Design method and manufacturing method of 3D printing 8-shaped titanium plate

Abstract

The invention discloses a design method and a manufacturing method of a 3D printing 8-shaped titanium plate. The design method comprises the following steps: S1, reconstructing a fracture model; s2, processing the fracture model to obtain a bone model after fracture reduction; s3, establishing an initial form of the titanium plate according to the skeleton model; s4, importing the skeleton model and the titanium plate in the initial form into finite element analysis software for stress analysis and displacement condition analysis of the bone fracture end; and S5, carrying out topological optimization on the stress value of the titanium plate and the displacement value of the bone fracture end for many times to obtain the 8-shaped titanium plate. The design data is more accurate, the design process and the production cycle of the titanium plate can be reduced, the surgical requirements of urgent patients can be met, the fixing effect of the fracture section can be better improved through the 8-shaped geometric structure, meanwhile, the production cost can be reduced, and blood supply at the fracture line is not affected.

Description

Technical Field

[0001] The present invention relates to the technical field of 3D printed medical implants, and more particularly to a design method and a manufacturing method of a 3D printed "8"-shaped titanium plate. Background Art

[0002] With the rapid development of medical technology, personalized medicine has become a key direction to enhance treatment effects and improve patients' quality of life. 3D printing-based titanium plate design and production technology has emerged, bringing about a revolution in the medical field.

[0003] Traditional implant products are mostly standardized and universal in design, which makes it difficult to meet the complex and changing individual differences of different patients. Each patient's bone morphology, lesion location and degree are unique. Standardized implants often have problems with poor fit in actual applications, which not only affects the surgical effect, but may also lead to postoperative complications and prolong the patient's recovery period. For example, in maxillofacial surgery, due to the complex and diverse facial bone morphology, universal maxillofacial implants often cannot accurately match the patient's facial contours. This not only affects the aesthetics, but may also hinder the recovery of functions such as chewing and swallowing.

[0004] Furthermore, on-site adjustments to implants during surgery are not only time-consuming and laborious, but can also fail to achieve the desired therapeutic effect due to limited precision. Furthermore, the production process for traditional implants is complex, requiring multiple steps and a long production cycle, which poses a significant challenge for patients who urgently require surgical treatment.

[0005] With the rapid development of digital technology, medical imaging technologies such as CT and MRI have become widely used, enabling the acquisition of highly precise three-dimensional data of patient lesions. This data provides a precise basis for the design of personalized implants. By processing and analyzing the patient's medical imaging data and utilizing computer-aided design (CAD) software, a three-dimensional implant model tailored to the patient's individual anatomical characteristics can be constructed. This process enables a shift from traditional empirical design to personalized design based on precise data.

[0006] 3D printing, also known as additive manufacturing, is a new manufacturing process with unique advantages. It can directly create products with complex shapes and intricate structures by depositing materials layer by layer based on digital models. Compared with traditional manufacturing processes, 3D printing eliminates the need for molds, significantly shortening production cycles and reducing costs. Furthermore, 3D printing enables highly personalized customization to meet the specific needs of individual patients.

[0007] Titanium and titanium alloys have become ideal implant materials due to their excellent biocompatibility, corrosion resistance, and mechanical properties. 3D-printed titanium plate design and production technology combines digital design with 3D printing to provide patients with customized titanium plate implants. This titanium plate can precisely fit the patient's lesion, improving surgical accuracy and success rates while reducing surgical trauma and postoperative complications. In orthopedics, titanium plates can better adapt to the anatomical structure of fracture sites and promote fracture healing; in oral and maxillofacial surgery, titanium plates can restore the normal morphology and function of the patient's face, improving their quality of life.

[0008] 3D-printed titanium plate design and fabrication technology emerged against the backdrop of growing demand for personalized medicine, the rapid advancement of digital technology, and the maturing of 3D printing technology. It presents new opportunities and challenges for the medical industry, and is expected to further advance medical technology and benefit more patients.

[0009] Therefore, how to design and manufacture titanium plates through 3D printing technology has become an urgent problem that needs to be solved by technicians in this field. Summary of the Invention

[0010] In view of this, the present invention provides a design method and a production method of a 3D-printed "8"-shaped titanium plate. Medical titanium plate implants are produced through 3D printing technology and applied in oral and maxillofacial repair and orthopedic surgery. The 3D printing technology can reduce the design process and production cycle of implants. The produced implant structure precisely fits the patient's broken bone surface, and the "8"-shaped geometric structure can better stabilize the fracture segment, reduce material waste, and will not affect the blood supply at the fracture line.

[0011] In order to achieve the above object, the present invention adopts the following technical solutions:

[0012] A design method for a 3D printed "8"-shaped titanium plate includes the following steps:

[0013] S1. Collect the original data of the patient's fracture location and import it into medical image data processing software to reconstruct the fracture model;

[0014] S2. Resetting the fracture model to obtain a bone model after fracture reduction;

[0015] S3, establishing the initial shape of the titanium plate based on the bone model;

[0016] S4. performing stress analysis and bone fracture displacement analysis on the bone model and the titanium plate in its initial form to obtain a stress distribution diagram of the titanium plate and a displacement cloud diagram of the bone fracture;

[0017] S5. The stress value of the titanium plate and the displacement value of the bone end are topologically optimized multiple times according to the variable density method, and an "8"-shaped titanium plate is obtained after slicing.

[0018] The beneficial effect of the technical solution of the present invention is that a fracture model is obtained by collecting patient data, and a bone model after fracture repair is obtained after processing. The titanium plate implant required by the patient can be accurately designed based on the fracture model and the bone model, and topological optimization is performed based on the stress characteristics to obtain an "8"-shaped titanium plate with accurate data and stable fracture segment fixation effect.

[0019] Preferably, in step S1, a three-dimensional model of the patient's fracture location is reconstructed based on CT or MRI scanning data of the patient's fracture location.

[0020] Preferably, in step S2, the processing of the fracture model includes removing spikes and redundant features, smoothing, and resetting the fracture position through virtual surgery.

[0021] Preferably, in step S5, the stress value and bone end displacement value of the titanium plate are imported into the finite element software, and the topology optimization function is used to remove the part of the material that is not subjected to stress or has relatively small stress to obtain the main force-bearing part of the titanium plate, and step S4 is repeated after each topology optimization.

[0022] Preferably, the condition for topology optimization is to remove 80% of the volume of the titanium plate according to the finite element analysis results, and use the obtained titanium plate as the basic shape of the titanium plate.

[0023] Preferably, based on the basic shape of the titanium plate, the thickness and width of the beam are designed using engineering design software, and a titanium plate with horizontal beams and oblique beams is designed on the surface of the bone to form an "8"-shaped titanium plate structure.

[0024] Preferably, the "8"-shaped titanium plate is imported into the e-stage software to automatically generate supports. After fitting with the upper structure, it is imported into the Concept Laser Build Processor for slicing to generate an "8"-shaped titanium plate model.

[0025] Preferably, the position of the 8-shaped titanium plate where the stress and deformation are the greatest is designed to be a buffer shape, and the width is reduced in the area where the stress and deformation are small.

[0026] The present invention also discloses a method for manufacturing a 3D printed "8"-shaped titanium plate. According to the design method in the above technical solution, an "8"-shaped titanium plate implant is designed at the patient's fracture location, comprising the following steps:

[0027] S1. Import the "8"-shaped titanium plate model into the 3D printer and print it into shape;

[0028] S2. Place the printed “8”-shaped titanium plate in a vacuum heat treatment furnace for heat treatment to eliminate thermal stress.

[0029] Preferably, the method further includes step S3: removing the support of the printed "8"-shaped titanium plate, smoothing it with a grinder, ultrasonically washing it with deionized water, and drying it for later use.

[0030] As can be seen from the above technical solutions, compared with the prior art, the present invention discloses a method for designing and manufacturing a 3D-printed "8"-shaped titanium plate. The "8"-shaped titanium plate designed and manufactured by the present invention can be used as a practical medical implant for oral and maxillofacial repair and orthopedic surgery. It can be customized according to the individual patient's anatomical structure and needs, and can accurately match the patient's bone structure, reducing adjustment time during surgery. Since the titanium plate has been pre-formed according to the patient's bone shape, it does not need to be bent during surgery, greatly shortening the operation time and anesthesia time.

[0031] By adopting the design method of the present invention, the design data is more accurate, the design process and production cycle of the titanium plate can be reduced, and the surgical needs of emergency patients can be met. The "8"-shaped structure can better improve the fixation effect of the fracture segment, while also reducing production costs and not affecting the blood supply at the fracture line. BRIEF DESCRIPTION OF THE DRAWINGS

[0032] In order to more clearly illustrate the embodiments of the present invention or the technical solutions in the prior art, the following briefly introduces the drawings required for use in the embodiments or the description of the prior art. Obviously, the drawings described below are merely embodiments of the present invention. For ordinary technicians in this field, other drawings can be obtained based on the provided drawings without paying any creative work.

[0033] Figure 1 The design flow chart of the "8"-shaped titanium plate provided by the present invention;

[0034] Figure 2 This is a flow chart for manufacturing the 8"-shaped titanium plate provided by the present invention;

[0035] Figure 3 This is a schematic diagram of the 8"-shaped titanium plate structure provided by the present invention.

[0036] in,

[0037] 1-screw; 2-diagonal beam; 3-horizontal beam. DETAILED DESCRIPTION

[0038] The following will clearly and completely describe the technical solutions in the embodiments of the present invention in conjunction with the accompanying drawings. 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 making creative efforts are within the scope of protection of the present invention.

[0039] Example 1:

[0040] See attached Figure 1 The embodiment of the present invention discloses a design method for a 3D printed "8"-shaped titanium plate, comprising the following steps:

[0041] S1. Collect the original data of the patient's fracture location and import it into medical image data processing software to reconstruct the fracture model;

[0042] Based on the original data of the patient's fracture location scanned by CT or MRI (magnetic resonance imaging technology), the original data is imported into medical image data processing software, the threshold of the patient's relevant bones is extracted, and a three-dimensional model of the patient's fracture site is reconstructed.

[0043] S2. Importing the fracture model into forward-inverse hybrid design software and processing it to obtain a bone model after fracture reduction;

[0044] The fracture model is surface-finished to remove spikes and redundant features, and is smoothed. The fracture segment is then virtual-operated and repositioned using three points to obtain a repositioned bone model.

[0045] S3, establishing the initial shape of the titanium plate based on the bone model;

[0046] The initial shape of the titanium plate is established on the CAD design software based on the bone model. Boolean operations are performed on it and the bone to make it fit the bone. After that, the plate is offset to form an initial titanium plate with a thickness of 1 mm.

[0047] S4. Importing the bone model and the titanium plate in its initial form into finite element analysis software to perform stress analysis and bone end displacement analysis, thereby obtaining a stress distribution diagram of the titanium plate and a displacement cloud diagram of the bone end;

[0048] The bone model at the fracture site and the titanium plate with the initial shape were imported into the finite element analysis software. Boundary constraints and muscle pulling forces were set, and static and stability analyses were performed to obtain the stress distribution diagram of the titanium plate and the displacement cloud diagram of the bone end.

[0049] S5. The stress value of the titanium plate and the displacement value of the bone end are topologically optimized multiple times according to the variable density method, and an "8"-shaped titanium plate is obtained after slicing.

[0050] Import the titanium plate's stress values ​​and bone end displacement values ​​into the finite element software. Based on the finite element analysis results, set the condition to remove 80% of the titanium plate's volume. Use the topology optimization function to remove parts of the material that are not subject to stress or have relatively low stress to obtain the main force-bearing part of the titanium plate. Repeat step S4 after each topology optimization to obtain the basic shape of the titanium plate.

[0051] Based on the basic shape of the titanium plate, the thickness of the titanium plate and the width of the crossbeam 3 and the oblique beam 2 are designed using engineering design software (such as CAD software). A titanium plate with the crossbeam 3 and the oblique beam 2 is designed on the bone surface to form an "8"-shaped titanium plate structure.

[0052] Find the areas with greater stress from the stress cloud map and design the areas with greater stress.

[0053] like Figure 3 As shown, the intersection of the oblique beam 2 is the node where the four screws 1 exchange forces and should be appropriately widened. The intersection of the oblique beam 2 is designed to be flat and wide, rather than long and narrow, to avoid affecting the blood supply at the fracture line.

[0054] The position of the 8-shaped titanium plate with the greatest stress and deformation is designed as a buffer shape, and the width is reduced in the area with less stress and deformation. For example, the connection between the screw hole and the beam is set as an arc-shaped buffer, and the width of the beam can be appropriately narrowed;

[0055] The topology optimization is performed multiple times according to the finite element analysis results. After each topology optimization is completed, the operation of step S4 is repeated. After multiple repetitions, the final shape of the "8"-shaped titanium plate is obtained.

[0056] Import the "8"-shaped titanium plate into the e-stage software (3D printing automatic support generation software), automatically generate supports, fit it with the upper structure, and then import it into the Concept Laser Build Processor (laser manufacturing processor) for slicing to generate the "8"-shaped titanium plate model. Export the CLS format file and print it for later use.

[0057] Example 2:

[0058] See attached Figure 2 The embodiment of the present invention discloses a method for manufacturing a 3D printed "8"-shaped titanium plate. According to the design method in Example 1, an "8"-shaped titanium plate implant is designed at the patient's fracture location, comprising the following steps:

[0059] S1. Import the "8"-shaped titanium plate model into the 3D printer and print it into shape;

[0060] Import the sliced ​​"8"-shaped titanium plate's CLS format file into the 3D printer for printing;

[0061] S2, placing the printed "8"-shaped titanium plate in a vacuum heat treatment furnace for heat treatment to eliminate thermal stress;

[0062] S3, removing the support and cleaning the annealed titanium plate;

[0063] The support of the printed "8"-shaped titanium plate was removed, and the plate was smoothed using a grinder, ultrasonically washed with deionized water, and dried for later use.

[0064] The various embodiments in this specification are described in a progressive manner, with each embodiment focusing on the differences from other embodiments. Reference can be made to the common and similar parts between the various embodiments. For the devices disclosed in the embodiments, since they correspond to the methods disclosed in the embodiments, the description is relatively simple, and the relevant parts can be referred to the method description.

[0065] The above description of the disclosed embodiments is intended to enable one skilled in the art to implement or use the present invention. Various modifications to these embodiments will be readily apparent to one skilled in the art, and the general principles defined herein may be implemented in other embodiments without departing from the spirit or scope of the present invention. Therefore, the present invention is not limited to the embodiments shown herein but is intended to conform to the widest scope consistent with the principles and novel features disclosed herein.

Claims

1. A design method for 3D printing "8" shaped titanium plate, characterized in that: The following steps are involved: S1. Collect the original data of the patient's fracture location and import it into medical image data processing software to reconstruct the fracture model; S2. Resetting the fracture model to obtain a bone model after fracture reduction; S3, establishing the initial shape of the titanium plate based on the bone model; S4. performing stress analysis and bone fracture displacement analysis on the bone model and the titanium plate in its initial form to obtain a stress distribution diagram of the titanium plate and a displacement cloud diagram of the bone fracture; S5. The stress value of the titanium plate and the displacement value of the bone end are topologically optimized multiple times according to the variable density method, and an "8"-shaped titanium plate is obtained after slicing.

2. The design method of a 3D printed "8" shaped titanium plate according to claim 1, characterized in that: In step S1 , a three-dimensional model of the patient's fracture location is reconstructed based on CT or MRI scanning data of the patient's fracture location.

3. The design method of a 3D printed "8" shaped titanium plate according to claim 2, characterized in that: In step S2, the processing of the fracture model includes removing spikes and redundant features, smoothing, and resetting the fracture position through virtual surgery.

4. The design method of a 3D printed "8" shaped titanium plate according to claim 1, characterized in that: In step S5, the stress value and bone end displacement value of the titanium plate are imported into the finite element software, and the topology optimization function is used to remove the part of the material that is not under stress or has relatively small stress to obtain the main force-bearing part of the titanium plate. Step S4 is repeated after each topology optimization.

5. The design method of a 3D printed "8" shaped titanium plate according to claim 4, characterized in that: The conditions for topology optimization are as follows: based on the results of finite element analysis, 80% of the volume of the titanium plate is removed, and the obtained titanium plate is used as the basic shape of the titanium plate.

6. The design method of a 3D printed "8" shaped titanium plate according to claim 5, characterized in that: Based on the basic shape of the titanium plate, its thickness and beam width are designed using engineering design software. A titanium plate with horizontal beams and oblique beams is designed on the surface of the bone to form an "8"-shaped titanium plate structure.

7. The design method of a 3D printed "8" shaped titanium plate according to claim 6, characterized in that: The "8"-shaped titanium plate is imported into the e-stage software to automatically generate supports. After fitting with the superstructure, it is imported into the Concept Laser Build Processor for slicing to generate the "8"-shaped titanium plate model.

8. The design method of a 3D printed "8" shaped titanium plate according to claim 6, characterized in that: The position of the 8-shaped titanium plate with the greatest stress and deformation is designed to be a buffer shape, and the width is reduced in the area with less stress and deformation.

9. A method for making a 3D printed "8" shaped titanium plate, characterized in that: The method for designing a 3D printed "8"-shaped titanium plate according to any one of claims 1 to 8 designs an "8"-shaped titanium plate at a patient's fracture location, comprising the following steps: S1. Import the "8"-shaped titanium plate model into the 3D printer and print it into shape; S2. Place the printed "8"-shaped titanium plate in a vacuum heat treatment furnace for heat treatment to eliminate thermal stress.

10. A method for manufacturing a 3D printed "8"-shaped titanium plate according to claim 8, characterized in that: The process also includes step S3: removing the support of the printed "8"-shaped titanium plate, smoothing it with a grinder, ultrasonically washing it with deionized water, and drying it for later use.

Images