Injection head and drug injection device equipped therewith

Abstract

The present invention provides an injection head and drug injection device that allow the operator to clearly check the state of air bubbles in the syringe before injection. [Solution] This drug injection head 110 comprises: a: a syringe holding part 140 that holds a syringe in which a piston member is slidably inserted into a cylindrical cylinder member; b: a piston driving mechanism 130 having a ram member 131 for moving the piston member of the syringe; and c: a first light-emitting part 133a that emits light in a first color to illuminate the syringe and a second light-emitting part 133b that emits light in a second color to illuminate the syringe, wherein the first light-emitting part 133a and the second light-emitting part 133b are positioned above the ram member 131 when viewed in the position of the injection head in use.

Description

Technical Field

[0001] The present invention relates to an injection head for injecting a chemical solution such as a contrast agent into a subject and a chemical solution injection device, and more particularly to an injection head and a chemical solution injection device that enable an operator to satisfactorily confirm the state of air bubbles mixed in a syringe before injection.

Background Art

[0002] As medical imaging diagnostic devices, CT (Computed Tomography) scanners, MRI (Magnetic Resonance Imaging) devices, PET (Positron Emission Tomography) devices, ultrasonic diagnostic devices, angiography imaging devices, etc. are known. When using such imaging devices, it may be necessary to inject a contrast agent, physiological saline, etc. (hereinafter, these are also simply referred to as "chemical solutions") into a patient.

[0003] Conventionally, various devices for automatically injecting chemical solutions have been known. The configuration and performance of the device vary depending on what kind of examination the device is used for (in other words, what kind of imaging device it is used with), etc. As a chemical solution injection device for angiography, for example, the one as described in Patent Document 1 is known. Angiography examination usually involves introducing a hollow tube called a thin catheter into a blood vessel, positioning the tip of the catheter near the target part of the blood vessel of interest, and then flowing a contrast agent or the like into the blood vessel and performing imaging. Thereby, the imaged blood vessel is displayed on a display or the like, and a doctor diagnoses and treats while looking at the image. Since angiography examination involves injecting a chemical solution through a thin catheter, it is characterized by extremely high injection pressure, which is one of the major differences from chemical solution injection devices for CT examination and MR examination.

Prior Art Documents

Patent Documents

[0004]

Patent Document 1

[0005] Incidentally, in angiography, it is common practice to set an empty syringe in the drug injection device and draw the required amount of contrast agent into the syringe and inject it within the hospital. When injecting the drug solution, it is desirable to be able to clearly check for air bubbles in the syringe before injection to prevent air bubbles from being introduced into the patient.

[0006] The present invention has been made in view of the above-mentioned problems, and its object is to provide an injection head and a drug injection device equipped therewith that allow the operator to clearly confirm the state of air bubbles in the syringe before injection. [Means for solving the problem]

[0007] An invention according to one embodiment of the present invention for solving the above problems is as follows: a: A syringe holder that holds a syringe in which a piston member is slidably inserted into a cylindrical cylinder member, b: A piston drive mechanism having a ram member for moving the piston member of the syringe, c: A first light-emitting part that emits light in a first color and illuminates the syringe, and a second light-emitting part that emits light in a second color and illuminates the syringe, An injection head equipped with, An injection head wherein the first light-emitting part and the second light-emitting part are positioned above the ram member (meaning above the center point of the ram member when viewed from the front) when the injection head is in use. "Position when using the injection head" refers to the position in which the tip of the syringe set in the injection head is at the same height as or lower than the rear end.

[0008] (Explanation of terms) • "Drug infusion device" refers to a drug infusion device that injects a drug solution, and in this specification, it refers to a device that injects at least a contrast agent (particularly a contrast agent used in angiography). The drug infusion device may inject the drug solution through a catheter. The drug infusion device may include some or all of the following components: one or more piston drive mechanisms, one or more control circuits (which may be control units, etc.), one or more head displays, and one or more displays. If the drug infusion device includes an injection head and a console, etc., (a) the injection head may be equipped with a piston drive mechanism and a head display, and the console may be equipped with a control unit and a display. (b) Both the injection head and the console may be equipped with control units. An example of this configuration is one in which a control circuit is located inside the injection head and other control circuits are located inside the console.

[0009] "Medicinal solution" refers to, for example, contrast agents, physiological saline, specified drugs, or mixtures thereof. • "Connection" - In this specification, when a given device is said to be connected to another device, it may be in the form of a wired connection or a wireless connection. This also includes cases where devices are directly connected to each other, as well as cases where they are indirectly connected through other elements.

[0010] Specific examples of "contrast agents" include (i) contrast agents with an iodine concentration of 240 mg / ml (e.g., viscosity of 3.3 mPa·s and specific gravity of 1.268-1.296 at 37°C), (ii) contrast agents with an iodine concentration of 300 mg / ml (e.g., viscosity of 6.1 mPa·s and specific gravity of 1.335-1.371 at 37°C), and (iii) contrast agents with an iodine concentration of 350 mg / ml (e.g., viscosity of 10.6 mPa·s and specific gravity of 1.392-1.433 at 37°C). Contrast agents with an iodine concentration of 370 mg / ml or higher are also available. · As a specific example of the physiological saline of "physiological saline", there is physiological saline containing 180 mg of sodium chloride in 20 mL of physiological saline (for example, having a viscosity of 0.9595 mPa·s and a specific gravity of 1.004 to 1.006 at 20 °C), etc.

Advantages of the Invention

[0011] According to the present invention, it is possible to provide an injection head that allows an operator to favorably confirm the state of air bubble mixing in a syringe before injection, and a chemical solution injection device equipped with the same.

Brief Description of the Drawings

[0012] [Figure 1] It is a schematic diagram showing a configuration example of a system including a chemical solution injection device according to an embodiment of one form of the present invention. [Figure 2] It is a perspective view showing an example of an injection head. [Figure 3] It is a perspective view of a syringe and a protective cover attached thereto. [Figure 4] It is a block diagram schematically showing the respective configurations of the chemical solution injection device. [Figure 5] It is a perspective view showing the front end portion of the injection head. [Figure 6] It is a front view showing the front end portion of the injection head. [Figure 7] It is a graphical user interface for setting injection conditions (initial screen). [Figure 8] It is a graphical user interface for setting injection conditions (state where one of the body sections is selected). [Figure 9] It is a graphical user interface for setting injection conditions (state where one of the imaging sites is selected). <​​​​​​A graphical user interface for setting injection conditions (changing the dilution ratio). [Figure 13] An example of a screen during chemical solution injection. [Figure 14] An example of a screen in a state where injection is temporarily stopped. [Figure 15] A graphical user interface for setting injection conditions (changing the imaging site). [Figure 16] An example of an icon for the imaging site. [Figure 17] ]>A six-sided view of an operation unit (console) of a chemical solution injector with an image displayed on a display as part of the design. [Figure 18] A perspective view showing an example of a holding mechanism for an injection head. [Figure 19] An example of a screen including an image indicating mixing using a mixing device. [Figure 20] Another example of a screen including an image indicating mixing using a mixing device. [Figure 21] Still another example of a screen including an image indicating mixing using a mixing device. [Figure 22] An example of a graphical user interface for setting injection conditions. [Figure 23] A figure showing another example of a screen during chemical solution injection. [Figure 24] A figure showing an example of the display mode of injection conditions. [Figure 25A] A figure showing an example of a hospital system including a chemical solution injection device. [Figure 25B] A figure showing an example of injection result display. [Figure 25C] A figure showing an example of detailed display of injection results. [Figure 26] A perspective view showing an example of a mechanism for holding an injection head. [Figure 27] A perspective view showing an example of an attachment mechanism for an injection head or the like. [Figure 28]Figure 27 shows the mounting mechanism as viewed from the front. [Figure 29] Figure 27 is a perspective view showing the details of the mounting mechanism. [Figure 30] Figure 27 shows the mounting mechanism as viewed from the side. [Figure 31] This is a perspective view showing an example of a retaining mechanism for an injection head. [Figure 32] Figure 31 is a perspective view showing the details of the holding mechanism. [Figure 33] Figure 31 is a perspective view showing details of the retaining mechanism (retaining assembly). [Figure 34] Figure 31 is a perspective view showing details of the holding mechanism (handle). [Figure 35] This is a perspective view showing another example of a mounting structure for an injection head, etc. [Figure 36] This is a perspective view showing another example of a mounting structure for an injection head, etc. [Figure 37] Figure 35 is a perspective view showing the details of the mounting structure. [Figure 38] Figure 35 shows a detailed view of the mounting structure (viewed from the side). [Figure 39A] This is an example of the infusion mode screen (checked state). [Figure 39B] This is an example of the infusion mode screen (standby state). [Figure 39C] This is an example of the infusion mode screen (start OK state). [Figure 39D] This is an example of the infusion mode screen (injection in progress). [Figure 40] This is a perspective view showing an example where the indicator portion, which is the light-emitting part of the injection head, has been modified. [Figure 41] This is a diagram to explain the light emission pattern. [Modes for carrying out the invention]

[0013] One embodiment of the present invention will be described below with reference to the drawings. While specific examples such as a drug injection device are disclosed below, the present invention is not necessarily limited to these specific configurations.

[0014] The drug injection device 100 of this embodiment comprises an injection head 110 and a console 210 electrically connected thereto, as shown in Figure 1 as an example. A power supply unit 190 may also be provided to supply power to the injection head 110 and the console 210. In Figure 1, two imaging devices 300-1 and 300-2 (also simply referred to as imaging device 300) are provided. However, there may be only one imaging device. The power supply unit 190 may have a built-in control circuit, which, for example, is connected to at least one of the injection head and the console to exchange signals. The drug injection device 100 in Figure 1 consists of three devices, but it may also consist of a console 210 and an injection head 110.

[0015] The imaging device 300 may include, for example, an X-ray CT imaging device 300-1 and an angiography imaging device 300-2. The angiography imaging device may have a C-arm. The imaging device 300 is connected to the drug injection device 100 in a manner that allows for cooperation and exchange of predetermined information between them. For example, the timing of the start or end of operation of one device may be synchronized with the start or end of operation of the other device.

[0016] [1. Angiography syringe and protective case] Regarding the configuration of syringes, the angiography syringe and its protective case may be as shown in Figure 3. The angiography syringe 800 (800A, 800B) has a cylindrical cylinder member 810 and a piston member 820 (see Figure 4) that is slidably inserted inside it. The capacity of the syringe 800 is not limited, but is, for example, about 50 ml to 300 ml or about 100 ml to 200 ml (in this specification, "a to b" means a or more and b or less).

[0017] The material of the cylinder member 810 may be resin, glass, or metal. The cylinder member 810 has a flange portion 811f formed at or near its base end. The contour shape of the flange portion 811f can be anything, for example, it may be circular, elliptical, or polygonal, or it may be a shape in which the outer circumference is partially cut off with a straight line. The flange portion 811f may have one or more notches formed therein. For example, one notch may be formed as a recess on one side of the flange portion 811f and one on the opposite side. A locking mechanism (not shown) provided on the injection head side locks into the notches. A long, slender, protruding conduit portion (nozzle portion) 811a is formed at the tip of the cylinder member 810. A Luer lock structure for connecting a chemical solution tube is formed at the tip of the conduit portion 811a. The piston member 820 (see Figure 4) is a so-called rodless type plunger, and a locking projection 814 is formed on the back surface of the piston member 820 to which a predetermined rod (not shown) or a ram member of a piston drive mechanism (see Figure 5 for details) can be connected.

[0018] Furthermore, syringes 800 for angiography typically have a specified guaranteed pressure rating. This guaranteed pressure rating may be, for example, 600 psi or higher, 800 psi or higher, or 1000 psi or higher. The syringe may be a pre-filled type with the drug solution (contrast agent or saline solution, etc.) already filled, or it may be an aspiration type where the drug solution is drawn into an empty syringe before use.

[0019] The angiography syringe 800 is inserted into a protective case 840, as illustrated in Figure 3, and then attached to the injection head 110. For example, such a protective case 840 may have a roughly cylindrical, hollow main body member 841. The main body member 841 is roughly closed at the front end and open at the rear end. The syringe 800 is inserted through the opening at the rear end of the protective case 840. An opening 841h is formed on the front surface of the main body member 841 for the passage of the syringe's conduit portion 811a. A flange portion 841f is formed at the base end of the protective case 840. The flange portion 841f is designed to have a shape and / or strength suitable for being held by a retaining structure (e.g., a clamping mechanism) on the injection head side. The material of the protective case 840 is not particularly limited, but may be resin, glass, metal, etc.

[0020] [2. Injection head] As shown in Figure 2, the injection head 110 has a housing 111, and two syringes 800A and 800B (see Figure 4) are attached to the front end of the housing 111. Although this explanation describes a two-cylinder injection head, the present invention can also be applied to single-type injection heads that hold a single syringe, etc.

[0021] The injection head 110 includes a syringe holder 140 that holds the syringe 800 while it is inside the protective case 840 (see Figure 3), a piston drive mechanism 130 (see Figures 4 and 5) located inside the housing 111, and a control circuit 150 (see Figure 4) electrically connected to the piston drive mechanism 130.

[0022] The syringe holder 140 includes a pair of clampers 145 and a protective case holder 141. The clampers 145 are retaining means that hold a portion of the protective case 840. The retaining means can be any configuration that can stably hold the protective case 840, for example, the method disclosed in Japanese Patent No. 5492873. The protective case holder 141 is located on the tip side of the clampers 145 and has a recess that holds the outer circumferential surface of the protective case 840. This recess is formed, for example, in an arc shape (approximately semicircular) corresponding to the shape of the outer circumferential surface of the protective case 840 and holds the lower side of the protective case 840. The protective case holder 141 may be made of a transparent or translucent material, or it may be made of an opaque material.

[0023] The injection head 110 of this embodiment is provided with light-emitting parts 133a and 133b (also referred to as light-emitting part 133) at the positions shown in Figure 5. Reference numeral 131 shown in Figure 5 is a ram member, which is an element of the piston drive mechanism, and is a member for sliding the piston member 820 of the syringe. The ram member 131 is a member with a generally rod-like shape, and its axis is designed, for example, to coincide with the central axis of the syringe 800.

[0024] The light-emitting parts 133a and 133b are located at the front end of the housing 111 of the injection head 110. Specifically, as shown in Figure 6, they are coaxial with the ram member 131 and the reference circle L 131 It is provided as an arc-shaped opening that follows the curve. The arc may be formed in a range such that its central angle is 90 degrees or less, or 60 degrees or less. One light-emitting part 133a may emit light in a predetermined color indicating that it is a first drug solution (for example, green as a color indicating that it is a contrast agent), and the other light-emitting part 133b may emit light in a different color (for example, white).

[0025] Regarding the light-emitting parts 133a' and 133b' on the other syringe side, one light-emitting part 133a' may emit light in a predetermined color indicating that it is a second drug solution (for example, blue to indicate that it is physiological saline), and the other light-emitting part 133b' may emit light in a different color (for example, white).

[0026] In another embodiment, the light-emitting unit 133a may be set to a first color (e.g., green) corresponding to the drug solution in the syringe, the light-emitting unit 133a' to a second color (e.g., blue) corresponding to the drug solution in the other syringe, and the light-emitting units 133b and 133b' to be any other color (a third color). By performing such a three-color or more light-emitting pattern when a certain state is reached, the operator can check the current state of drug injection by looking at the light-emitting pattern. The timing is not particularly limited, but for example, it may be when the standby state is released.

[0027] Other light emission modes will be explained using the light-emitting units 133a and 133b on the left side (A syringe side) of Figure 6 as an example. Although the A syringe side is used as an example, the B syringe side may be configured to operate similarly. For example, if the protective case 840 (Figure 3) is not attached, the light-emitting units 133a and 133b will not emit light. Once the protective case 840 is attached, either one or both of the light-emitting units 133a and 133b may be illuminated. Specifically, the white light-emitting unit 133b may be illuminated. Instead of illumination, the lights may blink. Such light emission switching may be triggered, for example, by the detection result of the presence or absence of the protective case 840, or by the detection result of the opening or closing of the clamper 145.

[0028] Regarding the luminescence mode during drug injection, for example, if injection is performed only from syringe A, syringe A will emit light only from light-emitting part 133a (e.g., green), and syringe B will emit light only from light-emitting part 133b' (e.g., white) (or neither). Light-emitting part 133a may be fixed in place or blinking. If injection is performed only from syringe B, syringe A will emit light only from light-emitting part 133b (e.g., white) (or neither), and syringe B will emit light only from light-emitting part 133a' (e.g., blue). Light-emitting part 133a' may be fixed in place or blinking.

[0029] As a lighting pattern during drug injection, the side injecting may be made to blink (especially with a color corresponding to the drug solution in the syringe), and the side not injecting may be made to light up (especially with a color corresponding to the drug solution in the syringe). This pattern may be used in protocols where the drug solution in syringe A and the drug solution in syringe B are injected. Next, in protocols where only syringe A is injected, the side injecting may blink (especially with a color corresponding to the drug solution in the syringe), and the side not injecting may be turned off. In protocols where only syringe B is injected, the side injecting may blink (especially with a color corresponding to the drug solution in the syringe), and the side not injecting may be made to light up (especially with a color corresponding to the drug solution in the syringe).

[0030] When injecting with syringe A and syringe B simultaneously, only light-emitting parts 133a (e.g., green) and 133a' (e.g., blue) may be illuminated, while light-emitting parts 133b and 133b' may not be illuminated. In this case, the illumination may be either constant or blinking.

[0031] If any error occurs, all light-emitting parts may be made to blink.

[0032] The light sources for the light-emitting sections 133a and 133b are not limited, but for example, LEDs (light-emitting diodes) can be used. The direction of illumination of the light sources may be parallel to the central axis of the syringe 800. By illuminating the drug solution inside the syringe with the light from the light-emitting sections 133a and 133b, the operator can clearly visually confirm the amount of drug solution inside the syringe and the presence of air bubbles. Reference circle L 131 The size of the light-emitting parts (in other words, the positions of the light-emitting parts 133a and 133b) may be approximately the same as the flange portion 841f of the protective case 840 (see Figure 3) (in this case, the light is directed onto the flange portion 841f), or it may be located outside the flange portion 841f.

[0033] As a specific example of configuration, the front end surface 111a of the injection head 110 may be formed as a vertical surface (when the head is in a horizontal position), and the light-emitting parts 133a and 133b may be openings formed on that surface. To prevent the ingress of chemical solution, a permeable resin member may be fitted into the opening. Furthermore, it is preferable, as an example, that the permeable resin member is formed flush with the front end surface 111a so as not to protrude or recess from it.

[0034] Conventional known configurations can be used for the multiple structural parts that make up the injection head 110, and although a detailed explanation will be omitted, the piston drive mechanism, control circuit, and various sensors may be as follows.

[0035] (Piston drive mechanism) As shown in Figure 4, the piston drive mechanism 130 includes a motor 139 as an actuator, a transmission mechanism 137 that transmits the rotational output of the motor 139, a ball screw 135 that is rotated by the transmission mechanism 137, a ball nut unit 132, a ram member 131 that moves back and forth in conjunction with the movement of the ball nut unit 132, and a frame (not shown) that holds at least a part of these elements. In one embodiment, an encoder (not shown) is provided on the ball screw 135, and is configured to detect the amount of rotation and the rotation angle.

[0036] A DC motor can be used as the motor 139, and among them, a DC brushless motor is particularly preferred. Brushless motors have the advantages of being quiet and highly durable due to the absence of brushes. Generally, brushless motors have a sensor to detect the position of the internal magnet. Therefore, the output from this sensor may be used to detect the amount of rotation and rotational speed of the motor. However, a rotation sensor 139s for detecting the amount of rotation and / or rotational speed of the motor may be provided separately. Specifically, a rotary encoder or resolver can be used. In order to inject contrast agent at relatively high pressure during angiography, it is also preferable to use a high-output motor, for example, one with an output of 70W or more, 150W, 250W or more, 300W or more, or 450W or more.

[0037] The output of the motor 139 is transmitted to the ball screw 135 via the transmission mechanism 137. The transmission mechanism 137 can be of any type, but one example is a first pulley (not shown) directly or indirectly connected to the output shaft of the motor 139, a second pulley (not shown) directly or indirectly connected to the ball screw 135, and a belt (not shown) wrapped between these two pulleys. In addition to such a belt transmission mechanism, a gear system or a chain transmission mechanism may be used.

[0038] (Explanation of block diagrams) As shown in Figure 4, the injection head 110, in one example, includes a control circuit 150, a memory unit 168, a physical button 161 as an input device, an operating knob 170 as another input device, various sensors 162-165, a display unit 146, a heater 141a, an indicator 173, and the like.

[0039] The operating knob 170 may be physically linked to a predetermined mechanism inside the housing 111 of the injection head 110, and when the operating knob 170 is rotated, the force is transmitted to the piston drive mechanism 130, causing the ram member 131 to move forward or backward. Alternatively, the operating knob 170 may not be physically linked to a predetermined mechanism inside the housing 111 (non-contact), and its rotation may be detected electrically, and the result of this detection is used to operate the drive source of the piston drive mechanism 130, causing the ram member 131 to move forward or backward. In the latter case, a configuration that provides a click in response to rotation may be adopted to make it easier for the operator to feel that they are turning the operating knob 170.

[0040] (control circuit) The control circuit 150 has a CPU (Central Processing Unit) for arithmetic processing, memory, and interfaces, and realizes various functions by executing computer programs stored in memory. The control circuit 150 may also have a processor such as a one-chip microcontroller. The processor may be mounted on a predetermined board, and various electrical circuits (e.g., motor drive circuits) may also be provided on that board. The control circuit 150 is electrically connected to various elements of the injection head.

[0041] The control circuit 150 may be configured (programmed) to perform the following processing as an example: - Performs predetermined calculations and control based on signals from various sensors. - A predetermined motor control signal is sent to the piston drive mechanism to control its operation. - Display specified information on the display. - Accepts input from the operator via physical buttons or other input devices. - Controlling the operation of heaters, etc.

[0042] (Various sensors, etc.) (a1) Position sensor The position sensor 162 is for defining the movable range of the ram member 131. For example, it may have a first sensor that detects when the ram member 131 has moved to its furthest forward position, and a second sensor that detects when the ram member 131 has moved to its furthest backward position. These sensors may be contact type or non-contact type. As a non-contact type, an optical sensor having a light-emitting element and a light-receiving element can be used. Specifically, it may be a photointerrupter that detects the decrease in the amount of light received by the light-receiving element when light is blocked by the object to be detected, and detects this decrease. Alternatively, a reflective photointerrupter may be used. The first sensor may be arranged on the front side (see reference numeral p1) in the direction of movement of the ram member, as schematically shown in Figure 4, and the second sensor may be arranged on the rear side (see reference numeral p2). Other position sensors that can be used include contact sensors that utilize physical contact, electrical sensors that electrically detect objects, magnetic sensors, Hall sensors, proximity sensors, etc.

[0043] (a2) Clamper sensor The clamper sensor 163 may be a contact-type sensor configured to contact a portion of the clamper 145 when it is closed to a predetermined closed position. Alternatively, it may be a non-contact-type sensor that optically or magnetically detects the position of a portion of the clamper 145 when it is closed to a predetermined closed position.

[0044] (a3) Syringe detection sensor The syringe sensor 164 is used to detect whether a syringe and / or protective case is attached. Furthermore, it may also be able to determine what type of syringe and / or protective case is attached. Such sensors may be either contact or non-contact, and examples of such sensors may be used: contact sensors that utilize physical contact, electrical sensors that electrically detect objects, magnetic sensors, Hall sensors, proximity sensors, etc.

[0045] The various sensors described above can be applied not only to syringe detection but also to the detection of protective cases. For example, one or more identification members may be provided on the protective case and detected by the sensor. Metal or magnets can be used as identification members. The information to be identified may include at least one of the following: the size of the protective case (diameter and / or length dimensions, etc. In other words, what diameter syringe it corresponds to and / or what length syringe it corresponds to) and information about the drug solution in the syringe. The information may also be identified by detecting the difference in polarity of the magnet. One or more magnets may be used. The position where the identification member is provided is not particularly limited, but for example, it may be on or around the flange of the protective case. Specifically, one or more identification members may be provided on a portion protruding from the flange. This "portion protruding from the flange" may be a roughly plate-shaped structure, and for example, it may be a shape that extends radially outward from the flange for a predetermined length.

[0046] As a specific example, by using multiple magnets, detection can be performed as follows: Type 1 if all are north poles, Type 2 if all are south poles, Type 3 if one is north pole and the other is south pole, Type 4 if one is south pole and the other is north pole, and so on. In one embodiment, it is preferable that the drug injection device is configured to automatically set the movable range of the ram member based on the information thus read. Furthermore, the drug injection device may be configured to recognize the type of drug, product name, or whether or not it is a pre-filled syringe based on the information thus read.

[0047] (a4) Pressure sensor The pressure sensor 165 is used to calculate the pressure that pushes the piston member 820 of the syringe, thereby allowing for the estimation of the drug solution pressure. The pressure sensor 165 may, for example, be a load cell. The load cell should be positioned so as to be able to detect the pressure that the ram member 131 of the piston drive mechanism 130 pushes against the piston member. When using the detection result of the load cell to estimate the pressure of the drug solution during injection, for example, the calculation may also take into account the needle size, the concentration of the drug solution, and the injection conditions. In addition to using the pressure sensor as described above, the pressure may also be calculated based on the motor current of the piston drive mechanism, and this motor current method may be used in combination with the pressure sensor or implemented independently without a pressure sensor.

[0048] (a5) Display One or more display units 146 for displaying predetermined information may be provided on or separately from the injection head. The display unit 146 may be an LCD (Liquid Crystal Display) or an organic EL (Organic Electro-Luminescence) display.

[0049] Next, the content displayed on the display unit 146 is not particularly limited, but may include at least one of the following: - Display related to self-check, - Display of predetermined status before injection begins, - Prescribed indication regarding the head's orientation, - Prescribed markings regarding syringe attachment, - Display of predetermined status during injection operation, - Display of the conditions for injecting the drug solution to be administered. - Display of the injection conditions for the injected drug solution. - Warning displays in case of abnormalities, etc.

[0050] (a6) Heater The injection head of this embodiment may be provided with a heating element for heating the drug solution inside the syringe, and as an example, a transparent heater 141a using an ITO membrane may be provided.

[0051] (a7) Interface Interface 169 is a connection point for exchanging signals with console 210. The connection between console 210 and injection head 110 may be wired or wireless.

[0052] (a8) Storage section The storage unit 168 can be any storage medium capable of storing data, and can consist of memory, a hard disk, etc. The storage unit 168 may store information related to the basic operation of the injection head (such as operation algorithms) and data tables. Some of this information may be stored in the storage unit 261 on the console side rather than on the injection head side.

[0053] (a9) Physical buttons The physical button 161 is not particularly limited, but may be one of the following: - A forward button for moving the ram member forward. - Retract button for advancing the ram member, - An accelerator button (acceleration button) that increases the movement speed of the ram member when pressed simultaneously with the forward or reverse button. - A return button to return the ram member to the retracted position. - A stop button to stop the head's movement, etc.

[0054] (a10) Light-emitting part Indicator 173 in Figure 4 is, for example, an LED (Light Emitting Diode) and is used to inform the operator of the operating status of the injection head.

[0055] [3. Console] The console 210 may include a control unit 250, a storage unit 261, a communication unit 262, a slot 257, a touch panel 253, and a display 251, as shown in Figure 4. For example, an integrated console may be provided in which the control unit 250 is located within a single enclosure and the display 251 is located on the front of that enclosure. A system utilizing multiple consoles is also possible.

[0056] The form of the enclosure is not limited in any way. The enclosure shape may be as preferable as appropriate depending on the context in which the console will be used. For example, it may be as follows: - A stationary housing shape suitable for placement on a control room table. - A housing shape that can be suitably attached to a predetermined support member or wall, etc. (for example, a thin housing with a substantially flat back side), etc.

[0057] The console's display may be a display unit utilizing an LCD (Liquid Crystal Display) or an organic EL (Organic Electro-Luminescence) display, or it may be a touch panel display.

[0058] The control unit 250 has a CPU (Central Processing Unit) for arithmetic processing, memory, and interfaces, and realizes various functions by executing computer programs stored in memory. The control unit 250 may also have a processor with hardware such as a CPU, ROM, RAM, and I / F, on which the program is implemented. The control unit 250 has many functions according to the implemented program, but some examples of console functions include: injection condition setting GUI display function, injection condition setting function, screen display function during injection, screen display function after injection, input detection function, injection control function, etc.

[0059] The computer program may be pre-stored in the console's memory, downloaded from an external source via a network or the like and stored in the memory, or read from an information storage medium inserted into a slot. The same applies to the computer program that controls the operation of the injection head; it may be stored in the head's memory or the console's memory, or read from an external source.

[0060] The above functions will be briefly explained below. The injection condition setting GUI display function displays a GUI screen on the display for setting injection conditions. As a specific example, it displays at least one of the following: a body category icon, an imaging area icon, etc. If selected, it presents the predetermined drug injection conditions on the display. Detailed GUI screens will be described later, referring to other drawings.

[0061] The infusion condition setting function sets the drug infusion conditions, as presented above, as instructed by a physician or healthcare professional after they have been reviewed and modified.

[0062] The infusion screen display function shows still images or animated images on the display while the drug solution is being injected. It also displays drug solution pressure information on the display during drug solution injection.

[0063] The post-injection screen display function shows information about the administered drug solution on the display.

[0064] The input detection function accepts input from doctors or medical professionals via touch panels, physical buttons, etc. (examples).

[0065] The injection control function operates the piston drive mechanism according to the set injection conditions to inject the drug solution. Information regarding the operating conditions of the piston drive mechanism may be transmitted from the console to the injection head, and the control circuit of the injection head may be configured to control the piston drive mechanism based on that information.

[0066] The control unit 250 may further have an injection history generation function. The injection history generation function is a function that generates injection history data. The "injection history data" may be one or more of the following, for example: - Data related to heater operation (heating start time, heating end time), - An injection operation ID, which is a unique identification piece for each injection operation. - Date and time of injection start and end, - Identification information for the drug injection device, - Information on the drug solution and imaging site, which are the injection conditions. - Information on the drug solution and injection pressure as a result of the injection, etc.

[0067] Referring again to Figure 4, slot 257 is a portion into which a predetermined information storage medium is inserted, and the console 210 can read predetermined data from this information storage medium. Interface 269 is a connection part for connecting to the infusion head 110. The console 210 may also be connectable to an external network (e.g., a hospital system or the internet) via a communication unit 262. Although not shown in Figure 4, the console 210 may have input means such as a hand switch or a foot switch. The hand switch may be connected to the console by wire or wireless and operated at the operator's hand, and may have a push-button type switch. The operation of the infusion head 110 and / or the console 210 may be controlled by operating these switches. The foot switch may, in other forms, be connected to the infusion head 110. The console may have a speaker (not shown) for outputting sound and / or voice. The console may have a microphone (not shown) for inputting voice.

[0068] [Graphical User Interface] The drug injection device 100 may have and display one or more screens such as: a startup / self-check screen, an angiography mode screen, a home screen, an injection result screen, a protocol setting screen, and an error screen, etc.

[0069] (b1: Screen transition) The drug injection device may display a user interface image as shown below. First, a screen for selecting the imaging area, as shown in Figure 7, is displayed. On this screen, an image of the human body shape 701 (also called the human body image 701) is displayed. The human body image 701 consists of multiple parts, and in this example, the head, chest, abdomen, and legs are displayed. Each part functions as an image button and can be selected. The remaining amount in each syringe set in the injection head 110 is also displayed on this screen.

[0070] Next, when one part of the human body image 701 is selected, one or more imaging areas 703 associated with that part are displayed, as shown in Figure 8. These imaging areas 703 may be, for example, multiple different blood vessels. The imaging areas 703 also function as image buttons and can be selected.

[0071] Next, when one of the displayed imaging areas 703 is selected, the drug injection conditions associated with that imaging area 703 are displayed, as shown in Figure 9. Here, the injection rate window 705a and the injection volume window 705b are displayed. In this example, the injection rate window 705a includes information on the injection rate (10 mL / sec) and information on the mixing conditions of the contrast agent and saline solution (injection rate of each drug solution). In this example, the injection volume window 705b includes information on the injection volume (30 mL) and information on the injection volume of each drug solution. Note that in the screen of Figure 9, an image button 711 is also displayed that displays information on the mixing conditions of the contrast agent and saline solution. Specifically, the image button 711 displays the information "50%" as the dilution ratio.

[0072] At the top of the screen in Figure 9, an image button 707 labeled "Check" (also called the check button 707) is displayed. The check state means that neither a test shot (test injection) nor a main injection is permitted. Here, a "test shot" refers to the injection of a small amount of contrast agent (meaning a smaller amount than the main injection; this may also mean an injection with a slower injection speed and / or lower pressure conditions than the main injection) for purposes such as confirming the position of the catheter tip. The injection may be continued only while the hand switch or foot switch is pressed, and stopped when it is released. In the state shown in Figure 9, the execution of this test shot is prohibited. By pressing the check button 707, this prohibition is lifted, and the test shot can be performed.

[0073] This state is the "standby" state shown in Figure 10. The standby state is a state in which a test shot can be performed, but the actual injection is prohibited. In the standby state, for example, once the catheter has been moved to the predetermined target location in the patient's body, the operator then presses the standby button 708.

[0074] Then, the system transitions to the Start OK state, where the image button 709, displaying "Start OK" as shown in Figure 11, appears. The Start OK state is a state in which drug injection can begin once final input is received from the operator. For example, by pressing the hand switch (or foot switch), drug injection starts, the injection head operates according to the set injection conditions, and the desired drug is injected.

[0075] In the above explanation, we described an example where selecting a body part on the screen in Figure 8 leads to the screen in Figure 9. However, it is also possible to omit the screen in Figure 9 and proceed directly to the screen in Figure 10 after selecting a body part.

[0076] (b2: Numeric keypad window) In this embodiment, when the image button 711 is pressed to change the numerical values ​​related to the mixing conditions (dilution conditions), a numeric keypad window 715 as shown in Figure 12 may be displayed. This numeric keypad window 715 displays the numeric keypad 712 and the Enter key 714, as well as a plurality of dilution setting buttons 713a to 713c. In this example, the dilution setting buttons displayed are the magnification method button 713a, the ratio method button 713b, and the ratio method button 713c.

[0077] These buttons 713a to 713c are used to switch the input method for numerical values ​​related to mixing conditions. The magnification method button 713a is used to change the dilution ratio of the contrast agent, for example, "2x", "3x", or "4x". By pressing this button 713a and selecting a number using, for example, the numeric keypad 712, the magnification ratio can be entered.

[0078] The ratio-based button 713b is used to change the mixing ratio of the contrast agent, for example, "30%", "50%", or "70%". The ratio-based button 713c is used to change the mixing ratio of the contrast agent to physiological saline, for example, "1:1", "2:1", or "3:1".

[0079] As described above, in this embodiment, the magnification method button 713a, the ratio method button 713b, and the ratio method button 713c are displayed, and the user can select one of the input methods and set a value, so the user can input and modify a value using the method they wish to use. In the example above, there was a configuration in which all three options—magnification, ratio, and ratio—were selectable, but it is also possible to have a configuration in which only two of them are displayed.

[0080] The above mode for changing the mixing condition values ​​can be exited by confirming the changes with the Enter key 714, or by pressing the "x" button displayed along with the numeric keypad window 715. The above information can be applied not only to the mixing of contrast agent and physiological saline, but also to the mixing of a first drug solution and a second drug solution of different concentrations.

[0081] (b3: Injection screen) Next, the image displayed during drug injection may be as shown in Figure 13. This image shows the first syringe 717a, the second syringe 717b, and a mixing device 718 displayed at the point where the two drug solutions merge. The mixing device 718 is a connector that generates a swirling flow inside to mix the two drug solutions well. Specifically, the device disclosed in Japanese Patent No. 5804543 can be used.

[0082] During drug injection, an animation may be displayed showing multiple droplets moving toward the subject through the path 719a connecting the first syringe 717a and the mixing device 718, and an animation may also be displayed showing multiple droplets moving toward the subject through the path 719b connecting the second syringe 717b and the mixing device 718.

[0083] Furthermore, the mixing device 718 may be configured to display an animation showing a diagonal striped pattern representing a swirling flow progressing toward the subject. By displaying the mixing device 718 on the screen during injection and animatizing the mixing by the swirling flow within the device, the operator can visually recognize that injection is being performed using the mixing device.

[0084] If drug injection is temporarily stopped due to a predetermined input from the operator (for example, pressing a button), a pause indicator 721 may be displayed, as shown in Figure 14. To resume injection, the operator makes a predetermined input (for example, pressing another button), causing the pause indicator 721 to disappear and the screen shown in Figure 13 to reappear, and injection to resume.

[0085] The image of drug injection may be similar to that shown in Figure 23. In this image, the two syringes 717a and 717b are displayed at a smaller size compared to Figure 13, while the mixing device 718 is displayed at a larger size. Other elements may be the same as in Figure 13, but in this example, multiple droplets are shown being dispensed from the tip of the mixing device 718. As in Figure 13, the droplets may be displayed as an animation. Note that in the image of Figure 13, multiple droplets may also be shown being dispensed from the tip of the mixing device 718.

[0086] Furthermore, this application also discloses partial designs in which the images in Figures 13 and 23 constitute part of the design (see Figure 17). It also discloses partial designs in which only a portion of the images in Figures 13 and 23 (for example, only the mixing device 718, only the display of droplets in pathways 719a, 719b, etc., or a combination of these with syringes 717a, 717b, etc.) is the part for which registration is sought, and the rest is depicted with dashed lines. Alternatively, it may be any combination of one or more other elements. The image in Figure 23 may be replaced with the image displayed on the console in Figure 17.

[0087] (b4: Screen related to body part selection, etc.) The screen for setting the injection conditions was described above with reference to Figures 7 to 9, but it may also be as shown in Figure 15. On this screen, a human body image 701 is displayed, and the chest is selected. Multiple imaging sites 703 corresponding to the chest (LCA, LVG, RCA, etc. in this example) are displayed, and one of them is selected.

[0088] The injection conditions associated with the selected imaging site 703 are displayed on the screen. This displays information such as injection rate, injection volume, and injection time. The screen also shows information on injection delay time, rise time, and pressure limit.

[0089] The delay time is based on the premise that the operation of the drug injection device and the operation of the imaging device are linked (synchronized). That is, when the imaging device starts scanning first and drug injection starts after a predetermined time has elapsed, the delay time is the time of delay relative to the start point of the imaging device's scan. In this example, it is 10 seconds. In this embodiment, when the imaging device starts scanning, the display of this delay time may decrease in a countdown manner.

[0090] Figure 15 shows a state where one imaging area 703 (LVG) has already been selected. From this state, one possible method to select another imaging area 703 is to first re-select a major body image 701 (chest), and then select another medium-sized imaging area 703 (e.g., LCA). However, in this embodiment, it is possible to switch directly to another imaging area 703 (e.g., LVG → LCA) without re-selecting the major body area 701. In other words, each of the multiple imaging areas 703 in Figure 15 is configured to be selectable, and by selecting one of them, another imaging area is directly selected and the associated conditions are set. With this selection method, there is no need to re-select the major body area 701, making it possible to operate simply and intuitively.

[0091] Regarding the imaging area 703, in addition to simply displaying the name of the target area (LCA, LVG, RCA, etc.), indicators 704a and 704b indicating what kind of drug solution is being injected may also be displayed, for example, as shown in Figure 16. Indicators 704a and 704b indicate that a first drug solution (contrast agent) and a second drug solution (physiological saline) are being injected, respectively. If only the first drug solution is injected, only indicator 704a will be displayed; if only the second drug solution is injected, only indicator 704b will be displayed; and if both are injected simultaneously, both indicators 704a and 704b will be displayed. The first drug solution (contrast agent) and the second drug solution (physiological saline) are displayed in different colors. With this configuration, it becomes possible to visually confirm the injection conditions for a given imaging area simply by looking at the button on the imaging area 703.

[0092] In addition to the screen shown in Figure 9, the system may transition to a screen like the one shown in Figure 24 after a body part has been selected. In this example, the chest is selected from the body parts, and then "LCA" is selected from its subcategories, which are imaging areas.

[0093] In the example in Figure 24, the first phase involves the mixing and injection of two drug solutions, while the second phase involves the injection of only one drug solution. The injection conditions for each phase are displayed in windows 1705a and 1705b, respectively. Each window displays information on the injection rate and injection volume. In particular, window 1705a for the first phase, which is a mixing injection, displays information on the injection rate and volume of the first drug solution, as well as information on the injection rate and volume of the second drug solution. While not limited to this, window 1705a, which contains more information, may be displayed at a larger size than window 1705b. Note that the screen in Figure 24, like that in Figure 9, is in a checked state.

[0094] (b5: Screen display of injection results) In angiography, a catheter is moved to a predetermined target location, a contrast agent is injected, then the catheter is advanced to another target location, and the contrast agent is injected under different injection conditions, and this process is repeated thereafter. Therefore, the screen display of the injection results may show multiple results sequentially for a given subject, such as the result of the first injection (including information such as time, injection volume, injection rate, dilution information, and injection site), and the result of the second injection (including information such as time, injection volume, injection rate, dilution information, and injection site). Each injection result may also be assigned a sequential number (e.g., "1" to "10") and displayed accordingly.

[0095] Furthermore, it is anticipated that the contrast agent syringe may need to be changed during angiography. For example, when the current syringe is removed from the injection head and another syringe in a protective case is inserted, the system may be configured to recognize that an examination for a different patient has begun, and to sequentially store and display the injection results for that patient. As mentioned above, the insertion of a syringe can be determined by the injection head recognizing the identification element provided on the protective case.

[0096] (Output of injection results) A drug injection device and system according to one embodiment of the present invention may be configured to output information of the injection result to an external source after the drug solution has been injected. As shown in Figure 25A, this hospital system comprises a drug injection device 100, a RIS 311, a PACS 313, an information management device 315, an information display terminal 317, and an imaging room monitor 319. Not all of these are essential, and one or more may be omitted.

[0097] In such a system, the drug injection device 100 may be configured to output one or more of the following pieces of information to the outside: - Information on the cumulative amount of drug solution injected, - Information on the set injection conditions (one or more of the following: injection pressure, injection volume, injection time, body category, imaging site, etc.) - Various information regarding the drug injection performed (one or more of the following: injection pressure, injection volume, injection time, body type, imaging site, etc.), etc.

[0098] Although not particularly limited, this information may be sent from the drug injection device 100 to the information management device 315, and the information management device 315 may communicate with each device to transmit the information.

[0099] The information display terminal 317 may, for example, be a portable tablet terminal, and may be configured to display at least one of the above-mentioned pieces of information.

[0100] It is also preferable that the system is configured to perform predetermined accounting processing using information such as the cumulative amount of drug solution injected. The information management device 315 may be configured to read subject information from the RIS 311. In this case, it is also preferable that the information management device 315 is configured to send the subject information along with the injection result information to each device (at least one of the information display terminal 317, the imaging room monitor 319, and the PACS 313). Furthermore, if the subject information includes information about the subject's renal function (for example, the estimated glomerular filtration rate (eGFR) value), this information may be sent to any device in the system and used to determine the appropriateness of the test or displayed as appropriate.

[0101] Furthermore, the injection results may be displayed in a manner that includes multiple injection result displays 1761 for each series of tests, as shown in Figure 25B. These injection result displays 1761 may include, for example, the test number, date, time the injection started, the total amount of drug solution injected in that test, and information about the site examined. One or more of these may be omitted, or other information not shown may be included.

[0102] In this example, ten injection result displays 1761, numbered "1" through "10", are displayed on a single screen. The timing of which events in a series of tests are grouped into a single injection result display 1761 can be freely determined as appropriate, but in this embodiment, for example, it may be as follows: A series of tests on a subject is completed, and the syringe is removed from the clamper 145 of the injection head 110 (see Figure 2) for the next test. Then, a new syringe is set in the clamper 145. When it is detected that the clamper 145 has opened, closed, or both, the injection result display 1761 for the next test may be automatically created (for example, if the previous test was "1", an injection result display 1761 of "2" will be automatically created). Such processing may be triggered not by the opening and closing of the clamper 145, but by the attachment or detachment of the syringe or protective case.

[0103] The screen in Figure 25B also includes a mode display 1762 indicating the mode of drug injection performed. The mode display 1762 may show "Angiography," "Infusion," "CT," etc. The device in this embodiment can perform multiple modes, such as angiography mode, infusion mode, and CT mode (details described later). For example, suppose the first examination is in angiography mode, the next examination is infusion mode, and the next examination is in CT mode. The display method for the injection results may be to display all three together on one screen, but in this embodiment, the display method is as follows. That is, the injection results performed for each mode are grouped and displayed. In other words, in the example in Figure 25B, the angiography mode display 1762 is selected, so the results "1" to "10" displayed here are all results from angiography mode. The three mode displays 1762 can be selected as image buttons. For example, selecting "Infusion" displays a series of injection results grouped as "Infusion Mode," and selecting "CT" displays a series of injection results grouped as "CT Mode." This display configuration is useful because it allows users to check the results of drug injection for each mode in which it was performed.

[0104] By selecting one of the multiple injection result displays 1761 in Figure 25B, the system may be configured to display the detailed results contained therein, for example, as shown in Figure 25C. In the screen of Figure 25C, as an example, the details of injection result number "9" are displayed in window 1763. The content of the detailed results may include, but are not limited to, one or more of the following items: time of drug injection, maximum velocity, injection volume, number of injection phases, whether it was an injection of a single drug or a simultaneous injection of multiple drugs (dilution injection), injection time, injection pressure, target site, mixing ratio, mixing multiplier, mixing ratio, delay time, and rise time. This information may be grouped by the examination or procedure performed and displayed with numbers such as "1" and "2". In addition, the total injection volume in a series of injections may be displayed as a detailed result. As a specific example of displaying detailed results, an indicator may be used as described with reference to Figure 16. For example, if an injection is performed that includes a first phase (dilution injection) and a second phase (injection of a single drug solution), two indicators are displayed to visually represent the first phase and one indicator is displayed to represent the second phase (see the display content of the result numbered "3" in Figure 25C. The indicator for the second phase is displayed to the right of the indicator for the first phase). Such indicator displays are preferable because the content of each injection phase can be accurately grasped by looking at the number and color of the indicators. Also, compared to displaying text information, it is possible to convey a sufficient amount of information even with a relatively small size, making it particularly suitable for displaying injection results in the manner shown in Figure 25C.

[0105] (b6: Other screen displays) As an indication that mixing is being performed using a mixing device, a mixing device image 707s may be displayed within a predetermined window 707w on the screen, as shown in Figure 19. In this example, window 707w is a bar-shaped window near the top edge of the screen. By displaying the mixing device image 706s in this way, the operator can intuitively confirm that mixing is being performed using a mixing device.

[0106] Alternatively, the display configuration may be as shown in Figure 20. In this example, injection conditions including two phases are set, and the injection conditions for each phase (injection rate, injection amount, etc.) are displayed in the first phase display unit 706a and the second phase display unit 706b, respectively. The mixing device image 706s is displayed in the first phase display unit 706a and the second phase display unit 706b. This indicates that mixing injection is performed in each phase.

[0107] The mixing device image 706s may also function as an image button. When the mixing device image 706s is pressed, a predetermined injection condition change screen (e.g., Figure 22) may be displayed. In the example of Figure 22, a numeric keypad window 715′ similar to that in Figure 12 is displayed, and dilution setting buttons 713a to 713c are displayed within this window. The mixing device image 715s and / or the current dilution ratio (here, "50%") may also be displayed within the same window.

[0108] As shown in the display configuration of Figure 21, only the first phase display unit 706c may be displayed, with the mixing device image 706s displayed nearby (to the side in this example). This image may also function as an image button, as described above.

[0109] Although specific embodiments of the present invention have been described above with reference to the drawings, the present invention can be modified as appropriate without departing from its spirit.

[0110] (1) For example, in the above configuration, the graphical user interface was described as being displayed on the console's display, but other than that, such functions may also be implemented in a workstation set up as a desktop computer or a tablet terminal.

[0111] The series of graphical user interface display modes described above can be expressed as an invention concerning a display method, and also as an invention concerning a computer program for causing a computer to implement said method.

[0112] (2) For example, the injection head may have a tilt sensor that detects the tilt of the injection head. Generally, this type of injection head is used when the front end (i.e., the syringe side) is facing upwards when aspirating the drug solution into the syringe. On the other hand, drug solution injection is performed when the front end of the injection head is facing relatively downwards (with the tip slightly pointed downwards). By using the detection result of the tilt sensor, it is possible to prevent drug solution aspiration or injection in an undesirable position. In addition, based on the detection result of the tilt sensor, it may be possible to identify whether the injection head is facing upwards or downwards and control the orientation of the characters displayed on the display unit 146 to be inverted vertically. With such a configuration, the operator can easily check the displayed content regardless of the orientation of the injection head.

[0113] (3) The mechanism for holding the injection head 110 may be as shown in Figure 18. This holding mechanism 1320 comprises a base portion 1325, a first arm member 1331 rotatably connected to the base portion 1325, a second arm member 1337 rotatably connected to the base portion 1325, and a holding member 1341 to which the tip ends of the first and second arm members are rotatably connected and to which the injection head 110 is attached. The base portion 1325, the first and second arm members 1331 and 1337, and the holding member 1341 constitute a parallel link.

[0114] The base portion 1325 is fixed to a predetermined mounting position on the support column (not shown) of the movable stand or on the bed of the imaging device, with or without the use of other components. The holding mechanism in Figure 18 is provided as a parallel link mechanism, so that the injection head 110 can be rotated in the front-rear direction while maintaining the same posture.

[0115] To attach the injection head holding mechanism 1320 shown in Figure 18 to a designated location within a medical facility or to a designated medical device, a mounting mechanism like the one shown in Figure 26 can be used. This mounting mechanism 500 is for fixing the injection head, etc., to the guide rail of the imaging device (details below).

[0116] The mounting mechanism 500 is broadly composed of a retaining assembly 510 for holding a part of the injection head retaining mechanism 1320, and a base assembly 550 that supports the retaining assembly 510. The retaining assembly 510 and the base assembly 550 may be separate parts or may be integrally constructed.

[0117] As shown in Figure 27, the retaining assembly 510 is a component having a receiving hole 515 into which the round shaft 1327 provided in the injection head retaining structure 1320 is inserted. In this example, the receiving hole 515 is a round hole that extends vertically. Details of the structure of the receiving hole 515 and the structure for fixing the round shaft 1327 will be described later with reference to other drawings.

[0118] The base assembly 550 is a component that is removably fixed to the guide rail 330 of the imaging device. The guide rail 330 is provided, for example, on the side of the patient's bed of the imaging device, and various medical devices are attached to it as needed. The guide rail 330 is generally a long, rectangular metal component.

[0119] The base assembly 550 has the retaining assembly 510 fixed to its upper surface. In this example, the base assembly 550 is mounted on the guide rail 330 from above. As shown in Figure 27, the base assembly 550 has two extensions 551A and 551B that extend downward. The extensions 551A and 551B (also referred to simply as extension 551) are provided with receiving grooves 560 formed vertically upward from the lower surface, into which the guide rail 330 fits.

[0120] The overall shape of the base assembly 550 is not particularly limited, but in this embodiment, as shown in Figure 28 (viewed from a direction perpendicular to the side of the guide rail 330), it is roughly inverted V-shape (consisting of a horizontal portion and two portions extending diagonally downward from both ends). The base assembly 550 may be composed of a rectangular block-shaped member as shown by reference numeral 559 in Figure 28, but in this embodiment, the overall shape is such that the left and right shoulder portions 559a, 559b and the central lower portion 559c of such a block-shaped member 559 are omitted. This results in a compact and lightweight structure while maintaining holding stability.

[0121] As shown in Figures 29 and 30, the extension portion 551 is provided with a tightening handle 556, and by rotating this handle, the contact member 555 is configured to advance into the receiving groove 560. In this example, the contact member 555 has a flat pressing surface 555a, which contacts the side surface of the guide rail.

[0122] The mechanism of retention by the retention assembly 510 will be explained with reference to Figures 31 to 34. As shown in Figures 31 and 32, the round shaft 1327 of the retention structure 1320 protrudes downward from the base portion 1325, and a recess 1327a is formed in a part of it. The recess 1327a is a part in which the diameter of the round shaft 1327 is partially reduced, and the contact member 527 of the retention assembly 510, which will be described later, is fitted into this recess. Near the base end of the round shaft 1327, a key portion 1327b is formed that protrudes radially outward from the shaft. The key portion 1327b may have a mountain-like shape formed by two slanted sides on the left and right and a apex that connects the two by a gentle curve.

[0123] The round shaft 1327 formed in this manner is inserted into the receiving hole 515 of the retaining assembly 510. Near the entrance of the receiving hole 515, as shown in Figure 33, a recess 515c (with a shape complementary to the key portion 1327b) is formed, and the round shaft 1327 is installed so that the key portion 1327b of the round shaft 1327 fits into this recess, thereby restricting the rotation of the round shaft 1327.

[0124] By rotating the handle 526 provided on the holding assembly 510, the engaging member 527 advances into the receiving hole 515. The engaging member 527 has a curved surface 527a at its tip that conforms to the outer circumference of the recess 1327a of the round shaft 1327. When the engaging member 527 is advanced to a predetermined position, the tip of the engaging member 527 enters the recess 1327a, thereby preventing the round bar 1327 from coming out of the receiving hole 515.

[0125] In the holding structure described above, both the rotational and axial movement of the round shaft 1327 is restricted. Therefore, it is prevented that the round shaft 1327 may come loose due to unforeseen circumstances, causing the holding structure 1320 (and the injection head 110 held by it) to fall. Furthermore, since the rotation is restricted by the engagement of the key portion 1327b and the recess 515c, the structure is simple, and no complicated work is required during installation to restrict rotation. Preventing the round bar 1327 from coming loose is also easy, as it only requires turning the handle 526.

[0126] Furthermore, a structure as shown in Figures 35 to 38 may be adopted. This mounting structure 500' basically has the same function as the mounting structure 500 described above, but the method of fixing it to the guide rail 330 is different. Regarding the structure and function which are the same as the mounting structure 500, the explanation will be omitted to avoid duplication. In other words, instead of attaching the mounting structure 500 to the guide rail 330 from above, the mounting structure 500 is attached by sliding it from the end side of the guide rail 330.

[0127] As shown in Figures 37 and 38, the extension 551 is formed in a roughly U-shape, surrounding the guide rail when viewed from the direction of arrow A. The "roughly U-shape" is composed of a first portion 557 facing one side of the guide rail 330, a second portion 558a and a third portion 558b along the upper and lower surfaces of the guide rail 330, and a fourth portion 559 facing the opposite side of the guide rail 330, as shown in Figure 38. More specifically, the fourth portion 559 is formed of an upper fourth portion 559 that abuts against the upper side of the guide rail 330 and a lower fourth portion 559 that abuts against the lower side of the guide rail 330. With this configuration, as a result, the gap S is formed as shown in Figure 38. 551 This configuration allows the mounting structure 500 to slide along the guide rail 330 without interfering with other components (not shown) attached to the guide rail 330.

[0128] In the examples shown in Figures 35 to 38, the shapes of the handles 526' and 556' differ from those described above, but various shapes and parts can be used for each part of the mounting structure 500. By rotating the handle 556', the flat contact surface 555a of the contact member 555 and the flat surface 559a of the fourth part 559 sandwich both sides of the guide rail 330, thereby achieving stable fixation of the mounting structure 500 to the guide rail 330.

[0129] (4) Supplementary explanation of the function of the drug injection device A drug injection device for angiography according to one embodiment of the present invention may perform automatic injection using an "infusion mode". In angiography, automatic injection of drug solution is usually performed only while the physician is pressing a predetermined switch on the drug injection device. However, in infusion mode, the drug solution is automatically injected over a predetermined period of time at a preset injection rate and / or injection volume. Examples of drugs used in this case include anticancer drugs. In this mode, the injection rate is set to a relatively low rate. In the example in Figure 39, it is 1.0 mL / sec. Images such as those shown in Figures 39A to 39D may be displayed when infusion mode is enabled.

[0130] Figure 39A shows the screen in the checked state. This screen displays information such as the syringe image 717p, the remaining syringe volume, the full injection button, the injection rate, the injection volume, the injection time, and the cumulative volume. Note that one or more of these may be omitted. Pressing the "Check" button on this screen will then transition to the standby state shown in Figure 39B. Note that in these states, the system may be configured so that pressing, for example, the home button (not shown) will return to the home screen (a screen from which various modes can be selected and accessed).

[0131] When the "Standby" button is pressed on the screen shown in Figure 39B, the system then transitions to the standby state shown in Figure 39C. On this screen, for example, the words "Start OK" and a button that has been switched to indicate the start of injection are displayed. By pressing this button 722, or by pressing any other designated button, automatic injection in infusion mode is started.

[0132] During injection, a screen similar to that shown in Figure 39D may be displayed. This injection image displays an animation showing multiple droplets being dispensed from a single syringe 717p. To ensure that healthcare professionals can easily confirm that it is in infusion mode, in one configuration, the color of the drug solution and / or droplets in the syringe may be displayed in different colors than those used on the injection screen during normal injection for angiography. For example, during normal injection, contrast agent may be shown in green and saline solution in blue, while in infusion mode, the drug solution may be shown in other colors. Regarding the injection time, the remaining time may be displayed in a countdown format, or a visually verifiable indicator may be displayed.

[0133] In the infusion mode, the injection may basically continue until all the medication in the syringe is used up, but it is configured to be interrupted or stopped midway as needed.

[0134] (5) CT mode injection using an angiography drug injection device As shown in Figure 18, the injection head of an angiography drug injection device requires injection of contrast agent through a thin catheter, and therefore injection is basically performed at high pressure (for example, 500 psi to 1200 psi). However, a "CT mode" that performs relatively low-pressure injection, similar to that performed with injection heads for CT scans, may be provided. In drug injection in CT mode, for example, injection is performed in a range of 300 psi or less. In addition, a different upper limit for the injection rate (e.g., 10 ml / sec or less) may be set compared to angiography. Although not limited to this, the system may be configured so that the operator can select which mode (in this case, angiography mode and CT mode) to perform drug injection via a graphical user interface. For example, icons representing each mode may be displayed on the console screen, and the operator may select one of them.

[0135] In a configuration that allows injection in different modes, such as angiography mode and CT mode, the drug injection in each mode may be initiated by a common input operation. However, in this embodiment, the system may be configured as follows: the input for initiating injection in one mode and the input for initiating injection in another mode are set to be different operations. Specifically, to perform injection in angiography mode, it is necessary to press a hand switch, for example, and to perform injection in CT mode, it is necessary to press a predetermined switch on a different device, for example. By deliberately requiring different inputs in this way, safer drug injection can be performed.

[0136] In a configuration where the drug injection device 100 is communicatively connected to the angiography imaging device 300-2, it is preferable in one embodiment that the two devices are configured to operate in conjunction. For example, when a predetermined device on the imaging device 300-2 is operated, the drug injection device 100 may start injecting. An image (icon, etc.) indicating that the linkage is ON may be displayed on a predetermined display device of the drug injection device 100. An image (icon, etc.) indicating that the linkage is ON may be displayed when the device switches to the standby screen. For example, if the device becomes disconnected due to an unexpected cable disconnection, it may be configured to perform the following actions: -If the device becomes disconnected while in standby mode, the standby state will be terminated. - If an injection is in progress, interrupt the injection.

[0137] (6) Light emission pattern Regarding the operation of the injection head 110, the light-emitting unit 173' may be configured to emit light in a predetermined pattern depending on when the operating knob 170 (see Figure 40) is turned or the operating status of the piston drive mechanism. Various patterns can be used for the arrangement of the light-emitting elements of the light-emitting unit 173', but here, as shown in Figure 41, multiple light-emitting elements are arranged in a manner that surrounds the operating knob 170.

[0138] As light-emitting elements, a single element capable of emitting light in multiple colors may be arranged in a sequence, or elements with different emission colors may be arranged alternately or in a predetermined order. In Figure 41, the first color 173a and the second color 173b are shown schematically to illustrate the difference in color.

[0139] The injection head 110 may be configured to display an animation in which the first color 173a is sequentially displayed clockwise or counterclockwise when the ram member of the piston drive mechanism is advanced (for example, when the operating knob is operated manually during drug injection). In this case, the second color 173b is not emitted. When the operating knob is operated manually, the speed of the animation display (i.e., the speed at which the emission state of the light-emitting element is switched) may be changed in accordance with the speed of rotation. When the ram member is retracted, the display is performed in the opposite direction to the above. In the case of automatic injection, the speed of the animation display (i.e., the speed at which the emission state of the light-emitting element is switched) may be changed in accordance with the set drug injection speed.

[0140] It is also preferable that the light emission pattern of the light-emitting unit 173' indicates the current status of the drug injection device. Therefore, in one embodiment of the present invention, for example, if the device is in the "Start OK" state, it may be configured to display the following: Of the two light-emitting parts 173' of the injection head 110, one light-emitting part is illuminated with a first color (e.g., green) corresponding to the first syringe, and the other light-emitting part is illuminated with a second color (e.g., light blue) corresponding to the second syringe.

[0141] If an error occurs for any reason, one or both of the two light-emitting units 173' may be configured to repeatedly switch between being on and off.

[0142] The individual technical features disclosed herein can be combined with other technical features as appropriate. Furthermore, one or more of the elements may be omitted.

[0143] Furthermore, the various components (devices, apparatus, means, parts, units, etc.) referred to in this specification do not need to be independent entities; multiple components may be formed as a single member. One component may be formed from multiple members. One component may be part of another component. Parts of one component may overlap with parts of other components.

[0144] (Note) This application discloses the following. The reference numerals in parentheses are provided for reference only and are not intended to limit the invention. 1.a: A syringe holder (140) that holds a syringe in which a piston member is slidably inserted into a cylindrical cylinder member, b: A piston drive mechanism (130) having a ram member (131) for moving the piston member of the syringe, c: A first light-emitting part (133a) that emits light in a first color and illuminates the syringe, and a second light-emitting part (133b) that emits light in a second color and illuminates the syringe, An injection head (110) comprising, The first light-emitting part (133a) and the second light-emitting part (133b) are positioned above the ram member (131) when viewed in the orientation of the injection head during use. Injection head (110).

[0145] 2. The first light-emitting part (133a) and the second light-emitting part (133b) are formed in an arc shape.

[0146] 3. The first light-emitting part (133a) and the second light-emitting part (133b) are arc-shaped and coaxial with the central axis of the ram member.

[0147] 4. The syringe is held in the syringe holder while inside the protective case (840).

[0148] 5. Regarding the light emission of the first light-emitting part (133a) and the second light-emitting part (133b) described above, In the preparation phase for drug injection, the first light-emitting unit (133a) is not turned on or blinked. The system is configured to light up or blink the first light-emitting unit (133a) during the drug injection phase.

[0149] The "preparation phase for drug injection" refers to the phase before the drug injection phase, including the stage where the syringe is set in the injection head and the stage where the drug solution is filled into the syringe. The "drug injection phase" may refer only to the stage in which the drug is actually injected, or it may include the stage immediately preceding it (for example, the stage in which the operator makes the final input to start the injection, such as pressing "Start OK"), and / or the stage immediately following it (the stage in which the injection is stopped).

[0150] In this way, by changing the pattern of light emission between the preparation phase and the injection phase, the operator can know what phase is currently in place.

[0151] 6. When the syringe described above is detected, or when the protective case attached to the syringe is detected, either the first light-emitting unit or the second light-emitting unit, or both, are configured to light up or flash (transition from off state to on / flashing state).

[0152] 7. The syringe holder has a clamping mechanism that holds a part of the syringe or a part of the protective case attached to the syringe. The clamp mechanism described above is configured to light up or flash either the first light-emitting unit or the second light-emitting unit, or both, when it switches from the open state to the closed state or from the closed state to the open state (transition from off state to on / flashing state).

[0153] 8. A drug injection device comprising an injection head (110) as described in any of the above, and a console (210) connected to the injection head.

[0154] 9.1 or more displays (146) and A control device (250) that holds information for a graphical user interface for setting injection conditions in a device that pushes out chemicals from a first chemical solution container (800A) filled with a first chemical solution and a second chemical solution container (800B) filled with a second chemical solution, An injection condition setting system (210) comprising, The graphical user interface described above is A display unit (716) that shows information regarding the mixing conditions of the first chemical solution and the second chemical solution, A window (715) for changing the mixing conditions, the window (715) including an input button image (712) for the operator to input information and a plurality of mixing method setting buttons (713) for selecting a mixing method, An injection condition setting system, including the above.

[0155] 10. At least two of the following are displayed as the multiple mixing method setting buttons (713): a magnification method button (713a), a ratio method button (713b), and a proportion method button (713c).

[0156] 11. The input buttons shown in the image above (712) for the operator to input data are the numeric keypad.

[0157] 12. The first liquid medicine container described above is the first syringe, and the second liquid medicine container described above is the second syringe. [Explanation of Symbols]

[0158] 100 Drug injection device 110 Injection head 111 cabinets 111a Front end surface 130 Piston drive mechanism 131 Ram member 132 Ball Nut Unit 133a, 133b(133), 133a′, 133b′ Light-emitting part 135 Ball screw 137 Transmission Mechanism 139 Motor 139s Rotation Sensor 140 Syringe holder 141 Protective Case Holder 145 Clamper 146 Display section 150 Control circuits 161 Physical Buttons 162 Position Sensor 163 Clamper Sensor 164 Syringe Sensor 165 Pressure Sensor 168 Storage section 169 Interfaces 170 Operating knobs 173 Indicators 190 Power Supply Units 210 Console 250 Control Unit 251 displays 253 Touch Panel 257 slots 261 Storage section 262 Communications Department 269 ​​Interfaces 300 (300-1, 300-2) Imaging device 330 Guide Rail 311 RIS 313 PACS 315 Information management device 317 Information display terminal 319 In-room imaging monitor 500 Mounting mechanism 510 Retaining Assembly 515 Receiving hole 526 Handle 527 Engaging member 550 Base Assembly 551A, 551B extension part 555 Contact Member 556, 556' Handle 557, 558a, 558b, 559 Part 1 ~ Part 4 560 Receiving groove 701 Human Body Images 703 Imaging site 704a, 704b indicators 705a Injection rate window 705b Injection volume window 706a, 706b, 706c Phase Indicator 706s, 707s Mixing Device Images 707w window Image buttons 707-709 711 Image button 712 Numeric Keypad 713a~713c Dilution setting button 714 Enter key 715, 715′ Numeric keypad window 717a, 717b, 717p syringes 718 Mixing Devices Routes 719a and 719b 721 Pause display 722 Image Buttons 800 (800A, 800B) Syringe 810 Cylinder component 820 Piston component (plunger) 840 Protective Case 1320 Retention mechanism 1325 Base section 1327 Round bar 1331, 1337 Arm members 1341 Retaining member 1705a, 1705b windows 1761 Injection result display 1762 Mode Display 1763 Window

Claims

1. a: A syringe holder that holds a syringe in which a piston member is slidably inserted into a cylindrical cylinder member, b: A piston drive mechanism having a ram member for moving the piston member of the syringe, c: A first light-emitting part that emits light in a first color and illuminates the syringe, and a second light-emitting part that emits light in a second color and illuminates the syringe, An injection head equipped with, The first and second light-emitting units are positioned above the ram member when viewed in the orientation of the injection head during use. Injection head.

2. The injection head according to claim 1, wherein the first light-emitting part and the second light-emitting part are formed in an arc shape.

3. The injection head according to claim 2, wherein the first light-emitting part and the second light-emitting part have an arc shape coaxial with the central axis of the ram member.

4. The injection head according to any one of claims 1 to 3, wherein the syringe is held in the syringe holding section while housed in a protective case.

5. Regarding the light emission of the first light-emitting unit and the second light-emitting unit, During the preparation phase for drug injection, the first light-emitting unit is not illuminated or flashed. During the drug injection phase, the first light-emitting unit is turned on or flashes. An injection head according to any one of claims 1 to 4, configured as follows.

6. The injection head according to any one of claims 1 to 5, configured to light up or flash either or both of the first light-emitting unit or the second light-emitting unit when the syringe is detected or when a protective case attached to the syringe is detected.

7. The syringe holder has a clamping mechanism that holds a part of the syringe or a part of the protective case attached to the syringe. The injection head according to any one of claims 1 to 6, wherein the clamp mechanism is configured to light up or flash either or both of the first light-emitting part or the second light-emitting part when it switches from an open state to a closed state, or when it switches from a closed state to an open state.

8. An injection head according to any one of claims 1 to 7, A console connected to the injection head, A drug injection device equipped with the following features.

9. One set of displays, A control device that holds information for a graphical user interface for setting injection conditions in a device that pushes out a drug solution from a first drug solution container filled with a first drug solution and a second drug solution container filled with a second drug solution, An injection condition setting system comprising, The aforementioned graphical user interface is A display unit showing information regarding the mixing conditions of the first chemical solution and the second chemical solution, A window for changing mixing conditions, which includes an input button image for the operator to enter information and multiple mixing method setting buttons for selecting a mixing method, An injection condition setting system, including the above.

10. As the aforementioned multiple mixing method setting buttons, At least two of the following buttons are displayed: a magnification button, a percentage button, and a ratio button. The injection condition setting system according to claim 9.

11. The injection condition setting system according to claim 1, 9, or 10, wherein the input button image for the operator to input is a numeric keypad.

12. The first liquid medicine container is the first syringe, The second liquid medicine container is a second syringe. An injection condition setting system according to any one of claims 9 to 11.

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