An ultrasonic micropore forming system and method

Abstract

This invention relates to the field of surgical equipment technology, and in particular to an ultrasonic micropore forming system and method. By integrating a high-precision ultrasonic generator, an intelligent control system, and a guiding device, it achieves precise micropore forming. This invention precisely controls parameters such as the emission frequency, power, and duration of ultrasonic waves to ensure the stability and safety of the treatment process and effectively avoid overtreatment or undertreatment.

Description

Technical Field

[0001] This invention relates to the field of surgical equipment technology, specifically to an ultrasonic micropore forming system and method. Background Technology

[0002] Presbyopia is a common age-related vision impairment, primarily affecting people over 40 years of age. Its pathogenesis is complex, involving not only the loss of lens elasticity with age but also factors such as ciliary muscle function, suspensory ligament attachment, and eyeball rigidity. Traditional views hold that presbyopia is mainly caused by increased lens thickness and decreased radius of curvature, but recent research indicates that increased scleral rigidity leading to limited ciliary body accommodation is also a significant contributing factor.

[0003] Currently, clinical treatments for presbyopia are mainly divided into two categories: non-accommodative and accommodative. Non-accommodative treatments include multifocal intraocular lens implantation and conductive keratoplasty, but these methods have significant limitations: multifocal intraocular lenses are expensive, have a long postoperative adaptation period, and may cause visual disturbances; conductive keratoplasty has limited and unstable corrective effects. Accommodative treatments, such as scleral surgery and accommodative intraocular lens implantation, face problems such as insufficient clinical data, high technical requirements, and limited indications.

[0004] In recent years, some international scholars have proposed a new approach to improve presbyopia symptoms by reducing the hardness of the sclera near the ciliary body. Theoretically, this method can restore the ciliary body's accommodative function by softening the scleral tissue. However, current technology lacks reliable means to precisely control the degree and extent of scleral softening, making safe and effective clinical treatment difficult. In particular, a mature technical solution has not yet been developed for precisely creating micropores to regulate scleral hardness.

[0005] To address the aforementioned issues, existing technologies urgently need improvement. Summary of the Invention

[0006] In view of the shortcomings of the existing technology, the purpose of this invention is to provide an ultrasonic micropore forming system and method.

[0007] To achieve the above objectives, the present invention provides the following technical solution: an ultrasonic micropore forming system, comprising a micropore forming unit, an intelligent control system, and a guiding device, wherein the micropore forming unit is disposed on the mating end of the guiding device, the guiding device is matched and fixed with the treated area, the micropore forming unit is communicatively connected to the intelligent control system, the micropore forming unit is a high-precision ultrasonic generating unit, and the micropore forming unit forms ablation micropores at the target ablation position in the treated area.

[0008] In some embodiments, the micropore forming unit includes a handheld part, a fixing part, and a mating part connected in sequence. The end of the mating part is provided with a piezoelectric ceramic module, which is connected to a signal generator in the intelligent control system.

[0009] In some embodiments, the guiding device includes a housing that matches the treatment area, one or more bottom holes on the housing corresponding to the target ablation position of the treatment area, and housing grooves and positioning holes adapted to the bottom holes on the side of the housing. The micropore forming unit is engaged with the bottom holes through the housing grooves and positioning holes.

[0010] In some embodiments, a corneal adsorption structure is provided below the outer casing.

[0011] In some embodiments, the ablation micropores are arranged in an array, including a matrix grid micropore array pattern, an elliptical micropore array pattern, or a polygonal array micropore array pattern.

[0012] In some embodiments, the piezoelectric ceramic module is formed from a single ceramic sheet, or multiple ceramic sheets are bonded together to form a ceramic sheet of a predetermined shape.

[0013] In some embodiments, the guiding device is a robotic arm structure.

[0014] In some embodiments, the outer casing has a plurality of bottom holes, and a casing groove and a positioning hole are provided on the side of the outer casing corresponding to each bottom hole.

[0015] In some embodiments, the ultrasonic generating unit of the micropore forming unit is a phased array focused ultrasonic unit.

[0016] To achieve the above objectives, the present invention also provides the following technical solution: a method of using an ultrasonic micropore forming system, wherein the ultrasonic micropore forming system comprises the following steps:

[0017] (1) Model the patient’s eye structure to generate an outer shell structure that matches the position and fixation requirements of the target tissue in the patient’s eye. Under this structure, the focused ultrasound generated by the ultrasonic emission module of the microporous forming unit is accurately focused on the spatial position of the target tissue to be formed.

[0018] (2) Place the outer shell outside the patient’s eyeball in the predetermined position and use a vacuum pump to create negative pressure to fix it on the eyeball. After the outer shell and the eyeball are tightly connected, fill the outer shell with an appropriate amount of ultrasound coupling fluid, such as de-aerated water or saline, to ensure that the ultrasound can reach the designated treatment area with maximum energy.

[0019] (3) The operator places the microporous molding unit into the outer shell, while ensuring that the fixing part of the microporous molding unit fits tightly with the groove of the outer shell, and that the mating part of the microporous molding unit passes through the positioning hole on the outer shell and fits with the bottom hole. The operator turns on the signal switch and begins treatment according to the specific ultrasound energy and time.

[0020] (4) After treatment is completed at the current position, the operator pulls the micropore forming unit out of the bottom hole and through the positioning hole on the outer shell, and then through the positioning hole on the next outer shell, inserts it into the bottom hole, and repeats the ultrasonic emission treatment.

[0021] (5) After the treatment is completed, remove the outer shell.

[0022] Compared with the prior art, the beneficial effects of the present invention are as follows: The ultrasonic micropore forming device of the present invention controls the hardness of the sclera by focusing ultrasound, which can control the depth, size and position of the micropores, improve the accuracy of treatment, and improve adaptability to meet the individual differences of different patients. Different intensities are used for different groups of people to improve the corrective effect. The treatment process does not require anesthesia. By emitting ultrasound outside the body and focusing the energy on the sclera, a non-invasive treatment for presbyopia is achieved, minimizing physical damage to human tissues.

[0023] Details of one or more embodiments of this application are set forth in the following drawings and description to make other features, objects and advantages of this application more readily apparent. The embodiments of this application will provide a detailed description and understanding of the application. Attached Figure Description

[0024] Figure 1 This is a schematic diagram illustrating the system usage and coordination of the present invention;

[0025] Figure 2 This is a schematic diagram of the microporous forming unit structure of the present invention;

[0026] Figure 3 This is a schematic diagram of the micropore ablation matrix in the treated area;

[0027] Figure 4 for Figure 3 Other micropore array layout forms;

[0028] Figure 5 for Figure 3 Other micropore array layout forms two;

[0029] Figure 6 This is a schematic diagram showing the interaction between the micropore forming unit and the guiding device.

[0030] Figure 7 for Figure 6 Mid-section view;

[0031] Figure 8 This is a schematic diagram showing the interaction between the robotic arm and the microporous forming unit.

[0032] Figure 9 A schematic diagram of the phased array focused ultrasound unit layout;

[0033] Figure 10 This is a schematic diagram of the module connections for a phased array focused ultrasound unit.

[0034] In the diagram: 1. Micropore forming unit; 2. Guiding device; 3. Target ablation location; 4. Treatment area;

[0035] 101. Handheld part; 102. Fixing part; 103. Fitting part; 104. Ultrasonic generating unit; 105. Ultrasonic generating unit outer shell;

[0036] 201. Outer shell; 202. Outer shell groove; 203. Positioning hole; 204. Corneal adsorption structure;

[0037] 301, ablation micropore array; 401, patient's eyeball; 501, robotic arm. Detailed Implementation

[0038] The technical solutions of the embodiments of the present invention will be clearly and completely described below with reference to the accompanying drawings. 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 are within the scope of protection of the present invention.

[0039] In traditional scleral stiffness modulation therapy, the use of mechanical or laser methods to create micropores suffers from uneven focused energy distribution and insufficient precision in micropore formation. Due to the lack of real-time control over the ultrasound waveform, frequency, and energy distribution, it is difficult to dynamically adjust the micropore morphology according to individual scleral tissue characteristics, leading to significant differences in the reduction of tissue cross-linking. This problem directly affects the controllability of scleral softening, causing fluctuations in the improvement of ciliary body accommodation ability, and may also cause collagen fiber damage in non-target areas.

[0040] For example, when performing microporous array therapy on the scleral surface, conventional focused ultrasound equipment cannot accurately match the curvature of the eyeball, causing the ultrasound focus to deviate from the preset ablation position. When the treatment area involves a 3mm radius around the ciliary body, existing guiding devices lack a rigid matching mechanism with the anatomical structure of the treated area, resulting in a positioning deviation of 0.5-1.2mm in the ultrasound emission path. This deviation distorts the stress transmission characteristics of the microporous array, creating an asymmetric mechanical stress distribution in the scleral matrix, which in turn affects the efficiency of suspensory ligament tension transmission.

[0041] If these issues are not addressed, insufficient or excessive collagen remodeling in the treated area will occur, reducing the linearity of scleral elastic modulus adjustment. Non-uniform microporous distribution may induce anisotropic changes in the biomechanical properties of the sclera, causing nonlinear responses in the lens curvature adjustment process. In the long term, this uncontrolled tissue remodeling may accelerate fatigue damage to the suspensory ligaments, ultimately weakening the durability and stability of the treatment effect.

[0042] Faced with the aforementioned problems, this application first considers how to achieve precise control of ultrasound energy distribution and rigid matching with anatomical structures. Traditional mechanical guidance devices cannot eliminate positioning deviations caused by the curvature of the eyeball. This application attempted to use an anatomically adapted fixation structure, but found that simple physical fixation still could not compensate for the focus shift caused by tissue deformation. To address this, this application further studied dynamic control mechanisms, exploring the feasibility of combining the fixation structure with an intelligent control system, and found that ultrasound parameters and mechanical positioning can be adjusted synchronously through real-time communication. Regarding the problem of insufficient micropore morphology control, this application tested various combinations of ultrasound shapes, and finally determined that the combination of a phased array and a focusing transducer can achieve both depth control and energy distribution optimization.

[0043] In this regard, such as Figure 1-8As shown, this application proposes an ultrasonic micropore formation system, including a micropore formation unit, an intelligent control system, and a guiding device. The micropore formation unit is disposed on the mating end of the guiding device, which is matched and fixed to the treated area. The micropore formation unit is communicatively connected to the intelligent control system. The micropore formation unit is a high-precision ultrasound generating unit. The micropore formation unit forms ablation micropores at the target ablation location in the treated area. Through a phased array focused ultrasound array or a focused ultrasound transducer, softening treatment of the sclera is achieved. Ultrasound can reduce scleral hardness by reducing the degree of cross-linking of scleral tissue, forming micropores on the sclera, and promoting the regeneration of softened collagen tissue, thereby enhancing the accommodation ability of the ciliary body. The function of the micropore formation unit is to generate focused ultrasound and form micropores at the target location. Possible methods include: thermal effect ultrasound, non-thermal tissue fragmentation ultrasound, and other waveforms that can form micropores on the sclera. The function of the micropore formation unit is to emit ultrasound of specific frequency, energy, and morphology to achieve micropore formation for different individuals. The micropore formation unit can be fixed to the guiding device through slots, channels, clamps, or other structures. The guiding device is used to adjust and fix the position and orientation of the microporous forming unit. The guiding device is fixed on the surface of the treated area. Through special size and shape design, the guiding device can ensure that the ultrasonic focal point of the microporous forming unit is consistent with the target ablation position of the treated area.

[0044] The micropore-forming unit refers to a device capable of generating focused ultrasound waves and forming micropores at the target location. Specifically, it can be implemented using a high-precision ultrasound generator unit, such as a phased array focused ultrasound array or a focused ultrasound transducer. It reduces the degree of cross-linking of scleral tissue and generates softened collagen tissue through waveforms such as thermal effects or non-thermal tissue fragmentation. The intelligent control system is an automated control module that communicates with the micropore-forming unit. Specifically, it can be implemented using a combination of a signal generator and a phase shifter. It controls the ultrasound emission parameters by inputting predetermined waveform, frequency, and energy parameters to adapt to the treatment needs of different individuals. The guiding device is a mechanical structure used to adjust and fix the position and orientation of the micropore-forming unit. Specifically, it can be implemented using a combination of a shell and a corneal adsorption structure. It is fixed to the surface of the treated area by negative pressure adsorption, ensuring spatial consistency between the ultrasound focal point and the target ablation location. The phased array focused ultrasound array is an ultrasound emission module composed of multiple crystals. Specifically, it can be implemented using a piezoelectric ceramic module. By adjusting the phase difference of the ultrasound waves emitted by each element, an interference beam is formed, achieving focusing effects at different depths. Among them, a focused ultrasonic transducer refers to a transmitting device that can concentrate ultrasonic energy at a specific point. Specifically, it can be implemented using a single crystal or multi-crystal bonded structure, and generates ultrasonic waves with specific waveforms and energy through the piezoelectric effect at the resonant frequency.

[0045] The core innovation of this application lies in the synergistic effect of combining a micropore forming unit, an intelligent control system, and a guiding device. By emitting ultrasound waves with specific parameters through a phased array focused ultrasound array or a focused ultrasound transducer, precise and controllable ablation micropores are formed in the target area of ​​the sclera. At the same time, the spatial positioning function of the guiding device is used to ensure treatment accuracy, ultimately achieving the therapeutic effect of reducing scleral hardness and enhancing the ciliary body's accommodation ability.

[0046] The working process and principle of this application are as follows: the ultrasonic micropore formation system includes a micropore formation unit, an intelligent control system, and a guiding device. The micropore formation unit is disposed on the mating end of the guiding device and is used to generate focused ultrasound and form micropores at the target location. The guiding device is matched and fixed to the treated area, adjusting and fixing the position and orientation of the micropore formation unit. The intelligent control system is communicatively connected to the micropore formation unit and controls the frequency, energy, and morphology of the ultrasound waves.

[0047] The micropore-forming unit is a high-precision ultrasound generator that uses a phased array focused ultrasound array or a focused ultrasound transducer to soften the sclera. Ultrasound reduces the degree of cross-linking in the scleral tissue, forms micropores on the sclera, and promotes the regeneration of softened collagen tissue, thereby reducing scleral rigidity and enhancing the ciliary body's accommodative ability. Waveforms such as thermal ultrasound and non-thermal tissue fragmentation ultrasound can be used.

[0048] The guiding device, through its specially designed dimensions and shape, ensures that the ultrasound focal point of the micropore-forming unit aligns with the target ablation location in the treated area. The micropore-forming unit is secured to the guiding device using slots, channels, and clamping structures. The entire system works in concert to achieve precise positioning of the sclera and micropore-forming treatment.

[0049] As a preferred embodiment, the solution of this application is specifically implemented as follows:

[0050] The micropore forming unit employs a phased array focused ultrasonic array, composed of 64 piezoelectric ceramic units. Each unit can independently control its phase and amplitude, achieving dynamic focusing. The operating frequency is 4MHz, and the maximum acoustic power is 50W.

[0051] The guide device is made of medical-grade silicone and has a ring-shaped structure with an inner diameter of 40mm, an outer diameter of 60mm, and a height of 15mm. The ring structure has multiple microporous molding unit fixing grooves, allowing adjustment of the angle and depth of the microporous molding units. The bottom of the guide device has a vacuum adsorption structure for stable fixation to the surface of the eyeball.

[0052] The intelligent control system includes a signal generator, a power amplifier, and control software. The control software can automatically generate optimal ultrasound parameters and focusing positions based on the eye's anatomy and treatment needs.

[0053] In use, the guide device is first fixed to the surface of the eyeball, and then the micropore-forming unit is inserted into the fixing groove. The intelligent control system is then activated, automatically adjusting the ultrasonic parameters to achieve precise micropore formation at the target location. During treatment, the system monitors tissue feedback in real time and dynamically adjusts the ultrasonic parameters to ensure treatment effectiveness.

[0054] Through the above-described method, this application achieves precise positioning and controllable micropore formation of scleral tissue. Compared with traditional mechanical or laser methods, the ultrasonic micropore formation system has the following advantages: First, through an intelligent control system and phased array technology, precise control of ultrasonic energy distribution can be achieved, improving the accuracy of micropore formation. Second, the guiding device matches the anatomical structure of the eyeball, reducing positioning deviation and ensuring the accuracy of treatment location. Third, the system can dynamically adjust ultrasonic parameters according to individual differences, achieving personalized treatment. Finally, the non-invasive treatment reduces the risk of complications. These advantages collectively improve the precision, safety, and effectiveness of scleral softening treatment, providing new possibilities for the treatment of presbyopia.

[0055] This application further proposes a micropore forming unit comprising a handheld part, a fixing part, and a mating part connected in sequence. The end of the mating part is provided with a piezoelectric ceramic module, which is connected to a signal generator in an intelligent control system. By inputting ultrasonic waves with predetermined waveforms, frequencies, and energy, micropore forming at a specific position is achieved.

[0056] The handheld part, which is directly gripped by the operator, can have anti-slip textures or ergonomic curved surfaces. The fixing part, serving as a transition structure between the handheld part and the mating part, has an inclination angle consistent with the outer ring angle of the guide device housing, ensuring surface contact with the housing's protrusions. A piezoelectric ceramic module installed at the end of the mating part is connected to a signal generator via wires. This module can be made of single-layer or multi-layer stacked piezoelectric ceramic sheets, fixed to the end of the mating part by adhesive bonding or mechanical clamping. The resonant frequency range of the piezoelectric ceramic module covers 1MHz to 10MHz, and the peak-to-peak input voltage is controlled between 50V and 200V to adapt to scleral tissues of different depths.

[0057] Specifically, the operator pushes the micropore forming unit along the outer groove of the guide device using the handheld part. The tilt angle of the fixing part matches the outer ring of the outer shell, ensuring a tight fit and preventing wobbling. After the mating part is inserted into the positioning hole, its end piezoelectric ceramic module aligns with the bottom hole in the treatment area. The signal generator outputs a pulse signal with preset parameters to the piezoelectric ceramic module, causing the ceramic sheet to vibrate mechanically under the inverse piezoelectric effect, generating a focused ultrasound beam. When a multi-layer ceramic sheet structure is used, the phase difference between each layer is adjusted by an intelligent control system to achieve superposition and enhancement of sound waves. The ultrasound generated by the piezoelectric ceramic module is transmitted to the target area of ​​the sclera through the bottom hole, forming micropores with a diameter of 50-200μm through thermal or mechanical effects. During treatment, the contact surface between the fixing part and the outer groove provides radial constraint force, and the fitting structure between the mating part and the positioning hole prevents axial displacement, ensuring the positional stability of the piezoelectric ceramic module during continuous operation.

[0058] As a preferred embodiment, the solution of this application is specifically implemented as follows:

[0059] The micropore forming unit comprises a handheld part, a fixing part, and a mating part connected in sequence. A piezoelectric ceramic module is mounted at the end of the mating part. The piezoelectric ceramic module is connected to a signal generator in the intelligent control system. Micropore forming at a specific position is achieved by inputting ultrasonic waves with predetermined waveforms, frequencies, and energy.

[0060] The handle is ergonomically designed, cylindrical in shape with a diameter of 25mm and a length of 120mm, and features a non-slip textured surface. The fixing part is shaped like a truncated cone, with the upper diameter matching the handle and the lower diameter of 20mm and a length of 30mm. The mating part is cylindrical, with a diameter of 15mm and a length of 25mm. The piezoelectric ceramic module is made of PZT-4 material, 1mm thick and 10mm in diameter.

[0061] The signal generator can output a sine wave signal in the range of 1-10MHz, with a maximum output power of 100W. By adjusting the output parameters of the signal generator, micropores of different depths and sizes can be formed. For example, for scleral tissue, typical operating parameters are: frequency 5MHz, power 50W, pulse width 100μs, repetition frequency 1kHz, and treatment time 10s.

[0062] Through the above technical solution, this application achieves a modular design for the micropore forming unit, improving the system's flexibility and reliability. The handheld part facilitates operator grip and control, while the fixing and mating parts precisely engage with the guiding device, ensuring the accuracy of micropore forming. The combined use of the piezoelectric ceramic module and signal generator allows for flexible adjustment of ultrasonic parameters according to the needs of different patients and treatment sites, achieving personalized and precise treatment. This design simplifies the system structure, reduces manufacturing and maintenance costs, and simultaneously improves treatment effectiveness and patient comfort.

[0063] This application further proposes a guiding device including a housing that matches the treated area, one or more bottom holes on the housing corresponding to the target ablation position of the treated area, a housing groove and a positioning hole on the side of the housing that are adapted to the bottom holes, a micropore forming unit that is engaged with the bottom holes through the housing groove and the positioning hole, a handheld part of the micropore forming unit as the main part provided for the operator to hold and operate, a fixed part that is generally inclined and the inclination angle is the same as the outer ring angle of the housing, a mating part that is generally inclined and the inclination angle is the same as the fixed part, and the length is related to the depth of focus.

[0064] The outer shell corresponds to the target ablation position through a bottom hole, and the outer shell groove and positioning hole provide a physical positioning reference for the micropore forming unit. The handheld part adopts an ergonomic structural design, making it easy for the operator to grip and apply force. The tilt angle of the fixing part is consistent with the outer ring angle of the outer shell, ensuring that the contact surfaces of the two are completely fitted and avoiding displacement caused by gaps. The tilt angle of the mating part is the same as that of the fixing part, and its length is adjusted according to the focusing depth, so that it can abut against the edge of the bottom hole when embedded in the positioning hole, forming multi-point constraint.

[0065] Specifically, the operator pushes the micropore forming unit into the outer shell along the outer groove. The inclined surface of the fixing part automatically aligns with the outer ring of the outer shell after contact, and the mating part passes through the positioning hole and inserts into the bottom hole. Because the fixing part and the outer shell are at the same angle, the contact surfaces fit tightly, eliminating lateral displacement; the length of the mating part matches the focusing depth, ensuring the ultrasound focal point is located at the target tissue depth. During treatment, the outer shell is fixed to the surface of the eyeball by an adsorption structure, and the micropore forming unit is positioned by both the outer groove and the positioning hole, avoiding displacement caused by uneven force applied by the operator or eye movement. After treatment, the operator pulls out the micropore forming unit along the outer groove in the opposite direction, and then treats adjacent areas through the next set of positioning holes and bottom holes, achieving continuous and precise micropore array forming.

[0066] As a preferred embodiment, the solution of this application is specifically implemented as follows:

[0067] The guiding device includes a housing that matches the treatment area, one or more bottom holes on the housing corresponding to the target ablation position of the treatment area, and housing grooves and positioning holes on the side of the housing that are adapted to the bottom holes. The micropore forming unit is engaged with the bottom holes through the housing grooves and positioning holes.

[0068] The handheld portion of the micropore forming unit, as its main component, provides the operator with a handheld grip, improving convenience and accuracy. The fixing portion, serving as the outer fixing part of the micropore forming unit, is inclined at the same angle as the outer ring angle of the outer shell. It primarily serves to ensure tight contact with the outer shell and its grooves, securing the handheld unit and enhancing convenience. The mating portion, serving as the inner fixing part of the micropore forming unit, is also inclined. For ease of manufacturing, its inclination angle is the same as the fixing portion, and its length is related to the focusing depth. It primarily serves to engage with the positioning holes on the outer shell, securing the micropore forming unit, preventing loosening during treatment, and ensuring the reliability and accuracy of the treatment.

[0069] In practical implementation, the outer shell can be made of biocompatible materials, such as medical-grade polycarbonate. The shape of the outer shell can be designed as an arc-shaped structure matching the curvature of the eyeball surface to ensure a close fit. Multiple bottom holes can be provided, for example, eight, evenly distributed in a ring on the outer shell, with each bottom hole having a diameter of 5mm. The outer shell grooves can be designed as recessed structures matching the shape of the microporous molding unit's fixing part, with a depth of 2mm. The positioning holes can be designed as cylinders with the same diameter as the mating part of the microporous molding unit to achieve precise positioning. The handle of the microporous molding unit can be ergonomically designed, with a length of 100mm and a diameter of 20mm, and a non-slip textured surface. The fixing part can be designed at a 15° tilt angle with a length of 30mm. The mating part can be designed at the same 15° tilt angle as the fixing part with a length of 25mm. This design ensures that the microporous molding unit, guided by the guide device, is accurately aligned with the target treatment position.

[0070] Through the above technical solution, this application achieves precise coordination between the micropore forming unit and the guiding device, improving the positioning accuracy of ultrasonic micropore forming. The design of the guiding device allows the micropore forming unit to be stably fixed in the target position, reducing operational errors. Simultaneously, the multiple bottom holes allow for multi-point ablation within the same treatment area, improving treatment efficiency. The three-part structural design of the micropore forming unit increases operational convenience and comfort, enabling doctors to perform prolonged operations more easily. Furthermore, the matching design of the outer shell with the surface of the eyeball ensures stability during treatment, reducing treatment risks. Overall, this design significantly improves the accuracy, efficiency, and safety of ultrasonic micropore forming treatment.

[0071] This application further proposes that a corneal adsorption structure is provided at the bottom of the outer shell, which is fixed to the treatment area by a negative pressure adsorption method through a true hole. The corneal adsorption structure provides the micropore forming unit with an accurate position, ensuring the accurate position of the ultrasonic wave emission path during the treatment process and long-term stable operation.

[0072] The corneal adsorption structure physically connects to the surface of the treatment area via a negative pressure adsorption method through true pores. Its interior contains adsorption channels connected to a negative pressure source. Multiple adsorption holes are located at the bottom of the outer shell, connected to the negative pressure source via tubing. When the negative pressure is activated, the outer shell is adsorbed and fixed to the eye surface. An ultrasound coupling fluid, such as deaerated water or saline solution, is filled between the outer shell and the eye surface to ensure efficient delivery of ultrasound energy to the target area. The adsorption force of the corneal adsorption structure can be adjusted to adapt to different patients' eye surface morphologies by adjusting the negative pressure intensity, avoiding tissue damage due to excessive pressure.

[0073] Specifically, before treatment, the outer shell is pre-placed on the patient's eye surface. After negative pressure adsorption is activated, the outer shell adheres tightly to the eye surface, eliminating relative displacement caused by eye movement or manipulation. During treatment, the outer shell maintains a fixed state through adsorption, ensuring that the ultrasound focal point of the microporous molding unit is always aligned with the target ablation site. The filling of ultrasound coupling fluid further reduces energy loss of ultrasound waves during transmission, avoiding scattering or attenuation caused by air gaps. The negative pressure adsorption fixation method does not rely on external mechanical locking devices, simplifying the operation process while improving treatment accuracy, and is especially suitable for scenarios with complex curvature of the eye surface or requiring long-term continuous treatment.

[0074] As a preferred embodiment, the solution of this application is implemented as follows: A corneal adsorption structure is provided at the bottom of the outer shell. The corneal adsorption structure is fixed to the treatment area by vacuum negative pressure adsorption. The corneal adsorption structure includes an annular adsorption groove, which is connected to a vacuum pump. In use, the outer shell is placed on the surface of the eyeball, and the vacuum pump is activated to create negative pressure in the adsorption groove, so that the outer shell and the cornea are tightly adhered. The corneal adsorption structure also has multiple micro-vents to prevent excessive negative pressure from damaging the cornea. Through the corneal adsorption structure, an accurate positional reference can be provided for the microporous molding unit, ensuring the accurate positioning of the ultrasound emission path and long-term stable operation during treatment.

[0075] Through the above technical solution, this application achieves stable fixation between the outer shell and the eyeball. The corneal adsorption structure uses negative pressure adsorption to firmly adhere the outer shell to the surface of the eyeball, avoiding relative displacement during treatment. This fixation method is not only simple to operate but also adaptable to eyeballs of different shapes and sizes. This ensures the positional accuracy of the microporous molding unit, thereby ensuring that the ultrasound waves can accurately act on the predetermined treatment area. Simultaneously, stable fixation makes long-term treatment possible, improving the continuity and effectiveness of treatment. Furthermore, by setting micro-ventilation holes, the risk of corneal damage is reduced, improving the safety of treatment.

[0076] This application further proposes that the ablation micropores be arranged in an array form, including a matrix grid micropore array pattern, an elliptical micropore array pattern, or a polygonal array micropore array pattern. The rectangular grid micropore array pattern, through its equally spaced and regular rectangular layout, forms a uniformly distributed group of micropores within the target area, thereby systematically regulating the stiffness, elasticity, and stress transmission characteristics of the tissue, suitable for scenarios requiring large-area, standardized treatment. The elliptical array micropores are equally spaced, arranged in an elliptical layout, with a major-to-minor axis ratio of 2:1 and a dot spacing of 400 μm. There are 17 points in total, which can act on a smaller area. Using a smaller dot matrix, the corner stress is more uniform compared to the rectangular layout. It can better adapt to the stiffness adjustment of the ciliary body on the sclera and is suitable for small areas and mild scenarios. Taking the hexagonal array as an example, the polygonal array micropore distribution is evenly distributed and uniformly distributed within the hexagonal layout. Compared with the rectangular array and elliptical array, the stress distribution is smaller and can better adjust the stiffness, elasticity and stress transmission characteristics of the tissue. It is suitable for large areas and medium-height scenarios. When the sclera is extremely hard, the circular array micropore distribution can also be used.

[0077] Among them, the matrix grid micropore array mode adopts an equally spaced rectangular layout, and the micropore spacing can be adjusted according to the treatment area area, with the spacing range controlled between 200-600um. The tissue stiffness can be adjusted through the uniformly distributed micropore group; the elliptical array micropore distribution adopts an elliptical layout with a major-to-minor axis ratio of 2:1, with a fixed point spacing of 400um and a total of 17 points, which is suitable for small-area treatment around the ciliary body; the hexagonal array micropore distribution adopts an equally spaced hexagonal arrangement, with the spacing between adjacent micropores being positively correlated with the treatment depth, and the spacing range controlled between 300-500um. The scleral softening effect is improved through multi-directional stress dispersion.

[0078] Specifically, when treating large, standardized areas, a matrix-grid array generates a rectangular array of micropores at fixed intervals. This alters the cross-linking structure of the scleral tissue through uniformly distributed mechanical stress. For example, a rectangular array with a 600µm spacing can be used to cover an 8mm × 8mm area in the central region of the sclera. When treating small, mild lesions, an elliptical array generates 17 micropores with a 400µm spacing, distributed along the annular region of the ciliary body. This elliptical layout reduces stress concentration at corners, allowing for treatment in areas such as 3mm × 1.5mm. When treating high-rigidity sclera, a hexagonal array generates a honeycomb-like array of micropores with a 300µm spacing. This hexagonal stress distribution achieves more uniform tissue remodeling, for example, in scleral areas with a hardness exceeding 50kPa. Different array patterns are automatically matched by an intelligent control system, selecting corresponding parameters based on preoperative modeling data. Precise placement is achieved using the positioning holes of the guide device, and finally, the corresponding micropore array is generated by the phased array focused ultrasound unit.

[0079] As a preferred embodiment, the solution of this application is specifically implemented as follows:

[0080] The ablation micropores are arranged in an array. The array types include matrix grid micropore array, elliptical micropore array, or polygonal micropore array.

[0081] The regular arrangement of rectangular grid micropore arrays forms a uniformly distributed group of micropores in the target area through an equally spaced and regular rectangular layout, thereby systematically regulating the stiffness, elasticity and stress transmission characteristics of the tissue, and is used in scenarios that require large-area and standardized treatment.

[0082] The elliptical array of micropores is evenly spaced in an elliptical layout with a major-to-minor axis ratio of 2:1 and a dot spacing of 400μm, totaling 17 dots. This design can be applied to smaller areas, allowing for the use of smaller dot arrays. Compared to rectangular layouts, it provides more uniform corner stress and better adapts to the stiffness adjustment of the suprascleral ciliary body, making it suitable for small-area, mild cases.

[0083] Taking a hexagonal array as an example, the polygonal array micropore distribution employs an evenly spaced distribution, with uniform distribution within the hexagonal layout. Compared to rectangular and elliptical arrays, this method results in a more subtle stress distribution, better adjusting the tissue's stiffness, elasticity, and stress transmission characteristics, making it suitable for large-area, medium-height applications. For applications with extremely high scleral hardness, a circular array micropore distribution can also be used.

[0084] Through the above technical solution, this application can select an appropriate micropore array pattern according to different treatment needs, achieving precise adjustment of the scleral tissue. The rectangular grid pattern is suitable for large-area standardized treatment, the elliptical array is suitable for small-area mild treatment, and the polygonal array is suitable for large-area moderate to high-degree treatment. This flexible array design allows the ultrasonic micropore shaping system to provide customized treatment plans for different degrees of presbyopia symptoms, improving the accuracy and effectiveness of treatment. Simultaneously, by adjusting the stiffness and elasticity of the scleral tissue, the accommodative ability of the ciliary body is enhanced, thereby improving the visual accommodation function of presbyopia patients.

[0085] This application further proposes a piezoelectric ceramic module formed from a single ceramic sheet or multiple ceramic sheets bonded together to form a pre-defined ceramic sheet. It can also be arranged in a square array to form the desired micropore shape. Its main function is to receive electrical signals generated by a signal generator and generate ultrasound waves with specific waveforms and energy at a resonant frequency, thereby achieving micropore formation in the target area and realizing precise treatment of the lesion area.

[0086] The piezoelectric ceramic module can be formed in three ways: single-chip molding, multi-chip bonding, and array arrangement. Single-chip molding uses a single piezoelectric ceramic material for integral processing and is suitable for generating simple micropore shapes. Multi-chip bonding involves bonding multiple independent ceramic sheets at preset angles and positions to form a composite structure that can generate complex waveforms. Array arrangement involves arranging multiple ceramic sheets in a matrix and forming a specific interference field by independently controlling the phase difference of the electrical signals of each unit, thereby generating an ultrasonic beam that matches the target micropore array.

[0087] Specifically, in the piezoelectric ceramic module's array arrangement, the ceramic sheets are arranged in a 4×4 or 8×8 matrix, with each sheet independently connected to the multi-channel output of the signal generator. When the signal generator applies an electrical signal with a phase difference to different ceramic sheets, the ultrasonic waves generated by each sheet interfere during propagation, forming a focused area that matches the preset micropore array. For example, when generating a rectangular grid micropore array, the ceramic sheets are arranged in an equally spaced matrix, with each element emitting ultrasonic waves of the same frequency but different phases. These beams are superimposed on the scleral surface to form regular micropores with a spacing of 400 μm. When generating a hexagonal micropore array, the ceramic sheets are arranged in a hexagonal pattern, and by adjusting the phase difference between adjacent elements, the focused area exhibits a hexagonal stress distribution. The resonant frequency of the piezoelectric ceramic module is controlled within the range of 1-10 MHz, the pulse width of the electrical signal is 10-100 μs, and the energy of a single pulse is 50-200 mJ. By adjusting the above parameter combinations, the micropore depth can be precisely controlled within the range of 50-200 μm.

[0088] As a preferred embodiment, the solution of this application is specifically implemented as follows:

[0089] The piezoelectric ceramic module is composed of multiple ceramic sheets bonded together to form a predetermined shape. Specifically, it uses four rectangular ceramic sheets, each measuring 10mm x 5mm x 1mm. These four ceramic sheets are bonded together with epoxy resin to form a square, with a side length of 10mm. A 2mm diameter circular hole is made in the center of the square ceramic sheet for mounting a focusing lens.

[0090] Furthermore, a square array is used to form the desired micropore shape. For example, a 4x4 square array with 16 piezoelectric ceramic units is used. Each unit is 2.5mm x 2.5mm in size, and the spacing between units is 0.5mm. This arrangement can form a 4x4 rectangular micropore array.

[0091] The piezoelectric ceramic module receives an electrical signal generated by a signal generator. This generates ultrasound waves with specific waveforms and energy at a resonant frequency of 20 kHz. Specifically, the generated ultrasound power is 5 W, the pulse duration is 100 ms, and the pulse repetition frequency is 1 Hz. These parameter settings allow for micropore formation in the target area, enabling precise treatment of lesions.

[0092] Through the above technical solution, this application enables flexible configuration of the piezoelectric ceramic module, improving the precision and efficiency of micropore formation. By using a multi-ceramic sheet bonding method, the shape and size of the ceramic module can be customized according to different treatment needs. The square array design further enhances the focusing effect of ultrasound, resulting in a more uniform and controllable distribution of micropores formed in the target area. Furthermore, by adjusting the parameters of the signal generator, the frequency, power, and waveform of the ultrasound can be precisely controlled, thereby achieving customized treatment for different individuals and different degrees of lesions. This highly adjustable design greatly improves the flexibility and applicability of treatment, effectively overcoming the limitations of traditional ultrasound therapy equipment in personalized treatment.

[0093] This application further proposes a robotic arm structure for the guiding device, which is electrically controlled and driven by a motor to lock the micropore forming unit, activate the ultrasonic emission module, and use the piezoelectric ceramic module to emit ultrasonic waves to treat the patient's eyes, fundamentally reducing the complexity of the operation. The locking device is easy to operate, requiring minimal skill from the operator, and can move in any area, reducing errors in the treatment area caused by device inaccuracies.

[0094] The robotic arm structure includes a multi-axis linkage mechanism, which uses servo motors to drive translation and rotation in three-dimensional space. The motor drive system communicates with the intelligent control system, receives preset path commands, and moves the micro-hole forming unit to the target coordinates. The locking device uses electromagnetic adsorption or pneumatic clamping mechanisms to automatically lock the unit after positioning to prevent displacement deviation. The activation signal of the ultrasonic emission module is triggered by the intelligent control system, and the piezoelectric ceramic module generates ultrasonic waves of a predetermined frequency after receiving the electrical signal.

[0095] Specifically, the robotic arm's electric control system uses a preset program to plan the path, with motors driving each joint to the target position. A locking device automatically secures the microporous forming unit after positioning. The intelligent control system simultaneously activates the piezoelectric ceramic module, emitting a focused ultrasonic beam. Because the mechanical motion precision reaches the micrometer level, the spatial error between the ultrasonic focal point and the target area of ​​the sclera is controlled within 50 micrometers. During treatment, the operator only needs to select treatment parameters through the control interface; the robotic arm automatically completes the positioning, locking, and energy emission processes, reducing single-point treatment time to less than 10 seconds. This structure allows for repeated execution of the treatment path, avoiding path deviations caused by manual operation, and is particularly suitable for continuous multi-area treatment of curved scleral surfaces.

[0096] As a preferred embodiment, the solution of this application is specifically implemented as follows:

[0097] The guiding device employs a robotic arm structure, electrically controlled. The robotic arm structure includes a base, a support, joints, and an end effector. The base is fixed to the treatment table, and the support is connected to the base via joints. The joints are driven by servo motors, enabling multi-degree-of-freedom movement. The end effector is designed to be replaceable, adaptable to different models of microporous molding units.

[0098] The robotic arm adjusts its position via a motor drive. The control system employs a PID closed-loop control algorithm to monitor and adjust the robotic arm's position in real time. Position sensors are installed at each joint to provide precise position feedback.

[0099] The locking mechanism employs an electromagnetic lock design. Once the micropore forming unit is in place, the control system issues a locking command, energizing the electromagnetic lock to generate magnetic force and secure the micropore forming unit. The locking force is adjustable to accommodate different treatment requirements.

[0100] Activation of the ultrasonic transmitting module is achieved through a linkage between the control system and the robotic arm. Once locking is complete, the control system automatically sends an activation signal to the piezoelectric ceramic module, initiating ultrasonic transmission. Transmission parameters such as frequency, power, and duration can be preset.

[0101] The entire treatment process is controlled by a graphical interface. The operator only needs to select the treatment area and parameters on the interface, and the system can automatically complete the entire process of positioning, locking, and ultrasound emission.

[0102] Through the above technical solutions, this application reduces operational complexity and improves treatment precision. The robotic arm structure enables precise positioning of the micropore forming unit, and the electric locking mechanism ensures stability during treatment. The automated control system simplifies the operation process and reduces human error. Furthermore, this solution offers high flexibility and can adapt to different patients and treatment requirements.

[0103] This application further proposes that the outer shell is provided with multiple bottom holes, and the side of the outer shell is provided with an outer shell groove and a positioning hole corresponding to each bottom hole. At least one or more combinations of bottom holes-outer shell groove-positioning holes can be formed on the outer shell, thereby achieving multi-point ablation of the same treatment area.

[0104] The multiple bottom holes on the outer shell allow for the simultaneous or sequential placement of multiple micropore forming units. Each bottom hole corresponds to an outer shell groove and a positioning hole, ensuring precise alignment of the micropore forming unit with the target ablation site. This combination of bottom holes, outer shell grooves, and positioning holes allows the operator to flexibly adjust the number and location of ablation points, covering a larger treatment area. At least one pair of these combinations is allowed, such as two or three pairs, to meet the clinical needs of different treatment ranges.

[0105] Specifically, the outer shell utilizes a combination design of multiple sets of bottom holes, outer shell grooves, and positioning holes to allow the operator to repeatedly insert the micropore forming unit at different locations within the same treatment area. When the micropore forming unit is inserted into the bottom hole through the outer shell groove and positioning hole, its mating part engages with the positioning hole, and its fixing part makes tight contact with the outer shell groove, ensuring that the ultrasound focal point is always aligned with the target ablation location. After treatment is completed at the current location, the operator can remove the micropore forming unit and move it to the next set of holes to repeat the ablation operation. This structure, through physical constraints and geometric matching, prevents device displacement during treatment, ensuring the accuracy and consistency of multi-point ablation. For example, the outer shell can be configured with three sets of bottom holes, outer shell grooves, and positioning holes, forming a triangular distribution, allowing the ablation micropores to evenly cover the periphery of the ciliary body, effectively reducing the overall hardness of the sclera.

[0106] As a preferred embodiment, the solution of this application is implemented as follows: The outer shell is configured to include eight sets of bottom holes, outer shell grooves, and positioning holes, each set of structures being distributed at equal angles along the circumference of the shell. The bottom holes adopt a tapered opening design, with an opening diameter of 3.2 mm and a terminal diameter of 2.0 mm, forming a clearance fit with the end of the mating part. The outer shell groove is provided with an inclined guide surface, the inclination angle of which is consistent with the slope of the outer contour of the fixing part, ensuring that the microporous forming unit can slide along a predetermined path when inserted. The inner wall of the positioning hole is provided with an annular limiting boss, which forms a mechanical interlock with the annular groove at the end of the mating part when the mating part is fully inserted. During treatment, the operator can sequentially insert the microporous forming unit into the combination structure at different positions, and achieve precise ablation of the eight quadrants around the ciliary body by rotating the outer shell.

[0107] Through the above technical solution, this application achieves multi-point ablation of the same treatment area, effectively solving the problem of limited coverage in traditional single-point treatment. With multiple pre-set combination structures, the operator can complete multi-directional treatment without repeatedly disassembling the guide device, avoiding the cumulative errors caused by repeated device positioning during treatment. The mechanical interlocking structure ensures the repeatability of each positioning, making the geometric distribution of multi-point ablation perfectly match the preoperative plan, significantly improving the uniformity of scleral stiffness adjustment and the controllability of treatment effects.

[0108] This application further proposes a method of using an ultrasonic micropore forming system, comprising the following steps: (1) modeling the patient's eyeball structure to generate an outer shell structure that matches the position and fixation requirements of the target tissue to be treated on the patient's eye. Under this structure, the focused ultrasound generated by the ultrasonic emission module of the micropore forming unit is accurately focused on the spatial position of the target tissue to be formed; (2) placing the outer shell outside the patient's eyeball at a predetermined position and using a vacuum pump to create negative pressure to fix it on the eyeball. After the outer shell and the eyeball are tightly connected, filling the outer shell with an appropriate amount of ultrasonic coupling fluid, such as deaerator water. Or saline solution, to ensure that the ultrasound can reach the designated treatment area with maximum energy; (3) The operator puts the micropore forming unit into the outer shell, while ensuring that the fixing part of the micropore forming unit fits tightly with the groove of the outer shell, and that the mating part of the micropore forming unit passes through the positioning hole on the outer shell and fits with the bottom hole. Turn on the signal switch and start the treatment according to the specific ultrasound energy and time; (4) After the treatment is completed at the current position, the operator pulls the micropore forming unit out from the bottom hole and passes it out from the positioning hole on the outer shell, and then passes it in from the positioning hole on the next outer shell and inserts it into the bottom hole to repeat the ultrasound emission treatment. (5) After the treatment is completed, remove the outer shell.

[0109] In step (1), the modeling process constructs a geometric model of the eyeball using 3D scanning or medical imaging data. The curvature of the inner surface of the generated outer shell matches the surface of the sclera, with the error controlled within ±0.1mm. In step (2), the negative pressure adsorption pressure is set to -20kPa to -30kPa, the coupling fluid filling volume is controlled at 0.5-1.0ml, and the fluid layer thickness is maintained at 1-2mm. In step (3), the ultrasonic energy density is set to 10-30mJ / mm², and the single action time is 50-100ms. In step (4), the repeated positioning is achieved through a pre-set positioning hole array on the outer shell, with the distance error between adjacent holes not exceeding ±50μm.

[0110] Specifically, in the ocular structure modeling stage, reverse engineering technology is used to obtain the three-dimensional coordinates of the scleral surface. The generated outer shell is CNC machined, with its inner surface curvature radius deviating from the scleral curvature radius by less than 2%. During negative pressure fixation, the annular sealing ring of the corneal adsorption structure forms an airtight contact with the limbus, and the vacuum pump suction rate is controlled at 0.5 L / min. The coupling fluid filling uses a constant temperature control system to maintain the liquid temperature at 35-37℃ to avoid refractive index fluctuations caused by temperature changes. During treatment, the phased array focused ultrasound unit dynamically adjusts the phase difference of each array element to control the focal spot diameter at 200-300 μm, and the depth of focus adjustment accuracy reaches ±0.05 mm. During repeated treatments, the tapered fit structure of the positioning hole and the bottom hole ensures repeatable positioning accuracy, with the cone angle tolerance controlled at ±0.5°. After treatment, the negative pressure release valve slowly restores atmospheric pressure at a rate of 0.1 MPa / s to prevent sudden pressure changes from damaging ocular tissues.

[0111] As a preferred embodiment, the specific implementation of this application is as follows: First, the anterior segment structure data of the patient's eyeball is acquired using a three-dimensional scanning device. A transparent polymer shell matching the curvature of the sclera is constructed based on computer-aided design software. An annular adsorption groove is provided at the edge of the shell, and a micro-vacuum pump is used to create an airtight connection between the adsorption groove and the limbus. Then, preheated sodium hyaluronate gel at 35°C is injected into the cavity between the shell and the sclera, and after air is removed, a uniform acoustic coupling layer is formed. The operator selects the positioning hole marked in red on the side of the shell and pushes the cylindrical ultrasound probe along the guide rail until the pressure sensor at the probe tip detects a contact pressure of 0.2N. The phased array ultrasound emission program is activated, and irradiation is performed continuously for 120 seconds with parameters of a center frequency of 3MHz, a pulse width of 50μs, and a peak negative pressure of 8MPa. After single-point treatment, the positioning hole is rotated sequentially along the preset spiral trajectory of the shell, and the above irradiation process is repeated until all eight treatment sites are covered.

[0112] Through the above technical solutions, this application achieves personalized adaptation to the biomechanical characteristics of the eyeball. The combination of physical limiting structures and negative pressure fixation ensures spatial consistency of the treatment path, and the dynamic filling of the acoustic coupling medium effectively eliminates acoustic impedance differences at the tissue interface. During treatment, the mechanical positioning error of the probe is controlled within ±50μm, and the focal domain positioning accuracy of the phased array beam reaches sub-millimeter level, significantly reducing the risk of damage to non-target areas due to instrument displacement. This implementation maintains the advantages of non-invasive treatment while shortening the treatment time to within 15 minutes through standardized operating procedures. Postoperative follow-up data shows an average increase in accommodative amplitude of 1.75D with no cases of corneal endothelial cell loss.

[0113] like Figure 9-10As shown, this application further proposes that during ultrasonic wave emission, the intelligent control system generates a reference signal, assigns different phases to each unit via a phase shifter, and the phased array probe adjusts the phase of the ultrasonic waves emitted by each array element to focus on a specific depth of the human body. By changing the specific phase difference, focusing at different depths on the curved surface can be achieved. The phased array probe consists of multiple crystals, and the ultrasonic waves emitted by each activated crystal are secondary waves. These secondary waves interfere with each other to form an ultrasonic beam. The phased array section applies piezoelectric pulse signals with different delays according to preset rules to the crystals to be activated, thereby generating different beams, giving the ultrasonic beams corresponding waveforms, and enabling them to be focused at different depths.

[0114] Its basic principle is based on the interference properties of waves and the nature of beamforming. The interference property of waves means that when multiple electromagnetic waves of the same frequency propagate in space, they will interfere due to phase differences. If two waves are in phase, they will reinforce each other (constructive interference); if they are in opposite phases, they will destructively interfere with each other. The essence of beamforming is that a phased array adjusts the phase of the signals transmitted by each antenna element, causing the electromagnetic waves to superimpose and amplify in the target direction due to their identical phase, forming a high-intensity beam; in other directions, they cancel each other out due to their different phases, thus achieving directional beam radiation.

[0115] As a preferred embodiment, the solution of this application is implemented as follows: The phased array focused ultrasound unit consists of 128 rectangular piezoelectric crystals arranged in a ring array, with each crystal having a thickness of 0.5 mm and a width of 1.2 mm. After generating a 10 MHz reference electrical signal, the intelligent control system applies a phase shift within the range of 0-360° to each crystal via a digital phase shifter. When the treatment target is located in the superficial layer of the sclera, the phase shifter controls the phase difference between each crystal within a 1 / 4 wavelength range, causing the ultrasound beam to form a focal spot 0.3 mm from the probe surface; when it is necessary to act on deeper tissues, the phase shifter adjusts to provide an arithmetically increasing phase delay for each crystal, causing the secondary waves to coherently superimpose at a distance of 1.2 mm from the surface. The ultrasound frequency generated by each crystal is 5 MHz, the single pulse width is 50 microseconds, and the pulse repetition frequency is 1 kHz. The phased array probe is connected to a signal generator via a flexible circuit board, and the waveform synthesis module built into the signal generator can generate linear frequency modulated waveforms or Gaussian envelope waveforms.

[0116] Through the above technical solution, this application achieves the technical effect of non-mechanical dynamic adjustment of ultrasound focusing depth. By replacing the traditional mechanical movement of the transducer with electronically controlled phase difference, the focal spot position can be continuously adjusted within the range of 0.3-1.5 mm, overcoming the technical limitation of existing ultrasound therapy devices that require physical movement of the transducer to change the depth of action. This solution maintains the structural stability of the device while enabling ultrasound energy to precisely act on the target layered structure of the sclera, avoiding damage to adjacent ocular tissues and improving the safety and controllability of the treatment process.

[0117] The above embodiments merely illustrate several implementation methods of this application, and while the descriptions are relatively specific and detailed, they should not be construed as limiting the scope of the invention patent. It should be noted that those skilled in the art can make various modifications and improvements without departing from the concept of this application, and these all fall within the protection scope of this application. Therefore, the protection scope of this patent application should be determined by the appended claims.

[0118] Although embodiments of the invention have been shown and described, it will be understood by those skilled in the art that various changes, modifications, substitutions and alterations can be made to these embodiments without departing from the principles and spirit of the invention, the scope of which is defined by the appended claims and their equivalents.

Claims

1. An ultrasonic micropore forming system, comprising a micropore forming unit, an intelligent control system, and a guiding device, wherein the micropore forming unit comprises a handheld part, a fixing part, and a mating part connected in sequence, wherein a piezoelectric ceramic module is provided at the end of the mating part, and the piezoelectric ceramic module is connected to a signal generator in the intelligent control system; the guiding device comprises a shell matching the treatment area, and one or more bottom holes provided on the shell corresponding to the target ablation position of the treatment area, wherein the shell side is provided with a shell groove and a positioning hole adapted to the bottom holes, and the micropore forming unit is mated with the bottom holes through the shell groove and the positioning hole; the micropore forming unit is disposed on the mating end of the guiding device, the guiding device is matched and fixed to the treatment area, the micropore forming unit is communicatively connected to the intelligent control system, the micropore forming unit is a high-precision ultrasonic generating unit, and the micropore forming unit forms ablation micropores at the target ablation position of the treatment area.

2. The ultrasonic micropore forming system according to claim 1, characterized in that: A corneal adsorption structure is provided at the bottom of the outer shell.

3. The ultrasonic micropore forming system according to claim 1, characterized in that: The ablation micropores are arranged in an array, including a matrix grid micropore array pattern, an elliptical micropore array pattern, or a polygonal array micropore array pattern.

4. The ultrasonic micropore forming system according to claim 3, characterized in that: The piezoelectric ceramic module is formed from a single ceramic sheet or multiple ceramic sheets bonded together to form a ceramic sheet of a preset shape.

5. The ultrasonic micropore forming system according to claim 1, characterized in that: The guiding device is a robotic arm structure.

6. The ultrasonic micropore forming system according to claim 1, characterized in that: The outer shell has multiple bottom holes, and a shell groove and a positioning hole are provided on the side of the outer shell corresponding to each bottom hole.

7. The ultrasonic micropore forming system according to claim 1, characterized in that: The ultrasonic generating unit of the micropore forming unit is a phased array focused ultrasonic unit.

8. A control method for an ultrasonic micropore forming system, using the ultrasonic micropore forming system according to any one of claims 1-7, comprising the following steps: (1) Model the patient’s eye structure to generate an outer shell structure that matches the position and fixation requirements of the target tissue in the patient’s eye. Under this structure, the focused ultrasound generated by the ultrasonic emission module of the microporous forming unit is accurately focused on the spatial position of the target tissue to be formed. (2) Place the outer shell outside the patient’s eyeball in the predetermined position, and use a vacuum pump to create negative pressure to fix it on the eyeball. After the outer shell and the eyeball are tightly connected, fill the outer shell with an appropriate amount of ultrasound coupling fluid to ensure that the ultrasound can reach the designated treatment area with maximum energy. (3) The operator places the microporous forming unit into the outer shell, while ensuring that the fixing part of the microporous forming unit fits tightly with the groove of the outer shell, and that the mating part of the microporous forming unit passes through the positioning hole on the outer shell and fits with the bottom hole. The operator turns on the signal switch and starts ultrasonic emission according to the specific ultrasonic energy and time. (4) After ultrasonic emission is completed at the current position, the operator pulls the micropore forming unit out of the bottom hole and through the positioning hole on the outer shell, and then through the positioning hole on the next outer shell, inserts it into the bottom hole, and repeats the ultrasonic emission. (5) After completing the ultrasonic emission, remove the outer shell.

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