Condyle positioning device and mandible fixator with condyle positioning device

Abstract

The invention provides a condyle positioning device and a lower jaw fixator with the condyle positioning device.The condyle positioning device comprises a condyle positioning component, a tooth retention guide plate and a dividing structure formed between the condyle positioning component and the tooth retention guide plate. Wherein the tooth retention guide plate and the condyle positioning component are of an integrated structure and can be separated along the segmentation structure, the condyle positioning component is suitable for being fixed to the front edge of the ramus of the mandible of a patient, and the tooth retention guide plate is manufactured based on the tooth form of the mandible part of the patient and fixed to the corresponding dentition. The condyle positioning component is connected with the lower jaw fixator through a mortise and tenon joint structure so as to position the specific position of the condyle of the patient after the lower jaw operation.

Description

Technical Field

[0001] This invention relates to the field of oral medicine, and more particularly to a condylar positioning device and a mandibular fixator with a condylar positioning device. Background Technology

[0002] In the field of oral and maxillofacial surgery, bilateral sagittal split osteotomy of the mandibular ramus (BSSO) is a key surgical procedure in orthognathic surgery for correcting mandibular deformities. It is widely used to treat various dentofacial deformities, including mandibular prognathism, open bite, micrognathia, asymmetry, and first and second branchial arch syndrome. The core goal of orthognathic surgery is to correct the pre-existing malocclusion and carefully construct a new terminal occlusal relationship. In this process, precise movement of the dentition leads to accurate displacement of the distal segment of the mandible after sagittal split osteotomy. The condyle on the proximal segment, due to its crucial role in maintaining normal temporomandibular joint function and overall facial stability, is generally required to be maintained in its pre-operative physiological position during the surgical procedure.

[0003] However, current BSSO surgery suffers from significant deficiencies in intraoperative condylar localization. Currently, condylar localization relies heavily on the surgeon's extensive clinical experience, performed using a free-hand approach. This traditional method severely lacks objective and precise reference standards, greatly increasing the uncertainty and risk of the surgical procedure. During actual surgery, the lack of precise guidance makes it difficult for the surgeon to accurately control the condylar position, easily leading to adverse outcomes such as condylar rotation or displacement. Once the condylar position deviates from its normal physiological position, it is highly likely to cause a series of serious postoperative complications, with recurrence of deformity and temporomandibular joint disorder symptoms being particularly common. Although the condyle itself has a certain capacity for self-remodeling and repositioning, clinical studies have shown that this self-repair mechanism cannot completely compensate for displacement deviations caused during surgery, thus adversely affecting surgical outcomes and the patient's long-term quality of life.

[0004] Further analysis from the perspective of patient group differences reveals significant differences in condylar characteristics and postoperative condylar stability among different types of dentofacial deformities. For example, compared to Class III patients, patients with skeletal Class II deformities have a relatively smaller condylar head volume. This anatomical difference makes skeletal Class II patients less able to resist the complex muscle forces surrounding them postoperatively, often resulting in condylar instability. Clinical data shows that skeletal Class II patients are more prone to condylar displacement after orthognathic surgery than other types, which is one of the important reasons for the relatively higher rate of postoperative deformity recurrence in this group.

[0005] In summary, existing BSSO procedures have significant shortcomings in condylar localization techniques, failing to meet the urgent clinical needs for improved surgical precision, reduced complication rates, and better long-term patient outcomes. Developing a new technology or device that can provide an objective and precise reference standard for intraoperative condylar localization has become a critical issue urgently needing resolution in the field of oral and maxillofacial surgery, possessing significant clinical importance and broad application prospects.

[0006] The description herein provides only background information in relation to the present invention and does not necessarily constitute prior art. Summary of the Invention

[0007] A major advantage of this invention is that it provides a highly accurate and easy-to-operate condylar positioning device and a mandibular fixator with a condylar positioning device. By combining preoperative digital design with intraoperative mechanical positioning structure, it effectively solves the problem of condylar rotation / displacement caused by the reliance on surgeon experience in traditional manual positioning, and significantly reduces the risk of postoperative temporomandibular joint disorder and recurrence of deformity.

[0008] Another advantage of this invention is that it provides a modular and detachable 3D printed positioning system. By using an integrated condylar positioning device in conjunction with a tooth retention guide and a terminal occlusal plate, the anatomical position of the condyle can be reproduced in three dimensions during surgery. Compared with existing CAD / CAM titanium plate positioning technology, it significantly reduces preoperative preparation time and material and manufacturing costs, and is more conducive to clinical application.

[0009] Another advantage of this invention is that it provides a condylar positioning device with self-calibration function and a mandibular fixator with condylar positioning device. Through the dual anchoring mechanism of tooth arch wrapping retention guide and bone surface fitting positioning clip, the surgeon can complete the six-degree-of-freedom precise positioning of the proximal bone segment without complicated operation, which helps to reduce condylar positioning error.

[0010] Another major advantage of this invention is that it provides an anatomically adaptable three-stage positioning system. The tooth retention guide's dentition-wrapping fixation and the bone surface fit design of the condylar positioning device help to shorten the preoperative retention hole positioning operation time, and the intraoperative positioning device installation process can be completed in a short time.

[0011] Another advantage of this invention is the development of a modular, split positioning structure. The cutting line design formed by 3D integrated printing reduces the time spent on surgical dissection operations. Combined with concave-convex matching components, it enables rapid alignment and installation of the terminal jaw plate and positioning clips, significantly improving the efficiency of the surgical procedure.

[0012] Another advantage of this invention is the construction of a precise biomechanical anchoring mechanism. Through the dual stabilizing structure of intermaxillary ligation and titanium screw fixation, the positioning accuracy of the proximal bone segment is improved, the positioning error is reduced compared with the traditional method, and the operation complexity index is reduced to a level that can be mastered by novice physicians.

[0013] The key innovation of this invention lies in establishing an operating system with zero training costs. Through the synergistic effect of anatomical adaptation structures and mechanical limiting devices, the surgical process completely eliminates the need for image navigation equipment, and the incidence of postoperative complications is reduced compared to existing technologies.

[0014] This application aims to provide a condylar positioning device and a mandibular fixator with a condylar positioning device to overcome the shortcomings of existing condylar positioning techniques. Specifically, addressing the problems of current manual positioning methods, which require high levels of skill from surgeons, carry significant risks, and incur high training costs, as well as the complex fabrication and assembly, long operation time, and high cost of CAD / CAM titanium plate positioning methods, this invention is dedicated to developing a new device that can achieve accurate condylar positioning while being inexpensive, easy to manufacture, and easy to operate, thus meeting the urgent needs of oral and maxillofacial surgery clinicians for improved surgical precision and reduced surgical risks and costs.

[0015] The positioning device of this invention can provide a more accurate and objective reference standard for condylar positioning during surgery, which greatly reduces the risk of condylar rotation or displacement due to inaccurate positioning, thereby effectively reducing the occurrence of postoperative deformity recurrence and temporomandibular joint disorders, and significantly improving the treatment effect and long-term prognosis of orthognathic surgery.

[0016] Compared to the complex CAD / CAM titanium plate positioning method, the condyle positioning device of this application is simpler in terms of manufacturing process. It does not require complex technology or high-end equipment, which can effectively reduce manufacturing costs and time costs, and is conducive to large-scale production and application.

[0017] The condylar positioning device described in this application is simple and easy to operate, requiring no lengthy special training for doctors to master the operating skills. This greatly reduces the learning cost and technical threshold for doctors, and helps to promote its application in a wider range of medical environments, thereby improving the overall level of orthognathic surgery.

[0018] According to one aspect of the invention, a condylar positioning device of the present invention, capable of achieving the aforementioned and other objects and advantages, includes a condylar positioning member, a tooth retention guide, and a segmented structure formed between the condylar positioning member and the tooth retention guide, wherein the tooth retention guide and the condylar positioning member are integrally formed and separable along the segmented structure. The condylar positioning member is adapted to be fixed to the anterior border of the mandibular ramus of a patient, and the tooth retention guide is fabricated based on the morphology of the patient's mandibular teeth and fixed in the corresponding dentition. The condylar positioning member is connected to a mandibular fixator via a tenon-and-mortise structure to position the patient's condyle at a specific location after mandibular surgery.

[0019] According to one embodiment of the present invention, the condyle positioning device includes a left condyle positioning device and a right condyle positioning device, wherein the left condyle positioning device is adapted to locate the left condyle of the patient, and the right condyle positioning device is adapted to locate the right condyle of the patient.

[0020] According to one embodiment of the present invention, the dividing structure is a dividing line, a groove, or an intermittent hole.

[0021] According to one embodiment of the present invention, the condylar positioning member includes a positioning body and a positioning connecting member integrally extending from the positioning body, wherein the positioning connecting member and the positioning body are integrally structured, and wherein the positioning connecting member is adapted to be connected to a jaw plate device connecting the patient's mandible.

[0022] According to one embodiment of the present invention, the positioning body is provided with a positioning groove, wherein the positioning groove has a U-shaped structure and gradually increases in size from top to bottom to conform to the growth shape of the mandible.

[0023] According to one embodiment of the present invention, the positioning body further includes an inner portion and an outer portion, wherein a positioning groove is formed between the inner portion and the outer portion, the inner portion of the positioning body is fitted to the inner side of the patient's mandible, and the outer portion of the positioning body is fitted to the outer side of the patient's mandible.

[0024] According to one embodiment of the present invention, the positioning body is further provided with at least one retaining hole, wherein the retaining hole is formed on the inner side portion and the outer side portion of the positioning body, and the retaining hole extends through the inner side portion and the outer side portion of the positioning body.

[0025] According to one embodiment of the present invention, the tooth retention guide further includes a guide connector and a housing structure, wherein the guide connector connects the housing structure to the positioning body, and the housing structure is adapted to the shape of the patient's human dental arch.

[0026] According to one embodiment of the present invention, the positioning connecting member includes a positioning end and a connecting end integrally extending from the positioning end, wherein the positioning end is connected to the positioning body, and the connecting end of the positioning connecting member is adapted to be connected to the jaw plate device through a tenon and mortise structure, and to fix and support the jaw plate device.

[0027] According to another aspect of this application, this application further provides a mandibular fixation device, including a condylar positioning device and a jaw plate device as described above, wherein the two sides of the jaw plate device are connected to the condylar positioning device by two mortise and tenon structures, and the jaw plate device is adapted to be fixed to the patient's maxillary and mandibular teeth to fix the final ramus and condylar position according to the terminal mandibular body and the matching jaw plate device.

[0028] According to one embodiment of the present invention, the jaw plate device further includes a jaw plate device body and a jaw plate connecting member, wherein the jaw plate connecting member and the jaw plate device body are integrally formed, the jaw plate device body is adapted to the patient's mandibular teeth, and the jaw plate device body at least partially covers the patient's teeth, wherein the jaw plate device body is fixed to the patient's mandible.

[0029] According to one embodiment of the present invention, the jaw plate connecting member is disposed on both sides of the jaw plate device body, and the jaw plate connecting member corresponds to the positioning connecting member of the condyle positioning member, and the jaw plate connecting member can be connected to the positioning connecting member of the condyle positioning member.

[0030] According to one embodiment of the present invention, the condylar positioning member, the tooth retention guide, and the jaw plate device are 3D printed parts.

[0031] The further objects and advantages of the invention will become fully apparent from the following description and accompanying drawings.

[0032] These and other objects, features and advantages of the present invention will become fully apparent from the following detailed description and accompanying drawings. Attached Figure Description

[0033] The technical solution of the present invention will be further described in detail below with reference to the accompanying drawings and embodiments. In the drawings, unless otherwise specified, the same reference numerals are used to denote the same parts. Wherein:

[0034] Figure 1A and Figure 1B This is a schematic diagram of the overall structure of the condyle positioning device according to a first preferred embodiment of the present invention.

[0035] Figure 2A and Figure 2B This is a schematic diagram of the installation state of the condyle positioning device according to the first preferred embodiment of the present invention.

[0036] Figure 3 This is a schematic diagram of the overall structure of the mandibular fixator according to a first preferred embodiment of the present invention.

[0037] Figure 4This is a schematic diagram of the mandibular fixator in use according to a first preferred embodiment of the present invention. Detailed Implementation

[0038] It should be noted that the embodiments shown in the accompanying drawings are merely examples used to specifically and vividly explain and illustrate the concept of the present invention. They are not necessarily drawn to scale in terms of size and structure, nor do they constitute a limitation on the concept of the present invention.

[0039] The directional terms such as up, down, left, right, front, back, front, back, top, and bottom mentioned or possibly used in this specification are defined relative to the structures shown in the various accompanying drawings. They are relative concepts and may therefore vary depending on their location and usage. Therefore, these or other directional terms should not be interpreted as restrictive.

[0040] It is understood that the term "a" should be understood as "at least one" or "one or more", that is, in one embodiment, the number of an element can be one, while in another embodiment, the number of the element can be multiple, and the term "a" should not be understood as a limitation on the number.

[0041] Refer to the accompanying drawings in this application specification. Figures 1A to 4 The condylar positioning device 100, which is a first preferred embodiment of this application, and the mandibular fixator with the condylar positioning device 100 are described below. The condylar positioning device 100 is an intraoperative positioning tool for orthognathic surgery (such as BSSO surgery). Its core function is to accurately maintain or restore the original physiological position of the proximal condyle after osteotomy through an anatomically adapted three-dimensional mechanical structure, thereby avoiding the condylar rotation / displacement problems caused by traditional free-hand positioning.

[0042] The mandibular fixation device further includes a jaw plate device 200, wherein the jaw plate device 200 is connected to the condylar positioning device 100 on both sides, and the jaw plate device 200 is adapted to be fixed to the patient's maxillary and mandibular teeth to fix the final ramus position according to the terminal mandibular body and the matching jaw plate device 200.

[0043] Specifically, the condyle positioning device 100 includes a left condyle positioning device and a right condyle positioning device, wherein the left condyle positioning device is adapted to locate the left condyle of the patient, and the right condyle positioning device is adapted to locate the right condyle of the patient. Hereinafter, the left condyle positioning device and the right condyle positioning device are collectively referred to as condyle positioning devices.

[0044] The condylar positioning device 100 includes a condylar positioning component 10 and a tooth retention guide 20, wherein the tooth retention guide 20 and the condylar positioning component 10 are integrally formed. The condylar positioning component 10 is adapted to be fixed to the anterior edge of the mandibular ramus of the patient, and the tooth retention guide 20 is fabricated based on some of the patient's mandibular teeth and fixed in the corresponding dentition. The condylar positioning component 10 is connected to the jaw plate device 200 through a tenon and mortise structure to locate the specific position of the patient's condyle after mandibular surgery.

[0045] The condylar positioning device 100 further includes a split structure 30, which is formed between the condylar positioning member 10 and the tooth retention guide 20, allowing the condylar positioning member 10 and the tooth retention guide 20 to be separated from each other via the split structure 30. Specifically, during use, after the condylar positioning member 10 is positioned by the tooth retention guide 20, the tooth retention guide 20 and the condylar positioning member 10 are separated by the split structure 30, and the tooth retention guide 20 is removed.

[0046] The segmentation structure 30 of the condylar positioning device 100 may be, but is not limited to, a segmentation line, a groove, or an intermittent hole. As an example, in a specific example of this application, the segmentation structure 30 is a recessed cutting line formed between the tooth retention guide 20 and the condylar positioning member 10, wherein the thickness of the segmentation line is thinner than the thickness of the condylar positioning member 10 and the tooth retention guide 20, thereby facilitating the separation of the condylar positioning member 10 and the tooth retention guide 20 from the segmentation structure 30.

[0047] The condylar positioning component 10 is fixed at the condyle of the patient's mandible. The condylar positioning component 10 includes a positioning body 11 and a positioning connecting component 12 integrally extending from the positioning body 11. The positioning body 11 is U-shaped, with the U-shape gradually increasing from top to bottom to conform to the growth shape of the mandible. During use, the positioning body 11 fits tightly against the patient's mandible, preventing displacement and making the operation more convenient and condylar positioning more accurate. The positioning connecting component 12 is an integral structure with the positioning body 11. The positioning connecting component 12 can be connected to the jaw plate device 200, thereby fixing the jaw plate device 200 through the positioning body 11 and the positioning connecting component 12 of the condylar positioning component 10.

[0048] The positioning body 11 is provided with a positioning groove 110, wherein the positioning groove 110 has a U-shaped structure and gradually increases from top to bottom to conform to the growth shape of the mandible. The positioning groove 110 of the positioning body 11 fits tightly against the patient's mandible and is not prone to displacement, thereby making the operation process more convenient and the condyle positioning more accurate.

[0049] The positioning body 11 further includes an inner portion 111 and an outer portion 112, wherein a positioning groove 110 is formed between the inner portion 111 and the outer portion 112. The inner portion 111 of the positioning body 11 fits against the inner side of the patient's mandibular ramus, and the outer portion 112 fits against the outer side of the patient's mandibular ramus. During fixation, a fixing element, such as a screw, is used to fix the positioning body 11 at a specific position on the patient's mandible.

[0050] The positioning body 11 is further provided with at least one retention hole 113, wherein the retention hole 113 is formed in the inner side portion 111 and the outer side portion 112 of the positioning body 11, and the retention hole 113 penetrates the inner side portion 111 and the outer side portion 112 of the positioning body, and the fixing element fixes the condylar positioning device to the patient's mandible through the retention hole 113 of the positioning body 11.

[0051] like Figure 1A and 1B As shown, the tooth retention guide 20 further includes a guide connector 21 and a housing structure 22. The guide connector 21 connects the housing structure 22 to the positioning body 11. The housing structure 22 is adapted to the shape of the patient's human dental arch and can enclose and accommodate multiple teeth. Its shape conforms to the corresponding crown shape, so that the housing structure 21 can closely fit and enclose the corresponding maxillary and mandibular dental arches of the patient during use, making the tooth retention guide 2 less prone to displacement and increasing the accuracy of positioning.

[0052] It is worth mentioning that the shape of the shell structure 22 of the tooth retention guide 20 is adapted to the shape of the patient's human dental arch. When worn, the position of the condylar positioning member 10 is located by the shell structure 22 of the tooth retention guide 20, and then the specific position of the condylar positioning member 10 is recorded by drilling.

[0053] The positioning connecting member 12 is used to connect and fix the jaw plate device 200, and one end of it extends integrally from the positioning body 11. The positioning connecting structure 12 protrudes from the front end of the positioning body 11. Preferably, in this preferred embodiment of the present application, the positioning connecting structure 12 is a connecting rod.

[0054] The positioning connecting member 12 extends integrally from the front end of the positioning body 11 of the condyle positioning member 10, wherein the positioning connecting member 12 includes a positioning end 121 and a connecting end 122 integrally extending from the positioning end 121, wherein the positioning end 121 is connected to the positioning body 11, and the connecting end 122 of the positioning connecting member 12 is adapted to connect to the jaw plate device 200 and fix and support the jaw plate device 200.

[0055] Preferably, in a specific example of this application, the positioning connecting member 12 can be installed as an integral structure with the jaw plate device 200 through a concave-convex structure, a snap-fit ​​structure or a threaded connection structure.

[0056] like Figure 3 and Figure 4 As shown, the jaw plate device 200 is adapted to the patient's maxillary and mandibular teeth. After bilateral mandibular ramus sagittal split osteotomy, the upper and lower teeth are placed in the jaw plate device 200 and intermaxillary ligation is performed. The position of the bilateral mandibular ramus is adjusted so that its anterior edge fits against the condylar positioning components 10 on both sides. The condylar positioning components 10 are fixed with titanium screws along the retention holes of the condylar positioning components 10, thereby positioning the condyle on the proximal bone segment to the preoperatively designed position. Then, the mesial and distal bone segments of the bilateral mandibles are fixed. This objective positioning method can effectively reduce the occurrence of condylar displacement.

[0057] The jaw plate device 200 further includes a jaw plate device body 210 and a jaw plate connecting member 220, wherein the jaw plate connecting member 220 and the jaw plate device body 210 are integrally formed, the jaw plate device body 210 is adapted to the patient's maxillary and mandibular teeth, and the jaw plate device body 210 at least partially covers the patient's teeth, wherein the jaw plate device body 210 is fixed to the patient's mandible.

[0058] The jaw plate connecting member 220 is disposed on both sides of the jaw plate device body 210, and the jaw plate connecting member 220 corresponds to the positioning connecting member 12 of the condyle positioning member 10. The jaw plate connecting member 220 can be connected to the positioning connecting member 12 of the condyle positioning member 10, thereby fixing the jaw plate device 200 and the mandible bound to the jaw plate device 200 by the condyle positioning member 10.

[0059] The positioning connecting member 12 of the condyle positioning member 10 and the jaw plate connecting member 220 of the jaw plate device 200 form a connecting and fixing member, and the jaw plate device body 210 of the jaw plate device 200 is fixed in a specific position by the positioning connecting member 12 and the jaw plate connecting member 220.

[0060] As an example, in a specific example of this application, the positioning connecting member 12 is implemented as a protruding connecting rod, and the jaw plate connecting member 220 of the jaw plate device 200 is a groove structure adapted to the protruding connecting rod. During the connection process, the positioning connecting member 12 is inserted into the groove structure of the jaw plate connecting member 220 to achieve connection and fixation.

[0061] like Figure 3 and Figure 4 As shown, the condylar positioning member 10 fits against the patient's mandible, and the tooth retention guide 20 tightly wraps around part of the patient's posterior teeth. Both are used to fix and position the relative position of the condylar positioning member and part of the patient's lower teeth. A segmentation structure 30 is provided between the condylar positioning member 10 and the tooth retention guide 20 for segmentation.

[0062] Once the condylar positioning member 10 is positioned relative to the patient's mandible, the positioning body 11 of the condylar positioning member 10 is positioned relative to the patient's mandible through the retention hole 113 of the condylar positioning member 10.

[0063] After the condylar positioning member 10 is positioned, the tooth retention guide 20 is separated from the condylar positioning member 10 by the segmentation structure 30, i.e., the excess tooth retention guide 20 is removed. When the tooth retention guide 20 has been cut and separated from the condylar positioning member 10 along the segmentation structure 30, the condylar positioning member 10 fits against the patient's mandible and is positioned and fixed along the retention hole. The positioning connecting member 12 on the outside of the condylar positioning member 10 and the jaw plate connecting member 220 on the outside of the jaw plate device 200 are installed in a concave-convex interlocking manner, thus achieving the expected use effect. The condylar positioning member accurately positions the patient's condyle during surgery.

[0064] It is worth mentioning that the jaw plate connecting member 220 of the jaw plate device 200 is spherical and is located on the buccal side of the jaw plate device 200. The jaw plate connecting member 220 is provided with a concave structure that matches the positioning connecting member 12 of the condyle positioning member 10.

[0065] Preferably, in this preferred embodiment of the present application, the condylar positioning member 10, the tooth retention guide 20, and the jaw plate device 200 are 3D printed parts. More preferably, the material used is med610. It is understood that the specific structural type and material of the condylar positioning device 100 and the jaw plate device 200 are merely examples and not limitations.

[0066] The following further explains the use of the mandibular fixator with the condylar positioning device, which includes preoperative positioning calibration, intraoperative device installation, and terminal sac matching and bone segment positioning. First, during preoperative positioning calibration (preoperative preparation stage), the 3D-printed condylar positioning device (including left and right condylar positioning devices and tooth retention guides) is sterilized, and its anatomical compatibility with the patient's mandibular dentition and the anterior border of the mandibular ramus is confirmed. The shell structure of the tooth retention guide must completely enclose the target tooth crown (usually from the mandibular first molar to the canine) to ensure no loosening.

[0067] The U-shaped structure of the left and right condylar positioning devices is fitted to the anterior edge of the mandibular ramus and adjusted to be in complete contact with the bone surface. The elastic clamping force of the devices is used to achieve initial fixation. At this time, the tooth retention guide plate needs to be tightly engaged with the corresponding tooth crown to form a double anchoring of "dental arch-bone surface".

[0068] Using a specialized drill bit, holes are drilled in the mandibular ramus along the pre-set retention holes (usually 2-3) of the condylar positioning device to a depth of approximately 5-8 mm. After drilling, the device is removed, leaving the bone holes as reference markers for intraoperative positioning.

[0069] Secondly, after the bilateral mandibular ramus sagittal osteotomy is completed during the intraoperative device installation (preoperative osteotomy), the condylar positioning device is re-attached: the tooth retention guide is precisely repositioned to the crown position recorded preoperatively; the U-shaped structure of the condylar positioning device is once again fitted to the anterior edge of the mandibular ramus to ensure that the retention hole is completely aligned with the preoperative drilling position.

[0070] Use a bone chisel or fissure drill to separate the condylar positioning device from the tooth retention guide along the recessed cutting line (material med610, thickness 0.5-1mm) at the connection between the condylar positioning device and the tooth retention guide, leaving only the condylar positioning device attached to the bone surface, and then remove the tooth retention guide.

[0071] Third, the matching and bone segment positioning of the terminal occlusal plate (i.e., the occlusal plate device) are crucial. A custom-made terminal occlusal plate (including the buccal spherical connector) is placed between the upper and lower dentition, and occlusal relationship reconstruction is achieved through intermaxillary ligation (arch splints or wire fixation). The concave structure of the terminal occlusal plate connector precisely matches the convex strip structure (5-10mm long) on ​​the outer side of the condylar positioning device.

[0072] The surgeon holds the proximal segments of the mandible (including the condyles) on both sides with both hands and makes slight adjustments to their position so that the anterior edge of the ramus is completely in contact with the inner wall of the condyle positioning device. At the same time, the concave-convex matching structure of the terminal plate restricts the rotational freedom of the bone segments (internal and external rotation, anteroposterior tilt), allowing only fine vertical adjustments.

[0073] Titanium screws (1.5-2.0 mm in diameter) are inserted along the fixation holes recorded preoperatively to fix the condylar positioning device to the ascending ramus of the mandible. At this time, the condyle on the proximal bone segment has been forcibly positioned to the physiological position designed preoperatively.

[0074] Fourth, final fixation and device removal of the mandibular osteotomy segment. After confirming the condylar position is correct, titanium plates / screws are used to fix the proximal and distal segments of the bilateral mandibles, completing the post-osteotomy segment splicing. The intermaxillary ligation device of the terminal plate is cut, and the terminal plate and condylar positioning device are removed.

[0075] In short, the mandibular fixator described in this application transforms condylar positioning from subjective experience judgment to mechanical limit control through a three-stage operation of "preoperative recording - intraoperative repositioning - final matching". This shortens the traditional positioning process, which takes more than 30 minutes, to within 10 minutes, and reduces the error rate to ±1.0mm (compared to ±2mm for traditional methods).

[0076] Those skilled in the art should understand that the embodiments of the present invention described above and shown in the accompanying drawings are merely examples and do not limit the present invention. The objectives of the present invention have been fully and effectively achieved. The functions and structural principles of the present invention have been demonstrated and explained in the embodiments, and any variations or modifications may be made to the implementation of the present invention without departing from the stated principles.

[0077] The technical scope of this invention is not limited to the content described above. Those skilled in the art can make various modifications and variations to the above embodiments without departing from the technical concept of this invention, and all such modifications and variations fall within the protection scope of this invention.

Claims

1. A condylar positioning device, characterized in that, The device includes a condylar positioning member, a tooth retention guide, and a segmented structure formed between the condylar positioning member and the tooth retention guide, wherein the tooth retention guide and the condylar positioning member are integrally formed, the condylar positioning member is adapted to be fixed to the anterior margin of the mandibular ramus, the tooth retention guide positions the condylar positioning member at a specific position on the patient's mandibular condyle based on the position of at least some of the patient's mandibular teeth, and wherein the condylar positioning member and the tooth retention guide are separable along the segmented structure.

2. The condyle positioning device according to claim 1, wherein the condyle positioning device includes a left condyle positioning device and a right condyle positioning device, wherein the left condyle positioning device is adapted to locate the left condyle of the patient, and the right condyle positioning device is adapted to locate the right condyle of the patient.

3. The condyle positioning device according to claim 1, wherein the dividing structure is a dividing line, a groove, or an intermittent hole.

4. The condylar positioning device according to claim 3, wherein the condylar positioning component includes a positioning body and a positioning connecting component integrally extending from the positioning body, wherein the positioning connecting component and the positioning body are integrally structured, and wherein the positioning connecting component is adapted to be connected to the patient jaw plate device via a tenon and mortise structure.

5. The condylar positioning device according to claim 4, wherein the positioning body is provided with a positioning groove, wherein the positioning groove has a U-shaped structure, and the positioning groove gradually increases from top to bottom to conform to the growth shape of the mandible.

6. The condylar positioning device according to claim 5, wherein the positioning body further comprises an inner portion and an outer portion, wherein a positioning groove is formed between the inner portion and the outer portion, the inner portion of the positioning body is fitted to the inner side of the patient's mandible, and the outer portion of the positioning body is fitted to the outer side of the patient's mandible.

7. The condyle positioning device according to claim 6, wherein the positioning body further comprises at least one retaining hole, wherein the retaining hole is formed on the inner side portion and the outer side portion of the positioning body, and the retaining hole penetrates through the inner side portion and the outer side portion of the positioning body.

8. The condylar positioning device according to claim 7, wherein the tooth retention guide further comprises a guide connector and a housing structure, wherein the guide connector connects the housing structure to the positioning body, and the housing structure is adapted to the shape of the patient's human dental arch.

9. The condylar positioning device according to claim 8, wherein the positioning connecting member includes a positioning end and a connecting end integrally extending from the positioning end, wherein the positioning end is connected to the positioning body, and the connecting end of the positioning connecting member is adapted to be connected to the jaw plate device through a tenon and mortise structure, and to fix and support the jaw plate device.

10. A mandibular fixator, characterized in that, Includes the condylar positioning device and jaw plate device as described in any one of claims 1 to 9, wherein the jaw plate device is connected to the condylar positioning device on both sides, and the jaw plate device is adapted to be fixed to the patient's maxillary and mandibular teeth to fix the final ramus and condylar position according to the terminal mandibular body and the matching jaw plate device.

11. The mandibular fixation device according to claim 10, wherein the mandibular plate device further comprises a mandibular plate device body and a mandibular plate connecting member, wherein the mandibular plate connecting member and the mandibular plate device body are integrally formed, the mandibular plate device body is adapted to the patient's maxillary and mandibular teeth, and the mandibular plate device body at least partially covers the patient's teeth, wherein the mandibular plate device body is fixed to the patient's mandible.

12. The mandibular fixator according to claim 11, wherein the jaw plate connecting member is disposed on both sides of the jaw plate device body, and the jaw plate connecting member corresponds to the positioning connecting member of the condyle positioning member, and the jaw plate connecting member can be connected to the positioning connecting member of the condyle positioning member.

13. The mandibular fixation device according to claim 11, wherein the condylar positioning member, the tooth retention guide, and the jaw plate device are 3D printed parts.

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