Degradable regenerated skull repair body based on 3D printing composite material preparation
The composite material of magnesium three-dimensional mesh support and mineralized collagen scaffold prepared by 3D printing technology solves the limitations of existing cranial repair materials, realizes the precise matching and excellent performance of fully degradable regenerated cranial repair body, and promotes bone tissue regeneration.
Patent Information
- Authority / Receiving Office
- CN · China
- Patent Type
- Utility models(China)
- Current Assignee / Owner
- BEIJING UNION UNIVERSITY
- Filing Date
- 2025-04-09
- Publication Date
- 2026-06-19
AI Technical Summary
Existing skull repair materials have problems such as limited autologous bone sources, risk of immune rejection of allogeneic bone, and potential complications from long-term implantation of metal or plastic materials. Magnesium alloys have excessively rapid degradation rates and insufficient mechanical support properties in skull defect repair.
A composite material consisting of a magnesium three-dimensional mesh support and a mineralized collagen scaffold was prepared using 3D printing technology. Combined with a biomimetic mineralized transition membrane and mineralized collagen bone paste, a fully degradable and regenerated cranial prosthesis was formed, providing excellent mechanical support and biocompatibility, and simulating the structure of bone tissue.
It achieves precise matching and repair of large-area irregular skull defects, provides excellent mechanical properties and osseointegration performance, the material is fully degradable and does not require secondary surgery, and promotes bone tissue regeneration.
Smart Images
Figure CN224370037U_ABST
Abstract
Description
Technical Field
[0001] This utility model relates to the field of biomedical materials and biodegradable medical devices, specifically to a fully degradable and regenerated cranial repair body prepared based on 3D printed composite materials. Background Technology
[0002] Skull defects are a common surgical problem in clinical practice, often caused by accidental trauma such as car accidents, congenital malformations, etc. Traditional methods of skull repair mainly include autologous bone grafting, allogeneic bone grafting, and implantation of metal or plastic materials. However, these methods each have their limitations, such as the limited availability of autologous bone, the risk of immune rejection with allogeneic bone, and the potential for complications with long-term implantation of metal or plastic materials.
[0003] In recent years, the rapid development of biomaterials science and 3D printing technology has provided new insights for the research and development of fully degradable regenerative skull prostheses. 3D printing technology can precisely fabricate personalized prostheses that closely match the defect site based on individual patient differences, thereby maximizing the restoration of the skull's appearance and function. Simultaneously, prostheses prepared using biomaterials with excellent biocompatibility and degradation properties can gradually degrade during the repair process, providing space for the growth of new bone tissue and ultimately achieving natural healing of the skull.
[0004] Currently, metal-based biomaterials show great promise for bone defect repair due to their excellent mechanical properties and biodegradability. Among them, magnesium and magnesium alloys have attracted widespread attention due to their abundant resources, similar bone density to human bone, and the fact that their degradation products can participate in metabolism. However, magnesium alloys suffer from problems such as excessively rapid degradation rates and insufficient mechanical support properties, which limit their application in skull defect repair. To overcome these shortcomings, researchers have proposed methods such as surface modification and alloying to improve the properties of magnesium alloys, but the effects have been limited. Utility Model Content
[0005] To address at least one of the above technical problems, this invention provides a fully degradable regenerated skull repair body prepared based on 3D printed composite materials, which has excellent mechanical support and biodegradability properties and is suitable for repairing large-area, irregular, and thin-walled skull defects.
[0006] A fully degradable and regenerated cranial prosthesis prepared based on 3D printed composite materials includes: a magnesium three-dimensional mesh support and a mineralized collagen scaffold. The mineralized collagen scaffold fills the gaps of the magnesium three-dimensional mesh support and covers the sides of the magnesium three-dimensional mesh support. A biomimetic mineralization transition membrane is disposed on the upper side of the mineralized collagen scaffold, and mineralized collagen bone paste is disposed on the upper side of the biomimetic mineralization transition membrane.
[0007] Preferably, the magnesium three-dimensional mesh support is made of magnesium-calcium alloy with a thickness of 46-47 μm.
[0008] In any of the above embodiments, the magnesium three-dimensional mesh support comprises at least two layers of magnesium-calcium alloy wires, wherein the magnesium-calcium alloy wires in each layer are arranged in a regular or irregular geometric pattern.
[0009] In any of the above embodiments, the magnesium-calcium alloy wires in each layer are arranged in parallel, and the magnesium-calcium alloy wires in adjacent layers cross each other in the arrangement direction.
[0010] Preferably, the magnesium three-dimensional mesh support is prepared by metal 3D printing.
[0011] In any of the above embodiments, the mineralized collagen scaffold is preferably prepared using a mineralized collagen solution doped with magnesium and calcium cations.
[0012] Preferably, in any of the above embodiments, the mineralized collagen scaffold has a porous structure.
[0013] Preferably, in any of the above embodiments, the porous structure includes at least one of rhomboid holes, circular holes, triangular holes, and rectangular holes.
[0014] Preferably, in any of the above embodiments, the thickness of the mineralized collagen scaffold is 190-210 μm.
[0015] Preferably, the mineralized collagen scaffold is prepared by low-temperature deposition 3D printing.
[0016] Preferably, in any of the above embodiments, the thickness of the biomimetic mineralization transition film is 39~40μm.
[0017] Preferably, in any of the above embodiments, the thickness of the mineralized collagen bone paste is 0.3-0.6 mm.
[0018] In any of the above embodiments, the mineralized collagen bone paste is shaped by a mold and then placed on the upper side of the biomimetic mineralization transition membrane.
[0019] The fully degradable and regenerated cranial prosthesis prepared based on 3D printed composite materials of this invention has the following beneficial effects:
[0020] 1. The magnesium three-dimensional mesh support provides sufficient mechanical support to ensure the stability of the prosthesis in the early stage of implantation; the mineralized collagen scaffold has good biocompatibility and osteogenic induction ability, which can effectively induce the formation of new bone tissue; the biomimetic mineralized transition membrane can enhance the bonding force between the mineralized collagen scaffold and the mineralized collagen bone paste while simulating the periosteum, and also has osteogenic induction; the mineralized collagen bone paste enables large-area irregular filling of the prosthesis;
[0021] 2. Fully biodegradable material: The prosthesis is made of fully biodegradable material, which does not cause rejection reaction with human tissue and can be completely degraded and absorbed with bone tissue regeneration, without the need for a second surgery to remove it;
[0022] 3. Structural biomimetic design: The prosthesis prepared by 3D printing technology can accurately match the shape and size of the patient's skull defect, while possessing excellent mechanical properties, osteocompatibility and osteointegration performance;
[0023] 4. Functionalization: The prosthesis is doped with magnesium and calcium cations, and the outer layer forms a transition layer that mimics the periosteum through biomimetic mineralization. This not only provides a static osteogenic macroenvironment, but also forms a dynamic osteogenic microenvironment through synergistic degradation, promoting bone tissue regeneration.
[0024] 5. Repair of large-area irregular skull defects: The prosthesis can achieve customized repair of large-area irregular skull defects, and is especially suitable for repairing defects with irregular shapes, thus expanding the application range of skull prostheses. Attached Figure Description
[0025] Figure 1 This is a structural rendering of a preferred embodiment of the fully degradable regenerated cranial prosthesis prepared based on 3D printed composite materials according to the present invention.
[0026] Figure 2 For example, the fully degradable regenerated cranial prosthesis prepared according to the present invention based on 3D printed composite materials... Figure 1 A partial structural diagram of the embodiment shown.
[0027] Figure 3 This is a schematic diagram of the magnesium three-dimensional mesh support and mineralized collagen scaffold structure of another embodiment of the fully degradable regenerated cranial prosthesis based on 3D printed composite materials according to the present invention.
[0028] Figure 4 For example, the fully degradable regenerated cranial prosthesis prepared according to the present invention based on 3D printed composite materials... Figure 3 A schematic diagram of the porous structure of the mineralized collagen scaffold in the embodiment shown. Detailed Implementation
[0029] To better understand this utility model, the following detailed description is provided in conjunction with specific embodiments.
[0030] Example 1
[0031] like Figure 1 and Figure 2As shown, a fully degradable and regenerated cranial prosthesis prepared based on 3D printed composite materials includes: a magnesium three-dimensional mesh support 1' and a mineralized collagen scaffold 2'. The mineralized collagen scaffold 2' fills the gaps of the magnesium three-dimensional mesh support 1' and covers the sides of the magnesium three-dimensional mesh support 1'. A biomimetic mineralized transition membrane 3' is provided on the upper side of the mineralized collagen scaffold 2', and a mineralized collagen bone paste 4' is provided on the upper side of the biomimetic mineralized transition membrane 3'.
[0032] The magnesium three-dimensional mesh support 1' is made of magnesium-calcium alloy and has a thickness of 46-47 μm. The magnesium three-dimensional mesh support 1' comprises at least two layers of magnesium-calcium alloy wires, with the magnesium-calcium alloy wires in each layer arranged in a regular or irregular geometric pattern. In this embodiment, preferably, as shown... Figure 1 As shown, the magnesium three-dimensional mesh support 1' comprises three layers of magnesium-calcium alloy wires. The magnesium-calcium alloy wires in each layer are arranged in parallel, and the magnesium-calcium alloy wires in adjacent layers intersect each other perpendicularly in the arrangement direction. The magnesium three-dimensional mesh support 1' is fabricated by metal 3D printing.
[0033] The mineralized collagen scaffold 2' is prepared using a mineralized collagen solution doped with magnesium and calcium cations. The mineralized collagen scaffold 2' has a porous structure, including at least one of rhomboid, circular, triangular, and rectangular pores. The mineralized collagen scaffold 2' has a thickness of 190-210 μm and is fabricated using low-temperature deposition 3D printing.
[0034] The thickness of the biomimetic mineralization transition film 3' is 39~41μm.
[0035] The mineralized collagen bone paste 4' has a thickness of 0.3-0.6 mm, and after being shaped by a mold, it is placed on the upper side of the biomimetic mineralized transition membrane.
[0036] Example 2
[0037] This embodiment is similar to the previous embodiments, except that, in this embodiment, it is preferred that, as Figure 3 and Figure 4 As shown, the mineralized collagen scaffold 2' has a porous structure, which includes rhomboid pores and circular pores, and the rhomboid pores and circular pores are arranged in a matrix.
[0038] In this embodiment, it is further preferred that, as Figure 3 and Figure 4 As shown, in both the horizontal and vertical directions, a row (column) of rhomboid holes is alternated with a row (column) of circular holes. It should be noted that the porous structure of the mineralized collagen scaffold 2' described in this embodiment is merely illustrative and not a limitation.
[0039] Example 3
[0040] The preparation method of the fully degradable regenerated skull prosthesis based on 3D printed composite materials can refer to the following steps.
[0041] Step 1: Prepare the materials.
[0042] Preparation of metal 3D printing materials: Magnesium-calcium alloy powder is prepared as the raw material for metal 3D printing to form the magnesium three-dimensional mesh support 1'. Magnesium-calcium alloy powder has excellent mechanical properties and biocompatibility, and also has good biodegradability.
[0043] Preparation of low-temperature deposition 3D printing materials: Prepare a mineralized collagen solution doped with magnesium and calcium cations as a raw material for low-temperature deposition 3D printing to form the mineralized collagen scaffold 2'. During the mineralization process, the mineralized collagen solution can achieve the orderly arrangement of hydroxyapatite nanocrystals on collagen, and self-assemble to obtain a biomimetic material with a natural bone layer structure.
[0044] Step 2: Design a skull defect model.
[0045] Spiral CT scans were used to acquire data on the defect sites of patients with skull defects. Three-dimensional reconstruction technology was then used to precisely design skull defect repair models suitable for the patient's defect size. The model design included designing a magnesium three-dimensional mesh support 1' to simulate the compact bone of the skull and a mineralized collagen scaffold 2' to simulate the cancellous bone of the skull.
[0046] As an illustrative example and not a limitation, in this embodiment, the magnesium three-dimensional mesh support 1' is designed with an overall structure of a quarter sphere, with an outer diameter of 1.856 mm, an inner diameter of 1.7632 mm, and a thickness of 46.4 μm, composed of four layers of magnesium-calcium alloy wires; the mineralized collagen scaffold 2' also has an overall structure of a quarter sphere, with an outer diameter of 2 mm, an inner diameter of 1.6 mm, and a thickness of 0.2 mm, and its porous structure adopts... Figure 4 The structure shown has a rhomboid hole with a side length of 100 μm and included angles of 60° and 120° between adjacent sides, respectively. The circular hole has a diameter of 100 μm. Both the rhomboid hole and the circular hole penetrate the mineralized collagen scaffold 2'. The biomimetic mineralized transition membrane 3' is also designed as a 1 / 4 spherical structure with an outer diameter of 2.08 mm, an inner diameter of 2 mm, and a thickness of 40 μm. The mineralized collagen bone paste 4' has a thickness of 0.5 mm.
[0047] Step 3: 3D printing.
[0048] Using a metal 3D printer, magnesium-calcium alloy powder was printed layer by layer according to a designed structure simulating the compact bone of the skull, forming the magnesium three-dimensional mesh support 1'. It should be noted that printing parameters must be strictly controlled during the printing process to ensure the dimensional accuracy and mechanical properties of the magnesium three-dimensional mesh support 1'.
[0049] Within the gaps of the already printed magnesium three-dimensional mesh support 1', a mineralized collagen solution doped with magnesium and calcium cations was printed layer by layer using low-temperature deposition 3D printing technology to form the designed mineralized collagen scaffold 2' that mimics cancellous bone. It should be noted that by adjusting the printing parameters, the porosity and mechanical properties of the mineralized collagen scaffold 2' can be controlled to achieve an ideal effect similar to the structure of natural cancellous bone.
[0050] Step 4: Prepare a biomimetic mineralization transition membrane 3'.
[0051] A biomimetic mineralization transition membrane 3' was prepared on the upper side (i.e., the side closest to the scalp) of the 3D-printed mineralized collagen scaffold 2' using low-temperature deposition. The biomimetic mineralization transition membrane 3' forms a uniform calcium-phosphorus coating of designed thickness on the upper surface of the mineralized collagen scaffold 2' using a biomimetic mineralization deposition method. The coating composition is close to the inorganic matter of human bone, exhibiting good biocompatibility and osteoinductive properties. The biomimetic mineralization transition membrane 3' not only enhances the bonding force between the mineralized collagen scaffold 2' and the mineralized collagen bone paste 4', but also improves the bioactivity and osseointegration capacity of the prosthesis.
[0052] Step 5: Bone plaster shaping and restoration integration.
[0053] Using a mold (such as a crescent-shaped mold), the mineralized collagen bone paste 4' is shaped and then coated onto the upper side of the biomimetic mineralized transition membrane 3' (i.e., the side closest to the scalp). This ensures that the bone paste thickness meets design requirements, and that its shape and size match the bone defect site, while maintaining the structure of the magnesium three-dimensional network support 1'. The integrated prosthesis possesses good mechanical support properties, excellent biocompatibility, and fully degradable characteristics, making it suitable for repairing large-area irregular skull defects.
[0054] Post-treatment of the integrated restoration, such as heat treatment, cleaning, and disinfection, is performed to ensure the sterility and mechanical properties of the restoration.
[0055] It should be noted that the technical solutions of this application involve improvements in hardware and not software. For parts without specified models, any commonly used components in the prior art can be selected without model limitation. For components with specified models in the embodiments, they are only used to illustrate the technical solutions of this application in detail. It should be understood that the technical solutions to be protected by this utility model are not limited to these models, and there are many alternatives to these components in the prior art.
[0056] The above embodiments are only used to illustrate the technical solutions of this utility model, and are not intended to limit it. Although the foregoing embodiments have described this utility model in detail, those skilled in the art should understand that modifications can be made to the technical solutions described in the foregoing embodiments, or equivalent substitutions can be made to some or all of the technical features therein. However, these substitutions do not cause the essence of the corresponding technical solutions to deviate from the scope of the technical solutions of this utility model.
Claims
1. A fully degradable and regenerated cranial prosthesis prepared based on 3D printed composite materials, characterized in that: include: A magnesium three-dimensional mesh support and a mineralized collagen scaffold are provided. The mineralized collagen scaffold fills the gaps of the magnesium three-dimensional mesh support and covers the sides of the magnesium three-dimensional mesh support. A biomimetic mineralization transition membrane is provided on the upper side of the mineralized collagen scaffold, and mineralized collagen bone mud is provided on the upper side of the biomimetic mineralization transition membrane.
2. The fully degradable regenerated cranial prosthesis prepared based on 3D printed composite materials as described in claim 1, characterized in that: The magnesium three-dimensional mesh support is made of magnesium-calcium alloy with a thickness of 46-47 μm.
3. The fully degradable regenerated cranial prosthesis prepared based on 3D printed composite materials as described in claim 2, characterized in that: The magnesium three-dimensional mesh support comprises at least two layers of magnesium-calcium alloy wires, and the magnesium-calcium alloy wires in each layer are arranged in a regular or irregular geometric pattern.
4. The fully degradable regenerated cranial prosthesis prepared based on 3D printed composite materials as described in claim 3, characterized in that: The magnesium-calcium alloy wires in each layer are arranged in parallel, and the magnesium-calcium alloy wires in adjacent layers cross each other in the arrangement direction.
5. The fully degradable regenerated cranial prosthesis prepared based on 3D printed composite materials as described in claim 1, characterized in that: The mineralized collagen scaffold is prepared using a mineralized collagen solution doped with magnesium and calcium cations.
6. The fully degradable regenerated cranial prosthesis prepared based on 3D printed composite materials as described in claim 5, characterized in that: The mineralized collagen scaffold has a porous structure.
7. The fully degradable regenerated cranial prosthesis prepared based on 3D printed composite materials as described in claim 6, characterized in that: The porous structure includes at least one of rhomboid holes, circular holes, triangular holes, and rectangular holes.
8. The fully degradable regenerated cranial prosthesis prepared based on 3D printed composite materials as described in claim 6, characterized in that: The thickness of the mineralized collagen scaffold is 190-210 μm.
9. The fully degradable regenerated cranial prosthesis prepared based on 3D printed composite materials as described in claim 1, characterized in that: The thickness of the biomimetic mineralization transition film is 39–40 μm.
10. The fully degradable regenerated cranial prosthesis prepared based on 3D printed composite materials as described in claim 1, characterized in that: The thickness of the mineralized collagen bone paste is 0.3-0.6 mm.