Gingival papilla regeneration inducing device based on negative pressure incremental forming

Abstract

The application discloses a gingival papilla regeneration induction device based on negative pressure incremental forming, relates to the field of oral medical instruments and periodontal tissue regeneration technology, and comprises a mouthpiece carrier, which is internally provided with tooth placing grooves matched with the tooth arrangement contour of a patient; a regeneration induction part is arranged on the inner side wall of the mouthpiece carrier and is located at positions corresponding to the outside of teeth; at least one unitized flexible capsule is installed on the regeneration induction part and is located between the roots of adjacent two teeth; and a micro air capsule is arranged in the unitized flexible capsule. The micro air capsule is expanded to push the unitized flexible capsule to expand towards interdental gingival tissue, so that the slow-release type bioactive coating is closely attached to the gingival surface. The continuously controllable mechanical expansion force is used to directionally guide the epithelial cells and fibroblasts to gradually migrate to the crown side, so that the non-surgical induction regeneration of the gingival papilla is realized.

Description

Technical Field

[0001] This invention relates to the fields of oral medical devices and periodontal tissue regeneration technology, specifically to a gingival papilla regeneration induction device based on negative pressure progressive shaping. Background Technology

[0002] The gingival papilla refers to the gingival tissue located in the interproximal space between two adjacent teeth. Its height and morphology have a significant impact on oral aesthetics and periodontal health. When the gingival papilla recedes in the anterior region, resulting in visible gaps in the interproximal space, it forms what is clinically known as a "black triangle." This not only severely affects the aesthetic appearance of the patient's anterior smile but may also induce food impaction, plaque accumulation, gingivitis, and even further damage to periodontal tissues. Repairing receding gingival papillae has always been a key focus and challenge in the field of oral aesthetic restoration. Currently, the main clinical treatment methods include: connective tissue transplantation surgery, hyaluronic acid injection into the gingival papilla, gingival papilla preservation combined with guided tissue regeneration technology, and soft tissue augmentation technology based on 3D bioprinting. However, due to the unique anatomical structure of the gingival papilla area—sparse blood supply and extremely narrow operating space—tissue reconstruction in this region is widely recognized as one of the most difficult treatments in oral aesthetics.

[0003] However, in practical clinical applications, the aforementioned existing technologies present several challenges. The surgery requires harvesting autologous connective tissue grafts from the patient's palate, demanding advanced microsurgical skills and a long learning curve. Furthermore, the surgery is highly invasive, causing significant postoperative pain, and some patients experience persistent sensory abnormalities at the graft donor site. While hyaluronic acid injection is non-invasive, the injected hyaluronic acid is easily lost in the narrow interdental spaces due to chewing and saliva rinsing. Frequent repeat injections (every 3-6 months) are usually necessary to maintain limited clinical efficacy, resulting in poor patient compliance and high long-term treatment costs. All of these methods are passive repair strategies, merely filling the defect area with exogenous materials, lacking a treatment approach that actively and continuously mobilizes the regenerative potential of autologous tissue. Summary of the Invention

[0004] The purpose of this invention is to provide a gingival papilla regeneration induction device based on negative pressure progressive shaping, so as to solve the technical problem that the existing technology cannot achieve precise control of the negative pressure microenvironment of tissues in the interdental region.

[0005] To achieve the above objectives, the present invention provides the following technical solution: a gingival papilla regeneration induction device based on negative pressure progressive shaping, comprising a dental crown carrier having a tooth placement groove inside that matches the contour of the patient's dentition;

[0006] The regeneration induction part is disposed on the inner wall of the dental brace carrier and located at the corresponding position on the outer side of each tooth;

[0007] At least one modular flexible capsule is mounted on the regeneration induction unit and located between the roots of two adjacent teeth;

[0008] Miniature airbags are disposed inside each of the modular flexible airbags;

[0009] A sustained-release bioactive coating is applied to the outer surface of each of the unitized flexible capsules for contact with the gingival tissue surface;

[0010] An air pressure control unit is installed on the brace carrier and is in fluid communication with the micro air bladder;

[0011] The pressure control unit inflates the micro-airbag by filling it with gas, thereby pushing the modular flexible bladder toward the interdental gingival tissue. This allows the sustained-release bioactive coating to adhere tightly to the gingival surface between the roots of adjacent teeth. Through continuous and controllable mechanical expansion force, a directional compression microenvironment is created in the interdental black triangle area, and mechanical stimulation is used to guide local epithelial cells and fibroblasts to migrate gradually toward the coronal direction.

[0012] Furthermore, the dental brace carrier has an upward or downward opening, which is used to accommodate the maxillary or mandibular dentition, respectively; the cross-section of the dental brace carrier is arc-shaped and is prepared by digital three-dimensional printing or hot pressing molding process using transparent hot-press film material; the base plate of the dental brace carrier is provided with spaced ventilation holes.

[0013] Furthermore, the regeneration induction section is an inclined surface formed on the inner wall of the brace carrier, and the inclined surface gradually slopes downward from the top towards the direction away from the teeth to form a downward pressure guiding surface.

[0014] Furthermore, the cross-section of the unitized flexible capsule is arc-shaped, and the arc opening faces the tooth side; the unitized flexible capsule is molded from medical-grade thermoplastic elastomer or silicone rubber material, and the side facing the gingival papilla is a compressible flexible working part, while the opposite side is a rigid support part integrally formed or bonded to the dental crown carrier.

[0015] The outer surface of the flexible working part is provided with a concave-convex microgroove structure. This concave-convex microgroove structure is configured to form a multi-point contact fit with the interdental gingival mucosa surface under the expansion of the micro air bladder, so as to prevent tissue damage caused by excessive local pressure during expansion, and at the same time enhance the fit stability.

[0016] Furthermore, the position and size of the modular flexible capsule on the dental carrier are generated based on the patient's intraoral scan data, and a 0.2-0.5 mm tissue growth margin is reserved.

[0017] Furthermore, the sustained-release bioactive coating is an asymmetric multilayer composite coating, comprising, from the inside out: a reservoir layer closely attached to the flexible working part on the unitized flexible capsule, a controlled-release layer in the middle, and a bioadhesion layer on the outermost layer; the reservoir layer is loaded with at least one bioactive component selected from platelet-derived growth factor, fibroblast growth factor, transforming growth factor-β, platelet-rich fibrin lysate, or hyaluronic acid, and the bioactive component is dispersed in a biodegradable polymer matrix in the form of liposomes or microspheres to achieve sustained release; the controlled-release layer is composed of polylactic acid-glycolic acid copolymer or porous silica-based material, used to regulate the release rate of the bioactive component; the bioadhesion layer is composed of chitosan or sodium alginate, used to enhance the adhesion between the coating and the gingival mucosa.

[0018] Furthermore, the bioactive coating also contains a pH-responsive release regulator. When the local pH value in the interdental area deviates from the preset physiological range due to inflammatory response, the pH-responsive release regulator changes the porosity or degradation rate of the coating, thereby adjusting the release rate of the bioactive components to cope with changes in the tissue microenvironment.

[0019] Furthermore, the air pressure regulation unit includes a micro air pump, at least one pressure sensor, and a central control module; the micro air pump and the central control module are installed on the outer surface of the brace carrier or embedded in the wall of the brace carrier; the micro air pump is connected to each of the micro airbags through an air guide tube, and each connecting branch is equipped with an independently controlled solenoid valve to achieve independent adjustment of the expansion pressure in each interdental area;

[0020] The pressure sensor is installed inside each of the micro-airbags or on the flexible working part of each of the unitized flexible airbags. It is used to collect pressure data inside the airbag or contact pressure data between the flexible working part and the gingiva in real time and feed it back to the central control module. The central control module is configured to dynamically adjust the output power of the micro air pump and the opening and closing sequence of each solenoid valve through a PID control algorithm based on preset treatment parameters and real-time pressure data fed back by the pressure sensor, so that the pressure value inside each micro-airbag gradually increases at a preset rate within the range of 5kPa to 30kPa.

[0021] Furthermore, the central control module is pre-set with at least three treatment modes for different gingival biotypes and degrees of recession, including: mild recession mode, with a pressure progressive range of 5 kPa to 15 kPa and a treatment cycle of 4-6 weeks; moderate recession mode, with a pressure progressive range of 8 kPa to 22 kPa and a treatment cycle of 6-8 weeks; and severe recession mode, with a pressure progressive range of 10 kPa to 30 kPa and a treatment cycle of 8-12 weeks; the pressure rise rate in each treatment mode is configured to not exceed 0.5 kPa / day.

[0022] Furthermore, it also includes an oral physiological parameter monitoring module, which is integrated on the dental brace carrier and is used to collect temperature, tissue impedance or microcirculation blood flow parameters in the interdental area in real time, and transmit the collected parameters to the central control module as an auxiliary feedback signal for pressure regulation.

[0023] Compared with the prior art, the present invention provides a gingival papilla regeneration induction device based on negative pressure progressive shaping. By controlling the expansion of the micro-air bladder, the flexible working part of the unitized flexible bladder expands outward, and the slow-release bioactive coating is tightly attached to the interdental gingival surface. The continuous and programmable expansion pressure is used to construct a directional compression microenvironment in the interdental black triangle area.

[0024] This design overcomes the technical bottleneck in existing technologies, which make it difficult to achieve effective contact and continuous force application between the device and the gingival tissue due to the narrow anatomical structure and limited operating space in the interdental area. It enables the treatment device to maintain stable contact pressure in the dynamic environment of the oral cavity (such as chewing and speaking), thereby providing a continuous and reliable mechanical guidance signal for the directional migration of epithelial cells and fibroblasts.

[0025] Meanwhile, this invention combines mechanical expansion stimulation with the chemical induction effect of sustained-release bioactive coatings. The former promotes cell proliferation and migration by activating cell mechanosensitive channels, while the latter provides biochemical signals such as growth factors to synergistically promote tissue remodeling. This forms a regeneration induction mode that is synergistically enhanced by physical and chemical factors, solving the problem that existing passive repair strategies (such as autologous tissue transplantation or hyaluronic acid injection) cannot provide continuous directional guidance signals, resulting in unpredictable treatment effects and the need for frequent repeated interventions.

[0026] Furthermore, by independently and progressively adjusting the expansion pressure of each interdental area through the air pressure control unit, this invention can provide individualized treatment based on the differences in the degree of gingival recession in different parts of the patient, avoiding unnecessary pressure on normal tissues. At the same time, the digitally customized brace carrier and modular capsule structure improve wearing comfort and treatment compliance, reduce the patient's dependence on professional clinical operations, and provide a non-invasive, home-based, and controllable clinical solution for gingival papilla regeneration. Attached Figure Description

[0027] To more clearly illustrate the technical solutions in the embodiments of this application or the prior art, the drawings used in the embodiments will be briefly introduced below. Obviously, the drawings described below are only some embodiments recorded in this invention. For those skilled in the art, other drawings can be obtained based on these drawings.

[0028] Figure 1A schematic diagram of the overall structure of the gingival papilla regeneration induction device based on negative pressure progressive shaping provided in an embodiment of the present invention;

[0029] Figure 2 This is a schematic diagram of the bottom structure of the brace carrier provided in an embodiment of the present invention;

[0030] Figure 3 This is a schematic diagram of the structure of components such as the regeneration induction part inside the dental brace carrier provided in an embodiment of the present invention;

[0031] Figure 4 This is a schematic diagram of the structure of the modular flexible capsule and sustained-release bioactive coating provided in an embodiment of the present invention;

[0032] Figure 5 This is a schematic diagram of the flexible working part and the concave-convex microgroove structure provided in the embodiments of the present invention;

[0033] Figure 6 This is a schematic diagram of the structure of the miniature airbag and pressure sensor provided in an embodiment of the present invention;

[0034] Figure 7 This is a schematic diagram of the structure of the reservoir layer, controlled release layer, and bioadhesion layer components provided in an embodiment of the present invention.

[0035] Explanation of reference numerals in the attached figures:

[0036] 1. Bracket carrier; 101. Regeneration induction section; 2. Tooth placement slot; 3. Unitized flexible capsule; 301. Flexible working section; 301a. Microgroove structure; 302. Rigid support section; 4. Micro air bladder; 5. Sustained-release bioactive coating; 501. Reservoir layer; 502. Controlled-release layer; 503. Bioadhesive layer; 6. Ventilation hole; 7. Micro air pump; 8. Pressure sensor; 9. Central control module; 10. Air duct; 11. Solenoid valve; 12. Oral physiological parameter monitoring module. Detailed Implementation

[0037] To enable those skilled in the art to better understand the technical solution of the present invention, the present invention will be further described in detail below with reference to the accompanying drawings.

[0038] As attached Figure 1 To be continued Figure 7 As shown:

[0039] Example 1:

[0040] The present invention provides a gingival papilla regeneration induction device based on negative pressure progressive shaping, comprising a dental brace carrier 1, a tooth placement groove 2 formed inside the dental brace carrier 1, a regeneration induction part 101 disposed on the inner sidewall of the dental brace carrier 1, at least one modular flexible capsule 3 installed on the regeneration induction part 101, a micro air bladder 4 disposed inside each modular flexible capsule 3, a slow-release bioactive coating 5 disposed on the outer surface of each modular flexible capsule 3, and an air pressure control unit installed on the dental brace carrier 1.

[0041] The brace carrier 1 has tooth placement slots 2 that match the contours of the patient's dentition. Specifically, the brace carrier 1 has an upward or downward opening for accommodating the maxillary or mandibular dentition, respectively. The cross-section of the brace carrier 1 is arc-shaped and is fabricated from a transparent thermoforming film material (e.g., PETG, TPU, or EVA copolymer) using digital 3D printing or thermoforming processes.

[0042] Ventilation holes 6 are spaced out on the base plate of the brace carrier 1. The function of the ventilation holes 6 is to allow saliva and air to circulate during wear, preventing the formation of a closed and humid environment in the tooth placement slot 2 that could cause discomfort to the patient, and also helping to maintain a normal metabolic environment for the local tissues.

[0043] The brace carrier 1 is made of transparent material, which allows clinicians and patients to directly observe the fit between the interdental gingival tissue and the capsule, as well as the real-time changes in the morphology of the gingival papilla during the wearing process.

[0044] The regeneration guiding part 101 is disposed on the inner wall of the dental brace carrier 1 and located at the corresponding position on the outer side of each tooth. In this embodiment, the regeneration guiding part 101 is a slope formed on the inner wall of the dental brace carrier 1, and the slope gradually slopes downward from the top towards the direction away from the tooth, thereby forming a downward pressure guiding surface. After the patient wears the dental brace carrier 1, this slope structure enables the unitized flexible capsule 3 to generate a downward component force along the slope direction when expanding, which helps to more effectively transmit the mechanical expansion force to the root of the interdental gingival tissue and guide the local tissue to grow coronally.

[0045] The modular flexible capsule 3 is mounted on the regeneration induction unit 101, with each modular flexible capsule 3 located between the roots of two adjacent teeth. The number of modular flexible capsules 3 is determined according to the number of black triangle areas that the patient actually needs to treat, covering the anterior teeth to the premolar area. The position and size of the modular flexible capsule 3 on the dental bracket carrier 1 are generated based on the patient's intraoral scan data, with a 0.2mm to 0.5mm allowance for tissue growth. This allowance ensures that during treatment, as new gingival tissue gradually forms and occupies the interdental space, the capsule will not excessively compress the new tissue, allowing the device to adaptively match the volume changes of tissue regeneration and reduce the risk of secondary pressure injury.

[0046] The modular flexible capsule 3 has an arc-shaped cross-section, with the arc facing towards the tooth side. The modular flexible capsule 3 is molded from medical-grade thermoplastic elastomer or silicone rubber. Its side facing the gingival papilla is a compressible flexible working part 301, while the opposite side is a rigid support part 302, integrally formed with the dental crown carrier 1 or bonded to it with medical-grade adhesive. The rigid support part 302 provides structural support, ensuring the overall shape of the capsule remains stable when the micro-inflatable capsule 4 expands, preventing deformation away from the tooth; the flexible working part 301, under internal pressure, can expand outwards and conform to the microscopic morphology of the interdental gingival mucosa surface, achieving a close fit.

[0047] The outer surface of the flexible working part 301 is provided with a concave-convex microgroove structure 301a. The height of the micro-protrusions in the concave-convex microgroove structure 301a is 50μm to 150μm, the width of the grooves is 100μm to 300μm, and the distance between adjacent protrusions is 200μm to 400μm. Under the expansion of the micro-inflatable bladder 4, the concave-convex microgroove structure 301a forms a multi-point contact fit with the interdental gingival mucosa surface. This multi-point contact fit disperses the contact pressure, avoiding excessive pressure per unit area on the local gingival tissue by the flexible working part 301, thereby helping to prevent tissue ischemia or pressure injury; at the same time, the microgrooves increase the surface roughness, which can enhance the frictional stability between the bladder and the moist gingival mucosa in the saliva environment, reducing the possibility of accidental displacement of the device during oral movement.

[0048] Miniature airbags 4 are disposed inside each modular flexible capsule 3. The miniature airbag 4 is made of a highly elastic, low-permeability medical polymer material (such as silicone rubber or polyurethane film), and its interior is a sealed chamber. The miniature airbag 4 is connected to the pressure control unit via an air delivery tube 10. When the pressure control unit inflates the miniature airbag 4, the miniature airbag 4 expands, thereby pushing the flexible working part 301 of the modular flexible capsule 3 towards the interdental gingival tissue, allowing the sustained-release bioactive coating 5 to adhere tightly to the gingival surface between the roots of adjacent teeth. Through continuous and controllable mechanical expansion force, a directional compression microenvironment is constructed in the interdental black triangle area, using mechanical stimulation to directionally guide local epithelial cells and fibroblasts to gradually migrate coronally. This design overcomes the technical bottleneck of achieving effective adhesion between the device and gingival tissue in narrow interdental areas, enabling the treatment device to maintain relatively stable contact pressure in dynamic oral environments (such as chewing and speaking), providing continuous mechanical guidance signals for directional cell migration.

[0049] A sustained-release bioactive coating 5 is disposed on the outer surface of each unitized flexible capsule 3, specifically loaded on the outer surface of the flexible working part 301. The sustained-release bioactive coating 5 is an asymmetric multilayer composite coating, which includes, from the inside out: a reservoir layer 501 in close contact with the flexible working part 301, a controlled-release layer 502 in the middle layer, and a bioadhesive layer 503 in the outermost layer.

[0050] The reservoir layer 501 is composed of a biodegradable polymer matrix selected from one or more combinations of polylactic-co-glycolic acid copolymer, polycaprolactone, or gelatin. The reservoir layer 501 is loaded with at least one bioactive ingredient selected from platelet-derived growth factor, fibroblast growth factor, transforming growth factor-β, platelet-rich fibrin lysate, or hyaluronic acid, and the bioactive ingredient is dispersed in the biodegradable polymer matrix in the form of liposomes or microspheres to achieve sustained release. This structure allows the bioactive ingredient to be released continuously at a controlled rate over a treatment cycle of several weeks, avoiding the problem of rapid drug clearance after a single injection.

[0051] The controlled-release layer 502, composed of polylactic-co-glycolic acid copolymer or porous silica-based material, is used to regulate the release rate of bioactive ingredients. By adjusting the composition and thickness of the controlled-release layer 502, the overall release cycle of the coating can be set to 2 to 6 weeks, matching the treatment cycle and achieving near-zero-order sustained-release kinetics of the drug. This design allows for the maintenance of a relatively constant growth factor concentration in the interdental gingiva throughout the treatment process, providing a stable chemical signaling environment for the continuous proliferation and migration of cells.

[0052] The bioadhesion layer 503, composed of chitosan or sodium alginate, enhances the adhesion between the coating and the gingival mucosa. Containing numerous amino or carboxyl functional groups, the bioadhesion layer 503 forms hydrogen bonds and electrostatic interactions with mucin glycoproteins on the gingival mucosa surface, thereby firmly adhering the coating to the interdental gingival mucosa surface and reducing coating detachment caused by saliva rinsing or oral movements.

[0053] The bioactive coating 5 also includes a pH-responsive release regulator. When the local pH value in the interdental region deviates from the preset physiological range (normal gingival crevicular fluid pH is approximately 6.8 to 7.2, which can drop to 5.0 to 6.5 under inflammatory conditions) due to an inflammatory response, the pH-responsive release regulator alters the porosity or degradation rate of the coating, thereby adjusting the release rate of the bioactive components to respond to changes in the tissue microenvironment. For example, when local inflammation worsens and causes a decrease in pH, the solubility of the pH-sensitive polymer increases, the porosity of the controlled-release layer 502 increases, and the release rate of the bioactive components accelerates accordingly, thus providing more anti-inflammatory and repair-promoting signals; when the local pH returns to normal, the release rate returns to the normal level. This stress-responsive release regulation helps to make the treatment more aligned with the dynamic needs of the tissue repair process.

[0054] The air pressure control unit is mounted on the dental brace carrier 1. The air pressure control unit includes a miniature air pump 7, at least one pressure sensor 8, and a central control module 9. The miniature air pump 7 and the central control module 9 are mounted on the outer surface of the dental brace carrier 1 or embedded in the wall of the dental brace carrier 1. The miniature air pump 7 is connected to each miniature airbag 4 via an air guide tube 10, and each connecting branch is equipped with an independently controlled solenoid valve 11 to achieve independent adjustment of the expansion pressure in each interdental region. This independent adjustment design allows for individualized treatment of the differences in gingival recession in different parts of the oral cavity—for example, a higher pressure can be set for more severe recession in the anterior teeth region, while a lower pressure can be set for less severe recession in the lateral teeth region, avoiding unnecessary pressure on normal tissues.

[0055] Pressure sensors 8 are installed inside each micro-airbag 4 or on the flexible working part 301 of each unitized flexible airbag 3. These sensors collect real-time pressure data within the airbag or between the flexible working part 301 and the gingiva, and feed this data back to the central control module 9. The central control module 9 is configured to dynamically adjust the output power of the micro-air pump 7 and the opening and closing sequence of each solenoid valve 11 using a PID control algorithm based on preset treatment parameters and the real-time pressure data from the pressure sensors 8. This ensures that the pressure value within each micro-airbag 4 gradually increases at a preset rate within the range of 5 kPa to 30 kPa. This closed-loop control automatically compensates for pressure fluctuations caused by temperature changes, material creep, or wear displacement, ensuring that the actual expansion pressure experienced by each interdental region maintains a small deviation from the set value.

[0056] The central control module 9 is pre-configured with at least three treatment modes for different gingival biotypes and degrees of recession: a mild recession mode with a progressive pressure range of 5 kPa to 15 kPa and a treatment cycle of 4 to 6 weeks; a moderate recession mode with a progressive pressure range of 8 kPa to 22 kPa and a treatment cycle of 6 to 8 weeks; and a severe recession mode with a progressive pressure range of 10 kPa to 30 kPa and a treatment cycle of 8 to 12 weeks. The pressure escalation rate for each treatment mode is configured to not exceed 0.5 kPa / day. This progressive pressure escalation strategy matches the cell's mechanical adaptability, avoiding excessively rapid pressure increases that could cause tissue discomfort or damage, while simultaneously providing cells with progressively enhanced mechanical guidance signals.

[0057] An oral physiological parameter monitoring module 12 is integrated into the dental brace carrier 1. It is used to collect real-time temperature, tissue impedance, or microcirculatory blood flow parameters in the interdental region and transmit the collected parameters to the central control module 9 as auxiliary feedback signals for pressure regulation. Specifically, a miniature temperature sensor (accuracy ±0.1°C) is used to monitor for local inflammatory temperature elevation; a miniature impedance sensor (using a dual-electrode configuration, measurement frequency 10kHz to 1MHz) is used to monitor the impedance spectrum of the gingival tissue in the interdental region to estimate cell density and the degree of tissue edema. When the impedance sensor detects a decrease in tissue impedance (indicating tissue edema exceeding a safe threshold) or the temperature sensor detects a local temperature consistently above 37.5°C, the central control module 9 can automatically pause or reduce the pressure value of the miniature airbag 4 in that area. This auxiliary feedback mechanism helps to promptly detect early signs of tissue intolerance during treatment and intervene accordingly, improving the safety of the treatment.

[0058] Example 2:

[0059] This embodiment, based on Embodiment 1, further details the operating mode of the pressure control unit. Any content not described in Embodiment 1 shall be based on this embodiment.

[0060] In this embodiment, the central control module 9 is configured to operate in an intermittent pressure loading mode. That is, during the effective wearing period on each treatment day, the pressure of the micro-airbag 4 is not maintained constant, but rather cyclically controlled according to a periodic waveform of "loading-maintaining-unloading-resting". Specifically, each loading cycle includes three stages:

[0061] Loading phase: The pressure inside the micro-inflator 4 increases from the current baseline value to the current target value at a preset rate (e.g., 0.1 kPa to 0.2 kPa / min). This slow loading process allows the gingival tissue sufficient time to adapt to the pressure change, reducing discomfort caused by sudden expansion.

[0062] Maintenance phase: The pressure within the micro-air sac 4 is maintained within ±2 kPa of the current target value for a duration preset to 30 to 120 minutes. This maintenance phase provides continuous and stable mechanical expansion stimulation, allowing sufficient time for cellular mechanosensing and migration responses.

[0063] Unloading phase: The pressure inside the micro airbag 4 drops from the current target value to zero or a preset base value (e.g., 2 kPa). The rate of decrease is usually set to 0.5 kPa to 1.0 kPa / minute, which relatively quickly relieves the pressure and allows the tissue to enter a resting state.

[0064] A rest interval is set between adjacent loading cycles, and the duration of the rest interval is preset to be 0.5 to 2 times the total duration of the loading, maintenance, and unloading phases. For example, if a complete loading-maintenance-unloading cycle lasts 2 hours, the rest interval can be set to 1 to 4 hours. The purpose of this intermittent loading mode is to provide periodic mechanical stimulation to activate cellular mechanosensitive signaling pathways while allowing the tissue sufficient recovery window, avoiding tissue adaptation failure or local circulatory disorders that may be caused by continuous constant pressure loading. By adjusting the ratio of loading cycles to rest intervals, individual adjustments can be made for the tissue responsiveness of different patients.

[0065] Furthermore, the central control module 9 in this embodiment is also equipped with a safety protection program. When the pressure value inside any miniature airbag 4 deviates from the preset threshold range by more than ±3 kPa for more than 30 seconds, the central control module 9 automatically activates the safety protection program, cuts off the solenoid valve 11 corresponding to the airbag, sends an alarm prompt to the user interaction module (such as an LED indicator or display screen), and simultaneously controls the miniature air pump 7 to stop supplying air to that branch. This protection program helps prevent accidental tissue damage caused by uncontrolled pressure due to sensor failure or jamming of the solenoid valve 11.

[0066] The air pressure control unit in this embodiment also includes a data storage module and a wireless communication module (not shown in the figure). The data storage module records the pressure-time curve of each micro-inflator 4 during treatment, the actual daily wearing time of the patient (calculated by changes in wearing status detected by the pressure sensor 8), and the cumulative release amount of the bioactive coating 5 estimated based on a preset release kinetic model. The wireless communication module (Bluetooth or Wi-Fi) transmits this data in real time to an external terminal device (such as a smartphone or tablet) or a cloud server. Clinicians can view the patient's treatment compliance and progress through a remote monitoring platform and adjust treatment parameters as needed; patients can also view their wearing status and remaining treatment cycles on a mobile app. This function helps improve the remote management capability of treatment.

[0067] How to use the device:

[0068] The following is a brief description of the clinical use steps of the device of the present invention:

[0069] First, a three-dimensional digital model of the patient's entire dentition is obtained using an intraoral scanner. Then, based on the distribution and degree of recession of the black triangles, the location, size, and allowance for tissue growth of the brace carrier 1 and each modular flexible capsule 3 are designed using computer-aided design software. Finally, the personalized brace carrier 1 and the integrated modular flexible capsule 3 are fabricated using digital 3D printing or thermoforming processes.

[0070] Next, the sustained-release bioactive coating 5 is applied to the outer surface of the flexible working part 301 of the unitized flexible capsule 3 through a layer-by-layer spraying or impregnation-drying process. The micro airbag 4 is placed inside the unitized flexible capsule 3 and connected to the air pressure control unit through the air guide tube 10.

[0071] When using the device, the patient wears the brace carrier 1 on the dentition (maxillary or mandibular) requiring treatment, ensuring that each modular flexible capsule 3 is aligned with the corresponding interdental triangular area. The treatment program is initiated via a user interaction module (such as a mobile app or a button on the device), selecting the corresponding treatment mode (mild, moderate, or severe retraction mode). The central control module 9 controls the micro-air pump 7 to inflate each micro-inflator 4 according to a preset intermittent loading mode, causing the flexible working part 301 to expand outwards and adhere the sustained-release bioactive coating 5 to the interdental gingival surface. Daily wear time is generally 6 to 10 hours (e.g., nighttime wear or multiple sessions), and the treatment cycle is 4 to 12 weeks depending on the degree of retraction. Patients can have regular follow-up appointments, where clinicians can access treatment records from the data storage module via wireless communication to assess efficacy and adjust parameters.

[0072] After treatment, remove the braces carrier 1, clean it with water or a mild detergent, and then dry and store it.

[0073] The foregoing has only described certain exemplary embodiments of the present invention by way of illustration. Undoubtedly, those skilled in the art can modify the described embodiments in various ways without departing from the spirit and scope of the present invention. Therefore, the foregoing drawings and descriptions are illustrative in nature and should not be construed as limiting the scope of protection of the claims of the present invention.

Claims

1. A gingival papilla regeneration induction device based on negative pressure progressive shaping, characterized in that, include: The brace carrier (1) has a tooth placement slot (2) inside that matches the outline of the patient's dentition. The regeneration induction part (101) is disposed on the inner sidewall of the dental bracket carrier (1) and located at the corresponding position on the outer side of each tooth; At least one modular flexible capsule (3) is mounted on the regeneration induction part (101) and located between the roots of two adjacent teeth; Miniature airbags (4) are disposed inside each of the modular flexible airbags (3); A sustained-release bioactive coating (5) is disposed on the outer surface of each of the modular flexible capsules (3) for contact with the gingival tissue surface; The air pressure control unit is installed on the brace carrier (1) and is in fluid communication with the micro airbag (4); The air pressure control unit fills the micro air bladder (4) with gas to make it expand, thereby pushing the modular flexible bladder (3) to expand toward the interdental gingival tissue, so that the slow-release bioactive coating (5) is closely attached to the gingival surface between the roots of adjacent teeth. Through continuous and controllable mechanical expansion force, a directional compression microenvironment is constructed in the interdental black triangle area, and the mechanical stimulation is used to guide the local epithelial cells and fibroblasts to migrate gradually toward the coronal direction.

2. The gingival papilla regeneration induction device based on negative pressure progressive shaping according to claim 1, characterized in that, The dental brace carrier (1) has an upward or downward opening, which is used to accommodate the maxillary dentition or the mandibular dentition, respectively; the cross-section of the dental brace carrier (1) is arc-shaped and is prepared by digital three-dimensional printing or hot pressing molding process using transparent hot pressing film material; the base plate of the dental brace carrier (1) is provided with vent holes (6) distributed at intervals.

3. The gingival papilla regeneration induction device based on negative pressure progressive shaping according to claim 1, characterized in that, The regeneration induction section (101) is an inclined surface formed on the inner wall of the brace carrier (1), and the inclined surface gradually slopes from the top downwards towards the direction away from the teeth to form a pressure guide surface from top to bottom.

4. The gingival papilla regeneration induction device based on negative pressure progressive shaping according to claim 1, characterized in that, The unitized flexible capsule (3) has an arc-shaped cross section with the arc opening facing the tooth side; the unitized flexible capsule (3) is molded from medical-grade thermoplastic elastomer or silicone rubber material, with a compressible flexible working part (301) on the side facing the gingival papilla, and a rigid support part (302) integrally formed or bonded to the dental bracket carrier (1) on the other side. The outer surface of the flexible working part (301) is provided with a concave-convex microgroove structure (301a). The concave-convex microgroove structure (301a) is configured to form a multi-point contact fit with the interdental gingival mucosa surface under the expansion of the micro air bladder (4) to prevent tissue damage caused by excessive local pressure during expansion, while enhancing the fit stability.

5. The gingival papilla regeneration induction device based on negative pressure progressive shaping according to claim 4, characterized in that, The position and size of the modular flexible capsule (3) on the dental carrier (1) are generated based on the patient's intraoral scan data and a 0.2-0.5 mm tissue growth margin is reserved.

6. The gingival papilla regeneration induction device based on negative pressure progressive shaping according to claim 4, characterized in that, The sustained-release bioactive coating (5) is an asymmetric multilayer composite coating, comprising, from the inside out: a reservoir layer (501) closely attached to the flexible working part (301) on the unitized flexible capsule (3), a controlled-release layer (502) in the middle layer, and a bioadhesive layer (503) in the outermost layer; the reservoir layer (501) is loaded with at least one bioactive component selected from platelet-derived growth factor, fibroblast growth factor, transforming growth factor-β, platelet-rich fibrin lysate, or hyaluronic acid, and the bioactive component is dispersed in a biodegradable polymer matrix in the form of liposomes or microspheres to achieve sustained release; the controlled-release layer (502) is composed of polylactic acid-glycolic acid copolymer or porous silica-based material, used to regulate the release rate of the bioactive component; the bioadhesive layer (503) is composed of chitosan or sodium alginate, used to enhance the adhesion between the coating and the gingival mucosa.

7. The gingival papilla regeneration induction device based on negative pressure progressive shaping according to claim 6, characterized in that, The bioactive coating also contains a pH-responsive release regulator. When the local pH value in the interdental area deviates from the preset physiological range due to inflammatory response, the pH-responsive release regulator changes the porosity or degradation rate of the coating, thereby adjusting the release rate of the bioactive components to cope with changes in the tissue microenvironment.

8. The gingival papilla regeneration induction device based on negative pressure progressive shaping according to claim 1, characterized in that, The air pressure control unit includes a micro air pump (7), at least one pressure sensor (8), and a central control module (9); the micro air pump (7) and the central control module (9) are installed on the outer surface of the brace carrier (1) or embedded in the wall of the brace carrier (1); the micro air pump (7) is connected to each of the micro airbags (4) through an air guide tube (10), and each connecting branch is equipped with an independently controlled solenoid valve (11) to realize independent adjustment of the expansion pressure of each interdental area; The pressure sensor (8) is disposed inside each of the micro air bladders (4) or on the flexible working part (301) of each of the unitized flexible bladders (3) to collect pressure data inside the air bladder or contact pressure data between the flexible working part (301) and the gingiva in real time, and feed it back to the central control module (9); the central control module (9) is configured to dynamically adjust the output power of the micro air pump (7) and the opening and closing sequence of each solenoid valve (11) based on preset treatment parameters and real-time pressure data fed back by the pressure sensor (8) through a PID control algorithm, so that the pressure value inside each micro air bladder (4) gradually increases at a preset rate within the range of 5kPa to 30kPa.

9. The gingival papilla regeneration induction device based on negative pressure progressive shaping according to claim 8, characterized in that, The central control module (9) is pre-set with at least three treatment modes for different gingival biotypes and degrees of recession, including: mild recession mode, with a pressure progressive range of 5 kPa to 15 kPa and a treatment cycle of 4-6 weeks; moderate recession mode, with a pressure progressive range of 8 kPa to 22 kPa and a treatment cycle of 6-8 weeks; and severe recession mode, with a pressure progressive range of 10 kPa to 30 kPa and a treatment cycle of 8-12 weeks; the pressure rise rate under each treatment mode is configured to not exceed 0.5 kPa / day.

10. The gingival papilla regeneration induction device based on negative pressure progressive shaping according to claim 8, characterized in that, It also includes an oral physiological parameter monitoring module (12), which is integrated on the dental brace carrier (1) and is used to collect temperature, tissue impedance or microcirculation blood flow parameters in the interdental area in real time, and transmit the collected parameters to the central control module (9) as an auxiliary feedback signal for pressure regulation.

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