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 medical equipment comprises a host and a control end. The main machine comprises a pulse power supply and a balloon pressurizing pump which are integrally mounted; the balloon pressurizing pump is used for pressurizing the balloon; the pulse power supply is used for conveying pulse voltage to the electrode pair in the balloon; and the control end is used for controlling start and stop of the pulse power supply and start and stop of the balloon pressurizing pump. According to the shock wave balloon catheter, the pulse power source and the balloon pressurizing pump are integrated to form the main machine, one main machine can provide the pulse voltage needed by the shock wave balloon catheter and pressurizing and depressurizing of the balloon at the same time, the equipment integration degree is higher, and equipment application is easier and more convenient.

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 plaque in peripheral vessels and coronary arteries will gradually calcify. This bone-like structure analogue can cause vessel stenosis, reduce vessel blood flow, and eventually can cause vessel complete occlusion.

[0003] For the calcified lesion of the vessel, a shock wave balloon catheter device is provided; 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 a shock wave in the fluid; the shock wave hits 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] In an optional embodiment, the pulse power supply and the balloon pressurizing pump used with the shock wave balloon catheter are two completely independent devices; the pulse power supply and the balloon pressurizing pump used with the shock wave balloon catheter are prepared separately for treatment by the shock wave balloon catheter; this brings inconvenience to multiple links in the application process of the shock wave balloon catheter. SUMMARY

[0005] Embodiments of the present application provide a shock wave balloon catheter device and a medical device, which have high integration and simplify the application of the shock wave balloon catheter.

[0006] In an optional embodiment of the present application, a medical device is provided, which includes a host and a control end; the host includes an integrated pulse power supply and a balloon pressurizing pump; the balloon pressurizing pump is used to pressurize the balloon; the pulse power supply is used to deliver pulse voltage to the electrode pair in the balloon; the control end is used to control the start and stop of the pulse power supply and the start and stop of the balloon pressurizing pump.

[0007] In another optional embodiment of the present application, a shock wave balloon catheter device is provided, which includes a catheter, a balloon sealed around the outer periphery of the catheter, and at least one electrode pair arranged in the balloon; the device further includes the above-mentioned medical device; the pulse power supply is used to send pulse voltage to the electrode pair; the balloon pressurizing pump is used to deliver liquid pressure to the balloon; when the pulse power supply applies voltage to the electrode pair, the electrode pair can generate a discharge arc in the liquid in the balloon.

[0008] The embodiment provided by the application integrates the pulse power supply and the balloon inflation pump to form a host, and one host can simultaneously provide the pulse voltage required by the shock wave balloon catheter and inflation and deflation of the balloon, so that the degree of integration of the equipment is higher, and the equipment is more convenient to use. BRIEF DESCRIPTION OF DRAWINGS

[0009] In order to more clearly illustrate the technical solutions in the embodiments of the present application or the prior art, the drawings needed to be used in the embodiments or the 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.

[0010] Figure 1 The structural schematic diagram of the shock wave balloon catheter device provided by one embodiment of the present application is shown in the figure.

[0011] Figure 2 The system block diagram of the shock wave balloon catheter device provided by one embodiment of the present application is shown in the figure.

[0012] 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.

[0013] Figure 4 The flowchart of the shock wave treatment performed by the controller in one embodiment of the present application is shown in the figure.

[0014] Figure 5 The flowchart of the shock wave treatment performed by the controller in another embodiment of the present application is shown in the figure.

[0015] Figure 6 The flowchart of another shock wave treatment performed by the controller in another embodiment of the present application is shown in the figure. DETAILED DESCRIPTION

[0016] 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 fall within the scope defined by the present application.

[0017] It should be noted that when an element is referred to as being "provided 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 being "connected" to another element, it can be directly connected to the other element or there can be a middle element.

[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 fall within the scope defined by the present application. Figures 1 to 6The shockwave balloon catheter device and medical equipment of the embodiments of the present application are explained and described. 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 each other.

[0019] With the growth of age and the progression of disease of the heart disease patients, the plaque in the peripheral blood vessels and coronary arteries will gradually calcify. This bone-like structure analogue can cause the vessel stenosis, reduce the vessel blood flow, and eventually can cause the vessel complete occlusion.

[0020] The indication of the shockwave balloon catheter device includes the interventional treatment of the calcified lesions of the blood vessels. The shockwave balloon catheter device includes a catheter, a balloon sealed around the periphery of the catheter, and at least one electrode pair arranged in the balloon; the balloon can be filled with a fluid; each of the electrode pairs includes 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, so that a bubble is generated in the fluid, which expands and collapses, and then a mechanical shock wave is formed in the balloon, which is mechanically transmitted through the fluid and the balloon to apply a mechanical force or pressure to break any calcified plaque on or in the vessel wall.

[0021] In the treatment, the balloon on the catheter is pushed to the calcified area of the vessel; then the doctor operates the inflation device to inflate and pressurize the balloon; the doctor operates the pulse power supply to apply a high-voltage pulse to the electrode pair in the balloon to make the electrode pair discharge to generate a shock wave in the fluid; the shock wave hits the balloon wall to break the calcified plaque; after the calcified plaque is broken, the doctor again operates the inflation device to inflate and pressurize the balloon to open the vessel.

[0022] In an alternative, the pulse power supply and the balloon inflation pump used in conjunction with the shockwave balloon catheter are two completely independent devices; the pulse power supply and the balloon inflation pump used in conjunction with the shockwave balloon catheter need to be purchased and stored separately for treatment; the pulse power supply and the balloon inflation pump need to be prepared in the operating room for treatment; in addition, the matching of the shockwave balloon catheter with the pulse power supply and the balloon inflation pump also needs to be considered; this brings inconvenience to multiple links in the application process of the shockwave balloon catheter.

[0023] The medical equipment provided in an embodiment of the present application, such as Figure 1 , Figure 2 and Figure 3As shown in the figure, the medical device comprises a host 1 and a control end; the host 1 comprises an integrated pulse power supply 101 and a balloon inflation pump 102; the balloon inflation pump 102 is used to inflate the balloon 2; the pulse power supply 101 is used to deliver pulse voltage to the electrode pair in the balloon 2; the control end is used to control the start and stop of the pulse power supply 101 and the start and stop of the balloon inflation pump 102.

[0024] The pulse power supply 101 and the balloon inflation pump 102 are integrated into the host 1, and one host 1 can simultaneously provide the pulse voltage required by the shock wave balloon catheter and the inflation and deflation of the balloon 2, so that the purchase, transportation, carrying and operation of the device are more convenient, the degree of integration of the device on the shock wave treatment operation site is higher, and the device is more simple.

[0025] Optionally, the host 1 comprises a shell; the pulse power supply 101 is fixed in the shell or on the outer wall of the shell; and the balloon inflation pump 102 is fixed in the shell or on the outer wall of the shell.

[0026] In an optional solution, the pulse power supply and the balloon inflation pump used with the shock wave balloon catheter are two completely independent devices, and the switch control buttons of the two are 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 switch key; the balloon inflation pump has another control handle, and the another control handle is provided with a balloon inflation pump switch key. This makes the operation of the doctor more cumbersome, and the doctor needs to switch between the two handles many times, which also increases the risk of operation errors.

[0027] The medical device in the embodiment of the present application provides an optional solution, as shown in Figure 1 and Figure 2 As shown in the figure, the control end comprises an operation platform and pulse power supply control keys and balloon inflation pump control keys integrated on the operation platform; the pulse power supply control keys are operated by a user to control the start and stop of the pulse power supply; and the balloon inflation pump control keys are operated by the user to control the start and stop of the balloon inflation pump.

[0028] Optionally, the operation platform can be a handle 103, and the pulse power supply control keys 1031 and the balloon inflation pump control keys 1032 are mechanical keys integrated on the handle 103; or the operation platform can be a display screen 104, and the pulse power supply control keys 1031 and the balloon inflation pump control keys 1032 are virtual keys integrated on the display screen 104. The pulse power supply control keys 1031 and the balloon inflation pump control keys 1032 can be in the form of keys, knobs, sliding push buttons, etc.

[0029] The controller is configured to perform Figure 4 the following steps shown in the figure:

[0030] S1, in response to the user issuing a start instruction through the balloon inflation pump control key 1032, the controller starts the balloon inflation pump 102 to inflate the balloon in the folded state; when the balloon 2 pressure reaches a first pressure threshold, the balloon inflation pump 102 is turned off; the first pressure threshold can be set as needed, for example, 4 atm (atmospheric pressure);

[0031] S2, in response to the user issuing a start instruction through the pulse power supply control key 1031, the controller starts the pulse power supply 101 to send pulse voltage; when the pulse power supply 101 sends a preset number of pulse voltages, or the pulse power supply 101 sends pulse voltage for a first preset time, the pulse power supply is turned off; for example, the pulse power supply 101 sends 10 pulse voltages, and the pulse power supply 101 is turned off;

[0032] S3, start the balloon inflation pump 102 to inflate the balloon 2; when the balloon 2 pressure reaches a second pressure threshold, the balloon inflation pump 102 is turned off; wherein the second pressure threshold is greater than the first pressure threshold; the first pressure threshold can be set as needed, for example, 6 atm;

[0033] S4, when the time length after the balloon pressure reaches the second pressure threshold is greater than a second preset time, start the balloon inflation pump 102 to deflate the balloon to the folded state, and then turn off the balloon inflation pump; or the medical device further comprises a pressure relief valve connected to the balloon 2 inner cavity; when the time length after the balloon 2 pressure reaches the second pressure threshold is greater than a second preset time, open the pressure relief valve to deflate the balloon 2 to the folded state; the second preset time can be set as needed, for example, 10 seconds.

[0034] In an optional scheme of the embodiment, part of the operations with high risk are performed by the doctor; for example, in step S1, the doctor starts the balloon inflation pump 102 through the balloon inflation pump control key 1032, and in step S2, the doctor starts the pulse power supply 101 through the pulse power supply control key 1031, while steps S3, S4, step S1 of starting the balloon inflation pump 102, and step S2 of starting the pulse power supply 101 are automatically performed by the controller.

[0035] In an optional scheme provided by the present application, the pulse power supply control key 1031 and the balloon inflation pump control key 1032 are integrated and installed on the operation platform, the inflation and deflation of the balloon 2 and the start and stop of the pulse power supply 101 are performed according to the preset steps, and the shock wave treatment is completed, which is simple and safe to operate.

[0036] Optionally, the medical device further comprises a pressure sensor; the pressure sensor is used to detect the pressure of the balloon 2 and transmit the pressure signal to the controller.

[0037] In step S1 of the optional scheme of the embodiment, after the doctor (operator) confirms that the balloon 2 is delivered to the lesion site and reaches the treatment condition, the doctor issues a start instruction by operating the controller to start the balloon inflation pump 102 to inflate the balloon 2 in the folded state.

[0038] In step S1, another optional scheme is to identify the position of the balloon 2 by machine, and in the case of first inflation after the balloon 2 is delivered to the lesion site, the machine sends an enable signal to the controller. After the controller receives the enable signal, the controller issues a start instruction to start the balloon inflation pump 102 to inflate the balloon 2 in the folded state; wherein the machine identifies the position of the balloon 2 by image processing algorithm, or the machine is a vascular intervention surgery robot, which can deliver the balloon 2 and identify the position of the balloon 2.

[0039] In step S2 of the optional scheme of the embodiment, the start of the pulse power supply 101 includes one of the following:

[0040] Method one, in response to the start instruction of the pulse power supply 101 issued by the operator, the controller starts the pulse power supply 101; method two is that considering that starting the pulse power supply 101 has a certain risk, the doctor needs to make a comprehensive judgment whether to start, so the doctor performs this operation.

[0041] Method two, in response to the pressure of the balloon 2 in the folded state reaching the first pressure threshold and the balloon inflation pump 102 being in the closed state, the controller issues a signal that the pulse power supply 101 can be started; in response to the start instruction of the pulse power supply 101 issued by the operator, the controller starts the pulse power supply 101; method two first judges by the controller whether the start condition of the pulse power supply 101 is met, and then issues a signal that the pulse power supply 101 can be started. The signal can be an audible and light prompt, or a text prompt on the display. After the doctor receives the above signal, the doctor further judges whether to start the pulse power supply 101; this helps the doctor to make a more accurate judgment faster and simplifies the operation of the doctor.

[0042] In another optional scheme of the medical device in the embodiment, as shown in Figure 3 The control end comprises an operation platform and a main control key arranged on the operation platform; in response to the start instruction issued by the user through the main control key, the pulse power supply and the balloon inflation pump are in an enabled state.

[0043] Optionally, the operation platform can be a handle 103, and the master key 1033 is a mechanical key integrated on the handle 103; or the operation platform can be a display screen 104, and the master key 1033 is a virtual key integrated on the display screen 104. The master key 1033 can be in the form of a button, a knob, a sliding push button, etc.

[0044] In another optional solution of the embodiment, in response to a start instruction issued by the user through the master key 1033, the pulse power supply 101 and the balloon inflation pump 102 are in an enabled state, and the controller automatically operates to complete the shock wave treatment; for example, the balloon is in a folded state, in response to a start instruction issued by the user through the master key 1033, the controller automatically executes the following steps in sequence as shown in Figure 5

[0045] S1, start the balloon inflation pump 102 to inflate the balloon 2 in the folded state; when the pressure of the balloon 2 reaches a first pressure threshold, the balloon inflation pump 102 is turned off;

[0046] S2, start the pulse power supply 101 to send a pulse voltage; when the pulse power supply 101 sends a preset number of pulse voltages, or the pulse power supply 101 sends a pulse voltage for a time period reaching a first preset time period, the pulse power supply 101 is turned off;

[0047] S3, start the balloon inflation pump 102 to inflate the balloon 2; when the pressure of the balloon 2 reaches a second pressure threshold, the balloon inflation pump 102 is turned off; wherein the second pressure threshold is greater than the first pressure threshold;

[0048] S4, when the time period after the balloon pressure reaches the second pressure threshold is greater than a second preset time period, start the balloon inflation pump 102 to deflate the balloon 2 to the folded state, and then turn off the balloon inflation pump 102; or the medical device further comprises a pressure relief valve communicating with the balloon 2 inner cavity; when the time period after the balloon 2 pressure reaches the second pressure threshold is greater than a second preset time period, the pressure relief valve is opened to deflate the balloon 2 to the folded state.

[0049] In another optional solution of the embodiment, in response to a start instruction issued by the user through the master key 1033, the pulse power supply 101 and the balloon inflation pump 102 are in an enabled state, and part of the operation of the shock wave treatment is automatically executed by the controller, and another part of the operation with higher risk is executed after the doctor issues an instruction; for example, the controller is configured to execute the following steps as shown in Figure 6

[0050] ​​S1, the balloon 2 is in a folded state, in response to the user first through the master key 1033 issued start instruction, the controller starts the balloon inflation pump 102, to the folded state of balloon 2 inflation; when the balloon 2 pressure reaches the first pressure threshold, the balloon inflation pump 102 is closed;

[0051] S2, in response to the user second through the master key 1033 issued start instruction, the controller starts the pulse power supply 101, sends pulse voltage; when the pulse power supply 101 sends a preset number of pulse voltage, or the pulse power supply 101 sends pulse voltage duration reaches the first preset duration, the pulse power supply 101 is closed; in this scheme, the step S1 is ended, and the 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 that the doctor performs the operation, and the operator second through the master key 1033 start instruction, the controller executes the step S2;

[0052] S3, start the balloon inflation pump 102, to the balloon inflation; when the balloon 2 pressure reaches the second pressure threshold, the balloon inflation pump 102 is closed; wherein, the second pressure threshold is greater than the first pressure threshold;

[0053] S4, when the balloon pressure reaches the second pressure threshold after the duration is greater than the second preset duration, the balloon inflation pump 102 is started, and the balloon 2 is depressurized to the folded state, and then the balloon inflation pump 102 is closed; or the medical device further comprises a pressure relief valve connected to the balloon 2 inner cavity; when the balloon 2 pressure reaches the second pressure threshold after the duration is greater than the second preset duration, the pressure relief valve is opened, and the balloon 2 is depressurized to the folded state.

[0054] Another optional scheme of the embodiment is that the pulse power supply control key and the balloon inflation pump control key are integrated into a master key 1033, and the operator can control the pulse power supply 101 and the balloon inflation pump 102 through the master key 1033; specifically, the start instruction is sent through the master key 1033, and the steps S1, S2, S3 and S4 are completed; this greatly reduces the operation difficulty and the risk of personnel operation error. Optionally, the master key 1033 is a mechanical key arranged on a handle 103; or the master key 1033 is a virtual key arranged on a display screen 104. The master key 1033 can be a key, a knob, a sliding push button or the like.

[0055] Optionally, the controller of the above embodiment has an automatic mode and a manual mode;

[0056] When being placed in the manual mode, at least part of the operations in the above steps S1, S2, S3, S4 with higher risk are performed after the doctor issues an instruction; for example, the starting of the balloon inflation pump 102 in step S1 and the starting of the pulse power supply 101 in step S2 are performed after the doctor issues an instruction, while the steps S3, S4, the starting of the balloon inflation pump 102 in step S1 and the starting of the pulse power supply 101 in step S2 are automatically performed by the controller. Alternatively, in the manual mode, all the operations in the above steps S1, S2, S3, S4 are performed after the doctor issues an instruction.

[0057] When being placed in the automatic mode, the above steps S1, S2, S3, S4 can all be automatically operated by the controller after the controller issues a starting instruction; for example, in step S2, in response to the pressure of the balloon 2 in the folded state reaching the first pressure threshold and the balloon inflation pump 102 being in the closed state, the controller starts the pulse power supply 101.

[0058] In the embodiment, the pressure relief of the balloon provides two implementation manners:

[0059] Manner one, the balloon inflation pump 102 can complete the inflation and pressure relief of the balloon 2; the balloon inflation pump 102 has a first operating state and a second operating state; in the first operating state, the balloon inflation pump 102 is used for inflating the balloon 2; in the second operating state, the balloon inflation pump 102 is used for relieving the pressure of the balloon 2.

[0060] Manner two, the balloon inflation pump 102 is used for inflating the balloon 2; the pressure relief valve is used for discharging the fluid in the balloon 2.

[0061] The balloon inflation pump 102 can be driven by a motor, a hydraulic pressure or a pneumatic pressure, and can be an injection pump, a screw pump or other pumps, which are not limited in the application.

[0062] Optionally, the pressure relief valve is also used for pressure protection of the balloon 2; in response to the pressure of the balloon 2 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 pressure of the balloon 2 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 relieved.

[0063] In this embodiment, completing steps S1, S2, S3 and S4 is regarded as completing one round of shock wave treatment. The pulse power supply 101 applies 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 and hinders the effective transmission of the shock wave, making it difficult for the shock wave to break the calcified plaque and resulting in unsatisfactory treatment effect.

[0064] 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 pulse voltage for a first preset time length, and then the pulse power supply 101 is turned off; and in step S4, the balloon inflation pump is started to discharge the liquid in the balloon 2, so that the balloon 2 is depressurized to a folded state.

[0065] 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 sends a start command through the controller, and the controller executes step S1 to inject new liquid into the folded balloon 2 for inflation, and then performs another round of shock wave treatment.

[0066] Specifically, when the controller includes a pulse power supply control key 1031 and a balloon inflation pump control key 1032, after step S4 is completed, the doctor operates the balloon inflation pump control key 1032 to make the controller start executing step S1.

[0067] When the controller includes a main control key 1033, after step S4 is completed, the doctor operates the main control key to make the controller start executing step S1.

[0068] In order to improve the safety of the device, the present embodiment also provides the following optional scheme:

[0069] In step S1 of the embodiment, optionally, the balloon inflation pump 102 is started to inflate the balloon 2 in the folded state. After the balloon inflation pump 102 is started to inflate the balloon 2 in the folded state for a third preset time period, if the pressure of the balloon 2 does not reach the first pressure threshold, it is possible that the balloon 2 leaks or other faults occur. The controller stops the balloon inflation pump 102 to inflate the balloon 2, so that the doctor can check the equipment or end the treatment. For example, in a normal state, the balloon inflation pump 102 is started to inflate the balloon 2 in the folded state for 5 seconds, and the balloon 2 can reach the first pressure threshold. The third preset time period can be set to 10 seconds. After the balloon inflation pump 102 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 pump 102 to deflate the balloon 2 to the folded state, or stops the balloon inflation pump 102 to inflate the balloon 2.

[0070] 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. The third pressure threshold is less 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 can have a leak or other faults. The risk of starting the pulse power supply 101 to discharge is very high. Therefore, the controller disables the pulse power supply 101.

[0071] In step S3 of the embodiment, the balloon inflation pump is started to inflate the balloon 2. After the balloon inflation pump is started to inflate the balloon 2 for a fourth preset time period, if the pressure of the balloon 2 does not reach the second pressure threshold, the controller stops the balloon inflation pump 102 to inflate the balloon 2.

[0072] Optionally, the controller further includes a reset key. In response to a reset instruction issued by the operator through the reset key, the controller closes the pulse power supply 101 and deflates the balloon 2 to the folded state. When an abnormal condition occurs, the doctor can quickly close the pulse power supply 101 through the reset key to minimize the risk. The balloon 2 can also be deflated to the folded state to withdraw the balloon 2 from the patient's body to end the treatment or prepare for the next round of treatment.

[0073] Another embodiment of the present application provides a control method as described above. Figures 1 to 3An example shockwave balloon catheter device includes a catheter, a balloon 2 sealed around the catheter, and at least one pair of electrodes disposed within the balloon 2; the device also includes the medical device described above; the pulse power source 101 is configured to send a pulsed voltage to the pair of electrodes; the balloon inflation pump 102 is configured to deliver a liquid inflation to the balloon 2 and to deflate the balloon 2 by draining the liquid from the balloon 2; when the pulse power source 101 applies a voltage to the pair of electrodes, the pair of electrodes can generate an electrical discharge arc in the liquid within the balloon 2.

[0074] It should be noted that, in the description of the present specification, the terms "first", "second", and the like are only used for the purpose of description and distinguishing similar objects, and there is no precedence order or relative importance between them. In addition, in the description of the present specification, unless otherwise specified, the meaning of "a plurality of" is two or more.

[0075] The above examples are only for illustrating the technical concept and characteristics of the present application, and the purpose is to enable those skilled in the art to understand the content of the present application and to implement it, and cannot limit the protection scope of the present application. Any equivalent changes or modifications made according to the spirit and essence of the present application shall be covered within the protection scope of the present application.

[0076] It should be understood that the above description is for illustration purposes only and not for limitation. Many implementations and many applications other than the examples provided will be apparent to those skilled in the art from this description. For the purpose of completeness, the disclosure of all articles and references, including patent applications and publications, is incorporated herein by reference.

Claims

1. A medical device, comprising a host and a control terminal; the host comprises an integrated pulse power supply and a balloon inflation pump; the balloon inflation pump is used to inflate a balloon; the pulse power supply is used to deliver a pulse voltage to a pair of electrodes in the balloon; the control terminal is used to control the start and stop of the pulse power supply and the start and stop of the balloon inflation pump.

2. The medical device of claim 1, wherein: The control terminal comprises an operation platform and pulse power supply control keys and balloon inflation pump control keys integrated on the operation platform; the pulse power supply control keys are operated by a user to control the start and stop of the pulse power supply; the balloon inflation pump control keys are operated by a user to control the start and stop of the balloon inflation pump.

3. The medical device of claim 2, wherein: The controller is configured to perform the following steps: S1, in response to a start instruction issued by a user through the balloon inflation pump control keys, the controller starts the balloon inflation pump to inflate a balloon in a folded state; when the balloon pressure reaches a first pressure threshold, the balloon inflation pump is turned off; S2, in response to a start instruction issued by a user through the pulse power supply control keys, the pulse power supply is started to deliver a pulse voltage; When the pulse power supply delivers a preset number of pulse voltages, or the pulse power supply delivers a pulse voltage for a time period reaching a first preset time period, the pulse power supply is turned off; S3, the balloon inflation pump is started to inflate the balloon; when the balloon pressure reaches a second pressure threshold, the balloon inflation pump 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, the balloon inflation pump is started to deflate the balloon to the folded state, and then the balloon inflation pump is turned off; or the medical device further comprises a pressure relief valve connected to the balloon inner cavity; when the time period after the balloon pressure reaches the second pressure threshold is greater than a second preset time period, the pressure relief valve is opened to deflate the balloon to the folded state.

4. The medical device of claim 1, wherein: The control terminal comprises an operation platform and a master control key arranged on the operation platform; in response to a start instruction issued by a user through the master control key, the pulse power supply and the balloon inflation pump are in an enabled state.

5. The medical device of claim 2 or 4, wherein: The operation platform comprises a handle or a display screen.

6. The medical device of claim 4, wherein: When the balloon is in a folded state, in response to a start instruction issued by a user through the master control key, the controller automatically performs the following steps in sequence: S1, the balloon inflation pump is started to inflate the balloon in a folded state; when the balloon pressure reaches a first pressure threshold, the balloon inflation pump is turned off; S2, the pulse power supply is started to deliver a pulse voltage; When the pulse power supply delivers a preset number of pulse voltages, or the pulse power supply delivers a pulse voltage for a time period reaching a first preset time period, the pulse power supply is turned off; S3, the balloon inflation pump is started to inflate the balloon; when the balloon pressure reaches a second pressure threshold, the balloon inflation pump 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, the balloon inflation pump is started to deflate the balloon to the folded state, and then the balloon inflation pump is turned off; or the medical device further comprises a pressure relief valve connected to the balloon inner cavity; when the time period after the balloon pressure reaches the second pressure threshold is greater than a second preset time period, the pressure relief valve is opened to deflate the balloon to the folded state. S4, when the balloon pressure reaches the second pressure threshold after a time greater than a second preset time, the balloon inflation pump is started to deflate the balloon to the folded state, and then the balloon inflation pump is closed; or the medical device further comprises a pressure relief valve connected to the balloon cavity; when the balloon pressure reaches the second pressure threshold after a time greater than a second preset time, the pressure relief valve is opened to deflate the balloon to the folded state.

7. The medical device of claim 4, wherein: The controller is configured to perform the following steps: S1, when the balloon is in the folded state, in response to the user's first start instruction through the main control key, the controller starts the balloon inflation pump to inflate the folded balloon; when the balloon pressure reaches a first pressure threshold, the balloon inflation pump is closed; S2, in response to the user's second start instruction through the main control key, the controller starts 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 reaching a first preset time, the pulse power supply is closed; S3, start the balloon inflation pump to inflate the balloon; when the balloon pressure reaches a second pressure threshold, the balloon inflation pump is closed; wherein the second pressure threshold is greater than the first pressure threshold; S4, when the balloon pressure reaches the second pressure threshold after a time greater than a second preset time, the balloon inflation pump is started to deflate the balloon to the folded state, and then the balloon inflation pump is closed; or the medical device further comprises a pressure relief valve connected to the balloon cavity; when the balloon pressure reaches the second pressure threshold after a time greater than a second preset time, the pressure relief valve is opened to deflate the balloon to the folded state.

8. The medical device of claim 3 or 7, wherein: In step S2, in response to the pressure of the folded balloon reaching the first pressure threshold and the balloon inflation pump being in the closed state, the controller sends a signal that the pulse power supply can be started.

9. The medical device of claims 3, 6, or 7, 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.

10. The medical device of claims 3, 6, or 7, wherein: In step S1, after the balloon inflation pump is started to inflate the folded balloon for a time reaching a third preset time, if the pressure of the balloon does not reach the first pressure threshold, the balloon inflation pump is stopped.

11. The medical device of claims 3, 6, or 7, wherein: In step S3, after the balloon inflation pump is started to inflate the balloon for a time reaching a fourth preset time, if the pressure of the balloon does not reach the second pressure threshold, the balloon inflation pump is stopped.

12. The medical device of claims 3, 6, or 7, wherein: After step S4, in response to the user's start instruction through the controller, the controller performs step S1.

13. The medical device of claims 3, 6, or 7, wherein: The medical device further comprises a pressure relief valve connected to the balloon cavity; in response to the balloon pressure being greater than a fourth pressure threshold, the pressure relief valve is switched from a closed state to an open state; wherein the fourth pressure threshold is greater than the second pressure threshold.

14. The medical device of claims 3, 6, or 7, wherein: The controller has an automatic mode and a manual mode; When placed in the manual mode, in step S2, in response to the operator's start instruction of the pulse power supply, the controller starts the pulse power supply; When being put into the automatic mode, the controller starts the pulse power source in response to the pressure of the balloon in the folded state reaching a first pressure threshold and the balloon inflation pump being in the closed state.

15. The medical device of claim 1, wherein: The controller comprises a reset key; in response to a reset instruction issued by a user through the reset key, the controller performs the following steps: turning off the pulse voltage; starting the balloon inflation pump, and turning off the balloon inflation pump after the balloon is deflated to the folded state; or, the medical device further comprises a deflation valve connected to the balloon cavity, and the controller opens the deflation valve to deflate the balloon to the folded state.

16. The medical device of claim 1, wherein: The host comprises a shell; the pulse power source is fixed in the shell or on the outer wall of the shell; the balloon inflation pump is fixed in the shell or on the outer wall of the shell.

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

18. 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 1-17; the pulse power source is used to send a pulse voltage to the electrode pair; the balloon inflation pump is used to deliver liquid inflation to the balloon; when the pulse power source applies voltage to the electrode pair, the electrode pair can generate an electric discharge arc in the liquid in the balloon.

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