Low-pressure side automatic liquid supplementing closed-loop fast charging device for high-pressure injector

Abstract

The application provides a low-pressure side automatic liquid supplement closed loop fast charging device for a high-pressure injector, comprising a high-pressure injector main machine provided with a first liquid storage bin and a second liquid storage bin in parallel, wherein the high-pressure injector main machine is respectively provided with a first bin driving mechanism and a second bin driving mechanism for driving the first liquid storage bin and the second liquid storage bin to inject or create a negative pressure environment for liquid supplement; further comprising a contrast agent liquid supply assembly and a switching manifold assembly, wherein the contrast agent liquid supply assembly is arranged on one side of the high-pressure injector main machine and is connected with the first liquid storage bin and the second liquid storage bin through a first low-pressure liquid supplement branch and a second low-pressure liquid supplement branch to perform low-pressure liquid supplement; the switching manifold assembly is connected with the output ends of the first liquid storage bin and the second liquid storage bin and is used for realizing output switching of the first liquid storage bin and the second liquid storage bin to avoid that the two bins simultaneously deliver contrast agent to a patient end. The application can obviously improve the continuity of contrast agent supply, reduce the frequency of manual operation and improve injection safety.

Description

Technical Field

[0001] This invention relates to an automatic closed-loop fast-charging device for low-pressure side fluid replenishment in a high-pressure injector, belonging to the field of medical device auxiliary device technology. Background Technology

[0002] High-pressure injectors used in catheterization labs, angiography rooms, and cardiovascular interventional procedures typically employ a single injection chamber / single syringe reservoir structure. Their basic components generally include: a main drive mechanism, an injection syringe, a piston propulsion mechanism, high-pressure connecting tubing, a patient-end connection assembly, a control panel, and corresponding disposable consumables. The injection syringe is mounted at the front end of the high-pressure injector body. A pressure-changing piston propelled forward by a motor or transmission mechanism within the main unit delivers the contrast agent within the syringe to the catheter, pigtail catheter, or other interventional device tip via the high-pressure connecting tubing, under set pressure, flow rate, and volume parameters, thus completing the contrast agent injection.

[0003] Before use, existing equipment typically requires medical staff to aspirate the contrast agent from the contrast agent vial into the syringe, and then put it into standby mode after purging. During the procedure, if the remaining contrast agent in the syringe is insufficient, the injection must be paused or the patient waits for a non-critical time point before manual aspiration, fluid replenishment, and purging are performed to restart the injection process. For general coronary angiography or procedures with small single injection volumes, this structure can meet clinical needs; however, for scenarios such as transcatheter aortic valve replacement (TAVR), complex aortic interventions, left ventricular angiography, multiple root angiography, and long-segment peripheral vascular angiography, the following drawbacks exist:

[0004] Existing single-compartment structures often suffer from insufficient fluid volume per administration. When the total amount of contrast agent used during surgery is large, multiple refills are often required, which cannot meet the requirements for continuous and efficient fluid supply in complex procedures and affects the surgical rhythm. At the same time, manual fluid refill methods often involve manual replacement of contrast agent bottles, aspiration of fluid, and venting of air. If the operation is not standardized or time is tight during the repeated connection, disconnection, aspiration, and venting, problems such as residual microbubbles, air entering the fluid circuit, or damage to the sterile barrier can easily occur, thereby increasing the risks of injection and infection.

[0005] Therefore, there is an urgent need in the field for an automatic closed-loop fast-charging device for low-pressure side replenishment of high-pressure injectors to solve the above problems. Summary of the Invention

[0006] The purpose of this invention is to provide a high-pressure injection auxiliary device that can automatically replenish fluid on the low-pressure side of a high-pressure injector and adopts a dual-storage hot-switching method, so as to solve the problems of frequent fluid replenishment, operation interruption, low efficiency and high risk in the prior art.

[0007] To achieve the above-mentioned technical objectives and effects, this application provides the following technical solution: This invention provides a low-pressure side automatic fluid replenishment closed-loop fast-charging device for a high-pressure injector, comprising a high-pressure injector main unit, on which a first fluid reservoir and a second fluid reservoir are connected in parallel. The high-pressure injector main unit is respectively equipped with a first reservoir driving mechanism and a second reservoir driving mechanism to drive the first and second fluid reservoirs for injection or to create a negative pressure environment for fluid replenishment. Both the first and second fluid reservoirs are equipped with pressure sensing units to provide feedback on the pressure status within the reservoirs. The device also includes a contrast agent supply assembly and a switching manifold assembly. The contrast agent supply assembly is located on one side of the high-pressure injector main unit and is connected to the first and second fluid reservoirs via a first low-pressure replenishment branch and a second low-pressure replenishment branch for low-pressure replenishment. The switching manifold assembly is connected to the output ends of the first and second fluid reservoirs to achieve output switching between the first and second fluid reservoirs, preventing simultaneous delivery of contrast agent to the patient from both reservoirs. Finally, a controller is included to realize the operation control, status identification, logic switching, and safety interlock of the entire device.

[0008] Preferably, a pressure-changing piston is slidably disposed in both the first and second liquid storage chambers, and the first and second chamber drive mechanisms have the same structure and are both disposed in the high-pressure injector main unit to drive the sliding of the pressure-changing piston.

[0009] Preferably, the contrast agent supply assembly includes a bottle positioning base, a contrast agent bottle, a bottle stopper puncturist, and a supply tubing. The bottle positioning base is detachably connected to the main unit of the high-pressure injector. The contrast agent bottle has a bottle body and a rubber cap. The bottle body is snapped onto the bottle positioning base. The bottle stopper puncturist has a hollow inner cavity and is open at both ends. One end of the bottle stopper puncturist is sharply positioned and inserted into the rubber cap, and the other end is connected to the supply tubing to form at least one contrast agent bottle interface for connecting the first low-pressure infusion branch and the second low-pressure infusion branch. The bottle stopper puncturist is pressed through the rubber cap to connect the supply tubing and the inner cavity of the bottle body.

[0010] Furthermore, the fluid supply hose is connected to the first low-pressure fluid replenishment branch and the second low-pressure fluid replenishment branch via a fluid connection connector.

[0011] Preferably, both the first low-pressure replenishment branch and the second low-pressure replenishment branch are sequentially connected to a check valve, a bubble trapping chamber, a bubble detection sensor, a filter unit, and an electromagnetic replenishment valve. Both the first low-pressure replenishment branch and the second low-pressure replenishment branch are provided with an exhaust bypass that is connected to the bubble trapping chamber. The exhaust bypass is connected to the waste liquid bag through an exhaust / waste discharge valve.

[0012] Furthermore, the high-pressure injector main unit is equipped with an audible and visual alarm unit, which is electrically connected to the controller. The controller is electrically connected to the pressure sensing unit and the bubble detection sensor.

[0013] Preferably, the first low-pressure rehydration branch and the second low-pressure rehydration branch are respectively connected to the low-pressure rehydration interface at the rear end or side rear end of the first and second reservoirs, and are not directly connected to the high-pressure output main channel at the patient end.

[0014] Preferably, the switching manifold assembly includes a pressure-resistant manifold, a control valve, and a high-pressure output main. The pressure-resistant manifold has a first input terminal, a second input terminal, and a common output terminal. The first input terminal is connected to the high-pressure output port at the front end of the first liquid storage tank, and the second input terminal is connected to the high-pressure output port at the front end of the second liquid storage tank. The common output terminal is connected to the first input terminal, the second input terminal, and the high-pressure output main. The control valve is disposed within the common output terminal to allow only one of the first input terminal or the second input terminal to be connected to the common output terminal at any given time.

[0015] Preferably, the output ends of both the first and second liquid storage tanks are connected to the pressure-resistant manifold via Luer connectors or pressure-resistant threaded connectors.

[0016] Preferably, the first liquid storage tank and the second liquid storage tank are arranged in parallel and the center distance is set to 80-160 mm.

[0017] The automatic liquid replenishment closed-loop fast charging device for the low-pressure side of a high-pressure injector provided by this invention has the following advantages: 1. This invention employs a dual-compartment parallel structure with a first and second fluid reservoir. When one reservoir is in injection mode, the other can be in standby or automatically replenished in the background, thus avoiding the problem of "insufficient fluid volume requiring shutdown for replenishment" in existing single-compartment structures. Especially in TAVR, aortic intervention, left ventricular angiography, structural heart disease intervention, and other scenarios involving multiple high-dose contrast imaging, it can significantly improve the continuity of contrast agent supply.

[0018] 2. This invention achieves automatic fluid replenishment and rapid switching of the fluid storage chamber through an automatic fluid replenishment circuit on the low-pressure side and a dual-chamber thermal switching mechanism. This can significantly reduce the number of times contrast agent is manually withdrawn from the contrast agent bottle during the operation, reduce the frequency of manual operation, and thus reduce surgical interruptions and time delays caused by fluid replenishment.

[0019] 3. This invention incorporates a check valve, a bubble trapping chamber, a bubble detection sensor, a filter unit, and an exhaust / waste removal assembly in the low-pressure replenishment branch, forming a closed-loop structure for the replenishment circuit. It also automatically monitors the circuit status and controls exhaust during the replenishment process. Compared to existing manual aspiration and exhaust methods, this invention more effectively reduces the risk of residual bubbles and air entering the circuit, thus improving injection safety.

[0020] 4. This invention, through its closed-loop fluid supply assembly, disposable sterile flow path, low-pressure side fluid replenishment branch, and automatic control method, can reduce the repeated disassembly, aspiration, and manual venting operations during surgery, thereby reducing the risk of contamination caused by frequent exposure of the fluid path and making it easier to maintain a sterile state in the surgical area. Attached Figure Description

[0021] Figure 1 A schematic diagram of the structure of the low-pressure side automatic liquid replenishment closed-loop fast charging device for a high-pressure injector provided in the embodiments of this application. Figure 1 ; Figure 2 A schematic diagram of the structure of the low-pressure side automatic liquid replenishment closed-loop fast charging device for a high-pressure injector provided in the embodiments of this application. Figure 2 ; Figure 3 This is a cross-sectional schematic diagram illustrating the connection relationship between the liquid storage tank and the variable pressure piston drive structure, which is the main embodiment of this application. Figure 1 ; Figure 4 for Figure 3 Enlarged diagram of section A in the middle; Figure 5 This is a cross-sectional schematic diagram illustrating the connection relationship between the liquid storage tank and the variable pressure piston drive structure, which is the main embodiment of this application. Figure 2 .

[0022] In the picture: 100. High-pressure injector main unit; 101. Mounting base; 111. Chamber positioning groove; 102. Controller; 103. Touch screen display; 104. Power supply assembly; 105. Communication interface assembly; 201. First liquid storage chamber; 202. Second liquid storage chamber; 20A. Chamber body; 20B. Variable piston; 20B1. Piston rod; 20B2. Connector; 20C. Low-pressure replenishment interface; 301. First chamber drive mechanism; 302. Second chamber drive mechanism; 30A. Drive motor; 30B. Reducer; 30C. Lead screw; 30D. Nut slider; 30E. Push rod connecting seat; 400. Pressure transmitter 500. Sensing unit; 501. Contrast agent supply assembly; 502. Bottle position fixing seat; 503. Contrast agent bottle; 504. Bottle body; 505. Rubber cap; 505. Bottle stopper puncture device; 506. Supply hose; 607. Switching manifold assembly; 608. Pressure-resistant manifold; 609. Control valve; 600. High-pressure output main pipe; 700. First low-pressure replenishment branch; 800. Second low-pressure replenishment branch; 901. Check valve; 902. Bubble trapping chamber; 903. Bubble detection sensor; 904. Filter unit; 905. Electromagnetic replenishment valve; 10. Exhaust bypass; 20. Audible and visual alarm unit; 30. Sealing ring. Detailed Implementation

[0023] The technical solutions of the embodiments of this application will be clearly and completely described below with reference to the accompanying drawings. Obviously, the described embodiments are only some embodiments of the present invention, and not all embodiments. Based on the embodiments of this application, all other embodiments obtained by those skilled in the art without creative effort are within the scope of protection of the present invention.

[0024] Reference Figures 1-5This invention provides a low-pressure side automatic fluid replenishment closed-loop fast charging device for a high-pressure injector, comprising a high-pressure injector main unit 100, a first fluid reservoir 201, and a second fluid reservoir 202. The high-pressure injector main unit 100 is a body having a mounting base 101, a controller 102, a touch screen display 103, a power supply component 104, and a communication interface component 105. The mounting base 101 adopts a combination structure of a metal frame and a medical engineering plastic shell, preferably using an aluminum alloy frame and an ABS or PC shell. The touch screen display 103 has a built-in human-machine interaction control system. The controller 102 is electrically connected to the electrical components within the device to realize the operation control, status identification, logic switching, and safety interlock of the entire device. The power supply component 104 uses a medical power module. The communication interface component 105 uses a serial port, CAN bus, or Ethernet interface for subsequent linkage with the main unit system. The front of the mounting base 101 has two parallel mounting positions for respectively mounting the first fluid reservoir 201 and the second fluid reservoir 202. In feasible embodiments, the first liquid storage tank 201 and the second liquid storage tank 202 can be tanks of any shape. In this embodiment, a circular tank is preferred.

[0025] Furthermore, the two chamber mounting positions are arranged in parallel, with the center distance set according to the diameter of the liquid storage chamber, preferably 80-160 mm. The front end of the mounting position faces the high-pressure output side, and the rear end is connected to the drive mechanism. The chamber mounting position is a chamber positioning groove 111 opened on the mounting base 101. The first liquid storage chamber 201 and the second liquid storage chamber 202 are fixed in the chamber positioning groove 111 by a snap-locking structure. The snap-locking structure includes, but is not limited to, cantilever snap-lock, flip / twist snap-lock, ring snap-lock, or double snap-lock / symmetrical claw structure, etc., which are existing technologies and will not be described in detail. In this embodiment, the snap-locking structure is preferably a flip snap-lock.

[0026] Furthermore, the first and second liquid storage chambers 201 and 202 are identical piston-type sealed liquid storage chambers, including a chamber body 20A and a pressure-changing piston 20B. The chamber body 20A can be made of transparent, pressure-resistant medical-grade polycarbonate material, or other materials that can withstand medical liquids, facilitate observation of the liquid level, and have sufficient mechanical strength. Preferably, each liquid storage chamber has a nominal capacity of 120–200 mL. The end of the chamber cylinder 20A facing away from the mounting base 101 is the front high-pressure output port, and the rear end or side rear end is integrally formed with a low-pressure replenishment interface 20C; the pressure-changing piston 20B is slidably disposed inside the chamber cylinder 20A and the end facing away from the front high-pressure output port of the chamber cylinder 20A is integrally formed with a piston rod 20B1. The end of the piston rod 20B1 facing away from the pressure-changing piston 20B protrudes from the chamber cylinder 20A and has a connector 20B2 integrally formed at the tail end. A sealing ring 30 is provided on the inner wall of the chamber cylinder 20A at the point where the piston rod 20B1 passes through and the chamber cylinder 20A. The pressure-changing piston 20B adopts a structure with medical rubber covered with low friction material to ensure good sealing and low resistance during reciprocating motion. Pressure sensing units 400 are installed in both the first liquid storage tank 201 and the second liquid storage tank 202 to provide feedback on the pressure status inside the tank. The pressure sensing units 400 can be pressure transmitters, ceramic pressure sensors, and thin-film pressure sensors, etc. The installation and use are existing technologies and will not be described in detail.

[0027] Reference Figures 1-5 The high-pressure injector main unit 100 is equipped with a first chamber drive mechanism 301 and a second chamber drive mechanism 302, which drive the first liquid storage chamber 201 and the second liquid storage chamber 202 to inject or create a negative pressure environment for replenishing liquid. The first chamber drive mechanism 301 and the second chamber drive mechanism 302 have the same structure and are both located inside the high-pressure injector main unit 100 to drive the sliding of the pressure changing piston 20B.

[0028] Taking the first chamber drive structure as an example, the first chamber drive structure includes a drive motor 30A, a reducer 30B, a lead screw 30C, a nut slider 30D, and a push rod connecting seat 30E. The drive motor 30A is a servo motor or a stepper motor, mounted on the rear mounting plate of the mounting base 101. The output shaft of the drive motor 30A is connected to the reducer 30B, and the output shaft of the reducer 30B is coaxially and fixedly connected to the lead screw 30C to drive the rotation of the lead screw 30C. The lead screw 30C is arranged parallel to the axis of the corresponding first liquid storage chamber 201. The nut slider 30D is screwed onto the lead screw 30C and limited by the inner wall of the mounting base 101, thereby driving the nut slider 30D to move forward or backward through the reciprocating rotation of the lead screw 30C. The end of the nut slider 30D facing the pressure transformer piston 20B is connected to the push rod connecting seat 30E, which is engaged with the connector 20B2. A limit ring is detachably installed at the end of the lead screw 30C away from the drive motor 30A via bolts. When the drive motor 30A rotates in the forward direction, the lead screw 30C drives the nut slider 30D to move forward, pushing the pressure-changing piston 20B to achieve high-pressure injection; when the drive motor 30A rotates in the reverse direction, the piston retracts to create negative pressure, performing low-pressure liquid replenishment.

[0029] Furthermore, the first chamber drive structure also includes a position encoder (not shown in the figure) and a travel limit switch (not shown in the figure). The position encoder is mounted on the free shaft at the rear end of the drive motor 30A and rotates synchronously with the main shaft of the drive motor 30A, thereby accurately converting the rotation angle of the drive motor 30A into piston displacement to achieve piston displacement detection. The travel limit switch includes a front travel limit switch and a rear travel limit switch, which are respectively mounted on the front and rear parts of the inner wall of the mounting base 101, that is, located to the side / direct front of the maximum forward movement position of the nut slider 30D and to the side / rear of the maximum backward movement position of the nut slider 30D, to prevent overtravel. In this embodiment, the installation and use of the position encoder and travel limit switch are existing technologies and will not be described in detail.

[0030] Reference Figure 1 and Figure 2 The low-pressure side automatic fluid replenishment closed-loop fast charging device for high-pressure injectors also includes a contrast agent supply component 500 and a switching manifold component 600. The contrast agent supply component 500 is installed on one side of the high-pressure injector main unit 100 and is connected to the first reservoir 201 and the second reservoir 202 through the first low-pressure fluid replenishment branch 700 and the second low-pressure fluid replenishment branch 800, respectively, for low-pressure fluid replenishment. The switching manifold component 600 is connected to the output ends of the first reservoir 201 and the second reservoir 202 to realize the output switching between the first reservoir 201 and the second reservoir 202 to avoid simultaneous delivery of contrast agent to the patient from both reservoirs.

[0031] Reference Figure 1 and Figure 2The contrast agent supply assembly 500 includes a bottle position fixing seat 501, a contrast agent bottle 502, a bottle stopper puncturist 503, and a supply tubing 504. The bottle position fixing seat 501 is detachably connected to the mounting base 101 of the high-pressure injector host 100 by bolts. The contrast agent bottle 502 has a bottle body 5021 and a rubber cap 5022. The bottle body 5021 is snapped onto the bottle position fixing seat 501. The bottle stopper puncturist 503 has a hollow inner cavity and is open at both ends. One end of the bottle stopper puncturist 503 is sharp and inserted into the rubber cap 5022, and the other end is connected to the supply tubing 504 to form at least one contrast bottle interface for connecting the first low-pressure replenishment branch 700 and the second low-pressure replenishment branch 800. The bottle stopper puncturist 503 is pressed through the rubber cap 5022 to connect the supply tubing 504 with the inner cavity of the bottle body 5021. In this embodiment, the bottle stopper puncture device 503 and the fluid supply tubing 504 are respectively provided with two sets, thus forming two contrast bottle interfaces that are respectively connected to the first low-pressure fluid supply branch 700 and the second low-pressure fluid supply branch 800. The fluid supply tubing 504 is connected to the first low-pressure fluid supply branch 700 and the second low-pressure fluid supply branch 800 through the fluid connection connector 20B2.

[0032] Furthermore, a check valve 900, a bubble trapping chamber 901, a bubble detection sensor 902, a filter unit 903, and a solenoid replenishment valve 904 are sequentially connected and installed on both the first low-pressure replenishment branch 700 and the second low-pressure replenishment branch 800. The check valve 900 is used to prevent backflow of liquid in the reservoir. The filter unit 903 uses a medical disposable microporous filter to filter the contrast agent to further ensure safety. The bubble trapping chamber 901 preferably adopts a structure that is wider at the top and narrower at the bottom. The bubble detection sensor 902 is an ultrasonic bubble detection sensor installed on the replenishment branch and connected to the controller 102 for signal transmission. It is used to detect the presence of bubbles in the liquid path. The solenoid replenishment valve 904 is a normally closed medical solenoid valve electrically connected to the controller 102. It is activated by the controller 102 when replenishment is performed. Both the first low-pressure replenishment branch 700 and the second low-pressure replenishment branch 800 are equipped with an exhaust bypass 10 that is connected to the bubble collection chamber 901. The exhaust bypass 10 is connected to the waste liquid bag through an exhaust / waste discharge valve. The exhaust / waste discharge valve is a normally closed solenoid valve and is connected to the controller 102 via a signal. When bubbles are present, the controller 102 controls the opening of the exhaust / waste discharge valve to allow air to be discharged through the bubble collection chamber 901 and the exhaust bypass 10. After the bubble detection sensor 902 confirms that there are no obvious bubbles in the liquid path, the exhaust valve is closed.

[0033] Furthermore, the first low-pressure rehydration branch 700 and the second low-pressure rehydration branch 800 are respectively connected to the low-pressure rehydration interface 20C at the rear end or side rear end of the first reservoir 201 and the second reservoir 202, and are not directly connected to the high-pressure output main channel at the patient end.

[0034] Reference Figure 1 and Figure 2 The switching manifold assembly 600 includes a pressure-resistant manifold 601, a control valve 602, and a high-pressure output main 603. The pressure-resistant manifold 601 is a tee pipe consisting of a first input end, a second input end, and a common output end. The housing material of the pressure-resistant manifold 601 is preferably made of metal or high-strength medical engineering plastic and can withstand high-pressure injection conditions. The first input end is connected to the high-pressure output port at the front end of the first reservoir 201 via a Luer connector or a pressure-resistant threaded connector. The second input end is connected to the high-pressure output port at the front end of the second reservoir 202 via a Luer connector or a pressure-resistant threaded connector. The common output end is connected to the first input end, the second input end, and the high-pressure output main 603. The control valve 602 is installed inside the common output end to allow only one of the first input end or the second input end to be connected to the common output end at any given time. In feasible embodiments, the control valve 602 can be a switching valve core or two one-way output valves respectively installed at the connection points between the first input end and the common output end and the second input end and the common output end. The control valve 602 is connected to the controller 102 via signal to achieve on / off control.

[0035] Reference Figure 1 and Figure 2 An audible and visual alarm unit 20 is installed on the mounting base 101 of the high-pressure injector main unit 100. The audible and visual alarm unit 20 adopts a buzzer and warning light structure and is electrically connected to the controller 102. In this embodiment, the controller 102 includes a main control board, a power management board, a drive board, and a signal acquisition board. The external power supply is connected to the power management board, which provides multi-channel regulated outputs to power the main control board, drive board, signal acquisition board, external sensors, and switches, all sharing a common ground. The main control board is connected to the drive board via pulse and direction signals (or RS485 / CAN communication) to issue start / stop, steering, and speed commands, and simultaneously receives drive board fault signals. The position encoder, pressure sensing unit 400, travel limit switch, bubble detection sensor 902, electromagnetic replenishment valve 904, exhaust / waste discharge valve, and control valve 602 are all connected to the signal acquisition board. After signal conditioning, the data is uploaded to the main control board via hardwiring or bus. The audible and visual alarm unit 20 will sound an alarm when any of the above electrical components malfunctions.

[0036] In a further embodiment, a manual control switch that directly controls the opening and closing of the first chamber drive mechanism 301 and the second chamber drive mechanism 302 can also be installed on the high-pressure injection host to facilitate manual intervention in the injection. This is existing technology and will not be described in detail.

[0037] The assembly steps of the automatic liquid replenishment closed-loop fast charging device for the low-pressure side of a high-pressure injector provided by the present invention are as follows: The first compartment drive mechanism 301 and the second compartment drive mechanism 302 are fixed to the rear mounting plate of the mounting base 101; Install the first liquid storage tank 201 and the second liquid storage tank 202 to the front mounting position and connect them to the corresponding push rod connecting seat 30E respectively; Connect the first low-pressure replenishment branch 700 and the second low-pressure replenishment branch 800 to their respective low-pressure replenishment interfaces 20C. Connect the output of the contrast agent supply assembly 500 to the first low-pressure replenishment branch 700 and the second low-pressure replenishment branch 800 respectively. Connect the front-end output ports of the first liquid storage tank 201 and the second liquid storage tank 202 to the switching manifold assembly 600; Connect the common output terminal of the switching manifold assembly 600 to the high voltage output main 603; Connect the exhaust / waste discharge valve and waste liquid bag to the exhaust bypass 10 of each replenishment branch; Finally, complete the electrical connections between each motor, valve, sensor and controller 102, and fix and insulate the lines.

[0038] The automatic liquid replenishment closed-loop fast charging device for the low-pressure side of a high-pressure injector provided by this invention requires the following debugging after assembly: 1. No-load operation and debugging The first compartment drive mechanism 301 and the second compartment drive mechanism 302 are controlled to run in the forward and reverse directions respectively, and the forward and backward movement of the transformer piston 20B is checked to see if it is smooth and if the limit is accurate.

[0039] 2. Valve on / off adjustment Test the operation of each solenoid replenishing valve 904, exhaust valve, and control valve 602 in sequence to ensure that the valve opening and closing are consistent with the control command.

[0040] 3. Bubble detection and debugging A mixture of liquid and air bubbles is introduced into the liquid replenishment branch, and the air bubble sensor is used to detect whether it can identify abnormal air bubbles and trigger an alarm.

[0041] 4. Dual-chamber switching debugging Set the first liquid storage tank 201 as the working tank and the second liquid storage tank 202 as the standby tank. Simulate the liquid level in the first liquid storage tank 201 dropping to the threshold state and observe whether the system can automatically switch to the second liquid storage tank 202 and start the background liquid replenishment process of the first liquid storage tank 201.

[0042] 5. Continuous operation and debugging of the whole machine Through multiple rounds of switching tests, the stability and reliability of the dual-compartment alternating operation, automatic liquid replenishment, and venting processes were confirmed.

[0043] The method of using the automatic liquid replenishment closed-loop fast charging device for the low-pressure side of a high-pressure injector provided by this invention is as follows: S1, Preparation before use First, connect the device of the present invention to the high-pressure injector host 100 and confirm that the first liquid storage tank 201, the second liquid storage tank 202, the low-pressure replenishment branch, the high-pressure output main pipe 603, the switching manifold assembly 600, and the exhaust bypass 10 are correctly connected to the external waste bag.

[0044] Install the contrast agent vial 502 onto the vial position fixing seat 501, and establish a closed fluid supply passage by puncturing the vial stopper with the vial stopper puncture device 503. Connect the patient end high-pressure injection extension tube to the high-pressure output main pipe 603.

[0045] Turn on the power and start the system.

[0046] S2, Initial liquid loading and venting The operator selects the "Initial Filling / Venting" mode via the touch display screen 103. The controller 102 controls the first low-pressure replenishment branch 700 and the second low-pressure replenishment branch 800 to open sequentially, and drives the pressure-changing piston 20B of the first reservoir 201 and the second reservoir 202 to move backward, so that the contrast agent enters the reservoir from the contrast agent bottle 502 through the replenishment branch.

[0047] If air is present in the replenishment branch, the controller 102 simultaneously opens the exhaust bypass 10 to allow the air to be discharged through the exhaust / waste discharge valve. After the bubble detection component confirms that there are no obvious bubbles in the liquid path, the exhaust valve is closed.

[0048] The system displays "Dual tanks ready" once both the first and second liquid storage tanks 201 have reached their set filling levels.

[0049] S3, Set operating parameters The operator inputs or selects injection parameters on the touch screen 103, including: single injection flow rate; single injection volume; upper limit of injection pressure; working chamber volume warning threshold; working chamber switching threshold; target volume for refilling; refilling mode (automatic / semi-automatic); and whether to enable dual-bottle switching.

[0050] For high-dose angiography scenarios such as TAVR, the warning threshold can be set higher so that the system can prepare to switch in advance.

[0051] S4, normal injection The system defaults to the first liquid storage tank 201 as the initial working tank and the second liquid storage tank 202 as the standby tank.

[0052] The controller 102 controls the switching manifold assembly 600 to connect the first reservoir 201 to the high-pressure output main 603, and then drives the first reservoir drive mechanism 301 forward to deliver the contrast agent to the patient according to the set parameters. At this time, the second reservoir 202 remains in standby mode and does not participate in the output.

[0053] S5, hot-switching process When the liquid level in the first liquid storage tank 201 drops to a preset switching threshold, the controller 102 checks whether the second liquid storage tank 202 meets the following conditions: a) The liquid level has been filled to the set volume; b) The switching path is normal; c) No bubble alarm; d) No abnormal pressure; e) The valve is in the correct condition.

[0054] If the conditions are met, the switching manifold assembly 600 will be switched to the second reservoir 202 automatically or after manual confirmation, and the second reservoir drive mechanism 302 will take over the injection.

[0055] At this point, the first liquid storage tank 201 automatically exits the output state.

[0056] S6, automatic fluid replenishment in the background During injection in the second reservoir 202, the controller 102 opens the solenoid replenishment valve 904 of the first low-pressure replenishment branch 700 and drives the first reservoir drive mechanism 301 to run in reverse, causing the pressure-changing piston 20B of the first reservoir 201 to retract, creating low-pressure liquid aspiration conditions. The contrast agent automatically enters the first reservoir 201 via the contrast agent supply assembly 500 and the first low-pressure replenishment branch 700.

[0057] If air bubbles are detected during the replenishment process, the system will first activate the vent / waste valve to vent the air, and then continue replenishing the liquid after the liquid circuit returns to normal.

[0058] After the fluid replenishment is completed, the first fluid storage tank 201 enters standby mode again, waiting for the next switchover.

[0059] S7, alternating operation When the liquid level in the second liquid storage tank 202 drops to the switching threshold, the controller 102 repeats the above logic, switches the working state back to the first liquid storage tank 201, and simultaneously puts the second liquid storage tank 202 into the background liquid replenishment state.

[0060] This allows for a cyclical operation mode that alternates between the two chambers, performing injections and fluid replenishment in rotation.

[0061] S8, intraoperative bottle change When the volume of the first contrast agent vial 502 is insufficient, the system can issue a remaining volume alarm through the human-machine interface and prompt the user to switch to the liquid source corresponding to the interface of the second contrast agent vial 502.

[0062] If the contrast agent supply assembly 500 adopts a dual-bottle switching manifold structure, the controller 102 can automatically switch to the other bottle source, and the operator can then replace the empty bottle at non-critical times.

[0063] This further reduces the waiting time caused by changing vials during the procedure.

[0064] S9, Abnormal Situation Handling If the system detects any of the following: a) There are persistent air bubbles in the liquid path; b) A certain liquid storage tank was not installed in place; c) The switching manifold was not switched correctly; d) Abnormal pressure during fluid resuscitation; e) The injection pressure exceeds the set upper limit; f) The valve did not operate as instructed; g) Motor overtravel; The controller 102 immediately terminates the current related action, closes the electromagnetic replenishment valve 904 and the control valve 602, and issues an audible and visual alarm through the audible and visual alarm unit 20, while simultaneously displaying the abnormality type on the display interface.

[0065] After the operator performs the inspection, venting, reinstallation or reset according to the prompts, the equipment can be used again.

[0066] S10, Post-use processing After the surgery, stop the injection procedure, shut off the 603 high-voltage output main pipe, and disconnect the patient's end connection.

[0067] The control system executes an "empty / shutdown" procedure to empty or recycle the remaining liquid in the dual storage tanks according to a set method.

[0068] Remove the disposable low-pressure fluid replenishment branch, fluid storage tank, contrast agent supply component 500, and waste fluid bag, and dispose of them in accordance with medical waste disposal regulations.

[0069] The installation body, mounting brackets, and non-disposable parts shall be cleaned and disinfected in accordance with hospital disinfection standards.

[0070] The above description is merely a preferred embodiment of the present invention and is not intended to limit the present invention in any form or substance. It should be noted that those skilled in the art can make various improvements and additions without departing from the present invention, and these improvements and additions should also be considered within the scope of protection of the present invention. Any modifications, alterations, and equivalent changes made by those skilled in the art based on the above-disclosed technical content without departing from the spirit and scope of the present invention are equivalent embodiments of the present invention. Furthermore, any modifications, alterations, and evolutions made to the above embodiments based on the essential technology of the present invention still fall within the scope of the technical solution of the present invention.

Claims

1. A closed-loop fast-charging device for automatic liquid replenishment on the low-pressure side of a high-pressure injector, characterized in that, The device includes a high-pressure injector main unit (100), on which a first liquid storage chamber (201) and a second liquid storage chamber (202) are connected in parallel. The high-pressure injector main unit (100) is provided with a first chamber drive mechanism (301) and a second chamber drive mechanism (302) to drive the first liquid storage chamber (201) and the second liquid storage chamber (202) to inject or to create a negative pressure environment for replenishing liquid. The first liquid storage chamber (201) and the second liquid storage chamber (202) are each provided with a pressure sensing unit (400) to provide feedback on the pressure status inside the chamber. It also includes a contrast agent supply assembly (500) and a switching manifold assembly (600). The contrast agent supply assembly (500) is located on one side of the high-pressure injector main unit (100) and is connected to the first reservoir (201) and the second reservoir (202) through the first low-pressure infusion branch (700) and the second low-pressure infusion branch (800) for low-pressure infusion. The switching manifold assembly (600) is connected to the output ends of the first reservoir (201) and the second reservoir (202) to realize the output switching between the first reservoir (201) and the second reservoir (202) to avoid the simultaneous delivery of contrast agent to the patient from both reservoirs. It also includes a controller (102) for realizing the operation control, status identification, logic switching and safety interlock of the entire device.

2. The low-pressure side automatic liquid replenishment closed-loop fast charging device for a high-pressure injector according to claim 1, characterized in that, A pressure-changing piston (20B) is slidably disposed in both the first liquid storage chamber (201) and the second liquid storage chamber (202). The first chamber drive mechanism (301) and the second chamber drive mechanism (302) have the same structure and are both disposed in the high-pressure injector host (100) to drive the sliding of the pressure-changing piston (20B).

3. The low-pressure side automatic liquid replenishment closed-loop fast charging device for a high-pressure injector according to claim 1, characterized in that, The contrast agent supply assembly (500) includes a bottle holder (501), a contrast agent bottle (502), a bottle stopper puncturist (503), and a supply tubing (504). The bottle holder (501) is detachably connected to the high-pressure injector main unit (100). The contrast agent bottle (502) has a bottle body (5021) and a rubber cap (5022). The bottle body (5021) is secured to the bottle holder (501). The bottle stopper puncturist (503)... 503) has a hollow inner cavity and is open at both ends. One end of the bottle stopper puncturer (503) is sharp and inserted into the rubber cap (5022), and the other end is connected to the fluid supply hose (504) to form at least one contrast bottle interface for connecting the first low-pressure fluid supply branch (700) and the second low-pressure fluid supply branch (800). The bottle stopper puncturer (503) is pressed through the rubber cap (5022) to connect the fluid supply hose (504) and the inner cavity of the bottle body (5021).

4. The low-pressure side automatic liquid replenishment closed-loop fast charging device for a high-pressure injector according to claim 3, characterized in that, The liquid supply hose (504) is connected to the first low-pressure liquid replenishment branch (700) and the second low-pressure liquid replenishment branch (800) through a liquid connection connector (20B2).

5. The low-pressure side automatic liquid replenishment closed-loop fast charging device for a high-pressure injector according to claim 1, characterized in that, The first low-pressure replenishment branch (700) and the second low-pressure replenishment branch (800) are sequentially connected to a check valve (900), a bubble collection chamber (901), a bubble detection sensor (902), a filter unit (903), and an electromagnetic replenishment valve (904). The first low-pressure replenishment branch (700) and the second low-pressure replenishment branch (800) are both provided with an exhaust bypass (10) connected to the bubble collection chamber (901). The exhaust bypass (10) is connected to the waste liquid bag through an exhaust / waste discharge valve.

6. The low-pressure side automatic liquid replenishment closed-loop fast charging device for a high-pressure injector according to claim 5, characterized in that, The high-pressure injector host (100) is equipped with an audible and visual alarm unit (20), which is electrically connected to the controller (102). The controller (102) is electrically connected to the pressure sensing unit (400) and the bubble detection sensor (902).

7. The low-pressure side automatic liquid replenishment closed-loop fast charging device for a high-pressure injector according to claim 1, characterized in that, The first low-pressure rehydration branch (700) and the second low-pressure rehydration branch (800) are respectively connected to the low-pressure rehydration interface (20C) at the rear end or side rear end of the first reservoir (201) and the second reservoir (202), and are not directly connected to the high-pressure output main channel at the patient end.

8. The low-pressure side automatic liquid replenishment closed-loop fast charging device for a high-pressure injector according to claim 1, characterized in that, The switching manifold assembly (600) includes a pressure-resistant manifold (601), a control valve (602), and a high-pressure output main (603). The pressure-resistant manifold (601) has a first input end, a second input end, and a common output end. The first input end is connected to the high-pressure output port at the front end of the first liquid storage tank (201), and the second input end is connected to the high-pressure output port at the front end of the second liquid storage tank (202). The common output end is connected to the first input end, the second input end, and the high-pressure output main (603). The control valve (602) is located in the common output end so that at any given time, only one of the first input end or the second input end is allowed to be connected to the common output end.

9. The low-pressure side automatic liquid replenishment closed-loop fast charging device for a high-pressure injector according to claim 8, characterized in that, The output ends of the first liquid storage tank (201) and the second liquid storage tank (202) are both connected to the pressure manifold (601) via Luer connectors or pressure-resistant threaded connectors.

10. The low-pressure side automatic liquid replenishment closed-loop fast charging device for a high-pressure injector according to claim 1, characterized in that, The first liquid storage tank (201) and the second liquid storage tank (202) are arranged in parallel and the center distance is set to 80-160 mm.

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