Multi-biological parameter monitoring system and invisible leading appliance thereof

Abstract

The invention provides a multi-biological parameter monitoring system and an invisible leading appliance thereof. The multi-biological parameter monitoring system comprises a micro airflow sensor which is arranged in an upper anterior tooth area palate side structure of the invisible leading appliance and is used for monitoring the airflow rate, flow and rhythm in an oral cavity in real time; the biochemical sensor array is arranged in an area, corresponding to the gum edge, of the inner side of the invisible leading appliance and is used for detecting various different biochemical parameters; the main control chip is electrically connected with the micro airflow sensor and the biochemical sensor array respectively; the data storage module is electrically connected with the main control chip and is used for storing data information of the main control chip; the wireless transmission module is electrically connected with the main control module and is used for establishing wireless communication with external equipment; and the micro battery is used for supplying power to the micro airflow sensor, the biochemical sensor array, the main control chip and the wireless transmission module.

Description

Technical Field

[0001] This invention relates to the field of orthodontic equipment technology, and in particular to a multi-biological parameter monitoring system and its invisible pre-aligner. Background Technology

[0002] Mandibular retrusion is a common maxillofacial developmental problem, and currently, orthodontic devices known as mandibular pre-leader appliances are often used for functional correction. However, traditional pre-leader appliances only provide mechanical guidance and cannot objectively monitor the patient's wearing behavior, oral function status, and biological responses during the treatment process.

[0003] Therefore, doctors usually have to rely on patients' subjective feedback and regular follow-up visits for observation, making it difficult to obtain key data such as actual wearing compliance, nighttime breathing patterns, and periodontal tissue response. This results in a lag and subjectivity in the assessment of treatment efficacy, and also makes it impossible to achieve early risk warning and personalized orthodontic adjustments.

[0004] In recent years, some designs have attempted to incorporate sensing elements into pre-orthodontic appliances, such as strain gauge-based force monitoring or contact sensor-based wear detection. However, these pre-orthodontic appliances generally suffer from limitations such as limited functionality and low integration, failing to meet the practical application needs for multi-parameter and comprehensive oral environment monitoring. Summary of the Invention

[0005] This invention provides a multi-biological parameter monitoring system and its invisible pre-orthodontic appliance, aiming to solve the technical problem that existing pre-orthodontic appliances cannot meet the practical application needs of multi-parameter and comprehensive oral environment monitoring.

[0006] In a first aspect, embodiments of the present invention provide a multi-biological parameter monitoring system for use with invisible pre-contrast orthodontic devices. This multi-biological parameter monitoring system includes: a miniature airflow sensor disposed within the palatal structure of the maxillary anterior region of the clear aligner; the miniature airflow sensor is used to monitor the airflow rate, flow rate, and rhythm within the oral cavity in real time; a biochemical sensor array disposed on the inner side of the clear aligner, corresponding to the gingival margin; the biochemical sensor array is used to detect various biochemical parameters, including pH value, temperature, microbial metabolic markers, and inflammatory factor concentrations; a main control chip electrically connected to both the miniature airflow sensor and the biochemical sensor array; the main control chip is specifically used to: identify mouth breathing events based on the miniature airflow sensor; a data storage module electrically connected to the main control chip for storing the data information of the main control chip; a wireless transmission module electrically connected to the main control chip for establishing wireless communication with external devices; and a miniature battery electrically connected to the main control chip for powering the miniature airflow sensor, the biochemical sensor array, the main control chip, and the wireless transmission module.

[0007] Optionally, the micro battery includes: a flexible thin-film lithium battery or an all-solid-state micro battery that supports wireless charging; wherein the shape of the micro battery is adapted to the internal housing structure of the invisible pre-aligner.

[0008] Optionally, the main control chip, the data storage module, and the wireless transmission module are integrated on a flexible circuit board using system-in-package technology; the flexible circuit board is embedded in the thickened area of ​​the palate of the invisible pre-aligner.

[0009] Optionally, the biochemical sensor array includes: a pH sensor, a temperature sensor, a microbial metabolic marker sensor, and an inflammatory factor sensor.

[0010] Optionally, the multi-biological parameter monitoring system further includes: a pulse oximeter based on photoplethysmography; wherein the pulse oximeter is communicatively connected to the main control chip through the wireless transmission module, and the pulse oximeter is used to collect pulse oximetry parameters and provide them to the main control chip.

[0011] Optionally, the pulse oximetry parameters include at least one of the following parameters: blood oxygen saturation, pulse rate, and heart rate.

[0012] Secondly, embodiments of the present invention provide an invisible pre-orthodontic device, including an orthodontic device body and a multi-biological parameter monitoring system integrated inside the orthodontic device body as described above.

[0013] At least one beneficial effect of the multi-biological parameter monitoring system of the present invention is that it has the characteristics of high integration and miniaturization, and can be effectively embedded inside the invisible pre-orthodontic appliance. Without affecting the orthodontic function and wearing comfort, it can realize real-time dynamic monitoring of key indicators such as oral airflow and gingival crevicular fluid biomarkers, providing doctors with objective data support and assisting in accurate efficacy assessment and early risk intervention. Attached Figure Description

[0014] Figure 1 This is a functional block diagram of the multi-biological parameter monitoring system according to an embodiment of the present invention; Figure 2 This is a functional block diagram of the biochemical sensor array according to an embodiment of the present invention; Figure 3 This is a schematic diagram showing the position of the biochemical sensor array in the invisible pre-aligner according to an embodiment of the present invention; Figure 4 This is a schematic diagram showing the position of the miniature airflow sensor in the invisible pre-aligner according to an embodiment of the present invention; Figure 5 This is a functional block diagram of a multi-biological parameter monitoring system according to another embodiment of the present invention; Figure 6 This is a schematic diagram showing the connection between the flexible circuit board and the micro battery according to an embodiment of the present invention. Detailed Implementation

[0015] To facilitate understanding of the present invention, a more detailed description is provided below with reference to the accompanying drawings and specific embodiments. It should be noted that when an element is described as being "fixed to" another element, it can be directly on the other element, or one or more intermediate elements may exist between them. When an element is described as being "connected" to another element, it can be directly connected to the other element, or one or more intermediate elements may exist between them. The terms "upper," "lower," "inner," "outer," "bottom," etc., used in this specification indicate the orientation or positional relationship based on the orientation or positional relationship shown in the accompanying drawings, and are only for the convenience of describing the present invention and simplifying the description, and do not indicate or imply that the device or element referred to must have a specific orientation, or be constructed and operated in a specific orientation, and therefore should not be construed as a limitation of the present invention. Furthermore, the terms "first," "second," "third," etc., are used for descriptive purposes only and should not be construed as indicating or implying relative importance.

[0016] Unless otherwise defined, all technical and scientific terms used in this specification have the same meaning as commonly understood by one of ordinary skill in the art to which this invention pertains. The terminology used in this specification is for the purpose of describing particular embodiments only and is not intended to limit the invention. The term "and / or" as used in this specification includes any and all combinations of one or more of the associated listed items.

[0017] Furthermore, the technical features involved in the different embodiments of the present invention described below can be combined with each other as long as they do not conflict with each other.

[0018] Figure 1 This is a functional block diagram of the multi-biological parameter monitoring system provided in this embodiment of the invention. It can be applied to the invisible pre-aligner 10 to monitor multiple biological parameters.

[0019] like Figure 1 As shown, the multi-biological parameter monitoring system includes: a miniature airflow sensor 11, a biochemical sensor array 12, a main control chip 13, a data storage module 14, a wireless transmission module 15, and a miniature battery 16.

[0020] Among them, such as Figure 4 As shown, the miniature airflow sensor 11 is installed in the palatal structure of the upper anterior teeth region of the invisible pre-orthodontic appliance 10, and is used to monitor the airflow rate, flow rate and rhythm in the oral cavity in real time.

[0021] Specifically, the miniature airflow sensor 11 can be a sensor that detects the rate, flow rate, and rhythm of mouth breathing airflow based on the microthermal effect. It can generate a raw signal of voltage / current values ​​that vary over time in relation to changes in the velocity and temperature of the airflow passing through the sensor.

[0022] like Figure 3 As shown, the biochemical sensor array 12 is arranged on the inner side of the invisible pre-aligner 10 in the area corresponding to the gingival margin, and is used to detect a variety of different biochemical parameters (e.g., pH value, temperature, microbial metabolic markers and inflammatory factor concentrations).

[0023] Specifically, the biochemical sensor array 12 is a multi-parameter electrochemical sensing platform that can use flexible printed electrodes (SPE) as a substrate and modify the working electrode surface with specific sensitive materials for different analytes to achieve selective detection.

[0024] The main control chip 13 is the core of the entire system. It is electrically connected to the miniature airflow sensor 11 and the biochemical sensor array 12 to process and analyze the detected raw signals. Specifically, the main control chip 13 can identify mouth breathing events based on the data detected by the miniature airflow sensor 11.

[0025] The data storage module 14 is a device used to store data information. It is electrically connected to the main control chip 13 and is used to store the data information of the main control chip.

[0026] The wireless transmission module 15 is a device used to establish wireless communication. It is electrically connected to the main control module 13 and can establish wireless communication with external devices, enabling wireless data interaction between the main control module 13 and external devices.

[0027] Specifically, the main control chip 13 can periodically wake up to collect signals from various sensors, and after analog-to-digital conversion and preliminary filtering, store them in the data storage module 14. This data can also be transmitted to external devices via Bluetooth BLE at set intervals or by command, or quickly exported from the charging dock via near-field communication.

[0028] In other embodiments, this data can be further analyzed in depth on external devices such as the cloud or terminals to automatically generate relevant parameter reports, such as the respiratory event index (REI) and gingival crevicular fluid inflammation trend chart, to assist doctors in making diagnostic decisions and adjusting treatment plans.

[0029] The micro battery 16 is a power source for storing electrical energy. It is electrically connected to the main control chip 13 and serves as a power source for multiple functional modules, including the micro airflow sensor 11, the biochemical sensor array 12, the main control chip 13, and the wireless transmission module 15.

[0030] Specifically, the micro-battery 16 can be a flexible thin-film lithium battery or an all-solid-state micro-battery that supports wireless charging. Its shape is adapted to the internal housing structure of the invisible pre-aligner, making it easy to integrate and fix within the invisible pre-aligner body.

[0031] In other embodiments, such as Figure 5 As shown, the multi-biological parameter monitoring system also includes a pulse oximeter 17 based on photoplethysmography.

[0032] Among them, the pulse oximeter 17 is a sensor based on the principle of photoplethysmography (PPG). It obtains optical signals that change with the heart cycle by emitting light of one or more wavelengths into human tissue, thereby extracting parameters related to the human pulse and calculating blood oxygen-related parameters.

[0033] Based on the needs of practical applications, the pulse oximeter 17 can be implemented in any suitable form. For example, the pulse oximeter 17 can be a finger clip or ear clip pulse oximeter probe with a transmissive structure, or a skin-attached / forehead patch reflective pulse oximeter probe. It can also be other sensing modules that integrate light-emitting devices, photodetectors, and signal conditioning units, thereby realizing the acquisition of pulse oximeter parameters.

[0034] It communicates with the main control chip 13 via a wireless transmission module 15, and through this wireless communication connection, provides the collected pulse oximetry parameters to the main control chip 13. Specifically, the pulse oximetry parameters include at least one of the following parameters: blood oxygen saturation, pulse rate, and heart rate. In some embodiments, such as Figure 6 As shown, the main control chip 13, data storage module 14, and wireless transmission module 15 are integrated on the flexible circuit board 20 using system-in-package (SIP) technology. The micro battery 16 is electrically connected to the flexible circuit board 20, providing power to the flexible circuit board 20 and, in turn, powering the micro airflow sensor 11 and the biochemical sensor array 12.

[0035] Specifically, the micro battery 16 is a power generation unit based on a piezoelectric electret-type piezoelectric thin-film energy conversion device. This type of piezoelectric thin-film energy conversion device adopts a sandwich structure composed of FEP / PVDF-TrFE / FEP. It is realized by constructing a multi-scale porous structure on the surface of the PVDF-TrFE layer to store space charge and setting electrodes on both sides.

[0036] Therefore, when the invisible pre-aligner is subjected to micro-deformation loads caused by chewing, swallowing, speaking, occlusal contact or breathing in the oral environment, the space charge will undergo relative displacement and generate output electrical energy between the electrodes. After being converted and stored by electrical energy devices such as capacitors, it supplies power to the functional circuits on the flexible circuit board 20.

[0037] In practical applications, the flexible circuit board 20 can be embedded into the thickened area of ​​the palate of the invisible pre-aligner. The micro battery 16 can be placed near the dome / mid-palatine suture within the thickened area of ​​the palate to reduce the impact on wearing comfort and tongue movement and improve packaging reliability.

[0038] In some embodiments, the main control chip 13 can detect mouth breathing events in the following manner: First, the raw signal from the miniature airflow sensor 11 is filtered (e.g., low-pass filtered) to remove high-frequency noise. Then, several key feature parameters are extracted using a preset algorithm.

[0039] These characteristic parameters may include: respiratory waveform: a waveform composed of periodic airflow signals; respiratory rate: the number of complete respiratory cycles (inhalation and exhalation) per unit time; inhalation / exhalation time ratio; peak airflow rate; and tidal volume estimation: estimating the gas volume of a single breath by integrating the airflow rate over time.

[0040] Finally, based on these key feature parameters, a multi-feature fusion decision algorithm is used to detect mouth breathing events: First, if a clear, regular airflow waveform with a certain flow rate (e.g., exceeding a preset threshold, such as 5 mL / s) can be continuously detected when the patient is wearing the orthodontic appliance, it can be preliminarily determined that the breathing channel is either oral or a combination of oral and nasal.

[0041] Furthermore, if only extremely weak or irregular signals can be detected over a longer period of time (possibly related to weak oral reflux during nasal breathing), while other related devices (such as smart bracelets) show that the patient is asleep and has chest and abdominal breathing movements, then it is nasal breathing, ruling out mouth breathing.

[0042] Then, the multi-feature fusion decision algorithm can establish a normal nasal breathing model. When the detected airflow pattern deviates significantly from the model, it is marked as a suspected mouth breathing event.

[0043] Finally, a multi-feature fusion decision algorithm makes a comprehensive judgment. When the flow and pattern conditions for mouth breathing are met in multiple consecutive respiratory cycles, a "mouth breathing event" is finally determined to have occurred. The algorithm further outputs quantitative indicators such as the mouth breathing event index (i.e., the number of mouth breathing events per hour) and the proportion of mouth breathing to the total breathing time, providing doctors with an intuitive assessment basis.

[0044] In some embodiments, the biochemical sensor array can be a multi-parameter electrochemical detection platform implemented using flexible printed electrodes and functionalized nanosensitive materials to non-invasively and continuously monitor pH, temperature, specific microbial metabolites (such as volatile sulfides), and inflammatory factors (such as IL-1β, MMP-8) in gingival crevicular fluid.

[0045] Specifically, such as Figure 2 As shown, the biochemical sensor array 12 includes: a pH sensor 121, a temperature sensor 122, a microbial metabolic marker sensor 123, and an inflammatory factor sensor 124.

[0046] The pH sensor 121 is an electrochemical sensor employing a potentiometric method. Its working electrode surface is modified with a hydrogen ion-sensitive membrane (such as a conductive polymer based on polyaniline or a metal oxide such as IrO2). When the H⁺ concentration changes, the membrane potential at the interface between the sensitive membrane and the solution changes. By measuring this change in potential (relative to the reference electrode), the pH value can be calculated.

[0047] Temperature sensor 122 is a resistive temperature detector (RTD). It utilizes the characteristic that the resistance of metals such as platinum resistance thermometers changes linearly with temperature to detect temperature.

[0048] The microbial metabolic biomarker sensor 123 is an electrochemical sensor employing the amperometric method. Its working electrode surface is modified with a material exhibiting highly selective catalytic activity towards target gas molecules (e.g., metal oxides such as WO3 used for detecting H2S). Thus, when volatile sulfur compound molecules diffuse to the electrode surface, an oxidation or reduction reaction occurs under a set operating voltage, generating a current signal proportional to the concentration of the target molecules.

[0049] The inflammatory factor sensor 124 is an electrochemical sensor employing the principle of immunosensing. It immobilizes antibodies targeting specific inflammatory factors (such as IL-1β) on the surface of the working electrode. When the target factor diffuses from the GCF and specifically binds to the antibody, an immune complex is formed on the electrode surface, thereby altering the electron transfer resistance or capacitance at the electrode / solution interface. Thus, the concentration of the target factor can be detected by measuring changes in the EIS spectrum or the current of a specific redox probe.

[0050] Based on the aforementioned multi-bioparameter monitoring system, this invention further provides an invisible pre-aligner. This invisible pre-aligner includes an aligner body and the aforementioned multi-bioparameter monitoring system. The multi-bioparameter monitoring system is integrated within the aligner body to avoid affecting orthodontic function and wearing comfort.

[0051] Preferably, this invisible pre-aligner also comes with a wireless charging dock. The aligner can be charged and synchronized with data after being placed on the wireless charging dock. Therefore, daily use only requires routine cleaning of the aligner, without any special maintenance.

[0052] In practical applications, medical-grade transparent polymer materials (such as PETG or multi-layer TPU) are used to prepare personalized orthodontic appliance bodies through digital oral scanning, CAD / CAM design, and 3D printing or thermoforming technology. Furthermore, embedding channels and cavities for sensing elements and wires are reserved during the modeling stage.

[0053] The aforementioned miniature airflow sensor is encapsulated within the palatal orthodontic appliance material of the upper anterior teeth using micro-injection molding, with the sensing surface facing the oral airway to avoid direct impact from saliva. The biochemical sensor array can be fabricated as a flexible circuit board, which is then bonded to the corresponding area on the inner gingival margin of the appliance using a transfer process, with the surface covered by a protective film against protein adhesion to ensure long-term stability.

[0054] A flexible circuit board integrating a main control chip, a data storage module, and a wireless transmission module is integrated into the thickened area of ​​the palate. It is cured and insulated using biocompatible encapsulant to ensure the insulation and safety of the circuit.

[0055] In summary, the invisible pre-orthodontic appliance provided in this embodiment of the invention has the ability to monitor multiple parameters simultaneously, realizing real-time monitoring of oral airflow dynamics and biochemical markers. It can improve the accuracy of nighttime breathing pattern monitoring and efficacy evaluation, and through dynamic monitoring of gingival crevicular fluid composition, it can achieve early warning of periodontal inflammation and enamel demineralization, providing multi-dimensional data support for comprehensive evaluation of orthodontic efficacy and oral health status.

[0056] Moreover, all sensors and electronic units in the entire multi-biological parameter monitoring system are miniaturized and flexible, and are completely embedded inside the orthodontic appliance, so as not to affect the original appearance, comfort and wearing function of the appliance.

[0057] Furthermore, data from patients wearing invisible pre-aligner can be wirelessly uploaded to the cloud, allowing doctors to access and evaluate the data remotely. This is particularly useful for telemedicine or long-term follow-up scenarios, improving diagnostic efficiency and patient engagement.

[0058] The above description is merely an embodiment of the present invention and does not limit the patent scope of the present invention. Any equivalent structural or procedural transformations made based on the content of the present invention's specification and drawings, or direct or indirect applications in other related technical fields, are similarly included within the patent protection scope of the present invention.

Claims

1. A multi-biological parameter monitoring system, applied to invisible pre-aligner orthodontic appliances, characterized in that, include: A miniature airflow sensor is installed in the palatal structure of the upper anterior region of the invisible pre-orthodontic appliance; the miniature airflow sensor is used to monitor the airflow rate, flow rate and rhythm in the oral cavity in real time. A biochemical sensor array is arranged on the inner side of the invisible pre-aligner, in the area corresponding to the gingival margin; the biochemical sensor array is used to detect a variety of different biochemical parameters. The biochemical parameters include: pH value, temperature, concentration of microbial metabolic markers and inflammatory factors; The main control chip is electrically connected to the miniature airflow sensor and the biochemical sensor array, respectively; the main control chip is specifically used to: identify mouth breathing events based on the miniature airflow sensor. A data storage module, which is electrically connected to the main control chip, is used to store the data information of the main control chip; A wireless transmission module, electrically connected to the main control module, is used to establish wireless communication with external devices; and A micro battery, electrically connected to the main control chip, is used to power the micro airflow sensor, the biochemical sensor array, the main control chip, and the wireless transmission module.

2. The multi-biological parameter monitoring system according to claim 1, characterized in that, The micro battery includes: a flexible thin-film lithium battery or an all-solid-state micro battery that supports wireless charging. The shape of the micro battery is adapted to the internal housing structure of the invisible pre-aligner.

3. The multi-biological parameter monitoring system according to claim 1, characterized in that, The main control chip, the data storage module, and the wireless transmission module are integrated on a flexible circuit board using system-level packaging technology; the flexible circuit board is embedded in the thickened area of ​​the palate of the invisible pre-aligner.

4. The multi-biological parameter monitoring system according to claim 1, characterized in that, The biochemical sensor array includes: a pH sensor, a temperature sensor, a microbial metabolic marker sensor, and an inflammatory factor sensor.

5. The multi-biological parameter monitoring system according to claim 1, characterized in that, Also includes: Pulse oxygen sensor based on photoplethysmography; The pulse oximeter sensor is connected to the main control chip via the wireless transmission module. The pulse oximeter sensor is used to collect pulse oximeter parameters and provide them to the main control chip.

6. The multi-biological parameter monitoring system according to claim 5, characterized in that, The pulse oximetry parameters include at least one of the following parameters: blood oxygen saturation, pulse rate, and heart rate.

7. An invisible pre-alignment orthodontic appliance, comprising an appliance body, characterized in that, The orthodontic appliance body integrates a multi-biological parameter monitoring system as described in any one of claims 1-4.

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