3D printing of a supporting bone plate and a forming method thereof

Abstract

The present application belongs to the technical field of matching type 3D printing support bone plate, and discloses a 3D printing bone plate with support and a forming method thereof. The bone plate is a three-dimensional wedge-shaped support bone plate which is matched with the angle of the osteotomy distraction blank area and the bone surface, and has the functions of supporting the distraction blank area. The wedge-shaped support bone plate is made by 3D printing. The wedge-shaped support bone plate comprises: an upper surface layer, a plurality of surface layer holes for promoting lightweight design are arranged on the upper surface layer; a lower part of the surface layer hole is provided with an inner layer hole for providing strength mechanical support, and the gradient change hole diameter of the inner layer hole is larger than that of the surface layer hole; and a three-dimensionally arranged multi-directional inclined screw hole is arranged on the side surface of the support bone plate body. According to the three-dimensional model, the lower limb force line and the osteotomy distraction angle are accurately planned before the operation, and the individual wedge-shaped support bone plate angle is fixed, so that the force line correction is accurate, the support is reliable, and the operation effectiveness and accuracy are improved.

Description

Technical Field

[0001] This invention belongs to the field of matching 3D printed support bone plates, and particularly relates to a 3D printed bone plate that also provides support and its molding method. Background Technology

[0002] The following are the main problems with the current clinical application of traditional bone plates: (1) Fixed structure and poor adaptability: The mainstream traditional bone plates on the market are fixed on the outer side of the cortical bone. Their shape, length, width and thickness are all fixed specifications, which cannot be flexibly adapted to the individual bone shape of the patient.

[0003] (2) The open area of ​​osteotomy has a blank, which affects weight-bearing and rehabilitation: After open osteotomy, the open area will have a local bone defect blank area, which is difficult to obtain effective support, directly affecting the patient's early postoperative weight-bearing and walking function recovery.

[0004] (3) Bone defect filling methods are prone to secondary damage: existing blank area filling methods mostly use autologous bone transplantation, which requires bone to be taken from other parts of the patient's own body, which can easily cause donor site complications and cause secondary damage.

[0005] (4) Significant soft tissue irritation and strong foreign body sensation: Traditional bone plates are attached to the outer side of the cortical bone and protrude from the bone surface, which easily irritates the surrounding soft tissues, resulting in a significant foreign body sensation in patients after surgery.

[0006] (5) The operation is complicated and the risk of radiation exposure is high: The angle and position of osteotomy need to be confirmed by fluoroscopy multiple times during the operation, which is complicated and increases the risk of radiation exposure for doctors and patients.

[0007] In summary, existing bone plates and their manufacturing methods are clearly insufficient in adapting to patient needs and meeting the requirements of complex surgeries. Summary of the Invention

[0008] To overcome the problems existing in related technologies, the present invention discloses an embodiment of a 3D printed bone plate that also provides support and a method for forming the same.

[0009] The technical solution is as follows: A method for molding a 3D-printed bone plate that also provides support, the method comprising the following steps: S1. Acquire the patient's raw CT / MRI image data; use Mimics medical image processing software to process the skeletal region and reconstruct a three-dimensional skeletal model. S2, mark key points on the 3D bone model; through parametric analysis using 3-matic design software, calculate the coronal / sagittal angles to be corrected, determine the osteotomy position, osteotomy plane, wedge-shaped opening angle and the size of the opening gap in the osteotomy opening blank area, perform virtual open osteotomy on the 3D bone model, and open the bone ends according to the coronal / sagittal angles to be corrected; S3, based on the bone contour of the reconstructed 3D bone model, performs curved surface fitting design on the cortical bone on the lateral side of the osteotomy-opened blank area, so that the outer side of the wedge-shaped support bone plate fits closely with the bone surface, reducing soft tissue irritation; according to the size of the opening gap and the wedge opening angle determined preoperatively, a wedge-shaped support bone plate is designed at the position of the osteotomy-opened blank area, and the outer side of the designed wedge-shaped support bone plate fits closely with the bone surface, reducing soft tissue irritation; the designed wedge-shaped support bone plate is 3D printed and exported.

[0010] In step S2, key points are marked on the three-dimensional skeletal model: the center of the femoral head, the center of the knee joint, and the center of the ankle joint. The center of the femoral head and the center of the ankle joint are connected. This is the patient's current abnormal force line. The abnormal force line is adjusted according to the center of the knee joint to form the corrected force line.

[0011] In step S3, the designed wedge-shaped support bone plate includes: the inner and outer end support heights of the support bone plate body (1) are consistent with the size of the opening gap; The wedge angle of the wedge-shaped support plate is consistent with the wedge-shaped opening angle of the osteotomy.

[0012] For different application subjects, the raw CT / MRI image data of patients are acquired; Mimics medical image processing software is used to process the bone area, reconstruct an individualized three-dimensional bone model, and design a personalized wedge-shaped support bone plate.

[0013] Another objective of this invention is to provide a 3D-printed bone plate that also provides support. The bone plate is angled to the open blank area of ​​the osteotomy and is fitted to the bone surface in a matching manner. Its shape conforms to the contour of the bone. The bone plate is a three-dimensional wedge-shaped support bone plate that supports the open blank area.

[0014] The wedge-shaped support bone plate is manufactured using 3D printing and specifically includes: Support plate body; the upper surface of the support plate body fits against the bone surface of the osteotomy; The upper surface layer has multiple surface holes for promoting lightweight design; The side of the supporting bone plate body has multi-directional oblique screw holes arranged in three dimensions.

[0015] The multi-directional oblique screw hole supports the bone plate body and is fixedly connected to the osteotomy and the bone below the osteotomy by through screws.

[0016] The multi-directional oblique screw hole includes a first transverse oblique screw hole, a second transverse oblique screw hole, and a first vertical oblique screw hole; Both the first and second transverse oblique screw holes are set through the upper surface layer; The first vertical oblique screw hole passes through the bottom of the supporting bone plate body and is fixedly connected to the bone below the osteotomy by screws.

[0017] There are multiple first transverse oblique screw holes, second transverse oblique screw holes, or first vertical oblique screw holes.

[0018] The three-dimensional intersecting triangular fixing structure formed by the first transverse oblique screw hole, the second transverse oblique screw hole, and the first vertical oblique screw hole.

[0019] Combining all the above technical solutions, the beneficial effects of this invention are as follows: First, this invention reconstructs an individualized three-dimensional bone model based on the patient's CT / MRI images. By parametrically designing the wedge-shaped support plate shape at the angle of the expanded blank area, it eliminates the use of standardized, fixed sizes, achieving precise matching and fit between the wedge-shaped support plate and the patient's bone surface, significantly improving adaptability. The wedge-shaped support plate structure, with its fixed angle and supporting function, is directly designed according to the angle of the expanded blank area after osteotomy. This provides effective support to the bone defect blank area, restoring local mechanical stability and facilitating early postoperative weight-bearing and walking function recovery. Relying on the support structure of the wedge-shaped support plate itself to replace traditional bone grafting, it eliminates the need to harvest bone from other parts of the patient's body, fundamentally avoiding donor site damage and related complications, and achieving zero secondary trauma.

[0020] Secondly, the wedge-shaped support plate features a bone-surface-matching design, conforming more closely to the bone contour and reducing excessive stimulation of surrounding soft tissues by the plate protrusion, significantly alleviating postoperative foreign body sensation and discomfort. Preoperatively, the osteotomy angle, force line correction plan, and plate shape are planned using a 3D bone model. This eliminates the need for multiple fluoroscopic adjustments during surgery, reducing radiation exposure, shortening surgical time, and improving operational precision. Preoperatively, the lower limb force line and osteotomy angle are precisely planned based on the 3D model, combined with individualized wedge-shaped support plate angle fixation, ensuring accurate force line correction and reliable support, thus improving surgical effectiveness and precision.

[0021] Third, this invention can replace traditional osteotomy and bone grafting methods, becoming a core implant for lower limb alignment correction and open osteotomy, eliminating the need for autologous bone harvesting and reducing the probability of secondary surgery for patients. Traditional bone plates, both domestically and internationally, only provide fixation, not support; bone grafts only provide filling, not fixation. This invention is the first to integrate support, fixation, and fit, using a single implant to achieve structural support and bone end fixation in the osteotomy opening area. Traditional bone plates protrude from the bone surface, irritating soft tissue. This invention perfectly fits the bone contour and is flush with the bone groove, filling the gap in low-irritation osteotomy support bone plates.

[0022] Fourth, while the industry generally believes that bone grafting is necessary for bone defects, this invention proves that reliable structural support and a well-designed lightweight interface can achieve bone healing without the need for grafting, breaking the prejudice that bone healing is impossible without grafting. Traditionally, it is believed that bone plates can only be placed on the outside of the bone. This invention achieves zero-notch embedding, proving that low protrusion is safer and more comfortable, overcoming the morphological prejudice that bone plates must protrude. Attached Figure Description

[0023] The accompanying drawings, which are incorporated in and form part of this specification, illustrate embodiments consistent with the disclosure of this invention and, together with the description, serve to explain the principles of this disclosure; Figure 1 This is a schematic diagram of a 3D-printed bone plate that also provides support, provided in an embodiment of the present invention. Figure 2 This is a schematic diagram of a multi-directional oblique screw hole provided in an embodiment of the present invention; Figure 3 This is a side view of the multi-directional oblique screw hole provided in an embodiment of the present invention; Figure 4 This is an illustration of the effect of implanting the wedge-shaped support bone plate into osteotomy according to an embodiment of the present invention; Figure 5 This is a flowchart of the molding method for a 3D-printed bone plate that also provides support, provided in an embodiment of the present invention. Figure 6 This is a schematic diagram of a 3D-printed bone plate that also provides support, implanted into an osteotomy to resist load, provided by an embodiment of the present invention. Figure 7 This is the load test curve provided by the present invention; Figure 8 This is a wire diameter and aperture measurement diagram provided by the present invention; Figure 9 This is a porosity measurement diagram provided by the present invention; Figure 10 This is a flowchart of the dynamic testing process for a 3D-printed bone plate that also provides support, as provided by the present invention. Figure 11 A structural schematic diagram of a bone plate provided for the prior art; In the figure: 1. Support plate body; 2. Upper surface layer; 3. Surface hole; 4. Inner hole; 5. Screw; 6. First transverse oblique screw hole; 7. Second transverse oblique screw hole; 8. First vertical oblique screw hole. Detailed Implementation

[0024] To make the above-mentioned objects, features, and advantages of the present invention more apparent and understandable, specific embodiments of the present invention will be described in detail below with reference to the accompanying drawings. Many specific details are set forth in the following description to provide a thorough understanding of the present invention. However, the present invention can be practiced in many other ways different from those described herein, and those skilled in the art can make similar modifications without departing from the spirit of the present invention. Therefore, the present invention is not limited to the specific embodiments disclosed below.

[0025] The innovation of this invention lies in the following: Based on the patient's CT / MRI data, a three-dimensional bone model is reconstructed, precisely calculating the osteotomy angle, gap size, and slope parameters. An integrated wedge-shaped support structure is designed to perfectly match the bone surface and the expansion zone. Through multi-directional oblique screw holes, a three-dimensional cross-triangular stable fixation system is formed, achieving a unified function of support, fixation, bone integration, and low soft tissue stimulation. This system can replace traditional bone grafting and standard bone plates (such as…). Figure 11 As shown, this improves the precision, stability, and postoperative rehabilitation of osteotomy and correction.

[0026] This invention features a precise calculation method for personalized parameters (spread angle, gap size, and slope angle), as well as a structural design and molding method for an integrated wedge-shaped support bone plate that perfectly matches these parameters. It also includes a layered gradient pore size and structural layout for a porous structure design, a layout of multi-directional oblique screw holes, and the resulting three-dimensional triangular stable fixing structure.

[0027] Example 1: A 3D-printed bone plate that also provides support is a three-dimensional wedge-shaped support bone plate made by 3D printing. The angle of the support blank area of ​​the osteotomy is matched and it fits the bone surface in a matching manner. The shape conforms to the bone contour and has the function of supporting and opening the blank area. like Figure 1 The wedge-shaped support bone plate includes: Supporting the bone plate body 1; the supporting bone plate body 1 and the upper surface layer 2 are in contact with the bone surface of the osteotomy. Multiple surface holes 3 are provided on the upper surface layer 2 to promote lightweight design; The lower part of the surface hole 3 has an inner hole 4 with a diameter larger than that of the surface hole 3, which is opened by a gradient change and is used to provide strength mechanical support. The side of the supporting bone plate body 1 is provided with a three-dimensionally arranged multi-directional oblique screw hole. The multi-directional oblique screw hole passes through the supporting bone plate body 1 and is fixedly connected to the osteotomy and the bone below the osteotomy by the through screw 5. The multi-directional oblique screw hole includes a first transverse oblique screw hole 6, a second transverse oblique screw hole 7, and a first vertical oblique screw hole 8; such as Figure 2 , Figure 3 As shown; Preferably, to further enhance the fixing effect, the multi-directional oblique screw holes not only include the first transverse oblique screw hole 6, the second transverse oblique screw hole 7, and the first vertical oblique screw hole 8, but can also include additional transverse oblique screw holes or vertical oblique screw holes, such as... Figure 3 The multi-directional oblique screw holes mentioned in this invention, including the first transverse oblique screw hole 6, the second transverse oblique screw hole 7, and the first vertical oblique screw hole 8, are merely one specific embodiment.

[0028] For example, the wedge angle of the wedge-shaped support plate matches the osteotomy opening angle determined preoperatively; In another example, both the first transverse oblique screw hole 6 and the second transverse oblique screw hole 7 penetrate the upper surface layer 2; The three-dimensional intersecting triangular fixing structure formed by the first transverse oblique screw hole 6, the second transverse oblique screw hole 7, and the first vertical oblique screw hole 8.

[0029] The multi-directional oblique screw hole has an oblique channel with a diameter of 6.9 mm and a depth that penetrates the support bone plate body 1 of the wedge-shaped support bone plate, which can meet the needs of complex osteotomy planes.

[0030] Triangular stabilizing structure: Screw 5 forms a three-dimensional cross fixation through multi-directional oblique screw holes, reducing the loosening rate of screw 5.

[0031] like Figure 4 As shown, the wedge-shaped support bone plate is implanted in the osteotomy and can be completely embedded in the bone groove of the osteotomy, flush with the bone surface, achieving "zero notch". This reduces postoperative foreign body sensation and soft tissue complications. Its unique gradient mechanical structure and triangularly stable multi-directional oblique screw holes give it strong support and stability on its own. It does not rely on external structures and achieves biological fixation, with stability far superior to simple mechanical fixation.

[0032] The wedge-shaped support plate is made of titanium alloy TC4ELI, which has good osteogenic integration with bone tissue (from Beijing Yijia 3D Technology Co., Ltd., and has passed the inspection of Tianjin Kangernuo Technology Co., Ltd.).

[0033] Example 2: Using the 3D-printed bone plate with support provided in Example 1, the patient's original CT / MRI image data is acquired for different applications; medical image processing software such as Mimics is used to process the bone area and reconstruct a high-precision individualized three-dimensional bone model, that is, to design a personalized wedge-shaped support bone plate.

[0034] Example 3, as Figure 5As shown, the molding method for a 3D-printed bone plate that also provides support includes: S1. Acquire the patient's raw CT / MRI image data; use Mimics medical image processing software to process the skeletal region and reconstruct a three-dimensional skeletal model. For example, in step S1, a high-precision individualized three-dimensional bone model can be reconstructed; an STL (Stereolithography) model that can be used for design, namely a three-dimensional bone model (an individualized three-dimensional bone model reconstructed based on the patient's CT / MRI images), is exported to prepare for subsequent force line analysis and bone plate design.

[0035] S2, mark key points on the 3D bone model; through parametric analysis using 3-matic design software, calculate the coronal / sagittal angles to be corrected, determine the osteotomy position, osteotomy plane, wedge-shaped opening angle and the size of the opening gap in the osteotomy opening blank area, perform virtual open osteotomy on the 3D bone model, and open the bone ends according to the coronal / sagittal angles to be corrected; The Lower Limb Rotation Alignment (HKA) method, combined with Paley's osteotomy correction theory, is employed. HKA (Hip-Knee-Ankle) refers to the mechanical axis of the lower limb, formed by connecting the centers of the femoral head, knee, and ankle joints. Paley's theory calculates the required wedge angle, centered on the center of rotation (CORA), to restore the mechanical axis to a neutral position. The CORA is located within the proximal tibial metaphysis or distal femoral metaphysis, specifically in the enlarged area between the diaphysis and epiphysis, near the articular surface.

[0036] Calculate the wedge-shaped opening angle: Mark the center of the femoral head, knee joint, and ankle joint on the 3D skeletal model, and draw the lower limb mechanical axis; measure the angle between the actual mechanical axis and the neutral mechanical axis to obtain the total correction angle; based on the Paley deformity analysis principle, with the deformity apex as the center, convert the total correction angle into the osteotomy opening wedge angle and the size of the opening gap, as the design parameters for the wedge-shaped support plate. Osteotomy location and plane: Tibial metaphysis, 3-5cm below the tibial plateau (most commonly used location for HTO osteotomy); distal femoral metaphysis, 3-4cm above the femoral condyle (most commonly used location for DFO osteotomy).

[0037] For example, in step S2, key points are marked on the three-dimensional skeletal model: the center of the femoral head, the center of the knee joint, and the center of the ankle joint. The center of the femoral head and the center of the ankle joint are connected. This is the patient's current abnormal force line. The abnormal force line is adjusted according to the center of the knee joint to form the corrected force line.

[0038] Femoral head center: the center of the femoral head contour; Knee joint center: the center of the intercondylar fossa of the femur; Ankle joint center: the midpoint between the medial and lateral malleolar surfaces at the distal articular surface of the tibia. S3, based on the bone contour of the reconstructed 3D bone model, performs curved surface fitting design on the cortical bone on the lateral side of the osteotomy-opened blank area, so that the outer side of the wedge-shaped support bone plate fits closely with the bone surface, reducing soft tissue irritation; according to the size of the opening gap and the wedge opening angle determined preoperatively, a wedge-shaped support bone plate is designed at the position of the osteotomy-opened blank area, and the outer side of the designed wedge-shaped support bone plate fits closely with the bone surface, reducing soft tissue irritation; the designed wedge-shaped support bone plate is 3D printed and exported.

[0039] For example, in step S3, the designed wedge-shaped support bone plate includes: the inner and outer end support heights of the support bone plate body 1 are consistent with the size of the opening gap; The wedge angle of the wedge-shaped support plate is consistent with the wedge-shaped opening angle of the osteotomy; this ensures effective filling of the product and also serves as a check during the operation. If the opening angle is insufficient during the operation, the wedge-shaped support plate cannot be inserted; if the opening is too large, there will be a gap between the opening area and the wedge-shaped support plate. The consistency of the two angles ensures accurate osteotomy and correction, and achieves precise correction while checking during the operation.

[0040] Directly fill the gaps created by osteotomy (bone defect gaps) to provide structural support.

[0041] The computational methods and image or data information processing methods or programs involved in this invention can be implemented using existing classical algorithms. The purpose of this invention is to obtain wedge-shaped support bone plates through classical methods and to perform 3D printing. Those skilled in the art can implement the technical solutions of this invention through the disclosed methods.

[0042] As can be seen from the above embodiments, the wedge-shaped support bone plate matching design proposed in this invention not only fully meets the personalized needs of special patients in clinical applications, but also demonstrates excellent flexibility and forward-looking technology. The following is a systematic description of its key functions: Personalized design: The wedge-shaped support plate perfectly matches the patient's bone surface contour; through preoperative parametric calculations, the opening angle, osteotomy plane, and opening gap are precisely determined, achieving accurate correction of the lower limb force line and improving surgical efficacy; it has a built-in wedge-shaped support structure that perfectly matches the opening gap, directly filling the bone defect area and avoiding secondary trauma and complications caused by autologous bone harvesting; all planning is completed preoperatively, eliminating the need for repeated fluoroscopy to confirm angles during surgery, simplifying the operation process and reducing radiation exposure for both doctors and patients; the outer surface of the wedge-shaped support plate fits closely to the bone surface, with a smooth and conforming shape, significantly reducing irritation to surrounding soft tissues and alleviating postoperative foreign body sensation and discomfort; the support structure directly bears the load, providing stable support to the opening area, effectively supporting the patient's early postoperative weight-bearing and walking, and accelerating the recovery process.

[0043] Pore ​​structure design: A layered gradient pore size design is adopted to achieve both osseointegration and structural stability, solving the contradiction that traditional porous structures are too strong for bone growth and too loose for strength. The porous structure reduces the weight of the bone plate while ensuring strength, further reducing soft tissue burden and postoperative discomfort.

[0044] Multi-directional screw hole fixation system: The multi-angle cross screws 5 form a spatial triangular stability system, which, together with the wedge-shaped support structure, achieves dual stability of structural support and multi-directional locking, providing a continuous and reliable mechanical environment for osteotomy healing.

[0045] In summary, this invention not only has high clinical applicability, but also provides patients with safer and more effective treatment options through advanced technology.

[0046] In the above embodiments, the descriptions of each embodiment have different focuses. For parts that are not described in detail or recorded in a certain embodiment, please refer to the relevant descriptions of other embodiments.

[0047] To further illustrate the effects of the embodiments of the present invention, the following experiments were conducted.

[0048] Experimental Example 1.

[0049] Static testing of a 3D-printed bone plate with supporting structure. Test environment: 23℃, 60%RH. Test equipment: This experiment used the displacement method, which assesses connection strength by applying a controllable displacement load and measuring the stress response at the interface between the base and the superstructure.

[0050] like Figure 6 A schematic diagram of static load resistance test of a 3D-printed bone plate with both support and implantation in osteotomy using the displacement method; Equipment name: Microcomputer-controlled electronic universal testing machine; Equipment model: WDW-50J.

[0051] Experimental procedures.

[0052] Sample Placement: Place the test sample according to... Figure 6 The fixture is fixed to the testing machine in the following manner, and its position is determined as follows: (a) The bone model is fixed to the inner surface of the tooling.

[0053] (b) Apply displacement X.

[0054] (c) Loading speed: 0.04 mm / s; (d) Stop the experiment when the load reaches the predetermined position and record the relevant load.

[0055] The test parameters included: the bone model was polyetheretherketone (PEEK); the displacement X was 3 mm; and the loading rate was 0.04 mm / s. Experimental results are shown in Table 1.

[0056] Table 1 Test Results of Example 1

[0057] The load test curve is shown below. Figure 7 As shown. Figure 7 The three straight lines at the top are curves 001, 002, and 003 of this invention; the three straight lines at the bottom are curves 001, 002, and 003 of the prior art.

[0058] Experimental Example 2.

[0059] Objective: To verify whether the porous structure of the test sample meets the requirements of YY / T 0988.14.

[0060] Test environment: 23℃, 60%RH. Test equipment: stereo microscope.

[0061] Experimental Methods. Following the requirements of YY / T 0988.14 standard, the sample was placed on the test stage, and the wire diameter, pore size, and porosity were measured using a stereomicroscope according to the stereomicroscope operation and maintenance procedures. For wire diameter and pore size measurement, see [link to relevant documentation]. Figure 8 Porosity measurement is shown in Figure 9 The test results are shown in Table 2; Table 2 Test Results of Example 2

[0062] Conclusion. The 3D-printed bone plate, which also provides support, was measured according to the stereographic evaluation method for porous coatings in YY / T 0988.14 Surgical Implant Coatings. The measurement results meet the product technical requirements.

[0063] Experimental Example 3.

[0064] Dynamic testing of a 3D-printed bone plate with supporting function. Displacement method testing. Experimental equipment: fatigue testing machine. Test procedures are detailed below. Figure 10 Fix the test sample onto the fixture as described in step 6, and then fix the fixture onto the testing machine, determining its position as follows: (a) The bone model is fixed to the inner surface of the tooling.

[0065] (b) Apply load F; (c) Calibrate the axis of the test specimen so that it is perpendicular to the axis of the bone model; (d) Test samples with set test parameters.

[0066] Test method (displacement method).

[0067] Bone model: Polyetheretherketone (PEEK); Load: 600 N; Frequency (Hz): 10; Cycle count: 1 million cycles; Test results: At an R ratio of 0.1: In the prior art unsupported model, at a frequency of 10 Hz and 1 million cycles, curve 001 showed maximum bending moments of 9.56 N·m and 13.39 N·m without fracture; curve 002 showed a maximum bending moment of 8.75 N·m without fracture, but fractured after 5,689,541 cycles at 14.69 N·m; curve 003... The curve did not break at a maximum bending moment of 10.12 N·m, but broke after 6,811,265 cycles at 13.86 N·m. In the supported configuration of this invention, at a frequency of 10 Hz and 1 million cycles, the maximum bending moments of curves 001 (4.33 N·m and 8.55 N·m) did not break; curves 002 (3.12 N·m and 7.96 N·m) and 003 (4.58 N·m and 6.56 N·m) did not break. The above description is only a preferred embodiment of the present invention, but the scope of protection of the present invention is not limited thereto. Any modifications, equivalent substitutions and improvements made by those skilled in the art within the scope of the technology disclosed in the present invention and within the spirit and principles of the present invention should be covered within the scope of protection of the present invention.

Claims

1. A method for molding a 3D-printed bone plate that also provides support, characterized in that, The method includes the following steps: S1. Acquire the patient's raw CT / MRI image data; use Mimics medical image processing software to process the skeletal region and reconstruct a three-dimensional skeletal model. S2, mark key points on the 3D bone model; through parametric analysis using 3-matic design software, calculate the coronal / sagittal angles to be corrected, determine the osteotomy position, osteotomy plane, wedge-shaped opening angle and the size of the opening gap in the osteotomy opening blank area, perform virtual open osteotomy on the 3D bone model, and open the bone ends according to the coronal / sagittal angles to be corrected; S3, based on the bone contour of the reconstructed 3D bone model, performs curved surface fitting design on the cortical bone on the lateral side of the osteotomy-opened blank area, so that the outer side of the wedge-shaped support bone plate fits closely with the bone surface, reducing soft tissue irritation; according to the size of the opening gap and the wedge opening angle determined preoperatively, a wedge-shaped support bone plate is designed at the position of the osteotomy-opened blank area, and the outer side of the designed wedge-shaped support bone plate fits closely with the bone surface, reducing soft tissue irritation; the designed wedge-shaped support bone plate is 3D printed and exported.

2. The method for forming a 3D-printed bone plate that also provides support according to claim 1, characterized in that, In step S2, key points are marked on the three-dimensional skeletal model: the center of the femoral head, the center of the knee joint, and the center of the ankle joint. The center of the femoral head and the center of the ankle joint are connected. This is the patient's current abnormal force line. The abnormal force line is adjusted according to the center of the knee joint to form the corrected force line.

3. The method for forming a 3D-printed bone plate that also provides support according to claim 1, characterized in that, In step S3, the designed wedge-shaped support bone plate includes: the inner and outer end support heights of the support bone plate body (1) are consistent with the size of the opening gap; The wedge angle of the wedge-shaped support plate is consistent with the wedge-shaped opening angle of the osteotomy.

4. The method for forming a 3D-printed bone plate that also provides support according to claim 1, characterized in that, For different application subjects, the raw CT / MRI image data of patients are acquired; Mimics medical image processing software is used to process the bone area, reconstruct an individualized three-dimensional bone model, and design a personalized wedge-shaped support bone plate.

5. A 3D-printed bone plate that also provides support, characterized in that, The bone plate is manufactured using the molding method of the 3D printed bone plate with support as described in any one of claims 1-4. The bone plate is angled to match the open blank area of ​​the osteotomy and is fitted to the bone surface in a matching manner. Its shape conforms to the contour of the bone. The bone plate is a three-dimensional wedge-shaped support bone plate that supports the open blank area.

6. The 3D-printed bone plate with supporting function according to claim 5, characterized in that, The wedge-shaped support bone plate is manufactured using 3D printing and specifically includes: Support plate body (1); the upper surface (2) of the support plate body (1) is in contact with the bone surface of the osteotomy; The upper surface layer (2) has multiple surface holes (3) for promoting lightweight design; The side of the supporting bone plate body (1) is provided with multi-directional oblique screw holes arranged in three dimensions.

7. The 3D-printed bone plate with supporting function according to claim 5, characterized in that, The multi-directional oblique screw hole supports the bone plate body (1) and is fixedly connected to the osteotomy and the bone below the osteotomy by the through screw (5).

8. The 3D-printed bone plate with supporting function according to claim 7, characterized in that, The multi-directional oblique screw hole includes a first transverse oblique screw hole (6), a second transverse oblique screw hole (7), and a first vertical oblique screw hole (8); The first transverse oblique screw hole (6) and the second transverse oblique screw hole (7) are both set through the upper surface layer (2); The first vertical oblique screw hole (8) passes through the bottom of the supporting bone plate body (1) and is fixedly connected to the bone below the osteotomy by screws (5).

9. The 3D-printed bone plate with supporting function according to claim 8, characterized in that, There are multiple first transverse oblique screw holes (6), second transverse oblique screw holes (7), or first vertical oblique screw holes (8).

10. The 3D-printed bone plate with supporting function according to claim 8, characterized in that, The three-dimensional intersecting triangular fixing structure formed by the first transverse oblique screw hole (6), the second transverse oblique screw hole (7), and the first vertical oblique screw hole (8)

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