Uterine myoma tissue interface 3D model, manufacturing method and phase-controlled transducer focal region form regulation and control system

Abstract

The invention discloses a hysteromyoma tissue interface 3D model, a manufacturing method and a phase-controlled transducer focal domain form regulation and control system. The method comprises the following steps: firstly, acquiring a hysteromyoma MRI image of a patient; then, the MRI image is processed to obtain two-dimensional image data with contour marks; a three-dimensional model with mark information is constructed; and finally, according to the three-dimensional model, selecting a material of which the acoustic characteristics are similar to that of the biological tissue, and performing 3D printing to obtain a 3D model. The 3D hysteromyoma tissue interface model can accurately reflect boundary interface shapes and acoustic impedance differences among different biological tissues. Through the model, the form of the focal region can be more effectively regulated and controlled, so that the accuracy and the treatment effect of the HIFU in treatment of uterine fibroid are improved. The model integrates tissue thickness, acoustic impedance characteristics and multi-dimensional information of interaction of the tissue thickness, the acoustic impedance characteristics and the multi-dimensional information, and important support is provided for preclinical verification and personalized treatment scheme formulation of medical instruments.

Description

Technical Field

[0001] The present invention relates to the field of ultrasonic medical phase control technology, in particular to a 3D model of a uterine fibroid tissue interface and a manufacturing method thereof, and a phase-controlled transducer focal zone morphology control system. Background Art

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

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

[0004] Therefore, there is an urgent need to develop phantom models that can accurately simulate these interfaces in order to optimize the regulation of the focal region. Summary of the invention

[0005] In view of this, the purpose of the present invention is to provide a 3D model of uterine fibroid tissue interface and a production method and a phased transducer focal zone morphology control system, which can effectively control the focal zone morphology by using a model with boundary interface characteristics.

[0006] In order to achieve the above object, the present invention provides the following technical solutions: The method for making a 3D model of a uterine fibroid tissue interface provided by the present invention comprises the following steps: S1: Obtain MRI images of the patient's uterine fibroids; S2: Processing the MRI image to obtain two-dimensional image data with contour markings; S3: constructing three-dimensional modeling with labeling information using two-dimensional image data with contour labels; S4: Based on the three-dimensional model, a material having acoustic properties similar to those of biological tissue is selected to obtain a 3D model through 3D printing.

[0007] Further, the image in step S2 is processed in the following manner: S21. De-noising the uterine fibroid MRI image; S22. The contour image of the boundary area of ​​the tumor is obtained by contrast enhancement processing: S23. Marking the contour image to obtain two-dimensional image data with contour marking; S24. Determine the type and thickness parameters of the phantom material for making the 3D model based on the MRI image and ultrasound parameters.

[0008] Furthermore, the three-dimensional modeling in step S3 is performed in the following manner: S31. Importing the two-dimensional image data with contour marks into the three-dimensional model making software; S32. Determine tissue characteristics of different regions of the three-dimensional model; S33. Making a three-dimensional model based on the two-dimensional image data with contour marks and the tissue characteristics of different regions; using the corresponding phantom material according to the tissue characteristics of different regions through the three-dimensional model making software to obtain the morphological characteristic images of the three-dimensional boundaries of the uterus and fibroids based on the marking information; S34. Use different colors to mark the interface shapes between different tissues as well as the acoustic impedance and acoustic attenuation parameters of each tissue.

[0009] Further, the biological tissue-similar material includes a polymer or a composite material; Furthermore, the biological tissue-similar material includes any one or more of polymethyl methacrylate, polyurethane, hydrogel, polylactic acid, polyvinyl alcohol, alumina, ear wax plaster, and barium titanate.

[0010] The present invention provides a uterine fibroid tissue interface model made according to the above-mentioned uterine fibroid tissue interface 3D model making method, including several sub-models for simulating the shapes of different tissue regions in the uterus, wherein 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 made of phantom materials; The uterine fibroid area is located in the center of the model and simulates the fibroids in the actual uterus; the skin area is located in the outermost layer and surrounds the other parts; the abdominal wall muscle tissue area is located between the skin and fat and simulates the real abdominal wall tissue; the fat area is usually located between the abdominal wall muscle tissue and the uterine fibroid; the bone area is located at the bottom or inner layer of the model and simulates the structure of the real bone; the fascia area is located between the fat and the abdominal wall muscle and plays a role in connecting and isolating different tissues.

[0011] Furthermore, the phantom material is configured in the following manner: polymethyl methacrylate is used to simulate skin tissue, polyurethane is used to simulate fat or uterine fibroid tissue, ear wax plaster or hydrogel is used to simulate soft tissue, polylactic acid is used to simulate muscle tissue, and aluminum oxide is used to simulate bone tissue.

[0012] The present invention provides a dynamic control system of focal area shape based on high-intensity focused ultrasound constructed according to the above-mentioned uterine fibroid tissue interface model, including a water tank, a uterine fibroid phantom model, a phased transducer, a hydrophone, a sound field scanning host, a host computer, a phased transducer driver, a three-dimensional stepping motor driver, and a three-dimensional stepping motor; The water tank is used to hold water as a sound propagation medium; The uterine fibroid phantom model is used to simulate real uterine fibroid tissue, reflect the acoustic characteristics of biological tissue, and ensure the effectiveness of the testing and application of the HIFU system in real situations; The phase-controlled 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 to achieve dynamic regulation; The hydrophone receives the sound waves emitted by each 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 ultrasonic wave; The acoustic field scanning host is responsible for controlling the acoustic field scanning process and coordinating the operation of each component, including adjusting the transducer emission parameters and analyzing the received acoustic field data to achieve effective acoustic wave focusing and transmission; The host computer is used to perform data processing and analysis, monitor the operating status of the system, provide a user interface, help control the experiment and process the collected ultrasonic data; The phase-controlled transducer driver provides an electrical signal to drive the phase-controlled transducer so that it operates at a predetermined frequency and phase to achieve a desired sound wave emission mode; The three-dimensional stepper motor drive is used to accurately control the motor so that the hydrophone on the motor fixture moves at a uniform speed in three dimensions; The three-dimensional stepping motor performs actual mechanical movement, allowing the hydrophone to move at a constant speed along the X, Y, and Z axes in three-dimensional space to meet different experimental requirements and control effects.

[0013] Furthermore, the dynamic control system of focal zone shape based on high-intensity focused ultrasound is carried out according to the following steps: Drive the three-dimensional stepper motor to achieve uniform motion in the X, Y, and Z axes; The hydrophone is fixed, and the free-field focal sound pressure distribution of the phased transducer is scanned to obtain the reference focal area shape S1; The hydrophone was placed at the focal point P, and the uterine fibroid phantom model was placed; Focus the phased transducer, scan the sound field distribution at the focus P, and obtain the distorted focal range morphology S2; The control algorithm performs phase and amplitude compensation, rescans the sound pressure distribution at the focus P, and obtains an improved focal area shape S3; Compare the area and shape changes of S1, S2, and S3 to evaluate the results of focal area regulation.

[0014] The beneficial effects of the present invention are: The present invention provides a 3D model of uterine fibroid tissue interface, a production method, and a phased transducer focal zone morphology control system. The method first obtains an MRI image of a patient's uterine fibroids; then processes the MRI image to obtain two-dimensional image data with contour markings; and constructs a three-dimensional model with marking information; finally, according to the three-dimensional model, a material with acoustic properties similar to biological tissue is selected 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 differences between different biological tissues. Through this model, the focal zone morphology can be more effectively controlled, thereby improving the accuracy and therapeutic effect of HIFU in the treatment of uterine fibroids. The model integrates multidimensional information of tissue thickness, acoustic impedance characteristics, and their interactions, providing important support for preclinical verification of medical devices and formulation of personalized treatment plans.

[0015] By combining the uterine fibroid tissue interface model with the focal region regulation of the phase-controlled transducer, the present invention has multiple beneficial effects.

[0016] 1. The model can accurately evaluate the impact of the phased-control transducer on the surrounding healthy tissue under different operating parameters, 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 range control parameters of the phased-control transducer, including ultrasonic frequency, output power, pulse duration, phase modulation parameters of each array element, and amplitude settings, to determine the optimal treatment plan.

[0017] 2. This model provides important support in the preclinical validation of medical devices. By simulating the individual characteristics of different patients, it can help researchers predict the expected effects of HIFU treatment on various patients. This not only provides a scientific basis for the implementation of individualized treatment plans, but also significantly improves the success rate and safety of treatment.

[0018] 3. Based on this model, doctors can develop personalized treatment strategies targeting specific uterine fibroid characteristics, thereby achieving more efficient and accurate treatment results.

[0019] Other advantages, objectives and features of the present invention will be described in the following description to some extent, and to some extent, will be obvious to those skilled in the art based on the following examination and study, or can be taught from the practice of the present invention. The objectives and other advantages of the present invention can be realized and obtained through the following description. BRIEF DESCRIPTION OF THE DRAWINGS

[0020] In order to make the purpose, technical solution and beneficial effects of the present invention clearer, the present invention provides the following drawings for explanation.

[0021] Figure 1 Construct a flow chart for the uterine fibroid tissue interface model.

[0022] Figure 2 Schematic diagram of the uterine fibroid tissue interface model.

[0023] Figure 3 This is a framework diagram of the application scenario of the uterine fibroid tissue interface model.

[0024] Figure 4 Schematic diagram of focal area regulation. Figure 5 Schematic diagram of focal area regulation.

[0025] In the picture, 1 is uterine fibroids, 2 is skin, 3 is abdominal wall muscle tissue, 4 is fat, 5 is bone, and 6 is fascia. DETAILED DESCRIPTION

[0026] The present invention is further described below in conjunction with the accompanying drawings and specific embodiments so that those skilled in the art can better understand the present invention and implement it, but the embodiments are not intended to limit the present invention.

[0027] Example 1 like Figure 1 As shown, Figure 1 The flowchart for constructing the uterine fibroid tissue interface model is provided in this embodiment. The method for making a 3D model of the uterine fibroid tissue interface provided in this embodiment includes the following steps: S1: Obtain MRI images of the patient's uterine fibroids; First, use medical imaging software (such as DICOMViewer) to export images from the patient's MRI examination. These images should use high-resolution sequences that can clearly show the details of the uterus and its surrounding tissues. During this process, special attention should be paid to selecting sequences with good contrast (such as T2-weighted images) to ensure that the difference between the uterine fibroids and its boundaries and the surrounding tissues is clearly visible.

[0028] S2: Processing the MRI image to obtain two-dimensional image data with contour markings; Tools: Use professional image processing software (such as Itk-snap, MATLAB or 3DSlicer) to process the image. The steps are as follows: S21. Denoising: Applying filters (such as Gaussian filtering) to remove image noise can improve the image quality, especially in the border area of ​​the fibroid, which helps to accurately define the contour of the fibroid; S22. Enhance contrast: By adjusting the brightness and contrast of the image, the visualization of the uterus and fibroids is ensured to be clearer, which helps in subsequent contouring; S23. Contour marking: Outline the shape of the uterus and the outline of the fibroids on a clear image, especially highlighting the border shape of the fibroids. It should be noted that the border shape of the fibroids may vary between different patients, but this detail is crucial for the subsequent simulation of its biological and acoustic properties. At the same time, mark the surrounding soft tissues, such as skin, fat, muscle, fascia, and the shape and position of the uterine wall; S24. Acoustic parameter acquisition: According to the relationship between MRI images and sound velocity, density, and acoustic attenuation, the relevant parameters of the personalized sample are evaluated, and the phantom material and thickness are determined.

[0029] S3: constructing three-dimensional modeling with labeling information using two-dimensional image data with contour labels; Software: Use 3D modeling software (such as Blender, MeshLab, or MATLAB) to generate the phantom model. The specific steps are as follows: S31. Import the two-dimensional image data processed by S2 into the model software. In this process, the three-dimensional shapes of the uterus and fibroids need to be accurately constructed using the image marking information, and special attention needs to be paid to the morphological characteristics of their boundaries; S32. Carefully define each part of the model, taking into account the tissue characteristics of different areas (such as the different densities of fibroids and their connection characteristics with surrounding tissues). During the modeling process, the difference in interface acoustic impedance should be reflected through different material properties, such as using different sound speed and acoustic impedance parameters to simulate the interface between different soft tissues (such as muscle and fat). The parameters for defining the characteristics of each tissue are as follows: Table 1 defines the parameters of each tissue characteristic as follows: Organization 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 Acoustic attenuation coefficient (dB / cm) 0.5 0.5 1.0 1.0 0.7 1.0 2.0 Sound speed C(m / s) 1540 1450 1600 1560 1580 1570 3500 Manifestations of interface acoustic impedance differences: In acoustic applications, acoustic impedance is an important property of sound waves when they propagate at the interface of a material. The difference in acoustic impedance directly affects the reflection and transmission behavior of sound waves. Usually, acoustic impedance is defined as the product of the density of the material and the speed of sound: in, is the acoustic impedance, is the density of the material, is the speed of sound. For different soft tissues (such as muscle, fat and bone), the difference in density and speed of sound leads to different acoustic impedance. This difference will produce reflection and transmission at the interface of the component. Usually the speed of sound for soft tissue is between 1,500m / s and 1,600m / s, while the speed of sound for bone is significantly higher. These sound speeds are crucial for acoustic simulation and sound wave propagation analysis because they will directly affect the propagation behavior, reflection, transmission and attenuation of sound waves.

[0030] Reflection of sound waves: When sound waves pass through two media with different acoustic impedances, reflection occurs at the interface. The reflection coefficient can be calculated using the following formula: in, and are the acoustic impedances of the incident medium and the reflecting medium, respectively. A high impedance difference will result in a stronger reflection, while a smaller impedance difference will result in a lower reflection. Although the acoustic impedance difference between soft tissues is not large, there is still a certain reflection phenomenon, especially when the thickness of the tissue changes (such as 1mm material thickness corresponds to 5mm muscle tissue sound propagation), the reflection coefficient may increase.

[0031] Transmission of sound waves: The calculation of the transmission coefficient will be based on the difference between the acoustic impedance of the incident sound wave and the acoustic impedance of the interface, which can be simulated to a certain extent by the design of the phantom model to analyze the behavior of the sound wave under different thicknesses and boundary shapes. For sound waves entering different media, the transmission coefficient can be calculated by the following formula: In addition, the attenuation of sound waves during transmission will vary depending on tissue thickness and sound attenuation characteristics. As mentioned above, 1mm of material thickness can compress 5mm of muscle tissue and be reflected in the attenuation of sound waves.

[0032] Attenuation of sound waves: Sound attenuation refers to the reduction in the intensity of sound waves during propagation due to the characteristics of the medium. Sound attenuation is usually expressed as a sound attenuation coefficient, with units of decibels per meter (dB / m) or decibels per centimeter (dB / cm). The following is the basic method and formula for calculating sound attenuation: Where A is the attenuation (usually measured in decibels, dB); α is the sound attenuation coefficient, with the unit of dB / m or dB / cm. It indicates the attenuation of the intensity of the sound wave per unit distance; d is the distance the sound wave travels, in meters (m) or centimeters (cm). Different materials have different sound attenuation coefficients; For example, materials such as muscle, fat, bone, and air have widely varying sound attenuation coefficients; S33. The boundary shape should be carefully reflected in the model so that the shape, size and position of the boundary can be realistically reproduced in the subsequent acoustic analysis, especially under the action of the sound field, the change of the interface will affect the reflection and transmission of the sound wave.

[0033] S34. Feature annotation includes: the interface shapes between different tissues marked with different colors and the acoustic impedance and acoustic attenuation parameters of each tissue.

[0034] S4: Select materials with acoustic properties similar to those of biological tissues according to the three-dimensional model and obtain a 3D model through 3D printing; In this embodiment, when selecting materials similar to biological tissues, materials with similar acoustic properties to biological tissues are selected. Such materials can also be used for 3D printing. Some specific polymers and composite materials 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 selected: PMMA is a transparent plastic with good acoustic propagation properties. Its sound velocity is close to that of many biological tissues, such as skin and fat tissue. PMMA can be used to make acoustic sensor housings, parts of medical imaging equipment, etc.

[0035] Polyurethane (PU): Polyurethane can simulate different types of biological tissues due to its adjustable hardness and density. Soft polyurethane can mimic fat tissue, while harder polyurethane can mimic bone. At the same time, polyurethane has good wear resistance and elasticity.

[0036] Hydrogels: Hydrogels are usually composed of hydrophilic polymers, such as polyvinyl alcohol (PVA), and are often used in biomedical applications. The sound propagation properties of hydrogels are close to those of biological tissues, and are widely used in medical ultrasound devices and tissue engineering.

[0037] Polylactic acid (PLA): Although primarily an organic material, it may be combined with inorganic fillers in certain composite 3D prints to help mimic the acoustic properties of tissue.

[0038] Polyvinyl alcohol (PVA): Can be combined with inorganic materials to help create biocompatible models.

[0039] Alumina: has good acoustic properties and can be used to simulate bone tissue.

[0040] DentalStone: Commonly used in medical phantoms, it has good acoustic impedance characteristics and is suitable for simulating soft tissue.

[0041] Barium Titanate: has excellent acoustic properties and is used in high-intensity ultrasonic applications.

[0042] The rationally designed boundary shapes of these materials can effectively reflect the boundary shape differences and acoustic impedance differences between different biological tissues (such as muscle, fat and tumor tissue), thereby significantly improving the accuracy and effectiveness of HIFU treatment.

[0043] Prepare for printing: Convert the modeled 3D phantom into a format that can be used for 3D printing (such as an STL file) and set the printing parameters. Make sure that the selected material is similar to biological tissue in acoustic properties so that a reasonable response can be obtained when simulating ultrasonic behavior. For example, a polymer material with a certain thickness that can reflect different acoustic impedance characteristics can be selected.

[0044] Printing process and verification: After printing, the size and shape of the model are carefully checked, especially how the thickness and boundaries of different tissues affect the propagation of sound waves, to ensure that it accurately reflects the characteristics of actual biological tissues.

[0045] like Figure 2 As shown, Figure 2 Schematic diagram of a uterine fibroid tissue interface model, the uterine fibroid tissue interface model includes several sub-models for simulating the shapes of different tissue regions in the uterus, the sub-models include a uterine fibroid region 1 made of a phantom material, a skin region 2, an abdominal wall muscle tissue region 3, a fat region 4, a bone region 5, and a fascia region 6; Uterine fibroid area 1, located in the center of the model, simulates the fibroids in the actual uterus. The acoustic properties of this part should be close to those of a real uterine fibroid to ensure accuracy during the sound wave transmission process.

[0046] Skin region 2, the outermost layer, surrounds 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 taken into account.

[0047] The abdominal wall muscle tissue area 3, located between the skin 2 and the fat 4, simulates the real abdominal wall tissue. Its acoustic properties will affect the propagation of sound waves, especially in the interaction with other tissues.

[0048] Fatty areas 4, usually located between the abdominal wall muscle tissue and uterine fibroids, can affect the propagation speed and attenuation characteristics of sound waves.

[0049] The bone region 5, located at the bottom or inner layer of the model, simulates the structure of real bones. The speed of sound and density of bones significantly affect the propagation characteristics of sound waves.

[0050] The fascia area 6 is usually sandwiched between fat and abdominal wall muscles, which plays a role in connecting and isolating different tissues. The acoustic properties of the fascia affect its sound wave transmission with other soft tissues.

[0051] Layout and feature relationship: Relative position: Skin 2 is the outermost layer, next to it is the abdominal wall muscle tissue 3, followed by fat 4, uterine fibroids 1 is in the center, bones 5 may be at the bottom, and fascia 6 connects the fat and muscle tissue.

[0052] Acoustic properties: The acoustic properties of each material should be carefully designed to match the characteristics of biological tissues and better simulate the response of biological tissues to sound waves in order to establish an accurate acoustic model.

[0053] Example 2 like Figure 3 As shown, Figure 3 This is a block diagram of the application scenario of the uterine fibroid tissue interface model. According to the above model, this embodiment constructs a dynamic control system of focal shape based on high-intensity focused ultrasound (HIFU), including a water tank, a uterine fibroid tissue interface phantom model, a phased transducer, a hydrophone, an acoustic field scanning host, a host computer, a phased transducer driver, a three-dimensional stepping motor driver, and a three-dimensional stepping motor; The water tank is used to hold water as a sound propagation medium to ensure efficient conduction of sound waves and provide a suitable environment for the emission and focusing of ultrasonic waves. At the same time, it helps reduce the attenuation of sound waves to improve system performance; The uterine fibroid tissue interface phantom model is used to simulate the boundary interface shape between different biological tissues of a real uterine fibroid, and can accurately reflect the acoustic characteristics of biological tissues, thereby ensuring the effectiveness of the testing and application of the HIFU system in real situations; The phase-controlled transducer is responsible for converting electrical signals into high-intensity ultrasonic waves, and by adjusting the amplitude and phase of each array element, accurately controlling the direction and focus of the ultrasonic waves to achieve dynamic regulation; The hydrophone receives the sound waves emitted by each element of the phased array, monitors the sound pressure, amplitude and other information, provides real-time feedback for system optimization, and ensures the focusing accuracy of the ultrasonic wave; The acoustic field scanning host is responsible for controlling the acoustic field scanning process and coordinating the operation of each component, including adjusting the transducer emission parameters and analyzing the received acoustic field data to achieve effective acoustic wave focusing and transmission; The host computer is used to perform data processing and analysis, monitor the operating status of the system, provide a user interface, help control the experiment and process the collected ultrasonic data; The phase-controlled transducer driver provides an electrical signal to drive the phase-controlled transducer so that it operates at a predetermined frequency and phase to achieve a desired sound wave emission mode; The three-dimensional stepper motor drive is used to accurately control the motor so that the hydrophone on the motor fixture moves at a uniform 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 meet different experimental requirements and control effects; like Figure 4 As shown, Figure 4Flow chart of the focal area shape control method. In the phased transducer focal area control system of this embodiment, each array element can independently drive and adjust the output phase and amplitude to achieve dynamic control of the focal area shape. The specific process is as follows: start; Drive the three-dimensional stepper motor to achieve uniform motion in the X, Y, and Z axes; The hydrophone is fixed, and the free-field focal sound pressure distribution of the phased transducer is scanned to obtain the reference focal area shape S1; The hydrophone was placed at the focal point P, and the uterine fibroid phantom model was placed; Focus the phased transducer, scan the sound field distribution at the focus P, and obtain the distorted focal range morphology S2; The control algorithm performs phase and amplitude compensation, rescans the sound pressure distribution at the focus P, and obtains an improved focal area shape S3; Compare the area and shape changes of S1, S2, and S3 to evaluate the results of focal area regulation; Finish.

[0054] This embodiment implements dynamic control of the focal area shape according to the following steps: First, the acoustic field scanning system drives the three-dimensional stepper motor, which can move at a constant speed in the three directions of X, Y, and Z; The hydrophone is fixed on the motor to scan the free-field focal sound pressure distribution of the phased transducer. The focal area shape S1 at this time is used as the reference for focal area control. Secondly, the hydrophone is placed at the focal point P, and the uterine fibroid phantom is placed in the acoustic channel for phased transducer focusing; The sound field distribution at the original focus P is scanned again to obtain the distorted focal area shape S2. After phase modulation and amplitude compensation by the control algorithm, a focusing experiment is performed. The sound pressure distribution is scanned at the original focus P to obtain the improved focal area shape S3, thus achieving the purpose of focal area control. Compare and calculate the changes in the area and shape of S1, S2, and S3 to evaluate the effect of focal range control. Figure 5 As shown, Figure 5 Schematic diagram of focal area regulation.

[0055] This embodiment provides a new phantom model for HIFU treatment using a phased transducer. It uses appropriate inorganic materials to accurately reflect the shape and acoustic information of different tissue interfaces based on MRI image information, and simulates the scheme of phased acoustic field regulation before HIFU surgery based on this model. This model can effectively reflect the boundary shape differences and acoustic impedance differences between different biological tissues (such as muscle, fat and tumor tissue) by designing a reasonable boundary shape. Significantly improve the accuracy and effectiveness of HIFU treatment.

[0056] In this embodiment, polymethyl methacrylate (PMMA) is used to simulate skin tissue, polyurethane (PU) is used to simulate fat or uterine fibroid tissue, dental stone or hydrogel is used to simulate soft tissue, polylactic acid (PLA) is used to simulate muscle tissue, and alumina is used to simulate bone tissue, which can effectively reflect the boundary shape differences and acoustic impedance differences between different biological tissues (such as muscle, fat and tumor tissue), thereby significantly improving the accuracy and effectiveness of HIFU treatment.

[0057] The inorganic materials used in this embodiment can not only be preserved for a long time, but also can better restore the interface acoustic impedance differences between multi-layer tissues through reasonable material selection, and restore the tissue attenuation of the corresponding thickness by setting an appropriate material thickness ratio. Combined with 3D printing and profiling, the boundary shape of personalized samples can be better restored, so that the boundary characteristics of real biological tissues can be better reflected when calculating sound wave propagation and thermal effects. Model-based phase-controlled treatment plan verification can be performed before HIFU surgery to provide a reference for surgical phase adjustment plans.

[0058] At the same time, this phantom model will play an important role in the following application scenarios: HIFU tissue experiment: Verify the effectiveness of different focal area regulation schemes through multiple experiments to find the best treatment parameters (such as frequency, energy density, etc.). Personalized treatment plan design: Adjust the focal area morphology according to the patient's specific tissue interface shape to achieve a more accurate personalized phase adjustment plan. Preclinical verification: Before actual clinical application, fully verify the new technology or equipment to ensure the safety and effectiveness of the treatment.

[0059] Therefore, this model can reflect the interfaces of various tissues, which not only has important clinical application value, but also provides an innovative solution for HIFU treatment of uterine fibroids, making the acoustic field distribution and tissue response during treatment as close to the actual situation as possible, thereby improving the effectiveness and safety of patient treatment.

[0060] The above-described embodiments are only preferred embodiments for fully illustrating the present invention, and the protection scope of the present invention is not limited thereto. Equivalent substitutions or changes made by those skilled in the art based on the present invention are within the protection scope of the present invention. The protection scope of the present invention shall be subject to the claims.

Claims

1. A method for making a 3D model of a uterine fibroid tissue interface, characterized in that: The following steps are involved: S1: Obtain MRI images of the patient's uterine fibroids; S2: Processing the MRI image to obtain two-dimensional image data with contour markings; S3: constructing three-dimensional modeling with labeling information using two-dimensional image data with contour labels; S4: Based on the three-dimensional model, a material having acoustic properties similar to those of biological tissue is selected to obtain a 3D model through 3D printing.

2. The method for making a 3D model of a uterine fibroid tissue interface according to claim 1, characterized in that: The image in step S2 is processed in the following manner: S21. De-noising the uterine fibroid MRI image; S22. The contour image of the boundary area of ​​the tumor is obtained by contrast enhancement processing: S23. Marking the contour image to obtain two-dimensional image data with contour marking; S24. Determine the type and thickness parameters of the phantom material for making the 3D model based on the MRI image and ultrasound parameters.

3. The method for making a 3D model of a uterine fibroid tissue interface according to claim 1, characterized in that: The three-dimensional modeling in step S3 is performed in the following manner: S31. Importing the two-dimensional image data with contour marks into the three-dimensional model making software; S32. Determine tissue characteristics of different regions of the three-dimensional model; S33. Making a three-dimensional model based on the two-dimensional image data with contour marks and the tissue characteristics of different regions; using the corresponding phantom material according to the tissue characteristics of different regions through the three-dimensional model making software to obtain the morphological characteristic images of the three-dimensional boundaries of the uterus and fibroids based on the marking information; S34. Use different colors to mark the interface shapes between different tissues as well as the acoustic impedance and acoustic attenuation parameters of each tissue.

4. The method for making a 3D model of a uterine fibroid tissue interface according to claim 1, characterized in that: The biological tissue-similar material includes a polymer or a composite material.

5. The method for making a 3D model of a uterine fibroid tissue interface according to claim 1, characterized in that: The biological tissue-similar material includes any one or more of polymethyl methacrylate, polyurethane, hydrogel, polylactic acid, polyvinyl alcohol, alumina, ear wax plaster, and barium titanate.

6. The uterine fibroid tissue interface model produced by the uterine fibroid tissue interface 3D model production method according to any one of claims 1 to 5, characterized in that: The invention comprises several sub-models for simulating the shapes of different tissue regions in the uterus, wherein 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 made of phantom materials; the uterine fibroid region is located at the center of the model and simulates the fibroids in the actual uterus; the skin region is located at the outermost layer and surrounds the other parts; The abdominal wall muscle tissue area is located between the skin and fat, simulating the 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 the real bone; the fascia area is located between the fat and the abdominal wall muscle, and plays a role in connecting and isolating different tissues.

7. The uterine fibroid tissue interface model according to claim 6, characterized in that: The phantom material is arranged in the following manner: polymethyl methacrylate is used to simulate skin tissue, polyurethane is used to simulate fat or uterine fibroid tissue, ear wax plaster or hydrogel is used to simulate soft tissue, polylactic acid is used to simulate muscle tissue, and aluminum oxide is used to simulate bone tissue.

8. A dynamic control system of focal zone shape based on high intensity focused ultrasound constructed according to the uterine fibroid tissue interface model of claim 6, characterized in that: It includes a water tank, a uterine fibroid phantom model, a phased transducer, a hydrophone, a sound field scanning host, a host computer, a phased transducer driver, a three-dimensional stepping motor driver and a three-dimensional stepping motor; The water tank is used to hold water as a sound propagation medium; The uterine fibroid phantom model is used to simulate real uterine fibroid tissue, reflect the acoustic characteristics of biological tissue, and ensure the effectiveness of the testing and application of the HIFU system in real situations; The phase-controlled 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 to achieve dynamic regulation; The hydrophone receives the sound waves emitted by each 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 ultrasonic wave; The acoustic field scanning host is responsible for controlling the acoustic field scanning process and coordinating the operation of each component, including adjusting the transducer emission parameters and analyzing the received acoustic field data to achieve effective acoustic wave focusing and transmission; The host computer is used to perform data processing and analysis, monitor the operating status of the system, provide a user interface, help control the experiment and process the collected ultrasonic data; The phase-controlled transducer driver provides an electrical signal to drive the phase-controlled transducer so that it operates at a predetermined frequency and phase to achieve a desired sound wave emission mode; The three-dimensional stepper motor drive is used to accurately control the motor so that the hydrophone on the motor fixture moves at a uniform speed in three dimensions; The three-dimensional stepping motor performs actual mechanical movement, allowing the hydrophone to move at a constant speed along the X, Y, and Z axes in three-dimensional space to meet different experimental requirements and control effects.

9. The focal zone shape dynamic control system based on high-intensity focused ultrasound according to claim 8, characterized in that: The dynamic control system of focal zone shape based on high-intensity focused ultrasound is carried out according to the following steps: Drive the three-dimensional stepper motor to achieve uniform motion in the X, Y, and Z axes; The hydrophone is fixed, and the free-field focal sound pressure distribution of the phased transducer is scanned to obtain the reference focal area shape S1; The hydrophone was placed at the focal point P, and the uterine fibroid phantom model was placed; Focus the phased transducer, scan the sound field distribution at the focus P, and obtain the distorted focal range morphology S2; The control algorithm performs phase and amplitude compensation, rescans the sound pressure distribution at the focus P, and obtains an improved focal area shape S3; Compare the area and shape changes of S1, S2, and S3 to evaluate the results of focal area regulation.

Images