A personalized fracture internal fixation splint with bone regeneration ability and a preparation method thereof

Abstract

The application relates to a personalized fracture internal fixation splint with bone regeneration capability and a preparation method, which comprises arc-shaped splints formed by 3D printing; the arc-shaped splints have inner wall surfaces matched with the anatomical shape of fracture positions; two arc-shaped splints are arranged in a clamping mode; when the adjacent end surfaces of the two arc-shaped splints abut against each other, a closed bone repair environment matched with an intramedullary nail device is formed on the inner wall surfaces of the two arc-shaped splints; when a gap is left between the adjacent end surfaces of the two arc-shaped splints, a metal bone plate is attached to the gap, and an unclosed bone repair environment matched with a metal bone plate device is formed on the inner wall surfaces of the two arc-shaped splints. The arc-shaped splints can stably fix the fracture positions, and are favorable for anatomical reduction, fracture alignment and alignment operation; the two arc-shaped splints can form a closed bone repair environment or an unclosed bone repair environment at the fracture positions, so that a more effective osteogenesis microenvironment can be provided for different fracture positions to accelerate fracture healing.

Description

Technical Field

[0001] This invention relates to the field of orthopedic repair technology, specifically to a personalized fracture internal fixation splint with bone regeneration capabilities and its preparation method. Background Technology

[0002] Fractures caused by high-energy trauma or osteoporosis are common. Internal fixation using metal plates or intramedullary nails is currently the main clinical treatment for fractures. However, the high elastic modulus of metal materials can cause loosening, breakage, or poor reduction of the internal fixation device due to stress shielding, leading to secondary fractures. Furthermore, the lack of bioactivity in metal materials often results in nonunion or delayed healing. Additionally, the leaching of harmful metal ions such as nickel and aluminum can cause tissue lesions. Therefore, in fracture treatment, besides the mechanical support provided by internal fixation devices like metal plates or intramedullary nails, there is an urgent need to develop bioactive auxiliary devices to guide vascular ingrowth, tissue regeneration, and accelerate fracture healing.

[0003] Existing orthopedic repair assistive devices have the following technical problems:

[0004] It is impossible to create a closed or non-closed bone repair environment that matches the specific fracture site, making it difficult to provide a more effective osteogenic microenvironment to accelerate fracture healing. Summary of the Invention

[0005] One of the objectives of this invention is to address the problems existing in the prior art: to provide a personalized internal fixation splint for fractures with bone regeneration capabilities, which can create a closed or non-closed bone repair environment that matches the specific fracture site, and can provide a more effective osteogenic microenvironment to accelerate fracture healing.

[0006] The second objective of this invention is to provide a method for preparing a personalized internal fixation splint for fractures with bone regeneration capabilities.

[0007] To achieve the above objectives, the present invention adopts the following technical solution:

[0008] A personalized fracture internal fixation splint with bone regeneration capability, characterized in that it includes an arc-shaped splint made by 3D printing;

[0009] The arc-shaped splint has an inner wall surface that conforms to the anatomical shape of the fracture site;

[0010] There are two curved clamps, which are arranged together.

[0011] Specifically, when the adjacent end faces of the two arc-shaped splints abut each other, a closed bone repair environment matching the intramedullary nail device for fixation is formed on the inner wall surface of the two arc-shaped splints; or, when there is a gap between the adjacent end faces of the two arc-shaped splints, a metal bone plate is attached to the gap, and a non-closed bone repair environment matching the metal bone plate device for fixation is formed on the inner wall surface of the two arc-shaped splints.

[0012] Furthermore, the arc-shaped clamp is made of bioactive ceramic material.

[0013] Furthermore, the bioactive ceramic material is a calcium phosphate-based or calcium silicate-based bioactive ceramic material.

[0014] Furthermore, the outer surface of the curved clamp is a dense layer.

[0015] Furthermore, the thickness of the dense layer is 0.4mm-1.5mm.

[0016] Furthermore, the inner wall of the arc-shaped clamp has a porous structure.

[0017] Furthermore, the pore size of the porous structure ranges from 50 μm to 1200 μm.

[0018] Furthermore, a splint body is provided between the outer surface and the inner wall of the arc-shaped splint. The thickness of the splint body is adjusted according to the anatomical structure of the fracture site, with an average thickness of 1mm-5mm.

[0019] Furthermore, the curved splint has a pre-drilled hole for installation, which allows for the use of absorbable sutures to bind and fix the two splints together during implantation.

[0020] A method for preparing a personalized fracture internal fixation splint with bone regeneration capacity includes the following steps:

[0021] Step 1: Collect the patient's CT imaging data, perform three-dimensional reconstruction on the acquired raw CT data, simulate the effect of internal fixation splint with metal bone plate device or intramedullary nail device after implantation on the computer, extract relevant data information of arc splint, and export the arc splint model in STL format.

[0022] Step 2: Import the arc-shaped clamp model data exported in Step 1 into the 3D computer-aided design software, set the thickness of the clamp body and the dense layer on the outer surface, as well as the pore diameter of the porous structure on the inner wall, reserve several mounting through holes on the arc-shaped clamp, and save the designed arc-shaped clamp model data in STL format that can be recognized by the 3D printer software.

[0023] Step 3: Import the arc-shaped splint model from Step 2 into the 3D printer control software, set the printing parameters, and then print to obtain a personalized fracture internal fixation splint with bone regeneration capabilities.

[0024] In summary, the present invention has the following advantages:

[0025] The 3D-printed arc-shaped splint has an inner wall surface that conforms to the anatomical shape of the fracture site. When two arc-shaped splints are used to hold the fracture site together, the fracture can be stably fixed, which is beneficial for anatomical reduction and fracture alignment. Depending on the fracture site, the two arc-shaped splints can create a closed or open bone repair environment at the fracture site. Intramedullary nails can be used in conjunction with the closed bone repair environment, and metal bone plates can be used in conjunction with the open bone repair environment. This provides a more effective osteogenic microenvironment for different fracture sites to accelerate fracture healing, solving the problem of poor clinical fracture treatment results. It has important application value and market prospects. Attached Figure Description

[0026] Figure 1 This is an image of the personalized β-tricalcium phosphate (β-TCP) fixation splint from Embodiment 1 of the present invention.

[0027] Figure 2 This is a diagram illustrating the anatomical reduction effect of a personalized fracture internal fixation splint in Embodiment 1 of the present invention.

[0028] Figure 3 This is a simulation of the fixation effect of a personalized fracture internal fixation splint and metal bone plate in Embodiment 1 of the present invention.

[0029] Figure 4 This is a design drawing of the reserved hole for the personalized fracture internal fixation splint in Embodiment 1 of the present invention.

[0030] Figure 5 This is a schematic diagram of the thickness of the personalized fracture internal fixation splint in Embodiment 1 of the present invention.

[0031] Figure 6 This is a diagram illustrating the personalized fracture internal fixation splint and its assembly effect in Embodiment 1 of the present invention.

[0032] Figure 7 Image of the personalized β-tricalcium phosphate (β-TCP) fixation splint in Embodiment 2 of the present invention.

[0033] Figure 8 This is a simulation of the effect of personalized fracture internal fixation splint and metal intramedullary nail fixation in Embodiment 2 of the present invention.

[0034] Figure 9 This is a design drawing of the reserved hole for the personalized fracture internal fixation splint in Embodiment 2 of the present invention.

[0035] Figure 10 This is an assembly effect diagram of the personalized fracture internal fixation splint according to Embodiment 2 of the present invention.

[0036] In the picture:

[0037] 1-Arc-shaped clamping plate, 11-Dense layer, 12-Clamping plate body, 13-Inner wall surface, 14-Mounting through hole; 2-Metal bone plate. Detailed Implementation

[0038] The present invention will now be described in further detail.

[0039] Example 1

[0040] like Figure 1 As shown, the personalized fracture internal fixation splint with bone regeneration capacity prepared in this embodiment is a personalized β-tricalcium phosphate (β-TCP) fixation splint, which is used in conjunction with metal bone plate 2 for internal fixation to treat femoral shaft fractures.

[0041] The β-tricalcium phosphate (β-TCP) fixation splint consists of two arc-shaped splints 1, which together hold the fracture site during installation.

[0042] like Figure 5 As shown, the arc-shaped clamp 1 includes an outer surface, a clamp body 12, and an inner wall surface 13 connected in sequence.

[0043] The inner wall surface 13 of the arc-shaped splint 1 (close to the fracture surface) perfectly matches the anatomical shape of the fracture site.

[0044] The outer surface of the arc-shaped clamp 1 is a dense layer 11 with a thickness of 1.03 mm, the inner wall surface 13 is a porous structure with a pore size of 600 μm, and the thickness of the clamp body 12 is 2.02-8.22 mm.

[0045] like Figure 4 , Figure 6 As shown, five mounting holes 14 with a diameter of 6.5 mm are reserved on the arc-shaped splint 1, which are reserved for binding and fixing the two arc-shaped splints 1 with absorbable sutures during implantation.

[0046] Bioactive ceramics have wide applications as bioabsorbable materials and tissue engineering scaffolds. As a bioactive material, materials similar to bone apatite or carbonate hydroxyapatite can be rapidly formed on the ceramic surface. These not only possess the ability to form strong bonds between bone and biomaterial interfaces but also promote cell functionalization and expression. Furthermore, after porous treatment, these biomaterials can bind and collect growth factors, becoming osteoinductive biomaterials that allow osteoblast adhesion and promote mesenchymal cell migration. Precision orthopedic treatment can completely solve complex cases that cannot be treated with traditional surgery, representing a new medical model that intersects multiple disciplines such as orthopedics, equipment manufacturing, imaging, and materials science. 3D printing technology can personalize medical devices with complex structural designs that are impossible to achieve using traditional processing methods. Personalized design is the biggest advantage of 3D printing technology, which is reflected not only in the personalization of the implant's shape but also in the personalization of its internal structure. Ceramic materials, as biomaterials, play an important role in bone repair. 3D printing technology has the advantages of small-batch manufacturing of complex components and low cost, which can meet patients' needs for personalized implant customization.

[0047] The design and manufacturing steps of the curved clamp 1 are as follows:

[0048] 1. Acquire the patient's CT imaging data and perform 3D reconstruction on the raw CT data. Simulate the effect of implantation of the regenerating splint combined with the metal bone plate internal fixation system on a computer, such as... Figure 3 As shown. Extract relevant data information about the recycled splint and export the recycled splint model in STL format.

[0049] 2. Import the regenerated splint model data exported in step 1 into the 3D computer-aided design software. The splint body 12 is designed with a thickness of 2.02-8.22 mm. A 1.03 mm thick dense layer 11 is added to the outer surface of the arc-shaped splint 1, and the inner wall surface 13 has a porous structure with a pore diameter of 600 μm. Five 6.5 mm diameter mounting holes 14 are pre-drilled on the arc-shaped splint 1 for binding and fixing the two splints with absorbable sutures during implantation. The design of the arc-shaped splint 1 and the assembly effect of the two arc-shaped splints 1 are shown below. Figure 6 As shown. Save the model data of the two designed curved clamps 1 in STL format that can be recognized by the 3D printer software.

[0050] 3. Import the arc-shaped clamp 1 model from step 2 above into the 3D printer control software, set the printing parameters, and then print.

[0051] This customized β-tricalcium phosphate (β-TCP) fixation splint was used in conjunction with metal bone plate 2 during later surgeries.

[0052] Example 2

[0053] The difference between this embodiment and Embodiment 1 is that:

[0054] like Figure 7 , Figure 8 , Figure 10 As shown in this embodiment, a personalized β-tricalcium phosphate (β-TCP) fixation splint is used in conjunction with intramedullary metal nail fixation to treat femoral shaft fractures.

[0055] The outer surface of the arc-shaped clamp 1 is a dense layer 11 of 1.5 mm, the inner wall surface 13 is a porous structure with a pore size of 400 μm, and the thickness of the clamp body 12 is 1.83-3.46 mm.

[0056] like Figure 9 As shown, two 5mm diameter mounting holes 14 are reserved on the arc-shaped splint 1, which are used to bind and fix the two arc-shaped splints 1 with absorbable sutures during implantation.

[0057] This custom-designed β-tricalcium phosphate (β-TCP) fixation splint is used in conjunction with a metal intramedullary nail fixation device during later surgeries.

[0058] This invention utilizes a 3D-printed arc-shaped splint 1 with an inner wall surface 13 that conforms to the anatomical shape of the fracture site. When two arc-shaped splints 1 are used to hold the fracture site, the fracture site can be stably fixed, which is beneficial for anatomical reduction and fracture alignment. Depending on the fracture site, the two arc-shaped splints 1 can form a closed or non-closed bone repair environment at the fracture site. An intramedullary nail device is used in conjunction with the closed bone repair environment, and a metal bone plate device is used in conjunction with the non-closed bone repair environment. This provides a more effective osteogenic microenvironment for different fracture sites to accelerate fracture healing.

[0059] The above embodiments are preferred embodiments of the present invention, but the embodiments of the present invention are not limited to the above embodiments. Any changes, modifications, substitutions, combinations, or simplifications made without departing from the spirit and principle of the present invention shall be considered equivalent substitutions and shall be included within the protection scope of the present invention.

Claims

1. A personalized internal fixation splint for fractures with bone regeneration capabilities, characterized in that: Including curved clamps made by 3D printing; The arc-shaped splint has an inner wall surface that conforms to the anatomical shape of the fracture site; There are two curved clamps, which are arranged together. Specifically, when the adjacent end faces of the two arc-shaped splints abut each other, a closed bone repair environment matching the intramedullary nail device for fixation is formed on the inner wall surface of the two arc-shaped splints; when there is a gap between the adjacent end faces of the two arc-shaped splints, a non-closed bone repair environment matching the metal bone plate device for fixation is formed on the inner wall surface of the two arc-shaped splints. The outer surface of the curved splint is a dense layer; The thickness of the dense layer is 0.4mm-1.5mm; The inner wall of the arc-shaped clamp has a porous structure; The pore size of the porous structure ranges from 50mm to 1200mm; The outer and inner surfaces of the arc-shaped splint are provided with the splint body. The thickness of the splint body is adjusted according to the anatomical structure of the fracture site, and the average thickness of the splint body is 1mm-5mm. The arc-shaped clamp is made of bioactive ceramic material; The curved splint has pre-drilled holes for installation, which are used to bind and fix the two splints together with absorbable sutures during implantation.

2. The personalized fracture internal fixation splint with bone regeneration capacity according to claim 1, characterized in that: The bioactive ceramic material is a calcium phosphate-based or calcium silicate-based bioactive ceramic material.

3. A method for preparing a personalized fracture internal fixation splint with bone regeneration capacity as described in claim 1 or 2, characterized in that: Includes the following steps, Step 1: Collect the patient's CT imaging data, perform three-dimensional reconstruction on the acquired raw CT data, simulate the effect of internal fixation splint with metal bone plate device or intramedullary nail device after implantation on the computer, extract relevant data information of arc splint, and export the arc splint model in STL format. Step 2: Import the arc-shaped clamp model data exported in Step 1 into the 3D computer-aided design software, set the thickness of the clamp body and the dense layer on the outer surface, as well as the pore diameter of the porous structure on the inner wall, reserve several mounting through holes on the arc-shaped clamp, and save the designed arc-shaped clamp model data in STL format that can be recognized by the 3D printer software. Step 3: Import the arc-shaped splint model from Step 2 into the 3D printer control software, set the printing parameters, and then print to obtain a personalized fracture internal fixation splint with bone regeneration capabilities.

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