Shockwave balloon catheter system, identification device, method, ivl system, and system

Abstract

A shockwave balloon catheter system, identification device, method, IVL system and system, the system comprises a balloon catheter and a power supply main body, wherein: the balloon catheter comprises a main body part and a catheter connector. The main body part comprises an elongated carrier, a balloon and at least one pair of shockwave generators in the form of electrodes, the balloon is provided to receive the fluid for inflating the balloon therein, and the shockwave generators are coupled to a high-voltage pulse power supply through the catheter connector. The catheter connector is provided with an internal module therein, and the system further comprises a connector port, and the voltage change of the connector terminal of the port is associated with the power supply of the internal module. The identification device monitors and determines the change between the access state and the removal state of the balloon catheter by monitoring the voltage change of the connector terminal. The present application can quickly identify whether the balloon catheter is accessed and removed through the voltage change of the connector terminal, and at the same time has a communication function, and can read the data of the built-in storage chip of the balloon catheter.

Description

TECHNICAL FIELD

[0001] The present application relates to the field of medical devices, in particular to a shockwave balloon catheter system, an identification device, a method, an IVL system and a system (pointing to a medical module identification system). BACKGROUND

[0002] With the trend of population aging and the signs of cardiovascular disease becoming younger, the incidence of arterial calcification is increasing year by year. For arterial calcification lesions, the commonly used clinical treatment methods include non-compliant balloon, cutting balloon, scoring balloon, atherectomy, excimer laser, etc. These traditional methods of treating calcified plaques have certain limitations, especially in the treatment of medial calcification, eccentric calcified nodules or severe calcification, and even have no effect. How to use more effective means to fully pretreat calcified lesions is the focus of attention of clinicians at home and abroad. Intravascular lithotripsy (IVL) is a new technology for the clinical treatment of arterial calcification lesions, which provides an ideal solution for calcified plaques that were previously unable to be treated.

[0003] IVL technology is inspired by extracorporeal lithotripsy in urology. Its working principle is to perfectly combine the acoustic wave calcification fracturing technology with the balloon catheter. The flexible balloon has a micro high-voltage discharge device built in. During treatment, the balloon is first expanded at low pressure at the calcified lesion, tightly adhering to the blood vessel wall, and then the shockwave pulse power is controlled by the treatment switch to output intermittent high-voltage excitation pulses, which act on the micro high-voltage discharge device in the balloon. Under the excitation of high-voltage electric pulses, the balloon instantaneously discharges high pressure, causing part of the mixed solution of saline and contrast agent in the balloon to be instantaneously vaporized, generating non-focused, circumferential, and pulse acoustic pressure waves. The acoustic pressure waves mainly selectively act on solid calcified substances that cause arterial vascular lesions, and almost pass through soft tissues such as human blood vessels and muscles that have a density close to saline. Therefore, the acoustic pressure waves can efficiently and safely impact and destroy superficial and deep vascular calcification lesions, causing the calcified material to break and loosen, and the blood vessels to be moderately softened, thereby maximizing the lumen diameter and significantly improving the vascular compliance, making it easier to implant a stent or drug balloon afterwards.

[0004] The foreign SHOCKWAVE MEDICAL company applies the liquid-electric lithotripsy technology in angioplasty or valve calcification angioplasty. Its basic principle is to generate bubbles in the balloon filled with liquid by using a certain voltage, and the bubbles collapse in a very short time to generate shock waves, so as to achieve the purpose of crushing calcified lesions. The patent with application number CN104519809A discloses a shock wave valve angioplasty with multiple balloons. This patent describes a shock wave device and method for calcified heart valve treatment. At the same time, there are technologies in the prior art that use ultrasonic waves to crush stones in other parts such as the urethra or bile duct. It is a technology that directly acts on the lesion tissue by using the transmission of ultrasonic waves to make the stones resonate at a certain frequency and then break the stones. Therefore, the shock wave balloon catheter system of the applicant is not limited to a medical component acting on a certain tissue site, but a shock wave catheter system, which includes a catheter having a balloon at its distal end, the balloon being arranged to be inflated with a liquid. Inside the balloon is placed a shock wave generator in the form of, for example, a pair of electrodes, which are coupled through a connector to a high-voltage source at the proximal end of the catheter. When the balloon is placed adjacent to the calcified area of the vein or artery and a high voltage is applied between the electrodes, a shock wave is formed, which propagates through the fluid and hits the balloon wall and the calcified area, and the pulse breaks the calcium without damaging the surrounding soft tissue.

[0005] The storage chip is built in the balloon catheter connector, and the host can identify the balloon type and working parameters by reading the data in the storage chip. Because a plurality of high-voltage wires pass through the balloon catheter connector at the same time, the storage chip is close to the high-voltage wires due to space limitations. When high-voltage discharge generates a shock wave, the storage chip in the balloon catheter connector will be disturbed by high voltage and be easily damaged. At this time, the communication between the host and the balloon catheter fails, and the host cannot determine whether the balloon is removed and whether the operation is completed. In actual clinical application, a new balloon catheter needs to be replaced to continue the operation. Even in the case of short circuit caused by breakdown of the storage chip, the normal operation of the host power supply cannot be guaranteed, and the normal operation of the operation cannot be guaranteed. SUMMARY

[0006] The first object of the present application is to provide a shock wave balloon catheter identification device, an identification method, an IVL system and a medical module identification system, to solve the technical problem of quickly and reliably identifying the access and removal state of the balloon catheter.

[0007] In a first aspect, the present application provides a shock wave balloon catheter system, comprising a balloon catheter, a power supply main body comprising a high-voltage pulse power supply, a connector port and an identification device, wherein:

[0008] The balloon catheter comprises a main body part and a catheter connector,

[0009] The main body part comprises an elongated carrier, a balloon and at least one pair of shock wave generators in the form of electrodes, the balloon and the carrier are in a sealed relationship to surround the carrier, the balloon is provided with a fluid for receiving the inflated balloon, and the shock wave generators are coupled to a high-voltage pulse power supply through a catheter connector;

[0010] The catheter connector is provided with an internal module for storing current data information of the balloon catheter,

[0011] The connector port is connected to the internal module on one side and connected to the master module of the power supply main body on the other side, the voltage change of the connector terminal of the port is associated with the power supply of the internal module;

[0012] The identification device monitors and determines whether the balloon catheter is in an access state or a removal state by monitoring the voltage change of the connector terminal.

[0013] The balloon catheter main body and the balloon catheter connector are a whole and are disposable. The connector terminal voltage change in a suitable amplitude such as (12V→5V) must be connected to the balloon catheter. Therefore, the present application is very easy to make voltage changes to obtain the current state of the balloon catheter, if it is connected, the corresponding various working parameters or states can be obtained to control the parameters and other information to facilitate the work of the balloon catheter. If it is removed, it can be further judged whether the operation is completed.

[0014] One example of the present scheme is that the connector terminal is connected to the internal module, and the voltage of the connector terminal provides the working power voltage to the internal module to realize the change of the port voltage between the access state and the removal state of the balloon catheter.

[0015] One example of the present scheme is that the connector terminal is connected to the internal module through a first current limiting unit, and the voltage of the connector terminal provides the working voltage to the internal module through the voltage reduction of the first current limiting unit. The first current limiting unit is used to be within the safe current allowed by the identification device and less than the maximum allowed current of the balloon catheter internal module in the state of the connected balloon catheter internal module damage failure or short circuit fault.

[0016] One example of the present scheme is that the identification device further comprises a voltage providing unit for providing the working voltage of the identification device, a first voltage dividing unit, a second voltage dividing unit and an amplifying circuit. The voltage providing unit provides the working voltage, which is connected to GND through the first voltage dividing unit and the second voltage dividing unit. The Vo end and the GND end of the first voltage dividing unit and the second voltage dividing unit in series are connected to the connector terminal, respectively. The voltage dividing value Vs of the second voltage dividing unit for monitoring the voltage of the connector port is transmitted to the master module of the power supply main body after being amplified by the amplifying circuit.

[0017] One of the examples of the present solution is: further comprising a voltage stabilizing unit for stabilizing the built-in module within a preset working voltage range.

[0018] One of the examples of the present solution is: the voltage stabilizing unit further comprises a precision adjustable Zener voltage stabilizer U1, a third voltage dividing unit and a fourth voltage dividing unit, the cathode voltage of the precision adjustable Zener voltage stabilizer U1 is adjusted by the voltage dividing ratio of the third voltage dividing unit and the fourth voltage dividing unit, so that the power supply voltage VCC of the built-in module is the normal working voltage required by the built-in module.

[0019] One of the examples of the present solution is: further comprising a filter unit connected in parallel with the voltage stabilizing unit, the filter unit is a capacitor or a plurality of capacitors connected in series or associated.

[0020] One of the examples of the present solution is: the built-in module further comprises a built-in chip, the built-in chip uses an MCU with an EEPROM inside or an MCU with an external EEPROM memory.

[0021] One of the examples of the present solution is: the identification device further comprises a second current limiting unit,

[0022] The identification device further comprises a second current limiting unit, the voltage supply unit VDD is connected to the second current limiting unit through the connector terminal Vo end, and then connected to the third voltage dividing unit, the fourth voltage dividing unit and the GND end of one of the connector terminals, the second current limiting unit is used to reduce the instantaneous impact current on the port when the balloon catheter accesses the host connector.

[0023] One of the examples of the present solution is: the identification device further comprises a port filtering capacitor unit for eliminating noise interference and port voltage jitter, connected in parallel across the first voltage dividing unit and the second voltage dividing unit.

[0024] One of the examples of the present solution is: the built-in module further comprises an interface chip, the interface chip is connected to the corresponding configuration interface chip through at least two terminals of the connector port, and then connected to the host control module to read the data of the built-in module in the connector, identify the current data including balloon type and working parameters.

[0025] One of the examples of the present solution is: the interface chip further comprises one of an RS232 chip and a 485 interface chip, the RS232 chip / 485 interface chip is connected to the corresponding configuration interface chip through at least two terminals of the connector port, and then connected to the host control module.

[0026] One of the examples of the present solution is that the identification device further comprises a sampling resistor, and the system further comprises an operation unit arranged between the catheter connector and the main control module of the power supply body, the operation unit is provided with a treatment switch, the sampling resistor is connected in series with the treatment switch, and the sampling resistor is connected in parallel with the second voltage dividing unit, one end of the treatment switch is connected to one of the terminals of the connector in series with the sampling resistor, and the other end is connected to the fourth voltage dividing unit, when the treatment switch is triggered, the voltage change of the voltage dividing value Vs of the second voltage dividing unit is monitored to monitor the action of the treatment switch in real time.

[0027] One of the examples of the present solution is that the operation unit is arranged between the catheter connector and the main control module of the power supply body, the operation unit is provided with one or more switch components, the switch components are connected in series with the corresponding number of resistors, and then connected to the connector port and connected in parallel with the second voltage dividing unit, when one or any combination of the switch components is triggered, the voltage change of the voltage dividing value Vs of the first voltage dividing unit is monitored to monitor the action of the switch components in real time.

[0028] In the second aspect, the present application also provides an identification device for a shock wave balloon catheter, which is applied to the shock wave balloon catheter system, the system further comprises a balloon catheter and a power supply body comprising a high-voltage pulse power supply, and comprises:

[0029] a connector, one side of the connector port is connected to the balloon catheter, and the other side is connected to the main control module of the power supply body, the voltage change of the connector terminals of the connector port is associated with the power supply of the balloon catheter,

[0030] an identification unit for monitoring and determining whether the balloon catheter is in an access state or a removal state by monitoring the voltage change on the terminals of the connector interface.

[0031] The identification unit comprises a voltage providing unit for providing a working voltage of the identification device, a first voltage dividing unit, a second voltage dividing unit and an amplification circuit, the voltage providing unit provides a working voltage, which is connected to the ground through the first voltage dividing unit and the second voltage dividing unit, the first voltage dividing unit and the second voltage dividing unit are connected in series to the connector terminals of the connector interface, the voltage dividing value Vs of the second voltage dividing unit for monitoring the port voltage of the connector is amplified by the amplification circuit and then transmitted to the main control module of the power supply body through the main control module connection interface, so as to monitor the voltage change of the connector terminals.

[0032] In the third aspect, the present application provides a shock wave balloon catheter identification method, which comprises:

[0033] A balloon catheter, a connector port, and a power supply body are provided. The catheter has a balloon body and a catheter connector at its distal end. The balloon is configured to be inflated with liquid. A shock wave generator containing at least one pair of electrodes is placed inside the balloon. The pair of electrodes is coupled to a high voltage source at the proximal end of the catheter via the catheter connector. The catheter connector has a built-in module for storing current data information of the balloon catheter. One side of the connector port is connected to the built-in module, and the other side is connected to the main control module of the power supply body. The voltage change of the connector terminals of the port is related to the power supply of the built-in module.

[0034] By monitoring voltage changes at the connector terminals, the system can monitor and determine whether the balloon catheter is in an engaged or disengaged state. When the balloon catheter body is detected to be in an engaged state, the system reads data from the built-in module to obtain at least one of the following data: balloon catheter type, operating parameters, etc.

[0035] Fourthly, the present invention provides an IVL system, including a balloon catheter and a power supply unit containing a high-voltage pulse power source. The balloon catheter has a built-in miniature high-voltage discharge device, and the system is also equipped with an identification device to monitor and determine the change between the balloon catheter insertion state and the removal state.

[0036] In operation, the system reads data from the built-in module to obtain at least one of the following data: balloon catheter type and operating parameters.

[0037] The balloon is operated in a working mode adapted to the balloon catheter type. First, low-pressure dilation is performed, and then the shock wave pulse power supply outputs intermittent high-voltage excitation pulses, which act on the miniature high-voltage discharge device inside the balloon. Under the excitation of the high-voltage pulse, the balloon is instantaneously discharged at high voltage, causing the solution inside the balloon to be vaporized instantly, generating non-focused, circumferential pulsed sound pressure waves.

[0038] Fifthly, the present invention provides a medical module access identification system, comprising a main body and a medical module, wherein the medical module is configured with a main body access state and a main body removal state, wherein...

[0039] The main body is equipped with connector ports. One side of the connector port can be connected to the medical module, and the other side is connected to the main control module of the main body. The voltage change of the connector terminals of the port is related to the power supply of the medical module.

[0040] The identification device monitors and determines whether the medical module is in the connected or disconnected state by monitoring voltage changes at the connector terminals. Furthermore, when the medical module is connected to the main body, the voltage at the connector terminals provides operating power to the medical module, allowing the port voltage to change between the connected and disconnected states.

[0041] Compared with the prior art, the present application has the following advantages:

[0042] 1) The access and removal state of the balloon catheter is monitored and determined in real time through the voltage change of the connector terminal. The present application can quickly identify whether the balloon catheter is accessed and removed through the voltage change of the connector terminal, and at the same time has a communication function, which can read the data of the built-in storage chip of the balloon catheter.

[0043] 2) The connector terminal can provide a current-controllable working power supply for the built-in chip and circuit of the balloon catheter. In the prior art, the host machine provides a fixed voltage through the connector port, and when the built-in chip of the balloon catheter is short-circuited and damaged, it is easy to cause the host machine to work abnormally, affect the normal operation of the surgery, and exist a safety hazard. The connector terminal of the power supply host machine of the present application provides a working power supply for the built-in chip of the balloon catheter through a current-limiting resistor, that is, the port voltage changes with the access and removal of the balloon catheter, so that the host machine can respond in time and adjust the working state, and at the same time, the maximum working current of the balloon catheter is also limited and protected. In the event of unexpected situations such as high-voltage pulse discharge and strong electromagnetic interference, the built-in chip of the balloon catheter will not be damaged and fail, which will not affect the normal operation of the shock wave power supply and avoid causing greater losses. At the same time, the surgery can be carried out normally, ensuring the safety and reliability of the IVL surgery.

[0044] 3) The built-in storage chip and communication chip of the balloon catheter have reliable communication. Compared with the I2C communication used in the existing balloon catheter, the present application uses a 485 communication chip, which has strong anti-interference performance, long communication distance, and ensures the reliability of communication.

[0045] 4) The voltage change of the connector terminal can monitor and respond to the key state of the operation handle in real time. The connector of the prior art needs to monitor the working state of the handle keys through another multiple ports and corresponding multiple wires, which increases the number of connection lines between the host and the operation handle. The present application only needs to use another port of the connector and a corresponding wire to monitor and respond to multiple different keys of the operation handle. The number of ports of the connector is reduced, thereby reducing the size of the connector and the number of connection wires between the host and the operation handle.

[0046] 5) The present application is not limited to shock wave balloon catheters, but can be applied to the identification of many medical modules connected to the host module. BRIEF DESCRIPTION OF DRAWINGS

[0047] In order to more clearly illustrate the technical solutions in the embodiments of the present application, the following will briefly introduce the drawings needed to be used in the embodiments or the prior art description. Obviously, the drawings in the following description are only some embodiments of the present application, and those skilled in the art can obtain other drawings according to these drawings without creating any creative labor.

[0048] Figure 1 The basic schematic diagram for the balloon catheter system is created;

[0049] Figure 2 The simplified schematic diagram for the balloon catheter system is created;

[0050] Figure 3 The first embodiment of the balloon catheter system is created;

[0051] Figure 4 The second embodiment of the balloon catheter system is created;

[0052] Figure 5A The third embodiment of the balloon catheter system is created;

[0053] Figure 5B The fourth embodiment of the balloon catheter system is created;

[0054] Figure 6 The fifth embodiment of the balloon catheter system is created;

[0055] Figure 7A The third embodiment of the balloon catheter system is created;

[0056] Figure 7B The fourth embodiment of the balloon catheter system is created;

[0057] Figure 8 The flowchart of the shockwave balloon catheter identification method is created;

[0058] Figure 9 The schematic diagram of the IVL system is created. DETAILED DESCRIPTION

[0059] In the following description, for purposes of explanation and not limitation, specific details are set forth such as particular architectures, techniques, etc. in order to provide a thorough understanding of the embodiments of the present application. However, it will be apparent to those skilled in the art that the present application can be practiced in other embodiments that depart from these specific details. In other instances, detailed descriptions of well-known methods, devices, and circuits are omitted so as not to obscure the description of the present application with unnecessary detail.

[0060] It should be understood that the term "includes" when used in the specification and the appended claims herein is used to indicate included, but not to the exclusion of, one or more additional features, integers, steps, operations, elements, and / or groups thereof. It should also be understood that the term "and / or" when used in the specification and the appended claims herein is used to mean one or the other and / or both in the various combinations of items it conjoins, including in the items listed with "comprising."

[0061] As used in the specification and the appended claims herein, the term "if' can be construed to mean "when" or "once," or "in response to a determination" or "in response to a detection" of, depending on the context. Similarly, the phrase "if it is determined" or "if [a described condition or event] is detected" can be construed to mean "once it is determined" or "in response to a determination" or "once [a described condition or event] is detected" or "in response to a detection" of [a described condition or event], depending on the context. Additionally, the terms "first," "second," "third," etc. as used in the description and the appended claims herein are used only to distinguish different elements, and can convey no relative importance or order of completion. References in the specification and the appended claims herein to "one embodiment" or "some embodiments" mean that a particular feature, structure, or characteristic described is included in at least one embodiment of the application. Thus, the appearance of the phrases "in one embodiment" or "in some embodiments" in various places in the specification are not necessarily all referring to the same embodiment, although it can be. Furthermore, the terms "comprise," "comprising," "include," "including," and the like as used herein are specifically intended to be construed as "including but not limited to."

[0062] The conduit type identification method provided by the embodiments of the present application can be applied to terminal devices such as mobile phones, tablet computers, wearable devices, vehicle-mounted devices, augmented reality (AR) / virtual reality (VR) devices, notebook computers, ultra-mobile personal computers (UMPCs), netbooks, personal digital assistants (PDAs), and the like, and can also be applied to high-voltage pulse power mainframes. The embodiments of the present application do not limit the specific types of terminal devices.

[0063] First, the creation process of the present application is introduced. As shown in FIG. 1, the present application is created in the following steps. Figure 1As shown, the applicant finds that in the balloon catheter system, the balloon catheter 2 and the power supply main body 1 containing high-voltage pulse power supply, through the high-voltage pulse circuit 12 of the power supply main body 1, there are multiple high-voltage wires to provide high-voltage pulse to the shock wave balloon. When the shock wave balloon 22 of the balloon catheter 2 is pulsed discharged to generate shock wave under the excitation of high-voltage pulse, the storage chip working at low voltage (generally referred to as the built-in module 23 of the catheter connector 21) is easily interfered by strong pulse, damaged and failed, affecting the operation. The balloon catheter 2 and the power supply main body 1 are generally operated through the operating part 3 (such as the operating handle) and the like.

[0064] After many studies, the applicant conceals the operating handle and the shock wave balloon which have no direct connection with the balloon catheter recognition, and simplifies it to Figure 2 The balloon catheter system diagram as shown. The other drawings of the present application are similar to this, and the operating handle operation part and the shock wave balloon are concealed if unnecessary. The catheter connector 21 can be provided with a connector port 24 (or a separate port) to communicate between the power supply main body 1 and the balloon catheter 2 (especially the built-in module 23).

[0065] Possible problems of traditional balloon catheter recognition: whether the balloon catheter is connected to the power supply main body or not cannot be identified. After the built-in module 23 (such as the built-in storage chip) of the balloon catheter fails or is damaged, the operation cannot continue and a new balloon catheter needs to be replaced. The short circuit of the storage chip may even affect the normal operation of the main machine power supply main control module 11. Although the built-in circuit of the built-in module of the balloon catheter of some manufacturers is slightly different, the overall principle is as above, with little change.

[0066] Therefore, after many research and development, the applicant thinks as follows: if the power supply of the built-in module of the balloon catheter, including the built-in storage chip, is changed, and if a certain component can know the power supply change of the built-in module, for example, the connection and removal of the balloon catheter, the connection and removal of the balloon catheter can be detected directly through the power supply change of the built-in module, then the voltage change on the certain component needs to be detected directly to know whether the balloon catheter is in the connected state or the removed state. The simplest way is to provide power voltage to the built-in module through the component to achieve this function in principle. And, a device containing the component can be developed separately, or the function of the component can be expanded in the existing device in the current system, such as developing the function of the component (such as the recognition device) in the existing connector. Some embodiments are described separately below.

[0067] First embodiment

[0068] Please refer to Figure 3Fig. 1 is a schematic diagram of the principle of the shockwave balloon catheter system. It includes a balloon catheter 240, a power supply main body 210 containing a high-voltage pulse power supply, a connector port 230, and an identification device 220. The connector port 230, one side of which is connected to the built-in module 242 of the balloon catheter 240, and the other side of which is connected to the main control module 212 of the power supply main body 210. The connector port 230 can also be plug-in, one part of which is arranged on the catheter connector of the balloon catheter 240, and the other part of which is arranged on the power supply main body 210. When in use, it can be inserted into the other part. The identification device 220 can also be arranged in the power supply main body 210. In this case, the identification device 220 can be connected to the main control module 212 inside it, and connected to the balloon catheter 240 through the connector port 230. When the identification device 220 is a module developed independently, the connector port 230 can include a first connector port independently connected to the power supply main body 210, and a second connector port connected to the catheter connector, and the first connector port and the second connector port can also be plug-in respectively. In other words, the above-mentioned balloon catheter 240, power supply main body 210 containing a high-voltage pulse power supply, connector port 230, and identification device 220 are only logical component division, but not to be specifically localized in the physical arrangement of the components.

[0069] The following will specifically introduce each component.

[0070] The balloon catheter 240 includes a main body part and a catheter connector (not shown in the figure), the main body part includes an elongated carrier, a balloon, and at least one pair of shockwave generators in the form of electrodes, the balloon and the carrier are in a sealed relationship to surround the carrier, the balloon is arranged to receive the fluid for inflating the balloon therein, and the shockwave generators are coupled to the high-voltage pulse power supply through the catheter connector. The shockwave generators can involve multiple pairs of electrodes, and the catheter connector can be provided with one or more interface parts specially used for transmitting high-voltage pulses.

[0071] The catheter connector is also provided with a built-in module 242 for storing current data information of the balloon catheter. The built-in module 242 can save the current model of the balloon catheter, whether it is within the valid period, a specific working mode, how many high-voltage discharge times the power supply host needs to output for this working mode, the pulse high-voltage amplitude, and other parameter information. When the balloon catheter 240 needs to be used, especially in the initial connection state, the main control module 212 of the power supply needs to obtain these information in the first time, so as to output the appropriate control information to control the current working state of the balloon catheter 240. Two or more connector ports can be arranged in the catheter connector, one of which connects the shockwave generator and the high-voltage pulse power supply. One of the connector ports is the above-mentioned connector for connecting the built-in module and the main control module.

[0072] Connector port 230, one side of connector port 230 is connected to built-in module 242, the other side is connected to main control module 212 of power supply body. This point has been described before, in general, in this example, the voltage change of the connector terminal of connector port 230 is associated with the power supply of built-in module 242.

[0073] Identification device 220 monitors and determines the change between balloon catheter access state and removal state by monitoring the voltage change of the connector terminal.

[0074] The power supply of built-in module 242 can be associated with the connector terminal, for example, by supplying power to built-in module 242 through the connector terminal, whether built-in module 242 is in access state or removal state can be directly known by detecting the corresponding connector terminal. Built-in module 242 can also include an interface chip, which is connected to the corresponding configuration interface chip through at least two terminals of the connector port, and then connected to the main control module 212, so as to facilitate the main control module 212 to read the data of built-in module 242, identify the current data of balloon type and working parameters. In this example, without increasing the number of shock wave power supply and balloon catheter connection wires, the access and removal state of balloon catheter can be identified quickly and reliably, and the data of the built-in storage chip in the balloon catheter connector can be read to identify the balloon type and working parameters.

[0075] Identification device 220 can integrate the developed functions on power supply body 210, or partially integrate on power supply body 210 and partially integrate on catheter connector. The simplest implementation principle is that the connector terminal connects built-in module 242, and the voltage of the connector terminal provides working power voltage to built-in module 242 in the balloon catheter access state, so as to realize the change of port voltage between balloon catheter access state and removal state.

[0076] Second embodiment

[0077] Please refer to Figure 4 , which is a circuit diagram of an implementation of balloon catheter system. Compared with the existing balloon catheter identification, the power supply circuit and communication mode of the built-in chip of the balloon catheter are improved, the reliability of communication is improved, and the access and removal of the balloon catheter are no longer based on the storage chip, but based on the change of interface output voltage. The specific principle is shown in Figure 4 .

[0078] The connector terminal connects the built-in module through the first current limiting unit, the voltage of the connector terminal is reduced by the first current limiting unit and then provides working voltage to the built-in module 242, and the first current limiting unit is used to limit the current flowing therethrough within the safe current allowed by the identification device and less than the maximum allowable current of the balloon catheter built-in module when the connected balloon catheter built-in module is damaged, fails or has a short circuit fault. The identification device 220 further includes a voltage providing unit for providing identification device working voltage, a first voltage dividing unit, a second voltage dividing unit and an amplification circuit 221, the voltage providing unit provides working voltage, is connected with GND through the first voltage dividing unit and the second voltage dividing unit, the two ends (Vo end and GND end) of the first voltage dividing unit and the second voltage dividing unit connected in series are connected with the connector terminal respectively, and the voltage dividing value Vs of the first voltage dividing unit for monitoring the voltage of the connector terminal is transmitted to the master control module of the power supply main body after being amplified by the amplification circuit.

[0079] The system further includes a voltage stabilizing unit for stabilizing the built-in module in a preset working voltage range. One embodiment of the voltage stabilizing unit is implemented by a Zener voltage stabilizer U1 (U1 is a Zener voltage stabilizer with a maximum working voltage of 36V, which is much higher than the maximum working voltage (generally less than 5.5V) of the storage chip and the MCU, has strong anti-interference performance, and is a bidirectional device and is not easy to be damaged.), and can also be implemented by a voltage stabilizing tube. Taking the Zener voltage stabilizer U1 as an example, one step includes a precisely adjustable Zener voltage stabilizer U1, a third voltage dividing unit and a fourth voltage dividing unit (R1 and R2 in Figure 4 are one implementation of the third voltage dividing unit and the fourth voltage dividing unit), and the output voltage (cathode voltage, VCC in the figure) of the precisely adjustable Zener voltage stabilizer U1 is adjusted by changing the voltage dividing ratio of the third voltage dividing unit and the fourth voltage dividing unit, so that the power supply voltage VCC of the built-in module is the normal working voltage required by the built-in module.

[0080] The system further includes a filtering unit (one embodiment is C1 in Figure 4 ) connected in parallel with the voltage stabilizing unit, and the filtering unit is a capacitor or a plurality of capacitors connected in series or associated.

[0081] The built-in module can further include a built-in chip, and the built-in chip can adopt an ECU with an EEPROM inside or an ECU with an external EEPROM memory.

[0082] The identification device can further comprise a first current limiting unit (one embodiment of the first current limiting unit is R4), the voltage supply unit VDD is connected to the first current limiting unit, and then connected to the first voltage dividing unit and one of the connector terminals, the first voltage dividing unit and the second voltage dividing unit are parallel resistors of the connector port, and the first current limiting unit is used to, when the balloon catheter built-in module is damaged, fails or has a short circuit fault, be within the safe current allowed by the identification device 220 and less than the maximum allowed current of the balloon catheter built-in module 242. Furthermore, the identification device further comprises a port filtering capacitor unit (one embodiment is C2 in FIG. 6) connected in parallel between the first voltage dividing unit and the second voltage dividing unit, for eliminating noise interference and port voltage jitter. Figure 4

[0083] The first voltage dividing unit and the second voltage dividing unit can be implemented by a plurality of resistors, etc. Figure 4 As shown in FIG. 6, the first voltage dividing unit and the second voltage dividing unit can be R5 and R6, and the voltage dividing value Vs of the second voltage dividing unit (such as R6) for monitoring the voltage of the connector port 230 is transmitted to the main control module 212 of the power supply main body after being amplified by an amplification circuit. The amplification circuit can be a conventional amplification circuit, as long as the voltage can be amplified to a range readable by the main control module 212.

[0084] (1) The catheter connector of the balloon catheter is added with a voltage stabilizing circuit mainly composed of a precisely adjustable Zener voltage stabilizer U1, and by adjusting the ratio of R1 and R2, the cathode voltage VCC of U1 is the normal working voltage required by the storage chip. C1 is a filtering capacitor, and R3 is a protection resistor (the second current limiting unit R3 is used to reduce the instantaneous impact current of the port when the balloon catheter is connected to the port). Figure 4 As shown in FIG. 7, which is a basic circuit form, U1 is a precisely adjustable Zener voltage stabilizer TL431 (or other brands such as LM431, CD431, CJ431, ZR431, etc.). Simple variations based on it are within the scope of protection. For example, C1 can be formed by connecting two or more capacitors in series or in parallel, R1, R2 and R3 can be realized by connecting resistors in parallel or in series, and U1 can be a Zener voltage stabilizer of different brands and different precision. The second current limiting unit R3 is connected to the second current limiting unit R3 through the connector terminal Vo, and then connected to the third voltage dividing unit, the fourth voltage dividing unit and one of the connector terminals GND, and the second current limiting unit is used to reduce the instantaneous impact current of the port when the balloon catheter is connected to the host connector.

[0085] (2) The balloon catheter built-in module adopts an MCU with an EEPROM inside, or adopts an MCU externally connected to an EEPROM memory, to realize communication and data storage and uploading. Figure 4 It can also be an external EEPROM structure of the MCU. ​

[0086] (3) The host power supply adds the function of the identification device, VDD is the working voltage of the identification device, R4 is a current-limiting resistor, R5 and R6 are series resistors of the connector port, which also play a role in voltage division, the voltage value Vs on the resistor R6 is used to monitor the voltage of the connector port, Vs is amplified by an amplification circuit and input to the host module shown by the MCU, and is converted into a digital quantity by the ADC module built in the MCU, so that the actual voltage of the connector port is identified. C2 is a port filtering capacitor, which is used to eliminate noise interference and port voltage jitter. Further, the MCU of the host module can realize the same function by using a DSP, an FPGA, etc. When the host module does not have an integrated ADC module, an analog-to-digital converter can also be externally added for analog-to-digital conversion.

[0087] (4) The RS485 chip can be used to realize the communication interface between the balloon catheter and the host, which has strong anti-interference performance and long communication distance. The 485 interface chip of the interface chip can also be replaced by an RS232 chip, and the RS232 chip / 485 interface chip is connected to the host module after being connected to the corresponding configuration interface chip through at least two terminals of the connector port.

[0088] The voltage range of VCC is 2.7V-5.5V, and the voltage range of VDD is 5.5V-15V. R3 has a small value, which illustrates the main working principle of the system. The specific principle is as follows: as shown in Figure 2 R3 has a small value of about 10 ohms, and the normal voltage drop thereon is not higher than 0.2V. After the connector is connected to the balloon, the voltage Vo (connected to the left end of R3) at the port is basically the same as VCC, which can be regarded as VCC, and the influence of R3 can be ignored.

[0089] The voltage range of VCC is 2.7V-5.5V, and the voltage range of VDD is 5.5V-15V.

[0090] The value of the VCC of the built-in circuit of the balloon catheter is,

[0091] When the connector port is not externally connected to the balloon catheter,

[0092] When the connector port is externally connected to the balloon catheter,

[0093] According to the change of Vs, the MCU can judge in real time whether the balloon catheter is connected or removed, without the need for periodic communication inquiry. When the balloon catheter is connected, the data of the storage chip of the balloon catheter is read, so that the type and working parameters of the balloon catheter are obtained.

[0094] In the host balloon identification circuit, R4 is a current-limiting resistor, and the working current of the balloon catheter built-in circuit is limited by R4. When the balloon catheter built-in storage chip and MCU are damaged and fail (not short-circuited), the sampling voltage Vs is a normal value (formula 3), and the host can monitor the connection state of the balloon, and the host circuit works normally. When the balloon catheter built-in storage chip and MCU are damaged and fail (short circuit fault), VCC is 0V, and the host connection port Vo is close to 0V. Due to the current-limiting protection of R4, the maximum current provided to the balloon catheter is: only 5-20mA, which is very small and does not affect the normal operation of the host circuit.

[0095] Optionally, the circuit can be further simplified or deformed, such as removing the protection resistor R3 in Figure 5A . Or further, U1 uses a voltage stabilizing diode, removes resistors R1 and R2, and stabilizes the working voltage of the storage chip within the working voltage range allowed by the chip, etc. as shown in Figure 5B , as shown in Figure 6 . All within the scope of the right protection.

[0096] Please refer to Figure 7A , the balloon catheter and the host adopt various communication protocol interfaces for interface communication, such as RS232 chip 222, 243, 485 interface chip, etc. The communication interface is realized by the interface, which has strong anti-interference performance and long communication distance. Another implementation system of the balloon catheter built-in module of the present application. The balloon built-in storage chip can use an I2C interface EEPROM chip, and the host and the balloon catheter communication mode uses an I2C mode. The balloon built-in storage chip uses an UNI / O interface EEPROM chip, and the host and the balloon catheter communication mode uses a single-wire I2C mode.

[0097] Third embodiment

[0098] Compared with the first embodiment, as shown in Figure 7A , the system is additionally provided with a treatment switch (a conventional design is that an operation part 250 is arranged between the catheter connector and the main control module of the power supply main body, and a treatment switch 251 is arranged on the operation part), and the identification device further comprises a sampling resistor (such as R7 in Figure 7A ). The sampling resistor is connected in series with the treatment switch and is connected in parallel with the second voltage dividing unit, and the treatment switch is connected in series with the sampling resistor after one end of the treatment switch is connected to one of the terminals of the connector, and the other end of the treatment switch is connected to the fourth voltage dividing unit. When the treatment switch is triggered, the voltage change of the second voltage dividing unit is monitored to monitor the action of the treatment switch in real time. Figure 7B In , the treatment switch 251 is connected in series with R7 and is connected in parallel with the sampling resistor R6. When the treatment switch is pressed, the Vs voltage changes, and thus the host can monitor the action of the treatment switch in real time.

[0099] In this embodiment, only one pin needs to be added. The sampling resistor is connected in series with the treatment switch 251 to monitor the operation of the treatment switch 251 in real time.

[0100] Fourth embodiment

[0101] As shown in Figure 7B , the system can further include an operation part 250 (such as an operation handle). The operation part is arranged between the catheter connector and the main control module of the power supply main body. The operation part is provided with one or more switch components. After being connected in series with an adaptive number of resistors, the switch components are connected to the connector port and connected in parallel with the second voltage dividing unit. When one or any combination of the switch components is triggered, the voltage change of the voltage dividing value Vs of the first voltage dividing unit is monitored to monitor the operation of the switch components in real time.

[0102] Figure 2 In this embodiment, there are three keys in the handle, SW1, SW2, and SW3, which are connected in series with R7, R8, and R9 with different resistances, and then connected in parallel with R6 of the balloon recognition circuit inside the host computer through the connector port. When one or any combination of SW1, SW2, and SW3 is pressed, the Vs of the host computer balloon recognition circuit changes. Therefore, the host computer can monitor the operation of different switches or simultaneous operation in real time.

[0103] In this embodiment, only one pin needs to be added. The sampling resistor is connected in series with the treatment switch 251 to monitor the operation of the treatment switch 251 in real time.

[0104] Fifth embodiment

[0105] In this embodiment, a shock wave balloon catheter recognition device can be developed separately and applied to a shock wave balloon catheter system. The system further includes a balloon catheter and a power supply main body including a high-voltage pulse power supply, which includes:

[0106] A connector, one side of the connector port is connected to the balloon catheter, and the other side is connected to the main control module of the power supply main body. The voltage change of the connector terminal of the connector port is associated with the power supply of the balloon catheter,

[0107] A recognition unit monitors and determines whether the balloon catheter is in an access state or a removal state by monitoring the voltage change on the terminal of the connector interface.

[0108] The identification unit comprises a voltage supply unit for providing an operating voltage of the identification device, a first voltage dividing unit, a second voltage dividing unit and an amplification circuit. The voltage supply unit provides the operating voltage, and the first voltage dividing unit and the second voltage dividing unit are connected to the ground after being divided by the voltage supply unit. The first voltage dividing unit and the second voltage dividing unit are connected to the connector terminals of the connector interface in series, respectively. The voltage dividing value Vs of the second voltage dividing unit for monitoring the port voltage of the connector is amplified by the amplification circuit and transmitted to the master control module of the power supply main body through the master control module connection interface, so as to monitor the voltage change of the connector terminal. By monitoring the voltage change of the connector terminal, it is determined whether the balloon catheter is in the access state or the removal state.

[0109] The difference from the second embodiment is that the identification device in the connector interface is arranged as a separate module, which can be connected to the master control module and the built-in module through separate interfaces, respectively. The interface connected to the built-in module can adopt a connector port, and the interface connected to the master control module can also be arranged as a separate interface. The other contents are basically the same as those of the second embodiment, and will not be described in detail here. Figure 8

[0110] Sixth embodiment

[0111] Please refer to Figure 9 , which is a flowchart of an identification method of a shockwave balloon catheter, comprising:

[0112] S110: providing a balloon catheter, the catheter having a balloon at a distal end of the catheter and a catheter connector, the balloon being arranged to be inflated with a liquid, and the balloon contains at least one pair of electrodes in the form of a shockwave generator, the pair of electrodes being coupled to a high-voltage source at a proximal end of the catheter through the catheter connector; the catheter connector is provided with a built-in module for storing current data information of the balloon catheter, and the system further comprises a connector port, one side of the connector port being connected to the built-in module, and the other side being connected to a master control module of a power supply main body, and the voltage change of the connector terminal of the port is associated with the power supply of the built-in module;

[0113] S120: by monitoring the voltage change of the connector terminal, it is determined whether the balloon catheter is in the access state or the removal state, and when the access state of the balloon catheter is monitored, the data of the built-in module is read, so as to obtain at least one of the data of the balloon catheter type, the working parameters and the like.

[0114] The balloon catheter can be provided in the system of the first embodiment to the fifth embodiment. In the access state of the balloon catheter, the voltage of the connector terminal provides the operating power voltage to the built-in module, so as to realize the change of the voltage of the connector port with the change between the access state and the removal state of the balloon catheter.

[0115] ​The connector terminal can provide operating power for the built-in module via a current-limiting resistor, limit and protect the maximum operating current of the balloon catheter, and provide an operating current less than the maximum operating current of the balloon catheter when the built-in module of the balloon catheter is damaged or fails.

[0116] An implementation can further include that, in order to identify the type of the pressure wave balloon catheter, the high-voltage pulse power host can send a test signal to the pressure wave balloon catheter. After receiving the test signal sent by the high-voltage pulse power host, the pressure wave balloon catheter can send the test signal to the pressure wave generator in the pressure wave balloon catheter; wherein the test signal can generate electrical characteristic information after passing through the circuit of the pressure wave generator. After generating the electrical characteristic information, the pressure wave balloon catheter can package the electrical characteristic information to generate balloon test information, and send the balloon test information to the high-voltage pulse power host.

[0117] Application example

[0118] IVL technology, drawing on the extracorporeal lithotripsy of urology. Its working principle is to perfectly combine the acoustic wave calcification fracturing technology with the balloon catheter. The flexible balloon has a micro high-voltage discharge device built-in. During treatment, the balloon first expands at low pressure at the calcified lesion, tightly adheres to the blood vessel wall at the lesion, and then the high-voltage pulse power source is controlled by the treatment switch to output intermittent high-voltage excitation electric pulses, which act on the micro high-voltage discharge device in the balloon. Under the excitation of high-voltage electric pulses, the balloon instantaneously discharges high voltage, and part of the mixed solution of saline and contrast agent in the balloon is instantaneously vaporized, generating non-focused, circumferential, and pulse acoustic pressure waves. The acoustic pressure waves mainly selectively act on solid calcified substances that cause arterial vascular lesions, and almost damage the soft tissues such as human blood vessels and muscles with density close to saline. Therefore, the acoustic pressure waves can efficiently and safely impact and destroy superficial and deep vascular calcified lesions, making the calcified substances break and loosen, and the blood vessels moderately soften, thereby maximizing the lumen diameter and significantly improving the vascular compliance, making it easy to implant a stent or a drug balloon afterwards.

[0119] Based on the unique mechanism of action of IVL technology, this treatment method is not only effective for superficial and deep calcification, but also has obvious therapeutic effect on eccentric and non-eccentric calcified lesions, while reducing soft tissue damage and the risk of complications such as dissection and perforation. Its safety is superior to other plaque pretreatment modification techniques such as excimer laser and rotational atherectomy.

[0120] IVL is an innovative breakthrough in the field of interventional therapy. Whether it is left main lesion, angulation lesion, incomplete stent expansion, or annular, eccentric calcification, as well as superficial and deep calcification, IVL has shown great advantages in clinical application. In the clinical treatment of arterial calcified lesions, it has been increasingly recognized and promoted by the medical system.

[0121] One IVL system of the present application is an application of a balloon catheter in intravascular lithotripsy. The IVL system comprises a balloon catheter and a power supply main body comprising a high-voltage pulse power supply, the balloon catheter is internally provided with a micro high-voltage discharge device, and an identification device is further arranged in the system to monitor and determine the change between the balloon catheter access state and the removal state,

[0122] In the working state, the data of the built-in module is read to obtain at least one of the data of the balloon catheter type, the working parameters, etc.

[0123] and the balloon works in the working mode adapted to the balloon catheter type (in the IVL system, the balloon is mainly used for expanding the blood vessel and breaking the calcification of the blood vessel. The purpose of reading the balloon parameters is to output the high-voltage discharge times and the pulse high-voltage amplitude of the power supply main machine within the allowable range of the balloon), and then the intermittent high-voltage excitation electric pulse of the shock wave pulse power supply is output to act on the micro high-voltage discharge device in the balloon. Under the excitation of the high-voltage electric pulse, the balloon instantaneously discharges high voltage, so that the solution in the balloon is instantaneously vaporized to generate a non-focused, circumferential direction pulse type acoustic pressure wave.

[0124] The identification device can adopt at least one structure or circuit in the first embodiment to the fifth embodiment, and will not be described in detail here. For other specific structures, please refer to ​ The system further comprises:

[0125] The shock wave power supply is a key equipment of the IVL system. The power supply outputs a high-voltage electric pulse under the control of the power supply treatment switch or the operation handle treatment switch, provides a high-voltage electric pulse excitation for the balloon of the IVL system, and the balloon generates a pulse discharge under the excitation of the electric pulse to generate a pulse type acoustic pressure shock wave.

[0126] The operation handle 250 is convenient for connecting the power supply and the balloon catheter and is convenient for the doctor to operate. Components: 20 - operation handle; 21 - handle treatment switch;

[0127] The balloon catheter is used for expanding and pretreating the calcified lesions of the arterial blood vessel. Components: 30 - balloon catheter; 31 - catheter connector; 32 - storage chip; 33 - balloon; 34 - high-voltage pulse discharge electrode. In the application example, an identification technology of the balloon catheter is designed to adapt to the sudden abnormal situation of the clinical balloon catheter, so that the IVL clinical treatment is safer and more efficient.

[0128] Seventh embodiment

[0129] The present principles are not limited to the shock balloon catheter, but also apply to any medical module having two operating states with respect to the main body, an inserted state and a removed state. For example, the present principles can also be applied to an ultrasound transducer, to identify the inserted state. In other words, a medical module insertion identification system includes a main body and a medical module configured to be in an inserted state and a removed state, wherein,

[0130] The main body is provided with a connector port, one side of the connector port is connectable to the medical module, and the other side is connected to a main control module of the main body. The voltage change of the connector terminal of the connector port is associated with the power supply of the medical module.

[0131] An identification device monitors and determines whether the medical module is in the inserted state or the removed state by monitoring the voltage change of the connector terminal. The connector terminal is connected to the medical module. In the inserted state, the voltage of the connector terminal provides the operating voltage to the medical module to change the port voltage between the inserted state and the removed state.

[0132] Similarly, the connector terminal is connected to the medical module through a first current limiting unit. The voltage of the connector terminal provides the operating voltage to the medical module after being stepped down by the first current limiting unit. The first current limiting unit is configured to, when the inserted medical module is in a damaged, failed or short-circuit fault state, provide a safe current allowed by the identification device and less than the maximum allowed current of the medical module.

[0133] The above application of specific examples is used to help understand the present principles and does not limit the present principles. For those skilled in the art to which the present principles belong, according to the idea of the present principles, a number of simple deductions, deformations or substitutions can be made.

Claims

1. A shockwave balloon catheter system, characterized by, The balloon catheter, the power supply body containing the high-voltage pulse power supply, the catheter connector and the identification device, wherein: The balloon catheter comprises a body part and a catheter connector, The body part comprises an elongated carrier, a balloon and at least one pair of electrodes in the form of a shock wave generator for emitting a shock wave, the balloon is sleeved on the carrier, the balloon is arranged to be capable of receiving a fluid for inflating it, and the at least one pair of electrodes is coupled to the high-voltage pulse power supply through the catheter connector; The catheter connector is internally provided with a built-in module for storing current data information of the balloon catheter, The catheter connector is internally provided with a connector port, one side of the connector port is connected to the built-in module, and the other side is connected to a master control module of the power supply body, the voltage change of a connector terminal of the connector port is associated with the power supply of the built-in module; The identification device monitors and determines whether the balloon catheter is in an access state or a removal state by monitoring the voltage change of the connector terminal, and the identification device comprises a voltage providing unit, a first voltage dividing unit, a second voltage dividing unit and an amplification circuit; the voltage providing unit provides a working voltage of the built-in module, and is connected to GND through the first voltage dividing unit and the second voltage dividing unit, the Vo terminal and the GND terminal of the first voltage dividing unit and the second voltage dividing unit in series are connected to the connector terminal; the second voltage dividing unit is used for monitoring the voltage of the connector port, the voltage dividing value Vs of the second voltage dividing unit is transmitted to the master control module of the power supply body after being amplified by the amplification circuit, and whether the connector port is externally connected to the balloon catheter, the voltage dividing value Vs of the second voltage dividing unit will change, and whether the balloon catheter is in the access state or the removal state is determined by monitoring the change of the voltage dividing value Vs of the second voltage dividing unit.

2. The shockwave balloon catheter system of claim 1, wherein, The connector terminal is connected to the built-in module, and the voltage of the connector terminal provides a working power voltage to the built-in module in the access state of the balloon catheter, so as to change the voltage of the connector port between the access state and the removal state of the balloon catheter.

3. The shockwave balloon catheter system of claim 2, wherein, The connector terminal is connected to the built-in module through a first current limiting unit, the voltage of the connector terminal provides a working voltage to the built-in module after being stepped down by the first current limiting unit, and the first current limiting unit is used for limiting the current flowing through the first current limiting unit within the safe current allowed by the identification device and smaller than the maximum allowable current of the built-in module of the balloon catheter when the built-in module of the accessed balloon catheter is damaged and fails.

4. The shockwave balloon catheter system of claim 3, wherein, It also comprises a voltage stabilizing unit for stabilizing the built-in module within a preset working voltage range.

5. The shockwave balloon catheter system of claim 4, wherein, The voltage stabilizing unit comprises a Zener voltage stabilizer U1, a third voltage dividing unit and a fourth voltage dividing unit, the cathode voltage of the Zener voltage stabilizer U1 is adjusted by the voltage dividing ratio of the third voltage dividing unit and the fourth voltage dividing unit, so that the power supply voltage VCC of the built-in module is the working voltage required by the built-in module.

6. The shockwave balloon catheter system of claim 4, wherein, It also comprises a filter unit connected in parallel with the voltage stabilizing unit, and the filter unit is a capacitor or a plurality of capacitors connected in series or parallel.

7. The shockwave balloon catheter system of claim 1, wherein, The built-in module further comprises a built-in chip, which is an MCU with an EEPROM inside or an MCU with an external EEPROM memory.

8. The shockwave balloon catheter system of claim 5, wherein, The identification device further comprises a second current limiting unit, the voltage providing unit VDD connects the second current limiting unit through the connector terminal Vo end, and then connects the third voltage dividing unit, the fourth voltage dividing unit and the GND end of one of the connector terminals, and the second current limiting unit is used to reduce the instantaneous impact current on the connector port when the balloon catheter accesses the host connector.

9. The shockwave balloon catheter system of claim 8, wherein, The identification device further comprises a port filtering capacitor unit for eliminating noise interference and port voltage jitter, which is connected in parallel between the first voltage dividing unit and the second voltage dividing unit.

10. The shockwave balloon catheter system of claim 1 or 4, wherein, The built-in module further comprises an interface chip, which is connected to the corresponding configuration interface chip through at least two terminals of the connector port, and then connected to the host control module to read the data of the built-in module in the catheter connector, identify the current data of the balloon catheter type and working parameters.

11. The shockwave balloon catheter system of claim 10, wherein, The interface chip further comprises one of an RS232 chip and a 485 interface chip, which is connected to the corresponding configuration interface chip through at least two terminals of the connector port, and then connected to the host control module.

12. The shockwave balloon catheter system of claim 5, wherein, The identification device further comprises a sampling resistor, and the system further comprises an operation part, which is arranged between the catheter connector and the host control module of the power supply body, and a treatment switch is arranged on the operation part, the sampling resistor is connected in series with the treatment switch, and then connected in parallel with the second voltage dividing unit, and one end of the treatment switch is connected to one of the terminals of the catheter connector in series with the sampling resistor, and the other end is connected to the fourth voltage dividing unit, when the treatment switch is triggered, the voltage change of the voltage dividing value Vs of the second voltage dividing unit is monitored to monitor the action of the treatment switch in real time.

13. The shockwave balloon catheter system of claim 5, wherein, The system further comprises an operation part, which is arranged between the catheter connector and the host control module of the power supply body, and one or more switch components are arranged on the operation part, which are connected in series with an adaptive number of resistors, and then connected to the connector port and connected in parallel with the second voltage dividing unit, when one of the switch components or any combination is triggered, the voltage change of the voltage dividing value Vs of the first voltage dividing unit is monitored to monitor the action of the switch component in real time.

14. A shockwave balloon catheter identification device for use in a shockwave balloon catheter system, the system further comprising a balloon catheter and a power source body comprising a high pressure pulse power source, characterized in that, The balloon catheter comprises a catheter connector, and the catheter connector is provided with a built-in module for storing current data information of the balloon catheter; The catheter connector is provided with a connector port, one side of the connector port is connected to the built-in module, and the other side is connected to the host control module of the power supply body, and the voltage change of the connector terminal of the connector port is associated with the power supply of the built-in module; The catheter connector is provided with a connector port, one side of the connector port is connected to the built-in module, and the other side is connected to the host control module of the power supply body, and the voltage change of the connector terminal of the connector port is associated with the power supply of the built-in module; The identification device includes an identification unit that monitors and determines whether the balloon catheter is in an access state or a removal state by monitoring voltage changes on the terminals of the connector port, and the identification unit includes a voltage providing unit, a first voltage dividing unit, a second voltage dividing unit, and an amplification circuit; the voltage providing unit provides the working voltage of the built-in module, which is connected to GND after passing through the first voltage dividing unit and the second voltage dividing unit, and the Vo end and the GND end of the first voltage dividing unit and the second voltage dividing unit in series are connected to the connector terminals; the second voltage dividing unit is used to monitor the voltage of the connector port, and the voltage dividing value Vs of the second voltage dividing unit is transmitted to the main control module of the power supply body after being amplified by the amplification circuit; whether the connector port is externally connected to the balloon catheter, the voltage dividing value Vs of the second voltage dividing unit will change, and by monitoring the change of the voltage dividing value Vs of the second voltage dividing unit, it is determined whether the balloon catheter is in an access state or a removal state.

15. A method of identifying a shockwave balloon catheter, the method comprising: It comprises: Providing a shock wave balloon catheter system including a balloon catheter and a power supply body, the balloon catheter has a balloon body portion and a catheter connector at its proximal end, the balloon is arranged to be capable of receiving a fluid to inflate it, and placed inside the balloon is a shock wave generator in the form of at least one pair of electrodes for emitting shock waves, which is coupled to the power supply body at the catheter proximal end through the catheter connector; the catheter connector is arranged with a built-in module for storing current data information of the balloon catheter, and the catheter connector is provided with a connector port, one side of the connector port is connected to the built-in module, and the other side is connected to the main control module of the power supply body, and the voltage change of the connector terminal of the connector port is associated with the power supply of the built-in module; By monitoring the voltage change of the connector terminal, it is monitored and determined whether the balloon catheter is in an access state or a removal state, and when the balloon catheter body access state is monitored, the data of the built-in module is read to obtain at least one of the balloon catheter type, working parameters and the like; The identification device includes a voltage providing unit, a first voltage dividing unit, a second voltage dividing unit, and an amplification circuit; the voltage providing unit provides the working voltage of the built-in module, which is connected to GND after passing through the first voltage dividing unit and the second voltage dividing unit, and the Vo end and the GND end of the first voltage dividing unit and the second voltage dividing unit in series are connected to the connector terminals; the second voltage dividing unit is used to monitor the voltage of the connector port, and the voltage dividing value Vs of the second voltage dividing unit is transmitted to the main control module of the power supply body after being amplified by the amplification circuit; whether the connector port is externally connected to the balloon catheter, the voltage dividing value Vs of the second voltage dividing unit will change, and by monitoring the change of the voltage dividing value Vs of the second voltage dividing unit, it is determined whether the balloon catheter is in an access state or a removal state.

16. The method of claim 15, wherein, It also includes: When the balloon catheter is in an access state, the voltage of the connector terminal provides the working power voltage to the built-in module to change the voltage of the connector port between the access state and the removal state of the balloon catheter.

17. The method of claim 16, wherein, The connector terminal provides working power supply for the built-in module via a current-limiting resistor, limits the maximum working current of the balloon catheter, and provides a maximum working current within the safe current allowed by the identification device and less than the maximum allowed current of the balloon catheter built-in module when the balloon catheter built-in module is damaged.

18. The method of claim 16, wherein, The identification device further comprises a sampling resistor, and the system further comprises an operation part arranged between the catheter connector and the master module of the power supply body, wherein a treatment switch is arranged on the operation part, the sampling resistor is connected in series with the treatment switch and connected in parallel with the second voltage dividing unit, one end of the treatment switch is connected in series with the sampling resistor after being connected to one of the terminals of the catheter connector, and the other end of the treatment switch is connected to the fourth voltage dividing unit. When the treatment switch is triggered, the voltage change of the voltage division value Vs of the second voltage dividing unit is monitored to monitor the action of the treatment switch in real time.

19. The method of claim 16, wherein, Further comprising: An operation part is arranged between the catheter connector and the master module of the power supply body, wherein one or more switch components are arranged on the operation part, connected in series with an adaptive number of resistors, connected to the connector port, and connected in parallel with the second voltage dividing unit. When one or any combination of the switch components is triggered, the voltage change of the voltage division value Vs of the first voltage dividing unit is monitored to monitor the action of the switch components in real time.

20. The method of claim 15, wherein, Further comprising: A voltage stabilizing unit is provided to stabilize the built-in module within a preset working voltage range.

21. An IVL system characterized in that, The shock wave balloon catheter system according to any one of claims 1-13, In the access state, the master module reads the current data information of the balloon catheter in the built-in module to obtain the balloon catheter type and / or the working parameters of the balloon catheter; and makes the balloon catheter execute a working mode adapted to the balloon catheter type, first low-pressure expansion, then intermittent high-voltage excitation electric pulse output by the high-voltage pulse power, acting on the at least one pair of electrode form shock wave generators in the balloon for emitting shock waves, under the high-voltage excitation electric pulse, at least one pair of electrode balloon instantaneous high-voltage discharge, so that the solution in the balloon is instantaneously vaporized, generating non-focused, circumferential direction pulse sound pressure wave.

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