Systems and methods related to automated data collection

Abstract

A system for the automatic collection and distribution of metrics and other data from an oral appliance to a cloud storage system is disclosed. The oral appliance may transfer metrics and other data to a charging station or directly to a network gateway, coordinator, or controller via BLE or other wireless communication methods, which may then pass it to a cloud storage system for access by the appliance manufacturer, clinician, and / or user / patient as needed.

Description

[Technical Field]

[0001] The present invention relates to systems and methods for promoting general oral hygiene or beauty, treating periodontal diseases such as gingivitis and periodontitis, killing or altering oral microorganisms including bacteria that cause dental caries, reducing oral biofilm, increasing blood flow in oral tissues, increasing saliva secretion, promoting gingival tissue regeneration, developing osteogenesis of osseous structures of teeth, mouth and related areas, treating systemic diseases associated with oral bacteria, and / or treating other periodontal and oral diseases through non-invasive application of direct current electricity to intraoral surfaces, and also relates to a device suitable for providing direct current electricity for these therapeutic, preventive, cosmetic and regenerative effects. [Background Art]

[0002] Periodontal disease has been identified by both dentists and physicians as a risk factor for various systemic diseases. These diseases include cardiovascular disease, adverse pregnancy outcomes, and diabetes mellitus, and newly emerging evidence supports its association with pancreatic disease and arthritis. While many studies have established a correlation between the presence of periodontal disease and these systemic conditions, for most of these conditions, a causal relationship remains a subject of ongoing research.

[0003] Some of the biological mechanisms that have been proposed regarding how oral bacteria resulting from periodontal disease can cause systemic diseases are as follows. 1. Direct effects of oral infection: Oral microorganisms and their by-products can gain access to the whole body via the circulatory system through progression through damaged tissue and inflamed periodontal tissue in the oral cavity. By gaining access to the whole body, oral microorganisms have the potential to directly influence subclinical mediators of various systemic diseases. 2. Inflammation: Individuals with periodontal disease have elevated levels of systemic inflammatory markers due to the burden of increased levels of oral bacteria. Treatment of periodontal disease has been reported to reduce systemic inflammation levels. 3. Cross-reactivity: The progression of systemic disease may be accelerated by an immune response to bacterial heat shock proteins, which produces antibodies that cross-react with endogenous heat shock proteins expressed on cells in damaged tissue.

[0004] cardiovascular disease Studies investigating the potential link between periodontal disease and cardiovascular disease, including atherosclerosis, coronary heart disease, and stroke, have found a significant positive correlation between poor oral hygiene and the prevalence of cardiovascular disease. While both diseases share some common risk factors, recent research suggests that periodontitis may precede and thus contribute to the complications of atherosclerosis. Indeed, meta-analyses have shown that individuals with periodontitis experience an increased risk of developing cardiovascular disease.

[0005] While it is not definitively established whether these bacteria initiate atherosclerosis or rather invade already damaged arteries, antibodies against periodontal bacteria, including Fusobacterium nucleatum and Streptococcus oralis, have been found in serum and are associated with an increased risk of coronary heart disease. Mouse studies have found that intravenous inoculation with Porphyromonas gingivalis accelerated the development of atherosclerosis. Furthermore, P. gingivalis DNA was found in the aortic tissue of infected mice that showed observable signs of accelerated early atherosclerosis after oral inoculation. Another study names F. nucleatum as a synergistic agent with P. gingivalis. F. nucleatum enhances P. gingivalis's ability to invade host cells, due to a co-aggregation effect between the two organisms. This is important because bacteria within the ather can lead to the formation of atherosclerotic plaques. Evidence to date supports the idea that periodontitis leads to systemic exposure to oral bacteria, which act as a potential source of systemic inflammation vectors, and that cytokines produced in infected periodontal tissues have the ability to initiate or exacerbate atherosclerosis and coronary heart disease upon entering the bloodstream. Clinical research on periodontal disease has also revealed a positive association with coronary artery disease, and there is a growing emphasis on understanding the precise relationship between periodontal disease and atherosclerosis.

[0006] Premature birth Fusobacterium nucleatum is one of the most common bacterial species found in amniotic fluid and placental infections that cause premature birth, and is often named as the sole infectious agent in premature births with complete fetal membranes. F. nucleatum is also highly associated with various types of periodontal disease. During periodontal infection, if the oral mucosa is damaged and inflamed, and the amount of periodontal pathogens increases dramatically, transient levels of bacteria may appear in the bloodstream, leading to selective colonization at undesirable sites. One study demonstrated that pregnant mice injected hematogenously with F. nucleatum isolated from either amniotic fluid infection or oral origin resulted in fetal death.

[0007] Recently, analyses of human stillbirth cases have revealed that F. nucleatum actually originates from the maternal oral cavity, a fact that had not been previously proven. F. nucleatum is thought to translocate from the maternal mouth via the bloodstream, where it has the ability to traverse the endothelium and proliferate and colonize within the fetal membranes, amniotic fluid, and fetus, and its presence is believed to lead to fetal death. In a mouse model, hematogenous injection of F. nucleatum into pregnant mice resulted in specific bacterial colonization in the placenta and caused local inflammation. F. nucleatum was completely cleared from maternal circulation within 24 hours after injection. However, once colonized in the immunologically privileged placenta, the bacteria proliferated rapidly, causing fetal death within 3 days. Chronic periodontal disease may mediate infection through the translocation of periodontal bacteria / inflammatory markers to the fetal-placental unit.

[0008] diabetes Diabetes mellitus is an endocrine disorder caused by genetic, environmental, and behavioral risk factors. While diabetes has long been considered a modifier of periodontal disease, recent studies suggest a bidirectional relationship between the two. Furthermore, the presence of periodontal disease has been associated with a risk of diabetic complications, namely poor glycemic control. Recent longitudinal and systematic studies have found that periodontal disease correlates with a higher risk of ischemic heart disease, diabetic nephropathy, mortality from end-stage renal disease, and increased insulin resistance compared to patients with mild or no periodontal disease. In type II diabetes, insulin resistance is linked to the action of pro-inflammatory cytokines. It is thought that periodontal disease leads to significantly higher levels of serum markers of these inflammations, thereby conferring insulin resistance. Human studies examining bacterial content in adults with and without type II diabetes have found that diabetic patients have significantly more severe periodontitis and higher levels of many oral bacteria, including Streptococcus oralis.

[0009] Suppurative liver abscess F. nucleatum has recently been associated with suppurative liver abscesses (PLA). While PLA is usually caused by biliary tract diseases, diverticular diseases and bowel malignancies, atrophic gastritis, and liver diseases of unknown etiology, PLA caused by F. nucleatum is very rare, with Escherichia coli, Klebsiella, and Enterobacter being the most commonly isolated microorganisms in drained abscesses. F. nucleatum was found in liver abscesses, and no other sources of infection were found except for tooth extraction. It is hypothesized that due to the co-aggregating properties of F. nucleatum, it can cross and penetrate the colonic mucosa, leading to bacteremia, which in turn can result in liver abscesses.

[0010] Osteomyelitis Osteomyelitis is a bone infection caused by bacteria, fungi, or other pathogens. Generally, bacteria spread from infected skin, muscle, or tendon to the bone, often occurring beneath skin ulcers. Infection can also originate in another part of the body and spread hematogenously. Occasionally, Fusobacterium species have been isolated from bone / joint infections in the head and neck region and associated with chronic periodontitis. A recent study reports a case of osteomyelitis caused by F. nucleatum in conjunction with a muscle abscess. The patient had no known predisposition and no other sources of infection except a history of periodontal disease. It is thought that poor oral hygiene in the patient may have led to the development of F. nucleatum bacteremia, resulting in hematogenous osteomyelitis of the lower leg.

[0011] arthritis Numerous clinical studies have suggested a potential link between rheumatoid arthritis (RA) and periodontal disease, based on the isolation of several oral bacterial species, including P. gingivalis and Prevotella intermedia, from the synovial fluid of patients. Periodontal disease is thought to allow bacteria to penetrate the permeable pocket epithelium in the oral cavity and reach the underlying gingival connective tissue. From there, they can be transported into the bloodstream, having the ability to colonize other locations in the body. Oral bacteria found in the synovial fluid of patients with rheumatoid arthritis (RA) are thought to be due to synovial inflammation favorably capturing oral bacterial DNA, suggesting that periodontal disease may have a persistent effect on joint disease. Therefore, periodontitis may indeed be a contributing factor to the autoimmune inflammatory response characteristic of rheumatoid arthritis (RA). Patients with rheumatoid arthritis (RA) may also be at higher risk of developing periodontal disease, suggesting a bidirectional relationship between the two conditions. A particular study examined the presence of bacterial DNA in the synovial fluid of natural and faulty prosthetic joints in patients with arthritis. Of the five patients in whom bacterial DNA was found, F. nucleatum was detected in four of them. This suggests that this bacterium can translocate from the oral cavity to the synovial fluid, as F. nucleatum was also found in plaque samples from the patients.

[0012] Oral biofilm Periodontitis, gingivitis, and dental caries are oral infections in which oral biofilms and bacteria play a causal role. Biofilm formation is also involved in the pathogenesis of dental implant failure, such as peri-implantitis, denture stomatitis, and oral fungal infections like candidiasis. Oral biofilm formation begins with the formation of a dental pellicle on the tooth. This pellicle is mainly composed of salivary proteins that cover the exposed surface of the tooth, primarily above the gingival margin, and to which free-floating bacteria begin to adhere. Aerobic bacteria, including Gram-positive cocci such as S. oralis, are early colonizers that initiate the formation of the initial biofilm colonies, mainly through the cell division of adherent bacteria.

[0013] Once the initial colonies are established, other co-aggregating bacterial species, such as F. nucleatum, P. gingivalis, and other Gram-negative anaerobic bacteria, attach to the previously formed colonies. As these colonies mature, they grow to cover the subgingival surface of the teeth and begin to induce inflammation in the periodontal tissues. [Prior art documents] [Patent Documents]

[0014] [Patent Document 1] U.S. Patent No. 4244373 [Patent Document 2] U.S. Patent No. 4509519 [Overview of the initiative]

[0015] The system and method according to the present invention provide an oral device capable of transferring data from the oral device via wireless communication and storing it outside the oral device.

[0016] According to one embodiment of the data transfer system of the present invention, the system includes an oral appliance comprising a controller coupled to a mouthpiece. The controller may extend from the mouthpiece so that it is located outside the mouth during use. Alternatively, the controller may be located at a distance from the mouthpiece and coupled to it by a wire so that it can be placed in the user's pocket or worn on the user's head. Alternatively, the controller may be substantially located within the mouthpiece, or a large portion of the controller may be located within the outer boundary of the mouthpiece so that a large portion or all of the controller is located inside the mouth during use. The controller is configured to log data relating to at least one of the following: the operation of the oral appliance, information received from one or more secondary electronic devices, and environmental parameters monitored by or by one or more secondary electronic devices. The controller is also configured to wirelessly transmit the logged data substantially periodically, automatically when the data changes, and in response to a request from a wireless communication device. A controller configured to log and transmit data is generally understood to include an electronic power supply, a microprocessor or microcontroller programmed with or accessible by instructions (e.g., software) to perform a specified function, non-volatile electronic memory, and a radio, along with all other necessary circuitry to perform the instructed function.

[0017] According to another embodiment of the data transfer system of the present invention, the wireless communication device is a device comprising a charging station configured to recharge a rechargeable battery in an oral appliance (e.g., using a Qi-compliant interface), a Thread border router, a Wi-Fi access point, a Zigbee coordinator, a Matter controller, and / or an IEEE 802.15.4 coordinator.

[0018] According to yet another aspect of the data transfer system according to the present invention, the controller is configured to generate an indicator of change in logged data, and a wireless communication device is configured to receive the indicator from the controller by a first wireless communication. The wireless communication device is also configured to send a data request to the controller by a second wireless communication, receive logged data from the controller by a third wireless communication, and relay the data to a communication network for remote storage. The indicator may be a plurality of bits of digital data (which may be in a BLE advertising packet), each bit which may reflect a change in data, such as an increase in the treatment start counter, an increase in the treatment stop counter, an increase in the open circuit counter, an increase in the effectiveness failure counter, an increase in the failure counter, an increase in the low battery counter, an increase in the critical battery counter, elapsed time for complete data transfer, the controller's current time status, the controller being charged, and / or an increase in the manual power-on counter.

[0019] The wireless communication device may be a charging station, which is configured to mechanically receive and support the oral appliance. The first wireless communication may be near-field communication (NFC), Bluetooth (BLE) communication, Wi-Fi communication, LoRa / LoRaWAN communication, or communication compliant with IEEE standard 802.15.4 or other radio, preferably RF communication. The second wireless communication may be near-field communication (NFC), Bluetooth (BLE) communication, Wi-Fi communication, LoRa / LoRaWAN communication, or communication compliant with IEEE standard 802.15.4 or other radio, preferably RF communication. The third wireless communication may be near-field communication (NFC), Bluetooth (BLE) communication, Wi-Fi communication, LoRa / LoRaWAN communication, or communication compliant with IEEE standard 802.15.4 or other radio, preferably RF communication. Relay of data or indicators of data change preferably includes relay communication from the controller or charging station to the communication network, which may be to a network gateway. Such a network gateway may be a low-power wide-area network (LPWAN) gateway. The relay communication may be near-field communication (NFC), Bluetooth (BLE) communication, Wi-Fi communication, LoRa / LoRaWAN communication, or communication compliant with IEEE standard 802.15.4, or other wireless, preferably RF, or wired network communication.

[0020] According to yet another embodiment of the data transfer system of the present invention, the remote storage comprises a cloud storage system.

[0021] According to one aspect of the method of the present invention, the method comprises the step of logging data related to at least one of: operation of an electronic device configured to be supported in the mouth, information received from one or more secondary electronic devices, and environmental parameters monitored by the electronic device or monitored by one or more secondary electronic devices. The method further comprises the step of wirelessly transmitting the logged data at least one of substantially periodically, automatically when the data changes, and in response to a request from a wireless communication device. The wireless communication device may be a charging station configured to recharge a rechargeable battery in the electronic device, a handheld mobile device, an LPWAN gateway, a device comprising a Thread border router, a device comprising a Wi-Fi access point, a device comprising a Zigbee coordinator, a device comprising a Matter controller, or a device comprising an IEEE standard 802.15.4 coordinator.

[0022] According to another aspect of the method of the present invention, the electronic device is configured to generate an indicator of a change in logged data, and the wireless communication device is configured to receive the indicator from the electronic device via a first wireless communication. The wireless communication device is also configured to transmit a request for at least part of the data to the electronic device via a second wireless communication, either in response to the first wireless communication or without receiving the first wireless communication, and receive the requested data from the electronic device via a third wireless communication. The received data may then be relayed to a communication network for remote storage.

[0023] According to still another aspect of the method according to the present invention, the wireless communication device is a charging station, and the charging station is configured to monitor network communication 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 other wireless communication devices, and the information comprises at least one of 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.

[0024] According to still another aspect of the method according to the present invention, the method comprises the step of detecting nearby Wi-Fi networks and logging up to 10 network identifiers that exhibit the maximum RSSI. The method further comprises, by comparing the logged network identifiers with a list of previously logged network identifiers, indicating and logging a first geographical location change of the charging station when 70% or more of the number of the logged network identifiers are not present in the list, and 50% or more of the number of the previously logged network identifiers are not present in the logged network identifiers. Additionally or alternatively, the method may comprise, by comparing the RSSI values of the logged network identifiers with a list of RSSI values of previously logged network identifiers, indicating and logging a second geographical location change of the charging station when 20% to 50% of the number of the RSSI values of the logged network identifiers change by about 3 dB to about 10 decibels (dB) compared with the RSSI values of the previously logged network identifiers.

[0025] According to a further embodiment of the method of the present invention, an electronic device is capable of delivering electrical stimulation to the mouth, and the method further comprises the step of permanently disabling the electrical stimulation delivery capability of the device after logging a predetermined number of minutes for delivering electrical stimulation, the predetermined number of minutes being between 30,000 and 41,760 minutes. [Brief explanation of the drawing]

[0026] [Figure 1] This is a perspective view of an intraoral electrical stimulation device and an associated storage and / or charging stand according to the present invention. [Figure 2] This is a top view of a mouthpiece and controller according to the present invention. [Figure 3] This is a bottom view of the mouthpiece and controller according to the present invention. [Figure 4] This is a left side view of a mouthpiece and controller according to the present invention. [Figure 5] This is a rear view of the mouthpiece and controller according to the present invention. [Figure 6] This is a schematic representation of the electrical circuit of the controller according to the present invention. [Figure 7] This is a partial cross-sectional view of an embodiment of the controller according to the present invention, taken along line 7-7 in Figure 3. [Figure 8A] This includes a schematic diagram of the electrical circuit portion in an embodiment of the controller according to the present invention. [Figure 8B] This includes a schematic diagram of the electrical circuit portion in an embodiment of the controller according to the present invention. [Figure 8C] This includes a schematic diagram of the electrical circuit portion in an embodiment of the controller according to the present invention. [Figure 8D] This includes a schematic diagram of the electrical circuit portion in an embodiment of the controller according to the present invention. [Figure 9] Figure 1 is a front perspective view of the embodiment, showing the mouthpiece / controller supported by a stand. [Figure 10]This is a front perspective view of a charging stand / case for receiving a mouthpiece / controller according to the present invention. [Figure 11] This provides a table of user interface feedback that occurs at a predetermined time under a given device or software state. [Figure 12A] The present invention provides a table of programmable parameters stored in the memory of a controller. [Figure 12B] The present invention provides a table of programmable parameters stored in the memory of a controller. [Figure 13A] The present invention provides a table of counters or metrics that should be logged when each event occurs during the operation of the controller. [Figure 13B] The present invention provides a table of counters or metrics that should be logged when each event occurs during the operation of the controller. [Figure 14] This provides a table of events recorded by the software and associated event data. [Figure 15A] The present invention provides a table of controller operating functions, associated user tasks, and responses. [Figure 15B] The present invention provides a table of controller operating functions, associated user tasks, and responses. [Figure 15C] The present invention provides a table of controller operating functions, associated user tasks, and responses. [Figure 16] This flowchart shows the operating or non-operating states of the controller according to the present invention. [Figure 17A] This flowchart shows the transfer of information between a device, a charging base, an LPWAN gateway, and a cloud storage system according to the present invention. [Figure 17B] This flowchart shows an alternative information transfer method between a device, an LPWAN gateway, and a cloud storage system according to the present invention. [Figure 18]This is a graph that identifies parameters for monitoring the delivered current. [Modes for carrying out the invention]

[0027] While the disclosure herein is detailed and precise enough to enable those skilled in the art to carry out the invention, the physical embodiments disclosed herein are merely illustrative of the invention as it may be embodied in other specific structures. Preferred embodiments are described, but details may be modified without departing from the invention.

[0028] It is known in the art that oral bacteria cannot survive when exposed to low microampere direct current. Methods for killing oral bacteria and treating bacterial diseases such as gingivitis have been demonstrated in Nachman's U.S. Patent No. 4,244,373 (January 13, 1981) and Detsch's U.S. Patent No. 4,509,519 (April 9, 1985). Killing oral bacteria has the additional benefit of preventing dental caries and decay. Generally, caries is attributed to aerobic acid-producing bacteria whose acid causes decompensatory demineralization of teeth. However, Nachman does not teach an optimal approach to reducing oral bacteria, including aerobic and anaerobic bacteria, at the species level, but instead teaches general, untargeted treatments.

[0029] In the course of studying the effects of direct current on the oral cavity, the applicant discovered that by increasing the current level to a general range of 50 to 250 microamperes, direct current stimulation can yield novel and unexpected therapeutic, preventive, cosmetic, and regenerative benefits previously unknown in the art.

[0030] Specifically, by utilizing direct current within the aforementioned range, it has been found that such stimulation not only kills bacteria but also kills or inactivates viruses and fungi. Research from the field of podiatry has shown that higher current levels than those used in existing oral electrical stimulation are required to effectively treat fungal infections ("Low-Voltage Direct Current as a Fungicidal Agent for Treating Onychomycosis," Kalinowski et al., Journal of the American Podiatric Medical Association Vol. 94 No.6:565-572, 2004). By applying this finding regarding increased current levels obtained from research outside the art, the applicant was able to add mycogenic and virogenic benefits to a method already known to be bactericidal. The applicant's research shows that these microbiotacitogenic properties begin to take effect within approximately 5 and 15 minutes of stimulation, reducing both supragingival and subgingival microorganisms.

[0031] In addition, the applicant's clinical studies unexpectedly demonstrated that direct current in the approximate range of 50–250 microamperes can regenerate gingival tissue, providing a non-surgical alternative for those with receding gingiva. While the ossogenic properties of electricity were known in the art, the relationship between non-ossicular tissue regeneration and electricity was not well known in the art prior to these experiments. The unique current range associated with the method and apparatus of the present invention is one of the few effective methods for achieving effective gingival tissue regeneration in a non-surgical manner in the dental field.

[0032] In further research, the applicant conducted a preclinical study to investigate the effects of direct current stimulation on three different oral bacteria (F. nucleatum, S. oralis, and P. gingivalis) in both saline and salivary solutions. This study varied the current level, bacterial inoculation, solution medium, and stimulation time to achieve optimal reduction of these three bacterial species, which are associated with both periodontal disease and systemic disease.

[0033] The results of this study yielded unexpected findings, demonstrating that each different bacterium exhibited different dose-responses to DC stimulation. Through this study, the applicant identified stimulation parameters capable of killing up to 100% of S. oralis, 99.1% of F. nucleatum, and 52.3% of P. gingivalis in a single stimulation session of 30 minutes or less. This study resulted in specifications for DC-based stimulation of target pathogens previously unknown in the art. The optimal stimulation parameters discovered in this study and described herein may reduce these three types of bacteria in both supragingival and subgingival environments, thus providing an innovative method for preventing and / or treating periodontal disease, biofilm formation, and their associated complications, including systemic diseases associated with these oral pathogens.

[0034] In addition, to better understand the mechanism by which the method according to the present invention can reduce bacterial levels, scanning electron microscopy (SEM) was performed on F. nucleatum colonies before and after 30 minutes of stimulation according to the method of the present invention. SEM images suggested that the method according to the present invention can disrupt bacterial cell division and weaken the outer membrane (cell membrane), resulting in a fragile cellular structure that can be easily destroyed. This phenomenon is intended to be an example of electroporation, in which the permeability of the cell membrane can be temporarily or permanently affected by electrical stimulation. It is further intended that the electroporation induced by the method according to the present invention can utilize this cell permeability to play a role in the development of novel therapeutics in molecular biology, introducing new substances into cells of oral pathogens or oral tissues through mechanisms including, but not limited to, genetic material (transfection) such as DNA, RNA, sRNA, siRNA, and plasmids. These effects could make them novel tools in targeted gene therapy for oral applications.

[0035] Specifically, the method according to the present invention has been shown to reduce the number of viable colony-forming units (CFUs) in various oral bacteria.

[0036] Table 1 below shows the effectiveness of the stimulation according to the present invention at current levels of 50 microamperes or 500 microamperes over durations of 5, 10, 20, and 30 minutes for bacterial cultures of Streptococcus oralis ranging from 10⁴ to 10⁷ colony-forming units (CFUs) in physiological saline solution.

[0037] [Table 1]

[0038] Table 2 below shows the effectiveness of the stimulation according to the present invention at current levels of 50 microamperes or 500 microamperes over durations of 5, 10, 20, and 30 minutes for bacterial cultures of Streptococcus oralis ranging from 10⁴ to 10⁷ CFU in saliva solution.

[0039] [Table 2]

[0040] Table 3 below shows the effectiveness of the stimulation according to the present invention at current levels of 50 microamperes or 500 microamperes over durations of 5, 10, 20, and 30 minutes for bacterial cultures of Fusobacterium nucleatum in physiological saline solution, comprising 10⁴ and 10⁶ CFU.

[0041] [Table 3]

[0042] Table 4 below shows the effectiveness of the stimulation according to the present invention at current levels of 50 microamperes or 500 microamperes over durations of 5, 10, 20, and 30 minutes for bacterial cultures of Fusobacterium nucleatum in saliva ranging from 10⁴ to 10⁶ CFU.

[0043] [Table 4]

[0044] Table 5 below shows the effectiveness of the stimulation according to the present invention at current levels of 50 microamperes or 500 microamperes over durations of 5, 10, 20, and 30 minutes for a bacterial culture of Porphyromonas gingivalis in physiological saline solution containing 10⁴ CFU.

[0045] [Table 5]

[0046] Therefore, this method and the corresponding apparatus can achieve multiple preventive, therapeutic, cosmetic, and regenerative effects that were previously unknown or unavailable in the art. These effects include promoting oral bone formation, destroying or inactivating oral microorganisms, regenerating gingival tissue, reducing and preventing oral biofilm formation, preventing caries, dilating oral blood vessels and increasing oral blood flow, treating common oral diseases such as gingivitis and periodontitis, treating systemic diseases and conditions associated with oral pathogens, and improving overall oral hygiene.

[0047] Referring here to the drawings, Figure 1 shows one embodiment of the stimulator 10 according to the present invention. The stimulator 10 is preferably a standalone device comprising a mouthpiece 100 and a controller 300, which may be physically supported by a charging station or stand 400 and may be operationally rechargeable. Generally, the mouthpiece 100 is sized and configured to be received in the oral cavity of a human, with one or more electrodes positioned at desired locations within the oral cavity.

[0048] See also Figures 2 to 5, the mouthpiece 100 includes at least one substantially U-shaped channel 110 configured to receive either a maxillary or mandibular tooth of a human, preferably including an upper U-shaped channel 110T and an opposing lower U-shaped channel 110B, wherein the channels 110 are preferably configured to receive either a maxillary tooth and either mandibular tooth of the same human simultaneously. The two U-shaped channels 110 are preferably separated from each other by a channel base 114 along at least a large portion of their length 112. Forming the channel 110 in relation to the channel base 114 are opposing lingual 120 and buccal 130 side walls, preferably extending substantially perpendicularly from the channel base 114.

[0049] The lingual sidewall 120 terminates at a lingual free edge 122, and one or more lingual electrodes 124 are provided along most of it (preferably along the entire lingual free edge 122). The lingual electrodes 124 are preferably formed from conductive silicone and may be separated by one or more insulating gaps, such as a lingual sidewall air gap or a notch 126 or other electrically insulating material. The buccal sidewall 130 terminates at a buccal free edge 132, and one or more buccal electrodes 134 are provided along most of it (preferably along the entire buccal free edge 132). The buccal electrodes 134 are preferably formed from conductive silicone and may be separated by one or more insulating gaps, such as a buccal sidewall air gap or a notch 136 or other electrically insulating material, such as electrically insulating silicone. The mouthpiece 100 is preferably formed from a relatively comfortable tissue-facing material such that it has a Shore A hardness of 80 or less (e.g., molded).

[0050] The connection between electrodes 124, 134 and the circuit in the controller 300 is made through the neck portion 200. The connection from electrodes 124, 134 to the neck portion 200 can be achieved using flexible circuit techniques such as copper-clad polyimide, but multi-stage injection molding including a first electrical insulating material and a second conductive material for forming the conductive traces 140 may be more preferred. That is, conductive silicone can be formed into a desired pattern using a first mold and stretched from the first connector end to and including one or more electrodes 124, 134 to create a conductive skeleton. The conductive skeleton can then be overmolded with electrical insulating silicone to form the majority of the mouthpiece 100 and to insulate the conductive traces 140 forming the skeleton from each other. After insulation, the exposed conductive areas are electrodes 124, 134 and the terminal surfaces in the neck portion 200.

[0051] The conductive trace 140 within the mouthpiece 100 is then electrically coupled to a header connector 210 which is mounted or to be mounted within the controller housing 310, as will be further described below. Specifically, the header connector includes pins 212, each pin being associated with a conductive silicone path (140 in Figure 7) to preferably an electrode 124 or 134 and physically inserted. The maximum resistance of any conductive path from the terminal surface 142 of the trace 140 within the neck portion 200 to either portion of each electrode 124, 134 is preferably less than 25 kilohms.

[0052] See also Figure 7, the controller 300 preferably comprises a housing 310 configured to be fixed to the mouthpiece 100. The housing 310 houses a battery 302 and electronic circuitry that roughly controls the timing of the connection (i.e., switching) of electrodes 124, 134 to deliver charge from the battery 302. The battery 302 is preferably a rechargeable lithium-ion battery having a full charge capacity capable of running at least seven consecutive stimulation sessions, each with a session duration of 20 minutes. The battery 302 is preferably rechargeable in less than 12 hours from a fully discharged state. The battery 302 is preferably rated for at least 200 charge / discharge cycles.

[0053] The circuit may be operably mounted on one or more printed circuit boards 304, but two circuit boards (lower board 304L and upper board 304U) are preferred to provide an improved mounting footprint. The housing 310 may comprise one or more housing components (e.g., top, bottom, and sides) made of molded polycarbonate plastic, polycarbonate / ABS alloy (PC / ABS), and is preferably biocompatible. Regardless of the materials used to construct the mouthpiece 100 and controller 300, the device 10 can preferably withstand a gravity drop (approximately 9.81 m / s²) from a distance of about 2 meters (2 m) onto a relatively hard surface (e.g., stone or ceramic tile, vinyl on a wood substrate, or concrete). The housing components may be individually formed and fastened to each other, and attempts are made to minimize water ingress, which may include the use of gaskets (e.g., O-rings) with mechanical connections (e.g., snap locks, screw fasteners). More preferably, the housing components are ultrasonically welded to provide a desirable waterproof rating (e.g., IPX1 to IPX9).

[0054] Figure 6 schematically provides a diagram of the functional block of the circuit housed in the enclosure 310, and includes a programmable microprocessor (preferably used in conjunction with a communication antenna), an inductive charging circuit for receiving wireless inductive charging to the battery 302, hardware overcurrent protection, current and voltage feedback for monitoring delivery parameters and open-circuit conditions, and user interface components.

[0055] The controller 300 preferably provides a user input interface in the form of a single push button 306 (preferably debounced in hardware or software) and a user output or feedback interface which preferably includes one or more of a battery indicator light 312, a status (or stimulation or treatment indicator) light 314, and an audible buzzer or speaker 316. The status (on / off) of the push button 306 is monitored to control its functionality. The battery indicator light 312 may preferably display multiple colors (e.g., white and amber) in one of the following states: preferably always on, flashing (which may be at different rates), or alternating colors, depending on the feedback provided. The treatment indicator 314 may preferably display multiple colors (e.g., red, white, and blue) in one of the following states: preferably always on, flashing (which may be at different rates), or alternating colors, depending on the feedback provided. User feedback may be provided additionally or alternatively tactilely through the use of a tactile feedback generator such as a vibration motor. Preferred feedback is as shown in the table provided in Figure 11.

[0056] The following are notes related to Figure 11 (indicated by superscripts in the table): 1. If the device transitions from the COMPLETE state to the LOW BATTERY state, the treatment LED 314 will continue to flash white and audible feedback will be turned off. 2. The LED flashes white while the battery is charging and remains constantly lit white when charging is complete. 3. If the device is placed on the charging stand while in the FAULT state, the device will continue to display the treatment indicator light 314 flashing red. The device will display the battery indicator light 312 according to the current battery charge level (flashing white / constantly lit white), but will not provide audible feedback when placed on the charger to avoid being mistaken for a fault clear. 4. If the device 10 is left on the charger 400 for more than 10 minutes after charging is complete, the battery indicator light 312 will turn off. If the battery voltage falls below the charging threshold, the charger 400 will continue charging during this period, but the battery indicator 312 will remain off.

[0057] Generally, an electrical circuit can be described as having multiple channels controlled and monitored by a microprocessor, each channel associated with the operation of one or more electrodes 124, 134. Channels can be enabled or disabled independently of other channels, but each channel can control multiple electrodes. Additionally or alternatively, one or more electrodes may be permanently designated and operated solely as return electrodes. A preferred embodiment includes eight channels, each capable of driving a DC current of 125 microamperes (plus or minus 10%) across a resistance of up to 50 kiloohms.

[0058] As shown in Figures 8A to 8D, for each electrode channel, an enable signal 802 is received by the channel drive circuit 810. When activated, the enable signal 802 flips a switch (a MOSFET in this example) to supply voltage to the 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 how much current is flowing. The CS_HIGH and CS_LOW signals are passed through a comparator circuit that activates the CH_CURRENT signal to indicate that current is flowing. CH_VOLTAGE may be monitored to determine the voltage and current levels delivered to each channel.

[0059] The controller 300 is operated by a user (not shown) preferably by pressing a push button 306. For example, the user can start or pause the delivery of current to the mouthpiece 100 by pressing the push button 306. To prevent unintended operation, the duration of the press on the push button 306 is detected and debounced.

[0060] The controller 300 is preferably configured by a clinician or other trained staff member before the user interfaces with the stimulator 10. Additionally or alternatively, the patient may configure the controller 300. Preferably, the configuration of the controller 300 is performed through the attachment of additional hardware (not shown) connected to the controller 300, but may also be performed via wireless connectivity (e.g., Bluetooth, Wi-Fi, near-field communication (NFC), infrared, magnetic). Finally, the controller 300 may be provided with a default stimulation prescription plan to reduce or eliminate the effort required for initial configuration by the clinician or patient.

[0061] The configuration parameters preferably include: selection of an electrode configuration for providing a DC current for stimulation; selection of a DC current output value, e.g., 6 microamperes, 12 microamperes, 18 microamperes, 25 microamperes, 50 microamperes, 62 microamperes, 75 microamperes, 100 microamperes, 125 microamperes, 150 microamperes, 200 microamperes, and 250 microamperes (preferably the total current across all delivery electrodes does not exceed 2,000 microamperes at any given time); and selection of the duration of the stimulation session (preferably selectable in 1-minute increments from 1 minute to 30 minutes). Exemplary preferred configuration parameters can be seen in the tables provided in Figures 12A and 12B.

[0062] The controller 300 may preferably monitor compliance with protocols and stimulation sessions performed by the stimulator 10 and record several performance metrics, such as counts of predetermined and monitored events and / or data associated with such events, in non-volatile memory (e.g., FLASH memory). The recordings may be used by a clinician (not shown) to evaluate and discuss stimulation response and effectiveness. The controller 300 may also be configured to dynamically monitor electrical characteristics (i.e., resistance, voltage, current) and adjust stimulation parameters or settings without intervention from a clinician or user. Preferably, a real-time clock is used and referenced to record the time and date when metrics and data are collected. Separately from the real-time clock (which may be seeded by a wireless communication device or network), real-time counters are maintained to track the timing of automatic state changes and to track uptime.

[0063] For example, a counter may be set up to track the number of times a particular event occurs. The counter may be maintained in non-volatile memory, such as a preferred counter as shown in the tables in Figures 13A and 13B. Some of the metrics and data collected may include (along with the date and time of such occurrences): the number of initiated stimulation sessions (e.g., therapy); the number of successfully completed stimulation sessions (e.g., therapy); the number of open-circuit failures; the number of stimulation sessions (e.g., therapy) with open circuits; the number of stimulation sessions (e.g., therapy) with open circuits but still successfully completed; the number of overcurrent failures; the number of low battery failures; the number of times the device was paused; the number of paused stimulation sessions (e.g., therapy) that still successfully completed; the number of times the user turned on the device; the number of times the device was powered off by the user; the number of times the device was powered off by software; and the total number of minutes the device was operational (e.g., delivering stimuli) since a memory reset. The counter is incremented by 1 each time one of the listed events occurs.

[0064] The recorded metrics and data are stored only in the non-volatile memory within the controller 300 and can be accessed via a physical connection (e.g., a serial UART connection when the enclosure 310 is removed, or a serial connector provided through the enclosure 310). Additionally or alternatively, the recorded metrics and data can be accessed via a wireless connection (e.g., through a software application on a BLE-enabled wireless communication device), or even automatically pushed to a wireless communication device via a wireless network and stored on or remotely from the wireless communication device, for example, on a remote data storage device networked with the wireless communication device (which may be cloud storage or a remote server associated with the manufacturer and / or distributor of the device 10, a healthcare provider (e.g., a physician, nurse, dentist, dental hygienist, administrative staff), an insurance company, or a user (or the user's guardian).

[0065] A subset of counters may be predetermined for monitoring, and their increase (or change) may be indicated by a software flag which may be communicated to another wireless communication device such as a mobile phone, a charging station 400, or an LPWAN gateway 530 (described later). In a preferred embodiment, the counters identified in Figure 13A that are monitored for flagging have reference numbers 1 (manual power on), 5 (critical battery power off), 8 (treatment initiated), 9 (successfully completed treatment), 10 (open circuit), 11 (low battery), 12 (fault), and 13 (effective fault). After a change occurs in one or more of these counters, wireless communication (e.g., a BLE advertising packet) transmitted from device 10 indicates that such a change has occurred. That is, one or more bytes of data may contain a one-bit flag to indicate the change in each monitored counter. The flags may be cleared after the counter data has been transmitted from device 10, or upon successful transmission of complete or summary data from device 10, as further described below.

[0066] Automatic data push may also occur based on time intervals or the occurrence of events, such as a transition from OFF to READY, a transition to the CHARGING state, or a transition to the OFF state. The data pushed may include user stimulation session data (e.g., patient compliance metrics), firmware version, device errors, and / or the physical location of the device 10 and / or charger 400 (if GPS or network location functionality is provided).

[0067] The specific technologies used for such data push can be assembled from generally known hardware technologies, but have not traditionally been known to be used in connection with any oral appliance. Data push from the controller 300 can be directly performed on the charger 400, which acts as an intermediate for transfer over a wireless communication network (e.g., WAN, LAN, etc.), such as WiFi / LoRa / LoRaWAN / WiFi HaLow / Helium, or even a low-power wide-area network or mesh network.

[0068] Not only can the count of specific events be maintained, but data related to the occurrence of specific events can also be logged. The types of events logged in the controller's event log can also be stored in non-volatile memory, including those shown in the table in Figure 14. Preferably, the event log can store a minimum of 2,000 events. If the non-volatile memory allocated to the event log is exceeded, the oldest events are overwritten to make way for new data.

[0069] For example, environmental and / or geographic location information may be logged and / or estimated. The controller 300, or a wireless communication device associated with the controller 300, may 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 communications (e.g., WiFi and / or Bluetooth) with the wireless communication device. Network communications are monitored to discover 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 serial number (of the other communication device). The wireless communication device discovers nearby Wi-Fi networks and creates a list of discovered network identifiers, a number (e.g., 1 to 10) that exhibit the highest RSSI. That is, the list includes several discovered networks that have a higher RSSI than other potentially discovered networks.

[0070] A first geographical change may be indicated and logged by a wireless communication device if, by comparing the logged network identifiers to a preceding list of previously logged network identifiers, more than 70% of the count of logged network identifiers are not present in the list and more than 50% of the count of previously logged network identifiers are not present in the logged network identifiers (e.g., a large geographical change). A second geographical change may be indicated and logged by a wireless communication device if, by comparing the RSSI value of the logged network identifiers to a list of RSSI values ​​of previously logged network identifiers, 20% to 50% of the count of RSSI values ​​of logged network identifiers have changed by approximately 3 to approximately 10 decibels (dB) compared to the RSSI values ​​of previously logged network identifiers (e.g., a small geographical change).

[0071] The non-volatile memory preferably stores at least the following occurrence and related information: the number of minutes of stimulation completed by the user in a session (maximum 30 minutes); whether the mouthpiece was disconnected during operation (e.g., occurrence of an OPEN state); whether an overcurrent fault occurred; the total charge delivered per channel for a specific stimulation duration (e.g., treatment) (in units of coulombs (C) or microcoulombs); and whether a low battery fault occurred.

[0072] The controller 300 preferably provides a user input interface in the form of a single push button 306 (preferably debounced in hardware or software) and a user output or feedback interface, preferably including one or more of a battery indicator light 312, a status (or stimulation or treatment indicator) light 314, and an audible buzzer or speaker 316. The state (operated / deactivated) of the push button 306 is monitored to control its functionality. The battery indicator light 312 may preferably display multiple colors (e.g., white and amber) and may preferably be consistently lit, flashing (which may be at different rates), or alternating colors depending on the feedback provided. The treatment indicator 314 may preferably display multiple colors (e.g., red, white, and blue) and may preferably be consistently lit, flashing (which may be at different rates), or alternating colors depending on the feedback provided. User feedback may be provided further, or alternatively, by touch, through the use of a haptic feedback generator such as a vibration motor. Favorable feedback is shown in the table provided in Figure 11, and the relevant annotations in Figure 11 (shown in superscript in the table) are as follows: 1. If the device transitions from the COMPLETE state to LOW BATTERY, the treatment LED314 will continue to flash white, and the audible feedback will be turned off. 2. The light flashes white while the battery is charging, and turns on white when charging is complete. 3. If the device is placed on the charging stand while in a FAULT state, the device will continuously display a flashing red treatment indicator light 314. The device will display a battery indicator light 312 depending on battery charging (flashing white / on white), but will not provide audible feedback when placed on the charger to avoid being misunderstood as having cleared a fault. 4. The battery indicator light 312 will turn off if the device 10 remains on the charger 400 for more than 10 minutes after charging is complete. The charger 400 will continue charging during this time period if the battery voltage falls below the charging threshold, but the battery indicator 312 will remain off.

[0073] An electrical circuit can generally be described as having multiple channels controlled and monitored by a microprocessor, each channel associated with the operation of one or more electrodes 124, 134. Channels can be enabled or disabled independently of other channels, but each channel can control multiple electrodes. In addition, or alternatively, one or more electrodes can be permanently designated and act only as return electrodes. A preferred embodiment includes eight channels, each capable of driving a direct current of 125 μA (±10%) across a resistance up to 50 kΩ.

[0074] As shown in Figures 8A-8D, for each electrode channel, the enable signal 802 is received by the channel drive circuit 810. When activated, the enable signal 802 flips a switch (a MOSFET in this example) to supply voltage to the current source regulator, which then supplies current to the channel output 812. The sense resistor 814 is used to determine whether current is flowing, and preferably how much current is flowing. The CS_HIGH and CS_LOW signals are performed through the comparator circuit to activate the CH_CURRENT signal, which indicates that current is flowing. CH_VOLTAGE is an optional parameter to monitor to determine the voltage and current levels delivered to each channel.

[0075] The operation of the controller 300 by the user (not shown) is preferably performed by pressing a push button 306. For example, the user can start or pause the delivery of current to the mouthpiece 100 by pressing the push button 306. To prevent unintended operation, the duration of the press on the push button 306 is sensed and debounced.

[0076] The controller 300 is preferably configured by a clinician or other trained staff member before the user interacts with the stimulator 10. In addition, or alternatively, the patient may configure the controller 300. Preferably, the configuration of the controller 300 is performed through the connection of additional hardware parts (not shown) connected to the controller 300, but may also be performed through a wireless connection (e.g., Bluetooth®, Wi-Fi, Near Field Communication (NFC), infrared, magnetic). Finally, the controller 300 may be provided with a default stimulation prescription plan to reduce or eliminate the effort of initial configuration by the clinician or patient.

[0077] The configuration parameters preferably include: selection of an electrode configuration for providing a direct current for stimulation; selection of a direct current output value, e.g., 6 μA, 12 μA, 18 μA, 25 μA, 50 μA, 62 μA, 75 μA, 100 μA, 125 μA, 150 μA, 200 μA, and 250 μA (preferably not exceeding a total current of 2,000 μA across all delivery electrodes at any given time); and selection of the duration of the stimulation session (preferably selectable in 1-minute increments from 1 minute to 30 minutes). Exemplary preferred configuration parameters can be seen in the tables provided in Figures 12A and 12B.

[0078] The controller 300 may preferably monitor protocol compliance and stimulation sessions performed by the stimulator 10, and may record several performance metrics, such as counts of predetermined events and / or data associated with such events, in non-volatile memory (e.g., FLASH memory). The records may be used by a clinician (not shown) to evaluate and discuss stimulation response and effectiveness. The controller 300 may also be configured to dynamically monitor electrical characteristics (i.e., resistance, voltage, current) and adjust stimulation parameters or settings without intervention from a clinician or user. A real-time clock is preferably used and referenced to record the time and date when metrics and data were collected. Apart from the real-time clock (which may be seeded by a wireless communication device or network), real-time counters are maintained for tracking the timing and execution time (uptime) of automatic state changes.

[0079] For example, a counter may be established to track the number of times a particular event occurs. The counter may be maintained in non-volatile memory, such as a preferred counter as shown in the tables in Figures 13A and 13B. Some of the metrics and data collected may include (as well as the date and time of such occurrences): the number of initiated stimulation sessions (e.g., therapy); the number of successfully completed stimulation sessions (e.g., therapy); the number of open-circuit failures; the number of stimulation sessions (e.g., therapy) with open circuits; the number of stimulation sessions (e.g., therapy) with open circuits and successfully completed; the number of overcurrent failures; the number of low battery failures; the number of times the device was paused; the number of paused but still successfully completed stimulation sessions (e.g., therapy); the number of times the user turned on the device; the number of times the device was powered off by the user; the number of times the device was powered off by software; and the total number of minutes the device has run (e.g., delivered stimuli) since the memory reset. The counter is incremented by 1 each time the stated event occurs. The recorded metrics and data are stored only in non-volatile memory within the controller 300 and may be accessed via a physical connection (e.g., a serial UART connection if the housing 310 is removed, or a serial connector provided through the housing 310). In addition, or alternatively, the recorded metrics and data may be accessed via a wireless connection (e.g., through a software application on a BLE-enabled wireless communication device), or automatically pushed to a wireless communication device via a wireless network and then stored remotely on or from the wireless communication device (such as cloud storage or a remote server, which may be associated with the manufacturer and / or seller's equipment 10, caregivers (e.g., doctors, nurses, dentists, dental hygienists, administrative staff), insurance companies, or users (or the user's guardians)). A subset of counters may be predetermined to be monitored, and increases (or changes) may be indicated by software flags and communicated to another wireless communication device (a mobile phone, a charging station 400, or an LPWAN gateway 530).In a preferred embodiment, the counters identified in Figure 13A are monitored for flagging and are reference numbers 1 (manual power on), 5 (critical battery power on), 8 (initiated treatment), 9 (successfully completed treatment), 10 (open circuit), 11 (low battery), 12 (fault), and 13 (effective fault). When one or more of these counters change, a wireless communication (e.g., a BLE advertising packet) transmitted from device 10 indicates that such a change has occurred. That is, one or more bytes of data may include a one-bit flag to indicate each change of the monitored counter. The flag may be cleared after the counter data has been transmitted from device 10, or after a successfully completed or summary data transfer from device 10.

[0080] Automatic data pushing may also be performed based on time intervals or event occurrences (such as transitions from OFF to READY, input of CHARGING state, input of OFF state, etc.). Pushed data may include user stimulation session data (e.g., patient compliance metrics), firmware version, device errors, and / or the physical location of device 10 and / or charger 400 (if GPS or network location functionality is provided).

[0081] The specific technologies used for such data pushing may be assembled from generally known hardware technologies and have not traditionally been used in combination with any oral appliance. Data push from the controller 300 may be direct to the charger 400 as an intermediate, and may be transmitted via a wireless communication network (e.g., WAN, LAN, etc.) (e.g., WiFi / LoRa / LoRaWAN / WiFi HaLow / Helium), or even via a low-power wide-area network or mesh network.

[0082] Not only is the occurrence count of a particular event maintained, but data associated with the occurrence of that particular event may also be logged. The types of events recorded in the controller's event log may also be stored in non-volatile memory, including those shown in the table in Figure 14. Preferably, the event log can store at least 2,000 events. If the non-volatile memory exceeds the number of events allocated to the event log, the oldest events are overwritten to make way for new data. For example, environmental and / or geographic location information may be logged and / or inferred. The controller 300, or the wireless communication device associated with the controller 300, may 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 communications (e.g., WiFi and / or Bluetooth) wireless communication device. Network communications may be monitored to discover 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 Serial Number (of the other communication device). The wireless communication device detects nearby Wi-Fi networks and creates a list of several (e.g., 1-10) detected network identifiers, indicating the highest RSSI. That is, the list may include multiple detected networks with a higher RSSI than other networks. A first geographical change may be indicated and logged (e.g., a major geographical change) by the wireless communication device by comparing the logged network identifiers to a list of previously logged network identifiers if more than 70% of the logged network identifiers by count are not in the list, and / or more than 50% of the previously logged network identifiers by count are not in the logged network identifiers.A second geographical change may be indicated and logged (for example, a small geographical change) by the wireless communication device by comparing the RSSI value of the logged network identifier with a list of previously logged RSSI values ​​of network identifiers, counting 20% ​​to 50% of the logged network identifier RSSI values ​​if they have changed by approximately 3 to 10 decibels (dB) compared to the previously logged RSSI values ​​of network identifiers.

[0083] The non-volatile memory preferably stores at least the following occurrence and related information: the number of minutes of stimulation completed by the user for the session (maximum 30 minutes); whether the mouthpiece was disconnected during execution (e.g., OPEN state occurred); whether an overcurrent fault occurred; the total charge delivered to each channel for a specific stimulation duration (e.g., treatment) (in units of coulombs (C) or microcoulombs (μC)); and whether a low battery fault occurred.

[0084] The controller 300 may also be configured to detect if the mouthpiece 100 is not positioned in the user's oral cavity during a stimulation session, as described in relation to Figure 8. To do so, the controller 300 monitors the delivery of current and whether current is detected at any of the multiple cathode electrodes. If no current is detected, the controller 300 may pause the stimulation and indicate a fault condition. For example, the controller 300 monitors the stimulation circuit, which includes the anode and cathode electrodes. The controller 300 may include a circuit for measuring or predicting the amount of current to be delivered to the mouthpiece 100 (delivery current) and may also measure the amount of return current received from the mouthpiece 100 (return current). The circuit then compares the return current to the delivery current, and if the difference is greater than a predetermined value (e.g., a percentage of the delivery current, e.g., from 10% to about 50%), the stimulation is preferably paused at all electrodes and a fault message is displayed to the controller. When the difference between the delivery current and the return current falls below a predetermined amount, the stimulation program or prescription plan is resumed from where it left off, preferably with little to no loss of stimulation time.

[0085] Figure 18 provides parameters for monitoring the current delivered to the delivery electrodes. As described above, the running current setpoint and duration "T" are determined and set during configuration before the patient uses the stimulator 10, with a recommended setting of 2 seconds for duration "T". The open circuit is preferably about 80% of the running current setpoint, and the overcurrent fault limit is preferably 120% of the running current setpoint. The hardware limit is preferably about 200-300 μA per stimulation channel (e.g., per anode electrode).

[0086] When the controller 300 is supplying current to any delivery electrode, the current is preferably polled 8 times per second.

[0087] If the detected current is found to be less than the open-circuit limit, the stimulus is paused and a notification is displayed. If the detected current is found to be greater than the overcurrent fault limit for a longer period than specified, the stimulus is paused and a fault notification is displayed.

[0088] The stimulator 10 is intended to communicate with the user's electronic device (not shown) (such as a cellular phone, tablet, or personal computer), and is further intended to be fully compatible with wireless technologies such as Bluetooth® technology, short-range communication, and Wi-Fi. Preferably, the user can review usage history, prescribed stimulation plans, and / or comparisons of usage history versus stimulation plans. The stimulator 10 may also provide notifications regarding prescribed stimulation sessions to any of the user's electronic devices. This function is intended to operate through an application (not shown) downloadable to the user's electronic device. The application may also be configured to share this data with a central server (for storage, remote monitoring by the prescribing clinician, providing one-way or two-way communication between the patient and the clinician, and / or allowing the clinician to remotely adjust stimulation parameters). Furthermore, firmware upgrades may be supplied wirelessly to the controller 300.

[0089] The controller 300 may include wireless communication technology, such as a Bluetooth Low Energy (BLE) module, which may be incorporated in a microprocessor package. When the controller 300 is powered on (i.e., not in the OFF state), the controller may periodically transmit BLE advertising packets, which may include a device identifier (e.g., a unique device identifier (UDI)) which may be assigned by a regulatory authority such as the USFDA. The BLE communication channel is preferably used to transmit information contained in or about the controller 300, such as software version, programmable parameters, event log data, counter data, and / or software state (e.g., READY, RUN, OPEN, etc.) and / or changes (since the last transmission). The BLE interface may also be used for information exchange with a software application (such as a user or physician service application) on a remote wireless communication device such as a tablet computer, mobile phone, or other BLE-enabled device, which may also include a real-time clock. The real-time clock data may be received from the controller 300 by the application and stored and referenced to start, maintain, and / or update its own real-time clock.

[0090] Specifically, an application (running on a wireless communication device) can scan for BLE advertising packets transmitted by the controller 300 (on request or periodically). A user can pair the device with the stimulator 10 by operating the user interface on the device, and then by selecting it from a list of nearby advertising BLE-enabled devices. Alternatively, the application can pair the device with the stimulator 10, preferably via RSSI (Received Signal Strength Indicator), where the wireless device only needs to be brought within a predetermined proximity to the device 10. The user can engage or disengage the RSSI function by operating the device's user interface.

[0091] When a mobile device is paired with device 10, the current date and time (local time stored on the mobile device, or from a network such as Wi-Fi or cellular) is preferably sent to device 10 for storage in the event log. The application can verify 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 an option to highlight and notify the user of changes in the event log, parameter values, or counter values ​​(providing real-time updates on device 10 as they occur (or immediately afterward)).

[0092] The application may also preferably display the current software state of the device 10 and information associated with that state. For example, when the device 10 is in the RUN or OPEN state (i.e., when stimulation is in progress or paused), the application may display a timer counting down the remaining time in the stimulation cycle, as well as electrical current and voltage measurements for each channel on the device 10. While in these states, the application may also preferably store event logs, parameter values ​​and counters, the UDI of the device 10, the Bluetooth MAC address(s) of the paired device 10, and other information from the device 10, providing the option to store them for future display within the wireless device application or as a log file stored in memory that is searchable without using the application (e.g., a searchable or movable electronic file (a formatted file such as an ASCii text file or a comma-separated variable (*.csv) file)).

[0093] The application also preferably provides a user interface for transitioning the device 10 between software states and allows remote control of the device 10 (instead of requiring physical interaction with the button 306), such as the use of virtual buttons. For example, the device 10 may transition from a READY, CHARGING, or FAULT state to a SERVICE state, or vice versa. In the SERVICE state, the application preferably allows the user to clear the contents of the event log, reset counters, update parameter values, or perform firmware updates on the device 10. The states are discussed in more detail below.

[0094] A charging station 400 according to the present invention preferably comprises a base 402 and a shell 410, as shown in at least Figures 1 and 10. The base 402 preferably comprises a power input (not shown), such as a USB-C receptacle. The power input is configured to receive input power from a power input source (not shown) (e.g., a DC transformer providing AC power connected to a standard electrical outlet). The input power is functionally coupled to a wireless charging coil (not shown), such as one defined by the Qi wireless charging standard. The controller 300 may be configured to wirelessly charge without the charger 400, but in cooperation with a different (preferably Qi-compliant) wireless charger in proximity.

[0095] The base 402 includes a controller support interface 420, a cradle ridge 422, and a cradle surface 422a. The cradle ridge 422 is configured to mat with the controller support ridge 322 to assist in supporting the controller 300 and assist in registering the relative positions of the wireless charging circuit components. The relative positioning and registration of the controller 300 is further assisted with respect to the base 402, preferably by one or more magnets (not shown) fixed in the controller housing 310 and the base 402. In this way, when the controller 300 is supported by the controller support interface 420, the inductive charging coil (in the base 402) generates a magnetic field through the shell 410, which is used by the receiving coil (in the controller 300) to charge the battery 302.

[0096] The shell 410 is preferably hollow and defines a shell cavity 412, configured to receive the entire controller 300 / mouthpiece 100 combination (for storage or travel). The shell cavity 412 may be accessed by repositioning the shell 410, removing the shell 410 (for example, if a circumferential snap-fit ​​cooperation with the base 402 is used), or by rotating the shell 410 around a hinge point 414, such as a pinned hinge or living hinge. Within the shell cavity 412 is an arc-shaped saddle surface 416, preferably integrally formed with a portion of the base 402, configured to receive the U-shaped mouthpiece 100.

[0097] To increase the electrical conductivity across or within oral tissue adjacent to an electrode, ionic or colloidal liquids or gels may be used as conductive media to reduce electrical resistance. Such media may be placed along any desired area of ​​the desired electrical contact, such as teeth, gums, or surrounding oral tissue. Examples of such media, but not limited to these, include 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.

[0098] Colloidal silver, either on its own or in combination, not only increases electrical current flow but also offers additional bactericidal effects. Colloidal silver is known to be bactericidal at concentrations of around 5 parts per million by inhibiting the production of two adenosine triphosphates by bacteria.

[0099] This conductive medium may also contain food hygiene supplements, including but not limited to oregano oil. Oregano oil has many health benefits and is considered microbiosidal. Such microbiosidal properties may be effective in supporting the treatment and preventive oral care of common oral infections and diseases.

[0100] This conductive medium may also contain a teeth whitening agent. This would make it possible to add teeth whitening to the list of cosmetic benefits offered by embodiments of the present invention. A whitening agent catalyzed by a direct current may be included, which may even reduce the teeth whitening stimulation time compared to a non-electrically catalyzed whitening agent.

[0101] Similar to the methods used to flavor dental fluoride treatments, artificial or natural flavorings can also be added to this conductive medium to provide a more appealing taste for the user. This flavoring will mask any unpleasant tastes from the components of the conductive medium, as well as the taste of the mouthpiece or electrode itself.

[0102] Therefore, at least one embodiment addresses the desired need in the oral hygiene and dental fields to treat common oral diseases and symptoms more effectively, less invasively, and more inexpensively simultaneously. These embodiments promote general oral hygiene, reduce oral biofilm, treat periodontal diseases such as gingivitis and periodontitis, kill oral microorganisms including bacteria to prevent caries and tooth decay, increase vasodilation and blood flow in oral tissues, promote gingival tissue regeneration, promote bone formation in the bone structures of teeth, oral cavity, and related areas, treat systemic diseases associated with oral pathogens, and treat other periodontal and oral diseases through the non-invasive application of a weak direct current to the oral cavity surface.

[0103] In some cases, dental procedures can disrupt oral bacterial colonies found in biofilms, introducing bacteria into the bloodstream and potentially causing bacteremia and other infections. It is further intended that the mouthpiece according to the present invention be used immediately before performing dental procedures. The stimulator 10 according to the present invention can be used by the patient at home or in a dental clinic. In this way, live bacteria both supragingivally and subgingivally in the patient's oral cavity can be reduced before the procedure, thereby reducing the risk of bacteremia and other infections. For example, but not limited to, the stimulator 10 may be used in a dental clinic before dental preventive procedures or scaling and root planing procedures to reduce the risk of introducing bacteria into the patient's bloodstream.

[0104] The stimulator 10 may also be used for infection prevention after clinical procedures in scenarios including, but not limited to, infection prevention after tooth extraction or implant placement.

[0105] In operation, it may be preferable that the number of anode electrodes equals the number of cathode electrodes, but alternative arrangements with different numbers of anode and cathode electrodes are contemplated. It should be understood that targeted stimulation may be delivered selectively, as is desirable for the treatment of a given gingival area. To deliver targeted stimulation, the delivery of current to other parts of the oral cavity is preferably prevented or reduced mechanically or electrically.

[0106] As an example, mechanical prevention or reduction can be achieved by specific electrode placement, for example, by providing an anode or cathode electrode on the mouthpiece at a first location in the gingival tissue at least partially surrounding (a) a tooth to be removed and replaced by an implant, (b) an empty alveolar cavity where a tooth has already been removed intentionally or accidentally, or (c) a portion of a previously placed dental implant. Mechanical prevention or reduction can be further enhanced by providing a cathode or anode electrode on the mouthpiece at a second location in the gingival tissue (preferably opposite the tooth from the first location), in (a) a tooth to be removed and replaced by an implant, (b) an empty alveolar cavity where a tooth has already been removed intentionally or accidentally, or (c) a portion of a previously placed dental implant. If two electrodes are provided as described above and no other electrodes are placed on the mouthpiece, mechanical reduction of electrical stimulation is achieved. In this way, by mechanically positioning electrodes on the mouthpiece to target electrical stimulation toward the dental implant site, the mouthpiece can be customized for a particular user.

[0107] One example of electrical prevention or reduction of untargeted current is selective electrode control by a controller. That is, mechanically, multiple electrodes may be provided on the mouthpiece, spaced apart around the mouthpiece, as shown and described herein. However, through electrical control of such electrodes, each electrode may have a selectable state for providing stimulation. The selectable electrode state may be anode, cathode, or off (e.g., tristate). Thus, if a targeted current is desired, the first electrode on the mouthpiece may be selected as the anode or cathode electrode. The position of the first electrode on the mouthpiece may correspond to a first location of gingival tissue at least partially surrounding a portion of a previously placed dental implant, either (a) a tooth to be removed and replaced by an implant, (b) an empty alveolar cavity where a tooth has already been removed intentionally or accidentally, or (c) a portion of gingival tissue that at least partially surrounds a portion of a previously placed dental implant.

[0108] Electrical prevention or reduction of untargeted electrical stimulation can be further enhanced by selecting a first electrode on the mouthpiece as a cathode electrode or an anode electrode (opposite to the first electrode). The position of a second electrode on the mouthpiece may correspond to a second position of gingival tissue (opposite the tooth from the first position), where the gingival tissue at least partially surrounds (a) a tooth to be removed and replaced by an implant, (b) an empty alveolar socket where a tooth has already been removed intentionally or accidentally, or (c) a portion of a previously placed dental implant. Electrical reduction of current stimulation is achieved when the two electrodes are selected as described above and the other electrode is not activated on the mouthpiece (e.g., all other electrodes are turned off or set to high impedance or tristate mode). In this way, the mouthpiece can be mechanically standardized for multiple users but can be electrically customized to target electrical stimulation toward dental implant sites.

[0109] While the mechanical and electrical prevention or reduction of stray or untargeted currents has been described in relation to the targeting of a single dental implant site, it should be understood that such targeting can be achieved simultaneously or in a chronological order across multiple implant sites (for example, one target site being stimulated for a predetermined time, followed by a different target site being stimulated for a predetermined time).

[0110] During operation, the controller 300 generally cycles through and / or between software states, some of which can be seen listed in the tables provided in Figures 15A, 15B, and 15C. Referring here to Figure 16, the preferred states of the controller 300 can be seen. In the OFF state, the microprocessor is not powered, or is placed in sleep or low-power mode, with minimal power supplied to maintain operation, preferably only the real-time clock and possibly visual indicators (always or intermittently). The OFF state can be transitioned from any other state of the controller if the push button 306 has been activated for a predetermined time (e.g., at least 3 seconds). The OFF state can also be transitioned from the following states based on a predetermined inactivity period: OPEN, READY, COMPLETE, LOW BATTERY, CRITICAL_BATTERY, or FAULT. The predetermined inactivity period is used to monitor user activity (i.e., pressing the push button 306) or correction of the OPEN state. If either of these occurs within the inactivity period, a different state other than OFF is transitioned from the respective state. The predetermined inactivity period is preferably a programmable software variable, preferably separately programmable with respect to inactivity (i.e., READY, COMPLETE, LOW BATTERY, CRITICAL_BATTERY, and / or FAULT states) and OPEN modification (i.e., current starts flowing again before the expiration of this time). The OFF state is terminated by operating the push button 306 for a predetermined time (e.g., at least 2 seconds).

[0111] The READY state is the state of the controller in which stimulation can be initiated. The READY state can be transitioned from the OFF state by operating the push button 306 for a predetermined time (e.g., at least 2 seconds). The controller 300 remains in the READY state until the push button 306 is operated by the user or until the controller exits the READY state and returns to the OFF state due to a period of inactivity.

[0112] The RUN state is a state in which the delivery electrode is activated and current is delivered through it at a predetermined programmed current level for a predetermined programmed time. The RUN state is transitioned from the READY state by intermittent or periodic activation of the push button 306. The software causes current delivery to the activated (i.e., turned-on) electrode channel (i.e., the controller software transitions to the RUN state) preferably only from the READY state when the user presses the push button 306 (or a virtual button). The software monitors a stimulation (e.g., treatment) duration counter that increments at least once per second while current is being delivered. The software compares the stimulation duration counter to a programmed TREATMENT_DURATION to determine when current delivery should be terminated. Alternatively, upon transitioning to the RUN state, the software sets the initial value of the decrement counter to TREATMENT_DURATION, then monitors the counter to determine when it reaches zero, thereby indicating a halt to current delivery, and preferably causing a halt to current delivery.

[0113] Assuming that the current is delivered successfully and the stimulation duration counter has expired, the controller software transitions to the COMPLETE state, where current delivery is stopped. Generally, the software then transitions from the COMPLETE state to the OFF state after a predetermined period of time.

[0114] After a stimulation session is complete, or after the user has finished using the device, the device may be cleaned by the following process or an equivalent process: 1) Rinse mouthpiece 100 in cold water for about 30 seconds; 2) (Occasionally, 2-4 times a month) Gently scrub the mouthpiece 100 with a toothbrush using a mild detergent (e.g., dish soap or hand soap), then rinse the mouthpiece 100 with water to remove the soap; and 3) Allow to air dry (for example, by supporting it on a stand 400).

[0115] In addition, or alternatively, the mouthpiece may be placed in a denture cleaning solution for up to 30 minutes occasionally or regularly.

[0116] However, if there is an interruption in current delivery during the RUN state, as determined by monitoring the channel current and / or voltage of one or more channel combinations over a certain period of time (e.g., indicating that the device 10 may have been removed from the user's mouth) (e.g., no current is delivered across all active channels for 2 seconds), the software transitions to the OPEN state, thereby pausing the stimulation duration timer. If current delivery resumes within a predetermined time period (e.g., before the expiration of the counter set in the programmed INACTIVITY_DURATION_OPEN parameter), as determined by monitoring the channel current and / or voltage of one or more channel combinations, the software returns to the RUN state, resumes current delivery to the activated channels, and restarts (but does not reset) the paused stimulation duration timer. If current delivery is not resumed within a predetermined time period (e.g., not before the expiration of the counter set in the programmed INACTIVITY_DURATION_OPEN parameter), as determined by monitoring the channel current and / or voltage of one or more channel combinations, the software returns to the OFF state.

[0117] Furthermore, during the RUN state, operational failures such as effectiveness (undercurrent) failures and overcurrent failures may occur, causing the controller software to transition to a failure state in which current delivery is stopped, and the controller 300 provides a visual and / or audible indication. An effectiveness failure may occur for a predetermined programmable time (MIN_CURRENT_TIM, e.g., 30 seconds) if the total current delivered across all active electrode channels is less than a predetermined programmable percentage (MIN_CURRENT_PERCENT, e.g., 75% (75%)). Thus, using exemplary parameter values, if four channels are active and the target current delivery is 125 μA / channel, an effectiveness failure will occur for more than 30 seconds if the total current delivered falls below 375 μA (125 μA / channel × 4 channels × 0.75), as determined by monitoring the channel currents of all active channels. An overcurrent fault may occur when the current being delivered in any channel exceeds a predetermined level (e.g., about 200 μA), as determined by monitoring the current level of each channel, or at one of the programmable parameters, such as a percentage of a programmable target current level (e.g., 110% of the programmed target current level). The FAULT condition is preferably required to terminate user intervention and return to the OFF state, which may require pressing button 306 (or a virtual button) for a predetermined time, such as 3 seconds.

[0118] The CHARGING state is transitioned each time the controller 300 interfaces with a charging stand supplied in any state except FAULT (preferably with current delivery to the electrode channels disabled). If the controller 300 is placed on the charging stand 400 in the FAULT state, it is in the FAULT state and preferably allows battery charging. If the controller 300 is removed from the charging stand 400, it is not automatically exited from the FAULT state if it was in the FAULT state. Rather, the FAULT state remains and preferably requires user intervention, for example, by pressing button 306 (or a virtual button) for a predetermined time such as 3 seconds, or to exit to return to the OFF state.

[0119] Other states besides those shown in Figure 11 (such as the LOW BATTERY state, CRITICAL BATTERY state, and SERVICE state) may be defined and used. The circuit monitors the voltage available in battery 302. In the LOW and CRITICAL BATTERY states, electrical current delivery is deactivated, and the user is informed of the battery state through visual and / or audible indicators. The LOW BATTERY state may be entered when the user attempts to transition to the RUN state and the voltage of battery 302 is below a first predetermined battery RMS value (e.g., 3.5 volts). The LOW BATTERY state may also be entered during the transition between the RUN and COMPLETE states, when the voltage of battery 302 is below a second predetermined battery RMS value (e.g., 3.6 volts), preferably higher than the first predetermined battery RMS value. The CRITICAL BATTERY state is entered into all states except the FAULT state, preferably when the voltage of battery 302 is below a predetermined value (e.g., 3.1 volts) lower than the LOW BATTERY predetermined value. This allows event logging to non-volatile memory before the microprocessor brownout, enabling a controlled shutdown of the system. If the controller 300 is powered off (for example, by pressing button 306 for a predetermined time), it is preferable to power it on again following that same state if it is in a CRITICAL BATTERY state and is not placed on the charger 400.

[0120] The SERVICE state is transitioned through the use of a wireless communication device application communicating with the controller 300, allowing parameters to be programmed through a user interface. The SERVICE state can be transitioned from any of the READY, CHARGING, or FAULT states. The SERVICE state can provide the following functions: Display and modification of programmable parameters (e.g., those shown in Figures 12A-B); The controller 300 provides a display of counter values ​​(for example, one or more counters as shown in Figures 13A-B); Resetting one or more counter values ​​on the controller 300 (and / or archiving counter labels and values ​​on the paired wireless communication device during or after pairing); The controller 300 provides a display of the event log (for example, one or more events as shown in Figure 14); Clear the event log; clear one or more events from the controller 300 from the event log (and / or archive the event log on the paired wireless communication device during or after pairing); and / or A non-destructive, preferably authenticated, update of the firmware on the controller 300.

[0121] Furthermore, the controller 300 may be placed in an END OF LIFE, non-stimulatory state when an event occurs, when a certain number of events have been counted (e.g., number of charges, number of stimulations), or when a predetermined running time has expired, preferably when the running time (e.g., total running time) is 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 may display an indication of the state (e.g., flashing light color or pattern) or automatically communicate the state directly to the charger 400 or a wider wireless network, but stimulation may not be activated.

[0122] Once data is acquired from the controller 300, it may be transmitted manually or automatically across the wireless network by a wireless communication device, stored remotely, and associated with a remote data storage device networked with the wireless communication device (such as cloud storage or a remote server, which may be associated with the manufacturer and / or seller's equipment 10, caregivers (e.g., dentists, hygienists, administrative staff), insurance companies, or users (or the user's guardians)).

[0123] If the user has completed any of the above tasks (i.e., if the user wants to exit the SERVICE state), the user can do so by using an application on a mobile wireless device. From the SERVICE state, the controller transitions to READY if the device 10 is not on an active charger 400, to CHARGING if it is on an active charger 400, and to FAULT if the SERVICE state has transitioned from the FAULT state.

[0124] Prevention of systemic diseases The mouthpiece according to the present invention is envisioned to be used to prevent or treat systemic diseases, as will be outlined in more detail below. The method according to the present invention has been shown to be effective in reducing the amount of oral bacteria, specifically F. nucleatum, P. gingivalis, and S. oralis.

[0125] 1.Cardiovascular disease The use of the mouthpiece according to the present invention is envisioned to reduce the microbial load caused by the translocation of oral bacteria, including but not limited to S. oralis, P. gingivalis, and F. nucleatum, from gingival tissue to the rest of the body, and to reduce the amount of inflammatory mediators produced by oral bacteria. Furthermore, by reducing F. nucleatum, the ability of P. gingivalis to invade host cells is reduced, and therefore, the incidence of bacteremia, which has been associated with the development / exacerbation of atherosclerosis and coronary heart disease, is envisioned to decrease.

[0126] The mouthpiece according to the present invention is intended to be used to prevent, treat, and / or alleviate cardiovascular disease in accordance with a predetermined stimulation prescription plan. In the predetermined stimulation prescription plan, the patient would wear the mouthpiece according to the present invention at a predetermined current level for a predetermined period of time at predetermined time intervals. It is further intended that the specific stimulation prescription plan may be determined based on the bacterial level present in the patient. According to one embodiment of the present invention, the stimulation prescription plan would consist of the patient wearing the mouthpiece according to the present invention once a day for 20 minutes at a current level of 500 microamperes. In the case of an acute cardiovascular condition, this stimulation may be continued daily until the condition is resolved. In the case of chronic cardiovascular disease, this stimulation may be repeated continuously several times a week.

[0127] 2. Stillbirth It is further assumed that stimulation sessions with the mouthpiece according to the present invention, in accordance with a predetermined stimulation protocol, will reduce the oral population of F. nucleatum associated with periodontal disease, and thus prevent, treat, and / or mitigate stillbirth. This reduction will then reduce the likelihood of F. nucleatum translocating from the oral cavity into the bloodstream and from there migrating to the placenta to form colonies. It is assumed that the mouthpiece according to the present invention may be used to prevent stillbirth in accordance with a predetermined stimulation prescription plan. In a predetermined stimulation prescription plan, the patient would wear the mouthpiece according to the present invention at a predetermined time interval, at a predetermined current level, for a predetermined time. It is further assumed that a specific stimulation prescription plan may be determined based on the bacterial levels present in the patient. According to one embodiment of the present invention, a stimulation prescription plan would consist of the patient wearing the mouthpiece according to the present invention once a day for 20 minutes at a current level of 500 microamperes during pregnancy. The stimulation parameters outlined above have been demonstrated to be highly efficient in reducing the levels of S. oralis and F. nucleatum at an inoculation size of 10^7 colony-forming units (CFU).

[0128] 3. Diabetes It is envisioned that, according to a predetermined stimulation protocol, the mouthpiece according to the present invention may be used to prevent, treat, and / or alleviate diabetes by reducing S. oralis in the oral cavity and consequently reducing the amount of serum inflammatory markers produced by bacterial infection. In a predetermined stimulation prescription plan, the patient would wear the mouthpiece according to the present invention at a predetermined time interval for a predetermined period of time at a predetermined current level. It is further envisioned that a specific stimulation prescription plan may be determined based on the bacterial levels present in the patient. According to one embodiment of the present invention, a stimulation prescription plan would consist of the patient wearing the mouthpiece according to the present invention once a day for 20 minutes at a current level of 500 microamperes to effectively reduce the oral level of S. oralis and thereby reduce the amount of systemic inflammatory markers. This stimulation may be repeated several times a week to help reduce inflammatory markers.

[0129] 4. Suppurative liver abscess It is envisioned that, according to a predetermined stimulation protocol, the mouthpiece according to the present invention may be used to prevent, treat, and / or alleviate suppurative liver abscesses by reducing F. nucleatum. Specifically, it is envisioned that a stimulation session with the mouthpiece according to the present invention may reduce bacterial levels, prevent F. nucleatum and other oral bacterial species from migrating to the liver, and reduce overall bacteremia. In a predetermined stimulation prescription plan, the patient would wear the mouthpiece according to the present invention for a predetermined time, at a predetermined current level, at predetermined time intervals. It is further envisioned that a specific stimulation prescription plan may be determined based on the bacterial levels present in the patient. According to one embodiment of the present invention, a stimulation prescription plan may consist of the patient wearing the mouthpiece according to the present invention once a day for 20 minutes at a current level of 500 microamperes to effectively reduce oral levels of F. nucleatum and prevent any bacteria from being transported systemically from the oral cavity. This stimulation may be repeated several times a week until the abscess is reduced.

[0130] 5. Osteomyelitis It is envisioned that, according to a predetermined stimulation protocol, the mouthpiece according to the present invention may be used to prevent, treat, and / or alleviate osteomyelitis by reducing F. nucleatum. In a predetermined stimulation prescription plan, the patient would wear the mouthpiece according to the present invention at a predetermined time interval for a predetermined period of time at a predetermined current level. It is further envisioned that a specific stimulation prescription plan may be determined based on the bacterial levels present in the patient. According to one embodiment of the present invention, a stimulation prescription plan would consist of the patient wearing the mouthpiece according to the present invention at a current level of 500 microamperes for 20 minutes per stimulation session to effectively reduce oral levels of F. nucleatum bacteria and prevent the systemic transport of any bacteria from the oral cavity. This stimulation may be used in conjunction with or separately from standard antibiotic-based treatment for osteomyelitis. When used in conjunction with antibiotics, stimulation sessions would typically occur within a period of 29 to 42 days. When used separately from antibiotics, this stimulation may be used once a day for several months for acute conditions, or continuously several times a week for chronic conditions.

[0131] 6. Arthritis It is envisioned that, according to a predetermined stimulation protocol, the mouthpiece according to the present invention may be used to prevent, treat, and / or alleviate arthritis by reducing F. nucleatum. In a predetermined stimulation prescription plan, the patient would wear the mouthpiece according to the present invention at a predetermined time interval for a predetermined period of time at a predetermined current level. It is further envisioned that a specific stimulation prescription plan may be determined based on the bacterial levels present in the patient. According to one embodiment of the present invention, a stimulation prescription plan would consist of the patient wearing the mouthpiece according to the present invention once a day for 20 minutes at a current level of 500 microamperes to effectively reduce oral levels of F. nucleatum bacteria, prevent any bacteria from being transported from the oral cavity and translocating to the synovial fluid, and reduce associated inflammation. This stimulation may be repeated continuously several times a week for this type of chronic condition.

[0132] Reduce biofilms and prevent biofilm formation. It is envisioned that, according to a predetermined stimulation protocol, the mouthpiece according to the present invention can be used to prevent, treat, and / or reduce oral biofilms, since all of these are involved in oral biofilm formation, by reducing F. nucleatum, P. gingivalis, and / or S. oralis. In a predetermined stimulation prescription plan, the patient would wear the mouthpiece according to the present invention at a predetermined time interval for a predetermined period of time at a predetermined current level. It is further envisioned that a specific stimulation prescription plan may be determined based on the bacterial levels of specific bacterial species present in the patient. According to one embodiment of the present invention, a stimulation prescription plan would consist of the patient wearing the mouthpiece according to the present invention once a day for 20 minutes at a current level of 500 μA to effectively reduce oral levels of F. nucleatum bacteria, prevent further biofilm formation caused by F. nucleatum, and reduce the viability of existing F. nucleatum biofilm colonies.

[0133] According to another embodiment of the present invention, the stimulation prescription plan would consist of the patient wearing a mouthpiece according to the present invention once a day for 20 minutes at a current level of 50 μA to effectively reduce oral levels of P. gingivalis bacteria, prevent further biofilm formation caused by P. gingivalis, and reduce the viability of existing P. gingivalis biofilm colonies.

[0134] Furthermore, according to another embodiment of the present invention, the stimulation prescription plan would consist of the patient wearing the mouthpiece according to the present invention once a day for 20 minutes at a current level of 500 μA to effectively reduce oral levels of S. oralis bacteria, prevent further biofilm formation caused by S. oralis, and reduce the viability of existing biofilm colonies of S. oralis.

[0135] These stimulation sessions for biofilm reduction and prevention may be repeated daily for 3 to 6 weeks for acute biofilm-based problems, or continuously at least once a week for chronic biofilm problems.

[0136] Treatment and / or prevention of peri-implantitis Peri-implantitis is generally inflammation of oral tissues that are in physical contact with, surrounding, or otherwise near a dental implant after the placement of a dental implant. This inflammation can be reduced or prevented using the methods according to the present invention. The methods can be performed before and / or after dental implant surgery, such as the placement or replacement of a dental implant.

[0137] A method to reduce the likelihood of peri-implantitis involves applying or directing an electric current to the gingival tissue near or at the oral site of the future implant placement before the dental implant is placed or replaced, in whole or in part. The current may be distributed to other parts of the oral tissue, but at least 6 microamperes, more preferably at least about 50 microamperes (preferably 300 microamperes or less), is delivered to the gingival tissue near or at the designated oral site of the future implant placement. The preoperative stimulation plan may consist of about 20 minutes of electrical stimulation per day for 1 to 14 days prior to the dental implant surgery.

[0138] A method to reduce the likelihood of peri-implantitis (if peri-implantitis has not yet begun) or to reduce peri-implantitis (if peri-implantitis has already begun) includes applying or directing an electric current to the gingival tissue near or at the oral site of implantation after the dental implant has been placed or replaced, in whole or in part. The current may be distributed to other parts of the oral tissue, but at least 6 microamperes, more preferably at least about 50 microamperes (preferably 300 microamperes or less), is delivered to the gingival tissue near or at the designated oral site of implantation. The postoperative stimulation regimen may consist of about 20 minutes of electrical stimulation per day for 1 to 14 days after the dental implant surgery, or may be continued until the desired reduction in inflammation occurs.

[0139] While pre- and post-operative methods have been described separately for clarity, it should be understood that either or (preferably) both methods may be applicable to certain patients or mouthpiece users.

[0140] As briefly stated above, the controller 300 and the charging station 400 (or other electronic devices) have the ability to transfer data between them via a wireless communication system such as Bluetooth, BLE, or NFC technology. Preferably, one or both of the controller 300 and the charging station 400 have the ability to transfer data automatically (e.g., periodically, at predetermined times of the day, and / or when the controller 300 becomes in use or inactive) and / or manually to remote (e.g., cloud) storage. As seen in Figures 17A and 17B, this data transfer system 500 preferably allows the manufacturer, clinician, and user / patient to access the data recorded from the controller 300 and / or charging station 400.

[0141] The data transfer system 500 may take the form of the embodiment shown in Figure 17A. The controller 300, which records metrics and data related to the patient use of the stimulator 10, preferably includes local storage 512 for internally storing the metrics and data over a period of time. As described above, when the controller 300 is docked to (or near) the charging station 400, the metrics and data are preferably wirelessly transferred to the charging station 400 to local storage 522, etc. Wireless transmission is preferably achieved through the use of Bluetooth and / or BLE technology, but can also be achieved through infrared communication, radio, microwave communication, Wi-Fi, LoRa, Wi-Fi HaLow, Z-Wave, IEEE 802.15.4-based formats, or any other wireless communication system.

[0142] According to various embodiments of the data transfer system 500, the collected metrics and data stored in the charging station 400 are further transferred to a remote server and / or a database cloud storage system 540. This transfer can be achieved through multiple means.

[0143] For example, device 10 or charging station 400 may use LoRa wireless communication to connect to an LPWAN (or LoRaWAN) gateway 530. LoRa uses a license-free sub-gigahertz radio frequency band to enable long-distance transmission with low power consumption. The LPWAN gateway operates similarly to a Wi-Fi router, receiving RF signals into a LoRa concentrator, which then converts the signals into server-compatible signals (such as Wi-Fi signals) to transmit data to the internet. In other words, the LPWAN gateway enables RF-enabled devices to transfer information to an internet cloud server. The LPWAN gateway can also convert Bluetooth or BLE signals in much the same way. Thus, charging station 400 may use LoRa and / or BLE to transfer metrics and data to the LPWAN gateway 530, which then passes the metrics and data to a cloud storage system 540 on the internet. Examples of devices that can function as an LPWAN gateway include the Amazon Echo system, the Amazon Alexa system, and the Ring home security system using the Amazon Sidewalk network. Other Internet of Things (IoT) devices can also function as LPWAN gateways.

[0144] Alternatively, device 10 or charging station 400 may transfer data directly to cloud storage system 540 using wireless communication, Wi-Fi, and / or a Helium network.

[0145] Data transfers from device 10 for external storage may occur substantially periodically, automatically when data changes, or in response to requests from wireless communication devices. For example, device 10 may periodically broadcast a flag (e.g., in a BLE advertising packet) indicating that a data transfer should be performed. The data transfer may be a full data transfer or a summary data transfer. A full data transfer may be indicated as available in one of the broadcast flags. A full data transfer includes the transmission of predetermined data from device 10, which comprises 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 sending from the device 10 the serial number assigned to the device, all other parameter identifiers and / or values ​​(see, for example, Figures 12A and B), all event log entries not previously sent in the data transfer (see, for example, Figure 14), and all counter identifiers and / or values ​​(see, for example, Figures 13A and B).

[0146] Summary data transfer may be indicated by a single broadcast flag, or alternatively by performing a logical OR of multiple broadcast flags. As described above, separate flags may be used to indicate changes in each of the following counters identified in Figure 13A: 1 (manual power on), 5 (critical battery power off), 8 (treatment initiated), 9 (successfully completed treatment), 10 (open circuit), 11 (low battery), 12 (fault), and 13 (effectiveness fault). Summary data transfer preferably involves transmitting less information than full data transfer, and preferably includes transmitting at least one of the serial number assigned to device 10, parameter values, event log entries, and / or counter values. More preferably, summary data transfer includes sending from the device the serial number assigned to device 10, all counter identifiers and / or values ​​(see, for example, Figures 13A and B) for each of the following counters indicated by the broadcast flag as having been modified: 1 (manual power on), 5 (critical battery power off), 8 (treatment initiated), 9 (successfully completed treatment), 10 (open circuit), 11 (low battery), 12 (fault), and 13 (effectiveness fault).

[0147] Once transferred to the cloud storage system 540, data and metrics from either or both the controller 300 and / or the 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 may be any quantitative storage-enabled service such as Amazon Web Services, IBM Cloud Storage, Microsoft OneDrive, or Apple iCloud. Metrics and data transferred to and stored in the cloud storage system 540 may include treatment data, device health metrics, and location data. Meanwhile, the cloud storage system 540 may automatically or via queries send firmware updates, diagnostics, and / or data queries for the stimulator 10 and / or charging stand 400.

[0148] Preferably, the manufacturer of the stimulator 10, the clinician, and the user / patient can each access and analyze the metrics and data stored in the cloud storage system 540. Access may be permitted through an account in the shared cloud storage system 540 and / or by scanning a special code (i.e., a quick response (QR) code). The manufacturer, clinician, and user / patient can each preferably access the cloud storage system 540 via Wi-Fi or LAN through a desktop or mobile system.

[0149] In another embodiment of the data transfer system 500 according to the present invention, the charging station 400 is not required to achieve the desired metrics and data transfer. In this embodiment, device 10 preferably includes RF functions such as BLE technology, LoRa technology, or other RF functions including mesh networking technologies such as Z-Wave, Zigbee, SigFox, Helium, Wi-Fi HaLow, IEEE 802.15.4, or optionally Thread. Device 10 may preferably interface directly with the LPWAN gateway 530 (or other electronic device) to transfer metrics and data to the cloud storage system 540 without the additional step of transfer via the charging station 400. Such other electronic devices may include portable mobile devices such as mobile phones or tablet computers, devices with Thread border routers, devices with Wi-Fi access points, devices with Zigbee coordinators, devices with Matter controllers, or devices with IEEE 802.15.4 coordinators. Alternatively, device 10 may connect directly to the cloud storage system 540, at least partially utilizing the RF functionality or other networking capabilities described above. The metrics and data can then be used by the manufacturer, clinicians, and / or users / patients in much the same manner as described above.

[0150] In the embodiment of the data transfer system 500 described above, the metrics and data transferred from either or both of the controller 300 and the charging station 400 to the cloud storage system 540 may be one or all of the following: - Current date and time - Device identification information - Complete event log of controller 300, including events as shown in Figure 14. - Controller parameters before, during, and after use of each device 10, such as those shown in Figures 12A and 12B. - Controller counters such as those shown in Figures 13A and 13B - The state of the device 10 as shown in Figure 11. - Firmware version of each controller 300 used - Notable events (defined as the start or stop of treatment, or the device 10 entering a default state, low battery state, or critical battery state) - Serial number of Controller 300 - Event log for Charging Station 400 - Location and status of charging station 400 - BLE advertising data and RSSI of any nearby controller 300 - BLE advertising data and RSSI of any nearby BLE device

[0151] The transmitted metrics and data are preferably stored indefinitely on the cloud storage system 540, or at least for a period sufficient to analyze the data for any reason. To protect the confidentiality of the data, multiple copies of the transmitted data may be stored. For example, to analyze more sensitive data, multiple levels of security may be required to access it. However, for more general or anonymized information, the data may be mixed with data from other stimulators 10 or otherwise accessible with fewer restrictions.

[0152] The foregoing should be considered only as illustrative examples of the principles of the present invention. Furthermore, since numerous modifications and changes will be readily conceivable to those skilled in the art, it is not desirable to limit the present invention to the exact structures and operations shown and described. While preferred embodiments have been described, details can be modified without departing from the present invention.

Claims

1. A data transfer system comprising an oral apparatus having a controller coupled to a mouthpiece, wherein the controller records data relating to at least one of the operation of the oral apparatus, information received from one or more secondary electronic devices, and environmental parameters monitored by the oral apparatus or the one or more secondary electronic devices, and is configured to wirelessly transmit the recorded data substantially periodically, automatically in response to changes in the data, 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 a charging station configured to recharge a rechargeable battery in the oral appliance, a handheld mobile device, an LPWAN gateway, a device comprising a Threed border router, a device comprising a Wi-Fi access point, a device comprising a Zigbee coordinator, a device comprising a Matter controller, and a device comprising an IEEE 802.15.4 coordinator.

3. The system according to claim 1, wherein the controller is configured to generate a display of changes in the recorded data, and the wireless communication device is configured to receive the display from the controller by a first wireless communication, transmit a request for the data to the controller by a second wireless communication, receive the recorded data from the controller by a third wireless communication, and relay the data to a communication network for remote storage.

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

5. A system according to 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 (BLE) communication, Wi-Fi communication, LoRa / LoRaWAN communication, and communication compliant with IEEE standard 802.15.

4.

6. The system according to claim 3, wherein the relay 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 according to claim 7, wherein the relay communication includes at least one of Bluetooth communication and LoRa communication.

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

10. A data transfer system according to claim 3, wherein the display is a plurality of bits of digital data.

11. A data transfer system according to claim 10, wherein the change in data is at least one of the following: an increase in the treatment start counter, an increase in the treatment stop counter, an increase in the open circuit counter, an increase in the effectiveness failure counter, an increase in the failure counter, an increase in the low battery counter, an increase in the critical battery counter, the passage of time for complete data transfer, the current time status of the controller, the controller charging status, and an increase in the manual power-on counter.

12. A data transfer system according to claim 3, wherein the first wireless communication includes a Bluetooth advertising packet.

13. A method comprising the steps of: recording data on an electronic device configured to be supported by a mouth, relating to the operation of the electronic device, information received from one or more secondary electronic devices, and at least one of environmental parameters monitored by the electronic device or the one or more secondary electronic devices; and wirelessly transmitting the recorded data substantially periodically, automatically in response to changes in the data, and in response to a request from a wireless communication device.

14. A method according to claim 13, wherein the wireless communication device is selected from the group consisting of a charging station configured to recharge a rechargeable battery in the electronic device, a handheld mobile device, an LPWAN gateway, a device comprising a Threed border router, a device comprising a Wi-Fi access point, a device comprising a Zigbee coordinator, a device comprising a Matter controller, and a device comprising an IEEE 802.15.4 coordinator.

15. A method according to claim 13, wherein the electronic device is configured to generate a display of changes in the recorded data, and the wireless communication device is configured to receive the display from the electronic device by a first wireless communication, transmit a request for the data to the electronic device by a second wireless communication, receive the recorded data from the electronic device by a third wireless communication, and relay the data to a communication network for remote storage.

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

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

18. A method according to claim 17, wherein the network communication includes information relating to the other wireless communication device, the information including at least one of a media access control (MAC) address, received signal strength indicator (RSSI), service set identifier (SSID), basic service set identifier (BSSID), system name, and serial number.

19. A method according to claim 18, further comprising the steps of: detecting nearby Wi-Fi networks and recording up to 10 network identifiers that show the highest RSSI; and at least one of the following: displaying and recording a first geographical change of the wireless communication device by comparing the recorded network identifiers with a list of previously recorded network identifiers, wherein 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 among the recorded network identifiers; and displaying and recording a second geographical change of the wireless communication device by comparing the RSSI values ​​of the recorded network identifiers with a list of RSSI values ​​of previously recorded network identifiers, wherein 20% to 50% of the RSSI values ​​of the recorded network identifiers have changed by about 3 to about 10 decibels (dB) compared with the RSSI values ​​of previously recorded network identifiers.

20. A method according to claim 13, wherein the electronic device has the ability to deliver electrical stimulation to the mouth, and the method further comprises the step of permanently disabling the electrical stimulation delivery ability of the electronic device after recording a predetermined number of minutes for which the electrical stimulation has been delivered, wherein the predetermined number of minutes is between 30,000 and 41,760.

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