A portable low energy extracorporeal shock wave lithotripter system

Abstract

This invention relates to the field of medical technology, specifically to a portable low-energy extracorporeal shock wave lithotripsy system; comprising: a portable main unit module, a low-energy shock wave module, a miniature ultrasound positioning module, an AI intelligent control module, and a respiratory compensation module. This invention constructs a dual-focal constructive interference acoustic field and energy optimization model of a piezoelectric ceramic array. Within a safe range where the single pulse energy density is reduced, it effectively pulverizes stones using the shear stress generated by the sound pressure gradient between the two focal points, thereby significantly reducing the system's hardware dependence on power reserves and high-power heat dissipation, achieving a transformation from a single-pulse system to a trolley-type portable structure. Simultaneously, the system overcomes the off-target problem caused by dynamic respiratory displacement by using ultrasound image coordinate matrix mapping and an electro-mechanical dual-mode collaborative compensation mechanism, with microsecond-level instantaneous deflection of the electronic focal domain of the phased array to offset the mechanical response lag of the servo motor through phased array microsecond-level electronic focal domain instantaneous deflection.

Description

Technical Field

[0001] This invention relates to the field of medical technology, specifically to a portable low-energy extracorporeal shock wave lithotripsy system. Background Technology

[0002] Extracorporeal shock wave lithotripsy (ESWL) is currently the preferred non-invasive treatment for urinary tract stones. Traditional large-scale ESWL equipment mainly relies on increasing the peak sound pressure level and energy density of a single shock wave pulse. To ensure a high stone fragmentation rate, high-energy-density shock waves, when penetrating human tissue and undergoing nonlinear acoustic cavitation within the focal region, can easily cause micromechanical damage to the renal parenchyma and capillary network surrounding the stone, often manifesting clinically as postoperative hematuria or subcapsular hematoma. Furthermore, to support continuous high-energy pulse transmission, traditional systems must be equipped with high-power high-voltage generators and bulky external forced water-cooling systems. This results in the entire machine typically weighing hundreds of kilograms and requiring it to be fixed in a dedicated machine room with special power supply and shielding conditions, failing to meet the clinical needs of mobile lithotripsy at primary healthcare institutions or emergency bedsides.

[0003] In recent years, the industry has attempted to improve safety and reduce equipment size by lowering the energy emitted by shock waves. However, simply reducing energy density faces a critical problem: lithotripsy efficiency decreases exponentially under physiological dynamic conditions. In actual treatment, kidney or upper ureteral stones can move with the patient's respiratory cycle, resulting in significant amplitude variations in three-dimensional space. The periodic displacement of the stone. Traditional positioning and tracking systems typically use only a single mechanical servo mechanism to drive the treatment head for physical following. Due to the inherent mass inertia and response delay of the mechanical transmission system, the control cycle of mechanical following lags significantly behind the instantaneous displacement of the stone, causing the acoustic focus to frequently miss the target. Under low-energy output conditions, because the effective sound pressure gradient range of the focal zone itself is small, this focusing error caused by mechanical lag leads to a sharp decrease in the number of effective pulses hitting the stone, making it impossible to accumulate enough stress within the safe treatment time to cause fatigue fracture of the stone, ultimately rendering low-energy lithotripsy protocols clinically impractical. Summary of the Invention

[0004] To achieve the above objectives, the present invention provides a portable low-energy extracorporeal shock wave lithotripsy system, comprising: The portable host module has a trolley-type mobile support structure. The portable host module integrates a power conversion unit to convert mains power into system operating power. A low-energy shock wave module is movably mounted on the trolley-type mobile support structure. The center of the sound-emitting surface of the low-energy shock wave module has a through-hole central receiving cavity for emitting focused shock waves to the space target area. A miniature ultrasound positioning module is embedded and fixed in the central receiving cavity and coaxially integrated with the low-energy shock wave module. The center line of the ultrasound imaging angle of the miniature ultrasound positioning module coincides with the geometric focal axis of the focused shock wave, and is used to acquire ultrasound images of the spatial target area in real time. The AI ​​intelligent control module is communicatively connected to the miniature ultrasound positioning module and the low-energy shock wave module. The AI ​​intelligent control module is used to extract the three-dimensional contour and position coordinates of the stone in real time based on the ultrasound image, and automatically adjust the output parameters of the low-energy shock wave module based on the extraction results. The breathing compensation module is communicatively connected to the AI ​​intelligent control module and the low-energy shock wave module. The breathing compensation module is used to extract the periodic displacement vector of the stone in the spatial target area caused by human respiration, and convert the periodic displacement vector into a spatial compensation command and send it to the low-energy shock wave module to drive the focal position of the focused shock wave to dynamically follow and shift, so that the shifted focal position is continuously locked on the stone.

[0005] Furthermore, the overall weight of the portable host module satisfy: Furthermore, the bottom of the trolley-type mobile support structure is equipped with at least four omnidirectional wheels with locking function; The power conversion unit includes: AC filter circuit, connected to 220V AC mains input terminal; AC-DC power conversion module is used to convert AC power into DC voltage required by various modules inside the system; An energy storage capacitor array, connected to the low-energy shock wave module, is used to provide instantaneous energy support for the high-frequency pulse emission of the shock wave.

[0006] Furthermore, the structural layout of the portable host module satisfies the following instability determination formula: in, The overall center of gravity height of the portable low-energy extracorporeal shock wave lithotripsy system, The wheelbase span of the trolley-type mobile support structure in the direction of movement is [missing information]. The system has a preset maximum safe tilt angle; by placing the power conversion unit and energy storage capacitor array at the bottom of the portable host module, the risk of tilting is reduced. This value enables anti-tipping protection during movement; The portable host module also includes a self-circulating micro heat dissipation component, which includes an air intake grille, an exhaust fan, and a heat pipe heat sink attached to the surface of the power conversion unit, all disposed on the side wall of the host housing. The heat dissipation component dynamically adjusts the speed of the exhaust fan according to the real-time temperature of the power conversion unit, so that the whole machine can be freed from the limitation of an external water cooling system.

[0007] Furthermore, the low-energy shock wave module uses a piezoelectric ceramic array as the shock wave source; the piezoelectric ceramic array is formed by arranging multiple independently excited piezoelectric ceramic units on the inner surface of a spherical base, and the acoustic axes of all the piezoelectric ceramic units converge at the geometric center of the spatial target area; The working energy density of the shock wave generated by the low-energy shock wave module in the space target area satisfy: ; The piezoelectric ceramic array is divided into an inner ring array and an outer ring array. The AI ​​intelligent control module applies an excitation signal with a preset phase difference to the inner ring array and the outer ring array to form a dual-focus sound field in the spatial target area. The dual-focus sound field includes a first focus and a second focus distributed longitudinally along the sound axis. The shear force generated by the sound pressure difference between the first focus and the second focus crushes the stones.

[0008] Furthermore, the focusing characteristics of the low-energy shock wave module satisfy the following focal gain formula: in, For focal sound pressure gain, The peak sound pressure level at the focal point. The initial sound pressure on the surface of the piezoelectric ceramic unit. The center frequency of the shock wave The effective aperture radius of the spherical base is [missing information]. The speed of sound in human tissue. Let be the radius of curvature of the spherical base; By increasing the effective aperture radius And reduce the radius of curvature This allows the low-energy shock wave module to... At lower levels, through high gain To achieve the crushing of stones; The low-energy shock wave module also includes a liquid-controlled coupling water bladder disposed outside the sound-emitting surface. The liquid-controlled coupling water bladder is filled with degassed water and is attached to human skin through a flexible membrane.

[0009] Furthermore, the miniature ultrasound positioning module includes: The ultrasonic transducer array uses a high-frequency convex array or phased array probe, with an operating frequency range of 3.5MHz to 5MHz. A sealed acoustic window is disposed at the end of the central receiving cavity and flush with the emitting surface of the low-energy shock wave module. The sealed acoustic window is made of sound-permeable material and is used to isolate the ultrasonic transducer array from the external coupling liquid. A probe driving mechanism is disposed within the central receiving cavity and is used to drive the ultrasonic transducer array to extend or rotate circumferentially along the axial direction of the central receiving cavity in order to adjust the imaging focal length and scanning section. Specifically, the ultrasonic transducer array employs a miniature linear ultrasonic probe or a high-frequency convex array probe. To achieve the optimal balance between penetration depth and imaging resolution, ensuring that the imaging area clearly covers the stone outline at the depth of the shock wave focal point, its operating frequency range is strictly limited to 3.5MHz to 5MHz.

[0010] Furthermore, the real-time ultrasound images acquired by the miniature ultrasound positioning module are converted into the physical focus coordinates of the low-energy shock wave module using the following spatial coordinate mapping model: in, These are the pixel coordinates of the stone in the real-time ultrasound image. The actual physical size corresponding to a unit pixel. The target depth is determined by ultrasound. The static transformation matrix of the system is determined by the coaxial mounting structure. For dynamic calibration compensation matrix, The three-dimensional spatial position of the stone in the physical coordinate system of the shock wave; The AI ​​intelligent control module compares real-time calculations... With the shock wave's preset geometric focus deviation value Generate feedback control signals; when When the value exceeds a preset threshold, the AI ​​intelligent control module activates the breathing compensation module for dynamic focusing; The coaxiality deviation between the central axis of the ultrasonic transducer array and the geometric central axis of the low-energy shock wave module is less than or equal to 0.2 mm, and the near-field dead zone of the ultrasonic transducer array is less than or equal to 10 mm.

[0011] Furthermore, the AI ​​intelligent control module has an embedded convolutional image segmentation network model trained with features; The AI ​​intelligent control module inputs the continuously received ultrasound images into the convolutional image segmentation network model, extracts the pixel features of strong echo bands and posterior acoustic shadows on the surface of the stone, reconstructs the three-dimensional contour of the stone using multi-view tomography, and calculates the physical volume of the stone based on the grayscale distribution. With equivalent morphological acoustic impedance parameters ; Based on the physical volume With equivalent morphological acoustic impedance parameters Calculate and adjust the single-pulse output energy of the low-energy shock wave module. and estimated total number of target pulses : in, The low-energy basic safety threshold set for the system, To provide a hardness compensation coefficient for different types of stones, Let be the stone crushing efficiency constant. This represents the system's estimated focus hit rate. Based on the calculation The voltage amplitude excited by the shock wave is dynamically adjusted and approximated based on the actual number of triggers. When the value is reached, the pulse emission frequency is automatically reduced; The AI ​​intelligent control module also includes a sound path safety early warning unit; The acoustic path safety warning unit is used to establish a three-dimensional virtual acoustic path channel model along the geometric focal axis of the focused shock wave. When abnormal ultrasound echoes with bone tissue obstruction or large blood vessel features are detected in the three-dimensional virtual acoustic path channel model, the acoustic path safety warning unit generates a hardware-level blocking signal to forcibly cut off the emission trigger circuit of the low-energy shock wave module until the multi-degree-of-freedom positioning mechanism drives the coaxial treatment head assembly to adjust to a safe obstacle avoidance incident angle.

[0012] Furthermore, the breathing compensation module obtains the movement state of the stone through the following displacement vector extraction algorithm: in, for Time-based stone relative to the initial reference time The three-dimensional displacement vector, The output is the real-time coordinates; The breathing compensation module is based on the above. The temporal variation characteristics were analyzed, and the frequency of human respiration was extracted using Fourier transform. With phase And predict the movement trajectory of the stones in the next cycle; The respiratory compensation module employs an electro-mechanical dual-mode compensation strategy: Set the displacement compensation threshold to : when At the same time, electronic focal deflection compensation is performed: by changing the excitation phase of each piezoelectric ceramic unit in the low-energy shock wave module, the focus of the shock wave is instantaneously deflected in space; when At the same time, mechanical-electronic collaborative compensation is performed: while performing electronic focal deflection, a position correction command is sent to the multi-degree-of-freedom positioning mechanism to drive the coaxial treatment head assembly to perform macroscopic displacement following.

[0013] Furthermore, in the electronic focal deflection compensation, the pulse delay time of each piezoelectric ceramic unit... Follow the phase control formula as follows: in, For the speed of sound, For the first The center coordinates of each piezoelectric ceramic unit The initial geometric focus coordinates of the system. The coordinates of the target focus after compensation; The AI ​​intelligent control module calculates... The excitation waveform of the low-energy shock wave module is adjusted in real time. The mechanical-electronic collaborative compensation is achieved through the following feedback closed-loop logic: The breathing compensation module takes the predicted trajectory deviation as input and generates the servo drive parameters of the multi-degree-of-freedom positioning mechanism through a PID control algorithm. During the response delay of mechanical movement, the electronic focal deflection compensation remains active and cancels out the dynamic residual difference between the servo drive parameters and the actual mechanical displacement in real time, so as to ensure that the actual focal point of the low-energy shock wave module coincides with the centroid of the stone by more than 90% throughout the entire respiratory cycle.

[0014] Beneficial effects This invention constructs a dual-focal constructive interference acoustic field and energy optimization model for a piezoelectric ceramic array, achieving a single-pulse energy density reduction to [missing value]. Within the safe range, the shear stress generated by the sound pressure gradient between the two focal points effectively crushes stones, thereby significantly reducing the system's hardware dependence on power reserves and high-power heat dissipation, and realizing the transformation of the whole machine into a ≤80kg class trolley-type portable structure; at the same time, the system uses ultrasonic image coordinate matrix mapping and electro-mechanical dual-mode collaborative compensation mechanism to offset the mechanical response lag of the servo motor with the instantaneous deflection of the electronic focal domain at the microsecond level of the phased array, overcoming the off-target problem caused by dynamic breathing displacement, and effectively ensuring high accuracy and stone crushing efficiency under dynamic working conditions while maintaining an extremely low risk of tissue damage. Attached Figure Description

[0015] Figure 1 This is a system architecture diagram of the present invention; Figure 2 This is a timing and feedback logic diagram of the respiratory motion compensation control of the present invention. Detailed Implementation

[0016] To enable those skilled in the art to better understand the present invention, the technical solutions of the present invention will be clearly and completely described below with reference to the accompanying drawings of the embodiments of the present invention. Obviously, the described embodiments are only some embodiments of the present invention, and not all embodiments. Based on the embodiments of the present invention, all other embodiments obtained by those skilled in the art without creative effort should fall within the scope of protection of the present invention.

[0017] It should be noted that the terms "first," "second," etc., in the specification, claims, and accompanying drawings of this invention are used to distinguish similar objects and are not necessarily used to describe a specific order or sequence. It should be understood that such data can be interchanged where appropriate so that the embodiments of the invention described herein can be implemented in orders other than those illustrated or described herein. Furthermore, the terms "comprising" and "having," and any variations thereof, are intended to cover a non-exclusive inclusion; for example, a process, method, system, product, or apparatus that comprises a series of steps or units is not necessarily limited to those steps or units explicitly listed, but may include other steps or units not explicitly listed or inherent to such processes, methods, products, or apparatus.

[0018] The present invention will now be described in further detail with reference to the accompanying drawings: Example: like Figure 1-2 As shown, the present invention provides a portable low-energy extracorporeal shock wave lithotripsy system, comprising: The portable host module has a trolley-type mobile support structure. The portable host module integrates a power conversion unit to convert mains power into system operating power. The low-energy shock wave module is movably mounted on a trolley-type mobile support structure. The center of the sound-emitting surface of the low-energy shock wave module has a through-hole central receiving cavity for emitting focused shock waves to the space target area. The miniature ultrasound positioning module is embedded and fixed in the central cavity and coaxially integrated with the low-energy shock wave module. The center line of the ultrasound imaging angle of the miniature ultrasound positioning module coincides with the geometric focal axis of the focused shock wave, which is used to acquire ultrasound images of the space target area in real time. The AI ​​intelligent control module is a communication connection between the miniature ultrasound positioning module and the low-energy shock wave module. The AI ​​intelligent control module is used to extract the three-dimensional contour and position coordinates of the stone in real time based on the ultrasound image, and automatically adjust the output parameters of the low-energy shock wave module based on the extraction results. The breathing compensation module is connected to the AI ​​intelligent control module and the low-energy shock wave module respectively. The breathing compensation module is used to extract the periodic displacement vector of the stone in the spatial target area caused by human breathing, and convert the periodic displacement vector into a spatial compensation command and send it to the low-energy shock wave module to drive the focal position of the focused shock wave to dynamically follow the shift, so that the shifted focal point is continuously locked on the stone.

[0019] Furthermore, the specific implementation process of the portable host module is as follows: The external support structure of the portable main unit module is a trolley-type mobile support structure. Its internal support frame is assembled from aluminum alloy profiles using argon arc welding, and is covered with a sheet metal shell with electromagnetic shielding properties. By controlling the wall thickness of the frame and the density of internal components, the total static weight M of the portable main unit module, along with other modules mounted on top, is strictly controlled within the range of M≤80kg. Four casters are fixed to the four corners of the chassis bearing surface of the trolley-type mobile support structure via flanges. Each caster is equipped with a mechanical locking pedal mechanism, which can lock the axle by pressing the pedal.

[0020] In terms of internal spatial layout, the portable main unit module is vertically divided into a bottom power compartment, a middle main control compartment, and a top operating platform. To meet the mechanical anti-tipping requirements of the system under different damped ground movement conditions, the center of gravity of the portable main unit module's mass distribution is subject to strict physical position constraints. Specifically, the power conversion unit and energy storage capacitor array, which account for the largest mass proportion of the system, are fixedly mounted on the base plate of the bottom power compartment using countersunk screws and anti-vibration pads. By placing the high-density mass source at the bottom of the system, the overall center of gravity height after the entire unit is physically assembled is reduced. Wheelbase span of the trolley-type mobile support structure in the direction of movement and the system's preset maximum safe tilt angle. The condition is satisfied between them according to the following formula: In this spatial assembly layout, the gravity vector reaches [value missing] at the system tilt angle. At that time, its extension line still falls within the geometric area of ​​the supporting polygon formed by the four omnidirectional wheels.

[0021] In terms of electrical connection and energy transfer, the power conversion unit in the bottom power compartment starts at a 220V AC mains input interface embedded in the back panel of the outer shell. The live, neutral, and ground terminals of this interface are connected to the input pins of the AC filter circuit through insulated wire harnesses. The common-mode inductor and X / Y capacitor network inside the AC filter circuit perform high-frequency attenuation of electromagnetic interference from the input mains power. The filtered clean AC power is directly fed into the rectification and buck topology of the AC-DC power conversion module through a copper busbar, converting it into the DC voltage required by the system bus. The DC output of the AC-DC power conversion module is connected in parallel to two main power supply circuits: the first power supply circuit is connected to the middle main control compartment to provide low-voltage DC power to the control circuit board; the second high-current main circuit is connected to the positive and negative busbars of the energy storage capacitor array through multiple strands of copper wires. The energy storage capacitor array consists of several high-voltage film capacitors with millisecond-level charge and discharge characteristics connected in parallel, and its discharge output is directly electrically connected to the input of the high-voltage trigger circuit of the low-energy shock wave module. When the system executes the pulse transmission command, the AC-DC power conversion module charges the energy storage capacitor array with constant current during the transmission interval. At the moment of triggering, the accumulated charge in the energy storage capacitor array is released to the shock wave generator through the thyristor switching network, completing one cycle of energy pumping process. Furthermore, to adapt to the complex power environments of mobile healthcare and emergency care, the portable host module also integrates an electrical safety protection unit in series. This protection unit is communicatively connected to the power conversion unit, monitors the power supply status and system energy output in real time, and has leakage protection, overcurrent protection, and energy anomaly monitoring and alarm functions. In the event of an abnormal state, it can forcibly disconnect the high-voltage circuit, improving the overall safety of the device.

[0022] To address the heat buildup generated by the power conversion unit and energy storage capacitor array during energy pumping, a self-circulating micro-heat dissipation component is installed in the bottom power compartment. An array of air intake grilles is located on the side wall of the portable host module's casing, and an exhaust fan is screwed onto the inner wall of the casing on the opposite side via a shock-absorbing bracket. In terms of heat conduction path construction, the flat heat-absorbing end of a heat pipe heatsink made of high thermal conductivity copper is press-fitted to the surface of the core power switching transistor and transformer core of the AC-DC power conversion module using thermally conductive silicone grease. The condensation end of the heat pipe heatsink extends and floats within the negative pressure zone of the exhaust fan. A temperature sensor in the bottom power compartment collects the absolute temperature parameters of the power device surfaces in real time and converts these parameters into analog voltage signals, which are then transmitted to the control circuit board. The microcontroller on the control circuit board outputs a corresponding PWM duty cycle signal to the drive end of the exhaust fan according to a preset temperature-speed mapping function. External cold air is passively drawn into the bottom power compartment through the air intake grille, flows through the surface of the energy storage capacitor array and the condenser end of the heat pipe heat sink for heat exchange, and the heated airflow after absorbing heat is forced to be discharged outward by the exhaust fan, thus constructing a forced convection air cooling cycle process within the closed casing.

[0023] Furthermore, the specific operating procedure for the low-energy shock wave module is as follows: The core actuator of the low-energy shock wave module is a spherical base, which is integrally machined from high-strength stainless steel or aerospace-grade aluminum using a high-precision five-axis CNC machine tool. Its inner surface is ground to a preset radius of curvature. The spherical shape, the radius of curvature The center point constitutes the initial physical geometric focus of this system. On the inner surface of the spherical cap base, multiple independent piezoelectric ceramic units are bonded together by an array of high-strength acoustically conductive epoxy resin, and the geometric axis of each piezoelectric ceramic unit points to the center of the spherical cap base.

[0024] In terms of physical partitioning and assembly structure, these piezoelectric ceramic units are defined as electrically isolated inner and outer ring array regions according to their radial distribution. A central receiving cavity extending through the thickness direction is formed at the geometric apex of the spherical cap base. This cavity has a high-precision positioning step surface machined inside for coaxially nesting the probe sleeve of the miniature ultrasonic positioning module. Through interference fit and axial locking nuts, the acoustic imaging axis of the miniature ultrasonic probe and the shock wave geometric focal axis of the spherical cap base are ensured to be highly coincident in three-dimensional space, with a coaxiality deviation controlled to ≤0.2mm. At the front opening of the spherical cap base, a hydraulically controlled coupling water bladder made of medical-grade polyurethane material is sealed. The bladder is filled with degassed water that has undergone vacuum degassing treatment via a circulating pump, serving as a low-loss coupling medium for acoustic wave transmission.

[0025] Regarding the generation and focusing control logic of the shock wave, the system applies a high-voltage transient electrical pulse to the piezoelectric ceramic unit through an excitation circuit. Driven by the inverse piezoelectric effect, the piezoelectric ceramic unit generates micron-level mechanical deformation, emitting high-frequency acoustic pressure pulses into the degassed water medium. To achieve efficient stone fragmentation at low energy, the system utilizes the constructive interference principle of sound waves for energy focusing. The AI ​​intelligent control module provides the inner and outer ring arrays with preset phase differences. The trigger signal. When the excitation signal is fed in, the spherical acoustic wavefronts generated by the inner and outer ring arrays propagate towards the geometric focus. Due to the path difference and phase difference, constructive interference superposition occurs on the acoustic axis, thus forming a first focus and a second focus longitudinally in the spatial axis. This dual-focus structure utilizes the sound pressure gradient between the two focuses to generate a strong shear force, causing the stone to be compressed while generating tensile stress, thereby achieving a lower single-pulse energy density. The following is achieved: brittle fracture.

[0026] Furthermore, "to ensure that fatigue stress of the stone can be effectively accumulated under low energy output conditions, while also providing sufficient acoustic relaxation time to the surrounding tissues to avoid micromechanical damage, the pulse emission frequency of the low-energy shock wave module in the space target area is set to 1-2 Hz."

[0027] The focusing efficiency of the low-energy shock wave module is controlled by the geometric convergence gain of the spherical base. According to the focal gain formula: ,in The effective aperture radius of the spherical base is [missing information]. The pulse center frequency, The speed of sound. During implementation, the opening diameter of the spherical base is increased. And optimize the radius of curvature. This results in an initial sound pressure level on the piezoelectric ceramic surface. Under the premise of a low safety threshold, through high geometric gain The sound energy is highly focused on the target area. When the sound beam passes through the liquid-controlled coupling water bladder, it is adhered to the human skin by a flexible membrane. Due to the high acoustic impedance matching between the degassed water and human tissue, the sound waves can penetrate the body wall and enter the body with extremely low reflection loss.

[0028] During dynamic tracking and breathing compensation, the breathing compensation module calculates the pulse delay time. The triggering timing of each piezoelectric ceramic unit is finely adjusted in real time. This microsecond-level time-domain adjustment changes the wavefront phase formed by acoustic wave interference, enabling the physical focus to deflect in space and achieve real-time locking of stone displacement.

[0029] Furthermore, the specific implementation process of the miniature ultrasonic positioning module is as follows: The miniature ultrasonic positioning module is embedded within the central cavity of the low-energy shock wave module via a cylindrical probe sleeve. The probe sleeve is made of biocompatible polyetheretherketone (PEEK) material with high mechanical rigidity. Its outer diameter and the inner diameter of the central cavity are precisely fitted with tolerances to ensure that the radial runout of both is controlled under heated or pressurized conditions. .

[0030] The front end of the probe sleeve is sealed and fixed with a high-frequency ultrasonic transducer array, which is micro-machined from multilayer piezoelectric composite material units, and its central operating frequency is selected at [frequency value missing]. Within the range. To eliminate acoustic energy reflection at the transmitting interface, an acoustic impedance matching layer made of epoxy resin material with acoustic impedance matching that matches human soft tissue is fixed above the radiating surface of the transducer array, and a layer with a thickness of [missing information] is encapsulated at the front end of the probe sleeve. The sealed acoustic window is formed by a flexible adhesive to the inner wall of the probe sleeve, creating a sealed cavity filled with acoustic coupling oil to prevent external coupling liquid from entering the transducer array.

[0031] During motion adjustment and depth tracking, the rear end of the probe sleeve is mechanically connected to the probe drive mechanism located deep within the central receiving cavity via a linkage mechanism. The probe drive mechanism includes a miniature DC servo motor and a high-precision lead screw assembly fixed to its output shaft. When the AI ​​intelligent control module detects a significant displacement of the stone in the depth direction (Z-axis), the servo motor drives the lead screw to rotate, causing the probe sleeve to reciprocate linearly along the axis of the central receiving cavity. This motion process is controlled in a closed loop by an encoder integrated at the rear end of the motor, thereby achieving high-resolution imaging of the stone target at different depth planes and ensuring that the physical focus of the ultrasonic beam always covers the stone target area.

[0032] In terms of coordinate mapping and focusing logic, the analog echo signal acquired by the miniature ultrasound positioning module is amplified and logarithmically compressed by the front-end analog processing circuit, then converted into a digital image signal by an analog-to-digital converter and transmitted to the AI ​​intelligent control module. The AI ​​intelligent control module extracts pixels from the center of the stone in the real-time ultrasound image to obtain the pixel coordinates. Subsequently, the system calls the pre-stored coordinate mapping model to perform spatial analytical transformation: in, This is a static transformation matrix defined based on the probe's initial installation position within the central receiving cavity. This represents the acoustic ranging depth calculated using the ultrasonic pulse echo time difference. The calculated physical coordinates are... The data is sent in real time to the breathing compensation module as a reference input to drive the deflection of the shock wave focus, thereby establishing a dynamic coordinate association system from ultrasonic vision capture to the physical impact of the shock wave.

[0033] Furthermore, the specific implementation process of the AI ​​intelligent control module is as follows: The AI ​​intelligent control module is integrated into the middle control compartment of the portable host module. Its core hardware carrier is a heterogeneous processing unit with parallel computing capabilities, including a central processing unit (CPU) and a graphics processing unit (GPU) or neural network processor (NPU) for accelerating deep learning inference.

[0034] During the image processing and feature recognition stage, the AI ​​intelligent control module receives digital ultrasound radio frequency signals transmitted by the miniature ultrasound positioning module in real time via a high-speed serial bus. Internally, the module runs a pre-trained convolutional image segmentation network employing a multi-layer residual convolutional structure. In the inference process, the AI ​​intelligent control module first performs pixel-level feature search on the input two-dimensional ultrasound cross-section, focusing on extracting the unique strong echo band features of the stone boundary and the accompanying acoustic attenuation features. Through feature fusion of multiple consecutive frame cross-sectional images, the module constructs a voxel model of the stone in a three-dimensional coordinate system and accurately calculates the physical volume of the stone based on voxel counting. Simultaneously, based on the gray-scale gradient distribution and echo intensity of the strong echo band, the equivalent morphological acoustic impedance parameters of the stone are derived using a pre-defined acoustic characteristic mapping table. Used to characterize the hardness of stones and the difficulty of breaking them.

[0035] The AI ​​intelligent control module performs energy optimization calculations through its internal arithmetic logic unit (ALU). The module calculates energy based on real-time volume data. With acoustic impedance parameters The control parameters are generated according to the following mathematical model: First, based on the formula... The system calculates the output energy of a single pulse, whereby it matches the high-voltage charging voltage amplitude of the low-energy shock wave module. Target value; subsequently, based on the formula Estimate the total number of pulses required to break the stone. During the lithotripsy process, the AI ​​intelligent control module continuously monitors the fragmentation of the stones (i.e., the degree of discretization of the ultrasonic echo characteristics) and dynamically corrects the process. The parameters are used to achieve adaptive adjustment of the pulse emission frequency and energy intensity.

[0036] The AI-powered intelligent control module constructs a three-dimensional virtual acoustic path model in real time. This model uses the physical focus of the shock wave as its apex and the effective aperture of the spherical base as its base, forming a cone-shaped detection area. Within this area, the AI-powered intelligent control module automatically identifies obstacles, using grayscale thresholding and edge detection algorithms to determine the presence of high-density bone tissue or pulsating features of large blood vessels in the acoustic path. Once the algorithm determines that there is obstruction or potential damage risk within the acoustic path, the AI-powered intelligent control module immediately sends a low-level blocking signal to the trigger control circuit of the low-energy shock wave module. This forcibly cuts off the high-voltage discharge circuit through a logic AND gate, thereby stopping energy output within milliseconds and ensuring the acoustic safety of non-target tissues.

[0037] Furthermore, the specific implementation process of the respiratory compensation module is as follows: During the displacement vector extraction and prediction stage, the respiratory compensation module establishes a time-series coordinate library to record the instantaneous coordinates of the stones in three-dimensional space. The logic unit calculates the current time relative to the reference time of the onset of respiration. Three-dimensional displacement vector To eliminate image acquisition noise and improve the predictability of compensation, the breathing compensation module performs continuous image acquisition... The signal is subjected to Fast Fourier Transform (FFT) analysis to extract characteristic frequencies from the human respiratory cycle. With phase Based on the extracted respiratory feature parameters, the module constructs a Kalman filter prediction model to calculate the expected physical location of the stone at the moment of the next shock wave pulse trigger, thereby offsetting the location lag caused by system processing delay.

[0038] In the dual-mode compensation mechanism at the execution level, the system calculates the displacement vector magnitude based on the predicted displacement vector magnitude. With preset displacement compensation threshold The quantization relationship is automatically switched to adjust the compensation path. When detected... When the stone is in the stage of slight respiratory fluctuations, the system performs electronic focal deflection compensation. At this time, the respiratory compensation module calculates the pulse delay time required by each piezoelectric ceramic unit in the low-energy shock wave module. The calculation formula follows: .in, To predict the target location of the kidney stone, the module uses a timing controller with microsecond-level precision to adjust the pulse excitation phase of each piezoelectric ceramic unit in the drive circuit. This allows the acoustic focus formed by constructive interference to deflect instantaneously in space without mechanical movement, precisely aligning with the center of the moving kidney stone.

[0039] When detected When a patient takes a deep breath, causing a significant displacement of the stone, the system activates a mechanical-electronic collaborative compensation mode. The respiratory compensation module converts the large displacement component into a control quantity for a multi-degree-of-freedom positioning mechanism. A servo motor is driven by a PID control algorithm to perform macroscopic position tracking, causing the entire coaxial treatment head assembly to track the stone. During this mechanical movement, due to the inertial delay in mechanical transmission, the respiratory compensation module simultaneously maintains electronic focal deflection compensation, utilizing the extremely fast response speed of the sound beam deflection to offset the dynamic residual difference between the mechanical drive parameters and the actual physical displacement. This "coarse adjustment + fine adjustment" collaborative logic ensures that the spatial overlap between the high-pressure focal zone center of the shock wave and the centroid of the stone remains above 90% throughout the entire respiratory cycle.

[0040] Throughout the dynamic execution of respiratory motion compensation, the respiratory compensation module maintains a detection accuracy of no more than 0.1 mm for the displacement of stones within the target area. Simultaneously, relying on the efficient synergy of the electro-mechanical dual-mode compensation strategy, the overall response time from capturing the displacement change command to actually completing the focus deflection correction is no more than 50 ms, thereby significantly improving the real-time performance and accuracy of dynamic tracking.

[0041] In addition, the breathing compensation module is also equipped with a synchronous linkage interface with the pulse triggering circuit. When the prediction model determines that the stone's movement speed is too fast (exceeding the system's maximum compensation capacity) or the displacement exceeds the preset safety envelope, the module outputs a trigger prohibition signal to suspend the emission of the shock wave. The firing will resume after the stone returns to the controllable movement range, thereby avoiding the risk of accidentally damaging normal tissues around the target area from the physical execution level.

[0042] The above embodiments are only used to illustrate the technical solutions of the present invention, and are not intended to limit it. Although the present invention has been described in detail with reference to the foregoing embodiments, those skilled in the art should understand that modifications can still be made to the technical solutions described in the foregoing embodiments, or equivalent substitutions can be made to some of the technical features. Such modifications or substitutions will not cause the essence of the corresponding technical solutions to deviate from the spirit and scope of the technical solutions of the embodiments of the present invention.

Claims

1. A portable low-energy extracorporeal shock wave lithotripsy system, characterized in that, include: The portable host module has a trolley-type mobile support structure. The portable host module integrates a power conversion unit to convert mains power into system operating power. A low-energy shock wave module is movably mounted on the trolley-type mobile support structure. The center of the sound-emitting surface of the low-energy shock wave module has a through-hole central receiving cavity for emitting focused shock waves to the space target area. A miniature ultrasound positioning module is embedded and fixed in the central receiving cavity and coaxially integrated with the low-energy shock wave module. The center line of the ultrasound imaging angle of the miniature ultrasound positioning module coincides with the geometric focal axis of the focused shock wave, and is used to acquire ultrasound images of the spatial target area in real time. The AI ​​intelligent control module is communicatively connected to the miniature ultrasound positioning module and the low-energy shock wave module. The AI ​​intelligent control module is used to extract the three-dimensional contour and position coordinates of the stone in real time based on the ultrasound image, and automatically adjust the output parameters of the low-energy shock wave module based on the extraction results. The breathing compensation module is communicatively connected to the AI ​​intelligent control module and the low-energy shock wave module. The breathing compensation module is used to extract the periodic displacement vector of the stone in the spatial target area caused by human respiration, and convert the periodic displacement vector into a spatial compensation command and send it to the low-energy shock wave module to drive the focal position of the focused shock wave to dynamically follow and shift, so that the shifted focal position is continuously locked on the stone.

2. The portable low energy extracorporeal shock wave lithotripter system according to claim 1, wherein, The total weight M of the portable host module satisfies: M≤80kg; And the bottom of the trolley type mobile support structure is provided with at least four universal wheels with locking function. The power conversion unit includes: AC filter circuit, connected to 220V AC mains input terminal; AC-DC power conversion module is used to convert AC power into DC voltage required by various modules inside the system; An energy storage capacitor array, connected to the low-energy shock wave module, is used to provide instantaneous energy support for the high-frequency pulse emission of the shock wave.

3. The portable low-energy extracorporeal shock wave lithotripsy system according to claim 2, characterized in that, The structural layout of the portable host module satisfies the following instability determination formula: in, The overall center of gravity height of the portable low-energy extracorporeal shock wave lithotripsy system, The wheelbase span of the trolley-type mobile support structure in the direction of movement is [missing information]. The system has a preset maximum safe tilt angle; by placing the power conversion unit and energy storage capacitor array at the bottom of the portable host module, the risk of tilting is reduced. This value enables anti-tipping protection during movement; The portable host module also includes a self-circulating micro heat dissipation component, which includes an air intake grille, an exhaust fan, and a heat pipe heat sink attached to the surface of the power conversion unit, all disposed on the side wall of the host housing. The heat dissipation component dynamically adjusts the speed of the exhaust fan according to the real-time temperature of the power conversion unit, so that the whole machine can be freed from the limitation of an external water cooling system.

4. The portable low energy extracorporeal shock wave lithotripter system according to claim 3, wherein, The low-energy shock wave module uses a piezoelectric ceramic array as the shock wave source; the piezoelectric ceramic array is formed by arranging multiple independently excited piezoelectric ceramic units on the inner surface of a spherical base, and the acoustic axes of all the piezoelectric ceramic units converge at the geometric center of the spatial target area; The working energy density of the shock wave produced by the low-energy shock wave module in the spatial target region satisfies: ; The piezoelectric ceramic array is divided into an inner ring array and an outer ring array. The AI ​​intelligent control module applies an excitation signal with a preset phase difference to the inner ring array and the outer ring array to form a dual-focus sound field in the spatial target area. The dual-focus sound field includes a first focus and a second focus distributed longitudinally along the sound axis. The shear force generated by the sound pressure difference between the first focus and the second focus crushes the stones.

5. The portable low energy extracorporeal shock wave lithotripter system according to claim 4, wherein, The focusing characteristics of the low-energy shock wave module satisfy the following focal gain formula: in, For focal sound pressure gain, The peak sound pressure level at the focal point. The initial sound pressure on the surface of the piezoelectric ceramic unit. The center frequency of the shock wave The effective aperture radius of the spherical base is [missing information]. The speed of sound in human tissue. Let be the radius of curvature of the spherical base; By increasing the effective aperture radius And reduce the radius of curvature This allows the low-energy shock wave module to... At lower levels, through high gain To achieve the crushing of stones; The low-energy shock wave module also includes a liquid-controlled coupling water bladder disposed outside the sound-emitting surface. The liquid-controlled coupling water bladder is filled with degassed water and is attached to human skin through a flexible membrane.

6. A portable low-energy extracorporeal shock wave lithotripsy system according to claim 5, characterized in that, The miniature ultrasound positioning module includes: The ultrasonic transducer array uses a high-frequency convex array or phased array probe, with an operating frequency range of 3.5MHz to 5MHz. A sealed acoustic window is disposed at the end of the central receiving cavity and flush with the emitting surface of the low-energy shock wave module. The sealed acoustic window is made of sound-permeable material and is used to isolate the ultrasonic transducer array from the external coupling liquid. A probe driving mechanism is disposed within the central receiving cavity and is used to drive the ultrasonic transducer array to extend or rotate circumferentially along the axial direction of the central receiving cavity in order to adjust the imaging focal length and scanning section. Specifically, the ultrasonic transducer array employs a miniature linear ultrasonic probe or a high-frequency convex array probe. To achieve the optimal balance between penetration depth and imaging resolution, ensuring that the imaging area clearly covers the stone outline at the depth of the shock wave focal point, its operating frequency range is strictly limited to 3.5MHz to 5MHz.

7. A portable low-energy extracorporeal shock wave lithotripsy system according to claim 6, characterized in that, The real-time ultrasound images acquired by the miniature ultrasound positioning module are converted into the physical focus coordinates of the low-energy shock wave module through the following spatial coordinate mapping model: in, Here are the pixel coordinates of the stone in the real-time ultrasound image. The actual physical size corresponding to a unit pixel. The target depth is determined by ultrasound. The static transformation matrix of the system is determined by the coaxial mounting structure. For dynamic calibration compensation matrix, The three-dimensional spatial position of the stone in the physical coordinate system of the shock wave; The AI ​​intelligent control module compares real-time calculations... With the shock wave's preset geometric focus deviation value Generate feedback control signals; When When the AI intelligent control module starts the breathing compensation module for dynamic focusing. The coaxiality deviation between the central axis of the ultrasonic transducer array and the geometric central axis of the low-energy shock wave module is less than or equal to 0.2 mm, and the near-field dead zone of the ultrasonic transducer array is less than or equal to 10 mm.

8. A portable low-energy extracorporeal shock wave lithotripsy system according to claim 7, characterized in that, The AI ​​intelligent control module has a built-in convolutional image segmentation network model trained with features. The AI ​​intelligent control module inputs the continuously received ultrasound images into the convolutional image segmentation network model, extracts the pixel features of strong echo bands and posterior acoustic shadows on the surface of the stone, reconstructs the three-dimensional contour of the stone using multi-view tomography, and calculates the physical volume of the stone based on the grayscale distribution. With equivalent morphological acoustic impedance parameters ; Based on the physical volume With equivalent morphological acoustic impedance parameters Calculate and adjust the single-pulse output energy of the low-energy shock wave module. and estimated total number of target pulses : in, The low-energy basic safety threshold set for the system, To provide a hardness compensation coefficient for different types of stones, Let be the stone crushing efficiency constant. This represents the system's estimated focus hit rate. Based on the calculation The voltage amplitude excited by the shock wave is dynamically adjusted and approximated based on the actual number of triggers. When the value is reached, the pulse emission frequency is automatically reduced; The AI ​​intelligent control module also includes a sound path safety early warning unit; The acoustic path safety warning unit is used to establish a three-dimensional virtual acoustic path channel model along the geometric focal axis of the focused shock wave. When abnormal ultrasound echoes with bone tissue obstruction or large blood vessel features are detected in the three-dimensional virtual acoustic path channel model, the acoustic path safety warning unit generates a hardware-level blocking signal to forcibly cut off the emission trigger circuit of the low-energy shock wave module until the multi-degree-of-freedom positioning mechanism drives the coaxial treatment head assembly to adjust to a safe obstacle avoidance incident angle.

9. The portable low energy extracorporeal shock wave lithotripter system of claim 8, wherein, The breathing compensation module obtains the motion state of the stone through the following displacement vector extraction algorithm: wherein, is the three-dimensional displacement vector of the calculus at the moment relative to the initial reference moment is the output real-time coordinate;​ The breathing compensation module is based on the above. The temporal variation characteristics were analyzed, and the frequency of human respiration was extracted using Fourier transform. With phase And predict the movement trajectory of the stones in the next cycle; The respiratory compensation module employs an electro-mechanical dual-mode compensation strategy: The displacement compensation threshold is set to : When electronic focal field deflection compensation is performed: by changing the excitation phase of each piezoceramic cell in the low-energy shock wave module, the shock wave focal point is instantaneously deflected in space; When mechanical-electronic cooperative compensation is performed: while performing electronic focal spot deflection, position correction instructions are sent to the multi-degree-of-freedom positioning mechanism to drive the coaxial treatment head assembly to perform macro displacement following.

10. The portable low energy extracorporeal shock wave lithotripter system of claim 9, wherein, In the electronic focal field deflection compensation, the pulse delay time of each piezoelectric ceramic unit The phase control formula is as follows: wherein, is the sound velocity, is the center coordinate of the th piezoelectric ceramic unit, is the initial geometric focal point coordinate of the system, is the compensated target focal point coordinate; The AI intelligent control module adjusts the excitation waveform of the low-energy shock wave module in real time according to the calculated real-time adjustment of the excitation waveform of the low-energy shock wave module; The mechanical-electronic collaborative compensation is achieved through the following feedback closed-loop logic: The breathing compensation module takes the predicted trajectory deviation as input and generates the servo drive parameters of the multi-degree-of-freedom positioning mechanism through a PID control algorithm. During the response delay of mechanical movement, the electronic focal deflection compensation remains active and cancels out the dynamic residual difference between the servo drive parameters and the actual mechanical displacement in real time, so as to ensure that the actual focal point of the low-energy shock wave module coincides with the centroid of the stone by more than 90% throughout the entire respiratory cycle.

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