An ablation system and method

Abstract

The application discloses an ablation system and method, which integrates a handheld ablation unit and a guide device. The handheld ablation unit is fixed and directionally guided by the guide device fixed on the surface of the tissue to be ablated. In combination with intelligent image guidance and energy self-adaptive regulation technology, the focus of focused ultrasound is located at the target ablation position, and accurate positioning of the target ablation position is realized. The system utilizes digital twin navigation technology and combines with a millimeter-level micro parallel robot to realize high-precision automatic measurement and ablation site positioning, reduce the workload of manual adjustment of doctors, optimize the treatment process, greatly improve the treatment efficiency, and is suitable for a larger range of patient groups.

Description

TECHNICAL FIELD

[0001] The present application belongs to the technical field of surgical treatment equipment, and particularly relates to an ablation system and method. BACKGROUND

[0002] Glaucoma is a blinding eye disease that seriously threatens vision, and its main characteristics are optic nerve damage and visual field defects. Elevated intraocular pressure (IOP) is a key factor leading to the progression of glaucoma. Current clinical treatment mainly relies on drugs, lasers and surgical methods to reduce eye pressure. However, drug treatment needs long-term dependence, and some patients have poor compliance and obvious side effects. Laser treatment can reduce eye pressure to some extent, but the effect is greatly affected by individual differences and may cause inflammation and tissue damage. Surgical treatment (such as trabeculectomy and drainage implantation) has a significant effect on reducing eye pressure, but the surgical risk is high, which may cause complications such as low eye pressure, infection and decreased visual function. Therefore, finding a treatment method with small trauma, safety and effectiveness and repeatable operation has become the focus of current glaucoma treatment research.

[0003] In recent years, high-intensity focused ultrasound (HIFU) technology has been introduced into the field of glaucoma treatment, and ultrasound cycloplasty (ultrasound ablation) has been developed. This technology selectively destroys the epithelial cells of the ciliary process by using precisely focused ultrasound energy on the ciliary body, reduces aqueous humor production, and promotes aqueous humor outflow, thereby reducing eye pressure. Ultrasound ablation is a non-invasive treatment method that does not require surgical incision, is easy to operate, has short recovery time, and can be repeated according to patient needs, especially suitable for patients with refractory glaucoma who are ineffective for drug treatment or have high surgical risk.

[0004] In the field of glaucoma treatment, the prior art mainly achieves the goal of reducing intraocular pressure or nerve protection through three paths of device verification, drug intervention and energy control. For example, the Chinese patent application with publication number CN116929817A provides an ultrasonic therapeutic instrument testing device, which uses a three-dimensional sliding table and a negative pressure control system to adsorb animal eyeballs to simulate a treatment environment for verifying mechanical precision. The Chinese patent technology with publication number CN115105500B develops a nicotinamide-pyruvic acid oral composition, which uses nicotinamide as a precursor to enhance the metabolic function of retinal ganglion cells. The Chinese patent application with publication number CN117038090A provides an HIFU energy prediction model and parameter determination method, which further improves the accuracy of preoperative treatment planning through machine learning and multi-parameter training. However, the above-mentioned prior art has significant limitations: device verification cannot reflect the anatomical characteristics of the human eye using animal samples, drug regimens ignore the regulation of aqueous humor circulation and have low bioavailability, energy control lacks real-time feedback mechanism during surgery, resulting in insufficient treatment accuracy, and none of the technical solutions achieve the synergistic effect of inhibiting aqueous humor production and promoting drainage. In addition, existing ultrasonic ablation devices are usually large in size and are mainly fixed medical devices, which are mainly used in hospitals and professional ophthalmology clinics, limiting the convenience and popularity of the technology.

[0005] Therefore, there is an urgent need for a new glaucoma treatment scheme that integrates precise energy closed-loop control, dual mechanism synergistic intervention and individualized dynamic adaptation to break through the bottleneck of existing technology. SUMMARY

[0006] In view of the above, the present application provides an ablation system and method, which can further improve the flexibility and accessibility of ultrasonic ablation technology, and significantly improve the accuracy, safety and efficiency of ultrasonic ablation treatment.

[0007] An ablation system, comprising a handheld ablation unit and a guide device, the handheld ablation unit is installed on the guide device and adopts a handheld design, used to generate focused ultrasonic waves to perform high-temperature ablation on the tissue at the target ablation position; the guide device is fixed on the surface of the tissue to be ablated, used to provide guidance for the handheld ablation unit to the target ablation position.

[0008] Further, the handheld ablation unit comprises a pen-shaped handheld structure for the operator to hold, and a protruding structure is arranged on the handheld structure, which is tightly embedded with the guide device in the form of clamping slot, channel or clamping. An ultrasonic probe is arranged at the end of the handheld structure, and the ultrasonic probe uses a piezoelectric ceramic module as an ultrasonic wave emitting component to generate ultrasonic waves with specific frequency, energy and waveform through electrical signal driving.

[0009] Further, the guiding device comprises a horn-shaped housing body, which is provided with discrete or sliding holes at the bottom for inserting the ultrasonic probe of the handheld ablation unit to aim at the target ablation position; the inner side of the housing body is provided with a whole-circle edge groove for fitting the protruding structure of the handheld ablation unit; the lower part of the housing body is provided with an adsorption structure for tightly fixing the tissue to be ablated by negative pressure adsorption.

[0010] Further, the discrete holes are arranged in multiple through holes; the sliding holes are composed of an inner ring, an outer ring and a continuous structure connecting the inner and outer rings, wherein the end of the continuous structure divides the inner and outer ring structures into several treatment sliding grooves, which are hollow structures and can transmit ultrasonic waves, the ultrasonic probe of the handheld ablation unit continuously slides in the treatment sliding grooves to form a continuous treatment area; the continuous structure cannot transmit ultrasonic waves, which can avoid the ultrasonic waves hitting the parts with sensitive nerves and blood vessels on the tissue, and can ensure the safety of treatment.

[0011] Further, the adsorption structure is filled with an appropriate amount of coupling liquid to minimize energy loss during ultrasonic wave propagation and improve ablation effect.

[0012] As another embodiment, the guiding device comprises a double-truncated cone-shaped housing body, which is composed of two truncated cone structures connected by a connecting structure, the upper truncated cone is in contact with air, the lower truncated cone is in contact with the tissue to be ablated, the inner side of the upper truncated cone is provided with a whole-circle trapezoidal groove for fitting the protruding structure of the handheld ablation unit; the contact surface of the upper and lower truncated cones is provided with multiple holes for inserting the ultrasonic probe of the handheld ablation unit to aim at the target ablation position.

[0013] Further, a high-precision miniature camera is installed on the handheld structure to collect high-definition images of the target ablation position in real time and send feedback to the external device for display.

[0014] The treatment method using the above ablation system comprises the following steps:

[0015] (1) Modeling according to the structure of the tissue to be ablated of the patient, manufacturing a guiding device structure that accurately matches the tissue to be ablated of the patient;

[0016] (2) placing the guiding device on the tissue to be ablated of the patient according to the predetermined position, and forming negative pressure by suction to stabilize on the surface of the tissue to be ablated; after the guiding device and the tissue to be ablated are tightly fixed, filling an appropriate amount of coupling liquid into the adsorption structure of the guiding device;

[0017] (3) The operator places the handheld ablation unit into the guiding device, ensuring that the protruding structure of the handheld ablation unit is tightly fitted into the edge groove of the guiding device, and inserts the ultrasound probe of the handheld ablation unit into the corresponding hollow at the bottom of the guiding device to align the target ablation position;

[0018] (4) The ultrasound probe is driven by an electrical signal to generate ultrasound waves of a specific frequency, energy, and waveform, and high-temperature ablation treatment is performed on the tissue at the target ablation position. After completing the treatment at the current position, the handheld ablation unit is removed from the hollow and the edge groove, and the next target ablation position is aligned according to the operation of step (3).

[0019] (5) After completing the entire treatment cycle, the operator removes the handheld ablation unit from the guiding device and removes the guiding device from the patient's ablation tissue.

[0020] An ultrasound ablation device based on automatic positioning navigation includes a robot system, a handheld ablation unit, a feedback display screen, and an external camera. The external camera is used to collect image data of the patient's treatment area and feed it back to the robot system. The handheld ablation unit includes a pen-shaped handheld structure connected to the mechanical arm of the robot system. A high-precision miniature camera is provided on the handheld structure to collect high-definition images of the target ablation position in real time. The high-definition images collected are presented on the feedback display screen through the robot system. A temperature sensor and an ultrasound probe are provided at the end of the handheld structure. The ultrasound probe uses a piezoelectric ceramic module as an ultrasonic wave emitting component and is driven by an electrical signal to generate ultrasound waves of a specific frequency, energy, and waveform. The temperature sensor is used to collect temperature signals at the position of the ultrasound focus point during treatment and feed them back to the robot system.

[0021] The robot system obtains structural data of the patient's ablation tissue through high-precision image scanning before surgery and establishes a three-dimensional digital twin model of the ablation tissue in combination with anatomical parameters. The twin model is updated in real time during surgery using image data and temperature information. During treatment, the robot system guides the handheld ablation unit to move to the treatment area through the mechanical arm based on the image data fed back by the external camera. The high-definition images fed back by the built-in camera of the handheld ablation unit are used to detect the micro-movement of the ablation tissue. In combination with the digital twin navigation technology and the three-dimensional digital twin model, precise prediction of temperature and tissue response is achieved, and position errors caused by micro-movement are compensated. The position and angle of the handheld ablation unit are then fine-tuned to achieve precise positioning and stable control of the ultrasound probe. The position of the ultrasound focus point is dynamically adjusted to achieve automatic tracking and correction, so that the ultrasound focus point is always accurately aligned with the target ablation position.

[0022] The ultrasonic ablation device of the application integrates a high-precision ultrasonic generating unit, an intelligent control unit and an adjustable positioning device, so that it can be used in an outpatient environment, realizing convenient, safe and efficient glaucoma treatment; the handheld design not only improves the portability of the device, but also enhances the flexibility of the doctor's operation, and can combine intelligent image guidance and energy adaptive regulation technology to improve the degree of individualization and safety of treatment.

[0023] The handheld ultrasonic ablation system of the application optimizes ultrasonic energy transmission, improves treatment accuracy, and at the same time reduces patient discomfort. In addition, the system can be connected with a mobile terminal to realize remote monitoring and treatment record management, further improving the treatment experience and follow-up convenience of glaucoma patients, providing a safe, convenient and reusable glaucoma treatment scheme for glaucoma patients, promoting the wide application of ultrasonic ablation technology and benefiting more patients. Therefore, the application has the following beneficial technical effects:

[0024] 1. Improve treatment accuracy: traditional ultrasonic ablation devices are difficult to achieve precise focusing during treatment, affecting treatment effect and possibly damaging surrounding healthy tissues; the application establishes a patient-specific digital twin model, and combines intraoperative imaging and sensors to realize real-time monitoring and adjustment of ultrasonic focal point, ensuring that ultrasonic energy is accurately applied to the target area, improving treatment effect.

[0025] 2. Precise matching of diseased tissue: the application uses digital twin technology to establish a patient-specific anatomical model, so that the ultrasonic ablation area is precisely matched with the diseased tissue, ensuring that the ultrasonic focal point acts on the lesion and reducing the risk of damaging normal tissues, thereby improving the safety and effectiveness of treatment.

[0026] 3. Enhance the convenience of doctor's operation: the application is equipped with a high-precision feedback display system, which presents the position of the ultrasonic focal point, the temperature of the treatment area and other key information in real time, so that the doctor can intuitively monitor and quickly adjust the treatment parameters according to the feedback, improving the controllability and convenience of the operation.

[0027] 4. Individualized treatment plan: the system of the application establishes a precise model based on the individual anatomical characteristics of the patient, combines real-time imaging and sensor data to automatically optimize the treatment plan, realizes individualized treatment strategy, improves the pertinence and curative effect, and meets the needs of different patients.

[0028] 5. Reduce side effects and complications: the application uses precise focusing and intelligent temperature control technology to avoid damage to surrounding normal tissues by traditional treatment methods, reduce side effects and postoperative complications that may occur during treatment, and improve patient comfort and treatment safety.

[0029] 6. Improve treatment efficiency: The system of the present application uses digital twin navigation technology combined with millimeter-level micro parallel robots to realize high-precision automatic measurement and ablation site positioning, reduce the workload of manual adjustment by doctors, optimize the treatment process, and greatly improve the treatment efficiency, which is suitable for a larger range of patient groups.

[0030] 7. Wide applicability: The ultrasonic ablation technology and navigation scheme of the present application is not only suitable for glaucoma treatment, but also can be popularized to other medical fields that require precise positioning and energy control, such as tumor ablation, tissue repair, minimally invasive treatment, etc., which expands the application range of the technology and improves the medical accessibility. BRIEF DESCRIPTION OF DRAWINGS

[0031] Figure 1 It is a schematic diagram of the simple structure and application scene of the ablation system of the present application.

[0032] Figure 2 It is a schematic diagram of the structure of the handheld ablation unit.

[0033] Figure 3 It is a schematic diagram of the overall structure of the ablation system of the present application.

[0034] Figure 4 It is a schematic diagram of the cross-sectional structure of the ablation system of the present application.

[0035] Figure 5 It is a schematic diagram of one embodiment structure of the shell body.

[0036] Figure 6 It is a schematic diagram of one embodiment structure of the guide device.

[0037] Figure 7 It is a schematic diagram of the structure of the slidable cavity.

[0038] Figure 8 It is a schematic diagram of one embodiment structure of the ablation system of the present application.

[0039] Figure 9 It is a functional schematic diagram of the automatic positioning and navigation based ultrasonic ablation equipment of the present application.

[0040] Figure 10 It is a structural schematic diagram of the automatic positioning and navigation based ultrasonic ablation equipment of the present application.

[0041] In the diagram: 1—Handheld ablation unit, 2—Guiding device, 3—Tissue to be ablated, 4—Target ablation location, 5—Robot system and its robotic arm, 6—External camera, 101—Handheld structure, 102—Protruding structure, 103—Piezoelectric ceramic module, 104—High-precision miniature camera, 201—Outer shell, 202—Edge groove, 203—Adsorption structure, 301—Discrete structural cavity, 302—Sliding structural cavity, 303—Bottom cavity, 401—Patient's eyeball, 2011—Upper truncated cone, 2012—Lower truncated cone, 2022—Trapezoidal groove, 3011—Cavity, 3021 and 3022—Treatment sliding groove, 3023 and 3024—Continuous structure, 3025—Inner ring, 3026—Outer ring. Detailed Implementation

[0042] To describe the present invention in more detail, the technical solution of the present invention will be described in detail below with reference to the accompanying drawings and specific embodiments.

[0043] like Figure 1 As shown, the ablation system of the present invention includes a handheld ablation unit 1 and a guide device 2. The handheld ablation unit 1 generates focused ultrasound waves, which generate high temperature at the target ablation position 4 to complete the ablation. The guide device 2, which is fixed to the surface of the tissue to be ablated 3, fixes and guides the handheld ablation unit 1 so that the focus of the focused ultrasound waves is located at the target ablation position 4, thereby achieving precise positioning of the target ablation position 4.

[0044] The function of the handheld ablation unit 1 is to emit ultrasound waves of specific frequency, energy and shape to achieve precise ablation treatment of tissues at the target location. The handheld ablation unit 1 is fixed on the guide device 2 through a structure such as a slot, channel or clamp.

[0045] The function of the guide device 2 is to adjust and fix the position and direction of the handheld ablation unit 1. The guide device 2 is fixed on the surface of the tissue to be ablated 3. The guide device 2 can ensure that the focus of the focused ultrasound of the handheld ablation unit 1 is consistent with the target ablation position 4 through special size and shape design.

[0046] like Figure 2As shown, the handheld ablation unit 1 as the core component of the ultrasonic ablation system, including handheld structure 101, protruding structure 102 and piezoelectric ceramic module 103, wherein the handheld structure 101 as the main structure of the handheld ablation unit 1, for the operator to hold, to improve the convenience and stability of operation; protruding structure 102 is provided on the handheld ablation unit 1, used for when it is inserted into the guide device 2, and the edge groove 202 on the guide device 2 is tightly fitted, so as to prevent loosening during treatment, ensure the stability of the equipment, and improve the treatment accuracy; piezoelectric ceramic module 103 as an ultrasonic wave emitting component, driven by receiving electrical signals and generating ultrasonic waves of specific frequency, waveform and energy, forming ultrasonic ablation effect in the target focusing area, to realize precise treatment of the diseased tissue.

[0047] As shown in Figure 3 and Figure 4 The guide device 2 includes a shell body 201, which can be fixed on the surface of the tissue to be ablated by vacuum adsorption or other means. Its function is to provide fixed support, so that the handheld ablation unit 1 can work stably during treatment, and at the same time ensure that the treatment area is aligned with the ultrasonic wave emitting path. The shell body 201 is provided with one or more fixing structures, such as clamping slots, cavities, clamping, bolts and other fixing structures, for fixing the handheld ablation unit 1 and making the ultrasonic focusing point of the handheld ablation unit 1 located at the position to be ablated.

[0048] The present embodiment provides a special guide device structure design, which is provided with one or more discrete structure cavities 301 on the lower part of the shell body 201, for providing an insertion channel for the piezoelectric ceramic module 103, so that it can accurately align the target treatment area, and allow the doctor to move the handheld ablation unit 1 step by step during treatment to cover multiple ablation sites. In order to ensure that the handheld ablation unit 1 does not move, the upper part of the shell body 201 is additionally provided with one or more edge grooves 202, which are matched with the protruding structure 102 of the handheld ablation unit 1, and can form a stable mechanical fixation for the handheld ablation unit 1, so that the focused ultrasonic point is located at the ideal position, and the positioning error caused by the movement of the equipment during treatment is prevented, thereby improving the treatment accuracy.

[0049] The shell body 201 is provided below with an eye cornea adsorption structure 203, which functions to be fixed with the eyeball by negative pressure adsorption method, to avoid displacement during treatment and improve treatment accuracy. The handheld ablation unit 1 can realize the fixation of direction and spatial position through the combined positioning effect of the bottom cavity 301 and the edge groove 202, and then accurately treat the ablation site.

[0050] Obviously, at least one pair or more pairs of bottom hollows 301-edge recesses 202 combinations can be formed on the shell body 201, thereby achieving ablation of multiple ablation sites. In design, the positions of the shell body 201 and the bottom hollows 301 and the edge recesses 202 can be designed according to the clinical anatomical characteristics of the tissue to be ablated, combined with the ultrasonic field characteristics of the handheld ablation unit 1, to achieve precise ablation.

[0051] Unlike the conventional ultrasonic ablation device in which the ultrasonic transducer is directly fixed on the skin surface and the position is not movable, the piezoelectric ceramic module 103 in the present application is used to emit ultrasonic waves, and the module is connected to the handheld and movable handheld ablation unit 1, so that its position can be flexibly selected, thereby achieving ablation of one or more point positions. In addition, the structure of the shell body 201 is further optimized, and the outer part adopts a conical cylinder design, which is convenient for fitting with the patient's eye.

[0052] The adsorption structure is filled with an appropriate amount of coupling liquid (water) to ensure that the energy loss of ultrasonic waves during propagation is minimized and the ablation effect is improved. At the same time, the shell body 201 is provided with a plurality of circular hole-shaped treatment bottom hollows 301, each hollow has a diameter matched with the size of the handheld ultrasonic emission ultrasonic ablation unit, so that it can be smoothly inserted and closely fitted to ensure accurate transmission of ultrasonic energy. The layout of the multiple hollows is optimized to cover different treatment areas, allowing the doctor to adjust the insertion position of the handheld ablation unit 1 during treatment according to the needs to achieve ultrasonic ablation of multiple treatment point positions.

[0053] As another embodiment, as shown in Figure 5 The shell body 201 of the guide device 2 presents a double circular truncated cone, the upper circular truncated cone is in contact with air, and the lower circular truncated cone is in contact with the treated tissue, the upper circular truncated cone 2011 has a cross-sectional top angle of 76°, the lower circular truncated cone 2012 has a cross-sectional top angle of 106°, the lower hollow 3011 has a structure of a through hole with a diameter of 3 mm, the recess 2022 on the shell body has a cross-section of an embedded trapezoid, and the long side of the trapezoid faces outward, and the length ratio of the long side to the short side is 7:4, the protruding structure 102 of the handheld ablation unit 1 is designed to match the trapezoidal cross-section of the recess 2022, and the size of the treatment head of the handheld ablation unit 1 is designed to match the hollow 3011. The above design can form a stable mechanical fixation for the handheld ablation unit 1, so that the focused ultrasonic point is located at the ideal position.

[0054] In addition to the above structure, the present application provides another typical guide device structure, as shown in Figure 6As shown, the feature is that the lower part of the shell body 201 contains a slidable structure cavity 302, and the handheld ablation unit 1 is inserted into a slidable edge groove 202 on the shell body 201 for treatment. At this time, the protruding structure 102 of the handheld ablation unit 1 is still tightly fitted with the edge groove 202 on the shell body 201, and this structure ensures that the handheld ablation unit 1 will not be loose during treatment, and at the same time, the piezoelectric ceramic module 103 is aligned with the bottom slidable structure cavity 302 and activated to emit ultrasonic waves. During treatment, the doctor inserts and aligns the handheld ablation unit 1 with the slidable edge groove 202, emits ultrasonic waves with the piezoelectric ceramic module 103, and treats the patient's eye.

[0055] The design advantage of the above-mentioned slidable structure cavity 302 is that, unlike the discrete structure cavity 301 mentioned above, the groove here has a slidable space, and the doctor can continuously move the handheld ablation unit 1, so that the doctor can continuously ablate multiple points, and the treatment area will be more dense and larger, thereby improving the treatment effect. This treatment method gives the doctor more operating space, and the doctor can hold the handheld ablation unit 1 and move it within each treatable range to autonomously select the ablation treatment area.

[0056] As shown in Figure 7 The slidable structure cavity 302 is composed of an inner ring 3025, an outer ring 3026, and continuous structures 3023 and 3024 connecting the inner and outer rings, wherein the continuous structures 3023 and 3024 are not permeable to ultrasonic waves, and the edges of the inner ring 3025 and the outer ring 3026 and the continuous structures 3023 and 3024 respectively form treatment sliding grooves 3021 and 3022, which are hollow structures and can transmit ultrasonic waves. The outer ring 3026 is fixed on the fixed shell 201, and the lower part of the handheld ablation unit 1 can continuously slide in the grooves of the treatment sliding grooves 3021 and 3022, thereby forming a continuous treatment area. The continuous structures 3023 and 3024 can avoid the ultrasonic waves hitting the parts of the eyeball with sensitive nerves and blood vessels, and can ensure the safety of treatment.

[0057] In addition, the present application also provides a third typical guide device structure, as shown in Figure 8 The feature is that the bottom cavity 303 is a circular large cavity, and the handheld ablation unit 1 is guided by the high-precision miniature camera 104 to perform treatment in the bottom cavity 303, and the handheld ablation unit 1 is aligned with the bottom cavity 303 and activated to emit ultrasonic waves for treatment. During treatment, the doctor aligns the handheld ablation unit 1 with the bottom cavity 303, emits ultrasonic waves with the piezoelectric ceramic module 103, and treats the patient's eye.

[0058] Compared with Figure 6 , the present application has the advantages that Figure 8The bottom hole 303 in the middle has different shapes and structures, and the bottom hole 303 is a circular large hole. The handheld ablation unit 1 is not connected with the shell body 201 fixed on the edge groove 202, giving the doctor greater freedom. The doctor can choose the position, angle, height and other factors to perform ultrasonic ablation treatment. In order to ensure the accuracy of the doctor during use, realize the requirement of "hitting accurately", and increase the new structure of high-precision miniature camera 104 in the structure, through image and navigation algorithm, the spatial position of the ultrasonic focus of the handheld ablation unit 1 is assisted to calculate, so that the doctor user can know whether the ablation unit treatment is aligned or not, and adapt to different treatment needs. The doctor can adjust the angle of the handheld ablation unit 1 according to the actual situation to ensure the accuracy and effect of the treatment.

[0059] Based on the above system, the embodiment proposes a typical treatment method for glaucoma:

[0060] First step: modeling according to the anatomical structure of the patient's eyeball, generating a structure of the shell body 201 that accurately matches the position of the ablation target tissue (such as the ciliary body) of the patient's eye. Under this structure, the focused ultrasonic waves generated by the handheld ablation unit 1 can be accurately focused on the spatial position of the ablation target tissue (such as the ciliary body).

[0061] Second step: Place the shell body 201 according to the predetermined position outside the patient's eyeball 401, and form a stable fixation on the eyeball by forming a negative pressure through suction. After the shell and the eyeball form a close connection, fill the suction structure with an appropriate amount of ultrasonic coupling liquid (such as deaerated water / physiological saline, etc.), to provide a stable basis for the subsequent treatment steps.

[0062] Third step: The doctor holds the handheld ablation unit 1 into the shell body 201, ensures that the handheld ablation unit 1 is fixed on the bottom hole 301-edge groove 202, activates the ultrasonic wave emission switch, and starts the treatment according to the specific ultrasonic energy and ablation time.

[0063] Fourth step: After completing the treatment at the current position, the doctor pulls out the handheld ablation unit 1 from the bottom hole 301-edge groove 202 combination, inserts it into the treatment point corresponding to the next bottom hole 301-edge groove 202 combination, and repeats the ultrasonic wave emission treatment.

[0064] Fifth step: After completing the treatment, the doctor removes the shell body 201.

[0065] During the treatment, the doctor holds the handheld ablation unit handheld part 101, ensures that the protruding part 102 is tightly fitted with the edge groove 202 of the fixed shell 201; after one treatment in each hole, the next hole treatment is continued until the entire treatment cycle is completed, and then the device is removed.

[0066] In addition, the present application also provides an ultrasound ablation device based on automatic positioning navigation, aiming to solve the problems of existing ultrasound ablation devices in precise focusing, temperature control and treatment effect (such as focusing deviation, excessive or insufficient treatment temperature, etc.), which innovatively introduces digital twin navigation technology to realize personalized, precise and real-time monitoring of ultrasound ablation treatment plan.

[0067] The ultrasound ablation device establishes a personalized anatomical and mechanical characteristic model for each patient's eyeball through digital twin modeling before surgery, and updates the twin model in real time using image data and sensor information during surgery to ensure precise positioning and stable control of the ultrasound focal point. As shown in Figure 9 The core functions of the ultrasound ablation device include:

[0068] (1) Personalized digital twin modeling.

[0069] High-precision image scanning is used to obtain patient eyeball structure data, and anatomical parameters are combined to establish a three-dimensional digital twin model.

[0070] (2) Intraoperative image fusion and focal point real-time monitoring.

[0071] The device is equipped with a high-precision camera that can capture real-time patient eye images, automatically track and correct the focal point, accurately detect the micro-movement of the eyeball, and prevent the ultrasound from deviating from the treatment target due to eye rotation.

[0072] (3) Pupil automatic tracking and deviation correction.

[0073] Based on the pupil motion trajectory obtained by the camera, real-time tracking of the eyeball is realized, the ultrasound focal point position is dynamically adjusted, and the focal point is fine-tuned by a micro-actuator to compensate for treatment errors caused by slight eye movement of the patient.

[0074] (4) Millimeter-scale robot for precise positioning.

[0075] The device uses a robot system to achieve precise displacement adjustment of the ultrasound probe, so that the ultrasound focal point always remains in the target tissue area; the robot system's mechanical arm has high rigidity and high responsiveness, ensuring that the ultrasound energy can stably act on the target lesion area under complex eyeball physiological movement conditions, and through linkage with the digital twin model, precise prediction of temperature and tissue response is realized, making the treatment safer and more efficient.

[0076] As shown in Figure 10As shown, the handheld ablation unit 1 is the core component of the ultrasound ablation device, integrating ultrasound emission, real-time image monitoring, and precise positioning functions. Through digital twin navigation technology, the handheld ablation unit 1 closely cooperates with the robot system and its mechanical arm 5, achieving precise treatment operations. The robot system can accurately guide the handheld ablation unit 1 to position to the target ablation position 4 during treatment through real-time feedback and image processing, and capture real-time image information of the treatment area through the camera, ensuring accurate alignment of the focal point on the tissue to be ablated 3.

[0077] The high-precision control of the robot system combined with digital twin navigation technology enables automatic and precise ultrasound ablation treatment on the lesion area, significantly improving treatment efficiency and accuracy; the robot system adjusts the position and angle of the ablation unit in real time to ensure adaptation to different patient needs at different treatment stages.

[0078] The external camera 6 is mainly used for real-time image navigation. The camera captures image data of the patient's treatment area and feeds it back to the robot system, achieving precise ultrasound ablation treatment positioning. The real-time image information provided by the camera, combined with the digital twin navigation system, helps the robot system automatically adjust the position and angle of the handheld ablation unit 1, ensuring that the target ablation position 4 is accurately on the tissue to be ablated 3; the navigation function of the camera improves the accuracy and safety during treatment, ensuring the accuracy of the treatment area and providing real-time feedback to the doctor to optimize treatment effectiveness.

[0079] In addition, the ultrasound ablation device can perform human-computer interaction and real-time feedback, presenting the ultrasound focal point position, temperature changes, and patient eye movement status in real time during treatment through the feedback display screen, providing real-time adjustment basis for the doctor and improving the precision and safety of the operation. Through the intelligent interaction interface, the doctor can fine-tune the treatment parameters based on the data provided by the system to ensure optimal treatment effectiveness.

[0080] The above description of the embodiments is to facilitate the understanding and application of the present invention by those skilled in the art. Those skilled in the art can easily make various modifications to the above embodiments and apply the general principles described herein to other embodiments without creative effort. Therefore, the present invention is not limited to the above embodiments, and any improvements and modifications made by those skilled in the art based on the disclosure of the present invention should be within the scope of protection of the present invention.

Claims

1. An ablation system, characterized by, The application relates to a handheld ablation unit and a guide device, wherein the handheld ablation unit is mounted on the guide device and adopts a handheld design to generate focused ultrasonic waves for high-temperature ablation of tissues at a target ablation position; and the guide device is fixed on the surface of tissues to be ablated to provide a guide for the handheld ablation unit to the target ablation position. The handheld ablation unit comprises a pen-shaped handheld structure held by an operator, wherein a protruding structure is arranged on the handheld structure and is tightly embedded with the guide device in the form of a clamping groove, a channel or clamping; an ultrasonic probe is arranged at the end of the handheld structure, and the ultrasonic probe adopts a piezoelectric ceramic module as an ultrasonic wave emitting component to generate ultrasonic waves with specific frequency, energy and wave shape through electric signal driving. The guide device comprises a horn-shaped shell body, wherein a hollow hole with a discrete structure or a sliding structure is arranged at the bottom of the shell body to insert the ultrasonic probe of the handheld ablation unit to align the target ablation position; a whole-circle edge groove is arranged on the inner side of the shell body to embed the protruding structure of the handheld ablation unit; and a suction structure is arranged below the shell body to tightly fix the tissues to be ablated through negative pressure suction. Or the guide device comprises a double-truncated-cone-shaped shell body which is composed of two truncated-cone structures, wherein an upper truncated cone is in contact with air, a lower truncated cone is in contact with tissues to be ablated, a whole-circle trapezoidal groove is arranged on the inner side of the upper truncated cone to embed the protruding structure of the handheld ablation unit; and a plurality of hollow holes are arranged on the contact surface of the upper and lower truncated cones to insert the ultrasonic probe of the handheld ablation unit to align the target ablation position.

2. The ablation system of claim 1, wherein: The hollow hole with the discrete structure adopts a plurality of through holes arranged in design; the hollow hole with the sliding structure is composed of an inner ring, an outer ring and a continuous structure connecting the inner and outer rings, wherein the end of the continuous structure divides the inner and outer ring structures into a plurality of treatment sliding grooves which are hollow structures and can transmit ultrasonic waves, the ultrasonic probe of the handheld ablation unit continuously slides in the treatment sliding grooves to form a continuous treatment area; and the continuous structure cannot transmit ultrasonic waves.

3. The ablation system of claim 1, wherein: The suction structure is internally filled with a proper amount of coupling liquid.

4. The ablation system of claim 1, wherein: A high-precision miniature camera is mounted on the handheld structure to collect high-definition images of the target ablation position in real time and send feedback to external equipment for display.

Images