Shock wave generation device, control method thereof, medical apparatus, and computer medium

Abstract

The application relates to a shock wave generating device and a control method thereof, a medical instrument and a computer medium. The shock wave generating device comprises a shock wave generating module, a monitoring feedback module and a signal generating module. The shock wave generating module is used for generating target shock waves with single or composite vibration modes according to a target driving signal. The vibration modes include a transverse stretching vibration mode and a longitudinal stretching vibration mode. The monitoring feedback module is connected with the shock wave generating module and is used for monitoring and collecting vibration state parameters of the target shock waves generated by the shock wave generating module in real time, and generating a feedback signal according to the vibration state parameters. The signal generating module is connected with the monitoring feedback module and the shock wave generating module and is used for generating the target driving signal according to the feedback signal. The above shock wave generating device can reduce the operation time, improve problems caused by excessive X-ray exposure and the like, improve the working efficiency of the whole shock wave generating device and realize safety protection for operators and patients.

Description

Technical Field

[0001] This application relates to the field of medical device technology, and in particular to a shock wave generating device and its control method, a medical device, and a computer medium. Background Technology

[0002] Chronic total occlusion (CTO) refers to a lesion in which the coronary artery is 100% blocked and has been blocked for more than 3 months. Percutaneous coronary intervention (PCI) is now commonly required for treatment. However, the success rate of current PCI treatment is low and the incidence of complications is high.

[0003] The interventional devices commonly used in CTO treatment involve inserting a guidewire near the lesion under imaging guidance and penetrating the CTO tissue under a certain force. This process is prone to improper operation, leading to various complications and increasing the failure rate of CTO interventions. Furthermore, traditional endovascular interventional treatments for CTO, such as those using passive or active shockwave devices, suffer from long operation times, large contrast agent dosages, high X-ray exposure, and increased risk of patient complications. Therefore, there is an urgent need for a shockwave generating device to shorten operation time, reduce contrast agent dosage and X-ray exposure, and improve the success rate and reduce risks. Summary of the Invention

[0004] Therefore, it is necessary to address the problems mentioned in the background art by providing a shock wave generating device and its control method, medical device, and computer medium, so as to shorten the operation time, reduce the amount of contrast agent and X-ray exposure during the intervention process of CTO treatment, and provide better treatment results for patients.

[0005] To achieve the above and other related objectives, one aspect of this application provides a shock wave generating device, including a shock wave generating module, a monitoring feedback module, and a signal generating module. The shock wave generating module is used to generate a target shock wave with a single or composite vibration mode based on a target driving signal, the vibration modes including a lateral extension vibration mode and a longitudinal extension vibration mode; the monitoring feedback module is connected to the shock wave generating module and is used to monitor and acquire the vibration state parameters of the target shock wave generated by the shock wave generating module in real time, and generate a feedback signal based on the vibration state parameters; the signal generating module is connected to the monitoring feedback module and the shock wave generating module and is used to generate a target driving signal based on the feedback signal.

[0006] In the shock wave generating device of the above embodiments, the target shock wave is monitored in real time by a monitoring feedback module, and the collected information is used to generate a feedback signal so that the signal generating module generates a target driving signal. The target driving signal acts on the shock wave generating module to generate a new target shock wave, thereby forming a closed-loop feedback network. The output can be adjusted according to the real-time vibration state parameters of the target shock wave, reducing the acquisition delay of the target driving signal. The target driving signal is directly generated through the feedback signal, ensuring that the shock wave generating device works in a highly efficient resonant state. The vibration mode of the shock wave includes both lateral and longitudinal telescopic vibration modes, which can ensure effective forward penetration while expanding and modifying the penetration aperture, increasing the cavity for subsequent instruments to pass through, simplifying the subsequent surgical process and reducing the operation time. This reduces the risks caused by excessive X-ray exposure, excessive contrast agent, etc., thereby improving the overall working efficiency of the shock wave generating device. Compared with traditional shock wave generation technology, the shock wave generation device provided in this application improves the overall efficiency of CTO treatment intervention. In the treatment of lesions with severe calcification and larger CTO length, it improves the effectiveness and efficiency of CTO recanalization, which is conducive to subsequent treatment. At the same time, it can better control the accumulation of thermal effects, stress and strain, thereby ensuring the safety of the operator and the patient.

[0007] In some embodiments, the monitoring feedback module is further configured to match the frequency of the target driving signal with the resonant frequency of the target shock wave while generating the feedback signal or before / after generating the feedback signal.

[0008] In some embodiments, the monitoring feedback module includes a vibration acquisition unit and a feedback unit. The vibration acquisition unit is connected to the shock wave generation module and is used to monitor and acquire the vibration state parameters of the target shock wave generated by the shock wave generation module in real time. The feedback unit is connected to the vibration acquisition unit and the signal generation module and is used to generate a feedback signal based on the vibration state parameters, and to match the frequency of the target driving signal with the resonant frequency of the target shock wave simultaneously with, before, or after the generation of the feedback signal.

[0009] In some embodiments, the vibration acquisition unit is further configured to: acquire the initial frequency parameters of the shock wave generation module; generate an initial drive signal based on the initial frequency parameters of the shock wave generation module, and transmit the initial drive signal to the feedback unit to trigger the feedback unit to operate.

[0010] In some embodiments, there is a preset time interval between the time when the initial frequency parameters are acquired and the time when the target shock wave at the actual resonant frequency is generated.

[0011] In some embodiments, the preset time range is [300us, 800us].

[0012] In some embodiments, the vibration state parameters of the target shock wave include at least one of the waveform and amplitude of the current, the waveform and amplitude of the voltage, the phase difference between the current and the voltage, and the resonant frequency.

[0013] In some embodiments, the resonant frequency of the target shock wave is located within the resonant bandwidth of the shock wave generating device.

[0014] In some embodiments, the shock wave generating device further includes a switch control module connected to the shock wave generating module for controlling the pulse parameters of the target shock wave.

[0015] In some embodiments, the pulse parameters include at least one of pulse duration, duty cycle, and pulse frequency.

[0016] In some embodiments, the pulse duration of the target shock wave ranges from [1ms to 100ms].

[0017] In some embodiments, the pulse frequency range of the target shock wave is [1Hz, 100Hz].

[0018] In some embodiments, the transverse stretching vibration mode includes radial vibration.

[0019] In some embodiments, the longitudinal stretching vibration mode includes at least one of the piezoelectric material's thickness-direction stretching vibration and length-direction stretching vibration.

[0020] In some embodiments, the shock wave generating device further includes a conduction module connected to the shock wave generating module for conducting the target shock wave to the target area.

[0021] In some embodiments, the conduction module includes a conduit and a guidewire; the conduit is connected to the shock wave generating module for conducting the vibration of the target shock wave to the guidewire; the guidewire is connected to both the conduit and the target area for conducting the vibration of the target shock wave to the target area.

[0022] In some of these embodiments, the resonant frequency range of the target shock wave is [10 kHz, 10 MHz].

[0023] In some embodiments, the amplitude range of the target shock wave is [1µm, 100µm].

[0024] In some embodiments, this application also provides a medical device, including the shock wave generating device described in any one of the embodiments of this application.

[0025] In the medical device described in the above embodiments, the target shock wave generated by the shock wave generating module is output to the transmission module. The transmission module can transmit the mechanical vibration of the target shock wave to the target area and transmit the stress and strain generated by the shock wave generating module. Since the target shock wave can output single or composite vibration modes, the transmission module can easily pass through the reserved through hole and ensure effective forward penetration during subsequent operations. This facilitates the transmission module's passage through the cavity, simplifies the subsequent surgical procedure, reduces surgical time, and avoids excessive X-ray exposure and contrast agent overdose for the surgeon and patient due to prolonged surgical time.

[0026] In some embodiments, this application also provides a control method for a shock wave generating device, comprising: real-time monitoring and acquisition of vibration state parameters of a target shock wave generated by a shock wave generating module, and generating a feedback signal based on the vibration state parameters; generating a target driving signal based on the feedback signal; and controlling the shock wave generating module to generate a target shock wave with a single or composite vibration mode based on the target driving signal, wherein the vibration mode includes a transverse extension vibration mode and a longitudinal extension vibration mode.

[0027] In the control method of the shock wave generating device in the above embodiments, the vibration state parameters of the target shock wave are monitored and collected in real time, and a feedback signal is generated to generate a target driving signal to control the vibration state of the target shock wave. The feedback network ensures that the shock wave generating system operates at a highly efficient resonant frequency, thereby improving system efficiency. Furthermore, the generated target driving signal includes single or composite vibration modes, which is beneficial for opening and widening the lesion, increasing the cavity available for subsequent instruments, simplifying the subsequent surgical procedure, and reducing surgical time, thus facilitating subsequent treatment. This control method can improve upon the problems of large heat accumulation on the guidewire, delayed load monitoring, slow output shut-off, high perforation risk, and difficulty in subsequent treatment of CTO lesions in traditional techniques, thereby improving the overall efficiency and success rate of CTO interventional treatment.

[0028] In some embodiments, this application further provides a computer-readable storage medium having a computer program stored thereon, wherein the computer program, when executed by a processor, implements the steps of the control method for the shock wave generating device described in any one of the embodiments of this application. Attached Figure Description

[0029] To better describe and illustrate embodiments and / or examples of the applications disclosed herein, reference may be made to one or more accompanying drawings. Additional details or examples used to describe the drawings should not be considered as limiting the scope of any of the disclosed applications, the embodiments and / or examples currently described, or the best mode of conduct of these applications as currently understood.

[0030] Figures 1-4The diagram shows a simplified structural schematic of the shock wave generating device provided in different embodiments of this application.

[0031] Figure 5 The diagram shown is a flowchart illustrating the control method of a shock wave generating device provided in one embodiment of this application.

[0032] Explanation of reference numerals in the attached figures:

[0033] 10. Monitoring and feedback module; 11. Vibration acquisition unit; 12. Feedback unit; 20. Signal generation module; 30. Shock wave generation module; 31. Piezoelectric generator; 32. Handle; 40. Conduction module; 41. Conduit; 42. Guide wire. Detailed Implementation

[0034] To facilitate understanding of this application, a more complete description will be provided below with reference to the accompanying drawings, which illustrate preferred embodiments of the application. However, this application can be implemented in many different forms and is not limited to the embodiments described herein. Rather, these embodiments are provided to make the disclosure of this application more thorough and complete.

[0035] Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this application belongs. The terminology used herein in the specification of this application is for the purpose of describing particular embodiments only and is not intended to be limiting of the application. The term "and / or" as used herein includes any and all combinations of one or more of the associated listed items.

[0036] When using the terms “including,” “having,” and “comprising” as described herein, another component may be added unless explicitly qualifying terms such as “only,” “consisting of,” etc. are used. Unless otherwise stated, singular terms may include plural forms and should not be construed as having a quantity of one.

[0037] It should be understood that although the terms “first,” “second,” etc., may be used herein to describe various elements, these elements should not be limited by these terms. These terms are used only to distinguish one element from another. For example, without departing from the scope of this application, a first element may be referred to as a second element, and similarly, a second element may be referred to as a first element.

[0038] In this application, unless otherwise expressly specified and limited, the terms "connected" and "linked" should be interpreted broadly. For example, they can refer to a direct connection or an indirect connection through an intermediate medium, or they can refer to the internal connection of two elements or the interaction between two elements. Those skilled in the art can understand the specific meaning of the above terms in this application according to the specific circumstances.

[0039] CTO (Coronary artery occlusion) refers to 100% occlusion of the coronary artery lumen, requiring percutaneous coronary intervention (PCI). Currently, the average success rate of interventional treatment for CTO lesions is 60%–90%. The presence of calcification and fibrosis, as well as vessel size and tortuosity, can be potential causes of complications in CTO lesions. Even with adequate collateral circulation, the blood supply is functionally equivalent to that of a 90% stenotic vessel, barely maintaining myocardial viability at rest and blood supply to dormant myocardium. When myocardial oxygen consumption increases, patients experience symptoms of myocardial ischemia such as angina and decreased exercise tolerance. Therefore, successfully opening a CTO lesion can alleviate angina symptoms, improve left ventricular function, stabilize myocardial electrical activity, and thus enhance the patient's tolerance to future coronary events. Traditional interventional techniques for CTO treatment typically involve an operator inserting a thin guidewire near the lesion under imaging guidance. The guidewire then penetrates the CTO tissue under a certain force. However, due to the difficulty in controlling the guidewire material and the amount of penetration force, and the complexity of calcification and fibrosis tissue with the size and curvature of blood vessels, improper operation can easily occur during this process, leading to various complications such as coronary artery perforation or cardiac tamponade, which can also result in CTO intervention failure.

[0040] In view of the problems in the above-mentioned technology, this application provides a shock wave generating device and its control method, as well as a medical device, which can shorten the operation time, reduce the amount of contrast agent and X-ray exposure during the intervention process of CTO treatment, provide better treatment results for patients, and also improve the stability of the overall shock wave system and reduce risks.

[0041] For example, please refer to Figure 1 This application provides a shock wave generating device, including a shock wave generating module 30, a monitoring and feedback module 10, and a signal generating module 20. The shock wave generating module 30 generates a target shock wave with a single or composite vibration mode based on a target driving signal. The vibration modes include a lateral extension vibration mode and a longitudinal extension vibration mode. The monitoring and feedback module 10 is connected to the shock wave generating module 30 and is used to monitor and acquire the vibration state parameters of the target shock wave generated by the shock wave generating module 30 in real time, and generate a feedback signal based on the vibration state parameters. The signal generating module 20 is connected to the monitoring and feedback module 10 and the shock wave generating module 30 and is used to generate a target driving signal based on the feedback signal.

[0042] As an example, the shock wave generation module 30 can be used to generate a target shock wave with a transverse extension vibration mode based on the target driving signal, or it can also generate a target shock wave with a longitudinal extension vibration mode, or it can also generate a target shock wave with a composite mode that has both transverse extension vibration mode and longitudinal extension vibration mode.

[0043] As an example, the signal generation module 20 can provide an electrical signal input to the shock wave generation module 30 via a cable. The shock wave generation module 30 can include a piezoelectric generator and a handle. The piezoelectric generator is composed of multiple stacked piezoelectric ceramics and is fixed by the handle. After receiving the target drive signal, it generates the mechanical vibration of the target shock wave using the piezoelectric effect.

[0044] As an example, the ceramic material in the piezoelectric generator can be one or more of the following models: PZT-4, PZT-8, and PZT-4D; and the overall shape of the piezoelectric generator includes one or more of the following shapes: cylindrical, annular, and other highly centrally symmetrical shapes, with a diameter range of [20mm, 30mm]. For example, its diameter can be 20mm, 22mm, 24mm, 26mm, 28mm, or 30mm, etc.

[0045] Traditional techniques enhance the effectiveness and safety of CTO penetration by adding sensors or optimizing the structure of the existing guidewire, but they still essentially rely on passive guidewire penetration for treatment. Additionally, traditional techniques utilize mechanical wave generation, employing a piezoelectric generator to produce ultrasonic vibrations and transmitting these vibrations to the end of a maneuverable guidewire via a metal wire to facilitate direct CTO penetration. While this method effectively penetrates CTO tissue without requiring significant penetrating force and without damaging normal tissue, its overall efficiency is low. Furthermore, for lesions with severe calcification (e.g., calcification greater than 75%) or larger CTO lengths (e.g., greater than 110 mm), the effectiveness and efficiency of CTO recanalization are affected. The extremely thin guidewire tip, even after penetration, presents challenges due to the small orifice, hindering subsequent treatment. Moreover, the cumulative thermal effects, stress, and strain are difficult to control, posing risks to both the operator and the patient.

[0046] Compared to traditional technologies, the shock wave generating device in the above embodiment uses a monitoring feedback module 10 to monitor the target shock wave in real time and generate a feedback signal from the collected information. This allows the signal generating module 20 to generate a target driving signal, which in turn acts on the shock wave generating module 30 to generate a new target shock wave, thus forming a closed-loop feedback network. This network can adjust the output based on the real-time vibration state parameters of the target shock wave, reducing the delay in acquiring the target driving signal. By directly generating the target driving signal through the feedback signal, the shock wave generating device is ensured to operate in a highly efficient resonant state. Furthermore, the vibration modes of the shock wave include both lateral and longitudinal telescopic vibration modes, which ensures effective forward penetration while expanding and modifying the penetration aperture, increasing the cavity for subsequent instruments to pass through, simplifying the subsequent surgical procedure, reducing surgical time, and mitigating the risks caused by excessive X-ray exposure and contrast agent overdose, thereby improving the overall efficiency of the shock wave generating device. Compared with traditional shock wave generation technology, the shock wave generation device provided in this application improves the overall efficiency of CTO treatment intervention. In the treatment of lesions with severe calcification and larger CTO length, it improves the effectiveness and efficiency of CTO recanalization, which is conducive to subsequent treatment. At the same time, it can better control the accumulation of thermal effects, stress and strain, thereby ensuring the safety of the operator and the patient.

[0047] As an example, the monitoring feedback module 10 is also configured to match the frequency of the target drive signal with the resonant frequency of the target shock wave while generating the feedback signal or before / after generating the feedback signal.

[0048] For example, please refer to Figure 2 The monitoring feedback module 10 includes a vibration acquisition unit 11 and a feedback unit 12. The vibration acquisition unit 11 is connected to the shock wave generation module 30 and is used to monitor and acquire the vibration state parameters of the target shock wave generated by the shock wave generation module 30 in real time. The feedback unit 12 is connected to the vibration acquisition unit 11 and the signal generation module 20, and is used to generate a feedback signal based on the vibration state parameters. Simultaneously with, or before / after generating the feedback signal, the frequency of the target driving signal is matched with the resonant frequency of the target shock wave. This allows the monitoring feedback module 10 to efficiently acquire the feedback signal and simultaneously match the frequency of the target driving signal with the resonant frequency of the target shock wave, thereby improving the efficiency of shock wave generation.

[0049] As an example, the frequency of the target driving signal is matched with the resonant frequency of the target shock wave. The monitoring feedback module 10 reduces the acquisition delay of the target driving signal through matching networks, compensation networks, and feedback networks, directly generating the driving signal to ensure that the system operates in a highly efficient resonant state. This ensures that the frequency of the target driving signal matches the real-time resonant frequency of the target shock wave in the piezoelectric generator, achieving the ideal resonant state of the piezoelectric generator and improving the overall system efficiency.

[0050] As an example, the vibration acquisition unit 11 and feedback unit 12 described above can simultaneously act on the impedance matching and feedback of the shock wave system to achieve real-time detection and acquisition of the current. The vibration acquisition unit 11 monitors and acquires the status of the shock wave generation module 30 in real time and outputs a feedback signal in the feedback loop through the feedback network to trigger the feedback unit 12 to generate the target drive signal. During operation, the resonant frequency of the shock wave generation module 30 may change due to various factors such as the shock wave transmission medium, load status, and operating time and temperature. Therefore, by monitoring and acquiring the status of the shock wave generation module 30 in real time, the overall system efficiency can be improved and the frequency tracking delay can be greatly reduced.

[0051] As an example, the vibration acquisition unit 11 can be a module for acquiring system current. For example, a differential variable transformer can be used to compensate for the reactive and active components of the electrical arm of the shock wave generation module 30 by using bridge balancing. Only the dynamic series branch current of the shock wave generation module 30 is effective, thereby obtaining a low-delay current signal to efficiently acquire the current signal and generate a feedback signal, thereby improving the success rate of CTO interventional treatment.

[0052] As an example, the vibration acquisition unit 11 is also configured to: acquire the initial frequency parameters of the shock wave generation module 30; and generate an initial drive signal based on the initial frequency parameters of the shock wave generation module 30, and transmit the initial drive signal to the feedback unit 12 to trigger the feedback unit 12 to work.

[0053] As an example, after the device is powered on, the vibration acquisition unit 11 first acquires the inherent resonant frequency of the shock wave generation module 30. Through frequency stepping, the analog-to-digital conversion module detects the gradually changing voltage or current, phase difference, and other signals at the generator end. When the current-voltage phase difference is 0 degrees, or by comparing the current, voltage, waveform, or amplitude at a specific resonant point initially set, or by determining the frequency parameters when the impedance is minimum, an initial drive signal is generated. The initial drive signal is then transmitted to the feedback unit 12 to trigger the feedback unit 12 to work, and then the initial drive signal of the corresponding frequency is transmitted to the shock wave generation module 30.

[0054] As an example, there is a preset time between the time when the initial frequency parameters are obtained and the time when the target shock wave at the actual resonant frequency is generated, that is, there is a preset time between the initial resonant frequency at the time the shock wave generating device is turned on and the actual resonant frequency is tracked.

[0055] As an example, the preset time range is [300us, 800us]. Specifically, the preset time can be 300us, 350us, 400us, 450us, 500us, 550us, 600us, or 800us, etc. The shock wave generation technology provided in this application can reduce frequency tracking delay, making the tracking delay in the microsecond range, improving the accuracy and success rate of CTO treatment, and reducing operation time.

[0056] As an example, the vibration state parameters of the target shock wave include at least one of the following: waveform and amplitude of current, waveform and amplitude of voltage, phase difference between current and voltage, and resonant frequency.

[0057] As an example, the target driving signal includes, but is not limited to, one or more waveforms such as square wave, sine wave, and triangle wave.

[0058] As an example, the resonant frequency of the target shock wave is located within the resonant bandwidth of the shock wave generating device. By directly generating the target drive signal through feedback, the frequency tracking delay is reduced to the microsecond level. At the same time, the current sensing network participates in the overall resonant circuit matching, ensuring that the piezoelectric generator's operating frequency is within the system's resonant bandwidth, thereby guaranteeing that the system operates in a highly efficient resonant state.

[0059] As an example, the shock wave generating device also includes a switch control module connected to the shock wave generating module 30 for controlling the pulse parameters of the target shock wave.

[0060] As an example, pulse parameters include at least one of pulse duration, duty cycle, and pulse frequency. The duty cycle can be defined as the ratio of pulse duration to total time during a continuous operating period of the shock wave generating device.

[0061] As an example, the time interval between two consecutive activations of the shock wave generating device is approximately 100ms, and the duration of one operation of the shock wave generating device can be [5ms, 10ms]. Therefore, the duty cycle of the shock wave generating device is [5%, 10%]. Specifically, the duration of one operation of the shock wave generating device can be 5ms, 6ms, 7ms, 8ms, or 10ms, etc., and correspondingly, the duty cycle of the shock wave generating device can be 5%, 6%, 7%, 8%, or 10%, etc.

[0062] As an example, the pulse duration of the target shock wave ranges from [1ms to 100ms]. Specifically, the pulse duration can be 1ms, 10ms, 20ms, 50ms, or 100ms, etc.

[0063] As an example, the pulse frequency range of the target shock wave is [1Hz, 100Hz]. Specifically, the pulse frequency can be 1Hz, 10Hz, 30Hz, 60Hz, 80Hz, or 100Hz, etc.

[0064] The aforementioned switch control module may include, but is not limited to, one or more of the following: Insulated-Gate Bipolar Transistor (IGBT), Metal Oxide Semiconductor Field-Effect Transistor (MOSFET), electromagnetic relay, and solid-state relay, to control the pulse duration, duty cycle, and pulse frequency of the ultrasonic shock wave. By controlling these pulse parameters, heat accumulation during shock wave generation can be reduced, facilitating operation by the operator holding the handle 32; additionally, it can protect the patient's blood vessels and improve the stability and safety of the equipment. The switch control module, in conjunction with a frequency tracking feedback network, ensures that the shock wave generation module 30 is in optimal resonance for as much time as possible within the pulse duration of each target shock wave segment, reducing wasted energy, maximizing the efficiency of the target shock wave, reducing penetration time, and thus improving penetration efficiency.

[0065] As an example, transverse stretching vibration modes include radial vibration.

[0066] As an example, the longitudinal stretching vibration mode includes at least one of the stretching vibration in the thickness direction and the stretching vibration in the length direction of the piezoelectric material.

[0067] Since the conversion or coupling between the mechanical and electrical energy of the piezoelectric oscillator in the piezoelectric generator system is achieved by the vibration of an oscillator of a certain size and shape under a specific excitation electric field, in order to effectively excite the required vibration mode, for a piezoelectric oscillator made of a certain crystal material, a specific cut, specific external dimensions, and excitation method must be selected; while for an oscillator made of piezoelectric ceramic material, an appropriate polarization direction and a certain excitation method must be selected. For the same vibration mode of a piezoelectric material, there can be an infinite number of vibration modes. Vibration modes can be divided into transverse stretching vibration modes and longitudinal stretching vibration modes. Transverse stretching vibration modes include radial vibration, while longitudinal stretching vibration modes include stretching vibration in the thickness direction and stretching vibration in the length direction of the piezoelectric material. After penetrating the CTO lesion, in order for subsequent treatment devices to perform further treatment, it is necessary to ensure that the guidewire used in subsequent work can easily pass through the through-hole reserved after the metal wire penetration of the pulse generation system. Longitudinal vibration can ensure effective forward penetration, while radial vibration can expand and modify the penetration aperture, increase the cavity that can be passed through by subsequent instruments, simplify the subsequent surgical procedure, reduce the operation time, and avoid the harms of excessive surgery to the surgeon and patient, such as X-ray exposure and excessive contrast agent.

[0068] As an example, the transverse and longitudinal stretching vibration modes in this application can be realized not only based on vibrations under specific excitation electric fields in the above embodiments, but also based on switching between different electric fields or different voltage modes. It should be noted that in other embodiments, the transverse and longitudinal stretching vibration modes can also be generated based on other factors, and the implementation methods of these two vibration modes do not limit the scope of protection of this application.

[0069] The aforementioned single or combined vibration modes, based on frequency tracking and phase difference locking, precisely control the vibration state parameters of the target shock wave above the critical value of the combined vibration, so that the vibration modes of the target shock wave are in a superposition state. At the same time, through the transverse and longitudinal stretching vibration modes, the lesion can be effectively penetrated and the lesion aperture can be enlarged, which is conducive to subsequent treatment.

[0070] As an example, the output target shock wave can also be sampled and calculated against a set stable reference value. The result is then input into a PID (Proportion-Integration-Differentiation) control module to control voltage accuracy, enabling high-precision voltage control. This control process limits the voltage to a small fluctuation range, effectively reducing voltage output ripple and keeping the handle in an effective working state.

[0071] For example, please refer to Figure 3 The shock wave generating device also includes a transmission module 40, which is connected to the shock wave generating module 30 and is used to transmit the target shock wave to the target area.

[0072] In the transmission module 40 of the above embodiment, the target shock wave generated by the shock wave generating module 30 is output to the transmission module 40. The transmission module 40 can transmit the mechanical vibration of the target shock wave to the target area and transmit the stress and strain generated by the shock wave generating module 30. Since the target shock wave outputs a single or compound vibration mode, the transmission module 40 can easily pass through the reserved through hole and ensure effective forward penetration during subsequent work. This facilitates the transmission module 40 passing through the cavity, simplifies the subsequent surgical process, reduces the operation time, and avoids the harm of excessive X-ray exposure and excessive contrast agent to the surgeon and patient caused by excessive operation time.

[0073] For example, please refer to Figure 4 Radial vibration can be: the stretching vibration of any radial direction with o as the center in a circular cross-section perpendicular to the ox direction of the piezoelectric generator 31, for example... Figure 4 Vibration in the op direction can also be vibration in other radial directions centered at o; the stretching vibration in the thickness direction of the piezoelectric material can be: the stretching vibration in the thickness / height direction of the piezoelectric generator 31, for example... Figure 4 Vibration in the oy direction; longitudinal stretching vibration can be: stretching vibration of the piezoelectric generator 31 or the conduit 41 in the ox direction, for example in Figure 4 The stretching vibration in the ox direction; wherein the ox direction is perpendicular to the oy direction.

[0074] For example, please refer to Figure 4 The conduction module 40 includes a conduit 41 and a guide wire 42; the conduit 41 is connected to the shock wave generating module 30 and is used to conduct the vibration of the target shock wave to the guide wire 42; the guide wire 42 is connected to the conduit 41 and the target area and is used to conduct the vibration of the target shock wave to the target area.

[0075] As an example, please continue reading Figure 4 The shock wave generating module 30 may include a piezoelectric generator 31 and a handle 32. The piezoelectric generator 31 and the guide wire 42 are connected by internal and external threads, or by direct welding or other rigid connection methods.

[0076] As an example, catheter 41 can be made of biocompatible material, and its size must be sufficient for insertion into a blood vessel. The diameter can range from [0.8 mm to 2 mm], and the length can range from [1.3 m to 1.6 m]. Specifically, its diameter can be 0.8 mm, 1 mm, 1.2 mm, 1.5 mm, or 2 mm, etc., and its length can be 1.3 m, 1.4 m, 1.5 m, or 1.6 m, etc.

[0077] As an example, the material of the guide wire 42 may include one or more of stainless steel, aluminum, aluminum alloy, titanium, titanium alloy and nitinol, etc. The guide wire 42 can withstand and transmit the stress and strain generated by the piezoelectric generator 31. Its main body shape can be cylindrical, with a diameter range of [0.2mm, 0.5mm] and a length range of [1.5m, 1.8m]. Specifically, the diameter of the guide wire 42 can be 0.2mm, 0.3mm, 0.4mm or 0.5mm, etc., and the length can be 1.5m, 1.6m, 1.7m or 1.8m, etc.

[0078] As an example, the resonant frequency range of the target shock wave is [10KHz, 10MHz]. Specifically, the resonant frequency of the target shock wave can be 10KHz, 100KHz, 1MHz, or 10MHz, etc.

[0079] As an example, the amplitude range of the target shock wave is [1um, 100um]. Specifically, the amplitude of the target shock wave can be 1um, 5um, 10um, 20um, 50um, or 100um, etc.

[0080] As an example, this application also provides a medical device, including the shock wave generating device described in any one of the embodiments of this application.

[0081] For example, please refer to Figure 5 This application also provides a control method for a shock wave generating device, comprising:

[0082] Step S2: Monitor and collect the vibration state parameters of the target shock wave generated by the shock wave generation module in real time, and generate a feedback signal based on the vibration state parameters;

[0083] Step S4: Generate the target driving signal based on the feedback signal;

[0084] Step S6: Control the shock wave generation module to generate a target shock wave with a single or compound vibration mode according to the target driving signal. The vibration modes include transverse extension vibration mode and longitudinal extension vibration mode.

[0085] In step S2, please refer to Figure 2 and Figure 5In step S2, the state of the shock wave generating module 30 is monitored and acquired in real time, and the feedback signal in the output loop is triggered by the feedback network to generate the target drive signal by the feedback unit 12. During operation, the resonant frequency of the shock wave generating module 30 may change due to various factors such as the shock wave conduction medium, load state, and operating time and temperature. Therefore, by monitoring and acquiring the state of the shock wave generating module 30 in real time, the overall system efficiency can be improved and the frequency tracking delay can be greatly reduced.

[0086] In step S4, please refer to Figure 2 and Figure 5 In step S4, the target driving signal acts on the shock wave generation module 30 to generate a new target shock wave, thereby forming a closed-loop feedback network that can adjust its output according to the real-time vibration state parameters of the target shock wave, reducing the target driving signal acquisition delay.

[0087] In step S6, please refer to Figure 5 In step S6, the generated target driving signal includes single or compound vibration modes, which is beneficial for opening the lesion and widening the hole, increasing the cavity through which subsequent instruments can pass, simplifying the subsequent surgical procedure and reducing the operation time, so as to facilitate subsequent treatment.

[0088] In the control method of the shock wave generating device in the above embodiments, the vibration state parameters of the target shock wave are monitored and collected in real time, and a feedback signal is generated to generate a target driving signal to control the vibration state of the target shock wave. Through the feedback network, the shock wave generating system can be kept at a highly efficient resonant frequency, thereby improving the system's working efficiency. In addition, the output target driving signal includes single or compound vibration modes, which is beneficial for opening and widening the lesion, increasing the cavity that can be used for subsequent instruments, simplifying the subsequent surgical procedure and reducing the operation time, thus facilitating subsequent treatment. Through the above control method, the problems of large heat accumulation on the guidewire, delayed load status monitoring, slow output shut-off, high perforation risk, and difficulty in subsequent treatment of CTO lesions in traditional techniques are improved, thereby improving the overall efficiency and success rate of CTO interventional treatment.

[0089] As an example, before real-time monitoring and acquisition of the vibration state parameters of the target shock wave generated by the shock wave generation module, the following is also included:

[0090] Step S1: Obtain the initial frequency parameters of the shock wave generation module; and generate an initial drive signal based on the initial frequency parameters of the shock wave generation module, and transmit the initial drive signal to the feedback unit to trigger the feedback unit to work.

[0091] In step S1 above, please refer to Figure 2After the device is powered on, the inherent resonant frequency of the shock wave generation module 30 is first collected. Through frequency stepping, the analog-to-digital conversion module detects the gradually changing voltage or current, phase difference and other signals at the generator end. When the current-voltage phase difference is 0 degrees, or by comparing the current, voltage, waveform or amplitude of a specific resonant point set initially, or by determining the frequency parameters when the impedance is minimum, an initial drive signal is generated and transmitted to the feedback unit 12 to trigger the feedback unit 12 to work, and then transmit the initial drive signal of the corresponding frequency to the shock wave generation module 30.

[0092] In the shock wave generating device and its control method, and medical device described in the above embodiments, the shock wave generating device enables real-time high-speed monitoring of the system's resonant frequency and maintains the target drive signal in real-time tracking of the resonant frequency to generate a target shock wave. Simultaneously, it can adjust the pulse duration, duty cycle, and pulse frequency to generate a narrow-pulse-width, high-amplitude target shock wave with controllable energy. The vibration is then transmitted to the target area via a guidewire. Through the mechanical structure at the end of the guidewire, the mechanical vibration is effectively coupled to the guidewire, improving the effectiveness and recanalization efficiency of treating lesions with severe calcification and long CTO lengths. The technical solution provided in this application can reduce heat accumulation, stress, and strain on the guidewire, reducing the damage caused by heat energy to the operator and patient and lowering the risk of breakage. Simultaneously, through real-time monitoring, the output can be quickly shut off when the guidewire passes through the lesion, reducing the risk of perforation and improving the working efficiency of the target shock wave, reducing lesion passage time, and shortening the operation time. Furthermore, by outputting a mixed vibration mode, the lesion is efficiently opened and enlarged, improving the pass rate of subsequent treatments, increasing the success rate and safety of the operation.

[0093] Please note that the above embodiments are for illustrative purposes only and do not imply any limitation on this application.

[0094] It should be understood that, unless otherwise expressly stated herein, there is no strict order in which the steps are performed, and these steps may be performed in other orders. Moreover, at least some of the steps may include multiple sub-steps or multiple stages, which are not necessarily completed at the same time, but may be performed at different times, and the execution order of these sub-steps or stages is not necessarily sequential, but may be performed alternately or in turn with other steps or at least some of the sub-steps or stages of other steps.

[0095] As an example, this application also provides a computer device, including a memory and a processor, wherein the memory stores a computer program, and the processor executes the computer program to implement the steps of any one of the control methods for the shock wave generating device described above.

[0096] As an example, this application also provides a computer-readable storage medium storing a computer program thereon, which, when executed by a processor, implements the steps of any one of the control methods for the shock wave generating device described above.

[0097] As an example, this application also provides a computer program product, including a computer program that, when executed by a processor, implements the steps of any one of the control methods for the shock wave generating device described above.

[0098] Those skilled in the art will understand that all or part of the processes in the above embodiments can be implemented by a computer program instructing related hardware. The computer program can be stored in a non-volatile computer-readable storage medium, and when executed, it can include the processes of the embodiments described above. Any references to memory, databases, or other media used in the embodiments provided in this application can include non-volatile, volatile, or combinations thereof. Non-volatile memory can include read-only memory (ROM), magnetic tape, floppy disk, flash memory, optical memory, high-density embedded non-volatile memory, resistive random access memory (ReRAM), magnetic random access memory (MRAM), ferroelectric random access memory (FRAM), phase change memory (PCM), or graphene memory, etc. Volatile memory can include random access memory (RAM) or external cache memory, etc. By way of illustration and not limitation, RAM can take many forms, such as Static Random Access Memory (SRAM) or Dynamic Random Access Memory (DRAM). The databases involved in the embodiments provided in this application can include relational databases, non-relational databases, or combinations thereof. Non-relational databases can include, but are not limited to, blockchain-based distributed databases. The processors involved in the embodiments provided in this application can be general-purpose processors, central processing units, graphics processing units, digital signal processors, programmable logic devices, or quantum computing-based data processing logic devices, etc., and are not limited to these.

[0099] The various embodiments in this specification are described in a progressive manner, with each embodiment focusing on the differences from other embodiments. The same or similar parts between the various embodiments can be referred to each other.

[0100] The technical features of the above embodiments can be combined in any way. For the sake of brevity, not all possible combinations of the technical features in the above embodiments are described. However, as long as there is no contradiction in the combination of these technical features, they should be considered to be within the scope of this specification.

[0101] The embodiments described above are merely illustrative of several implementation methods of this application, and while the descriptions are relatively specific and detailed, they should not be construed as limiting the scope of the patent application. It should be noted that those skilled in the art can make various modifications and improvements without departing from the concept of this application, and these all fall within the protection scope of this application. Therefore, the protection scope of this patent application should be determined by the appended claims.

Claims

1. A shock wave generating device, characterized in that, include: The shock wave generation module is used to generate a target shock wave with a single or composite vibration mode based on the target driving signal. The vibration mode includes a transverse telescopic vibration mode and a longitudinal telescopic vibration mode. The transverse telescopic vibration mode includes radial vibration for expanding and modifying the aperture of the penetrating hole. A monitoring feedback module, connected to the shock wave generating module, is used to monitor and collect the vibration state parameters of the target shock wave generated by the shock wave generating module in real time, and generate a feedback signal based on the vibration state parameters; the resonant frequency of the target shock wave is located within the resonant bandwidth of the shock wave generating device. A signal generation module, connected to the monitoring feedback module and the shock wave generation module, is used to generate the target driving signal based on the feedback signal; The conduit is connected to the shock wave generating module and is used to transmit the vibration of the target shock wave to the guidewire; the guidewire is connected to both the conduit and the target area and is used to transmit the vibration of the target shock wave to the target area.

2. The shock wave generating device according to claim 1, characterized in that, The monitoring feedback module is also configured to: At the same time as, or before / after, the frequency of the target driving signal is matched with the resonant frequency of the target shock wave.

3. The shock wave generating device according to claim 2, characterized in that, The monitoring feedback module includes: A vibration acquisition unit, connected to the shock wave generation module, is used to monitor and acquire the vibration state parameters of the target shock wave generated by the shock wave generation module in real time. The feedback unit, connected to the vibration acquisition unit and the signal generation module, is used to generate a feedback signal based on the vibration state parameters, and to match the frequency of the target driving signal with the resonant frequency of the target shock wave while generating the feedback signal or before / after generating the feedback signal.

4. The shock wave generating device according to claim 3, characterized in that, The vibration acquisition unit is also configured to: Obtain the initial frequency parameters of the shock wave generating module; and An initial drive signal is generated based on the initial frequency parameters of the shock wave generation module, and the initial drive signal is transmitted to the feedback unit to trigger the feedback unit to work.

5. The shock wave generating device according to claim 4, characterized in that, There is a preset time interval between the time when the initial frequency parameters are obtained and the time when the target shock wave at the actual resonant frequency is generated.

6. The shock wave generating device according to claim 5, characterized in that, The preset time range is [300us, 800us].

7. The shock wave generating device according to any one of claims 1-4, characterized in that, The vibration state parameters of the target shock wave include at least one of the following: waveform and amplitude of current, waveform and amplitude of voltage, phase difference between current and voltage, and resonant frequency.

8. The shock wave generating device according to any one of claims 1-4, characterized in that, The target driving signal includes vibrations under a specific excitation electric field.

9. The shock wave generating device according to any one of claims 1-4, characterized in that, Also includes: A switch control module, connected to the shock wave generating module, is used to control the pulse parameters of the target shock wave.

10. The shock wave generating device according to claim 9, characterized in that, The pulse parameters include at least one of pulse duration, duty cycle, and pulse frequency.

11. The shock wave generating device according to claim 10, characterized in that: The pulse duration of the target shock wave is in the range of [1ms, 100ms]; and / or The pulse frequency range of the target shock wave is [1Hz, 100Hz].

12. The shock wave generating device according to any one of claims 1-4, characterized in that: The longitudinal stretching vibration mode includes at least one of the stretching vibration in the thickness direction and the stretching vibration in the length direction of the piezoelectric material.

13. The shock wave generating device according to any one of claims 1-4, characterized in that, The shock wave generating module includes a piezoelectric generator and a handle; The piezoelectric generator is fixed by the handle and, after receiving the target drive signal, generates the target shock wave using the piezoelectric effect.

14. The shock wave generating device according to claim 13, characterized in that, The diameter range of the piezoelectric generator is [20mm, 30mm].

15. The shock wave generating device according to any one of claims 1-4, characterized in that, Includes at least one of the following features: The resonant frequency range of the target shock wave is [10KHz, 10MHz]; and / or The amplitude range of the target shock wave is [1µm, 100µm].

16. A medical device, characterized in that, include: The shock wave generating device according to any one of claims 1-15.

17. A control method for a shock wave generating device, characterized in that, include: The vibration state parameters of the target shock wave generated by the shock wave generation module are monitored and collected in real time, and a feedback signal is generated based on the vibration state parameters. Generate a target driving signal based on the feedback signal; The target driving signal controls the shock wave generation module to generate a target shock wave with a single or compound vibration mode. The vibration mode includes a lateral telescopic vibration mode and a longitudinal telescopic vibration mode. The lateral telescopic vibration mode includes radial vibration for expanding and modifying the aperture of the penetrating hole. The resonant frequency of the target shock wave is located within the resonant bandwidth of the shock wave generation device. The target shock wave vibration is transmitted to the guidewire via a catheter; The guide wire transmits the vibration of the target shock wave to the target area.

18. A computer-readable storage medium having a computer program stored thereon, characterized in that, When the computer program is executed by the processor, it implements the steps of the control method for the shock wave generating device according to claim 17.

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