Layered cranioplasty material and method of making

Abstract

Disclosed are a layered skull repair material and a preparation method thereof, wherein the layered skull repair material comprises a first layer structure and a second layer structure stacked on the first layer structure. The first layer structure is provided with a first structure pattern, and the second layer structure is provided with a second structure pattern, and the first structure pattern and the second structure pattern form at least one micro-pore channel structure. The layered skull repair material improves the biological connection mode between the layered skull repair material and the surrounding tissue through the micro-pore channel structure, so as to optimize the skull defect repair effect of the layered skull repair material. Moreover, the layered skull repair material forms a non-penetrating micro-pore channel structure in a splicing manner, so as to reduce the difficulty in forming the micro-pore channel structure, improve the cleanliness and safety of the layered skull repair material, and improve the connectivity between the pores in the micro-pore channel structure.

Description

Technical Field

[0001] This application relates to the field of biomedical materials, and in particular to layered cranioplasty materials and their preparation methods. Background Technology

[0002] The research and clinical application of implant materials for permanent repair of skull defects have made progress in the past few decades. However, although the materials currently used in clinical practice can achieve physical filling of skull defects and restoration of intracranial pressure, problems such as chronic inflammation and wound ulceration still exist after implantation due to factors such as biocompatibility and bioinertness.

[0003] Titanium alloys, as a representative metallic material, have been used in cranioplasty for many years. However, due to their inherent physicochemical properties, titanium alloys still have some drawbacks in practical applications. For example, titanium alloys have poor thermal insulation properties, making the implanted material more sensitive to changes in external temperature, reducing user comfort; titanium alloys do not allow radiation to pass through, causing artifacts during CT and MRI examinations, affecting the examined structures; the mechanical properties of titanium alloys differ significantly from those of the skull, easily leading to stress shielding; and permanently retained titanium alloys can easily cause infections and rejection, and even complications such as epilepsy.

[0004] Polyaryletherketones (PAGEs) are thermoplastic polymers whose main chain contains benzene rings linked by functional groups such as ethers and ketones. Thanks to their unique molecular structure, PAGEs possess excellent properties. However, due to their excessively stable physicochemical properties and pronounced "bioinertness," implants made of PAGEs struggle to form stable biological connections with surrounding tissues. After implantation, disturbances and friction between the tissue and the implant can lead to wound ulceration and inflammation, causing serious problems.

[0005] Therefore, an optimized implant design is needed to enable implant materials to establish a more stable biological connection with the surrounding tissues. Summary of the Invention

[0006] One advantage of this application is that it provides a layered cranioplasty material, wherein the layered cranioplasty material improves its biological connection pattern with surrounding tissues through structural design optimization, thereby optimizing the cranioplasty defect repair effect of the layered cranioplasty material.

[0007] Another advantage of this application is that it provides a layered cranioplasty material, wherein the layered cranioplasty material establishes a biological connection between the side surface of the layered cranioplasty material and the surrounding soft tissue by providing growth channels for soft tissue ingrowth on its side surface facing the scalp flap soft tissue, thereby avoiding dead space between the two.

[0008] Another advantage of this application is that it provides a layered skull repair material, wherein the application forms a non-penetrating microporous structure by splicing. First, a penetrating channel is formed on one structure, and then it is spliced ​​with another structure to form the microporous structure. This reduces the difficulty of forming the microporous structure, thereby reducing the manufacturing difficulty of the skull repair material.

[0009] Another advantage of this application is that it provides a layered cranioplasty material. Compared with forming the microporous structure by forming non-penetrating blind holes in one structure, this application forms the microporous structure by forming penetrating channels in one structure and generating surface grooves in another structure. The combination of the two ensures the permeability of the channels, which is conducive to the removal of contaminants (such as chips and oil) in the channels, thereby reducing the difficulty of cleaning. It also facilitates the entry of sterilization media (such as alcohol and ethylene oxide), thereby improving the cleanliness and safety of the final implant.

[0010] Another advantage of this application is that it provides a layered cranioplasty material, wherein the layered cranioplasty material forms at least two channels penetrating its upper and lower surfaces in a first main structure, and forms at least one groove corresponding to the at least two channels in the upper part of its second main structure, which can ensure the communication between the at least two channels to improve the connectivity between the channels in the microporous structure. In this way, it helps soft tissue located on one side of the layered cranioplasty material to grow into the microporous structure and form intersecting and connected tissues.

[0011] Another advantage of this application is that it provides a layered cranial repair material, wherein, in some embodiments of this application, at least a portion of the groove in the lower groove of the second main structure extends to the outer periphery of the second main structure, which is conducive to the lateral material exchange of the layered cranial repair material, and can deliver the necessary nutrients to the soft tissue growing on the repair material, thereby promoting soft tissue growth and the establishment of biological connections.

[0012] Other advantages and features of this application will become apparent from the following description and can be realized by means and combinations particularly pointed out in the claims.

[0013] To achieve at least one of the aforementioned advantages, according to one aspect of this application, this application provides a layered cranioplasty material comprising:

[0014] The first layer structure includes a first main structure and a first structural pattern formed on the first main structure; and

[0015] The second layer structure superimposed on the first layer structure includes a second main structure and a second structural pattern formed on the second main structure;

[0016] Wherein, the first structural pattern and the second structural pattern form at least one micropore structure, the upper surface of the first layer structure and the lower surface of the second layer structure respectively form the opposite upper and lower surfaces of the layered cranioplasty material, and each micropore structure includes at least one connecting channel communicating with a first position on the upper surface of the layered cranioplasty material and a second position on the upper surface of the layered cranioplasty material.

[0017] In the layered cranial repair material according to this application, the first structural pattern includes at least two channels, at least two of which penetrate the upper surface of the first layer and the lower surface of the first layer opposite thereto.

[0018] In the layered cranial repair material according to this application, the second structural pattern includes at least one groove recessed downward relative to the upper surface of the second main structure, wherein at least one of the at least one groove corresponds to at least two of the at least two channels to form the at least one connecting channel with the at least two channels.

[0019] In the layered cranial repair material according to this application, the at least two channels include a first channel and a second channel, the first channel and the second channel extending from the upper surface of the first layer structure to the same location on the lower surface of the first layer structure.

[0020] In the layered cranial repair material according to this application, at least one of the at least one grooves is aligned with the first channel and the second channel.

[0021] In the layered cranial repair material according to this application, the first channel extends downward at a first position on the upper surface of the first layer structure, the second channel extends downward at a second position on the upper surface of the first layer structure, the slopes of the first channel and the second channel have opposite signs, and the connecting channel formed by the first channel and the second channel is a V-shaped channel.

[0022] In the layered cranial repair material according to this application, the at least two channels include a first channel and a second channel, the first channel and the second channel extending from the upper surface of the first layer structure to different positions on the lower surface of the first layer structure, and at least one of the at least one grooves is aligned with the first channel and the second channel, and extends between the position of the second layer structure corresponding to the first channel and the position corresponding to the second channel.

[0023] In the layered cranial repair material according to this application, the at least one connecting channel includes a plurality of connecting channels, and at least one of the at least one grooves communicates between at least two of the plurality of connecting channels.

[0024] In the layered cranial repair material according to this application, at least one of the at least one grooves extends from the at least one connecting channel toward the outer periphery of the first body structure.

[0025] In the layered cranial repair material according to this application, the at least two channels include a plurality of channels to form a channel array, and at least one of the at least one grooves corresponds to at least one row of channels in the channel array.

[0026] In the layered cranial repair material according to this application, at least one of the at least one grooves corresponds to at least one column of channels in the channel array.

[0027] In the layered cranial repair material according to this application, the first structural pattern further includes at least one upper groove recessed inward relative to the lower surface of the first main structure, wherein at least one upper groove corresponds to at least two of the at least two channels.

[0028] In the layered cranial repair material according to this application, all the upper grooves in the at least one upper groove are in communication with all the lower grooves in the at least one lower groove.

[0029] According to another aspect of this application, this application provides a method for preparing a layered cranial repair material, which includes: forming a first main structure and a second main structure;

[0030] A first structural pattern is formed in the first main structure to form a first layer structure;

[0031] A second structural pattern is formed in the second main structure to form a second layer structure; and

[0032] The first and second layer structures are spliced ​​together in an overlapping manner to form a layered cranial repair material;

[0033] The upper surface of the first layer structure and the lower surface of the second layer structure respectively form the opposite upper and lower surfaces of the layered cranioplasty material. The first structural pattern and the second structural pattern are adapted to overlap to jointly form at least one micropore structure. Each micropore structure includes at least one connecting channel communicating with a first position on the upper surface of the layered cranioplasty material and a second position on the upper surface of the layered cranioplasty material.

[0034] In the method for preparing the layered cranioplasty material according to this application, forming a first structural pattern on the first main structure to form a first layer structure includes: forming at least two channels in the first main structure that penetrate the upper surface of the first main structure and the lower surface of the first main structure opposite thereto; forming a second structural pattern on the second main structure to form a second layer structure includes: forming at least one groove in the second main structure corresponding to at least two of the at least two channels, the at least one groove being recessed downward relative to the upper surface of the second main structure.

[0035] In the preparation method of the layered cranial repair material according to this application, a first structural pattern is formed on the first main body structure to form a first layer structure, and the method further includes: forming at least one upper groove recessed inward relative to the lower surface of the first main body structure on the first main body structure, wherein at least one upper groove corresponds to at least two channels in the at least two channels, and all the upper grooves in the at least one upper groove are aligned with all the lower grooves in the at least one lower groove.

[0036] The further objectives and advantages of this application will become fully apparent from the following description and accompanying drawings.

[0037] These and other objects, features and advantages of this application are fully apparent from the following detailed description, the accompanying drawings and the claims. Attached Figure Description

[0038] The above and other objects, features, and advantages of this application will become more apparent from the more detailed description of the embodiments of this application in conjunction with the accompanying drawings. The drawings are provided to further illustrate the embodiments of this application and form part of the specification. They are used together with the embodiments of this application to explain this application and do not constitute a limitation thereof. In the drawings, the same reference numerals generally represent the same components or steps.

[0039] Figure 1 The illustration shows a schematic diagram of the application of a layered cranioplasty material according to an embodiment of this application.

[0040] Figure 2 The illustration shows a perspective view of a layered cranial repair material according to an embodiment of this application.

[0041] Figure 3 The illustration shows a partial schematic diagram of a layered cranioplasty material according to an embodiment of this application.

[0042] Figure 4 The illustration shows a partial disassembly diagram of a layered cranioplasty material according to an embodiment of this application.

[0043] Figure 5The illustration shows a partial schematic diagram of a modified embodiment of a layered cranial repair material according to an embodiment of this application.

[0044] Figure 6 The diagram shows Figure 5 The illustration shows a partial disassembly diagram of a layered cranioplasty material according to an embodiment of this application.

[0045] Figure 7 The illustration shows a partial schematic diagram of the upper surface of the first layer structure of the layered cranioplasty material according to an embodiment of this application.

[0046] Figure 8 The illustration shows a partial schematic diagram of the lower surface of the first layer structure of the layered cranioplasty material according to an embodiment of this application.

[0047] Figure 9 The illustration shows a partial schematic diagram of the lower surface of a modified embodiment of the first layer structure of a layered cranioplasty material according to an embodiment of this application.

[0048] Figure 10 The illustration shows a partial schematic diagram of the lower surface of another modified embodiment of the first layer structure of the layered cranioplasty material according to an embodiment of this application.

[0049] Figure 11 The illustration shows a partial schematic diagram of the upper surface of the second layer structure of the layered cranioplasty material according to an embodiment of this application.

[0050] Figure 12 The illustration shows a partial schematic diagram of the upper surface of a modified embodiment of the second layer structure of a layered cranioplasty material according to an embodiment of this application.

[0051] Figure 13 The illustration shows a partial cross-sectional schematic diagram of a layered cranioplasty material according to an embodiment of this application.

[0052] Figure 14 The illustration shows a partial cross-sectional schematic diagram of a modified embodiment of a layered cranioplasty material according to an embodiment of this application.

[0053] Figure 15 The illustration shows a partial cross-sectional schematic diagram of the microporous structure of a layered cranioplasty material according to an embodiment of this application.

[0054] Figure 16 The illustration shows a partial cross-sectional schematic diagram of a modified embodiment of the microporous structure of a layered cranioplasty material according to an embodiment of this application.

[0055] Figure 17 The illustration shows a partial cross-sectional schematic diagram of another modified embodiment of the microporous structure of the layered cranioplasty material according to an embodiment of this application.

[0056] Figure 18 The illustration shows a cross-sectional schematic diagram of the upper groove of a layered cranioplasty material according to an embodiment of this application.

[0057] Figure 19 The illustration shows a schematic diagram of the preparation process of a layered cranioplasty material according to an embodiment of this application.

[0058] Figure 20 The illustration shows another preparation process of a layered cranioplasty material according to an embodiment of this application. Detailed Implementation

[0059] Hereinafter, exemplary embodiments according to this application will be described in detail with reference to the accompanying drawings. Obviously, the described embodiments are merely some embodiments of this application, and not all embodiments of this application. It should be understood that this application is not limited to the exemplary embodiments described herein.

[0060] Application Overview

[0061] The inventors of this application optimize the implant from a structural design perspective to improve its implantation effect, such as the repair effect of skull defects. In this application, by providing channels for tissue growth on the side of the implant facing the scalp flap soft tissue, a bio-connection is established between the side surface of the implant and the surrounding soft tissue (mainly the scalp flap), avoiding dead space between them. It should be understood that due to the presence of these growth channels, the implant can form a bio-connection with the soft tissue, which not only enhances the stability of the implant within the patient's skull but also avoids adverse consequences such as skin ulceration and inflammation caused by repeated tissue stimulation under disturbance and friction due to a lack of organic connection between the implant and the scalp.

[0062] Based on this, the inventors of this application propose an implant with a microporous structure, wherein the microporous structure is formed by multiple non-penetrating channels, at least some of which are interconnected, allowing scalp flap soft tissue located on one side of the implant to grow into the interior of the implant. Furthermore, the soft tissue at various sites of the scalp flap soft tissue connects with each other inside the implant to form intersecting and interconnected tissues. In this way, the implant establishes a biological connection with the soft tissue on its side, thereby avoiding dead space.

[0063] In actual production, multiple non-penetrating channels can be formed by drilling blind holes on one side of a structure, thereby creating a microporous structure. However, the inventors of this application have discovered that this method has many problems. For example, it is difficult to clean and sterilize, the channel permeability is low, the connectivity between channels is limited, and drilling is difficult.

[0064] Specifically, because the channel is a non-penetrating channel—that is, it does not penetrate the upper and lower surfaces of the structure—and because the diameter of the channel is relatively small, the cutting material generated during drilling can easily remain inside the channel. It is difficult to completely remove this material using methods such as compressed air, high-pressure water jetting, or ultrasound. After the implant is placed in the patient's skull, the remaining cutting material inside the channel can easily trigger a rejection reaction, leading to inflammation in the patient and reducing the safety of the implant.

[0065] Because non-penetrating channels are formed by drilling blind holes, it is difficult to ensure that adjacent channels converge and connect with each other, and drilling is very difficult. Channels can only extend into the implant from the drilling side and connect at the convergence point, while there are no channels in other directions. The resulting connecting channels have low permeability, which limits the ingrowth of soft tissue into the implant and the formation of extensive and firm interconnections inside the implant, and has a negative impact on the integration between the implant and the soft tissue.

[0066] Theoretically, to improve penetration and connectivity between channels, channels could be formed through the upper and lower surfaces of the structure. However, from a machining perspective, if a channel penetrates the structure, its length (depth) would be tens to hundreds of times its diameter, far exceeding the drilling depth achievable with current micro-drills; furthermore, it would need to pass through implants with complex curved surfaces, which is impossible with existing drilling equipment. From a medical perspective, channels penetrating the structure could lead to adhesions between the scalp flap soft tissue on the upper surface of the implant and the dura mater soft tissue on the lower surface, or even dura mater ingrowth into the implant. If the implant must be removed due to inflammation or infection, the dura mater, implant, and scalp must be carefully separated without damaging the brain, significantly increasing bleeding and surgical complexity.

[0067] Based on this, this application proposes to form a non-penetrating microchannel structure through splicing. Specifically, firstly, a penetrating channel is formed in one structure, and then it is spliced ​​with another structure to form the microchannel structure. This facilitates the removal of contaminants (e.g., chips, oil stains), reducing cleaning difficulty, while ensuring that sterilization media (e.g., ethylene oxide, 75% alcohol) penetrates deep into the channel structure, improving the cleanliness and safety of the final implant; it also reduces the difficulty of forming the microchannel structure, thereby reducing the manufacturing difficulty of the implant. Furthermore, grooves corresponding to at least two channels can be formed on the upper part of the other structure, ensuring communication between at least two channels and improving the connectivity between the channels in the microchannel structure. Even further, at least a portion of the grooves formed in the other structure extend to the outer periphery of the structure, enhancing the channel permeability, improving the material exchange within the channels, and facilitating the delivery of nutrients to the channels and the implant, thereby ensuring sufficient material supply for soft tissue growth.

[0068] Accordingly, this application proposes a layered cranioplasty material, comprising: a first layer structure and a second layer structure stacked on the first layer structure. The first layer structure includes a first main structure and a first structural pattern formed on the first main structure. The second layer structure includes a second main structure and a second structural pattern formed on the second main structure. The first structural pattern and the second structural pattern form at least one microporous structure. The upper surface of the first layer structure and the lower surface of the second layer structure respectively form the opposing upper and lower surfaces of the layered cranioplasty material. Each microporous structure includes at least one connecting channel communicating between a first position on the upper surface of the layered cranioplasty material and a second position on the upper surface of the layered cranioplasty material.

[0069] This application also proposes a method for preparing a layered cranioplasty material, comprising: forming a first main structure and a second main structure; forming a first structural pattern on the first main structure to form a first layer structure; forming a second structural pattern on the second main structure to form a second layer structure; and splicing the first layer structure and the second layer structure in an overlapping manner to form a layered cranioplasty material; wherein the upper surface of the first layer structure and the lower surface of the second layer structure respectively form the opposing upper and lower surfaces of the layered cranioplasty material, the first structural pattern and the second structural pattern are aligned with each other to form at least one micropore structure, each micropore structure including at least one connecting channel communicating with a first position on the upper surface of the layered cranioplasty material and a second position on the upper surface of the layered cranioplasty material.

[0070] After introducing the basic principles of this application, various non-limiting embodiments of this application will be described in detail below with reference to the accompanying drawings.

[0071] Exemplary layered cranioplasty material

[0072] like Figures 1 to 6 As shown, a layered cranioplasty material 100 according to an embodiment of this application is illustrated, wherein the layered cranioplasty material 100 includes a first layer structure 10 and a second layer structure 20 stacked on the first layer structure 10. The upper surface of the first layer structure 10 and the lower surface of the second layer structure 20 respectively form the opposing upper surface 101 and lower surface 102 of the layered cranioplasty material 100. The first layer structure 10 is provided with a first layer structure pattern 12, and the second layer structure 20 is provided with a second structure pattern 22. The first layer structure pattern 12 and the second structure pattern 22 form at least one microporous structure 30 to establish a bioconnection between the layered cranioplasty material 100 and the soft tissue located on its upper surface 101 side.

[0073] Specifically, in this embodiment, the layered cranioplasty material 100 is adapted to be placed at the defect site of the patient's skull to be repaired, located between the patient's scalp flap soft tissue and dura mater soft tissue. In this embodiment, after the layered cranioplasty material 100 is placed into the patient's skull, the upper surface 101 of the layered cranioplasty material 100 faces the patient's scalp flap soft tissue, and the lower surface 102 of the layered cranioplasty material 100 faces the dura mater soft tissue.

[0074] Preferably, the shape and size of the layered cranioplasty material 100 match the shape and size of the defect in the skull to be repaired, and can be adjusted according to actual application. Furthermore, the layered cranioplasty material 100 has moderate mechanical properties to provide sufficient support, thereby achieving postoperative skull shape integrity. Preferably, the mechanical properties of the layered cranioplasty material 100 are similar to those of the skull to be repaired. The physicochemical properties of the layered cranioplasty material 100 are stable, allowing it to exist stably in the in vivo environment for a long time. Moreover, the layered cranioplasty material 100 has good biocompatibility to safely achieve the physiological integrity of the skull to be repaired.

[0075] In some embodiments of this application, the layered cranioplasty material 100 is made of polyaryletherketone (PAK) material. PAK material includes, but is not limited to, polyetheretherketone (PEEK) and polyetherketoneketone (PEKK) materials. PAK is a type of polymer whose main chain contains benzene rings linked by functional groups such as ethers and ketones. Thanks to this molecular structure, PAK possesses excellent properties and is suitable for use in cranioplasty.

[0076] Specifically, polyaryletherketone (PAGE) has strong plasticity and can be molded into layered cranioplasty material 100 with specific shapes and sizes according to actual applications. In some specific embodiments of this application, the layered cranioplasty material 100 made of PAGE has an arc-shaped surface with a certain curvature to better fit the cranium to be repaired and to make its shape closer to the shape of the damaged cranium. In some embodiments of this application, the layered cranioplasty material 100 can be embedded into the defective part of the cranium to be repaired, such as... Figure 1 As shown, the entire layered cranial repair material 100 corresponds to the gap in the skull to be repaired, avoiding protrusion from the skull to be repaired, which would produce an obvious foreign body sensation and affect the appearance.

[0077] Polyaryletherketone (PAGE) has moderate mechanical properties, which are similar to those of human cortical bone. Specifically, PAGE has an elastic modulus of 3-4 GPa (compared to 7-25 GPa for human cortical bone), low stress shielding risk, and a tensile strength greater than 120 MPa (compared to 50-150 MPa for human cortical bone).

[0078] Polyaryletherketone (PAGE) exhibits stable physicochemical properties, heat resistance, and a solubility of less than 0.1%, allowing it to remain stable in a liquid environment for extended periods. PAGE has good radiation permeability, allowing X-rays to penetrate it. It is non-magnetic and produces no artifacts in computed tomography (CT) or magnetic resonance imaging (MRI), minimizing its impact on imaging analysis. PAGE possesses strong thermal insulation properties, with a thermal conductivity of approximately 0.25 (W / (m·K)), protecting the implanted patient from significant temperature fluctuations caused by changes in external air temperature, thus avoiding discomfort caused by temperature variations ("cold in winter, hot in summer"). PAGE also demonstrates good biocompatibility, with a low likelihood of rejection in the human body, making it suitable for the preparation of permanent bone repair implants.

[0079] It is worth mentioning that, in some embodiments of this application, the layered cranioplasty material 100 may further include protrusions formed on the surface of the layered cranioplasty material 100 or depressions formed on its surface to increase the surface roughness of the layered cranioplasty material 100, thereby increasing its bonding area and bonding stability with soft tissue. Of course, other methods can be used to promote the bonding between the layered cranioplasty material 100 and surrounding tissues, for example, by appropriately reducing the hydrophobicity of the layered cranioplasty material 100 or constructing a bioactive coating on the surface of the layered cranioplasty material 100, which is not limited to this application.

[0080] The inventors of this application have discovered that the connection between the layered cranioplasty material 100 made of polyaryletherketone and the surrounding tissue is such that the soft tissue on one side of the scalp flap and the surface of the layered cranioplasty material 100 form a mechanical overlap similar to surfaces (the two cannot be connected). Furthermore, due to the material properties of polyaryletherketone, it cannot establish a connection with the soft tissue at the biological level, resulting in a dead space between the two.

[0081] Accordingly, the inventors of this application have optimized the layered cranioplasty material 100 from a structural design perspective to improve the cranioplasty defect repair effect of the layered cranioplasty material 100. In this way, a biological connection is established with the surrounding tissues (e.g., scalp flap soft tissue), and the connectivity between the channels in the microporous structure is improved. This helps the soft tissue located on one side of the layered cranioplasty material to grow into the microporous structure and form intersecting and connected tissues.

[0082] Since the soft tissues on both sides of the layered cranioplasty material 100 cannot communicate with each other, in this application, a growth channel for the growth of biological material is provided on the side of the layered cranioplasty material 100 facing the scalp flap soft tissue. This establishes a biological connection between the surface of the layered cranioplasty material 100 and its surrounding soft tissue, avoiding dead space between them. It should be understood that due to the presence of the growth channel, the layered cranioplasty material 100 can form a biological connection with the intracranial soft tissue. This biological connection not only enhances the bonding stability of the layered cranioplasty material 100 within the patient's skull but also improves its bonding affinity within the patient's skull.

[0083] Specifically, the microporous structure 30 is formed by multiple non-penetrating channels, at least some of which are interconnected, allowing the scalp flap soft tissue located on one side of the implant to grow into the interior of the implant. Furthermore, the soft tissue at various sites of the scalp flap soft tissue connects with each other within the implant to form intersecting and interconnected tissues.

[0084] In actual production, multiple non-penetrating channels can be formed by drilling blind holes on one side of a structure, thereby creating a microporous structure 30. However, the inventors of this application have found that this solution has many problems. For example, it is difficult to clean and sterilize, the channel permeability is low, the connectivity between channels is limited, and drilling is difficult.

[0085] Specifically, because the channels are non-penetrating channels—that is, they do not penetrate the upper and lower surfaces of the structure—and because the diameter of the channels is relatively small, the cuttings generated during drilling are easily retained inside the channels, and it is difficult to completely remove them using compressed air, high-pressure water jets, or ultrasound. After the layered cranioplasty material 100 is implanted into the patient's skull, the residual cuttings and other contaminants in the channels can easily trigger rejection reactions, leading to inflammation in the patient and reducing the safety of cranioplasty.

[0086] Because it is formed by drilling blind holes, it is difficult to determine whether adjacent channels intersect or whether the channels are interconnected. Drilling is difficult, and the channels can only connect at the convergence point, resulting in low connectivity. This limits the ingrowth of soft tissue into the implant and the formation of extensive and firm interconnections within the implant, negatively impacting the integration between the implant and the soft tissue.

[0087] Based on this, this application proposes to form a non-penetrating microporous structure 30 by splicing. Specifically, firstly, a penetrating channel is formed in one structure, and then it is spliced ​​with another structure to form the microporous structure 30. This facilitates the removal of contaminants (such as chips and oil stains), reduces cleaning difficulty, improves the cleanliness and safety of the final implant, and facilitates and reduces the difficulty of forming the microporous structure 30, thereby reducing the manufacturing difficulty of the layered cranioplasty material 100, and also improves the permeability of the channel.

[0088] Accordingly, in the embodiments of this application, the layered cranioplasty material 100 is formed by stacking the first layer structure 10 and the second layer structure 20, as shown below. Figure 3 and Figure 4 As shown. The shape and size of the first layer structure 10 and the second layer structure 20 are pre-designed to be stacked to form a layered cranioplasty material 100 with a pre-designed shape. The first layer structure 10 includes a first main structure 11 and a first layer structure pattern 12 formed on the first main structure 11. The second layer structure 20 includes a second main structure 21 and a second structure pattern 22 formed on the second main structure 21. The first layer structure pattern 12 and the second structure pattern 22 form at least one micropore structure 30. Each micropore structure 30 includes at least one connecting channel 31 communicating between a first position on the upper surface 101 of the layered cranioplasty material 100 and a second position on the upper surface 101 of the layered cranioplasty material 100.

[0089] The first layer structure pattern 12 includes at least two channels, at least two of which penetrate the upper surface and the lower surface of the first layer structure 10. The channels may intersect within the first main structure 11 or on the lower surface of the first main structure 11, or they may not intersect within the first main structure 11 or on the lower surface of the first main structure 11. This is not limited to the scope of this application.

[0090] Accordingly, each channel has a first opening formed on the upper surface of the first main body structure 11 and a second opening formed on the lower surface of the first main body structure 11. In some embodiments of this application, at least two channels intersect on the lower surface of the first main body structure 11 through their second openings, thus communicating with each other, such as... Figure 15 and Figure 16 As shown. In other embodiments of this application, at least two channels intersect and communicate with each other within the first main structure 11 through a portion between their first opening and second opening, as shown. Figure 17 As shown. In some other embodiments of this application, at least two channels do not intersect inside the first main structure 11 or on the lower surface of the first main structure 11.

[0091] To ensure connectivity between the channels, in this embodiment, at least one groove corresponding to at least two channels is formed on the upper part of the second main structure 21. Correspondingly, the second structural pattern 22 includes at least one recess 106 recessed downwards relative to the upper surface of the second main structure 21. At least one of the at least two recesses 106 corresponds to at least two of the at least two channels, forming at least one connecting channel 31 with the at least two channels. The connecting channel 31 extends downwards from a first position on the upper surface 101 of the layered cranioplasty material 100 between the lower surface of the first main structure 11 and the upper surface of the second main structure 21, and then upwards to a second position on the upper surface 101 of the layered cranioplasty material 100, thus connecting the first position and the second position of the upper surface 101 of the layered cranioplasty material 100.

[0092] In a specific example of this application, the at least two channels include a first channel 103 and a second channel 104, which extend from the upper surface of the first layer structure 10 to the same location on the lower surface of the first layer structure 10. Specifically, the first channel 103 extends downward at a first position on the upper surface of the first layer structure 10, and the second channel 104 extends downward at a second position on the upper surface of the first layer structure 10. The slopes of the first channel 103 and the second channel 104 are opposite, and the connecting channel 31 formed by the first channel 103 and the second channel 104 is a V-shaped channel. At least one groove 106 is aligned with the first channel 103 and the second channel 104 to ensure communication between the first channel 103 and the second channel 104.

[0093] In another specific example of this application, the first channel 103 and the second channel 104 extend from the upper surface of the first layer structure 10 to different positions on the lower surface of the first layer structure 10, and at least one groove 106 is aligned with the first channel 103 and the second channel 104, and extends between the position of the second layer structure 20 corresponding to the second opening of the first channel 103 and the position corresponding to the second opening of the second channel 104, so as to communicate between the first channel 103 and the second channel 104.

[0094] In some embodiments of this application, every two channels form a connecting channel 31. At least one groove 106 formed in the second main structure 21 connects at least two of the multiple connecting channels 31 to form a network connectivity structure, enabling soft tissue extending into the channels to form a biological tissue network within the layered cranioplasty material 100. The distribution and structural morphology of the channels can be designed to form a network connectivity structure with a specific pattern according to actual needs, allowing soft tissue to form a specific biological tissue network according to a specific pattern. Several specific examples illustrate the structure and distribution of the channels below.

[0095] In some embodiments of this application, each of the microchannel structures 30 includes n channels, where n is a positive integer greater than 2. Preferably, the number of channels is 4 or 6, that is, n is 4 or 6.

[0096] In some specific examples of this application, the n channels in a microchannel structure 30 are symmetrically distributed about the rotation axis l, and the n channels are arranged in a rotational array with a spacing of 360° / n around the rotation axis l set for the n channels. Furthermore, the n channels are interconnected at the same location on the lower surface of the first main body structure 11.

[0097] Each of the aforementioned channels has a diameter of 0.1 mm to 1 mm. Preferably, the diameter (D) of each of the aforementioned channels is greater than or equal to 400 μm to allow materials such as hydrogels and plasma to be contained therein, as well as the growth of vascularized soft tissue. The angle between the channel axis l' of each of the aforementioned channels and the rotation axis l is [insert angle here]. in, The range is greater than 0° and less than 90°. The distance (L) between the intersection of the channel axis l' of each of the n channels and the upper surface 101 of the layered cranioplasty material 100 and the rotation axis l is 1mm-2mm. The thickness (T) of the first layer structure 10 is determined by the structure and distribution of the channels of the microporous structure 30, and the thickness of the first layer structure 10 is less than or equal to the distance between the intersection of the channel axis of any of the n channels and the upper surface 101 of the layered cranioplasty material 100 and the rotation axis multiplied by [the distance]. Right now, The width (K) of each of the lower grooves 106 is greater than or equal to the diameter D of its corresponding channel divided by And it is less than or equal to the diameter D of its corresponding channel, that is, like Figure 18 As shown. The depth of each of the lower grooves 106 is greater than or equal to half of its width and less than or equal to its width.

[0098] In a specific example of this application, each of the micropore structures 30 includes six channels that extend downward from the upper surface of the first main body structure 11 and converge at the same position on the lower surface of the first main body structure 11 and are symmetrically distributed to form a lotus-shaped micropore structure 30.

[0099] In another specific example of this application, each of the micropore structures 30 includes four channels that extend downward from the upper surface of the first main body structure 11 and intersect at the same position on the lower surface of the first main body structure 11 and are symmetrically distributed to form a clover-shaped micropore structure 30.

[0100] In another specific example of this application, each of the micropore structures 30 includes four channels, wherein every two channels extend downward from the upper surface of the first main structure 11 and intersect with each other inside the first main structure 11 to form an X-shaped connecting channel 31.

[0101] In some specific examples of this application, at least two adjacent micropore structures 30 intersect each other through the first opening of the adjacent pores between them, such as... Figure 15 and Figure 17 As shown.

[0102] In some specific examples of this application, the first openings of adjacent channels between two adjacent microchannel structures 30 are spaced apart, such as... Figure 16 As shown.

[0103] In some embodiments of this application, at least one groove 106 formed in the second main body structure 21 extends from the at least one connecting channel 31 toward the outer periphery of the first main body structure 11, and extends to the outer periphery of the first main body structure 11, such as... Figure 12 As shown, this facilitates the establishment of a biological connection between the layered cranial repair material 100 and the soft tissue on one side.

[0104] In this embodiment, the first layer structure pattern 12 includes a plurality of channels to form a channel array, and the second structure pattern 22 includes a plurality of recesses 106. At least one recess 106 corresponds to at least one row of channels in the channel array, and at least one recess 106 corresponds to at least one column of channels in the channel array. The plurality of recesses 106 are distributed crisscrossingly in the second main structure 21, such as... Figure 11 and Figure 12 As shown.

[0105] It is worth noting that, here, "a row of channels" and "a column of channels" refer to two rows of channels with inconsistent extension directions, and do not limit the direction of a row of channels and a column of channels. For example, some channels in a plurality of channels extend in a first extension direction to form a row of channels, and some channels in a plurality of channels extend in a second extension direction at an angle to the first extension direction to form a column of channels. The angle between the first extension direction and the second extension direction can be 90°, 60°, 45°, or other values, and is not limited to this application.

[0106] Accordingly, in a specific example of this application, a portion of the lower groove 106 corresponds to multiple rows of channels extending along a first direction, and another portion of the lower groove 106 corresponds to multiple columns of channels extending along a second direction at a 90° angle to the first direction, with all grooves forming a square groove array.

[0107] In another specific example of this application, a portion of the lower groove 106 forms a square groove array, another portion of the lower groove 106 corresponds to multiple rows of channels extending along a third direction at a first acute angle to the first direction, and yet another portion of the lower groove 106 corresponds to multiple rows of channels extending along a fourth direction at a second acute angle to the first direction, and all the grooves form a star-shaped groove array.

[0108] In some embodiments of this application, the first layer structure pattern 12 further includes at least one upper groove 105 recessed inward relative to the lower surface of the first main body structure 11, the at least one upper groove 105 corresponding to at least two channels in the channel, and all the upper grooves 105 are aligned one-to-one with all the lower grooves 106, such as... Figure 5 , Figure 6 and Figure 14 As shown.

[0109] Accordingly, in a specific example of this application, the upper groove 105 forms a square groove array, such as... Figure 9 As shown. In another specific example of this application, the upper groove 105 forms a star-shaped groove array, as... Figure 10 As shown.

[0110] Of course, in some embodiments of this application, only the second structural pattern 22 has a groove, and the first layer structural pattern 12 does not have a groove; that is, the first layer structural pattern 12 does not include the upper groove 105, such as... Figure 13 As shown. In some other embodiments of this application, only the first layer structural pattern 12 has a groove, while the second structural pattern 22 does not have a groove.

[0111] As previously described, in this embodiment, the layered cranioplasty material 100 is formed by stacking a first layer structure 10 and a second layer structure 20. The specific splicing method of the first layer structure 10 and the second layer structure 20 is not limited to this application. In some embodiments of this application, the first layer structure 10 and the second layer structure 20 are fastened together with screws to achieve the splicing of the first layer structure 10 and the second layer structure 20. Accordingly, the first layer structure 10 has a first threaded hole (e.g., ...). Figure 7 As shown), the second layer structure 20 has a second threaded hole corresponding to the first threaded hole to form a fixing hole 107 for fixing the first layer structure 10 and the second layer structure 20, as shown. Figure 2 As shown. The diameter of the fixing hole 107 is 1mm to 3mm, and the distance between any two adjacent fixing holes 107 is 10mm to 50mm.

[0112] During surgery, it is sometimes necessary to suspend the dura mater. Accordingly, the layered cranioplasty material 100 has through-holes 108 for suspending the dura mater. For example... Figure 2 As shown. The diameter of the through hole 108 is 3mm to 10mm, and the distance between any two adjacent through holes 108 is 10mm to 50mm. The through hole 108 can be formed by creating a first through hole in the first layer structure 10 (e.g., Figure 7As shown in the figure, a second through hole corresponding to the first through hole is formed in the second layer structure 20. In addition, the layered cranioplasty material 100 also has at least one mounting hole located at the edge to provide a mounting position for fixing the layered cranioplasty material 100 to the patient's remaining skull.

[0113] In summary, a layered cranioplasty material 100 based on embodiments of this application is explained. The layered cranioplasty material 100 improves its bio-connection pattern with surrounding tissues through optimized structural design, thereby optimizing the cranioplasty defect repair effect of the layered cranioplasty material 100. Furthermore, this application forms a non-penetrating microporous structure 30 through splicing, reducing the difficulty of forming the microporous structure 30, improving the cleanliness and safety of the layered cranioplasty material 100, and improving the connectivity between the channels in the microporous structure 30.

[0114] Exemplary method for preparing layered cranioplasty material 100

[0115] According to another aspect of this application, a method for preparing a layered cranioplasty material 100 is proposed, comprising: S110, forming a first main structure and a second main structure; S120, forming a first structural pattern on the first main structure to form a first layer structure; S130, forming a second structural pattern on the second main structure to form a second layer structure; and S140, splicing the first layer structure and the second layer structure in an overlapping manner to form a layered cranioplasty material; wherein the upper surface of the first layer structure and the lower surface of the second layer structure respectively form the opposing upper and lower surfaces of the layered cranioplasty material, the first structural pattern and the second structural pattern are aligned with each other to form at least one micropore structure, each micropore structure including at least one connecting channel communicating with a first position on the upper surface of the layered cranioplasty material and a second position on the upper surface of the layered cranioplasty material.

[0116] In step S110, a first main structure 11 and a second main structure 21 are formed. Specifically, as shown... Figure 19 and Figure 20 As shown, firstly, raw materials are laid out, wherein the materials (raw materials) used to manufacture the first main structure 11 and the second main structure 21 are the same. Preferably, the materials used to manufacture the first main structure 11 and the second main structure 21 comprise polyaryletherketone. The materials used to manufacture the first main structure 11 and the second main structure 21 can be powder, flakes, or granules, and are not limited thereto by this application.

[0117] Next, the laid-out material is hot-pressed into shape using a flatbed press, and the hot-pressed material is cooled to obtain the first molded blank and the second molded blank.

[0118] Then, the shape and size of the first main structure 11 and the second main structure 21 are determined. The first main structure 11 and the second main structure 21 have the same shape and size, which can be obtained from the patient's imaging data and model design software. Specifically, CT images of the patient's skull are first acquired, and then imported into model design software to obtain a digital three-dimensional model of the skull repair material. The digital three-dimensional model of the skull repair material is then divided into an upper component model and a lower component model.

[0119] Subsequently, based on the upper component model and the lower component model, the first molding blank and the second molding blank are shaped to obtain a first main structure 11 and a second main structure 21 with preset shapes and preset dimensions. The first main structure 11 and the second main structure 21 have the same shape and size, and the shapes of the first main structure 11 and the second main structure 21 are respectively consistent with the shapes of the upper component model and the lower component model. Specifically, the first molding blank and the second molding blank can be shaped by CNC (Computer Numerical Control) through multi-point forming and / or cutting.

[0120] In step S120, a first structural pattern 12 is formed on the first main structure 11 to form a first layer structure 10. Specifically, during the formation of the first main structure 11, at least two channels are formed on the first main structure 11, penetrating the upper surface of the first main structure 11 and the lower surface of the first main structure 11 opposite thereto.

[0121] First, the model of the channel can be determined by model design software to determine the structural parameters and distribution of the channel. Then, the first main structure 11 is drilled, milled and processed to obtain the channel.

[0122] In some embodiments of this application, at least one upper groove 105 is also formed during the process of forming the first structural pattern 12 in the first main structure 11 to form the first layer structure 10. Specifically, in the process of forming an inwardly recessed upper groove 105 relative to the lower surface of the first main structure 11, at least one upper groove 105 corresponds to at least two of the at least two channels.

[0123] In some embodiments of this application, during the process of forming the first structural pattern 12 in the first main structure 11 to form the first layer structure 10, a first threaded hole for fixing the first layer structure 10 and the second layer structure 20, and a first through hole for suspending the dura mater on the layered cranial repair material 100 are also formed.

[0124] In step S130, a second structural pattern 22 is formed on the second main structure 21 to form a second layer structure 20. Specifically, during the formation of the second main structure 21, at least one groove 106 corresponding to at least two of the at least two channels is formed on the second main structure 21, and the at least one groove 106 is recessed downward relative to the upper surface of the second main structure 21.

[0125] First, the model of the lower groove 106 can be determined by model design software to determine the structural parameters and distribution of the lower groove 106. Then, the second main structure 21 is milled to obtain the lower groove 106.

[0126] In some embodiments of this application, all the upper grooves 105 in the at least one upper groove 105 are aligned with all the lower grooves 106 in the at least one lower groove 106.

[0127] In some embodiments of this application, during the process of forming the second structural pattern 22 in the second main structure 21 to form the second layer structure 20, a second threaded hole for fixing the first layer structure 10 and the second layer structure 20, and a second through hole for suturing the layered cranioplasty material 100 with the scalp flap soft tissue are also formed. The first threaded hole corresponds to the second threaded hole to form a fixing hole 107 for fixing the first layer structure 10 and the second layer structure 20, and the first through hole corresponds to the second through hole to form a through hole 108 for suspending the dura mater.

[0128] In some embodiments of this application, after forming the first layer structure 10 and the second layer structure 20, surface treatment is required for the first layer structure 10 and the second layer structure 20 to improve their compatibility with human tissue. For example, the first layer structure 10 and the second layer structure 20 may be roughened.

[0129] In this embodiment, before splicing the first layer structure 10 and the second layer structure 20, the first layer structure 10 and the second layer structure 20 need to be cleaned and then dried. Since the hole structures such as the channels, first threaded holes, and first through holes of the first layer structure 10, and the hole structures such as the second threaded holes and second through holes of the second layer structure 20 are all through structures, during the cleaning process of the first layer structure 10 and the second layer structure 20, contaminants such as chips and oil can be removed relatively easily, so as to ensure the cleanliness of the final layered cranioplasty repair material 100.

[0130] In step S140, the first layer structure 10 and the second layer structure 20 are spliced ​​together in an overlapping manner to form a layered cranioplasty material 100. Specifically, the first layer structure 10 and the second layer structure 20 are spliced ​​under aseptic conditions. The lower surface of the first layer structure 10 corresponds to the upper surface of the second layer structure 20, and the first structural pattern 12 of the first layer structure 10 and the second structural pattern 22 of the second layer structure 20 are aligned with each other in a specific manner. Thus, the upper surface of the first layer structure 10 and the lower surface of the second layer structure 20 respectively form the opposing upper surface 101 and lower surface 102 of the layered cranioplasty material 100. The first structural pattern 12 and the second structural pattern 22 form at least one micropore structure 30. Each micropore structure 30 includes at least one connecting channel 31 communicating between a first position and a second position of the upper surface 101 of the layered cranioplasty material 100. The micropore structure 30 has been referenced. Figures 1 to 18 The description of the layered cranioplasty material 100 shown is detailed here; therefore, the same description will be omitted.

[0131] In summary, the preparation method of the layered cranioplasty material 100 based on the embodiments of this application has been clarified. The preparation method of the layered cranioplasty material 100 reduces the difficulty of forming the microporous structure 30, improves the cleanliness and safety of the layered cranioplasty material 100, improves the connectivity between the various channels in the microporous structure 30, thereby improving the bio-connection mode between the layered cranioplasty material 100 and the surrounding tissues, and optimizing the cranioplasty defect repair effect of the layered cranioplasty material 100.

[0132] Those skilled in the art should understand that the embodiments of the present invention described above and shown in the accompanying drawings are merely examples and do not limit the present invention. The objectives of the present invention have been fully and effectively achieved. The functions and structural principles of the present invention have been demonstrated and explained in the embodiments, and any variations or modifications may be made to the implementation of the present invention without departing from the stated principles.

Claims

1. A layered cranioplasty material, characterized in that, include: The first layer structure includes a first main structure and a first structural pattern formed on the first main structure; and A second layer structure, wherein the second layer structure is adapted to be stacked on the first layer structure and includes a second main structure and a second structural pattern formed on the second main structure; Wherein, both the first layer structure and the second layer structure are polyaryletherketone substrates, and the first structural pattern and the second structural pattern are adapted to jointly form at least one non-penetrating microporous structure. Each microporous structure includes a connecting channel, and the microporous network covers the entire area of ​​the repair plate. Each connecting channel is laterally connected to form a mesh-like nutrient delivery pathway. The first position and the second position on the upper surface of the layered cranioplasty material are connected through the connecting channel. The upper surface of the first layer structure and the lower surface of the second layer structure respectively form the opposite upper and lower surfaces of the layered cranioplasty material. The connecting channel does not penetrate the lower surface of the layered cranioplasty material. The first structural pattern is at least two channels penetrating the upper and lower surfaces of the first layer structure. The second structural pattern is at least one groove recessed downward relative to the upper surface of the second main structure. The lower ends of the inclined intersecting channels of the first layer are embedded in the corresponding peripherally extended lower grooves of the second layer. The two layers are rigidly fastened together by threaded holes, and at least one of the lower grooves corresponds to the two channels to form at least one connecting channel with the two channels. The microporous structure provides a growth channel for the biological material of the scalp flap soft tissue, so that the soft tissues intersect and connect in the microporous structure to form a biological tissue network, which isolates the dura mater from contact with the scalp flap soft tissue and realizes the biological connection between the repair material and the scalp flap soft tissue.

2. The layered cranioplasty material according to claim 1, wherein, The two channels include a first channel and a second channel, which extend from the upper surface of the first layer structure to the same location on the lower surface of the first layer structure.

3. The layered cranioplasty material according to claim 2, wherein, At least one of the lower grooves is in communication with the first channel and the second channel.

4. The layered cranioplasty material according to claim 3, wherein, The first channel extends downward at a first position on the upper surface of the first layer structure, and the second channel extends downward at a second position on the upper surface of the first layer structure. The slopes of the first channel and the second channel have opposite signs, and the connecting channel formed by the first channel and the second channel is a V-shaped channel.

5. The layered cranioplasty material according to claim 1, wherein, The two channels include a first channel and a second channel, which extend from the upper surface of the first layer structure to different positions on the lower surface of the first layer structure. At least one of the lower grooves communicates with the first channel and the second channel and extends between the positions corresponding to the first channel and the second channel on the second layer structure.

6. The layered cranioplasty material according to claim 1, wherein, At least one of the lower grooves is connected between at least two of the connecting channels.

7. The layered cranioplasty material according to claim 6, wherein, At least one of the lower grooves extends from at least one of the connecting channels toward the outer periphery of the first main structure.

8. The layered cranioplasty material according to claim 6, wherein, The two channels include a plurality of channels to form a channel array, and at least one of the lower grooves corresponds to at least one row of channels in the channel array.

9. The layered cranioplasty material according to claim 8, wherein, At least one of the lower grooves corresponds to at least one column of channels in the channel array.

10. The layered cranioplasty material according to claim 1, wherein, The first structural pattern further includes at least one upper groove recessed inward relative to the lower surface of the first main structure, and at least one of the upper grooves corresponds to the two channels.

11. The layered cranioplasty material according to claim 10, wherein, At least one of the upper grooves is in communication with at least one of the lower grooves.

12. A method for preparing a layered cranioplasty material, characterized in that, include: Forming the first main structure and the second main structure; A first structural pattern is formed in the first main structure to form a first layer structure; A second structural pattern is formed in the second main structure to form a second layer structure; as well as The first and second layer structures are spliced ​​together in an overlapping manner to form a layered cranial repair material; The upper surface of the first layer structure and the lower surface of the second layer structure respectively form the opposite upper and lower surfaces of the layered cranioplasty material. The first structural pattern and the second structural pattern are adapted to overlap to jointly form at least one micropore structure. Each micropore structure includes at least one connecting channel communicating with a first position on the upper surface of the layered cranioplasty material and a second position on the upper surface of the layered cranioplasty material. The connecting channel does not penetrate the lower surface of the layered cranioplasty material. At least two channels are formed in the first main structure, penetrating the upper surface of the first main structure and the lower surface of the first main structure opposite thereto; At least one of the two channels is formed in the second main structure, and the at least one of the lower grooves is recessed downward relative to the upper surface of the second main structure. Before splicing, the first layer structure and the second layer structure are cleaned and sterilized respectively. After splicing, the lower groove and the at least two channels cooperate to form the connecting channel. The microporous structure provides a growth channel for the biological material of the scalp flap soft tissue, so that the soft tissues intersect and connect in the microporous structure to form a biological tissue network, realizing the biological connection between the repair material and the scalp flap soft tissue.

13. The method for preparing the layered cranioplasty material according to claim 12, wherein, The process of forming a first structural pattern in the first main structure to form a first layer structure further includes: At least one upper groove is formed inwardly recessed relative to the lower surface of the first main structure, the at least one upper groove corresponds to at least two of the two channels, and the at least one upper groove communicates with all the lower grooves.

Images