Uterine fibroid tissue interface 3D model and manufacturing method and phased transducer focal region form regulation system

Abstract

The application discloses a uterine fibroid tissue interface 3D model and a manufacturing method and a phased transducer focal region form regulation system, the method first acquires a uterine fibroid MRI image of a patient; then the MRI image is processed to obtain a two-dimensional image data with contour marking; and a three-dimensional modeling with marking information is constructed; finally, according to the three-dimensional model, a material similar to biological tissue in acoustic characteristics is selected to obtain the 3D model through 3D printing. The 3D uterine fibroid tissue interface model can accurately reflect the boundary interface shape and acoustic impedance difference between different biological tissues. Through this model, the focal region form can be more effectively regulated, thereby improving the precision and treatment effect of HIFU in treating uterine fibroids. The model integrates multi-dimensional information of tissue thickness, acoustic impedance characteristics and their interaction, and provides important support for preclinical verification of medical devices and development of personalized treatment plans.

Description

TECHNICAL FIELD

[0001] The present application relates to the field of ultrasonic medical phased array technology, in particular to a uterine fibroid tissue interface 3D model, a production method thereof and a phased array transducer focal region shape control system. BACKGROUND

[0002] Uterine fibroids are common benign tumors in women. Traditional treatment methods such as drugs and surgery have problems such as large trauma and long recovery period. HIFU as a non-invasive treatment method has been widely used in clinical practice. However, problems such as focal region divergence, focal point deviation, or skin burns often occur during treatment, which is mainly caused by differences in patient tissue structure and tissue interface shape. Although the acoustic characteristics of the tissue itself are relatively small, the existence of the boundary and its shape have a significant impact on the propagation of sound waves and the stability of the focal region.

[0003] The interface shape and thickness between different tissues are crucial in HIFU treatment, especially in soft tissue environments. Changes in boundary shape can cause reflection and transmission of sound waves, affecting treatment effectiveness.

[0004] Therefore, it is urgent to develop a phantom model that can accurately simulate these interfaces to optimize the control scheme of the focal region. SUMMARY

[0005] Therefore, the purpose of the present application is to provide a uterine fibroid tissue interface 3D model and a production method thereof and a phased array transducer focal region shape control system. The method uses a model with boundary interface characteristics to effectively control the shape of the focal region.

[0006] To achieve the above purpose, the present application provides the following technical solutions:

[0007] The uterine fibroid tissue interface 3D model production method provided by the present application comprises the following steps:

[0008] S1: Obtain uterine fibroid MRI images of a patient;

[0009] S2: Process the MRI images to obtain a two-dimensional image data with contour markers;

[0010] S3: Use the two-dimensional image data with contour markers to construct a three-dimensional model with marker information;

[0011] S4: Select a material with similar acoustic characteristics to biological tissue according to the three-dimensional model and obtain a 3D model through 3D printing.

[0012] Further, the image in step S2 is processed in the following manner:

[0013] S21. Denoising the uterine fibroid MRI images;

[0014] S22. Obtain a contour image of the boundary region of the myoma by contrast enhancement processing:

[0015] S23. Mark on the contour image to obtain a contour-marked two-dimensional image data;

[0016] S24. Determine the type and thickness parameters of the phantom material for making the 3D model according to the MRI image and the ultrasound parameters.

[0017] Further, the three-dimensional modeling in step S3 is performed in the following manner:

[0018] S31. Import the contour-marked two-dimensional image data into three-dimensional model making software;

[0019] S32. Determine the tissue characteristics of different regions of the three-dimensional model;

[0020] S33. Make a three-dimensional model according to the contour-marked two-dimensional image data and the tissue characteristics of different regions; and obtain a morphological feature image of the three-dimensional boundary of the uterus and myoma based on the marking information by using corresponding phantom materials according to the tissue characteristics of different regions through the three-dimensional model making software;

[0021] S34. Use different colors to mark the interface shape between different tissues and the acoustic impedance and acoustic attenuation parameters of each tissue.

[0022] Further, the biological tissue-similar material includes a polymer or a composite material.

[0023] Further, the biological tissue-similar material includes any one or more of polymethyl methacrylate, polyurethane, hydrogel, polylactic acid, polyvinyl alcohol, aluminum oxide, earwax plaster, and barium titanate.

[0024] The present application provides a uterine myoma tissue interface model made according to the above-mentioned method for making a uterine myoma tissue interface 3D model, which includes a plurality of sub-models for simulating the shape of different tissue regions in the uterus, and the sub-models include a uterine myoma region, a skin region, an abdominal wall muscle tissue region, a fat region, a bone region, and a fascia region composed of a phantom material.

[0025] The uterine myoma region is located at the center of the model and simulates the myoma in the actual uterus; the skin region is located at the outermost layer and surrounds other parts; the abdominal wall muscle tissue region is located between the skin and the fat and simulates the actual abdominal wall tissue; the fat region is usually located between the abdominal wall muscle tissue and the uterine myoma; the bone region is located at the bottom or inner layer of the model and simulates the structure of the real bone; and the fascia region is located between the fat and the abdominal wall muscle and serves to connect and isolate different tissues.

[0026] Further, the phantom material is configured as follows: polymethyl methacrylate simulates skin tissue, polyurethane simulates fat or uterine fibroid tissue, ear wax plaster or hydrogel simulates soft tissue, polylactic acid simulates muscle tissue, and aluminum oxide simulates bone tissue.

[0027] The application provides a focal region shape dynamic regulation system based on high-intensity focused ultrasound constructed according to the uterine fibroid tissue interface model, which comprises a water tank, a uterine fibroid phantom model, a phased transducer, a hydrophone, a sound field scanning host, an upper computer, phased transducer driving, three-dimensional stepper motor driving, and three-dimensional stepper motors.

[0028] The water tank is used for containing water as a sound propagation medium.

[0029] The uterine fibroid phantom model is used for simulating real uterine fibroid tissue, reflecting the acoustic characteristics of biological tissue, and ensuring the effectiveness of the HIFU system test and application in real conditions.

[0030] The phased transducer is responsible for converting electrical signals into high-intensity ultrasound waves and controlling the direction and focal point of the ultrasound waves by adjusting the amplitude and phase of each array element to achieve dynamic regulation.

[0031] The hydrophone receives the sound waves emitted by each array element of the phased array, monitors the sound pressure and amplitude information, provides real-time feedback for system optimization, and ensures the focusing accuracy of the ultrasound waves.

[0032] The sound field scanning host is responsible for controlling the sound field scanning process and coordinating the operation of various components, including adjusting the transducer emission parameters and analyzing the received sound field data to achieve effective sound wave focusing and transmission.

[0033] The upper computer is used for data processing and analysis, monitoring the running state of the system, providing a user interface, and helping to control the experiment and process the collected ultrasound data.

[0034] The phased transducer driving provides electrical signals to drive the phased transducer to work at a predetermined frequency and phase, achieving the desired sound wave emission mode.

[0035] The three-dimensional stepper motor driving is used to accurately control the motor so that the hydrophone on the motor clamp moves uniformly in three dimensions.

[0036] The three-dimensional stepper motor performs actual mechanical movement, allowing the hydrophone to move uniformly along the X, Y, and Z axes in three-dimensional space to adapt to different experimental requirements and regulation effects.

[0037] Further, the focal region shape dynamic regulation system based on high-intensity focused ultrasound is performed according to the following steps:

[0038] Drive the three-dimensional stepping motor to realize the uniform speed movement of X, Y and Z axes.

[0039] Fix the hydrophone, scan the free-field focal point sound pressure distribution of the phased transducer, and obtain a reference focal region form S1;

[0040] Place the hydrophone at the focal point P, and place the uterine fibroid phantom model;

[0041] Focus the phased transducer, scan the sound field distribution at the focal point P, and obtain a distorted focal region form S2;

[0042] The control algorithm performs phase and amplitude compensation, re-scans the sound pressure distribution at the focal point P, and obtains an improved focal region form S3;

[0043] Compare the area and shape changes of S1, S2 and S3 to evaluate the focal region regulation result.

[0044] The beneficial effects of the present application are:

[0045] The uterine fibroid tissue interface 3D model and the preparation method and the phased transducer focal region form regulation system provided by the present application first acquire the MRI image of the uterine fibroid of the patient; then process the MRI image to obtain a two-dimensional image data with contour markers; and construct a three-dimensional model with marker information; finally, according to the three-dimensional model, select a material similar in acoustic characteristics to biological tissue to obtain a 3D model through 3D printing. The 3D uterine fibroid tissue interface model can accurately reflect the boundary interface shape and acoustic impedance difference between different biological tissues. Through this model, the focal region form can be more effectively regulated, thereby improving the precision and treatment effect of HIFU in treating uterine fibroids. The model integrates multi-dimensional information of tissue thickness, acoustic impedance characteristics and their interaction, providing important support for preclinical verification of medical devices and development of personalized treatment plans.

[0046] By combining the uterine fibroid tissue interface model with the focal region regulation of the phased transducer, the present application has multiple beneficial effects.

[0047] 1. The model can accurately evaluate the influence of the phased transducer on the surrounding healthy tissue under different operating parameter conditions, thereby effectively identifying potential damage risks and ensuring the safety of the treatment process. Based on the uterine fibroid tissue interface model, researchers can further optimize the focal region regulation parameters of the phased transducer, including ultrasonic frequency, output power, pulse duration, phase adjustment parameters of each array element and amplitude setting, to determine the optimal treatment plan.

[0048] 2. This model provides crucial support for the preclinical validation of medical devices. By simulating the individual characteristics of different patients, it helps researchers predict the expected effects of HIFU treatment on various patient groups. This not only provides a scientific basis for implementing individualized treatment plans but also significantly improves the success rate and safety of treatment.

[0049] 3. Doctors can use this model to develop personalized treatment strategies targeting specific characteristics of uterine fibroids, thereby achieving more efficient and precise treatment results.

[0050] Other advantages, objectives, and features of the invention will be set forth in part in the description which follows, and in part will be apparent to those skilled in the art from the following examination, or may be learned from practice of the invention. The objectives and other advantages of the invention can be realized and obtained through the following description. Attached Figure Description

[0051] To make the objectives, technical solutions, and beneficial effects of this invention clearer, the following drawings are provided for illustration.

[0052] Figure 1 Flowchart for constructing a tissue interface model for uterine fibroids.

[0053] Figure 2 This is a schematic diagram of the tissue interface model of uterine fibroids.

[0054] Figure 3 A flowchart illustrating the application scenario of the uterine fibroid tissue interface model.

[0055] Figure 4 This is a schematic diagram of focal zone control.

[0056] Figure 5 This is a schematic diagram of focal zone control.

[0057] In the image, 1 represents a uterine fibroid, 2 represents skin, 3 represents abdominal wall muscle tissue, 4 represents fat, 5 represents bone, and 6 represents fascia. Detailed Implementation

[0058] The present invention will be further described below with reference to the accompanying drawings and specific embodiments, so that those skilled in the art can better understand and implement the present invention. However, the embodiments described are not intended to limit the present invention.

[0059] Example 1

[0060] like Figure 1 As shown, Figure 1 Flowchart for constructing a 3D model of the uterine fibroid tissue interface. The method for creating a 3D model of the uterine fibroid tissue interface provided in this embodiment includes the following steps:

[0061] S1: Obtain the MRI images of the patient's uterine fibroids;

[0062] First, export the images from the patient's MRI examination using medical imaging software (such as DICOMViewer). Choose high-resolution sequences that can clearly show the details of the uterus and its surrounding tissues. Pay special attention to selecting sequences with good contrast (such as T2-weighted images) to ensure that the differences between the uterine fibroids and their boundaries and the surrounding tissues are clearly visible.

[0063] S2: Process the MRI images to obtain two-dimensional image data with contour markers;

[0064] Tools: Use professional image processing software (such as Itk-snap, MATLAB, or 3DSlicer) for image processing, with the following steps:

[0065] S21. Denoising: Apply filters (such as Gaussian filters) to remove image noise and improve imaging quality, especially in the boundary area of the fibroids, which helps accurately define the contours of the fibroids;

[0066] S22. Contrast enhancement: Adjust the brightness and contrast of the image to ensure clearer visualization of the uterus and fibroids, which helps subsequent contouring;

[0067] S23. Contour marking: Outline the shape of the uterus and the contours of the fibroids on the clear image, especially highlighting the boundary shape of the fibroids. Note that the boundary shape of the fibroids may vary between patients, but this detail is crucial for subsequent simulation of their biological and acoustic properties. Also, mark the surrounding soft tissues such as skin, fat, muscle, fascia, uterine wall shape and location;

[0068] S24. Acoustic parameter acquisition: Evaluate the relevant parameters of the individual sample based on the relationship between MRI images and acoustic velocity, density, and acoustic attenuation, and select the phantom material and determine the thickness.

[0069] S3: Use two-dimensional image data with contour markers to construct a three-dimensional model with marker information;

[0070] Software: Use three-dimensional modeling software (such as Blender, MeshLab, or MATLAB) to generate the phantom model, with the following specific operations:

[0071] S31. Import the two-dimensional image data processed in S2 into the model software. In this process, use the marker information of the image to accurately construct the three-dimensional shape of the uterus and fibroids, and pay special attention to the morphological characteristics of their boundaries;

[0072] S32. Carefully define the various parts of the model, taking into account the tissue properties of different regions (such as the different densities of myomas and their interface properties with surrounding tissues). During modeling, the differences in interface acoustic impedance should be represented by different material properties, such as using different sound speeds and acoustic impedance parameters to simulate the interface between different soft tissues (such as muscle and fat). The parameters for defining the properties of each tissue are as follows:

[0073] Table 1: Parameters for defining the properties of each tissue are as follows:

[0074] Organ name Skin Fat Muscle Fascia Uterine wall Tumor Bone Density (g / cm3) 1.1 0.9 1.06 1.1 1.03 1.05 11.8 Sound attenuation coefficient (dB / cm) 0.5 0.5 1.0 1.0 0.7 1.0 2.0 Sound velocity C (m / s) 1540 1450 1600 1560 1580 1570 3500

[0075] Representation of interface acoustic impedance differences:

[0076] In acoustic applications, acoustic impedance is an important property of sound waves when they propagate across material interfaces. The difference in acoustic impedance directly affects the reflection and transmission behavior of sound waves. Generally, acoustic impedance is defined as the product of the density and sound speed of a material:

[0077]

[0078] where, is the acoustic impedance, is the density of the material, is the sound speed. For different soft tissues (such as muscle, fat, and bone), due to the differences in their density and sound speed, the acoustic impedance differs. This difference results in reflection and transmission at the interfaces of the components. The sound speed of soft tissues is typically between 1,500 m / s and 1,600 m / s, while the sound speed of bone increases significantly. These sound speeds are crucial for acoustic simulation and analysis of sound wave propagation, as they will directly affect the propagation behavior, reflection, transmission, and attenuation of sound waves.

[0079] Reflection of sound waves: When a sound wave passes through two media with different acoustic impedances, reflection occurs at the interface. The reflection coefficient can be calculated using the following formula:

[0080]

[0081] where, and are the acoustic impedances of the incident medium and the reflecting medium, respectively. High impedance differences will result in stronger reflection, while smaller impedance differences will result in lower reflection. In soft tissues, although the acoustic impedance difference is not large, there is still some reflection, especially when the thickness of the tissue changes (such as 1 mm of material corresponding to the sound propagation of 5 mm of muscle tissue), the reflection coefficient may increase.

[0082] Transmission of sound waves: The calculation of transmission coefficient will be based on the difference in acoustic impedance between the incident sound wave and the interface of the phantom model, which can be simulated to some extent by the design of the phantom model to analyze the behavior of sound waves under different thicknesses and boundary shapes. For sound waves entering different media, its transmission coefficient can be calculated by the following formula:

[0083]

[0084] In addition, the attenuation of sound waves during transmission will vary with tissue thickness and acoustic attenuation characteristics. As mentioned earlier, a material thickness of 1 mm can correspond to a muscle tissue of 5 mm and is reflected in the attenuation of sound waves.

[0085] Attenuation of sound waves: Acoustic attenuation refers to the reduction in intensity of a sound wave due to the properties of the medium during propagation. Acoustic attenuation is usually represented by the acoustic attenuation coefficient, with units of decibels per meter (dB / m) or decibels per centimeter (dB / cm). Here are the basic methods and formulas for calculating acoustic attenuation:

[0086]

[0087] where A is the amount of attenuation (usually calculated in decibels, dB);

[0088] α is the acoustic attenuation coefficient, with units of dB / m or dB / cm. It represents the attenuation of the intensity of the sound wave per unit distance;

[0089] d is the distance of sound wave propagation, with units of meters (m) or centimeters (cm), and different materials will have different acoustic attenuation coefficients;

[0090] For example, the acoustic attenuation coefficients of materials such as muscle, fat, bone, and air differ greatly;

[0091] S33. The boundary shape is carefully reflected in the model so that in subsequent acoustic analysis, the shape, size, and position of the boundary can be truly reproduced, especially under the action of the sound field, the change of the interface will affect the reflection and transmission of sound waves.

[0092] S34. Feature labeling includes: the interface shape between different tissues labeled by different colors, and the acoustic impedance and acoustic attenuation parameters of each tissue.

[0093] S4: According to the three-dimensional model, select materials with similar acoustic properties to biological tissues by 3D printing to obtain a 3D model;

[0094] When selecting materials similar to biological tissues, the materials should have similar acoustic properties to biological tissues and be suitable for 3D printing. Some specific polymers and composites can be considered. These materials have good acoustic transmission properties and can simulate the acoustic behavior of biological tissues. For example, polymethyl methacrylate (PMMA) is chosen:

[0095] PMMA is a transparent plastic with good acoustic transmission properties. Its sound speed is close to that of many biological tissues, such as skin and adipose tissue. PMMA can be used to make acoustic sensor housings, components for medical imaging devices, and other applications.

[0096] Polyurethane (PU): Polyurethane can simulate different types of biological tissues due to its adjustable hardness and density. Soft polyurethane can mimic adipose tissue, while harder polyurethane can mimic bone. In addition, polyurethane has good wear resistance and elasticity.

[0097] Hydrogels: Hydrogels are usually composed of hydrophilic polymers such as polyvinyl alcohol (PVA) and are commonly used in biomedical applications. Hydrogels have sound transmission properties close to biological tissues and are widely used in medical ultrasound devices and tissue engineering.

[0098] Polylactic acid (PLA): Although it is an organic material, it can be combined with inorganic fillers in some composite 3D printing to help simulate the acoustic properties of tissues.

[0099] Polyvinyl alcohol (PVA): Can be combined with inorganic materials to help create biocompatible models.

[0100] Alumina: Has good acoustic properties and can be used to simulate bone tissue.

[0101] Dental stone: Commonly used in medical prostheses, has good acoustic impedance properties and is suitable for simulating soft tissues.

[0102] Barium titanate: Has excellent acoustic properties and is used in high-intensity ultrasound applications.

[0103] These materials are designed with reasonable boundary shapes that effectively reflect the differences in boundary shapes and acoustic impedance between different biological tissues (such as muscle, fat, and tumor tissue), thereby significantly improving the accuracy and effectiveness of HIFU treatment.

[0104] Preparation for printing: Convert the modeled three-dimensional phantom model into a format suitable for 3D printing (such as an STL file) and set the printing parameters. Ensure that the chosen material has similar acoustic properties to biological tissue to obtain a reasonable response when simulating ultrasound behavior. For example, a polymer material with a certain thickness and capable of reflecting different acoustic impedance characteristics can be selected.

[0105] Printing process and verification: After printing is complete, carefully check the dimensions and shape of the model, especially how the thickness and boundaries of different tissues affect the propagation of sound waves, to ensure that they accurately reflect the characteristics of actual biological tissues.

[0106] As shown in Figure 2 , Figure 2 a uterine fibroid tissue interface model is shown, which includes several sub-models for simulating the shape of different tissue regions in the uterus, including a uterine fibroid region 1, a skin region 2, an abdominal wall muscle tissue region 3, a fat region 4, a bone region 5, and a fascia region 6 composed of phantom materials.

[0107] The uterine fibroid region 1 is located in the center of the model, simulating the actual fibroid in the uterus. The acoustic properties of this part should be close to the actual uterine fibroid to ensure accuracy during sound wave transmission.

[0108] The skin region 2 is located on the outermost layer, surrounding the other parts. The acoustic properties of the skin will affect the reflection and transmission of sound waves, and its thickness and elasticity need to be considered.

[0109] The abdominal wall muscle tissue region 3 is located between the skin 2 and the fat 4, simulating the actual abdominal wall tissue. Its acoustic properties will affect the propagation of sound waves, especially in interaction with other tissues.

[0110] The fat region 4, usually located between the abdominal wall muscle tissue and the uterine fibroid, can affect the propagation speed and attenuation characteristics of sound waves.

[0111] The bone region 5 is located at the bottom or inner layer of the model, simulating the structure of the actual bone. The speed of sound and density of the bone will significantly affect the propagation characteristics of sound waves.

[0112] The fascia region 6, which is usually sandwiched between fat and abdominal wall muscle, plays a role in connecting and isolating different tissues. The acoustic properties of the fascia will affect the sound wave conduction with other soft tissues.

[0113] Layout and feature relationship:

[0114] Relative position: The skin 2 is on the outermost layer, followed by the abdominal wall muscle tissue 3, then the fat 4, the uterine fibroid 1 is in the center, the bone 5 may be at the bottom, and the fascia 6 connects the fat and muscle tissue.

[0115] Acoustic properties: The acoustic properties of each material should be carefully designed to match those of biological tissue, better simulating the response of biological tissue to acoustic waves to establish an accurate acoustic model.

[0116] Embodiment 2

[0117] As Figure 3 shown, Figure 3 is a scene block diagram for a uterine fibroid tissue interface model, and this embodiment constructs a focal region shape dynamic regulation system based on high-intensity focused ultrasound (HIFU) according to the above model, which includes a water tank, a uterine fibroid tissue interface phantom model, a phased transducer, a hydrophone, a sound field scanning host, an upper computer, phased transducer driving, three-dimensional stepper motor driving, and a three-dimensional stepper motor.

[0118] The water tank is used to hold water as a sound propagation medium, ensuring efficient conduction of sound waves and providing a suitable environment for the emission and focusing of ultrasonic waves. At the same time, it helps to reduce the attenuation of sound waves to improve system performance.

[0119] The uterine fibroid tissue interface phantom model is used to simulate the boundary interface shape between different biological tissues of real uterine fibroids, which can accurately reflect the acoustic properties of biological tissues and ensure the effectiveness of HIFU system testing and application in real situations.

[0120] The phased transducer is responsible for converting electrical signals into high-intensity ultrasonic waves and precisely controlling the direction and focal point of ultrasonic waves by adjusting the amplitude and phase of each array element, achieving dynamic regulation.

[0121] The hydrophone receives the sound waves emitted by each array element of the phased array, monitors information such as sound pressure and amplitude, and provides real-time feedback for system optimization to ensure the accuracy of ultrasonic wave focusing.

[0122] The sound field scanning host is responsible for controlling the sound field scanning process and coordinating the operation of various components, including adjusting the transducer emission parameters and analyzing the received sound field data to achieve effective sound wave focusing and transmission.

[0123] The upper computer is used for data processing and analysis, monitors the running state of the system, provides a user interface, and helps control the experiment and process the collected ultrasonic data.

[0124] The phased transducer driving provides electrical signals to drive the phased transducer to work at a predetermined frequency and phase, achieving the desired sound wave emission mode.

[0125] The three-dimensional stepper motor driving is used to accurately control the motor so that the hydrophone on the motor clamp moves uniformly in three dimensions.

[0126] The three-dimensional stepper motor performs actual mechanical movement, and allows the hydrophone to move at a constant speed along the X, Y and Z axes in three-dimensional space, so as to adapt to different experimental requirements and regulation effects.

[0127] As shown in Figure 4 , Figure 4 The focal region shape regulation method flow chart, the phased transducer focal region regulation system of the embodiment, each array element can be independently driven and adjust the output phase and amplitude, to realize the dynamic regulation of focal region shape, the specific process is as follows:

[0128] Start;

[0129] Drive the three-dimensional stepper motor to realize the constant speed movement of the X, Y and Z axes;

[0130] Fix the hydrophone, scan the free field focal point sound pressure distribution of the phased transducer, and obtain the reference focal region shape S1;

[0131] Place the hydrophone at the focal point P, and place the uterine fibroid phantom model;

[0132] Carry out phased transducer focusing, scan the sound field distribution at the focal point P, and obtain the distorted focal region shape S2;

[0133] The control algorithm carries out phase and amplitude compensation, re-scans the sound pressure distribution at the focal point P, and obtains the improved focal region shape S3;

[0134] Compare the area and shape changes of S1, S2 and S3 to evaluate the focal region regulation result;

[0135] End.

[0136] The embodiment realizes the dynamic regulation of focal region shape according to the following steps:

[0137] First, the sound field scanning system drives the three-dimensional stepper motor, and the motor can move at a constant speed in the X, Y and Z axes;

[0138] The hydrophone is fixed on the motor to scan the free field focal point sound pressure distribution of the phased transducer, and the focal region shape S1 at this time is taken as the reference for focal region regulation;

[0139] Secondly, the hydrophone is placed at the focal point P, and the uterine fibroid phantom model is placed in the sound channel for phased transducer focusing;

[0140] Thirdly, the sound field distribution at the original focal point P is scanned to obtain the distorted focal region shape S2, and after phase and amplitude compensation by the control algorithm, the focusing experiment is carried out, the sound pressure distribution at the original focal point P is scanned, and the improved focal region shape S3 is obtained, so as to achieve the purpose of focal region regulation;

[0141] The effect of focal region regulation is evaluated by comparing and calculating the area and shape changes of S1, S2 and S3. Figure 5As shown, Figure 5 Schematic diagram for focal region regulation.

[0142] The embodiment provides a new phantom model applied to HIFU treatment by using a phased transducer, accurately reflects shapes and acoustic information of different tissue interfaces by using appropriate inorganic materials according to MRI image information, and performs scheme simulation of HIFU preoperative phased acoustic field regulation based on the model. The model can effectively reflect differences in boundary shapes and acoustic impedances among different biological tissues (such as muscle, fat and tumor tissues) by designing reasonable boundary shapes. The accuracy and effectiveness of HIFU treatment are significantly improved.

[0143] The embodiment uses polymethyl methacrylate (PMMA) to simulate skin tissue, polyurethane (PU) to simulate fat or uterine fibroid tissue, dental stone or hydrogel to simulate soft tissue, polylactic acid (PLA) to simulate muscle tissue, alumina to simulate bone tissue and the like, which can effectively reflect differences in boundary shapes and acoustic impedances among different biological tissues (such as muscle, fat and tumor tissues), thereby significantly improving the accuracy and effectiveness of HIFU treatment.

[0144] The embodiment uses inorganic materials, which can be stored for a long time, and can better restore the interface acoustic impedance difference among multiple layers of tissues by reasonable material selection, restore the attenuation of tissues with corresponding thickness by setting appropriate material thickness ratios, and better restore the boundary shape of personalized samples by combining 3D printing and profiling processing, so that the boundary characteristics of real biological tissues can be better reflected when calculating acoustic wave propagation and thermal effects. The model-based phased treatment scheme verification can be performed before HIFU surgery, and reference for surgical phase regulation scheme is provided.

[0145] Meanwhile, the phantom model will play an important role in the following application scenarios: HIFU tissue experiment: the effectiveness of different focal region regulation schemes is verified through multiple tests to find the best treatment parameters (such as frequency, energy density and the like). Personalized treatment scheme design: according to the specific tissue interface shape of a patient, the focal region morphology is adjusted to realize more accurate personalized phase regulation scheme formulation. Preclinical verification: before actual clinical application, new technologies or instruments are fully verified to ensure the safety and effectiveness of treatment.

[0146] Therefore, the model can reflect various tissue interfaces, has important clinical application value, and provides an innovative solution for HIFU treatment of uterine fibroids, so that the acoustic field distribution and tissue response in the treatment process are as close to the actual situation as possible, thereby improving the treatment effectiveness and safety of patients.

[0147] The above-described embodiments are merely preferred embodiments of the present application, and the protection scope of the present application is not limited thereto. Any equivalent substitutions or transformations made by those skilled in the art based on the present application are within the protection scope of the present application. The protection scope of the present application is subject to the claims.

Claims

1. A method for creating a 3D model of the interface of uterine fibroid tissue, characterized in that: Includes the following steps: S1: Obtain MRI images of the patient's uterine fibroids; S2: Process MRI images to obtain two-dimensional image data with contour markings; S3: Construct a 3D model with marked information using 2D image data with outline markings; S4: Based on the 3D model, select materials with acoustic properties similar to biological tissues and obtain the 3D model through 3D printing; The image in step S2 is processed in the following manner: S21. Denoise the MRI images of uterine fibroids; S22. Obtain the contour image of the boundary region containing the fibroid by enhancing contrast: S23. Marking on the contour image yields two-dimensional image data with contour markings; S24. Determine the type and thickness parameters of the phantom material for fabricating the 3D model based on MRI images and ultrasound parameters; The 3D modeling in step S3 is performed in the following manner: S31. Import the two-dimensional image data with outline markings into the three-dimensional model making software; S32. Determine the organizational characteristics of different regions of the three-dimensional model; S33. Based on two-dimensional image data with contour markings and the tissue characteristics of different regions, a three-dimensional model is created; based on the tissue characteristics of different regions, corresponding phantom materials are used to obtain morphological feature images of the three-dimensional boundaries of the uterus and fibroids based on the marking information using three-dimensional model manufacturing software; S34. Different colors are used to mark the interface shape between different tissues and the acoustic impedance and acoustic attenuation parameters of each tissue.

2. The method for creating a 3D model of the uterine fibroid tissue interface as described in claim 1, characterized in that: The biological tissue-like materials include polymers or composite materials.

3. The method for creating a 3D model of the uterine fibroid tissue interface as described in claim 1, characterized in that: The biological tissue-like material includes any one or more of polymethyl methacrylate, polyurethane, hydrogel, polylactic acid, polyvinyl alcohol, alumina, otolith, and barium titanate.

4. The uterine fibroid tissue interface model fabricated according to the 3D model fabrication method of any one of claims 1 to 3, characterized in that: It includes several sub-models for simulating the shape of different tissue regions within the uterus. The sub-models include a uterine fibroid region, a skin region, an abdominal wall muscle tissue region, a fat region, a bone region, and a fascia region made of phantom material. The uterine fibroid region is located at the center of the model and simulates a fibroid in an actual uterus. The skin region is located at the outermost layer and surrounds the other parts. The abdominal wall muscle tissue area, located between the skin and fat, simulates real abdominal wall tissue; the fat area is usually located between the abdominal wall muscle tissue and uterine fibroids; the bone area is located at the bottom or inner layer of the model, simulating the structure of real bones; the fascia area, located between fat and abdominal wall muscles, serves to connect and isolate different tissues.

5. The uterine fibroid tissue interface model as described in claim 4, characterized in that: The prosthetic material is configured as follows: polymethyl methacrylate to simulate skin tissue, polyurethane to mimic fat or uterine fibroid tissue, earwax plaster or hydrogel to simulate soft tissue, polylactic acid to simulate muscle tissue, and alumina to simulate bone tissue.

6. The dynamic focal zone shape control system based on high-intensity focused ultrasound constructed according to the uterine fibroid tissue interface model of claim 4, characterized in that: Includes a water tank, a uterine fibroid phantom model, a phased-array transducer, a hydrophone, a sound field scanning host, a host computer, a phased-array transducer driver, a three-dimensional stepper motor driver, and a three-dimensional stepper motor; The water tank is used to hold water as a sound transmission medium; The uterine fibroid phantom model is used to simulate real uterine fibroid tissue, reflect the acoustic properties of biological tissue, and ensure the effectiveness of the HIFU system in real-world testing and application. The phased-array transducer is responsible for converting electrical signals into high-intensity ultrasonic waves, and controlling the direction and focus of the ultrasonic waves by adjusting the amplitude and phase of each array element, thereby achieving dynamic control. The hydrophone receives sound waves emitted by each element of the phased array, monitors sound pressure and amplitude information, provides real-time feedback for system optimization, and ensures the focusing accuracy of the ultrasound. The sound field scanning host is responsible for controlling the sound field scanning process and coordinating the operation of various components, including adjusting the transducer emission parameters and analyzing the received sound field data, so as to achieve effective sound wave focusing and transmission. The host computer is used for data processing and analysis, monitoring the system's operating status, providing a user interface, and helping to control the experiment and process the collected ultrasound data. The phased transducer driver provides an electrical signal to drive the phased transducer, enabling it to operate according to a predetermined frequency and phase, thereby achieving the desired acoustic wave emission mode. The three-dimensional stepper motor drive is used to precisely control the motor so that the hydrophone on the motor fixture moves at a constant speed in three dimensions. The three-dimensional stepper motor performs the actual mechanical movement, allowing the hydrophone to move at a constant speed along the X, Y, and Z axes in three-dimensional space to adapt to different experimental needs and control effects.

7. The dynamic focal zone shape control system based on high-intensity focused ultrasound as described in claim 6, characterized in that: The dynamic control system for focal zone shape based on high-intensity focused ultrasound is performed according to the following steps: Drive a three-dimensional stepper motor to achieve uniform motion along the X, Y, and Z axes; With the hydrophone fixed, the free field focal sound pressure distribution of the phased-array transducer is scanned to obtain the reference focal morphology S1. Place the hydrophone at focal point P and place the uterine fibroid phantom model there; By focusing the phased-array transducer and scanning the sound field distribution at the focal point P, the distorted focal domain morphology S2 is obtained. The control algorithm performs phase and amplitude compensation, and rescans the sound pressure distribution at the focal point P to obtain an improved focal morphology S3. By comparing the changes in area and shape of S1, S2, and S3, the focal zone control results are evaluated.

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