Oral appliance device for treating non-airway obstruction OSA in children

Abstract

The present application relates to the technical field of medical health, in particular to a mouthpiece device for treating non-airway obstruction of OSA in children, comprising: a maxillary arch expansion and a mandibular lead; a support reset structure for oral correction is assembled between the maxillary arch expansion and the mandibular lead; the support reset structure comprises a shaft screw and a shaft frame plate for adjusting the degree of oral opening; the present application adjusts the relationship between the jaws, the support reset structure can limit the excessive closure of the mandible, and the lower dental bed and the upper dental bed are maintained flush or in a set lead position, which helps to correct the abnormal development of the jaw, improve the positional relationship between the upper and lower jaws, train the tongue position and the tongue muscle, and the tongue position training structure guides the tongue to move forward or backward through the tongue position driving belt, which not only can train the tongue to maintain the forward position and strengthen the tongue muscle strength, but also can drive the transmission mechanism to adjust the distance between the mandibular leads during the tongue muscle movement, so as to realize the dual functions of tongue position correction and dental arch width adjustment.

Description

Technical Field

[0001] This invention relates to the field of medical and health technology, and specifically to an oral appliance for treating non-airway obstruction OSA in children. Background Technology

[0002] Obstructive sleep apnea (OSA) in children is a common sleep disorder that can lead to a range of problems, including poor sleep quality, delayed growth and development, and attention deficit. Current treatments for childhood OSA include surgery, medication, and continuous positive airway pressure (CPAP), but these methods may have limitations, such as significant surgical trauma, medication side effects, and low patient compliance.

[0003] Orthodontic appliances, as a non-surgical treatment method, are gradually gaining attention in the treatment of obstructive pulmonary disease (OSA) in children. Traditional orthodontic appliances mainly improve breathing by expanding the airway space. However, for non-obstructive OSA in children, the pathogenesis may be related to factors such as abnormal jawbone development and abnormal tongue position, making it difficult for traditional appliances to achieve ideal treatment results.

[0004] Therefore, those skilled in the art have provided oral appliance devices for treating non-airway obstruction OSA in children to address the problems mentioned in the background art. Summary of the Invention

[0005] To solve the above-mentioned technical problems, the present invention provides a method...

[0006] Oral appliances for treating non-airway obstruction OSA in children include: maxillary expander and mandibular pre-leader; A support and repositioning structure for oral orthodontic treatment is fitted between the maxillary expander and the mandibular prefrontal cortex. The support and reset structure includes a shaft screw and a shaft frame plate that cooperate to adjust the degree of oral cavity opening; The maxillary expansion consists of two sets, which are respectively assembled with a support and repositioning structure and a mandibular guide. Both sets of mandibular anterior guide inner walls are fixed with arc-shaped support rod one and arc-shaped support rod two; The two sets of mandibular prefrontal cortexes are connected by arc-shaped support rods one and two, and a tongue position training structure is provided for tongue position training. The tongue position training structure has the function of adjusting the distance between the two sets of mandibular prefrontal cortexes.

[0007] Preferably, the tongue position training structure includes two sets of limiting plates that are fixedly assembled with arc support rod one and arc support rod two; The inner side of the limiting plate is provided with an inner sliding groove, and an inner screw plate fixed to the inner side of the limiting plate is provided in the middle of the inner sliding groove. The inner sides of the two sets of limiting plates are sealed with inner sliding plates via inner grooves.

[0008] Preferably, a mandibular pad is provided below the inner sliding plate, and the mandibular pad is located at the bottom of the tongue coating on the lower jaw.

[0009] Preferably, a bidirectional screw is rotatably mounted in the middle of the inner slide plate, and a worm gear is fixedly mounted in the middle of the bidirectional screw, with the worm gear meshing with a worm. The bidirectional screw is driven by the inner screw plate inside the limiting plate.

[0010] Preferably, a transmission rod is fixed in the middle of the worm gear, and a spiral bevel gear is fixedly mounted at both ends of the transmission rod. The top of the spiral bevel gear is interlocked with a spiral bevel gear. A transmission roller is fixed at the center of the two circles of the spiral bevel gear, and a limited shaft frame is provided on the outside of the transmission roller.

[0011] Preferably, the limiting frame is fixedly installed on the inner slide plate, and the inner slide plate is fixedly installed on the chin pad via the limiting frame. The outer sides of the two sets of transmission rollers are wound with tongue drive belts located inside the limiting frame.

[0012] Preferably, the support and repositioning structure includes a top shaft frame rotatably mounted on the outside of the maxillary arch expander, and the shaft screw and the top shaft frame are rotatably mounted. The end of the shaft frame plate away from the shaft screw is rotatably mounted with a bottom shaft bracket that is fixedly installed on the outer wall of the mandibular prefrontal cortex.

[0013] Preferably, a side shaft bracket is fixed to the bottom of the shaft frame plate, and a reset cylinder is fixedly installed on the side shaft bracket, with a tension spring assembled inside the reset cylinder; The reset cylinder is movably provided with a sliding shaft, and one end of the tension spring is assembled to the bottom wall of the reset cylinder, while the other end is assembled to the sliding shaft.

[0014] Preferably, an outer cover frame is fixedly mounted on the outer wall of the reset cylinder, a tensioning wheel is rotatably mounted inside the outer cover frame, and a worm gear two is fixed on the outer side of the tensioning wheel, with a worm gear two rotatably mounted on the inner side of the outer cover frame meshing at the bottom of the worm gear two.

[0015] Preferably, a steel wire rope is fixed inside the tensioning wheel, and the end of the steel wire rope away from the tensioning wheel is rotatably mounted on the outer wall of the sliding shaft.

[0016] The technical effects and advantages of this invention are as follows: This invention maintains airway patency by adjusting the distance between the upper and lower jaws through a support and repositioning structure, keeping the lower jaw in a protruding position, tightening the hyoid muscle group, expanding the airway space behind the tongue, preventing the tongue from falling back and obstructing the airway during sleep, effectively improving the respiratory status of children with non-airway obstruction OSA, promoting nasal breathing, and the maxillary arch expansion structure can gradually expand the narrow maxillary dental arch, increase nasal ventilation space, reduce mouth breathing dependence, and further optimize the breathing pattern.

[0017] This invention adjusts the jawbone relationship, and the supporting repositioning structure can limit excessive mandibular closure, promoting the lower and upper jaws to remain aligned or in a predetermined leading position. This helps correct jawbone developmental abnormalities, improves the positional relationship between the upper and lower jaws, and trains tongue position and tongue muscles. The tongue position training structure guides the tongue to push forward or pull backward through a tongue position drive band. This not only trains the tongue to maintain an anterior position and strengthens tongue muscle strength, but also drives a transmission mechanism to adjust the mandibular leading distance during tongue muscle movement, achieving the dual function of tongue position correction and dental arch width adjustment. Attached Figure Description

[0018] Figure 1 This is a schematic diagram of the oral appliance device for treating non-airway obstruction OSA in children provided in this application; Figure 2 This is a frontal structural diagram of the oral appliance device for treating non-airway obstruction OSA in children provided in this application; Figure 3 This is a side view of the oral appliance device for treating non-airway obstruction OSA in children provided in this application; Figure 4 This is a schematic diagram of the support and repositioning structure in the oral appliance device for treating non-airway obstruction OSA in children provided in this application; Figure 5 This application provides an oral appliance for treating non-airway obstruction OSA in children. Figure 4 Schematic diagram of the structure at point A; Figure 6 This application provides an oral appliance for treating non-airway obstruction OSA in children. Figure 4 Schematic diagram of the structure at point B; Figure 7 This is a schematic diagram of the tongue training structure in the oral appliance device for treating non-airway obstruction OSA in children provided in this application. Figure 8 This application provides an oral appliance for treating non-airway obstruction OSA in children. Figure 7 A schematic diagram of the structure of C; Figure 9 This is a schematic diagram of the tongue position drive band in the oral appliance device for treating non-airway obstruction OSA in children provided in this application; Figure 10 This is a schematic diagram of the limiting plate in the oral appliance device for treating non-airway obstruction OSA in children provided in this application; Figure 11 This is a schematic diagram of the axis limiting frame in the oral appliance device for treating non-airway obstruction OSA in children provided in this application; Figure 12This application provides an oral appliance for treating non-airway obstruction OSA in children. Figure 11 A schematic diagram of the structure of D in the middle; Figure 13 This application provides an oral appliance for treating non-airway obstruction OSA in children. Figure 10 A schematic diagram of the structure of E in the middle.

[0019] In the picture: 1. Maxillary arch expansion; 2. Mandibular anterior guide; 3. Arc-shaped strut one; 4. Arc-shaped strut two; 5. Tongue Position Training Structure; 501. Limiting Plate; 502. Jaw Pad; 503. Inner Slide Plate; 504. Two-Way Screw; 505. Worm Gear I; 506. Worm I; 507. Transmission Rod; 508. Helical Bevel Gear I; 509. Helical Bevel Gear II; 510. Transmission Roller; 511. Shaft Limiting Frame; 512. Tongue Position Drive Belt; 513. Inner Slide Groove; 514. Inner Screw Plate; 6. Support and reset structure; 601. Top shaft bracket; 602. Shaft screw; 603. Shaft frame plate; 604. Bottom shaft bracket; 605. Side shaft bracket; 606. Reset cylinder; 607. Tension spring; 608. Outer cover frame; 609. Tensioning wheel; 610. Steel wire rope; 611. Worm gear II; 612. Worm II; 613. Cross groove; 614. Sliding shaft rod. Detailed Implementation

[0020] The present invention will now be described in further detail with reference to the accompanying drawings and specific embodiments. Examples of the invention are given for illustrative and descriptive purposes only and are not intended to be exhaustive or to limit the invention to the forms disclosed. Many modifications and variations will be apparent to those skilled in the art. The embodiments were chosen and described to better illustrate the principles and practical application of the invention and to enable those skilled in the art to understand the invention and design various embodiments with various modifications suitable for a particular purpose.

[0021] Example 1: Please refer to Figures 1-4 In this embodiment, an oral appliance for treating non-airway obstruction OSA in children is provided, including: maxillary expander 1 and mandibular pre-guide 2; A support and repositioning structure 6 for oral orthodontic treatment is assembled between the maxillary expansion arch 1 and the mandibular pre-guide 2. The support and reset structure 6 includes a shaft screw 602 and a shaft frame plate 603 that cooperate to adjust the limitation of oral cavity opening degree; The shaft screw 602 is manually rotatable, and an inner threaded hole is provided on the inner side of one end of the top of the shaft frame plate 603, which is screwed and locked to the shaft screw 602. After the shaft screw 602 is manually rotated, the shaft screw 602 is driven spirally along the inner threaded hole of the shaft frame plate 603, so that the cooperation between the shaft screw 602 and the shaft frame plate 603 can adjust the distance between the maxillary arch expander 1 and the mandibular pre-guide 2, which is convenient for adjusting according to the oral cavity opening length and has flexibility. The 602 shaft screw is specifically a standard model M1.6×0.2DIN-8g (metric fine thread screw, accuracy ±0.01mm), with fine thread (pitch 0.2mm) and a vertical displacement of 0.2mm per revolution, matching the growth rate of children's jawbones (0.5-1mm / month); the DIN standard is specifically tolerance grade 8g (medium grade), ensuring no wobble when fitted with the inner threaded hole of the shaft frame plate (603) (clearance <0.05mm); The maxillary expansion arch 1 consists of two sets, which are respectively assembled with the mandibular pre-guide 2 via the support and repositioning structure 6; Both sets of mandibular anterior guide 2 have an arc-shaped support rod 3 and an arc-shaped support rod 4 fixed to the inner wall; Between the two sets of mandibular pre-guides 2, a tongue position training structure 5 for tongue position training is assembled via arc support rod 1 3 and arc support rod 2 4. The tongue position training structure 5 has the function of adjusting the distance between the two sets of mandibular pre-guides 2. The mandibular pre-guide 2 is fitted to the lower teeth of the oral cavity, and when the mandible bites, it works with the support and repositioning structure 6 to restrict the mandibular alveolar bone to be flush with the maxillary alveolar bone; Furthermore, during tongue position training, the tension between the mandibular premolars 2 can be adjusted by the driving force of the tongue position, which is beneficial for temporarily loosening the tension between the mandibular alveoli when there is oral discomfort, and can be gradually adjusted from loose to tight when worn for a long time. Example 2: Please refer to Figures 7-13 In this embodiment, a tongue training structure 5 is provided in an oral appliance for treating non-airway obstruction OSA in children. The tongue training structure 5 includes two sets of limiting plates 501 that are fixedly assembled with arc support rod 1 3 and arc support rod 2 4; The inner side of the limiting plate 501 is provided with an inner sliding groove 513, and an inner screw plate 514 fixed to the inner side of the limiting plate 501 is provided in the middle of the inner sliding groove 513. The inner sides of the two sets of limiting plates 501 are sealed with inner sliding plates 503 via inner sliding grooves 513; The two sets of limiting plates 501 are assembled in a sealed sliding manner along the middle of the inner sliding plate 503; A chin pad 502 is provided below the inner slide plate 503, and the chin pad 502 is located at the bottom of the tongue coating on the lower jaw. The chin pad 502 is made of medical-grade silicone rubber, which is biocompatible, soft, comfortable, resistant to saliva corrosion, and easy to clean. The inner slide plate 503 is rotatably mounted with a bidirectional screw 504 in the middle, and a worm gear 505 is fixedly assembled in the middle of the bidirectional screw 504. The worm gear 505 meshes with a worm 506. The bidirectional screw 504 is screwed to the inner screw plate 514 inside the limiting plate 501; When the worm gear 506 rotates, the worm gear 506 meshes with the worm wheel 505, and the worm wheel 505 synchronously drives the bidirectional screw 504 to rotate. The bidirectional screw 504 rotates and drives the limiting plates 501 on both sides through the inner screw plate 514, so that the limiting plates 501 move along the inner slide plate 503, thereby adjusting the maxillary arch expander 1 and mandibular pre-guide 2 mounted on them. The worm gear 506 is fixed with a transmission rod 507 in the middle, and both ends of the transmission rod 507 are fixedly equipped with a spiral bevel gear 508. The top of the spiral bevel gear 508 is interlocked with a spiral bevel gear 509 at a 90° angle. A transmission roller 510 is fixed at the center of the spiral bevel gear 509, and a limited shaft frame 511 is provided on the outer side of the transmission roller 510. There are two sets of the transmission rollers 510, and the transmission rollers 510 are rotatably mounted inside the shaft limiting frame 511. The limiting frame 511 is fixedly installed on the inner slide plate 503. The inner slide plate 503 is fixedly installed on the chin pad 502 via the limiting frame 511. The two sets of transmission rollers 510 are wrapped with a tongue position drive belt 512 located inside the limiting frame 511. The tongue drive belt 512 is made of medical-grade silicone rubber, which is biocompatible, flexible, wear-resistant, has moderate surface friction to facilitate tongue movement, is resistant to saliva corrosion, and is easy to clean. The tongue position drive belt 512 can be moved by forward or backward driving force, causing the moving tongue position drive belt 512 to drive the transmission roller 510 to rotate. The rotation of the transmission roller 510 drives the spiral bevel gear 509 to rotate, causing the spiral bevel gear 509 to mesh with the spiral bevel gear 508 to rotate. This causes the transmission rod 507, which is fixed to the spiral bevel gear 508, to rotate synchronously. The rotating transmission rod 507 synchronously drives the worm gear 506 to rotate. The worm wheel 505, which meshes with the worm gear 506, drives the bidirectional screw 504 to rotate, thus adjusting the tightness of the correction while training the tongue position. The tongue-positioning drive band 512 has a width of 4-5mm and a thickness of 0.8-1.0mm (made of medical-grade silicone). Its coefficient of friction is 0.7, which is higher than that of smooth silicone (0.3-0.5), ensuring that the tongue does not slip when it is pushed. The polyester fiber reinforcement layer has a tensile strength >50MPa to avoid repeated stretching and deformation (compared to the tensile strength of ordinary silicone tape >200%). The surface features a textured micro-bump design (increasing the coefficient of friction to 0.6-0.8). The worm gear-506 has a helix angle of 4° (self-locking), is single-ended, and left-handed (matching the helix direction of the worm wheel-505). It can also be customized to model SJA-M0.4×1-LH (left-handed self-locking type), with a module of 0.4mm. The 0.4mm module is beneficial for matching the oral space limitations of children (the width of the dental arch is usually 30-40mm), avoiding the exposure of parts and causing mucosal damage. Meanwhile, the application of single-head and left-hand rotation is beneficial. The single-head worm gear provides a high reduction ratio (reduction ratio of 25:1), which amplifies the small force of the tongue muscle (about 5N) to an effective orthopedic force (≥50N). The left-hand thread matches the rotation direction of the worm wheel, generating an axial clamping force during mouth opening, which enhances the self-locking reliability (superior to right-hand rotation). A spiral angle of 4° can be applied smaller than the friction angle (titanium alloy friction angle ≈ 6°), ensuring absolute self-locking and preventing the device from retracting due to relaxation of the tongue muscles during sleep. The worm gear 505 has a tooth tip circle diameter of ≤6mm (to avoid interference with the oral cavity), and is reinforced with 15% carbon fiber in PEEK (for creep resistance). The custom model SGW-M0.4-Z25-PEEK is also available, with a module of 0.4, 25 teeth, and is made of PEEK material. PEEK contains 30% carbon fiber and has a density of 1.4g / cm³ (60% lighter than metal), reducing the burden on children when wearing it. The creep resistance (deformation <0.1% at 70℃ / 24h) avoids long-term stress deformation, and the dry friction coefficient with the titanium alloy worm is only 0.1-0.2, reducing noise; With 25 teeth, it can be paired with a single worm gear to achieve a 25:1 reduction ratio, resulting in a displacement of only 0.125mm per revolution for the bidirectional screw 504 (precise control of the arch expansion speed). PEEK is biocompatible and has passed the ISO 10993-5 cytotoxicity test, with no risk of metal ion release. The two-way screw 504 has opposite thread directions at both ends (left-hand + right-hand), a thread length of 10mm (2mm limit on one side of the stroke), a lead of 0.125mm, an effective stroke of ±2mm, and is set as a trapezoidal thread (Tr). The tooth angle of 30° is more resistant to lateral forces than the metric thread of 60°, which avoids the mandibular anterior guide 2 from shifting and getting stuck. Furthermore, with a lead of 0.125mm and a very small adjustment per turn, a single action in a child's tongue training (pushing the band 3mm) only causes a change of 0.15mm in the width of the dental arch (within the safe threshold). The annual expansion can be controlled within 2mm (the limit of jawbone growth in children is 4mm / year), so that its range is within ±2mm, limiting the total adjustment range and preventing excessive expansion from causing temporomandibular joint disorder (TMD). The spiral bevel gear 508 is specifically the standard model Beverly 0.4M-12T-35°, with a module of 0.4, 12 teeth, and a 35° helix angle; The specific helical bevel gear 509 is the paired model Beverly 0.4M-24T-35°, with 24 teeth and a helix angle of 35°. It is matched with the helical bevel gear 508 (reduction ratio 2:1) to convert the linear speed (approximately 3 mm / s) of the tongue drive belt 512 into the rotational speed of the worm gear 506 at 150 rpm, which is suitable for the input requirements of the worm gear system. The output torque is amplified by 2 times to overcome the starting torque of the worm gear (approximately 0.2 N·m).

[0022] A 35° helix angle is higher than the load-carrying capacity of a straight bevel gear (contact ratio > 1.8); Example 3: Please refer to Figures 4-6 In this embodiment, a support and repositioning structure 6 is provided in an oral appliance for treating non-airway obstruction OSA in children. The support and reset structure 6 includes a top shaft frame 601 rotatably mounted on the outside of the maxillary arch expander 1, and the shaft screw 602 is rotatably mounted to the top shaft frame 601. The end of the shaft frame plate 603 away from the shaft screw 602 is rotatably mounted with a bottom shaft bracket 604 fixedly installed on the outer wall of the mandibular pre-guide 2; The shaft screw 602 is in conjunction with the top shaft bracket 601, and the shaft frame plate 603 is in conjunction with the bottom shaft bracket 604, so that the maxillary expander 1 and the mandibular pre-guide 2 are rotatably installed. When the oral cavity is occluded, the maxillary expander 1 and the mandibular pre-guide 2 are limited by the rotating shaft of the top shaft bracket 601 and the bottom shaft bracket 604. The bottom of the shaft frame plate 603 is fixed with a side shaft bracket 605, and a reset cylinder 606 is fixedly installed on the side shaft bracket 605. A tension spring 607 is assembled inside the reset cylinder 606. The reset cylinder 606 is movably provided with a sliding shaft 614, and one end of the tension spring 607 is assembled to the bottom wall of the reset cylinder 606, and the other end is assembled to the sliding shaft 614. The tension spring 607 is used to elastically reset the sliding shaft 614 when it moves inside the reset cylinder 606. The end of the sliding shaft 614 away from the reset cylinder 606 is rotatably mounted on the outer wall of the mandibular guide 2; The outer wall of the reset cylinder 606 is fixedly fitted with an outer cover frame 608. A tensioning wheel 609 is rotatably installed inside the outer cover frame 608, and a worm gear 611 is fixed on the outside of the tensioning wheel 609. A worm gear 612 rotatably fitted inside the outer cover frame 608 is engaged at the bottom of the worm gear 611. The worm gear 611 is made of 316L stainless steel with standard model SDP / SI A6B25-040-F, module 0.4, number of teeth 25. One end of the second worm gear 612 rotatably passes through the outside of the outer cover frame 608, and the end of the second worm gear 612 located outside the outer cover frame 608 is provided with a cross groove 613 that can be turned by an external tool. The worm gear 612 is specifically the standard model Eclipse04-001 (metric miniature worm gear) with a module of 0.4 and a cross groove 613 of PH00. The cross groove 613PH00 is compatible with dental universal miniature screwdrivers (torque 0.1 N·m) to prevent excessive tightening from damaging the spring. The module is 0.4mm and is strictly matched with the worm gear 2611, with a meshing backlash of ≤0.03mm (to avoid abnormal meshing noise). Physicians can adjust the worm gear 2 612 to complete the bite lock within 10 seconds (the steel wire rope 610 tightens by 2mm), improving the efficiency of follow-up visits; A steel wire rope 610 is fixed inside the tensioning wheel 609, and the end of the steel wire rope 610 away from the tensioning wheel 609 is rotatably mounted on the outer wall of the sliding shaft 614. After the position tool rotates the cross groove 613 of the worm gear 612, the worm gear 612 rotates and engages with the worm wheel 611, causing the worm wheel 611 to rotate synchronously with the tightening wheel 609. This tightens the steel wire rope 610 inside the tightening wheel 609, allowing it to pass through the steel wire rope 610 and be retracted into the reset cylinder 606 via the sliding shaft 614. The steel wire rope 610 limits the movement of the mandibular pre-guide 2 when it bites the maxillary arch expansion 1.

[0023] According to the above embodiments, the working principle of this invention is as follows: The overall structure consists of two groups of maxillary arch expansion 1, two groups of mandibular pre-guiding 2, tongue position training structure 5, and support and repositioning structure 6. The maxillary expansion arch 1 and the mandibular pre-guide 2 are connected by a support and repositioning structure 6. The core function of this structure is to adjust the distance between the maxillary and mandibular components, i.e. the degree of oral opening, and to provide occlusal support and repositioning force. The tongue position training structure 5 is connected to the inner side of the two mandibular pre-guides 2 via arc support rod 1 3 and arc support rod 2 4. Its main function is to adjust the spacing between the mandibular pre-guides 2, i.e. the tightness in the width direction of the lower dental arch, by using the tongue movement drive device. The six core functions of the support and reset structure are adjusted by distance and limited by engagement. The core components consist of a shaft screw 602, a shaft frame plate 603, a top shaft bracket 601, and a bottom shaft bracket 604. After distance adjustment, the shaft screw 602 is manually rotated; The top of the shaft frame plate 603 has an internal threaded hole that is screwed into the shaft screw 602. The rotating shaft screw 602 is screwed in or out of the internal threaded hole of the shaft frame plate 603, thereby changing the length of the mating part between the shaft screw 602 and the shaft frame plate 603; This length variation directly adjusts the distance between the maxillary expander 1 via the top axis frame 601 and the mandibular guide 2 via the bottom axis frame 604, thus controlling the vertical degree of oral opening during wear; this provides flexibility for different patients or different treatment stages. Occlusal restriction and rotational connection: the maxillary arch expander 1 is rotatably connected to the shaft screw 602 via the top shaft bracket 601; The mandibular preamble 2 is rotatably connected to the frame plate 603 via the base frame 604. This rotatable connection allows the mandible to perform physiological rotational movements during biting / opening. When the mandible occludes, the support and repositioning structure 6, as a whole, especially through the adjusted shaft screw 602 and shaft frame plate 603, limits the excessive upward closure of the mandible, prompting the lower and upper jaws to reach and maintain a level or set pre-leading / open position, preventing airway collapse. The tension of the resetting component is maintained. The component is connected to the outer wall of the mandibular pre-guide 2 via the side shaft bracket 605, resetting cylinder 606, tension spring 607, and sliding shaft rod 614. The function is achieved by placing the tension spring 607 inside the reset cylinder 606, with one end fixed to the bottom of the cylinder and the other end connected to the sliding shaft 614; when the patient opens their mouth, the mandibular guide 2 is pulled down, stretching the tension spring 607 through the sliding shaft 614; when the mouth opening ends or needs to be closed, the contraction force of the tension spring 607 provides the reset force, assisting the mandible to return to the set occlusal position and maintaining the overall tension of the device; The leading limiting engagement locking / reinforcement process passes through the outer cover frame 608, tightening wheel 609, worm gear 2 611, worm 2 612, cross groove 613, and wire rope 610. The connection is made through the tensioning wheel 609 inside the outer frame 608. The second worm gear 611 is fixed on the tensioning wheel 609, and the second worm 612 meshes with the second worm gear 611. One end of the wire rope 610 is fixed to the inside of the tensioning wheel 609, and the other end is connected to the outer wall of the sliding shaft 614. The function involves using a tool such as a screwdriver to rotate the cross groove 613 of the second worm gear 612, driving the second worm wheel 611 and the tensioning wheel 609 to rotate; the rotating tensioning wheel 609 winds the wire rope 610, thereby pulling the sliding shaft rod 614 into the reset cylinder 606; this is equivalent to shortening the effective length of the reset cylinder 606, the tension spring 607, and the sliding shaft rod 614; When the device is in the set occlusal position, tightening the wire rope 610 increases the restrictive force on the upward closure of the mandible, or more strictly maintains the mandible in the leading position to prevent mandibular retraction during sleep; the self-locking characteristic of the worm gear prevents accidental loosening of this adjustment. The tongue position training structure 5 has core functions through spacing adjustment and training. The core components include two limiting plates 501, inner sliding plate 503, bidirectional screw 504, worm gear 505, worm 506, transmission rod 507, transmission roller 510, and tongue position drive belt 512. The spacing adjustment mechanism is as follows: two limiting plates 501 are sealed on the inner slide plate 503 through the inner sliding groove 513 on their inner side and can slide along the inner slide plate 503. A bidirectional screw 504 is installed in the middle of the inner slide plate 503 and passes through the inner screw plate 514 on the limiting plate 501. Rotating the bidirectional screw 504 will drive the limiting plates 501 with inner screw plates 514 on both sides to move towards or away from each other along the inner slide plate 503. Since the limiting plate 501 is fixedly connected to the arc support rod 1 3 and the arc support rod 2 4, and the arc support rod is fixed to the mandibular pre-guide rods 2 on both sides, the rotation of the bidirectional screw 504 directly adjusts the horizontal distance between the mandibular pre-guide rods 2 on both sides, i.e. the width / tightness of the mandibular arch. The tongue-driven training mechanism is in place, with the power source passing through the tongue position drive belt 512, which is wrapped around two sets of transmission rollers 510 and located above the mandibular pad 502 at the bottom of the tongue. The transmission roller 510 has a diameter of 3mm and a width of 4mm (made of lightweight aluminum alloy). As the transmission path passes, the tongue pushes the tongue position drive belt 512 forward or backward, causing the transmission roller 510 to rotate. The transmission roller 510 is fixedly connected to the spiral bevel gear 2 509, which drives the spiral bevel gear 2 509 to rotate. The spiral bevel gear 2 509 and the spiral bevel gear 1 508 mesh at 90°, causing the spiral bevel gear 1 508 to rotate. The spiral bevel gear 508 is fixed at both ends of the transmission rod 507, which drives the transmission rod 507 to rotate. The transmission rod 507 is fixedly connected to the worm gear 506, which drives the worm gear 506 to rotate. The worm gear 506 meshes with the worm wheel 505, which drives the worm wheel 505 to rotate. The worm wheel 505 is fixed on the double-acting screw 504, which ultimately drives the double-acting screw 504 to rotate. The effect is that the tongue pushes the tongue position drive belt 512 forward, which drives the bidirectional screw 504 to rotate in the direction that makes the two side limiting plates 501 move in opposite directions, increasing the distance between the mandibular pre-guide 2, temporarily relaxing the tension between the lower teeth and relieving discomfort. The tongue pulls backward, and the tongue position drive belt 512 drives the bidirectional screw 504 to rotate in the direction that makes the two side limiting plates 501 move towards each other, reducing the distance between the mandibular pre-guide 2 and tightening the lower jaw. Therapeutic significance: Active training, through encouraging children to perform correct tongue positioning such as anterior placement and motor training, is crucial for improving breathing patterns and oral function. When children experience discomfort during the initial wearing period or when they actively push their tongue forward to temporarily relax the device, it can improve comfort and compliance. The progressive correction process involves gradually adjusting the device from a loose, large gap to a tight, small gap during long-term wear, based on the therapist's preset settings or the child's adaptation, to achieve a progressive adjustment of the mandibular / dental arch width; the self-ligating characteristics of the worm gear-505 and worm rod-506 ensure that the adjustment state can be maintained stably. The vertical control structure 6 controls the degree of oral cavity opening and closing and the position of the mandible, aiming to maintain the mandible in a forward position and prevent the tongue from falling back and obstructing the airway during sleep. The process involves manually adjusting the rotating shaft screw 602 via helical transmission to change the mating length between the shaft screw 602 and the shaft frame plate 603, adjusting the distance between the maxillary arch expander 1 and the mandibular pre-guide 2, and setting the vertical opening degree and pre-guide amount of the mandible. When the occlusal restriction passes through the mandibular closure, the rigid length of the support and repositioning structure 6 prevents the mandible from being excessively raised, forcibly maintaining the preset protruding position, tightening the hyoid muscle group, and expanding the posterior airway of the tongue; When the jaw is open, the tension spring 607 is stretched; when the jaw is closed, the spring contracts to provide a restoring force to assist the mandible in returning to the set position. Enhanced locking can be achieved by rotating the worm gear 612 to tighten the wire rope 610, pulling the sliding shaft 614 to shorten the length of the reset cylinder 606 component, increasing the pre-engagement restraint force during occlusion and preventing mandibular retraction during sleep. The tension spring 607 in the reset cylinder 606 has a wire diameter of 0.2 mm, an outer diameter of 1.5 mm, 10 coils, and an elastic modulus of 0.3 N / mm (low elasticity to avoid stress on the temporomandibular joint in children). The horizontal control of the tongue position training structure 5, which adjusts the width of the lower dental arch, aims to gradually increase the width of the lower dental arch, improve oral cavity volume, and provide short-term pressure relief. The passive adjustment of the doctor's operation is achieved by rotating the worm gear 506 to drive the worm wheel 505 to drive the bidirectional screw 504 to rotate. Through the screw transmission, the two limiting plates 501 on both sides move towards or away from each other along the inner sliding plate 503. Through the arc support rod 1 3 and the arc support rod 2 4, the two mandibular anterior guides 2 on both sides are brought together or opened to adjust the width of the lower dental arch. Actively adjust the patient's tongue drive path, the tongue push / pull tongue position drive belt 512 drives the transmission roller 510 to rotate and drive the spiral bevel gear 1 508 and spiral bevel gear 2 509 to rotate the transmission rod 507 and worm gear 1 506. The subsequent transmission is the same as above, and the lower dental arch spacing is adjusted in real time. The forward-pull drive band temporarily relaxes pressure and relieves discomfort by increasing the spacing, while the backward-pull drive band actively tightens the corrective force by decreasing the spacing. Sagittal and functional training is conducted through tongue positioning and muscle activation. Train the tongue to be positioned forward, strengthen the tongue muscles, and prevent the tongue from falling back during sleep; The 502 mandibular pad is positioned under the tongue to lift the base of the tongue, thus physically widening the airway inlet. The tongue position drive band 512 feedback requires the tongue to actively contact and push / pull the drive band to force the tongue to stay in the front position and avoid retraction, transforming tongue movement into mechanical regulation to enhance the patient's training awareness and compliance; The goal of maxillary arch expansion 1 is to widen the narrow maxillary dental arch, increase nasal ventilation space, and improve nasal breathing by slowly opening the mid-maxillary suture through an internal expansion screw, which is not described in detail in the mechanical force diagram, and reduces reliance on mouth breathing. Work process, initial wearing; The physician manually adjusts the mandibular protrusion amount vertically via the rotating shaft screw 602 and the initial width of the mandibular arch horizontally via the rotating worm gear 506. During sleep, the mandibular pre-guide 2 maintains airway closure to prevent tongue posterior displacement, the repositioning spring assists in jaw repositioning, and the enhanced locking, if activated, prevents bruxism from causing displacement. During the conscious period, the patient actively pushed the tongue drive band 512 forward to relax the pressure and adapt. In the middle and late stages of treatment, the patient actively pulled the drive band backward to participate in the correction. Continuous tongue muscle training improved function. The treatment was gradually adjusted, with regular follow-up visits. The length of the shaft screw 602 was gradually increased to increase the lead-in volume, and the worm gear 506 was gradually tightened to expand the lower dental arch. The resistance of the drive band was further optimized by combining tongue muscle strength.

[0024] Obviously, the described embodiments are only a part of the embodiments of the present invention, and not all of them. All other embodiments obtained by those skilled in the art and related fields based on the embodiments of the present invention without inventive effort should fall within the scope of protection of the present invention. Structures, devices, and operating methods not specifically described and explained in the present invention, unless otherwise specified or limited, shall be implemented according to conventional means in the art.

Claims

1. An oral appliance for treating non-airway obstruction OSA in children, characterized in that, include: Maxillary arch expansion (1), mandibular pre-guide (2); A support and repositioning structure (6) for oral orthodontic treatment is assembled between the maxillary expansion arch (1) and the mandibular pre-guide (2). The support and reset structure (6) includes a shaft screw (602) and a shaft frame plate (603) that cooperate to adjust the limitation of oral cavity opening. The maxillary expansion (1) consists of two sets, which are assembled with the mandibular pre-guide (2) via the support and repositioning structure (6); Both sets of mandibular guides (2) have arc-shaped support rod one (3) and arc-shaped support rod two (4) fixed on their inner sidewalls. The two sets of mandibular prefrontal guides (2) are connected by an arc support rod one (3) and an arc support rod two (4) to form a tongue position training structure (5), which has the function of adjusting the distance between the two sets of mandibular prefrontal guides (2). The tongue training structure (5) includes two sets of limiting plates (501) fixedly assembled with arc support rod one (3) and arc support rod two (4); the inner side of the limiting plate (501) is provided with an inner groove (513), and an inner screw plate (514) fixed to the inner side of the limiting plate (501) is provided in the middle of the inner groove (513); the inner sides of the two sets of limiting plates (501) are sealed with inner sliding plates (503) through the inner groove (513); A mandibular pad (502) is provided below the inner sliding plate (503), and the mandibular pad (502) is located at the bottom of the tongue coating on the lower jaw. A bidirectional screw (504) is rotatably mounted in the middle of the inner slide plate (503), and a worm gear (505) is fixedly mounted in the middle of the bidirectional screw (504). The worm gear (505) meshes with a worm (506). The bidirectional screw (504) is helically driven by the inner screw plate (514) on the inner side of the limiting plate (501). The worm gear (506) is fixed with a transmission rod (507) in the middle, and both ends of the transmission rod (507) are fixedly equipped with a spiral bevel gear (508). The top of the spiral bevel gear (508) is interlocked with a spiral bevel gear (509) at 90°. A transmission roller (510) is fixed at the center of the spiral bevel gear (509), and a limited shaft frame (511) is provided on the outside of the transmission roller (510). The limiting frame (511) is fixedly installed on the inner slide plate (503), and the inner slide plate (503) is fixedly installed on the chin pad (502) via the limiting frame (511). The two sets of transmission rollers (510) are wrapped with tongue position drive belts (512) located inside the limiting frame (511).

2. The oral appliance for treating non-airway obstruction OSA in children according to claim 1, characterized in that, The support and reset structure (6) includes a top shaft frame (601) rotatably mounted on the outside of the maxillary arch expander (1), and the shaft screw (602) and the top shaft frame (601) are rotatably mounted. The end of the shaft frame plate (603) away from the shaft screw (602) is rotatably mounted with a bottom shaft frame (604) fixedly installed on the outer wall of the mandibular guide (2).

3. The oral appliance for treating non-airway obstruction OSA in children according to claim 2, characterized in that, The bottom of the shaft frame plate (603) is fixed with a side shaft bracket (605), and a reset cylinder (606) is fixedly installed on the side shaft bracket (605). A tension spring (607) is assembled inside the reset cylinder (606). The reset cylinder (606) is movably provided with a sliding shaft (614). One end of the tension spring (607) is assembled on the bottom wall of the reset cylinder (606), and the other end is assembled with the sliding shaft (614).

4. The oral appliance for treating non-airway obstruction OSA in children according to claim 3, characterized in that, The outer wall of the reset cylinder (606) is fixedly fitted with an outer cover frame (608), and a tightening wheel (609) is rotatably installed inside the outer cover frame (608). A worm gear two (611) is fixed on the outside of the tightening wheel (609), and a worm gear two (612) rotatably fitted inside the outer cover frame (608) is engaged at the bottom of the worm gear two (611).

5. The oral appliance for treating non-airway obstruction OSA in children according to claim 4, characterized in that, A steel wire rope (610) is fixed inside the tensioning wheel (609), and the end of the steel wire rope (610) away from the tensioning wheel (609) is rotatably mounted on the outer wall of the sliding shaft (614).

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