An anti-shock balloon fatigue test device and its test method

Abstract

The present invention discloses an anti-pulsation balloon fatigue testing device and its testing method, which includes a testing box body, a visualization cylinder body and a pneumatic pressure compensation device. The balloon is connected to a positive pressure regulating valve and a negative pressure regulating valve respectively through air pipes, and solenoid valves are used to control the air flow. When positive pressure is injected into the balloon, the solenoid valve controlling the positive pressure is opened, and the solenoid valve controlling the negative pressure is closed. Conversely, the solenoid valve controlling the positive pressure is closed, and the solenoid valve controlling the negative pressure is opened, so as to achieve the switching state of positive and negative pressures inside the balloon. The testing box body not only provides positive and negative pressures inside the balloon, but also can record the number of cycles. The present invention simulates the environment of blood vessels in the human body through the visualization cylinder body, and realizes the diastolic and systolic functions of the anti-pulsation balloon through the alternating cycle test of positive and negative pressures, so as to realize the fatigue test of the anti-pulsation balloon, and the test is more efficient.

Description

Technical Field

[0001] The present invention relates to the technical field of medical devices, and in particular to an anti-pulsation balloon fatigue test device and a test method thereof. Background Art

[0002] Intra-aortic balloon pump is a method of mechanical circulatory assistance. Its basic principle is to place a balloon catheter in the descending aorta and connect it to an external control device, which inflates and deflates with the diastolic and systolic phases of the heart. When a patient has severe heart failure, the balloon simulates the frequency and amplitude of the heart's diastolic and systolic phases. When the heart contracts and the aortic valve opens, the balloon rapidly deflates to increase cardiac output; conversely, the balloon rapidly inflates to increase arterial diastolic pressure, thereby increasing coronary perfusion.

[0003] Under the control of an external device, the balloon uses positive and negative pressure to achieve the functions of diastolic and systolic phases according to the frequency range of the human heart beat. This places high requirements on the fatigue performance of the balloon. The so-called fatigue resistance refers to the ability to withstand repeated stress, that is, the balloon is pressurized within a specified time to make the pressure inside the balloon reach a specified value, then maintained for a period of time, and then the pressure inside the balloon is released within another specified time to make the pressure inside the balloon drop to another specified pressure value. Finally, this series of processes is repeated, and the test is stopped when this series of processes reaches the specified number of repetitions. If no leakage occurs during the whole process, it means that the fatigue of the balloon is qualified; otherwise, it is unqualified.

[0004] Existing balloon fatigue test devices, such as a balloon fatigue test device disclosed in Chinese patent document CN201410479072, use a liquid test system to test the fatigue performance of the balloon. Its disadvantage is that the fatigue test can only be carried out on a single balloon, with low efficiency. Its preferred cycle frequency is 20 - 25 times, which is quite different from the frequency of the anti-pulsation balloon simulating the diastolic and systolic phases of the heart, and is not suitable for the fatigue test of the anti-pulsation balloon; similar to a hydraulic test system of a balloon disclosed in another Chinese patent document CN201010120717, it uses liquid water injection into the balloon to explore the fatigue resistance performance of the balloon, and cannot meet the test requirements for the fatigue resistance performance generated after air pressure injection of the anti-pulsation balloon. The above-mentioned fatigue test devices cannot simulate the blood vessel environment in the human body. Summary of the Invention

[0005] The purpose of the present invention is to provide an anti-pulsation balloon fatigue test device and a test method thereof, which simulate the blood vessel environment in the human body, use an alternating cycle test method of positive pressure and negative pressure to test the fatigue performance of the anti-pulsation balloon, with stable state, convenient operation, a large adjustable range of cycle frequency, and can simultaneously test 1 - 12 balloons with high efficiency.

[0006] To achieve the above object, the present invention provides the following technical solutions:

[0007] On the one hand, the counterpulsation balloon fatigue test device includes a test box, a visual cylinder that can be used to simulate the vascular environment in the human body, a pneumatic pressure compensation device and a control circuit; the test box includes a positive pressure regulating valve and a negative pressure regulating valve for providing positive and negative pressure gas media in the balloon to be tested, and the positive pressure regulating valve and the negative pressure regulating valve are connected with an air path port; a balloon inlet and outlet channels and a balloon limiting device for installing the balloon to be tested are arranged in the visual cylinder; the air path port is connected to the balloon inlet and outlet channels through a pipeline; the inlet and outlet channels are connected to the balloon to be tested, and the balloon limiting device is used to limit the balloon to be tested; the visual cylinder Cylinder covers for sealing are also provided on both sides, and the inlet and outlet channels are penetrated through the cylinder cover on one side of the visualized cylinder body, and the cylinder cover on the other side of the visualized cylinder body is provided with an upper water outlet for controlling the liquid pressure and a lower water inlet for injecting liquid; the pneumatic pressure-boosting device includes a pressure regulating valve and a central water outlet, the air inlet of the pressure regulating valve is connected to the air supply end, the upper water outlet of the cylinder cover is connected to the central water outlet through a pipeline, and the pneumatic pressure-boosting device is used to maintain a constant pressure in the visualized cylinder body, and the central water outlet of the pneumatic pressure-boosting device is connected to the upper water outlet of the visualized cylinder body through an air pipe, and the pressures are communicated. When the balloon is dilated, the pressure of the liquid environment in the visual cylinder increases, and part of the liquid flows into the pneumatic pressure compensating device. The pressure regulating valve reduces the gas volume of the pneumatic pressure compensating device, which plays a role of reducing pressure. On the contrary, the pressure regulating valve increases the gas volume of the pneumatic pressure compensating device, thereby compressing the liquid volume in the pneumatic pressure compensating device, which plays a role of increasing pressure. The control circuit includes a solenoid valve for controlling the positive pressure regulating valve and the negative pressure regulating valve. The balloon to be tested is connected to the positive pressure regulating valve and the negative pressure regulating valve through the trachea, respectively. The solenoid valve is used to control the airflow. The control circuit controls the positive pressure regulating valve through the solenoid valve to pressurize the balloon to be tested within a specified time, so that the pressure in the balloon to be tested reaches a specified value, and then maintains it for a period of time, and then controls the negative pressure regulating valve to release the pressure in the balloon to be tested within another specified time, so that the pressure in the balloon to be tested drops to another specified pressure value and repeats the above process. The balloon is connected to the positive pressure regulating valve and the negative pressure regulating valve through the trachea, respectively, and the solenoid valve is used to control the airflow. When positive pressure is injected into the balloon, the solenoid valve controlling the positive pressure opens and the solenoid valve controlling the negative pressure closes. Conversely, the solenoid valve controlling the positive pressure closes and the solenoid valve controlling the negative pressure opens, thereby realizing the switching state of positive and negative pressure in the balloon.

[0008] When positive pressure is injected into the balloon to be tested, the solenoid valve controlling the positive pressure opens and the solenoid valve controlling the negative pressure closes. Conversely, the solenoid valve controlling the positive pressure closes and the solenoid valve controlling the negative pressure opens, thereby realizing the switching state of positive and negative pressure in the balloon.

[0009] In the above-mentioned counterpulsation balloon fatigue test device, the test box body further includes a test box body frame, on which a box body exhaust device, a touch screen, test control buttons, an emergency stop control button and a main power switch are arranged. A control circuit is arranged inside the test box body, and the control circuit is electrically connected to the exhaust device, the touch screen, the test control buttons, the emergency stop control button and the main power switch respectively. The control circuit provides positive and negative pressures for the balloon to be tested through controlling the positive pressure regulating valve and the negative pressure regulating valve and records the number of test cycles.

[0010] In the above-mentioned counterpulsation balloon fatigue test device, an arc-shaped bracket is further included, and the test box body is fixedly connected to the inside of the visualization cylinder through the arc-shaped bracket.

[0011] In the above-mentioned counterpulsation balloon fatigue test device, a water leakage guiding groove and a water immersion detector are further arranged at the bottom inside the visualization cylinder. The water immersion detector is located in the water leakage guiding groove, and the water immersion detector is connected to the control circuit and used to monitor the liquid leakage situation inside the visualization cylinder. When the visualization cylinder leaks water and the water flows through the guiding groove, the resistance value of the water immersion detector will change, thereby causing a change in current, making the water immersion detector emit a beeping alarm and stopping the fatigue test process.

[0012] In the above-mentioned counterpulsation balloon fatigue test device, the number of air inlets, the balloon inlet and outlet channels and the balloon limiting devices is 1 to 12. A circular hole is arranged at the center position of each balloon limiting device. The air inlets can work simultaneously or independently, and the on-off state is controlled by the test control system; the balloon inlet and outlet channels are provided with gaskets and locking gaskets, which can not only ensure the water tightness of the visualization cylinder, but also serve as the channels for the balloon to enter the visualization cylinder. A circular hole is arranged at the center position of each balloon limiting device, which can not only be used to limit the test position of the balloon, but also measure the degree of expansion and contraction of the balloon.

[0013] In the above-mentioned counterpulsation balloon fatigue test device, the liquid environment inside the visualization cylinder is glycerol or water or phosphate buffer solution. All three can simulate the liquid environment of blood vessels. Among them, glycerol can also simulate the viscosity of blood, and phosphate buffer solution can also simulate the pH environment of blood vessels.

[0014] In the above-mentioned counterpulsation balloon fatigue test device, the adjustment range of the positive pressure regulating valve is 0 to 750 kPa, and the adjustment range of the negative pressure regulating valve is -160 to 0 kPa.

[0015] The cycle frequency range of the above-mentioned counterpulsation balloon fatigue test device is 1 to 140 times / min.

[0016] On the other hand, the test method of the counterpulsation balloon fatigue test device uses the above-mentioned counterpulsation balloon fatigue test device, and includes the following steps:

[0017] Step 1: Remove the reinforcement component of the balloon inlet and outlet channels at the cylinder head. Pass the folded balloon to be tested through the balloon inlet and outlet channels via a sheath tube into the balloon limiting device, and connect the other end of the balloon to be tested to the solenoid valve, positive pressure regulating valve, and negative pressure regulating valve through a trachea;

[0018] Step 2: Connect the pressure regulating valve of the pneumatic pressure supplement device to the air supply end, connect the central water outlet to the upper water outlet of the cylinder head through a trachea, and connect the liquid source end to the lower water inlet of the cylinder head, then liquid can be injected. When the liquid in the pneumatic pressure supplement device reaches the appropriate position, stop injecting the liquid and seal the pneumatic pressure supplement device;

[0019] Step 3: Adjust the pneumatic pressure supplement device, positive pressure regulating valve, and negative pressure regulating valve to appropriate pressures; turn on the main power switch, set the inflation and deflation time to determine the cycle frequency; initialize the evacuated balloon; start the test after setting the number of tests. Stop the test when the expansion and contraction of the balloon reach the set number of times.

[0020] The beneficial effects of the present invention are:

[0021] The present invention simulates the environment of blood vessels in the human body through a visualizable cylinder body, including the liquid environment and the pressure environment, making the accuracy of the balloon fatigue test higher; through the alternating cycle test of positive pressure and negative pressure, the expansion and contraction functions of the counterpulsation balloon are realized; the pneumatic pressure supplement device dynamically adjusts the pressure fluctuations generated during the expansion and contraction of the balloon to maintain a constant internal pressure; by controlling multiple groups of valves and pressure sensors and using a gas medium to pressurize the balloon, the expansion and contraction functions with high frequencies can be achieved, thereby realizing the fatigue test of the counterpulsation balloon; through the multi-station fixing device, the tests of 1 to 12 groups of balloons can be carried out simultaneously, making the test more efficient.

[0022] The present invention has a carefully designed balloon inlet and outlet channel, which is easy for the installation of the balloon and has good sealing performance; through the transparent box body, a visualizable counterpulsation balloon simulation test system is realized. Description of the Drawings

[0023] Figure 1 It is a schematic diagram of the left-side structural principle of the present invention;

[0024] Figure 2 It is a schematic diagram of the right-side structure of the present invention;

[0025] Figure 3 It is a schematic diagram of the control circuit structural principle of the present invention;

[0026] In the figure:

[0027] 1: Test box; 1-1: Positive pressure pressure regulating valve; 1-2: Negative pressure pressure regulating valve; 1-3: Air port; 1-4: Arc bracket; 1-5: Leakage guiding groove; 1-6: Water immersion detector; 1-7: Box body exhaust device; 1-8: Test box frame; 1-9: Touch screen; 1-10: Test control button; 1-11: Emergency stop control button; 1-12: Main power switch; Solenoid valve 1-13; 2: Visual cylinder; 2-1: Balloon inlet and outlet channel; 2-2: Cylinder head; 2-3: Balloon limiting device; 2-4: Pressure monitoring device; Water outlet at the upper end of the cylinder head 2-5; Water inlet at the lower end of the cylinder head 2-6; 3: Pneumatic pressure supplement device; 3-1: Pressure regulating valve; 3-2: Central water outlet; 4: Control circuit. Detailed implementation manners

[0028] In order to make the objectives, technical solutions and advantages of the present invention clearer and more understandable, the present invention will be further described in detail below with reference to the accompanying drawings. It should be understood that the specific embodiments described herein are only used to explain the present invention and are not used to limit the present invention.

[0029] Reference Figures 1 to 3The present invention provides a counterpulsation balloon fatigue test device, comprising a test box 1, a visual cylinder 2 that can be used to simulate the vascular environment in the human body, a pneumatic pressure compensation device 3 and a control circuit 4; the test box 1 comprises a positive pressure regulating valve 1-1 and a negative pressure regulating valve 1-2 that provide positive and negative pressure gas media in the tested balloon, and the positive pressure regulating valve 1-1 and the negative pressure regulating valve 1-2 are connected with an air path port 1-3; a balloon inlet and outlet channel 2-1 and a balloon limiting device 2-3 for installing the tested balloon are arranged in the visual cylinder 2; the air path port 1-3 is connected to the balloon inlet and outlet channel 2-1 through a pipeline; the inlet and outlet The inlet and outlet channel 2-1 is connected to the balloon to be tested, and the balloon limiting device 2-3 is used to limit the balloon to be tested; cylinder covers 2-2 for sealing are also provided on both sides of the visualization cylinder body 2, and the inlet and outlet channels 2-1 are penetrated and arranged on the cylinder cover 2-2 on one side of the visualization cylinder body 2, and the cylinder cover 2-2 on the other side of the visualization cylinder body 2 is provided with a water outlet 2-5 at the upper end of the cylinder cover for controlling the liquid pressure and a water inlet 2-6 at the lower end of the cylinder cover for filling the liquid; the pneumatic pressure compensation device 3 includes a pressure regulating valve 3-1 and a central water outlet 3-2, the air inlet of the pressure regulating valve 3-1 is connected to the air supply end, and the water outlet 2-5 at the upper end of the cylinder cover is connected to the air supply end through the pipe The central water outlet 3-2 is connected to the pneumatic pressure compensating device 3, and the pneumatic pressure compensating device 3 is used to maintain a constant pressure in the visualization cylinder 2. The central water outlet 3-2 of the pneumatic pressure compensating device 3 is connected to the upper water outlet 2-5 of the visualization cylinder 2 through an air pipe, and the pressures are communicated; when the balloon is expanded, the pressure of the liquid environment in the visualization cylinder increases, and part of the liquid flows into the pneumatic pressure compensating device. The pressure regulating valve reduces the gas volume of the pneumatic pressure compensating device, which plays a role of reducing pressure. On the contrary, the pressure regulating valve increases the gas volume of the pneumatic pressure compensating device, thereby compressing the liquid volume in the pneumatic pressure compensating device, which plays a role of increasing pressure; the control circuit 4 includes a control circuit for controlling the positive The solenoid valve 1-13 of the positive pressure regulating valve 1-1 and the negative pressure regulating valve 1-2, the balloon to be tested is connected to the positive pressure regulating valve 1-1 and the negative pressure regulating valve 1-2 through the trachea, and the solenoid valve 1-13 is used to control the airflow. The control circuit 4 controls the positive pressure regulating valve 1-1 to pressurize the balloon to be tested within a specified time through the solenoid valve 1-13, so that the pressure in the balloon to be tested reaches a specified value, and then maintains it for a period of time, and then controls the negative pressure regulating valve 1-2 to release the pressure in the balloon to be tested within another specified time, so that the pressure in the balloon to be tested drops to another specified pressure value and repeats the above process. The balloon is connected to the positive pressure regulating valve and the negative pressure regulating valve through the trachea, and the solenoid valve is used to control the airflow. When positive pressure is injected into the balloon, the solenoid valve controlling the positive pressure opens, and the solenoid valve controlling the negative pressure closes. Conversely, the solenoid valve controlling the positive pressure closes, and the solenoid valve controlling the negative pressure opens, thereby realizing the switching state of positive and negative pressure in the balloon.

[0030] The test box 1 further includes a test box frame 1-8, on which a box body exhaust device 1-7, a touch screen 1-9, test control buttons 1-10, an emergency stop control button 1-11, and a main power switch 1-12 are provided. A control circuit 4 is arranged inside the test box 1, and the control circuit 4 is electrically connected to the exhaust device 1-7, the touch screen 1-9, the test control buttons 1-10, the emergency stop control button 1-11, and the main power switch 1-12 respectively. The control circuit 4 provides positive and negative pressures for the balloon to be tested through a positive pressure regulating valve 1-1 and a negative pressure regulating valve 1-2 and records the number of test cycles.

[0031] It further includes an arc-shaped bracket 1-4, and the test box 1 is fixedly connected inside the visualization cylinder 2 through the arc-shaped bracket 1-4.

[0032] A water leakage guiding groove 1-5 and a water immersion detector 1-6 are further arranged at the bottom inside the visualization cylinder 2. The water immersion detector 1-6 is located inside the water leakage guiding groove 1-5, and the water immersion detector 1-6 is connected to the control circuit 4 and is used to monitor the liquid leakage condition inside the visualization cylinder 2. When the visualization cylinder leaks water and the water flows through the guiding groove, the resistance value of the water immersion detector will change, thereby causing a change in current, making the water immersion detector emit a beeping alarm and stopping the fatigue test process.

[0033] The number of air inlets 1-3, the balloon inlet and outlet channels 2-1, and the balloon limiting devices 2-3 is 1 to 12. The air inlets 1-3 can work simultaneously or separately, and the on-off state is controlled by the test control circuit 4; the balloon inlet and outlet channels 2-1 are provided with gaskets and lock washers, which can not only ensure the water tightness of the visualization cylinder but also serve as channels for the balloon to enter the visualization cylinder; a circular hole is provided at the center position of each balloon limiting device 2-3, which can not only be used to limit the test position of the balloon but also measure the degree of balloon dilation and contraction.

[0034] The liquid environment inside the visualization cylinder 2 is glycerol or water or phosphate buffer solution. All three can simulate the liquid environment of blood vessels. Among them, glycerol can also simulate the viscosity of blood, and phosphate buffer solution can also simulate the pH environment of blood vessels.

[0035] The adjustment range of the positive pressure regulating valve 1-1 is 0 to 750 kPa, and the adjustment range of the negative pressure regulating valve 1-2 is -160 to 0 kPa.

[0036] The cycle frequency range of the above-mentioned counterpulsation balloon fatigue test device is 1 to 140 times / min.

[0037] The present invention also provides a test method for a counterpulsation balloon fatigue test device. Using the above-mentioned counterpulsation balloon fatigue test device, it includes the following steps:

[0038] Step 1: Remove the reinforcement component of the balloon inlet and outlet channel 2-1 at 2-2 of the cylinder head. Pass the folded balloon to be tested through the locking gasket and the sealing gasket via the sheath tube and pull it to an appropriate position. The balloon to be tested passes through the balloon inlet and outlet channel 2-1 and enters the balloon limiting device 2-3. Install the sealing gasket and the locking gasket in place, and connect the other end of the balloon to be tested to the solenoid valve 1-13, the positive pressure regulating valve 1-1, and the negative pressure regulating valve 1-2 through an air pipe.

[0039] Step 2: Connect the pressure regulating valve 3-1 of the pneumatic pressure compensation device 3 to the air supply end, connect the central water outlet 3-2 to the upper water outlet 2-5 of the cylinder head through an air pipe, and connect the liquid source end to the lower water inlet 2-6 of the cylinder head, then the liquid can be injected. When the liquid in the pneumatic pressure compensation device 3 reaches an appropriate position, stop injecting the liquid and seal the pneumatic pressure compensation device 3.

[0040] Step 3: Adjust the pneumatic pressure compensation device 3, the positive pressure regulating valve 1-1, and the negative pressure regulating valve 1-2 to appropriate pressures; turn on the main power switch 1-12, set the inflation and deflation time to determine the cycle frequency; initialize the evacuated balloon; start the test after setting the number of tests. Stop the test when the expansion and contraction of the balloon reach the set number of times. Embodiment

[0041] First, as shown in Figure 1 、 Figure 2 and Figure 3 , a counterpulsation balloon fatigue test device includes a test box body 1, a visualization cylinder body 2, and a pneumatic pressure compensation device 3. The test box body 1 includes a positive pressure regulating valve 1-1, a negative pressure regulating valve 1-2, an air port 1-3, an arc bracket 1-4, a water leakage guiding groove 1-5, a water immersion detector 1-6, a box body exhaust device 1-7, a test box body frame 1-8, a touch screen 1-9, a test control button 1-10, an emergency stop control button 1-11, and a main power switch 1-12. The test box body not only provides positive and negative pressures inside the balloon but also can record the number of cycles. The visualization cylinder body 2 is composed of a balloon inlet and outlet channel 2-1, a cylinder head 2-2, a balloon limiting device 2-3, and a pressure monitoring device 2-4. The visualization cylinder body simulates the blood vessel environment in the human body. The pneumatic pressure compensation device 3 includes a pressure regulating valve 3-1 and a central water outlet 3-2, and can maintain the pressure in the visualization cylinder body 2 constant.

[0042] In this embodiment, the liquid in the visualization cylinder body 2 is glycerol, which is injected into the visualization cylinder body 2 through the lower water injection port on the right cylinder head. Six balloon inlet and outlet channels 2-1 are evenly arranged on the left cylinder head 2-2, and the number of balloon limiting devices 2-3 arranged inside is six. The number of air ports 1-3 on the test box body 1 is six.

[0043] The pressure values ​​of the diastolic and contraction states of the counterpulsation balloon are adjusted by the positive pressure regulating valve 1-1 and the negative pressure regulating valve 1-2 respectively, wherein the setting value of the positive pressure regulating valve 1-1 is 50 kPa, the inflation time of each cycle is 0.428 s, the setting value of the negative pressure regulating valve 1-2 is -80 kPa, the deflation time of each cycle is 0.428 s, and the frequency is set to 70 times / min.

[0044] The pressure value set by the pressure regulating valve 3 - 1 of the pneumatic pressure compensation device 3 is 16 kPa, so as to maintain the pressure in the visualization cylinder constant.

[0045] The circuit diagram of the test equipment in the test box 1 is as follows Figure 3 As shown, according to Figure 3 The circuit logic will test the control button switch 1-10, the emergency stop control button switch 1-11, the main power switch 1-12, and the solenoid valve 1-13 components to form a circuit control system.

[0046] A method for testing a counterpulsation balloon fatigue test device comprises the following steps:

[0047] First, remove the reinforcement components of the balloon inlet and outlet passage 2-1 at the cylinder cover 2-2, pass the folded balloon through the locking gasket and the sealing gasket through the sheath and pull it to a suitable position, the balloon passes through the balloon inlet and outlet passage 2-1 and enters the balloon limiting device 2-3, install the sealing gasket and the locking gasket in place, and connect the other end of the balloon to the solenoid valve 1-13, the positive pressure regulating valve 1-1, and the negative pressure regulating valve 1-2 through the air pipe;

[0048] The pressure regulating valve 3-1 of the pneumatic pressure compensating device 3 is connected to the air supply end, the central water outlet 3-2 is connected to the water outlet 2-5 at the upper end of the cylinder head through an air pipe, and the liquid source end is connected to the water inlet 2-6 at the lower end of the cylinder head, so that liquid can be injected. When the liquid in the pneumatic pressure compensating device 3 reaches the half position, the injection of liquid is stopped, and the pneumatic pressure compensating device 3 is closed;

[0049] Adjust the pressure valve 3-1 of the pneumatic pressure compensation device 3 to 16 kPa, the positive pressure regulating valve 1-1 to 50 kPa, and the negative pressure regulating valve 1-2 to -80 kPa; turn on the main power switch 1-12, set the inflation time to 0.428 s and the deflation time to 0.428 s on the touch screen 1-9 to determine that the cycle frequency is 70 times / min; press the initialization button to evacuate the balloon; set the number of tests through the touch screen 1-9; press the start button to start the test, and stop the test when the balloon has expanded and contracted to the set number of times.

[0050] During the balloon test, if any abnormal phenomenon occurs, press the emergency stop button 1-11 to stop the fatigue test process; the water immersion detector 1-6 can emit a beeping alarm and stop the fatigue test process when water leakage occurs in the visualization cylinder 2.

[0051] The technical solution of the present invention has the following advantages:

[0052] 1. The present invention realizes a visualization counterpulsation balloon simulation test system through a transparent box body.

[0053] 2. The present invention simulates the environment of blood vessels in the human body through the visualization cylinder, including the liquid environment and the pressure environment, making the balloon fatigue test more accurate.

[0054] 3. The present invention has a carefully designed balloon inlet and outlet channel, which is easy for the installation of the balloon and has good sealing performance at the same time.

[0055] 4. The pneumatic pressure compensation device of the present invention dynamically adjusts the pressure fluctuations generated during the diastolic and systolic processes of the balloon to maintain a constant internal pressure.

[0056] 5. The present invention realizes the diastolic and systolic functions of the counterpulsation balloon through the alternating cycle test of positive pressure and negative pressure.

[0057] 6. The present invention controls multiple groups of valves and pressure sensors, and uses a gas medium to pressurize the balloon, and can achieve high-frequency diastolic and systolic functions, so as to realize the fatigue test of the counterpulsation balloon.

[0058] 7. The present invention can simultaneously test 1 to 12 groups of balloons through a multi-station fixing device, making the test more efficient.

[0059] The above is only the preferred specific implementation manner of the present invention, but the protection scope of the present invention is not limited thereto. Any person skilled in the art within the technical scope disclosed by the present invention, according to the technical solution and inventive concept of the present invention, makes equivalent substitutions or changes, and should be covered by the protection scope of the present invention.

Claims

1. An anti-shock balloon fatigue test device, characterized in that, Comprising: a test box body (1), a visualization cylinder body (2) that can simulate the blood vessel environment in the human body, a pneumatic pressure supplementing device (3), and a control circuit (4); the test box body (1) includes a positive pressure regulating valve (1-1) and a negative pressure regulating valve (1-2) that provide positive and negative pressure gas media for the balloon to be tested, and the positive pressure regulating valve (1-1) and the negative pressure regulating valve (1-2) are connected to an air port (1-3); a balloon inlet and outlet channel (2-1) and a balloon limiting device (2-3) for installing the balloon to be tested are arranged in the visualization cylinder body (2); the air port (1-3) is connected to the balloon inlet and outlet channel (2-1) through a pipeline; the inlet and outlet channel (2-1) is connected to the balloon to be tested, and the balloon limiting device (2-3) is used to limit the balloon to be tested; cylinder covers (2-2) for sealing are also arranged on both sides of the visualization cylinder body (2), the inlet and outlet channel (2-1) penetrates through the cylinder cover (2-2) on one side of the visualization cylinder body (2), and a water outlet (2-5) at the upper end of the cylinder cover for controlling the liquid pressure and a water inlet (2-6) at the lower end of the cylinder cover for liquid perfusion are arranged on the cylinder cover (2-2) on the other side of the visualization cylinder body (2); the pneumatic pressure supplementing device (3) includes a regulating valve (3-1) and a central water outlet (3-2), the air inlet of the regulating valve (3-1) is connected to the air supply end, the water outlet (2-5) at the upper end of the cylinder cover is connected to the central water outlet (3-2) through a pipeline, and the pneumatic pressure supplementing device (3) is used to keep the pressure in the visualization cylinder body (2) constant; the control circuit (4) includes a solenoid valve (1-13) for controlling the positive pressure regulating valve (1-1) and the negative pressure regulating valve (1-2), the balloon to be tested is connected to the positive pressure regulating valve (1-1) and the negative pressure regulating valve (1-2) respectively through air pipes, the solenoid valve (1-13) is used to control the air flow, the control circuit (4) controls the positive pressure regulating valve (1-1) to pressurize the balloon to be tested within a specified time through the solenoid valve (1-13) so that the pressure in the balloon to be tested reaches a specified value, then maintains for a period of time, and then controls the negative pressure regulating valve (1-2) to release the pressure in the balloon to be tested within another specified time so that the pressure in the balloon to be tested drops to another specified pressure value and repeats the above process; when positive pressure is injected into the balloon to be tested, the solenoid valve controlling the positive pressure is opened and the solenoid valve controlling the negative pressure is closed, and vice versa, the solenoid valve controlling the positive pressure is closed and the solenoid valve controlling the negative pressure is opened, so as to realize the switching state of positive and negative pressure in the balloon to be tested.

2. The counterpulsation balloon fatigue test device according to claim 1, wherein The test box (1) further includes a test box frame (1-8). A box body exhaust device (1-7), a touch screen (1-9), test control buttons (1-10), an emergency stop control button (1-11), and a main power switch (1-12) are arranged on the test box frame (1-8). A control circuit (4) is arranged in the test box (1). The control circuit (4) is electrically connected to the exhaust device (1-7), the touch screen (1-9), the test control buttons (1-10), the emergency stop control button (1-11), and the main power switch (1-12) respectively. The control circuit (4) provides positive and negative pressures for the balloon to be tested through a positive pressure regulating valve (1-1) and a negative pressure regulating valve (1-2) and records the number of test cycles.

3. The counterpulsation balloon fatigue test device according to claim 1, characterized in that, It further includes an arc-shaped bracket (1-4). The visualization cylinder (2) is fixedly connected to the test box (1) through the arc-shaped bracket (1-4).

4. The anti-pulsation balloon fatigue test device according to claim 1, characterized in that, A water leakage guiding groove (1-5) and a water immersion detector (1-6) are further arranged at the inner bottom of the visualization cylinder (2). The water immersion detector (1-6) is located in the water leakage guiding groove (1-5). The water immersion detector (1-6) is connected to the control circuit (4) and is used to monitor the liquid leakage in the visualization cylinder (2).

5. The anti-pulsation balloon fatigue test device according to claim 1, characterized in that, The number of the air ports (1-3), the balloon inlet and outlet channels (2-1), and the balloon limiting devices (2-3) is 1 to 12. A circular hole is provided at the center position of each balloon limiting device (2-3).

6. The anti-pulsation balloon fatigue test device according to claim 1, characterized in that, The liquid environment in the visualization cylinder (2) is glycerol, water, or phosphate buffer solution.

7. The anti-pulsation balloon fatigue test device according to claim 1, characterized in that, The adjustment range of the positive pressure regulating valve (1-1) is 0 to 750 kPa, and the adjustment range of the negative pressure regulating valve (1-2) is -160 to 0 kPa.

8. The counterpulsation balloon fatigue test device according to claim 1, wherein, The cycle frequency range of the counterpulsation balloon fatigue test device is 1 to 140 times / min.

9. A testing method for an anti-shock balloon fatigue testing device, characterized in that, Using the counterpulsation balloon fatigue test device according to any one of claims 1 to 8, includes the following steps: Step 1: Remove the balloon inlet and outlet channel (2-1) at the cylinder head (2-2). Pass the folded balloon to be tested through the balloon inlet and outlet channel (2-1) into the balloon limiting device (2-3) through a sheath tube, and connect the other end of the balloon to be tested to the solenoid valve (1-13), the positive pressure regulating valve (1-1), and the negative pressure regulating valve (1-2) through a trachea. Step 2: Connect the pressure regulating valve (3-1) of the pneumatic pressure compensation device (3) to the air supply end, connect the central water outlet (3-2) to the upper water outlet (2-5) of the cylinder head through a trachea, and connect the liquid source end to the lower water inlet (2-6) of the cylinder head, then the liquid can be perfused. When the liquid in the pneumatic pressure compensation device (3) reaches an appropriate position, stop injecting the liquid and seal the pneumatic pressure compensation device (3). Step 3: Adjust the pneumatic pressure compensation device (3), the positive pressure regulating valve (1-1), and the negative pressure regulating valve (1-2) to appropriate pressures; turn on the main power switch (1-12), set the inflation and deflation time to determine the cycle frequency; initialize and evacuate the balloon; start the test after setting the number of tests. Stop the test when the diastolic and systolic of the balloon reach the set number of times.

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