An orthodontic appliance and method of use thereof

Abstract

The embodiment of the present application relates to the technical field of oral orthodontics, and discloses an oral orthodontic correction device and a use method thereof.The correction device comprises a maxillary pad, a mandibular pad, a rear inclined surface, a front inclined surface and a rotatable connecting rod; wherein the maxillary pad and the mandibular pad are movably connected through the rotatable connecting rod; the front inclined surface is arranged at the rear end of the mandibular pad; the rear inclined surface is arranged at the front end of the maxillary pad; and the front inclined surface and the rear inclined surface are mutually fitted to guide mandibular protrusion.The present application solves the defect that the existing headgear myostimulator is inconvenient to wear and use.

Description

Technical Field

[0001] This invention relates to the field of orthodontic technology, and in particular to an orthodontic device and its method of use. Background Technology

[0002] In the field of orthodontic treatment, skeletal Class II malocclusion is a common craniofacial deformity, characterized by a disharmony in the sagittal relationship between the maxilla and mandible, with the mandible displaced posteriorly relative to the maxilla. Mandibular retrusion caused by mandibular hypoplasia or posterior displacement is the main pathogenesis of skeletal Class II malocclusion.

[0003] High-angle skeletal Class II malocclusion is more complex. From the perspective of three-dimensional craniofacial development, the core problem in this type of case is the excessive vertical development of the jawbone, with a significantly increased mandibular plane angle (SN-MP) (often greater than 40°) and insufficient development of the posterior height (S-Go), resulting in a clockwise rotation of the mandible. This leads to chin retrusion, excessive anterior and inferior height, and disordered temporomandibular joint fossa-condylar spatial relationship. It is also accompanied by a certain degree of disproportion between the width of the upper and lower jaws, which seriously affects the user's facial aesthetics and oral function.

[0004] For skeletal Class II high-angle patients at different stages of growth and development, commonly used clinical treatment methods include early functional orthodontic treatment, orthodontic compensation treatment, and combined orthodontic and orthognathic treatment.

[0005] For adolescent users, since they are still in the peak period of growth and development, early functional orthopedic treatment can make full use of their growth and development potential to guide the development of the mandible, while strictly controlling the vertical growth of the mandible, which is the preferred treatment option in clinical practice.

[0006] Currently, the appliance commonly used in early functional orthodontic treatment is the capitol muscle activator. Its mechanism of action is as follows: by guiding the mandible to protrude forward and stimulating condylar growth, it promotes mandibular development, and by using posterior and superior traction to inhibit excessive vertical development of the maxilla, it improves the vertical relationship of the jawbone.

[0007] However, the aforementioned capillary muscle activator still has many shortcomings in actual clinical application. On the one hand, the capillary muscle activator has limited corrective effect on the width discrepancy between the maxilla and mandible. It may further aggravate the width discrepancy between the maxilla and mandible due to the leading effect of the mandible, thus affecting the corrective effect.

[0008] On the other hand, this head cap muscle stimulator has an extraoral part, which cannot be worn when the user is chewing, leading to decreased user compliance and failing to fully utilize daily chewing and speaking muscle activities to stimulate mandibular protrusion, thus affecting treatment efficiency.

[0009] Furthermore, the traditional headgear traction direction design lacks precise basis, resulting in technical defects that make it difficult to accurately achieve reverse rotation of the jawbone, thus affecting the orthodontic effect.

[0010] Therefore, there is an urgent need to provide new orthodontic devices for the early correction of skeletal Class II high angle cases, in order to solve the problems of existing cap muscle activators being unable to simultaneously adjust the width of the upper and lower jaws and provide all-weather control, having low user compliance, and being unable to precisely control the direction of traction force. Summary of the Invention

[0011] The present invention provides a corrective device that aims to solve the shortcomings of existing head cap muscle activators, which are inconvenient to wear and use.

[0012] In a first aspect, embodiments of the present invention provide an orthodontic device. It includes: a maxillary pad, a mandibular pad, a posterior slope, an anterior slope, and a rotatable connecting rod; wherein the maxillary pad and the mandibular pad are movably connected via the rotatable connecting rod; the anterior slope is disposed at the rear end of the mandibular pad; the posterior slope is disposed at the front end of the maxillary pad; the anterior slope and the posterior slope fit together to guide mandibular protrusion.

[0013] Optionally, the front inclined surface and the rear inclined surface are made of stainless steel, and the inclined surface formed by the front inclined surface and the rear inclined surface fitting together has an inclination angle of 45°.

[0014] Optionally, the rotatable connecting rod has a rotation angle range of -90° to 90° and can be switched between an open state and a closed state;

[0015] When the rotatable connecting rod is in the closed state, the maxillary pad and the mandibular pad are connected to each other; when the rotatable connecting rod is in the open state, the maxillary pad and the mandibular pad can be separated from each other.

[0016] The rotatable connecting rod is also connected to an external bow tube connecting structure, which is a cylindrical structure connected to the rotatable connecting rod, and a rectangular through hole is provided in the cylindrical structure along the axial direction.

[0017] Optionally, the lower half of the maxillary pad and the upper half of the mandibular pad are provided with receiving grooves for accommodating the rotatable connecting rod. One end of the rotatable connecting rod is rotatably connected to the maxillary pad via a pivot, and the other end of the rotatable connecting rod is provided with a ball head. The bottom end of the receiving groove forms a circular cavity that is adapted to the ball head.

[0018] The rotatable connecting rod can rotate around the pivot, so that the rotatable connecting rod is embedded in the receiving groove, and the ball head is locked in the circular cavity, forming the closed state.

[0019] Optionally, the orthodontic device further includes an arch expander screw; the arch expander screw is embedded in the inner side of the maxillary pad and is used to adjust the width of the maxilla.

[0020] Optionally, the orthodontic device further includes: an extraoral arch; the extraoral arch is detachably connected to the posterior inclined surface; specifically, the extraoral arch is detachably connected to the extraoral arch tube connection structure;

[0021] The external bow includes a first end, a second end, and a body. The body is connected between the first and second ends of the external bow. The first end of the external bow engages with the headgear to provide upward and backward traction. The second end of the external bow is rectangular and fits perfectly with the rectangular through hole of the external bow tube connection structure.

[0022] Optionally, the rotatable connecting rod is further provided with a thin-film timer and a thin-film pressure sensor, which are respectively bonded to the rotatable connecting rod.

[0023] Optionally, the thin-film timer includes an integrated sealed shell, a sensor recognition module, a timing main control module, a reminder interaction module, a power supply module, and an adhesive fixing module. The integrated sealed shell is a medical-grade flexible silicone arc-shaped shell structure, including an upper shell and a lower shell. The upper shell and the lower shell are seamlessly sealed by ultrasonic pressing to form an IPX8 waterproof sealed cavity. The sensor recognition module, the timing main control module, the reminder interaction module, and the power supply module are all built into this cavity.

[0024] The sensing and recognition module includes a miniature pressure sensor, a six-axis attitude gyroscope, and a circuit board. The miniature pressure sensor is embedded in the fitting surface of the cavity of the integrated sealed shell. The six-axis attitude gyroscope is integrated on the circuit board. The miniature pressure sensor and the six-axis attitude gyroscope are connected to each other and are also connected to the timing main control module for dual verification and recognition of the orthodontic appliance wearing status.

[0025] The timing control module includes an ultra-low power micro MCU chip and a local storage unit. The ultra-low power micro MCU chip has a built-in customizable wearing time threshold program and a 24-hour automatic reset timing program, which is used to count and store the effective wearing time of the orthodontic device each day.

[0026] The reminder interaction module includes a miniature flat vibration motor and a hidden LED soft light. The vibration motor and the LED soft light are electrically connected to an ultra-low power micro MCU chip, which is used to output intermittent vibration and light reminders when the wearing time for the day is not up to standard, and to stop reminding when the wearing time reaches the standard.

[0027] The power supply module includes an ultra-thin micro lithium battery and external magnetic charging contacts. The magnetic charging contacts are embedded in an integrated sealed shell without openings. The magnetic charging contacts can be used with a magnetic charging base to achieve sealed charging. The power supply module integrates overcharge, overvoltage, and overcurrent protection circuits.

[0028] The adhesive fixing module is a medical removable double-sided adhesive layer located at the bottom of the sealed outer shell.

[0029] Secondly, embodiments of the present invention provide a method for using an orthodontic appliance. This includes the following steps:

[0030] Step 1: Obtain the impedance center of the maxilla using the three-dimensional finite element analysis method;

[0031] Step 2: Adjust the parameters of the headgear so that the traction angle of the external bow on the headgear to the external bow tube connecting structure is 45-60° with the synaptic plane. At this time, the traction direction is above the center of the maxillary resistance, so that the maxilla exhibits a counter-rotation trend.

[0032] Step 3: Wear the orthodontic appliance;

[0033] Step 4: Determine the wearing time. For example, if the timer has reached its set time or the wearer needs to eat, the rotatable connecting rod can be opened to separate the maxillary pad and mandibular pad. If the timer has not reached its set time or it is convenient for the wearer to wear the pad, the rotatable connecting rod can be in the closed state to connect the maxillary pad and mandibular pad, thus initiating the orthodontic process.

[0034] Preferably, the three-dimensional finite element analysis method includes the following steps:

[0035] Step 1: Establish a database based on the wearer's oral and maxillofacial cone-beam CT scan. The cone-beam CT scan parameters for the oral and maxillofacial region are: voltage 110KV, current 3.37~3.67mA, slice thickness 0.3mm, and field of view 12. 12cm;

[0036] Step 2: Image segmentation is performed using interactive medical imaging control system software, and mesh generation is performed using ANSYS software. The mesh uses tetrahedral elements with a size of 1-3 mm and a mesh quality ≥ 0.7. At the same time, the elastic moduli of the maxillary cortical bone, cancellous bone, teeth, and periodontal ligament are defined as 13.8 GPa, 1.38 GPa, 19.6 GPa, and 0.68 MPa, respectively, with Poisson's ratios of 0.3, 0.3, 0.3, and 0.45, respectively.

[0037] Step 3: In ANSYS software, a static analysis method is used, with the loading magnitude consistent with the traction force of the extraoral arch. The constraint conditions are fixed constraints on the top surface of the maxilla and the condyle of the mandible. By simulating the mechanical effects of different traction directions, the specific location of the impedance center of the maxilla is determined.

[0038] The beneficial effects of the orthodontic device provided in this invention are as follows: The width of the maxilla and mandible is adjusted by the expanding screw; the anterior and posterior inclined planes work together to guide mandibular protrusion; the rotatable connecting rod adapts to oral activities such as chewing; the extraoral arch assists in inhibiting excessive vertical development of the maxilla; simultaneously, a three-dimensional finite element model of the maxilla and mandible is established; the impedance center of the maxilla is identified through three-dimensional finite element analysis; the traction direction of the headgear is designed so that the traction force passes above the impedance center of the maxilla, achieving reverse rotation of the mandible; ultimately, it achieves all-weather mandibular control and synergistic correction of the imbalance between the width of the maxilla and mandible and reverse rotation of the mandible. This invention has a reasonable structure and is easy to wear. It can fully utilize the user's daily chewing, speaking, and other muscle activities to stimulate mandibular protrusion, improve user compliance, effectively guide mandibular development, control vertical growth of the mandible, and achieve reverse rotation of the mandible. It can be widely used in the early correction of adolescent skeletal Class II high-angle cases, and has significant clinical application value and promotion prospects. (The rotatable connecting rod opens to accommodate the user's oral activities such as chewing and speaking, eliminating the need for frequent removal and enabling all-day jawbone adjustment. Furthermore, combined with the guiding effect of the anterior and posterior inclines, it can fully utilize daily muscle activities to stimulate mandibular protrusion, improving treatment efficiency.)

[0039] In addition, it addresses the technical pain points of existing orthodontic timing devices, such as mistimed operation, cumbersome operation, strong foreign body sensation, poor waterproofing, non-reusability, and lack of intelligent reminders. It achieves automated and high-precision statistics of the effective wearing time of orthodontic devices, and intelligent reminders when the time is not up to standard. At the same time, it meets the usage requirements of lightweight, safety and hygiene, seamless reusability, and compatibility with all invisible orthodontic devices.

[0040] It is also equipped with a thin-film pressure sensor to sense whether the orthodontic device is being worn, thus preventing unnecessary operation of other internal components. Attached Figure Description

[0041] One or more embodiments are illustrated by way of example with reference to the accompanying drawings. These illustrations do not constitute a limitation on the embodiments. Elements having the same reference numerals in the drawings are denoted as similar elements. Unless otherwise stated, the figures in the drawings are not to be limited by scale.

[0042] Figure 1 This is a schematic diagram of the corrective device according to an embodiment of the present invention;

[0043] Figure 2 This is an exploded view of the corrective device according to an embodiment of the present invention;

[0044] Figure 3This is a schematic diagram of Embodiment 1 of the corrective device of the present invention;

[0045] Figure 4 This is a schematic diagram of Embodiment 2 of the corrective device of the present invention;

[0046] Figure 5 This is a schematic diagram of embodiment 3 of the corrective device of the present invention;

[0047] Figure 6 This is a schematic diagram of embodiment 4 of the corrective device of the present invention;

[0048] Figure 7 This is a schematic diagram of embodiment 5 of the corrective device of the present invention. Detailed Implementation

[0049] The present invention will now be described in detail with reference to specific embodiments. It should be emphasized that the following description is merely exemplary and is not intended to limit the scope and application of the present invention.

[0050] It should be noted that, unless otherwise expressly specified and limited, the terms "center," "longitudinal," "lateral," "upper," "lower," "vertical," "horizontal," "inner," and "outer," etc., used in this specification to indicate orientation or positional relationships are based on the orientation or positional relationships shown in the accompanying drawings, and are only for the convenience of describing the invention and simplifying the description, and do not indicate or imply that the device or element referred to must have a specific orientation, or be constructed and operated in a specific orientation, and therefore should not be construed as a limitation of the invention. The terms "installed," "connected," "linked," and "fixed," etc., should be interpreted broadly. For example, they can refer to a fixed connection, a detachable connection, or an integral connection; they can refer to a mechanical connection or an electrical connection; they can refer to a direct connection or an indirect connection through an intermediate medium. Furthermore, the terms "first" and "second" are used for descriptive purposes only and should not be construed as indicating or implying relative importance or implicitly specifying the number of indicated technical features; thus, features defined with "first" or "second" may explicitly or implicitly include one or more of that feature; "multiple" means two or more; and "and / or" includes any and all combinations of one or more related listed items. Those skilled in the art can understand the specific meaning of the above terms in this invention according to the specific circumstances.

[0051] This invention provides a corrective device. For example... Figure 1 and Figure 2 As shown, the orthodontic device includes: a maxillary pad, a mandibular pad, a posterior slope 11, an anterior slope 12, and a rotatable connecting rod 13.

[0052] Both the maxillary and mandibular pads have a U-shaped structure that matches the human dental arch. The inner surfaces (i.e., tissue surfaces) of both have an impression contour that conforms to the anatomical shape of the user's upper and lower teeth and alveolar bone, so that they can cover the user's upper and lower teeth when worn, serving as the wearing base of the orthodontic appliance.

[0053] Specifically, both the maxillary and mandibular pads can be made of medical-grade resin materials, which fit closely to the contours of the upper and lower teeth.

[0054] The posterior slope 11 and the anterior slope 12 are guide structures that guide the mandibular protrusion. The anterior slope 12 is located at the posterior end of the mandibular pad, while the posterior slope 11 is located at the anterior end of the maxillary pad. When the anterior slope 12 and the posterior slope 11 are in contact with each other, they form an inclined surface that guides the mandibular protrusion.

[0055] Specifically, the front slope 12 and the rear slope 11 are made of stainless steel. The angle of inclination of the inclined surface formed by the front slope 12 and the rear slope 11 is 45°, so as to achieve a better orthodontic effect.

[0056] The maxillary pad and mandibular pad are movably connected by a rotatable connecting rod 13, which is made of carbon structural steel, ensuring that the maxillary pad and mandibular pad maintain a unified linkage within the oral cavity. The end of the rotatable connecting rod 13 at the junction of the maxillary pad and mandibular pad is provided with a toothed structure to prevent displacement under traction force.

[0057] When the user wears the orthodontic device and performs a closed bite, the rotatable connecting rod 13 adapts to the relative movement of the upper and lower jaws and restricts their separation. At this time, the anterior slope 12 on the mandibular pad and the posterior slope 11 on the maxillary pad come into contact with each other and fit together, forming an inclined surface that generates a sliding guiding effect, forcibly guiding the user's mandible to slide forward along the inclined surface.

[0058] In some embodiments, the rotatable connecting rod 13 is a movable component that can switch between an open state and a closed state. Its rotation angle range is set to -90° to 90°, switching between the open and closed states depending on the rotation angle.

[0059] When the rotatable connecting rod 13 is in the closed state, the maxillary pad and the mandibular pad are connected to each other and cannot be separated due to the restriction of the rotatable connecting rod 13. When the rotatable connecting rod 13 is in the open state, the maxillary pad and the mandibular pad are no longer restricted by the rotatable connecting rod 13 and can be separated from each other.

[0060] The rotatable connecting rod 13 is also connected to an external bow tube connection structure, which is a cylindrical structure connected to the rotatable connecting rod 13, and a rectangular through hole is provided in the cylindrical structure along the axial direction.

[0061] For details, please continue reading. Figure 2 One end of the rotatable connecting rod 13 is rotatably connected to the rear inclined surface 11 via a pivot 14, allowing it to rotate within a range of rotation angles. The other end of the rotatable connecting rod 13 is provided with a ball head 15.

[0062] The lower half of the maxillary pad and the upper half of the mandibular pad are provided with receiving grooves 16 for accommodating the rotatable connecting rod 13. One end of the rotatable connecting rod 13 is rotatably connected to the maxillary pad through a rotating shaft, and the other end of the rotatable connecting rod 13 is provided with a ball head. The bottom end of the receiving groove 16 forms a circular cavity 17 that is adapted to the ball head 15.

[0063] The rotatable connecting rod 13 can rotate around the pivot so that it is embedded in the receiving groove 16, and the ball head is locked in the circular cavity 17 to form the closed state.

[0064] Therefore, when the rotatable connecting rod 13 rotates around the pivot 14 until the ball head 15 is embedded in the circular cavity 17, the ball head 15 will be stopped by the circular cavity 17, so that the maxillary pad and the mandibular pad are connected to each other and cannot be separated. The rotatable connecting rod 13 is in a closed state.

[0065] Conversely, when the rotatable connecting rod 13 rotates around the pivot 14 until the ball head 15 disengages from the circular cavity 17, the maxillary pad and mandibular pad can separate from each other and are no longer restricted by the rotatable connecting rod 13. At this time, the rotatable connecting rod 13 is in the open state.

[0066] In some embodiments, the posterior slope 11 and the anterior slope 12 can be securely fixed to the maxillary pad and the mandibular pad by means of pre-embedded fitting, mechanical locking or high-strength bonding.

[0067] For example, a metal retention structure is provided at the bottom of the rear slope 11 and the front slope 12 (i.e., the mating surface that contacts the resin pad). The retention structure can be a retention mesh bottom, barbs, or retention pins. During the resin molding or curing process of manufacturing the maxillary and mandibular pads, the retention structure is pre-embedded inside the resin material. After the resin cures, the stainless steel slope and the resin pad form a high-strength mechanical fit, effectively preventing the slope from falling off under stress.

[0068] For example, the bottom of the rear slope 11 and the front slope 12 are provided with a fixing plate with through holes, and the fixing plate is locked and fastened to the predetermined position of the maxillary pad and the mandibular pad by a micro medical screw.

[0069] In some embodiments, the orthodontic device further includes an arch expander screw. The arch expander screw is fitted inside the maxillary pad and is a functional component for adjusting the width of the maxilla.

[0070] The maxillary pad is divided into two independent left and right parts along the midsagittal plane (mid-palatal suture). The two ends of the arch expander screw are respectively fixed and embedded in the left and right parts of the maxillary pad, so that the left and right parts of the maxillary pad can be smoothly separated horizontally.

[0071] Specifically, the expander screw can be made of stainless steel, with an adjustment stroke of 8~12mm (e.g., 10mm) and an adjustment accuracy of 0.2~0.25mm (e.g., 0.25mm) for a single step adjustment (e.g., rotating the expander screw 1 / 4 turn).

[0072] In practice, by inserting a special key into the adjustment hole of the expander screw and rotating it in a specific direction, the left and right parts of the maxillary pad are pushed to separate smoothly in a horizontal direction, thereby gradually adjusting the width of the maxilla. This allows for the application of a continuous, uniform, and gentle lateral expansion force to the maxillary arch and palatal midline, precisely controlling the displacement and speed of the expander.

[0073] In other embodiments, the orthodontic device also includes an external oral bow. The external oral bow is a functional component that engages with a headgear to provide upward and backward traction. The traction force of the external oral bow can be adjusted using a traction rubber band.

[0074] The external oral arch and the posterior slope are detachably connected. When not in use, the external oral arch can be removed from the posterior slope and connected to the posterior slope only when sleeping at night, for use with other functional components of the orthodontic device.

[0075] Specifically, the rotatable connecting rod is also connected to an external bow tube connecting structure. This external bow tube connecting structure is a cylindrical structure extending from the rotatable connecting rod, and a rectangular through hole is provided along the axial direction inside the cylindrical structure. The external bow includes a first end, a second end, and a body part. The body part is connected between the first end and the second end of the external bow. The first end of the external bow cooperates with the head cap to provide a backward and upward traction force, and the second end of the external bow is cuboid in shape, which fits perfectly with the rectangular through hole of the external bow tube connecting structure.

[0076] The rotatable connecting rod is also equipped with a thin-film timer and a thin-film pressure sensor, which are respectively bonded to the rotatable connecting rod.

[0077] The thin-film timer includes an integrated sealed shell, a sensor recognition module, a timing control module, a reminder interaction module, a power supply module, and an adhesive fixing module. The integrated sealed shell is a medical-grade flexible silicone arc-shaped shell structure, including an upper shell and a lower shell. The upper shell and the lower shell are seamlessly sealed by ultrasonic pressing to form an IPX8 waterproof sealed cavity. The sensor recognition module, the timing control module, the reminder interaction module, and the power supply module are all built into this cavity.

[0078] The sensing and recognition module includes a miniature pressure sensor, a six-axis attitude gyroscope, and a circuit board. The miniature pressure sensor is embedded in the fitting surface of the cavity of the integrated sealed shell. The six-axis attitude gyroscope is integrated on the circuit board. The miniature pressure sensor is connected to the six-axis attitude gyroscope and is also connected to the timing main control module for dual verification and recognition of the orthodontic appliance wearing status.

[0079] The timing control module includes an ultra-low power micro MCU chip and a local storage unit. The ultra-low power micro MCU chip has a built-in customizable wearing time threshold program and a 24-hour automatic reset timing program, which is used to count and store the effective wearing time of the orthodontic device each day.

[0080] The reminder interaction module includes a miniature flat vibration motor and a hidden LED soft light. The vibration motor and LED soft light are electrically connected to an ultra-low power micro MCU chip, which is used to output intermittent vibration and light reminders when the wearing time for the day is not up to standard, and to stop reminding when the wearing time reaches the standard.

[0081] The power supply module includes an ultra-thin micro lithium battery and an external magnetic charging contact. The magnetic charging contact is embedded in an integrated sealed shell without any openings. The magnetic charging contact can be used with a magnetic charging base to achieve sealed charging. The power supply module integrates overcharge, overvoltage, and overcurrent protection circuits.

[0082] The adhesive fixing module is a removable double-sided medical adhesive layer located at the bottom of the sealed outer shell.

[0083] Precise timing is achieved through a dual-sensor, dual-verification mechanism, while intelligent statistics and reminders are provided by an ultra-low-power main control chip. After the device is powered on and in standby mode, it collects contact pressure data in real time through a miniature pressure sensor and spatial posture data through a gyroscope. It is considered to be worn effectively only when the pressure threshold is met and the posture angle matches the oral cavity wearing state, and the timing is started to accumulate. If any sensor data fails to meet the standard, the timing is immediately paused to prevent invalid timing.

[0084] The main control chip compares the cumulative wearing time with the preset threshold in real time, controls the reminder module based on the comparison results, and stores daily wearing data locally for visualized data management. The device automatically goes into sleep mode when idle to reduce power consumption; the timer function is locked while charging to avoid data errors, achieving automated, precise, and intelligent management of orthodontic wear time.

[0085] This orthodontic appliance is in the corrective process as long as it is worn inside the mouth, regardless of whether the connecting rod is open or closed. The difference is that in the open state, it only guides the mandible forward, while in the closed state, in conjunction with the external bow, it not only guides the mandible forward but also provides posterior and superior traction to control the growth of the maxilla. Generally, the traction should be worn for 12 hours a day. Therefore, our timing module needs to record: 1. Total wearing time of the appliance; 2. Time spent using the appliance in conjunction with traction.

[0086] Regarding point 1, the total wearing time of the orthodontic appliance is accumulated in real time by the main control chip. Regarding point 2, the recording of the time the orthodontic appliance is used in conjunction with traction requires the use of a thin-film timer and a thin-film pressure sensor. Because the rotatable connecting rod 13 is made of carbon structural steel, when the external oral arch is in working condition, the thin-film pressure sensor will be deformed by force, and the surface will produce a slight elastic deformation. The thin-film sensor undergoes a slight elastic deformation along with the surface of the rod, and the internal strain gauge deforms synchronously. The resistance of the thin-film pressure sensor changes accordingly. The greater the deformation, the more obvious the change in resistance. The thin-film pressure sensor is connected to the ultra-low power micro MCU chip of the thin-film timer for data recording. Therefore, there are two alarm situations: one is that the total wearing time has not reached 22 hours, and the other is that the time the orthodontic appliance is used in conjunction with external oral arch traction is less than 12 hours.

[0087] The reminder interaction module includes a miniature flat vibration motor and a hidden LED soft light. Both the vibration motor and the LED soft light are electrically connected to an ultra-low power micro MCU chip, which is used to output intermittent vibration and light reminders when the wearing time for the day is not up to standard, and to stop reminding when the wearing time reaches the standard.

[0088] However, considering that the miniature flat vibration motor may not be very comfortable to vibrate continuously in the mouth, other reminder modes can also be set, such as keeping only the hidden LED soft light.

[0089] Another embodiment is as follows:

[0090] The thin-film timer includes an integrated sealed shell, a sensor recognition module, a timing control module, a power supply module, and an adhesive fixing module. The integrated sealed shell is a medical-grade flexible silicone arc-shaped shell structure, including an upper shell and a lower shell. The upper shell and the lower shell are seamlessly sealed by ultrasonic pressing to form an IPX8 waterproof sealed cavity. The sensor recognition module, the timing control module, and the power supply module are all built into this cavity.

[0091] The sensing and recognition module includes a miniature pressure sensor, a six-axis attitude gyroscope, and a circuit board. The miniature pressure sensor is embedded in the fitting surface of the cavity of the integrated sealed shell. The six-axis attitude gyroscope is integrated on the circuit board. The miniature pressure sensor is connected to the six-axis attitude gyroscope and is also connected to the timing main control module for dual verification and recognition of the orthodontic appliance wearing status.

[0092] The timing control module includes an ultra-low power micro MCU chip and a local storage unit. The ultra-low power micro MCU chip has a built-in customizable wearing time threshold program and a 24-hour automatic reset timing program, which is used to count and store the effective wearing time of the orthodontic device each day.

[0093] This ultra-low power micro MCU chip features Bluetooth Low Energy (BLE) and is an integrated MCU chip with BLE. This BLE-enabled integrated MCU chip also works with a mobile app. After wearing the device, it pairs and connects via Bluetooth to the phone: searching for the device, binding the orthodontic appliance, and establishing a real-time connection. The reminder function can be set in the mobile app; for example, a targeted text message reminder can be sent if the required duration is not met.

[0094] The power supply module includes an ultra-thin micro lithium battery and an external magnetic charging contact. The magnetic charging contact is embedded in an integrated sealed shell without any openings. The magnetic charging contact can be used with a magnetic charging base to achieve sealed charging. The power supply module integrates overcharge, overvoltage, and overcurrent protection circuits.

[0095] The adhesive fixing module is a removable double-sided medical adhesive layer located at the bottom of the sealed outer shell.

[0096] This embodiment also provides a method for using the orthodontic device, including the following steps:

[0097] Step 1: Obtain the impedance center of the maxilla using the three-dimensional finite element analysis method;

[0098] Step 2: Adjust the parameters of the headgear so that the traction angle of the external arch on the headgear to the external arch tube connecting structure is 45-60° with the synaptic plane, and the traction direction is above the center of the maxillary resistance, so that the maxilla exhibits a counter-rotation tendency.

[0099] Step 3: Wear the orthodontic appliance;

[0100] Step 4: Determine the wearing time. For example, if the timer has reached its set time or the wearer needs to eat, the rotatable connecting rod can be opened to separate the maxillary pad and mandibular pad. If the timer has not reached its set time or the wearer is in a convenient position to wear the pad, the rotatable connecting rod is in the closed state, and the maxillary pad and mandibular pad are connected to each other, thus initiating the correction process.

[0101] The three-dimensional finite element analysis method includes the following steps:

[0102] Step 1: Establish a database based on the wearer's oral and maxillofacial cone-beam CT scan. The cone-beam CT scan parameters for the oral and maxillofacial region are: voltage 110KV, current 3.37~3.67mA, slice thickness 0.3mm, and field of view 12. 12cm;

[0103] Step 2: Image segmentation is performed using interactive medical imaging control system software, and mesh generation is performed using ANSYS software. The mesh uses tetrahedral elements with a size of 1-3 mm and a mesh quality ≥ 0.7. At the same time, the elastic moduli of the maxillary cortical bone, cancellous bone, teeth, and periodontal ligament are defined as 13.8 GPa, 1.38 GPa, 19.6 GPa, and 0.68 MPa, respectively, with Poisson's ratios of 0.3, 0.3, 0.3, and 0.45, respectively.

[0104] Step 3: In ANSYS software, a static analysis method is used, with the loading magnitude consistent with the traction force of the extraoral arch. The constraint conditions are fixed constraints on the top surface of the maxilla and the condyle of the mandible. By simulating the mechanical effects of different traction directions, the specific location of the impedance center of the maxilla is determined.

[0105] Regarding the traction angle of the extraoral arch to the extraoral arch tube connection structure being at an angle of 45-60° to the occlusal plane, with the traction direction above the center of the maxillary resistance, causing the maxilla to exhibit a counter-rotation tendency, the present invention has five embodiments, as follows:

[0106] In Example 1, the traction angle of the extraoral arch to the extraoral arch tube connecting structure is 0° with the occlusal plane. At this time, the traction direction is below the center of the maxillary resistance, so the upper anterior teeth are lingually tilted; the upper posterior teeth are distally tilted; the maxilla rotates clockwise, with the anterior part tilting backward and downward, and the posterior part tilting forward and upward.

[0107] as follows Figure 3 ;

[0108] In Example 2, the traction angle of the extraoral arch to the extraoral arch tube connection structure is 15° with the occlusal plane. At this time, the traction direction is below the center of the maxillary bone resistance, so the upper anterior teeth are lingually tilted; the upper posterior teeth are distally tilted; the maxilla rotates clockwise, with the anterior part tilting backward and downward, and the posterior part tilting forward and upward.

[0109] as follows Figure 4 ;

[0110] In Example 3, the traction angle of the extraoral arch to the extraoral arch tube connecting structure is 30° with the occlusal plane. At this time, the traction direction is below the center of the maxillary bone resistance, so the upper anterior teeth are lingually tilted; the upper posterior teeth are distally tilted; the maxilla rotates clockwise, with the anterior part tilting backward and downward, and the posterior part tilting forward and upward.

[0111] as follows Figure 5 ;

[0112] In Example 4, the traction angle of the extraoral arch to the extraoral arch tube connection structure is 45° with the occlusal plane. At this time, the traction direction is above the center of the maxillary bone resistance, so the maxillary incisor is lingually tilted; the maxillary canine is distally translated; the maxillary posterior teeth are distally tilted; and the anterior and posterior parts of the maxilla are both moved backward and upward.

[0113] as follows Figure 6 ;

[0114] In Example 5, the traction angle of the extraoral arch to the extraoral arch tube connecting structure is 60° with the occlusal plane. At this time, the traction direction is above the center of the maxillary resistance, so the upper anterior teeth are depressed as a whole; the upper posterior teeth are moved distally as a whole; the maxilla rotates counterclockwise, with the anterior part moving backward and upward, and the posterior part moving forward and downward.

[0115] as follows Figure 7 ;

[0116] In summary, the traction angle of the extraoral arch to the extraoral arch tube connecting structure is 45-60° with the occlusal plane, and the traction direction is above the center of the maxillary resistance, causing the maxilla to exhibit a counter-rotation trend, effectively controlling the mandibular plane angle (SN-MP), improving the clockwise rotation trend of the mandible, and alleviating problems such as chin retrusion, excessive anterior and inferior elevation, and temporomandibular joint disorders.

[0117] In practical use, specifically, the angle of traction and the angle of the occlusal plane can be further refined according to the angle of the upper incisor. For example, if the upper incisor is labially inclined, a traction angle of 45° is preferred. If the upper incisor is normal or lingually inclined, a traction angle of 60° is preferred.

[0118] This invention, through the inclusion of a rotatable connecting rod, adapts to the user's oral activities such as chewing and speaking, eliminating the need to remove it during chewing and enabling all-day jawbone control. Combined with the guiding effect of the anterior and posterior inclines, it fully utilizes daily muscle activity to stimulate mandibular protrusion, improving treatment efficiency. The coordinated use of the anterior and posterior inclines guides mandibular protrusion, stimulating condylar growth and promoting mandibular development.

[0119] This invention also allows for precise adjustment of the maxillary width by setting an expansion screw, which works in conjunction with the guide structure formed by the anterior and posterior slopes to achieve three-dimensional control in the sagittal, vertical, and width directions. This improves the problem of maxillary and mandibular width discrepancy in skeletal Class II high-angle cases and avoids the defect of existing capitol muscle activators that exacerbate width discrepancy due to mandibular anterior guidance.

[0120] The present invention also features a detachable external bow, which can be flexibly selected according to the user's schedule, reducing the impact on the user's daily activities and improving user compliance. For example, users of existing head cap muscle activators wear them for an average of 8-10 hours a day, while the present invention can achieve an average of more than 20 hours of wear per day, which can significantly increase the duration of action of the orthodontic device.

[0121] Furthermore, the maxillary and mandibular pads, made of medical-grade resin, conform to the tooth contours and reduce friction damage to oral soft tissues, resulting in high overall wearing comfort. The rotatable connecting rod's rotation angle adapts to daily oral activities, eliminating the need for frequent removal and improving user compliance. The parameters of the expander screw and extraoral arch can be flexibly adjusted according to the user's age and the severity of their condition, making it widely applicable for early orthodontic treatment of skeletal Class II high-angle cases in adolescents aged 10-15 years. It requires no modification to the user's existing oral structure and can be worn directly, facilitating large-scale clinical application.

[0122] The above description, in conjunction with specific / preferred embodiments, provides a further detailed explanation of the present invention, but it should not be construed as limiting the specific implementation of the invention to these descriptions. Those skilled in the art will recognize that various modifications and improvements can be made without departing from the concept of the present invention, and all such modifications and improvements fall within the scope of protection of the present invention.

Claims

1. An orthodontic appliance, characterized in that, include: Maxillary pad, mandibular pad, posterior slope, anterior slope, and rotatable connecting rod; The maxillary pad and the mandibular pad are movably connected by the rotatable connecting rod; the anterior inclined surface is located at the rear end of the mandibular pad; and the posterior inclined surface is located at the front end of the maxillary pad. The anterior slope and the posterior slope fit together to guide the mandible forward.

2. The corrective device according to claim 1, characterized in that, The front and rear inclined surfaces are made of stainless steel, and the inclined surface formed by the front and rear inclined surfaces fitting together has an inclination angle of 45°.

3. The corrective device according to claim 1, characterized in that, The rotatable connecting rod has a rotation angle range of -90° to 90° and can be switched between open and closed states. When the rotatable connecting rod is in the closed state, the maxillary pad and the mandibular pad are connected to each other; when the rotatable connecting rod is in the open state, the maxillary pad and the mandibular pad can be separated from each other. The rotatable connecting rod is also connected to an external bow tube connecting structure, which is a cylindrical structure connected to the rotatable connecting rod, and a rectangular through hole is provided in the cylindrical structure along the axial direction.

4. The corrective device according to claim 1, characterized in that, The lower half of the maxillary pad and the upper half of the mandibular pad are provided with receiving grooves for accommodating the rotatable connecting rod. One end of the rotatable connecting rod is rotatably connected to the maxillary pad through a rotating shaft, and the other end of the rotatable connecting rod is provided with a ball head. The bottom end of the receiving groove forms a circular cavity that is adapted to the ball head. The rotatable connecting rod can rotate around the pivot, so that the rotatable connecting rod is embedded in the receiving groove, and the ball head is locked in the circular cavity, forming the closed state.

5. The corrective device according to claim 1, characterized in that, Also includes: Expansion screw; the expansion screw is embedded in the inner side of the maxillary pad and is used to adjust the width of the maxilla.

6. The corrective device according to claim 3, characterized in that, The orthodontic device further includes: an extraoral bow; the extraoral bow is detachably connected to the posterior inclined surface; specifically, the extraoral bow is detachably connected to the extraoral bow tube connection structure; The external bow includes a first end, a second end, and a body. The body is connected between the first and second ends of the external bow. The first end of the external bow engages with the headgear to provide upward and backward traction. The second end of the external bow is rectangular and fits perfectly with the rectangular through hole of the external bow tube connection structure.

7. The corrective device according to claim 1, characterized in that, The rotatable connecting rod is also equipped with a thin-film timer and a thin-film pressure sensor, which are respectively adhered to the rotatable connecting rod.

8. The corrective device according to claim 7, characterized in that, The thin-film timer includes an integrated sealed shell, a sensor recognition module, a timing main control module, a reminder interaction module, a power supply module, and an adhesive fixing module. The integrated sealed shell is a medical-grade flexible silicone arc-shaped shell structure, including an upper shell and a lower shell. The upper shell and the lower shell are seamlessly sealed by ultrasonic pressing to form an IPX8 waterproof sealed cavity. The sensor recognition module, the timing main control module, the reminder interaction module, and the power supply module are all built into this cavity. The sensing and recognition module includes a miniature pressure sensor, a six-axis attitude gyroscope, and a circuit board. The miniature pressure sensor is embedded in the fitting surface of the cavity of the integrated sealed shell. The six-axis attitude gyroscope is integrated on the circuit board. The miniature pressure sensor and the six-axis attitude gyroscope are connected to each other and are also connected to the timing main control module for dual verification and recognition of the orthodontic appliance wearing status. The timing control module includes an ultra-low power micro MCU chip and a local storage unit. The ultra-low power micro MCU chip has a built-in customizable wearing time threshold program and a 24-hour automatic reset timing program, which is used to count and store the effective wearing time of the orthodontic device each day. The reminder interaction module includes a miniature flat vibration motor and a hidden LED soft light. The vibration motor and the LED soft light are electrically connected to an ultra-low power micro MCU chip, which is used to output intermittent vibration and light reminders when the wearing time for the day is not up to standard, and to stop reminding when the wearing time reaches the standard. The power supply module includes an ultra-thin micro lithium battery and external magnetic charging contacts. The magnetic charging contacts are embedded in an integrated sealed shell without openings. The magnetic charging contacts can be used with a magnetic charging base to achieve sealed charging. The power supply module integrates overcharge, overvoltage, and overcurrent protection circuits. The adhesive fixing module is a medical removable double-sided adhesive layer located at the bottom of the sealed outer shell.

9. A method of using an orthodontic appliance, characterized in that, Includes the following steps: Step 1: Obtain the impedance center of the maxilla using the three-dimensional finite element analysis method; Step 2: Adjust the parameters of the headgear so that the traction angle of the external bow on the headgear to the external bow tube connecting structure is 45-60° with the synaptic plane. At this time, the traction direction is above the center of the maxillary resistance, so that the maxilla exhibits a counter-rotation trend. Step 3: Wear the orthodontic appliance; Step 4: Determine the wearing time. For example, if the timer has reached its end or the wearer needs to eat, the rotatable connecting rod can be opened to separate the maxillary pad and the mandibular pad. If the timer has not reached its end or it is convenient for the wearer to wear the pad, the rotatable connecting rod can be in the closed state to connect the maxillary pad and the mandibular pad.

10. The method of using an orthodontic appliance according to claim 9, characterized in that, The three-dimensional finite element analysis method includes the following steps: Step 1: Establish a database based on the wearer's oral and maxillofacial cone-beam CT scan. The cone-beam CT scan parameters for the oral and maxillofacial region are: voltage 110KV, current 3.37~3.67mA, slice thickness 0.3mm, and field of view 12. 12cm; Step 2: Image segmentation is performed using interactive medical imaging control system software, and mesh generation is performed using ANSYS software. The mesh uses tetrahedral elements with a size of 1-3 mm and a mesh quality ≥ 0.

7. At the same time, the elastic moduli of the maxillary cortical bone, cancellous bone, teeth, and periodontal ligament are defined as 13.8 GPa, 1.38 GPa, 19.6 GPa, and 0.68 MPa, respectively, with Poisson's ratios of 0.3, 0.3, 0.3, and 0.45, respectively. Step 3: In ANSYS software, a static analysis method is used, with the loading magnitude consistent with the traction force of the extraoral arch. The constraint conditions are fixed constraints on the top surface of the maxilla and the condyle of the mandible. By simulating the mechanical effects of different traction directions, the specific location of the impedance center of the maxilla is determined.

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