Shock wave balloon catheter device and medical equipment

Abstract

The embodiment of the invention provides a shock wave balloon catheter device and medical equipment. The shock wave balloon catheter device comprises a pulse power source, a balloon pressure charging and discharging unit and a controller. The controller is configured to execute the steps that S1, the balloon pressure charging and releasing unit is started, and the balloon in the folded state is charged with pressure; when the pressure of the balloon reaches a first pressure threshold value, the balloon pressure charging and releasing unit is closed; s2, starting a pulse power supply, and sending pulse voltage; when the pulse power supply sends a preset number of pulse voltages, the pulse power supply is turned off; s3, starting a balloon pressure charging and releasing unit to charge pressure to the balloon; when the pressure of the balloon reaches a second pressure threshold value, the balloon pressure charging and releasing unit is closed; wherein the second pressure threshold value is greater than the first pressure threshold value; and S4, when the duration after the pressure of the balloon reaches the second pressure threshold value is greater than the second preset duration, starting the balloon pressure charging and releasing unit, and releasing the pressure of the balloon to a folded state. According to the embodiment, pressure charging and releasing of the balloon and starting and stopping of the pulse power supply are executed through the controller according to the preset steps, operation is easy and convenient, and safety is high.

Description

TECHNICAL FIELD

[0001] The present application relates to the technical field of medical devices, in particular to a shock wave balloon catheter device and a medical device. BACKGROUND

[0002] With the growth of age and the progression of disease of heart disease patients, the plaques in peripheral vessels and coronary arteries will gradually calcify. Such bone-like analogs can cause vessel stenosis, reduce vessel blood flow, and eventually cause complete vessel occlusion.

[0003] A shock wave balloon catheter device is provided for calcified lesions of vessels. During treatment, the balloon on the catheter is pushed to the calcified area of the vessel. Then the balloon is inflated and pressurized by a pressurizing device. High-voltage pulses are applied to the electrode pair in the balloon by a pulse power supply, so that the electrode pair discharges to generate shock waves in the fluid. The shock waves hit the balloon wall, causing the calcified plaque to break. After the calcified plaque breaks, the balloon can be inflated and pressurized again by the pressurizing device to open the vessel.

[0004] During the treatment of the above-mentioned shock wave balloon catheter device, the doctor needs to manually operate the start and stop of the pulse power supply according to the process, and manually operate the pressurizing device to inflate and deflate the balloon. The operation process is complicated, and there is a risk of human operation error. SUMMARY

[0005] Embodiments of the present application provide a shock wave balloon catheter device and a medical device, which are easy to operate and have high safety.

[0006] In an optional embodiment of the present application, a medical device is provided, which includes a pulse power supply, a balloon inflation and deflation unit, and a controller. The controller is configured to perform the following steps:

[0007] S1, starting the balloon inflation and deflation unit to pressurize the balloon in a folded state; when the balloon pressure reaches a first pressure threshold, the balloon inflation and deflation unit is turned off;

[0008] S2, starting the pulse power supply to send pulse voltage; when the pulse power supply sends a preset number of pulse voltages, or the time length of the pulse voltage sent by the pulse power supply reaches a first preset time length, the pulse power supply is turned off;

[0009] S3, starting the balloon inflation and deflation unit to pressurize the balloon; when the balloon pressure reaches a second pressure threshold, the balloon inflation and deflation unit is turned off; wherein the second pressure threshold is greater than the first pressure threshold;

[0010] S4, when the time length after the balloon pressure reaches the second pressure threshold is greater than a second preset time length, the balloon inflation and deflation unit is started to deflate the balloon to a folded state.

[0011] In another optional embodiment of the present application, a shock wave balloon catheter device is provided, comprising a catheter, a balloon sealed around the outer periphery of the catheter, and at least one pair of electrodes arranged in the balloon; the device further comprises the medical device described above; the pulse power source is used to send a pulse voltage to the electrode pair; the balloon pressure charging and discharging unit is used to deliver liquid to charge the balloon, and discharge the liquid in the balloon to release pressure; when the pulse power source applies voltage to the electrode pair, the electrode pair can generate an electric arc in the liquid in the balloon.

[0012] In the embodiments provided by the present application, the controller executes the balloon pressure charging and discharging and the start and stop of the pulse power source according to the preset steps to complete the shock wave balloon treatment, which is simple to operate and high in safety. BRIEF DESCRIPTION OF DRAWINGS

[0013] In order to more clearly illustrate the technical solutions of the embodiments of the present application or the prior art, the drawings needed to be used in the embodiments or prior art description will be briefly introduced. Obviously, the drawings in the following description are only some embodiments of the present application, and other drawings can be obtained by those skilled in the art without creative labor.

[0014] Figure 1 The structural schematic diagram of the shock wave balloon catheter device provided by an embodiment of the present application is shown in the figure;

[0015] Figure 2 The system block diagram of the shock wave balloon catheter device provided by an embodiment of the present application is shown in the figure;

[0016] Figure 3 The structural schematic diagram of the shock wave balloon catheter device provided by another embodiment of the present application is shown in the figure;

[0017] Figure 4 The flowchart of the shock wave treatment executed by the controller in an embodiment of the present application is shown in the figure. DETAILED DESCRIPTION

[0018] The technical solutions of the present application will be described in detail below with reference to the drawings and specific embodiments, and it should be understood that these embodiments are only used to illustrate the present application and not to limit the scope, and after reading the present application, various equivalent modifications of the present application made by those skilled in the art all fall within the scope defined by the present application.

[0019] It should be noted that when an element is referred to as "arranged on" another element, it can be directly on the other element or there can be a middle element. When an element is referred to as "connected" to another element, it can be directly connected to the other element or there can be a middle element.

[0020] The shockwave balloon catheter device and medical equipment of the embodiments of the present application will be explained and described below. Figures 1 to 4 It should be noted that in the embodiments of the present application, the same reference signs represent the same components. In order to be brief, the detailed description of the same components is omitted in different embodiments, and the description of the same components can be referred to and cited to each other.

[0021] With the growth of age and the progression of disease, the plaque in the peripheral blood vessels and coronary arteries will gradually calcify. This bone-like structure analogue can cause vessel stenosis, reduce vessel blood flow, and eventually cause complete vessel occlusion.

[0022] The indications of the shockwave balloon catheter device include interventional treatment of calcified lesions. The shockwave balloon catheter device comprises a catheter, a balloon sealed around the outer periphery of the catheter, and at least one electrode pair arranged in the balloon; the balloon can be filled with fluid; each of the electrode pairs comprises a first electrode and a second electrode; when a voltage is applied between the first electrode and the second electrode, a plasma arc is formed between the first electrode and the second electrode in the fluid in the balloon, thereby generating bubbles in the fluid, which expand and collapse, and then forming mechanical shock waves in the balloon, which are mechanically transmitted through the fluid and the balloon to exert mechanical force or pressure to break any calcified plaque on or in the vessel wall.

[0023] During treatment, the balloon on the catheter is pushed to the calcified area of the vessel; then the doctor operates the inflation device to inflate the balloon; the doctor operates the pulse power supply to apply high-voltage pulses to the electrode pair in the balloon to make the electrode pair discharge to generate shock waves in the fluid; the shock waves hit the balloon wall to break the calcified plaque; after the calcified plaque is broken, the doctor operates the inflation device again to inflate the balloon to open the vessel.

[0024] During the treatment of the above-mentioned shockwave balloon catheter device, the doctor needs to manually start and stop the pulse power supply according to the procedure, and manually operate the inflation device to inflate and deflate the balloon, which is complicated and has the risk of human operation error.

[0025] One embodiment of the present application provides a medical equipment as shown in Figures 1 to 3 The medical equipment comprises a pulse power supply 101, a balloon inflation and deflation unit, and a controller; the controller is configured to perform the following steps as shown in Figure 4

[0026] S1, start the balloon inflation and deflation unit to inflate the balloon 2 in the folded state; when the pressure of the balloon 2 reaches a first pressure threshold, turn off the balloon inflation and deflation unit; the first pressure threshold can be set as needed, for example, 4 atm (atmospheric pressure); ​

[0027] S2, start the pulse power supply 101 to send pulse voltage; when the pulse power supply 101 sends a preset number of pulse voltage, or the pulse power supply 101 sends the pulse voltage for a time length reaches a first preset time length, the pulse power supply 101 is closed; for example, the pulse power supply 101 sends 10 times pulse voltage, the pulse power supply 101 is closed;

[0028] S3, start the balloon inflation and pressure relief unit to inflate the balloon 2; when the balloon 2 pressure reaches a second pressure threshold, the balloon inflation and pressure relief unit is closed; wherein the second pressure threshold is greater than the first pressure threshold; the second pressure threshold can be set as needed, for example, 6 atm;

[0029] S4, when the balloon 2 pressure reaches the second pressure threshold after a time length greater than a second preset time length, the balloon inflation and pressure relief unit is started to deflate the balloon 2 to a folded state; the second preset time length can be set as needed, for example, 10 seconds.

[0030] The embodiments provided in the application complete the shock wave treatment by the controller executing the inflation and pressure relief of the balloon 2 and the start and stop of the pulse power supply 101 according to the preset steps, which is simple to operate and high in safety.

[0031] Optionally, the medical device further comprises a pressure sensor; the pressure sensor is used to detect the balloon 2 pressure and transmit the pressure signal to the controller.

[0032] In step S1 of the embodiment, optionally, the doctor (operator) confirms that the balloon 2 is delivered to the lesion site and reaches the treatment condition, and then the doctor sends a start instruction by operating the controller to start the balloon inflation and pressure relief unit to inflate the balloon 2 in the folded state.

[0033] In step S1, another optional, the position of the balloon 2 is recognized by the machine, and when the balloon 2 is delivered to the lesion site for the first time, the machine sends a start signal to the controller, and the controller sends a start instruction to start the balloon inflation and pressure relief unit to inflate the balloon 2 in the folded state after receiving the start signal; wherein the machine recognizes the position of the balloon 2 through an image processing algorithm, or the machine is a vascular interventional surgery robot, which can deliver the balloon 2 and recognize the position of the balloon 2.

[0034] In step S2 of the embodiment, the start of the pulse power supply 101 includes one of the following:

[0035] Mode one, in response to the pressure of the balloon 2 in the folded state reaching a first pressure threshold, and the balloon pressure charging and pressure relief unit being in the closed state, the controller starts the pulse power supply 101; that is, in this mode, the controller automatically starts after determining that the starting conditions of the pulse power supply 101 are met, without manual operation.

[0036] Mode two, in response to the operator issuing a start instruction of the pulse power supply 101, the controller starts the pulse power supply 101; mode two takes into account that starting the pulse power supply 101 has a certain risk, and the doctor needs to make a comprehensive judgment whether to start, so the doctor performs the operation.

[0037] Mode three, in response to the pressure of the balloon 2 in the folded state reaching a first pressure threshold, and the balloon pressure charging and pressure relief unit being in the closed state, the controller sends a signal that the pulse power supply 101 can be started; in response to the operator issuing a start instruction of the pulse power supply 101, the controller starts the pulse power supply 101; mode three first sends a signal that the pulse power supply 101 can be started by the controller after determining that the starting conditions of the pulse power supply 101 are met, and the signal can be an audible and light prompt, or a text prompt on the display; after receiving the above signal, the doctor further judges whether to start the pulse power supply 101; this helps the doctor make more accurate judgments faster and simplifies the doctor's operation.

[0038] After the controller sends the start instruction, the above steps S1, S2, S3, S4 can all be automatically operated by the controller; or, part of the operation can be automatically executed by the controller, and the other part of the operation with higher risk can be executed after the doctor issues an instruction, for example, in step S1, the balloon pressure charging and pressure relief unit is started, and in step S2, the pulse power supply 101 is started after the doctor issues an instruction, while in step S3, step S4, step S1, the balloon pressure charging and pressure relief unit is started, and in step S2, the pulse power supply 101 is started, which is automatically executed by the controller.

[0039] Optionally, the controller has an automatic mode and a manual mode.

[0040] When placed in the manual mode, at least part of the operation with higher risk in the above steps S1, S2, S3, S4 is executed after the doctor issues an instruction; for example, in step S1, the balloon pressure charging and pressure relief unit is started, and in step S2, the pulse power supply 101 is started after the doctor issues an instruction, while in step S3, step S4, step S1, the balloon pressure charging and pressure relief unit is started, and in step S2, the pulse power supply 101 is started, which is automatically executed by the controller. Alternatively, in the manual mode, all operations in the above steps S1, S2, S3, S4 are executed after the doctor issues an instruction.

[0041] When being placed in the automatic mode, the above steps S1, S2, S3 and S4 can be automatically operated by the controller after the start instruction is issued by the controller; for example, in step S2, in response to the pressure of the balloon in the folded state reaching the first pressure threshold and the balloon pressure charging and discharging unit being in the closed state, the controller starts the pulse power supply.

[0042] The balloon pressure charging and discharging unit in the embodiment can optionally include a balloon pressure charging pump 102, and the pressure charging and discharging of the balloon 2 is completed by the balloon pressure charging pump; the balloon pressure charging pump 102 has a first operating state and a second operating state; in the first operating state, the balloon pressure charging pump 102 is used to charge the balloon 2; in the second operating state, the balloon pressure charging pump 102 is used to discharge the balloon 2.

[0043] The controller is configured to perform:

[0044] The balloon pressure charging pump 102 is started to operate in the first operating state to charge the balloon 2;

[0045] The balloon pressure charging pump 102 is started to operate in the second operating state to discharge the balloon 2;

[0046] The balloon pressure charging pump 102 is closed.

[0047] The balloon pressure charging and discharging unit in the embodiment can alternatively include a balloon pressure charging pump 102 and a pressure relief valve; the balloon pressure charging pump 102 is used to charge the balloon 2; the pressure relief valve is used to discharge the fluid in the balloon 2.

[0048] The controller starts the balloon pressure charging and discharging unit to charge the balloon 2, including: the controller starts the balloon pressure charging pump 102 and closes the pressure relief valve to charge the balloon 2;

[0049] The controller closes the balloon pressure charging and discharging unit, including: the controller closes the balloon pressure charging pump 102 and closes the pressure relief valve;

[0050] The controller starts the balloon pressure charging and discharging unit to discharge the balloon 2 to the folded state, including: the controller closes the balloon pressure charging pump 102 and opens the pressure relief valve to discharge the balloon 2 to the folded state.

[0051] The balloon pressure charging pump 102 can be driven by a motor, hydraulics, pneumatics, etc., and can be selected from a syringe pump, a screw pump or other pumps, which are not limited in the application.

[0052] Optionally, the pressure relief valve is also used for balloon 2 pressure protection. In response to the balloon 2 pressure being greater than a fourth pressure threshold, the pressure relief valve is switched from the closed state to the open state; wherein the fourth pressure threshold is greater than the second pressure threshold. For example, the burst pressure of the balloon 2 is 30 atm, and the fourth pressure threshold can be set to 27 atm; in response to the balloon 2 pressure being greater than 27 atm, the pressure relief valve is automatically switched from the closed state to the open state, so that the balloon 2 is depressurized.

[0053] The existing pulse power supply and balloon inflation pump are two completely independent devices, and the switch control buttons of the two are respectively arranged on the respective devices; for example, the pulse power supply has one control handle, and the one control handle is provided with a pulse power supply key; the balloon inflation pump has another control handle, and the another control handle is provided with a balloon inflation pump key. This makes the operation of the doctor more cumbersome, and also increases the risk of operation failure.

[0054] The interactive mode of the embodiment provides the following optional schemes:

[0055] In the first optional scheme of the interactive mode, as shown in Figure 1 and Figure 2 The controller includes a pulse power supply control key 1031 and a balloon inflation and pressure relief unit control key; the pulse power supply control key 1031 is operated by the operator to control the start and stop of the pulse power supply 101; the balloon inflation and pressure relief unit control key is operated by the operator to control the balloon inflation and pressure relief unit to inflate and depressurize the balloon 2. In steps S1, S2, S3, S4 in this scheme, the start and stop of the balloon inflation and pressure relief unit and the start and stop of the pulse power supply 101 can all be automatically operated by the controller; or part of the operation can be automatically performed by the controller, and the other part of the operation with higher risk can be performed by the doctor, for example, in step S1, the doctor starts the balloon inflation and pressure relief unit through the balloon inflation and pressure relief unit control key, and in step S2, the doctor starts the pulse power supply 101 through the pulse power supply control key 1031, while in steps S3, S4, S1 of starting the balloon inflation and pressure relief unit and in step S2 of starting the pulse power supply 101, the controller automatically performs the operation.

[0056] In the first optional solution, the balloon inflation and deflation unit control keys include a balloon inflation pump control key 1032. The pulse power supply control key 1031 and the balloon inflation pump control key 1032 are integrally installed on an operation platform; the pulse power supply control key 1031 is operated by the operator to control the start and stop of the pulse power supply 101; the balloon inflation pump control key 1032 is operated by the operator to control the start and stop of the balloon inflation pump 102. The operation platform can be a handle 103, and the pulse power supply control key 1031 and the balloon inflation pump control key 1032 are mechanical keys integrally installed on the handle 103; or the operation platform can be a display screen 104, and the pulse power supply control key 1031 and the balloon inflation pump control key 1032 are virtual keys integrally installed on the display screen 104. The pulse power supply control key 1031 and the balloon inflation pump control key 1032 can be in the form of a key, a knob, a sliding push button, etc.

[0057] When the balloon inflation and deflation unit further includes a pressure relief valve, the balloon inflation pump 102 and the pressure relief valve can be controlled simultaneously by the balloon inflation pump control key 1032, for example, single-clicking the balloon inflation pump control key 1032 starts the balloon inflation pump 102 for inflation, and double-clicking the balloon inflation pump control key 1032 starts the pressure relief valve for pressure relief; or the balloon inflation and deflation unit control keys further include a pressure relief valve control key, which is integrally installed on the operation platform; the pressure relief valve control key is operated by the operator to control the opening and closing of the pressure relief valve.

[0058] In the second optional solution of the interactive mode, as shown in Figure 3 When the balloon 2 is in the folded state, the controller automatically performs steps S1, S2, S3, and S4 in response to the start instruction issued by the operator through the master control key 1033. In this solution, the pulse power supply control key and the balloon inflation and deflation unit control key are integrated into a master control key 1033, and the operator can control the pulse power supply 101 and the balloon inflation and deflation unit through the master control key 1033. Specifically, the start instruction issued through the master control key 1033 can complete steps S1, S2, S3, and S4, which greatly reduces the operation difficulty and the risk of personnel operation errors. Optionally, the master control key 1033 is a mechanical key provided on a handle 103; or the master control key 1033 is a virtual key provided on a display screen 104. The master control key 1033 can be in the form of a key, a knob, a sliding push button, etc.

[0059] In the third optional solution of the interactive mode, as shown in Figure 3As shown, the controller comprises a master key 1033; the balloon 2 is in the folded state, in response to the first start instruction of the operator through the master key 1033, the controller executes step S1; in response to the second start instruction of the operator through the master key 1033, the controller executes step S2. In this scheme, after the end of step S1, step S2 needs to start the pulse power supply 101, which has a certain risk, and the doctor needs to judge whether it can be started or not, so the doctor operates it, and the second start instruction of the operator through the master key 1033 makes the controller execute step S2.

[0060] In this embodiment, completing steps S1, S2, S3 and S4 is regarded as completing a round of shock wave treatment. The pulse power supply 101 applies a pulse voltage to the electrode pair, so that the electrode pair discharges in the liquid of the balloon 2; the discharge generates bubbles in the liquid of the balloon 2, and the bubbles generated after multiple discharges accumulate in the liquid, which changes the impedance of the liquid, thereby hindering the effective transmission of the shock wave, making it difficult to break the calcified plaque, and the treatment effect is not ideal.

[0061] Therefore, in step S2 of this embodiment, the pulse power supply 101 sends a preset number of pulse voltages, or the pulse power supply 101 sends the pulse voltage for a first preset time, and then the pulse power supply 101 is turned off; and in step S4, the balloon inflation and pressure relief unit is started to discharge the liquid in the balloon 2, so that the balloon 2 is depressurized to the folded state.

[0062] After step S4 is completed, the doctor evaluates the treatment effect, if the expected treatment effect is achieved, the balloon 2 can be withdrawn and the treatment is ended; if the expected treatment effect is not achieved, the doctor issues a start instruction through the controller, and the controller executes step S1 to inject new liquid into the folded balloon 2 to charge pressure, and then perform a round of shock wave treatment.

[0063] Specifically, when the controller comprises a pulse power supply control key 1031 and a balloon inflation and pressure relief unit control key, after step S4 is completed, the doctor operates the balloon inflation and pressure relief unit control key to make the controller start executing step S1.

[0064] When the controller comprises a master key 1033, after step S4 is completed, the doctor operates the master key to make the controller start executing step S1.

[0065] In this embodiment, optionally, Figure 1 and Figure 3As shown, the pulse power supply 101 and the balloon inflation pump 102 are integrated to form a main machine. Specifically, the main machine includes a housing; the pulse power supply 101 is fixed in the housing or on the outer wall of the housing; and the electric balloon inflation pump 102 is fixed in the housing or on the outer wall of the housing. The integration of the pulse power supply 101 and the balloon inflation pump 102 into the main machine makes the purchase, transportation, carrying and operation of the device more convenient.

[0066] In order to improve the safety of the device, the embodiment also provides the following optional scheme:

[0067] In step S1 of the embodiment, optionally, after the balloon inflation and pressure relief unit is started to inflate the balloon 2 in the folded state for a third preset time length, and the pressure of the balloon 2 does not reach the first pressure threshold, it is possible that the balloon 2 leaks or has other faults, and the controller stops the balloon inflation pump 102 from inflating the balloon 2, so as to facilitate the doctor to check the device or end the treatment. For example, in a normal state, after the balloon inflation and pressure relief unit is started to inflate the balloon 2 in the folded state for 5 seconds, the balloon 2 can reach the first pressure threshold; the third preset time length can be set to 10 seconds, and after the balloon inflation and pressure relief unit is started to inflate the balloon 2 in the folded state for 10 seconds, the balloon 2 still does not reach the first pressure threshold, the controller automatically starts the balloon inflation and pressure relief unit to deflate the balloon 2 to the folded state, or stops the balloon inflation pump 102 from inflating the balloon 2.

[0068] In step S2 of the embodiment, optionally, when the pressure of the balloon 2 is lower than a third pressure threshold, the controller disables the pulse power supply 101; wherein the third pressure threshold is lower than the first pressure threshold. For example, the first pressure threshold is 4 atm, and the third pressure threshold is set to 3 atm; when the pressure of the balloon 2 is lower than 3 atm, the balloon 2 may have a leak or other faults, and the risk of starting the pulse power supply 101 to discharge is very high, so the controller disables the pulse power supply 101.

[0069] In step S3 of the embodiment, after the balloon inflation and pressure relief unit is started to inflate the balloon 2 for a fourth preset time length, and the pressure of the balloon 2 does not reach the second pressure threshold, the controller stops the balloon inflation pump 102 from inflating the balloon 2.

[0070] Optionally, the controller further comprises a reset key; in response to a reset instruction issued by the operator through the reset key, the controller turns off the pulse power supply and starts the balloon pressure charging and discharging unit to discharge the balloon 2 to a folded state. When an abnormal condition occurs, the doctor can quickly turn off the pulse power supply 101 through the reset key to minimize the risk; the balloon 2 can also be discharged to a folded state to withdraw the balloon 2 from the patient's body to end the treatment or prepare for the next round of treatment.

[0071] Another embodiment of the present application provides a shock wave balloon catheter device as shown in Figures 1 to 3 The device further comprises the medical device described above; the pulse power supply 101 is used to send a pulse voltage to the electrode pair; the balloon pressure charging and discharging unit is used to deliver liquid to charge the balloon 2 and discharge the liquid in the balloon 2 to discharge the balloon 2; when the pulse power supply 101 applies voltage to the electrode pair, the electrode pair can generate an electric arc in the liquid in the balloon 2.

[0072] It should be noted that in the description of the present application, the terms "first", "second" and the like are only for the purpose of description and distinction of similar objects, and there is no sequence between them, nor can it be understood or implied as relative importance. In addition, in the description of the present application, unless otherwise stated, the meaning of "a plurality of" is two or more.

[0073] The above embodiments are only for the purpose of illustrating the technical concept and characteristics of the present application, so that those skilled in the art can understand the content of the present application and implement it, and cannot limit the protection scope of the present application. Any equivalent changes or modifications made in accordance with the spirit and essence of the present application shall be covered within the protection scope of the present application.

[0074] It should be understood that the above description is for illustration purposes only and not for limitation. Many implementations and many applications will be apparent to those skilled in the art upon reading the above description. For the purpose of completeness, all articles and references, including patent applications and publications, are incorporated herein by reference.

Claims

1. A medical device comprising a pulse power supply, a balloon inflation and deflation unit, and a controller; the controller is configured to perform the following steps: S1, starting the balloon inflation and deflation unit to inflate a balloon in a folded state; when the balloon pressure reaches a first pressure threshold, the balloon inflation and deflation unit is turned off; S2, starting the pulse power supply to send a pulse voltage; when the pulse power supply sends a preset number of pulse voltages, or the pulse power supply sends a pulse voltage for a time period reaching a first preset time period, the pulse power supply is turned off; S3, starting the balloon inflation and deflation unit to inflate the balloon; when the balloon pressure reaches a second pressure threshold, the balloon inflation and deflation unit is turned off; wherein the second pressure threshold is greater than the first pressure threshold; S4, when the time period after the balloon pressure reaches the second pressure threshold is greater than a second preset time period, starting the balloon inflation and deflation unit to deflate the balloon to a folded state.

2. The medical device of claim 1, wherein: In step S2, in response to the start instruction of the pulse power supply issued by the operator, the controller starts the pulse power supply; Or, in response to the pressure of the balloon in a folded state reaching a first pressure threshold and the balloon inflation and deflation unit being in an off state, the controller starts the pulse power supply.

3. The medical device of claim 1, wherein: The controller has an automatic mode and a manual mode; When placed in the manual mode, in step S2, in response to the start instruction of the pulse power supply issued by the operator, the controller starts the pulse power supply; When placed in the automatic mode, in step S2, in response to the pressure of the balloon in a folded state reaching a first pressure threshold and the balloon inflation and deflation unit being in an off state, the controller starts the pulse power supply.

4. The medical device of claim 1, wherein: In step S2, in response to the pressure of the balloon in a folded state reaching a first pressure threshold and the balloon inflation and deflation unit being in an off state, the controller issues a signal that the pulse power supply can be started; In response to the start instruction of the pulse power supply issued by the operator, the controller starts the pulse power supply.

5. The medical device of claim 1, wherein: The controller comprises a main control key; in response to the start instruction issued by the operator through the main control key when the balloon is in a folded state, the controller automatically executes steps S1, S2, S3, and S4 in sequence.

6. The medical device of claim 1, wherein: The controller comprises a main control key; in response to the start instruction issued by the operator through the main control key for the first time when the balloon is in a folded state, the controller executes step S1; in response to the start instruction issued by the operator through the main control key for the second time, the controller executes step S2.

7. The medical device of claim 1, wherein: The controller comprises a pulse power supply control key and a balloon inflation and deflation unit control key; the pulse power supply control key is operated by the operator to control the start and stop of the pulse power supply; the balloon inflation and deflation unit control key is operated by the operator to control the inflation and deflation of the balloon inflation and deflation unit to the balloon.

8. The medical device of claim 1, wherein: The balloon inflation and deflation unit comprises a balloon inflation pump; the balloon inflation pump has a first operating state and a second operating state; in the first operating state, the balloon inflation pump is used to inflate the balloon; in the first operating state, the balloon inflation pump is used to deflate the balloon. The controller is configured to perform: starting the balloon inflation pump to operate in a first operating state; starting the balloon inflation pump to operate in a second operating state; stopping the balloon inflation pump.

9. The medical device of claim 1, wherein: The balloon inflation and deflation unit comprises a balloon inflation pump and a deflation valve; the balloon inflation pump is used to inflate the balloon; the deflation valve is used to discharge fluid in the balloon; The controller starts the balloon inflation and deflation unit to inflate the balloon, comprising: the controller starts the balloon inflation pump and closes the deflation valve to inflate the balloon; The controller stops the balloon inflation and deflation unit, comprising: the controller stops the balloon inflation pump and closes the deflation valve; The controller starts the balloon inflation and deflation unit to deflate the balloon to a folded state, comprising: the controller stops the balloon inflation pump and opens the deflation valve to deflate the balloon to a folded state.

10. The medical device of claim 1, wherein: The balloon inflation and deflation unit comprises a deflation valve communicating with the balloon cavity; in response to the balloon pressure being greater than a fourth pressure threshold, the deflation valve is switched from a closed state to an open state; wherein the fourth pressure threshold is greater than the second pressure threshold.

11. The medical device of claim 1, wherein: When the pressure of the balloon is lower than a third pressure threshold, the controller disables the pulse power supply; wherein the third pressure threshold is less than the first pressure threshold.

12. The medical device of claim 1, wherein: In step S1, after the time length of starting the balloon inflation and deflation unit to inflate the balloon in the folded state reaches a third preset time length, if the pressure of the balloon does not reach the first pressure threshold, the controller stops the balloon inflation and deflation unit to inflate the balloon.

13. The medical device of claim 1, wherein: In step S3, after the time length of starting the balloon inflation and deflation unit to inflate the balloon reaches a fourth preset time length, if the pressure of the balloon does not reach the second pressure threshold, the controller stops the balloon inflation and deflation unit to inflate the balloon.

14. The medical device of claim 1, wherein: The controller comprises a reset key; in response to a reset instruction issued by the operator through the reset key, the controller stops the pulse power supply and starts the balloon inflation and deflation unit to deflate the balloon to a folded state.

15. The medical device of claim 1, wherein: After step S4 is completed, in response to a start instruction issued by the operator through the controller, the controller performs step S1.

16. The medical device of claim 1, wherein: The medical device further comprises a pressure sensor; the pressure sensor is used to detect the balloon pressure and transmit a pressure signal to the controller.

17. A Shockwave balloon catheter device comprising a catheter, a balloon sealed around the outer circumference of the catheter and at least one pair of electrodes disposed within the balloon; characterized by: The device further comprises the medical device of any one of claims 1-16; the pulse power supply is used to transmit a pulse voltage to the electrode pair; the balloon inflation and deflation unit is used to deliver liquid to inflate the balloon and discharge liquid in the balloon to deflate; when the pulse power supply applies voltage to the electrode pair, the electrode pair can generate an electric discharge arc in the liquid in the balloon.

Images