Systems and methods related to automatic data collection

Abstract

A system for automatically collecting metrics data and other data from an oral instrument and transmitting to a cloud storage system is disclosed herein. The oral cavity device can transmit the measurement data and other data to a charging station through BLE (Bluetooth Low Energy) or other wireless communication modes, or directly transmit the measurement data and other data to a network gateway, a coordinator or a controller; the charging station, network gateway, coordinator, or controller may then transmit the data to a cloud storage system for device manufacturers, clinicians, and / or users / patients to access as needed.

Description

Technical Field

[0001] This invention relates to systems and methods for improving overall oral hygiene or aesthetics, treating periodontal diseases such as gingivitis and periodontitis, killing or denaturing oral microorganisms including cariogenic bacteria, reducing oral biofilm, increasing blood flow in oral tissues, increasing saliva secretion, promoting gingival tissue regeneration, promoting bone formation in the bone structures of teeth, oral cavity and related areas, treating systemic diseases related to oral bacteria, and / or treating other periodontal and oral diseases by non-invasively applying direct current to the oral cavity surface. This invention also relates to an apparatus for providing direct current to achieve the above-mentioned therapeutic, preventive, cosmetic and regenerative effects. Background Technology

[0002] Periodontal disease has been identified by dentists and internists as a risk factor for a variety of systemic diseases. These include cardiovascular disease, adverse pregnancy outcomes, and diabetes, with recent evidence also supporting its association with pancreatic disease and arthritis. Although many studies have confirmed the correlation between the presence of periodontal disease and these systemic diseases, the causal relationship remains an ongoing research topic for most of these conditions. Several biological mechanisms have been proposed regarding how oral bacteria originating from periodontal disease can trigger systemic diseases: 1. Direct effects of oral infections: Oral microorganisms and their byproducts can enter the circulatory system through damaged tissues and inflamed periodontal tissues in the oral cavity, thereby gaining systemic access. In terms of gaining systemic access, oral microorganisms have the potential to directly influence subclinical mediators of various systemic diseases.

[0003] 2. Inflammation: Patients with periodontal disease have elevated levels of oral bacteria, and consequently, elevated levels of systemic inflammatory markers. It has been reported that periodontal disease treatment can reduce systemic inflammation levels.

[0004] 3. Cross-reaction: Immune responses to bacterial heat shock proteins can produce antibodies that cross-react with intrinsic heat shock proteins expressed on damaged tissue cells, thereby accelerating the development of systemic diseases.

[0005] Cardiovascular disease

[0006] Studies investigating the potential link between periodontal disease and cardiovascular disease (including atherosclerosis, coronary artery disease, and stroke) have found a significant positive correlation between poor oral health and the incidence of cardiovascular disease. Although both diseases share several risk factors, recent research suggests that periodontitis may precede atherosclerotic complications, thereby exacerbating their development. In fact, meta-analyses have shown that participants with periodontitis have an increased risk of developing cardiovascular disease.

[0007] While it's not yet definitively confirmed whether these bacteria directly cause atherosclerosis or invade already damaged arteries, antibodies against periodontal bacteria (including *Fusobacterium nucleatum* and *Streptococcus osticulatus*) have been detected in serum, and these antibodies are associated with an increased risk of coronary heart disease. A mouse study found that intravenous inoculation with *Porphyromonas gingivalis* accelerated the development of atherosclerosis. Furthermore, *Porphyromonas gingivalis* DNA was detected in the aortic tissue of infected mice showing significant early signs of accelerated atherosclerosis after oral inoculation. Another study indicated that *Fusobacterium nucleatum* enhances the ability of *Porphyromonas gingivalis* to invade host cells due to its co-aggregation effect with *Porphyromonas gingivalis*. This is significant because bacteria present within atherosclerotic plaques may contribute to their development. The evidence to date supports the idea that periodontitis leads to systemic exposure to oral bacteria, which constitute a potential source of systemic inflammatory mediators. These inflammatory mediators and cytokines produced in infected periodontal tissues can trigger or exacerbate atherosclerosis and coronary heart disease once they enter the bloodstream. Clinical studies on periodontal disease have also revealed a positive association between it and coronary artery disease, and current research is shifting towards understanding the exact relationship between periodontal disease and atherosclerosis.

[0008] Premature birth

[0009] Fusobacterium nucleatum is one of the most common bacterial species found in amniotic fluid and placental infections, causing preterm birth and often being identified as the sole pathogen in cases of preterm birth with intact membranes. Fusobacterium nucleatum is also highly associated with various periodontal diseases. During periodontal infection, when the oral mucosa is damaged and inflamed, and the number of periodontal pathogens increases dramatically, transient bacteremia may occur in the blood, leading to selective colonization of bacteria in non-target sites. One study showed that blood injection of Fusobacterium nucleatum isolated from amniotic fluid infection or oral cavity sources caused fetal death in pregnant mice.

[0010] Recent analysis of a human case of fetal arrest revealed that *Fusobacterium nucleatum* did indeed originate from the mother's oral cavity, a fact previously unconfirmed. *Fusobacterium nucleatum* likely migrates from the mother's oral cavity via the bloodstream, then penetrates endothelial cells, proliferates and colonizes in the fetal membranes, amniotic fluid, and fetus, ultimately leading to fetal death. In a mouse model, intravascular injection of *Fusobacterium nucleatum* into the bloodstream of pregnant mice resulted in placental-specific colonization and localized inflammation. Twenty-four hours after injection, *Fusobacterium nucleatum* was completely cleared from maternal circulation. However, once colonized in an immune-exempt placenta, the bacteria rapidly multiply and cause fetal death within three days. Chronic periodontitis may mediate infection through translocation of periodontal bacteria / inflammatory markers to the fetal placental unit.

[0011] diabetes

[0012] Diabetes mellitus is an endocrine disorder stemming from genetic, environmental, and behavioral risk factors. For decades, diabetes has been considered a moderating factor for periodontal disease, but recent research suggests a bidirectional relationship between the two. Furthermore, the presence of periodontal disease is now recognized as a risk factor for diabetic complications, particularly poor glycemic control. Recent longitudinal and systematic studies have found that patients with periodontal disease have a higher risk of death from ischemic heart disease, diabetic nephropathy, and end-stage renal disease, and exhibit more significant insulin resistance compared to those with mild or no periodontal disease. In type 2 diabetes, insulin resistance is associated with the role of pro-inflammatory cytokines. Periodontal disease leads to significantly elevated levels of these serum inflammatory markers, thereby contributing to insulin resistance. A human study comparing oral bacterial content in adults with and without type 2 diabetes found that diabetic patients had significantly more severe periodontitis and higher levels of various oral bacteria, including oral streptococci.

[0013] purulent liver abscess

[0014] Fusobacterium nucleatum has recently been identified as an associated cause of purulent liver abscesses (PLA). While purulent liver abscesses are typically caused by biliary tract diseases, diverticulosis, intestinal malignancies, atrophic gastritis, and cryptogenic liver disease, purulent liver abscesses caused by Fusobacterium nucleatum are very rare. The most commonly isolated microorganisms from drained abscesses are Escherichia coli, Klebsiella pneumoniae, and Enterobacteriaceae. Fusobacterium nucleatum was found in a case of liver abscess in which no other source of infection was identified besides a tooth extraction. It is speculated that due to the co-aggregating properties of Fusobacterium nucleatum, it can transport and penetrate the colonic mucosa, leading to bacteremia and subsequently causing a liver abscess.

[0015] osteomyelitis

[0016] Osteomyelitis is a bone infection caused by bacteria, fungi, or other pathogens. Typically, bacteria spread from infected skin, muscles, or tendons to the bone, often occurring beneath skin ulcers. Infection can also begin in other parts of the body and spread hematogenously. Occasionally, Fusobacterium species have been isolated from bone / joint infections in the head and neck region, and are associated with chronic periodontitis. A recent study reported a case of osteomyelitis complicated by a muscle abscess caused by Fusobacterium nucleatum. The patient had no known precipitating factors and no other source of infection besides a history of periodontal disease. It is believed that poor oral hygiene may have led to Fusobacterium nucleatum bacteremia, resulting in hematogenous osteomyelitis of the lower extremities.

[0017] arthritis

[0018] Numerous clinical studies have suggested a potential link between rheumatoid arthritis (RA) and periodontal disease, as various oral bacteria, such as *Porphyromonas gingivalis* and *Prevotella intermedia*, have been isolated from the synovial fluid of patients. Periodontal disease is thought to allow bacteria to penetrate the permeable pocket epithelium in the oral cavity to the underlying gingival connective tissue, thereby entering the bloodstream and colonizing other parts of the body. The presence of oral bacteria in the synovial fluid of RA patients, attributed to the synovial inflammation's susceptibility to capturing oral bacterial DNA, suggests that periodontal disease may have a lasting impact on joint disease. Therefore, periodontitis may indeed be a factor contributing to the characteristic autoimmune inflammatory response of RA. Patients with rheumatoid arthritis (RA) may also face a higher risk of developing periodontal disease, indicating a bidirectional association between the two diseases. One specific study examined the presence of bacterial DNA in the synovial fluid of arthritis patients' own joints and failed prosthetic joints. Of the five patients in whom bacterial DNA was detected, four tested positive for *Fusobacterium nucleatum*. This indicates that the bacteria can be transferred from the oral cavity to the synovial fluid, as Fusobacterium nucleatum was also detected in dental plaque samples from the same patient.

[0019] Oral biofilm

[0020] Periodontitis, gingivitis, and dental caries are infectious diseases of the oral cavity, in which oral biofilms and bacteria play a pathogenic role. Biofilm formation is also related to the pathogenesis of dental implant failure, such as peri-implantitis, denture stomatitis, and oral yeast infections like candidiasis. Oral biofilm formation begins with the formation of an acquired membrane on the tooth surface. This membrane, composed of salivary proteins, covers the exposed surfaces of the tooth (mainly the supragingival region), where planktonic bacteria initially adhere. Aerobic bacteria (including Gram-positive cocci such as oral streptococci) act as early colonizers, primarily forming initial biofilm colonies through cell division of the already adhered bacteria.

[0021] Once the initial colony is formed, other co-aggregating bacterial species (such as Fusobacterium nucleatum, Porphyromonas gingivalis, and other Gram-negative anaerobes) attach to the previously formed colony. As these colonies mature, their growth gradually covers the subgingival surface of the tooth and begins to induce periodontal inflammation. Summary of the Invention

[0022] The system and method according to the present invention provide an oral device capable of transmitting data wirelessly to an external location for storage.

[0023] According to one embodiment of the data transmission system of the present invention, the system includes an oral device comprising a controller connected to a braces. The controller may extend from the braces such that it is located outside the oral cavity during use. Alternatively, the controller may be positioned at a distance from the braces and connected to them via a wire, allowing the user to place the controller in a pocket or attach it to their head. Or, the controller may be substantially located inside the braces, or a large portion of the controller may be located within the outer boundary of the braces, such that a large portion or all of the controller is located inside the oral cavity during use. The controller is configured to record data related to at least one of the following: operation of the oral device, information received from one or more secondary electronic devices, and environmental parameters monitored by the oral device or by the one or more secondary electronic devices. The controller is also configured to wirelessly transmit the recorded data, the transmission being performed in at least one of the following ways: substantially periodically, automatically when the data changes, and in response to a request from a wireless communication device. The controller is configured to record and transmit data and should generally be understood to include: an electronic power supply, a microprocessor or microcontroller programmed or with accessible instructions (e.g., software) to perform a specified function, non-volatile electronic memory, a wireless radio frequency module, and all other necessary circuitry required to perform said function.

[0024] According to another aspect of the data transmission system of the present invention, the wireless communication device may be a charging station configured to charge a rechargeable battery in an oral device (e.g., using a Qi-compliant interface), a device including a Thread border router, a device including a Wi-Fi access point, a device including a Zigbee coordinator, a device including a Matter controller, and / or a device including an IEEE Std. 802.15.4 coordinator.

[0025] According to another aspect of the data transmission system of the present invention, the controller is configured to generate an indication that the recorded data has changed, and the wireless communication device is configured to receive the indication from the controller via a first wireless communication. The wireless communication device is further configured to send a data request to the controller via a second wireless communication, receive the recorded data from the controller via a third wireless communication, and relay the data to a communication network for remote storage. The indication may be multi-digit data (which may be located in a BLE broadcast packet), and each digit may reflect a change in one piece of data, such as: treatment start counter increment, treatment stop counter increment, open circuit counter increment, treatment failure counter increment, failure counter increment, low battery counter increment, critical battery counter increment, time elapsed for data transmission completion, current time state of the controller, controller charging, and / or manual power-on counter increment.

[0026] The wireless communication device can be a charging station configured to mechanically receive and support the oral device. The first wireless communication can be Near Field Communication (NFC), Bluetooth (BLE), Wi-Fi, LoRa / LoRaWAN, IEEE Std 802.15.4 compliant communication, or other wireless (preferably radio frequency) communication. The second wireless communication can be Near Field Communication (NFC), Bluetooth (BLE), Wi-Fi, LoRa / LoRaWAN, IEEE Std 802.15.4 compliant communication, or other wireless communication, preferably radio frequency (RF) communication. The third wireless communication can be Near Field Communication (NFC), Bluetooth (BLE), Wi-Fi, LoRa / LoRaWAN, IEEE Std 802.15.4 compliant communication, or other wireless communication, preferably radio frequency (RF) communication. Data relay or indication of data changes preferably includes relay communication from the controller or charging station to the communication network, which may point to a network gateway. Such a network gateway can be a Low Power Wide Area Network (LPWAN) gateway. According to another aspect of the data transmission system of the present invention, the relay communication may be near field communication (NFC), Bluetooth (BLE) communication, Wi-Fi communication, LoRa / LoRaWAN communication, communication conforming to IEEE Std 802.15.4, or other wireless (preferably radio frequency) or wired network communication.

[0027] According to another aspect of the data transmission system of the present invention, the remote storage includes a cloud storage system.

[0028] According to one aspect of the method of the present invention, the method includes the step of: recording data on an electronic device configured to be mouth-supported, relating to at least one of the following: operation of the electronic device, information received from one or more secondary electronic devices, and environmental parameters monitored by the electronic device or by the one or more secondary electronic devices. The method further includes wirelessly transmitting the recorded data in at least one of the following ways: generally periodic transmission, automatic transmission when data changes, and transmission in response to a request from a wireless communication device. The wireless communication device may be a charging station for charging a rechargeable battery in an electronic device, a handheld mobile device, a low-power wide-area network gateway, a device including a Thread border router, a device including a Wi-Fi access point, a device including a Zigbee coordinator, a device including a Matter controller, or a device including an IEEE Std 802.15.4 coordinator.

[0029] According to another embodiment of the method of the present invention, the electronic device is configured to generate an indication that the recorded data has changed, and the wireless communication device is configured to receive the indication from the electronic device via a first wireless communication method. The wireless communication device is further configured to, in response to the first wireless communication or without receiving the first wireless communication, send a request for at least a portion of the data to the electronic device via a second wireless communication, and receive the requested data from the electronic device in a third wireless communication. The received data can then be relayed to a communication network for remote storage.

[0030] According to another aspect of the method of the present invention, the wireless communication device is a charging station, which is configured to monitor network communications and discover at least one other communication device capable of network communication with the charging station. The network communication may be at least one of Wi-Fi communication and Bluetooth communication. The network communication may include information associated with another wireless communication device, including at least one of the following: Media Access Control (MAC) address, Received Signal Strength Indicator (RSSI), Service Set Identifier (SSID), Basic Service Set Identifier (BSSID), system name, and serial number.

[0031] According to another aspect of the method of the present invention, the method includes detecting a nearby Wi-Fi network and recording up to ten network identifiers indicating the strongest RSSI. The method may further include the step of indicating and recording a first geographical location change of the charging station by comparing the recorded network identifiers with a previously recorded list of network identifiers; indicating and recording a first geographical location change of the charging station if 70% or more of the recorded network identifiers are not in the list, and if 50% or more of the previously recorded network identifiers are not in the recorded list. The method may additionally or alternatively include the step of indicating and recording a second geographical location change of the charging station by comparing the RSSI values ​​of the recorded network identifiers with a previously recorded list of RSSI values ​​of network identifiers; indicating and recording a second geographical location change of the charging station if 20% to 50% of the recorded network identifiers have RSSI values ​​that change by approximately 3 to 10 dB compared to the RSSI values ​​of the previously recorded network identifiers.

[0032] According to another aspect of the method of the present invention, the electronic device is capable of applying electrical stimulation to the oral cavity, and the method further includes the step of permanently disabling the electrical stimulation output function of the device after recording the applied electrical stimulation for a predetermined number of minutes, the predetermined number of minutes being between 30,000 and 41,760 minutes. Attached Figure Description

[0033] Figure 1 This is a perspective view of the intraoral electrical stimulation device and related storage and / or charging base according to the present invention.

[0034] Figure 2 This is a top view of the braces and controller according to the present invention.

[0035] Figure 3 This is a bottom view of the braces and controller according to the present invention.

[0036] Figure 4 This is a left elevation view of the braces and controller according to the present invention.

[0037] Figure 5 This is a rear elevation view of the braces and controller according to the present invention.

[0038] Figure 6 This is a circuit diagram of the controller according to the present invention.

[0039] Figure 7 This is a partial cross-sectional view of a controller according to an embodiment of the present invention, along... Figure 3 Sectioned along line 7-7.

[0040] Figure 8 is a schematic diagram of a portion of the circuitry in one embodiment of the controller according to the present invention.

[0041] Figure 9 yes Figure 1 The front perspective view of the embodiment shown illustrates the braces / controller supported by a bracket.

[0042] Figure 10 This is a front perspective view of the charging holder / box for receiving the braces / controller according to the present invention.

[0043] Figure 11 It provides a user interface feedback form that occurs at a predetermined time under a predetermined device or software condition.

[0044] Figure 12A -B provides a programmable parameter table stored in memory in the controller according to the present invention.

[0045] Figure 13A -B provides a counter or index table to be recorded by the controller according to the invention when a corresponding event occurs during operation.

[0046] Figure 14 It provides a table of events and related event data recorded by the software.

[0047] Figure 15A -C provides the controller's operating functions, related user operation tasks, and response tables according to the present invention.

[0048] Figure 16 It is a flowchart depicting the operating or non-operating state of the controller according to the present invention.

[0049] Figure 17A This is a flowchart depicting the information transmission between the device, charging dock, low-power wide area network gateway, and cloud storage system according to the present invention.

[0050] Figure 17B This is a flowchart depicting another information transmission method between the device, low-power wide area network gateway, and cloud storage system according to the present invention.

[0051] Figure 18 It is a chart used to monitor output current parameters. Detailed Implementation

[0052] While the disclosure herein is detailed and accurate enough to enable those skilled in the art to practice the invention, the physical embodiments disclosed herein are merely illustrative, and the invention may be implemented in other specific structures. Although preferred embodiments have been described, details may be varied without departing from the scope of the invention.

[0053] It is known in the art that oral bacteria cannot survive exposure to low-microamp direct current. This method of killing oral bacteria and treating bacterial conditions such as gingivitis has been demonstrated in U.S. Patent No. 4,244,373 (Nachman), dated January 13, 1981, and U.S. Patent No. 4,509,519 (Detsch), dated April 9, 1985. Killing oral bacteria also has the added benefit of preventing tooth decay and cavities. Generally, tooth decay is attributed to aerobic acid-producing bacteria, whose acid production causes irreversible demineralization of teeth. However, Nachman did not guide the optimal approach for reducing oral bacteria at the species level (including aerobic and anaerobic bacteria), but rather taught a general, non-targeted treatment approach.

[0054] In studying the effects of direct current on the oral cavity, the applicant discovered that by increasing the current level to a range of approximately 50 to 250 microamps (µA), direct current stimulation can deliver novel and unexpected therapeutic, preventative, cosmetic, and regenerative benefits previously unknown in the art.

[0055] Specifically, using direct current within the aforementioned range, this stimulation not only kills bacteria but has also been found to kill or inhibit viruses and fungi. Research in the field of podiatry indicates that effective treatment of fungal infections requires higher current levels than those used in existing oral electrical stimulation therapies (Kalinowski et al., "Low-voltage direct current as a fungicide for treating onychomycosis," Journal of the American Podiatric Medical Association, Vol. 94, No. 6: 565-572, 2004). By applying knowledge from research on increasing current levels beyond this existing technology, the applicant was able to enhance the beneficial effects of fungicide and antiviral activity within methods known to have bactericidal effects. The applicant's research shows that these bactericidal properties begin to take effect approximately 5 to 15 minutes after stimulation, thereby reducing supragingival and subgingival microorganisms.

[0056] Furthermore, the applicant's clinical studies unexpectedly discovered that direct current in the range of approximately 50 to 250 microamps can promote gingival tissue regeneration, providing a non-surgical alternative for patients with gingival recession. Although the osteogenic properties of electrical stimulation are known in the art, prior to these experiments, the association between non-bone tissue regeneration and electrical stimulation was not fully understood in the field. The unique current range involved in the method and apparatus of this invention is one of the few effective methods in dentistry that can achieve effective gingival tissue regeneration non-surgically.

[0057] In further research, the applicant conducted preclinical testing to investigate the effects of direct current stimulation on three different oral bacteria (Fusobacterium nucleatum, Streptococcus stomatum, and Porphyromonas gingivalis) in saline and saliva solutions. This test determined the optimal eradication effect against these three bacteria, which are associated with periodontal disease and systemic illness, by varying the current intensity, bacterial inoculum size, solution medium, and stimulation time.

[0058] This test yielded unexpected results, demonstrating that each different bacterium responds differently to direct current stimulation. Through this test, the applicant determined that up to 100% of oral streptococci, 99.1% of nucleated fusobacteria, and 52.3% of gingival porphyria can be eliminated during a single stimulation session lasting 30 minutes or less. This study derives a direct current stimulation protocol targeting the pathogens that was previously unknown in the art. The optimal stimulation parameters discovered in this study and described in this method provide an innovative approach to reducing the abundance of these three bacteria in the supragingival and subgingival environments, thereby preventing and / or treating their associated complications, including periodontal disease, biofilm formation, and systemic diseases associated with these oral pathogens.

[0059] Furthermore, according to the method of the present invention, scanning electron microscopy (SEM) observations were performed on *Fusobacterium nucleatum* colonies before and after 30-minute stimulation to better understand the mechanism by which the method of the present invention can reduce bacterial levels. The SEM images showed that the method of the present invention can interfere with bacterial cell division and weaken its outer membrane (cell membrane), thereby leading to fragile and easily ruptured cell structures. This phenomenon can be considered a manifestation of electroporation, i.e., cell membrane permeability may be temporarily or permanently altered due to electrical stimulation. It is further conceivable that the electroporation effect induced by the method of the present invention may support the development of new therapies in the field of molecular biology, which can utilize this cell permeability mechanism to introduce new substances into the cells of oral pathogens or oral tissues, including but not limited to genetic material such as DNA, RNA, sRNA, siRNA, and plasmids (transfection). These effects will provide a new tool for targeted gene therapy in oral applications.

[0060] Specifically, the method according to the invention has been shown to reduce live colony-forming units (CFU) in a variety of oral bacteria.

[0061] Table 1 below shows the results of the following methods, based on the present invention, for 5 minutes, 10 minutes, 20 minutes, and 30 minutes at current levels of 50 µA or 500 µA, respectively, for a total of 10 colony-forming units (CFU) in the salt solution. 4 Up to 10 7 The stimulating effect of oral streptococcal cultures.

[0062]

[0063] Table 2 below shows the results of applying current levels of 50 µA or 500 µA to saliva solutions containing 10 µA of the present invention for durations of 5, 10, 20, and 30 minutes. 4 Up to 10 7 Bacterial cultures of CFU (Colombia ulmoides) were tested.

[0064]

[0065] Table 3 below shows the results of applying the present invention to salt solutions containing 10 µA under conditions of current levels of 50 µA or 500 µA and durations of 5, 10, 20, and 30 minutes. 4 and 10 6 CFU has the stimulating effect of bacterial cultures of Fusobacterium nucleatum.

[0066]

[0067] Table 4 below shows the results of the present invention, at current levels of 50 µA or 500 µA, for saliva containing 10 4Up to 10 6 The effects of CFU-containing Fusobacterium nucleatum bacterial cultures on stimulation for 5, 10, 20, and 30 minutes.

[0068]

[0069] Table 5 below shows the results of the present invention, at current levels of 50 µA or 500 µA, for salt solutions containing 10 4 The effects of CFU (Cytosporum gingivalis) bacterial cultures on stimulation for 5, 10, 20, and 30 minutes.

[0070]

[0071] Therefore, this method and corresponding apparatus can achieve a variety of preventive, therapeutic, cosmetic, and regenerative effects, combinations of which are previously unknown or unavailable in the art. Specifically, these effects include: promoting oral osteogenic formation, disrupting or inhibiting oral microorganisms, promoting gingival tissue regeneration, reducing and preventing oral biofilm formation, preventing dental caries, enhancing oral vasodilation and blood perfusion, treating common oral conditions such as gingivitis and periodontitis, treating systemic diseases and symptoms related to oral pathogens, and improving overall oral hygiene.

[0072] Now refer to the attached diagram, Figure 1 An embodiment of the stimulation device 10 according to the present invention is shown. The stimulation device 10 is preferably a standalone device comprising a dental brace 100 and a controller 300; the controller 300 is physically supported and operatively charged by a charging base or charging station 400. Generally, the dental brace 100 is sized and configured to fit within the oral cavity while positioning one or more electrodes at desired locations within the oral cavity.

[0073] Reference Figures 2 to 5The brace 100 includes at least one generally U-shaped channel 110 configured to accommodate any maxillary or mandibular teeth of a human body, and preferably includes a top U-shaped channel 110T and an opposing bottom U-shaped channel 110B, the channels 110 being configured to preferably accommodate any maxillary and any mandibular teeth of the same human body simultaneously. The two U-shaped channels 110 are preferably separated from each other by a channel base 114 along at least a majority of their length 112. Connected to the channel base 114 to form the channels 110 are opposing lingual walls 120 and buccal walls 130, the sidewalls preferably extending substantially perpendicularly from the channel base 114. The lingual wall 120 terminates at a lingual free edge 122, along a large portion of this edge (and preferably along the entire lingual free edge 122) of which one or more lingual electrodes 124 are provided. The lingual electrodes 124 are preferably formed of conductive silicone and may be separated by one or more insulating gaps, such as lingual wall air gaps or notches 126 or other electrically insulating materials. The buccal wall 130 terminates at a buccal free edge 132, along a large portion of this edge (preferably along the entire buccal free edge 132) of which one or more buccal electrodes 134 are provided. The buccal electrodes 134 are preferably formed of conductive silicone and may be separated by one or more insulating gaps, such as buccal wall air gaps or notches 136, or other electrically insulating materials, such as electrically insulating silicone. Preferably, the brace 100 is formed of a tissue-contact material by molding or other means, the material being relatively comfortable, for example, a material with a Shore A hardness of 80 or less.

[0074] The connection between electrodes 124 and 134 and the internal circuitry of controller 300 is achieved via neck portion 200. The connection from electrodes 124 and 134 to neck portion 200 can be achieved using flexible circuitry technology, such as copper-clad polyimide, but more preferably, the conductive path 140 is formed by multi-material injection molding comprising a first electrically insulating material and a second conductive material. That is, conductive silicone can be molded into a desired pattern using a first mold, extending from the first connector end and including one or more electrodes 124 and 134 to form a conductive framework. Subsequently, the conductive framework can be overmolded using electrically insulating silicone to form the main body of the dental brace 100, and to insulate the conductive paths 140 constituting the framework from each other. After insulation, the exposed conductive areas are electrodes 124 and 134 and the terminal surfaces located within neck portion 200.

[0075] Conductive paths 140 within the dental brace 100 are electrically coupled to connector 210 mounted or to be mounted within the controller housing 310 (described further below). Specifically, the connector includes a plurality of pins 212, each pin preferably coupled to a conductive silicone path ( Figure 7The conductive path 140 in the neck 200 is associated with and physically inserted therein, and this path leads to electrode 124 or 134. The maximum resistance of any conductive path from the terminal surface 142 of the conductive path 140 in the neck 200 to any part of either corresponding electrode 124, 134 is preferably less than 25 kΩ.

[0076] Also refer to Figure 7 The controller 300 preferably includes a housing 310 configured to be fixed to the dental brace 100. The housing 310 houses a battery 302 and electronic circuitry, which is typically used to control the timing of the connection (e.g., switching) of electrodes 124, 134 to deliver charge from the battery 302. The battery 302 is preferably a rechargeable lithium-ion battery with a full charge capacity capable of supporting at least seven consecutive stimulation sessions, each lasting 20 minutes. The battery 302 is preferably capable of being fully recharged within 12 hours from a depleted state. The battery 302 is preferably rated for at least 200 charge-discharge cycles. While the circuitry is operatively mounted on one or more printed circuit boards 304, two circuit boards (lower board 304L and upper board 304U) are preferably used to provide a better packaging layout. The housing 310 may include one or more housing components (e.g., top, bottom, sides, etc.) such as molded polycarbonate plastic or polycarbonate / ABS alloy (PC / ABS), preferably biocompatible. Regardless of the materials used to construct the brace 100 and controller 300, the device 10 is preferably capable of withstanding a gravity drop (approximately 9.81 m / s²) from a height of about two meters (2 m) onto a relatively hard surface (e.g., stone or tile, vinyl material overlaid on a wood substrate, or concrete) and remaining intact. The housing components may be individually molded and secured together by mechanical coupling (e.g., snap-locks, threaded fasteners), preferably minimizing moisture intrusion, which may include sealing with gaskets (e.g., O-rings). More preferably, the housing components are ultrasonically welded together to provide a preferred water intrusion protection level (e.g., IPX1 to IPX9).

[0077] Figure 6 Overall, a circuit functional block diagram is provided within the housing 310, including a programmable microprocessor (preferably combined with a communication antenna), an inductive charging circuit for receiving wireless inductive charging for the battery 302, hardware overcurrent protection, current and voltage feedback circuits for monitoring delivery parameters and open circuit states, and user interaction components.

[0078] The controller 300 preferably provides a user input interface in the form of a single button 306 (preferably debounced via hardware or software) and a user output or feedback interface, which preferably includes one or more of a battery indicator 312, a status (or stimulation or treatment indicator) light 314, and an audible buzzer or speaker 316. The status (activated / deactivated) of the button 306 is monitored to control the function. The battery indicator 312 is preferably capable of displaying multiple colors (e.g., white and amber) and is preferably in a constant state, a flashing state (which may flash at different frequencies), or an alternating color state, depending on the feedback required. The status indicator 314 is preferably capable of displaying multiple colors (e.g., red, white, and blue) and is preferably in a constant state, a flashing state (which may flash at different frequencies), or an alternating color state, depending on the feedback to be provided. User feedback can also be additionally or alternatively provided via haptics, for example, using a haptic feedback generator (e.g., a vibration motor). Preferred feedback schemes include... Figure 11 As shown in the table. (and) Figure 11 The relevant notes (indicated by superscript in the table) are as follows: 1. If the device has changed from the "Completed" state to the "Low Battery" state, the treatment status indicator 314 will continue to flash white light, and the sound feedback will be turned off.

[0079] 2. The battery flashes white light while charging and remains solid white when charging is complete.

[0080] 3. If the device is placed on the charging dock while in a "fault" state, the device will continuously flash the red status indicator 314. The device will display the battery indicator 312 (flashing white / solid white) according to the current battery level, but will not provide audible feedback when placed on the charger to avoid being misled into thinking that the fault has been cleared.

[0081] 4. If device 10 is placed on charger 400 for more than 10 minutes after charging is complete, battery indicator light 312 will turn off. During this period, if the battery voltage drops below the charging threshold, charger 400 will continue charging, but battery indicator light 312 will remain off.

[0082] Typically, the circuit can be described as having a multi-channel structure controlled and monitored by a microprocessor, where each channel is associated with the operation of one or more electrodes 124, 134. Each channel can be enabled or disabled independently of the other channels, although each channel can control multiple electrodes. Additionally or alternatively, one or more electrodes can be permanently designated and operate only as return electrodes. A preferred embodiment includes eight channels, each capable of driving up to 125 µA (±10%) of DC current through a resistor of up to 50 kΩ.

[0083] like Figures 8A-8DAs shown, the channel drive circuit 810 for each electrode channel receives an enable signal 802. When the enable signal 802 is activated, a switch (MOSFET in this example) is triggered to supply voltage to a current source regulator, which then supplies current to the channel output 812. A sense resistor 814 is used to determine whether current is flowing, and preferably to determine the amount of current flowing. The CS_HIGH and CS_LOW signals operate through a comparator circuit to activate the CH_CURRENT signal to indicate that current is flowing. The CH_VOLTAGE signal can be monitored to determine the voltage and current levels supplied to the corresponding channel.

[0084] The user (not shown) preferably operates the controller 300 by pressing button 306. For example, the user can press button 306 to start or stop the supply of current to the braces 100. To prevent accidental operation, the duration of button press 306 is sensed and debounced.

[0085] The controller 300 is preferably configured by a clinician or other trained personnel before the user engages with the stimulation device 10. Alternatively, the patient may also configure the controller 300. Configuration of the controller 300 is preferably accomplished via an additional hardware component (not shown) connected to the controller 300, but can also be done wirelessly (e.g., via Bluetooth). ® It can be implemented using Wi-Fi, Near Field Communication (NFC), infrared, and magnetic connections. Finally, a default stimulation scheme can be provided to the controller 300 to reduce or eliminate the initial configuration work required by clinicians or patients.

[0086] Preferred configuration parameters include: selecting the electrode configuration for providing direct current stimulation; selecting the direct current output value (e.g., 6µA, 12µA, 18µA, 25µA, 50µA, 62µA, 75µA, 100µA, 125µA, 150µA, 200µA, and 250µA, preferably with the total current of all delivering electrodes not exceeding 2,000µA at any given time); and selecting the duration of the stimulation session (preferably in 1-minute increments within a range of 1 to 30 minutes). Exemplary preferred configuration parameters are available. Figure 12A and Figure 12B The provided form.

[0087] The controller 300 preferably monitors the compliance of the protocol and stimulation session performed by the stimulation device 10 and records multiple performance metrics, such as counts of predetermined events and monitored events and / or data related to such events, in non-volatile memory (e.g., flash memory). Clinicians (not shown) can use these records to assess and discuss stimulation responses and efficacy. The controller 300 may also be configured to dynamically monitor electrical characteristics (i.e., resistance, voltage, current) and adjust stimulation parameters or settings without clinician or user intervention. A real-time clock is preferably used as a reference to record the time and date of metric and data collection. In addition to the real-time clock (which can be initialized by a wireless communication device or network), a real-time counter is configured to track the timing of automatic state changes and runtime (power-on time).

[0088] For example, a counter can be built to track the number of times a specific event occurs. The counter can be stored in non-volatile memory, such as... Figure 13A and Figure 13B The preferred counters are shown in the table. Some of the collected metrics and data may include the following (along with the date and time of such events): number of stimuli initiated (e.g., treatments); number of stimuli successfully completed (e.g., treatments); number of open-circuit faults; number of stimuli (e.g., treatments) with open-circuit faults; number of stimuli (e.g., treatments) with open-circuit faults but still successfully completed; number of overcurrent faults; number of low-battery faults; number of times the device was paused; number of stimuli (e.g., treatments) paused but still successfully completed; number of times the user turned on the device; number of times the user turned off the device; number of times the software turned off the device; and the total number of minutes the device has been running (e.g., stimuli have been implemented) since the memory was reset. The counter increments once each time the aforementioned event occurs.

[0089] The recorded metrics and data may be stored solely in non-volatile memory within controller 300 and accessible via a physical connection (e.g., via a serial UART connection if housing 310 is removed; or via a serial connector provided on housing 310). Alternatively, the recorded metrics and data may be accessed wirelessly (e.g., via a software application on a Bluetooth Low Energy (BLE)-enabled wireless communication device) or even automatically pushed to the wireless communication device via a wireless network, and then stored on the wireless communication device or in remote storage, such as on a remote data storage device networked to the wireless communication device (cloud storage or a remote server, which may be associated with the manufacturer and / or distributor of device 10, care provider (e.g., doctor, nurse, dentist, dental hygienist, administrator), insurance company, or user (or user's guardian)). A subset of counters to be monitored may be predetermined, and their increases (or changes) may be indicated by software flags and transmitted to another wireless communication device, such as a mobile phone, charging station 400, or a low-power wide-area network (LPWAN) gateway 530 as described below. In a preferred embodiment, Figure 13A The labeled monitoring flag counters include counters corresponding to 1 (manual power-on), 5 (battery critical power-off), 8 (treatment started), 9 (treatment successfully completed), 10 (open circuit fault), 11 (low battery), 12 (fault), and 13 (effectiveness fault). When one or more of these counters change, device 10 will send a wireless communication signal (e.g., a BLE broadcast data packet) to indicate the occurrence of such a change. That is, one byte or more of data may contain one flag bit to indicate the change status of each monitored counter. The flag bit may be cleared after the counter data is transmitted from device 10, or after device 10 successfully completes the transmission of complete data or summary data, as further described below.

[0090] Automatic data push can also be triggered based on time intervals or events, such as transitioning from OFF to READY, entering CHARGING, or returning to OFF. The pushed data may include user stimulation therapy data (e.g., patient compliance indicators), firmware version, device errors, and / or the physical location of device 10 and / or charger 400 (if GPS or network location functionality is provided).

[0091] The specific technologies used for this type of data push can be a combination of hardware technologies known in the art, which have not previously been known to be used in conjunction with any dental appliance. Data pushes from the controller 300 can be sent directly to the charger 400 as a relay for forwarding via wireless communication networks (such as wide area networks, local area networks, etc.), such as WiFi / LoRa / LoRaWAN / WiFi HaLow / Helium, or even low-power wide area networks or mesh networks.

[0092] The system can not only record the number of times a specific event occurs, but also record data related to the occurrence of a specific event. The types of events to be recorded in the controller event log can also be stored in non-volatile memory, including... Figure 14 The event types are shown in the table. Preferably, the event log is capable of storing at least 2000 events. If the non-volatile memory allocated to the event log is insufficient, the oldest event will be overwritten to store new data. For example, environmental information and / or geographic location information can be recorded and / or inferred. The controller 300 or its associated wireless communication device can be configured to monitor network communications and discover at least one other communication device (other than the controller 300 and / or the wireless communication device) capable of network communication (e.g., WiFi and / or Bluetooth communication) with the wireless communication device. The network communications are monitored to detect at least one of the following: Media Access Control (MAC) address, Received Signal Strength Indicator (RSSI), Service Set Identifier (SSID), Basic Service Set Identifier (BSSID), system name, and / or (the other communication device's) serial number. The wireless communication device detects nearby Wi-Fi networks and creates a list containing a certain number (e.g., 1-10) of detected network identifiers indicating the largest Received Signal Strength Indicator (RSSI). That is, the detected networks included in the list have a larger RSSI than other potentially detected networks. The wireless communication device can indicate and record a first geographic location change (e.g., a major geographic location change) by comparing the recorded network identifiers with a previously recorded list of network identifiers, provided that 70% or more of the recorded network identifiers are not in the list, and 50% or more of the previously recorded network identifiers are not in the recorded network identifiers. The wireless communication device can indicate and record a second geographic location change (e.g., a minor geographic location change) by comparing the received signal strength indication (RSSI) values ​​of the recorded network identifiers with a previously recorded list of RSSI values ​​of network identifiers, provided that 20% to 50% of the recorded network identifiers show a change in RSSI values ​​of approximately 3 dB to approximately 10 dB compared to the previously recorded network identifiers.

[0093] The non-volatile memory preferably stores at least the following events and related information: the duration of stimulation completed by the user in a session (up to 30 minutes); whether the aligner disconnected during operation (e.g., an "on" state event occurred); whether an overcurrent fault occurred; the total charge delivered to each channel during a specific stimulation duration (e.g., one treatment), in coulombs (C) or microcoulombs (µC); and whether a low battery fault occurred.

[0094] The controller 300 can also be configured to detect whether the braces 100 are not in the user's mouth during the stimulation treatment, as shown in Figure 8. To this end, the controller 300 monitors the delivery of current and whether current is detected on any of the multiple cathode electrodes. If no current is detected, the controller 300 can pause the stimulation and indicate a fault status. For example, the controller 300 monitors the stimulation circuitry, including both anode and cathode electrodes. The controller 300 includes circuitry for measuring or predicting the amount of current to be delivered to the braces 100 (delivery current) and can further measure the amount of return current received from the braces 100 (return current). The circuitry then compares the return current with the output current, and if the difference is greater than a predetermined value (e.g., a percentage of the output current, such as 10% to approximately 50%), the stimulation is paused—preferably on all electrodes—and a fault message is displayed on the controller. Once the difference between the output current and the return current is less than the predetermined value, the stimulation program or scheme resumes from the pause, preferably ensuring no or minimal loss of stimulation time.

[0095] Figure 18 Parameters are provided for monitoring the current from the output to the output electrode. As described above, the operating current setpoint and the duration "T" are determined and set during the configuration process before the patient uses the stimulation device 10, wherein the recommended setting for the duration "T" is 2 seconds. Preferably, the open-circuit current value is approximately 80% of the operating current setpoint, while the overcurrent fault limit is preferably 120% of the operating current setpoint. The hardware limit is preferably approximately 200 to 300 µA per stimulation channel (e.g., per anode electrode).

[0096] When the controller 300 supplies current to any of the delivery electrodes, the current is preferably polled at a frequency of 8 times per second.

[0097] If the detected current remains below the open-circuit current limit for a preset duration, the stimulation will pause and a notification will be displayed. If the detected current exceeds the overcurrent fault limit and persists for a preset duration, the stimulation will stop and a fault notification will be displayed.

[0098] Furthermore, the stimulation device 10 could be fully compatible with devices such as Bluetooth. ®The device utilizes wireless technologies such as near-field communication (NFC) and Wi-Fi to communicate with the user's electronic device (not shown) (e.g., a mobile phone, tablet, or personal computer). Preferably, the user can view usage history, preset stimulation plans, and / or a comparison of usage history with stimulation plans. The stimulation device 10 can also provide notifications about scheduled stimulation treatments to any of the user's electronic devices. This functionality is envisioned to operate via an application (not shown) downloadable to the user's electronic device. The application can also be configured to share this data with a central server for storage, remote monitoring by prescribing clinicians, providing one-way or two-way communication between patients and clinicians, and / or allowing clinicians to remotely adjust stimulation parameters. Furthermore, firmware upgrades can be wirelessly provided to the controller 300.

[0099] The controller 300 preferably includes a wireless communication technology, such as a Bluetooth Low Energy (BLE) module, which may be integrated within a microprocessor package. When the controller 300 is powered on (i.e., not in a powered-off state), the controller preferably periodically sends BLE broadcast data packets, which preferably contain a device identifier, such as a Unique Device Identifier (UDI) assigned by a regulatory agency (such as the U.S. FDA). Preferably, the BLE communication channel is used to transmit information related to or contained within the controller 300, such as software version, programmable parameters, event log data, counter data, and / or software status (e.g., ready, running, powered on, etc.) and / or changes in any of the foregoing (since the last transmission). The BLE interface can also be used to exchange information with software applications (e.g., user or physician service applications) on remote wireless communication devices (e.g., tablets, mobile phones, or other BLE-enabled devices), which preferably also include a real-time clock. The controller 300 may receive real-time clock data from the application and store and reference this data to start, maintain, and / or update its own real-time clock.

[0100] Specifically, an application running on the wireless communication device can scan (on demand or periodically) for BLE broadcast packets transmitted by the controller 300. By operating the user interface on the device, the user can then pair the device with the stimulation device 10 by selecting from a list of nearby BLE-enabled devices. Alternatively, the application is preferably capable of pairing the wireless device with the stimulation device 10 via RSSI (Received Signal Strength Indicator), where pairing is achieved simply by bringing the wireless device into a predetermined proximity range of the device 10. The user can operate the application's user interface to enable or disable the RSSI function.

[0101] Once the mobile device is paired with device 10, it preferably transmits the current date and time (from a local time stored on the mobile device or from a network such as Wi-Fi or cellular network) to device 10 for storage in an event log. The application can confirm this connection and transmission by displaying the contents of the event log for the user to view. Furthermore, the application can display parameter values ​​and counters of the paired device 10. Preferably, the application provides the option to highlight and notify the user when (or later) changes occur in the event log, parameter values, or counter values ​​of device 10, thereby enabling real-time updates.

[0102] The application also preferably displays the current software state of device 10 and information related to that state. For example, when device 10 is in a RUN or OPEN state (i.e., corresponding to stimulation in progress or paused, respectively), the application may display a timer for counting down the remaining time of the stimulation cycle, as well as current and voltage measurements for each channel on device 10. In these states, the application also preferably provides the following options: saving event logs, parameter values ​​and counters, the unique device identifier (UDI) of device 10, the Bluetooth MAC address of paired device 10, and other information from device 10 for future display within the wireless device application, or saving them as a log file to the memory of the wireless communication device, and such log file can be retrieved without using the application (e.g., a retrieveable or removable electronic file, such as an ASCII text file or a formatted file, such as a comma-separated variable). (.csv file).

[0103] The application also preferably provides a user interface to switch the device 10 between software states, thereby allowing remote control of the device 10 (e.g., by using virtual buttons) without physical interaction with button 306. For example, the device 10 can switch from a READY, CHARGING, or FAULT state to a SERVICE state, and vice versa. When in a SERVICE state, the application preferably allows the user to clear the contents of the event log, reset counters, update parameter values, or perform a firmware update on the device 10. These states will be discussed in more detail below.

[0104] The charging station 400 according to the present invention preferably includes a base 402 and a housing 410, such as Figure 1 and Figure 10As shown. The base 402 preferably includes a power input interface (not shown), such as a USB-C socket. The power input interface is configured to receive input power from a power input source (not shown) (e.g., a DC transformer plugged into a standard power outlet providing AC power). The input power is operatively coupled to a wireless charging coil (not shown), such as a wireless charging coil conforming to the Qi wireless charging standard. The controller 300 can be configured to perform wireless charging without the charger 400, but requires close proximity to another wireless charger (preferably Qi compliant).

[0105] The base 402 includes a controller support interface 420 having a support ridge 422 defining a support surface 422a. The support ridge 422 is configured to cooperate with the controller support ridge 322 to assist in supporting the controller 300 and to facilitate positioning and calibration of the relative positions of the wireless charging circuitry components. Positioning and calibration of the controller 300 relative to the base 402 is preferably further aided by one or more magnets (not shown) fixed within the controller housing 310 and the base 402. Thus, when the controller 300 is supported by the controller support interface 420, the inductive charging coil (located within the base 402) generates a magnetic field through the housing 410, which is utilized by the receiving coil (located within the controller 300) to charge the battery 302.

[0106] The housing 410 is preferably a hollow structure, defining a housing cavity 412, which is configured to accommodate the entire controller 300 / dental aligner 100 assembly, for example, for storage or carrying. Access to the housing cavity 412 can be made by changing the position of the housing 410, including removing the housing 410 (e.g., by using a circumferential snap-fit ​​engagement with the base 402) or pivoting the housing 410 about a hinge pivot point 414, such as a pin hinge or a movable hinge. Within the housing cavity 412, preferably integrally formed with a portion of the base 402, an arcuate saddle-shaped surface 416 is provided, configured to accommodate the U-shaped dental aligner 100.

[0107] To enhance the conductivity of electrodes adjacent to, bridging, or connected to oral tissues, ionic or colloidal liquids or gels can be used as conductive media to reduce resistance within the oral cavity. This medium can be applied to any area where electrical contact is desired, such as teeth, gums, or surrounding oral tissues. Examples of such media include, but are not limited to: colloidal silver gel, liquid colloidal silver, colloidal copper gel, liquid colloidal copper, colloidal gold gel, liquid colloidal gold, saline gel, liquid saline, or any combination thereof.

[0108] Colloidal silver, whether used alone or in combination, not only shows promise in enhancing electrical conduction but also provides additional bactericidal benefits. It is known that colloidal silver at concentrations as low as 0.5 parts per million can exert bactericidal effects by inhibiting the production of adenosine triphosphate (ATP) by bacteria.

[0109] The conductive medium may also contain dietary supplements, including but not limited to oregano oil. Oregano oil is believed to have a variety of health benefits and may have antibacterial properties. Such antibacterial properties can effectively treat common oral infections and diseases and aid in preventative oral care.

[0110] The conductive medium may also contain a teeth whitening agent. This would allow teeth whitening to be included as one of the cosmetic benefits provided by one embodiment of the invention. A whitening agent that can be electrocatalyzed by direct current may be included, potentially even providing a shorter teeth whitening stimulation time compared to a non-electrocatalyzed whitening agent.

[0111] Artificial or natural flavoring agents can also be added to the conductive medium to provide a more appealing taste for the user, similar to the flavoring methods used for dental fluoride treatments. These flavoring agents will mask any unpleasant tastes that the conductive medium components may produce, as well as any taste from the braces or electrodes themselves.

[0112] Therefore, at least one embodiment addresses a desired need in the fields of oral hygiene and dentistry for the simultaneous treatment of common oral diseases and symptoms in a more effective, minimally invasive, and economical manner. These embodiments promote overall oral hygiene, reduce oral biofilm, treat periodontal diseases such as gingivitis and periodontitis, prevent tooth decay and cavities by non-invasively applying a weak direct current to the oral surface, increase vasodilation and blood flow in oral tissues, promote gingival tissue regeneration, promote bone formation in the bony structures of teeth, oral cavity, and related areas, treat systemic diseases associated with oral pathogens, and treat other periodontal and oral diseases.

[0113] In some cases, dental treatments may disrupt oral bacterial colonies in biofilms and introduce bacteria into the bloodstream, leading to bacteremia and other infections. Furthermore, it may be beneficial to use the oral appliance according to the invention immediately before performing dental treatment. The stimulating device 10 according to the invention can be used by the patient at home or in a dental clinic. In this way, the number of live bacteria in the patient's oral cavity (including supragingival and subgingival areas) can be reduced before treatment, thereby reducing the risk of bacteremia and other infections. For example, but not limited to, the stimulating device 10 can be used in a dental clinic before dental prevention or scaling and root planing to reduce the risk of bacteria entering the patient's bloodstream.

[0114] The stimulation device 10 can also be used to prevent infection after clinical treatment, and applicable scenarios include, but are not limited to, infection prevention after tooth extraction or implantation.

[0115] In practice, preferably, the number of anode electrodes equals the number of cathode electrodes, but alternatively, the number of anode and cathode electrodes may differ. It should be understood that targeted stimulation can be selectively provided, for example, for treatment of a predetermined gingival region. To provide targeted stimulation, it is preferable to prevent or reduce the transmission of current to other parts of the oral cavity by mechanical or electrical means. For example, mechanical blocking can be achieved through optimized electrode placement, such as placing anode or cathode electrodes on an orthodontic appliance at a first location in the gingival tissue, which at least partially surrounds (a) a tooth to be extracted and replaced with an implant, or (b) an empty alveolar socket left after intentional or accidental tooth extraction, or (c) a portion of a previously placed dental implant. Mechanical prevention or reduction of non-targeted current stimulation can be further enhanced by placing cathode or anode electrodes on an appliance at a second location in the gingival tissue (preferably on the opposite side of the tooth from the first location). This second location at least partially surrounds (a) a tooth to be extracted and replaced with an implant, or (b) an empty alveolar socket formed after intentional or accidental tooth extraction, or (c) a portion of a previously implanted dental implant. If two electrodes are installed as described above, and no other electrodes are placed on the braces, the electrical stimulation can be reduced mechanically. In this way, by mechanically placing electrodes on the braces, electrical stimulation can be directed to the dental implant site, thus allowing for customized braces for specific users.

[0116] As an example of electrical prevention or reduction of non-targeted currents, selective electrode control can be achieved via a controller. That is, mechanically, multiple electrodes can be arranged around the gaps in the aligner, as shown and described herein. By electrically controlling these electrodes, each electrode can have a selectable stimulation state. This selectable electrode state can be an anodic state, a cathodic state, or an off state (e.g., a three-state mode). Thus, when a directional current is required, a first electrode on the aligner can be selected as either an anodic or cathodic electrode. The location of the first electrode on the occlusal element can correspond to a first location in the gingival tissue at least partially surrounding (a) a tooth to be extracted and replaced with an implant, or (b) an empty alveolar ridge left after a tooth has been intentionally or accidentally extracted, or (c) a portion of a previously implanted dental implant. Electrical prevention or reduction of non-targeted electrical stimulation can be further achieved by selecting the first electrode on the aligner as either a cathodic or a anodic electrode (opposite to the first electrode). The second electrode position on the brace corresponds to a second position in the gingival tissue (located on the opposite side of the tooth from the first position), where the gingival tissue at least partially surrounds one of the following: (a) the tooth to be extracted and replaced with an implant, or (b) an empty alveolar fossa formed after intentional or accidental tooth extraction, or (c) a portion of a previously implanted dental implant. If the two electrodes are selected in the manner described above, and no other electrodes on the brace are activated (e.g., all other electrodes are off or set to high impedance or tri-state mode), electrical attenuation of the current stimulation can be achieved. Thus, an intraoral device can be mechanically standardized for multiple users, but electrically customizable to precisely direct electrical stimulation to the dental implant site.

[0117] Although the foregoing has described mechanical and electrical methods for preventing or reducing stray or non-target currents for targeted stimulation of a single dental implant site, it should be understood that such targeted stimulation can also be performed simultaneously or sequentially on multiple implant sites (e.g., stimulating one target site for a predetermined duration first, followed by stimulating another target site for a predetermined duration).

[0118] During operation, the controller 300 typically cycles through multiple software states, some of which can be found in [reference needed]. Figure 15A , Figure 15B and Figure 15C The instructions in the attached table are as follows. Please refer to them now. Figure 16The preferred states of controller 300 are thus visible. In the off state, either no power is supplied to the microprocessor, or a minimal amount of power is supplied to put the microprocessor into a sleep or low-power mode, and preferably only the real-time clock is maintained, and the visual indicator (continuous or intermittent) may be maintained. If button 306 is pressed for a predetermined time (e.g., at least 3 seconds), the controller can enter the off state from any other state. Based on a predetermined inactivity period, the controller can also enter the off state from the following states: on, ready, completed, low battery, critical battery, or fault. The predetermined inactivity period is used to monitor user activity (i.e., pressing button 306) or to correct the on state. If any of the above occurs during the inactivity period, the controller will enter a state other than the off state from the corresponding state. The predetermined inactivity period is preferably a programmable software variable, and preferably can be programmed separately for inactivity states (i.e., in the READY, COMPLETE, LOW BATTERY, CRITICAL_BATTERY, and / or FAULT states) and OPEN state corrections (i.e., current resumes flowing before the time expires). The OFF state can be exited by activating button 306 for a predetermined time (e.g., at least 2 seconds).

[0119] The READY state is a controller state in which stimulation can be initiated. The READY state can be entered from the OFF state by activating button 306 for a predetermined time (e.g., at least 2 seconds). Controller 300 will remain in the READY state until the user activates button 306, or until a period of inactivity causes the controller to exit the READY state and return to the OFF state.

[0120] The RUN state refers to the state where the delivery electrodes are activated and current is delivered at a preset programmed time and programmed current level. The RUN state can be entered from the Ready state by activating button 306 (intermittently or continuously for a predetermined time). When the user presses button 306 (or a virtual button), the software activates the already activated (i.e., turned on) electrode channel for current delivery (i.e., the controller software switches to the RUN state), preferably only from the Ready state. The software monitors a stimulation (e.g., treatment) duration counter, which increments at least once per second during current delivery. The software compares the stimulation duration counter with the programmed treatment duration to determine when current delivery should end. Alternatively, upon entering the RUN (RU) state, the software can set the initial value of a decrementing counter to the treatment duration, then monitor the counter to determine when it reaches zero, thereby indicating and preferably causing current delivery to stop.

[0121] If the current has been successfully delivered and the stimulation duration counter has expired, the controller software will enter a completion state, in which current delivery stops. Typically, the software will transition to an off state after a predetermined time period from the completion state.

[0122] Once the stimulation treatment is complete, or the user otherwise ends use of the device, cleaning can be performed using the following procedure or an equivalent method: 1. Rinse the braces with cold water for about 30 seconds; 2. (Occasionally, 2-4 times per month) Use a toothbrush with mild soap (such as dish soap or hand soap) to clean the braces 100, then rinse the braces 100 with cold water to remove soap residue.

[0123] 3. Air dry (e.g., place on a charging dock 400).

[0124] Alternatively, dentures 100 can be occasionally or periodically soaked in denture cleaning solution for no more than 30 minutes.

[0125] However, if, during the RUN state, monitoring of the channel current and / or voltage of one or more channels over a period of time determines that there is an interruption in current delivery indicating that the device 10 may have been removed from the user's mouth (e.g., if there is no current delivery to all active channels within 2 seconds), the software will enter the OPEN state, thereby pausing the stimulation duration timer. If current delivery is detected to be restored within a predetermined time period by monitoring the channel current and / or voltage of one or more channels (e.g., before the counter set to the programmed INACTIVITY_DURATION_OPEN parameter expires), the software returns to the RUN state, resumes current delivery to the active channels, and restarts (but does not reset) the paused stimulation duration timer. If monitoring of the channel current and / or voltage of one or more channels determines that current delivery has not been restored within a predetermined time period (e.g., before the counter set to the programmed INACTIVITY_DURATION_OPEN parameter expires), the software returns to the OFF state.

[0126] During the RUN state, operational faults such as undercurrent and overcurrent faults may occur, causing the controller software to transition to a FAULT state, in which current delivery ceases and the controller 300 provides visual and / or audible indications. An undercurrent fault may occur if the total current delivered across all active electrode channels falls below a predetermined, programmable percentage target value (MIN_CURRENT_PERCENT, e.g., 75%) for a predetermined, programmable time (MIN_CURRENT_TIME, e.g., 30 seconds). Therefore, using the exemplary parameter values, if four channels are active and the target current delivery value per channel is 125 µA, an undercurrent fault will occur if the total delivery current, determined by monitoring the channel current of all active channels, remains below 375 µA (125 µA / channel × 4 channels × 0.75) for more than 30 seconds. An overcurrent fault may occur when the delivery current of any channel, determined by monitoring the current levels of each channel, exceeds a predetermined level (e.g., approximately 200 µA) or a programmable percentage of a predetermined target current level (e.g., 110% of the predetermined target current level). The fault state preferably requires user intervention to exit and return to the OFF state, for example, by requiring the pressing of button 306 (or a virtual button) for a predetermined time (e.g., 3 seconds).

[0127] The charging state is entered when the controller 300 is docked with the powered charging dock (preferably disabling current supply to the electrode channels), as long as the software is in any state other than the fault state at this time. When the controller 300 is placed on the charging dock 400 in the fault state, it preferably remains in the fault state but allows battery charging. If the controller 300 is in the fault state when placed on the charging dock 400, it preferably does not automatically exit the fault state when removed from the charging dock 400. Instead, the fault state persists, thus preferably requiring user intervention to exit and return to the off state, for example by requiring the pressing of button 306 (or a virtual button) for a predetermined time (e.g., 3 seconds).

[0128] Apart from Figure 11In addition to the states shown, other states can be defined and used, such as a low battery state, a critical battery state, and a service state. The circuit monitors the available voltage of battery 302. In the low battery and critical battery states, current delivery is disabled, and the battery status is communicated to the user via visual and / or audible indicators. When the user attempts to enter the operating state, a low battery state may be entered if the voltage of battery 302 is below a first predetermined battery operating value (e.g., 3.5 volts). During the transition between the operating and completed states, a low battery state may also be entered if the voltage of battery 302 is below a second predetermined battery operating value (e.g., 3.6 volts), which is preferably higher than the first predetermined battery operating value. If the voltage of battery 302 is below a predetermined voltage value lower than the low battery predetermined value (e.g., 3.1 volts) in any state (except a fault state), a critical battery state is preferably entered. This provides the ability to log events to non-volatile memory before the microprocessor becomes undervoltage, thereby shutting down the system in a controlled manner. If the controller 300 is powered off during a critical battery state (e.g., by pressing button 306 for a predetermined time) and is not placed on the charger 400 during this period, it will preferably remain in the same state upon subsequent power-on.

[0129] The service status can be accessed via a wireless communication device application that communicates with the controller 300, allowing parameters to be programmed through the user interface provided thereon. The service status can be entered from any of the following states: ready, charging, or fault. The service status provides the following functions: View and change programmable parameters (e.g.) Figure 12A (parameters listed in -B) View the counter value provided by controller 300 (e.g.) Figure 13A (values ​​of one or more counters listed in -B); Reset one or more counter values ​​on the controller 300 (and / or archive counter tags and values ​​on the paired wireless communication device during or after pairing). View the event log provided by controller 300 (e.g.) Figure 14 (one or more of the events listed in the document) Clear one or more events from the event log on controller 300 (and / or archive the event log on the paired wireless communication device during or after pairing); and / or Perform a non-destructive (preferably certified) update to the firmware on the controller 300.

[0130] Furthermore, upon the occurrence of an event, after reaching a certain number of event counts (e.g., charging times), after the number of stimulation runs (stimulation runs) reaches a predetermined number, or after the predetermined running time (e.g., the total time spent in operation) expires, the controller 300 can be placed in an END OF LIFE state, in which the stimulation function is inoperable. The running time is preferably less than 41,760 minutes, more preferably 25,000 to 35,000 minutes, and most preferably 30,000 to 31,000 minutes. In the END OF LIFE state, the device indicates the state with a display indicator (e.g., flashing light color or pattern), or may automatically transmit the state to the charger 400 or directly to a wider wireless network, but stimulation therapy cannot be activated.

[0131] Once data is acquired from controller 300, the data can be manually or automatically forwarded via wireless network by the wireless communication device, thereby being remotely stored in a remote data storage device (cloud storage or remote server) connected to the wireless communication device, which may be associated with the manufacturer and / or distributor of device 10, care provider (e.g., dentist, hygienist, administrator), insurance company, or user (or user's guardian).

[0132] When the user completes any of the above operations (i.e., when the user wishes to exit the service state), the user can do so through the application on the mobile wireless device. If the device 10 is not placed on the valid charger 400, the controller returns from the service state to the ready state; if it is validly placed on the charger 400, it transitions to the charging state; if the service state was entered from the fault state, it transitions to the fault state.

[0133] Prevention of systemic diseases

[0134] It is foreseeable that the oral instruments of the present invention can be used for the prevention or treatment of systemic diseases, and specific details will be further elaborated below. The method according to the present invention has been shown to effectively reduce the number of oral bacteria, particularly Fusobacterium nucleatum, Porphyromonas gingivalis, and Streptococcus oralis.

[0135] 1. Cardiovascular diseases

[0136] It is foreseeable that using the oral instruments according to the present invention can reduce the microbial load caused by the migration of oral bacteria (including but not limited to oral streptococci, porphyromonas gingivalis, and Fusobacterium nucleatum) from gingival tissue to other parts of the body, while reducing the amount of inflammatory mediators produced by oral bacteria. Furthermore, by reducing the amount of Fusobacterium nucleatum (… F. nucleatum ), Porphyromonas gingivalis ( P. gingivalis The ability to invade host cells will be weakened, thereby reducing the development of bacteremia associated with the occurrence or worsening of atherosclerosis and coronary heart disease.

[0137] It is anticipated that the oral device of the present invention can be used according to a predetermined stimulation protocol to prevent, treat, and / or alleviate cardiovascular diseases. In this predetermined stimulation protocol, the patient will wear the oral device according to the present invention at a predetermined current level, at predetermined time intervals, and for a predetermined duration. It is further anticipated that the specific stimulation protocol can be determined based on the bacterial levels present in the patient's body. According to one embodiment of the present invention, the stimulation protocol may include: the patient using the oral device provided by the present invention once daily for 20 minutes each time, at a current level of 500 μA. For acute cardiovascular conditions, this stimulation can be continued daily until the symptoms subside. For chronic cardiovascular diseases, this stimulation can be repeated several times per week and continued continuously.

[0138] 2. Fetal arrest

[0139] Furthermore, according to a predetermined stimulation protocol, stimulation treatment using the oral instruments provided by this invention will reduce the number of periodontal disease-associated Fusobacterium nucleatum in the oral cavity, thereby preventing, treating, and / or mitigating the risk of miscarriage. Correspondingly, this will reduce the likelihood of Fusobacterium nucleatum entering the bloodstream from the oral cavity, migrating to the placenta, and colonizing. The dental brace of this invention can be used to prevent stillbirth according to a preset stimulation protocol.

[0140] In the predetermined stimulation protocol, the patient will wear a dental brace according to the present invention, with a predetermined current level, for a predetermined duration at predetermined time intervals. Furthermore, the specific stimulation protocol can be determined based on the bacterial levels present in the patient's body.

[0141] According to one embodiment of the present invention, the stimulation protocol may include: the patient wearing the oral device once a day during pregnancy and stimulating for 20 minutes at a current level of 500 μA.

[0142] The above stimulation parameters have been shown to be effective at an inoculation dose of 10. 7 When colony-forming units (CFU) are used, they can effectively reduce the levels of oral streptococci and nucleated fusobacteria.

[0143] 3. Diabetes

[0144] The oral device provided by this invention can prevent, treat, and / or alleviate diabetes through a predetermined stimulation protocol, achieved by reducing oral streptococci. In the predetermined stimulation protocol, the patient will wear the oral device according to the invention at a predetermined current level for a predetermined duration at predetermined time intervals. Further consideration is that the specific stimulation protocol can be determined based on the bacterial levels present in the patient's oral cavity. According to one embodiment of the invention, the stimulation protocol may include: the patient wearing the oral device provided by the invention once daily at a current level of 500 μA for 20 minutes, thereby effectively reducing the level of oral streptococci in the oral cavity, and consequently reducing the number of systemic inflammatory markers caused by bacterial infection. This stimulation can be repeated multiple times per week and continuously to help reduce inflammatory markers.

[0145] 4. Suppurative liver abscess

[0146] According to the present invention, purulent liver abscesses can be prevented, treated, and / or alleviated using the oral instrument described herein through a predetermined stimulation protocol, the mechanism of which lies in reducing *Fusobacterium nucleatum*. Specifically, stimulation treatment using the oral instrument described herein can reduce bacterial levels and may prevent the transfer of *Fusobacterium nucleatum* and other oral bacterial species to the liver, and reduce overall bacteremia. In this predetermined stimulation protocol, the patient will wear the oral instrument according to the present invention and undergo treatment for a predetermined duration at predetermined current levels and at predetermined time intervals. The specific stimulation protocol can be determined based on the bacterial levels present in the patient's body. According to one embodiment of the present invention, the stimulation protocol includes: the patient wearing the dental brace of the present invention for 20 minutes once a day at a current level of 500 μA to effectively reduce the level of *Fusobacterium nucleatum* in the oral cavity, thereby preventing any bacteria from transferring from the oral cavity to the whole body. This stimulation can be repeated several times a week until the abscess subsides.

[0147] 5. Osteomyelitis

[0148] The dental brace of the present invention, according to a predetermined stimulation protocol, can be used to prevent, treat, and / or alleviate osteomyelitis by reducing the level of *Fusobacterium nucleatum*. In this predetermined stimulation protocol, the patient wears the dental brace according to the present invention for a predetermined duration at a predetermined current level within predetermined time intervals. It is further envisioned that the specific stimulation protocol can be determined based on the patient's bacterial levels. According to one embodiment of the present invention, the stimulation protocol includes the patient wearing the brace for 20 minutes each time at a current intensity of 500 μA to effectively reduce the level of *Fusobacterium nucleatum* in the oral cavity and prevent the bacteria from spreading from the oral cavity to the whole body. This stimulation can be used in combination with standard antibiotic-based treatment for osteomyelitis or alone. When used in combination with antibiotics, the stimulation course typically lasts 29 to 42 days. When used alone, for acute cases, stimulation can be performed once daily for several months; for chronic cases, stimulation can be performed several times a week continuously.

[0149] 6. Arthritis

[0150] It is anticipated that using the oral appliance of the present invention according to a predetermined stimulation protocol can prevent, treat, and / or reduce oral biofilm formation by reducing *Fusobacterium nucleatum*, *Porphyromonas gingivalis*, and / or *Streptococcus stomatologicus*. In the predetermined stimulation protocol, the patient will wear the oral appliance according to the present invention at a predetermined current level for a predetermined duration at predetermined time intervals. Further, the specific stimulation protocol can be determined based on the bacterial flora levels of specific bacterial species in the patient's body. According to one embodiment of the present invention, the stimulation protocol includes the patient wearing the oral appliance according to the present invention for 20 minutes once daily at a current level of 500 μA to effectively reduce the level of *Fusobacterium nucleatum* in the oral cavity, thereby preventing further biofilm formation caused by *Fusobacterium nucleatum* and reducing the activity of existing *Fusobacterium nucleatum* biofilm colonies.

[0151] According to another embodiment of the invention, the stimulation protocol includes the patient wearing an oral appliance according to the invention for 20 minutes once a day at a current level of 50 μA to effectively reduce the level of Porphyromonas gingivalis in the oral cavity, thereby preventing further biofilm formation caused by Porphyromonas gingivalis and reducing the activity of existing Porphyromonas gingivalis biofilm colonies.

[0152] Furthermore, according to another embodiment of the present invention, the stimulation protocol includes: the patient wearing the oral appliance according to the present invention for 20 minutes once daily at a current level of 500 μA to effectively reduce the level of oral streptococci in the oral cavity, thereby preventing further biofilm formation caused by oral streptococci and reducing the activity of existing oral streptococcal biofilm colonies.

[0153] For acute biofilm-related problems, such treatments to reduce and prevent biofilm irritation can be repeated daily for three to six weeks; for chronic biofilm problems, they can be repeated once or more weekly and continued continuously.

[0154] Treatment and / or prevention of peri-implantitis

[0155] Peri-implantitis typically refers to inflammation of the oral tissues that are in physical contact with, surround, or adjacent to a dental implant after placement. The method according to the invention can alleviate or prevent such inflammation. The method can be performed before and / or after dental implant placement or replacement surgery.

[0156] One method for reducing the likelihood of peri-implantitis involves applying or directing an electric current to or near the future implantation site before the dental implant is partially or completely placed or replaced. While the current may be distributed to other parts of the oral cavity, at least 6 µA, more preferably at least about 50 µA (and preferably not exceeding 300 µA), is delivered to the intended oral cavity site for future implantation or the gingival tissue nearby.

[0157] A method for reducing the likelihood of peri-implantitis (if it has not yet occurred) or alleviating peri-implantitis (if it has occurred) includes applying or channeling an electric current to the gingival tissue near or at the implant site after partial or complete implantation or replacement of a dental implant. Although the current may diffuse to other oral tissues, the current delivered to the gingival tissue near or at the intended implant site is at least 6 µA, more preferably at least about 50 µA (and preferably not more than 300 µA).

[0158] Postoperative stimulation may include approximately 20 minutes of electrical stimulation daily for 1 to 14 days before or after dental implant surgery, or until the desired reduction in inflammation is achieved. Although preoperative and postoperative methods have been described separately for clarity, it should be understood that either method or a combination of both may be used for a particular patient or braces user.

[0159] As briefly mentioned above, the controller 300 and charging dock 400 (or other electronic devices) can communicate via Bluetooth, etc. ® Wireless communication systems such as Bluetooth Low Energy or Near Field Communication (NFC) transmit data between each other. Preferably, one or both of the controller 300 and the charging station 400 also have the ability to automatically (e.g., periodically, at predetermined times of day, and / or when the controller 300 is in use or not) and / or manually store the transmitted data to a remote location (e.g., the cloud). As shown in Figures 17a and 17b, this data transmission system 500 preferably allows manufacturers, clinicians, and users / patients to access recorded data from the controller 300 and / or the charging station 400.

[0160] The data transmission system 500 may be implemented as shown in Figure 17a. The controller 300 records indicators and data related to the patient's use of the stimulation device 10, and preferably includes a local storage device 512 for storing the indicators and data internally for a period of time. As described above, when the controller 300 is docked to (or in the vicinity of) the charging station 400, the indicators and data are preferably wirelessly transmitted to the charging station 400, for example, to the local storage device 522. Wireless transmission is preferably performed using Bluetooth. ® and / or BLE ®It can be achieved through technology, but it can also be achieved through infrared communication, radio, microwave communication, Wi-Fi, LoRa, WiFiHaLow, Z-Wave, IEEE 802.15.4-based formats, or any other wireless communication system.

[0161] According to various embodiments of the data transmission system 500, the collected metrics and data stored in the charging station 400 are further transmitted to a remote server and / or a database cloud storage system 540. This transmission can be achieved in a variety of ways.

[0162] For example, device 10 or charging station 400 can use LoRa radio communication to connect to LPWAN (or LoRaWAN) gateway 530. LoRa utilizes unlicensed sub-gigahertz radio frequencies for long-range transmission with low power consumption. A low-power WAN gateway functions similarly to a Wi-Fi router, receiving radio frequency signals via a LoRa concentrator and then converting these signals into a server-compatible form (such as Wi-Fi signals) to transmit data to the internet. In other words, a low-power WAN gateway enables radio frequency-enabled devices to transmit information to internet cloud servers. A low-power WAN gateway can also convert Bluetooth® or Bluetooth Low Energy signals in substantially the same way. Therefore, charging station 400 can use LoRa and / or Bluetooth Low Energy to transmit measurement data to low-power WAN gateway 530, which then transmits this measurement data to cloud storage system 540 on the internet. Examples of devices that can function as low-power WAN gateways include those using Amazon Sidewalk. TM Amazon Echo on the Internet ® System, Amazon Alexa TM System and Ring TM Home security systems. Other Internet of Things (IoT) devices can also act as low-power wide-area network (LPWAN) gateways.

[0163] Alternatively, the device 10 or charging station 400 may use radio communication, Wi-Fi and / or Helium network to directly transmit data to cloud storage system 540.

[0164] The operation of transferring data from device 10 to an external storage location can be performed substantially periodically, automatically when data changes, or in response to a request from a wireless communication device. For example, device 10 may periodically broadcast a flag (e.g., in a Bluetooth BLE broadcast packet) indicating that data transfer should be performed. The data transfer can be a complete data transfer or a summary data transfer. A complete data transfer can be indicated as available in a broadcast flag. A complete data transfer involves transferring predetermined data from device 10, which includes at least two of the following: a serial number assigned to device 10, a first parameter value, a second parameter value, a first event log entry, a second event log entry, a first counter value, and / or a second counter value. More preferably, a complete data transfer includes transferring the serial number assigned to device 10, all other parameter identifiers and / or values ​​(see [link to relevant documentation]). Figure 12A (and B), all event log entries that were not previously transmitted during data transfer (see...) Figure 14 ) and all counter identifiers and / or values ​​(see Figure 13A And B).

[0165] A single summary data transmission can be indicated by a broadcast flag, or alternatively by performing a logical OR operation on multiple broadcast flags. As mentioned above, a separate flag can also be used for indication. Figure 13A The changes in the following counters are indicated in the data: 1 (manual power-on count), 5 (power-off count due to low battery), 8 (treatment start count), 9 (treatment successfully completed count), 10 (open circuit count), 11 (low battery count), 12 (failure count), and 13 (effectiveness failure count). Preferably, the summary data transmission involves less information than the complete data transmission, and preferably includes the transmission of at least one of the following: the serial number assigned to device 10, parameter values, event log entries, and / or counter values. More preferably, the summary data transmission includes the transmission from the device of the serial number assigned to device 10, all counter identifiers, and / or values ​​(see, for example...). Figure 13A For the following counters that are indicated as changed by the broadcast flag, refer to 13A and B: 1 (number of manual power-on times), 5 (number of critical power-off times), 8 (number of treatments started), 9 (number of treatments successfully completed), 10 (number of open circuit times), 11 (number of low power times), 12 (number of malfunctions), and 13 (number of treatment malfunctions).

[0166] Once transmitted to cloud storage system 540, data and metrics from one or both of controller 300 and / or charging station 400 can be reviewed and analyzed by device manufacturers, clinicians, and / or users / patients via desktop and / or mobile devices. The cloud storage system 540 can be any system that supports quantified storage, such as Amazon Web Services.TM IBM ® Cloud Storage, Microsoft OneDrive TM Apple iCloud TM The metrics and data transmitted and stored in the cloud storage system 540 may include treatment data, device health metrics, and location data. Accordingly, the cloud storage system 540 may automatically or via query transmit firmware updates, diagnostic information, and / or data queries for the stimulation device 10 and / or charging dock 400.

[0167] Preferably, the manufacturer of the stimulation device 10, clinicians, and users / patients can all access the metrics and data stored on the cloud storage system 540 for analysis by all parties. Access can be granted via a shared cloud storage system 540 account and / or by scanning a dedicated code (i.e., a quick response (QR) code). Preferably, the manufacturer, clinicians, and users / patients can access the cloud storage system 540 via Wi-Fi or a local area network through a desktop or mobile system.

[0168] In other embodiments of the data transmission system 500 of the present invention, the required metrics and data transmission can be achieved without the charging station 400. In this embodiment, device 10 preferably includes radio frequency capabilities, such as the aforementioned BLE technology, LoRa technology, or other radio frequency capabilities, including Z-Wave, ZigBee, SigFox, Helium, WiFi HaLow, IEEE 802.15.4, or possible mesh networking technologies, such as Thread. Device 10 may preferably interface directly with LPWAN gateway 530 (or other electronic devices) to transmit metrics and data to cloud storage system 540 without the need for additional steps via charging station 400. Such other electronic devices may include handheld mobile devices, such as mobile phones or tablets; devices including Thread border routers; devices including Wi-Fi access points; devices including Zigbee coordinators; devices including Matter controllers; or devices including IEEE Std 802.15.4 coordinators. Alternatively, device 10 may utilize the aforementioned RF capabilities or other networks to connect at least partially directly to cloud storage system 540. Subsequently, manufacturers, clinicians, and / or users / patients can use the metrics and data in essentially the same manner as described above.

[0169] In the embodiment of the data transmission system 500 described above, the metrics and data transmitted from one or both of the controller 300 and the charging dock 400 to the cloud storage system 540 may include one or all of the following: Current date and time; Equipment identification information; Complete controller 300 event log, for example Figure 14 The events described; The controller parameters of device 10 before, during, and after each use, such as Figure 12A and Figure 12B The parameters mentioned above; Controller counter, for example Figure 13A and Figure 13B The aforementioned counter; Device 10 status, for example Figure 11 The aforementioned state; The firmware version of controller 300 for each use; Notable events (defined as treatment starting or stopping, or device 10 entering default state, low battery state, or critical battery state). Controller 300 serial number; Charging station 400 event log; Location and status of charging station 400; BLE broadcast data and RSSI from any nearby controller 300; BLE broadcast data and RSSI from any nearby BLE device.

[0170] The transmitted data is preferably stored indefinitely in the cloud storage system 540, or at least for a sufficient period of time to allow for analysis for any reason. To protect data confidentiality, multiple copies of the transmitted data may be stored. For example, more confidential data may require multiple security levels for access; while for more general or de-identified information, the data may be mixed with data from other stimulation devices 10, or accessed in a less restricted manner.

[0171] The above description is intended to illustrate the principles of the invention by way of example only. Furthermore, since numerous modifications and variations will readily occur to those skilled in the art, the invention is not intended to be limited to the exact constructions and operations shown and described. Although preferred embodiments have been described, changes may be made to the details without departing from the scope of the invention.

Claims

1. A data transmission system, comprising: An oral device including a controller coupled to a dental brace, wherein the controller is configured to: Record data relating to at least one of the following: operation of the oral device, information received from one or more secondary electronic devices, and environmental parameters monitored by the oral device or by the one or more secondary electronic devices. Recorded data is transmitted wirelessly, and the transmission occurs in at least one of the following ways: substantially periodically, automatically when the data changes, and in response to a request from a wireless communication device.

2. The system according to claim 1, wherein, The wireless communication device is selected from the group consisting of the following: A charging station configured to charge the rechargeable battery in the oral device; Handheld mobile devices; as well as Low-power LPWAN gateway; Devices that include Thread border routers; Devices that include Wi-Fi access points; Devices that include a Zigbee coordinator; Devices that include a Matter controller; And devices that include the IEEE Std. 802.15.4 coordinator.

3. The system of claim 1, wherein the controller is configured to generate a change indication of the recorded data, the wireless communication device is configured to receive the indication from the controller via a first wireless communication, send a data request to the controller via a second wireless communication, receive the recorded data from the controller in a third wireless communication, and relay the data to a communication network for remote storage.

4. The system of claim 3, wherein the wireless communication device is a charging station configured to mechanically receive and support the oral cavity device.

5. The system of claim 3, wherein each of the first wireless communication, the second wireless communication, and the third wireless communication is selected from the group consisting of: Near Field Communication (NFC); Bluetooth Low Energy (BLE) communication; Wi-Fi communication; LoRa / LoRaWAN communication; And, communication in accordance with the IEEE Std 802.15.4 protocol.

6. The system of claim 3, wherein the repeater includes relay communication from the charging station to the network gateway.

7. The system according to claim 6, wherein the network gateway is a low-power wide area network (LPWAN) gateway.

8. The system of claim 6, wherein the relay communication includes Bluetooth communication and / or LoRa communication.

9. The system of claim 3, wherein the remote storage includes a cloud storage system.

10. The data transmission system according to claim 3, wherein the indication is multi-digit data.

11. The data transmission system according to claim 10, wherein the data change includes at least one of the following: treatment start counter increases, treatment stop counter increases, open circuit counter increases, efficacy failure counter increases, failure counter increases, low power counter increases, critical power counter increases, time required for complete data transmission expires, and current time status.

12. The data transmission system according to claim 3, wherein the first wireless communication includes a Bluetooth broadcast packet.

13. A method comprising the following steps: On an electronic device configured to be supported by the oral cavity, data related to at least one of the following is recorded: operational information of the electronic device, information received from one or more secondary electronic devices, and environmental parameters monitored by the electronic device or by the one or more secondary electronic devices; and The recorded data is transmitted wirelessly, and the transmission occurs at least in one of the following ways: substantially periodically, automatically when the data changes, and in response to a request from a wireless communication device.

14. The method of claim 13, wherein the wireless communication device is selected from the group consisting of: A charging station configured to charge the rechargeable battery in the electronic device; A handheld mobile device; Low-power LPWAN gateway; A device that includes a Thread border router; A device that includes a Wi-Fi access point; A device that includes a Zigbee coordinator; A device including a Matter controller; and A device that incorporates the IEEE Std 802.15.4 standard.

15. The method of claim 13, wherein the electronic device is configured to generate an indication that the recorded data has changed, the wireless communication device is configured to receive the indication from the electronic device via a first wireless communication, send a data request to the electronic device via a second wireless communication, receive the recorded data from the electronic device in a third wireless communication, and relay the data to a communication network for remote storage.

16. The method of claim 13, wherein the wireless communication device is configured to monitor network communications and discover at least one other communication device capable of network communication with the wireless communication device.

17. The method of claim 16, wherein the network communication includes at least one of Wi-Fi communication and Bluetooth communication.

18. The method of claim 17, wherein the network communication includes information associated with another wireless communication device, the information including at least one of the following: a Media Access Control (MAC) address, a Received Signal Strength Indicator (RSSI), a Service Set Identifier (SSID), a Basic Service Set Identifier (BSSID), a system name, and a serial number.

19. The method of claim 18, further comprising the following steps: Detect nearby Wi-Fi networks and record up to 10 network identifiers indicating the maximum RSSI; and Perform at least one of the following: A first geographical location change of the wireless communication device is indicated and recorded if 70% or more of the recorded network identifiers are not in the list and 50% or more of the previously recorded network identifiers are not in the recorded network identifiers by comparison with a previously recorded list of network identifiers. as well as A second geographic location change of the wireless communication device is indicated and recorded if, by comparison of the recorded RSSI values ​​of network identifiers with a previously recorded list of network identifier RSSI values, 20% to 50% of the recorded network identifier RSSI values ​​have changed by approximately 3 to approximately 10 dB compared to the previously recorded network identifier RSSI values.

20. The method of claim 13, wherein the electronic device is capable of delivering electrical stimulation to the oral cavity, the method further comprising the step of: The device's ability to deliver electrical stimulation is permanently disabled after a predetermined number of minutes of recorded electrical stimulation delivery, the predetermined number of minutes being between 30,000 and 41,760.

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