Craniomaxillofacial bone plate, manufacturing equipment and manufacturing method

Abstract

The present invention discloses a craniomaxillofacial plate, a manufacturing device and a manufacturing method. The craniomaxillofacial plate includes a plate, a screw and an anti-falling component. The plate includes a plate body, the plate body is composed of a strength component arranged inside and a protective layer arranged outside, and a plurality of mounting holes are provided on the plate body; the screw includes a screw body, the screw body is provided with a plurality of screw bodies, and a plurality of the screw bodies are threadedly connected in the plurality of the mounting holes. The plate provided by the present invention is composed of an inner stainless steel plate and an outer protective layer, the protective layer is a titanium alloy layer and a polymer biomaterial layer arranged on both sides of the stainless steel plate, so that the plate has good strength. At the same time, after the plate is installed, the side in contact with the bone is set as a titanium alloy layer, and the side in contact with the human tissue is set as a polymer biomaterial layer, which can avoid rejection between the plate and the human body and help the recovery of the fracture site of the patient.

Description

Technical Field

[0001] The invention belongs to the technical field of craniomaxillofacial bone fracture plates, and in particular relates to a craniomaxillofacial bone fracture plate, a manufacturing device and a manufacturing method. Background Art

[0002] The craniomaxillofacial plate is used to fix the fracture site after facial fracture, and is also used to correct craniomaxillofacial deformities. When in use, the plate is fixed to the bone with screws, so that the bone at the fracture site can be fixed through the plate, which helps prevent skeleton deformation and maintain the stability of the fracture.

[0003] The existing craniomaxillofacial plates cannot balance stability when fixed with screws. When the screws are made of stainless steel, the screws are easy to disassemble and assemble, making it convenient to disassemble and assemble the plates. However, the stainless steel screws are easy to fall off during use, which will lead to secondary operations. When the screws are made of pure titanium, pure titanium has good biocompatibility. Therefore, after installation, the screws are easy to fuse with the bones, making it difficult to remove the plates. At the same time, when installing the existing craniomaxillofacial plates, medical staff need to bend the plates according to the actual installation situation to facilitate the fitting of the plates to the patient's fracture site. However, this operation not only prolongs the operation time, but also the matching degree between the plates and the patient's fracture site is poor, resulting in discomfort for the patients after surgery.

[0004] The information disclosed in this background technology section is only intended to enhance the understanding of the overall background of the invention and should not be regarded as an acknowledgment or any form of suggestion that the information constitutes the prior art already known to a person skilled in the art. Summary of the invention

[0005] The object of the present invention is to provide a craniomaxillofacial bone plate, a manufacturing device and a manufacturing method, which can solve the problems that the stability of the bone plate after installation is difficult to control and the intraoperative manufacturing leads to a long operation time.

[0006] In order to achieve the above object, a technical solution provided by a specific embodiment of the present invention is as follows:

[0007] A craniomaxillofacial bone plate, comprising:

[0008] A bone fracture plate comprises a bone fracture plate body, wherein the bone fracture plate body is composed of a strength component arranged inside and a protective layer arranged outside. The strength component and the protective layer form the bone fracture plate body, so that the bone fracture plate body has sufficient strength when in use and avoids the problem of rejection between the bone fracture plate body and the patient. The bone fracture plate body is provided with a plurality of mounting holes, and the plurality of mounting holes are used to mount and fix the bone fracture plate body to ensure the stability of the bone fracture plate body after installation.

[0009] The screw comprises a screw body, wherein a plurality of the screw bodies are provided, and the plurality of the screw bodies are threadedly connected to the plurality of the mounting holes. The bone plate body can be fixed to the fracture site through the cooperation of the screw body and the mounting holes. At the same time, the screw body and the mounting holes are threadedly connected so that the screw bodies will not be displaced from each other when they are installed on the mounting holes, so that the bone plate body and the screw body are locked with each other to form a whole, thereby forming an internally implanted fracture fixation bracket, and the biological stress borne by the bone block will be directly transmitted to the bone plate body through the screw body.

[0010] The anti-dropping assembly includes an anti-dropping capsule, wherein a plurality of the anti-dropping capsules are provided, and the plurality of the anti-dropping capsules are respectively provided in a plurality of mounting holes. Since the strength of the screw body can be ensured when the screw body is made of stainless steel, the problem of easy drop-off occurs after installation. When the screw body is made of pure titanium, the drop-off between the two can be avoided, but the problems of low strength and difficulty in disassembly occur after installation. Therefore, in order to solve the actual problems of the screw body, an anti-dropping capsule is provided so as to solve the problem of easy drop-off of the screw body after installation.

[0011] In one or more embodiments of the present invention, the strength component of the plate body is a blank block, and the blank block is made of stainless steel, so that the blank block has sufficient strength. The protective layer of the plate body is a first protective layer and a second protective layer, the first protective layer is arranged on one side surface of the blank block, and the second protective layer is arranged on the other side surface of the blank block, the first protective layer is made of polymer biomaterial, and the second protective layer is made of titanium alloy material. Since the first protective layer is made of polymer biomaterial, it contacts with human tissue through the first protective layer, and since the biopolymer material has good compatibility with the human body, the problem of rejection between the plate body and the human body after installation is avoided. At the same time, since the second protective layer is made of titanium alloy material, it contacts with human bones through the second protective layer. The titanium alloy material is corrosion-resistant and will not be miscible with the bones, so it can be in good contact with the bones, ensuring the convenience of removing the plate body later.

[0012] In one or more embodiments of the present invention, the mounting hole includes an assembly groove and an external thread, the assembly groove is arranged on a side close to the first protective layer, the assembly groove is arranged in an inclined shape, and the external thread is arranged on a side close to the second protective layer.

[0013] In one or more embodiments of the present invention, the screw body is made of titanium alloy material, which has good strength and is not biocompatible with bones, so that the screw body can be installed in the bone, and it is convenient to remove the screw body when the bone plate body is removed in the later operation. The screw body includes a threaded rod and a screw head, and the end of the threaded rod close to the screw head is threadedly connected to the external thread, which can limit the movement of the screw body installed on the bone plate body, so that the bone plate body and the screw body are mutually locked. The screw head is sleeved in the assembly groove, so that when the screw body is installed on the bone plate body, the upper surface of the screw head is flush with the outer surface of the bone plate body. A plurality of grooves are provided on the inner side wall of the threaded circle of the threaded rod in an irregular manner, so that when the screw body rotates, the anti-falling particles in the anti-falling capsule can be attached to the grooves, and the friction between the threaded rod and the bone is increased by the anti-falling particles, thereby preventing the screw body from falling off after installation.

[0014] In one or more embodiments of the present invention, the anti-falling capsule includes an absorbable capsule shell and anti-falling particles, the anti-falling particles are stored in the absorbable capsule shell, and a plug-in hole is set at one end of the absorbable capsule shell close to the first protective layer, and the anti-falling particles are magnetic powder and titanium alloy particles. When in use, when the screw body is rotated, the front end of the threaded rod can be inserted into the absorbable capsule shell through the plug-in hole, and when the threaded rod is rotated, the thread ring will attach the anti-falling particles to the thread. Since the anti-falling particles are a mixture of magnetic powder and titanium alloy particles, the anti-falling particles can be adsorbed on the threaded rod, and the anti-falling particles can be moved to the groove on the threaded rod by rotation, so that the anti-falling particles will not affect the installation of the screw body in the bone. At the same time, the screw body is made of titanium alloy material, which will not be biocompatible with human bones after installation, making it convenient to remove the plate body through surgery later. In addition, by setting anti-falling particles, anti-falling particles are distributed between the threaded rod and the bone when the screw body is installed, so as to increase the friction between the threaded rod and the bone through the anti-falling particles to prevent the screw body from falling off during use.

[0015] A manufacturing device for a craniomaxillofacial bone plate, used for preparing a craniomaxillofacial bone plate, the manufacturing device comprising:

[0016] The 3D model building system includes an image acquisition component and a 3D production component; the image acquisition component is used to acquire images of the patient's fracture site, so as to obtain the bone shape of the patient's fracture site and the actual fracture situation. The 3D production component uses the acquired images to produce a 3D model of the patient's fracture site, so as to more clearly and comprehensively show the situation of the patient's fracture site.

[0017] The bone model building system is used to make a solid model of the fracture site, including 3D needle drawing. The 3D needle drawing makes a solid model of the fracture site based on the three-dimensional image of the fracture site obtained by the three-dimensional model building system; the bone model building system makes a proportional solid model through 3D needle drawing based on the three-dimensional model image of the fracture site. The solid model can display the patient's fracture site and fracture condition. At the same time, a bone plate is made through the solid model, which greatly improves the matching degree between the made bone plate and the patient.

[0018] The bone plate preparation system includes a laser cladding 3D printing all-in-one machine and a 3D bending device, which are used for prefabrication of blank blocks, bending of blank blocks, production of protective layers, production of mounting holes and production of screws. When making a bone plate, the size and shape of the bone plate are obtained according to the degree and range of the fracture, so as to fix the fracture site. After the size of the bone plate is determined, the blank block is prefabricated by the laser cladding 3D printing all-in-one machine to obtain a blank block that is proportionally reduced in size. When the bone plate is installed, in order to facilitate fitting with the fracture site, it is necessary to bend accordingly according to the curvature of the fracture site, so the blank block is bent by a 3D bending device, and the bent blank block needs to be compared on the physical model at the same time to ensure that the bent blank block and the physical model are completely fitted. After the bending is completed, a protective layer is produced on the surface of the blank block by the laser cladding 3D printing all-in-one machine. After the protective layer is produced, it is necessary to open holes on the physical model and the blank block according to the degree of fracture, the physical model and the shape of the blank block. Finally, the screws are made by 3D printing according to the size of the opening.

[0019] The automated control system is connected to the 3D model building system, the bone model building system and the bone plate preparation system by signals. The automated control system controls the production equipment to realize the production of the 3D image of the fracture site, the production of the physical model and the production of the bone plate.

[0020] In one or more embodiments of the present invention, the 3D needle painting includes a molding component and a driving component. The molding component is used to realize the molding of the solid model, and the driving component is used to drive the movement of the components on the molding component to realize the production of the solid model. The molding component includes a mounting plate and a molding needle. There are multiple molding needles, and the multiple molding needles are mounted on the mounting plate in a sliding connection manner. The molding needles can move on the mounting plate, so that a solid model can be produced by moving different molding needles. The molding needles are arranged at a high density, so that the produced solid model is more accurate. The driving component includes a driving plate and a driving needle. There are multiple driving needles, and the multiple driving needles are mounted on the driving plate in a sliding connection manner. The movement of the driving needles on the driving plate drives the molding needles to move on the mounting plate.

[0021] In one or more embodiments of the present invention, a shell is provided on the outside of the molding component and the driving component, one end of the shell is provided as an opening, the mounting plate is provided at the opening of the shell, and the positions of the plurality of molding needles and the plurality of driving needles correspond to each other, so that the driving needle can push the molding needle to move when it moves, so as to push the molding needle to the outside of the shell opening to form a solid model. A driving component is provided in the driving plate, and the driving component is used to drive the driving needle to move. The driving component is connected to the automatic control system signal, and the driving component is controlled by the automatic control system, so that the driving component controls the movement of the driving needle according to the three-dimensional model of the fracture site, so that the solid model of the fracture site can be obtained by extending different driving needles and different extension lengths. At the same time, the movement of the driving needle is controlled by the driving component, so that after the solid model is formed, when the bone plate is made on the molding needle, the molding needle will not be driven to move, so that the solid model can be in a stable state during the subsequent production of the bone plate.

[0022] In one or more embodiments of the present invention, the laser cladding 3D printing all-in-one machine is signal-connected to the 3D bending equipment and the automatic control system, and the printing materials used by the laser cladding 3D printing all-in-one machine are titanium alloy materials and polymer biomaterials.

[0023] A method for manufacturing a craniomaxillofacial bone plate, the manufacturing method comprising:

[0024] S1. Use a three-dimensional model building system to collect images of the patient's fracture site and produce a three-dimensional model of the patient's fracture site; collect images of the patient's fracture site through imaging equipment, and the three-dimensional modeling component can produce a three-dimensional model of the patient's fracture site through the images.

[0025] S2. The bone model building system produces a solid model of the fracture site through 3D needle painting based on the three-dimensional model of the fracture site; the automated control system controls the control components in the driving board to move the driving needle based on the three-dimensional model of the fracture site, and the driving needle pushes the molding needle to move, and finally a solid model of the fracture site is produced through the molding needle.

[0026] S3. The bone plate preparation system prepares the bone plate by cutting, bending, cladding and opening holes based on the solid model of the fracture site through a laser cladding 3D printing all-in-one machine and a 3D bending device. According to the degree and range of the fracture, the size and shape of the bone plate are obtained to facilitate the fixation of the fracture site. After the size of the bone plate is determined, the blank block is prefabricated by a laser cladding 3D printing all-in-one machine to obtain a proportionally reduced blank block of the bone plate. Since the bone plate needs to be bent accordingly according to the curvature of the fracture site when it is installed, the blank block is bent by a 3D bending device, and the bent blank block needs to be compared on the physical model to ensure that the bent blank block and the physical model are completely fitted. After the bending is completed, a protective layer is made on the surface of the blank block by a laser cladding 3D printing all-in-one machine. After the protective layer is made, it is necessary to open holes on the physical model and the blank block according to the degree of fracture, the physical model and the shape of the blank block. Finally, the screws are made by 3D printing according to the size of the opening.

[0027] Compared with the prior art, the present invention has the following advantages:

[0028] The bone fracture plate provided by the present invention is composed of an inner stainless steel plate and an outer protective layer, wherein the protective layer is a titanium alloy layer and a polymer biomaterial layer arranged on both sides of the stainless steel plate, so that the bone fracture plate has good strength. At the same time, after the bone fracture plate is installed, the side in contact with the bone is arranged as a titanium alloy layer, and the side in contact with the human tissue is arranged as a polymer biomaterial layer, which can avoid rejection between the bone fracture plate and the human body, and can effectively fix the fracture site, which is helpful for the recovery of the fracture site of the patient;

[0029] The screw provided by the present invention is made of titanium alloy material, so as to avoid biocompatibility between the screw and the bone after installation, so that the screw and the bone are easy to disassemble and assemble when the bone plate is removed; the screw and the bone plate are threadedly connected, so that the screw and the bone plate are mutually locked, and at the same time, when the screw is installed, the anti-falling particles in the anti-falling capsule are adsorbed, so that the friction between the screw and the bone is increased by the anti-falling particles, so that the screw is not easy to fall off between the bone after installation, and a secondary operation due to falling off is avoided;

[0030] When the bone plate provided by the present invention is manufactured, the 3D needle painting obtains a proportional physical model of the fracture site through the three-dimensional model of the fracture site, and the bone plate is manufactured according to the physical model, so that the manufactured bone plate is highly matched with the fracture site. At the same time, the bone plate is composed of a blank block and a protective layer, which greatly improves the efficiency of bone plate manufacturing and reduces the waiting time of patients after fractures; and the manufactured bone plate can be used directly during surgery, and medical staff only need to open a hole in the patient's fracture site to install the bone plate on the fracture site, which greatly shortens the operation time, reduces the pain of the patient during the operation, and improves the experience effect after the bone plate is installed. BRIEF DESCRIPTION OF THE DRAWINGS

[0031] In order to more clearly illustrate the embodiments of the present invention or the technical solutions in the prior art, the drawings required for use in the embodiments or the description of the prior art will be briefly introduced below. Obviously, the drawings described below are only some embodiments recorded in the present invention. For ordinary technicians in this field, other drawings can be obtained based on these drawings without paying creative work.

[0032] Figure 1 It is a front view of a craniomaxillofacial bone fracture plate in one embodiment of the present invention;

[0033] Figure 2 A three-dimensional diagram of a craniomaxillofacial bone plate according to an embodiment of the present invention;

[0034] Figure 3 An explosion-proof device for a craniomaxillofacial bone plate according to an embodiment of the present invention Figure 1 ;

[0035] Figure 4 An explosion-proof device for a craniomaxillofacial bone plate according to an embodiment of the present invention Figure 2 ;

[0036] Figure 5 It is a cross-sectional view of an anti-falling capsule in one embodiment of the present invention;

[0037] Figure 6 A three-dimensional diagram of a 3D needle painting in one embodiment of the present invention;

[0038] Figure 7 A cross-sectional view of a 3D needle painting according to an embodiment of the present invention;

[0039] Figure 8 Schematic diagram of the interior of a 3D needle painting in one embodiment of the present invention.

[0040] Description of main reference numerals:

[0041] 1-bone plate, 11-bone plate body, 1101-blank block, 1102-first protective layer, 1103-second protective layer, 12-mounting hole, 1201-assembly groove, 1202-external thread, 2-screw, 21-screw body, 2101-threaded rod, 2102-screw head, 3-protection component, 31-anti-falling capsule, 3101-absorbable capsule shell, 3102-anti-falling particles, 3103-plug hole, 4-3D needle painting, 41-model molding component, 4101-mounting plate, 4102-molding needle, 42-driving component, 4201-driving plate, 4202-driving needle, 43-shell. DETAILED DESCRIPTION

[0042] In order to enable those skilled in the art to better understand the technical solutions in the present invention, the technical solutions in the embodiments of the present invention will be clearly and completely described below in conjunction with the drawings in the embodiments of the present invention. Obviously, the described embodiments are only part of the embodiments of the present invention, not all of the embodiments. Based on the embodiments of the present invention, all other embodiments obtained by ordinary technicians in this field without creative work should fall within the scope of protection of the present invention.

[0043] like Figure 1~Figure 4 As shown, a craniomaxillofacial bone fracture plate in one embodiment of the present invention comprises a bone fracture plate 1, a screw 2 and an anti-fall-off component 3.

[0044] like Figure 1~Figure 4 As shown, the bone fracture plate 1 includes a bone fracture plate body 11, which is composed of a strength component arranged inside and a protective layer arranged outside. The strength component and the protective layer form the bone fracture plate body 11, so that the bone fracture plate body 11 has sufficient strength when used and avoids the problem of rejection between the bone fracture plate body 11 and the patient. The bone fracture plate body 11 is provided with a plurality of mounting holes 12, which are used to mount and fix the bone fracture plate body 11 to ensure the stability of the bone fracture plate body 11 after installation.

[0045] Specifically, the strength component of the bone plate body 11 is a blank block 1101, and the blank block 1101 is made of stainless steel, so that the blank block 1101 has sufficient strength. The protective layer of the bone plate body 11 is a first protective layer 1102 and a second protective layer 1103. The first protective layer 1102 is arranged on one side surface of the blank block 1101, and the second protective layer 1103 is arranged on the other side surface of the blank block 1101. The first protective layer 1102 is made of a polymer biomaterial, and the second protective layer 1103 is made of a titanium alloy material. Since the first protective layer 1102 is made of a polymer biomaterial, it contacts with human tissue through the first protective layer 1102. Since the biopolymer material has good compatibility with the human body, the problem of rejection between the bone plate body 11 and the human body after installation is avoided. At the same time, since the second protective layer 1103 is made of titanium alloy material, it contacts the human bones through the second protective layer 1103. The titanium alloy material is corrosion-resistant and will not dissolve with the bones. This ensures that the two can be easily separated after long-term contact with the bones, so as to effectively fix the fracture site and help the patient's fracture site to recover.

[0046] like Figure 3 and Figure 4 As shown, the mounting hole 12 includes an assembly groove 1201 and an external thread 1202 . The assembly groove 1201 is arranged on a side close to the first protective layer 1102 . The assembly groove 1201 is arranged in an inclined shape, and the external thread 1202 is arranged on a side close to the second protective layer 1103 .

[0047] like Figure 1~Figure 4 As shown, the screw 2 includes a screw body 21, and a plurality of screw bodies 21 are provided. The plurality of screw bodies 21 are threadedly connected to the plurality of mounting holes 12. The plate body 11 can be fixed to the fracture site by the cooperation of the screw body 21 and the mounting hole 12. At the same time, the screw body 21 and the mounting hole 12 are threadedly connected, so that the screw body 21 will not be displaced from each other when installed on the mounting hole 12, so that the plate body 11 and the screw body 21 are locked with each other to form a whole, forming an internal implanted fracture fixation bracket, and the biological stress borne by the bone block will be directly transmitted to the plate body 11 through the screw body 21.

[0048] Preferably, the screw body 21 is made of titanium alloy material, which has good strength and is not biocompatible with bones. Therefore, the screw body 21 will not be dissolved and combined with the bone when installed in the bone, and the screw body 21 can be easily removed when the bone plate body 11 is removed in a later operation.

[0049] like Figure 2~Figure 4As shown, the screw body 21 includes a threaded rod 2101 and a screw head 2102. One end of the threaded rod 2101 close to the screw head 2102 is threadedly connected to the external thread 1202, so that the movement of the screw body 21 installed on the bone plate body 11 can be limited, so that the bone plate body 11 and the screw body 21 are mutually locked. The screw head 2102 is sleeved in the assembly groove 1201, so that when the screw body 21 is installed on the bone plate body 11, the upper surface of the screw head 2102 is flush with the outer surface of the bone plate body 11. A plurality of grooves are formed in an irregular manner on the inner side wall of the threaded circle of the threaded rod 2101, so that when the screw body 21 rotates, the anti-falling particles in the anti-falling capsule 31 can be attached to the grooves, and the friction between the threaded rod 2101 and the bone is increased by the anti-falling particles, thereby preventing the screw body 21 from falling off after installation.

[0050] Preferably, the grooves on the threaded rod 2101 are arranged in an irregular manner, so that the anti-falling particles are distributed in the grooves in an irregular manner, so that the anti-falling particles contact the bones in an irregular manner, further increasing the friction between the threaded rod 2101 and the bones, thereby effectively preventing the screw body from falling off during use.

[0051] like Figure 3~Figure 5 As shown, the anti-dropping assembly 3 includes an anti-dropping capsule 31, and a plurality of anti-dropping capsules 31 are provided, and the plurality of anti-dropping capsules 31 are respectively provided in the plurality of mounting holes 12. Since the strength of the screw body 21 can be ensured when it is made of stainless steel, but there is a problem of easy falling off after installation, and the screw body 21 can avoid falling off between the two when it is made of pure titanium, but there are problems of low strength and difficulty in disassembly after installation. Therefore, in order to solve the actual problem of the screw body 21, an anti-dropping capsule 31 is provided, so that the problem of the screw body 21 being easy to fall off after installation can be solved by the anti-dropping capsule 31.

[0052] like Figure 5As shown, the anti-falling capsule 31 includes an absorbable capsule shell 3101 and anti-falling particles 3102, the anti-falling particles 3102 are stored in the absorbable capsule shell 3101, and the absorbable capsule shell 3101 is provided with a plug hole 3103 at one end close to the first protective layer 1102, and the anti-falling particles 3102 are magnetic powder and titanium alloy particles. When in use, when the screw body 21 is rotated, the front end of the threaded rod 2101 can be deeply inserted into the absorbable capsule shell 3101 through the plug hole 3103, and when the threaded rod 2101 is rotated, the thread ring will attach the anti-falling particles 3102 to the thread. Since the anti-falling particles 3102 are a mixture of magnetic powder and titanium alloy particles, the anti-falling particles 3102 can be adsorbed on the threaded rod 2101, and the anti-falling particles 3102 are moved to the groove on the threaded rod 2101 by rotation, so that the anti-falling particles 3102 will not affect the installation of the screw body 21 in the bone.

[0053] Preferably, the screw body 21 is made of titanium alloy material, which will not be biocompatible with human bones after installation, thereby making it convenient to remove the plate body 11 through surgery later. By providing anti-falling particles 3102, anti-falling particles 3102 are distributed between the threaded rod 2101 and the bone when the screw body 21 is installed, so that the friction between the threaded rod 2101 and the bone can be increased by the anti-falling particles 3102 to prevent the screw body 21 from falling off during use.

[0054] Furthermore, the absorbable capsule shell 3101 is attached between the mounting hole 12 and the screw body 21 by the rotation of the screw body 21, and the absorbable capsule shell is absorbed by the parts in contact with it. At the same time, the anti-falling particles set in the absorbable capsule shell 3101 are not too many so that they can be completely received by the grooves on the threaded rod 2101.

[0055] A device for manufacturing a craniomaxillofacial bone plate is used for manufacturing a craniomaxillofacial bone plate. The device comprises a three-dimensional model building system, a bone model building system, a bone plate manufacturing system and an automated control system.

[0056] Specifically, the 3D model building system includes an image acquisition component and a 3D production component; the image acquisition component is used to collect images of the patient's fracture site, so as to obtain the bone shape of the patient's fracture site and the actual fracture situation. The 3D production component uses the collected images to produce a 3D model of the patient's fracture site, so as to show the situation of the patient's fracture site more clearly and comprehensively.

[0057] Specifically, the bone model building system is used to make a solid model of the fracture site, including 3D Variety Needle Painting 4. 3D Variety Needle Painting 4 makes a solid model of the fracture site based on the three-dimensional image of the fracture site obtained by the three-dimensional model building system. The bone model building system makes a proportional solid model through 3D Variety Needle Painting 4 based on the three-dimensional model image of the fracture site. The solid model can display the patient's fracture site and fracture condition. At the same time, the bone plate is made through the physical model, which greatly improves the matching degree between the made bone plate and the patient.

[0058] Specifically, the bone plate preparation system includes a laser cladding 3D printing all-in-one machine and a 3D bending device, which are used for prefabrication of blank blocks, bending of blank blocks, production of protective layers, production of mounting holes and production of screws.

[0059] Furthermore, when the bone plate is made, the size and shape of the bone plate are obtained according to the degree and range of the fracture, so as to fix the fracture site. After the size of the bone plate is determined, the blank block is prefabricated by a laser cladding 3D printing all-in-one machine to obtain a proportionally reduced blank block of the bone plate. When the bone plate is installed, in order to facilitate fitting with the fracture site, it is necessary to bend accordingly according to the curvature of the fracture site. Therefore, the blank block is bent by a 3D bending device, and the bent blank block needs to be compared with the physical model at the same time to ensure that the bent blank block and the physical model are completely fitted.

[0060] Furthermore, after the bending is completed, a protective layer is made on the surface of the blank block through a laser cladding 3D printing all-in-one machine. When making the protective layer, different protective layers can be made on the surface of the blank block through 3D printing combined with cladding. After the protective layer is made, it is necessary to open holes in the physical model and the blank block according to the degree of fracture, the physical model and the shape of the blank block. Finally, the screws are made by 3D printing according to the size of the opening.

[0061] Specifically, the automated control system is connected to the 3D model building system, the bone model building system and the bone plate preparation system by signals. The automated control system controls the production equipment to achieve the production of the 3D image of the fracture site, the production of the physical model and the production of the bone plate.

[0062] like Figure 6~Figure 8As shown, the 3D needle painting 4 includes a forming component 41 and a driving component 42. The forming component 41 is used to realize the forming of the entity model, and the driving component 42 is used to drive the movement of the components on the forming component 41 to realize the production of the entity model. The forming component 41 includes a mounting plate 4101 and a forming needle 4102. There are multiple forming needles 4102, and the multiple forming needles 4102 are all installed on the mounting plate 4101 in a sliding connection manner. The forming needles 4102 can move on the mounting plate 4101, so that a physical model can be produced by moving different forming needles 4102. The density of the forming needles 4102 is relatively large, so that the produced physical model is more accurate. The driving component 42 includes a driving plate 4201 and a driving needle 4202. There are multiple driving needles 4202, and the multiple driving needles 4202 are installed on the driving plate 4201 in a sliding connection manner. The movement of the driving needles 4202 on the driving plate 4201 drives the forming needles 4102 to move on the mounting plate 4101.

[0063] like Figure 6~Figure 8 As shown, a shell 43 is provided outside the molding component 41 and the driving component 42, one end of the shell 43 is provided as an opening, and the mounting plate 4101 is provided at the opening of the shell 43. The positions of the plurality of molding needles 4102 and the plurality of driving needles 4202 correspond to each other, so that the driving needles 4202 can push the molding needles 4102 to move when they move, so as to push the molding needles 4102 to the outside of the opening of the shell 43 to form a physical model. A driving component is provided inside the driving plate 4201, and the driving component is used to drive the driving needles 4202 to move. The driving component is connected to the automatic control system signal, and the driving component is controlled by the automatic control system, so that the driving component controls the movement of the driving needles 4202 according to the three-dimensional model of the fracture site, so that the physical model of the fracture site can be obtained by extending different driving needles 4202 and different extension lengths.

[0064] Preferably, the movement of the driving pin 4202 is controlled by the driving assembly, so that after the solid model is formed, when the bone plate is made on the molding pin 4102, the molding pin 4102 will not be driven to move, so that the solid model can be in a stable state during the subsequent production of the bone plate.

[0065] Preferably, the laser cladding 3D printing all-in-one machine is signal-connected to the 3D bending equipment and the automatic control system, and the printing materials used by the laser cladding 3D printing all-in-one machine are titanium alloy materials and polymer biomaterials, so that the laser cladding 3D printing all-in-one machine can set a protective layer of titanium alloy material on one side surface and a protective layer of polymer biomaterial on the other side surface on the blank body by printing and cladding.

[0066] A method for manufacturing a craniomaxillofacial bone plate, the manufacturing method comprising:

[0067] S1. Use a three-dimensional model building system to collect images of the patient's fracture site and produce a three-dimensional model of the patient's fracture site; collect images of the patient's fracture site through imaging equipment, and the three-dimensional modeling component can produce a three-dimensional model of the patient's fracture site through the images.

[0068] S2. The bone model building system produces a solid model of the fracture site through 3D Needle Painting 4 according to the three-dimensional model of the fracture site; the automatic control system controls the control components in the driving board 4201 to move the driving needle 4202 according to the three-dimensional model of the fracture site, and the driving needle 4202 will push the molding needle 4102 to move, and finally the solid model of the fracture site is produced by the molding needle 4102.

[0069] S3. The bone plate preparation system prepares the bone plate by cutting, bending, cladding and opening holes based on the solid model of the fracture site through laser cladding 3D printing all-in-one machine and 3D bending equipment.

[0070] Specifically, the size and shape of the bone plate are obtained according to the degree and range of the fracture, so as to fix the fracture site. After the size of the bone plate is determined, the blank block is prefabricated by a laser cladding 3D printing all-in-one machine to obtain a blank block that is proportionally reduced in size for the bone plate. Since the bone plate needs to be bent accordingly according to the curvature of the fracture site when it is installed in order to facilitate fitting with the fracture site, the blank block is bent by a 3D bending device, and the bent blank block needs to be compared on the physical model to ensure that the bent blank block and the physical model are completely fitted. After the bending is completed, a protective layer is made on the surface of the blank block by a laser cladding 3D printing all-in-one machine. After the protective layer is made, it is necessary to open holes in the physical model and the blank block according to the degree of fracture, the physical model and the shape of the blank block. Finally, the screws are made by 3D printing according to the size of the opening.

[0071] It will be apparent to those skilled in the art that the invention is not limited to the details of the exemplary embodiments described above and that the invention can be implemented in other specific forms without departing from the spirit or essential features of the invention. Therefore, the embodiments should be considered exemplary and non-limiting in all respects, and the scope of the invention is defined by the appended claims rather than the foregoing description, and it is intended that all variations falling within the meaning and scope of the equivalent elements of the claims be included in the invention. Any reference numeral in a claim should not be considered as limiting the claim to which it relates.

[0072] In addition, it should be understood that although the present specification is described according to implementation modes, not every implementation mode contains only one independent technical solution. This description of the specification is only for the sake of clarity. Those skilled in the art should regard the specification as a whole. The technical solutions in each embodiment may also be appropriately combined to form other implementation modes that can be understood by those skilled in the art.

Claims

1. A craniomaxillofacial bone plate, characterized in that: include: A bone plate, comprising a bone plate body, the bone plate body consisting of a strength component arranged inside and a protective layer arranged outside, the bone plate body being provided with a plurality of mounting holes; the strength component of the bone plate body being a blank block, the blank block being made of stainless steel, the protective layers of the bone plate body being a first protective layer and a second protective layer, the first protective layer being arranged on a surface of one side of the blank block, the second protective layer being arranged on a surface of the other side of the blank block, the first protective layer being made of a polymer biomaterial, and the second protective layer being made of a titanium alloy material; A screw, comprising a screw body, wherein a plurality of screw bodies are provided, and the plurality of screw bodies are threadedly connected to the plurality of mounting holes; the mounting hole comprises an assembly groove and an external thread, wherein the assembly groove is provided on a side close to the first protective layer, and the external thread is provided on a side close to the second protective layer; the screw body is made of titanium alloy material, the screw body comprises a threaded rod and a screw head, an end of the threaded rod close to the screw head is threadedly connected to the external thread, the screw head is sleeved in the assembly groove, and a plurality of grooves are irregularly provided on the inner side wall of the threaded circle of the threaded rod; The anti-falling component includes an anti-falling capsule, wherein a plurality of the anti-falling capsules are provided and the plurality of the anti-falling capsules are respectively arranged in a plurality of mounting holes, wherein the anti-falling capsule includes an absorbable capsule shell and anti-falling particles, wherein the anti-falling particles are stored in the absorbable capsule shell, and an insertion hole is arranged at one end of the absorbable capsule shell close to the first protective layer, and the anti-falling particles are magnetic powder and titanium alloy particles.

2. A craniomaxillofacial plate manufacturing device, used for preparing a craniomaxillofacial plate as claimed in claim 1, characterized in that: The production equipment comprises: A three-dimensional model building system, including an image acquisition component and a three-dimensional production component; A bone model building system, used for making a physical model of a fracture site, including a 3D needle drawing, wherein the 3D needle drawing makes a physical model of the fracture site based on a three-dimensional image of the fracture site acquired by the three-dimensional model building system; the 3D needle drawing includes a forming component and a driving component, wherein the forming component includes a mounting plate and a forming needle, wherein a plurality of the forming needles are provided, and the plurality of the forming needles are all mounted on the mounting plate in a sliding connection manner; wherein the driving component includes a driving plate and a driving needle, wherein a plurality of the driving needles are provided, and the plurality of the driving needles are all mounted on the driving plate in a sliding connection manner; Bone plate preparation system, including laser cladding 3D printing all-in-one machine and 3D bending equipment, used for prefabrication of blank blocks, bending of blank blocks, production of protective layers, production of mounting holes and production of screws; An automated control system is signal-connected to a three-dimensional model building system, a bone model building system, and a bone plate preparation system.

3. The manufacturing device of the craniomaxillofacial bone plate according to claim 2, characterized in that: A shell is provided on the outside of the molding component and the driving component, one end of the shell is provided as an opening, the mounting plate is provided at the opening of the shell, the positions of the plurality of molding needles and the plurality of driving needles correspond to each other, a driving component is provided in the driving plate, the driving component is used to drive the driving needle to move, and the driving component is connected to the automatic control system signal.

4. The manufacturing device of the craniomaxillofacial bone plate according to claim 2, characterized in that: The laser cladding 3D printing all-in-one machine is signal-connected to the 3D bending equipment and the automatic control system, and the printing materials used by the laser cladding 3D printing all-in-one machine are titanium alloy materials and polymer biomaterials.

5. A method for manufacturing a craniomaxillofacial bone plate, used for the manufacturing device of a craniomaxillofacial bone plate as claimed in claim 2 to 4, characterized in that: The production method comprises: S1. Using a three-dimensional model building system to collect images of the patient's fracture site and create a three-dimensional model of the patient's fracture site; S2. The bone model building system uses 3D needle drawing to create a physical model of the fracture site based on the three-dimensional model of the fracture site; S3. The bone plate preparation system prepares the bone plate by cutting, bending, cladding and opening holes based on the solid model of the fracture site through laser cladding 3D printing all-in-one machine and 3D bending equipment.

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