WO2023036339A1 - 高压造影剂注射系统 - Google Patents

高压造影剂注射系统 Download PDF

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Publication number
WO2023036339A1
WO2023036339A1 PCT/CN2022/118452 CN2022118452W WO2023036339A1 WO 2023036339 A1 WO2023036339 A1 WO 2023036339A1 CN 2022118452 W CN2022118452 W CN 2022118452W WO 2023036339 A1 WO2023036339 A1 WO 2023036339A1
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WIPO (PCT)
Prior art keywords
contrast medium
syringe
injection
injection system
pressure
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Application number
PCT/CN2022/118452
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English (en)
French (fr)
Inventor
堀信一
堀笃史
五十岚光夫
五十岚亮莱昂纳多
宫田智治
Original Assignee
临床支持有限公司
科斯米克M.E.公司
阿波罗Rt有限公司
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Publication of WO2023036339A1 publication Critical patent/WO2023036339A1/zh

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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
    • A61M5/007—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 for contrast media
    • 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
    • A61M39/00—Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
    • A61M39/10—Tube connectors; Tube couplings
    • A61M39/105—Multi-channel connectors or couplings, e.g. for connecting multi-lumen tubes
    • 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
    • A61M5/142—Pressure infusion, e.g. using pumps
    • A61M5/145—Pressure infusion, e.g. using pumps using pressurised reservoirs, e.g. pressurised by means of pistons
    • A61M5/1452—Pressure infusion, e.g. using pumps using pressurised reservoirs, e.g. pressurised by means of pistons pressurised by means of pistons
    • 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
    • A61M5/16831—Monitoring, detecting, signalling or eliminating infusion flow anomalies
    • A61M5/1684—Monitoring, detecting, signalling or eliminating infusion flow anomalies by detecting the amount of infusate remaining, e.g. signalling end of infusion
    • 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
    • A61M5/36—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 with means for eliminating or preventing injection or infusion of air into body
    • A61M5/365—Air detectors
    • Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y02—TECHNOLOGIES OR APPLICATIONS FOR MITIGATION OR ADAPTATION AGAINST CLIMATE CHANGE
    • Y02A—TECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE
    • Y02A50/00—TECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE in human health protection, e.g. against extreme weather
    • Y02A50/30—Against vector-borne diseases, e.g. mosquito-borne, fly-borne, tick-borne or waterborne diseases whose impact is exacerbated by climate change

Definitions

  • the invention relates to the technical field of medical devices, in particular to a high-pressure contrast medium injection system.
  • Contrast agent is one of the most commonly used drugs in interventional radiology operations, mainly used for the display of blood vessels and body cavities to improve the accuracy of diagnosis.
  • contrast agents There are various types of contrast agents, and most of the contrast agents currently used in interventional radiology are iodine-containing preparations.
  • Contrast medium consumption is an independent risk factor for contrast nephropathy.
  • Cigarroa et al. proposed a formula for calculating the amount of contrast agent: 5ml ⁇ body weight (Kg)/Cr(mg/dl), and the maximum amount should not exceed 300ml. Studies have shown that the incidence of contrast nephropathy is 21%-37% if the dosage exceeds the threshold, and 0%-2% if the threshold is not exceeded.
  • the incidence and severity of physical-chemical reactions are related to the amount of contrast agent used.
  • the osmotic pressure of commonly used contrast agents is significantly higher than that of blood, which is 2 to 5 times that of blood, so it is easy to cause various damages, so reduce contrast agent
  • the dosage is beneficial to the patient.
  • the object of the present invention is to provide a high-pressure contrast medium injection system capable of injecting contrast medium at a precisely controlled low flow rate and small dose.
  • the present invention provides a high-pressure radiography injector and its accessories, including: a bedside stand arranged on the bedside, a contrast agent bag is suspended from the top of the bedside stand; A rocker arm assembly protruding from the side; an injection head arranged at the tip of the rocker arm assembly, the front end of the injection head is provided with a syringe; and a three-way pipeline with three ports, the three-way pipeline
  • the three ports are respectively connected to the contrast agent bag, the syringe, and the microcatheter for inputting the contrast agent to the patient;
  • the injection head includes an execution unit and a detection control unit; the detection control unit controls the execution unit to Precisely push and pull the rubber stopper in the syringe, continuously draw medicine from the contrast medium bag through the three-way pipeline and inject the contrast medium into the patient's body.
  • the three ports of the three-way pipeline include: a first port connected to the contrast agent bag through a drug suction circuit; a second port connected to the microcatheter through an injection circuit; and The third port of the syringe; the first port and the second port have one-way valves arranged in the same direction.
  • the drug inhalation circuit and the injection circuit are respectively provided with air bubble detection devices.
  • the execution unit includes a motor, a transmission assembly, and a screw assembly; Push and pull the rubber stopper in a straight line.
  • the detection control unit is connected with a Hall sensor, a limit sensor, an encoder and an injection head button.
  • the detection control unit is further connected with a syringe detection sensor for detecting whether a syringe is installed on the injection head.
  • the detection control unit is connected to the air bubble detection device, and stops the operation of the equipment and sends out an alarm when air bubbles are detected in the pipeline.
  • the theoretical injection accuracy of the injection head is 0.00413 mL.
  • the syringe is made of high-strength polymer material.
  • the capacity of the syringe is 30ml.
  • the invention can carry out the contrast agent with precisely controlled low flow rate and small dose, and reduces the adverse effect of the contrast agent on patients.
  • Fig. 1 shows a high-pressure contrast medium injection system according to an embodiment of the present invention
  • (a) is a schematic structural diagram of a high-pressure contrast medium injection system
  • (b) is a schematic diagram of a control display and a manual switch
  • (c) is a schematic diagram of a high-pressure contrast medium injection system.
  • Figure 2 shows the three-way pipeline and its connection;
  • Fig. 3 is a block diagram of a high-pressure contrast medium injection system
  • FIG. 4 is a flow chart showing the detection process in the control process of the high-pressure contrast medium injection system
  • FIG. 5 is a flow chart showing the injection flow in the control flow of the high-pressure contrast medium injection system
  • High-pressure contrast medium injection system 200. Bed; 101. Bedside track; 101a. Limiting piece; 102. Bedside column; 103. Bedside monitor; 110. Injection head; 111. First rocker arm; 112. The second rocker arm; 113, the injection head installation seat; 114, the three-way pipeline; 1141, the first port; 1142, the second port; 1143, the third port; Sensor; 1103, limit sensor; 1104, encoder; 1105, syringe detection sensor; 1106, injection head button; 1107, ICTAG module; 120, power box; 1201, drive MCU chip; 1202, motor drive module; 1203, current Detection sensor; 1204, power module; 1205, online module; 130, control display; 131, manual switch; 1301, control MCU chip; 1302, liquid crystal display; 1303, display button; 1304, touch screen; 1401, foot switch ; 1402, handle control switch; 1403, air bubble sensor.
  • a high-pressure contrast medium injection system capable of injecting contrast medium at a precisely controlled low flow rate and small dose.
  • Using the high-pressure contrast medium injection system can reduce the dose of contrast medium used during surgery and reduce damage to patients.
  • FIG. 1 shows a high-pressure contrast medium injection system 100 according to an embodiment of the present invention
  • (a) is a schematic structural diagram of the high-pressure contrast medium injection system 100
  • (b) is a schematic diagram of a control display 130 and a manual switch 131
  • (c) is a schematic diagram of the foot switch 1401
  • FIG. 3 is a block diagram of a high pressure contrast injection system 100
  • the outward direction of the paper in (a) in Figure 1 is defined as "front”
  • the inward direction of the paper is defined as “rear”
  • "upper", “lower”, “left”, and “right” are defined as “front” “Up”, “Down”, “Left", and “Right” directions when observing the high-pressure contrast medium injection system 100 .
  • orientation or positional relationship in the description of the present invention is based on the orientation or positional relationship shown in the drawings, which is only for the convenience of describing the present invention and simplifying the description, rather than indicating or implying that the referred device or element must have Certain orientations, constructed and operative in certain orientations, therefore are not to be construed as limitations on the invention.
  • the high-pressure contrast medium injection system 100 includes a bedside support set on the bedside, a rocker assembly protruding from the middle of the bedside support to one side, and a Injection head 110 , tee pipeline 114 , power box 120 and control display 130 .
  • the bedside support includes a pair of bedside rails 101 extending in the horizontal direction on both sides of a bed 200 for the patient lying on his back, and a limit position is set on the bedside rails 101.
  • 101a the position of the limiting member 101a can be adjusted along the bedside rail 101 by adjusting the knob on the limiting member 101a.
  • the stopper 101a protrudes outwards in the middle, where a bedside column 102 erected upwards is provided, and a device is provided on the top of the bedside column 102 to receive information from a driving MCU chip 1201 described later and display it on a display screen.
  • a handle control switch 1402 for controlling injection of contrast medium together with a foot switch 1401 described later is provided on the right bedside rail 101 .
  • the handle control switch 1402 is connected to the power supply box 120, and is used to control the injection in the variable-speed injection mode. The handle is pushed forward to start injection. Release automatically springs back to the starting position and the injection stops.
  • the manual switch 131 is connected to the display, and is used to control the start and stop of the injection in the angiography mode.
  • the button is kept pressed, the parameter injection is performed until the injection volume of the setting is completed, and the injection process is terminated when the button is released.
  • a swing arm assembly including a first swing arm 111 and a second swing arm 112 is formed on substantially the middle of the bedside column 102 .
  • the first rocker arm 111 extends linearly in a substantially horizontal direction, and is set on the bedside column 102 to swing freely on the horizontal plane with its base end as the center. 111 freely rotating movable joints are used as rocker arm seats.
  • a linear second rocker arm 112 that can swing freely on a vertical plane with the base end as the center is provided on the rocker arm base.
  • An injection head mount 113 for mounting the injection head 110 is provided at the tip end of the second rocker arm 112 .
  • the injection head mount 113 includes an upper portion of the mount and a lower portion of the mount.
  • the lower part of the mounting seat is connected to the tip end of the second rocker arm 112 in a form that can freely swing relative to the second rocker arm 112 in the vertical plane.
  • the upper part of the mounting part is formed in a substantially L-shape, the vertical part is rotatably connected to the lower part of the mounting seat, and the horizontal part is used to fix the injection head 110 by inserting the injection head handle of the injection head 110 which will be described later.
  • the position of the injection head 110 in the space can be adjusted with multiple degrees of freedom, which can meet the needs of the injection head 110 when injecting contrast media. various location requirements.
  • Injection head 110 is an injection head for a high-pressure syringe capable of injecting contrast medium with high precision and low flow rate.
  • a high-pressure contrast medium syringe is arranged on the syringe seat at the front end of the injection head 110.
  • the syringe can be made of medical-grade high-strength polymer material (such as PC material), and its capacity can be 30ml, which can ensure that the syringe can be used during injection. No deformation, thus improving injection accuracy.
  • the syringe is connected to the contrast agent bag mounted on the liquid medicine holder 115 through the three-way pipeline 114, and connected to the microcatheter for injecting the contrast agent into the patient, the details of which will be described later.
  • the execution unit includes a motor 1101 arranged on the frame of the injection head, a transmission assembly and a screw assembly, wherein the motor 1101 can be a high-precision motor, the transmission assembly can be a synchronous belt transmission mechanism, and the screw assembly is provided with glue with the syringe.
  • the push rod connected by the plug converts the rotational power transmitted by the transmission assembly into a linear displacement.
  • the motor 1101 runs under the control of the drive module 1202 of the motor 1101 in the power box 120 described later, and is converted into the forward and backward displacement of the push rod through the mechanical structure such as the transmission assembly and the screw assembly, thereby controlling the syringe to suck the contrast agent and inject the contrast agent Actions such as medicine.
  • the maximum speed of the motor 1101 can reach 16,900 revolutions, for example, and it is equipped with a planetary gear reducer. Its reduction ratio can be, for example, 20:1, and the precise reduction ratio is 81:4.
  • the transmission ratio of the synchronous belt transmission mechanism as the transmission assembly can be 20:12. With a high-precision encoder integrating 1024 counts per revolution and a screw pitch of 2mm, the theoretical injection accuracy of the injection head 110 can reach 0.00413mL.
  • the detection control unit is connected with Hall sensor 1102 , limit sensor 1103 , encoder 1104 , syringe detection sensor 1105 and injection head button 1106 .
  • the Hall sensor 1102 is disposed near the output shaft of the motor 1101 , and is mainly used to detect the number of rotations of the motor 1101 and transmit the detected data to the driving MCU chip 1201 .
  • the limit sensor 1103 is installed on the injection head frame, and it is set with a front limit (corresponding to the preset maximum liquid discharge volume of the syringe) and a rear limit (corresponding to the preset maximum liquid suction volume of the syringe) , is mainly used to detect whether the slider in the screw assembly has moved to the limit position. When it is detected that the slider has moved to the limit position, a signal will be sent to the driving MCU chip 1201, and the motor 1101 will be controlled to stop rotating by driving the MCU chip 1201.
  • the encoder 1104 is used to detect the rotation of the motor, and transmit the detection data to the driving MCU chip 1201 .
  • the syringe detection sensor 1105 is arranged on the syringe seat, used to detect whether the syringe is installed, and transmits the detection signal to the driving MCU chip 1201 .
  • the injection head button 1106 is set on the top of the injection head 110 housing, which may include a control button for controlling the injection speed and a stop button for stopping the machine, etc., and is mainly used to accept the operation of the staff and transmit the operation signal to the driving MCU chip 1201 .
  • the detection control unit can also include an ICTAG module 1107, which can be used for syringe identification, and the ICTAG module 1107 can read the The information in the chip is then sent to the driver MCU chip 1201.
  • the three-way pipeline 114 can include, for example, a multi-way valve and a plurality of connecting pipes.
  • the contrast agent bag, the third side is connected to the microcatheter through the connecting tube for outputting the contrast agent to the patient.
  • these connecting pipes are respectively provided with bubble sensors 1403 respectively corresponding to the connecting pipes for detecting whether there are bubbles in the flow path. And accept the feedback echo, because the echoes reflected in different media (especially liquid and air) are different, so when the echo signal is detected to change, it is determined that there are air bubbles flowing in the pipeline.
  • the bubble sensor 1403 can be at a high level when no bubble is detected, and be at a low level when a bubble is detected, and send a signal to the driving MCU chip 1201 .
  • FIG. 2 shows the tee line 114 and its connections.
  • the three-way pipeline 114 is provided with three-way three-way pipelines, which are respectively the first port 1141 connected to the contrast agent bag through the suction circuit, the second port 1142 connected to the microcatheter through the injection circuit, and the connection port 1141.
  • the three-way pipeline 114 is provided with co-directional one-way valves on the first port 1141 and the second port 1142 .
  • the one-way valve is provided with an umbrella-shaped top and a flexible valve plate that can bend under the action of liquid pressure difference.
  • the two one-way valves By setting the two one-way valves in the same direction, when you want to draw the contrast agent into the syringe and pull the rubber plug, you can communicate with the one-way valve on the first port 1141 and close the one-way valve on the second port 1142.
  • a one-way valve so that contrast media is not drawn from the injection circuit when contrast media is aspirated.
  • the one-way valve arranged on the second port 1142 can be communicated to close the one-way valve arranged on the first port 1141, so that there is no need to inject contrast agent when injecting the contrast agent.
  • the contrast medium will be drawn from the contrast medium bag. Therefore, the injection head 110 in the high-pressure contrast medium injection system can quickly inhale the drug and then inject again without disassembling the pipeline, avoiding repeated exhaust operations that may pollute the pipeline or cause air bubbles to enter the pipeline.
  • bubble detection devices 1403 are respectively provided on the drug absorption circuit and the injection circuit connected to the three-way pipeline 114.
  • the bubble detection device 1403 can be an ultrasonic bubble sensor, which emits ultrasonic waves into the pipeline and receives feedback. Echo, because the echoes reflected in different media (especially liquid and air) are different, so when a change in the echo signal is detected, it is determined that there are air bubbles flowing in the pipeline. More specifically, when the air bubble sensor 1403 on the suction circuit detects air bubbles, it means that there is no contrast medium in the contrast agent bag, and it prompts that the medicine bag needs to be replaced; when the air bubble sensor 1403 on the injection circuit detects air bubbles, the injection will be stopped and an alarm will be issued. sound, and a warning message is displayed on the monitor. At this time, manual intervention should be performed to remove the air in the circuit, and then the circuit should be connected, and the contrast medium injection should be performed again.
  • a power supply box 120 is provided under the bed 200 .
  • the power supply box 120 is the power supply and control center of the high-voltage contrast medium injection system 100. As shown in FIG.
  • the driver MCU (Micro Control Unit; micro control unit) chip 1201 is a micro control chip that integrates memory, counter, USB, A/D conversion, UART, PLC, DMA and other peripheral interfaces.
  • the driving MCU chip 1201 is the main control chip of the high-pressure contrast medium injection system 100, which stores control software inside, controls the operation and stop of the equipment, and monitors the operation status of the entire high-pressure contrast medium injection system 100 at the same time, and stops the equipment when abnormal operation is found run, and send an error signal to the control MCU chip 1301 arranged on the main board inside the control display 130 described later, and its specific work will be described later.
  • the motor driving module 1202 is mainly used to control the operation of the motor 1101 according to the instructions from the control MCU chip 1301 .
  • the current detection sensor 1203 is mainly used to detect the current when the motor is running, and then convert it into pressure to detect the pressure of the injection process.
  • the power module 1204 is mainly used to supply power to the high-pressure contrast medium injection system 100 .
  • the high-pressure contrast agent injection system 100 can be linked with external devices such as DSA (Digital subtraction angiography; digital subtraction angiography technology), C-arm machine, etc. through the online module 1205 .
  • the online module 1205 is used to receive signals from external devices (such as start injection signals) and send the signals to the driver MCU chip 1201, or receive signals to drive the MCU chip 1201 (generally include start signals, device running signals, device standby signals, etc.) ) and send this signal to the external device.
  • the driving MCU chip 1201 in the power supply box 120 is also electrically connected to the foot switch 1401 , the handle control switch 1402 and the air bubble sensor 1403 arranged on the three-way pipeline 114 described later.
  • the foot switch 1401 is used to accept the stepping operation.
  • an injection start signal is sent to the driving MCU chip 1201, and the injection is stopped when the foot switch 1401 is released. This function is only valid in the trial injection interface .
  • the handle control switch 1402 sends a signal to the driver MCU chip 1201 according to the position of the handle under the variable speed injection interface.
  • the change of the motor running speed can be controlled by the change of the handle position. For example, when the handle is at the initial position, the injection speed is zero, and the handle is different. The position represents different speeds.
  • the injection speed is controlled by controlling the position of the handle with the hand, and the handle automatically returns to the initial position when the handle is released.
  • the high pressure contrast medium injection system 100 further includes a control display 130 .
  • the control display 130 may be provided separately from other structures of the high-pressure contrast medium injection system 100 .
  • the control display 130 includes a control MCU chip 1301 , a liquid crystal display 1302 , display buttons 1303 and a touch screen 1304 for accepting input of injection parameters.
  • the display buttons 1303 may include, for example: a stop button, used to stop the action of the injection head; a record button, used to call the latest 20 injection records; a program button, used to store the set parameters or call the stored parameters; and the mode key, which is used to switch between different modes such as angiography, variable speed injection, trial injection, etc.
  • the parameter range of each mode is different, and the application is different in different occasions.
  • the control display 130 is installed with the main control program in the control MCU chip 1301 on the main board, and the injection parameters can be input through the touch screen 1304 to control the automatic injection of the injection head 110, and at the same time receive the feedback information of the injection head 100 during the injection process, And on the liquid crystal display 1302, the injection pressure map, injection flow rate, flow rate, injection time and other relevant information are displayed. These parameters include, for example, flow rate, flow rate, pressure limit, injection delay time, scan delay time, speed-up time and so on.
  • the control display 130 is also connected to a manual switch 131 .
  • Graphics processing software is stored in the control MCU chip 1301 to process received signals and display the running conditions on the liquid crystal display 1302 .
  • the control MCU chip 1301 receives the signal driving the MCU chip 1201. If it is an error or alarm signal, the corresponding error code or warning message will be displayed on the LCD screen 1302; if it is equipment operation information, it will be converted into a running diagram and displayed on the LCD screen. At 1302, information is sent to the driver MCU chip 1201 at the same time, and the driver MCU chip 1201 forwards the information to the bedside display 103 for synchronous display.
  • the control MCU chip 1301 also receives one or more of the input parameter information on the touch screen 1304, the start instruction information of the manual switch 131 and the signal of the display button 1303, and sends it to the driving MCU chip 1201.
  • the driving MCU chip 1201 of the present invention mainly works as follows: receive the signal of the Hall sensor 1102 and the signal of the encoder 1104, and convert it into the stroke of the push rod in the injection head 110 (that is, the stroke of the rubber stopper of the syringe) ), compared with the target stroke amount, when it is found that the difference is greater than 25%, an instruction is sent to the motor drive module 1202 to stop the operation of the motor 1101, and an error message is sent to the bedside display 103 and the control display 130 described later; Inspection (including whether each button is in the initial state, whether the signal transmission of each component is normal, etc.); monitoring during system operation (checking of signal transmission, motor working status or motor voltage, operating speed, power module, etc.); receiving control display 130 The signal (parameter input) of the control MCU chip 1301, when receiving the equipment operation instruction signal, sends the signal to the motor drive module 1202 according to the received parameter information, controls the operation of the motor 1101, and receives the signal
  • FIG. 4 is a flow chart showing a detection flow in the control flow of the high-pressure contrast medium injection system
  • FIG. 5 is a flow chart showing an injection flow in the control flow of the high-pressure contrast medium injection system.
  • the driving MCU chip 1201 first performs a system self-check, which includes checking whether each button is in an initial state, whether the signal transmission of each component is normal, and so on. If a system abnormality is detected (determined as no), restart the mirror after clearing the fault, and perform a system self-check again. If it is determined that everything is normal for each device (determined as Yes), then enter the initial interface.
  • a system self-check includes checking whether each button is in an initial state, whether the signal transmission of each component is normal, and so on. If a system abnormality is detected (determined as no), restart the mirror after clearing the fault, and perform a system self-check again. If it is determined that everything is normal for each device (determined as Yes), then enter the initial interface.
  • the syringe detection sensor 1105 After entering the initial interface, the syringe detection sensor 1105 detects whether a syringe is installed on the injection head 110 , and sends the detection signal to the driving MCU chip 1201 . If the syringe detection sensor 1105 does not detect the syringe (judgment is no), the MCU chip 1201 is driven to send an error signal, and the staff manually installs and fixes the syringe to the injection head 110, and then the syringe detection sensor 1105 performs syringe detection again . When the syringe detection sensor 1105 detects a syringe (YES), the system waits.
  • YES a syringe
  • the worker installs the three-way pipeline 114 to connect it with the syringe on the injection head 110, and presses the back button to draw the contrast medium into the syringe.
  • multiple air bubble sensors 1403 installed on the three-way pipeline 114 detect whether there are bubbles in the pipeline, and transmit the detection signal to the driving MCU chip 1201 . If the air bubble sensor 1403 determines that there are air bubbles in the pipeline (determined to be yes), the drive MCU chip 1201 will send corresponding error information according to which air bubble sensor 1403 determines that there are air bubbles in the pipeline. Air bubbles exist in which line, so artificial exhaust.
  • the air bubble sensor 1403 determines that no air bubbles are detected, that is, when it is determined that there is no air bubbles in the three-way pipeline 114, the process proceeds to the step of waiting for injection parameter input.
  • the staff inputs injection parameters by controlling the touch screen 1304 in the display 130 , and drives the MCU chip 1201 to determine whether the remaining amount of contrast medium in the syringe is sufficient after receiving the set injection parameters.
  • the front limit of the injection head can be set to the 0 position of the equipment.
  • the system will automatically calibrate the 0 position, and the display will show that the remaining amount is 0.
  • the encoder 1104 will count and record the position of the push rod, corresponding to the remaining amount of the syringe and displayed on the display.
  • the system will compare the set volume with the recorded remaining volume.
  • a system prompt is issued to request that the contrast agent be replenished into the syringe.
  • the staff first confirm the remaining amount of contrast agent in the contrast agent bag, and replace the contrast agent bag when the contrast agent in the contrast agent bag is insufficient. If the contrast agent in the contrast agent bag is sufficient, press the suction button to control The injection head 110 automatically draws the medicinal solution.
  • the limit sensor 1103 in the injection head 110 detects whether the slide block has moved to the limit position, and when it is determined that the rear limit is reached, that is, when the maximum pumping volume of the preset syringe is reached, a signal is sent to the driving MCU chip 1201, Control the motor 1101 by driving the MCU chip 1201 to stop taking medicine.
  • the air bubble sensor 1403 always detects whether there are air bubbles in the three-way pipeline 114 as described above, and sends an error message when detecting air bubbles, prompting the staff to manually exhaust air.
  • a request message is sent to ask the staff to confirm whether the system enters the standby state. If the staff presses the confirmation key, the system enters the standby state of waiting for the instruction. On the contrary, if the staff presses the start key, the injection is controlled by the variable speed handle 104 and the foot switch 1401, and the driving MCU chip 1201 sends out a The command controls the motor 1101 to work, and outputs the contrast agent solution according to the input injection parameters.
  • multiple air bubble sensors 1403 provided on the three-way pipeline always detect air bubbles.
  • the air bubble sensor 1403 sends a signal to the driving MCU chip 1201, and the driving MCU chip 1201 stops the injection and gives an alarm according to the signal.
  • the MCU chip 1201 is driven to control the motor 1101 to work again and continue to discharge the contrast agent solution until the amount corresponding to the set amount in the above injection parameters is output.
  • the driving MCU chip 1201 issues an instruction to end the whole process.

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Abstract

本发明涉及一种高压造影剂注射系统，包括：设置于床边的床边支架，所述床边支架的顶部悬挂有造影剂袋；从所述床边支架的中部向一侧伸出的摇臂组件；设置于所述摇臂组件的梢端的注射头，所述注射头的前端设置有针筒；和设有三个端口的三通管路，所述三通管路的三个端口分别连接所述造影剂袋、所述针筒以及向患者输入造影剂的微导管；所述注射头包括执行单元和检测控制单元；所述检测控制单元控制所述执行单元以规定的精度推拉所述针筒内的胶塞，通过所述三通管路从所述造影剂袋连续吸药并将造影剂注射至患者体内。本发明能以精确控制的低流速、小剂量进行造影剂，降低造影剂对患者的不良影响。

Description

高压造影剂注射系统 技术领域
本发明涉及医疗器械技术领域，尤其涉及一种高压造影剂注射系统。
背景技术
造影剂是介入放射学操作中最常使用的药物之一，主要用于血管、体腔的显示，提高诊断的准确性。造影剂种类多样，目前用于介入放射学的造影剂多为含碘制剂。造影剂用量是引起造影剂肾病的独立危险因素。Cigarroa等提出造影剂用量的计算公式：5ml×体重(Kg)/Cr(mg/dl)，最大用量不超过300ml。有研究显示越过阈值用量，造影剂肾病发生率为21％-37％，未越阈值者为0％-2％。物理-化学反应的发生率及严重程度与所用造影剂的量有关，目前常用的造影剂其渗透压均明显超过血液，是其2～5倍，故很易产生各种损害，因此减少造影剂用量对患者有益。
传统的血管造影高压注射系统在实际应用中，采用大剂量和高流速注射，病人往往不得不摄入不必要的过多剂量的造影剂。而在配合微导管使用时若要采用低流速和小剂量注射，往往会因为控制精度等原因而导致造影失败。
由此可见，市面上目前还没有一种能以精确控制的低流速、小剂量进行造影剂注射的高压造影剂注射系统。
发明内容
发明要解决的问题：
针对上述问题，本发明的目的在于提供一种能以精确控制的低流速、小剂量进行造影剂注射的高压造影剂注射系统。
解决问题的技术手段：
为解决上述问题，本发明提供一种高压造影注射器及附件，包括：设置于床边的床边支架，所述床边支架的顶部悬挂有造影剂袋；从所述床边支架的中部向一侧伸出的摇臂组件；设置于所述摇臂组件的梢端的注射头，所述注射头的前端设置有针筒；和设有三个端口的三通管路，所述三通管路的三个端口分别连接所述造影剂袋、所述针筒以及向患者输入造影剂的微导管；所述注射头包括执行单元和检测控制单元；所述检测控制单元控制所述执行单元以规定的精度推拉所述针筒内的胶塞，通过所述三通管路从所述造影剂袋连续吸药并将造影剂注射至患者体内。
也可以是，本发明中，所述三通管路的三个端口包括：通过吸药回路连接所述造影 剂袋的第一端口；通过注射回路连接所述微导管的第二端口；和连接所述针筒的第三端口；所述第一端口和所述第二端口上具有同向设置的单向阀。
也可以是，本发明中，所述吸药回路和所述注射回路上分别设置有气泡检测装置。
也可以是，本发明中，所述执行单元包括马达、传动组件和丝杆组件；所述丝杆组件的前端连接所述针筒内的胶塞，通过所述传动组件在所述马达的驱动下沿直线方向推拉所述胶塞。
也可以是，本发明中，所述检测控制单元连接霍尔传感器、极限传感器、编码器和注射头按键。
也可以是，本发明中，所述检测控制单元还连接用于检测所述注射头上是否安装有针筒的针筒检测传感器。
也可以是，本发明中，所述检测控制单元连接所述气泡检测装置，在检测到管路中存在气泡时停止设备运行并发出警报。
也可以是，本发明中，所述注射头的理论注射精度为0.00413mL。
也可以是，本发明中，所述针筒由高强度高分子材料构成。
也可以是，本发明中，所述针筒的容量为30ml。
发明效果：
本发明能以精确控制的低流速、小剂量进行造影剂，降低造影剂对患者的不良影响。
附图说明
图1示出了根据本发明的一种实施形态的高压造影剂注射系统，(a)是高压造影剂注射系统的结构示意图，(b)是控制显示器和手控开关的示意图，(c)是脚踏开关的示意图；图2示出了三通管路及其连接方式；
图3是高压造影剂注射系统的框图；
图4是示出高压造影剂注射系统的控制流程中的检测流程的流程图；
图5是示出高压造影剂注射系统的控制流程中的注射流程的流程图；
符号说明：
100、高压造影剂注射系统；200、床；101、床侧轨道；101a、限位件；102、床边立柱；103、床边显示器；110、注射头；111、第一摇臂；112、第二摇臂；113、注射头安装座；114、三通管路；1141、第一端口；1142、第二端口；1143、第三端口；115、药水支架；1101、马达；1102、霍尔传感器；1103、极限传感器；1104、编码器；1105、针筒检测传感器；1106、注射头按键；1107、ICTAG模块；120、电源箱；1201、驱动MCU芯片； 1202、马达驱动模块；1203、电流检测传感器；1204、电源模块；1205、联机模块；130、控制显示器；131、手控开关；1301、控制MCU芯片；1302、液晶显示屏；1303、显示器按键；1304、触摸屏；1401、脚踏开关；1402、手柄控制开关；1403、气泡传感器。
具体实施方式
以下结合附图和下述实施方式进一步说明本发明，应理解，附图和下述实施方式仅用于说明本发明，而非限制本发明。
在此公开一种能以精确控制的低流速、小剂量进行造影剂注射的高压造影剂注射系统，使用该高压造影剂注射系统能减少手术过程中造影剂的使用剂量，减轻对患者的损害。
图1示出了根据本发明的一种实施形态的高压造影剂注射系统100，(a)是高压造影剂注射系统100的结构示意图，(b)是控制显示器130和手控开关131的示意图，(c)是脚踏开关1401的示意图。图3是高压造影剂注射系统100的框图。在此，将图1中(a)的纸面向外方向定义为“前方”，纸面向内方向定义为“后方”，定义“上”、“下”、“左”、“右”为从正面观察高压造影剂注射系统100时的“上”、“下”、“左”、“右”方向。需要说明的是，本发明的描述中方位或位置关系为基于附图所示的方位或位置关系，仅是为了便于描述本发明和简化描述，而不是指示或暗示所指的装置或元件必须具有特定的方位、以特定的方位构造和操作，因此不能理解为对本发明的限制。
如图1中(a)所示，高压造影剂注射系统100包括设置于床边的床边支架、从床边支架的中部向一侧伸出的摇臂组件、设置于摇臂组件的梢端的注射头110、三通管路114、电源箱120和控制显示器130。
具体地，如图1中(a)所示，床边支架包括在供患者仰卧的床200两侧设置有沿水平方向延伸的一对床侧轨道101，在该床侧轨道101上设置有限位件101a，通过调节限位件101a上的旋钮能沿着床侧轨道101调节限位件101a的位置。限位件101a在中部向外突出，在该处设置有向上方竖起的床边立柱102，在该床边立柱102的顶端设置有接收来自后述驱动MCU芯片1201的信息并显示在显示屏上的床边显示器103以及用于挂载造影剂袋的药水支架115。另一方面，如图1中(c)所示，在位于右侧的床侧轨道101上设置有用于和后述的脚踏开关1401一起控制造影剂注射的手柄控制开关1402。本实施形态中，手柄控制开关1402连接电源箱120，用来在变速注射模式下控制注射，手柄前推开始注射，前推幅度越大，注射速度越快，推到底速度为设置的最大速度。释放自动回弹到起始位置，注射停止。
手控开关131连接显示器，用来在血管造影模式下控制注射的开始和停止，保持按 下时按设定的参数注射一直到完成设定的注射量，释放按键注射过程终止。
在床边立柱102的大致中部上形成摇臂组件，该摇臂组件包括第一摇臂111和第二摇臂112。
第一摇臂111大致水平方向直线状延伸，以其基端为中心在水平平面自由摇动地设置于床边立柱102，在第一摇臂111的梢端上设置有能相对于第一摇臂111自由转动的活动关节作为摇臂座。在该摇臂座上设置有能以基端为中心在竖直平面摇动自如的直线状的第二摇臂112。
在第二摇臂112的梢端设置有用于安装注射头110的注射头安装座113。本实施形态中，注射头安装座113包括安装座上部和安装座下部。安装座下部以能相对于第二摇臂112在竖直平面内自由摇动的形式连接第二摇臂112的梢端。安装部上部形成为大致L字状，其竖直部分转动自如地与安装座下部连接，水平部分则用于通过插入后述注射头110的注射头手柄来固定注射头110。
由此，通过配合使用第一摇臂111、第二摇臂112以及注射头安装座113，能以多个自由度来调节注射头110在空间中的位置，能满足注射造影剂时注射头110的各种位置需求。
[注射头]
注射头110是能以高精度低流量注射造影剂的高压注射器用注射头，其主要包括两侧设置有注射头手柄的壳体、设置于壳体前端的针筒座以及设置于壳体内部的注射头机架、执行单元和检测控制单元。在注射头110前端的针筒座上设置有高压造影剂针筒，该针筒可以由医用级高强度高分子材料(例如PC材料)构成，其容量可以是30ml，可以保证针筒在注射时不变形，从而提高注射精度。针筒通过三通管路114连接挂载在药水支架115上的造影剂袋，并连接向患者注入造影剂的微导管，具体内容后述。
执行单元包括设置在注射头机架上的马达1101、传动组件和丝杆组件，其中马达1101可以是高精度马达，传动组件可以是同步带传动机构，丝杆组件上设置有与针筒的胶塞连接的推杆，将传动组件传递的旋转动力转换成直线位移。马达1101在后述电源箱120中的马达1101驱动模块1202的控制下运转，通过传动组件和丝杆组件等机械结构转换成推杆的前后位移，由此控制针筒抽吸造影剂及注射造影剂等动作。
本实施形态中，作为高精度马达，马达1101的最高转速例如可达16900转，且自带行星齿轮减速箱，其减速比例如可以是20:1，精确减速比为81:4。作为传动组件的同步带传动机构的传动比可以是20:12。借助集成每圈计数1024的高精度编码器和2mm的丝杆螺 距，注射头110的理论注射精度能够达到0.00413mL。
检测控制单元如图3所示，连接霍尔传感器1102、极限传感器1103、编码器1104、针筒检测传感器1105和注射头按键1106。
霍尔传感器1102设置于马达1101的输出轴附近，主要用来检测马达1101的转动圈数，将检测到的数据传送到驱动MCU芯片1201中。极限传感器1103安装在注射头机架上，其设定有前极限(对应于预先设定的针筒的最大排液量)和后极限(对应于预先设定的针筒的最大抽液量)，主要用来检测丝杆组件中的滑块是否运行到极限位置，当检测到滑块运行到极限位置时，会发送信号给驱动MCU芯片1201，通过驱动MCU芯片1201控制马达1101停止转动。编码器1104用来检测马达转动，并将检测数据传送到驱动MCU芯片1201。针筒检测传感器1105设置于针筒座，用于检测针筒是否安装，并将检测信号传送至驱动MCU芯片1201。注射头按键1106设置于注射头110的壳体顶部，其可以包括控制注射速度的控制按钮和停机的停止按钮等，主要用于接受工作人员的操作，将操作信号传送到驱动MCU芯片1201。此外，检测控制单元还可以包括ICTAG模块1107，该ICTAG模块1107可用于针筒识别，通过在针筒上贴有烧录有针筒的批号、厂家、有效期等信息的芯片，ICTAG模块1107读取芯片中的信息后发送给驱动MCU芯片1201。
在准备注射时，将针筒的接口(即造影剂的输出口)与三通管路114连接。该三通管路114例如可以包括一个多通阀和多条连接管，多通阀可以一侧连接针筒的接口，另一侧通过连接管和插瓶针连接挂载在药水支架115上的造影剂袋，第三侧则通过连接管连接微导管用于向患者输出造影剂。本发明中，在这些连接管上分别设置有与各连接管分别对应的用于检测流路中是否存在气泡的气泡传感器1403，该气泡传感器1403可以是超声波气泡传感器1403，向管路中发射超声波并接受反馈的回声，由于在不同的介质(特别是液体和空气)中反射的回声不同，因此当检测到回声信号出现变化时判定管路中有气泡流过。气泡传感器1403可以在没有检测到气泡时为高电平，在检测到气泡时为低电平，并将信号发送给驱动MCU芯片1201。
[三通管路]
图2示出了三通管路114及其连接方式。如图2所示，三通管路114设有三个端口的三通管路，分别为通过吸药回路连接造影剂袋的第一端口1141、通过注射回路连接微导管的第二端口1142和连接针筒的第三端口1143。本实施形态中，三通管路114在第一端口1141和第二端口1142上设置有同向的单向阀。该单向阀中设置有伞状的顶尖和能够在液体压差作用下挠曲的挠性阀片。通过将两个单向阀同向设置，在希望向针筒内抽入造影剂而拉动胶塞 时，能连通设置在第一端口1141上的单向阀而关闭设置在第二端口1142上的单向阀，从而在吸取造影剂时不会从注射回路中也抽取造影剂。反之，在希望向患者体内注入造影剂而推动胶塞时，能连通设置在第二端口1142上的单向阀而关闭设置在第一端口1141上的单向阀，从而在注射造影剂时不会从造影剂袋中抽取造影剂。因此，高压造影剂注射系统中的注射头110能在不拆卸管路的情况下完成快速吸药后再次进行注射，避免反复排气的操作以致污染管路或是使管路中进入气泡。
出于安全考虑，在与三通管路114连接的吸药回路和注射回路上还分别设置有气泡检测装置1403，气泡检测装置1403可以是超声波气泡传感器，向管路中发射超声波并接受反馈的回声，由于在不同的介质(特别是液体和空气)中反射的回声不同，因此当检测到回声信号出现变化时判定管路中有气泡流过。更具体地，当吸药回路上的气泡传感器1403发现气泡时代表造影剂袋中已经没有造影剂时提示需要更换药袋；当注射回路上的气泡传感器1403发现气泡时，会停止注射并发出报警音，并在显示器显示警告信息，此时应人工干预排除回路中的空气后再链接回路，重新进行造影剂注射。
[电源箱]
如图1中(c)所示，在床200的下方设置有电源箱120。电源箱120是高压造影剂注射系统100的供电和控制中枢，又如图3所示，电源箱120包括驱动MCU芯片1201、马达驱动模块1202、电流检测传感器1203、电源模块1204和联机模块1205。
驱动MCU(Micro Control Unit；微控制单元)芯片1201是将内存、计数器、USB、A/D转换、UART、PLC、DMA等周边接口都整合在一起的微控制芯片。本发明中，驱动MCU芯片1201是高压造影剂注射系统100的主控芯片，内部存储有控制软件，控制设备运行和停止，同时监测整个高压造影剂注射系统100运行状态，发现运行异常时停止设备运行，并发送出错信号给设置在后述控制显示器130内部的主板上的控制MCU芯片1301，其具体工作后述。
马达驱动模块1202主要用于根据来自上述控制MCU芯片1301的指令控制马达1101运行。电流检测传感器1203主要用于检测马达运行时的电流，然后换算成压力，用来检测注射过程的压力。电源模块1204主要用于对高压造影剂注射系统100进行供电。
高压造影剂注射系统100可以通过联机模块1205与例如DSA(Digital subtraction angiography；数字减影血管造影技术)、C臂机等外部设备联动。该联机模块1205用于接收外部设备的信号(例如启动注射信号)并将该信号发送给驱动MCU芯片1201，或者接收驱 动MCU芯片1201的信号(一般包括启动信号、设备运行信号、设备待命信号等)并将该信号发送给外部设备。
另外，电源箱120中的驱动MCU芯片1201还与后述的脚踏开关1401、手柄控制开关1402以及设置在三通管路114上的气泡传感器1403电气连接。
脚踏开关1401用于接受踩踏操作，在脚踏开关1401被踩下时，发出注射启动信号给驱动MCU芯片1201，释放脚踏开关1401即为停止注射，这一功能仅在试注射界面下有效。
手柄控制开关1402在变速注射界面下根据手柄的位置将信号发送到驱动MCU芯片1201，可以通过手柄位置变化来控制马达运行速度变化，例如，手柄在初始位置时代表注射速度为零，手柄不同停留位置代表不同的速度，通过手控制手柄停留位置来控制注射速度，释放手柄则手柄自动回复到初始位置。
[控制显示器]
如图1中(b)所示，高压造影剂注射系统100还包括控制显示器130。控制显示器130可以与高压造影剂注射系统100的其他结构分开设置。如图3所示，控制显示器130包括控制MCU芯片1301、液晶显示屏1302、显示器按键1303和用于接受注射参数输入的触摸屏1304。具体地，显示器按键1303例如可以包括：停止键，用来停止注射头的动作；记录键，用来调取最近的20条注射记录；程序键，用来储存设定好的参数或调用已存储的参数；以及模式键，用以在血管造影、变速注射、试注射等不同模式之间切换，每个模式参数范围不同，应用与不同的场合。控制显示器130在设置在主板上的控制MCU芯片1301中安装有主控制程序，可通过触摸屏1304输入注射参数，用以控制注射头110自动注射，同时接受注射头100在注射过程中的反馈信息，并在液晶显示屏1302上显示注射压力图及注射流速、流量和注射时间等相关信息。这些参数例如包括流量、流速、压力限定、注射延时时间、扫描延时时间、提速时间等。此外，控制显示器130还与手控开关131相连。
控制MCU芯片1301中存储有图形处理软件，处理接收信号，将运行情况显示在液晶显示屏1302上。
具体说明控制MCU芯片1301执行的工作。控制MCU芯片1301接收驱动MCU芯片1201的信号，如果是出错或报警信号，则在液晶显示屏1302上显示相应错误代码或警告信息；如果是设备运行信息，则转换成运行图显示在液晶显示屏1302上，同时发送信息给驱动MCU芯片1201，驱动MCU芯片1201将该信息转发给床边显示器103同步显示。控制MCU芯片1301也接收触摸屏1304上输入的参数信息、手控开关131的开始指令信息和 显示器按键1303的信号之中的一个或多个，发送给驱动MCU芯片1201。
因此，根据上述结构，本发明的驱动MCU芯片1201主要如下工作：接收霍尔传感器1102的信号和编码器1104的信号，换算成注射头110中推杆的行程(即针筒的胶塞的行程)，与目标行程量进行对比，发现差异大于25％时，向马达驱动模块1202发出指令停止马达1101的运行，并向床边显示器103和后述的控制显示器130发出报错信息；开机对系统自检(包括各按键是否在初始状态、各部件信号传送是否正常等)；系统运行中的监测(信号传输的校验、马达工作状态或马达电压、运行速度、电源模块等)；接收控制显示器130的控制MCU芯片1301的信号(参数输入)，当接收到设备运行指令信号时，按接收到的参数信息，发送信号到马达驱动模块1202，控制马达1101运行，且接收霍尔传感器1102的信号换算成行程，发送给控制显示器130的控制MCU；接收到手柄控制开关1402的信号后，发送信号给马达驱动模块1202，控制马达1101运行；接收气泡传感器1403的信号，当气泡传感器1403的信号显示管路中有气泡时，停止系统运行，并发出警告信息到控制显示器130；发送信号给床边显示器103等。
[工作流程]
以下参照图4及图5说明高压造影剂注射系统100的工作流程。图4是示出高压造影剂注射系统的控制流程中的检测流程的流程图，图5是示出高压造影剂注射系统的控制流程中的注射流程的流程图。
如图4所示，在开机后，驱动MCU芯片1201首先进行系统自检，该系统自检包括检测各按键是否在初始状态、各部件信号传送是否正常等。若检测到系统异常(判定为否)，则在清楚故障后重新开镜，并再一次进行系统自检。若判定为各设备一切正常(判定为是)，则进至初始界面。
在进入初始界面后，由针筒检测传感器1105检测注射头110上是否安装有针筒，并将检测信号传送至驱动MCU芯片1201。若针筒检测传感器1105未检测到针筒(判定为否)，则驱动MCU芯片1201发出报错信号，工作人员手动将针筒安装固定至注射头110，之后针筒检测传感器1105再次进行针筒检测。在针筒检测传感器1105检测到了针筒(判定为是)时，系统进入等待。
之后，工作人员安装三通管路114，使之与注射头110上的针筒连接，并按下后退键向针筒内抽入造影剂。在向针筒内抽入造影剂后，安装在三通管路114上的多个气泡传感器1403检测管路中是否存在气泡，并将检测信号传送至驱动MCU芯片1201。如果气泡传感器1403判定为管路中存在气泡(判定为是)，则驱动MCU芯片1201根据是哪个气泡传感 器1403判定管路中存在气泡而发送对应的报错信息，工作人员能通过报错信息确认具体是哪根管路中存在气泡，从而进行人工排气。在气泡传感器1403判定为未检测到气泡时，即判定三通管路114中没有气泡时，进至等待注射参数输入步骤。
如图5所示，工作人员通过控制显示器130中的触摸屏1304输入注射参数，驱动MCU芯片1201接收到设定的注射参数后，判定针筒中造影剂剩余量是否足够。作为一种判断手法，例如可以使注射头前极限为设备0位，当推杆前进到前极限位置时，系统自动校准0位，显示器显示剩余量为0。在推杆运动时，编码器1104会计数并记录推杆的位置，对应为针筒的剩余量并显示在显示器上。当用户设定注射量时，系统会比较设定的量和记录的剩余量。如果驱动MCU芯片1201判定针筒中造影剂剩余量不足，则发出系统提示，要求向针筒中补充造影剂。工作人员看到系统提示后，首先确认造影剂袋中造影剂的余量，在造影剂袋中造影剂不足时更换造影剂袋，如果造影剂袋中造影剂充足，则按下吸药键控制注射头110自动吸取药液。在吸取药液时注射头110中的极限传感器1103检测滑块是否运行到极限位置，在判定到达后极限即到达预先设定的针筒的最大抽液量时，发送信号给驱动MCU芯片1201，通过驱动MCU芯片1201控制马达1101停止吸药。在上述过程中气泡传感器1403始终如上所述检测三通管路114中是否存在有气泡，并在检测到气泡时发出报错信息，提示工作人员进行人工排气。
当驱动MCU芯片1201判断针筒中造影剂剩余量足够时，发出请求信息要求工作人员确认系统是否进入待命状态。如果工作人员按下确认键，则系统进入等待指令的待命状态，反之如果工作人员按下启动键，通过变速手柄104和脚踏开关1401控制注射开始，驱动MCU芯片1201接到开始注射指令后发出指令控制马达1101工作，按照输入的注射参数输出造影剂药液。
在注射造影剂药液的过程中，三通管路上设置的多个气泡传感器1403始终进行气泡检测。在检测到管路中存在气泡时，气泡传感器1403向驱动MCU芯片1201发出信号，驱动MCU芯片1201根据该信号停止注射并进行警报。在人工排气并再次进行气泡检测确认管路中不存在气泡后，驱动MCU芯片1201控制马达1101重新工作继续排出造影剂药液直至输出与上述注射参数中的设定量对应的量。最后，驱动MCU芯片1201发出指令，结束整个流程。
以上的具体实施方式对本发明的目的、技术方案和有益效果进行了进一步详细说明，应当理解的是，以上仅为本发明的一种具体实施方式而已，并不限于本发明的保护范围，在不脱离本发明的基本特征的宗旨下，本发明可体现为多种形式，因此本发明中的实施 形态是用于说明而非限制，由于本发明的范围由权利要求限定而非由说明书限定，而且落在权利要求界定的范围，或其界定的范围的等价范围内的所有变化都应理解为包括在权利要求书中。凡在本发明的精神和原则之内的，所做出的任何修改、等同替换、改进等，均应包含在本发明的保护范围之内。

Claims (10)

  1. 一种高压造影剂注射系统，其特征在于，
    包括：
    设置于床边的床边支架，所述床边支架的顶部悬挂有造影剂袋；
    从所述床边支架的中部向一侧伸出的摇臂组件；
    设置于所述摇臂组件的梢端的注射头，所述注射头的前端设置有针筒；和
    设有三个端口的三通管路，所述三通管路的三个端口分别连接所述造影剂袋、所述针筒以及向患者输入造影剂的微导管；
    所述注射头包括执行单元和检测控制单元；
    所述检测控制单元控制所述执行单元以规定的精度推拉所述针筒内的胶塞，通过所述三通管路从所述造影剂袋连续吸药并将造影剂注射至患者体内。
  2. 根据权利要求1所述的高压造影剂注射系统，其特征在于，
    所述三通管路的三个端口包括：
    通过吸药回路连接所述造影剂袋的第一端口；
    通过注射回路连接所述微导管的第二端口；和
    连接所述针筒的第三端口；
    所述第一端口和所述第二端口上具有同向设置的单向阀。
  3. 根据权利要求2所述的高压造影剂注射系统，其特征在于，
    所述吸药回路和所述注射回路上分别设置有气泡检测装置。
  4. 根据权利要求1所述的高压造影剂注射系统，其特征在于，
    所述执行单元包括马达、传动组件和丝杆组件；
    所述丝杆组件的前端连接所述针筒内的胶塞，通过所述传动组件在所述马达的驱动下沿直线方向推拉所述胶塞。
  5. 根据权利要求4所述的高压造影剂注射系统，其特征在于，
    所述检测控制单元连接霍尔传感器、极限传感器、编码器和注射头按键。
  6. 根据权利要求5所述的高压造影剂注射系统，其特征在于，
    所述检测控制单元还连接用于检测所述注射头上是否安装有针筒的针筒检测传感器。
  7. 根据权利要求3所述的高压造影剂注射系统，其特征在于，
    所述检测控制单元连接所述气泡检测装置，在检测到管路中存在气泡时停止设备运行并发出警报。
  8. 根据权利要求1所述的高压造影剂注射系统，其特征在于，
    所述注射头的理论注射精度为0.00413mL。
  9. 根据权利要求1所述的高压造影剂注射系统，其特征在于，
    所述针筒由高强度高分子材料构成。
  10. 根据权利要求9所述的高压造影剂注射系统，其特征在于，
    所述针筒的容量为30ml。
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CN113713202A (zh) * 2021-09-13 2021-11-30 临床支持有限公司 高压造影剂注射系统

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