Porous composite scaffold and bone prosthesis

Abstract

A porous composite scaffold comprises a supported component and an elastic assembly formed from polymeric materials having biocompatibility and malleability. Said supported component includes a porous structure and is used for bone tissue growth. Said elastic assembly includes a first elastic component disposed on said supported component and having a plurality of first filament having sinusoidal shape. Said first filaments are orthogonally intertwined to form first sinusoidal filament network structure. This invention also provides a bone prosthesis, comprising said porous composite scaffold, a reconstruction plate and a plate fixed component. Said reconstruction plate is detachably disposed on said porous composite scaffold and includes a protective case and an extension arm assembly. Said porous composite scaffold has good mechanical properties and fits perfectly with a bone to avoid gaps, while said bone prosthesis can disperse stress and has good strength and stability, thus contributing to bone reconstruction.

Description

Technical Field

[0001] The present invention relates to a bone implant, in particular to a porous composite scaffold and a bone prosthesis. Prior Art

[0002] Autologous bone transplantation is considered the "gold standard" for treating bone defects. However, because it requires bone harvesting from the patient, it can cause additional damage and pain to the donor site, increasing recovery time and surgical complexity. Furthermore, the limited size and shape of autologous bone make it inadequate for repairing large bone defects.

[0003] To address the limitations of autologous bone transplants, artificial bone prostheses with complex geometries, customized through additive manufacturing, have become an alternative. Depending on the materials used in additive manufacturing, artificial bone prostheses can be broadly categorized as metal prostheses and polymer prostheses.

[0004] Metal bone prostheses offer excellent biocompatibility and mechanical strength, but there are differences in elastic modulus and relative density between them and native bone. While lattice structure design can reduce the density of metal bone prostheses, giving them a structure closer to the strength and rigidity of human bone, improper lattice design can still lead to stress shielding and absorption of surrounding bone tissue, potentially causing loosening and failure of the prosthesis. Furthermore, while metal prostheses produced using additive manufacturing techniques can provide customized contours, they cannot address the risks of surgical error, resulting in gaps between the metal prosthesis and native bone. Excessive gaps prevent healing between the bone tissue and the metal prosthesis, reduce the stability of the prosthesis, and easily lead to stress concentration in certain areas.

[0005] Polymer bone prostheses have elastic modulus and relative density that are closer to those of native human bone, and also possess excellent properties such as biodegradability, biocompatibility, and ease of processing. However, polymer bone prostheses suffer from insufficient mechanical strength and thus poor load-bearing capacity.

[0006] Based on the above, how to reduce the gap between the bone prosthesis and the native bone while providing a bone prosthesis with mechanical properties more consistent with the requirements of the native bone of the human body is a problem that the industry currently needs to solve. Summary of the Invention

[0007] Therefore, the first object of the present invention is to provide a porous composite scaffold that can reduce the gap between the bone prosthesis and the native bone and provide mechanical properties that meet the requirements of the native bone.

[0008] Therefore, the porous composite scaffold of the present invention is suitable for growth of bone tissue and includes a support member and an elastic component.

[0009] The support component comprises a porous structure and an inner space defined by the porous structure and is used for the growth of the bone tissue.

[0010] The elastic component includes a first elastic member disposed on a side surface of the support member. The first elastic member has a plurality of first silk threads with a sine wave shape, and the first silk threads are orthogonally interwoven to form a first sinusoidal silk network structure.

[0011] The support component and the elastic component are formed of a polymer material with biocompatibility and ductility.

[0012] Furthermore, the second object of the present invention is to provide a bone prosthesis that can reduce the gap between the prosthesis and the native bone and provide mechanical properties that meet the requirements of the native bone.

[0013] Therefore, the bone prosthesis of the present invention comprises a porous composite scaffold as described above, a reconstruction bone plate and a bone plate fixing member.

[0014] The reconstruction bone plate is detachably mounted on the porous composite support and comprises a protective shell and an extension arm assembly. The protective shell is disposed and covers the outer side and bottom of the porous composite support and is formed with a support fixing hole. The extension arm assembly comprises a plurality of extension arms, which are disposed on opposite sides of the protective shell and extend outwardly. Each extension arm is formed with a bone screw fixing hole.

[0015] The bone plate fixing piece is detachably inserted into the fixing hole of the bracket and is used to fix the reconstructed bone plate to the porous composite bracket.

[0016] The present invention's benefits lie in its ability to provide a favorable growth environment for bone tissue and mechanical properties consistent with those required for bone reconstruction. Furthermore, the elastic component allows the porous composite scaffold to conform perfectly to the uneven cross-section of native bone without creating gaps, thereby facilitating bone reconstruction. Furthermore, through the porous composite scaffold, the reconstruction bone plate, and the bone plate fixator, the bone prosthesis can be stably and securely attached to the bone defect area. Furthermore, the combination of the porous composite scaffold and the reconstruction bone plate can disperse stress during bone reconstruction, thereby facilitating the patient's postoperative recovery. Simple diagram description

[0017] Other features and effects of the present invention will be clearly presented in the embodiments with reference to the accompanying drawings, in which: Figure 1 is a perspective exploded view illustrating a bone prosthesis of the present invention; Figure 2 is a perspective schematic diagram illustrating a porous composite stent of the present invention; Figure 3 is a partial perspective schematic diagram illustrating a first elastic member of an elastic component of the porous composite stent; FIG4 is a perspective view illustrating the bone prosthesis installed in the bone defect area of the mandible; and FIG5 is a stress distribution diagram illustrating the stress distribution of the porous composite scaffold at different bone tissue contents. Implementation Method

[0018] Referring to FIG1 , an embodiment of a bone prosthesis 100 of the present invention is suitable for placement in a bone defect area between bones to reconstruct the bone defect area. The bone prosthesis 100 comprises a porous composite scaffold 1 , a reconstruction bone plate 2 , and a bone plate fixing member 3 .

[0019] 2 , the porous composite scaffold 1 is suitable for growth of bone tissue and includes a support member 11 and an elastic component 12 .

[0020] The support member 11 includes a porous structure 111 and an interior space 112 defined by the porous structure 111, which is used to accommodate bone tissue growth. The porous structure 111 of the support member 11 is not particularly limited in its design and can be designed to suit the desired structure based on the location of the bone defect, the bone reconstruction requirements, and the manufacturing method of the support member 11. In other words, the design of the porous structure 111 can impart different physical properties to the support member 11. For example, parameters such as the pore size, porosity, and thickness of the porous structure 111 can be adjusted based on the desired growth environment of the bone tissue. In some embodiments of the present invention, the bone prosthesis 100 is used for mandibular reconstruction. Therefore, the porous structure 111 of the support member 11 is designed based on the mandibular environment, thereby imparting the support member 11 with the strength required to withstand occlusal forces.

[0021] The shape of the internal space 112 of the support member 11 is not particularly limited and varies depending on the design of the porous structure 111. During bone reconstruction, the internal space 112 defined by the porous structure 111 facilitates the transport of cells, blood, and nutrients required for bone reconstruction within the support member 11. It also allows for the filling of the patient's autologous bone marrow, thereby promoting the growth of bone tissue and the generation of surrounding blood vessels and nerves, significantly improving the success rate of bone reconstruction. In other words, the internal space 112 can provide an environment suitable for bone growth.

[0022] The elastic component 12 includes a first elastic member 121 disposed on a side surface of the support member 11. The first elastic member 121 has a plurality of first sine-wave-shaped threads 122, which are interwoven orthogonally to form a first sinusoidal thread network structure. Specifically, referring to FIG3 , the first sinusoidal thread network structure is formed by repeatedly arranging a plurality of first threads 122 parallel to an X-direction, a plurality of first threads 122 parallel to a Y-direction, and a plurality of first threads 122 parallel to a Z-direction. The first threads 122 parallel to any two directions are interwoven orthogonally to each other, thereby constructing a three-dimensional structure. In some embodiments of the present invention, the distance between two adjacent vertical or horizontal intersections formed by the orthogonal intersection of the first threads 122 parallel to any two directions is a complete sinusoidal waveform. The first sinusoidal filament network structure can impart elasticity to the first elastic member 121, so that when the porous composite scaffold 1 is installed in a bone defect area defined by an uneven cross-section of native bone, the first elastic member 121 is compressed inwardly to transform the porous composite scaffold 1 from a state in which the volume is larger than the bone defect area to a state in which the volume is smaller than the bone defect area. After the porous composite scaffold 1 is placed in the bone defect area with the first elastic member 121 facing the uneven cross-section of the native bone, the first elastic member 121 rebounds and expands toward the uneven cross-section of the native bone, allowing the porous composite scaffold 1 to completely conform to the uneven cross-section of the native bone, thereby preventing a gap from forming between the porous composite scaffold 1 and the native bone.

[0023] 3 , in the first sinusoidal filament network structure, the periods Xp, Yp, and Zp and the amplitudes Xa, Ya, and Za of the sinusoidal wave shape of each first filament 122 are not particularly limited. It should be noted that the period and amplitude of the sinusoidal wave shape affect the elastic modulus of the first elastic member 121. Therefore, the period and amplitude of the sinusoidal wave shape can be arbitrarily adjusted as needed to obtain a desired first elastic member 121.

[0024] Referring to FIG. 2 , in some embodiments of the present invention, the elastic element 12 further includes a second elastic member 123. The second elastic member 123 is disposed on the other side of the support member 11, and the second elastic member 123 and the first elastic member 121 sandwich the support member 11. Referring to FIG. 2 and FIG. 3 , and regarding the first wire 122 in FIG. 3 as the second wire 124, the second elastic member 123 comprises a plurality of second wires 124 having a sinusoidal wave shape. These second wires 124 are orthogonally interwoven to form a second sinusoidal wire network structure. This second sinusoidal wire network structure is similarly formed by repeatedly arranging a plurality of second wires 124 parallel to an X-direction, a plurality of second wires 124 parallel to a Y-direction, and a plurality of second wires 124 parallel to a Z-direction. The second wires 124 parallel to any two directions are orthogonally interwoven to form a three-dimensional structure. The period and amplitude of the sinusoidal wave shape of each second wire 124 are not particularly limited and can be arbitrarily adjusted according to the desired elastic modulus. The second sinusoidal wire network structure can impart elasticity to the second elastic member 123. Therefore, when the porous composite scaffold 1 is installed in the bone defect area, the first elastic member 121 and the second elastic member 123 are compressed inwardly to transform the porous composite scaffold 1 from a state larger than the bone defect area to a state smaller than the bone defect area. After the porous composite scaffold 1 is placed in the bone defect area with the first elastic member 121 and the second elastic member 123 facing the uneven cross-section of the native bone, the first elastic member 121 and the second elastic member 123 rebound and expand toward the uneven cross-section of the native bone, respectively, so that both sides of the porous composite scaffold 1 can fully conform to the uneven cross-section of the native bone, thereby more effectively avoiding the formation of a gap between the porous composite scaffold 1 and the native bone.

[0025] Referring to FIG. 2 , in some embodiments of the present invention, the porous composite scaffold 1 further includes a side plate assembly 13 . The side plate assembly 13 comprises a first annular side plate 131 disposed on a side surface of the first elastic member 121 . The first annular side plate 131 and the support member 11 sandwich the first elastic member 121 . The first annular side plate 131 is designed to interface with the cortical bone of the native bone. The surface of the first annular side plate 131 in contact with the cortical bone is flat, thereby reducing friction between the porous composite scaffold 1 and the native bone, thereby preventing damage to the porous composite scaffold 1 from the native bone. The width W of the first annular side plate 131 is not particularly limited and can be adjusted to the thickness of the cortical bone of the native bone, so that the first annular side plate 131 can contact the cortical bone.

[0026] Referring again to Figure 2 , in some embodiments of the present invention, the side plate assembly 13 further includes a second annular side plate 132 disposed on a side surface of the second elastic member 123 . The second annular side plate 132 and the support member 11 sandwich the second elastic member 123 . This second annular side plate 132 is also used to interface with the cortical bone of the native bone. The surface of the second annular side plate 132 in contact with the cortical bone is also flat, thereby helping to reduce friction between the porous composite scaffold 1 and the native bone. The width of the second annular side plate 132 is not particularly limited and can be adjusted to the thickness of the cortical bone of the native bone, so that the second annular side plate 132 can correspond to the cortical bone.

[0027] In the present invention, the support member 11, the elastic element 12, and the side plate element 13 are all formed from a biocompatible and ductile polymer material. In some embodiments of the present invention, the polymer material is selected from polymers that are biocompatible and ductile and can be used in additive manufacturing techniques. In some embodiments of the present invention, the polymer material is selected from one of polycaprolactone (PCL) and thermoplastic polyurethane (TPU).

[0028] In the present invention, when the porous composite scaffold 1 includes the support member 11 and the elastic component 12, the support member 11 and the elastic component 12 are integrally formed. Alternatively, when the porous composite scaffold 1 includes the support member 11, the elastic component 12, and the side plate component 13, the support member 11, the elastic component 12, and the side plate component 13 are integrally formed. More specifically, the support member 11 and the elastic component 12, or the support member 11, the elastic component 12, and the side plate component 13, are integrally formed using a single type of polymer material using a laminated manufacturing technique, thereby obtaining the porous composite scaffold 1. It should be noted that the use of an integral molding method to form the porous composite scaffold 1 increases the overall structural strength of the porous composite scaffold 1, thereby enabling the porous composite scaffold 1 to have a density and strength closer to that of native bone.

[0029] Referring to Figures 1 and 2 , in some embodiments of the present invention, when the bone prosthesis 100 is used for mandibular reconstruction, three pre-reserved holes 113 are formed on the top of the support member 11 for use in dental implant-related procedures after bone reconstruction is completed. The porous composite scaffold 1 also includes three dust covers 14 corresponding to the pre-reserved holes 113 to prevent soft tissue from growing into the pre-reserved holes 113 during bone reconstruction, thereby affecting subsequent dental implant-related procedures. It should be noted that the number of pre-reserved holes 113 and dust covers 14 is not limited to three; the number of pre-reserved holes 113 and dust covers 14 can also be one, two, or more than four, and can be adjusted based on actual needs. Furthermore, the diameter and shape of the pre-reserved holes 113 are not particularly limited and can be adjusted based on the specifications of the dental implant.

[0030] 1 , the reconstruction bone plate 2 is detachably mounted on the porous composite scaffold 1 and includes a protective shell 21 and an extension arm assembly 22 , and is used to stably fix the porous composite scaffold 1 to the native bone, thereby facilitating the reconstruction of the bone defect area.

[0031] Referring to Figures 1 and 4 , the protective shell 21 is positioned to cover the outer side and bottom of the porous composite scaffold 1 and is formed with a scaffold fixing hole 211. The surface of the protective shell 21 in contact with the porous composite scaffold 1 is fully conformable to the porous composite scaffold 1, allowing the bone prosthesis 100 to better conform to the contours of the native bone. In other words, the overall shape of the protective shell 21 is designed based on the surface of the porous composite scaffold 1 and the appearance of the native bone. Furthermore, the protective shell 21 covering the outer side and bottom of the porous composite scaffold 1 provides support in two directions, ensuring good stability. It should be noted that when the bone prosthesis 100 is used for mandibular reconstruction, the protective shell 21 can also be used to resist loads caused by occlusal forces. The scaffold fixing hole 211 is designed to cooperate with the bone plate fixing member 3 to secure the reconstruction bone plate 2 to the porous composite scaffold 1. The diameter of the bracket fixing hole 211 is not particularly limited and can be adjusted arbitrarily according to the size of the bone plate fixing member 3. The number of the bracket fixing hole 211 is not limited to one and can be adjusted to multiple according to actual needs.

[0032] Referring to Figure 1 , the extension arm assembly 22 comprises four extension arms 221 disposed on opposite sides of the protective shell 21 and extending outward. Each extension arm 221 is formed with three bone screw fixing holes 222. The extension arm assembly 22 is designed to cooperate with the protective shell 21 to securely attach the porous composite scaffold 1 to the bone defect area. The extension arms 221 are designed to cover and conform to the surface of the native bone. Through the bone screw fixing holes 222 of each extension arm 221, the bone prosthesis 100 can be fixed to the native bone. The shape of the extension arms 221 is not particularly limited and can be adjusted to suit the surface morphology of the native bone. The number of extension arms 221 is not limited to four; it can also be one, two, three, or five or more, and can be adjusted to meet actual needs. The number of the bone screw fixing holes 222 on each extension arm 221 is not limited to three. The number of the bone screw fixing holes 222 can also be one, two, or more than four, which can be adjusted according to mechanical requirements. There is no special restriction on the aperture size and shape of the bone screw fixing holes 222, and they can be adjusted arbitrarily according to the specifications of the bone screw.

[0033] In the present invention, the protective shell 21 and the extension arm assembly 22 are integrally formed. Forming the reconstruction bone plate 2 in an integral manner allows the reconstruction bone plate 2 to better resist external forces. In some embodiments of the present invention, when the bone prosthesis 100 is used for mandibular reconstruction, the integrally formed reconstruction bone plate 2 can also effectively resist loads caused by occlusal forces.

[0034] In some embodiments of the present invention, the reconstruction bone plate 2 is formed from a biocompatible laminated material selected from metal, ceramic, and polymer. In one embodiment, the laminated material is metal. In some embodiments of the present invention, the protective shell 21 and the extension arm assembly 22 are integrally formed using a single type of laminated material and laminated manufacturing technology to obtain the reconstruction bone plate 2.

[0035] In the present invention, because the reconstruction bone plate 2 is detachably mounted on the porous composite scaffold 1, if a patient experiences complications related to the reconstruction bone plate 2, only the reconstruction bone plate 2 can be removed and replaced, thereby avoiding disruption to the porous composite scaffold 1 during bone integration. Furthermore, once healing between the porous composite scaffold 1 and the native bone is complete, the reconstruction bone plate 2 can be preventively removed, thereby reducing the amount of artificial implants in the patient's body and, in turn, minimizing the potential risks posed by the reconstruction bone plate 2.

[0036] Referring to Figures 1 and 4 , the bone plate fixing member 3 is removably inserted through the bracket fixing hole 211 and is used to secure the reconstructed bone plate 2 to the porous composite bracket 1. The bone plate fixing member 3 is not particularly limited; any fixing element capable of securing the reconstructed bone plate 2 to the porous composite bracket 1 is suitable for use in the present invention. In some embodiments of the present invention, the bone plate fixing member 3 is selected from screws. The number of bone plate fixing members 3 is not limited to one; the number of bone plate fixing members 3 may also be multiple, and can be adjusted accordingly based on the number of bracket fixing holes 211.

[0037] On the other hand, the overall appearance and shape of the bone prosthesis 100 of the present invention are based on the patient's actual bone defect area. Medical imaging techniques, such as computed tomography (CT) or magnetic resonance imaging (MRI), are used to create a 3D model that matches the patient's bone contours. This 3D model is then used in conjunction with additive manufacturing techniques to produce the porous composite scaffold 1 and the reconstruction bone plate 2 that conform to the bone contours. Both the porous composite scaffold 1 and the reconstruction bone plate 2 are integrally formed. Consequently, the bone prosthesis 100 is not only highly resistant to external loads, but also, because its shape conforms to the patient's native bone, installation of the bone prosthesis 100 eliminates the need for additional tapping, striking, bending, breaking, jagged edges, or abrasion to ensure the plate 2 conforms to the porous composite scaffold 1 and the native bone. This makes bone reconstruction surgery more convenient and faster, and helps restore the integrity of the patient's appearance after surgery.

[0038] To further illustrate the bone prosthesis 100, the present invention selects the more complex mandibular environment as an example. This is because, in addition to considering load-bearing conditions, the mandibular environment also requires consideration of the patient's postoperative occlusal ability and restoration of facial aesthetics. Furthermore, consideration must be given to subsequent implant-related requirements. Therefore, using the mandibular environment as an example demonstrates the comprehensiveness and versatility of the bone prosthesis 100 of the present invention.

[0039] Referring to FIG. 4 , in this embodiment, the present invention establishes a simulated environment that approximates real human occlusal conditions and explores the effectiveness and risks of the mandibular bone prosthesis 100 in resisting occlusal forces under conditions of varying degrees of bone tissue growth.

[0040] First, bone tissue of a specific thickness was expanded in all directions within the porous composite scaffold 1 to create multiple models with varying degrees of bone ingrowth. Then, to simulate a realistic occlusal environment, the temporomandibular joint was restricted in all directions, and a bite force was applied to the tooth area. The bite force load was set to 150 Newtons, the force required for daily human feeding. Finally, finite element analysis (FEA) was performed on these models to assess the effectiveness and risks of the mandibular bone prosthesis 100 in resisting occlusal forces. The results are shown in Tables 1 to 4 and Figure 5. Bone volume fraction (BVF) indicates bone tissue growth; a higher BVF indicates a higher bone tissue content.

[0041] Table 1 Bone volume fraction 0 0.13 0.26 0.38 0.50 0.61 Strain energy (mJ) Bone prosthesis and mandible 17.958 5.485 4.231 3.460 3.076 2.747 Reconstruction bone plate 4.122 1.021 0.678 0.365 0.257 0.147 Porous composite scaffold 10.608 1.887 1.411 1.165 0.983 0.823 bone nails 0.099 0.043 0.027 0.018 0.015 0.013 mandible 2.897 2.410 2.010 1.820 1.737 1.687

[0042] Table 2 Bone volume fraction 0 0.13 0.26 0.38 0.50 0.61 Average equivalent stress (MPa) Reconstruction bone plate 7.479 3.337 2.716 2.036 1.718 1.336 bone nails 1.291 0.895 0.746 0.646 0.601 0.561 cortical bone 0.906 0.759 0.606 0.518 0.474 0.442 cancellous bone 0.441 0.328 0.265 0.230 0.213 0.200 Support 0.429 0.509 0.561 0.592 0.626 0.648 Elastic components 0.052 0.137 0.294 0.424 0.510 0.536

[0043] Table 3 Bone volume fraction 0 0.13 0.26 0.38 0.50 0.61 Total deformation (mm) Reconstruction bone plate 0.347 0.098 0.068 0.051 0.045 0.040 bone nails 0.087 0.062 0.046 0.041 0.038 0.036 Support 0.524 0.115 0.078 0.057 0.049 0.043 Elastic components 0.516 0.115 0.077 0.056 0.047 0.040 cortical bone 0.109 0.082 0.061 0.050 0.044 0.040 cancellous bone 0.098 0.075 0.057 0.047 0.042 0.038

[0044] Table 4 Bone volume fraction 0 0.13 0.26 0.38 0.50 0.61 Maximum equivalent stress (MPa) Reconstruction bone plate 309.140 229.820 203.950 133.210 104.530 59.917 bone nails 129.850 149.540 149.120 97.875 80.075 78.762

[0045] Table 5 Bone volume fraction 0.13 0.26 0.38 0.50 0.61 Stress distribution threshold (MPa) Support 1.08 1.92 2.67 3.30 4.17 Elastic components 0.22 0.94 1.56 2.33 3.95

[0046] As shown in Table 1, the strain energy of the porous composite scaffold 1 and the reconstruction bone plate 2 in the bone prosthesis 100 decreases with the increase in bone tissue, indicating that the bone prosthesis 100 helps reduce the risk of material failure in the mandibular reconstruction system. As shown in Table 2, the average equivalent stress of the reconstruction bone plate 2 decreases significantly with the increase in bone tissue, indicating that the increase in bone tissue can effectively reduce the stress burden of the reconstruction bone plate 2. The average equivalent stress of the support member 11 and the elastic component 12 increases with the increase in bone tissue, indicating that the structural design of the porous composite scaffold 1 and the increase in bone tissue facilitate positive stress distribution. As shown in Table 3, the total deformation of the support member 11, the elastic component 12, and the reconstruction bone plate 2 all shows a significant downward trend in the early stages of bone tissue growth, and gradually converges in the later stages of bone tissue growth. Referring to Table 4, under normal occlusal conditions, the maximum equivalent stress of the reconstruction bone plate 2 is consistently well below the yield strength of the Ti6Al4V material, indicating that the reconstruction bone plate 2 has a low risk of material failure. Referring to Figure 5 and Table 5, in the stress distribution diagram of Figure 5, green indicates areas where the equivalent stress exceeds the yield strength, and blue indicates areas where the equivalent stress is less than the yield strength. Under normal occlusal conditions, the equivalent stress of the support member 11 and the elastic component 12 exceeding the yield strength is most pronounced during the initial implantation of the bone prosthesis 100. However, as bone tissue grows, the stress distribution threshold of the support member 11 and the elastic component 12 also increases, indicating that stress concentration gradually decreases. Furthermore, the equivalent stress of most areas of the support member 11 and the elastic component 12 is less than the yield strength. This indicates that under the premise of stable bone tissue growth, the use of the bone prosthesis 100 can reduce the risk of material failure and fatigue, thereby meeting the patient's daily needs after surgery.

[0047] As shown in Tables 1 through 4, Figure 5, and the results in Table 5, the bone prosthesis 100 of the present invention significantly contributes to mandibular reconstruction, particularly in restoring the patient's postoperative occlusal function. With the steady growth of bone tissue, the strength, rigidity, and stability of the bone prosthesis 100 gradually increase, allowing the patient to gradually regain normal occlusal function after surgery.

[0048] In summary, the porous composite scaffold 1 of the present invention, through the combination of the support member 11 and the elastic component 12, particularly the support member 11, can provide a favorable growth environment for bone tissue and mechanical properties that meet the requirements of bone reconstruction. Furthermore, the design of the elastic component 12 allows the porous composite scaffold 1 to completely conform to the uneven cross-section of the native bone, thereby preventing gaps between the porous composite scaffold 1 and the native bone. Furthermore, the support member 11 and the elastic component 12 are integrally formed from a biocompatible and ductile polymer material. Therefore, the porous composite scaffold 1 has a high overall structural strength and a density and strength close to that of native bone, thus facilitating bone reconstruction. Furthermore, the bone prosthesis 100 of the present invention, through the porous composite scaffold 1, the reconstruction bone plate 2, and the bone plate fixing member 3, can be stably and securely attached to the bone defect area. Furthermore, the combination of the porous composite scaffold 1 and the reconstruction bone plate 2 can disperse stress during bone reconstruction, thereby facilitating the patient's postoperative recovery, thereby effectively achieving the objectives of the present invention.

[0049] However, the above is merely an embodiment of the present invention and should not be used to limit the scope of implementation of the present invention. All simple equivalent changes and modifications made according to the scope of the patent application and the content of the patent specification of the present invention are still within the scope of the patent of the present invention.

[0050] 100: Bone prosthesis 1:Porous composite scaffold 11: Support 111: porous structure 112: Interior Space 113: Reserved hole 12: Elastic components 121: first elastic member 122: The First Thread 123: Second elastic member 124: Second Thread 13: Side panel assembly 131: first annular side plate 132: Second annular side plate 14: Dust cover 2: Reconstruction of bone plate 21: Protective shell 211: Bracket fixing hole 22: Extension arm assembly 221: Extension arm 222: Fixation hole for bone screw 3: Bone plate fixation X p, Y p, Z p: Period of the sine wave shape Xa, Ya, Za: Amplitude of the sine wave shape W: Ring width

Claims

1. A porous composite scaffold suitable for growth of bone tissue, comprising: a support member, including a porous structure and an internal space defined by the porous structure, and used for growth of the bone tissue; and an elastic component, including a first elastic member disposed on a side of the support member, the first elastic member having a plurality of first filaments having a sine wave shape, the first filaments being orthogonally interwoven to form a first sinusoidal filament network structure; wherein, The support member and the elastic component are formed of a polymer material with biocompatibility and ductility.

2. The porous composite bracket as described in claim 1 also includes a side plate assembly, which includes a first annular side plate arranged on a side of the first elastic member, and the first annular side plate and the support member clamp the first elastic member, and the side plate assembly is formed by the polymer material.

3. The porous composite scaffold according to claim 2, wherein: The elastic component also includes a second elastic member, which is arranged on the other side of the support member, and the second elastic member and the first elastic member clamp the support member. The second elastic member has a plurality of second silk threads with a sine wave shape, and the second silk threads are orthogonally interwoven with each other to form a second sinusoidal silk network structure.

4. The porous composite scaffold according to claim 3, wherein: The side plate assembly also includes a second annular side plate disposed on a side surface of the second elastic member, and the second annular side plate and the supporting member sandwich the second elastic member.

5. The porous composite scaffold according to any one of claims 2 to 4, wherein: The support member and the elastic component are integrally formed, or the support member, the elastic component and the side plate component are integrally formed.

6. The porous composite scaffold according to claim 1, wherein: The polymer material is selected from one of polycaprolactone and thermoplastic polyurethane.

7. The porous composite scaffold according to claim 1, wherein: A reserved hole is formed on the top of the support member, and the porous composite bracket also includes a dust cover arranged on the reserved hole.

8. A bone prosthesis, comprising: a porous composite scaffold as described in any one of claims 1 to 7; a reconstructed bone plate, detachably disposed on the porous composite scaffold, and including a protective shell, disposed and covering the outer side and bottom of the porous composite scaffold and forming a scaffold fixing hole, and an extension arm assembly, having a plurality of extension arms, the extension arms being disposed on opposite sides of the protective shell and extending outward, and each extension arm forming a fixing hole for a bone screw; and a bone plate fixing member, detachably inserted into the scaffold fixing hole, and used to fix the reconstructed bone plate to the porous composite scaffold.

9. The bone prosthesis according to claim 8, wherein: The reconstruction bone plate is formed of a biocompatible laminated material, and the laminated material is selected from metal, ceramic and polymer.

10. The bone prosthesis according to claim 8, wherein: The protective shell and the extension arm assembly are integrally formed.

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