WO2025077341A1 - Pulse type lesion fragmentation device - Google Patents

Abstract

The present invention provides a pulse type lesion fragmentation device. The pulse type lesion fragmentation device comprises a body portion and an operation portion which are detachably connected; the operation portion comprises an elastic diaphragm, a coupling portion, a liquid conduit and a balloon, one end of the coupling portion is connected to the elastic diaphragm, and the other end of the coupling portion is connected to the balloon by means of the liquid conduit; the interiors of the coupling portion, the fluid conduit and the balloon are communicated to form a liquid storage space for accommodating liquid, and the liquid storage space is closed by the elastic diaphragm; the body portion comprises a solenoid valve having an air inlet and an air outlet, a linear airflow channel is formed between the air outlet of the solenoid valve and the elastic diaphragm, and the airflow channel can discharge gas through an exhaust port; and when high-pressure gas enters the air inlet, the solenoid valve cooperates with the exhaust port to control the generation of periodic high-pressure pulse gas. The pulse type lesion fragmentation device provided by the present invention has the advantages of good safety, high working efficiency, etc.

Description

A pulsed lesion crushing device Technical Field

The invention relates to the field of medical devices, and in particular to a pulsed lesion crushing device.

Background Art

Intravascular calcified plaques are blockages caused by the deposition of calcium ions and fat in the blood vessels on the inner walls of the blood vessels. The blockages can reduce or even block blood flow, thereby triggering a series of ischemic diseases.

In the prior art, in order to solve a series of diseases caused by calcified plaques in blood vessels, drug treatment is usually used. For example, drugs that are commonly used in clinical practice to stabilize plaques and soften blood vessels mainly include lipid-regulating drugs, drugs that inhibit platelet aggregation, and Chinese patent medicines that improve microcirculation and promote blood circulation and remove blood stasis. However, most of these drugs can only inhibit the further generation of calcified plaques, and it is difficult to fundamentally solve the problem. To this end, in recent years, some new solutions have been proposed in the industry: using a crushing device to extend into the lesion to knock on the calcified plaque, so that the calcified plaque breaks, and then the calcified plaque blockage is cleared. For example, an ultrasonic electrode is transported to the treatment position, and a high-voltage electrode is used to emit ultrasonic waves to impact the calcified plaque and shatter it. However, if this method is used, if the voltage is too high, electrical breakdown is likely to occur, causing personal safety; if the voltage is low, the impact efficiency is too low.

Summary of the invention

Based on the above situation, the main purpose of the present invention is to provide a pulsed lesion crushing device which is safe to use and has high working efficiency.

To achieve the above-mentioned purpose, the technical solution adopted by the present invention is as follows: a pulsed lesion crushing device, the pulsed lesion crushing device comprises a main body part and an operating part, the main body part and the operating part are detachably connected;

The operating part includes an elastic diaphragm, a coupling part, a liquid tube and a balloon, one end of the coupling part is connected to the elastic diaphragm, and the other end is connected to the balloon through the liquid tube; the coupling part, the liquid tube and the inside of the balloon are connected to form a liquid containing space containing liquid, and the liquid containing space is closed by the elastic diaphragm;

The main body part includes a solenoid valve having an air inlet and an air outlet, a linear air flow channel is formed between the air outlet of the solenoid valve and the elastic diaphragm, and the air flow channel can be exhausted through the exhaust port; when high-pressure gas enters the air inlet, the solenoid valve and the exhaust port cooperate to control the generation of periodic high-pressure pulse gas;

A single generation cycle of the high-pressure pulse gas includes a first period and a second period. In the first period, the solenoid valve is turned on, the exhaust port is closed, the high-pressure gas advances along the air flow channel, and impacts the elastic diaphragm to deform the elastic diaphragm; in the second period, the solenoid valve is turned off, and the exhaust port is opened to exhaust, and the elastic diaphragm is reset.

Preferably, when the high-pressure pulse gas impacts the elastic diaphragm, the maximum gas pressure in the gas flow channel is P, 6atm≤P≤30atm;

In a single generation cycle of the high-pressure pulse gas, the maximum volume change of the liquid containing space is 0.01 ml;

The frequency of the high-pressure pulse gas generation is 5-20 Hz.

Preferably, the radial dimension of the airflow channel is 8-15 mm;

The coupling portion is a substantially conical structure, and the conical structure comprises a first end and a second end opposite to each other and located on the extension line of the airflow channel, the first end is larger than the second end, the radial dimension of the first end is larger than 15 mm, and the inclination angle of the inner wall thereof is 20-50°;

The radial dimension of the liquid pipe is 0.6-1.2 mm.

Preferably, in the first period, the flow velocity of the high-pressure pulse gas in the gas flow channel is greater than 5 m/s;

The maximum deformation amplitude of the elastic diaphragm in the axial direction of the airflow channel is 0.1-0.2 mm, and the time duration from deformation to reset of the elastic diaphragm is less than 0.1 s.

Preferably, the elastic diaphragm is a silicone film, a PTFE film, a TPU film, a PET film or a PU film, and the thickness of the elastic diaphragm is 0.7-3 mm.

Preferably, the opening and closing of the exhaust port is controlled according to the duration of the preset first time period and the second time period; or the opening and closing of the exhaust port is controlled according to the air pressure of the air flow channel.

Preferably, the main body portion includes a first docking portion arranged on the periphery of the airflow channel; the operating portion includes a second docking portion matching the first docking portion; when the main body portion and the operating portion are connected, the first docking portion and the second docking portion are tightly matched in a concave and convex manner to achieve a detachable connection;

The second docking portion is provided with a through hole for the airflow channel to pass through and a first threaded structure, and viewed in the axial direction of the through hole, the through hole is located in the area surrounded by the first threaded structure;

A second thread structure matching the first thread structure is provided on the outer surface of the coupling portion. When the first thread structure and the second thread structure are threadedly connected, the edge of the elastic diaphragm is clamped between the coupling portion and the second docking portion.

Preferably, an end of the coupling portion away from the liquid pipe is provided with a concave structure, and the elastic diaphragm is adhered to the concave structure;

The second docking portion is provided with a protruding portion protruding toward the coupling portion, the first threaded structure is arranged on the periphery of the protruding portion, and when the first threaded structure and the second threaded structure are threadedly connected, the protruding portion abuts the elastic diaphragm against the coupling portion.

Preferably, the operating part includes a shell fixedly arranged on the periphery of the coupling part; at least one annular surface is arranged on the periphery of the first threaded structure of the second docking part; and the side wall of the shell contacts the at least one annular surface to form at least one sealing structure.

Preferably, the first and second electrical connection parts that match each other are arranged on the docking surfaces of the first and second docking parts; when the first and second docking parts are docked, the first and second electrical connection parts are in contact to achieve electrical connection;

The main body portion includes a control circuit board electrically connected to the first electrical connection portion, and the operating portion is provided with an operating handle and a wire fixedly connected to the liquid pipe, one end of the wire is connected to the operating handle, and the other end passes through the space between the housing and the coupling portion, and passes through the second docking portion and is connected to the second electrical connection portion;

The liquid pipe and the wire located between the operating handle and the coupling portion are covered together by an insulating layer;

The length of the liquid pipe between the operating handle and the coupling portion is 0.8-1.4 m.

Preferably, the pulsed lesion crushing device further includes a control circuit board, an electric proportional valve, a pressure sensor, a manual ball valve and a ball valve state detector, wherein the electric proportional valve, the pressure sensor and the solenoid valve are all connected to the control circuit board, the manual ball valve is arranged on the air flow channel, and is connected to the control circuit board through the ball valve state detector; the electric proportional valve is connected to the solenoid valve, and the electric proportional valve can provide the high-pressure gas of the set air pressure; the pressure sensor can detect the air pressure on the air flow channel between the solenoid valve and the manual ball valve; the ball valve state detector is used to detect the working state of the manual ball valve and generate working state information to feed back to the control circuit board Manufacturing circuit boards;

The pulsed lesion crushing device includes a first working mode and a second working mode;

In the first working mode, the manual ball valve is closed, the ball valve state detector feeds back the working state information to the control circuit board, and the control circuit board at least controls the electric proportional valve and the solenoid valve to enter the self-test working mode, and determines whether one or more of the electric proportional valve, the solenoid valve, the manual ball valve and the gas path channel is abnormal through the air pressure detected by the pressure sensor;

In the second working mode, the manual ball valve is turned on, and the ball valve state detector feeds back the working state information to the control circuit board, and the control circuit board at least controls the electric proportional valve and the solenoid valve to generate the periodic high-pressure pulse gas.

The pulsed lesion crushing device provided by the present invention generates periodic high-pressure pulse gas, and the high-pressure pulse gas impacts the elastic diaphragm through a linear airflow channel, and the energy loss is small, which can provide a large force to the elastic diaphragm, so that the elastic diaphragm is suddenly deformed, and the liquid in the liquid holding space is compressed, that is, the high-pressure pulse gas is coupled with the liquid in the liquid holding space, and the pulse energy of the high-pressure pulse gas is transmitted to the balloon through the liquid, and the pulse energy is directly transmitted to the calcified plaque in contact with it through the balloon, giving the calcified plaque a certain impact force. Due to the large number of pores and adipose tissues inside the calcified plaque, there are serious inconsistencies in its mechanical properties, and severe stress concentration occurs under the action of pulse energy. Stress concentration can cause microcracks to appear in the defects inside the calcified plaque. With the increase in the number of impacts, the microcracks gradually expand and connect, and finally fatigue fracture of the calcified plaque occurs, which is propped open by the balloon to achieve the dredging of the blocked part of the calcified plaque. The whole process is safe and reliable, will not cause damage to peripheral tissues, and can improve the success rate and quality of subsequent balloon dilatation or stent implantation surgery.

The pulsed lesion crushing device includes a main body and an operating part that are detachably connected, which is convenient for medical staff to operate. The main body can be used reciprocatingly, and the operating part including the elastic diaphragm is a disposable device, which ensures the stability of the high-pressure pulse gas generation and the working efficiency of the device.

Other beneficial effects of the present invention will be explained in the specific implementation manner through the introduction of specific technical features and technical solutions. Through the introduction of these technical features and technical solutions, those skilled in the art should be able to understand the beneficial technical effects brought about by the technical features and technical solutions.

BRIEF DESCRIPTION OF THE DRAWINGS

The following is a preferred embodiment of a pulsed lesion crushing device according to the present invention with reference to the accompanying drawings. Describe it. In the figure:

FIG1 is a schematic diagram of the three-dimensional structure of a pulsed lesion crushing device according to the present invention.

FIG. 2 and FIG. 3 are schematic diagrams of the three-dimensional structure of a main body portion of a pulsed lesion crushing device according to the present invention at different angles.

FIG4 is a schematic diagram of a partial three-dimensional structure of a pulse lesion crushing device of the present invention after the outer shell is removed.

FIG5 is a schematic diagram of a partial cross-sectional structure of a pulsed lesion crushing device according to the present invention.

FIG. 6 is a schematic diagram of a circuit module of a pulsed lesion crushing device according to the present invention.

FIG. 7 and FIG. 8 are schematic diagrams of the three-dimensional structure of the operating part of the pulse lesion crushing device of the present invention at different angles.

FIG9 is a schematic diagram of a partial cross-sectional structure of an operating portion of a pulsed lesion crushing device according to the present invention.

FIG. 10 is a schematic diagram of the planar structure of an elastic diaphragm of an operating part included in a pulsed lesion crushing device of the present invention.

DETAILED DESCRIPTION

The present invention is described below based on embodiments, but the present invention is not limited to these embodiments. In the following detailed description of the present invention, some specific details are described in detail. In order to avoid confusing the essence of the present invention, known methods, processes, procedures, and components are not described in detail.

In addition, persons of ordinary skill in the art will appreciate that the drawings provided herein are for illustration purposes and are not necessarily drawn to scale.

Unless the context clearly requires otherwise, throughout the specification and claims, the words "include", "comprising" and similar words should be interpreted in an inclusive sense rather than an exclusive or exhaustive sense; that is, in the sense of "including but not limited to".

In the description of the present invention, it should be understood that the terms "first", "second", etc. are only used for descriptive purposes and cannot be understood as indicating or implying relative importance. In addition, in the description of the present invention, unless otherwise specified, "plurality" means two or more.

It should be noted that in the description of the present invention, "far" and "near" are relative to the operator of the equipment/device/device. The proximal end refers to the end close to the operator, and the distal end refers to the end far away from the operator. That is, for the same component, if it only partially extends into the patient's body, the end extending into the patient's body is the distal end. The end outside the body close to the operator is the proximal end.

The present invention provides a pulsed lesion crushing device suitable for various lesions that need to be crushed, including but not limited to calcified plaques in blood vessels. The present invention takes calcified plaques in blood vessels as an example for explanation, and it can be understood that this does not limit the application scenario of the pulsed lesion crushing device.

The invention provides a pulsed lesion crushing device, which comprises a main body part and an operating part, wherein the main body part and the operating part are detachably connected.

The operating part includes an elastic diaphragm, a coupling part, a liquid tube and a balloon. One end of the coupling part is connected to the elastic diaphragm, and the other end is connected to the balloon through the liquid tube. The coupling part, the liquid tube and the inside of the balloon are connected to form a liquid containing space containing liquid, and the liquid containing space is closed by the elastic diaphragm.

The main body portion includes a solenoid valve having an air inlet and an air outlet, a linear airflow channel is formed between the air outlet of the solenoid valve and the elastic diaphragm, and the airflow channel can be exhausted through the exhaust port; when high-pressure gas enters the air inlet, the solenoid valve and the exhaust port cooperate to control the generation of periodic high-pressure pulse gas.

A single generation cycle of the high-pressure pulse gas includes a first period and a second period. In the first period, the solenoid valve is turned on, the exhaust port is closed, the high-pressure gas advances along the air flow channel, and impacts the elastic diaphragm to deform the elastic diaphragm; in the second period, the solenoid valve is turned off, and the exhaust port is opened to exhaust, and the elastic diaphragm is reset.

The pulsed lesion crushing device provided by the present invention generates periodic high-pressure pulse gas, and the high-pressure pulse gas impacts the elastic diaphragm through a linear airflow channel, and the energy loss is small, which can provide a large force to the elastic diaphragm, so that the elastic diaphragm is suddenly deformed, and the liquid in the liquid holding space is compressed, that is, the high-pressure pulse gas is coupled with the liquid in the liquid holding space, and the pulse energy of the high-pressure pulse gas is transmitted to the balloon through the liquid, and the pulse energy is directly transmitted to the calcified plaque in contact with it through the balloon, giving the calcified plaque a certain impact force. Due to the large number of pores and adipose tissues inside the calcified plaque, there are serious inconsistencies in its mechanical properties, and severe stress concentration occurs under the action of pulse energy. Stress concentration can cause microcracks to appear in the defects inside the calcified plaque. With the increase in the number of impacts, the microcracks gradually expand and connect, and finally fatigue fracture of the calcified plaque occurs, which is propped open by the balloon to achieve the dredging of the blocked part of the calcified plaque. The whole process is safe and reliable, will not cause damage to peripheral tissues, and can improve the success rate and quality of subsequent balloon dilatation or stent implantation surgery.

The pulse lesion crushing device includes a main body and an operating part that are detachably connected, making it convenient for medical care. Personnel operation. The main body can be used reciprocatingly, including the operating part of the elastic diaphragm as a disposable device, which ensures the stability of the high-pressure pulse gas generation and the working efficiency of the device.

Referring to FIG. 1 , an embodiment of the present invention provides a pulsed lesion crushing device 1, which includes a main body 10 and an operating part 20, and the main body 10 and the operating part 20 are detachably connected. In some application scenarios, the main body operating part 20 can be used repeatedly, and the operating part 20 is a disposable device. Before use, the operating part 20 is sterilized, such as by ethylene oxide.

Please refer to Figures 2 to 4. As an embodiment, the main body part 10 includes a shell 18, an electric proportional valve 11, a solenoid valve 12, an exhaust port (unnumbered), an air pipe, a manual ball valve 14 and a pressure sensor 16. The electric proportional valve 11, the solenoid valve 12, the exhaust port, the air pipe, the manual ball valve 14 and the pressure sensor 16 are completely or partially contained in the shell 18, that is, each component is at least partially contained in the shell 18.

The air circuit pipe includes a first air circuit pipe 171, a second air circuit pipe 172 and a third air circuit pipe 173. The electric proportional valve 11, the solenoid valve 12 and the manual ball valve 14 all include an air inlet and an air outlet (it can be understood that in the orientation of Figure 4, the air inlet is located on the left side of the air outlet). The air outlet of the electric proportional valve 11 is connected to the air inlet of the solenoid valve 12 through the first air circuit pipe 171, and the air outlet of the solenoid valve 12 is connected to the air inlet of the manual ball valve 14 through the second air circuit pipe 172. The air outlet of the manual ball valve 14 is connected to the third air circuit pipe 173. The pressure sensor 16 can sense the air pressure in the second air line pipe 172 (including the space connected to the second air line pipe 172). As an embodiment, a fourth air line pipe 174 is provided, one end of the fourth air line pipe 174 is connected to the second air line pipe 172, and the other end is connected to the pressure sensor 16. The fourth air line pipe 174 is connected to the second air line pipe 172, so that the pressure sensor 16 can sense the air pressure in the second air line pipe 172. The exhaust port is connected to the air flow channel from the air outlet of the solenoid valve 12 to the operating part 20, and the gas in the air flow channel can be discharged to reduce the internal air pressure. The high-pressure gas source is input from the air inlet of the electric proportional valve 11. The electric proportional valve 11 processes the high-pressure gas source and outputs high-pressure gas of the set air pressure, and transmits the high-pressure gas to the solenoid valve 12 through the first air circuit pipe 171. The solenoid valve 12 and the manual ball valve 14 both have two states: on and off. When the manual ball valve 14 is off, the solenoid valve 12 is open and the exhaust port is closed. The transmission of the high-pressure gas is terminated at the manual ball valve 14. The pressure sensor 16 can detect the air pressure to determine whether the device is leaking. When the manual ball valve 14 is on, the solenoid valve 12 switches between the on and off states to generate high-pressure pulse gas. Among them, when the solenoid valve 12 is on, the exhaust port is closed, and the high-pressure gas passes through the second air circuit pipe 172 and the manual ball valve 14, and is discharged from the third air circuit pipe 173; .... In the cut-off state, the exhaust port is opened, and the high-pressure gas in the second gas line pipe 172 is discharged.

In the present invention, the air inlet and air outlet of the solenoid valve 12, the second air line pipe 172, the air inlet and air outlet of the manual ball valve 14, and the third air line pipe 173 are located on the same straight line, so that the path of the gas is linear, avoiding energy loss during the transmission of the gas. More preferably, the air inlet and air outlet of the electric proportional valve 11, the first air line pipe 171, the air inlet and air outlet of the solenoid valve 12, the second air line pipe 172, the air inlet and air outlet of the manual ball valve 14, and the third air line pipe 173 are all located on the same straight line, and there is basically no energy loss during the transmission of high-pressure gas.

Please continue to refer to Figures 2 to 5. As an embodiment, the electric proportional valve 11 includes a pressure regulating knob 111, which passes through the housing 18 and is located outside the housing 18. The user can adjust the pressure of the high-pressure gas output from the outlet of the electric proportional valve 11 through the pressure regulating knob 111, thereby meeting the device's requirements for different air pressures. The housing 18 is provided with a first through hole 181 at a position corresponding to the air inlet of the electric proportional valve 11. The air inlet of the electric proportional valve 11 is exposed to the external space at the position of the first through hole 181, so as to facilitate access to a high-pressure gas source.

As an embodiment, the pressure of the high-pressure gas output by the electric proportional valve 11 is P, 6atm≤P≤30atm (standard atmospheric pressure). Further, while reducing the air pressure and ensuring the acquisition of high-pressure pulse gas, preferably, 12atm≤P＜20atm; further, 12atm≤P＜15atm, or 16atm≤P＜18atm. Further, the pressure of the high-pressure gas can specifically be 12atm, 13atm, 14atm, 16atm, 17atm, 18atm or 19atm.

As an embodiment, the electric proportional valve 11 outputs high-pressure gas at multiple pressure levels, and the user can select a suitable pressure level. For example, the electric proportional valve 11 outputs high-pressure gas at two pressure levels, one level being 13.8 atm and the other being 17.8 atm. It can be understood that the specific pressure values corresponding to the levels can be adjusted. Preferably, the pressure difference between different levels is greater than 2.5 atm, and more preferably, the pressure difference between different levels is greater than 3.5 atm.

As an embodiment, the solenoid valve 12 is specifically a high-frequency solenoid valve. It can be understood that the type of the solenoid valve 12 is not limited as long as the gas can be turned on and off under the control of an electrical signal.

As an embodiment, the exhaust port is integrated on the solenoid valve 12, and the exhaust port can discharge the gas at the exhaust port of the solenoid valve 12. As another embodiment, the exhaust port is not integrated with the solenoid valve 12, and the exhaust port can be a structure independent of the solenoid valve 12.

As an embodiment, the opening and closing of the exhaust port is controlled according to the preset duration of the first period and the second period. When the duration of the first period is reached, the exhaust port is opened, and when the duration of the second period is reached, the exhaust port is closed.

As an embodiment, the opening and closing of the exhaust port is controlled according to the air pressure of the air flow channel. For example, the pressure sensor 16 detects the air pressure in the air flow channel. When the detected air pressure value is less than the preset air pressure value, the solenoid valve 12 is turned on and the exhaust port is closed, that is, the first period of the generation cycle of a single high-pressure pulse gas is completed; when the detected air pressure value is greater than the preset air pressure value, the solenoid valve 12 is turned off and the exhaust port is opened, that is, the second period of the generation cycle of a single high-pressure pulse gas is completed; the preset air pressure value is the aforementioned P. In this way, the device can still ensure its impact effect on calcified plaques under different usage environments.

As an embodiment, the manual ball valve 14 includes a ball valve body 141 and a manual part 142, and the manual part 142 is connected to the ball valve body 141. The user can adjust the manual ball valve 14 to be turned on or off by operating the manual part 142. The manual part 142 penetrates the housing 18 and is exposed outside the housing 18 to facilitate user operation. The manual ball valve 14 is also connected to a ball valve state detector 15 (see FIG. 7 for the number), and the ball valve state detector 15 can detect the conduction state of the manual ball valve 14 and generate working state information, and the working state information is used to indicate whether the manual ball valve 14 is opened or closed. It can be understood that in the present invention, the conduction of the ball valve or the solenoid valve has the same meaning as opening, and the cutoff has the same meaning as closing.

It can be understood that the manual ball valve 14 is a mechanical ball valve, and the user can perform self-inspection on the device at any time according to the needs to ensure that there is no abnormality in each part of the device and it is safe and reliable. As a variation, the manual ball valve 14 can also be replaced with other non-mechanical ball valves, for example, by setting a program control device to perform self-inspection.

As an embodiment, the first gas circuit pipe 171 can be formed by a single section of pipe or by splicing multiple sections of pipe. The second gas circuit pipe 172 can be formed by a single section of pipe or by splicing multiple sections of pipe. The third gas circuit pipe 173 can be formed by a single section of pipe or by splicing multiple sections of pipe.

As an embodiment, the diameters of the first gas line pipe 171, the second gas line pipe 172, and the third gas line pipe 173 may be the same or different. The diameters of the first gas line pipe 171, the second gas line pipe 172, and the third gas line pipe 173 may be constant or variable.

In the embodiment where the diameters of the first gas line tube 171, the second gas line tube 172, and the third gas line tube 173 are constant and consistent with each other, the diameters can be 8-15 mm, specifically 8 mm, 9 mm, 10 mm, 11 mm, 12 mm, 13 mm, 14 mm, or 15 mm. Furthermore, the diameter is 8-12 mm. Under the diameter parameters, the high-pressure gas is transmitted smoothly, the energy is concentrated, and the pulse energy can be better provided.

In the embodiment where the diameters of the first gas line pipe 171, the second gas line pipe 172, and the third gas line pipe 173 are changed, that is, the first gas line pipe 171, the second gas line pipe 172, and the third gas line pipe 173 include at least two diameter sizes, the diameter size can be 8-15mm. As an embodiment, the third gas line pipe 173 includes at least two parts with different diameters: a first pipeline section 1731 and a second pipeline section 1732. Preferably, the radial dimension difference between the first pipeline section 1731 and the second pipeline section 1732 is 1-3mm, and further 1.2-2mm. As a specific embodiment, the radial dimension of the first pipeline section 1731 is 10-15mm, or 10-12mm, or 12-14mm. Specifically, the radial dimension of the first pipeline section 1731 is 10mm, 10mm, 11mm, 12mm, 13mm, 14mm, or 15mm. The radial dimension of the second pipeline section 1732 is 8-12 mm, or 8-10 mm, or 10-12 mm. Specifically, the radial dimension of the second pipeline section 1732 is 8 mm, 9 mm, 10 mm, 11 mm, or 12 mm. The first pipeline section 1731 and the second pipeline section 1732 cooperate with each other to provide high-pressure pulse gas with concentrated energy.

As an embodiment, a display screen 19 for users to observe the operating parameters of the device is fixed on the housing 18. The display screen may be a touch screen, and the user can operate the device to execute the set function through the touch control.

As an embodiment, one or more buttons 101 for user operation are fixed on the housing 18. The button 101 may be a power switch button 101 or the like.

As an embodiment, a support structure 184 is further disposed inside the housing 18 , and the support structure 184 is used to support one or more of the first gas line pipe 171 , the second gas line pipe 172 , and the third gas line pipe 173 .

Please refer to Fig. 6, a control circuit board 100 is arranged inside the housing 18, the electric proportional valve 11, the solenoid valve 12, the pressure sensor 16, and the button 101 are all connected to the control circuit board 100, and the manual ball valve 14 is connected to the control circuit board 100 through the ball valve state detector 15. The electric proportional valve 11 has a gas pressure detection function, and can return the gas pressure value of the processed high-pressure gas to the control circuit board 100.

As an embodiment, the pulsed lesion fragmentation device 1 includes a first working mode and a second working mode. The pulsed lesion fragmentation device 1 enters the second working mode after executing the first working mode. As a variation, in some cases, the second working mode may be directly entered. The first working mode may not be executed, or may be executed at a set time, such as executing the first working mode once a week. The user may also determine whether to execute the first working mode according to the usage.

The external power supply provides power to the device, and the high-pressure gas source is connected to the air inlet of the electric proportional valve 11. After the external power supply is turned on by the power switch button 101, the pulsed lesion crushing device 1 can enter the first working mode or second working mode.

In the first working mode, the user operates the manual part 142 of the manual ball valve 14 to close the manual ball valve 14, and the ball valve state detector 15 sends the working state information generated by the detection to the control circuit board 100. The control circuit board 100 determines that the manual ball valve 14 is closed according to the working state information, and then the control body part 10 enters the self-test working mode. The self-test working mode mainly detects whether there are abnormalities in the electric proportional valve 11, the solenoid valve 12, the exhaust port and the air flow channel, such as whether there is leakage, exhaust failure, etc. As an embodiment, in the self-test working mode, within a preset time, the electric proportional valve 11 provides high-pressure gas with a set air pressure, the solenoid valve 12 is turned on, the exhaust port is closed, the pressure sensor 16 detects the air pressure and returns the air pressure parameters to the control circuit board 100. The control circuit board 100 can determine whether there are abnormalities in one or more of the solenoid valve 12, the exhaust port, the electric proportional valve 11, the manual ball valve 14, and the air flow channel according to the air pressure parameters returned by the pressure sensor 16. As another embodiment, the control circuit board 100 can determine whether one or more of the solenoid valve 12, the exhaust port, the electric proportional valve 11, the manual ball valve 14, and the air flow channel are abnormal based on the air pressure parameters of the high-pressure gas provided by the electric proportional valve 11 and the air pressure parameters returned by the pressure sensor 16. On the basis of executing the above steps, the exhaust port is further opened, and the control circuit board 100 can determine whether the exhaust port is exhausted normally based on the air pressure parameters returned by the pressure sensor 16.

In the second working mode, the user operates the manual part 142 of the manual ball valve 14 to open the manual ball valve 14, and the ball valve state detector 15 sends the working state information generated by the detection to the control circuit board 100. The control circuit board 100 determines that the manual ball valve 14 is opened according to the working state information, and then at least controls the electric proportional valve 11, the solenoid valve 12 and the exhaust port to cooperate with each other to generate periodic high-pressure pulse gas. Specifically, the generation cycle of a single high-pressure pulse gas includes a first period and a second period. In the first period, the solenoid valve 12 is turned on and the exhaust port is closed; in the second period, the solenoid valve 12 is turned off, and the exhaust port is opened to exhaust.

As an embodiment, in the case where high-pressure gas with a set pressure can be provided externally, the electric proportional valve 11 can be omitted.

As an embodiment, the manual ball valve 14 and the ball valve state detector 15 may be omitted. In this embodiment, the second gas line pipe 172 and the third gas line pipe 173 are connected.

Please continue to refer to FIG. 2 . As an embodiment, the main body portion 10 includes a first docking portion 182 disposed on the periphery of the airflow channel. The first docking portion 182 is used to dock with the operating portion 20 to achieve connection between the two portions.

7 to 9, the operating part 20 includes an elastic membrane 21, a coupling part 22, a fluid line 23 and a balloon 24. One end of the coupling part 22 is connected to the elastic membrane 21, and the other end is connected to the balloon 24 through the fluid line 23. The coupling part 22, the liquid line tube 23 and the balloon 24 are all hollow structures. The coupling part 22, the liquid line tube 23 and the balloon 24 are connected to form a liquid containing space a for containing liquid. The liquid containing space a is closed by the elastic diaphragm 21 at the end of the coupling part 22 away from the liquid line tube 23. It can be understood that when the elastic diaphragm 21 is not fixed on the coupling part 22, the liquid containing space a at the end of the coupling part 22 away from the liquid line tube 23 can be connected to the external space. When the operating part 20 is connected to the main body part 10, the elastic diaphragm 21 is arranged at the end of the third gas line tube 173 away from the manual ball valve 14, and a linear air flow channel is formed between the elastic diaphragm 21 and the gas outlet of the solenoid valve 12, and then the solenoid valve 12 cooperates with the exhaust port to control the generation of periodic high-pressure pulse gas to impact on the elastic diaphragm 21. Specifically, in the first period of the generation cycle of a single high-pressure pulse gas, the high-pressure gas advances along the air flow channel and impacts the elastic diaphragm 21 to deform the elastic diaphragm 21. In the second period of the generation cycle of a single high-pressure pulse gas, the exhaust port is exhausted and the elastic diaphragm 21 is reset. During the deformation and reset process of the elastic diaphragm 21, the liquid in the liquid containing space a is compressed, and the high-pressure pulse gas is coupled with the liquid in the liquid containing space a. The pulse energy of the high-pressure pulse gas is transmitted to the balloon 24 through the liquid, and the pulse energy is directly transmitted to the calcified plaque in contact with it through the balloon 24, giving the calcified plaque a certain impact force. The periodic high-pressure pulse gas provides periodic impact force to gradually break up the calcified plaque.

As an embodiment, in a single generation cycle of the high-pressure pulse gas, the maximum volume change of the liquid containing space a is 0.01 ml, that is, the volume change in the liquid containing space is less than or equal to 0.01 ml. It can be understood that when the elastic diaphragm 21 moves to the maximum position, the volume change of the liquid containing space a is the largest, and the maximum volume change can further be 0.008-0.01 ml, or 0.008-0.009 ml.

As an embodiment, the frequency of the high-pressure pulse gas generation is 5-20 Hz. Taking into account the crushing effect, equipment requirements and safety, the preferred frequency is 10-20 Hz, and further can be 12-20 Hz, 16-19 Hz, 16-18 Hz.

As an embodiment, the liquid contained in the liquid containing space a is physiological saline and/or developer.

As an embodiment, the elastic membrane 21 can undergo elastic deformation when subjected to force, and when the force is removed, the deformation disappears and the elastic membrane is restored. The elastic membrane 21 can be specifically a silicone membrane, a PTFE membrane (polytetrafluoroethylene), a TPU membrane (thermoplastic polyurethane), a PET membrane (polyethylene terephthalate) or a PU membrane (polyurethane).

As an embodiment, the thickness of the elastic membrane 21 is 0.7-3 mm.

As an embodiment, the maximum deformation amplitude of the elastic diaphragm 21 in the axial direction of the air flow channel is 0.1-0.2 mm, and the time duration from deformation to reset of the elastic diaphragm 21 is less than 0.1 s.

As an embodiment, the coupling portion 22 is basically a conical structure, and the conical structure includes a first end and a second end that are opposite and located on the extension line of the airflow channel, and the size of the first end is larger than the size of the second end. The design of the conical structure is conducive to gathering pulse energy and reducing the loss of pulse energy during propagation.

As an embodiment, the radial dimension of the first end of the coupling part 22 is greater than 15 mm, and the radial dimension of the second end of the coupling part 22 is substantially consistent with the radial dimension of the liquid circuit tube 23, which is 0.6-1.2 mm. The inclination angle of the inner wall of the coupling part 22 is 20-50°. It can be understood that the radial dimension of the first end of the coupling part 22 is also the end dimension of the liquid containing space; the inclination angle of the inner wall refers to the angle between the inner wall of the coupling part 22 in contact with the liquid and the axis of the coupling part 22. Under the said parameters, the propagation loss of the pulse energy is small, and the generation of echoes is avoided.

As an embodiment, the radial dimension of the first end of the coupling portion 22 is preferably 15-20 mm, or 15-18 mm, or 16-18 mm, or 18-20 mm, and specifically 15 mm, 16 mm, 17 mm, or 18 mm. The radial dimension of the second end may also be 1.2-1.6 mm, 1-1.5 mm, or 1.4-1.8 mm, and specifically 1.2 mm, 1.3 mm, 1.4 mm, 1.5 mm, 1.6 mm, 1.7 mm, or 1.8 mm.

As an embodiment, the inclination angle of the inner wall of the coupling portion 22 may be 20°-45°, or 30°-45°, specifically 20°, 25°, 30°, 35°, 40° or 45°.

As an embodiment, the ratio of the diameter of the second pipeline section 1732 to the radial dimension of the first end of the coupling portion 22 is 1:(2-6), and can further be 1:(4-6). Under this ratio, the coupling effect between the high-pressure pulse gas and the liquid is better.

As an embodiment, when the diameter of the second pipeline section 1732 is 8-10 mm, the radial dimension of the first end of the coupling part 22 is 15-18 mm, and the inclination angle of the inner wall of the coupling part 22 is 30°-45°, the coupling effect between the high-pressure pulse gas and the liquid is better, and the propagation loss of the pulse energy is extremely small, and almost no echo is generated.

As an embodiment, in the first period, the flow velocity of the high-pressure pulse gas in the gas flow channel is greater than 5 m/s, so that when the high-pressure pulse gas impacts the elastic diaphragm 21, the elastic diaphragm 21 can be deformed suddenly.

As an embodiment, the radial dimension of the liquid pipe 23 is constant, which is 0.6-1.2 mm. Further, the radial dimension can also be 0.6-1 mm, or 0.6-0.8 mm, specifically 0.6 mm, 0.7 mm, 0.8 mm, 0.9 mm, 1 mm, 1 mm, 1.2 mm, 1.3 mm, 1.4 mm, 1.5 mm.

As an embodiment, the balloon 24 is non-elastic, so that after the high-pressure pulse gas at a relatively low pressure is coupled at the elastic diaphragm 21, the force exerted on the calcified plaque through the balloon 24 is pulsed, which can effectively impact the calcified plaque. It is understood that the balloon 24 can have different specifications and sizes. As an option, the balloon 24 is larger than the size of the calcified plaque.

As an embodiment, the operating portion 20 includes a second docking portion 25 that matches the first docking portion 182. When the main body portion 10 and the operating portion 20 are connected, the first docking portion 182 and the second docking portion 25 are tightly matched to achieve a detachable connection. Specifically, the first docking portion 182 and the second docking portion 25 are annular structures with different radial dimensions. The outer diameter of the first docking portion 182 is equal to the inner diameter of the second docking portion 25. The first docking portion 182 can be inserted into the second docking portion 25 to achieve a tight fit. The structures of the first docking portion 182 and the second docking portion 25 can be replaced with each other.

It can be understood that the specific structures of the first docking portion 182 and the second docking portion 25 are not limited, as long as they cooperate with each other to achieve a detachable connection.

As an embodiment, the second docking portion 25 is provided with a second through hole 252 for the airflow channel (third air path tube 173) to pass through. It can be considered that the third air path tube 173 and the second through hole 252 are respectively part of the first docking portion 182 and the second docking portion 25. A second threaded structure 222 is provided at one end of the second docking portion 25 away from the first docking portion 182. When viewed in the axial direction of the second through hole 252, the second through hole 252 is located in the area surrounded by the second threaded structure 222. A second threaded structure 222 matching the first threaded structure 251 is provided on the outer surface of the coupling portion 22. The coupling portion 22 and the second docking portion 25 are fixedly connected by the first threaded structure 251 and the second threaded structure 222. When the first threaded structure 251 and the second threaded structure 222 are threadedly screwed, the edge of the elastic diaphragm 21 is clamped between the coupling portion 22 and the second docking portion 25.

As an embodiment, the second docking portion 25 and the coupling portion 22 may be integrally formed.

As an embodiment, the end of the coupling part 22 away from the liquid pipe 23 is provided with a concave structure 221, the elastic diaphragm 21 is pasted in the concave structure 221, the second docking part 25 is provided with a protrusion 253 protruding toward the coupling part 22, and the second threaded structure 222 is arranged on the periphery of the protrusion 253. When the first threaded structure 251 and the second threaded structure 222 are screwed together, the protrusion 253 abuts the elastic diaphragm 21 against the coupling part 22. It can be understood that the abutment of the protrusion 253 and the elastic diaphragm 21 forms a sealing structure. The screwing of the first threaded structure 251 and the second threaded structure 222 forms another sealing structure to prevent leakage of high-pressure pulse gas.

Please refer to FIG. 10 , the elastic membrane 21 includes a fixed portion 211 and a deformable portion 212. 211 is located at the periphery of the deformation part 212, and the distance between the elastic membrane 21 and the part of the deformation part 212 facing away from the liquid pipe 23 is 2-3 mm. As an embodiment, the size of the space corresponding to this distance in the radial direction is equal to the size of the first end of the coupling part 22.

As an embodiment, the third gas circuit tube 173 passes through the second through hole 252 and is protruded relative to the end of the second through hole 252 close to the coupling portion 22. The distance between the end of the third gas circuit tube 173 away from the solenoid valve 12 and the elastic diaphragm 21 is 2-3 mm. When the elastic diaphragm 21 is reset, the released compressed liquid will give a force to the elastic diaphragm 21, thereby causing the elastic diaphragm 21 to move toward the third gas circuit tube 173. If the third gas circuit tube 173 is in contact with the elastic diaphragm 21 in a natural state, the elastic diaphragm 21 will hit the end of the third gas circuit tube 173 when it is reset, which is easy to cause damage to the elastic diaphragm 21. The setting of the distance between the third gas circuit tube 173 and the elastic diaphragm 21 can prevent the elastic diaphragm 21 from hitting the third gas circuit tube 173, protect the elastic diaphragm 21, and facilitate the setting of the protrusion 253. In addition, the setting of the micro-pitch under the above parameters is also conducive to the coupling of high-pressure pulse gas with liquid at the elastic diaphragm 21.

As an embodiment, the exhaust speed of the exhaust port in the second time period is variable, which includes a first exhaust speed and a second exhaust speed, the first exhaust speed is greater than the second exhaust speed, the exhaust port first exhausts at the first exhaust speed, and then exhausts at the second exhaust speed, which can avoid the diaphragm 21 from hitting the third air circuit tube 173.

It can be understood that when the third gas line tube 173 does not completely penetrate the second through hole 252, the part of the deformation portion 212 facing away from the liquid line tube 23 is the surface S of the second docking portion 25. The setting of the distance can prevent the diaphragm 21 from hitting the surface S of the second docking portion 25.

As an embodiment, the third gas line tube 173 is connected to the second through hole 252, such as the third gas line tube 173 only extends to the end of the second through hole 252 close to the manual ball valve 14, and a part of the air flow channel is formed by the second through hole 252. The third gas line tube 173 can also extend into a part of the second through hole 252, or pass through the second through hole 252 and be flush with the end of the second through hole 252 close to the coupling portion 22. As an embodiment, the end of the third gas line tube 173 can also contact the elastic diaphragm 21.

As an embodiment, the operating part 20 further includes a shell 26 fixedly arranged on the periphery of the coupling part 22, and the end of the shell 26 away from the main body part 10 is sealed and connected to the liquid circuit tube. At least one annular surface 254 is arranged on the periphery of the second threaded structure 222 of the second docking part 25; the side wall of the shell 26 contacts the at least one annular surface 254 to form at least one sealing structure. It can be understood that the annular surface 254 can be formed on the outer surface of the second docking part 25, or it can be an annular groove arranged on the second docking part 25, and the annular groove includes two opposite annular surfaces 254 with different radial diameters, and the outer shell 18 is inserted into the annular groove. When the housing 18 is in the shaped groove, the inner wall and the outer wall of the housing 18 form a double sealing structure with the two annular surfaces 254 respectively.

As an embodiment, the first docking portion 182 and the second docking portion 25 are provided with matching first electrical connection portions 183 and second electrical connection portions 255 on their docking surfaces; when the first docking portion 182 and the second docking portion 25 complete docking, the first electrical connection portion 183 and the second electrical connection portion 255 are in contact to achieve electrical connection.

It can be understood that the first electrical connection portion 183 and the second electrical connection portion 255 can be plug-in and/or magnetically adsorbed.

As an embodiment, the operating portion 20 is provided with an operating handle 27 and a wire (not shown) fixedly connected to the fluid tube 23, one end of the wire is connected to the operating handle 27, and the other end passes through the space P between the housing 26 and the coupling portion 22, and penetrates the second docking portion 25 to be connected to the second electrical connection portion 255. Since the handle portion is provided on the fluid tube 23, it is very convenient for medical staff to operate.

As an embodiment, the liquid pipe 23 and the wire located between the operating handle 27 and the coupling portion 22 are covered together by an insulating layer 231, so that the product appearance is simpler.

As an embodiment, the length of the liquid line tube 23 between the operating handle 27 and the coupling part 22 is 0.8-1.4m, which is convenient for medical staff to operate. Further, the length of the liquid line tube 23 between the operating handle 27 and the coupling part 22 is 0.8-1.2mm

As an embodiment, a liquid injection port 28 for injecting the liquid is provided on the liquid pipe 23 near the operating handle 27. The liquid injection port 28 is arranged at the operating handle 27 to avoid concentrated arrangement of components and increased manufacturing difficulty.

As an embodiment, the operating portion 20 is further provided with a hydraulic pressure detector, which can be provided on the liquid line tube 23 and communicated with the internal space of the liquid line tube 23 .

As an embodiment, the pulsed lesion crushing device 1 provided by the present invention has, when in operation, pressure parameters of the hydraulic detector and the pressure detector 16 that are substantially consistent, with a difference of less than 5%.

Those skilled in the art will appreciate that, without conflict, the above-mentioned preferred solutions can be freely combined and superimposed.

It should be understood that the above-mentioned embodiments are merely illustrative and not restrictive. Without departing from the basic principles of the present invention, various obvious or equivalent modifications or substitutions that can be made by those skilled in the art to the above-mentioned details will all be included in the scope of the claims of the present invention.

Claims (10)

A pulsed lesion crushing device, characterized in that: the pulsed lesion crushing device comprises a main body part and an operating part, the main body part and the operating part are detachably connected; The operating part includes an elastic diaphragm, a coupling part, a liquid tube and a balloon, one end of the coupling part is connected to the elastic diaphragm, and the other end is connected to the balloon through the liquid tube; the coupling part, the liquid tube and the inside of the balloon are connected to form a liquid containing space containing liquid, and the liquid containing space is closed by the elastic diaphragm; The main body part includes a solenoid valve having an air inlet and an air outlet, a linear air flow channel is formed between the air outlet of the solenoid valve and the elastic diaphragm, and the air flow channel can be exhausted through the exhaust port; when high-pressure gas enters the air inlet, the solenoid valve and the exhaust port cooperate to control the generation of periodic high-pressure pulse gas; A single generation cycle of the high-pressure pulse gas includes a first period and a second period. During the first period, the solenoid valve is turned on, the exhaust port is closed, the high-pressure gas advances along the air flow channel, and impacts the elastic diaphragm to deform the elastic diaphragm. During the second period, the solenoid valve is turned off, the exhaust port is opened to exhaust gas, and the elastic diaphragm is reset. The main body portion includes a first docking portion arranged on the periphery of the airflow channel; the operating portion includes a second docking portion matching the first docking portion; when the main body portion and the operating portion are connected, the first docking portion and the second docking portion are tightly matched with each other to achieve a detachable connection; The second docking portion is provided with a through hole for the airflow channel to pass through and a first threaded structure, and viewed in the axial direction of the through hole, the through hole is located in the area surrounded by the first threaded structure; A second thread structure matching the first thread structure is provided on the outer surface of the coupling portion. When the first thread structure and the second thread structure are threadedly connected, the edge of the elastic diaphragm is clamped between the coupling portion and the second docking portion. The pulsed lesion crushing device according to claim 1 is characterized in that: when the high-pressure pulse gas impacts the elastic diaphragm, the maximum gas pressure in the gas flow channel is P, 6atm≤P≤30atm; In a single generation cycle of the high-pressure pulse gas, the maximum volume change of the liquid containing space is 0.01 ml; The frequency of the high-pressure pulse gas generation is 5-20 Hz. The pulsed lesion crushing device according to claim 1, characterized in that: the radial dimension of the airflow channel is 8-15 mm; The coupling portion is a substantially conical structure, and the conical structure comprises a first end and a second end opposite to each other and located on the extension line of the airflow channel, the first end is larger than the second end, the radial dimension of the first end is larger than 15 mm, and the inclination angle of the inner wall thereof is 20-50°; The radial dimension of the liquid pipe is 0.6-1.2 mm. The pulsed lesion crushing device according to claim 1, characterized in that: in the first period, the flow velocity of the high-pressure pulse gas in the air flow channel is greater than 5 m/s; The maximum deformation amplitude of the elastic diaphragm in the axial direction of the airflow channel is 0.1-0.2 mm, and the time duration from deformation to reset of the elastic diaphragm is less than 0.1 s. The pulsed lesion crushing device as described in any one of claims 1-4 is characterized in that the elastic diaphragm is a silicone film, a PTFE film, a TPU film, a PET film or a PU film, and the thickness of the elastic diaphragm is 0.7-3 mm. The pulsed lesion crushing device according to any one of claims 1 to 4 is characterized in that: the opening and closing of the exhaust port is controlled according to the preset durations of the first time period and the second time period; or the opening and closing of the exhaust port is controlled according to the air pressure of the air flow channel. The pulsed lesion crushing device according to claim 1 is characterized in that: an end of the coupling portion away from the liquid pipe is provided with a concave structure, and the elastic diaphragm is adhered to the concave structure; The second docking portion is provided with a protruding portion protruding toward the coupling portion, the first threaded structure is arranged on the periphery of the protruding portion, and when the first threaded structure and the second threaded structure are threadedly connected, the protruding portion abuts the elastic diaphragm against the coupling portion. The pulsed lesion crushing device as described in claim 1 is characterized in that: the operating part includes a shell fixedly arranged on the periphery of the coupling part; at least one annular surface is arranged on the periphery of the first threaded structure of the second docking part; and the side wall of the shell contacts the at least one annular surface to form at least one sealing structure. The pulsed lesion crushing device according to claim 8 is characterized in that: the first docking portion and the second docking portion are provided with a first electrical connection portion and a second electrical connection portion that match each other on the docking surface. When the first docking portion and the second docking portion are docked, the first electrical connection portion and the second electrical connection portion are in contact to achieve electrical connection; The main body portion includes a control circuit board electrically connected to the first electrical connection portion, and the operating portion is provided with an operating handle and a wire fixedly connected to the liquid pipe, one end of the wire is connected to the operating handle, and the other end passes through the space between the housing and the coupling portion, and passes through the second docking portion and is connected to the second electrical connection portion; The liquid pipe and the wire located between the operating handle and the coupling portion are covered together by an insulating layer; The length of the liquid pipe between the operating handle and the coupling portion is 0.8-1.4 m. The pulsed lesion crushing device as described in claim 1 is characterized in that: the pulsed lesion crushing device further comprises a control circuit board, an electric proportional valve, a pressure sensor, a manual ball valve and a ball valve state detector, the electric proportional valve, the pressure sensor and the solenoid valve are all connected to the control circuit board, the manual ball valve is arranged on the air flow channel, and is connected to the control circuit board through the ball valve state detector; the electric proportional valve is connected to the solenoid valve, and the electric proportional valve can provide the high-pressure gas of the set air pressure; the pressure sensor can detect the air pressure on the air flow channel between the solenoid valve and the manual ball valve; the ball valve state detector is used to detect the working state of the manual ball valve and generate working state information to feed back to the control circuit board; The pulsed lesion crushing device includes a first working mode and a second working mode; In the first working mode, the manual ball valve is closed, the ball valve state detector feeds back the working state information to the control circuit board, and the control circuit board at least controls the electric proportional valve and the solenoid valve to enter the self-test working mode, and determines whether one or more of the electric proportional valve, the solenoid valve, the manual ball valve and the air flow channel are abnormal through the air pressure detected by the pressure sensor; In the second working mode, the manual ball valve is turned on, and the ball valve state detector feeds back the working state information to the control circuit board, and the control circuit board at least controls the electric proportional valve and the solenoid valve to generate the periodic high-pressure pulse gas.