A lingual muscle monitoring and training function integrated invisible aligner and a manufacturing method thereof
By integrating a three-layer flexible sensor into the invisible aligner, the issues of comfort and measurement accuracy in tongue muscle monitoring devices have been resolved, enabling precise monitoring and training of tongue muscle function and improving the wearing comfort and data accuracy of the aligner.
Patent Information
- Authority / Receiving Office
- CN · China
- Patent Type
- Applications(China)
- Current Assignee / Owner
- PEKING UNIV SCHOOL OF STOMATOLOGY
- Filing Date
- 2026-06-23
- Publication Date
- 2026-07-21
AI Technical Summary
Existing tongue muscle monitoring devices are uncomfortable, cannot be worn for extended periods, and have inaccurate measurements that fail to accurately reflect tongue muscle function. Traditional orthodontic appliances do not fit snugly against oral tissues, affecting measurement accuracy.
Design an invisible orthodontic appliance with tongue muscle monitoring and training functions. It adopts a three-layer structure, including an invisible orthodontic appliance body layer, a lower flexible film layer, an upper flexible film layer, and a flexible sensor. The flexible sensor is connected to the data acquisition module through a flexible circuit. The sensor is integrated into the orthodontic appliance to achieve real-time and accurate acquisition of pressure at multiple points.
It enables precise monitoring of multi-point pressure on the tongue muscles without compromising wearing comfort, providing comprehensive data support, improving patient training compliance and treatment effectiveness, and ensuring the accuracy and continuity of measurements.
Smart Images
Figure CN122423974A_ABST
Abstract
Description
Technical Field
[0001] This invention relates to the field of oral medical devices, and in particular to an invisible orthodontic appliance that also has tongue muscle monitoring and training functions, and its manufacturing method. Background Technology
[0002] Abnormal perioral forces caused by bad habits are one of the important causes of malocclusion. For example, in patients with a habit of tongue thrusting and swallowing, the tongue muscles exert pushing and pressing forces on the upper and lower anterior teeth, leading to anterior open bite and protrusion. In patients with a low tongue position, the tongue muscle forces act on the lower teeth and mandible, easily causing excessive development of the mandible and forming an underbite facial profile. In addition, the persistence of tongue muscle dysfunction will also affect the effectiveness of orthodontic treatment and may lead to relapse of malocclusion. Monitoring and diagnosing tongue muscle dysfunction and training normal muscle function are of great significance, which will be beneficial for the etiological analysis, etiological treatment, and efficacy evaluation of malocclusion. Therefore, it is necessary to integrate the function of tongue muscle monitoring and training into orthodontic appliances.
[0003] Traditional tongue muscle strength measurement devices are mostly single-function devices with only a single sensing point, which cannot comprehensively reflect the force on tissues such as teeth and palate; moreover, they are not comfortable and cannot be worn in the mouth for a long time, thus failing to meet the needs of daily long-term monitoring; in addition, these devices do not fit in close contact with oral tissues, which can interfere with tongue function and movement, and the measured values cannot truly reflect the actual situation of tongue muscle function.
[0004] Specifically, in the prior art, Chinese patent document CN204813917U (authorization announcement date December 2, 2015) discloses the use of a set of cantilever beam sensors for measurement. Since the cantilever beam sensor has a certain length of cantilever spring beam, the cantilever spring beam of the cantilever beam sensor needs to be fixed between the palatal guard plate and the measurement point during measurement to realize the measurement of the perioral force. The measurement is inconvenient and the measurement range is small.
[0005] To address the aforementioned issues, Chinese patent document CN211409109U (authorization announcement date September 4, 2020) discloses a multi-channel infant oral force measuring device, comprising a power supply, a control module, a display module, and a measurement module. The measurement module includes a pressure sensor, an amplifier circuit module, and an A / D conversion module. The pressure sensor is connected to the control module sequentially through the amplifier circuit module and the A / D conversion module. The display module is connected to the control module. The power supply is connected to and powers the control module, display module, and measurement module respectively. The pressure sensor measures the oral force and converts it into a voltage signal, which is then transmitted to the amplifier circuit module. The amplifier circuit module amplifies the voltage signal transmitted by the pressure sensor to the required amplitude value and transmits it to the A / D conversion module. The A / D conversion module converts the analog signal transmitted by the amplifier circuit module into a digital signal and transmits it to the control module. The control module receives the digital signal transmitted by the A / D conversion module, performs data acquisition and processing, and then transmits a display signal to the display module. The display module receives the display signal and displays the measured value. The pressure sensor is a diaphragm-type pressure sensor. However, the device in Chinese patent document CN211409109U does not fit snugly against oral tissues, which interferes with the functional movement of perioral tissues, and the measured values cannot truly reflect the actual situation of perioral force.
[0006] In recent years, flexible electronic devices, characterized by high stretchability, thinness, and portability, have shown promise in solving the problems of fit, comfort, and multi-point sensor placement in tongue muscle monitoring and training devices. Chinese patent document CN121533697A (publication date February 17, 2026) discloses a tongue muscle function detection system and method integrating flexible sensing functions. This system includes: a brace-type flexible thin-film sensor, a wireless transmission module, and a control module. However, this system only encapsulates the upper and lower flexible thin-film resin layers of the sensor, does not involve invisible aligners, and the resin layer is too flexible to provide an active orthodontic effect on the teeth.
[0007] Therefore, how to develop an invisible orthodontic device that combines tongue muscle monitoring and training functions, and integrates a flexible pressure sensor array with the orthodontic device body without affecting wearing comfort and treatment effect, to achieve real-time and accurate acquisition of pressure at multiple points on the tongue, has become a technical problem that urgently needs to be solved by researchers in this field. Summary of the Invention
[0008] The purpose of this invention is to provide an invisible orthodontic device with tongue muscle monitoring and training functions and its manufacturing method. It can integrate a flexible pressure sensor array with the orthodontic device body without affecting wearing comfort and orthodontic effect, so as to realize real-time and accurate acquisition of pressure at multiple points on the tongue.
[0009] To solve the above-mentioned technical problems, the present invention adopts the following technical solution: This invention discloses an invisible aligner with tongue muscle monitoring and training functions, comprising an invisible aligner body layer, a lower flexible film layer, an upper flexible film layer, flexible sensors, flexible circuitry, and a data acquisition module. The invisible aligner body layer, lower flexible film layer, and upper flexible film layer are sequentially pressed together. The shape of the invisible aligner body layer matches the shape of the patient's teeth and jaws, and the lower and upper flexible film layers are more flexible than the invisible aligner body layer. At least one flexible sensor is encapsulated and connected between the lower and upper flexible film layers. Each flexible sensor includes an upper flexible electrode, a lower flexible electrode, and a flexible gel dielectric layer. The upper flexible electrode is disposed on the bottom surface of the lower flexible film layer, the lower flexible electrode is disposed on the top surface of the upper flexible film layer, and the flexible gel dielectric layer is sandwiched between the upper and lower flexible electrodes. The flexible circuitry is used to electrically connect multiple flexible sensors to the data acquisition module, and the data acquisition module is used to receive and process the signals generated by the flexible sensors.
[0010] Preferably, the clear aligner body layer, the lower flexible film layer, and the upper flexible film layer together constitute a shell-shaped aligner that matches the patient's teeth and jaws and is integrally attached to and covers the teeth and palate structure. The shell-shaped aligner includes a dentition section and a palate section. The side of the clear aligner body layer away from the lower flexible film layer is used to contact the patient's teeth and palate, and the outer surface of the upper flexible film layer is used to contact the patient's tongue.
[0011] Preferably, the flexible sensor is packaged on the lingual surface of the teeth in the palatal and / or dental arch portion of the shell-shaped orthodontic appliance.
[0012] Preferably, the material of the invisible orthodontic body layer is PETG or its modified form, or TPU or its modified form, with a thickness of 0.5 to 1.0 mm; the material of the lower flexible film layer and the upper flexible film layer is PDMS or its modified form, TPU or its modified form, or PET or its modified form, with each thickness independently set to be greater than 0 mm and not greater than 0.2 mm.
[0013] Preferably, the flexible gel dielectric layer is an ion gel film, which is formed by photocuring an ion gel precursor liquid containing a polymer network and an ion solvent.
[0014] Preferably, the upper flexible electrode and the lower flexible electrode are respectively printed with conductive paste on the bottom surface of the lower flexible film layer and the top surface of the upper flexible film layer; The flexible circuit includes an upper circuit portion and a lower circuit portion. The upper circuit portion is printed with conductive paste on the bottom surface of the lower flexible film layer and is electrically connected to the upper flexible electrode. The lower circuit portion is printed with conductive paste on the top surface of the upper flexible film layer and is electrically connected to the lower electrode. Both the upper circuit portion and the lower circuit portion are electrically connected to the data acquisition module.
[0015] Preferably, the conductive slurry is a stretchable silver paste or a printable liquid gallium indium alloy slurry.
[0016] Preferably, the data acquisition module is an external structure that extends to the outside of the patient's oral cavity; Alternatively, the data acquisition module may be an embedded structure, attached and fixed to the body layer of the invisible aligner, and worn in the patient's mouth along with the shell-shaped aligner.
[0017] Preferably, the data acquisition module includes a signal acquisition unit and a communication unit. The signal acquisition unit is used to acquire the capacitance signal generated by the flexible sensor and convert it into a digital signal. The communication unit is used to transmit the digital signal to an external terminal wirelessly or via a wired connection.
[0018] A method for manufacturing an invisible orthodontic appliance that also features tongue muscle monitoring and training functions includes the following steps: Step 1: Obtain the patient's digital dental model and design the packaging points of the flexible sensor and the wiring path of the flexible circuit based on the digital dental model; the packaging points are determined according to clinical monitoring or training goals and are selected from at least one of the patient's lingual surface of the teeth, the hard palate, the labial and buccal surfaces of the teeth, or the occlusal surface of the teeth. Step 2: Using conductive paste, an upper flexible electrode and an upper circuit portion are printed on the bottom surface of the lower flexible film layer, and a lower flexible electrode and a lower circuit portion are printed on the top surface of the upper flexible film layer, wherein the upper circuit portion is electrically connected to the upper flexible electrode, and the lower circuit portion is electrically connected to the lower flexible electrode. Step 3: Place multiple flexible gel dielectric layers between the corresponding upper and lower flexible electrodes to form a sandwich-structured flexible sensor; Step 4: Stack the invisible aligner body layer, the lower flexible film layer with the upper flexible electrode and upper circuit printed on it, the flexible gel dielectric layer, and the upper flexible film layer with the lower flexible electrode and lower circuit printed on it in sequence, and press them onto the solid dental model by hot pressing to form the three-layer structure into one piece; the hot pressing film can be a one-time pressing film or a multi-stage pressing film. Step 5: After cooling, trim and shape the device, and electrically connect the flexible circuit to the data acquisition module to obtain an invisible orthodontic device with tongue muscle monitoring and training functions. Step 6: Configure the data acquisition module to perform the following signal processing: Establish a mapping matrix between standard force and capacitance signal under standard force loading conditions; The first capacitance signal was acquired while the tongue was at rest to determine the initial tongue muscle function assessment value. A second capacitance signal is acquired during tongue movement to correct the initial tongue muscle function assessment value, thereby obtaining a corrected tongue muscle function assessment value. The evaluation values are sent to an external terminal via wireless or wired means.
[0019] Compared with the prior art, the beneficial technical effects of the present invention are as follows: 1) This invention's invisible aligner utilizes a three-layer structure design, securely integrating multiple capacitive flexible sensors within a shell that conforms to the jawbone. The flexible thin film layers above and below the sensors are extremely soft and no more than 0.2 mm thick, allowing the outer surface of the aligner to sense the contact and pressure of the tongue like a thin, sensitive layer of skin while applying corrective force. When worn, the sensors accurately capture the subtle pressure changes generated at various points on the lingual surface of the teeth or the palate during tongue muscle activity and convert them into capacitive signals. This avoids measurement distortion caused by traditional measuring devices not conforming to the tissue, ensuring the accuracy of monitoring data and patient comfort during extended wear. 2) This orthodontic appliance is made by directly printing the upper flexible electrode, the lower flexible electrode and the connecting circuit on two flexible films respectively, and using a light-cured ion gel film as the intermediate dielectric layer to form an integrated sandwich sensing structure. This manufacturing method makes the sensor and the orthodontic appliance have strong integrity and resistance to bending and stretching, and the circuit is not easy to break during repeated activities such as speaking and chewing in the oral cavity.
[0020] 3) Based on a multi-point, customizable sensor layout, doctors can strategically place sensors on the lingual surfaces of the teeth, labial and buccal surfaces, occlusal surfaces, or hard palate, depending on the patient's specific situation, such as tongue thrusting and swallowing, low tongue position, or abnormal lip and cheek muscle function. This allows for comprehensive data covering the entire perioral muscle group's activity. The collected signals, after being processed by the module, can be wirelessly transmitted to external terminals such as mobile phones. Combined with human-computer interaction training programs, this transforms tedious tongue muscle function training into gamified motion control, improving patient, especially child, compliance while providing doctors with objective and continuous data support for adjusting treatment plans and evaluating rehabilitation effects. Attached Figure Description
[0021] The present invention will be further described below with reference to the accompanying drawings.
[0022] Figure 1 This is a schematic diagram of the overall structure of an invisible orthodontic device that also has tongue muscle monitoring and training functions according to the present invention. Figure 2 This is a cross-sectional structural diagram of an invisible orthodontic device with tongue muscle monitoring and training function according to the present invention. Figure 3 This is a schematic diagram of the connection structure between the shell-shaped orthodontic appliance and the flexible sensor in this invention.
[0023] Explanation of reference numerals in the attached drawings: 100, shell-shaped aligner; 101, clear aligner body layer; 102, lower flexible film layer; 103, upper flexible film layer; 200, flexible sensor; 300, flexible circuit; 400, solid dental model. Detailed Implementation
[0024] To make the technical problems to be solved, the technical solutions, and the beneficial effects of the present invention clearer, the present invention will be further described in detail below with reference to the accompanying drawings and embodiments. It should be understood that the specific embodiments described herein are only used to explain the present invention and are not intended to limit the present invention.
[0025] like Figure 1-3 As shown, an invisible aligner with tongue muscle monitoring and training functions includes an invisible aligner body layer 101, a lower flexible film layer 102, an upper flexible film layer 103, a flexible sensor 200, a flexible circuit 300, and a data acquisition module. The invisible aligner body layer 101, the lower flexible film layer 102, and the upper flexible film layer 103 are sequentially pressed together. The shape of the invisible aligner body layer 101 matches the shape of the patient's teeth and jaws, and the lower flexible film layer 102 and the upper flexible film layer 103 are more flexible than the invisible aligner body layer 101. At least one of the flexible sensors 200 is encapsulated and connected... Connected between the lower flexible thin film layer 102 and the upper flexible thin film layer 103, each flexible sensor 200 includes an upper flexible electrode, a lower flexible electrode, and a flexible gel dielectric layer. The upper flexible electrode is disposed on the bottom surface of the lower flexible thin film layer 102, the lower flexible electrode is disposed on the top surface of the upper flexible thin film layer 103, and the flexible gel dielectric layer is sandwiched between the upper and lower flexible electrodes. The flexible circuit 300 is used to electrically connect the multiple flexible sensors 200 to the data acquisition module, and the data acquisition module is used to receive and process the signals generated by the flexible sensors 200.
[0026] Specifically, the flexible sensor 200 in this embodiment is a capacitive sensor. When the patient's tongue comes into contact with the upper flexible film layer 103 and applies pressure to a certain flexible sensor 200, the flexible gel dielectric layer located within the sensor undergoes compression deformation, resulting in a decrease in its thickness. According to the capacitance calculation formula, the capacitance value of the flexible sensor 200 will increase accordingly at this time; when the pressure decreases or disappears, the flexible gel dielectric layer recovers its deformation, its thickness increases, and the capacitance value decreases accordingly. In this way, the flexible sensor 200 can convert the pressure applied by the tongue muscles into a measurable capacitance signal in real time, thereby achieving accurate monitoring of tongue muscle function. The advantage of this design is that the capacitive sensor is very sensitive to minute pressure changes, can capture subtle force changes during tongue muscle activity, and has a simple structure, making it suitable for integration between two flexible film layers without affecting the patient's comfort when wearing the orthodontic appliance.
[0027] Specifically, in addition to monitoring the pressure of the tongue muscles on the teeth and palate, this orthodontic appliance can also measure the pressure exerted on the teeth by the lip and cheek muscles, as well as the occlusal force between the patient's upper and lower teeth, as needed. In this case, it is only necessary to encapsulate flexible sensors 200 on the labial / buccal or occlusal surfaces of the teeth within the shell-shaped appliance 100. For example, placing sensors on the labial / buccal surfaces of the teeth can monitor for abnormal lip habits in the patient; placing sensors on the occlusal surfaces can assess the force exerted on the teeth during treatment. These sensors in different locations can be used individually or in combination to achieve comprehensive monitoring of the strength of the perioral muscle groups.
[0028] Specifically, this aligner also has a special application: it can be used to measure the corrective force exerted on the teeth by the aligner itself. The procedure involves swapping the positions of the aligner body layer 101 and the upper flexible film layer 103 in the original three-layer structure. That is, the harder, innermost aligner body layer 101 is moved to the outermost position, and the softer, outermost upper flexible film layer 103 is moved to the innermost position. The flexible sensor 200 remains encapsulated and connected between the upper flexible film layer 103 and the lower flexible film layer 102. After this adjustment, the outermost hard layer becomes the aligner membrane that generates the corrective force, while the innermost soft layer does not interfere with the sensing of force on the teeth. After being inserted into the mouth, the corrective force exerted on the teeth by the outermost hard layer is transmitted to the innermost soft layer through the middle sensor layer, causing a change in the sensor's capacitance, thereby measuring the actual magnitude and distribution of the corrective force at each point.
[0029] Specifically, the invisible aligner body layer 101, the lower flexible film layer 102, and the upper flexible film layer 103 together constitute a shell-shaped aligner 100 that matches the patient's teeth and jaws and is integrally attached to and covers the teeth and palate structure. The shell-shaped aligner 100 includes a dentition portion and a palatal portion. The side of the invisible aligner body layer 101 away from the lower flexible film layer 102 is used to contact the patient's teeth and palate, and the outer surface of the upper flexible film layer 103 is used to contact the patient's tongue.
[0030] Specifically, in this embodiment, the shell-shaped orthodontic appliance 100 is manufactured by pressing three layers of film onto the patient's solid dental model 400 using a thermoforming process, thus allowing for precise attachment to each of the patient's teeth and the surface of the palate. The innermost layer, the invisible appliance body layer 101, directly contacts the teeth and palate, serving to fix the appliance and apply corrective force. The outermost layer, the upper flexible film layer 103, directly contacts the patient's tongue. When the patient swallows, speaks, or performs specific tongue muscle training movements, the tongue naturally contacts and compresses the upper flexible film layer 103, thereby triggering the flexible sensor 200 located within it. This design, which conforms to the structure of the teeth and palate, makes the appliance very stable in the oral cavity, preventing displacement due to tongue movements. It also ensures that the sensor can accurately capture the actual pressure applied by the tongue to various points on the teeth and palate, avoiding the problem of measurement distortion caused by traditional measuring devices not conforming to the tissue.
[0031] Specifically, the flexible sensor 200 is packaged on the lingual surface of the teeth in the palatal and / or dental arch portion of the shell-shaped orthodontic appliance 100.
[0032] Specifically, the packaging location of the flexible sensor 200 can be customized according to different clinical monitoring and training needs. For example, if a patient has a habit of tongue thrusting and swallowing, causing the tongue muscles to exert force on the upper and lower anterior teeth, then the flexible sensor 200 needs to be packaged on the lingual surface of the anterior teeth in the dental arch. If the patient has a problem with a low tongue position, then the flexible sensor 200 needs to be packaged on the lingual surface of the mandibular teeth and the posterior part of the palate. In the palatal region, multiple sensors can be arranged in a matrix, such as a 3x3 matrix, to comprehensively monitor the contact between the tongue and different areas of the palate. This multi-point, customizable packaging method allows doctors to target the monitoring points according to each patient's specific type of tongue muscle dysfunction, thereby obtaining more comprehensive and accurate tongue muscle function assessment data than traditional single-point measurement devices.
[0033] Specifically, in addition to the two main locations on the hard palate and the lingual surfaces of the teeth, this orthodontic appliance can also encapsulate flexible sensors 200 on the labial / buccal or occlusal surfaces of the teeth, depending on clinical needs. For example, sensors on the labial / buccal surfaces of the teeth can monitor the pressure exerted on the teeth by the lip and cheek muscles, used to assess whether the patient has abnormal lip and cheek muscle function; sensors on the occlusal surfaces of the teeth can measure the distribution of occlusal force in a conscious state or during normal chewing. These additional sensors, used in conjunction with sensors on the lingual and palatal surfaces, enable dynamic functional monitoring of the entire perioral muscular system, providing more complete data for the etiological analysis and efficacy evaluation of malocclusion.
[0034] Specifically, the material of the invisible aligner body layer 101 is PETG or its modified form, or TPU or its modified form, with a thickness of 0.5 to 1.0 mm; the material of the lower flexible film layer 102 and the upper flexible film layer 103 is PDMS or its modified form, TPU or its modified form, or PET or its modified form, with each having a thickness independently set to be greater than 0 mm and not greater than 0.2 mm.
[0035] Specifically, in this embodiment, the body layer 101 of the invisible aligner uses PETG or its modified form, or TPU or its modified form, which has a certain degree of hardness and elasticity, and a thickness between 0.5 and 1.0 mm. This thickness and material selection ensures that the aligner can exert sufficient and lasting corrective force on the teeth, while also having good retention and preventing it from easily falling off in the mouth. The lower flexible film layer 102 and the upper flexible film layer 103 are made of very soft materials such as PDMS or its modified form, TPU or its modified form, or PET or its modified form, with each layer being no more than 0.2 mm thick. This structural design of an extremely thin outer layer and a relatively thick inner layer allows the aligner to maintain its orthodontic function while the outer layer can sensitively sense the slight touch and pressure of the tongue like a layer of "skin." Furthermore, due to its softness, the patient will not feel a significant foreign body sensation in their tongue when wearing the aligner, greatly improving the comfort and acceptance of wearing it for extended periods.
[0036] Specifically, the flexible gel dielectric layer is an ion gel film, which is formed by photocuring an ion gel precursor liquid containing a polymer network and an ion solvent.
[0037] Specifically, the flexible gel dielectric layer is a transparent and highly elastic film formed by uniformly coating an ionic gel precursor solution and then curing it under ultraviolet light. This ionic gel material is not only very soft, allowing it to bend and deform along with the outer film, but also possesses excellent biocompatibility, preventing allergic or inflammatory reactions of the oral mucosa even with prolonged placement. Its polymer network structure effectively locks in the ionic solvent, ensuring stable dielectric properties during repeated compression and rebound, thereby guaranteeing the stability and repeatability of the capacitive signal output. This material characteristic is crucial for medical devices that need to be worn in the oral cavity for extended periods.
[0038] Specifically, in actual manufacturing, the thickness of the flexible gel dielectric layer is generally controlled to be no more than 0.5 mm, corresponding to a pressure detection range of approximately 30 kPa. This range can cover the pressure values generated by normal tongue muscle activity, abnormal tongue protrusion, and low tongue position. Furthermore, to ensure uniform force distribution and signal stability of the sensor, the size of the flexible gel dielectric layer is typically designed to completely cover the entire area of both the upper and lower flexible electrodes. This ensures that the dielectric layer between the electrodes remains continuous and intact, avoiding measurement errors caused by leakage at electrode edges or missing dielectric layers.
[0039] Specifically, the upper flexible electrode and the lower flexible electrode are respectively printed with conductive paste on the bottom surface of the lower flexible thin film layer 102 and the top surface of the upper flexible thin film layer 103; The flexible circuit 300 includes an upper circuit portion and a lower circuit portion. The upper circuit portion is printed with conductive paste on the bottom surface of the lower flexible thin film layer 102 and is electrically connected to the upper flexible electrode. The lower circuit portion is printed with conductive paste on the top surface of the upper flexible thin film layer 103 and is electrically connected to the lower flexible electrode. Both the upper circuit portion and the lower circuit portion are electrically connected to the data acquisition module.
[0040] Specifically, during the manufacturing process, based on the circuit diagram designed according to the patient's dental mold, a high-precision printing device is used to directly print conductive paste onto the bottom surface of the lower flexible film layer 102 and the top surface of the upper flexible film layer 103. In this way, the electrodes of the flexible sensor 200 and the flexible circuit 300 connecting them are integrated into one unit. The printed electrodes and circuit surfaces are very smooth, the material distribution is uniform, and the resistance is low, which helps reduce signal loss and interference during transmission. By printing the electrodes and circuits separately onto two films and then sandwiching the dielectric layer in between through lamination, the sensor manufactured using this process has good overall integrity and strong stretchability, capable of withstanding repeated bending and slight stretching caused by the patient's daily activities such as speaking, swallowing, and chewing, without circuit breakage or failure.
[0041] Specifically, the conductive slurry is a stretchable silver paste material or a printable liquid gallium indium alloy slurry material.
[0042] Specifically, in actual manufacturing, stretchable silver paste material possesses excellent conductivity, ensuring the strength and stability of capacitive signals; while printable liquid gallium indium alloy material combines high conductivity with excellent stretchability, maintaining the continuity of conductive paths even under repeated bending and deformation. Both materials exhibit good stretchability, effectively preventing microcracks or open circuits from forming during the wearing and use of the orthodontic appliance due to bending or stretching, thus ensuring long-term electrical reliability.
[0043] Specifically, the data acquisition module is an external structure that extends to the outside of the patient's oral cavity; Alternatively, the data acquisition module is a built-in structure, attached and fixed to the body layer 101 of the invisible aligner, and worn in the patient's mouth together with the shell-shaped aligner 100.
[0044] Specifically, the external data acquisition module can be made into a small, handle-like device. It connects to the end of the flexible circuit 300 inside the mouth via a thin, flexible wire and extends to the outside of the patient's mouth, allowing it to be fixed to clothing or held by hand. The advantage of this approach is that the module can be made larger, accommodating a larger capacity battery and a more complex processing chip, while also being easy to replace and recharge. The internal data acquisition module, on the other hand, needs to be designed to be very compact, directly pasted or embedded in one side of the shell-shaped orthodontic appliance 100, with the entire device completely placed inside the mouth. The advantage of this approach is its superior concealment; the patient's daily speech, work, and social activities are completely unaffected, and 24-hour uninterrupted monitoring is possible. Both methods can be selected based on the patient's age, level of cooperation, and monitoring needs, offering greater flexibility.
[0045] Specifically, the data acquisition module includes a signal acquisition unit and a communication unit. The signal acquisition unit is used to acquire the capacitance signal generated by the flexible sensor 200 and convert it into a digital signal. The communication unit is used to transmit the digital signal to an external terminal wirelessly or via a wired connection.
[0046] Specifically, when the flexible sensor 200 generates a capacitance signal, the signal acquisition unit in the data acquisition module amplifies and filters these analog capacitance signals, and then converts them into digital signals via an analog-to-digital converter. The converted digital signals are then processed by the communication unit and can be transmitted wirelessly (e.g., via Bluetooth) to the patient's mobile phone or the doctor's computer, or directly via a wired connection. This allows doctors or patients to view the magnitude, trend, and distribution of tongue muscle pressure in real time on an external terminal display system. A detailed 24-hour tongue muscle activity monitoring report can be generated based on usage needs, providing objective data support for subsequent treatment plan adjustments and rehabilitation training effectiveness evaluation.
[0047] A method for manufacturing an invisible orthodontic appliance that also features tongue muscle monitoring and training functions includes the following steps: Step 1: Obtain the patient's digital dental model, and design the encapsulation points of the flexible sensor 200 and the wiring path of the flexible circuit 300 based on the digital dental model; the encapsulation points are determined according to clinical monitoring or training goals, and are selected from at least one of the patient's lingual surface of the teeth, the hard palate, the labial and buccal surfaces of the teeth, or the occlusal surface of the teeth. Step 2: Using conductive paste, an upper flexible electrode and an upper circuit portion are printed on the bottom surface of the lower flexible thin film layer 102, and a lower flexible electrode and a lower circuit portion are printed on the top surface of the upper flexible thin film layer 103, wherein the upper circuit portion is electrically connected to the upper flexible electrode, and the lower circuit portion is electrically connected to the lower flexible electrode. Step 3: Place multiple flexible gel dielectric layers between the corresponding upper and lower flexible electrodes to form a sandwich structure flexible sensor 200; Step 4: Stack the invisible aligner body layer 101, the lower flexible film layer 102 with the upper flexible electrode and upper circuit printed on it, the flexible gel dielectric layer, and the upper flexible film layer 103 with the lower flexible electrode and lower circuit printed on it in sequence, and press them onto the solid dental model 400 by hot pressing to form the three-layer structure into one piece; the hot pressing film can be a one-time pressing film or a multi-stage pressing film. Step 5: After cooling, trim and shape the device, and electrically connect the flexible circuit 300 to the data acquisition module to obtain an invisible orthodontic device with tongue muscle monitoring and training functions. Step 6: Configure the data acquisition module to perform the following signal processing: Establish a mapping matrix between standard force and capacitance signal under standard force loading conditions; The first capacitance signal was acquired while the tongue was at rest to determine the initial tongue muscle function assessment value. A second capacitance signal is acquired during tongue movement to correct the initial tongue muscle function assessment value, thereby obtaining a corrected tongue muscle function assessment value. The evaluation values are sent to an external terminal via wireless or wired means.
[0048] Specifically, orthodontic appliances made using this method can also be used in conjunction with interactive training programs on mobile phones or computers. For example, a "Fruit Ninja" or "Whack-a-Mole" game can be designed on a mobile phone, where the character's movements are controlled by the patient's tongue muscle pressure. When the patient presses their tongue against a sensor point on the palate of the orthodontic appliance, the fruit in the game is cut; when the patient presses the tip of their tongue against a sensor on the lingual side of their teeth, the whack-a-mole is hit. In this way, the originally tedious tongue muscle function training becomes a fun game, which can greatly improve the training compliance of patients, especially children. At the same time, the game program records the pressure value and reaction time of each press, and doctors can use this data to assess the patient's tongue muscle function recovery and adjust the training plan accordingly.
[0049] It should be noted that, in this document, relational terms such as "first" and "second" are used only to distinguish one entity or operation from another, and do not necessarily require or imply any such actual relationship or order between these entities or operations. Furthermore, the terms "comprising," "including," or any other variations thereof are intended to cover non-exclusive inclusion, such that a process, method, article, or apparatus that comprises a list of elements includes not only those elements but also other elements not expressly listed, or elements inherent to such process, method, article, or apparatus.
[0050] The embodiments described above are merely preferred embodiments of the present invention and are not intended to limit the scope of the present invention. Various modifications and improvements made by those skilled in the art to the technical solutions of the present invention without departing from the spirit of the present invention should fall within the protection scope defined by the claims of the present invention.
Claims
1. An invisible orthodontic device that also features tongue muscle monitoring and training functions, characterized in that: The device includes a clear aligner body layer (101), a lower flexible film layer (102), an upper flexible film layer (103), a flexible sensor (200), a flexible circuit (300), and a data acquisition module. The clear aligner body layer (101), lower flexible film layer (102), and upper flexible film layer (103) are sequentially pressed together. The shape of the clear aligner body layer (101) matches the shape of the patient's teeth and jaws, and the lower flexible film layer (102) and upper flexible film layer (103) are more flexible than the clear aligner body layer (101). At least one of the flexible sensors (200) is encapsulated and connected to the lower flexible film layer (103). Between the flexible thin film layer (102) and the upper flexible thin film layer (103), each of the flexible sensors (200) includes an upper flexible electrode, a lower flexible electrode and a flexible gel dielectric layer. The upper flexible electrode is disposed on the bottom surface of the lower flexible thin film layer (102), the lower flexible electrode is disposed on the top surface of the upper flexible thin film layer (103), and the flexible gel dielectric layer is sandwiched between the upper flexible electrode and the lower flexible electrode. The flexible circuit (300) is used to electrically connect the multiple flexible sensors (200) to the data acquisition module, and the data acquisition module is used to receive and process the signals generated by the flexible sensors (200).
2. The invisible orthodontic device with tongue muscle monitoring and training function according to claim 1, characterized in that: The invisible aligner body layer (101), lower flexible film layer (102), and upper flexible film layer (103) together constitute a shell-shaped aligner (100) that matches the patient's teeth and jaws and is integrally attached to and covers the teeth and palate structure. The shell-shaped aligner (100) includes a dental arch and a palate. The side of the invisible aligner body layer (101) away from the lower flexible film layer (102) is used to contact the patient's teeth and palate, and the outer surface of the upper flexible film layer (103) is used to contact the patient's tongue.
3. The invisible orthodontic device with tongue muscle monitoring and training function according to claim 2, characterized in that: The flexible sensor (200) is packaged on the lingual side of the teeth in the palate and / or dentition of the shell-shaped orthodontic appliance (100).
4. The invisible orthodontic device with tongue muscle monitoring and training function according to claim 1, characterized in that: The material of the invisible orthodontic body layer (101) is PETG or its modified form, or TPU or its modified form, with a thickness of 0.5 to 1.0 mm; the material of the lower flexible film layer (102) and the upper flexible film layer (103) is PDMS or its modified form, TPU or its modified form, or PET or its modified form, with each having a thickness independently set to be greater than 0 mm and not greater than 0.2 mm.
5. The invisible orthodontic device with tongue muscle monitoring and training function according to claim 1, characterized in that: The flexible gel dielectric layer is an ion gel film, which is formed by photocuring an ion gel precursor liquid containing a polymer network and an ion solvent.
6. The invisible orthodontic device with tongue muscle monitoring and training function according to claim 2, characterized in that: The upper flexible electrode and the lower flexible electrode are respectively printed with conductive paste on the bottom surface of the lower flexible thin film layer (102) and the top surface of the upper flexible thin film layer (103); The flexible circuit (300) includes an upper circuit portion and a lower circuit portion. The upper circuit portion is printed with conductive paste on the bottom surface of the lower flexible thin film layer (102) and electrically connected to the upper flexible electrode. The lower circuit portion is printed with conductive paste on the top surface of the upper flexible thin film layer (103) and electrically connected to the lower flexible electrode. Both the upper circuit portion and the lower circuit portion are electrically connected to the data acquisition module.
7. The invisible orthodontic device with tongue muscle monitoring and training function according to claim 6, characterized in that: The conductive slurry is a stretchable silver paste or a printable liquid gallium indium alloy slurry.
8. The invisible orthodontic device with tongue muscle monitoring and training function according to claim 6, characterized in that: The data acquisition module is an external structure that extends to the outside of the patient's oral cavity; Alternatively, the data acquisition module is a built-in structure, attached and fixed to the body layer (101) of the invisible aligner, and worn in the patient's mouth together with the shell aligner (100).
9. The invisible orthodontic device with tongue muscle monitoring and training function according to claim 8, characterized in that: The data acquisition module includes a signal acquisition unit and a communication unit. The signal acquisition unit is used to acquire the capacitance signal generated by the flexible sensor (200) and convert it into a digital signal. The communication unit is used to send the digital signal to an external terminal wirelessly or via wired means.
10. A method for manufacturing an invisible orthodontic appliance that also has tongue muscle monitoring and training functions, characterized in that: Includes the following steps: Step 1: Obtain the patient's digital dental model and design the encapsulation points of the flexible sensor (200) and the wiring path of the flexible circuit (300) based on the digital dental model; the encapsulation points are determined according to clinical monitoring or training objectives and are selected from at least one of the patient's lingual surface of the teeth, the hard palate, the labial and buccal surfaces of the teeth, or the occlusal surface of the teeth. Step 2: Using conductive paste, an upper flexible electrode and an upper circuit portion are printed on the bottom surface of the lower flexible thin film layer (102), and a lower flexible electrode and a lower circuit portion are printed on the top surface of the upper flexible thin film layer (103), wherein the upper circuit portion is electrically connected to the upper flexible electrode, and the lower circuit portion is electrically connected to the lower flexible electrode. Step 3: Place multiple flexible gel dielectric layers between the corresponding upper and lower flexible electrodes to form a sandwich structure flexible sensor (200). Step 4: Stack the invisible aligner body layer (101), the lower flexible film layer (102) with the upper flexible electrode and upper circuit printed on it, the flexible gel dielectric layer, and the upper flexible film layer (103) with the lower flexible electrode and lower circuit printed on it in sequence, and press them onto the solid dental model (400) by hot pressing to form the three-layer structure as a whole; the hot pressing film is a one-time pressing film or a multi-stage pressing film; Step 5: After cooling, trim and shape the device, and electrically connect the flexible circuit (300) to the data acquisition module to obtain an invisible orthodontic device with tongue muscle monitoring and training functions; Step 6: Configure the data acquisition module to perform the following signal processing: Establish a mapping matrix between standard force and capacitance signal under standard force loading conditions; The first capacitance signal was acquired while the tongue was at rest to determine the initial tongue muscle function assessment value. A second capacitance signal is acquired during tongue movement to correct the initial tongue muscle function assessment value, thereby obtaining a corrected tongue muscle function assessment value. The evaluation values are sent to an external terminal via wireless or wired means.