A device for replacing a temporomandibular joint, a method of manufacture and a surgical robot system

Abstract

The application provides a kind of mandibular prosthetic joint replacement device, preparation method and surgical robot system, mandibular fixation support is fixedly connected with the lateral surface of human mandible, temporal bone fixation support is fixedly connected with the lateral surface of human temporal bone, the inside of joint socket liner is provided with accommodating cavity, spherical joint head is movably arranged in the inside of accommodating cavity, and the inner wall of accommodating cavity is sequentially provided with base layer, variable stiffness elastic buffer layer and surface layer along the thickness direction of the side wall of joint socket liner.By the application, the efficient simulation of the real human temporomandibular joint structure by the temporomandibular artificial joint replacement device can be realized, the structural strength and use comfort of the temporomandibular artificial joint replacement device are improved, and based on artificial intelligence and surgical robot assisted technology, the preparation function and automatic assembly operation of the temporomandibular artificial joint replacement device adapted to human tissue structure are realized.

Description

Technical Field

[0001] This invention belongs to the field of medical device technology, and in particular relates to a temporomandibular joint replacement device, its preparation method, and a surgical robot system. Background Technology

[0002] The temporomandibular joint plays a crucial role in the human stomatognathic system. Damage to it can cause stomatognathic dysfunction and even secondary jaw deformities, seriously affecting the patient's health. Temporomandibular joint replacement surgery is one of the main treatment methods for severe joint damage, defects, or deformities. However, conventional temporomandibular joint replacement devices and their fabrication methods also have many problems. For example, conventional temporomandibular joint replacement devices mostly use standard parts, making it difficult to achieve personalized design. Furthermore, patients' anatomical structures vary greatly, leading to poor fit between the temporomandibular joint replacement device and the bone, resulting in gaps and poor stability. Additionally, conventional temporomandibular joint replacement devices are limited by structural design, resulting in low connection strength or mismatched biomechanical properties, making them prone to fatigue fracture or damage after prolonged use. Summary of the Invention

[0003] This invention provides a temporomandibular joint replacement device, a preparation method, and a surgical robot system to solve the technical problems of existing conventional temporomandibular joint replacement devices having low structural strength, making it difficult to fully adapt to different human skeletal structures, and failing to fully simulate the movement posture of the real human temporomandibular joint structure.

[0004] To solve the above problems, the technical solution of the present invention is: a temporomandibular joint replacement device, comprising: A mandibular assembly, the mandibular assembly comprising a mandibular fixation bracket, a connecting rod, and a ball joint head; The mandibular fixation bracket is fixedly connected to the outer surface of the human mandible, the connecting rod extends and is arranged in the mandibular condyle resection area, the bottom end of the connecting rod is fixedly connected to the top end of the mandibular fixation bracket, and the ball joint head is fixedly set at the top end of the connecting rod. Temporal bone assembly, the temporal bone assembly including a temporal bone fixation frame and a glenoid fossa pad; The temporal bone fixation bracket is fixedly connected to the lateral surface of the human temporal bone, the glenoid fossa pad is placed in the resection area of ​​the mandibular fossa of the human temporal bone, and the glenoid fossa pad is fixedly connected to the bottom end of the temporal bone fixation bracket. The glenoid fossa liner has a receiving cavity inside, and the receiving cavity has a receiving opening on the side facing the mandibular component. The ball joint head is movably disposed inside the receiving cavity, and the inner wall of the receiving cavity is provided with a base layer, a variable stiffness elastic buffer layer and a surface layer in sequence along the thickness direction of the side wall of the glenoid fossa liner. The temporomandibular joint replacement device is configured such that, during the opening movement of the human mandible, the ball joint head generates a hinge rotation movement at a first position in the glenoid fossa liner receiving cavity, and during the extension and retraction movement of the human mandible, the ball joint head generates a sliding movement between the first position and the second position in the glenoid fossa liner receiving cavity.

[0005] Preferably, the mandibular fixation bracket includes a first fixation branch and a second fixation branch, wherein the first fixation branch and the second fixation branch are fixedly connected to one end of the temporal bone component; The first fixed branch is configured to extend along the distal lateral wall of the mandibular ramus, and the second fixed branch is configured to extend along the mandibular notch of the mandible. The center point of the ball joint head, the farthest stress point of the first fixed branch away from the temporal bone component, and the farthest stress point of the second fixed branch away from the temporal bone component form an equilateral triangle.

[0006] Preferably, the first fixing branch, the second fixing branch, and the temporal bone fixing bracket are each provided with a plurality of fixing holes. The fixing holes are configured to allow the insertion of a fixing member into the human mandibular body or the human temporal bone body, so that the mandibular fixing bracket is fixedly connected to the human mandibular body, and the temporal bone fixing bracket is fixedly connected to the human temporal bone.

[0007] Preferably, during the preparation stage, the first fixed branch and the second fixed branch are configured with lengths and widths adapted to the physiological parameters of different target human bodies, based on the personalized stress distribution conditions of the mandibular ramus region and mandibular notch region in the mandible of different target human bodies.

[0008] Preferably, during the manufacturing stage, the connecting rod is made to form a personalized inclined distribution between the first position of the glenoid fossa liner accommodating cavity and the top end of the mandibular fixation bracket, based on the relative distribution positions of the mandibular and temporal bones of different target human bodies and the extension direction conditions of the first and second fixing branches. Furthermore, the angle formed by the extension line of the force center of the connecting rod to the first fixed branch is equal to the angle formed by the extension line of the force center of the connecting rod to the second fixed branch.

[0009] Preferably, the base layer is made of magnesium alloy material and extends and fits to the inner wall of the receiving cavity of the joint socket liner; The variable stiffness elastic buffer layer is made of an extracellular matrix biomimetic gradient hydrogel material and is extended and adhered to the inner wall surface of the base layer. The variable stiffness elastic buffer layer includes a first partition, a second partition, a third partition, and an edge layer. The first partition is located on the circumferential inner wall of the first position of the articular socket liner receiving cavity. The wall thickness of the first partition is limited to 1.5-2.0 mm, and the material hardness of the first partition is limited to 10-20 A. The second partition is located on the circumferential inner wall of the articular socket liner receiving cavity between the first and second positions. The inner wall of the second partition has a wall thickness of 1.0-1.5 mm and a material hardness of 30-50 A. The third partition is located on the circumferential inner wall of the second position of the socket liner receiving cavity, with a wall thickness of 2.0-3.2 mm and a material hardness of 60-80 A. The edge layer is located at the edge of the socket liner receiving opening, with a width of 1.0-1.5 mm and a material hardness of at least greater than 80 A. The surface layer is made of nano-reinforced composite polyvinyl aldehyde material and is extended and attached to the inner wall surface of the variable stiffness elastic buffer layer.

[0010] Preferably, the mandibular fixation bracket is provided with a plurality of anchor posts on the outer side of the condylar neck and the anterior edge of the mandibular ramus. The anchor posts adopt a barbed, forked, or umbrella-shaped structure and form gaps on the surface. The anchor posts are used to make contact with and actively interlock with the human ligaments and soft tissues. The mandibular fixation bracket is provided with several guide channels on the outer side of the condylar neck and the outer side of the anterior edge of the mandibular ramus. The guide channels are used to assist in the artificial suturing and fixation of human ligaments and soft tissues.

[0011] Preferably, the mandibular fixation bracket, the connecting rod, and the ball joint head are made of zirconium oxynitride bioceramic composite material and manufactured using an integral molding process, and the temporal bone fixation bracket and the glenoid fossa liner are made of zirconium oxynitride bioceramic composite material and manufactured using an integral molding process.

[0012] Based on the same concept, the present invention also provides a method for preparing a temporomandibular joint replacement device, which is used to prepare a temporomandibular joint replacement device as described above, comprising the following steps: S1: Based on CBCT or CT scanning technology, obtain three-dimensional structural data of the target human jawbone and joint area in static and dynamic states, and obtain dental occlusion data of the target human based on intraoral scanning technology. Register the three-dimensional structural data of the target human jawbone and joint area with the dental occlusion data to the same standard coordinate system to generate a digital model. S2: Define the osteotomy line positions for the diseased mandibular condyle region and the diseased temporal fossa region in the digital model; S3: Calculate the apparent bone density of the outer surface of the mandible of the target human body based on CBCT or CT scan data, and establish a mandibular dynamic model based on the three-dimensional structural data of the mandible and joint area of ​​the target human body in motion state. Calculate the stress distribution of the outer surface of the mandible of the target human body in motion state through inverse dynamic algorithm. S4: Based on the relative positional distribution of the mandible and temporal bone in the digital model, the relative movement relationship of the mandible and temporal bone recorded by the electronic face bow and virtual jaw frame, and combined with the apparent bone density and stress distribution of the outer surface of the mandible, a personalized mandibular component and temporal bone component are prepared.

[0013] Based on the same concept, the present invention also provides a surgical robot system for temporomandibular joint replacement, for performing the temporomandibular joint replacement device preparation method as described above, including: The 3D model scanning module is used to acquire 3D structural data of the target human jawbone and joint area in static and dynamic states through CBCT or CT scanning technology, and to acquire the target human dentition occlusion data through intraoral scanning technology. The 3D structural data of the target human jawbone and joint area and the dentition occlusion data are registered to the same standard coordinate system to generate a digital model. The osteotomy line positioning module is used to define the location of the osteotomy line in the target human body for the diseased mandibular condyle region and the diseased temporal bone mandibular fossa region in the digital model; The stress distribution calculation module is used to calculate the apparent bone density of the outer surface of the mandible of the target human body based on CBCT or CT scan data, and to establish a mandibular dynamic model based on the three-dimensional structural data of the mandible and joint area of ​​the target human body in motion state. The stress distribution of the outer surface of the mandible of the target human body in motion state is calculated by the inverse dynamic algorithm. The medical device fabrication module is used to fabricate personalized mandibular and temporal bone components based on the relative positional distribution of the mandible and temporal bone in the target human body in the digital model, the relative movement relationship of the mandible and temporal bone recorded by the electronic face bow and virtual jaw frame, and the apparent bone density and stress distribution of the outer surface of the target human mandible. The surgical robot assembly module is used to assist in the assembly surgery of the temporomandibular joint replacement device based on the structural characteristics of the jawbone and joint area after osteotomy of the target human body.

[0014] Because of the above technical solutions, this invention has the following advantages and positive effects compared with the prior art: This invention provides a temporomandibular joint replacement device, a preparation method, and a surgical robot system. The temporomandibular joint replacement device includes a mandibular component and a temporal bone component. The mandibular component includes a mandibular fixation bracket, a connecting rod, and a ball joint head. The mandibular fixation bracket is fixedly connected to the lateral surface of the human mandible. The connecting rod extends and is arranged in the mandibular condyle resection area. The bottom end of the connecting rod is fixedly connected to the top end of the mandibular fixation bracket. The ball joint head is fixedly disposed at the top end of the connecting rod. The temporal bone component includes a temporal bone fixation bracket and a glenoid fossa pad. The temporal bone fixation bracket is fixedly connected to the lateral surface of the human temporal bone. The glenoid fossa pad is arranged in the mandibular fossa resection area of ​​the human temporal bone. The glenoid fossa pad is fixedly connected to the bottom end of the temporal bone fixation bracket. At the same time, the glenoid fossa pad has a receiving cavity inside. The receiving cavity has a receiving opening on the side facing the mandibular component. The ball joint head is movably disposed inside the receiving cavity. The inner wall of the receiving cavity is provided with a base layer, a variable stiffness elastic buffer layer, and a surface layer in sequence along the thickness direction of the glenoid fossa pad sidewall. In this invention, the mandibular component and temporal bone component are designed and generated based on the actual human temporomandibular joint structure, so that the temporomandibular joint replacement device can fully simulate the usage form of the actual human temporomandibular joint structure. At the same time, based on the personalized design of the mandibular component, the temporomandibular joint replacement device can be fully adapted to the target human skeletal structure, improving the structural strength and user comfort of the temporomandibular joint replacement device. Furthermore, based on artificial intelligence and surgical robot-assisted technology, the device can be prepared to adapt to human tissue structure and the assembly surgery can be automated. Attached Figure Description

[0015] Figure 1 A schematic diagram of the temporomandibular joint replacement device provided by the present invention in a human closed-mouth posture; Figure 2 A schematic diagram of the temporomandibular joint replacement device provided by this invention in the human mouth-opening posture; Figure 3 A schematic diagram of the temporomandibular joint replacement device provided by the present invention in the human mandibular forward displacement posture; Figure 4 A cross-sectional view of the temporomandibular joint replacement device provided by the present invention; Figure 5 A schematic flowchart of the preparation method of the temporomandibular joint replacement device provided by the present invention.

[0016] Explanation of reference numerals in the attached drawings: 1: First fixation branch; 2: Second fixation branch; 3: Connecting rod; 4: Ball joint head; 5: Temporal bone fixation bracket; 6: Joint socket pad; 7: First position; 8: Second position; 9: Fixation hole; 10: Base layer; 11: First zone; 12: Second zone; 13: Third zone; 14: Edge layer; 15: Surface layer. Detailed Implementation

[0017] The following detailed description, in conjunction with the accompanying drawings and specific embodiments, provides a temporomandibular joint replacement device, its preparation method, and a surgical robot system based on the present invention. The advantages and features of the present invention will become more apparent from the following description and claims.

[0018] First Embodiment See Figures 1-4 This embodiment provides a temporomandibular joint replacement device to simulate the structure and morphology of the real human temporomandibular joint. The temporomandibular joint replacement device specifically includes a mandibular component and a temporal bone component.

[0019] The mandibular component includes a mandibular fixation bracket, a connecting rod 3, and a ball joint head 4. The mandibular fixation bracket is fixedly connected to the outer surface of the human mandible, the connecting rod 3 extends and is positioned in the mandibular condyle resection area, the bottom end of the connecting rod 3 is fixedly connected to the top end of the mandibular fixation bracket, and the ball joint head 4 is fixedly mounted on the top end of the connecting rod 3.

[0020] The temporal bone assembly includes a temporal bone fixation frame 5 and a glenoid fossa pad 6. The temporal bone fixation frame 5 is fixedly connected to the lateral surface of the human temporal bone, and the glenoid fossa pad 6 is placed in the resection area of ​​the mandibular fossa of the human temporal bone, and the glenoid fossa pad 6 is fixedly connected to the bottom end of the temporal bone fixation frame 5.

[0021] Meanwhile, the glenoid fossa liner 6 has a receiving cavity adapted to the ball joint head 4. The receiving cavity has a receiving opening on the side facing the mandibular component. The ball joint head 4 is movably disposed inside the receiving cavity. Specifically, the receiving cavity is a cylindrical cavity, with its front and rear ends designated as a first position 7 and a second position 8. The ball joint head 4 can rotate in multiple directions within the receiving cavity and can also move parallel along the length of the receiving cavity. In addition, the inner wall of the receiving cavity is provided with a base layer 10, a variable stiffness elastic buffer layer, and a surface layer 15 along the thickness direction of the side wall of the glenoid fossa liner 6, to simulate the joint capsule and other soft tissues in a real human articular disc.

[0022] Therefore, in this embodiment, after the mandibular component and the temporal bone component are assembled, the ball joint head 4 is limited to move inside the glenoid fossa liner 6. Specifically, when the human body maintains a normal closed mouth posture, the ball joint head 4 is located at the first position 7 of the glenoid fossa liner 6 (the side of the glenoid fossa liner 6 away from the human face). When the human mandible moves to open, the ball joint head 4 generates a hinge rotation movement at the first position 7 of the glenoid fossa liner 6. When the human mandible moves to extend or retract, the ball joint head 4 generates a sliding movement between the first position 7 and the second position 8 of the glenoid fossa liner 6 (the side of the glenoid fossa liner 6 closer to the human face), thereby simulating the movement structure of the real human temporomandibular joint under different oral postures.

[0023] The specific structure and function of the temporomandibular joint replacement device provided in this embodiment will be described in further detail below: Preferably, in one embodiment, the mandibular fixation bracket includes a first fixation branch 1 and a second fixation branch 2, which are fixedly connected to one end of the temporal bone component, that is, the bottom end of the connecting rod 3 is fixedly connected to the connecting end formed by the first fixation branch 1 and the second fixation branch 2.

[0024] The first fixed branch 1 is configured to extend along the distal lateral wall of the mandibular ramus, and the second fixed branch 2 is configured to extend along the mandibular notch of the mandible. At the same time, the center point of the ball joint head 4, the farthest stress point of the first fixed branch 1 away from the temporal bone component, and the farthest stress point of the second fixed branch 2 away from the temporal bone component form an equilateral triangle. Based on the stable structure of the equilateral triangle, the mandible can withstand more complex three-dimensional loads (pressure, tension, shear force, and torsion) during chewing, speaking, and other activities. The forces from the ball joint head 4 in various directions are evenly distributed and transmitted to the two different anatomical regions of the mandible (mandibular ramus and mandibular notch region), thereby resisting multi-directional loads and significantly improving the long-term stability of the temporomandibular joint replacement device.

[0025] Preferably, in one embodiment, a plurality of fixing holes 9 are evenly provided in the first fixing branch 1, the second fixing branch 2 and the temporal bone fixing bracket 5. The fixing holes 9 are configured to allow the fixing member to be inserted into the human mandibular body or the human temporal bone body, so that the mandibular fixing bracket is fixedly connected to the human mandibular bone and the temporal bone fixing bracket 5 is fixedly connected to the human temporal bone.

[0026] Furthermore, in one embodiment, during the preparation stage, the first fixed branch 1 and the second fixed branch 2 are configured with lengths and widths adapted to different target human physiological parameters based on the personalized stress distribution conditions of the mandibular ramus region and mandibular notch region in the mandible of different target human bodies.

[0027] Furthermore, in one embodiment, during the preparation stage, the connecting rod 3 is configured to form a personalized inclined distribution between the first position 7 of the cavity accommodating the joint socket liner 6 and the top end of the mandibular fixation bracket, based on the relative distribution of the mandible and temporal bone of different target human bodies in a normal closed-mouth posture, and the extension direction of the first fixed branch 1 and the second fixed branch 2.

[0028] Furthermore, the angle formed by the extension line of the force center of the connecting rod 3 to the first fixed branch 1 is equal to the angle formed by the extension line of the force center of the connecting rod 3 to the second fixed branch 2. This allows the main load transmitted from the connecting rod 3 (the main input point of the force) to be transmitted to the first fixed branch 1 and the second fixed branch 2 along two completely symmetrical paths with the same efficiency, forming a symmetrical torque. This maximizes the counteraction of the inherent tendency of the mandibular component to rotate or bend, thereby enhancing the structural stability and durability of the mandibular component and reducing the risk of fatigue fracture.

[0029] Preferably, in one embodiment, the inner wall of the receiving cavity is provided with a base layer 10, a variable stiffness elastic buffer layer, and a surface layer 15. The base layer 10 is made of magnesium alloy material and extends and fits against the inner wall of the receiving cavity of the joint socket liner 6. The base layer 10 and the joint socket liner 6 are fixedly connected, further improving the structural strength of the inner wall of the receiving cavity and the joint socket liner 6.

[0030] The variable stiffness elastic buffer layer is made of an extracellular matrix biomimetic gradient hydrogel material, which extends and adheres to the inner wall of the base layer 10 to simulate the heterogeneous structure and composition of a natural articular disc. The matrix material of the variable stiffness elastic buffer layer is methacryloyl gelatin (GelMA). During the preparation of the extracellular matrix biomimetic gradient hydrogel material, the stiffness of the final variable stiffness elastic buffer layer can be adjusted by changing the material and proportion of biological additives. Specifically, the variable stiffness elastic buffer layer is formed according to the distribution area, including a first partition 11, a second partition 12, a third partition 13, and an edge layer 14.

[0031] The first partition 11 is located on the inner wall of the first position 7 of the cavity of the articular socket liner 6. The wall thickness of the first partition 11 is limited to 1.5-2.0 mm, and the material hardness of the first partition 11 is limited to 10-20A. The extracellular matrix biomimetic gradient hydrogel material of the first partition 11 is composed of bio-ink A and bio-ink B mixed in a specific ratio. Bio-ink A is a soft matrix containing 10% methacryloyl gelatin (GelMA) and loaded with matrix cell-derived factor-1, and bio-ink B is a 5% pure GelMA solution. By mixing the two, the desired low-hardness material is obtained. The extremely low hardness of the first partition 11 ensures flexibility and low frictional resistance in the initial stage of human mouth opening and closing movements. At the same time, the added matrix cell-derived factor-1 can actively attract surrounding soft tissue cells, promoting the adhesion and integration of human tissues.

[0032] The second partition 12 is located on the circumferential inner wall of the cavity housing the articular socket liner 6 between the first position 7 and the second position 8. The wall thickness of the second partition 12 is limited to 1.0-1.5 mm, and the material hardness of the second partition 12 is limited to 30-50 A. Similarly, the extracellular matrix biomimetic gradient hydrogel material of the second partition 12 is composed of different formulations of bio-ink A and bio-ink B. Bio-ink A is a 5% concentration of pure GelMA solution, while bio-ink B is a 10% concentration of GelMA with 1% type II collagen fibers incorporated as a reinforcing phase. By mixing the two, the desired medium-hardness material is obtained. The second partition 12 is the main load-bearing transition zone. The medium-hardness variable stiffness elastic buffer layer provides the necessary support during occlusion, preventing excessive deformation of the temporomandibular joint replacement device. The addition of type II collagen fibers simulates the structure of the collagen fiber network in the natural articular disc, which can significantly improve the mechanical strength and durability of the material.

[0033] The third section 13 is located on the inner wall of the second position 8 of the cavity of the articular socket liner 6. The wall thickness of the third section 13 is limited to 2.0-3.2 mm, and the material hardness of the third section 13 is limited to 60-80A. Similarly, the extracellular matrix biomimetic gradient hydrogel material of the third section 13 is composed of a mixture of bio-ink B and bio-ink C. Bio-ink B is a complex of 10% GelMA and 1% type II collagen fibers, while bio-ink C is a high-concentration GelMA of 15% loaded with 2% elastin microfibers. The high stiffness and high elastic modulus of the third section 13 fully simulate the function of the posterior band of the natural articular disc and the posterior temporal ligament. During wide opening, the condyle compresses this area, providing non-linearly increasing resistance, effectively preventing anterior joint dislocation. The elastin microfibers further endow the material with excellent resilience and fatigue resistance.

[0034] The edge layer 14 is located at the edge of the opening of the glenoid fossa liner 6. The width of the edge layer 14 is limited to 1.0-1.5 mm, and the material hardness of the edge layer 14 is limited to at least 80A. Similarly, the extracellular matrix biomimetic gradient hydrogel material of the edge layer 14 is composed of bio-ink C, namely 15% high-concentration GelMA, 2% elastin microfibers, and an additional 3% nano-hydroxyapatite. The edge layer 14 is designed to mimic the temporomandibular ligament. Its ultra-high hardness provides strong lateral restraint to the joint, effectively resisting the outward displacement of the condyle during lateral movement and ensuring joint stability. At the same time, the addition of nano-hydroxyapatite further enhances the stiffness and wear resistance of the material and can form a better mechanical interface with the surrounding bone tissue.

[0035] The surface layer 15 is made of nano-reinforced composite polyvinyl aldehyde material and is extended and attached to the inner wall of the variable stiffness elastic buffer layer. The matrix material of the surface layer 15 is selected as a polyvinyl aldehyde aqueous solution (15-20 wt%), and cellulose nanofibers (3-5 wt%) and graphene oxide nanosheets (1-2 wt%) are added to give the surface layer 15 better lubricity and biocompatibility, thereby meeting the needs of frequent and high-intensity friction between the ball joint head 4 and the joint socket pad 6.

[0036] Preferably, in one embodiment, the mandibular fixation bracket is provided with a plurality of anchor posts on the outer side of the condylar neck and the anterior edge of the mandibular ramus. The anchor posts adopt a barbed, forked, or umbrella-shaped structure and have gaps on their surface. The anchor posts are used to make contact with and actively interlock with the human ligaments and soft tissues.

[0037] Specifically, during the implantation of a temporomandibular joint replacement device, the surgeon can trim the free ligament fragments or fascia tissue flaps into a "brush" shape to expose more fibers. The prepared ligament tissue is then directly fitted or wrapped around the anchor post. The barbed, forked, or umbrella-shaped structure can immediately provide initial mechanical fixation to prevent ligament slippage. The highly porosity surface of the anchor post provides an excellent scaffold for the ingrowth of fibroblasts, blood vessels, and collagen fibers. Postoperatively, the ligament tissue will truly "grow" and achieve biofusion with the anchor post, i.e., the mandibular fixation device, forming a strong and durable connection.

[0038] Meanwhile, the mandibular fixation bracket is provided with several guide channels on the lateral side of the condylar neck and the anterior edge of the mandibular ramus. These guide channels are used to assist in the artificial suturing and fixation of human ligaments and soft tissues.

[0039] Specifically, during the implantation of a temporomandibular joint replacement device, a portion of the ligament tissue that is too long or cannot be directly fitted onto the anchor post is selected. The suture is passed through the ligament, and then the suture is guided through the passage and tied to fix it, thereby providing transitional stability for the ligament to heal and grow to the anchor post.

[0040] Preferably, in one embodiment, the mandibular fixation bracket, connecting rod 3, and ball joint head 4 are made of zirconium oxynitride bioceramic composite material and manufactured using an integral molding process. The temporal bone fixation bracket 5 and the articular socket pad 6 are also made of zirconium oxynitride bioceramic composite material and manufactured using an integral molding process. The zirconium oxynitride bioceramic composite material is a composite ceramic with zirconium oxide as the matrix and a specific ratio of zirconium nitride and yttrium oxide incorporated. In this embodiment, it specifically comprises 85-90 mol% zirconium oxide, 8-12 mol% zirconium nitride, and 3-5 mol% yttrium oxide, thereby achieving high wear resistance and high strength characteristics of the temporomandibular joint replacement device.

[0041] Second Embodiment Based on the same concept, see Figure 5 The present invention also provides a method for preparing a temporomandibular joint replacement device, which is used to prepare the temporomandibular joint replacement device as described in the first embodiment, comprising the following steps: S1: Based on CBCT or CT scanning technology, obtain three-dimensional structural data of the target human jawbone and joint area in static and dynamic states, and obtain dental occlusion data of the target human based on intraoral scanning technology. Register the three-dimensional structural data of the target human jawbone and joint area with the dental occlusion data to the same standard coordinate system to generate a digital model.

[0042] Digital models can be used to characterize data such as the morphology, motion trajectory, and motion speed of the target human mandible in three-dimensional space.

[0043] S2: Define the osteotomy line positions for the diseased mandibular condyle region and the diseased temporal fossa region in the digital model.

[0044] S3: Based on CBCT or CT scan data, calculate the apparent bone density ρ of the lateral surface of the mandible of the target human body according to empirical formulas. In CBCT or CT scan data, for different regions of bone structure, there is a linear proportional relationship between CBCT or CT scan data and apparent bone density. For example, in this embodiment, for the lateral surface (anterior) of the mandible, ρ1 = 0.00108 × HU_CBCT + 1.103, or ρ1 = 0.00097 × HU_CT + 1.062; for the lateral surface (middle) of the mandible, ρ2 = 0.00115 × HU_CBCT + 1.078, or ρ2 = 0.00103 × HU_CT + 1.041; for the lateral surface (posterior) of the mandible, ρ3 = 0.00121 × HU_CBCT + 1.052, or ρ3 = 0.00108 × HU_CT + 1.029.

[0045] Subsequently, a mandibular dynamic model is established based on the three-dimensional structural data of the target human mandible and joint area under motion. The stress distribution on the outer surface of the target human mandible under motion is calculated by the inverse dynamic algorithm. That is, in this embodiment, the morphology, motion trajectory and motion speed of the target human mandible in three-dimensional space in the digital model are input into the mandibular dynamic model to calculate the magnitude and direction of the force that each masticatory muscle needs to apply under different motion movements of the target human mandible, and then simulate the reaction force generated at the temporomandibular joint.

[0046] S4: Based on the relative positional distribution of the mandible and temporal bone in the digital model, the relative movement relationship of the mandible and temporal bone recorded by the electronic face bow and virtual jaw frame, and combined with the apparent bone density and stress distribution of the outer surface of the mandible of the target human body, personalized mandibular components and temporal bone components are prepared. That is, the structure and distribution of the connecting rod 3, the first fixed branch 1 and the second fixed branch 2 are all in a highly efficient fit with the objective physiological data of the target human body.

[0047] Third Embodiment Based on the same concept, the present invention also provides a surgical robot system for temporomandibular joint replacement, for performing the method for preparing a temporomandibular joint replacement device as described in any of the second embodiments, comprising: The 3D model scanning module is used to acquire 3D structural data of the target human jawbone and joint area in static and dynamic states using CBCT or CT scanning technology, and to acquire the target human's dental occlusion data using intraoral scanning technology. The 3D structural data of the target human jawbone and joint area and the dental occlusion data are registered to the same standard coordinate system to generate a digital model.

[0048] The osteotomy line positioning module is used to define the location of the osteotomy line in the target human body for the diseased mandibular condyle region and the diseased temporal bone mandibular fossa region in the digital model.

[0049] The stress distribution calculation module is used to calculate the apparent bone density of the outer surface of the mandible of the target human body based on CBCT or CT scan data, and to establish a dynamic model of the mandible based on the three-dimensional structural data of the mandible and joint area of ​​the target human body in motion. The stress distribution of the outer surface of the mandible of the target human body in motion is calculated through the inverse dynamics algorithm.

[0050] The medical device fabrication module is used to fabricate personalized mandibular and temporal bone components based on the relative positional distribution of the mandible and temporal bone in the target human body in the digital model, the relative movement relationship of the mandible and temporal bone recorded by the electronic face bow and virtual jaw frame, and the apparent bone density and stress distribution of the outer surface of the target human mandible.

[0051] The surgical robot assembly module is used to assist in the assembly surgery of the temporomandibular joint replacement device based on the structural characteristics of the jawbone and joint area after osteotomy of the target human body.

[0052] The surgical robot assembly module specifically includes an actuator for performing tasks such as resection of lesions in the temporal fossa, resection of lesions in the condyle of the mandible, and assembly of the mandibular component and temporal bone component. This embodiment does not impose specific limitations on the device structure of the actuator.

[0053] The functions of each component in the surgical robot system for temporomandibular joint replacement device described above correspond to the steps in the embodiment of the preparation method of temporomandibular joint replacement device described above, and their functions and implementation processes will not be described in detail here.

[0054] This embodiment also provides an electronic device, including a processor and a memory. The memory stores machine-executable instructions that can be executed by the processor, and the processor executes the machine-executable instructions to implement the above-described method for preparing a temporomandibular joint replacement device.

[0055] This embodiment also provides a computer-readable storage medium storing computer-executable instructions. When the computer-executable instructions are called and executed by a processor, the computer-executable instructions cause the processor to implement the above-described method for preparing a temporomandibular joint replacement device.

[0056] In summary, this invention provides a temporomandibular joint replacement device, a preparation method, and a surgical robot system. The temporomandibular joint replacement device includes a mandibular component and a temporal bone component. The mandibular component includes a mandibular fixation bracket, a connecting rod, and a ball joint head. The mandibular fixation bracket is fixedly connected to the lateral surface of the human mandible. The connecting rod extends and is positioned in the mandibular condyle resection area. The bottom end of the connecting rod is fixedly connected to the top end of the mandibular fixation bracket. The ball joint head is fixedly disposed at the top end of the connecting rod. The temporal bone component includes a temporal bone fixation bracket. The bracket 5 and the glenoid fossa pad 6 are fixedly connected. The temporal bone fixation bracket 5 is fixedly connected to the lateral surface of the human temporal bone. The glenoid fossa pad 6 is placed in the resection area of ​​the mandibular fossa of the human temporal bone. The bottom end of the glenoid fossa pad 6 is fixedly connected to the temporal bone fixation bracket 5. At the same time, the glenoid fossa pad 6 has a receiving cavity inside. The receiving cavity has a receiving opening on the side facing the mandibular component. The ball joint head 4 is movably disposed inside the receiving cavity. The inner wall of the receiving cavity is provided with a base layer 10, a variable stiffness elastic buffer layer and a surface layer 15 in sequence along the thickness direction of the side wall of the glenoid fossa pad 6. In this invention, the mandibular component and the temporal bone component are designed and generated based on the actual human temporomandibular joint structure, so that the temporomandibular joint replacement device can fully simulate the usage mode of the actual human temporomandibular joint structure. At the same time, based on the personalized design of the mandibular component, the temporomandibular joint replacement device can fully adapt to the target human skeletal structure, improving the structural strength and user comfort of the temporomandibular joint replacement device. Furthermore, the surgical robot system described in this invention can automatically generate a virtual structure of an individualized temporomandibular joint replacement device using artificial intelligence technology, based on anatomical information obtained from individual imaging data. This virtual structure is then processed by specialized equipment to generate physical mandibular and temporal bone components. To ensure precise implantation of the artificial joint, artificial intelligence generates the required skeletal surface morphology and the robot's surgical trajectory. The surgical robot then completes the corresponding operational tasks under the supervision of the surgeon. Ultimately, based on artificial intelligence technology, from the design and processing of the temporomandibular joint replacement device to the preparation and shaping of the implantation bed by the surgical robot according to the design scheme, a new technological system and surgical paradigm are formed.

[0057] The embodiments of the present invention have been described in detail above with reference to the accompanying drawings, but the present invention is not limited to the above embodiments. Even if various changes are made to the present invention, if these changes fall within the scope of the claims of the present invention and their equivalents, they shall still fall within the protection scope of the present invention.

Claims

1. A temporomandibular joint replacement device, characterized in that, include: A mandibular assembly, the mandibular assembly comprising a mandibular fixation bracket, a connecting rod, and a ball joint head; The mandibular fixation bracket is fixedly connected to the outer surface of the human mandible, the connecting rod extends and is arranged in the mandibular condyle resection area, the bottom end of the connecting rod is fixedly connected to the top end of the mandibular fixation bracket, and the ball joint head is fixedly set at the top end of the connecting rod. Temporal bone assembly, the temporal bone assembly including a temporal bone fixation frame and a glenoid fossa pad; The temporal bone fixation bracket is fixedly connected to the lateral surface of the human temporal bone, the glenoid fossa pad is placed in the resection area of ​​the mandibular fossa of the human temporal bone, and the glenoid fossa pad is fixedly connected to the bottom end of the temporal bone fixation bracket. The glenoid fossa liner has a receiving cavity inside, and the receiving cavity has a receiving opening on the side facing the mandibular component. The ball joint head is movably disposed inside the receiving cavity, and the inner wall of the receiving cavity is provided with a base layer, a variable stiffness elastic buffer layer and a surface layer in sequence along the thickness direction of the side wall of the glenoid fossa liner. The base layer is made of magnesium alloy and extends and fits to the inner wall of the receiving cavity of the articular socket liner; the variable stiffness elastic buffer layer is made of extracellular matrix biomimetic gradient hydrogel material and extends and fits to the inner wall of the base layer; the variable stiffness elastic buffer layer includes a first partition, a second partition, a third partition and an edge layer, the first partition is located on the circumferential inner wall of the receiving cavity of the articular socket liner at a first position, the wall thickness of the first partition is limited to 1.5-2.0 mm, and the material hardness of the first partition is limited to 10-20 A; The second partition is located on the circumferential inner wall of the socket liner receiving cavity between the first and second positions. The wall thickness of the second partition is limited to 1.0-1.5 mm, and the material hardness of the second partition is limited to 30-50 A. The third partition is located on the circumferential inner wall of the socket liner receiving cavity at the second position. The wall thickness of the third partition is limited to 2.0-3.2 mm, and the material hardness of the third partition is limited to 60-80 A. The edge layer is located at the edge of the socket liner receiving opening. The width of the edge layer is limited to 1.0-1.5 mm, and the material hardness of the edge layer is limited to at least greater than 80 A. The surface layer is made of nano-reinforced composite polyvinyl aldehyde material and is extended and fitted onto the inner wall surface of the variable stiffness elastic buffer layer. The temporomandibular joint replacement device is configured such that, during the opening movement of the human mandible, the ball joint head generates a hinge rotation movement at a first position in the glenoid fossa liner receiving cavity, and during the extension and retraction movement of the human mandible, the ball joint head generates a sliding movement between the first position and the second position in the glenoid fossa liner receiving cavity.

2. The temporomandibular joint replacement device as described in claim 1, characterized in that, The mandibular fixation bracket includes a first fixation branch and a second fixation branch, and the first fixation branch and the second fixation branch are fixedly connected to one end of the temporal bone component; The first fixed branch is configured to extend along the distal lateral wall of the mandibular ramus, and the second fixed branch is configured to extend along the mandibular notch of the mandible. The center point of the ball joint head, the farthest stress point of the first fixed branch away from the temporal bone component, and the farthest stress point of the second fixed branch away from the temporal bone component form an equilateral triangle.

3. The temporomandibular joint replacement device as described in claim 2, characterized in that, The first fixing branch, the second fixing branch, and the temporal bone fixing bracket are each provided with a plurality of fixing holes evenly distributed. The fixing holes are configured to allow the insertion of a fixing member into the human mandibular body or the human temporal bone body, so that the mandibular fixing bracket is fixedly connected to the human mandibular bone, and the temporal bone fixing bracket is fixedly connected to the human temporal bone.

4. The temporomandibular joint replacement device as described in claim 3, characterized in that, During the preparation stage, the first and second fixed branches are configured with lengths and widths that are adapted to the physiological parameters of different target human bodies, based on the personalized stress distribution conditions of the mandibular ramus region and mandibular notch region in the mandible of different target human bodies.

5. The temporomandibular joint replacement device as described in claim 4, characterized in that, During the manufacturing stage, based on the relative distribution of the mandible and temporal bone of different target human bodies, and the extension direction of the first fixing branch and the second fixing branch, the connecting rod body forms a personalized inclined distribution between the first position of the glenoid fossa liner accommodating cavity and the top end of the mandibular fixation bracket. Furthermore, the angle formed by the extension line of the force center of the connecting rod to the first fixed branch is equal to the angle formed by the extension line of the force center of the connecting rod to the second fixed branch.

6. The temporomandibular joint replacement device as described in claim 1, characterized in that, The mandibular fixation bracket has several anchor posts on the outer side of the condylar neck and the anterior edge of the mandibular ramus. The anchor posts adopt a barbed, forked, or umbrella-shaped structure and form gaps on the surface. The anchor posts are used to make contact with and actively interlock with the human ligaments and soft tissues. The mandibular fixation bracket is provided with several guide channels on the outer side of the condylar neck and the outer side of the anterior edge of the mandibular ramus. The guide channels are used to assist in the artificial suturing and fixation of human ligaments and soft tissues.

7. The temporomandibular joint replacement device as described in claim 1, characterized in that, The mandibular fixation bracket, the connecting rod, and the ball joint head are made of zirconium oxynitride bioceramic composite material and manufactured using an integral molding process. The temporal bone fixation bracket and the glenoid fossa liner are made of zirconium oxynitride bioceramic composite material and manufactured using an integral molding process.

8. A method for preparing a temporomandibular joint replacement device, characterized in that, The method for preparing a temporomandibular joint replacement device as described in any one of claims 1-7 comprises the following steps: S1: Based on CBCT or CT scanning technology, obtain three-dimensional structural data of the target human jawbone and joint area in static and dynamic states, and obtain dental occlusion data of the target human based on intraoral scanning technology. Register the three-dimensional structural data of the target human jawbone and joint area with the dental occlusion data to the same standard coordinate system to generate a digital model. S2: Define the osteotomy line positions for the diseased mandibular condyle region and the diseased temporal fossa region in the digital model; S3: Calculate the apparent bone density of the outer surface of the mandible of the target human body based on CBCT or CT scan data, and establish a mandibular dynamic model based on the three-dimensional structural data of the mandible and joint area of ​​the target human body in motion state. Calculate the stress distribution of the outer surface of the mandible of the target human body in motion state through inverse dynamic algorithm. S4: Based on the relative positional distribution of the mandible and temporal bone in the digital model, the relative movement relationship of the mandible and temporal bone recorded by the electronic face bow and virtual jaw frame, and combined with the apparent bone density and stress distribution of the outer surface of the mandible, a personalized mandibular component and temporal bone component are prepared.

9. A surgical robot system for temporomandibular joint replacement, characterized in that, The method for preparing a temporomandibular joint replacement device as described in claim 8 includes: The 3D model scanning module is used to acquire 3D structural data of the target human jawbone and joint area in static and dynamic states through CBCT or CT scanning technology, and to acquire the target human dentition occlusion data through intraoral scanning technology. The 3D structural data of the target human jawbone and joint area and the dentition occlusion data are registered to the same standard coordinate system to generate a digital model. The osteotomy line positioning module is used to define the location of the osteotomy line in the target human body for the diseased mandibular condyle region and the diseased temporal bone mandibular fossa region in the digital model; The stress distribution calculation module is used to calculate the apparent bone density of the outer surface of the mandible of the target human body based on CBCT or CT scan data, and to establish a mandibular dynamic model based on the three-dimensional structural data of the mandible and joint area of ​​the target human body in motion state. The stress distribution of the outer surface of the mandible of the target human body in motion state is calculated by the inverse dynamic algorithm. The medical device fabrication module is used to fabricate personalized mandibular and temporal bone components based on the relative positional distribution of the mandible and temporal bone in the target human body in the digital model, the relative movement relationship of the mandible and temporal bone recorded by the electronic face bow and virtual jaw frame, and the apparent bone density and stress distribution of the outer surface of the target human mandible. The surgical robot assembly module is used to assist in the assembly surgery of the temporomandibular joint replacement device based on the structural characteristics of the jawbone and joint area after osteotomy of the target human body.

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