Cleft lip and palate deformity correction training model and manufacturing method thereof

Through CT scanning and SLA 3D printing technology, combined with advanced materials, a cleft lip and palate correction training model with appearance and texture close to the soft tissue of the human cleft lip and palate skin is constructed, solving the shortcomings of the existing models in terms of flexibility and suturability, and improving the authenticity and effectiveness of the training.

CN120048175APending Publication Date: 2025-05-27WEST CHINA HOSPITAL SICHUAN UNIV
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Patent Information

Application Number
CN202510183143.9
Authority / Receiving Office
CN · China
Patent Type
Applications(China)
Current Assignee / Owner
Filing Date
2025-02-19
Publication Date
2025-05-27

AI Technical Summary

Technical Problem

When simulating surgical operation, the existing cleft lip and palate deformity correction training model is difficult to accurately simulate the human body from both appearance and texture, especially in terms of flexibility and sutureability.

Method used

CT scanning technology is used to build a three-dimensional model of cleft lip and palate, combined with SLA 3D printing technology, and high-level materials such as agilus30A, 40A, 50A, 60A, 70A, 85A, 95A for printing, ensuring that the appearance and texture of the model are close to the soft tissue of the skin of the real human cleft lip and palate.

Benefits of technology

The high accuracy and authenticity of the cleft lip and palate correction training model is achieved, the doctor's surgical skills and training effects are improved, and a safe and controllable simulation environment is provided, suitable for multiple suture exercises.

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Abstract

The invention discloses a cleft lip and palate deformity correction training model and a manufacturing method thereof. According to the method, the cleft lip and palate deformity correction training model can be directly printed in one step from the digital model through precise CT scanning and an advanced three-dimensional reconstruction technology in combination with an SLA 3D printing technology. The advantage of this one-step molding is that it avoids the complexity and errors of multi-step assembly and joining that may occur in conventional manufacturing methods. And each model is integrally formed, so that the accuracy of the model and the integrity of the structure are ensured. According to the method, a training model of which the appearance and the texture are very close to those of real human cleft lip and palate skin soft tissues can be manufactured by using high-grade materials and a fine 3D printing technology. The skin soft tissue part of the model has elasticity, texture and color similar to those of real tissues, so that a surgeon can obtain more real and visual experience during operation training.
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Description

Technical Field

[0001] The present invention belongs to the technical field of medical teaching aids, and specifically relates to a training model for cleft lip and palate deformity correction and a manufacturing method thereof. Background Art

[0002] Cleft lip and palate deformity is a common birth defect that occurs during the development of the oral and facial regions, resulting in the splitting of the lip, palate, or both. The incidence of this deformity is relatively high, with approximately 1 in 700 infants being affected. Cleft lip and palate deformity not only affects an individual's appearance but may also have long-term effects on their physical and mental health. Patients with cleft lip and palate deformity require surgical treatment for cleft lip and palate deformity correction. In cleft lip and palate correction surgery, the correction operation requires high precision and is one of the most challenging operations in maxillofacial surgery. Behind a doctor's efficient completion of this technical operation, a large amount of time is needed to simulate and practice cleft lip and palate correction surgery.

[0003] Existing training models include easily accessible pig snouts and specially made silicone casting models.

[0004] AGILUS 30FLX935 POLYJET SLA 3D printed cleft lip and palate model: ① CT scan the patient's maxillofacial region; ② Extract the CT cleft lip and palate model and perform post-processing on the model; ③ SLA 3D printing, using AGILUS 30FLX935 material for 3D printing to obtain the required cleft lip and palate model.

[0005] Silicone cast costal cartilage model: ① Use CT to scan the patient's maxillofacial region to obtain cleft lip and palate data and perform post-processing, and design the mold for the three-dimensional cleft lip and palate model; ② 3D print and manufacture a metal mold; ③ Pour the liquid material into the cleft lip and palate model; ④ Demold to obtain the cleft lip and palate model.

[0006] However, the shape of natural materials (pig snouts) is very different from that of human skin soft tissues, and doctors cannot well simulate the surgical operation environment during practice, resulting in poor practice effects. The texture of the silicone cast cleft lip and palate deformity model still has differences from that of human skin soft tissues, especially in terms of flexibility and suture ability.

[0007] In view of the above problems, the present invention aims to simulate the human situation during surgery in terms of both appearance and texture, and improve the problems of insufficient flexibility and suture ability of the model in the existing technical solutions. Summary of the Invention

[0008] The purpose of the present invention is to provide a training model for cleft lip and palate deformity correction and a manufacturing method thereof in order to solve the above-mentioned problems.

[0009] The technical solution adopted by the present invention is as follows: A manufacturing method of a training model for cleft lip and palate deformity correction, characterized in that: the

[0010] Step 1: Construction of a three-dimensional model of cleft lip and palate based on CT;

[0011] Step 1.1: Acquisition of CT scan images of cleft lip and palate (unilateral and bilateral cleft lip and palate);

[0012] Step 1.2: Use Materialise Mimics Medical to extract the cleft lip and palate model and perform post-processing of the model to construct the final cleft lip and palate model;

[0013] Step 2: 3D printing of the cleft lip and palate model; printing using SLA (stereolithography); printing with materials such as agilus30A, 40A, 50A, 60A, 70A, 85A, 95A;

[0014] Step 2.1: Model preparation: Use computer-aided design software to design and convert the cleft lip and palate model to be printed into the required file format; the file contains the geometric information of the model for slicing and printing;

[0015] Step 2.2: Slicing and path generation: Slice the file into multiple thin layers to generate a sequence of lithography layer thicknesses;

[0016] Step 2.3: Curing of liquid photosensitive resin: The laser beam irradiates the liquid photosensitive resin layer by layer, causing it to gradually cure into a solid layer; the curing of each layer forms a thin slice, and the slices are gradually stacked to form the entire model;

[0017] Step 2.4: Layer-by-layer printing: Repeat the coating and curing steps until the entire model is printed;

[0018] Step 2.5: Post-processing: Remove the uncured resin, perform surface finishing, and then collect and process the obtained model to complete the manufacturing method of the entire cleft lip and palate deformity correction training model.

[0019] In a preferred embodiment, in step 1.1, the following steps are specifically included:

[0020] Patient preparation: Ensure that the patient has no metal objects, such as metal parts on jewelry or clothing, as these will interfere with the CT scan.

[0021] Scanning parameter setting: Select appropriate scanning parameters, such as tube voltage, tube current, slice thickness, and pitch, to ensure high-quality images are obtained.

[0022] Scanning execution: Instruct the patient to remain stationary and perform a continuous scan from the head to the chest to obtain detailed data of the cleft lip and palate area.

[0023] Image storage: Store the scanned image data in DICOM format for subsequent processing.

[0024] In a preferred embodiment, in step 1.2, the following steps are specifically included:

[0025] Data import: Import the CT image data in DICOM format into the Materialise Mimics Medical software.

[0026] Threshold segmentation: Use the threshold segmentation tool of the software to separate the cleft lip and palate area from the background according to the density difference of tissues.

[0027] 3D reconstruction: Utilize the 3D reconstruction function of the software to generate a 3D model of the segmented cleft lip and palate area.

[0028] Model optimization: Smooth the reconstructed 3D model, remove unnecessary noise, and optimize the structure of the model.

[0029] Model verification: Check the accuracy of the model to ensure that it conforms to the actual cleft lip and palate structure.

[0030] In a preferred embodiment, in step 2.1, the following steps are specifically included:

[0031] Repair geometric problems: Check and repair possible geometric errors in the model in CAD software, such as holes, overlaps, or gaps.

[0032] Model positioning: Ensure the correct position and orientation of the model on the printing platform for easy printing and post-processing.

[0033] In a preferred embodiment, in step 2.2, the following steps are specifically included:

[0034] Select slicing parameters: Set parameters such as slice thickness, printing speed, laser power, etc. to meet specific printing requirements.

[0035] Generate printing path: The software will calculate the movement path of the laser beam on each layer to ensure accurate printing of the model.

[0036] In a preferred embodiment, in step 2.3, the laser beam irradiates the resin according to the slicing path, and the curing of each layer forms a thin slice, gradually stacking to form the entire model.

[0037] In a preferred embodiment, in step 2.4, the following steps are specifically included:

[0038] Monitor the printing process: Monitor the formation of the model during printing to ensure that no printing errors occur.

[0039] Support structure: For parts with overhanging or complex structures, support structures may need to be added to maintain the stability of the model during printing.

[0040] In a preferred embodiment, in step 2.5, it specifically includes the following steps:

[0041] Clean the model: Use appropriate solvents and tools to carefully remove the uncured resin and support structures on the surface of the model.

[0042] Surface treatment: According to requirements, polish, buff or coat the model to improve its surface finish and durability.

[0043] Inspection and verification: Finally, check the printed cleft lip and palate model to ensure that it meets the accuracy and quality requirements for medical applications.

[0044] In summary, due to the adoption of the above technical solutions, the beneficial effects of the present invention are:

[0045] 1. In the present invention, through precise CT scanning and advanced three-dimensional reconstruction technology, combined with SLA 3D printing technology, it is possible to directly print a training model for cleft lip and palate deformity correction surgery from a digital model in one step. The advantage of this one-step forming is that it avoids the complexity and errors of multi-step assembly and joining that may occur in traditional manufacturing methods. Each model is integrally formed, ensuring the accuracy of the model and the integrity of the structure. This method not only improves production efficiency but also reduces the possibility of human errors, thereby improving the reliability of the model and the training effect. Doctors and surgeons can use these models for surgical simulation and training without worrying about the inaccuracy or unreality of the models.

[0046] 2. In the present invention, by using advanced materials and fine 3D printing technology, this method can manufacture a training model whose appearance and texture are very close to the real human cleft lip and palate skin and soft tissues. The skin and soft tissue part of this model has similar elasticity, texture and color to real tissues, enabling surgeons to obtain a more real and intuitive experience during surgical training. This highly realistic model not only improves the authenticity of training but also allows doctors to practice and test different surgical techniques and methods under different conditions, thereby improving surgical skills and the success rate of surgery.

[0047] 3. In the present invention, the materials used have excellent toughness, enabling the training model to better withstand the stress of suturing and operation during the simulation of the surgical process. The superior performance of this material makes the model show better durability and stability during repeated use and simulation of surgical operations. In addition, due to the excellent suture performance of the material, doctors can perform multiple suture practices on the model to master and improve suture skills. This highly realistic simulation environment not only improves doctors' surgical skills but also provides them with a safe and controllable platform to experiment and improve new surgical techniques and methods. Specific embodiments

[0048] In order to make the objectives, technical solutions and advantages of the present invention more clear and understandable, the present invention will be further described in detail below in conjunction with embodiments. It should be understood that the specific embodiments described herein are only used to explain the present invention and are not used to limit the present invention.

[0049] Embodiment:

[0050] A manufacturing method for a training model for cleft lip and palate deformity correction, comprising the following steps:

[0051] Step 1: Construction of a three-dimensional model of cleft lip and palate based on CT;

[0052] Step 1.1 Collect CT scan images of cleft lip and palate (unilateral and bilateral cleft lip and palate);

[0053] Step 1.2 Use Materialise Mimics Medical to extract the cleft lip and palate model and perform post-processing of the model to construct the final cleft lip and palate model;

[0054] Step 2: 3D printing of the cleft lip and palate model; printing using SLA (stereolithography); printing using materials such as agilus 30A, 40A, 50A, 60A, 70A, 85A, 95A;

[0055] Step 2.1 Model preparation: Use computer-aided design software to design and convert the cleft lip and palate model to be printed into the required file format; the file contains the geometric information of the model for slicing and printing;

[0056] Step 2.2 Slicing and path generation: Slice the file into multiple thin layers to generate a sequence of photolithography layer thicknesses;

[0057] Step 2.3 Curing of liquid photosensitive resin: The laser beam irradiates the liquid photosensitive resin layer by layer, causing it to gradually cure into a solid layer; the curing of each layer forms a thin slice, and the slices are gradually stacked to form the entire model;

[0058] Step 2.4 Layer-by-layer printing: Repeat the coating and curing steps until the entire model is printed;

[0059] Step 2.5 Post-processing: Remove the uncured resin, perform surface finishing, and then collect and process the obtained model to complete the manufacturing method of the training model for cleft lip and palate deformity correction.

[0060] In Step 1.1, it specifically includes the following steps:

[0061] Patient preparation: Ensure that the patient has no metal objects, such as metal parts on jewelry or clothing, as these will interfere with the CT scan.

[0062] Scanning parameter settings: Select appropriate scanning parameters such as tube voltage, tube current, slice thickness, and pitch to ensure high-quality images are obtained.

[0063] Scanning execution: Instruct the patient to remain stationary and perform a continuous scan from the head to the chest to obtain detailed data of the cleft lip and palate area.

[0064] Image storage: Store the scanned image data in DICOM format for subsequent processing.

[0065] In Step 1.2, the following steps are specifically included:

[0066] Data import: Import the CT image data in DICOM format into the Materialise Mimics Medical software.

[0067] Threshold segmentation: Use the threshold segmentation tool of the software to separate the cleft lip and palate area from the background according to the density difference of tissues.

[0068] 3D reconstruction: Utilize the 3D reconstruction function of the software to generate a 3D model of the segmented cleft lip and palate area.

[0069] Model optimization: Smooth the reconstructed 3D model, remove unnecessary noise, and optimize the structure of the model.

[0070] Model verification: Check the accuracy of the model to ensure it conforms to the actual cleft lip and palate structure.

[0071] In Step 2.1, the following steps are specifically included:

[0072] Repair geometric problems: Check and repair possible geometric errors in the model in CAD software, such as holes, overlaps, or gaps.

[0073] Model positioning: Ensure the correct position and orientation of the model on the printing platform for easy printing and post-processing.

[0074] In Step 2.2, the following steps are specifically included:

[0075] Select slicing parameters: Set parameters such as slice thickness, printing speed, and laser power to meet specific printing requirements.

[0076] Generate printing path: The software will calculate the movement path of the laser beam on each layer to ensure accurate printing of the model.

[0077] In Step 2.3, the laser beam irradiates the resin according to the slicing path, and the curing of each layer forms a thin slice, gradually stacking to form the entire model.

[0078] In Step 2.4, the following steps are specifically included:

[0079] Monitor the printing process: Monitor the formation of the model during printing to ensure that no printing errors occur.

[0080] Support structure: For parts with overhanging or complex structures, it may be necessary to add a support structure to maintain the stability of the model during printing.

[0081] In step 2.5, it specifically includes the following steps:

[0082] Clean the model: Carefully remove the uncured resin and support structure on the surface of the model using appropriate solvents and tools.

[0083] Surface treatment: According to requirements, polish, buff, or coat the model to improve its surface finish and durability.

[0084] Inspection and verification: Finally, check the printed cleft lip and palate model to ensure that it meets the accuracy and quality requirements for medical applications.

[0085] Afterwards, the above method can be used to prepare the training model for cleft lip and palate deformity correction surgery.

[0086] In the present invention, through precise CT scanning and advanced three-dimensional reconstruction technology, combined with SLA 3D printing technology, it is possible to directly print the training model for cleft lip and palate deformity correction surgery in one step from a digital model. The advantage of this one-step molding is that it avoids the complexity and errors of multi-step assembly and joining that may occur in traditional manufacturing methods. Each model is integrally formed, ensuring the accuracy of the model and the integrity of the structure. This method not only improves production efficiency but also reduces the possibility of human errors, thereby enhancing the reliability of the model and the training effect. Doctors and surgeons can use these models for surgical simulation and training without worrying about the inaccuracy or unreality of the models.

[0087] In the present invention, by using advanced materials and fine 3D printing technology, this method can manufacture a training model whose appearance and texture are very close to the real human cleft lip and palate skin and soft tissues. The skin and soft tissue part of this model has similar elasticity, texture, and color to real tissues, enabling surgeons to obtain a more real and intuitive experience during surgical training. This highly simulated model not only improves the authenticity of training but also allows doctors to practice and test different surgical techniques and methods under different conditions, thereby improving surgical skills and the success rate of surgery.

[0088] In the present invention, the materials used have excellent toughness, enabling the training model to better withstand the stresses of suturing and manipulation during the simulated surgical process. The superior performance of this material enables the model to exhibit better durability and stability during repeated use and simulated surgical operations. In addition, due to the excellent suturing performance of the material, doctors can perform multiple suturing exercises on the model to master and improve their suturing skills. This highly realistic simulation environment not only improves doctors' surgical skills but also provides them with a safe and controllable platform to experiment with and improve new surgical techniques and methods.

[0089] It should be noted that in this article, relational terms such as first and second are only used to distinguish one entity or operation from another entity or operation, and do not necessarily require or imply any actual relationship or order between these entities or operations. Moreover, the terms "comprising", "including" or any other variant thereof are intended to cover non-exclusive inclusion, so that a process, method, article or device comprising a series of elements not only includes those elements but also includes other elements not expressly listed, or also includes elements inherent in such process, method, article or device. Without further limitation, an element defined by the statement "comprising an..." does not exclude the presence of additional identical elements in the process, method, article or device comprising the element.

[0090] The above embodiments are only used to illustrate the technical solutions of the present invention and are not intended to limit them; although the present invention has been described in detail with reference to the foregoing embodiments, those of ordinary skill in the art should understand that they can still modify the technical solutions described in the foregoing embodiments, or perform equivalent replacements for some of the technical features; and these modifications or replacements do not cause the essence of the corresponding technical solutions to deviate from the spirit and scope of the technical solutions of the various embodiments of the present invention.

Claims

1. A method for manufacturing a training model for cleft lip and palate correction, characterized in that: The method comprises the following steps: Step 1: Construction of 3D model of cleft lip and palate based on CT; Step 1.1 Acquire CT scan images of cleft lip and palate; Step 1.2: Use MaterialiseMimicsMedical to extract the cleft lip and palate model, and perform post-processing on the model to construct the final cleft lip and palate model; Step 2: 3D print the cleft lip and palate model; use SLA printing: use agilus30A, 40A, 50A, 60A, 70A, 85A, 95A materials for printing; Step 2.1 Model preparation: Use computer-aided design software to design the cleft lip and palate model to be printed and convert it into the required file format; the file contains the geometric information of the model for slicing and printing; Step 2.2 Slicing and path generation: Slice the file into multiple thin layers and generate a sequence of photolithography layer thicknesses; Step 2.3: Liquid photosensitive resin solidification: The laser beam is irradiated onto the liquid photosensitive resin layer by layer, so that it gradually solidifies into a solid layer; each layer solidifies to form a thin sheet, which is gradually stacked to form the entire model; Step 2.4 Print layer by layer: Repeat the coating and curing steps until the entire model is printed; Step 2.5 post-processing: remove the uncured resin, perform surface finishing, and then collect the obtained model to complete the manufacturing method of the cleft lip and palate deformity correction training model.

2. The method for manufacturing a training model for cleft lip and palate correction as claimed in claim 1, characterized in that: The step 1.1 specifically includes the following steps: Patient preparation: Make sure the patient has no metal objects, including jewelry or metal parts on clothing, as these can interfere with the CT scan; Scan parameter setting: select appropriate scanning parameters, including tube voltage, tube current, layer thickness and pitch; Scan execution: Instruct the patient to remain still while a continuous scan from head to chest is performed to obtain detailed data of the cleft lip and palate area; Image storage: The scanned image data is stored in DICOM format, waiting for subsequent processing.

3. The method for manufacturing a training model for cleft lip and palate correction as claimed in claim 1, characterized in that: The step 1.2 specifically includes the following steps: Data import: Import CT image data in DICOM format into Materialise Mimics Medical software; Threshold segmentation: Use the threshold segmentation tool of the software to separate the cleft lip and palate area from the background based on the density difference of the tissue; Three-dimensional reconstruction: Use the three-dimensional reconstruction function of the software to generate a three-dimensional model of the segmented cleft lip and palate area; Model optimization: Smooth the reconstructed 3D model, remove excess noise, and optimize the model structure; Model Validation: Check the accuracy of the model to ensure that it matches the actual cleft lip and palate structure.

4. The method for manufacturing a training model for cleft lip and palate correction according to claim 1, characterized in that: The step 2.1 specifically includes the following steps: Repair geometry problems: Check and repair possible geometric errors in the model in CAD software; Model positioning: Ensure the correct position and orientation of the model on the printing platform for easy printing and post-processing.

5. The method for manufacturing a training model for cleft lip and palate correction as claimed in claim 1, characterized in that: The step 2.2 specifically includes the following steps: Select slice parameters: set slice thickness, printing speed, laser power and other parameters to meet specific printing requirements; Generate printing path: The software will calculate the movement path of the laser beam on each layer to ensure accurate printing of the model.

6. The method for manufacturing a training model for cleft lip and palate deformity correction according to claim 1, characterized in that: In step 2.3, the laser beam irradiates the resin along the slicing path, and each layer is solidified to form a thin slice, which is gradually stacked to form the entire model.

7. The method for manufacturing a training model for cleft lip and palate correction according to claim 1, characterized in that: The step 2.4 specifically includes the following steps: Monitor the printing process: monitor the formation of the model during the printing process to ensure that no printing errors occur; Support structure: For suspended or complex parts, support structures need to be added to maintain the stability of the model.

8. The method for manufacturing a training model for cleft lip and palate deformity correction according to claim 1, characterized in that: The step 2.5 specifically includes the following steps: Clean the model: Use appropriate solvents and tools to remove uncured resin and support structures on the surface of the model; Surface treatment: grinding, polishing or coating the model as needed to improve its surface finish and durability; Inspection and verification: Finally, the printed cleft lip and palate model is inspected to ensure that it meets the accuracy and quality requirements for medical applications.

9. A cleft lip and palate deformity correction training model, characterized in that: The model is prepared by the method according to any one of claims 1 to 8.