Chemical injection device
The liquid medicine injector adjusts contrast agent and saline mixing ratios based on enhancer concentration to maintain bolus properties and reduce noise in fluoroscopic imaging, addressing the challenge of low tube voltage imaging with varying contrast agents.
Patent Information
- Application Number
- JP2024016449
- Authority / Receiving Office
- JP · JP
- Patent Type
- Patents
- Current Assignee / Owner
- Priority Date
- 2016-08-26
- Filing Date
- 2024-02-06
- Publication Date
- 2025-12-22
- Estimated Expiration
- 2037-08-25
Smart Images

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Abstract
Description
[Technical Field]
[0001] The present invention relates to a liquid injector that injects a contrast agent into a subject to obtain a good contrast effect when a fluoroscopic image of the subject is taken by an imaging diagnostic apparatus. [Background technology]
[0002] Medical imaging diagnostic devices include CT scanners, MRI scanners, PET scanners, angiography scanners, MRA scanners, 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. The contrast agent contains a contrast enhancing agent.
[0003] Typically, these medicinal liquids are filled into containers such as syringes or bottles before use, and a medicinal liquid injector is generally used to inject the medicinal liquid from the container. The 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.
[0004] When injecting a drug solution, the injection conditions are set so that optimal fluoroscopic images can be obtained for diagnostic imaging. For example, in CT imaging, the amount of contrast agent injected is set so that the CT value, which is proportional to the concentration of the contrast agent in the blood, remains above a certain value at least during the imaging period.
[0005] On the other hand, for example, in a CT scanner, there is a proportional relationship between the CT value and the injection amount of contrast agent, and between the CT value and the injection speed of the contrast agent. The CT value also correlates with the intensity of 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 obtained CT value. Therefore, by lowering the tube voltage setting, an optimal CT value can be obtained with a smaller amount of contrast agent. Taking advantage of this relationship, Patent Document 1 describes taking the tube voltage of the CT scanner into consideration when calculating the injection amount of contrast agent, and gradually changing the tube voltage depending on the purpose of the imaging, the subject's symptoms, etc. [Prior art documents] [Patent documents]
[0006] [Patent Document 1] Patent No. 5416761 Summary of the Invention [Problem to be solved by the invention]
[0007] As described above, capturing fluoroscopic images at a lower tube voltage enables imaging with a smaller amount of contrast agent, thereby reducing the physical burden on the subject. However, capturing fluoroscopic images at a low tube voltage results in images with a lot of noise, so imaging at a low tube voltage has not been commonly performed in the past. However, recent improvements in image processing technology have led to progress in reducing noise, and as a result, it has become possible to obtain images with less noise even when capturing images at a lower tube voltage.
[0008] However, if the tube voltage is set to a low value and the injection volume of contrast agent is reduced, a new problem arises. Even if the injection volume of contrast agent is reduced, the injection time is usually not changed because it is often determined based on the imaging time. Therefore, reducing the injection volume of contrast agent results in a reduction in the injection rate. If the injection volume 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.
[0009] 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.
[0010] To maintain good bolus performance even with a small amount of contrast agent, diluting the contrast agent with saline is considered. However, there are several types of contrast agents with different concentrations of contrast enhancers (e.g., iodine) that affect the contrast effect. Therefore, to obtain good contrast effects regardless of the type of contrast agent, it is necessary to determine a new dilution ratio for the contrast agent depending on the type of contrast agent, particularly the contrast enhancer concentration, and to set an injection protocol based on the new dilution ratio.
[0011] An object of the present invention is to easily set an appropriate amount of contrast agent while maintaining bolus properties, even when the type of contrast agent is changed. [Means for solving the problem]
[0012] According to one aspect of the present invention, there is provided 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 agent to flow out of a first container filled with the contrast agent, 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 entry 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.
[0013] 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 operable to cause the contrast agent to flow from the first container and a second drive mechanism operable to cause the saline to flow from the second container; at least one data entry 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.
[0014] 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: a step in which, 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:
[0015] 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:
[0016] 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.). When multiple types of medicinal liquids, such as a contrast medium and saline, are to be injected, the injection protocol also includes the order of their injections and their respective injection conditions.
[0017] In the present invention, the term "fluoroscopic imaging device" refers to a device that captures a fluoroscopic image by irradiating electromagnetic waves, such as a CT device, an angiography device, or an MRI device. The "fluoroscopic imaging device" has an "electromagnetic wave irradiator" that irradiates electromagnetic waves. The CT device and the angiography device have an X-ray tube as the "electromagnetic wave irradiator," and the MRI device has a high-frequency pulse transmitter that irradiates high-frequency pulses as the "electromagnetic wave irradiator."
[0018] In the present invention, the term "contrast agent" refers to a medicinal solution administered to a subject to provide contrast to the image or to emphasize specific tissues when a fluoroscopic image of the subject is taken using a fluoroscopic imaging device, and contains a "contrast enhancer." Examples of "contrast enhancers" include iodine (used when taking images using a CT device or an angiography device), gadolinium (used when taking images using an MRI device), barium, and carbon dioxide.
[0019] In the present invention, the "mixing ratio" means the amount of contrast agent relative to the total amount of injected contrast agent and physiological saline, expressed as (amount of contrast agent) / (amount of contrast agent+amount of physiological saline). [Effects of the Invention]
[0020] According to the present invention, even if the type of contrast agent used is changed, the mixing ratio of the contrast agent and saline is changed according to the contrast enhancer concentration of the changed contrast agent, so that it is extremely easy to set an appropriate amount of contrast agent while maintaining bolus properties. [Brief explanation of the drawings]
[0021] [Figure 1] 1 is a layout diagram of a fluoroscopic imaging system according to an embodiment of the present invention; [Figure 2] FIG. 2 is a front view of the console shown in FIG. [Figure 3] FIG. 2 is a perspective view of the injection head shown in FIG. 1. [Figure 4] 2A to 2C are diagrams illustrating the procedure for attaching a syringe to the injection head shown in FIG. 1. [Figure 5] 2A to 2C are diagrams illustrating the procedure for attaching a syringe to the injection head shown in FIG. 1. [Figure 6] FIG. 2 is a block diagram showing the main functions of a control system in the fluoroscopic imaging system shown in FIG. [Figure 7] 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. [Figure 8] 10A and 10B are diagrams showing one form of an extension tube connected to a syringe. [Figure 9] 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. [Figure 9A] FIG. 10 is a diagram showing the next step of the injection condition call screen shown in FIG. 9. [Figure 10]FIG. 10 is a diagram showing an example of a protocol screen displayed on a display unit in one embodiment of the present invention. [Figure 11A] 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. [Figure 11B] 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. [Figure 12] 1 is a perspective view showing one embodiment of the structure of a syringe that can be used in the present invention. [Figure 13] FIG. 10 is a perspective view showing another form of syringe structure that can be used in the present invention. [Figure 14A] 10A and 10B are diagrams schematically showing other forms of extension tubes connected to syringes. [Figure 14B] FIG. 13B is a perspective view of a mixing device provided in the extension tube shown in FIG. 13A. [Figure 14C] FIG. 14B is a cross-sectional view of a mixing tube provided in the extension tube shown in FIG. 14A. [Figure 15A] 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. [Figure 15B] 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. [Figure 16] FIG. 2 is a block diagram of a fluoroscopic imaging system in accordance with another aspect of the present invention. DETAILED DESCRIPTION OF THE INVENTION
[0022] 1 shows a fluoroscopic imaging system according to one embodiment of the present invention, 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.
[0023] Imaging fluoroscopic apparatus 200 has scanner 201 that performs imaging operations and an imaging control unit (not shown) that controls the operation of scanner 201, and is capable of acquiring medical images of a subject into which a liquid has been injected by liquid injector 100. Scanner 201 has electromagnetic wave irradiator 153 (see FIG. 6) that irradiates electromagnetic waves, and the setting of the electromagnetic wave irradiation intensity of electromagnetic wave irradiator 153 is changeable. The imaging control unit may include a display device such as a liquid crystal display that can display imaging conditions and acquired tomographic images, and an input device such as a keyboard and / or a mouse for inputting imaging conditions, etc. The display device may have a touch screen that also serves as an input device.
[0024] Liquid injector 100 includes, for example, injection head 110 mounted on the top of stand 121 via swivel arm 122 so as to be freely rotatable in the vertical direction, and console 101 equipped with various functions for controlling the overall operation of liquid injector 100. While injection head 110 and console 101 can be configured in a single housing, in this embodiment, injection head 110 and console 101 are configured as separate units. In this case, injection head 110 can be placed in an examination room together with scanner 201, and console 101 can be placed in an operation room together with the imaging control unit of imaging fluoroscopic apparatus 200. Stand 121 can be equipped with casters to facilitate movement of injection head 110.
[0025] 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 Fig. 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 a home screen, and a power button 102c for turning the power on and off, and a touch panel 103 that doubles as an input unit and a display unit.
[0026] As shown in FIGS. 3 to 5, 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 physiological saline. 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. Injection head 110 has two cylinder holding mechanisms 111 that hold these cylinders, and two linear motion units that move in the axial direction of syringe 800 to operate the piston of syringe 800 (e.g., pushing it into the cylinder) when the cylinder is held by cylinder holding mechanism 111.
[0027] The linear motion unit includes a rod 113 that is moved back and forth by an appropriate rotational motion conversion mechanism, such as a lead screw mechanism or a rack and pinion mechanism, that 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 rod 113 and presser 112 and moves linearly) for moving the piston back and forth is referred to herein as a piston drive mechanism. In this embodiment, injection head 110 is equipped with two piston drive mechanisms.
[0028] 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 the first driving mechanism, respectively, and the cylinder holding mechanism and piston driving mechanism for the saline solution are sometimes referred to as the second holding mechanism and the second driving mechanism, respectively. Also, in the illustrated example, one cylinder holding mechanism and one piston driving mechanism for the contrast agent are provided, but there may be more than one of each. Similarly, there may also be more than one of each of the cylinder holding mechanisms and piston driving mechanisms for the saline solution.
[0029] A DC motor can be used as the motor that drives the piston drive mechanism, and a DC brushless motor is particularly preferred. Brushless motors are quieter and more durable because they have no brushes. Furthermore, because brushless motors are capable of higher speed rotation, increasing the external gear ratio and reducing the torque applied to the motor can reduce the current required to inject the drug 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.
[0030] Except for a portion of the piston drive mechanism (e.g., presser 112), injection head 110 is entirely covered in a synthetic resin housing 115. Several operation buttons 116 are arranged on the top surface of housing 115 so that the piston drive mechanism can be operated by a user.
[0031] For example, in this embodiment, the injection head 110 includes, as operation buttons 116, a check button 116a operated to prepare the device for injection, a start button 116b operated to start injection, a forward button 116c operated to move the presser 112 forward a desired distance (e.g., at a speed of 1.5 ml / sec), an acceleration button 116d operated to accelerate the movement speed of the presser 112 (e.g., to add an additional 8 ml / sec to the current speed; both forward and backward movement are possible), a backward button 116e operated to move the presser 112 backward a desired distance (e.g., at a speed of 1.5 ml / sec), an auto-return button 116f operated to move the presser 112 backward to the initialized position, stop buttons 116g and 116h operated to manually stop or interrupt operation, and a route switch 116h operated to move the presser forward / backward at a slow speed (e.g., 0.7 ml / sec). In this embodiment, there are two each of the forward button 116c, the acceleration button 116d, the backward button 116e, and the auto-return button 116f so that each piston drive mechanism can be operated independently.
[0032] Note that the initialized position, which is the retracted end to which 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 attach 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 arbitrarily set by the operator depending on the type of syringe 800 and / or the type of adapter 600, or may be automatically set by the fluoroscopic imaging system.
[0033] When the initialization position can be set by the fluoroscopic imaging system, for example, if RFID technology can be used to identify the type of syringe 800, as will be described in detail later, the initialization position can be set based on the results. Also, 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 of this adapter sensor.
[0034] Like the initialized position, the most forward position of presser 112 may be set to a different position for each size of syringe 800 and / or each type of medicinal solution filled therein, or even each type of adapter 600. Like the initialized position, the most forward position of 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 most forward position according to the identified type of syringe 800 and / or adapter 600.
[0035] Cylinder holding mechanism 111 is configured so that syringe 800 is attached via adapter 600. Syringes 800 are available in various sizes depending on the volume of medicinal liquid that can be filled. Adapters 600 are provided for each size of syringe 800, and as shown in FIG. 4, each adapter 600 is configured to hold a cylinder flange 801 formed on the end of the cylinder of the corresponding syringe 800, and is detachably attached to cylinder holding mechanism 111 of injection head 110. In this embodiment, syringe 800 is configured so that it is attached via adapter 600, but syringe 800 may also be configured so that it is attached directly to injection head 110 without using adapter 600.
[0036] Syringe 800 can be attached to injection head 110, for example, by attaching adapter 600 to cylinder holding mechanism 111 of injection head 110 and then holding the cylinder flange 801 of syringe 800 in adapter 600. Adapter 600 has a groove that receives cylinder flange 801, and syringe 800 is held in adapter 600 by inserting cylinder flange 801 into the groove. Adapter 600 may also have a locking mechanism that locks the cylinder by rotating syringe 800 a predetermined angle (e.g., 90 degrees) around its axis after cylinder flange 801 is inserted into the groove of adapter 600. In this way, by preparing adapters 600 according to the size of syringe 800, syringes 800 of various sizes can be attached to injection head 110.
[0037] Syringe 800 may be a pre-filled syringe provided by a pharmaceutical manufacturer in a state filled with a medicinal solution, or may be a field-filled syringe filled with a medicinal solution at a medical site.
[0038] When injecting a liquid into a subject and capturing images, scanner 201 and injection head 110 of the above-described configuration are installed in an examination room, while the imaging control unit of imaging fluoroscopic apparatus 200 and console 101 of liquid 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 console 101 and 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 console 101 and injection head 110 via wireless communication, which eliminates the need for a cable passage in the wall. For wireless communication, console 101 and injection head 110 can each be equipped with a wireless communication unit (not shown).
[0039] The flow of data and the like in the above-described fluoroscopic imaging system will be described below with reference to the block diagram shown in Fig. 6. Note that Fig. 6 shows only the main functions of the control system in the fluoroscopic imaging system of this embodiment, and the present invention is not limited to this.
[0040] The imaging control unit 152 can be incorporated into, for example, the imaging control unit of the imaging fluoroscopic apparatus 200, and is configured to control the overall operation of the imaging fluoroscopic 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 imaging fluoroscopic apparatus 200 is implemented in the ROM. The CPU controls the operation of each part of the imaging fluoroscopic 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 imaging fluoroscopic apparatus 200.
[0041] The electromagnetic wave irradiator 153 is a device provided in the fluoroscopic imaging apparatus 200 (see FIG. 1), and is configured to irradiate electromagnetic waves with 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 signals obtained by irradiating the subject with electromagnetic waves.
[0042] Injection control unit 150 can be incorporated into console 101, for example, and is configured to generally control the operation of console 101 and injection head 110. More specifically, injection control unit 150 can control the screen and data to be displayed on display unit 154 in response to input of data, information, etc. from input unit 156 and data and information input from RFID module 166, determine an injection protocol including the injection amount and injection rate of the medicinal liquid using the data, etc. input from input unit 156, and control the operation of piston drive mechanism 140 in accordance with the determined injection conditions.
[0043] 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 the 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.
[0044] Display unit 154 can be touch panel 103 of console 101. Input unit 156 is a data input interface of the present invention that is configured to accept data input operations by an operator. Input unit 156 can include touch panel 103, buttons 102 of console 101, and buttons 116 of injection head 110. Touch panel 103 is typically a modular combination of a display that functions as display unit 154, a touch screen that functions as an input unit, and control circuits for these.
[0045] Any display can be used as the display, including a liquid crystal display and an organic electroluminescence (EL) display. Any touch screen can be used, including a capacitive type and a pressure-sensitive type. The control circuit of touch panel 103 displays predetermined screens and data on the display based on signals transmitted from injection control unit 150, and transmits input information to injection control unit 150 based on signals generated from the touch screen when an operator or the like touches the touch screen.
[0046] RFID module 166 has an RFID control circuit 164 and an antenna 165. In this embodiment, syringe 800 has an RFID tag 802, which is a data carrier, attached to the outer circumferential surface of the cylinder (see FIG. 4 ). RFID module 166 reads information recorded in RFID tag 802 from RFID tag 802 using antenna 165 and transmits the read information to injection control unit 150. RFID module 166 may further have a function of writing information transmitted from injection control unit 150 to RFID tag 802. RFID control circuit 164 controls the information transmission and reception operations of RFID module 166. That is, RFID module 166 functions as a reader that reads information from RFID tag 802, or as a reader / writer that writes information to RFID tag 802.
[0047] The fluoroscopic imaging system may further include a memory card reader / writer 158 connected to the injection control unit 150 so as to be able to send and receive data. The memory card reader / writer 158 may be built into the console 101 shown in Fig. 2, for example. In this 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.
[0048] 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 memory card reader / writer 158 and transmitted to injection control unit 150. Conversely, an injection protocol set in injection control unit 150 can be written to a memory card via 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.
[0049] When transmitting data via a memory card in this manner, it is preferable to prevent unauthorized transmission and reception of data by setting a password, etc. Also, the control program of the liquid injector can be recorded on a memory card, and the control program can be installed in injection control unit 150 or the installed control program can be updated via memory card reader / writer 158.
[0050] The memory card may be any memory card such as a CF memory card or an SD memory card, and any device suitable for reading and writing data from and to a memory card may be used as the memory card reader / writer 158. Here, the data exchange between the memory card and the injection control unit 150 has been described as involving both writing and reading data, but a memory card reader or writer that only writes or reads data may also be connected to the injection control unit 150.
[0051] As described above, the RFID module 166 receives data input from the RFID tag 802, and in this sense, the RFID module 166, together with the input unit 156, constitutes a data input interface in the present invention.
[0052] 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, if the medicinal liquid is a contrast medium, the contrast medium contains iodine as a contrast enhancing agent, and the iodine concentration, which is the amount of iodine contained per unit amount of the contrast medium, etc.), 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, lot number, etc. At least a part of this information can be transmitted to the imaging fluoroscopic apparatus 200.
[0053] The RFID control circuit 164 can be installed in any position, but it is desirable that the antenna 165 be installed in a position facing the RFID tag 802 when the syringe 800 is properly held in the cylinder holding mechanism 111.
[0054] 4, RFID tag 802 has a shape with a longitudinal direction, and is attached so that the longitudinal direction coincides with the circumferential direction of syringe 800. Syringe 800 is designed to be held normally by being inserted into cylinder holding mechanism 111, or to be held normally by being inserted and then rotated so that syringe 800 is oriented in a specific direction, with RFID tag 802 facing downward when held normally.
[0055] Antenna 165 of RFID module 166 has an FPC (flexible printed circuit board) formed with a predetermined pattern (for example, one or more loop-shaped patterns) made of a conductor, and is arranged, as shown in Fig. 7, bent in an arc shape so as to be concentric with syringe 800, at a position facing RFID tag 802 of syringe 800 when the cylinder is properly held by the cylinder holding mechanism. This increases the detection range of RFID tag 802 attached to a curved surface.
[0056] Furthermore, in this embodiment, antenna 165 has a larger area than RFID tag 802 so that RFID tag 802 can reliably face antenna 165 even if there is variation in the attachment position of RFID tag 802. Therefore, it is preferable to design the size of antenna 165 taking into consideration the variation in the attachment position of RFID tag 802 on syringe 800.
[0057] On the other hand, when antenna 165 is bent into an arc, the smaller the radius of curvature of antenna 165 and the longer the circumferential length of antenna 165, the more likely radio waves for communication to interfere with each other, and communication sensitivity tends to decrease. Therefore, in order to suppress radio wave interference, antenna 165 preferably has ferrite sheet 165a on the surface opposite to the surface facing RFID tag 802 of the FPC.
[0058] The output of RFID module 166 can be set to, for example, 200 mW. By setting the output to such a weak level, data can be read out successfully from RFID tag 802 when syringe 800 is attached in the correct position where RFID tag 802 directly faces antenna 165, but data cannot be read out when syringe 800 is not attached in the correct position. As a result, if data cannot be read out from RFID tag 802, injection control unit 150 can alert the operator by displaying on display unit 154 that syringe 800 may not be attached correctly.
[0059] Next, the operation of the above-described fluoroscopic imaging system will be described in more detail, focusing on the operation of the liquid injector 100, using an example in which the fluoroscopic imaging apparatus 200 is an X-ray CT apparatus. Note that the following description is provided as a mere example, and the present invention is not limited to the example described below.
[0060] First, liquid injector 100 and imaging fluoroscopic apparatus 200 are powered on, and liquid injector 100 and imaging fluoroscopic apparatus 200 are started up. When liquid injector 100 is started up, injection control unit 150 causes display unit 154 (e.g., touch panel 103) to display injection condition call screen 300 as shown in Fig. 9. The operator can use this injection condition call screen 300 to call up preset injection conditions.
[0061] 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 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. FIGS. 9 and 9A show a state in which the abdomen is selected as the region and the liver is selected as the region.
[0062] When the site is selected in the above manner, the injection control unit 150 calls up parameters that have been pre-registered corresponding to the selected site, sets an injection protocol by calculation or the like using the called-up parameters, and displays the set injection protocol as a protocol screen on the display unit 154.
[0063] An example of a protocol screen is shown in Fig. 10. The protocol screen 310 shown in Fig. 10 displays various data / information, including an imaging region icon 301 and an injection graph thumbnail 311. Note that the "A" and "B" indications on the protocol screen 310 represent the contrast agent and saline, respectively.
[0064] The imaging region icon 301 is the same as the imaging region icon 301 displayed on the injection condition call screen 300 described above, and indicates which imaging region the displayed injection protocol is for.
[0065] 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 need to be an image that resembles a human body, and may be any icon, such as an image of an organ alone representing the imaging region, an image of an organ alone representing the imaging region, or a combination of these. This also applies to the imaging region icons 301 on other screens.
[0066] The weight icon 312 is used to display and input the weight of the subject. 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 weight of the subject.
[0067] 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 body weight. The injection time is often set to the same time 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 body weight icon 312. Predetermined values for the subject's body weight, injection time, and reference iodine amount may be stored in the memory of the injection control unit 150, and these values may be displayed as the corresponding icons by default. Alternatively, at least one of these data items may be transmitted from an external unit to the liquid injector 100 to the injection control unit 150, and the transmitted data may be displayed as the corresponding icon. Examples of external units include the fluoroscopic imaging device 200, a RIS, a PACS, and an HIS (Heterogeneous System), which will be described later.
[0068] 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. As with the weight icon 305, the pressure limit icon 309 allows the operator to input a numerical value. 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 as with the weight icon 305. The syringe capacity icon 316 displays the remaining volume of the medicinal liquid in the syringe 800, calculated by the injection control unit 150 in accordance with the position of the presser 112.
[0069] 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, the iodine concentration can be changed by an operator's operation.
[0070] 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 imaging fluoroscopic apparatus 200. When the operator taps timing icon 318, the injection control unit 150 displays a screen for setting 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 a specified operation to start the test injection. This causes the injection control unit 150 to control the operation of the liquid injector according to the settings, thereby performing the test injection.
[0071] Route icon 319 is an icon operated when causing the liquid injector to execute a route test. A route test is a test to confirm whether the injection circuit from 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, a liquid leak in the injection circuit may be suspected, and conversely, if the pressure is higher than the predetermined range, a blockage in the injection circuit may be suspected.
[0072] The injection graph thumbnail 311 represents the injection protocol in a time-varying graph format. The injection protocol shown in the injection graph thumbnail 311 of FIG. 10 consists of two phases: a first phase in which a contrast agent and saline are mixed and 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 tube voltage than normal. 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 to reduce 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.
[0073] As an example only, 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 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.
[0074] 10 may be configured to 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 according to the injection protocol displayed in the injection graph thumbnail 311.
[0075] The operator checks protocol screen 310, and if the displayed content is acceptable, taps check icon 321 or operates check button 116a on injection head 110. This temporarily stores the displayed injection volume, injection rate, and other data required to set the injection protocol in memory within injection control unit 150, and the injection protocol is finalized.
[0076] Next, the operator attaches syringe 800 filled with a medicinal liquid to injection head 110 using a predetermined procedure. When syringe 800 is attached, RFID module 166 reads the data / information recorded on RFID tag 802. Here, the description will be given assuming that two syringes 800, specifically a contrast medium syringe filled with a contrast medium and a saline syringe filled with saline, are attached to injection head 110. In this specification, when distinguishing the syringes by the type of medicinal liquid they contain, a syringe filled with a contrast medium may be denoted by the suffix C, as syringe 800C, and a syringe filled with saline may be denoted by the suffix P, as syringe 800P.
[0077] After syringe 800C filled with contrast medium and syringe 800P filled with saline have been attached to injection head 110, the operator connects extension tube 400, as shown in FIG. 8, to each of syringes 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 syringes 800C and 800P, respectively, and connector 403 of another type is attached to the end of the tube facing the subject. Connectors 401 and 402 each have a cylindrical portion with a threaded portion at the tip, and may be connected to a conduit portion provided at the tip of syringe 800C or 800P via a luer lock system. Of these connectors 401 and 402, at least connector 402 connected to syringe 800P for saline may have a 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 extension tube 400, contrast medium and saline can be injected into a subject simultaneously or separately.
[0078] When the contrast agent syringe 800 is attached, data on at least the iodine content per unit dose of contrast agent is read from the 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 movable range of the presser 112, 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 standby position of the piston.
[0079] This completes the preparation for injection. After completing the preparation for injection, when the operator operates start button 116b on injection head 110, a corresponding signal is sent to injection control unit 150. Injection control unit 150 uses this signal as a trigger to read various data stored in memory and control the operation of piston drive mechanism 140 so that piston drive mechanism 140 operates according to the confirmed injection protocol. This allows the medicinal liquid filled in syringe 800 to be injected into the subject.
[0080] The injection protocol displayed on the protocol screen 310 shown in Fig. 10 is determined according to pre-registered parameters. The registration of parameters necessary for setting this injection protocol will be described below.
[0081] It is preferable that the input of parameters for setting the injection protocol be performed using a menu separate from the series of steps described above, for example, the series of steps using the protocol screen 310. This prevents the registered parameters from being erased or changed due to an erroneous operation during the injection preparation stage.
[0082] For example, a protocol setting procedure can be called from a home screen for parameter registration. 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 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 a protocol setting and then selecting a user to perform protocol setting.
[0083] In the protocol setting procedure, first, a site is selected. The site selection may be similar to the procedure for calling up the injection conditions described above. That is, the injection control unit 150 displays the imaging site icon 301 and the site detail icon 302 as shown in FIGS. 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.
[0084] Once the site for setting the injection protocol has been determined, the injection control unit 150 displays an injection protocol setting screen on the display unit 154. Before displaying the injection protocol setting screen, the operator may be prompted to give a name to the injection protocol to be set. The operator can give any name that will make it easy to identify the registered injection protocol when editing or deleting it later.
[0085] 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 icons 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.
[0086] When the detailed name tab 351 is selected, a list of 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.
[0087] When the injection pattern tab 352 is selected, several injection patterns are displayed in the main display area 355, as shown in FIG. 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 the injection rate. The injection patterns displayed in the upper row are injection patterns for injecting only contrast medium, and the injection patterns displayed in the lower row are injection patterns for injecting contrast medium and saline. The operator can select an injection pattern by tapping one of the multiple injection pattern icons displayed.
[0088] In addition to the icons representing the injection patterns, 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 the selection can be visually identified. In the example shown in FIG. 11A, the liver is selected as the site in advance, so that the parenchymal system is automatically selected, and the injection pattern selected is a mixed injection consisting of a first phase in which a contrast agent and saline are simultaneously injected, and a second phase in which only saline is injected.
[0089] 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 of 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 important, so the injection rate, etc. are determined based on the total amount of iodine used.
[0090] After determining the infusion pattern, the operator taps "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 amount 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 when input into the parameter input icons displayed in the main display area 355 is complete, the operator taps this "Next" icon 358.
[0091] 11B, parameter input icons corresponding to second item tab 354 are displayed in main display area 355. The operator inputs appropriate numerical values and conditions into each parameter input icon displayed in main display area 355. The input numerical values and conditions are temporarily stored in the memory of injection control unit 150.
[0092] In the example shown in FIG. 11B, the following parameters are specifically input as the second items: Phase 1 (injection of a mixture of contrast medium and saline) Standard injection time: 25[sec] Standard mixing ratio: 0.7 (contrast medium volume: saline volume = 70:30) Reference iodine content: 500 [mgI / kg] Reference iodine concentration: 300 [mgI / mL] Phase 2 (saline injection only) Injection speed: A tracking (*1) Injection volume: 20[mL] Injection time: Automatic setting others Pressure limit: 10.0 kg / cm 2 ] (*1) Inject at the same injection rate as the overall injection rate in the first phase.
[0093] In this embodiment, all parameters required for calculating the injection protocol are input in the first item tab 353 and the second item tab 354. After inputting 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 out the parameters temporarily stored in memory and calculates the injection protocol, specifically, the injection amounts and injection rates 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.
[0094] 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. The injection volume L [mL] of contrast agent is calculated as follows, where W [kg] is the subject's weight, I [mgI / kg] is the standard amount of iodine required per unit weight of the subject, C [mgI / mL] is the standard iodine concentration per unit amount of contrast agent, and T [sec] is the injection time of contrast agent.
[0095]
number
[0096] For example, if W = 60 [kg], I = 500 [mgI / kg], C = 300 [mgI / mL], and T = 25 [sec], then the injection volume of contrast agent L = 100 [mL] is calculated from formula (1), and the injection rate of contrast agent S = 4.0 [mL / sec] is calculated from formula (2).
[0097] Next, the injection volume and injection rate of the contrast agent and saline 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 × 0.7 = 70 mL, and the injection rate is 100 mL × (1 - 0.7) = 30 mL.
[0098] 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], and since the injection amount is 20 [mL], the injection time is calculated as 5 [sec].
[0099] In the above formula (1), the injection amount L of the contrast agent is calculated using the amount of iodine I required per subject's body weight, but 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 injection amount can be calculated using the following formula (1'):
[0100]
number
[0101] As mentioned above, if the injection amount of contrast agent is too small or the injection rate of contrast agent 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 amount 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 amount and injection rate, and issues a warning if at least one of the calculated injection amount and injection rate is smaller than the preset value. The lower limit for the injection amount of contrast agent set in the injection control unit 150 may be preferably 30 mL, 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, more preferably 5 mL / sec. These lower limits may be set for each imaging site or may be freely changeable by the operator. The warning may 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.
[0102] The injection protocol obtained as described above 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) is displayed in the menu display area or main display area, and when the operator taps the "Save" icon or the "Save overwrite" icon, the parameter used to set one of the injection protocols for that specific site, etc. is registered in the memory of the injection control unit 150.
[0103] When the injection conditions are called up as described above, the calculation of the injection protocol (a series of calculations for determining 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. The calculation of the injection protocol using the pre-registered parameters may also be performed at any timing.
[0104] 10 , as described above, the injection protocol and parameters displayed on protocol screen 310, except for the volume value displayed in syringe volume icon 316 and the iodine amount value displayed in actual iodine amount icon 320, can be changed arbitrarily by the operator depending on actual conditions or automatically according to data read from RFID tag 802. For example, the weight of each subject varies, and the reference iodine amount and reference iodine concentration vary depending on the type of contrast agent used.
[0105] Therefore, when the parameters displayed on the protocol screen 310 are changed according to 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.
[0106] As an example, the following describes calculations for a case where a contrast agent with an iodine concentration of 350 [mgI / mL] is used, as shown by actual iodine concentration icon 317 in Fig. 10, even though the injection amount and injection rate are calculated using a registered injection protocol with a reference iodine concentration of 300 [mgI / mL] as shown in Fig. 11B. Note that in this example, the contrast agent is injected only in the first phase, and therefore the following description is for the first phase.
[0107] First, the injection control unit 150 determines the reference iodine amount I n_base and the standard mixture ratio R base From this, the actual iodine amount I, which is the amount of iodine in the contrast agent injected in this injection protocol, n is calculated using the following formula (2). In=I n_base ×R base ...Equation (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], standard mixing ratio R base =0.7, so Actual iodine content I n = 500 [mgI / mL] × 0.7 = 350 [mgI / mL] In other words, the registered injection protocol will inject 350 mgI / mL of iodine.
[0108] Next, the injection control unit 150 calculates the reference iodine amount I n_base , reference iodine concentration I c_baseand the subject's weight W, the reference injection volume V, which is the injection volume when the contrast agent is not diluted with saline, is calculated. total is calculated using the following formula (3).
[0109]
number
[0110] Furthermore, the injection control unit 150 calculates the actual iodine concentration, which is the iodine concentration of the contrast agent used in the current examination, as I c Then, the actual mixing ratio R, which is the mixing ratio when injection is performed with the changed parameter (iodine concentration in this example), is calculated using the following formula (4). This allows for the calculation of the mixing ratio at which the contrast agent is injected with the same amount of iodine as that injected in the registered injection protocol, even if the contrast agent is changed to one with a different iodine concentration.
[0111]
number
[0112] If the calculated actual mixing ratio R is greater than 1, the actual mixing ratio R is set to 1, and the injection protocol is one in which only the contrast agent is injected. On the other hand, if the actual mixing ratio R is 0, this means that the contrast agent is not injected, so one of the changeable parameters is changed, and the procedure does not proceed to the next step until an actual mixing ratio R greater than 0 is obtained.
[0113] In this way, by automatically changing the mixing ratio according to the iodine concentration of the contrast agent actually injected, the amount of iodine injected does not change even when the contrast agent is changed, and as a result, good contrast effects can be obtained with various contrast agents with different iodine concentrations. Furthermore, an appropriate mixing ratio can be obtained by multiplying a predetermined reference mixing ratio by a coefficient, which is the ratio of a predetermined reference iodine concentration to the actual iodine concentration of the contrast agent actually used.
[0114] Once the actual blending ratio R is calculated as described above, the injection control unit 150 calculates the actual blending ratio R and the reference injection volume V total From this, the injection volume of contrast agent V A [mL] and saline injection volume V B These are given by the following formulas (5) and (6). V A [mL]=V total [mL]×R...Equation (5) V B [mL]=V total [mL] × (1-R) Equation (6)
[0115] Standard injection volume V total From the injection time t [sec] and the injection volume in mL, the reference injection rate F total [mL / sec] is F total =V total [mL] / t[sec]...Equation (7) From equation (7), the injection rate of the contrast agent F A[mL / sec] and saline infusion rate F B The values of [mL / sec] can be calculated using the following equations (8) and (9). F A [mL / sec]=F total [mL / sec]×R...Equation (8) F B [mL / sec]=F total [mL / sec]×(1-R)...Equation (9)
[0116] The injection control unit 150 applies the parameters determined as described above to the injection protocol and displays the changed injection protocol on the protocol screen 310. Thereafter, the injection operation is performed in the same sequence of steps as described above. Note that the changes made here are changes to the called-up injection protocol, and the registered injection protocol itself is not changed. Creation and editing of injection protocols can only be performed from the protocol setting screen 350, which is called up from the home screen.
[0117] 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 two decimal places to inject 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.
[0118] Therefore, when the iodine concentration is changed, the injection control unit 150 is configured to change the mixing ratio according to the changed iodine concentration and apply the changed mixing ratio to the injection protocol. Here, the mixing ratio is preferably changed within a range that does not affect the contrast effect, and more preferably changed so as not to change the amount of iodine used.
[0119] The above description has been given with an example in which the mixing ratio in the injection protocol is changed due to a change in iodine concentration. However, the injection protocol can also be changed due to changes in other parameters. For example, if the base iodine amount is changed, the actual iodine amount, injection rate, and injection volume in the injection protocol are changed. If the mixing ratio is changed, the actual iodine amount in the injection protocol is changed. If the subject's weight is changed, the injection rate and injection volume in the injection protocol are changed. Furthermore, if the injection time is changed, the injection volume is changed if the imaging target is the vascular system, and the injection rate is changed if the imaging target is the parenchymal system.
[0120] In the above description, an injection protocol is set for each imaging region. However, an injection protocol may also be registered for each manufacturer and / or specification of the imaging fluoroscopic apparatus. An imaging fluoroscopic apparatus generally performs image processing using an iterative approximation method or an iterative approximation method when reconstructing an image. This image processing differs depending on the manufacturer of the imaging fluoroscopic apparatus, and may also differ depending on the specifications of the imaging fluoroscopic apparatus even for the same manufacturer. The image quality of an image obtained when a drug solution is injected under the same injection conditions varies depending on the type of image processing. Therefore, an injection protocol corresponding not only to the imaging region but also to the imaging fluoroscopic apparatus to be used may be registered.
[0121] When a contrast agent is injected as a 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, prior to injection for capturing a tomographic image using the imaging fluoroscopic apparatus 200, a test injection is performed in which the medicinal liquid is injected in an amount smaller than the amount injected for the actual capture, and the timing of the capture is determined based on the result of the test injection.
[0122] In such a case, the injection operation of the liquid after the test injection can be started by the injection control unit 150 receiving a command transmitted from the imaging fluoroscopic apparatus 200 from the imaging control unit 152. The imaging fluoroscopic apparatus 200, for example, captures a tomographic image displayed on the monitor of the imaging fluoroscopic apparatus 200 with a CCD camera (not shown), monitors the brightness (whiteness) of the ROI of 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 measures the signal strength from a cable connected to the monitor, and when the measurement result exceeds a predetermined threshold. Furthermore, when a test injection is performed prior to injection for capturing a tomographic image (main injection), the CT value and TDC (Time Density Curve) during the test injection may be monitored, an injection protocol may be determined based on the results, and an optimal imaging start command suitable for the protocol may be transmitted from the liquid injector 100 to the imaging fluoroscopic apparatus 200.
[0123] In the above-described embodiment, the fluoroscopic imaging apparatus 200 is an X-ray CT apparatus, but in the present invention, the fluoroscopic imaging apparatus 200 may be any fluoroscopic imaging apparatus that uses electromagnetic wave irradiation to acquire images, such as an angiography apparatus, an MRI apparatus, an MRA apparatus, a PET apparatus, or an ultrasound imaging apparatus, in addition to an X-ray CT apparatus. When the fluoroscopic imaging apparatus 200 is an apparatus other than an X-ray CT apparatus, the configuration, screen display, operating procedures, operations, etc. of the liquid injector 100 may be appropriately changed as necessary.
[0124] For example, if the fluoroscopic imaging apparatus 200 is an MRI apparatus, the MRI apparatus has a radio-frequency pulse transmitter that radiates radio-frequency pulses as an electromagnetic wave irradiator, and the radio-frequency pulse transmitter can change the irradiation intensity of the radio-frequency pulses by setting. Normally, the stronger the irradiation intensity of the radio-frequency pulse, the more enhanced the contrast effect of the contrast agent. Therefore, when the irradiation intensity of the radio-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 intensity of the electromagnetic wave irradiation intensity set in the electromagnetic wave irradiator is reversed from that in the X-ray CT apparatus.
[0125] 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, thereby simplifying the overall system.
[0126] Furthermore, certain functions of 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 imaging fluoroscopic apparatus 200, and the remaining functions can be incorporated into console 101 of liquid injector 100. In this case, there is no need to redundantly input data common to setting imaging conditions and setting injection conditions into imaging fluoroscopic apparatus 200 and liquid injector 100. Data that is missing when setting injection conditions may be input from the imaging control unit, or may be transmitted from console 101 of liquid injector 100 to the imaging control unit.
[0127] The functions of the imaging control unit 152 and the injection control unit 150 can be realized by using various hardware as needed, but are mainly realized by the CPU functioning in accordance with a computer program.
[0128] 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 above-described program 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 program.
[0129] Structurally, injection head 110 and console 101 can also be configured as a single unit. When console 101 and injection head 110 are configured as a single unit, console 101 is also placed in the examination room. Therefore, remote controller 170 (see FIG. 1) can be used to start and stop the injection operation. By using remote controller 170, the operator can control the start and stop of the injection operation from within the operation room.
[0130] Specifically, the syringe may be as shown in FIGS. 12(a) and 12(b). This syringe may be, for example, a 100 ml syringe. This syringe includes a cylinder member 501 and a piston member 502. A cylinder flange 501a formed at the end of the cylinder member 501 has an I-cut contour, 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, having two coaxially arranged inner and outer cylindrical portions. As shown in FIG. 12(b), a ring-shaped protrusion 501c may be formed on the rear surface of the cylinder flange 501a.
[0131] Another example of a syringe may be one as shown in FIGS. 12(a) and 12(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 profile. 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 FIG. 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.
[0132] 13 shows cylinder flange 501a having both notch 505 and rib 501d, it may have only one of them (for example, no notch 505). Rib 501d may have only two ribs, one at the top and one at the bottom, of the multiple ribs aligned vertically in the figure, with the other ribs omitted. A syringe with such a group of ribs formed on only one of the left and right sides of the flange may also be used.
[0133] As shown in Figures 12 and 13, an adapter to which a syringe having a notch 505 in a cylinder flange 501a is attached preferably has a groove into which the cylinder flange 501a is inserted from above in the orientation shown in the figures, and a protrusion that engages with the notch 505 when the cylinder flange 501a is inserted and further 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 acts on the syringe, the syringe is firmly held, making the cylinder flange 501a less likely to be damaged. Furthermore, it is less likely to cause an unbalanced load due to the syringe being attached at an angle, and liquid leakage due to a gap between the piston and the cylinder can be prevented.
[0134] The syringes shown in FIGS. 12 and 13 may also have an RFID tag on the outer circumferential surface of the cylinder, similar to the syringe 800 described above.
[0135] (Other configurations that the chemical liquid injection device 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 can 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 the detection of 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 usually detected using the load cell, and the injection pressure can be measured using the motor current measurement results only when the load cell fails.
[0136] (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.
[0137] The extension tube has a first tube 231a connecting a syringe filled with contrast medium to mixing device 241, a second tube 231b connecting a syringe filled with saline to mixing device 241, and a third tube 231c connected to a liquid outlet (details below) of mixing device 241 and extending toward the patient. Although not particularly limited, first and second tubes 231a and 231b may be connected to conduit portions of the syringes via connectors 239a and 239b, respectively. Similarly, third tube 231c may be connected to a catheter or the like via connector 239c.
[0138] 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) First, the contrast medium is pushed out from the contrast medium syringe, then the saline is pushed out from the saline syringe, and then the drug solutions are pushed out from both syringes simultaneously; (c) There is also a method in which first the saline solution is pushed out from the saline syringe, and then the contrast medium is pushed out from the contrast medium syringe, thereby filling the entire circuit with the liquid medicine.
[0139] The liquid injector may be provided with a function for automatically performing the above-described priming operation, and the trigger for starting the priming operation may be, for example, an input operation by the operator.
[0140] Next, the mixing device 241 will be described in detail. As shown in FIGS. 14A and 14B, the mixing device 241 includes 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 narrow 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 narrow 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 side direction can be various shapes formed by a circle, an ellipse, or other curves. The swirling flow generating chamber can also be configured to have a narrowing shape that narrows as it approaches the narrow chamber.
[0141] Conduit section 243a, to which first tube 231a is connected, is provided on the upstream side of main body 242 of mixing device 241, and conduit section 243c, to which third tube 231c is connected, is provided on the downstream side. Conduit section 243b, to which second tube 231b is connected, is located upstream from the center of swirl flow generating chamber 242a (details below).
[0142] In this example, the contrast medium flows in through conduit 243a and the saline solution flows in through conduit 243b, and the two liquids are mixed in the mixing device. Thereafter, the mixed liquid of the contrast medium and the saline solution flows out from conduit 243c, which serves as a liquid outlet.
[0143] Conduit section 243a, into which the chemical liquid with a high specific gravity 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 a 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 vortex generated within the mixing device can be improved. In other words, vortices can be generated uniformly within the space without stagnation, improving mixing efficiency.
[0144] On the other hand, conduit section 243b, into which the chemical solution with a low specific gravity flows, is disposed on the side of swirl flow generating chamber 242a and extends in a tangential direction 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 solution 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 in a tangential direction to the circumference of the curved inner surface of swirl flow generating chamber 242a, thereby generating a swirling flow of the chemical solution that flows in from this flow path. Furthermore, as is clear from the drawing, narrowed chamber 242b has an inclined inner surface that narrows toward the downstream side in the flow direction, so that the generated swirling flow is concentrated in the direction of the central axis of the vortex.
[0145] Furthermore, conduit portion 243a, into which the contrast agent flows, communicates with 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 into which saline solution flows communicates with the swirling flow generating chamber via flow path 241fb. For example, the inner diameter of flow path 241fb may be smaller than the inner diameter of flow path 241fa, into which the contrast agent flows. With this configuration, when a 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. Therefore, it is possible to avoid a decrease in the mixing efficiency of the chemicals due to the 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.
[0146] In mixing device 241 configured as described above, for example, when contrast medium and saline solution are introduced into the device, the contrast medium flows from flow path 241fa into the swirling flow generating chamber and flows downstream in the axial direction. On the other hand, 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 concentrated in the direction of the central axis of the swirling flow. Such a vortex is known as a Rankine vortex, and it is possible to concentrate the inertial force of the swirling flow near the axis of rotation of the vortex.
[0147] When two medicinal solutions are simultaneously injected using an extension tube having such mixing device 241, the two medicinal solutions are mixed well. That is, in this example, a diluted contrast medium in which the contrast medium and physiological saline are mixed well can be obtained, and as a result, unevenness in the concentration of the contrast medium is eliminated, and a superior contrast effect can be expected compared to the case of a general branch tube.
[0148] (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 medicinal solution are performed by an operator operating 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, removing air from the tubing, and checking the operation of injection head 110. During this preparation stage, 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.
[0149] The second display unit A151 can display various data related to the injection of the medicinal liquid, such as the region to be imaged, the subject's weight, the injection rate of the medicinal liquid, the injection amount of the medicinal liquid, the type of medicinal liquid to be injected, the injection protocol of the medicinal liquid, etc. The display format of these data may be arbitrary, and may be displayed on the same screen as the touch panel 103 provided on the console 101, or on a different screen. The second display unit A151 can also display the aforementioned injection condition call screen (FIGS. 9 and 9A) 300 and protocol screen 310 (FIG. 10). Additionally, when the operation of the piston pressing unit is stopped during the preparation operation and the injection operation, a message or icon to that effect can be displayed.
[0150] The second display unit A151 is preferably a touch panel. By configuring the second display unit A151 as a touch panel and allowing data input for setting injection conditions, starting and stopping the operation of the injection head 110, and other operations to be performed from the second display unit A151, the operator can change the injection conditions or stop the injection on the spot during the preparation or early stages of the 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 a drug 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.
[0151] 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. FIG. 15A shows an example of a second display unit A151 integrally mounted on the injection head 110. 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.
[0152] 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 the console 101 may be a wired connection via a cable or a wireless connection.
[0153] With the above-described configuration, the orientation of second display unit A151 can be adjusted over a wide range in the vertical and horizontal directions, regardless of the orientation of injection head 110, making second display unit A151 easier for the operator to view. Furthermore, by arranging second display unit A151 at a distance from injection head 110, second display unit A151 can be positioned optimally to minimize the impact of noise on injection head 110 and other devices. Furthermore, by providing a wireless connection for second display unit A151, noise transmission via a cable can be prevented.
[0154] (Other forms of fluoroscopic imaging systems) 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 so as to enable 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 so as to enable 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 on 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 on RFID tag 802 by 912.
[0155] The fluoroscopic imaging system may further include a liquid medicine filling device 920. The liquid medicine filling device 920 is a device that can mount an empty syringe that is not filled with a liquid medicine and fill the empty syringe with the 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 warmer 900, and the waste box 910, or may be connected to at least one of them via a network for data communication. A liquid medicine container 930 of any form, such as a bag or bottle containing the liquid medicine, is connected to the empty syringe via a tube or the like with the piston in the most forward position. After the empty syringe and the liquid medicine container 930 are connected, the empty syringe can be filled with the liquid medicine by retracting the piston using the liquid medicine filling device 920. An RFID tag, which serves as a data carrier, is preferably attached to the empty syringe. In the following description, the empty syringe is assumed to be a syringe 800 with an RFID tag 802 attached thereto before being filled with a liquid medicine.
[0156] An RFID tag 932, which is a data carrier, is also attached to liquid medicine container 930. RFID tag 932 stores data related to the liquid medicine, such as the type of liquid medicine contained, the volume, the pharmaceutical manufacturer, the product number, the viscosity, the expiration date, and, if the liquid medicine is a contrast medium, the iodine content per unit amount of contrast medium. Liquid medicine filling device 920 includes reader 922a that can read data from RFID tag 932 and writer 922b that can write data to RFID tag 802 attached to syringe 800.
[0157] In the above configuration, when liquid medicine filling device 920 is used to fill syringe 800 with liquid medicine from liquid medicine container 930, reader 922a reads data recorded on RFID tag 932 attached to liquid medicine container 930. Liquid medicine filling device 920 includes 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 liquid medicine filling device 920 and operates liquid medicine filling device 920.
[0158] As a result, a set amount of medicinal liquid is filled into syringe 800. The filling amount can be set according to a predetermined operating procedure of medicinal liquid filling device 920. After filling with the medicinal liquid, writer 922b writes the amount of medicinal liquid filled and the filling date and time to RFID tag 802 of syringe 800, along with the data temporarily stored in the storage device. As a result, syringe 800 is filled with the medicinal liquid, and data related to the filled medicinal liquid is recorded in RFID tag 802.
[0159] Note that data related to the syringe, as described above, may be pre-recorded in RFID tag 802. Reader 922a that reads data from RFID tag 932 of liquid medicine container 930 may also be a reader / writer that can write data. In this case, the current content volume (remaining amount) obtained by subtracting the filled amount from the content volume contained in liquid medicine container 930 before filling may be written to RFID tag 932. The remaining amount may be calculated by a CPU included in liquid medicine filling device 920.
[0160] As described above, the injection control unit 150 has a clock function for measuring the current time. Using this function, the RFID module 166 (see FIG. 6) reads the refill date and time recorded in the RFID tag 802, and the injection control unit 150 (see FIG. 6) compares the current date and time measured by the clock 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 medicinal liquid. Examples of processing to prevent the injection of the medicinal liquid 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 medicinal liquid has passed, and issuing a sound or audio warning from a sound unit (not shown), such as a buzzer. The expiration date of the medicinal liquid is preset in the injection control unit 150, but the set expiration date can also be changed at will by the operator. In this way, by managing the refill date and time of the medicinal liquid, the safety of the injected contrast agent can be ensured.
[0161] Each medical device constituting the fluoroscopic imaging system, such as the liquid injector 100, the fluoroscopic imaging apparatus 200, the warmer 900, the waste box 910, and the liquid filling device 920, may be connected to a medical network, which makes it possible to easily store and track the history of treatments given to subjects, the history of liquid use, the history of syringe use, and so on.
[0162] At least liquid injector 100 and imaging fluoroscopic apparatus 200 may be connected to a medical network. This allows the results of injection, including the injection rate, injection time, injection amount, and injection graph of the liquid injected by liquid injector 100, as well as the imaging conditions (including the imaging time and, if the imaging device is a CT scanner, the tube voltage) of imaging fluoroscopic apparatus 200, to be stored as injection data in a fluoroscopic imaging apparatus, a RIS (Radiology Information System), a PACS (Picture Archiving and Management System), an HIS (Hospital Information System), or the like 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 medical records or used for accounting purposes. Furthermore, the subject's physical information, such as weight, ID, name, examination site, and examination method, can be acquired from the RIS, PACS, HIS, or the like and displayed on the liquid injector, allowing appropriate injections to be performed. This information, as well as the data obtained 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 device 200, or may be transmitted directly from the liquid injector 100 to a RIS, PACS, HIS, etc.
[0163] Furthermore, 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 physician or other professional. The factors used to calculate the injection amount, or the injection amount value determined by a physician or other professional, can be entered by the operator or 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.
[0164] The injection amount 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. That is, the injection amount of liquid may 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 the injection rate and injection time, as well as the injection amount of liquid, can be created by that computer device.
[0165] 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 liquid injector 100 is used to fill an empty syringe with a liquid medicine, presser 112 has a flange holding structure, such as a claw or hook, for detachably holding a flange formed on the end of the piston of the empty syringe attached to injection head 110. With the flange of the piston held by this flange holding structure and the syringe connected to liquid medicine container 930, presser 112 can be retracted to fill the syringe with the liquid medicine from liquid medicine container 930.
[0166] (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 filled in the first and second containers without passing through a syringe. In this case, liquid medicine filling device 920 is not required.
[0167] (Addendum) The present application discloses the following inventions.
[0168] [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 agent to flow out of a first container filled with the contrast agent, 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 entry 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.
[0169] [2] 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 mixing ratio that is set in advance, and the concentration of the contrast enhancer of 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.
[0170] [3] The actual mixing ratio is R, and the standard mixing ratio is R base , the preset concentration of the contrast enhancing agent is I c_base , the concentration of the contrast enhancing agent in the contrast agent actually used is I c When The injection control unit is configured by the following formula: R=(I c_base / I c )×R base The chemical solution injection device according to [2], wherein the actual mixing ratio is calculated by the following.
[0171] [4] Further having a display unit; The liquid injector 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.
[0172] [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], wherein one of the input interfaces is an RFID reader that acquires data from the RFID tag.
[0173] [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 operable to cause the contrast agent to flow from the first container and a second drive mechanism operable to cause the saline to flow from the second container; at least one data entry 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.
[0174] [7] 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 mixing ratio that is set in advance, and the concentration of the contrast enhancer of 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.
[0175] [8] The actual mixing ratio is R, and the standard mixing ratio is R base , the preset concentration of the contrast enhancing agent is I c_base , the concentration of the contrast enhancing agent in the contrast agent actually used is I c When The injection control unit is configured 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:
[0176] [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.
[0177]
[10] The first container has an RFID tag having data recorded thereon including a concentration of a contrast enhancing agent in the contrast agent; 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.
[0178]
[11] 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 the operation 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:
[0179]
[12] The step of changing the mixing 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 mixing ratio, which is the actual mixing ratio, from a reference mixing ratio, which is a preset mixing ratio, and a concentration of a contrast enhancer in the contrast agent;
[11] The method for controlling a liquid injector according to
[11] , further comprising a step in which the injection control unit calculates the injection amount of the contrast agent and the injection amount of the saline solution using the calculated reference injection amount and the calculated actual mixing ratio.
[0180]
[13] The step of changing the blending ratio may be performed by changing the actual blending ratio to R and the reference blending ratio to R. base , the preset concentration of the contrast enhancing agent is I c_base , the concentration of the contrast enhancing agent in the contrast agent actually used is I c When The injection control unit is 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 the following method.
[0181]
[14] A method for calculating an injection protocol including a mixed injection in which a contrast agent and a physiological saline solution are injected at a predetermined mixing ratio in a chemical 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; Calculation method for an injection protocol having: [Explanation of symbols]
[0182] 100 Chemical injection device 101 Console 103 Touch Panel 112 Presser 110 Injection Head Stand 121 140 Piston drive mechanism 150 Injection control unit 152 Imaging control unit 153 Electromagnetic wave irradiator 154 Display Unit 156 input units 164 RFID control circuit 165 Antenna 166 RFID modules 200 Fluoroscopic imaging device 300 Injection condition call screen 310 Protocol Screen 350 Protocol setting screen 600 adapter 800 syringes 802 RFID tags
Claims
1. 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.
2. The chemical liquid injector of claim 1 , further comprising at least one data input interface for receiving input of data.
3. 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.
4. 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.
5. 5. The liquid injector according to claim 1, wherein, when the contrast agent is changed to a contrast agent 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.
6. 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.
7. 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.
8. 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.
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