Liquid medicine injection apparatus

Abstract

To provide a chemical liquid injector or the like capable of preventing the occurrence of injection delay caused by the operation of a one way valve of a chemical liquid circuit or a or the like generated in the chemical liquid circuit.SOLUTION: This device is a drug solution injection device including a driving mechanism that applies pressure to a drug solution in a container to push out the drug solution, and a control unit for setting operating conditions thereof, wherein the control unit includes a main injection condition determination unit that determines an injection condition of the main injection, and an injection preliminary operation condition determination unit that determines an injection condition of the injection preliminary operation, and is configured such that the injection preliminary operation and the main injection are continuously performed in this order at the time of drug solution injection.SELECTED DRAWING: Figure 8

Description

[Technical Field]

[0001] The present invention relates to a liquid medicine injector that injects a liquid medicine into a subject, and more particularly to a liquid medicine injector that can prevent injection delays caused by the operation of a one-way valve in a liquid medicine circuit or kinks in the liquid medicine circuit. [Background technology]

[0002] Medical imaging diagnostic devices include CT scanners, MRI scanners, angiography scanners, PET scanners, MRA scanners, and ultrasound diagnostic imaging devices. When using these devices to capture medical images, medical fluids such as contrast agents or saline solutions are often injected into the patient to enhance the contrast effect. The medical fluids to be injected are often loaded into syringes, and the medical fluids loaded into the syringes are automatically injected according to pre-set injection conditions using a medical fluid injector. When injecting medical fluids, a medical fluid circuit is formed using catheters, indwelling needles, various tubing, etc. to connect the syringes mounted on the medical fluid injector to the patient.

[0003] Patent Document 1 discloses a twin-cylinder injection head A110 as shown in FIG. 14. The injection head A110 includes a housing A113 with two recesses A114 for holding syringes A200C and A200P, respectively. Several operation buttons A116 are located on the top surface of the housing A113, and sub-panels A115 are provided on the sides of the housing as needed. Syringes 200C and 200P each consist of a cylinder member A210 and a piston member A220 inserted into it. One syringe, A200C, is filled with contrast medium, and the other, A200P, is filled with saline. A piston drive mechanism A130 is a mechanism for moving the piston member A220.

[0004] A liquid medicine circuit A230 is connected to syringes 200C and 200P. In this example, liquid medicine circuit A230 has a one-way valve A240 disposed in a circuit portion connected to syringe A200C containing contrast medium, and another one-way valve A250 disposed in a circuit portion connected to syringe A200P containing physiological saline. [Prior art documents] [Patent documents]

[0005] [Patent Document 1] Patent No. 5800713 Summary of the Invention [Problem to be solved by the invention]

[0006] Although not shown in the drawings, the mechanism of drug solution injection in a drug solution circuit in which a one-way valve is arranged as described above is as follows. First, in the initial state, the valve disc of the one-way valve is in a predetermined closed position (or has a predetermined initial shape), thereby blocking the circuit. From this state, when the piston drive mechanism is operated to push the piston member of the syringe, the pressure of the drug solution in the syringe increases. Then, when the pressure of the drug solution increases to a certain level, the valve disc of the one-way valve moves to an open position (or deforms into a predetermined shape) and enters an open state. The drug solution in the syringe then flows through the one-way valve to the patient side.

[0007] In order to change the valve from a closed state to an open state in this series of operations, a certain amount of pressure must be applied to the valve element, and smooth opening of the one-way valve is important for achieving responsive drug injection. Furthermore, the same problem can arise not only when a one-way valve is provided, but also when, for example, a relatively slight kink occurs in the tubing of the circuit, and the kink disappears when a certain amount of pressure is applied.

[0008] SUMMARY OF THE INVENTION It is therefore an object of the present invention to provide a chemical liquid injector that can prevent injection delays caused by the operation of a one-way valve in a chemical liquid circuit or kinks in the chemical liquid circuit. [Means for solving the problem]

[0009] In order to achieve the above object, a chemical liquid injector according to one aspect of the present invention is as follows: a: a drive mechanism that applies pressure to the chemical solution in the container to push out the chemical solution; b: a control unit for setting the operating conditions; A chemical liquid injector comprising: The control unit a main injection condition determination unit that determines the injection conditions for the main injection; a preliminary injection operation condition determination unit that determines an injection condition for the preliminary injection operation, The liquid medicine injector is configured so that, during liquid medicine injection, the preliminary injection operation and the main injection are performed consecutively in this order.

[0010] (Definition of terms) A "medicinal solution circuit" refers to a flow path for a medicinal solution connected to a syringe for injecting the medicinal solution into a subject's blood vessel. The medicinal solution circuit includes at least one tube through which the medicinal solution flows and various components attached to the tube. The medicinal solution circuit may include a catheter inserted into the subject's blood vessel or an indwelling needle inserted into the subject's blood vessel. When multiple medicinal solutions can be injected, the medicinal solution circuit may be configured with multiple tubes, with the distal end opposite the distal end connected to the catheter or indwelling needle branching into multiple branches. Depending on the configuration during use, the medicinal solution circuit can be classified into an "extracorporeal circuit portion," which is located entirely outside the subject's body, and an "internal circuit portion," which is located at least partially inside the body. According to this classification, the catheter or indwelling needle belongs to the internal circuit portion, and the other components belong to the external circuit portion. Therefore, the "medicinal solution circuit" can be said to include at least the external circuit portion of the internal and external circuit portions.

[0011] Specific examples of "contrast media" include: (i) contrast media with an iodine concentration of 240 mg / ml (e.g., viscosity 3.3 mPa·s, specific gravity 1.268-1.296 at 37°C), (ii) contrast media with an iodine concentration of 300 mg / ml (e.g., viscosity 6.1 mPa·s, specific gravity 1.335-1.371 at 37°C), (iii) contrast media with an iodine concentration of 350 mg / ml (e.g., viscosity 10.6 mPa·s, specific gravity 1.392-1.433 at 37°C), etc. Contrast media with iodine concentrations of 370 mg / ml or higher can also be used. A specific example of saline solution is saline solution containing 180 mg of sodium chloride in 20 mL of saline solution (for example, viscosity 0.9595 mPa·s at 20°C, specific gravity 1.004-1.006).

[0012] An "injection protocol" indicates what type of medicinal liquid is to be injected, in what amount, and at what speed. The "injection rate" may be constant or may change over time. When multiple types of medicinal liquids, such as a contrast medium and saline, are to be injected, the injection protocol also includes information such as the order in which these medicinal liquids are to be injected. Any known injection protocol can be used as the injection protocol. Known procedures can also be used for creating injection protocols. An injection protocol may also include a maximum allowable injection pressure (pressure limit). If a pressure limit is set, the injection pressure is monitored during the injection operation, and the operation of the piston drive mechanism is controlled so that the injection pressure does not exceed the set pressure limit.

[0013] The "driving mechanism" may be, for example, a piston driving mechanism that pushes out a liquid medicine from a syringe, or a pump mechanism that pushes out a liquid medicine contained in a container such as a liquid medicine bag or bottle. A "control unit" is a device that has one or more processors and performs computations, and may be a standalone device or part of another device. [Effects of the Invention]

[0014] According to the present invention, it is possible to provide a chemical liquid injector and the like that can prevent the occurrence of injection delays due to the operation of a one-way valve in a chemical liquid circuit or kinks occurring in the chemical liquid circuit. [Brief explanation of the drawings]

[0015] [Figure 1] 1 is a perspective view showing the appearance of a chemical liquid injector according to an embodiment of the present invention; [Figure 2] FIG. 2 is a perspective view showing the injection head shown in FIG. 1 together with a syringe and other components attached thereto. [Figure 3] 1 is a block diagram of a system according to one embodiment of the present invention. [Figure 4] FIG. 2 is a diagram showing one embodiment of the chemical liquid circuit shown in FIG. [Figure 5] FIG. 2 is a schematic diagram of an example of a mixing device that can be provided in a chemical liquid circuit. [Figure 6] FIG. 6 is a perspective view of the mixing device shown in FIG. 5. [Figure 7] FIG. 6 is a cross-sectional view of the mixing device shown in FIG. 5. [Figure 8] FIG. 10 is a diagram showing injection control in which a preliminary injection operation is performed before the main injection. [Figure 9] FIG. 2 is a diagram showing functional parts (units) that a control unit may have. [Figure 10] FIG. 10 is a diagram showing an example of a preparatory injection operation in the case of simultaneous injection. [Figure 11] 10 is a table showing an example of a mixing ratio of a contrast medium and physiological saline. [Figure 12] FIG. 10 is a diagram showing an example of conditions for the injection preparatory operation phase. [Figure 13] FIG. 10 is a diagram showing another example of conditions for the injection preparatory operation phase. [Figure 14] FIG. 1 is a diagram illustrating an example of a conventional configuration. DETAILED DESCRIPTION OF THE INVENTION

[0016] Hereinafter, one embodiment of the present invention will be described with reference to the drawings. Note that, although the following example will be described using a so-called two-cylinder injection head, the present invention is not limited to this.

[0017] [Chemical Liquid Injection Device and System] Liquid injector 100 shown in Fig. 1 is an angiography device used in angiography examinations. Liquid injector 100 includes an injection head 110, a console 112, and a main unit 114. Liquid injector 100 is used as part of a system such as that shown in Fig. 3. The system shown in Fig. 3 includes liquid injector 100, a liquid circuit 200 connected to liquid injector 100, and an imaging device 500.

[0018] (injection head) 1, injection head 110 and console 112 are connected to main unit 114. Injection head 110 and console 112 are configured to be able to send and receive predetermined information to and from each other. In this example, injection head 110 is rotatably supported on the upper part of stand 116. In another embodiment (not shown), injection head 110 may be supported on a swivel arm fixed to the ceiling.

[0019] Specifically, the injection head 110 may have a configuration as shown in Figure 2. That is, in this example, the injection head 110 is provided with a pair of piston drive mechanisms 130a, 130b (see also Figure 3). Each piston drive mechanism 130a, 130b is driven independently to advance and retract a piston 322 of a syringe 320 (the syringe will be described in detail later).

[0020] 2, each of the piston drive mechanisms 130a and 130b (see FIG. 3) has a ram member 131 and also has a drive source (not shown) such as a motor that moves the ram member 131 forward and backward. The ram member 131 is configured to hold a protrusion (described in detail below) formed on the end of the piston 322.

[0021] Here, syringe 320 and protective cover 370 will be described (see FIG. 2). Syringe 320 is generally called a rodless syringe, and has cylinder 321 and piston 322. Cylinder 321 has nozzle portion 321b formed at its tip. Also, flange 321a is formed at its end. Piston 322 is inserted into cylinder 321 so as to be able to move back and forth, and a convex portion (not shown) is formed at its end which is held (or locked) by part of the piston drive mechanism.

[0022] Protective cover 370 is attached to syringe 320 so as to cover syringe 320. Syringe 320 is attached to injection head 110 while inserted into protective cover 370. Protective cover 370 is a member having a substantially cylindrical shape as a whole. Protective cover 370 has an inner diameter dimension such that when cylinder 321 is inserted, there is almost no gap between it and the outer peripheral surface of cylinder 321.

[0023] An opening is formed at the tip of protective cover 370, through which nozzle portion 321b of syringe 320 passes. Syringe 320 is held with nozzle portion 321b protruding from this opening. A cover flange 371 is formed at the end of protective cover 370. A recess (not shown) is formed in the end face of cover flange 371, which is shaped like a contour to receive flange 321a of cylinder 321.

[0024] Contrast media have a relatively high viscosity, and catheters used in angiography generally have an extremely thin inner diameter of less than 1 mm (for example). Therefore, when a drug solution is injected, a very high internal pressure is generated in cylinder 321. Protective cover 370 serves to prevent expansion, deformation, and rupture of cylinder 321. Therefore, protective cover 370 is preferably formed from a material and with a thickness strong enough to withstand the internal pressure acting on cylinder 321 during injection of the drug solution.

[0025] Although protective cover 370 is used in the above embodiment, syringe 320 may be directly attached to injection head 110.

[0026] Referring again to Figure 2, syringe receiver 120 and clamper 140 are provided at the tip of injection head 110. Syringe receiver 120 is a syringe mounting portion on which syringe 320 fitted with protective cover 370 is placed. Syringe receiver 120 is located closer to the tip than clamper 140 and has two recesses 121 for individually receiving the outer circumferential surfaces of protective covers 370. Clamper 140 is supported so as to be able to open and close relative to syringe receiver 120, and individually holds cover flange 371 of each protective cover 370.

[0027] Each syringe 320 is set in recess 121 with nozzle portion 321b facing the tip side, and is fixed to injection head 110 by closing clamper 140.

[0028] The shape of the housing (exterior cover) of injection head 110 is not particularly limited. As an example, it may be exterior cover 125 that covers the entire mechanism except for the portion containing syringe receiver 120 and clamper 140. Exterior cover 125 may be provided with various buttons 123, light-emitting unit 126, etc. Exterior cover 125 may have markers 125a at positions corresponding to each ram member 131 to distinguish the corresponding ram member 131. The markers 125a may be any letters or symbols, and in this embodiment, the letters "A" and "B" are used.

[0029] (Chemical solution circuit) Next, the liquid medicine circuit 200 will be described with reference to Fig. 4 etc. The liquid medicine circuit 200 forms a liquid path connecting the syringe and the subject.

[0030] Liquid medicine circuit 200 may include at least one tube, at least one connector, and, if necessary, a flow rate sensor. Specifically, liquid medicine circuit 200 may include tubes 201, 202, and 203 and a connector 204 connecting them, as shown in Figure 4. This circuit as a whole has a configuration in which two liquid paths merge into one midway.

[0031] Tubes 202 and 203 have connectors 205 and 206 at their ends, respectively, for connection to syringe 320 (see FIG. 2). Tube 201 has connector 207 at its end for connection to a catheter or the like (internal circuit portion). Medical solution circuit 200 may further include an internal circuit portion such as a catheter or an indwelling needle. The catheter or the indwelling needle may be connected via connector 207.

[0032] At least one of connectors 205, 206 connected to first tubes 202, 203, respectively, may be equipped with a one-way valve. The one-way valve has a valve element that is actuated by back pressure of the liquid to close the flow path, and serves to prevent backflow of liquid from the side of liquid medicine circuit 200 to which a catheter or the like is connected to the side to which a syringe is connected. Although not necessarily limited thereto, in this embodiment, it is assumed that the valve element of the one-way valve is initially in a predetermined closed position (or has a predetermined initial shape), thereby closing the circuit. Note that a liquid medicine circuit without a one-way valve may also be used.

[0033] The liquid medicine circuit 200 may further include a flow rate sensor 210. Although not described in detail, the flow rate sensor 210 may include a conduit and output an electrical signal corresponding to the movement of a liquid (liquid medicine) within the conduit. Based on this output signal, for example, the liquid medicine injector 100 detects the flow rate of the liquid medicine in real time. The liquid medicine injector 100 may be configured to use the detection results to determine various items related to the liquid medicine and the liquid medicine injector.

[0034] (Mixing Device) In the chemical liquid circuit 200 of Figure 4, a general connector 204 is disposed at the junction. However, a mixing device 241 as shown in Figures 5 to 7 may be provided instead of this connector 204. The mixing device 241 includes a main body 242 having a first chamber which is a swirling flow generating chamber 242a that generates a swirling flow, and a second chamber which is a narrow chamber 242b that concentrates the swirling flow in the axial direction.

[0035] In this example, the swirl flow generating chamber 242a has a cylindrical internal space, and the narrow chamber 242b has a conical internal space coaxial with the swirl flow generating chamber 242a. The cross-sectional shape of the swirl flow generating chamber in the short direction can be a circle, an ellipse, or any other shape formed from a curve. The swirl flow generating chamber may also have a narrowing shape that tapers toward the narrow chamber.

[0036] Conduit section 243a, to which one tube 202 (see FIG. 2, etc.) is connected, is provided on the upstream side in the flow direction of main body section 242 of mixing device 241, and conduit section 243c, to which tube 201 (see FIG. 2, etc.) is connected, is provided on the downstream side. Conduit section 243b, to which tube 203 (see FIG. 2, etc.) is connected, is located at a position (side wall section) slightly upstream from the center of swirl flow generating chamber 242a.

[0037] In this example, the contrast medium flows in through conduit 243a and the saline solution flows in through conduit 243b, and the two liquids are mixed in the mixing device. Thereafter, the mixed liquid of the contrast medium and the saline solution flows out from conduit 243c, which serves as a liquid outlet.

[0038] Conduit section 243a, into which the chemical liquid with a relatively high specific gravity flows, is located upstream in the flow direction, in the center of the upstream wall of swirl flow generating chamber 242a. Conduit section 243c, which serves as a liquid outlet, is located so that the center line of conduit section 243c coincides with the center line of conduit section 243a (i.e., so that the two are coaxial). By arranging each section so that they are coaxial, the isotropy of the vortex generated within the mixing device can be improved. In other words, vortices can be generated uniformly within the space without stagnation, improving mixing efficiency.

[0039] On the other hand, conduit section 243b, into which the chemical liquid having a relatively low specific gravity flows, is disposed on the side surface of swirling flow generating chamber 242a and extends in the tangential direction to the circumference of swirling flow generating chamber 242a, which has a circular cross section. In other words, conduit section 243b is disposed at a position shifted toward the periphery from the central axis of the cylindrical space of swirling flow generating chamber 242a, thereby generating a swirling flow of the chemical liquid having a low specific gravity that flows in from conduit section 243b.

[0040] 7, flow path 241fb is configured to extend in the circumferential tangent direction of the curved inner surface of swirl flow generating chamber 242a, so that the chemical solution flowing in from this flow path becomes a swirling flow. Furthermore, as is clear from the drawing, narrow chamber 242b has an inner surface that is inclined and narrows toward the downstream side in the flow direction, so that the generated swirling flow is concentrated in the direction of the central axis of the vortex.

[0041] Conduit 243a, through which the contrast medium flows, is connected to swirl flow generating chamber 242a via flow path 241fa. This allows the medicinal liquid with a higher specific gravity to be introduced into the swirl flow generating chamber in a direction parallel to the central axis of the swirl flow of the medicinal liquid with a lower specific gravity. In other words, the medicinal liquid with a higher specific gravity is introduced in a direction parallel to the central axis of the cylindrical space of the swirl flow generating chamber. Conduit 243a, through which the physiological saline solution flows, is connected to the swirl flow generating chamber via flow path 241fb.

[0042] For example, the inner diameter of flow path 241fb may be smaller than the inner diameter of flow path 241fa into which the contrast medium flows. With this configuration, when a medicinal liquid is injected at a predetermined pressure, the flow rate of the medicinal liquid with a low specific gravity flowing through flow path 241fb, which has a relatively small cross-sectional area, is faster than the flow rate of the medicinal liquid with a high specific gravity. Therefore, it is possible to prevent and suppress a decrease in the mixing efficiency of the medicinal liquids due to attenuation of the inertial force of the swirling flow and the resulting lack of swirling strength, which may occur when the flow rate of the medicinal liquid with a low specific gravity is slow.

[0043] In the mixing device 241 configured as described above, for example, when contrast medium and saline solution are introduced into the device, the contrast medium flows from the flow path 241fa into the swirling flow generating chamber and flows downstream in the axial direction. On the other hand, the saline solution flows from the flow path 241fb into the swirling flow generating chamber and forms a swirling flow that swirls along the curved inner surface of the chamber. The swirling flow of saline solution is then guided into the narrow chamber and concentrates in the direction of the central axis of the swirling flow. This type of vortex is known as a Rankine vortex, and it is possible to concentrate the inertial force of the swirling flow near the axis of rotation of the vortex.

[0044] When two liquid medications are simultaneously injected using a liquid medication circuit having such mixing device 241, the two liquid medications are mixed well. That is, in this example, a diluted contrast medium in which the contrast medium and the physiological saline are mixed well can be obtained, and a superior contrast effect can be expected compared to a general liquid medication circuit having a connector at the liquid medication mixing section.

[0045] (Console and main unit) Console 112 and other components of liquid injector 100 will be described with reference to Figures 1 and 3 again. Console 112 is configured as a device including input unit 103 and display device 104 (see Figure 3), for example. In one form, console 112 has a touch panel display, which corresponds to input unit 103 and display device 104 described above.

[0046] Main unit 114 has a power supply (not shown) that supplies power to injection head 110 and console 112. Injection control unit 101 shown in FIG. 3 may be located within main unit 114 or within console 112. Alternatively, some of the functions may be provided in console 112, and other functions may be provided in injection head 110.

[0047] (switch) Liquid injector 100 may optionally further include hand switch 118 and / or foot switch 119. Hand switch 118 has an operation button and may be used to control the start and stop of an injection operation so that injection head 110 injects liquid only while the operation button is pressed. Hand switch 118 may be a variable hand switch having an operation button for inputting multiple or continuously changing values, and the injection rate may be changed by operating this switch. Foot switch 119 may be used to control the start and stop of an injection operation so that injection head 110 injects liquid only while foot switch 119 is pressed, for example, when performing a test injection.

[0048] (Configuration related to the operation of the injection head, etc.) The control unit 101 performs the following operations, for example: - setting injection conditions (main injection conditions) such as the injection amount and injection speed of the medicinal liquid using at least a part of the data input from the input unit 103; - controlling the operation of the piston drive mechanisms 130a and 130b so that the medicinal liquid is injected from the syringe according to the determined injection conditions; - Controlling the display of the display device 104; -Determine the injection conditions for the "pre-injection operation" described later in detail, etc.

[0049] The injection control unit 101 may be configured to include a so-called computer, and has a CPU, ROM, RAM, and interfaces with other devices. A computer program is installed in the ROM. The CPU controls the operation of each part of the liquid injector by executing various functions in accordance with the computer program. The injection control unit 101 may have a graphical user interface for setting injection conditions (i.e., a function for displaying a GUI on a display device). GUI data is stored in a predetermined memory area.

[0050] Input unit 103 is used to input data used to determine the injection conditions of the medicinal liquid in injection control unit 101. Input unit 103 may be, for example, a device such as a keyboard and / or a mouse. Data input from input unit 103 is transmitted to injection control unit 101, and data displayed on display device 104 is transmitted from injection control unit 101.

[0051] Display device 104 is controlled by injection control unit 101 and displays data necessary for determining the injection conditions of the medicinal liquid, the injection protocol, the injection operation, various warnings, etc. Display device 104 may be a known display device such as a liquid crystal display device.

[0052] (imaging device) 3, imaging device 500 includes imaging operation unit 520 that performs imaging operation, and imaging control unit 510 that controls the operation of imaging operation unit 520. Imaging device 500 can acquire medical images including tomographic images and / or three-dimensional images of a subject into whom a liquid has been injected by liquid injector 100.

[0053] The imaging operation unit 520 typically includes a bed for the subject, an electromagnetic wave irradiation unit for irradiating electromagnetic waves into a predetermined space above the bed, etc. The imaging control unit 510 controls the operation of the entire medical imaging apparatus, such as determining imaging conditions and controlling the operation of the imaging operation unit 520 according to the determined imaging conditions.

[0054] The imaging control unit 510 can be configured to include a so-called computer, and may have a CPU, ROM, RAM, and an interface with other devices. The ROM has a computer program installed therein for controlling the medical imaging apparatus 500. The CPU controls the operation of each part of the medical imaging apparatus 500 by executing various functions in accordance with the computer program.

[0055] The liquid injector 100 and the medical imaging device 500 may be connected to each other so as to transmit and receive data therebetween, and the connection between them may be wired or wireless.

[0056] The medical image capturing apparatus 500 may further include a display unit 504 such as a liquid crystal display for displaying the imaging conditions, acquired medical images, etc., and an input unit 503 such as a keyboard and / or a mouse for inputting the imaging conditions, etc. At least a part of the data used to determine the imaging conditions is input from the input unit 503 and transmitted to the imaging control unit 510.

[0057] The data displayed on the display unit 504 is transmitted from the imaging control unit 510. A touch panel having a touch screen arranged as an input unit on the display of the display unit can also be used as the input unit 503 and the display unit 504. A part of the input unit 503, the display unit 504, and the imaging control unit 510 may be incorporated into a single housing as a console for a medical imaging device.

[0058] (Chemical Solution Injection Operation in This Embodiment) Hereinafter, the operation of injecting chemical liquid in this embodiment will be described with reference to FIGS.

[0059] As shown in Fig. 8, the liquid medicine injection of this embodiment is configured to first perform a preliminary injection phase Ph-i, followed by a main injection phase Ph-ii. The preliminary injection phase Ph-i is an injection phase aimed at opening the one-way valve or eliminating kinks. The main injection phase Ph-ii is a phase in which the liquid medicine is injected under conditions set as an injection protocol according to the subject's physical information, the region to be imaged, etc.

[0060] The duration of the preparatory injection operation phase Ph-i is set to a very short time. For example, in one embodiment, the injection time is preferably 2.0 seconds or less, 1.5 seconds or less, or 1.0 seconds or less. In another embodiment, the injection time is preferably at least 0.3 seconds or more, or 0.5 seconds or more. Specifically, the range of the injection time of the preparatory injection operation may be 0.5 seconds to 2.0 seconds, or 0.7 seconds to 1.5 seconds or less (a to b means a or more and b or less).

[0061] During the pre-infusion phase, the infusion rate may be constant, preferably 2.0 ml / sec or greater, 3.0 ml / sec or greater, 4.0 ml / sec or greater, or 5.0 ml / sec or greater.

[0062] In relation to the main injection, the speed of the pre-injection operation is set higher than the speed of the main injection, and the injection time is set shorter than the time of the main injection.

[0063] The detailed conditions for the preparatory injection operation depend on the material and size of the syringe, the remaining amount of medicinal liquid, the catheter diameter (e.g., 2.1 Fr, 2.5 Fr, etc.), the type of medicinal liquid, etc. However, when injecting medicinal liquid using, for example, a microcatheter (here, this refers to one of 2.5 Fr or less), the realistic injection speed and injection amount are somewhat limited. Therefore, it is preferable to automatically determine the conditions for the preparatory injection operation (injection time, injection amount) from prepared coefficients, a predetermined formula, or a table.

[0064] The injection rate of the preliminary injection operation can be calculated using the following formula, for example: y a =ax+by+c where: y a : Injection speed of preliminary injection operation x: Set injection speed for this injection y: remaining syringe amount a, b, c: constant

[0065] The injection speed of the preliminary injection (y a For example, the correspondence may be such that when the main injection rate is 1.0 ml / sec, the preparatory injection rate is 3.0 ml / sec, when the main injection rate is 2.0 ml / sec, the preparatory injection rate is 4.0 ml / sec, and when the main injection rate is 3.0 ml / sec, the preparatory injection rate is 5.0 ml / sec.

[0066] The injection amount of the preliminary injection operation can be calculated, for example, by the following formula: y b =(k·z+c b )×x+(k b z+c b ) where: y b : Injection amount of preliminary injection x: Set injection speed z: Remaining syringe amount k b : Coefficient (positive number, e.g., 0.005 to 0.020) c b : Constant (positive number, e.g., 0.3 to 0.5)

[0067] In each of the above calculations, the parameter values ​​may be determined appropriately, taking into consideration the amount of iodine in the contrast medium, its concentration (viscosity), the size of the catheter, etc. In the case of a two-barrel syringe (described in detail later), the injection amount may be calculated using the same calculation formula for both syringes. However, this is not limiting, and the injection amount may be calculated using different calculation formulas and different parameters.

[0068] Regarding the correction of the calculation formula, it is also preferable that, for example, information such as the density of the image obtained as a result of contrast (contrast image) is acquired, and the calculation formula is corrected based on that information to obtain a more appropriate contrast effect. For example, if the contrast is denser than a predetermined standard, the calculation formula is corrected to weaken the contrast effect. Conversely, if the contrast is too faint compared to the predetermined standard, the calculation formula is corrected to increase the contrast effect. The injection results and contrast image may be stored in a storage area of ​​a predetermined server, etc., and the above-mentioned corrections may be made based on that.

[0069] In the example of Figure 8, the injection preparatory operation phase Ph-i has an injection speed of 3.0 ml / sec and an injection volume of 4.0 ml (hence the injection time is approximately 1.3 seconds). The injection control of Figure 8 is as if the injection preparatory operation phase Ph-i was inserted before the main injection phase Ph-ii. The main injection is performed immediately after the injection preparatory operation (without any gap).

[0070] As described above, according to the injection control of this embodiment, which includes the preliminary injection phase Ph-i before the main injection phase Ph-ii, the ram advances faster and for a shorter period of time during the preliminary injection phase than during the main injection, and the increased pressure of the liquid chemical causes the one-way valve to open smoothly, enabling excellent liquid chemical injection with good response. Furthermore, if a slight kink occurs, it can also be used to help resolve the kink.

[0071] (Control unit) The device that performs the process for setting the conditions for the injection preparation phase is not particularly limited, and may be injection head 110, console 112, or a device housed in another device. As shown in Figure 9, injection control unit 101 may include setting screen display unit 101a, injection protocol creation unit 101b, and injection control unit 101c.

[0072] Here, the injection protocol creation unit 101b may be configured to include a "main injection condition setting unit" and a "pre-injection operation condition setting unit." The main injection condition setting unit determines the injection conditions for the main injection. The main injection condition setting unit determines the injection conditions for the pre-injection operation. In this case, the conditions may be set using parameters of the injection conditions for the main injection and a pre-prepared calculation formula, as described above. In FIG. 9, the pre-injection operation condition setting unit is included in the injection protocol creation unit as an example, but it may also be included in the injection control unit 101c. The setting screen display unit 101a corresponds to a function such as displaying a graphical user interface for condition setting. The injection control unit 101c corresponds to a function such as advancing the ram member in accordance with the set injection conditions and the corresponding automatically determined operation conditions for the pre-injection operation.

[0073] The automatically determined conditions for the preparatory injection operation can be represented as a graph, as shown in Fig. 8, for example, but this content does not necessarily have to be displayed on a display or the like. That is, a liquid injector according to one embodiment of the present invention may be configured so that, as long as the operator determines the conditions for the main injection phase, the liquid injector automatically creates an appropriate preparatory injection operation and performs the preparatory injection operation prior to the main injection phase. This allows the operator to perform the examination without being aware of the preparatory injection operation.

[0074] To set the conditions for the preliminary injection operation, predetermined coefficients and / or calculation formulas, etc. may be prepared in advance, and the conditions may be automatically determined by, for example, referring to a table, etc. Parameters that may be taken into consideration include the shape of the syringe (diameter, stroke, etc.), the shape of the needle and / or catheter (diameter, length, etc.), the remaining amount of medicinal liquid (current position of the ram member), the type and physical properties of the medicinal liquid, and the elastic properties of the syringe and / or protective cover.

[0075] Various pieces of information for determining conditions (e.g., information about the syringe itself and / or the liquid medicine in the syringe, information about the subject, etc.) may be input in various other ways. For example, information may be read and input from an information recording medium such as an RFID tag (IC tag). This information storage medium may be provided on the syringe and / or protective cover, or on other accessories or parts of the liquid medicine injector. A device for reading information from the information storage medium may be, for example, an RFID tag (IC tag) reader, which may be provided on the injection head, for example. Furthermore, the information storage medium may be provided on another device, or may be provided as a standalone device. An information storage medium such as a barcode may also be used instead of or in combination with the information storage medium. In this case, a barcode reader is provided, and barcode information is read by the reader.

[0076] 8 shows only one phase of the main injection at 1.0 ml / sec for 10 seconds, but the present invention is not necessarily limited to this single phase. For example, the above phase may be followed by a predetermined hold state, and then the next phase (injection at a constant rate for a predetermined period of time) may be performed once or repeatedly.

[0077] (In case of diluted injection) With a two-barrel injection head such as that shown in Figure 2, a first medicinal liquid and a second medicinal liquid may be simultaneously injected (diluted injection). For example, two contrast agents with different concentrations may be injected, or saline and contrast agent may be mixed at a predetermined ratio and injected. The mixing ratio is not limited to 5:5, but may be 4:6, 3:7, etc., or in some cases 1:9 (1 part contrast agent to 9 parts saline) or 9:1, etc.

[0078] When physiological saline and contrast medium are mixed and injected, the difference in specific gravity between the two liquids makes it difficult for them to mix. Therefore, using the aforementioned mixing device is useful in one embodiment. If there is a delay in injection due to the operation of a one-way valve or the occurrence of a kink, the time until the desired mixed state is achieved may also be somewhat delayed. Note that the above issue is also a problem not only with the mixing device disclosed in this application, but also with circuits that simply merge and mix two liquids.

[0079] Therefore, in this embodiment, even when the first and second chemical liquids are simultaneously injected, the injection preparatory operation phase as described in the above embodiment is included in the injection conditions. As a specific example, as shown in Figure 10, an injection preparatory operation phase Ph-i is set immediately before a main injection phase Ph-ii.

[0080] In this example, the contrast medium and saline are mixed at a ratio of 14%:86%. The injection conditions (injection rate, injection volume) are as follows: Contrast medium 0.14ml / sec, 4.2ml Saline 0.86ml / sec, 25.8ml

[0081] Meanwhile, in this example, the injection conditions for the preparatory injection operation are the same for the contrast medium and the saline solution, e.g., 2.5 ml / sec and 3.0 ml, respectively. The injection conditions for the preparatory injection operation for simultaneous injection can also be automatically determined using the above-mentioned formulas. Note that, depending on the remaining volume of the syringe, the conditions for the preparatory injection operation may be set to different conditions for the contrast medium and the saline solution.

[0082] By controlling the injection in this way, the medicinal liquids can be mixed well within the mixing device (or a regular connector). As a result, even in an examination such as angiography, where a relatively small amount of medicinal liquid is injected, it is possible to deliver medicinal liquids mixed at a ratio close to the set ratio to the target site. This makes it easier to achieve the desired contrast effect during angiography examinations.

[0083] In the case of a two-cylinder type, the following explanation is provided regarding handling when the conditions for the preparatory injection operation differ between the first and second chemical liquids. For example, when the remaining amount of the first chemical liquid is relatively small and the remaining amount of the second chemical liquid is relatively large, it is conceivable that the operation time for the preparatory injection operation for the first chemical liquid will be short (e.g., 0.5 seconds) and the operation time for the preparatory injection operation for the second chemical liquid will be long (e.g., 1.5 seconds).

[0084] In such a case, it is preferable to perform subsequent liquid drug injections based on the preliminary injection operation with the shorter injection time. In other words, in the above example, after the "0.5-second" preliminary injection operation is completed, the set first and second liquid drug injections are performed simultaneously. In this way, by controlling the operation timing according to the operating conditions of the shorter operation and then performing the subsequent first and second injections, the simultaneous injection of the first and second liquid drug can be performed satisfactorily under the desired conditions.

[0085] (Other examples of operation) Regarding the preparatory injection operation for simultaneous injection, for example, the conditions for the preparatory injection operation phase for each liquid may be set in consideration of the ease of mixing of the first liquid (here, a contrast medium) and the second liquid (here, physiological saline). Note that the processing described below can be applied when the remaining amounts of liquid in both syringes are approximately the same, and can also be applied when the remaining amounts are different.

[0086] Specific examples will be described below with reference to Figures 11 to 13. As shown in Figure 11, for example, when the contrast agent and saline solution are mixed in a ratio of 90:10 to 70:30 (when the contrast agent ratio is relatively high), it is expected that it will take longer for the two medicinal solutions to mix than when the ratio is 50:50. Although this depends on the tubes and connectors used, the viscosity of the contrast agent, etc., the reason for this is that the injection rate of the contrast agent is faster than that of the saline solution, and the injection volume is greater than that of the saline solution.

[0087] To address this, in one embodiment of the present invention, as shown in Fig. 12, the conditions for the preliminary injection of the contrast medium may be changed so that, for example, the speed is reduced from v0 (the same as the speed for the preliminary injection of saline) to v1. While the specific numerical value is not particularly limited, for example, the speed v1 may be set to 90% or less of the speed v0. Meanwhile, in one embodiment, it is preferable that the injection time be the same.

[0088] By setting such conditions, even when a contrast medium is mixed and injected at a relatively high ratio, it is possible to smoothly mix the two medicinal liquids.

[0089] In the above, only the conditions for the contrast agent were changed, but other processing such as (i) increasing the velocity of the saline solution without changing the velocity of the contrast agent, or (ii) increasing the velocity of the saline solution while decreasing the velocity of the contrast agent, may also be performed. Furthermore, in the above explanation, the velocity of the preliminary injection of the contrast agent and the velocity of the preliminary injection of the saline solution are calculated in advance (velocity v0), and the velocity is changed based on this, but this is not necessarily limited to this. A velocity equivalent to v1 may also be calculated directly using a formula or table.

[0090] In the above example, the injection time of the pre-injection operation is the same for both the contrast agent and the saline solution, and only the injection rate is changed. However, in one embodiment of the present invention, the injection time may be changed while the injection rate is the same, or both the injection rate and the injection time may be changed. Furthermore, in the above example, the velocity of the contrast agent is changed to be relatively slower than that of the saline solution, but conversely, the velocity of the saline solution may be controlled to be relatively faster than that of the contrast agent.

[0091] For example, as shown in FIG. 13, after the start of the preliminary injection of physiological saline, a predetermined delay (time t s The preliminary injection of the contrast agent may be started after a certain time (the time between t0 and t1). By slightly extending the injection time of the saline solution, the effect of the preliminary injection is enhanced, and as a result, even when the contrast agent and the saline solution are injected at a ratio of, for example, 90:10 to 70:30 (contrast agent:saline), the contrast agent and the saline solution can be mixed well. Even in this case, it is preferable that the timing (t1) of the transition to the main injection is the same for both the contrast agent and the saline solution. While the above description is of an example in which the injection of the contrast agent is started after the injection of the saline solution, the injection of the saline solution may be started conversely after the injection of the contrast agent.

[0092] The technical concepts disclosed above can be used in appropriate combinations. Furthermore, while the above embodiments have been described using a liquid injector for angiography examination, the technical concepts of the present invention may also be applied to a liquid injector for CT examination. A configuration for CT examination does not require as high a pressure as angiography examination, and an injection head with a relatively low motor output for the piston drive mechanism is used. Furthermore, a protective cover for the syringe is generally not used.

[0093] The chemical liquid injector of the present invention may also have the following functions: (1) Preparatory action execution mode Whether the actual injection is performed after the "preparatory injection phase" or without the "preparatory injection phase" depends on the technique of the contrast examination and the syringe and drug solution used. For example, in angiography examinations, particularly when a microcatheter is used, it is preferable that the "preparatory injection phase" be performed automatically. Note that such a mode may be referred to as a "microcatheter mode," for example.

[0094] To implement this function, for example, the liquid injector 100 (see FIG. 1) may provide a user interface (e.g., a graphical user interface) that accepts input from the user. Specifically, the user inputs to the console 112 to select the "automatic preparatory operation execution mode." This input may be, for example, the selection of an icon (or the pressing of a physical button). The liquid injector 100 then operates to perform the "preparatory injection phase" and start the actual injection.

[0095] The liquid injector 100 may also be configured to input information about the diameter of the catheter to be used (e.g., French number). The input French number may be used as a parameter to determine the conditions for the preliminary injection operation. The information can be input in various ways, such as through a touch panel display, by voice, or by gesture input using body movements. The input information may also include one or more of the manufacturer information, model number information, length information, etc. of the liquid circuit.

[0096] (Addendum) This application discloses the following inventions. Note that the reference symbols in parentheses are provided for reference purposes only and are not intended to limit the present invention: 1.a: A drive mechanism (130) that applies pressure to the chemical solution in the container to push out the chemical solution; b: a control unit (101) for setting its operating conditions; A chemical liquid injector comprising: The control unit a main injection condition determination unit that determines the injection conditions for the main injection; a preliminary injection operation condition determination unit that determines an injection condition for the preliminary injection operation, The liquid medicine injector is configured so that, during liquid medicine injection, the preliminary injection operation and the main injection are performed consecutively in this order.

[0097] 2. The injection speed of the liquid medicine in the preliminary injection operation is faster than the injection speed of the liquid medicine in the main injection.

[0098] 3. The injection time of the liquid medicine in the preliminary injection operation is shorter than the injection rate of the liquid medicine in the main injection.

[0099] 4. The control unit (101) is configured to automatically set at least one parameter of the injection rate and injection amount of the preliminary injection operation based on the parameter of the injection condition of the main injection.

[0100] 5. The control unit (101) is configured to automatically set both the injection speed and injection amount parameters of the preliminary injection operation based on the parameters of the injection conditions of the main injection.

[0101] 6. The main injection includes a phase in which the injection is performed at a constant injection rate for a predetermined injection period.

[0102] 7. The drive mechanism (130) includes a first piston drive mechanism (130a) that is provided in the injection head and moves the piston member of a first syringe filled with a first contrast agent, and a second piston drive mechanism (130b) that is provided in the injection head and moves the piston member of a second syringe filled with a second contrast agent or physiological saline.

[0103] 8. Further, a liquid medicine circuit connected to the first and second syringes is provided, The liquid medicine circuit includes a first liquid path connected to a first syringe; The syringe has a second liquid path connected to a second syringe, a connector provided where the first and second liquid paths join, and a third liquid path extending from the connector.

[0104] 9. The connector is a mixing device that generates a swirling flow to mix the liquids.

[0105] 10. The control unit (101) Injection conditions for the preliminary injection operation by the first piston drive mechanism; Injection conditions for the preliminary injection operation by the second piston drive mechanism; is configured to set

[0106] 11. When the operation time of one preparatory injection operation differs from the operation time of the other preparatory injection operation, the operation timing of the first and second piston drive mechanisms is controlled to match the shorter operation time.

[0107] 12. Further, the apparatus includes one or more display devices, and the control unit does not cause the one or more display devices to display the injection conditions of the preliminary injection operation.

[0108] 13. A method for controlling a liquid medicine injector including a drive mechanism that applies pressure to a liquid medicine in a container to push out the liquid medicine, and a control unit that controls the operation of the drive mechanism, a: A step in which a computer determines injection conditions for a preliminary injection operation using parameters of the injection conditions for the main injection; b) performing the preliminary injection operation and the main injection operation in succession in this order; Equipped with.

[0109] 14. The injection rate of the liquid medicine in the preliminary injection operation is faster than the injection rate of the liquid medicine in the main injection.

[0110] 15. The injection time of the liquid medicine in the preliminary injection operation is shorter than the injection rate of the liquid medicine in the main injection.

[0111] In the above description, the calculation processing is performed by the console of the liquid injector, but the calculation processing may be performed by another entity (for example, a computer constituting part of the imaging device, or another computer). In this case, one aspect of the present invention can be expressed as follows: A method for setting operating conditions of a drive mechanism that applies pressure to a chemical solution in a container to push out the chemical solution, comprising: a: A method including a step in which a computer determines injection conditions for a preliminary injection operation using parameters of the injection conditions for the main injection.

[0112] The operating conditions (preliminary injection conditions) of the drive mechanism of the liquid injector may be set by a predetermined computer, and the computer may transfer the operating conditions to the liquid injection conditions.

[0113] This application also discloses the inventions described above as methods and apparatuses as embodiments of the present invention expressed as computer program inventions. The computer program may operate a part of a liquid injector (e.g., a console), or may operate other equipment (a computer). Furthermore, the individual technical features disclosed in this application may be combined as appropriate within the scope of the present invention. [Explanation of symbols]

[0114] 100 Chemical injection device 101 Control Unit 103 Input Unit 104 Display Devices 110 Injection Head 112 Console 114 Main Unit 116 Stand 121 recess 125 exterior cover 130a, 130b (130) Piston drive mechanism 131 Ram member 140 Clamper 200 Chemical circuit 201, 202, 203 Tubes 204 Connector 210 Flow Sensor 241 Mixing Device 300 Syringe Assembly 320 Syringe 321 Cylinder 321a flange 322 Piston 370 Protective Cover 371 Cover flange 500 Imaging device 503 Input Unit 504 display device 510 Imaging control unit 520 Imaging operation unit

Claims

1. a: a drive mechanism that applies pressure to the chemical solution in the container to push out the chemical solution; b) a control unit for setting its operating conditions; A chemical liquid injector comprising: The control unit a main injection condition determination unit that determines the injection conditions for the main injection; a preliminary injection operation condition determination unit that determines an injection condition for the preliminary injection operation, The liquid medicine injector is configured so that, during liquid medicine injection, the preliminary injection operation and the main injection are performed consecutively in this order.

2. 2. The chemical liquid injector according to claim 1, wherein an injection rate of the chemical liquid in the preliminary injection operation is higher than an injection rate of the chemical liquid in the main injection.

3. 3. The liquid injector according to claim 1, wherein the liquid injection time of the preliminary injection operation is shorter than the liquid injection rate of the main injection.

4. The control unit The device is configured to automatically set at least one parameter of an injection rate and an injection amount of the preliminary injection operation based on a parameter of the injection condition of the main injection. The chemical liquid injector according to any one of claims 1 to 3.

5. The control unit The device is configured to automatically set both the injection rate and injection amount parameters of the preliminary injection operation based on the parameters of the injection conditions of the main injection. The chemical liquid injector according to any one of claims 1 to 3.

6. 6. The chemical liquid injector according to claim 1, wherein the main injection includes a phase in which the injection is performed at a constant injection rate for a predetermined injection period.

7. The drive mechanism includes: a first piston driving mechanism provided in the injection head and configured to move a piston member of a first syringe filled with a first contrast agent; a second piston driving mechanism provided in the injection head for moving a second syringe piston member filled with a second contrast medium or physiological saline; The chemical liquid injector according to any one of claims 1 to 6, comprising:

8. moreover, a drug solution circuit connected to the first and second syringes; The chemical liquid circuit includes: a first fluid path connected to the first syringe; a second fluid path connected to a second syringe; a connector provided at a location where the first and second liquid paths join; and a third fluid path extending from the connector. The chemical liquid injector according to claim 7.

9. 7. The chemical liquid injector according to claim 6, wherein the connector is a mixing device that generates a swirling flow to mix the liquids.

10. The control unit an injection condition for a preliminary injection operation by the first piston drive mechanism; an injection condition for a preliminary injection operation by the second piston drive mechanism; The chemical liquid injector according to claim 7 , configured to set

11. The liquid injection device of claim 10, wherein when the operation time of one injection preparatory operation is different from the operation time of the other injection preparatory operation, the operation timing of the first and second piston drive mechanisms is controlled to match the shorter operation time.

12. further comprising one or more display devices; 12. The chemical liquid injector according to claim 1, wherein the control unit does not cause the one or more display devices to display the injection conditions of the preliminary injection operation.

13. A method for controlling a liquid medicine injector including a drive mechanism that applies pressure to a liquid medicine in a container to push out the liquid medicine, and a control unit that controls the operation of the drive mechanism, a: A step in which a computer determines injection conditions for a preliminary injection operation using parameters of the injection conditions for the main injection; b) performing the preliminary injection operation and the main injection operation consecutively in this order; A method for controlling a chemical liquid injector, comprising:

14. The control method according to claim 13 , wherein an injection rate of the liquid medicine in the preliminary injection operation is higher than an injection rate of the liquid medicine in the main injection.

15. 15. The control method according to claim 13, wherein the injection time of the preliminary injection operation is shorter than the injection rate of the main injection.

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