection for capturing a tomographic image using the imaging fluoroscopic device 200, in which a smaller amount of medicinal liquid is injected than the amount injected for that image, and the timing of the imaging is determined based on the results.

In such cases, the injection operation of the liquid medicine after the test injection can be initiated by the injection control unit 150 receiving a command from the imaging control unit 152 transmitted from the imaging fluoroscopic apparatus 200. For example, the imaging fluoroscopic apparatus 200 captures a tomographic image displayed on its monitor using a CCD camera (not shown), monitors the brightness (whiteness) of the ROI in the tomographic image, and transmits a command to start the injection operation to the injection control unit 150 when the brightness exceeds a predetermined threshold, or when it measures the signal strength from the cable connected to the monitor and the measurement result exceeds a predetermined threshold. Furthermore, when a test injection is performed prior to the injection for capturing a tomographic image (main injection), the CT value and TDC (Time Density Curve) during the test injection can be monitored, an injection protocol can be determined based on the results, and an optimal imaging start command appropriate for the protocol can be transmitted from the liquid medicine injector 100 to the imaging fluoroscopic apparatus 200.

In the above-described embodiment, the fluoroscopic imaging device 200 is an X-ray CT device. However, in the present invention, the fluoroscopic imaging device 200 may be any fluoroscopic imaging device that uses electromagnetic wave irradiation to acquire images, such as an X-ray CT device, an angiography device, an MRI device, an MRA device, a PET device, or an ultrasound imaging device. If the fluoroscopic imaging device 200 is a device other than an X-ray CT device, the configuration, screen display, operating procedures, operations, etc. of the liquid injector 100 may be modified accordingly as needed.

For example, if the fluoroscopic imaging device 200 is an MRI device, the MRI device has a high-frequency pulse transmitter that emits high-frequency pulses as an electromagnetic wave irradiator, and the high-frequency pulse transmitter can change the irradiation intensity of the high-frequency pulses by setting it. Normally, the stronger the irradiation intensity of the high-frequency pulse, the more enhanced the contrast effect of the contrast agent. Therefore, if the irradiation intensity of the high-frequency pulse set in the electromagnetic wave irradiator is higher than a specific irradiation intensity, the injection control unit 150 performs a process to dilute the contrast agent with physiological saline. The specific procedure for this process can be the same as the procedure described above, except that the relationship between the strength and weakness of the irradiation intensity of the electromagnetic waves set in the electromagnetic wave irradiator is reversed from that in the case of an X-ray CT device.

In the above-described embodiment, the imaging control unit 152 is incorporated into the imaging control unit, and the injection control unit 150 is incorporated into the console 101 of the liquid injector 100. However, the imaging control unit 152 and the injection control unit 150 may both be incorporated into the imaging control unit, or the imaging control unit 152 and the injection control unit 150 may both be incorporated into the console 101, or the imaging control unit 152 and the injection control unit 150 may both be incorporated into a programmable computer device (not shown) separate from the imaging control unit and the console 101. This eliminates the need for the console 101 of the liquid injector 100 or the console of the imaging fluoroscopic apparatus 200, simplifying the overall system.

Furthermore, certain functions of the injection control unit 150 can be incorporated into a unit separate from the remaining functions. For example, the injection protocol determination (calculation) function can be incorporated into the imaging control unit of the fluoroscopic imaging apparatus 200, and the remaining functions can be incorporated into the console 101 of the liquid injector 100. In this case, there is no need to redundantly input data common to the imaging condition settings and the injection condition settings into the fluoroscopic imaging apparatus 200 and the liquid injector 100. Data that is missing when setting the injection conditions can be input from the imaging control unit, or can be sent from the console 101 of the liquid injector 100 to the imaging control unit.

The functions of the imaging control unit 152 and the injection control unit 150 can be realized using various hardware as needed, but are primarily realized by the CPU functioning in accordance with a computer program.

The computer program executes at least part of the above-described steps, for example:
When a concentration of a contrast enhancing agent of the contrast agent among a plurality of parameters used to set a registered injection protocol is changed, the mixing ratio is changed in accordance with the changed concentration;
applying the modified mixing ratio to the injection protocol;
The present invention can be implemented as a computer program for causing the fluoroscopic imaging apparatus 200, the liquid injector 100, or a fluoroscopic imaging system including the fluoroscopic imaging apparatus 200 and the liquid injector 100 to execute the above.

Structurally, the injection head 110 and console 101 can also be configured as a single unit. If the console 101 and injection head 110 are configured as a single unit, the console 101 will also be placed in the examination room. Therefore, a remote controller 170 (see Figure 1) can be used to start and stop the injection operation. By using the remote controller 170, the operator can control the start and stop of the injection operation from within the operation room.

Specific examples of the syringe include those shown in Figures 12(a) and 12(b). This syringe can hold, for example, 100 ml. It includes a cylinder member 501 and a piston member 502. The cylinder flange 501a formed at the end of the cylinder member 501 has an I-cut profile, and two notches 505 (only one of which is shown) are formed on the outer periphery of the flange 501a. The conduit portion 501b at the tip of the cylinder member 501 may be for a luer lock connection, with two coaxially arranged inner and outer cylindrical portions. As shown in Figure 12(b), a ring-shaped protrusion 501c may be formed on the rear surface of the cylinder flange 501a.

Another example of a syringe may be one as shown in Figures 12(a) and (b), which may be, for example, a 200 ml syringe. Like the syringe described above, this syringe also includes a cylinder member 501 and a piston member 502. The cylinder flange 501a formed at the end of the cylinder member 501 may have an I-cut contour. Two notches 505 (only one of which is shown) are formed on the outer periphery of the cylinder flange 501a. The conduit portion 501b at the tip of the cylinder member 501 may be for a luer lock connection, having two coaxially arranged inner and outer cylindrical portions. As shown in Figure 12(b), the rear surface of the cylinder flange 501a may be formed with a ring-shaped protrusion 501c and multiple ribs 501d extending outward from the protrusion 501c.

Note that while Figure 13 shows the cylinder flange 501a having both the notch 505 and the rib 501d formed therein, it may also be that only one of these is formed (for example, the notch 505 is not formed). Furthermore, the rib 501d may be configured such that only the upper and lower two ribs of the multiple ribs aligned vertically in the figure remain, with the other ribs omitted. A syringe may also be configured such that a group of ribs is formed on only one of the left and right sides of the flange.

As shown in Figures 12 and 13, an adapter to which a syringe having a notch 505 in the cylinder flange 501a is attached preferably has a groove into which the cylinder flange 501a is inserted from above in the orientation shown, and a protrusion that engages with the notch 505 when the cylinder flange 501a is inserted and rotated 90 degrees around the axis. This more securely holds the cylinder. Therefore, even if a malfunction occurs in the injection pressure control during an injection operation and excessive pressure is applied to the syringe, the syringe is firmly held, making the cylinder flange 501a less likely to be damaged. In addition, uneven loads caused by attaching the syringe at an angle are less likely to occur, and liquid leakage due to gaps between the piston and cylinder can be prevented.

The syringes shown in Figures 12 and 13 may also have an RFID tag on the outer surface of the cylinder, similar to syringe 800 described above.

(Other Configurations That the Chemical Solution Injector May Have)
The chemical solution injector may further include a load cell for detecting the injection pressure. The load cell may be provided, for example, in the presser 112. When multiple pressers 112 are provided as shown in FIG. 3 , at least one of them may be provided with a load cell. The injection pressure may also be detected by measuring the motor current. As the load acting on the presser 112 increases, the motor current that drives the piston drive mechanism 140 increases accordingly. This fact is utilized in detecting the injection pressure using the motor current. The injection pressure may be detected using either the load cell or the motor current, or both may be used together. When both methods are used together, the injection pressure is normally detected using the load cell, and the injection pressure can be measured using the motor current measurement results only when the load cell fails.

(Other forms of extension tube)
The extension tube is preferably equipped with a mixing device that ensures good mixing of the contrast medium and the saline solution. An example of an extension tube equipped with a mixing device is described with reference to Figures 14A, 14B and 14C.

This extension tube has a first tube 231a that connects the syringe filled with contrast medium to the mixing device 241, a second tube 231b that connects the syringe filled with saline to the mixing device 241, and a third tube 231c that is connected to the liquid outlet (details below) of the mixing device 241 and extends toward the patient. Although not particularly limited, the first and second tubes 231a and 231b may be connected to the conduit portions of the syringes via connectors 239a and 239b, respectively. Similarly, the third tube 231c may be connected to a catheter or the like via connector 239c.

Before the injection of the liquid medicine using the liquid medicine injector, priming is performed to remove air. There are several methods for this priming, and the extension tube is filled with either saline or contrast medium. Specific examples include the following:
(a) First, the contrast medium is pushed out from the contrast medium syringe, filling the first tube up to the mixing device with the contrast medium. Next, saline is pushed out from the saline syringe, filling the second tube, the mixing device, the third tube, and the catheter with saline. This fills the entire circuit with the drug solution, and removes any air. In addition,
(b) A method in which the contrast medium is first pushed out from the contrast medium syringe, then the physiological saline is pushed out from the physiological saline syringe, and then the drug solutions are pushed out from both syringes simultaneously;
(c) There is also a method in which first physiological saline is pushed out from the physiological saline syringe, and then contrast medium is pushed out from the contrast medium syringe, thereby filling the entire medical solution circuit with the medical solution.

The chemical liquid injector may be equipped with a function to automatically perform the priming operation described above, and the trigger for starting the priming operation may be, for example, an input operation by the operator.

Next, the mixing device 241 will be described in detail. As shown in Figures 14A and 14B, the mixing device 241 comprises a main body 242 having a first chamber, which is a swirling flow generating chamber 242a that generates a swirling flow, and a second chamber, which is a narrowing chamber 242b that concentrates the swirling flow in the axial direction. In this example, the swirling flow generating chamber 242a has a cylindrical internal space, and the narrowing chamber 242b has a conical internal space coaxial with the swirling flow generating chamber 242a. The cross-sectional shape of the swirling flow generating chamber in the short direction can be a circle, an ellipse, or any other shape formed from a curve. The swirling flow generating chamber can also be configured to have a narrowing shape that tapers as it approaches the narrowing chamber.

A conduit section 243a to which the first tube 231a is connected is provided on the upstream side of the main body section 242 of the mixing device 241, and a conduit section 243c to which the third tube 231c is connected is provided on the downstream side. The conduit section 243b to which the second tube 231b is connected is located upstream from the center of the swirl flow generating chamber 242a (details below).

In this example, contrast medium flows in through conduit portion 243a and saline flows in through conduit portion 243b, and the two medicinal solutions are mixed within the mixing device. The mixed medicinal solution of contrast medium and saline then flows out through conduit portion 243c, which serves as a liquid outlet.

Conduit section 243a, into which the high-specific-gravity chemical solution flows, is located upstream in the flow direction, in the center of the upstream wall of swirl flow generating chamber 242a. Conduit section 243c, which serves as the liquid outlet, is located so that the center line of conduit section 243c coincides with the center line of conduit section 243a, i.e., so that the two are coaxial. By arranging each section so that they are coaxial, the isotropy of the vortexes generated within the mixing device can be increased. In other words, vortices can be generated uniformly within the space without stagnation, improving mixing efficiency.

On the other hand, conduit section 243b, into which the chemical liquid with a low specific gravity flows, is disposed on the side of swirl flow generating chamber 242a and extends tangentially to the circumference of swirl flow generating chamber 242a, which has a circular cross section. In other words, conduit section 243b is positioned offset from the central axis of the cylindrical space of swirl flow generating chamber 242a toward the periphery, thereby generating a swirling flow of the chemical liquid with a low specific gravity that flows in from conduit section 243b. More specifically, as shown in FIG. 14C , flow path 241fb is configured to extend tangentially to the circumference of the curved inner surface of swirl flow generating chamber 242a, causing the chemical liquid that flows in from this flow path to become a swirling flow. Furthermore, as is clear from the drawing, narrowed chamber 242b has an inclined inner surface that narrows downstream in the flow direction, so that the generated swirling flow is concentrated in the direction of the central axis of the vortex.

Furthermore, conduit portion 243a, through which the contrast agent flows, is connected to swirling flow generating chamber 242a via flow path 241fa. This allows the medicinal liquid with a high specific gravity to be introduced into the swirling flow generating chamber in a direction parallel to the central axis of the swirling flow of the medicinal liquid with a low specific gravity. In other words, the medicinal liquid with a high specific gravity is introduced in a direction parallel to the central axis of the cylindrical space of the swirling flow generating chamber. Furthermore, the conduit portion through which saline solution flows is connected to the swirling flow generating chamber via flow path 241fb. In one example, the inner diameter of flow path 241fb may be smaller than the inner diameter of flow path 241fa, through which the contrast agent flows. With this configuration, when the medicinal liquid is injected at a predetermined pressure, the flow rate of the medicinal liquid with a low specific gravity flowing through flow path 241fb, which has a relatively small cross-sectional area, is faster than the flow rate of the medicinal liquid with a high specific gravity. This prevents a decrease in the mixing efficiency of chemicals due to attenuation of the inertial force of the swirling flow and the resulting lack of swirling strength, which can occur when the flow rate of a chemical with a low specific gravity is slow.

When contrast medium and saline solution are introduced into the mixing device 241 configured as described above, for example, the contrast medium flows from flow path 241fa into the swirling flow generating chamber and flows axially downstream. Meanwhile, saline solution flows from flow path 241fb into the swirling flow generating chamber and becomes a swirling flow that swirls along the curved inner surface of the chamber. The swirling flow of saline solution is then guided into the narrow chamber and concentrates in the direction of the central axis of the swirling flow. Such vortices are known as Rankine vortices, and the inertial force of the swirling flow can be concentrated near the axis of rotation of the vortex.

When two medicinal solutions are simultaneously injected using an extension tube equipped with this type of mixing device 241, the two solutions are mixed well. In other words, in this example, a diluted contrast agent in which the contrast agent and saline are mixed well can be obtained. As a result, there is no unevenness in the concentration of the contrast agent, and superior contrast effects can be expected compared to the case of a typical branch tube.

(Second display unit)
In addition to the display unit 154 (touch panel 103 provided on console 101), the fluoroscopic imaging system may also include a second display unit A151, as shown in FIGS. 15A and 15B . Typically, injection head 110 is located in an examination room together with fluoroscopic imaging apparatus 200, and console 101 is often located in an operation room adjacent to the examination room. Various settings related to the injection of the drug solution are performed by an operator using console 101 located in the operation room. However, during the preparation stage for injection, the operator performs various tasks in the examination room, such as inserting the injection needle into the subject or inserting the catheter, purging air from the tubing, and checking the operation of injection head 110. During this preparation stage, the second display unit A151 is preferably located in the examination room so that the operator can check the injection conditions and other information without moving to the operation room.

The second display unit A151 can display various data related to the injection of medicinal liquid, such as the area to be imaged, the subject's weight, the injection rate of the medicinal liquid, the amount of the medicinal liquid injected, the type of medicinal liquid to be injected, and the medicinal liquid injection protocol. These may be displayed in any format, and may be displayed on the same screen as the touch panel 103 provided on the console 101, or on a different screen. It is also possible to display the aforementioned injection condition call screen (Figures 9 and 9A) 300 and protocol screen 310 (Figure 10). Additionally, when the operation of the piston pressing unit is stopped during the preparation operation and injection operation, a message or icon to that effect can be displayed.

The second display unit A151 is preferably a touch panel. By using the second display unit A151 as a touch panel and allowing data input for setting injection conditions, etc., and operations such as starting and stopping the operation of the injection head 110, the operator can change the injection conditions on the spot during the preparation and early stages of injection without returning to the control room. Examples of reasons for changing the injection conditions or stopping the injection include when the subject's physical condition is poor and it is determined that the injection conditions should be relaxed compared to the standard injection conditions, or when medicinal solution leaks from a blood vessel. Even if the second display unit A151 is not a touch panel, if the second display unit A151 is configured with appropriate operation switches, the injection conditions can be set and/or changed by operating the operation switches.

The second display unit A151 is preferably located near the injection head 110, especially within the examination room. For example, it can be integrally mounted on the injection head 110 or mounted on a member supporting the injection head. Referring to FIG. 15A, an example of a second display unit A151 integrally mounted on the injection head 110 is shown. In the example shown in FIG. 15B, the injection head 110 and the second display unit A151 are supported by a head support structure A158. The head support structure A158 may be part of a known movable stand or part of a multi-joint support arm assembly fixed to the ceiling. As shown in FIG. 15B, the support arm assembly 160 may include, for example, a base 161 fixed to the ceiling and a multi-joint arm 163 extending from the base 161. In the example shown in FIG. 15B, the second display unit A151 is attached to the middle of the arm 163, which extends vertically and to the lower end of which the injection head 110 is attached.

The second display unit A151 is connected to the head support structure A158 via a coupling mechanism A155. Although not particularly limited, the second display unit A151 may be located above the injection head 110 with a gap therebetween. The coupling mechanism A155 may hold the injection head 110 so that the injection head 110 can rotate around a vertical axis and/or a horizontal axis, for example. The connection between the second display unit A151 and the injection head 110 and/or console 101 may be a wired connection via a cable, or a wireless connection.

With the above-described configuration, the orientation of the second display unit A151 can be adjusted over a wide range in the vertical and horizontal directions, regardless of the orientation of the injection head 110, making the second display unit A151 easier for the operator to view. Furthermore, by positioning the second display unit A151 at a distance from the injection head 110, the second display unit A151 can be placed in an optimal position that minimizes the impact of noise on the injection head 110 and other devices. Furthermore, by connecting the second display unit A151 wirelessly, noise transmission via cables can be prevented.

Other Forms of Fluoroscopic Imaging Systems
As shown in FIG. 16 , in addition to the liquid injector 100 and the fluoroscopic imaging apparatus 200, the fluoroscopic imaging system may further include a warmer 900 that warms a syringe 800 to a predetermined temperature before use and a disposal box 910 that stores used syringes 800 to be discarded. The warmer 900 and the disposal box 910 may be devices independent of the liquid injector 100 and the fluoroscopic imaging apparatus 200, or may be connected to at least one of them via a network for data communication. The warmer 900 and the disposal box 910 may also be independent of each other, or may be connected to each other via a network for data communication. The warmer 900 and the disposal box 910 may each include a reader/writer 902, 912 for reading information recorded on an RFID tag 802 and writing information to the RFID tag 802. Syringe 800 is heated by heater 900, and reader/writer 902 records information indicating that syringe 800 has been heated in RFID tag 802 of syringe 800. When used syringe 800 is stored in disposal box 910, information indicating that syringe 800 has been discarded is recorded in RFID tag 802 by 912.

The fluoroscopic imaging system may further include a liquid medicine filling device 920. The liquid medicine filling device 920 is equipped with an empty syringe that is not filled with liquid medicine and can fill this empty syringe with liquid medicine. The liquid medicine filling device 920 may also be a device independent of the liquid medicine injector 100, the fluoroscopic imaging device 200, the heater 900, and the waste box 910, or may be connected to at least one of them via a network for data communication. With the piston in the most forward position, a liquid medicine container 930 of any form, such as a bag or bottle, containing liquid medicine is connected to the empty syringe via a tube or the like for fluid communication. After connecting the empty syringe and the liquid medicine container 930, the liquid medicine can be filled into the empty syringe by retracting the piston using the liquid medicine filling device 920. The empty syringe preferably has an RFID tag attached, which serves as a data carrier. In the following explanation, the empty syringe is assumed to be a syringe 800 equipped with an RFID tag 802 before being filled with medicinal liquid.

An RFID tag 932, which is a data carrier, is also attached to the liquid medicine container 930. The RFID tag 932 stores information about the liquid medicine, such as the type of liquid medicine contained, the volume, pharmaceutical manufacturer, product number, viscosity, expiration date, and, if the liquid medicine is a contrast agent, the iodine content per unit amount of contrast agent. The liquid medicine filling device 920 is equipped with a reader 922a that can read data from the RFID tag 932, and a writer 922b that can write data to the RFID tag 802 attached to the syringe 800.

In the above configuration, when the liquid medicine filling device 920 is used to fill the syringe 800 with liquid medicine from the liquid medicine container 930, the data recorded on the RFID tag 932 attached to the liquid medicine container 930 is read by the reader 922a. The liquid medicine filling device 920 is equipped with a storage device such as a memory, and the read data is temporarily stored in this storage device. Next, the operator sets the filling amount in the liquid medicine filling device 920 and operates the liquid medicine filling device 920.

This fills the syringe 800 with a set amount of medicinal liquid. The filling amount can be set according to a predetermined operating procedure of the medicinal liquid filling device 920. After filling the medicinal liquid, the writer 922b writes the amount of medicinal liquid filled and the filling date and time to the RFID tag 802 of the syringe 800, along with the data temporarily stored in the storage device. In this way, the syringe 800 is filled with medicinal liquid, and data related to the filled medicinal liquid is recorded on the RFID tag 802.

The RFID tag 802 may have data about the syringe recorded in advance, as described above. The reader 922a that reads data from the RFID tag 932 of the liquid medicine container 930 may also be a reader/writer that can write data. In this case, the current content (remaining amount) obtained by subtracting the filled amount from the content amount contained in the liquid medicine container 930 before filling may be written to the RFID tag 932. The remaining amount can be calculated by the CPU of the liquid medicine filling device 920.

As mentioned above, the injection control unit 150 has a current timekeeping function. Using this function, the RFID module 166 (see FIG. 6) reads the refill date and time recorded on the RFID tag 802, and the injection control unit 150 (see FIG. 6) compares the current date and time measured by the timing function with the read refill date and time. If the current date and time is a predetermined period of time after the refill date and time, i.e., the expiration date has passed, the injection control unit 150 can perform processing to prevent the injection of the liquid medicine. Examples of processing to prevent the injection of the liquid medicine include disabling the operation of the piston drive mechanism 140 (see FIG. 6), displaying on the display unit 154 (see FIG. 6) that the expiration date of the liquid medicine has passed, and issuing an audible or voice warning from a sound unit (not shown), such as a buzzer. The expiration date of the liquid medicine is preset in the injection control unit 150, but the operator can change the set expiration date at will. In this way, by managing the refill date and time of the liquid medicine, the safety of the injected contrast agent can be ensured.

Each medical device that makes up the fluoroscopic imaging system, such as the liquid injector 100, fluoroscopic imaging device 200, warmer 900, waste box 910, and liquid filling device 920, may be connected to a medical network. This makes it easy to store and track the history of treatments given to patients, the history of liquid medication use, the history of syringe use, and so on.

At least the liquid injector 100 and the imaging fluoroscopic device 200 may be connected to a medical network. This allows the results of the liquid injection by the liquid injector 100, including the injection rate, injection time, injection amount, and injection graph, as well as the imaging conditions by the imaging fluoroscopic device 200 (including the imaging time and, if the imaging device is a CT scanner, the tube voltage, etc.), to be stored as injection data in the imaging fluoroscopic device, RIS (Radiology Information System), PACS (Picture Archiving and Management System), HIS (Hospital Information System), etc. via the medical network. This allows the stored injection data to be used for managing injection history. In particular, the injection amount can be recorded as used liquid in the patient's medical record or used for accounting purposes. Furthermore, the patient's physical information, such as weight, ID, name, examination area, and examination method, can be obtained from the RIS, PACS, HIS, etc. and displayed on the liquid injector, allowing appropriate injections to be performed. This information, as well as the data acquired from the RFID tag 802 by the RFID module 166, may be transmitted from the liquid injector 100 to a RIS, PACS, HIS, etc. via the fluoroscopic imaging apparatus 200, or may be transmitted directly from the liquid injector 100 to a RIS, PACS, HIS, etc.

The amount of medicinal liquid filled by the medicinal liquid filling device 920 can be the amount of medicinal liquid to be injected into the subject. This allows the filled medicinal liquid to be used without waste. The injection amount can be calculated using a formula that takes into account factors such as the subject's physical characteristics, such as weight, the imaging site, and imaging time, or the value can be determined directly by a doctor or other professional. The factors used to calculate the injection amount, or the injection amount value determined by a doctor or other professional, can be entered by the operator, or can be obtained from an external database such as a RIS, HIS, PACS, external server, or cloud connected via a network or direct line. Obtaining the factors used to calculate the injection amount from an external database prevents input errors by the operator.

The injection volume is calculated using the formula by the injection control unit 150. The functions of the injection control unit 150 may be performed by any computer device, such as the various control circuits included in the liquid injector, fluoroscopic imaging device, and liquid filling device. In other words, the liquid injection volume can be calculated by any other computer device, rather than the liquid injector. Furthermore, by having the functions of the console control circuit performed by any other computer device, rather than the liquid injector, an injection protocol using parameters such as injection rate and injection time, as well as the liquid injection volume, can be created by that computer device.

The liquid injector 100 can be used to fill an empty syringe with a liquid medicine. This eliminates the need for a liquid medicine filling device. When using the liquid injector 100 to fill an empty syringe with a liquid medicine, the presser 112 has a flange holding structure, such as a claw or hook, for removably holding the flange formed on the end of the piston of the empty syringe attached to the injection head 110. This flange holding structure holds the flange of the piston, and by retracting the presser 112 with the syringe connected to the liquid medicine container 930, the liquid medicine in the liquid medicine container 930 can be filled into the syringe.

(Container and driving mechanism)
In the above-described embodiment, the container filled with the liquid medicine is a syringe. However, in the present invention, the container is not limited to a syringe and may be a liquid medicine bottle, a liquid medicine bag, or the like. In this case, the drive mechanism for injecting the liquid medicine from the container may be a tube pump-type drive mechanism or a drive mechanism appropriate for the shape of the container. Also, for example, in the embodiment shown in FIG. 16 , liquid medicine container 930 may be a first container filled with a contrast medium and a second container filled with physiological saline. Liquid medicine injector 100 may have first and second holding mechanisms and first and second drive mechanisms corresponding to these first and second containers, respectively, to directly hold the first and second containers and directly inject the liquid medicine from the first and second containers without using a syringe. In this case, liquid medicine filling device 920 is not required.

(Additional Note)
The present application discloses the following inventions.

[1] A liquid medicine injector that injects a contrast agent and a physiological saline solution into a subject prior to capturing a medical image of the subject using a fluoroscopic imaging device having an electromagnetic wave irradiator, the liquid medicine injector comprising:
an injection head including a first drive mechanism that operates to cause a contrast medium to flow out of a first container filled with the contrast medium, and a second drive mechanism that operates to cause a saline solution to flow out of a second container filled with the saline solution;
at least one data input interface for accepting input of data;
an injection control unit configured to set an injection protocol for the contrast agent and the physiological saline using data input via the data input interface, and to control operations of the first drive mechanism and the second drive mechanism in accordance with the set injection protocol;
and
a plurality of parameters, including a mixed injection in which a contrast agent and a physiological saline solution are injected at a predetermined mixing ratio, which are used as a basis for setting the injection protocol, are registered in the injection control unit;
The injection control unit is configured to change the mixing ratio in accordance with the changed concentration when the concentration of the contrast enhancer of the contrast agent among the registered plurality of parameters is changed, and to apply the changed mixing ratio to the injection protocol.

[2] The liquid injector described in [1] is configured such that the injection control unit determines a reference injection amount, which is the injection amount when only the contrast agent is injected, and also determines an actual mixing ratio, which is the actual mixing ratio, from a reference mixing ratio, which is a preset mixing ratio, and the concentration of the contrast enhancing agent in the contrast agent, and then determines the injection amount of the contrast agent and the injection amount of the saline solution using the determined reference injection amount and actual mixing ratio.

[3] When the actual mixing ratio is R, the base mixing ratio is R _base , the preset concentration of the contrast enhancer is I _{c — base} , and the concentration of the contrast enhancer of the contrast medium actually used is I _c ,
The injection control unit is configured to calculate the injection amount by the following formula: R=(I _{c _ base} /I _c )×R _base
The liquid medicine injection device according to [2], wherein the actual mixing ratio is calculated by:

[4] Further having a display unit,
The liquid injection device according to any one of [1] to [3], wherein the injection control unit is configured to display on the display unit a protocol screen representing the injection protocol and a protocol setting screen used to register the parameters using menus that are independent of each other.

[5] The first container has an RFID tag on which data including a concentration of a contrast enhancing agent in the contrast agent is recorded;
The liquid injector according to any one of [1] to [4], further comprising an RFID reader for acquiring data from the RFID tag as one of the input interfaces.

[6] A fluoroscopic imaging device having an electromagnetic wave irradiator;
a plurality of containers including a first container for a contrast medium and a second container for a saline solution;
an injection head including a first drive mechanism operative to cause the contrast agent to flow from the first container and a second drive mechanism operative to cause the saline to flow from the second container;
at least one data input interface for accepting input of data;
an injection control unit configured to set an injection protocol for the contrast agent and the physiological saline using data input via the data input interface, and to control operations of the first drive mechanism and the second drive mechanism in accordance with the set injection protocol;
and
a plurality of parameters, including a mixed injection in which a contrast agent and a physiological saline solution are injected at a predetermined mixing ratio, which are used as a basis for setting the injection protocol, are registered in the injection control unit;
the injection control unit is configured, when a concentration of a contrast enhancing agent of the contrast agent among the registered plurality of parameters is changed, to change the mixing ratio in accordance with the changed concentration and apply the changed mixing ratio to the injection protocol.

[7] The fluoroscopic imaging system described in [6], wherein the injection control unit is configured to calculate a reference injection amount, which is the injection amount when only the contrast agent is injected, and to calculate an actual mixing ratio, which is the actual mixing ratio, from a reference mixing ratio, which is the preset mixing ratio, and the concentration of the contrast enhancing agent in the contrast agent, and to calculate the injection amount of the contrast agent and the injection amount of the saline solution using the calculated reference injection amount and actual mixing ratio.

[8] When the actual mixing ratio is R, the base mixing ratio is R _base , the preset concentration of the contrast enhancer is I _{c — base} , and the concentration of the contrast enhancer of the contrast medium actually used is I _c ,
The injection control unit is configured to calculate the injection amount by the following formula: R=(I _{c _ base} /I _c )×R _base
The fluoroscopic imaging system according to [7], wherein the actual mixing ratio is calculated by:

[9] Further having a display unit,
The fluoroscopic imaging system according to any one of [6] to [8], wherein the injection control unit is configured to display, on the display unit, a protocol screen representing the injection protocol and a protocol setting screen used to register the parameters using menus that are independent of each other.

[10] The first container has an RFID tag on which data including a concentration of a contrast enhancing agent in the contrast agent is recorded;
The fluoroscopic imaging system according to any one of [6] to [9], further comprising an RFID reader for acquiring data from the RFID tag as one of the input interfaces.

[11] A control method for a chemical liquid injector comprising: a first drive mechanism that operates to cause a contrast agent to flow out of a first container filled with the contrast agent; a second drive mechanism that operates to cause physiological saline to flow out of a second container filled with the physiological saline; and an injection control unit that sets an injection protocol for the contrast agent and the physiological saline and controls operations of the first drive mechanism and the second drive mechanism in accordance with the set injection protocol, wherein a plurality of parameters, including a mixed injection in which the contrast agent and the physiological saline are injected at a predetermined mixing ratio, which are the basis for setting the injection protocol, are registered in the injection control unit,
when a concentration of a contrast enhancing agent in the contrast agent among a plurality of registered parameters is changed, the injection control unit changes the mixing ratio in accordance with the changed concentration;
the injection controller applying the changed mixing ratio to the injection protocol;
A method for controlling a chemical liquid injector, comprising:

[12] The step of changing the blending ratio includes the injection control unit determining a reference injection amount, which is an injection amount when only the contrast agent is injected, and determining an actual blending ratio, which is an actual blending ratio, from a reference blending ratio, which is a preset blending ratio, and a concentration of a contrast enhancing agent in the contrast agent;
The method for controlling a chemical liquid injector according to claim 11, further comprising the step of: determining an injection amount of the contrast agent and an injection amount of the saline solution using the determined reference injection amount and the determined actual mixing ratio.

[13] The step of changing the blending ratio may include the following steps: where R is the actual blending ratio, R _base is the reference blending ratio, I _{c — base} is a preset concentration of the contrast enhancer, and I _c is a concentration of the contrast enhancer of the contrast medium actually used:
The injection control unit is configured to calculate the base current R by the following formula: R=(I _{c _ base} /I _c )×R _base
The method for controlling a chemical liquid injector according to [12], further comprising determining the actual mixing ratio by

[14] A method for calculating an injection protocol including a mixed injection in which a contrast medium and a physiological saline solution are injected at a predetermined mixing ratio in a liquid injector having an injection control unit, comprising:
the injection control unit determining a reference injection amount, which is an injection amount when only the contrast agent is injected in the mixed injection;
the injection control unit calculating an actual mixing ratio, which is an actual mixing ratio, from a reference mixing ratio, which is a preset mixing ratio, and a concentration of a contrast enhancing agent in the contrast agent;
the injection control unit calculating the injection amount of the contrast agent and the injection amount of the physiological saline using the calculated reference injection amount and the calculated actual mixing ratio;
A method for calculating an injection protocol having:

REFERENCE SIGNS LIST 100 Liquid injector 101 Console 103 Touch panel 112 Presser 110 Injection head 121 Stand 140 Piston drive mechanism 150 Injection control unit 152 Imaging control unit 153 Electromagnetic wave irradiator 154 Display unit 156 Input unit 164 RFID control circuit 165 Antenna 166 RFID module 200 Fluoroscopic imaging device 300 Injection condition call screen 310 Protocol screen 350 Protocol setting screen 600 Adapter 800 Syringe 802 RFID tag

Claims (8)

1. A liquid medicine injector that injects a contrast agent containing a contrast enhancing agent and physiological saline as liquid medicines into a subject prior to capturing a medical image of the subject, when the subject is to be imaged, comprising:
an injection control unit configured to set an injection protocol for the contrast agent and the physiological saline, display the set injection protocol as a protocol screen, and control the injection of the medicinal liquid in accordance with the set injection protocol;
The injection control unit is a liquid injection device configured to display on the protocol screen a reference amount of contrast agent, which is the amount of contrast agent required per subject's body weight, an actual amount of contrast agent, which is the amount of contrast agent injected per subject's body weight when the contrast agent is injected using the injection protocol, and the mixing ratio of the contrast agent and the saline solution. The chemical solution injector of claim 1, further comprising at least one data input interface for accepting data input. the data entry interface includes a baseline contrast agent amount icon displayed on the protocol screen;
The liquid injector according to claim 2 , wherein the reference amount of contrast enhancer can be changed by a user operating an icon for the reference amount of contrast enhancer. the contrast agent is held in a liquid container having an RFID tag on which data including the concentration of the contrast enhancer is recorded;
the data input interface includes an RFID reader that acquires data from the RFID tag;
3. The liquid injector according to claim 2, wherein the injection control unit changes the value of the actual amount of contrast enhancer in accordance with data acquired from the RFID tag by the RFID reader. The liquid injector according to any one of claims 1 to 4, wherein when the contrast agent is changed to one having a different concentration of the contrast enhancer, the injection control unit calculates the mixing ratio so that the actual amount of contrast enhancer does not change, and changes the mixing ratio within a range that does not affect the contrast effect. a fluoroscopic imaging device;
a medical solution injector that injects a contrast agent containing a contrast enhancing agent and physiological saline as medical solutions into the subject prior to capturing a medical image of the subject using the fluoroscopic imaging apparatus;
and
the liquid injector has an injection control unit configured to set an injection protocol for the contrast agent and the physiological saline, display the set injection protocol as a protocol screen, and control injection of the liquid in accordance with the set injection protocol;
The injection control unit is configured to display on the protocol screen a reference amount of contrast agent, which is the amount of contrast agent required per body weight of the subject, an actual amount of contrast agent, which is the amount of contrast agent injected per body weight of the subject when the contrast agent is injected according to the injection protocol, and a mixing ratio of the contrast agent and the physiological saline. A computer program for controlling a liquid injector that injects a contrast agent containing a contrast enhancing agent and physiological saline as liquids into a subject prior to capturing a medical image of the subject, when capturing a medical image of the subject, the computer program comprising:
Computer,
setting an injection protocol for the contrast agent and the physiological saline solution, displaying the set injection protocol as a protocol screen, and functioning as an injection control unit configured to control the injection of the medicinal liquid in accordance with the set injection protocol;
A computer program that displays on the protocol screen a reference amount of contrast agent, which is the amount of contrast agent required per subject's body weight, an actual amount of contrast agent, which is the amount of contrast agent injected per subject's body weight when the contrast agent is injected using the injection protocol, and a mixing ratio of the contrast agent and the saline solution. A computer program for controlling a fluoroscopic imaging system having a fluoroscopic imaging apparatus and a liquid injector that injects a contrast agent containing a contrast enhancing agent and physiological saline as liquids into a subject prior to capturing a medical image of the subject using the fluoroscopic imaging apparatus, the computer program comprising:
Computer,
setting an injection protocol for the contrast agent and the physiological saline solution, displaying the set injection protocol as a protocol screen, and functioning as an injection control unit configured to control the injection of the medicinal liquid in accordance with the set injection protocol;
The injection control unit is a computer program that displays on the protocol screen a reference amount of contrast enhancer, which is the amount of contrast enhancer required per subject's body weight, an actual amount of contrast enhancer, which is the amount of contrast enhancer injected per subject's body weight when the contrast agent is injected using the injection protocol, and a mixing ratio of the contrast agent and the saline.