Preparation method of 3D surgical guide plate with X-ray radiation resistance

Abstract

The invention relates to the technical field of medical instruments, and discloses a preparation method of a 3D operation guide plate with X-ray radiation resistance, which comprises the following steps: clinical image data acquisition and processing: acquiring fault data of a bone defect part of a patient through a medical image technology, and processing by utilizing three-dimensional reconstruction software to obtain a bone defect solid model; designing a surgical guide plate: determining the type of the surgical guide plate according to the condition of the patient and surgical requirements, and designing a structure for guiding surgical operation on the guide plate; preparing printable slurry: uniformly mixing zirconia ceramic powder and a photosensitive resin material according to a specific ratio to obtain the printable slurry with X-ray radiation resistance and high mechanical strength; 3D printing: importing the surgical guide plate model file into a 3D printer. The preparation method of the 3D operation guide plate with the X-ray radiation resistance aims at solving the problems that an existing 3D printing operation guide plate is insufficient in mechanical strength and poor in X-ray radiation resistance in the aspect of material selection.

Description

Technical Field

[0001] The present invention relates to the technical field of medical devices, and in particular to a method for preparing a 3D surgical guide with X-ray blocking properties. Background Art

[0002] The application of 3D printed surgical guides in the field of orthopedic surgery marks a major leap forward in medical technology. It is based on the patient's individualized CT or MRI data and uses sophisticated 3D modeling and printing technology to accurately replicate the patient's bone three-dimensional structure, providing doctors with an intuitive and accurate surgical reference tool. During surgery, doctors can perform precise bone cutting, positioning or implantation based on the precise markings and guiding structures on the guide, thereby significantly improving the accuracy and safety of the surgery. This personalized surgical guide reduces errors and uncertainties during surgery, helps shorten surgery time, reduces surgical risks, and promotes the patient's postoperative recovery.

[0003] Currently, 3D printed surgical guides still face challenges in material selection. Although metal guides can provide sufficient mechanical strength, their high cost and reliance on high-end printing equipment limit their widespread application. In contrast, resin materials are favored for their good formability and low cost, but their mechanical strength is relatively low and it is difficult to meet the strength requirements in complex surgeries. More importantly, resin materials do not develop well under X-rays, which is not conducive to doctors accurately positioning the guide and surrounding bone structures during surgery, thereby affecting the accuracy and safety of the surgery. Summary of the invention

[0004] The purpose of the present invention is to solve the problems of insufficient mechanical strength and poor X-ray radiopacity faced by current 3D printed surgical guides in material selection, and to propose a method for preparing a 3D surgical guide with X-ray radiopacity.

[0005] The technical solution of the present invention to solve the above technical problems is as follows: A method for preparing a 3D surgical guide with X-ray opacity comprises the following steps: S10. Clinical imaging data acquisition and processing: Obtain the cross-sectional data of the patient's bone defect site through medical imaging technology, and use three-dimensional reconstruction software to obtain a bone defect entity model; S20. Surgical guide design: Determine the type of surgical guide based on the patient's condition and surgical needs, and design a structure on the guide to guide surgical operations; S30, preparing a printable slurry: uniformly mixing a specific ratio of zirconium oxide ceramic powder and a photosensitive resin material to obtain a printable slurry having X-ray resistance and high mechanical strength; S40, 3D printing: importing the surgical guide model file into a 3D printer, and printing it using a printable slurry to obtain a preliminary surgical guide model; S50, follow-up processing and quality inspection: the surgical guide model is cleaned, dried, post-cured, and quality inspected.

[0006] Based on the above technical solution, the present invention can also be improved as follows.

[0007] Furthermore, in the step S10, CT or MRI technology is used to scan the bone defect area of ​​the patient. After the scanning is completed, the obtained tomographic data is stored in the DICOM format and finally saved as a file in the STL format.

[0008] Furthermore, the types of surgical guides in S20 include osteotomy guides and positioning guides. At the same time, fixed guides and guide brackets are manufactured according to specific surgical requirements. In addition to guide holes, guide grooves, and cutting guide lines, the structure for guiding surgical operations is also designed with positioning pins, snap-on structures, and sliding rails to adapt to different surgical instruments and guidance requirements.

[0009] Furthermore, the materials used to prepare the 3D surgical guide in S30 include additives in addition to zirconium oxide ceramic powder and photosensitive resin material to ensure that the overall performance of the guide meets the surgical requirements, wherein the mass fraction of zirconium oxide ceramic powder is 5%-30%, providing the mechanical strength and X-ray radiopacity required for the guide, and the mass fraction of photosensitive resin material is 2%-8%, giving the guide molding and curing properties. In addition, additives are added in a mass fraction ratio of 62%-93%, wherein the additives include but are not limited to curing agents, plasticizers, stabilizers, pigments and fillers to adjust the flexibility, heat resistance, color and reduce costs of the guide. After all materials are mixed in proportion, they need to be dispersed using a stirrer or an ultrasonic disperser.

[0010] Furthermore, the specific parameters of the 3D printing process in S40 include layer thickness, printing speed and light intensity, as well as key parameters such as filling rate, support structure setting, printing direction, and inter-layer exposure time.

[0011] Furthermore, in the cleaning process in S50, 75% ethanol is used to clean the excess resin remaining on the surface of the surgical guide model. In the drying process, the guide model is placed in a drying box for drying to remove surface moisture and ethanol residues. In the post-curing treatment, the dried surgical guide model is placed in a UV curing light box for ultraviolet irradiation to further cure the photosensitive resin material.

[0012] Furthermore, the quality inspection in S50 includes appearance inspection, dimension measurement, mechanical property test and X-ray radioactivity test, wherein the mechanical property test includes the test of tensile strength, compressive strength and bending strength, and the X-ray radioactivity test irradiates the guide plate through an X-ray fluoroscopy device to observe its development effect under X-rays.

[0013] Furthermore, the results of the mechanical property test and the X-ray radiopacity test should meet the preset quality standards, which are formulated based on the use requirements and safety requirements of the surgical guide, including the minimum value of mechanical strength and the clarity index of X-ray radiopacity.

[0014] Furthermore, the preparation method also includes rigorous packaging and sterilization steps for the finished surgical guide to ensure its safety and sterility in clinical use. During the packaging process, medical-grade polyethylene or polyvinyl chloride film is used to fully seal the guide. Sterilization is carried out using high-temperature and high-pressure steam sterilization or ethylene oxide sterilization. The high-temperature and high-pressure steam sterilization method kills microorganisms on the surface and inside of the guide through a high-temperature and high-pressure steam environment, and the ethylene oxide sterilization method uses the penetrability and bactericidal properties of ethylene oxide gas to sterilize the guide.

[0015] Compared with the prior art, the technical solution of this application has the following beneficial technical effects: The present invention obtains the tomographic data of the bone defect site of the patient through medical imaging technology, and uses 3D reconstruction software to obtain an accurate bone defect entity model, which provides a solid foundation for the personalized design of the surgical guide, ensures the perfect match between the guide and the patient's bone structure, thereby improving the accuracy and safety of the operation. Secondly, according to the patient's condition and surgical needs, the type of surgical guide is determined, and a structure guiding the surgical operation is designed on the guide. This personalized design not only meets the needs of different surgeries, but also improves the flexibility and efficiency of the operation. By mixing a specific proportion of zirconium oxide ceramic powder and photosensitive resin material, an X-ray-blocking The addition of zirconium oxide ceramic powder significantly improves the mechanical strength and X-ray radiopacity of the guide, while the photosensitive resin material ensures the good formability and printing efficiency of the guide. The surgical guide model file is printed into a preliminary surgical guide model using 3D printing technology. This process not only realizes the rapid manufacturing of the guide, but also ensures the high precision and complex structure of the guide. Finally, the surgical guide model is cleaned, dried, post-cured, and quality inspected to ensure that the guide meets the design requirements and quality standards. This strict quality inspection process ensures the reliability and safety of the guide in clinical use. BRIEF DESCRIPTION OF THE DRAWINGS

[0016] Figure 1A 3D printed 3D surgical guide plate made by mixing zirconium oxide powders in different proportions according to the present invention; Figure 2 The standard samples of 3D printing guide plates mixed with different proportions of zirconium oxide powder of the present invention are subjected to in-situ X-ray imaging by comparison with bovine bones and Kirschner pins; Figure 3 The process flow chart of the present invention is as follows; Figure 4 The present invention is a flow chart of the steps of the preparation method. DETAILED DESCRIPTION

[0017] The following will be combined with the drawings in the embodiments of the present invention to clearly and completely describe the technical solutions in the embodiments of the present invention. Obviously, the described embodiments are only part of the embodiments of the present invention, not all of the embodiments. Based on the embodiments of the present invention, all other embodiments obtained by ordinary technicians in this field without creative work are within the scope of protection of the present invention.

[0018] Combination Figure 1-Figure 4 As shown, a method for preparing a 3D surgical guide with X-ray opacity of the present invention comprises the following steps: S10. Clinical imaging data acquisition and processing: Obtain the cross-sectional data of the patient's bone defect site through medical imaging technology, and use three-dimensional reconstruction software to obtain a bone defect entity model; S20. Surgical guide design: Determine the type of surgical guide based on the patient's condition and surgical needs, and design a structure on the guide to guide surgical operations; S30, preparing a printable slurry: uniformly mixing a specific ratio of zirconium oxide ceramic powder and a photosensitive resin material to obtain a printable slurry having X-ray resistance and high mechanical strength; S40, 3D printing: importing the surgical guide model file into a 3D printer, and printing it using a printable slurry to obtain a preliminary surgical guide model; S50, Subsequent processing and quality inspection: Clean, dry, post-curing and quality inspection of the surgical guide model to ensure that the guide meets the design requirements and quality standards In a preferred embodiment, the present invention can be further configured as follows: in step S10, CT or MRI technology is used to scan the bone defect site of the patient. After the scanning is completed, the obtained tomographic data is stored in the DICOM format and finally saved as a file in the STL format. By using CT (computed tomography) or MRI (magnetic resonance imaging) technology to scan the bone defect site of the patient, these two medical imaging technologies can provide high-precision, high-resolution tomographic images, providing a detailed data basis for subsequent three-dimensional reconstruction. CT technology, with its excellent density resolution, can clearly display the bone structure and its defects; and MRI technology has a higher resolution for soft tissue, which helps doctors to have a more comprehensive understanding of the condition of the patient's bones and surrounding tissues. After the scanning is completed, the obtained tomographic data is stored in the DICOM (Digital Imaging and Communications in Medicine) format. This standard format ensures the integrity and compatibility of the data and is convenient for transmission and processing between different medical devices and software. Finally, these data are converted into a file in the STL (stereolithography) format. The STL format is a file format widely used in the field of 3D printing. It contains the three-dimensional geometric information of the guide model and provides an accurate digital model for subsequent 3D printing.

[0019] When using CT or MRI technology for scanning, in order to obtain the best scanning effect, it is necessary to select appropriate scanning parameters according to the patient's specific situation and scanning site, such as scanning layer thickness, reconstruction interval, scanning range, etc. The optimized setting of these parameters can ensure the accuracy and completeness of the tomographic data, and provide stronger support for subsequent three-dimensional reconstruction and guide design. At the same time, during the data conversion process, professional medical image processing software is used to pre-process the DICOM format data, such as denoising, contrast enhancement, etc., to improve the accuracy and quality of the STL file.

[0020] In a preferred embodiment, the present invention can be further configured as follows: in S20, the types of surgical guides are not limited to osteotomy guides and positioning guides, and fixed guides and guide brackets can also be manufactured according to specific surgical requirements. In addition to guide holes, guide grooves, and cutting guide lines, the structure for guiding surgical operations can also be designed with positioning pins, buckle structures, and sliding rails to adapt to different surgical instruments and guidance requirements. When designing, it is necessary to comprehensively consider the factors of surgical site, instrument type, operation accuracy, and safety to ensure that the guide structure can accurately guide the surgical instrument to a predetermined position. By expanding the types of surgical guides, it is not limited to traditional osteotomy guides and positioning guides, but also covers multiple types such as fixed guides and guide brackets, enriching the application scenarios of surgical guides. Different types of guides can provide more accurate and efficient guidance for different types of surgical requirements, thereby improving the flexibility and success rate of the operation. At the same time, the structure designed on the guide to guide surgical operations is also more diversified. In addition to the common guide holes, guide grooves, and cutting guide lines, new structures such as positioning pins, buckle structures, and sliding rails are also introduced. These structures can better adapt to different surgical instruments and guidance requirements, ensuring the stability and accuracy of surgical operations.

[0021] When designing a surgical guide, in addition to considering conventional factors such as the surgical site, instrument type, and operating accuracy, the importance of safety is also emphasized. In order to ensure that the guide structure can accurately guide the surgical instrument to the predetermined position, the designer needs to comprehensively consider the individual differences of the patient, the anatomical structure of the surgical site, the physical properties of the surgical instrument, and various possible situations during the operation, and carry out refined design. For example, when designing the locating pin, it is necessary to ensure that its size, shape, and position can accurately match the interface of the surgical instrument to avoid slippage or dislocation during the operation; when designing the buckle structure and sliding track, it is necessary to consider the selection of materials, strength verification, and motion trajectory planning to ensure that the guide can stably and reliably guide the surgical instrument for precise operation during use.

[0022] In a preferred embodiment, the present invention can be further configured as follows: the materials used to prepare the 3D surgical guide in S30 include, in addition to zirconium oxide ceramic powder and photosensitive resin material, other auxiliary materials to ensure that the overall performance of the guide meets the surgical requirements, wherein the mass fraction ratio of zirconium oxide ceramic powder is 5%-30%, providing the mechanical strength and X-ray radiopacity required for the guide, the mass fraction ratio of photosensitive resin material is 2%-8%, giving the guide molding processing performance and curing characteristics, in addition, additives with a mass fraction ratio of 62%-93% can be added, wherein the additives include but are not limited to curing agents, plasticizers, stabilizers, pigments and fillers to adjust the flexibility, heat resistance, color and reduce costs of the guide, after all the materials are mixed in proportion, they need to be fully dispersed using a stirrer or an ultrasonic disperser to ensure that the materials are evenly mixed, and by introducing a variety of auxiliary materials, not only the advantages of zirconium oxide ceramic powder and photosensitive resin material are retained, that is, providing the mechanical strength and X-ray radiopacity required for the guide X-ray radiopacity, as well as good molding and curing properties, further enrich the overall performance of the guide plate, making it better meet surgical needs. Specifically, the mass fraction of zirconia ceramic powder is controlled at 5%-30%. This ratio range not only ensures that the guide plate has sufficient mechanical strength and X-ray radiopacity, but also avoids the cost increase and processing difficulty caused by excessive content; the mass fraction of photosensitive resin material is controlled at 2%-8%, ensuring that the guide plate has good molding and curing properties, while reducing material costs. In addition, by adding additives with a mass fraction ratio of 62%-93%, such as curing agents, plasticizers, stabilizers, pigments and fillers, the flexibility, heat resistance, color and other properties of the guide plate can be significantly adjusted, while reducing costs and improving the cost-effectiveness of materials. This multi-material composite design concept not only overcomes the performance limitations of existing materials, but also provides more possibilities for customized design of surgical guides.

[0023] In the process of preparing 3D surgical guides, after all materials are mixed in proportion, they need to be fully dispersed using a stirrer or ultrasonic disperser. This is a key step to ensure uniform mixing of materials. The stirrer can use mechanical stirring to allow various materials to fully contact and disperse during the mixing process; while the ultrasonic disperser uses the cavitation effect and mechanical effect of ultrasound to perform high-frequency vibration and micro-jet impact on the mixed system, thereby achieving a more refined and uniform dispersion effect. The choice of these two dispersion methods depends on the properties of the materials and the characteristics of the mixed system, aiming to ensure that the final printable slurry has a uniform composition and stable performance. At the same time, during the dispersion process, process parameters such as stirring speed, dispersion time and temperature must be strictly controlled to avoid the occurrence of adverse phenomena such as material denaturation or agglomeration, thereby ensuring that the final quality of the guide meets surgical requirements.

[0024] In a preferred embodiment of the present invention, the specific parameters of the 3D printing process in S40 are not limited to layer thickness, printing speed and light intensity, but also include but are not limited to key parameters such as filling rate, support structure setting, printing direction, and inter-layer exposure time. By refining the specific parameters of the 3D printing process, not only the basic parameters such as layer thickness, printing speed and light intensity are considered, but also key parameters such as filling rate, support structure setting, printing direction, and inter-layer exposure time are introduced. This comprehensive and detailed parameter setting greatly improves the accuracy and efficiency of 3D printed surgical guides. The reasonable combination of layer thickness and printing speed can ensure that the printed guides have smooth surface quality and accurate dimensional accuracy. degree; the adjustment of light intensity directly affects the curing degree of the material and the printing efficiency, and the optimization of the filling rate can reduce the use of materials and reduce costs while ensuring the mechanical properties of the guide; the rationality of the support structure setting can effectively avoid deformation and collapse during printing and improve the printing success rate; the careful selection of the printing direction can maximize the use of material properties and reduce the workload after printing; the precise control of the interlayer exposure time can ensure the full curing of each layer of material and the interlayer bonding strength, thereby improving the overall performance of the guide. The comprehensive optimization of these parameters enables 3D printed surgical guides to better meet surgical needs and improve the accuracy and safety of surgery.

[0025] In actual operation, the setting of these key parameters needs to take into account a variety of factors, including the properties of the material, the shape and size of the guide, the performance of the printing equipment, and the specific needs of the surgery. For example, for guides with complex shapes and high dimensional accuracy requirements, a smaller layer thickness and a slower printing speed are required to ensure printing accuracy; and for guides that need to withstand greater mechanical stress, the filling rate needs to be appropriately increased to enhance their mechanical properties. At the same time, the design of the support structure also needs to be reasonably planned according to the shape of the guide and the printing direction, in order to ensure stability during the printing process and facilitate subsequent removal and processing. During the printing process, it is also necessary to monitor the printing status in real time, such as environmental factors such as temperature and humidity, as well as the wear of the print head, to ensure the stability and continuity of the printing process.

[0026] Among them, the layer thickness determines the resolution of the guide plate in the Z-axis direction. A thinner layer thickness can improve the surface accuracy and detail expression of the guide plate, but it will also increase the printing time and cost. The printing speed affects the molding efficiency and thermal stress distribution of the guide plate. Too fast a printing speed may cause defects or deformation inside the guide plate. The light intensity is directly related to the curing depth and curing rate of the photosensitive resin material. Too strong light intensity may cause the material to be over-cured, while too weak light intensity may not ensure that the material is fully cured. The filling rate is the proportion of the filling material inside the guide plate, which affects the mechanical strength and weight of the guide plate. A higher filling rate can improve the strength and stability of the guide plate, but it will also increase the weight of the guide plate and the printing time. The support structure is set to ensure that the guide plate will not deform or collapse due to its own weight or insufficient interlayer adhesion during the printing process. Reasonable support structure settings can effectively improve the guide plate. The printing direction refers to the direction in which the guide plate is placed in the 3D printer, which affects the molding accuracy and subsequent processing difficulty of the guide plate. When selecting the printing direction, it is necessary to comprehensively consider factors such as the shape, size, structure and subsequent processing requirements of the guide plate. The interlayer exposure time refers to the time required for each layer of material to solidify after being exposed to light, which affects the degree of solidification and the interlayer bonding strength of the guide plate. Reasonable interlayer exposure time can ensure that the layers of the guide plate are closely bonded and improve the overall strength and stability of the guide plate. During the 3D printing process, the above parameters need to be accurately set and optimized according to the model of the 3D printer used, the characteristics of the printable slurry and the specific requirements of the guide plate. Through reasonable parameter setting and process optimization, it can be ensured that the 3D printed surgical guide has high precision, high strength and good X-ray radiopacity to meet the needs of clinical surgery.

[0027] In a preferred embodiment of the present invention, the present invention can be further configured as follows: in S50, the cleaning process uses 75% ethanol to clean the excess resin remaining on the surface of the surgical guide model; in the drying process, the guide model is placed in a drying box for drying treatment to remove surface moisture and ethanol residue; in the post-curing treatment, the dried surgical guide model is placed in a UV curing light box for UV irradiation to further cure the photosensitive resin material; by using 75% ethanol as the cleaning liquid, the ethanol of this concentration has good degreasing, decontamination and sterilization capabilities, and can effectively remove the excess resin remaining on the surface of the surgical guide model without causing corrosion or damage to the guide material; in the drying treatment after cleaning, by The guide model is placed in a drying oven for high-temperature drying, which not only removes moisture and ethanol residue on the surface, but also ensures the dryness and cleanliness of the guide in subsequent use, avoiding the risk of surgical infection caused by moisture or ethanol residue. In addition, the introduction of the post-curing treatment step places the dried surgical guide model in a UV curing light box for ultraviolet irradiation. This step further promotes the curing reaction of the photosensitive resin material, improves the hardness and wear resistance of the guide, and ensures the stability and durability of the guide during the operation. It not only optimizes the preparation process of 3D printed surgical guides, but also significantly improves the quality and safety of the guides, providing a strong guarantee for the successful implementation of the operation.

[0028] In actual operation, the specific implementation details of the cleaning, drying and post-curing steps are also crucial to the quality of the guide plate. During the cleaning process, in addition to selecting a suitable cleaning solution, the cleaning time and temperature must be controlled to ensure the cleaning effect while avoiding unnecessary damage to the guide plate material. During the drying process, the temperature and time of the drying box should be reasonably set according to the thermal sensitivity and size of the guide plate material, ensuring that moisture and ethanol are completely removed while avoiding deformation or cracking of the guide plate due to overheating. In the post-curing step, the power, irradiation time and distance of the UV curing light box and other parameters must also be precisely controlled according to the characteristics of the photosensitive resin material and the thickness of the guide plate to achieve the best curing effect. At the same time, during the entire process, the ambient humidity and temperature must be strictly controlled to avoid adverse effects on the quality of the guide plate due to environmental changes.

[0029] In a preferred embodiment of the present invention, the quality inspection in S50 includes appearance inspection, dimension measurement, mechanical property test and X-ray radiopacity test, wherein the mechanical property test includes the test of tensile strength, compressive strength and bending strength indexes, and the X-ray radiopacity test irradiates the guide plate through an X-ray fluoroscopy device to observe its development effect under X-rays. By introducing a comprehensive quality inspection process, including appearance inspection, dimension measurement, mechanical property test and X-ray radiopacity test, the appearance inspection can timely discover the defects and flaws on the surface of the guide plate, such as cracks, bubbles, impurities, etc., to ensure the neatness and integrity of the appearance of the guide plate; the dimension measurement verifies whether the guide plate meets the design requirements to ensure The guide is tested for its accuracy and adaptability during surgery. Mechanical property tests, especially tests of tensile strength, compressive strength and bending strength, comprehensively evaluate the mechanical properties of the guide, ensuring that it can withstand various stresses and loads during surgery and is not prone to breakage or deformation. The X-ray radiopacity test irradiates the guide through an X-ray fluoroscopy device to observe its development effect under X-rays. It verifies the visibility and positioning accuracy of the guide during surgery, providing doctors with a clear surgical field of view and a reliable positioning reference. The comprehensive application of these quality inspection measures not only improves the quality level of surgical guides, but also reduces surgical risks and the incidence of complications, providing a strong guarantee for patient safety and surgical success.

[0030] In actual operation, each link of the quality inspection process needs to strictly follow the established standards and specifications. For example, during the appearance inspection, a high-resolution camera or microscope should be used to conduct a comprehensive and detailed observation of the guide plate to ensure that no minor defects are missed. For dimensional measurement, high-precision measuring tools and methods, such as a three-coordinate measuring machine, a laser rangefinder, etc., are required to ensure the accuracy and reliability of the measurement results. When testing the mechanical properties, appropriate test methods and standards should be selected according to the specific purpose of the guide plate and the surgical requirements. For example, tensile, compressive and bending strength tests should be conducted in accordance with international standards such as ASTM or ISO. When testing X-ray radiopacity, in addition to observing the development effect of the guide plate under X-rays, the development density, uniformity and contrast parameters should also be recorded and analyzed to comprehensively evaluate the X-ray radiopacity of the guide plate. At the same time, during the entire quality inspection process, the test environment, such as temperature, humidity, light, etc., needs to be strictly controlled to avoid environmental factors from interfering with the test results.

[0031] In a preferred embodiment, the present invention can be further configured as follows: the results of the mechanical property test and the X-ray radiopacity test should meet the preset quality standards. The quality standards are formulated according to the use requirements and safety requirements of the surgical guide, including the minimum value of mechanical strength and the index of clarity of X-ray radiopacity. By clearly setting the quality standards of the mechanical property test and the X-ray radiopacity test and formulating them according to the use requirements and safety requirements of the surgical guide, a specific and quantifiable basis is provided for the quality control of the 3D printed surgical guide. The minimum value of the mechanical strength is set to ensure that the guide can withstand various stresses and loads during the operation and is not prone to breakage or deformation, thereby ensuring the smooth progress of the operation and the safety of the patient. The clarity index of X-ray radiopacity verifies the development effect of the guide under X-rays, provides doctors with a clear surgical field of view and a reliable positioning reference, and helps to accurately implement the operation. The setting of these quality standards not only improves the quality level of the surgical guide, but also reduces the surgical risks and the incidence of complications, providing a strong guarantee for the safety of the patient and the success of the operation.

[0032] In actual operation, the formulation and implementation of quality standards need to take into account a variety of factors. First, the minimum value of mechanical strength should be reasonably set according to the specific purpose of the guide, surgical site, patient age and weight, etc., to ensure that the guide can maintain sufficient strength and stability in different usage scenarios. At the same time, the influence of factors such as the material, structural design and manufacturing process of the guide on the mechanical strength should also be considered to formulate more scientific and reasonable quality standards. Secondly, the clarity index of X-ray radiopacity should also be set according to factors such as surgical requirements, the performance of X-ray equipment and the operating habits of doctors. For example, for surgeries requiring high-precision positioning, a higher clarity index should be set to ensure that the development effect of the guide under X-rays can meet the surgical requirements. At the same time, the absorption and scattering characteristics of the guide material to X-rays, as well as the exposure time and dose of the X-ray equipment, should also be considered to optimize the methods and parameters of the X-ray radiopacity test. In addition, in the implementation of quality standards, a strict quality monitoring and feedback mechanism should be established to regularly sample and test the guides, promptly discover and correct quality problems, and ensure that each batch of guides can meet the preset quality standards.

[0033] In a preferred embodiment, the present invention can be further configured as follows: the preparation method also includes the steps of rigorous packaging and sterilization of the finished surgical guide to ensure its safety and sterility in clinical use. During the packaging process, medical-grade polyethylene or polyvinyl chloride film is used to fully seal the guide. The sterilization process uses high-temperature and high-pressure steam sterilization or ethylene oxide sterilization. The high-temperature and high-pressure steam sterilization kills microorganisms on the surface and inside of the guide through a high-temperature and high-pressure steam environment. The ethylene oxide sterilization method uses the penetrability and bactericidal properties of ethylene oxide gas to perform a comprehensive and in-depth sterilization of the guide. Through rigorous packaging and sterilization of the finished surgical guides, and the use of medical-grade polyethylene or polyvinyl chloride film for fully enclosed sealed packaging, the invasion of outside air, moisture and microorganisms is effectively isolated, providing a clean and stable storage environment for the guides. At the same time, the application of high-temperature and high-pressure steam sterilization or ethylene oxide sterilization ensures the complete killing of microorganisms on the surface and inside of the guides, meeting the strict requirements of clinical use for sterility. The comprehensive implementation of these measures not only extends the shelf life and service life of surgical guides, but also greatly reduces the risk of surgical infection, providing a strong guarantee for the safety of patients.

[0034] In actual operation, the specific implementation details of the packaging and sterilization steps are also crucial to the quality and safety of surgical guides. In the packaging process, in addition to selecting packaging materials that meet medical standards, the humidity, temperature and cleanliness of the packaging environment must be strictly controlled to avoid microbial contamination during the packaging process. At the same time, the choice of packaging method should also be reasonably designed according to the shape, size and usage requirements of the guide to ensure the tightness and stability of the packaging. In terms of sterilization, high-temperature and high-pressure steam sterilization and ethylene oxide sterilization have their own advantages and disadvantages. The former has a fast and reliable sterilization effect, but may cause certain thermal stress to the guide material; the latter has stronger penetration and bactericidal properties, and is suitable for sterilization of complex structures and difficult-to-reach areas, but attention should be paid to the problem of ethylene oxide residues. Therefore, when choosing a sterilization method, it is necessary to comprehensively consider factors such as the characteristics of the guide material, sterilization effect and safety to formulate the optimal sterilization plan. At the same time, after the sterilization process is completed, the guide must be strictly verified for sterilization effect and residue detection to ensure the thoroughness and safety of the sterilization process.

[0035] This preparation method aims to manufacture a 3D surgical guide with X-ray opacity to meet the precise positioning and guidance requirements in complex surgeries. The entire preparation process is carefully designed, starting from the acquisition and processing of clinical imaging data to the final packaging and sterilization. Each step is strictly controlled to ensure the high quality and clinical safety of the guide. First, the cross-sectional data of the patient's bone defect is obtained through advanced medical imaging technology (such as CT or MRI) and stored in DICOM format. It is then converted into an STL file and processed using 3D reconstruction software to obtain an accurate solid model of the bone defect. This step provides a solid foundation for the subsequent guide plate design. Next, the type of surgical guide is determined according to the patient's condition and surgical needs, and structures to guide surgical operations are designed on the guide, such as guide holes, guide grooves, cutting guide lines, etc., and even complex structures such as positioning pins, buckle structures, and sliding rails to accommodate different surgical instruments and guidance needs. The design needs to comprehensively consider factors such as the surgical site, instrument type, operating accuracy, and safety to ensure that the guide structure can accurately guide the surgical instruments to the predetermined position. When preparing the printable slurry, a specific proportion of zirconium oxide ceramic powder and photosensitive resin material are mixed evenly, and appropriate amounts of additives such as curing agent, plasticizer, stabilizer, pigment and filler are added to adjust the flexibility, heat resistance, color and cost of the guide plate. After all the materials are mixed in proportion, they need to be fully dispersed to ensure that the materials are evenly mixed to obtain a printable slurry with X-ray radiopacity and high mechanical strength. It should also be noted that if Figure 2 As shown, with the increase of zirconium oxide powder content, the imaging contrast is enhanced and the relative position to the bone is clearer; Subsequently, the surgical guide model file is imported into the 3D printer and printed according to specific printing parameters (such as layer thickness, printing speed, light intensity, filling rate, support structure setting, printing direction, inter-layer exposure time, etc.) to obtain a preliminary surgical guide model; After printing, the surgical guide model is processed and inspected for quality. This includes using 75% ethanol to clean the excess resin remaining on the surface of the guide model, placing the guide in a drying oven for drying to remove moisture and ethanol residue, and placing the dried guide in a UV curing light box for UV irradiation to further cure the photosensitive resin material. The quality inspection covers appearance inspection, dimensional measurement, mechanical property testing (tensile strength, compressive strength, bending strength) and X-ray radiopacity testing to ensure that the guide meets the design requirements and quality standards, especially the clarity indicators of mechanical strength and X-ray radiopacity; Finally, the finished surgical guides are rigorously packaged and sterilized. Medical-grade polyethylene or polyvinyl chloride film is used for fully enclosed sealed packaging to prevent external contamination. High-temperature and high-pressure steam sterilization or ethylene oxide sterilization is used for sterilization to ensure that the microorganisms on the surface and inside of the guides are completely killed to meet the sterility requirements for clinical use. In summary, through careful design and control, this preparation method successfully manufactured a 3D surgical guide with X-ray radioactivity, high mechanical strength, precise guidance function and clinical safety, providing a strong guarantee for the successful implementation of complex operations.

[0036] It should be noted that, in this article, relational terms such as first and second, etc. are only used to distinguish one entity or operation from another entity or operation, and do not necessarily require or imply any such actual relationship or order between these entities or operations. Moreover, the terms "include", "comprise" or any other variants thereof are intended to cover non-exclusive inclusion, so that a process, method, article or device including a series of elements includes not only those elements, but also other elements not explicitly listed, or also includes elements inherent to such process, method, article or device. In the absence of further restrictions, the elements defined by the sentence "comprise a ..." do not exclude the existence of other identical elements in the process, method, article or device including the elements.

[0037] Although embodiments of the present invention have been shown and described, it will be appreciated by those skilled in the art that various changes, modifications, substitutions and variations may be made to the embodiments without departing from the principles and spirit of the present invention, and that the scope of the present invention is defined by the appended claims and their equivalents.

Claims

1. A method for preparing a 3D surgical guide with X-ray opacity, characterized in that: The following steps are involved: S10. Clinical imaging data acquisition and processing: Obtain the cross-sectional data of the patient's bone defect site through medical imaging technology, and use three-dimensional reconstruction software to obtain a bone defect entity model; S20. Surgical guide design: Determine the type of surgical guide based on the patient's condition and surgical needs, and design a structure on the guide to guide surgical operations; S30, preparing a printable slurry: uniformly mixing a specific ratio of zirconium oxide ceramic powder and a photosensitive resin material to obtain a printable slurry having X-ray resistance and high mechanical strength; S40, 3D printing: importing the surgical guide model file into a 3D printer, and printing it using a printable slurry to obtain a preliminary surgical guide model; S50, follow-up processing and quality inspection: the surgical guide model is cleaned, dried, post-cured, and quality inspected.

2. The method for preparing a 3D surgical guide with X-ray opacity according to claim 1, characterized in that: In the step S10, CT or MRI technology is used to scan the bone defect of the patient. After the scanning is completed, the obtained tomographic data is stored in the DICOM format and finally saved as a file in the STL format.

3. The method for preparing a 3D surgical guide with X-ray opacity according to claim 1, characterized in that: The types of surgical guides in S20 include osteotomy guides and positioning guides. Fixed guides and guide brackets are manufactured according to specific surgical requirements. In addition to guide holes, guide grooves, and cutting guide lines, the structure for guiding surgical operations is also designed with positioning pins, snap-fit ​​structures, and sliding rails to adapt to different surgical instruments and guidance requirements.

4. The method for preparing a 3D surgical guide with X-ray opacity according to claim 1, characterized in that: The materials used to prepare the 3D surgical guide in S30 include, in addition to zirconium oxide ceramic powder and photosensitive resin material, additives to ensure that the overall performance of the guide meets surgical requirements, wherein the mass fraction of zirconium oxide ceramic powder is 5%-30%, providing the mechanical strength and X-ray radiopacity required for the guide, and the mass fraction of photosensitive resin material is 2%-8%, giving the guide molding and curing properties. In addition, additives are added in a mass fraction ratio of 62%-93%, wherein the additives include but are not limited to curing agents, plasticizers, stabilizers, pigments and fillers to adjust the flexibility, heat resistance, color and reduce costs of the guide. After all materials are mixed in proportion, they need to be dispersed using a stirrer or an ultrasonic disperser.

5. The method for preparing a 3D surgical guide with X-ray opacity according to claim 1, characterized in that: The specific parameters of the 3D printing process in S40 include layer thickness, printing speed and light intensity, as well as key parameters such as filling rate, support structure setting, printing direction, and inter-layer exposure time.

6. The method for preparing a 3D surgical guide with X-ray opacity according to claim 1, characterized in that: In the cleaning process of S50, 75% ethanol is used to clean the excess resin remaining on the surface of the surgical guide model. In the drying process, the guide model is placed in a drying box for drying to remove surface moisture and ethanol residue. In the post-curing process, the dried surgical guide model is placed in a UV curing light box for ultraviolet irradiation to further cure the photosensitive resin material.

7. The method for preparing a 3D surgical guide with X-ray opacity according to claim 1, characterized in that: The quality inspection in S50 includes appearance inspection, dimension measurement, mechanical property test and X-ray radiopacity test, wherein the mechanical property test includes the test of tensile strength, compressive strength and bending strength, and the X-ray radiopacity test irradiates the guide plate through an X-ray fluoroscopy device to observe its development effect under X-rays.

8. The method for preparing a 3D surgical guide with X-ray opacity according to claim 7, characterized in that: The results of the mechanical property test and the X-ray radiopacity test should meet the preset quality standards. The quality standards are formulated based on the use requirements and safety requirements of the surgical guide, including the minimum value of mechanical strength and the clarity index of X-ray radiopacity.

9. A method for preparing a 3D surgical guide with X-ray opacity according to any one of claims 1 to 8, characterized in that: The preparation method also includes rigorous packaging and sterilization steps for the finished surgical guide to ensure its safety and sterility in clinical use. During the packaging process, medical-grade polyethylene or polyvinyl chloride film is used to fully seal the guide. High-temperature and high-pressure steam sterilization or ethylene oxide sterilization is used for sterilization. The high-temperature and high-pressure steam sterilization kills microorganisms on the surface and inside of the guide through a high-temperature and high-pressure steam environment. The ethylene oxide sterilization method uses the penetrability and bactericidal properties of ethylene oxide gas to sterilize the guide.

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