A synergistic therapeutic system and method for generating extracorporeal shock waves.

Abstract

This invention discloses a synergistic therapeutic system and method for generating extracorporeal shock waves. The system includes an ultrasound transmitting device, an image guidance module, a synchronization module, and a control module. The image guidance module is used to image the cardiac structure in real time and determine the target point. The synchronization module controls a first transducer array to emit pacing pulses according to a preset pacing rhythm, determining and maintaining the heart at a stable pacing rhythm. Based on the real-time images fed back by the image guidance module within the pacing rhythm, it obtains the treatment window for each heartbeat cycle. The control module controls the image guidance module, receives the treatment window signal calculated by the synchronization module, and triggers a second transducer array to emit treatment pulses towards the target point within the treatment window to soften the target point. The frequency of the treatment pulses is an integer multiple of the pacing rhythm or is set synchronously. This achieves safe, efficient, and synergistic integrated ultrasound softening therapy for sclerotic valves.

Description

Technical Field

[0001] This invention relates to the field of medical device technology, and in particular to a synergistic treatment system and method capable of generating extracorporeal shock waves. Background Technology

[0002] Traditional treatments for heart valve calcification and sclerosis (such as aortic stenosis) include medication, surgical valve replacement or repair, and transcatheter aortic valve replacement (TAVR). These methods are all invasive, high-risk, or expensive. Extracorporeal shock wave therapy has been explored for softening calcified valves, but its application faces significant challenges: the heart is constantly beating, and shock wave therapy requires precise targeting of the moving point and application of energy at specific phases of the cardiac cycle (such as valve closure) to avoid ineffective treatment or damage to surrounding tissues (such as the blood vessel wall and myocardium).

[0003] Traditional techniques primarily utilize ECG gating, which is divided into prospective and retrospective ECG gating. Prospective ECG gating utilizes pre-acquired ECG waveforms to pre-calibrate the R-wave and trigger the scan with a delay, ensuring the acquired data falls on a specific real phase, thus reducing pulsation artifacts and lowering the scan dose. Retrospective ECG gating involves simultaneous ECG acquisition and CT scanning, synchronizing cardiac anatomy and pulsation data. After scanning, the desired real phase within the cardiac cycle can be selected from the synchronously recorded ECG for reconstruction, acquiring images of different real phases. While this technique can trigger treatment through ECG signals at specific time phases, it requires a stable patient rhythm. This technique cannot handle arrhythmias induced by shock waves or other factors during treatment, potentially leading to the treatment pulse being emitted at the wrong time, causing off-target effects or even damage.

[0004] For patients with arrhythmias, retrospective ECG gating technology can be used, which can be corrected using ECG editing techniques. This allows for the remarking of erroneous R-wave positions, restoring the image to the correct phase and ensuring image quality. Therefore, prospective ECG gating technology can be used clinically for patients with low heart rates and stable rhythms, reducing radiation dose while maintaining image quality. However, this reconstruction scheme is based on tissue speckle tracking motion correction technology. Although it can track tissue displacement and adjust the beam in real time, it relies on complex algorithms and does not account for arrhythmias caused by shockwave therapy. When sudden arrhythmias occur, causing the motion pattern to exceed the algorithm's prediction range, there is still a risk of off-target effects, potentially leading to further arrhythmias.

[0005] In summary, current technologies lack a non-invasive system that can actively control the heart rhythm and synchronize this rhythm with the precise treatment of the valves, resulting in low treatment efficiency and questionable safety. Summary of the Invention

[0006] The present invention aims to overcome the above-mentioned defects of the prior art and provide a synergistic treatment system and treatment method that can generate extracorporeal shock waves. After achieving cardiac pacing control, it simultaneously performs ultrasound softening treatment on sclerotic valves, thereby achieving safe, efficient and synergistic integrated treatment.

[0007] In a first aspect, this application provides a synergistic therapeutic system capable of generating extracorporeal shock waves, comprising:

[0008] An ultrasonic transmitting device, comprising a first transducer array and a second transducer array;

[0009] Image-guided module for real-time imaging of cardiac structures and identification of target points;

[0010] The synchronization module, connected to the image guidance module and the ultrasound transmitting device, is used to control the first transducer array to emit pacing pulses according to a preset pacing rhythm, determine and maintain the heart stable in the pacing rhythm; and obtain the treatment window within each heartbeat cycle based on the real-time images fed back by the image guidance module within the pacing rhythm.

[0011] The control module, connected to both the image guidance module and the synchronization module, is configured as follows:

[0012] The image guidance module is controlled, and the treatment window signal calculated by the synchronization module is received. Within the treatment window, the second transducer array is triggered to emit treatment pulses to the target point to soften the target point.

[0013] The frequency of the treatment pulse is an integer multiple of the pacing rhythm or is set synchronously.

[0014] Optionally, it also includes:

[0015] A body surface electrocardiogram (ECG) signal acquisition module, connected to the control module, is used to acquire ECG signals provided by body surface electrodes;

[0016] The control module is also used to confirm that pacing is successful and the heart rhythm is stable based on the electrocardiogram signal and the real-time images from the image guidance module.

[0017] Optionally, the synchronization module is further configured to:

[0018] Real-time monitoring of surface electrocardiogram signals and real-time comparison of preset pacing rhythm with feedback surface electrocardiogram signals;

[0019] When pacing capture is lost consecutively, the second transducer array is controlled to pause the transmission of therapeutic pulses, while the first transducer array is controlled to continue transmitting pacing pulses to maintain the heart at a stable pacing rhythm.

[0020] Optionally, the first transducer array is also used to acquire echo signals. Based on the feedback echo signals, the image guidance module identifies the real-time position of the target point, generates three-dimensional coordinates, and outputs a real-time motion image of the target point on the display.

[0021] Optionally, the first transducer array and / or the second transducer array are further configured to receive passive cavitation signals returned from the treatment focal region;

[0022] The control module is also used to dynamically adjust the emitted sound pressure of the second transducer array according to the passive cavitation signal strength and / or spectral characteristics, forming a closed-loop feedback control.

[0023] Optionally, the first transducer array and the second transducer array are arranged in a concentric circle layout;

[0024] The first transducer array is integrated in the central region of concentric circles; the second transducer array is arranged around the periphery of the first transducer array.

[0025] Optionally, the first transducer array is a two-dimensional matrix phased array imaging probe, composed of high-frequency array elements, and is also used to receive ultrasonic echo signals and generate real-time images; the second transducer array is a two-dimensional matrix transducer array, composed of multiple array units, each array unit forming at least three circular arrays with the first transducer array as the center.

[0026] Optionally, the array element is a monolithic piezoelectric ceramic with a matching layer and a backing, and a backing is attached to the back of each ceramic element.

[0027] Based on the same inventive concept, embodiments of this application also provide a synergistic treatment method capable of generating extracorporeal shock waves. The synergistic treatment is performed using the synergistic treatment system capable of generating extracorporeal shock waves provided in the first aspect. The synergistic treatment method includes the following steps:

[0028] According to the preset pacing rhythm, the first transducer array is controlled to send pacing pulses to a specific pacing point of the heart, so that the heart beats according to the preset pacing rhythm and establishes a stable external heart rhythm clock.

[0029] Based on the stable external heart rhythm clock, combined with the real-time images fed back by the image guidance module, the treatment window for complete valve closure within each heartbeat cycle is obtained.

[0030] Within the treatment window, the second transducer array is controlled to emit treatment pulses toward the sclerotic valve target to achieve valve softening treatment; wherein, the frequency of the treatment pulses is an integer multiple of the pacing rhythm or is set synchronously.

[0031] Optionally, the specific steps for obtaining the treatment window within each heartbeat cycle based on the real-time images fed back by the image guidance module within the pacing rhythm are as follows:

[0032] The synchronization module acquires a known, fixed pacing rhythm and, based on the population average and individualized real-time imaging correction method, calculates the time window for target valve closure within each heartbeat cycle, which serves as the treatment window.

[0033] Optionally, during the process of controlling the second transducer array to emit therapeutic pulses toward the sclerotic valve target, the treatment method further includes:

[0034] Real-time monitoring of passive cavitation signals generated in the treatment focus area, and analysis of their intensity and / or spectral characteristics;

[0035] Based on the analysis results, the emission sound pressure of subsequent pacing pulses is dynamically adjusted to maintain an effective and safe cavitation effect.

[0036] Optionally, during the process of controlling the second transducer array to emit therapeutic pulses toward the sclerotic valve target, the treatment method further includes:

[0037] The synchronization module monitors the surface electrocardiogram (ECG) signal in real time and compares the set pacing rhythm with the feedback surface ECG signal. When pacing capture is lost continuously, the second transducer array is controlled to pause the transmission of treatment pulses, and the first transducer array is controlled to transmit pacing pulses to maintain the heart at a stable pacing rhythm.

[0038] In summary, the collaborative treatment system that generates extracorporeal shock waves provided in this application first achieves precise control (pacing) of the heart rhythm through extracorporeal ultrasound focusing technology, and then simultaneously performs ultrasound softening treatment on sclerotic valves under this controllable pacing rhythm, thereby achieving safe, efficient and collaborative integrated treatment. Attached Figure Description

[0039] Figure 1 A control module diagram of a collaborative therapy system capable of generating extracorporeal shock waves, provided in this application;

[0040] Figure 2 A schematic diagram of the transducer array layout for the ultrasonic transmitting device provided in this application;

[0041] Figure 3 A flowchart illustrating a synergistic treatment method that generates extracorporeal shock waves, as provided in this application.

[0042] The accompanying diagram is described as follows:

[0043] 10. Ultrasonic transmitting device; 20. Image guidance module; 30. Synchronization module; 40. Control module; 11. First transducer array; 12. Second transducer array; Detailed Implementation

[0044] The present invention will now be described in further detail with reference to the accompanying drawings and embodiments. It is to be understood that the specific embodiments described herein are merely illustrative of the invention and not intended to limit it. Furthermore, it should be noted that, for ease of description, the accompanying drawings show only the parts relevant to the invention and not all structures. Various modifications and variations can be made to the present invention without departing from its spirit or scope, which will be apparent to those skilled in the art. Therefore, the present invention is intended to cover modifications and variations falling within the scope of the corresponding claims (the claimed technical solutions) and their equivalents. It should be noted that the embodiments provided in the present invention can be combined with each other without contradiction.

[0045] In view of one or more of the problems existing in the prior art, the present invention proposes a synergistic treatment system capable of generating extracorporeal shock waves. The system first achieves precise control (pacing) of the heart rhythm through extracorporeal ultrasound focusing technology, and then simultaneously performs ultrasound softening treatment on sclerotic valves under this controllable pacing rhythm, thereby achieving safe, efficient and synergistic integrated treatment. Figure 1 This application provides a control module diagram of a collaborative therapy system capable of generating extracorporeal shock waves. Figure 2 This is a schematic diagram of the transducer array layout of the ultrasonic transmitting device provided in this application, with reference to... Figure 1 and Figure 2 This application provides a collaborative therapy system capable of generating extracorporeal shock waves. The collaborative therapy system includes an ultrasound transmitting device 10, an image guidance module 20, a synchronization module 30, and a control module 40. The ultrasound transmitting device 10 includes a first transducer array 11 and a second transducer array 12.

[0046] The image guidance module 20 is used for real-time imaging of the cardiac structure and identification of target points. The synchronization module 30, connected to the image guidance module 20 and the ultrasound transmitting device 10, controls the first transducer array 11 to emit pacing pulses according to a preset pacing rhythm, determining and maintaining cardiac stability within the pacing rhythm; and obtains the treatment window within each heartbeat cycle based on the real-time images fed back by the image guidance module 20 within the pacing rhythm. The control module 40, connected to both the image guidance module 20 and the synchronization module 30, is configured to control the image guidance module 20, receive the treatment window signal calculated by the synchronization module 30, and trigger the second transducer array 12 to emit treatment pulses towards the target point within the treatment window to soften the target point. The frequency of the treatment pulses is an integer multiple of the pacing rhythm or is set synchronously.

[0047] Specifically, refer to Figure 1 The ultrasound transmitting device 10 includes at least two focused ultrasound transducer arrays, namely a first transducer array 11 (pacing array) and a second transducer array 12 (therapeutic array).

[0048] Optionally, refer to Figure 2 The first transducer array 11 and the second transducer array 12 are arranged in a concentric circle. This arrangement is most suitable for transthoracic wall treatment and can maximize the use of high-resolution imaging in the central region. Specifically, the first transducer array 11 is integrated in the central region of the concentric circles, and the second transducer array 12 is arranged in an array around the outer periphery of the first transducer array 11.

[0049] Optionally, the first transducer array 11 is a conventional two-dimensional matrix phased array imaging probe, consisting of high-frequency array elements 110 (e.g., 3-5 MHz), used to receive ultrasound echo signals and generate real-time images, such as providing high-frame-rate real-time two-dimensional / three-dimensional cardiac ultrasound images. Simultaneously, the first transducer array 11 can also function as a first pacing array. By applying different electronic delay laws, pacing pulses can be transmitted to the heart within a very short time interval between imaging frames. This avoids the need for an additional dedicated pacing array, thus simplifying the structural design of the pacing and imaging components of the ultrasound transmitting device 10.

[0050] For example, the high-frequency array 110 employs a type 1-3 piezoelectric composite material. This structure embeds one-dimensionally connected piezoelectric ceramic pillars into a three-dimensionally connected polymer matrix, combining the high-voltage piezoelectricity of piezoelectric ceramics (PZT) with the flexibility and low impedance of polymers, perfectly meeting the needs of reuse. Figure 2 As shown, the multiple high-frequency array elements 110 adopt a hexagonal design and are arranged in the most compact way (also known as honeycomb structure), clustered in the central area of ​​the concentric circle layout, making the imaging of the first transducer array 11 clearer and the pacing function more stable.

[0051] Based on the above embodiments, refer to Figure 2 In the outer ring area (treatment area) of the central area of ​​the concentric circle layout, the second transducer array 12 is a two-dimensional matrix transducer array, and each array unit 120 forms at least three circular arrays with the first transducer array 11 in the central area as the center.

[0052] Specifically, the second transducer array 12 can be constructed by arranging multiple large-sized, low-frequency ultrasound transducer rings around a central imaging / pacing array. Through electronic phased array technology, all rings work together to converge multiple sound beams into a high-energy focal point in deep tissues (such as heart valves) to generate a cavitation effect.

[0053] For example, each array element 120 employs a high-voltage piezoelectric hard PZT ceramic (such as PZT-4 or PZT-8). The array element 120 is a monolithic piezoelectric ceramic with a matching layer and a backing (not shown in the figure), and a strong backing is attached to the back of each ceramic element. The backing absorbs rearward-propagating sound waves and dampens vibrations, thereby generating a short pulse (e.g., 4-10 cycles), which is crucial for cavitation therapy. One or two acoustic matching layers (not shown in the figure) are attached to the front of the array element 120. Their function is to optimize the matching between the high impedance of the hard PZT ceramic and the lower impedance of the human body, thereby maximizing the transmission efficiency of acoustic energy into the body (up to 90% or more), and reducing heat accumulation on the probe surface.

[0054] The array unit 120 can be a matrix array with 64-256 array elements. This array structure design allows the second transducer array 12 to perform electronic focusing and rapid scanning at any point in three-dimensional space without moving the probe. This avoids multiple focusing operations and equipment stabilization adjustments caused by movement during treatment, thus reducing treatment time.

[0055] In the treatment of valvular calcification and sclerosis (such as aortic stenosis), the first transducer array 11 (pacing array) is used to emit low-energy, high-frequency focused ultrasound pulses (pacing pulses) to specific pacemaker sites in the heart (such as the right atrium, right ventricle, etc.). These pulses penetrate the chest wall tissue and precisely target specific pacemaker sites in the heart (such as the sinoatrial node, atrioventricular node, His bundle, or ventricular apex). Through acoustic effects (mainly radiation force and acoustic aperture effect), the pulses stimulate myocardial cells, triggering action potentials and thus controlling the heart rhythm. Its working principle is as follows: short-pulse focused ultrasound produces minute mechanical displacements (radiation force) or alters cell membrane permeability (acoustic aperture effect) at the focal point on the myocardial tissue, thereby activating mechanosensitive ion channels (such as pressure-controlled ion channels), simulating electrical signals, leading to myocardial cell depolarization.

[0056] As an example, the key parameter ranges for the focused ultrasound pulses (pacing pulses) emitted by the first transducer array 11 are shown in Table 1.

[0057] Table 1. Key parameter ranges for focused ultrasound pulses (pacing pulses)

[0058]

[0059] Specifically, the working process and control method of the first transducer array 11 can be as follows:

[0060] Target selection: The operator selects the target pacemaker (such as the apex of the right ventricle) on the cardiac anatomy using real-time images fed back by the image guidance module 20.

[0061] Shock beamforming: The control module 40 calculates and applies the corresponding delay rule to each element of the first transducer array 11, which is a phased array, so that the ultrasonic energy is precisely focused on the selected target point.

[0062] Pulse emission: Emit ultrasound pulses with the above parameters at the set pulse repetition frequency (PRF, i.e., target pacing rhythm).

[0063] Effectiveness Verification: Real-time monitoring of ECG signals using surface ECG electrodes confirmed that each ultrasound pulse was followed by a corresponding QRS wave (i.e., successful pacing). The QRS wave is the most direct feedback signal. Physiologically, the QRS wave represents the electrical activity of the ventricular depolarization process; it is the electrical command that triggers ventricular pumping. Clinically, the QRS wave is a core indicator for determining heart rhythm and diagnosing ventricular arrhythmias and ventricular lesions.

[0064] Dynamic adjustment: If pacing fails, the system automatically fine-tunes the focus position or slightly increases the output intensity (within safe limits) until the heart rhythm is regained.

[0065] In the treatment of calcification and sclerosis of heart valves (such as aortic stenosis), the second transducer array 12 (treatment array) is used to emit high-energy focused ultrasound pulses (or shock waves, treatment pulses) to the target sites of sclerotic heart valves (such as aortic and mitral valves) to soften and break down calcifications on the valve. The treatment mechanism is as follows: the treatment pulse generates a peak negative pressure (e.g., approximately 10-20 MPa) slightly above the cavitation threshold at the focal point, thereby inducing cavitation clouds in and around the calcification foci. The intense oscillation, growth, and collapse (inertial cavitation) of these microbubbles generate localized, high-intensity mechanical stresses (shear forces, microjets), which effectively physically break down calcified nodules and remodel collagen fibers, thereby "softening" the valve and improving its compliance.

[0066] As an example, the key parameter ranges for the focused ultrasound pulses (therapeutic pulses) emitted by the second transducer array 12 are shown in Table 2.

[0067] Table 2 Key Parameter Ranges for Focused Ultrasound Pulses (Therapeutic Pulses)

[0068]

[0069] Among them, the focused ultrasound pulses (treatment pulses) shown in Table 2 can achieve a balance between the heart rate and the depth of penetration and the focusing accuracy; the pulse length can achieve a balance between the therapeutic effect of a single shock wave and the overall treatment efficiency; the extremely low duty cycle ensures a sufficiently long heat dissipation time to avoid heat accumulation damage; and the peak negative pressure (core parameter) is carefully controlled at a level that is sufficient to induce cavitation but does not excessively cause tissue damage.

[0070] As an example, the optimal pulse repetition rate (PRF) is one therapeutic pulse delivered per heartbeat (i.e., 1 pulse per cardiac cycle). For instance, if the pacing heart rate is 60 beats per minute (1 Hz), then the PRF is also 1 Hz.

[0071] Based on the above embodiments, the first transducer array 11 and / or the second transducer array 12 are also used to acquire echo signals. The image guidance module 20 identifies the real-time position of the target point based on the feedback echo signals, generates three-dimensional coordinates, and outputs a real-time motion image of the target point on the display.

[0072] The image guidance module 20 can employ an integrated ultrasound imaging probe or external imaging equipment (such as Magnetic Resonance Imaging, MRI) for real-time ultrasound imaging of cardiac structures, identification of valve locations, localization of calcified lesions, and real-time tracking of heart and valve movement. The ultrasound transmitter 10 and the image guidance module 20 can be integrated into a single treatment head, which is placed in the patient's chest cavity during treatment.

[0073] The synchronization module 30 receives cardiac ultrasound imaging signals (such as valve opening and closing status, ventricular systole / diastole) from the image guidance module 20 and / or electrocardiogram (ECG) signals from the patient's body surface. Based on a set pacing rhythm, the synchronization module 30 controls the first transducer array 11 to emit pacing pulses, establishing a stable and known heart rhythm R (pacing rhythm). More importantly, based on this known heart rhythm R, the synchronization module 30 precisely calculates the timing window for complete valve closure in each heartbeat cycle as the optimal treatment window. This ensures that each brief high-energy treatment pulse is precisely emitted at the moment of valve closure and relative stillness, solving the problem of extremely stringent timing requirements in cavitation therapy.

[0074] The control module 40 is connected to the synchronization module 30 and the image guidance module 20. It receives the treatment window signal calculated by the synchronization module 30. Within this precise time window, the control module 40 triggers the second transducer array 12 to emit treatment pulses towards the target valve. The control module 40 can be a microprocessor, such as a central processing unit (CPU), or other general-purpose processors, digital signal processors (DSPs), application-specific integrated circuits (ASICs), field-programmable gate arrays (FPGAs), or other programmable logic devices, transistor logic devices, hardware components, or any combination thereof.

[0075] Based on the above embodiments, the collaborative treatment system also includes a surface electrocardiogram (ECG) signal acquisition module connected to the control module 40. Figure 1 (Not shown in the image), this module acquires the electrocardiogram (ECG) signal provided by the body surface electrodes. The control module 40 confirms that pacing is successful and the heart rhythm is stable based on the ECG signal and the real-time image of the image guidance module 20.

[0076] Among them, the image guidance module 20, control module 40, and synchronization module 30 can be further combined into a time-series deep coupling system. This system establishes a stable external heart rhythm clock through forced ultrasound pacing, uses real-time images to individually predict the optimal treatment window within each heartbeat, and emits high-energy ultrasound pulses within this window accurate to milliseconds. At the same time, it achieves adaptive closed-loop control of the emitted energy by listening to cavitation noise, and finally completes valve softening treatment safely and efficiently.

[0077] Based on the same inventive concept, embodiments of this application also provide a synergistic treatment method capable of generating extracorporeal shock waves. The synergistic treatment system capable of generating extracorporeal shock waves provided in the above embodiments is used to perform synergistic treatment, combined with... Figures 1-3 The synergistic treatment method for generating extracorporeal shock waves provided in this application includes the following steps:

[0078] S101. According to the preset pacing rhythm, control the first transducer array to send pacing pulses to a specific pacing point of the heart, so that the heart beats according to the preset pacing rhythm and establishes a stable external heart rhythm clock.

[0079] S102. Based on a stable external heart rhythm clock and combined with real-time images fed back by the image guidance module, a treatment window in which the valves are completely closed within each heartbeat cycle is obtained.

[0080] S103. Within the treatment window, control the second transducer array to emit treatment pulses toward the sclerotic valve target to achieve valve softening treatment.

[0081] The frequency of the treatment pulse is either an integer multiple of the pacing rhythm or set synchronously.

[0082] Specifically, the collaborative therapy system capable of generating extracorporeal shock waves provided in this application establishes a high-precision, unified master clock source internally. The timestamps of all modules (pacing, imaging, and therapy) are based on this, thereby eliminating errors caused by internal communication delays.

[0083] At the same time, the collaborative therapy system that can generate extracorporeal shock waves is equipped with a multimodal data synchronous acquisition card to synchronously acquire the following signals:

[0084] Electrocardiogram (ECG) signals from surface electrodes are used to provide a baseline of cardiac electrical activity. Ultrasound imaging signals from image guidance module 20 are used to provide real-time images of cardiac structure and motion. Passive cavitation signals are received from the first transducer array 11. Control module 40 employs a high-speed real-time processor that stores preset driving algorithms for real-time calculation and processing of the aforementioned received signals.

[0085] Specifically, the workflow of the time-deeply coupled system consisting of the image guidance module 20, control module 40, and synchronization module 30 is as follows:

[0086] Step 1: In the pacing phase, establish and dominate the heart rhythm.

[0087] Specifically, after the system is started, the patient's own irregular heart rhythm is ignored first. The synchronization module 30 controls the first transducer array 11 to emit pacing pulses at preset, fixed time intervals (e.g., once per second, corresponding to 60 bpm) according to the control instructions of the control module 40.

[0088] The control module 40 controls the surface electrocardiogram (ECG) signal acquisition module to monitor the patient's body surface and obtain ECG signals. Based on the ECG signals, it confirms that each pacing pulse has successfully "captured" the heartbeat, generating a QRS wave. At this time, the heart rhythm R is completely controlled by the instrument, becoming a stable and predictable periodic signal (T_cycle = 60 seconds / heart rate). This application transmits pacing pulses through the first transducer array 11, transforming an irregular natural system into a regular, known clock system as the basis for subsequent treatment stages.

[0089] After the heart rhythm R is the pacing rhythm, the calculation phase of the optimal treatment window is performed.

[0090] The second step: In the calculation phase, the treatment window is accurately predicted. The treatment window is defined as "the period of time during which the valve is completely closed and relatively still," which usually corresponds to the ST segment (isovolumetric contraction) and TP segment (isovolumetric relaxation) on the electrocardiogram.

[0091] The synchronization module 30 acquires a known, fixed heart rate cycle T_cycle (pacing rhythm) and, based on population averages and an individualized real-time imaging correction method, accurately calculates the time window [T_start, T_end] for target valve closure within each heart rate cycle, i.e., the treatment window. For example, it starts 250ms after the QRS wave and lasts for 100ms.

[0092] The population mean was obtained based on the typical opening-closing time points of each valve (aortic valve and mitral valve) at different heart rates stored in the system's built-in database. For example, the aortic valve closes 200ms after the QRS wave and lasts for 400ms. This population mean is the initial estimate.

[0093] The individualized real-time imaging correction is obtained by using real-time images (ultrasound imaging) fed back by the pacing rhythm intracardiac image guidance module 20. After several pacing cycles, the individualized physiological parameters of the current patient are measured and learned in real time. These individualized physiological parameters include pre-ejection phase (PEP), ejection time (ET), and ventricular filling time.

[0094] Pre-ejection phase (PEP) is the time from the onset of the QRS complex to the opening of the aortic valve. Ejection time (ET) is the time from the opening of the aortic valve to its closing. Ventricular filling time is the time it takes for the mitral valve to open.

[0095] Step 3: During the treatment phase, treatment pulses are emitted via timing-gated control.

[0096] The control module 40 synchronously triggers the first transducer array 11 and the second transducer array 12. In each heartbeat cycle, the control module 40 sends a trigger command to the second transducer array 12 at the beginning time point T_start of the time window [T_start, T_end], and controls the second transducer array 12 to emit therapeutic pulses to the target point (valve) to soften the target point.

[0097] The control module 40 stores the transmission protocol of the treatment pulse, such as the second transducer array 12 (treatment array) transmitting a single high-energy ultrasound pulse or a short pulse train (e.g., 10 cycles, 10μs).

[0098] Preferably, a therapeutic pulse is emitted with each heartbeat, and this emission occurs precisely at the moment the valve closes during that heartbeat cycle. This ensures that the energy is applied most efficiently to the stationary or relatively stationary valve target, thereby greatly avoiding aiming errors caused by heartbeats.

[0099] This application achieves absolute time-locking by setting the frequency of the treatment pulse to be an integer multiple of the pacing heart rate or set synchronously, ensuring that the transmission time of the treatment pulse is strictly locked with the phase of the heartbeat cycle and is absolutely synchronized with the heart rate (F_treatment=R_pace). For example, with a heart rate of 60 bpm, only one treatment pulse is transmitted per second.

[0100] Based on the above embodiments, in step S102, during the process of controlling the second transducer array 12 to emit treatment pulses towards the sclerotic valve target, the following is also included:

[0101] S201. Monitor the passive cavitation signal generated in the treatment focus area in real time and analyze its intensity and / or spectral characteristics.

[0102] S202. Based on the analysis results, dynamically adjust the emission sound pressure of subsequent pacing pulses to maintain an effective and safe cavitation effect.

[0103] Specifically, in the process of controlling the second transducer array 12 to emit therapeutic pulses towards the target point of the sclerotic valve, the system also has a feedback phase for real-time monitoring and adaptive adjustment. Specifically, the first transducer array 11 and / or the second transducer array 12 can also receive passive cavitation signals returned from the treatment focus area in real time. The control module 40 dynamically adjusts the emitted sound pressure of the second transducer array 12 according to the intensity and / or spectral characteristics of the passive cavitation signal, forming a closed-loop feedback control.

[0104] Specifically, the first transducer array 11 (central imaging array) and / or the second transducer array 12 (treatment array) switch to "listening" mode within a very short time (e.g., microseconds) after emitting a high-energy focused pulse to receive broadband noise signals returned from the focal region, such as passive cavitation signal strength and spectral characteristics.

[0105] The passive cavitation signal strength indicates the severity of the cavitation effect. Spectral characteristics can distinguish between stable "steady-state cavitation" and the more destructive "inertial cavitation." This application utilizes this feedback to achieve advanced functions that ensure safety and effectiveness. The system achieves closed-loop control through passive cavitation detection.

[0106] The control module 40 processes and analyzes these noise signals in real time and performs feedback control:

[0107] If the passive cavitation signal is too weak, the system can slightly increase the sound pressure of the next treatment pulse (e.g., from 15 MPa to 15.5 MPa) within safe limits to ensure effective treatment. Specifically, by increasing the sound pressure of the treatment pulse, the power of the high-frequency array elements in the second transducer array 12 is increased, thereby achieving treatment pulse power control and ensuring treatment effectiveness.

[0108] If the passive cavitation signal is too strong, the system will automatically reduce the sound pressure (power) of the next treatment pulse to prevent the cavitation effect from getting out of control and damaging the surrounding healthy tissue.

[0109] If an "invalid emission" is detected (e.g., due to a sudden movement causing the focus to deviate and there is no passive cavitation signal), the system can record the failure and fine-tune the focus coordinates in the next cycle.

[0110] Based on the above embodiments, in step S102, during the process of controlling the second transducer array 12 to emit treatment pulses towards the sclerotic valve target, the following is also included:

[0111] S203, the control synchronization module 30 monitors the surface electrocardiogram signal in real time, compares the set pacing rhythm with the feedback surface electrocardiogram signal in real time; when pacing capture loss occurs continuously, it controls the second transducer array 12 to stop transmitting treatment pulses and controls the first transducer array 11 to transmit pacing pulses to maintain the heart stable at the pacing rhythm.

[0112] Specifically, during the treatment phase, the synergistic treatment method provided in this application embodiment also includes safety interlocking and fault tolerance mechanisms.

[0113] During the process of the second transducer array 12 transmitting therapeutic pulses to the sclerotic valve target, the synchronization module 30 simultaneously monitors for loss of pacing capture. If the ECG signal shows that two consecutive pacing pulses have failed to induce a heartbeat, the system immediately suspends the transmission of therapeutic pulses and issues an alarm to prevent the therapeutic pulses from being transmitted at the wrong time (such as when the valve is open).

[0114] Meanwhile, the collaborative treatment system provided in this application can also integrate respiratory gating, and deliver treatment pulses at the end of the patient's expiration and during the period when the chest wall movement is most stable, further reducing target movement caused by breathing and achieving synchronization between treatment and breathing.

[0115] Based on the above embodiments, the collaborative treatment system provided in this application also integrates an emergency stop button. The operator holds the emergency stop button and can stop the treatment with one click if any abnormality occurs in the patient during the treatment phase, so as to ensure the patient's safety.

[0116] The following are some specific embodiments to illustrate the application of the synergistic therapy system capable of generating extracorporeal shock waves provided in this application.

[0117] Example 1

[0118] Treatment for patients with calcification and sclerosis of the heart valves (such as aortic stenosis).

[0119] In this embodiment, reference Figures 1-2 The first transducer array 11 is integrated into a two-dimensional matrix transducer array at the center of the probe. This array combines imaging and pacing functions, has an outer diameter of approximately 50 mm, and is composed of 64 tightly packed hexagonal elements. The elements are made of type 1-3 piezoelectric composite material, and each element has an independent control unit, allowing for individual delay control of each element. The frequency is 3 MHz, the physical focal length is 100 mm, and a focal length variation of 10 mm can be achieved. By applying different delay rules, pacing pulses can be emitted during the imaging gap.

[0120] The second transducer array 12 surrounds the first transducer array 11 and is a two-dimensional matrix transducer array. Each array unit forms three rings with the pacing array as the center. The array elements are PZT-8 and have a square appearance, totaling 64 array units. Each array unit has an independent control unit, allowing for individual delay control of each unit. The transducer frequency is 3MHz, and the physical focal length is 100mm. The phased array can achieve a focal length variation of 10mm for emitting high-energy therapeutic pulses.

[0121] In this embodiment, the specific implementation method of the treatment method is as follows:

[0122] During system initialization: The patient lies supine, and the treatment head, which integrates an ultrasound transducer array and an imaging probe, is placed at the corresponding position on the chest wall. The image guidance module 20 identifies cardiac structures, and the operator manually marks the pacemaker (such as the apex of the heart) and the treatment target (valvular calcifications).

[0123] Pacing mode activation: Control module 40 sets an initial pacing frequency (e.g., 70 beats / minute). The first pacing array begins emitting focused ultrasound pulses (parameter example: frequency = 2MHz, pulse width = 0.5ms, acoustic power = 50-200W), stimulating the heart to beat in sync with the rhythm. The first transducer array 11 acquires echo data. After the data is returned, the image guidance module 20 identifies the echoes, determines the real-time position of the heart valves, generates three-dimensional coordinates, and outputs a real-time motion image of the heart valves on the display. Control module 40 monitors the cavitation effect of the focused ultrasound in real time, providing feedback on the strength and size of the cavitation cloud. The ECG signal passing through the heart and the real-time image confirm successful pacing and a stable heart rhythm.

[0124] During the synchronization and treatment phase:

[0125] The synchronization module 30 predicts the "valve closure period" in each cycle, i.e. the optimal treatment window, based on a stable pacing rhythm.

[0126] Within the optimal treatment window, the control module 40 instructs the second transducer array 12 to emit a treatment pulse within a predicted closed window for each (or every N) heartbeats. Exemplarily, the treatment ultrasound center frequency is 0.75-1.25 MHz. The pulse repetition frequency (PRF) is synchronized with the heartbeat or is an integer multiple of the heartbeat cycle, such as once per heartbeat.

[0127] During the treatment phase, sound power or sound pressure is monitored simultaneously: when the peak negative pressure is greater than 10MPa, the image guidance module 20 integrates passive cavitation detection (PCD) function to monitor the passive cavitation signal (wideband noise) generated at the treatment focus in real time and feed it back to the control module 40 to form a closed-loop feedback system.

[0128] The control module 40 can dynamically fine-tune the emitted sound pressure (e.g., within the range of 12-18 MPa) based on the intensity of the passive cavitation signal (reflecting the intensity of cavitation activity) to stabilize the therapeutic effect at the optimal level while avoiding excessive cavitation. The synchronization module 30 can also compare the set pacing rhythm with the feedback electrocardiogram (ECG) signal in real time. When abnormalities occur continuously, it instructs the second transducer array 12 to suspend operation until the ECG signal returns to normal under the guidance of the first transducer array 11.

[0129] Finally, treatment endpoints and assessments: Treatment continues for a period of time (e.g., 30 minutes) or until real-time imaging shows improved valve compliance (e.g., Doppler ultrasound showing a reduced transvalvular pressure gradient). After treatment, pacing pulses are stopped, the heart resumes its own rhythm, or pacing support is maintained for a period of time as needed.

[0130] Example 2

[0131] In vitro tissue phantom experiments

[0132] The purpose of the in vitro tissue phantom experiments provided in this application embodiment is to quantify and verify the core functions of the system in a controlled environment, including: 1) the focusing accuracy of the dual array; 2) the mechanical effect of the pacing pulse; 3) the ability of the therapeutic pulse to induce cavitation; and 4) the accuracy of the synchronization timing.

[0133] Step S11, Experimental Model and Setup:

[0134] Phantom fabrication: A customized polyacrylamide hydrogel phantom was used, with sound velocity (1540 m / s) and attenuation coefficient (0.5 dB / cm / MHz) similar to human soft tissue. The phantom dimensions were 20 cm × 20 cm × 15 cm.

[0135] Pacing target simulation: A small piece (5mm×5mm×3mm) of decellularized porcine myocardial tissue was provided and embedded 60mm below the phantom.

[0136] Treatment target simulation: A spherical calcified phantom with a diameter of 8 mm is provided, which is made of hydroxyapatite (70%) and epoxy resin (30%) mixed and cured, and is embedded at a depth of 85 mm below the phantom, 30 mm away from the pacing target at the same level.

[0137] Synergistic treatment system coupling: The treatment head is coupled to the upper surface of the phantom through an acoustically transparent water bladder filled with degassed water to ensure efficient transmission of acoustic energy.

[0138] Step S12: System calibration and target localization.

[0139] The phantom was scanned using the 3.5MHz imaging function of the central array, clearly displaying the two target points. The operator precisely marked the three-dimensional coordinates of the two target points on the phantom image acquired by the image guidance module and recorded the coordinates: pacing target point 1 (x1, y1, z1 = 60mm) and treatment target point 2 (x2, y2, z2 = 85mm).

[0140] Step S13: Verify pacing function (demonstration of mechanical effects)

[0141] The control module 40 calculates the delay law focusing on the pacing target and loads it into the first transducer array 11 (pacing array). The pacing pulse parameters are set as follows: center frequency 2.5MHz (slightly lower than the imaging frequency to optimize penetration and focusing); pulse length 300μs; pulse repetition frequency (PRF) 60Hz; peak negative pressure 2.8MPa (preliminary experiments have shown that this pressure can produce observable mechanical effects at the focal point); pulse duty cycle <0.03%.

[0142] The image guidance module uses a high-speed camera, which is aimed at the pacing target area for experimental observation and image acquisition. During image acquisition, it is clear that an instantaneous displacement of about 5-10 μm is generated on the surface of the myocardial tissue with each pacing pulse, confirming that the "radiation force" effect is accurately delivered to the target.

[0143] Step S14: Perform treatment and synchronization function verification (cavitation induction and assessment).

[0144] The master clock of the collaborative treatment system is set to a cycle T_cycle = 1000ms. The synchronization module 30 is configured to open a 100ms "treatment window" at time T0+300ms in each cycle. Within this window, the control module 40 triggers the second transducer array 12 (treatment array) to emit treatment pulses to the calcified phantom. Here, T0 represents the time from the start to the end of cycle T_cycle.

[0145] The initial treatment pulse parameters are as follows: center frequency is 1.0 MHz; pulse length is 8 cycles (i.e. 8 μs); pulse repetition frequency (PRF) is 60 Hz; and peak negative pressure is 16.0 MPa (estimated based on cavitation threshold from preliminary experiments).

[0146] The image guidance module uses a high-speed camera, which is aimed at the pacing target area for experimental observation and image acquisition. The cavitation cloud generated with each ultrasound pulse emission can be clearly observed.

[0147] Finally, the phantom was dissected: after the experiment, the phantom was opened, revealing microcracks on the surface of the calcified phantom, while the surrounding gel remained intact. This indicates that the in vitro experiment, through the specific parameters and procedures described above, quantitatively verified the feasibility and accuracy of the core function of the system of this invention, providing crucial parameter basis and safety assurance for subsequent live animal experiments.

[0148] In summary, the synergistic therapy system and method for generating extracorporeal shock waves provided in this application actively establishes and guides the heart rhythm through extracorporeal ultrasound, and achieves precise synchronous treatment with the valve closure window under this controllable rhythm, solving the problem of moving target therapy. Simultaneously, it achieves adaptive energy regulation through cavitation feedback, significantly improving the safety, precision, and efficiency of non-invasive heart valve treatment. Compared with existing technologies, it has at least the following advantages:

[0149] First, it is completely non-invasive: avoiding all the risks and complications of implantation surgery.

[0150] Second, synergistic treatment: integrating cardiac pacing with valve therapy solves the technical bottleneck of mobile target therapy.

[0151] Third, it is extremely precise and safe: by adopting the strategy of "controlling the rhythm first and then treating synchronously", it ensures that the treatment energy is applied only at the moment when the valve is closed and the position is most stable, which greatly improves the treatment efficiency and protects the surrounding healthy tissues to the greatest extent.

[0152] Fourth, adjustable and personalized: The treatment rhythm and energy output can be dynamically adjusted according to the patient's real-time response to achieve the best treatment effect.

[0153] Note that the above description is merely a preferred embodiment of the present invention and the technical principles employed. Those skilled in the art will understand that the present invention is not limited to the specific embodiments described herein, and various obvious changes, readjustments, combinations, and substitutions can be made without departing from the scope of protection of the present invention. Therefore, although the present invention has been described in detail through the above embodiments, the present invention is not limited to the above embodiments, and may include many other equivalent embodiments without departing from the concept of the present invention, the scope of which is determined by the scope of the appended claims.

Claims

1. A synergistic therapeutic system capable of generating extracorporeal shock waves, characterized in that, include: An ultrasonic transmitting device, comprising a first transducer array and a second transducer array; Image-guided module for real-time imaging of cardiac structures and identification of target points; The synchronization module, connected to the image guidance module and the ultrasound transmitting device, is used to control the first transducer array to emit pacing pulses according to a preset pacing rhythm, determine and maintain the heart stable in the pacing rhythm; and obtain the treatment window within each heartbeat cycle based on the real-time images fed back by the image guidance module within the pacing rhythm. The control module, connected to both the image guidance module and the synchronization module, is configured as follows: The image guidance module is controlled, and the treatment window signal calculated by the synchronization module is received. Within the treatment window, the second transducer array is triggered to emit treatment pulses to the target point to soften the target point. The frequency of the treatment pulse is an integer multiple of the pacing rhythm or is set synchronously.

2. The synergistic treatment system according to claim 1, characterized in that, Also includes: A body surface electrocardiogram (ECG) signal acquisition module, connected to the control module, is used to acquire ECG signals provided by body surface electrodes; The control module is also used to confirm that pacing is successful and the heart rhythm is stable based on the electrocardiogram signal and the real-time images from the image guidance module.

3. The synergistic treatment system according to claim 1, characterized in that, The synchronization module is also used for: Real-time monitoring of surface electrocardiogram signals and real-time comparison of preset pacing rhythm with feedback surface electrocardiogram signals; When pacing capture is lost consecutively, the second transducer array is controlled to pause the transmission of therapeutic pulses, while the first transducer array is controlled to continue transmitting pacing pulses to maintain the heart at a stable pacing rhythm.

4. The synergistic treatment system according to claim 1, characterized in that, The first transducer array is also used to acquire echo signals. Based on the feedback echo signals, the image guidance module identifies the real-time position of the target point, generates three-dimensional coordinates, and outputs a real-time motion image of the target point on the display.

5. The collaborative treatment system according to claim 1, characterized in that, The first transducer array and / or the second transducer array are also used to receive passive cavitation signals returned from the treatment focal region; The control module is also used to dynamically adjust the emitted sound pressure of the second transducer array according to the passive cavitation signal strength and / or spectral characteristics, forming a closed-loop feedback control.

6. The synergistic treatment system according to claim 1, characterized in that, The first transducer array and the second transducer array are arranged in a concentric circle layout; The first transducer array is integrated in the central region of concentric circles; the second transducer array is arranged around the periphery of the first transducer array.

7. The synergistic treatment system according to claim 6, characterized in that, The first transducer array is a two-dimensional matrix phased array imaging probe, composed of high-frequency array elements, and is also used to receive ultrasonic echo signals and generate real-time images; the second transducer array is a two-dimensional matrix transducer array, composed of multiple array units, each array unit forming at least three circular arrays with the first transducer array as the center.

8. The synergistic treatment system according to claim 6, characterized in that, The array unit is a monolithic piezoelectric ceramic with a matching layer and a backing, and a backing is attached to the back of each ceramic array element.

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