Silicone snore guard manufacturing system and method

Abstract

The present application relates to a kind of silica gel snore stopper manufacturing method, belong to medical product technical field.The method includes the following steps: S1, data acquisition and modeling;S2, registration: three-dimensional dental model is registered with head lateral film, realize the spatial alignment of dental model and airway soft tissue;S3, measurement analysis: measure airway gap, tongue shape and jaw position parameters;S4, personalized correction: according to the measurement result, automatically set the amount of mandibular protrusion and vertical opening, according to WALA ridge and FA point design dental arch expansion width, design tongue induction screen angle to guide tongue to move forward and upward;S5, manufacture.The present application breaks through the limitation that traditional snore stopper can only single forward mandible, by synergistic control mandibular three-dimensional position, dental arch width and tongue posture, realize the stereoscopic comprehensive expansion to airway length, width and height, effectively increase airway volume, improve ventilation efficiency, significantly improve the correction effect to OSAHS.

Description

Technical Field

[0001] This invention belongs to the field of medical product technology, specifically relating to a personalized anti-snoring device based on digital design and manufacturing. Background Technology

[0002] Obstructive sleep apnea-hypopnea syndrome (OSAHS) is a common sleep disorder characterized by repeated upper airway obstruction during sleep, leading to apnea or insufficient ventilation, resulting in symptoms such as snoring, daytime sleepiness, and hypoxemia, which seriously affect patients' quality of life and health.

[0003] Currently, mandibular advancement appliances (MADs) have gained widespread international recognition in the sleep medicine community as a non-invasive physical therapy method for obstructive sleep apnea-hypopnea syndrome (OSAHS). Traditional MADs primarily improve ventilation by advancing the mandible to expand airway space. However, these devices have significant limitations in their design: their treatment approach focuses on the anterior-posterior movement of the mandible, failing to systematically integrate key factors such as arch width, tongue position, and soft palate morphology, making it difficult to achieve three-dimensional synergistic optimization of the airway. Furthermore, the amount of mandibular protrusion and vertical opening largely depends on manual settings based on the physician's experience, lacking objective quantitative data. This can easily lead to excessive protrusion causing temporomandibular joint discomfort, or insufficient protrusion resulting in poor efficacy, making it difficult to balance treatment effectiveness with patient comfort.

[0004] With the development of digital technology, some existing methods for manufacturing anti-snoring devices (such as the method for manufacturing a digital anti-snoring device disclosed in application number 202211114014.9, which achieves digital fabrication of the anti-snoring device through oral scanning and jaw fixation) can achieve digital shaping of the anti-snoring device by means of oral scanning and jaw fixation. However, such methods still cannot be separated from clinical trial and manual intervention in the mandibular positioning stage, and have not yet achieved fully automatic design and multi-dimensional parameter adjustment based on airway imaging data, which restricts their personalization and clinical applicability. Summary of the Invention

[0005] To address the limitations of traditional anti-snoring devices, which rely on doctors' experience and can only move the mandible forward in a single way, this invention proposes a personalized manufacturing method that can synergistically control mandibular position, dental arch width, and tongue posture. This method achieves a balance between therapeutic efficacy and comfort by comprehensively widening the airway in three dimensions. The objective of this invention can be achieved through the following technical solutions: A method for manufacturing a silicone anti-snoring device includes the following steps: S1. Data Acquisition and Modeling: Acquire three-dimensional scanning data of the soft and hard tissues in the patient's mouth, establish a dental model, and perform tooth segmentation and landmark setting on the model. S2. Registration: Register the three-dimensional dental model with the lateral cephalometric radiograph to achieve spatial alignment between the dental model and the airway soft tissue; S3. Measurement and Analysis: Based on the registered image data, automatically identify airway landmarks and measure airway gaps, tongue morphology, and jawbone position parameters. S4. Personalized Orthodontics: Based on the results of the measurement and analysis steps, the following operations are performed automatically: S41. The forward protrusion and vertical opening of the mandible are automatically set according to the cephalometric data; S42. The expansion width of the upper and lower dental arches is automatically designed according to the WALA ridge on the buccal side of the mandible and the FA point of the crown; S43. The slope angle of the tongue guide screen is designed to guide the tongue to move forward and upward. S5. Manufacturing: Based on the output data of the personalized correction design steps, the personalized silicone anti-snoring device is manufactured using an integral molding method.

[0006] Furthermore, in step S41, based on the SNB angle and FMA angle in the cephalometric measurement, the forward extension of the mandible in the sagittal direction and the opening in the vertical direction are calculated and set, and the forward extension and the opening in the vertical direction are controlled within the range of 8-10 mm.

[0007] Further, in step S42, the arch expansion width is calculated using the following formulas: Lower arch width = WALA ridge width - FA point width - WALA ridge width / FA point width; Upper arch width = Lower arch width + 5mm Further, in step S43, the angle of the tongue induction screen includes: the tongue tip angle and the tongue side angle, and the tongue tip angle = 180° - [90° - (Go - Gn - AH)]; the tongue side angle = the tongue tip angle - 30°.

[0008] The present invention further proposes a silicone anti-snoring device manufacturing system, comprising: The 3D modeling module is used to acquire 3D scanning data of the soft and hard tissues in the patient's mouth, establish a dental model, and perform tooth segmentation and marker point setting. The jawbone and tongue registration module is used to register the three-dimensional dental model with the lateral cephalometric radiograph to achieve spatial alignment between the dental model and the airway soft tissue. The measurement and analysis module is used to automatically identify airway landmarks and measure airway gaps, tongue morphology, and jawbone position parameters based on the registered image data. The correction module includes: an automatic jawbone position setting module, used to automatically set the mandibular protrusion and vertical opening based on cephalometric data; an automatic dental arch width setting module, used to automatically design the expansion width of the upper and lower dental arches based on the WALA ridge and FA point; and a tongue position setting module, used to design the slope angle of the tongue induction screen to guide the tongue to move forward and upward. A manufacturing module is used to integrally mold a personalized silicone anti-snoring device based on the output data of the correction module.

[0009] Furthermore, the anti-snoring device is a one-piece molded silicone component, comprising: an occlusal pad covering the upper and lower teeth; an upper and lower labial guard connected to the labial side of the occlusal pad; a buccal shield connecting the upper and lower labial guards and extending to the posterior teeth region; and a tongue guiding screen disposed on the lingual side of the anterior teeth region, the tongue guiding screen including a tongue tip bevel near the tongue tip and a lingual side bevel near the tongue root; wherein the connection between the occlusal pad and the tongue guiding screen is smoothly designed in the vertical direction. Compared with the prior art, the advantages and positive effects of the present invention are as follows: 1. By automatically identifying airway landmarks and measuring key parameters through computer software, this system abandons the traditional model that relies on doctors' subjective experience and achieves objective diagnosis and design based on quantitative data. The system compares and analyzes data against a normal adult airway cephalometric database to ensure that treatment plans are based on scientific benchmarks, significantly improving the accuracy and repeatability of anti-snoring device design.

[0010] 2. This invention overcomes the limitation of traditional anti-snoring devices that can only move the mandible forward. By synergistically controlling the three-dimensional position of the mandible, the width of the dental arch, and the posture of the tongue, it achieves a comprehensive three-dimensional expansion of the airway length, width, and height. This multi-dimensional synergistic effect can more effectively increase airway volume and improve ventilation efficiency, thereby fundamentally improving the treatment effect of OSAHS.

[0011] 3. This invention features a personalized design based on individual patient characteristics and utilizes integrated 3D printing technology to manufacture a medical-grade silicone anti-snoring appliance. The appliance is highly adapted to the patient's oral structure in both form and function. Its tongue-guided screen actively guides the tongue forward and upward, effectively preventing the tongue root from falling back during sleep. Combined with the tongue-accommodating space provided by the expanded dental arch, this creates a more stable intraoral environment. This design helps restore the balance of buccal and lingual muscle strength, playing a positive role in maintaining long-term airway patency and preventing symptom recurrence. This invention not only optimizes the tongue-palatal posture, dental arch width, and mandibular position, but also significantly reduces common problems of traditional orthodontic appliances such as strong foreign body sensation and joint discomfort, effectively improving wearing comfort and treatment compliance. Attached Figure Description

[0012] The invention will now be further described with reference to the accompanying drawings.

[0013] Figure 1 This is a schematic diagram of the silicone anti-snoring device structure according to an embodiment of the present invention. Figure 1 ; Figure 2 This is a schematic diagram of the silicone anti-snoring device structure according to an embodiment of the present invention. Figure 2 ; Figure 3 These are comparison photos of patients before and after wearing the silicone anti-snoring device of this invention; In the above figures: 1. Occlusal pad; 2. Upper tooth labial guard; 3. Tongue guide screen; 4. Buccal screen; 8. Lower tooth labial guard; 31. Tongue tip bevel; 32. Tongue side bevel; 100. Connecting part; 311. Tongue tip tilt angle; 321. Tongue side tilt angle. Detailed Implementation

[0014] The technical solutions of the embodiments of the present invention will be clearly and completely described below with reference to the accompanying drawings. Obviously, the described embodiments are only some embodiments of the present invention, and not all embodiments. Based on the embodiments of the present invention, all other embodiments obtained by those skilled in the art without creative effort are within the scope of protection of the present invention.

[0015] Example 1: This example proposes a silicone anti-snoring device manufacturing system, including: a 3D modeling module, a jawbone and tongue registration module, a measurement and analysis module, an correction module, and a manufacturing module.

[0016] The first module, 3D modeling, is used to scan the dentition and mucosa of snoring patients, establish a 3D model of the soft and hard tissues in the patient's mouth, and automatically separate the 3D dental model into individual crowns and set tooth feature markers.

[0017] II. Jawbone and tongue registration module, used to register the three-dimensional dental model with the lateral cephalometric radiograph to achieve spatial alignment between the dental model and the airway soft tissue.

[0018] After obtaining the three-dimensional dental model and lateral cephalometric radiograph, the incisal points of the maxillary central incisors and the mesiobuccal cusp of the maxillary first molar on the three-dimensional dental model and the lateral cephalometric radiograph are aligned until the incisal points of the mandibular central incisors on the three-dimensional dental model and the lateral cephalometric radiograph are completely aligned. Then, it is determined whether the lateral image of the three-dimensional dental model projected onto the midsagittal plane coincides with the image of the lateral X-ray radiograph. If so, the image is output to the measurement and analysis module; otherwise, it is output to the measurement and analysis module after correction. During correction, the midsagittal plane is rotated left and right around the central axis of the dental arch to make the lateral image coincide with the image of the lateral X-ray radiograph.

[0019] Specifically, this module first acquires a 3D dental model and a lateral cephalometric radiograph of the patient. Using a feature point matching algorithm, it aligns the incisal point of the maxillary central incisor and the mesobrous cusp of the maxillary first molar on the model with their corresponding anatomical landmarks on the lateral radiograph. Based on this, it further verifies whether the incisal point of the mandibular central incisor on the 3D model completely overlaps with the lateral radiograph image. After initial registration, the system projects the 3D dental model onto the midsagittal plane, generating its lateral contour image, and assesses its overlap with the lateral radiograph image. If the projected image overlaps with the radiograph image, the registration result is directly output to the measurement and analysis module; otherwise, an automatic correction mechanism is activated. During correction, the system uses the dental midline as the rotation center and finely adjusts the direction of the midsagittal plane within a reasonable angle range. Through iterative optimization, the system achieves optimal overlap between the projected image of the 3D model and the lateral radiograph image. Finally, the corrected registration result is output to the measurement and analysis module, providing a reliable spatial data foundation for subsequent airway parameter measurements and soft tissue analysis.

[0020] Third, the measurement and analysis module is used to perform quantitative analysis on the registered fused image data: First, it identifies and locates the hard and soft tissue landmarks related to the airway; then, based on these landmarks, it accurately measures the gap width of each region of the airway, the morphological parameters of the tongue, and the spatial position parameters of the jawbone; finally, it outputs structured measurement data to provide a basis for subsequent orthodontic design.

[0021] During the analysis, the module performs calculations based on the following anatomical structures and measurement benchmarks:

[0022] Definition of the posterior pharyngeal airway space:

[0023] Life gap (PAS): refers to the distance between the TB point and the TPPW point; TB point: The intersection of the line connecting the angle of the mandible (Go) and the lower alveolar seat (B) (Go–B) with the surface of the root of the tongue; TPPW point: The intersection of the Go–B line extended towards the posterior pharyngeal wall and the surface of the soft tissue of the posterior pharyngeal wall.

[0024] Tongue-related landmarks:

[0025] Lingual tip point (T): Located at the midpoint of the lingual fossa of the lower central incisor, marking the most anterior position of the tongue; Valley of the epiglottis (V): The lowest point at the junction of the epiglottis and the base of the tongue; Tongue dorsal point (H): The highest point where a perpendicular line drawn from the V-T line intersects the outline of the tongue dorsal surface; Hyoid point (AH): The junction of the uppermost and anteriormost edges of the hyoid body.

[0026] Jaw and craniofacial landmarks:

[0027] Go (Angle of the Mandible): The point where the lower posterior border of the mandible turns; Chin vertex (Gn): the most anterior and inferior point of the chin of the mandible; Saddle center (S): The center point of the saddle structure; Nasal root point (N): the foremost and uppermost point of the nasofrontal suture; Lower alveolar seat point (B): the most concave point of the lower alveolar bone margin; Orbital point (O): The lowest point of the infraorbital margin; Ear point (P): the highest point of the external auditory canal.

[0028] Key jawbone position measurement parameters:

[0029] SNB angle: Composed of points S, N and B, it reflects the anteroposterior positional relationship of the mandible relative to the skull base. It is the angle between the line connecting the center point of the sella turcica and the root of the nose and the line connecting the root of the nose and the lower alveolar seat.

[0030] FMA angle: formed by the orbitoauricular plane (OP) and the mandibular plane (GoGn), i.e. the angle between the orbitoauricular plane and the mandibular plane, used to assess the spatial posture of the mandible in the vertical direction.

[0031] IV. The correction module includes: an automatic jawbone position setting module, which automatically sets the mandibular protrusion and vertical opening based on cephalometric data; an automatic dental arch width setting module, which automatically designs the expansion width of the upper and lower dental arches based on the WALA ridge and FA point; and a tongue position setting module, which designs the slope angle of the tongue guide screen to guide the tongue to move forward and upward.

[0032] 1. The automatic jawbone position setting module first performs positioning based on cephalometric parameters: it sets the anteroposterior target position of the mandible based on the SNB angle, determines the vertical target position based on the FMA angle, and evaluates and manually corrects the lateral deviation of the mandible by matching the midline of the mandibular arch with the midline of the face. Details are as follows: S11, Data Input The module receives data from the measurement module including: SNB angle (sagittal position), FMA angle (vertical position), and G-value (posterior airway gap at the base of the tongue). S12, Lateral Skew Correction Load the three-dimensional models of the upper and lower jaws, extract the midline data of the dental arch and the facial midline, align the midline by geometric feature points, calculate the midline deviation, and compare the midline of the dental arch with the midline of the basal bone. The physician can manually adjust the mandibular model to align the midline of the mandibular incisors with the facial midline to complete the initial lateral positioning.

[0033] S13, Automatic Calculation of Mandibular Three-Dimensional Position The total movement T range is set according to clinical rules: T∈[8,10] mm.

[0034] Calculate the overall adjustment amount based on the input parameters: θ=0.2×(80.1−SNB)+0.1×(FMA−30.19)+0.3×(10.13−G) Distribution of forward and vertical movement: Forward extension Lx = 0.7T + θ; Vertical opening Ly = T − Lx; Constraints: If Lx < 0.55T, then Lx = 0.55T and Ly = 0.45T; if Lx > 0.9T, then Lx = 0.9T and Ly = 0.1T.

[0035] S14. Three-dimensional jaw position relationship simulation and output Using the midline alignment results obtained in the lateral correction stage, the mandibular model is translated along the X-axis (lateral) in three-dimensional space to the alignment position; Lx is moved along the sagittal axis (anteroposterior direction); Ly is moved along the vertical axis; the mandibular plane inclination is adjusted according to the FMA angle, and the final target position coordinates of the mandible in three-dimensional space are output, generating the adjusted three-dimensional dentition model of the upper and lower jaws. By guiding the mandible forward, the pressure of the tongue on the soft palate and uvula is reduced or eliminated, making the palatopharyngeal airway unobstructed, thereby increasing air volume and effectively eliminating or reducing the number of apneas and snoring.

[0036] 2. Automatic Arch Width Setting Module: This module, based on the biomechanical characteristics of the mandible, enables personalized arch expansion design for both the maxilla and mandible. By collecting morphological data of the mandibular WALA ridge, this module automatically calculates the optimal arch width that conforms to physiological characteristics, thereby expanding the inherent oral cavity space and improving tongue accommodation.

[0037] In clinical applications, for snoring patients with open bite and narrow maxillary arch features, this module simultaneously generates corresponding upper lip guard and buccal shield auxiliary structure designs. Specifically, by lengthening and thickening the upper lip guard, and increasing the thickness of the maxillary posterior buccal shield and the buffer gap with the tooth surface, it synergistically achieves the correction goals of arch expansion in the maxillary posterior region and open bite. The increase in maxillary width helps the tongue move forward naturally, thereby promoting airway expansion.

[0038] The specific implementation process is as follows: S21, Data Input Based on the aforementioned three-dimensional dental arch model of the upper and lower jaws, the module automatically identifies and measures the position of the most prominent part of the mandibular fasciculus line, the WALA ridge, as well as the FA points, which are the equidistant points of the long axis of the clinical crown in the gingival direction of each tooth. The module has built-in reference values ​​for the "physiological distance from the FA point to the WALA ridge" for different tooth positions (approximately 0.1 mm at the FA point for incisors and approximately 2 mm at the WALA ridge for molars), which can serve as a reliable reference for determining the width of the mandibular dental arch.

[0039] S22. Calculation of dental arch curve and width The module calculates the distance from the FA point to the WALA ridge based on the patient's actual WALA ridge position and the normal physiological distance from the FA point to the WALA ridge for each tooth. It then projects the ideal FA point for each tooth onto the umbo plane and uses curve fitting to generate a smooth ideal mandibular dental arch curve. Subsequently, based on the normal overbite relationship between the maxillary and mandibular posterior teeth, the corresponding width of the maxillary dental arch is determined. The specific calculation formulas are as follows: Mandibular arch width = WALA ridge width - FA point width - WALA ridge width / FA point width; Maxillary arch width = Mandibular arch width + 5mm.

[0040] S23, Bow Expansion Simulation Based on the calculated target width, the original dental arch curve is horizontally scaled. A target dental arch curve is generated using either proportional scaling or selective expansion strategies for the posterior teeth. The FA points of each tooth are aligned to their corresponding positions on the target dental arch curve. The long axis direction of the teeth is maintained to achieve overall arch expansion.

[0041] 3. The tongue position setting module is based on biomechanical principles and uses a parametric design method to construct a personalized tongue induction screen to guide the tongue to move forward and upward. The specific implementation process is as follows: S31, Input of head shadow measurement data The module receives coordinate data of cephalometric markers, including: epiglottis V; highest point of the tongue dorsum H; tip of the tongue T; anterior superior point of the hyoid bone AH; angle of the mandible Go and chin apex Gn.

[0042] S32, Calculation of tongue parameters Based on the input markers, the following are automatically calculated: tongue length TGL=Distance(V,T); tongue height TGH=Distance(H,Line(V,T)), where TGH is defined as the vertical distance from point H to the line connecting point VT; and the posterior airway gap PAS (calculated using relevant markers).

[0043] S32. Tongue position and status determination Based on preset physiological thresholds, conditional judgments are made: If (PAS < 10.13 mm) & (TGL > 88.06 mm) & (TGH < 32.79 mm), and the above conditions are met, the system determines that the tongue is in a "low-positioned posterior" state and triggers the tongue guide screen design process. Otherwise, the tongue guide screen is not extended and only makes conformal contact with the alveolar mucosa.

[0044] S33, Tongue Induction Screen Modeling Based on the geometric relationship of head shadow measurement, the key angle parameters of the tongue guidance screen are automatically generated: The angle of the tongue tip slope = 180° - [90° - (Go - Gn - AH)], and the angle of the tongue side slope = the angle of the tongue tip slope − 30°.

[0045] 3D Surface Generation: Based on the tongue tip and side slope angles, a double-sloping transition surface is constructed. A parametric surface modeling method is used to achieve continuous control of angles and curvature. A thickness gradient is set along the vertical direction (Z-axis), and the thickness is increased at the bottom to form a support structure.

[0046] The parametric surface is converted into a solid model containing the complete tongue guide screen structure. The tongue guide screen pushes the tongue upward from the floor of the mouth to the palatal side of the upper anterior teeth. By increasing the angle between the screen and the horizontal reference plane, the tongue is lifted, and the position of the tongue tip is adjusted from the lingual protuberance of the lower anterior teeth to the lingual fossa of the occlusal pad between the upper and lower anterior teeth, thereby expanding the airway and restoring the balance of the buccal and lingual muscles.

[0047] V. Manufacturing module, used to manufacture a personalized silicone anti-snoring device in one piece based on the output data of the correction module.

[0048] Example 2: This example provides a method for manufacturing a personalized silicone anti-snoring device, including the following steps: I. Data Acquisition and 3D Modeling Three-dimensional scan data of the soft and hard tissues in the patient's mouth are acquired. Based on the data, a three-dimensional dental model is constructed, and the model is automatically segmented and its feature markers are calibrated. Specifically, the three-dimensional dental model is automatically segmented into individual crowns, and tooth feature markers are set.

[0049] II. Multimodal Image Registration Spatial registration was performed between the 3D dental model and the patient's lateral cephalometric radiograph to achieve precise alignment between the hard tissue model of the dental arch and the soft tissue image of the airway. Specifically, this involved aligning the incisal points of the maxillary central incisors and the mesobobiniar cusp of the maxillary first molar on the 3D dental model and the lateral cephalometric radiograph. Further verification was conducted to confirm whether the incisal point of the mandibular central incisor on the 3D dental model completely overlapped with the lateral radiograph image. The registered 3D dental model was projected onto the midsagittal plane to generate its lateral profile image, and its overlap with the lateral radiograph image was assessed. If the projected image overlapped with the radiograph image, registration was complete; otherwise, the direction of the midsagittal plane was finely adjusted left and right within a reasonable angular range, using the dental midline as the rotation center. Iterative optimization was used to achieve optimal overlap between the projected image of the 3D model and the lateral radiograph image, ultimately completing the correction.

[0050] III. Measurement of Airway Structure and Jawbone Parameters Based on the registered fused image data, airway-related hard and soft tissue landmarks are automatically identified, and multiple feature values, including the gaps between different airway regions, tongue morphology parameters, and three-dimensional position parameters of the jawbone, are quantitatively measured. The specific identification of key anatomical landmarks and the calculation of key parameters have been detailed in Example 1.

[0051] IV. Generation of Personalized Correction Plans Based on the above measurement results, the following correction design operations will be automatically executed: Automatic jawbone position setting: Based on cephalometric data, automatically calculates and sets the mandible's protrusion in the sagittal direction and its opening in the vertical direction; Automatic arch width setting: Based on the correspondence between the WALA ridge on the buccal side of the mandible and the FA point on the crown, an arch expansion width scheme for the upper and lower dental arches is generated; Tongue position setting: Based on the position of the hyoid bone and the morphological parameters of the tongue, the angle of the inclined plane of the tongue induction screen is obtained to guide the tongue to move forward and upward.

[0052] For detailed setup steps, please refer to Example 1.

[0053] V. 3D Printing Manufacturing of Anti-Snoring Devices Based on the digital model generated by the personalized correction plan, a personalized silicone anti-snoring device that matches the patient's oral structure and treatment needs is manufactured using a one-piece molding process.

[0054] Example 3, reference Figure 1 and Figure 2 This embodiment proposes a silicone anti-snoring device, and this embodiment describes the silicone anti-snoring device in detail.

[0055] The anti-snoring device in this embodiment is a one-piece molded medical silicone component, including an occlusal pad 1, an upper tooth labial guard 2, a tongue guiding screen 3, a lower tooth labial guard 8, and a buccal screen 4 that connects the upper and lower tooth labial guards and extends to the posterior teeth area. All components are integrated into a structurally coordinated whole through an integrated design.

[0056] The tongue guiding screen 3 has a double-sloped structure, including a tongue tip slope 31 near the tongue tip region and a tongue side slope 32 near the tongue root region. The angle between the tongue tip slope 31 and the horizontal base plane is defined as the tongue tip tilt angle 311, and the angle between the tongue side slope 32 and the horizontal base plane is defined as the tongue side tilt angle 321.

[0057] The design features of this double-sloping structure are that the tip of the tongue tilt angle 311 is greater than the side of the tongue tilt angle 321, and both are obtuse angles. This angle configuration makes the tip of the tongue slope 31 gentler, which facilitates the natural resting of the tip of the tongue and guides the tongue forward; while the side of the tongue slope 32 is relatively steep, which can effectively squeeze and lift the root of the tongue, raising the tongue from the floor of the mouth upward.

[0058] In addition, the thickness of the tongue induction screen 3 increases in a gradient along the vertical direction, and the thick edge structure formed at its bottom provides stable support for the tongue, preventing the tongue from falling backward and into the sublingual area, thereby maintaining the patency of the airway.

[0059] In terms of structural connection, the occlusal pad 1 and the tongue guide screen 3 are smoothly connected via a connecting part 100. This connecting part has no protrusions in the vertical direction and has a smooth and continuous surface; at the same time, the corner of the occlusal pad 1 away from the connecting part is also rounded. This seamless connection structure avoids undue interference with tongue movement, ensures that the tongue can be fully guided by the tongue guide screen, and improves wearing comfort and safety.

[0060] This embodiment achieves effective control over tongue position, thereby improving ventilation, balancing cheek and tongue muscle strength, and enhancing the effectiveness of anti-snoring treatment. In practice, the silicone anti-snoring device of this embodiment has achieved significant therapeutic effects for patients with long-term snoring. Figure 3 The comparison shows the patient's condition before and after wearing the device, where a represents the state before wearing and b represents the state after wearing the device.

[0061] To quantitatively assess the efficacy, we performed upper airway cephalometric analysis, and the specific data are shown in Table 1: Table 1 shows the upper airway cephalometric analysis before and after wearing the orthodontic appliance.

[0062] In the table: SPP-SPPW is the distance between the posterior and posterior pharyngeal walls of the soft palate; U-MPW is the distance between the tip of the uvula and the midpharyngeal wall; V-LPW is the distance between the vallecula and the pharyngeal wall.

[0063] As shown in the table: the SNB angle increased significantly compared to before wearing, indicating that the mandible has been adjusted forward; the Go-Gn-AH angle decreased, reflecting a shortened distance from the hyoid bone to the mandibular plane; multiple upper airway space indices (SPP-SPPW, U-MPW, PAS, V-LPW) all showed significant improvement, indicating an effective expansion of the airway space; and tongue-related parameters (TGH, TGL) tended towards the normal physiological range. These measurement results anatomically validate the clinical efficacy of the silicone anti-snoring device of this embodiment in improving upper airway structure and expanding the respiratory passage.

[0064] The foregoing has provided a detailed description of one embodiment of the present invention, but this description is merely a preferred embodiment and should not be construed as limiting the scope of the invention. All equivalent variations and modifications made within the scope of the claims of this invention should still fall within the patent coverage of this invention.

Claims

1. A method of manufacturing a silicone snore guard, characterized by, Includes the following steps: S1. Data Acquisition and Modeling: Acquire three-dimensional scanning data of the soft and hard tissues in the patient's mouth, establish a three-dimensional dental model, and perform tooth segmentation and landmark point setting on the model. S2. Registration: Register the three-dimensional dental model with the lateral cephalometric radiograph to achieve spatial alignment between the three-dimensional dental model and the airway soft tissue; S3. Measurement and Analysis: Based on the registered image data, automatically identify airway landmarks and measure airway gaps, tongue morphology, and jawbone position parameters. S4. Personalized Orthodontics: Based on the results of the measurement and analysis steps, the following operations are performed automatically: S41. The forward protrusion and vertical opening of the mandible are automatically set according to the cephalometric data; S42. The expansion width of the upper and lower dental arches is automatically designed according to the WALA ridge on the buccal side of the mandible and the FA point of the crown; S43. The slope angle of the tongue guide screen is designed to guide the tongue to move forward and upward. S5. Manufacturing: Based on the output data of the personalized correction design steps, the personalized silicone anti-snoring device is manufactured using an integral molding method.

2. The method of claim 1, wherein: In step S41, based on the SNB angle and FMA angle in the cephalometric measurement, the forward extension of the mandible in the sagittal direction and the opening in the vertical direction are calculated and set, and the forward extension and the opening in the vertical direction are controlled within the range of 8-10 mm.

3. The method according to claim 1, characterized in that: In step S42, the arch expansion width is calculated using the following formulas: Lower arch width = WALA ridge width - FA point width - WALA ridge width / FA point width, Upper arch width = Lower arch width + 5mm.

4. The method according to claim 1, characterized in that: In step S43, the angles of the tongue induction screen include: the tongue tip angle and the tongue side angle, and the tongue tip angle = 180° - [90° - (Go - Gn - AH)]; the tongue side angle = the tongue tip angle - 30°.

5. A silicone anti-snoring device manufacturing system, characterized in that, include: The 3D modeling module is used to acquire 3D scanning data of the soft and hard tissues in the patient's mouth, establish a 3D dental model, and perform tooth segmentation and marker point setting. The jawbone and tongue registration module is used to register the three-dimensional dental model with the lateral cephalometric radiograph to achieve spatial alignment between the three-dimensional dental model and the airway soft tissue. The measurement and analysis module is used to automatically identify airway landmarks and measure airway gaps, tongue morphology, and jawbone position parameters based on the registered image data. The correction module includes: an automatic jawbone position setting module, used to automatically set the mandibular protrusion and vertical opening based on cephalometric data; an automatic dental arch width setting module, used to automatically design the expansion width of the upper and lower dental arches based on the WALA ridge and FA point; and a tongue position setting module, used to design the slope angle of the tongue induction screen to guide the tongue to move forward and upward. A manufacturing module is used to integrally mold a personalized silicone anti-snoring device based on the output data of the correction module.

6. A silicone anti-snoring device manufactured using the method described in any one of claims 1-4, characterized in that, The anti-snoring device is a one-piece molded silicone component, comprising: an occlusal pad covering the upper and lower teeth; an upper and lower labial guard connected to the labial side of the occlusal pad; a buccal shield connecting the upper and lower labial guards and extending to the posterior teeth region; and a tongue guiding screen disposed on the lingual side of the anterior teeth region, the tongue guiding screen including a tongue tip bevel near the tongue tip and a lingual side bevel near the tongue root; wherein the connection between the occlusal pad and the tongue guiding screen is smoothly designed in the vertical direction.

Images