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WO2016208611A1 - Dispositif d'injection de liquide médicamenteux - Google Patents

Dispositif d'injection de liquide médicamenteux Download PDF

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Publication number
WO2016208611A1
WO2016208611A1 PCT/JP2016/068479 JP2016068479W WO2016208611A1 WO 2016208611 A1 WO2016208611 A1 WO 2016208611A1 JP 2016068479 W JP2016068479 W JP 2016068479W WO 2016208611 A1 WO2016208611 A1 WO 2016208611A1
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WO
WIPO (PCT)
Prior art keywords
injection
chemical
container
chemical solution
injection device
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Ceased
Application number
PCT/JP2016/068479
Other languages
English (en)
Japanese (ja)
Inventor
齋藤　剛
根本　茂
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Nemoto Kyorindo Co Ltd
Original Assignee
Nemoto Kyorindo Co Ltd
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Nemoto Kyorindo Co Ltd filed Critical Nemoto Kyorindo Co Ltd
Priority to JP2017524938A priority Critical patent/JP6792104B2/ja
Publication of WO2016208611A1 publication Critical patent/WO2016208611A1/fr
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/14—Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/14—Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
    • A61M5/168—Means for controlling media flow to the body or for metering media to the body, e.g. drip meters, counters ; Monitoring media flow to the body
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/14—Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
    • A61M5/168—Means for controlling media flow to the body or for metering media to the body, e.g. drip meters, counters ; Monitoring media flow to the body
    • A61M5/172—Means for controlling media flow to the body or for metering media to the body, e.g. drip meters, counters ; Monitoring media flow to the body electrical or electronic
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178—Syringes
    • A61M5/31—Details
    • A61M5/315—Pistons; Piston-rods; Guiding, blocking or restricting the movement of the rod or piston; Appliances on the rod for facilitating dosing ; Dosing mechanisms

Definitions

  • the present invention relates to an infusion device for injecting medicinal liquid filled in a container such as a syringe through a tube and having an purging function for removing air from the container and the tube prior to infusion of the medicinal solution.
  • a container such as a syringe
  • the purging function for removing air from the container and the tube prior to infusion of the medicinal solution.
  • CT Computer Tomography
  • MRI Magnetic Resonance Imaging
  • PET PET
  • ultrasound diagnostic devices angiographic devices
  • angiography angiography
  • a chemical solution such as a contrast medium or physiological saline may be injected into a patient using the chemical solution injection device.
  • treatment techniques using an image diagnostic device can be developed only from previous image diagnosis by developing X-ray equipment, catheters, contrast agents, and the like.
  • IVR Interventional Radiology
  • an image diagnostic device can be developed only from previous image diagnosis by developing X-ray equipment, catheters, contrast agents, and the like.
  • Considering the procedure it can be divided into local injection (arterial injection) of a drug solution using a catheter, embolization of a blood vessel, expansion and opening of a blood vessel.
  • Subjects include tumors, bleeding, vascular lesions and the like.
  • TAE Transcatheter Arterial Embolization
  • For bleeding there are continuous arterial infusion of vasoconstrictors and arterial embolization, and for vascular lesions, there are thrombolysis and percutaneous angioplasty (PTA: Percutaneous Transluminal Angioplasty).
  • PTCA Percutaneous transluminal coronary angioplasty
  • PTCA Percutaneous Transluminal Coronary Angioplasty
  • atherectomy It can be roughly divided into intracoronary resection (surgery) and stent implantation.
  • various blood vessels directly connected to organs and lesions in the head, chest (including the heart), abdomen, and lower limbs are selectively or repeatedly imaged the same blood vessels (complexity).
  • change the imaging angle to know the anteroposterior relationship of the blood vessels, finely adjust the injection conditions so that the catheter can not be removed, and confirm it after treatment). Is required.
  • an angiographic apparatus that can acquire a tomographic image similar to a CT apparatus has been put into practical use.
  • a desired image can be captured only by the angiographic device. Combined testing and treatment are expected to increase further in the future.
  • the contrast agent concentration and the injection speed are appropriately adjusted according to the blood vessel site, and the contrast agent is repeatedly injected. This is one difference from the CT inspection and MR inspection.
  • Patent Document 1 discloses an example of a chemical solution injection device for angiography.
  • This chemical solution injection device is used for angiography by a catheter method, for example.
  • a catheter is percutaneously introduced into a blood vessel (artery) by a guide wire without incising the skin.
  • the drug solution injection device is operated to inject a contrast medium using a predetermined injection protocol, and continuous imaging is performed using the imaging device.
  • an image representing the contrasted blood vessel is displayed on a predetermined display, and the doctor performs diagnosis and treatment while viewing the image.
  • a device including an injection head and a console is known as a chemical solution injection device for angiography.
  • the injection head for angiography has the following characteristics that are different from the injection head for CT examination and MR examination. That is, the angiography has a feature that the injection pressure becomes very high because the drug solution is injected through an elongated catheter introduced into the blood vessel. Therefore, many syringes are configured to be attached to the injection head in a state where the syringe is put in a protective cover or the like. This is different from an injection head for CT inspection or MR inspection in which a syringe is directly attached or attached via an adapter that holds a part of the syringe.
  • extension tube is filled with a chemical solution by connecting with an extension tube, also called a branch tube, and simultaneously driving both piston drive mechanisms according to a predetermined operation by the operator to advance the piston of each syringe.
  • Patent Document 1 International Publication No. 2006/068171
  • Patent Document 2 International Publication No. 2011/136218
  • the injection condition of the chemical solution may be changed and repeatedly injected as in the case of the angiography described above.
  • concentration of the contrast medium among the injection conditions for example, an injection head that can be equipped with two syringes is used, and a syringe filled with a contrast medium and a syringe filled with physiological saline are attached to the injection head. It can be carried out by injecting the agent while diluting with physiological saline.
  • the drug solution remaining in the extension tube remains the same as the contrast agent concentration before the change, so that the drug solution remaining in the extension tube at this point Is injected, and then the drug solution is injected at the changed contrast agent concentration. Therefore, the time lag from the start of the injection operation of the chemical solution to the injection of the chemical solution having a desired contrast agent concentration increases. When the time lag becomes large, the imaging operation is executed at an imaging timing that is not an appropriate contrast agent concentration, and there is a possibility that a good image cannot be acquired. As a result, an excessive amount of contrast medium is injected, and the physical burden on the subject increases accordingly.
  • An object of the present invention is to provide a chemical solution injection apparatus and a chemical solution injection system that can arbitrarily change the concentration of a chemical solution even in a purge operation, thereby solving the above-described problems.
  • a chemical liquid injector for injecting a chemical liquid filled in a container, A first drive mechanism configured to release a chemical from the first container; A second drive mechanism configured to release the chemical from the second container; An injection device controller that controls at least the operations of the first drive mechanism and the second drive mechanism; Have The injection device control unit receives an input of a degree of dilution of the chemical liquid released from the first container by the chemical liquid released from the second container, and uses at least the input dilution degree to input the chemical liquid.
  • the condition for releasing the chemical solution from the first and second containers in the purge operation performed prior to the injection of the liquid is set, and the operation of the first and second drive mechanisms is controlled according to the set release condition A configured chemical injection device is provided.
  • the chemical injection device of the present invention A first container and a second container that are detachably attached to the chemical liquid injector; An injection circuit connected to the first container and the second container; A chemical injection system is provided.
  • the chemical solution injection system of the present invention A fluoroscopic imaging device for obtaining a medical image from a subject into which a liquid medicine has been injected by the liquid medicine injection system; A fluoroscopic imaging system is provided.
  • the first container and the second container are detachably mounted, and the first driving mechanism for discharging the chemical liquid from the first container and the chemical liquid from the second container are provided.
  • a method for operating a chemical injection device comprising a second drive mechanism for releasing Receiving an input of the degree of dilution of the chemical from the first container with the chemical from the second container; Setting a condition for releasing the chemical solution from the first and second containers in a purge operation performed prior to the injection of the chemical solution, using at least the input dilution degree; and Performing the purge operation by controlling the operation of the first and second piston drive mechanisms according to a set release condition;
  • a method of operating a chemical injection device having
  • injection circuit means a path for circulating a drug solution connected to a container such as a syringe for injection of the drug solution into the blood vessel of the subject, and is a catheter or a subject inserted into the blood vessel of the subject An indwelling needle to be pierced into the blood vessel.
  • the injection circuit further includes an extension tube branched into a plurality of ends connected to the container, and the distal end of the extension tube is connected to the catheter or the indwelling needle.
  • at least one member such as another tube may be connected between the extension tube and the catheter or indwelling needle.
  • the injection circuit can be divided into an “extracorporeal circuit portion” that is all located outside the body and an “internal circuit portion” that is at least partially located inside the body, depending on the arrangement in use.
  • the catheter or the indwelling needle belongs to an in-vivo circuit
  • a member such as the extension tube that connects the portion of the in-vivo circuit portion located outside the body and the container belongs to the extra-corporeal circuit portion.
  • “Purge operation” means an operation of releasing a chemical solution from a container in order to fill the extracorporeal circuit portion of the injection circuit with a desired chemical solution prior to the injection of the chemical solution to a subject. When it also serves the purpose of discharging air in the container and / or the extracorporeal circuit, it may be referred to as “air bleeding”. In this purge operation, no chemical solution is injected into the subject's body.
  • “Dilution degree” means the ratio of the amount of one chemical solution to the amount of the other chemical solution when one chemical solution is diluted with the other chemical solution.
  • “Purge amount” means the total amount of chemicals released from all containers attached to the injection head in the purge operation.
  • the degree of dilution of the chemical solution from each container in the purge performed prior to the chemical solution injection can be set, Purge operation at any degree of dilution is possible. This minimizes the time lag until the desired chemical solution is injected and the degree of dilution of the injected chemical solution reaches the desired level. As a result, a good image can be obtained with a smaller amount of chemical solution and in a shorter time. Can be obtained.
  • FIG. 1 is a schematic block diagram of a fluoroscopic imaging system according to an embodiment of the present invention. It is a perspective view which shows an example of the external appearance of the chemical injection device by one Embodiment of this invention. It is a perspective view which shows the injection
  • FIG. 6 is a diagram illustrating an example of a screen displayed when the dilution degree is changed when the injection mode is the dilution injection mode on the injection condition setting screen shown in FIG. 5.
  • FIG. 10B is a perspective view of a mixing device provided in the extension tube shown in FIG. 10A. It is sectional drawing of the mixing device with which the extension tube shown to FIG. 10A is equipped.
  • FIG. 1 there is shown a block diagram of a fluoroscopic imaging system according to an embodiment of the present invention having a chemical injection device 100 and a fluoroscopic imaging device 500.
  • the chemical injection device 100 and the fluoroscopic imaging device 500 can be connected to each other so that data can be transmitted and received between them.
  • the connection between the two can be a wired connection or a wireless connection.
  • the fluoroscopic imaging device 500 is an angio device
  • the chemical solution injection device 100 is an injection device for an angio test suitable for injecting at least a contrast medium as a chemical solution in an angio test. An example will be described.
  • the fluoroscopic imaging apparatus is an arbitrary fluoroscopic imaging apparatus such as an X-ray CT apparatus, an MRI apparatus, and a PET apparatus as long as it constitutes a system capable of performing an inspection using a plurality of types of chemical solutions.
  • the chemical solution injection device may be any injection device compatible with the fluoroscopic imaging device. Therefore, the configuration described in detail below can be appropriately changed according to the types of the fluoroscopic imaging device and the chemical liquid injector.
  • the fluoroscopic imaging device 500 includes an imaging operation unit 520 that performs an imaging operation, and an imaging control unit 510 that controls the operation of the imaging operation unit 520.
  • a medical image including a tomographic image and / or a 3D image can be acquired.
  • the imaging operation unit 520 includes a subject bed, an electromagnetic wave irradiation unit that irradiates electromagnetic waves to a predetermined space on the bed, and the like.
  • the imaging control unit 510 controls the operation of the entire fluoroscopic imaging apparatus, such as determining imaging conditions and controlling the operation of the imaging operation unit 520 according to the determined imaging conditions.
  • the imaging control unit 510 can be configured by a so-called microcomputer, and can have an interface with a CPU, ROM, RAM, and other devices.
  • a computer program for controlling the fluoroscopic imaging apparatus 500 is installed in the ROM.
  • the CPU controls the operation of each part of the fluoroscopic imaging apparatus 500 by executing various functions corresponding to this computer program.
  • the fluoroscopic imaging apparatus 500 may further include a display unit 504 such as a liquid crystal display capable of displaying imaging conditions and acquired medical images, and an input unit 503 such as a keyboard and / or mouse for inputting imaging conditions and the like. it can. Data input from the input unit 503 is transmitted to the imaging control unit 510, and data displayed on the display unit 504 is transmitted from the imaging control unit 510.
  • a touch panel in which a touch screen is arranged as an input unit on the display unit display can also be used as the input unit 503 and the display unit 504.
  • the drug solution injection device 100 is a device used to inject a drug solution filled in a syringe as a container into a blood vessel of a subject via an injection circuit, and includes a plurality of piston drive mechanisms 130a and 130b, and an input unit. 103, a display unit 104, and an injection control unit 101.
  • the piston drive mechanisms 130a and 130b are mechanisms for operating the piston of the syringe so as to release the chemical solution from the syringe. In this embodiment, the two syringes can be injected separately or simultaneously.
  • Two piston drive mechanisms 130a and 130b for independently operating the pistons are provided. However, there may be a plurality of at least one of the piston driving mechanism 130a for injecting one chemical liquid and the piston driving mechanism 130b for injecting the other chemical liquid.
  • the injection control unit 101 determines the injection conditions such as the injection amount and the injection speed of the chemical liquid, controls the operation of the piston drive mechanisms 130a and 130b so that the chemical liquid is injected from the syringe according to the determined injection conditions,
  • This chemical solution injection device controls the display of the unit 104 and sets purge conditions such as the discharge amount and discharge speed of the chemical solution released from the syringe in the purge operation performed prior to the injection of the chemical solution to the subject. Control overall operation.
  • the injection control unit 101 can be constituted by a so-called microcomputer, and can have an interface with a CPU, ROM, RAM, and other devices.
  • a computer program for controlling the chemical injection device 100 is mounted in the ROM.
  • the CPU can control the operation of each part of the chemical solution injector 100 by executing various functions in response to the computer program.
  • the input unit 103 is a unit used to input data necessary for determining the injection condition of the chemical solution by the injection control unit 101.
  • the input unit 103 may be a known input device such as a keyboard and / or a mouse. Data input from the input unit 103 is transmitted to the injection control unit 101, and data displayed on the display unit 104 is transmitted from the injection control unit 101.
  • the display unit 104 is controlled by the injection control unit 101 to display data and the like necessary for determining the injection condition of the chemical solution, display the injection protocol, display the injection operation, display various warnings, and the like.
  • the display unit 104 may be a known display device such as a liquid crystal display device.
  • a touch panel in which a touch screen is arranged as an input unit on the display unit display can also be used as the input unit 103 and the display unit 104.
  • FIG. 2 is an example of the chemical liquid injector 100 shown in FIG.
  • An injection device for an angio device (angiography device) is shown, and has an injection head 110, a console 112, and a main unit 114.
  • the injection head 110 and the console 112 are electrically connected via the main unit 114.
  • the injection head 110 is supported by the upper part of the stand 116 so as to be able to turn, but may be supported by a turning arm fixed to the ceiling.
  • the console 112 can include the input unit 103 and the display unit 104 described above.
  • the console 112 includes a touch panel, which corresponds to the input unit 103 and the display unit 104 described above.
  • the main unit 114 can include a power supply (not shown) and can supply power to the injection head 110 and the console 112 from this power supply.
  • the injection control unit 101 illustrated in FIG. 1 may be disposed in the main unit 114 or may be disposed in the console 112.
  • the injection head 110 is configured so that two sets of syringe assemblies 200 can be detachably mounted (in FIG. 4, only one set of syringe assemblies 200 is shown for the sake of simplicity). )
  • the syringe assembly 200 includes a syringe 220 and a protective cover 270 into which the syringe 220 is inserted.
  • the syringe 220 is generally called a rodless syringe, and includes a cylinder 221 having a flange 221a formed at the end and a nozzle portion 221b formed at the tip, and a piston 222 inserted into the cylinder 221 so as to be able to move forward and backward. have.
  • an extension tube 300 as shown in FIG. 4 that constitutes the extracorporeal circuit portion of the injection circuit can be connected to the tip of each syringe 220.
  • the extension tube 300 has a first tube 301, a second tube 302, a third tube 303, and a T-shaped connector 304 for connecting them, and as a whole takes the form of a branch tube branched at the end side. ing.
  • the first tube 301 and the second tube 302 have connectors 305 and 306 at their ends for connection with the nozzle portion 211b of the syringe 220, respectively.
  • the third tube 303 has a connector 307 for connection with a catheter or the like at the tip thereof.
  • At least one of the connectors 305 and 306 connected to the first tube 301 and the second tube 302 may include a one-way valve.
  • the valve has a valve body that is operated by the back pressure of the fluid to close the flow path, and the syringe 220 is connected from the distal end side of the extension tube 300 to the distal end side, that is, the side to which the catheter or the like is connected. It works to prevent back flow of fluid to the side.
  • at least one of the one valves may have a release function that can arbitrarily hold the valve body at the open position of the flow path by a predetermined operation.
  • valve since the valve has a release function, it is possible to prevent blood from flowing back to the syringe 220 side normally, but blood is used to confirm whether the tip of the catheter or the like is normally located in the blood vessel of the subject. A so-called route check or the like can be performed.
  • the end of the internal circuit portion such as a catheter inserted into the blood vessel of the subject is connected to the third tube 303, so that Can be injected.
  • the chemical solution filled in the syringe 220 for example, the syringe 220 connected to the first tube 301 is filled with a contrast agent, and the syringe 220 connected to the second tube 302 is filled physiologically. It can be a saline solution. Alternatively, a syringe 220 filled with contrast agents having different concentrations may be connected to the first tube 301 and the second tube 302, respectively.
  • Contrast agents used for imaging medical images have a relatively high viscosity, and in particular, contrast agents used for imaging an angio apparatus have a higher viscosity than other types of contrast agents.
  • the catheter is generally very thin with an inner diameter of less than 1 mm. Therefore, when the contrast medium is filled in the syringe 220 as a chemical solution and the piston 222 is advanced to inject the contrast medium, a very high internal pressure is generated in the cylinder 221. This high internal pressure may cause the cylinder 221 to expand and cause various troubles in contrast agent injection.
  • the protective cover 270 suppresses expansion due to an increase in the internal pressure of the cylinder 221 at the time of injecting a chemical solution.
  • the cylinder is sized so that there is almost no gap between the outer periphery and the outer surface. Shaped member.
  • the protective cover 270 is preferably formed with a thickness having a mechanical strength that can sufficiently withstand the internal pressure acting on the cylinder 221 during the injection of the chemical liquid.
  • An opening through which the nozzle part 221b of the syringe 220 passes is formed at the tip of the protective cover 270, and the syringe 220 is held in a state where the nozzle part 221b protrudes from the opening.
  • a cover flange 271 is formed at the end of the protective cover 270 in which a ring-shaped recess for receiving the flange 221a of the cylinder 221 is formed on the end surface.
  • the injection head 110 has first and second piston drive mechanisms 130a and 130b (see FIG. 1) that are driven independently of each other to advance and retract the pistons 222 of the two sets of syringe assemblies 200 mounted.
  • the syringe assemblies 200 are arranged corresponding to the positions where they are mounted.
  • Each of the piston drive mechanisms 130a and 130b includes a presser 131 that holds a convex portion formed at the end of the piston 222, a drive source such as a motor that moves the presser 131 forward and backward, and a power transmission mechanism that connects them.
  • the syringe assembly 200 attached to the injection head 110 can inject the medical solution filled in the syringe 220 into the subject separately or simultaneously by the piston 222 being advanced by the piston drive mechanisms 130a and 130b. it can.
  • the piston drive mechanism 130 a known mechanism generally used in this type of injection device can be employed.
  • the tip of the injection head 110 is provided with a syringe receiver 120 and a clamper 140 that constitute a syringe mounting portion on which the syringe assembly 200 is placed.
  • the syringe receiver 120 is located on the tip side of the clamper 140 and has two recesses 121 so as to receive the outer peripheral surface of each syringe assembly 200 individually.
  • the clamper 140 is supported so as to be openable and closable with respect to the syringe receiver 120, and is configured to individually hold the cover flange 271 of the protective cover 270 of each syringe assembly 200.
  • Each syringe assembly 200 is positioned in the recess 121 with the nozzle portion 221b facing the distal end side, and the syringe assembly 200 is fixed to the injection head 110 by closing the clamper 140.
  • the protective cover 270 is not an essential component, and the syringe 220 may be directly attached to the injection head 110. That is, the present invention includes both those in which the syringe 220 is directly attached to the injection head 110 and those in which the syringe 220 is indirectly attached via another member.
  • the injection head 110 can have an exterior cover 125 that covers the entire mechanism except for the portion having the syringe receiver 120 and the clamper 140.
  • the exterior cover 125 can have a mark 125 a for distinguishing the corresponding presser 131 at a position corresponding to each presser 131.
  • the sign 125a may be any character or symbol, and in this embodiment, the characters “A” and “B” are used. This marker can also be used to distinguish the syringe 220 (medical solution) on an injection condition setting screen 400 (see FIG. 5) described later.
  • the chemical solutions filled in the syringes 220 attached to the syringe receiver 120 corresponding to the label 125a may be referred to as “medical solution A” and “chemical solution B”.
  • the chemical injection device 100 may further include a hand switch 118 and / or a foot switch 119 as an option.
  • the hand switch 118 has an operation button, and is used to control the start and stop of the injection operation so that the injection operation of the chemical solution by the injection head 110 is performed only while the operation button is pressed. it can.
  • the foot switch 119 is used to control the start and stop of the injection operation so that the injection operation of the chemical solution by the injection head 110 is performed only while the foot switch 119 is stepped on, for example, when performing test injection. Can do.
  • Test injection is performed as necessary prior to imaging for acquiring a medical image, for example, to grasp individual differences in contrast effects and / or to confirm the tip position of an injection circuit. It is the injection of chemicals.
  • the injection of a medical solution for acquiring a medical image may be referred to as “main injection” for the purpose of distinction from the test injection.
  • main injection a smaller amount of chemical solution is usually injected than in the main injection.
  • the injection rate of the chemical solution in the test injection is usually set in advance or set to be the same as the injection rate of the chemical solution in the main injection. This test injection can also be performed by operating the hand switch 118.
  • the hand switch 118 is operated at the stage where the setting of the injection protocol for the chemical solution is completed and the preparation for injection is completed (standby state), the main injection is executed, but the hand switch 118 is operated at the previous stage. If so, a test injection can be performed.
  • the power of the chemical injection device 100 is turned on by the operator. Thereafter, the syringe assembly 200 filled with a chemical to be poured into the subject is attached to the injection head 110.
  • a chemical solution container (not shown) is connected to the nozzle portion 221b via an appropriate tube, and in this state, the piston drive mechanism
  • the syringe assembly 200 filled with the chemical solution may be mounted on the injection head 110 by retracting the piston 222 and filling the syringe assembly 200 with the chemical solution.
  • the former filled with the chemical solution by the manufacturer is called a prefilled type, and the latter is filled with the chemical solution at the medical site. This is also called a post-filling type.
  • the mounting of the syringe assembly 200 to the injection head 110 can be performed, for example, by the following procedure.
  • the operator closes the clamper 140, whereby the syringe assembly 200 is held by the injection head 110.
  • the injection head 110 preferably has a lock mechanism (not shown) that locks the clamper 140 so that it can be opened in the closed position.
  • the lock mechanism may be any mechanism as long as it can lock and release the clamper 140 in the closed position. By having the locking mechanism, it is possible to prevent the syringe assembly 200 attached to the injection head 110 from being detached from the injection head 110.
  • the injection head 110 preferably includes at least one detector that detects that the syringe assembly 200 is attached to the injection head 110.
  • a first detector that detects that the syringe assembly 200 is placed on the syringe receiving recess 121 and that the clamper 140 is in the closed position are detected.
  • the first detector for example, a detector that is arranged in the syringe receiving recess 121 and can detect the syringe assembly 200 in the syringe receiving recess 121 can be used.
  • the second detector for example, a detector that is built in the injection head 110 and can detect the tip of the clamper 140 when the clamper 140 is in the closed position can be used.
  • any of these detectors can detect an object to be detected when the distance between the object to be detected such as the syringe assembly 200 or the clamper 140 is less than a predetermined distance (including contact).
  • an optical sensor that optically detects the presence or absence of an object in a detection region
  • a proximity sensor that detects the presence or absence and position of an object using magnetism as a detection medium
  • a contact with an object to be detected A mechanical switch that is switched on / off by non-contact can be used.
  • the mechanical switch any switch including, for example, a tact switch and a limit switch can be used as long as it is switched on / off by contact / non-contact of the object to be detected.
  • the injection head 110 does not need to include both the first detector and the second detector in order to detect that the syringe assembly 200 is attached to the injection head 110, but only one of them. It may be.
  • the injection control unit 101 displays information indicating that the mounting of the syringe assembly 200 is completed on the display unit 104. It is possible to display it and visually notify the operator, or to move the operation of the chemical injection device 100 to the next step.
  • the information displayed on the display unit 104 may be a message by text or information represented by a symbol.
  • a light emitting lamp (not shown) is provided separately from the display unit 104, and the injection control unit 101 turns on the light emitting lamp to visually notify the operator that the mounting of the syringe assembly 200 is completed. it can.
  • the light emitting lamp can be provided in the injection head 110.
  • the position of the light-emitting lamp provided in the injection head 110 may be arbitrary, but is preferably in the vicinity of the part that is last operated by the operator when the syringe assembly 200 is mounted, for example, in the vicinity of the clamper 140. In particular, as shown in FIG.
  • an indicator 125a (specifically, letters “A” and “B”) is provided to allow the two piston drive mechanisms 130a and 130b to be identified. It is preferable to arrange two light-emitting lamps so that these label portions each emit light as a light-emitting portion.
  • the color visually recognized by the lighting of the light-emitting lamp may be arbitrary, and may be a different color for each corresponding chemical solution, for example, blue and green.
  • the injection head 110 can also include a light emitting unit 126 that emits light by turning on another light emitting lamp that emits light in the standby state described above. In the form shown in FIG. 3, the light emitting units 126 are arranged at positions distant from each other, but by doing so, it is possible to visually recognize that they are in the standby state from any direction.
  • the injection control unit 101 executes an operation for injecting the chemical solution.
  • This operation can include, for example, the following series of steps. (1) Acceptance of data input and setting of injection conditions (2) Purge operation (3) Execution of injection operation according to the set injection conditions (4) Injection operation end processing These processes will be described in order below. .
  • the injection control unit 101 causes the display unit 104 to display a screen for setting injection conditions, and inputs to the input unit 103 for setting injection conditions. Make the operation possible.
  • FIG. 5 shows an example of the injection condition setting screen 400.
  • the injection condition setting screen 400 shown in FIG. 5 includes an injection mode icon 401, a quick memory icon 402, a confirmation icon 403, a speed setting icon 404, an injection amount setting icon 405, an injection time setting icon 406, a dilution degree setting icon 407, and a syringe.
  • An information icon 408, a purge icon 409, and the like can be included.
  • the syringe information icon 408 graphically displays information about the syringe 220 attached to the injection head 110 (see FIG. 3).
  • the information displayed on the syringe icon 408 can include the amount of the chemical solution filled in the attached syringe 220.
  • the operator can visually recognize the chemical liquid injection operation by displaying an arbitrary animation.
  • the injection mode icon 401 is an icon that indicates in which injection mode the injection operation is to be executed among a plurality of injection modes preset in the injection control unit 101.
  • the injection mode for example, “normal injection mode” in which injection is performed only with the chemical A, “flash mode” in which the chemical B is injected after the injection of the chemical A, and “dilution” in which the chemical A and the chemical B are injected simultaneously. “Mode”, “multi-mode” in which only the chemical solution A is injected in a plurality of phases, and the like.
  • FIG. 5 shows a state where the “dilution mode” is selected.
  • the injection control unit 101 switches the display of the injection mode icon 401, thereby switching the injection mode.
  • the quick memory icon 402 is operated when an injection condition registered in the memory of the injection control unit 101 is called.
  • the confirmation icon 403 is operated when the operator approves the injection condition displayed on the injection condition setting screen 400.
  • the injection control unit 101 moves the chemical injection device 100. It is possible to shift to the next step of the chemical solution injection procedure by setting the standby state.
  • the speed setting icon 404, the injection amount setting icon 405, and the injection time setting icon 406 are used for setting the injection speed, the injection amount, and the injection time of the chemical solution, respectively.
  • the injection control unit 101 displays a ten-key icon (not shown) for inputting the injection speed on the injection condition setting screen 400 in an overlapping manner.
  • the operator can set the injection rate by inputting and confirming a numerical value through the numeric keypad screen.
  • the injection amount and the injection time can also be set in the same manner as the setting of the injection rate.
  • the numeric keypad icon may be the same as the numeric keypad icon 431 (see FIG. 6) on the ratio setting screen 430 described later, for example.
  • what is set by the speed setting icon 404 and the injection amount setting icon 405 is the total injection speed and injection amount of the chemical liquid A and the chemical liquid B.
  • the dilution degree setting icon 407 is an icon operated when setting the ratio of the target chemical solution to the reference chemical solution injected in the dilution injection mode.
  • the degree of dilution There are several ways of expressing the degree of dilution.
  • the amount of the chemical solution A with respect to the total amount of the chemical solution A and the chemical solution B, that is, the chemical solution A is based on the idea that the chemical solution A is diluted with the chemical solution B. It is represented by a dilution ratio calculated by / (chemical solution A + chemical solution B).
  • the dilution ratio may be set to 50% as a default value, for example.
  • the dilution ratio can be set as follows, for example.
  • the injection control unit 101 pops up a dilution ratio input screen 430 as shown in FIG. 6 on the injection condition setting screen 400 or an injection condition setting screen.
  • the display is switched from 400 to the dilution ratio input screen 430.
  • the dilution ratio input screen 430 can include a numeric keypad icon 431 and a ratio setting bar 432. With the numeric keypad icon 431, the ratio of the amount of the chemical solution A to the total amount of the chemical solution A and the chemical solution B can be set numerically.
  • the injection control unit 101 determines the input numerical value as a dilution ratio.
  • the ratio setting bar 432 may have a ratio display part 432a and a slider icon 432b.
  • the ratio display unit 432a indicates the ratio between the chemical solution A and the chemical solution B as a band graph, and the slider icon 432b is displayed at a display position so that the slider icon 432b can be moved along the ratio display unit 432a while being touched by the operator. Is controlled.
  • the injection control unit 101 sets the dilution ratio to a ratio corresponding to the position of the slider icon 432b.
  • the ratio display unit 432a may display the drug solution A side and the drug solution B side in different colors with respect to the position of the slider icon 432b.
  • the dilution ratio can be set from either the numeric keypad icon 431 or the ratio bar 432.
  • the dilution ratio input screen 430 may have only one of the numeric keypad icon 431 and the ratio bar 432.
  • the input of the dilution ratio is not limited to the above method, and any method can be used.
  • the injection control unit 101 deletes the pop-up display of the dilution ratio input screen 430 from the injection condition setting screen 400 or the injection condition setting screen according to the display form of the dilution ratio input screen 430.
  • the display is switched to 400, and the set dilution ratio is displayed on the dilution ratio icon 407 of the injection condition setting screen 400.
  • the operator performs a data input operation as necessary according to the display of the injection condition setting screen 400.
  • the display is switched to “start OK”, and the chemical injection device 100 is in a standby state in which chemical injection is possible. Become.
  • the purge operation is performed after the extracorporeal circuit part (for example, extension tube) of the injection circuit is connected to the syringe assembly 200 and before the injection operation of the chemical solution is started. Then, the fluid containing air and the chemical liquid in the extracorporeal circuit unit is released from the injection circuit by the chemical liquid in the syringe 220. In order to release the fluid in the extracorporeal circuit unit from the injection circuit, the purge operation is performed in a state where the tip of the extracorporeal circuit unit is not connected to the end of the intracorporeal circuit unit or between the extracorporeal circuit unit and the intracorporeal circuit unit.
  • the extracorporeal circuit part for example, extension tube
  • the purge operation is basically performed when the extracorporeal circuit unit is not filled with the chemical solution, so as to fill the extracorporeal circuit unit with the chemical solution, and needs to be performed when the extension tube 300 is filled with the chemical solution. There is no. However, if the dilution ratio is changed, such as when the second injection is performed at a different dilution ratio from the first injection following the first injection, even if the extracorporeal circuit unit is filled with the chemical solution, the purge is performed. It is preferable to perform the operation.
  • the trigger for executing the purge operation is given by the operator.
  • the injection head 110 can have a purge button 123 (see FIG. 3).
  • a purge icon 409 can be displayed on the injection condition setting screen 400.
  • both the purge button 123 and the purge icon 409 can be provided.
  • the injection control unit 101 executes the purge operation.
  • a purge operation is performed so that a chemical solution is discharged from each syringe 220 at an equal discharge amount and discharge speed, and purge conditions such as these discharge amounts and discharge speeds.
  • the injection control unit 101 sets a release ratio that is a ratio of the release amount of the chemical solution A to the total of the release amount of the chemical solution A and the release amount of the chemical solution B, and the chemical solution is released according to the set release ratio. In this way, the operations of the piston drive mechanisms 130a and 130b are controlled.
  • the discharge ratio in the purge operation preferably follows a dilution ratio that is one of the injection conditions of the chemical solution.
  • the injection control unit 101 receives the input of the dilution ratio via the injection condition setting screen 400, and the release ratio is set to a value equal to the dilution ratio input here.
  • the chemical solution A and the chemical solution B are released from each syringe 220 with the amount of the chemical solution A and the amount of the chemical solution B according to the dilution ratio, respectively.
  • the extracorporeal circuit unit is an extension tube (see FIG. 4)
  • the drug solution A and the drug solution B released from each syringe 220 pass through the first tube 301 and the second tube 302 in the extension tube 300, respectively. Then, they merge in the third tube 303, where a mixed liquid of the chemical liquid A and the chemical liquid B is obtained.
  • the concentration of the chemical solution A in this mixed solution is equal to the concentration of the chemical solution A diluted at the set dilution ratio.
  • the release speed that is, the control based on the movement speed of the presser 131 of the piston drive mechanisms 130a and 130b
  • the discharge amount That is, control based on the movement amount of the piston drive mechanisms 130a and 130b
  • the injection control unit 101 receives the input of the total injection rate of the drug solution A and the drug solution B via the injection condition setting screen 400.
  • the operation of the piston drive mechanisms 130a and 130b can be controlled using the injection speed input here, for example, as follows.
  • the set dilution ratio is R (%) and the drug solution A input using the speed setting icon 404 is used.
  • the total injection rate of the chemical solution B is St (mL / sec)
  • the release rate of the chemical solution A in the purge operation is Sa (mL / sec)
  • the release rate of the chemical solution B in the purge operation is Sb (mL / sec)
  • Sa (mL / sec) St (mL / sec) ⁇ R (%)
  • Sb (mL / sec) St (mL / sec) -Sa (ml / sec)
  • the piston drive mechanisms 130a and 130b are operated so that By doing so, the purge operation can be performed at the same release ratio as the set dilution ratio.
  • the two piston driving mechanisms 130a and 130b can be operated simultaneously and for the same time, but the length of time may be arbitrary.
  • the total amount of the medicinal solution A and the medicinal solution B released from the two syringes 220 is preferably equal to or greater than the volume of the extracorporeal circuit unit. Therefore, if the purge amount, which is the total amount of the chemical solution A and the chemical solution B released during the purge operation, is determined in advance in consideration of the volume of the extracorporeal circuit unit that is assumed to be used, the control based on the discharge amount The extracorporeal circuit portion can be filled with the chemical solution A and the chemical solution B.
  • the purge amount may be an amount that can fill the extracorporeal circuit portion with a desired chemical solution, and the amount is smaller than the injection amount set as one of the injection conditions of the chemical solution. Therefore, the purge amount is preferably set in the injection control unit 101 separately from the injection amount at the time of injection of the chemical solution.
  • a preferable value of the purge amount depends on the volume of the extracorporeal circuit unit to be used, but can generally be 5 to 10 mL.
  • the purge amount is determined in advance, the set dilution ratio is R (%), the purge amount is Dt (mL), the release amount Da (mL) of the chemical solution A in the purge operation, and the purge operation
  • the release amount Db (mL) of the chemical solution B of Da (mL) Dt (mL) ⁇ R (%)
  • Db (mL) Dt (mL) ⁇ Da (mL)
  • the piston drive mechanisms 130a and 130b are operated so that In this way, the purge operation can be performed with the same release ratio as the set dilution ratio.
  • the operation timings of the piston drive mechanisms 130a and 130b may be the same or different.
  • the release rate of the chemical solution in the purge operation is arbitrary as long as the final release amount becomes a desired amount, and is the same as the injection rate set as the chemical solution injection condition. It may be different or different. Further, the release rate may be constant for at least a part of time from the start to the end of the purge operation or may be changed with time.
  • the injection control unit 101 discharges both chemical solutions at the same release rate at the start of the purge operation, and then sets the release rate of at least one of the chemical solutions over time until the end of the purge operation. It is possible to set the condition for releasing the chemical solution in the purge operation so that the final dilution degree becomes the target dilution degree.
  • the injection control unit 101 releases only the chemical solution B (for example, contrast agent) at the start of the purge operation, and then sets the release rate of the chemical solution A for a time until the end of the purge operation. While decreasing, the purge rate is increased so that the release rate of drug solution A (eg, physiological saline) increases from zero over time, so that the final dilution level becomes the target level. It is also possible to set a condition for releasing the chemical liquid during operation. In this case, it is preferable to set the release conditions of each chemical solution so that the total release rate of the chemical solution A and the chemical solution B is constant. Further, the relationship between the chemical liquid A and the chemical liquid B may be reversed. FIG.
  • the chemical solution B for example, contrast agent
  • the present invention is not limited to these, and the ratio between the release rate of the chemical solution A and the release rate of the chemical solution B at the start of the purge operation may be arbitrarily set. Also, regarding the increasing tendency and decreasing tendency of the release rate, the release rate of each chemical solution is changed so as to achieve a predetermined predetermined dilution degree before the purge operation ends, and thereafter the release rate of each chemical solution until the purge operation ends.
  • the release conditions may be set so that the above is maintained.
  • both the chemical solutions are mixed more uniformly in the extracorporeal circuit unit, and the extracorporeal circuit unit Air bubbles can be eliminated well. If the ratios of the two chemicals released in the purge operation differ greatly, depending on the characteristics of the injection circuit and the physical properties (viscosity, specific gravity, etc.) of each chemical to be mixed, both chemicals are sufficient in the purge operation. In such a case, the release control as described above is effective.
  • the purge operation is performed in a state where the extracorporeal circuit unit is not connected to the extracorporeal circuit unit, and the extracorporeal circuit unit is operated by the operator after the purge operation is completed. Connected to the circuit section.
  • the purge operation is performed by operating the purge button 123 or the like even in an injection mode other than the dilution injection mode described above, for example, a normal injection mode in which only a contrast medium is injected, when the extracorporeal circuit unit is not filled with a chemical solution. Is possible. However, when only the contrast agent is injected, it can be considered as a special case where the dilution ratio is 0% in the dilution injection mode. In this case, when the above-described procedure is applied, the purge operation is performed only by releasing the contrast agent. Done.
  • the extracorporeal circuit unit in the state where the extracorporeal circuit unit is not filled with the chemical solution, the extracorporeal circuit unit has a portion through which only one of the chemical solutions circulates until both of the chemical solutions are merged. It is difficult to fill the whole with chemicals. Therefore, when only one of the chemicals is injected, it is preferable to perform a purge operation so that the chemicals are released at a predetermined fixed dilution ratio, for example, the above-described default value.
  • the injection operation of the chemical liquid is performed by the injection control unit 101 controlling the operations of the piston drive mechanisms 130a and 130b so that the chemical liquid is injected under the set injection conditions (injection speed, injection amount, injection time, etc.). Is called.
  • the injection mode is the dilution injection mode
  • both piston drive mechanisms 130a and 130b are operated simultaneously so that the chemical liquid A and the chemical liquid B are injected at the set dilution ratio.
  • the purge operation is performed prior to the injection operation, and the distal end side of the junction portion of the extracorporeal circuit portion (for example, the T-shaped connector 304 of the extension tube 300 shown in FIG. 4) is already at a desired dilution ratio.
  • the drug solution is filled in a diluted state, immediately after the injection operation is started, the drug solution diluted at a desired dilution ratio is injected. This minimizes the time lag until injection of waste chemicals and the dilution ratio of the injected chemicals reaches the desired ratio. As a result, a good image can be obtained in a smaller amount of chemicals and in a shorter time. Can be obtained.
  • a catheter used for injecting a contrast medium as an in-vivo circuit portion usually has an inner diameter of 2 mm or less and an effective length of about 1 m. Therefore, the volume of the catheter is extremely small compared to the amount of the chemical solution injected in one examination.
  • the fluoroscopic imaging device 500 starts an imaging operation corresponding to the chemical solution injection operation by the chemical solution injection device 100.
  • the imaging operation by the fluoroscopic imaging device 500 may be executed with an operation by the operator as a trigger, or may be automatically executed in conjunction with the injection operation by the chemical solution injection device 100.
  • the imaging operation and the imaging operation are linked, for example, after the injection operation is started, the imaging operation is started after a predetermined time required for the injected drug solution to reach the target site.
  • the injection control unit 101 of the chemical solution injection device 100 transmits an injection start signal to the imaging control unit 510 of the fluoroscopic imaging device 500, and the imaging control unit 510 that has received the injection start signal receives the imaging operation unit 520 after the predetermined time has elapsed.
  • the injection control unit 101 transmits an injection start signal to the image pickup control unit 510 after the elapse of the predetermined time after the injection operation is started, and the image pickup control unit 510 receives the injection start signal.
  • the imaging operation unit 520 can be controlled to start the imaging operation.
  • the imaging control unit 510 can reconstruct the data obtained by the imaging operation of the imaging operation unit 520 to acquire a medical image, and display the acquired medical image on the display unit 504 in real time.
  • the imaging control unit 510 displays the data in the display unit 503. Some or all of the injection conditions can be displayed in real time together with or separately from medical images and imaging conditions.
  • the cumulative up to the imaging stage The injection amount and the X-ray irradiation amount can be displayed. As a result, it is judged on the spot whether the cumulative X-ray irradiation dose does not exceed the reference value, and whether the injection amount of the contrast medium does not exceed the reference value for subjects with poor liver function, When the X-ray irradiation amount and / or the injection amount is likely to exceed the reference value, the X-ray irradiation amount and the contrast agent injection amount can be adjusted as necessary.
  • the injection control unit 101 can display the injection result on the display unit 104 as one of the injection operation end processes. Examples of displayed results include injection end date and time, injection mode, set imaging location, injection speed, injection volume, dilution ratio (in dilution injection mode), time required for injection, maximum pressure during injection, etc. And at least one of these items may be displayed. Further, as one of the injection operation end processes, the injection control unit 101 records these injection results in an appropriate memory device inside or outside the chemical solution injection device 100 or transmits them to the fluoroscopic imaging device 500. Can do.
  • the injection control unit 101 can display the injection condition setting screen 400 on the display unit 104 again by a predetermined operation by the operator.
  • the injection conditions are set on the injection condition setting screen 400, and the chemical solution may be injected under the set injection conditions. it can.
  • the purge operation is performed. Thereby, even in the next injection, a good image can be obtained in a smaller amount of chemical solution and in a shorter time.
  • the degree of dilution can also be expressed as a dilution factor.
  • the dilution ratio is the total amount of the drug solution A and the drug solution B, that is, (the drug solution A + Calculated as “chemical solution B) / chemical solution A”.
  • the injection condition setting screen will be changed as necessary.
  • the dilution rate setting icon 407 displayed on the injection condition setting screen displays the currently set dilution rate.
  • the injection control unit 101 pops up a dilution rate input screen 440 as shown in FIG. 8B on the injection condition setting screen, for example. .
  • the dilution rate input screen 440 can have at least one of a numeric keypad icon 441 and a magnification setting bar 442, like the dilution ratio input screen 430 shown in FIG.
  • a dilution factor represented by the total amount of the chemical solution A and the chemical solution B with respect to the amount of the chemical solution A can be set as a numerical value.
  • the injection control unit 101 determines the input numerical value as a dilution factor.
  • the magnification setting bar 442 can have a magnification display portion 442a and a slider icon 442b.
  • the magnification display unit 442a shows the set magnification in a logarithmic graph format.
  • the display position of the slider icon 442b is controlled so that the slider icon 442b can be moved along the magnification display unit 442a while being touched by the operator.
  • the injection control unit 101 sets the dilution magnification to a magnification corresponding to the position of the slider icon 442b.
  • the chemical solution A side and the chemical solution B side may be displayed in different colors with respect to the position of the slider icon 442b.
  • the injection control unit 101 sets the purge condition in the purge operation using the dilution rate input in this way as one of the parameters, and the operation of the piston drive mechanisms 130a and 130b according to the set purge condition during the purge operation. To control. Control of the operation of the piston drive mechanisms 130a and 130b during the purge operation by the injection control unit 101 may be the same as when the purge condition is set based on the dilution ratio.
  • the contrast agent when the drug solution A is a contrast agent and the drug solution B is a physiological saline, the contrast agent has an extremely large viscosity as compared with the physiological saline and hardly flows in the extracorporeal circuit portion. Therefore, if the contrast ratio of the contrast medium is greatly different when the contrast medium is diluted with saline, a small amount of discharge such as a purge operation may cause dilution unevenness in which the contrast medium and the saline are not sufficiently mixed. , Bubbles in the extracorporeal circuit may not be excluded.
  • the purge operation may be performed at a constant rate so that the dilution rate is 50%.
  • a purge operation is performed at a rate that is not the rate of the amount to be injected
  • a dilution degree reference value is set in advance in the injection control unit 101
  • the injection control unit 101 performs processing for setting injection conditions.
  • the degree of dilution of the contrast agent (medical solution A) with respect to the total injection amount of the contrast agent (medical solution A) and physiological saline (medical solution B) set in step 1 is compared with the reference value, and the degree of dilution is less than the reference value.
  • the operations of the piston drive mechanisms 130a and 130b are controlled so that the contrast medium and the physiological saline are released at the set dilution level.
  • the contrast is increased as described above.
  • the operations of the piston drive mechanisms 130a and 130b can be controlled so that the same amount of the agent and the physiological saline are released.
  • the piston drive mechanism 130a when the dilution level is equal to or less than the reference value, the piston drive mechanism 130a, so that the same amount of contrast medium and physiological saline are released.
  • the operation of the piston driving mechanisms 130a and 130b is controlled so that the contrast medium and the physiological saline are discharged at the set dilution degree when the operation degree is controlled and the dilution degree exceeds the reference value. May be.
  • the reference value can be set, for example, by the ratio of the amount of contrast agent to the total amount of contrast agent and physiological saline, and the specific value can be set to 50%, for example. This value may be arbitrarily changed by the operator or according to the type of contrast agent used.
  • a reference range of the discharge rate in the purge operation is set in the injection control unit 101 in advance, and if the value of the injection rate set as one of the injection conditions is out of this reference range, the release in the purge operation is performed. It is preferable to set the speed to the lower limit value or the upper limit value of the reference range.
  • the reference range of the release rate can be, for example, 1.5 (mL / sec) to 2.5 (mL / sec).
  • the chemical solution release conditions e.g., release speed, release amount, degree of dilution, etc.
  • the discharge field right in the purge operation may be set independently of the injection conditions.
  • a purge setting icon (not shown) is displayed on the injection condition setting screen 400 shown in FIG. 5 in addition to the above-described various icons, and when this purge setting icon is tapped, the injection control unit 101 For example, a screen for accepting the input of the degree of dilution such as the dilution ratio input screen 430 shown in FIG. 6 or the dilution rate display screen 440 shown in FIG. 8A is displayed. The screen for accepting the input of the degree of dilution may be displayed as a pop-up on the injection condition setting screen 400, or may be displayed after being switched to the injection condition setting screen 400. Next, the injection control unit 101 sets the degree of dilution according to the data input from these screens.
  • the injection control unit 101 deletes the display for receiving the input of the dilution degree from the injection condition setting screen 400 according to the display form, or displays the display screen. Return to the injection condition setting screen 400.
  • This display change may be performed after the purge operation is completed.
  • the total discharge amount and discharge speed of the chemical liquid A and the chemical liquid B in the purge operation may be set in advance in the injection control unit 101, or an appropriate data input icon (not shown) is displayed to input this data. It can also be set according to data input by the operator from the icon.
  • Data input icons may be, for example, the speed setting icon 404 and the injection amount setting icon 405 shown in FIG.
  • the injection control unit 101 executes a purge operation with a predetermined operation by an operator such as pressing of the purge button 123 (see FIG. 3) as a trigger after the purge conditions such as the degree of dilution, the discharge speed, and the discharge amount are set. Thereafter, in the same manner as described above, the injection condition of the chemical solution is set according to the data input by the operator, and the injection operation of the chemical solution is executed.
  • the container filled with the chemical solution is a syringe
  • the container is not limited to a syringe, and may be a chemical solution bottle or a chemical solution bag.
  • a drive mechanism for discharging the chemical solution from the container a drive mechanism corresponding to the form of the container, such as a tube pump type drive mechanism, can be used.
  • the injection control unit 101 is included in the chemical injection device 100 and the imaging control unit 510 is included in the fluoroscopic imaging device 500 as illustrated in FIG.
  • both the injection control unit 101 and the imaging control unit 510 may be included in the chemical solution injection device 100, or both the injection control unit 101 and the imaging control unit 510 may be included in the fluoroscopic imaging device 500.
  • both the injection control unit 101 and the imaging control unit 510 may be included in a programmable computer device (not shown) separate from the chemical injection device 100 and the fluoroscopic imaging device 500. By doing so, it is not necessary for the chemical injection device 100 and the fluoroscopic imaging device 500 to have separate consoles, and the input unit and the display unit of each control unit can be shared. As a result, the configuration of the entire system can be simplified.
  • the injection control unit 101 can be incorporated in a unit different from the remaining other functions.
  • the injection condition determination (calculation) function can be incorporated into the imaging control unit 510 and the remaining other functions can be incorporated into the injection control unit 101.
  • the injection condition determination (calculation) function can be incorporated into the imaging control unit 510 and the remaining other functions can be incorporated into the injection control unit 101.
  • Data that is insufficient when determining the injection conditions may be input from the imaging control unit 510, or may be transmitted from the injection control unit 101 to the imaging control unit 510.
  • the function of the injection control unit 101 and the function of the imaging control unit 510 can be realized by using various hardware as required, but the main body is realized by the function of the CPU corresponding to the computer program.
  • the computer program is at least part of the procedure described above, for example, Receiving an input of the degree of dilution of the chemical solution released from the first syringe (container) by the chemical solution released from the second syringe (container); Using at least the input dilution level, setting a discharge condition of the chemical solution from the first and second syringes (containers) in a purge operation performed prior to the injection of the chemical solution; Performing the purge operation by controlling the operations of the first and second (piston) drive mechanisms provided in the chemical injection device according to the set release conditions; Can be implemented as a computer program for causing a medical imaging apparatus 100, a fluoroscopic imaging apparatus 500, or a fluoroscopic imaging system including the chemical liquid injection apparatus 100 and the fluoroscopic imaging apparatus 500 to execute.
  • the injection head 110 and the console 112 shown in FIG. 2 can be integrally configured.
  • the console 112 is also arranged in the examination room. Since the hand switch 118 can be used to start and stop the injection operation, the operator can control the start and stop of the injection operation in the operation chamber by the hand switch 118.
  • the two piston drive mechanisms 130a and 130b are mounted on the common injection head 110.
  • the chemical liquid injector has two injection heads each equipped with one piston drive mechanism, and at the time of purge operation and injection, the injection control unit 101 interlocks each injection head to dilute a plurality of chemical liquids. It can also be done.
  • the chemical solution injector 100 can further include a load cell that detects the injection pressure.
  • the load cell can be provided in the presser 131 (see FIG. 3), for example. As shown in FIG. 3, in the case of having a plurality of pressers 131, at least one of them may have a load cell.
  • the injection pressure can also be detected by measuring the current of the motor that is the drive source of the piston drive mechanisms 130a and 130b. When the load acting on the presser 131 increases, the motor current increases according to the load. This is used for detecting the injection pressure using the motor current.
  • the detection of the injection pressure may be either one of detection using a load cell and detection using a motor current, or both may be used in combination. When both are used together, the injection pressure is usually detected by the load cell, and the injection pressure can be measured using the measurement result of the motor current only when the load cell fails.
  • the chemical liquid injector 100 can further include an RFID module 166.
  • RFID module 166 is for reading data from the RFID tag 352 and / or for recording data in the RFID tag 352. Since the chemical liquid injector 100 includes the RFID module 166, the data recorded in the RFID tag 352 can be used to control the operation of the chemical liquid injector 100 by the injection control unit 101. 9, the same components as those shown in FIG. 1 are denoted by the same reference numerals as those in FIG. 1, and the description thereof is omitted here.
  • the RFID module 166 has an RFID control circuit 164 and an antenna 165, reads data recorded in the RFID tag 352 by the antenna 165, transmits the read data to the injection control unit 101, and / or the injection control unit.
  • the data transmitted from the terminal 101 can be recorded on the RFID tag 352.
  • the RFID control circuit 164 controls data transmission / reception operations in the RFID module 166. That is, the RFID module 166 functions as a reader that reads data from the RFID tag 352 or a reader / writer that records data in the RFID tag.
  • the antenna 165 of the RFID module 166 is built in the injection head 110 (see FIG. 2), and data is automatically received from the RFID tag 352 when a container 350 containing a chemical is appropriately attached to the injection head 110.
  • the unit may be a handy type unit other than the injection head 110, and the operator reads the data from the RFID tag 352 by bringing the unit and the RFID tag 352 relatively close to each other. You may do it.
  • the data recorded in the RFID tag 352 includes various data relating to the chemical solution contained in the container 350, such as the manufacturer, the type of chemical solution, the product number, and the contained components (particularly, the iodine-containing concentration when the chemical solution is a contrast agent). ), Amount of stored chemical, lot number, expiry date, etc.
  • various data related to the syringe 220 for example, a unique identification number such as a manufacturer and a product number, an allowable pressure value, a capacity of the syringe, a piston stroke, dimensions of necessary parts, a lot number, and the like can be included. At least a part of these data can be transmitted to the fluoroscopic imaging apparatus 500.
  • the extension tube is preferably equipped with a mixing device that ensures good mixing of the contrast agent and saline.
  • a mixing device that ensures good mixing of the contrast agent and saline.
  • the extension tube includes a first tube 231a that connects the syringe filled with the contrast medium and the mixing device 241; a second tube 231b that connects the syringe filled with the physiological saline and the mixing device 241; And a third tube 231c connected to a liquid outlet (detailed below) of the mixing device 241 and extending toward the patient.
  • the first and second tubes 231a and 231b may be connected to the conduit portion of the syringe via connectors 239a and 239b, respectively.
  • the third tube 231c may be connected to a catheter or the like via the connector 239c.
  • at least one of the connectors 239a and 239b connected to the first tube 231a and the second tube 231b may include a one-way valve. At least one may have a release function.
  • the mixing device 241 includes a first chamber that is a swirl flow generation chamber 242a that generates a swirl flow, and a second chamber that is a constriction chamber 242b that concentrates the swirl flow in the axial direction.
  • a main body 242 is provided.
  • the swirl flow generation chamber 242a has a cylindrical inner space
  • the constriction chamber 242b has a conical inner space coaxial with the swirl flow generation chamber 242a.
  • the cross-sectional shape in the short direction of the swirl flow generating chamber may be various shapes formed from a circle, an ellipse, or other curves.
  • the swirl flow generation chamber can be configured to have a narrowed shape that narrows as it approaches the narrowed chamber.
  • a conduit portion 243a to which the first tube 231a is connected is provided on the upstream side of the main body portion 242 of the mixing device 241, and a conduit portion 243c to which the third tube 231c is connected is provided on the downstream side.
  • the conduit portion 243b to which the second tube 231b is connected is disposed at a position upstream from the center of the swirl flow generation chamber 242a (details below).
  • the contrast agent flows from the conduit portion 243a and the physiological saline flows from the conduit portion 243b, and both drug solutions are mixed in the mixing device. Thereafter, the mixed drug solution of the contrast medium and physiological saline flows out from the conduit portion 243c as a liquid outlet.
  • the conduit portion 243a into which a high specific gravity chemical solution flows is provided in the central portion of the upstream side wall surface of the swirl flow generation chamber 242a on the upstream side in the flow direction.
  • the conduit portion 243c serving as the liquid outlet is provided so that the center line of the conduit portion 243c and the center line of the conduit portion 243a coincide, that is, both are coaxial.
  • the conduit portion 243b into which the chemical liquid having a small specific gravity flows is disposed on the side surface of the swirl flow generation chamber 242a and extends in the tangential direction of the circumference of the swirl flow generation chamber 242a having a circular cross section.
  • the conduit portion 243b is provided at a position shifted to the peripheral side from the central axis of the cylindrical space included in the swirl flow generation chamber 242a, and thereby, the chemical liquid having a small specific gravity flowing from the conduit portion 243b.
  • the swirl flow is generated. More specifically, as shown in FIG.
  • the flow path 241fb is configured to extend in the circumferential tangential direction of the curved inner surface of the swirl flow generation chamber 242a, and thereby flows from this flow path.
  • the chemical becomes a swirl flow.
  • the constriction chamber 242b has an inclined inner surface that swells 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. Become.
  • the conduit portion 243a into which the contrast agent flows is in communication with the swirling flow generation chamber 242a through the flow path 241fa.
  • the chemical liquid having a large specific gravity can be introduced into the swirling flow generating chamber in a direction parallel to the central axis of the swirling flow of the chemical liquid having a small specific gravity. That is, the chemical liquid having a large specific gravity is introduced in a direction parallel to the central axis of the cylindrical space included in the swirl flow generation chamber.
  • the conduit part into which the physiological saline flows is in communication with the swirl flow generation chamber via the flow path 241fb.
  • the inner diameter of the flow path 241fb may be smaller than the inner diameter of the flow path 241fa into which the contrast agent flows.
  • the mixing device 241 configured as described above, for example, when a contrast medium and physiological saline are flowed into the device, the contrast medium that has flowed into the swirl flow generation chamber from the flow path 241fa flows toward the downstream side in the axial direction. Become.
  • the physiological saline flowing into the swirl flow generation chamber from the flow path 241fb becomes a swirl flow swirling along the curved inner surface of the same chamber, and the swirl flow of the physiological saline is guided to the stenosis chamber and swirls. Concentrate in the direction of the central axis of the flow.
  • a vortex is known as a Rankine vortex, and the inertial force of the swirling flow can be concentrated in the vicinity of the rotation axis of the vortex.
  • both chemicals will be mixed well. That is, in this example, it is possible to obtain a diluted contrast agent in which the contrast agent and physiological saline are well mixed. As a result, there is no unevenness in the concentration of the contrast agent. An excellent contrast effect can be expected compared to the case of the extension tube.
  • At least the drug solution injection device 100 and the fluoroscopic imaging device 500 may be connected to a medical network.
  • the injection speed, injection time, and injection volume of the drug solution injected by the drug solution injection device 100 (when multiple injections are performed in one examination and / or treatment, the injection amount for each injection) And the total injection amount of a series of injections), the injection graph, the type of the injected medicinal solution, the injection result including the dilution ratio when the dilution injection is performed, and the imaging conditions by the fluoroscopic imaging device 500 are obtained through the medical network.
  • injection data can be stored as injection data in a fluoroscopic imaging device, RIS (radiological information system), PACS (medical image storage management system), HIS (hospital information system), and the like.
  • RIS radio information system
  • PACS medical image storage management system
  • HIS hospital information system
  • the stored injection data is used for management of injection history.
  • the injection amount or the like can be recorded in the chart information as a used chemical solution or used for accounting.
  • physical information such as the body weight of the subject, ID, name, examination site, and examination method can be acquired from RIS, PACS, HIS, etc., and displayed on the drug solution injector, and injection can be performed accordingly.
  • Such information may be transmitted from the chemical injection device 100 to the RIS, PACKS, HIS, or the like via the fluoroscopic imaging device 500, or may be transmitted directly from the chemical injection device 100 to the RIS, PACKS, HIS, or the like.
  • the chemical injection device 100 includes the RFID module 166
  • data transmitted to the RIS, PACKS, HIS, or the like can include data acquired from the RFID tag 352 by the RFID module 166.

Landscapes

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

Abstract

L'invention concerne un dispositif d'injection de liquide médicamenteux permettant de modifier la concentration d'un liquide médicamenteux à volonté, même pendant une opération d'expulsion. Ce dispositif d'injection de liquide médicamenteux 100 comprend : une tête d'injection dotée de deux mécanismes d'entraînement de piston 130a et 130b, actionnant chacun une seringue; et une unité de commande d'injection 101. L'unité de commande d'injection 101 accepte en entrée un degré de dilution du liquide médicamentaux, utilise au moins le degré de dilution qui a été entré pour établir des conditions de décharge du liquide médicamenteux au cours d'une opération d'expulsion et commande le fonctionnement des mécanismes d'entraînement de piston 130a et 130b, conformément aux conditions de décharge établies.
PCT/JP2016/068479 2015-06-24 2016-06-22 Dispositif d'injection de liquide médicamenteux Ceased WO2016208611A1 (fr)

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WO2018190367A1 (fr) * 2017-04-12 2018-10-18 株式会社根本杏林堂 Dispositif d'injection de solution de médicament
WO2019103110A1 (fr) * 2017-11-24 2019-05-31 株式会社根本杏林堂 Tête d'injection et dispositif d'injection de produit chimique la comprenant
CN110987584A (zh) * 2019-11-25 2020-04-10 湖南省计量检测研究院 溶液的稀释方法和系统
CN111330116A (zh) * 2020-03-23 2020-06-26 江苏省人民医院（南京医科大学第一附属医院） 一种超声阻滞用脚控式推药装置
JP2023058672A (ja) * 2017-06-29 2023-04-25 アセンディス ファーマ エー／エス 再構成処理サポートを有する自動注入装置

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CN112218668B (zh) 2018-04-19 2023-07-18 拜耳医药保健有限公司 流体注入器中空气检测的系统和方法
US12208239B2 (en) 2018-08-28 2025-01-28 Bayer Healthcare Llc Fluid injector system, method of preventing fluid backflow, and computer program product
AU2019332923A1 (en) 2018-08-28 2021-02-11 Bayer Healthcare Llc Fluid injector system with improved ratio performance

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JP2023103465A (ja) * 2017-04-12 2023-07-26 株式会社根本杏林堂 薬液注入装置
JP2022065048A (ja) * 2017-04-12 2022-04-26 株式会社根本杏林堂 薬液注入装置
CN110753562A (zh) * 2017-04-12 2020-02-04 株式会社根本杏林堂 化学液体注入装置
JPWO2018190367A1 (ja) * 2017-04-12 2020-02-27 株式会社根本杏林堂 薬液注入装置
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JP7028472B2 (ja) 2017-04-12 2022-03-02 株式会社根本杏林堂 薬液注入装置
CN110753562B (zh) * 2017-04-12 2022-04-12 株式会社根本杏林堂 化学液体注入装置
JP2025041947A (ja) * 2017-06-29 2025-03-26 アセンディス ファーマ エー／エス 再構成処理サポートを有する自動注入装置
JP7615188B2 (ja) 2017-06-29 2025-01-16 アセンディス ファーマ エー／エス 再構成処理サポートを有する自動注入装置
JP2023058672A (ja) * 2017-06-29 2023-04-25 アセンディス ファーマ エー／エス 再構成処理サポートを有する自動注入装置
CN111629769B (zh) * 2017-11-24 2023-08-15 株式会社根本杏林堂 注射头和使用该注射头的药液注射器
WO2019103110A1 (fr) * 2017-11-24 2019-05-31 株式会社根本杏林堂 Tête d'injection et dispositif d'injection de produit chimique la comprenant
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EP3714923A4 (fr) * 2017-11-24 2021-11-24 Nemoto Kyorindo Co., Ltd. Tête d'injection et dispositif d'injection de produit chimique la comprenant
JP2023027283A (ja) * 2017-11-24 2023-03-01 株式会社根本杏林堂 注入ヘッドおよびそれを備える薬液注入装置
CN111629769A (zh) * 2017-11-24 2020-09-04 株式会社根本杏林堂 注射头和使用该注射头的药液注射器
US12337149B2 (en) 2017-11-24 2025-06-24 Nemoto Kyorindo Co., Ltd. Injection head and chemical injection device comprising same
CN110987584B (zh) * 2019-11-25 2022-07-01 湖南省计量检测研究院 溶液的稀释方法和系统
CN110987584A (zh) * 2019-11-25 2020-04-10 湖南省计量检测研究院 溶液的稀释方法和系统
CN111330116A (zh) * 2020-03-23 2020-06-26 江苏省人民医院（南京医科大学第一附属医院） 一种超声阻滞用脚控式推药装置

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