Personal device and system for detecting volatile biomarker

Abstract

Describe is a device, such as a personal hygiene device, e.g., a toothbrush, having sensor or sensors capable of detecting a volatile or air-borne chemical, or a plurality or combination of chemicals, which produce a detectable odor or scent associated with a disease state or health condition of the individual. A system and method employing the device are also described.

Description

PERSONAL DEVICE AND SYSTEM FOR DETECTING VOLATILE BIOMARKERBACKGROUND OF THE INVENTION

[0001] Human-exhaled volatile organic compounds (VOCs) can be altered by different health conditions and become identifiable biomarkers. Certain health conditions or disease states in humans, such as cancer, have been associated with particular scents or odors which can be distinguished and detected.

[0002] Scientists have been interested in volatile organic compounds (VOCs) released by human bodies for more than five decades. In 1971 , Nobel Prize winner Linus Pauling revealed that breath is a complex mixture comprised of approximately 250 VOCs. In 1999, Phillips et al. detected over 3400 different volatile compounds in exhaled human breath. Metabolic processes of the human body produce these compounds; they enter the lungs via blood and are exhaled. Therefore, variations in exhaled breath compounds’ concentrations can be directly linked to a disease. For example, it is known that dogs, with their keen sense of smell, have been trained to associate a scent with a health condition and have shown remarkable abilities to detect various diseases, including cancer. However, training quality, environmental conditions, and other factors can affect the accuracy of scent detection and disease identification using dogs.

[0003] Many bacteria and fungi can contribute to volatile organic compounds (VOCs) and halitosis. For example, certain anaerobic gram-negative bacteria: Fusobacterium nucleatum can produce hydrogen sulfide (H2S). Prevotella intermedia produces H2S and methyl mercaptan. Porphyromonas gingivalis is associated with gum disease also produces H2S. Anaerobic grampositive bacteria, such as Peptostreptococcus spp. can produce H2S, indole, and skatole. Tannerella forsythia, which is involved in gum disease, produces H2S, and aerobic gram-positive bacteria, such as Streptococcus spp., while not major VOC producers, contribute to oral biofilm formation, indirectly aiding other bacteria.

[0004] Fungus producing VOCs include Candida albicans which can contribute to halitosis, especially in immunocompromised individuals, by producing acetaldehyde and other odorous compounds.

[0005] Efforts have been made to develop electronic sensing devices (“electronic noses”) that can replicate or assist in scent detection capabilities of dogs or other animals having highly sensitive olfactory senses. Systems and methods for a mobile electronic system that gathers and analyzes odors, airborne chemicals and / or compounds are described in US PublishedPatent Application No. US 2020 / 0183925. Electronic noses are equipped with sensors that can detect and measure various chemical compounds present in a scent. These technologies, in tandem with Artificial Intelligence (Al) and machine learning, are applied in fields such as food and beverage quality control, environmental monitoring, and industrial processes, and aim to provide a more standardized and accessible approach to scent-based disease detection.

[0006] Algorithms have been developed to analyze sensor data and identify specific scents or patterns. Machine learning techniques train Al models to recognize and distinguish between different scents. By using labeled scent data, Al models can learn to associate specific patterns or features with different smells. Machine learning and Al algorithms can be applied to Gas Chromatography-Mass Spectrometry (GC-MS) or other chemical analysis techniques to analyze the chemical composition of scents and identify specific odorants or chemical signatures associated with different smells. This approach has been used in fragrance development, where Al models are trained on large databases of scent molecules to generate new fragrance combinations.

[0007] By integrating data from different modalities, Al algorithms can enhance scent analysis and improve the accuracy of scent identification and classification, including early detection of disease states or health conditions in humans, all in a non-invasive manner.

[0008] What is needed or desired is a simple and frequently used (e.g., daily, weekly, or monthly) device having one or more sensors incorporated in the device such that the device or sensor is capable of detecting a volatile or air-borne chemical or a plurality or combination of chemicals that produce a detectable odor or scent corresponding to a disease state or health condition.

[0009] What is further needed or desired is a simple device which is frequently used by an individual and has incorporated therein one or more sensors capable of employing or connectable to artificial intelligence (Al) or machine learning sources to improve the sensitivity, accuracy, and reliability of the data collected by the sensors.

[0010] In view of the cost and potential radiation exposure of currently available diagnostic examinations, what is needed and desired in the health field is an effective, radiation-free, and less invasive approach for detecting disease screening can be established by personal devices.

[0011] These and other needs and desires are met by the device, system, or method of the subject invention described and illustrated herein.BRIEF SUMMARY OF THE INVENTION

[0012] The subject invention concerns a device useable by an individual, the device comprising at least one sensor capable of detecting a volatile or air-borne chemical, or a plurality or combination of chemicals, which produce a detectable odor or scent associated with a disease state or health condition of the individual.

[0013] The subject invention concerns a device useable by an individual, the device comprising at least one sensor capable of detecting a volatile or air-borne chemical, or a plurality or combination of chemicals capable of detecting pre-concentrated target airborne biomarkers with high sensitivity and specificity.

[0014] The subject invention concerns a device that can achieve detection capable of detecting a volatile or air-borne chemical, or a plurality or combination of chemicals in the parts-per-bi Ilion (ppb) and parts-per-trillion (ppt) range when diluted by ordinary air and when the level of dilution depends on factors like breathing rate, tidal volume, and the presence of interfering substances.

[0015] The subject invention further concerns a system whereby the device used by the individual is connectable to a computer or program running an Artificial Intelligence (Al) algorithm or machine learning program which monitors the individual’s scent over time, and can detect, record, and track changes in scent for assessing the health and well-being of the individual. The Al and machine learning capability can improve sensitivity, accuracy, and reliability of the sensor over time.

[0016] The device used in the system can be a “smart” device, meaning that it is connectable to a database, e.g., through the internet or cell phone network, where the data collected by the one or more sensors can be analyzed using a smartphone application (app) or accessed by a healthcare expert, such as a physician, for analyzing the data and diagnosing the health of the individual, including diagnosing a disease state in the individual.

[0017] A method for monitoring the health status of an individual by detecting an odor or scent emitted from the individual or detecting changes in the body chemistry of the individual, wherein the odor or scent is a biomarker for a disease or other health condition and can be used to identify or diagnose a disease or health condition in the individual, is also considered part of theinvention. The results of the monitoring of health status and condition can be used to provide personalized health recommendations or trigger alerts of medical conditions.

[0018] Examples of a device in accordance with the subject invention include, but are not limited to, a toothbrush, toothpaste tube / container, floss container, razor, hairbrush or comb, tongue cleanser, hand-held mirror, or the like, or a personal accessory worn by an individual, such as a smartwatch, bracelet, pendant or necklace, eyeglass frames, or the like, wherein a sensor for detecting an odor or scent is disposed onto or integrated into such a device. The device can include a microprocessor, i.e., an integrated circuit, capable of processing data received from the one or more sensor.

[0019] Such a device can be advantageous because it can be used without disruption of the individual’s routine habits, allowing the individual to manage their health, in real-time, through detection of airborne biomarkers in their breath or personal odor cloud while brushing their teeth, combing their hair, or the like. The personal aspect of the device also prevents generalization of data that may be affected by individual differences in body chemistry or metabolism, allowing the Al and machine learning to interpret results personally suited to the individual user.

[0020] In use, exhaled breath or personal skin odor cloud or scent of an individual can contact a receptor site of a sensor integrated within the device, whereby detection of presence of an airborne biomarker molecule can activate a microchip and is guided through a microfluidic circuit, which is reported to a smartphone app and management system where the data can be stored or utilized for analysis and evaluation. Cleaning of the device and sensor can reset the sensor for subsequent use and detection. In one preferred embodiment, the sensor chip is included in a single-use, replaceable component of the device, such as a replaceable toothbrush head.

[0021] One embodiment exemplifying a device of the invention is a rechargeable electric toothbrush comprising a sensor which can detect an airborne or volatile scent wherein the sensor data is processed using a microchip programmed to perform as an electric nose which can distinctly identify a biomarker for a disease state such as cancer, e.g., oral cancer.

[0022] The toothbrush can provide direct feedback to the user, e.g., incorporating a visual display or audio or voice signal for delivering information alerting the user that a biomarker of interest is detected. Alternatively, the toothbrush can be included in a system according to the invention, whereby sensor-collected data is communicated to a remote database for analysis. For example, the toothbrush can communicate sensor-collected data via internet connectionwhich can be wired or wireless, e.g., via a wired or wireless modem or cell phone connection, by infrared or Bluetooth connection, or the like. The internet connection can be integrated into a handle of the toothbrush or into a recharging base for the rechargeable electric toothbrush.

[0023] It would be readily understood that the sensor and information communication features, such as direct feedback or internet connection, or both, described for the toothbrush and toothbrush system can be employed in other devices and systems, including personal hygiene devices, such as a toothbrush, toothpaste tube / container, floss container, razor, hairbrush or comb, tongue cleanser, hand-held mirror, or the like, or can be integrated into an accessory worn by the individual, such as on eyeglass frames (prescription glasses, readers, or sunglasses), a smartwatch, bracelet, ring, necklace or pendant, or the like.BRIEF DESCRIPTION OF THE DRAWINGS

[0024] FIG. 1 shows a toothbrush device according to the subject invention, illustrating an embodiment comprising a replaceable brush head having a microprocessor disposed therein, and further comprising a scent sensor.

[0025] FIG. 2 shows a toothbrush embodiment of a device according to the subject invention, illustrating the sensor receiving the airborne or volatile chemicals or particles for analysis.

[0026] FIG. 3 is a block diagram showing an embodiment of a system according to the subject invention.

[0027] FIG. 4 is a depiction of various personal care products that can include a microchip and sensor for detecting airborne or volatile biomarkers according to the invention, and illustrates wireless connectivity to an app downloaded to a mobile communication device, such as a cell phone.DETAILED DESCRIPTION OF THE INVENTION

[0028] The subject invention concerns a device useable by an individual comprising at least one sensor capable of detecting a volatile or air-borne chemical, or a plurality or combination of chemicals, which produce a detectable odor or scent associated with a disease state or health condition of the individual. For example, a device of the invention can be a smart toothbrush comprising a sensor capable of sensing an airborne particle of volatile chemical associated with a scent. The device further comprises a microprocessor, also termed a “microchip” or “chip,” in communication with the sensor, for processing scent data received by the sensor.

[0029] The subject invention concerns a device useable by an individual comprising at least one sensor capable of detecting a volatile or air-borne chemical concentration levels in the range of parts per million (1 -999 ppm) by volume. More preferably, the subject invention concerns a device usable by an individual comprising at least one sensor capable of detecting a volatile or air-borne chemical concentration levels in the range of parts per billion (1 -999 ppb) by volume.

[0030] The sensor and microprocessor can be programmed to process scent data in a manner mimicking the mammalian olfaction process. Advantageously, an airborne sensor and microchip are small and lightweight, facilitating their integration into or onto a personal hygiene device, such as a toothbrush, toothpaste tube / container, floss container, razor, hairbrush or comb, tongue cleanser, hand-held mirror, or the like, or can be integrated into an accessory worn by the individual, such as on eyeglass frames (prescription glasses, readers, or sunglasses), a smartwatch, bracelet, ring, necklace or pendant, or the like.

[0031] In one embodiment, the sensor and microprocessor can be incorporated into or affixed to a handle of an implement used by a health care provider, such as a nurse, physician, dental hygienist or dentist. This embodiment can be particularly advantageous for dental implements or tools due to the dental professional’s access and working proximity to a patient’s oral cavity where breath and saliva can be easily sampled. For example, a sensor or microprocessor can be included in or on the handle area a low-speed handpiece used by a dental hygienist for removing plaque and tartar from teeth or for polishing teeth.

[0032] These dental low-speed handpieces utilize single use (attachable and detachable) prophylaxis cups, referred to as “prophy cups,” comprising antibacterial nanofibers prophylaxis paste. A sensor or microprocessor, preferably a waterproof sensor and microprocessor, can be included in or on these attachable and detachable single-use prophy cups. A prophy cup is a small, cup-shaped tool used by professional dental hygienist to remove plaque and tartar from the teeth. It is made of a variety of materials, including plastic, rubber, and metal. Prophy cups come in a variety of shapes and sizes. This use of a sensor and microprocessor in connection with a dental low-speed handpiece or prophylaxis cup can allow the dental professional to sense one or more biomarkers and regularly monitor a patient’s health over time by tracking levels of certain biomarkers of interest.

[0033] Airborne sensors and microchips are relatively inexpensive to manufacture and are readily available on the market. Airborne sensor microchips can be highly sensitive to odors, airborne chemicals, and volatile compounds, making them ideal for detecting small concentrations of airborne chemicals in exhaled breath, sweat and personal skin odor cloud.Such devices are advantageously relatively small, being able to be held in a hand of the user, lightweight, facilitating manipulation of the device, and portable, providing the user with the ability to carry the device from place to place as needed, such as during travel.

[0034] The airborne sensor microchip used in a device of the invention works by using a sensor array to measure the electrical response of different materials to airborne chemicals. The sensor array typically comprises a variety of different materials, each of which is sensitive to a different type of airborne scent molecule.

[0035] A microchip is used in a device of the invention to improve performance of the device in medical use. Coupled with Artificial Intelligence (Al) and machine learning capabilities, the microchip can also be used to improve the sensitivity and selectivity of the device. The microchip can be programmed to amplify the electrical signal from the sensor array, which improves the sensitivity of the device, and can be programmed to filter out unwanted signals, which improves the selectivity of the device.

[0036] Known microchips that can be used in a device of the invention are:Microfluidic Olfactory Sensor Arrays (MOSAs): MOSAs are microchips that use microfluidics to detect and identify odors. Microfluidics is a technology that uses small channels to control the flow of fluids. MOSAs use microfluidic channels to transport odorants to a sensor array. The sensor array measures the electrical response of the materials to the odorants. The data from the sensor array is then used to identify the odor.Quantum Dot Olfactory Sensors (QDOs): QDoS are microchips that use quantum dots to detect and identify odors. Quantum dots are tiny particles that can emit light when they are exposed to certain wavelengths of light. QDoS use quantum dots to detect the presence of odorants. The light emitted by the quantum dots is then used to identify the odor.Graphene Olfactory Sensors (GOSs): GOSs are microchips that use graphene to detect and identify odors. Graphene is a material that is made up of a single layer of carbon atoms. GOSs use graphene to detect the presence of odorants. The electrical response of the graphene is then used to identify the odor.

[0037] One embodiment exemplifying a device of the invention is a rechargeable electric toothbrush comprising a sensor which can detect an airborne or volatile scent wherein the sensor data is processed using a microchip programmed to perform as an electric nose which can distinctly identify a biomarker for a disease state such as cancer, e.g., oral cancer.

[0038] Compounds known to be associated with certain health conditions or disease include benzene, toluene, xylene, acetone, ethanol, and tumor associated proteins like alpha-fetoprotein (AFP), carcinoembryonic antigen (CEA), cancer antigen 125 (CA-125), squamous cell carcinoma antigen (SCCA), and prostate-specific antigen (PSA).

[0039] Tumor-associated DNA (tDNA) is DNA that is released from cancer cells into the bloodstream. This tDNA can be detected in the breath, and it has been linked to a number of different types of cancer. This includes Telomeric DNA, Microsatellite DNA, and Gene fusion DNA.

[0040] In certain embodiments, a device of the invention can further include sensors which detect physiologic parameters not associated with odors or scent. For example, “non-scent” sensors that can be incorporated into a device of the invention include:Temperature sensors, to measure the body temperature of a user of the device; Blood pressure sensors, to measure the blood pressure of a user of the device; Heart rate sensors, to measure the heart rate of a user of the device;Calorimeter, to measure caloric content or use;Oxygen sensors, to measure the oxygen concentration levels in the blood of a user of the device; andMotion sensors, to track the geographical location or movement of a user of the device.

[0041] Other sensors that can be used in connection with the identification of components of samples include chemical or biosensors that measure chemical or biological elements, such as enzymes, antibodies, or nucleic acids, to detect or measure the presence of a specific analyte in a sample. Analytes can be blood components, such as glucose, or can be microbes, such as bacteria or viruses for indicating infection. Still other sensors that can be used include: a conductivity sensor, an enzymatic sensor, an Enzyme-Linked Assay sensor, an infrared ( IR ) spectroscopy sensor, a Nuclear Magnetic Resonance ( NMR ) sensor , an optical sensor, a permittivity sensor, a gas sensor, a Radio Frequency (RF) sensor (including a multi - frequency RF sensor), a cantilever sensor, an acoustic wave sensor, a piezoelectric sensor, a responsive polymer based sensor, a quartz microbalance sensor, a metal oxide sensor , an X - ray Fluorescence ( XRF ) sensor, a nucleic acid-based sensor, or a regenerable sensor.

[0042] Sensor technologies also vary and are selected based on their capability, applicability, intended use, and desired target of detection. Examples of sensor technology include:■ Membrane-based sensors: These sensors use a thin membrane to detect airborne chemicals. The membrane is made of a material that is sensitive to airborne chemicals. When a chemical molecule binds to the membrane, it changes the electrical properties of the membrane. This change in electrical properties is then used to identify the airborne chemical;Conductive polymer sensors: These sensors use conductive polymers to detect airborne chemicals. Conductive polymers are polymers that can conduct electricity. When an airborne chemical molecule binds to a conductive polymer, it changes the conductivity of the polymer. This change in conductivity is then used to identify the airborne chemical;Field-effect transistors (FETs): FETs are transistors that can be used to detect airborne chemicals. FETs are made of semiconductor material. When an airborne chemical molecule binds to the semiconductor material, it changes the current flowing through the FET. This change in current is then used to identify the airborne chemical; andQuartz crystal microbalances (QCMs): QCMs are devices that can be used to detect airborne chemicals. QCMs are made of a quartz crystal. When an airborne chemical molecule binds to the quartz crystal, it changes the frequency of the crystal. This change in frequency is then used to identify the airborne chemical.

[0043] A sensor used in a device of the invention preferably includes a sensor array, which is the functional part of the microprocessor, and comprises a plurality of sensors, each sensitive to a different scent carried by the airborne chemicals. The sensors in the sensor array can be made of a variety of materials, such as metal oxide semiconductors, conductive polymers, or quartz crystal microbalances. In communication with the sensor array can be a signal processing unit to amplify and filter the signals received from the sensor array. The signal processing unit can also be used to perform calibration and data analysis. The signal processing unit can be either pre-defined, optimized or determined through machine learning.

[0044] A preferred sensor according to the invention employs additional systems in communication with the sensor, being either integral with the sensor or remote therefrom. These additional systems can include a data acquisition system to acquire the data from the signal processing unit. The data acquisition system can be a simple computer, smartphone, cloud server computer, or a more complex system that uses a data logger. Also in communication with the sensor, and either integral with or remote from the sensor is a data analysis system used to analyze the data from the data acquisition system. The data analysis system can be a simple software program or a more complex system that uses artificial intelligence and machine learning.

[0045] A device of the invention can also include a sample delivery component for delivering the airborne sample to the sensor or sensor array provided in the microchip. The sample delivery component can be a simple port allowing passive transport of the sample from the sensor to the microchip array, or can be a more complex system that uses a pump or valve to deliver the sample to the detector or processor.

[0046] Apparatuses or implements, systems, and methods are described herein for implementing the use of a device of the invention and are exemplified using an example of a smart toothbrush, which can provide sensing data on a periodic basis, e.g., daily, with daily toothbrushing, by gathering and analyzing airborne biomarker chemicals and compounds from exhaled breath, sweat and personal skin odor cloud. Referring to the smart toothbrush depicted in FIG. 1 , the toothbrush comprises a handle portion and a replaceable head portion. Preferably, the toothbrush head comprises bristles which are an antibacterial nanotechnology material.

[0047] Within the handle portion of the toothbrush is housed a sensor microchip serving to process information and data gathered by the sensor. The microchip can be capable of communicating with a database remote from the microprocessor, or integrated within the microprocessor such that information and data are processed as received from the sensor.

[0048] The sensor can be disposed within the handle portion of the toothbrush or can be disposed on the replaceable head portion of the toothbrush. Preferably, the sensor is disposed in the replaceable head portion of the toothbrush so that a clean, fresh sensor is available for each use. The sensor can detect scent particles or molecules from the breath of the user or from the personal skin odor cloud of the user. The breath sensor and personal odor cloud sensor can be separate or can be integrated into a single sensor.

[0049] The sensor can also be disposed within the bristle of the toothbrush using nanotechnology. For example, the toothbrush bristles can comprise at least one layer of nanostructured sensor wherein a plurality of nanoparticles can comprise capture molecules specific to a target oral biomarker. The nanoparticle layer or layers can include a conductive pathway integrated therewithin for transmitting an electrical signal upon interaction between the capture molecules and the target biomarker. Such conductive pathway can be functionalized using piezoelectric elements that generate a measurable voltage change upon mechanical pressure from captured biomarkers, magneto-resistive elements that detect changes in magnetic field when exposed to certain biomarker molecules, or fluorescent / luminescent elements that emit light at specific wavelengths upon interaction with target biomarkers.

[0050] The bristles can further comprising a microfluidic channel for directing captured biomarkers towards the nanostructured sensor layer, such as nanoscale filtration features for enhanced target molecule selectivity, nanowires having conductive nanomaterial filaments embedded within the sensor layer, or carbon nanotubes comprising high-conductivity nanotubes woven into the bristle structure for robust and flexible signal pathways. Alternatively, the toothbrush bristle can comprise a wireless communication module integrated within the base structure for transmitting the detected electrical signal to an external device in real-time.

[0051] Each bristle can target a different breath biomarker, allowing for simultaneous multianalyte detection and comprehensive health assessment. Interchangeable brush heads can be customized according to biomarker detection needs.

[0052] Also shown in the toothbrush embodiment exemplified in FIG. 1 is an on / off switch and a transmitter, such as a Bluetooth transmitter to communicate wirelessly with another component of the system or a computer, or a speaker for transmitting sound signals from the device.

[0053] FIG. 2 shows the sample collection process for detecting and analyzing airborne or volatile scent chemicals, illustrating that breath or skin odor cloud is delivered to the sensor, and transmitted to the microprocessor within the handle portion of the toothbrush. Exhaled breath creates relatively positive pressure inside the device relative to the outside pressure. This causes air to flow and pass through the device. The toothbrush the sensor, receiving or charging component can include an intake device such as a micro-fan to increase airflow. Also depicted is the cell phone having therein an app for receiving and further interpreting the data transmitted thereto from the microprocessor.

[0054] The system and process for collecting and reporting data collected by the device, and transmitting the data for analysis or diagnosis is illustrated in FIG. 3. For example, a text or email message, vibration, sound, and intermittent lighting mechanisms can be generated based on a result exceeding a pre-set concentration of an analyte or the presence of a chemical or compound, such as an airborne cancer-related biomarker coming from the breath or personal skin chemical cloud of the individual user.

[0055] FIG. 4 is a depiction of various personal care products that can include a microchip and sensor for detecting airborne or volatile biomarkers according to the invention, and illustrates (arrows) wireless connectivity to an app downloaded to a mobile communication device, such as a cell phone.

[0056] The toothbrush sensors can be different or unique shapes and sizes in order to bind, gather and analyze different airborne biomarker chemicals and compounds from exhaled breath,sweat, and personal skin odor cloud. The toothbrush sensor can be provided with sound capabilities producing sound alerts or messages to the user.

[0057] When a chemical binds to a sensor receptor, it causes a change in the receptor's electrical activity. This change in electrical activity then triggers a series of events that ultimately lead to the transmission of signals to a processing CPU unit and out to a computer server. The sensory receptors can react to various chemicals within the receptor site. The reaction can cause physical or electrical properties of the sensory site. Each sensory unit can be programmed to react in a specific manner to a particular chemical biomarker. A CPU can transform the reaction of the sensory unit into a text, voice message, video, or image format. The text, voice message, video, or image format can be wirelessly transmitted to medical and non-medical software for monitoring and treatment planning purposes.

[0058] The sensor can be fixed, removable or disposable, and can be adapted for single use or multiple uses.

[0059] A wet sensor can be dried by a micro-fan, heat or left to dry to be reset and functional.

[0060] The sensor can also be waterproof using a coating that is impermeable to water. This coating can be made of a variety of materials, such as silicone, epoxy, or polyurethane. Another way to make a biosensor waterproof is to use a hermetic seal. This seal can be made of a variety of materials, such as glass, metal, or plastic. Methods for making biosensors waterproof include coating with a water-resistant material, such as silicone or epoxy, hermetic seal, or passivation, wherein the surface of the biosensor is treated with a chemical that makes it water- resistant.

[0061] A biosensor that will be used in a humid environment on the head of the toothbrush will need to be more water-resistant than a biosensor that will be used in a dry environment on the handle of the toothbrush.

[0062] The sensor cleaning process can be part of the conventional toothbrush, typically rinsing with tap water out of the sink. However, the sensor can be self-cleaning, with an integrated cleaning mechanism like self-vibration, self-healing, self-ventilation using a micro-fan or self-light system as part of the smart toothbrush components. The way to clean odor sensors will vary depending on the specific type of sensor used. The sensor can be cleaned with a wet towel, isopropyl alcohol, soap water, or compressed air.

[0063] Removal of bound molecules or VOCs from a reusable sensor depends on several factors like the sensor type, desired outcome, and target molecules. Options for such removaland making the sensor available for re-use can employ machine learning and can employ techniques such as:• Thermal Desorption, as used for metal oxide semiconductors (MOS) and chemo-resistor sensors. The sensor is heated, typically between 150-400°C, causing bound molecules to evaporate and be carried away by a clean gas flow.• Chemical Regeneration, for sensors with reversible binding materials like polymers or specific capture molecules. Exposing the sensor to a specific chemical disrupts the binding, releasing the VOCs without harming the sensor.• Biological Regeneration, using enzymes or microbes to break down bound molecules into harmless products.• Sensor Modulation, useful for sensors such as quartz microbalance (QMB) and surface acoustic wave (SAW) that can be altered by changing voltage or frequency, affecting binding interactions.

[0064] Membrane Filters can also be used to protect the surface of the sensor. A replaceable membrane filter can be placed over the sensor wherein the filter allows target molecules to pass therethrough, but blocks non-target molecules and interferences. After analysis, the filter can be discarded and replaced, effectively "resetting" the sensor.

[0065] Optimal sensor choices can depend on factors such as sensor type and material properties, e.g., heat tolerance and regeneration suitability, the target molecules, whether complete removal of VOCs is needed for accurate reanalysis, and cost.

[0066] A device of the invention can also include voice command, using artificial intelligence (Al) and machine learning (ML) to improve healthcare delivery and individual experience such as Nuance Communications (Microsoft), Suki Al, Saykara, Orbita, Sensory Inc, and the like.

[0067] In use, a microprocessor used in a device or system of the invention can perform more efficiently when information input into the system is complete and robust. The input component of the system can receive information about heart rate, blood pressure, tongue color or conformation, data by answering a questionnaire, data from healthcare providers, and can respond to voice command input, such as “find information” related to this new chemical or odor.” Another sample of the input component can process a voice command such as “using Google Bard (to be replaced by Gemini) Gemini, ChatGPT, Med PaLM, artificial intelligence “send me a list of symptoms associated with a particular chemical or odor.”

[0068] Another input component can include the use Google AMIE’s technology for supplemental information on conversational medical conditions and diagnosis. Applying Google AMIE's technology directly to a personal medical device presents exciting possibilities. Input potential applications can include:• Symptom screening and triage: An personal device like toothbrush with AMIE-powered app can guide users through symptom-based questionnaires, potentially suggesting initial care options or directing them to appropriate healthcare providers.• Chronic disease management: AMIE could assist individuals with chronic conditions by monitoring symptoms, prompting medication adherence, and offering personalized advice based on the user's data and medical history.• Mental health support: An AMIE-powered virtual assistant could provide basic mental health support or act as a first point of contact for individuals seeking further assistance.• Health education and information: AMIE could answer user questions about health topics, providing reliable and personalized information based on their specific needs and concerns.

[0069] Another input component can include the use of a camera or video for supplemental information gathering and documentation. The camera or video can be a visual / image biomarker and can capture information about the tongue, gum tissue, teeth calculus, mouth ulcer, throat tissue, and tooth surface information. Machine learning technology with data mapping can be used to map the input image for a differential identification of oral and throat lesions and conditions. The input can be coupled with a questionnaire regarding the description of a symptom or symptoms as an additional input data point.

[0070] Video or image information relating to the tongue can assist a physician or medical professional with a diagnosis, for example:• Color: The color of the tongue can indicate the state of the internal organs. For example, a red tongue may indicate inflammation, while a pale tongue may indicate anemia.• Shape: The shape of the tongue can indicate the state of the nervous system. For example, a tongue that is curled up at the sides may indicate a stroke.• Coating: The coating on the tongue can indicate the state of the digestive system. For example, a thick coating may indicate constipation, while a thin coating may indicate diarrhea.• Moisture: The moisture of the tongue can indicate the state of the body fluids. For example, a dry tongue may indicate dehydration, while a wet tongue may indicate excess fluid.• Movement: The movement of the tongue can indicate the state of the muscles. For example, a tongue that is weak and unable to move may indicate a neurological disorder.

[0071] Another input component can include the use of a camera or video for supplemental information gathering and documentation for mental health. For example, the camera or video can (be a visual / image biomarker and) capture information about the eye function. Machine learning technology with data mapping can be used to map the input image for a differential identification of mental health and conditions. The input can be coupled with a questionnaire regarding the description of a symptom or symptoms as an additional input data point. Eye function and neurotransmitters. Pupillary Response: recording data between pupil size to determine neurotransmitter activity. For instance, changes in pupil dilation or constriction can be associated with specific neurotransmitter responses. Ocular Motility: There can be a connection between neurotransmitters and eye movement control. Ocular Blood Flow: Neurotransmitter activity can influence blood flow to the eye.

[0072] Another input component can include the use of a camera or video for supplemental information gathering and documentation for clinical eye exams and tests for eye health and medical conditions. The camera or video can (be a visual / image biomarker and) capture information about the eye function and anatomy information. Machine learning technology with data mapping can be used to map the input image for a differential identification of eye abnormalities and conditions. The input can be coupled with a questionnaire regarding the description of a symptom or symptoms as an additional input data point.

[0073] A routine daily eye exam can involve a combination of clinical examinations and tests using a personal device such as a toothbrush to assess eye health and potentially identify underlying medical conditions. Using cameral or video the personal device, such as a toothbrush, can performer the following:• Routine and daily self-clinical examinations: Visual Acuity Test: This can measure how well the individual can see the personal at various distances, using wall projected standardized charts or optotypes (letters or symbols) coming from the personal device.• External Eye Examination: Scan the eyelids, eyelashes, conjunctiva (white part of the eye), iris (colored part), pupil, and cornea (clear outer surface) for any abnormalities.• Slit-Lamp Examination: using a bright light coming from the device can be used to examine the structures at the front of the eye in, including the cornea, conjunctiva, iris, and lens.• Ocular Motility Examination: This evaluates how well individual eyes move together in different directions, assessing coordination and potential nerve issues.• Pupillary Light Reflex Test: This checks how your pupils respond to light, shining a light into each eye and observing pupil constriction.• Visual Field Test: This test can assesses individual peripheral vision (side vision) by identifying areas where the individual might have blind spots or vision loss.• Color Vision Testing: using the system app this test evaluates individual ability to distinguish different colors, used to detect potential color vision deficiencies.

[0074] A routine and self-service eye exam can be an essential part of preventive eyecare. These routine tests using a personal device, such as toothbrush, can help diagnose eye and medical conditions. The specific tests performance during individual routine eye exam can depend on the individual needs and medical history. However, these routine exams and tests can help identify and diagnose various eye conditions like: Refractive Errors (Nearsightedness, Farsightedness, Astigmatism), Glaucoma, Cataracts, Diabetic Retinopathy, Age-related Macular Degeneration, Amblyopia (Lazy Eye), Strabismus (Crossed Eyes), Eye Infections, And other eye-related conditions.

[0075] Another input data can be an airborne chemical sensor to identify tap water chemical composition used for tooth brushing. Many public water systems add chlorine (a process known as "chlorination") to their water supply for the purpose of disinfection. The smart toothbrush airborne sensor can detect if the water has chlorine and any other airborne chemicals of interest.

[0076] Another input component can include audio recording for monitoring audio biomarkers. The audio recording can capture, detect and identify voice changes which are one of the most common non-motor symptoms of Parkinson's disease. They can occur early in the course of the disease and can be a major source of communication difficulty. This audio detection of voice quality can include:Monotone: The voice becomes less expressive and has a reduced range of pitch and loudness.Softness: The voice becomes quieter and harder to hear.Breathiness: The voice becomes breathy and has a reduced volume.Hoarseness: The voice becomes hoarse and raspy.Rhythmic disturbances: The voice may become slower, more halting, or spasmodic. Changes in articulation: The voice may become less distinct and may slur words together.

[0077] Other input information of interest includes age, gender, weight and height.

[0078] Other input data can include heart rate. A heart sensor on the smart toothbrush works in the same way as the pulse monitors seen in hospital emergency departments. Infra-red light is sent through the tip of the finger holding the smart toothbrush with one or two sensors that measures changes in the amount of light received. As the heart beats blood is sent around the body, with each beat the blood density is the finger changes and it is these changes that are recorded by the smart toothbrush finger sensor.

[0079] Other input data can include vagus nerve tone. The vagus nerve is the longest cranial nerve that runs from your brain to your intestines and could be a key player in nervous system balance. A higher vagal tone is associated with better physical, emotional, and social regulation, and lower levels of self-reported stress. Vagal tone can be indirectly measured by heart rate variability (HRV): a higher HRV often indicates a more balanced nervous system and better stress resilience, and personal wearable technology like a wrist strap can monitor, or a personal ring can help you track and measure the HRV.A higher vagal tone can also inhibit oxidative stress, inflammation, and excessive sympathetic activity, potentially reducing the risk of chronic disease and decreasing the risk of cardiovascular death], HRV can also be a biomarker for frailty in older adults because HRV shows changes in cardiac autonomic function. The system can help improve vagal tone by suggesting these daily habits before, during or after using a personal device such as a toothbrush:• Deep Breathing: Taking slow, deep breaths-around 4.5-6.5 breaths per minute-can stimulate the vagus nerve by lowering heart rate and blood pressure.• Exercise: Regular moderate-intensity exercise strengthens the vagus nerve, leading to improved HRV and a calmer state.• Massage: Evidence suggests that pressure massages on the neck can stimulate the vagus nerve by releasing endorphins and oxytocin, which reduces stress and promotes relaxation.• Laughter: Laughing also stimulates the vagus nerve, boosting your mood and promoting vagal tone.• Cold Exposure: Splashing cold water on your face or submerging your face during a cold plunge triggers the mammalian dive reflex, which slows heart rate and improves vagal tone.• Singing: Singing or humming has been shown to increase both HRV and vagal tone.

[0080] Other input components are the date, time, and year; communication from healthcare management systems; geolocation; diet information; information from smart refrigerators; information from smartphone food delivery apps; questionnaire of sleep pattern and sleep duration information; information from sleep pattern and sleep duration smartphone apps; prescribed medication information; information relating to over-the-counter supplements taken; medical diagnosis by healthcare providers; generic health assessment information; blood type’ daily water volume intake; communications with online pharmacies and pharmacy prescription services; health insurance information; communications with healthcare providers, outpatient clinics and hospitals; Amazon delivery activities and items delivered, and the like.

[0081] The analyzed data can be processed in real time and can be uploaded to a cloud server for sharing, monitoring, and healthcare management services.

[0082] A smart device of the invention can also include one or more biometric sensors. A biometric sensor can include a 3-D accelerometer for heart rate. Biometric sensors can also capture a pulse and body temperature, respectively.

[0083] Other sensor technologies on the device can include bioimpedance, photoplethysmography, accelerometry, and skin temperature sensors. A smart device includes sensor design, data acquisition, and algorithms for interpreting sensor signals. A smart device can be useful for extracting these biomarkers from different sensors data and using them for health and medical conditions diagnosis and monitoring.

[0084] A smart device of the invention can include functionality by a mobile application (app), including data visualization, data presentation personalized insights, and algorithms for generating personalized recommendation and biofeedback features.

[0085] A device of the invention can share data information with smartphones using Bluetooth, wi-Fi: mobile data, USB, and cloud storage. Cloud storage is a good option for sharing data with multiple devices or for sharing large amounts of data.

[0086] A device of the invention can wirelessly connect or “pair” with an external device comprising a smartphone, laptops, desktops, home security alarm system, and carPlay.

[0087] A device of the invention can have a LED display module that can display numbers, text, graphical images or video information.

[0088] A device of the invention can be programmed to require a security password, fingerprint or optical eye and palm fingerprint sensor to authenticate a user. It can also be programmed to safeguard user data collected by devices and applications. It can also be programmed to ensure data encryption, secure storage, and user control over their information.

[0089] A device of the invention, such as a toothbrush, can have a replaceable and customizable toothbrush head having bristles, but provided without a handle, which is a multi-use component. The replaceable head can save about 60% on the amount of plastic used for manufacture. The brush can come in various shapes and sizes depending on the area being sampled. Cylindrical brushes with rounded ends are for general oral biopsies, while angled brushes might be used for specific locations like the tonsils or the back of the tongue.

[0090] A preferred toothbrush of the invention can operate on an ultra-low power. Detection of movement, vibration, or simply picking the toothbrush up from the charger can turn the toothbrush on. It can be charged by a battery or a magnetic charging station.

[0091] A toothbrush of the invention can also include customized sensors based on any particular prescription medication for the purpose of gathering and analyzing a particular airborne concentration from exhaled breath, sweat, and personal skin odor cloud. The toothbrush can also include customized sensors based on metal detection sensors for the purpose to gather and analyze inorganic and metal airborne chemical concentrations from exhaled breath, sweat, and personal skin odor cloud. Like amalgam vapor or mercury vapor within the amalgam dental restoration. A number of metals can be present in exhaled breath, including Beryllium, Cadmium, Chromium, Lead, Nickel, Vanadium, and Zinc. The levels of these metals in exhaled breath can be used to assess exposure to these metals. For example, high levels of beryllium in exhaled breath can be a sign of beryllium lung disease.

[0092] A toothbrush of the invention can also include a prescription detachable toothbrush head for the purpose to gather, analyze, provide treatment and managing a particular health condition. The prescription toothbrush head can also include prescription drugs and oral surgery recovery non- invasive therapy like bio-stimulation, and dentin hypersensitivity monochromatic light (or other electromagnetic radiation) therapy for patients having gingival recession and post operatory periodontal scaling and root treatment. Monochromatic light (or other electromagnetic radiation) therapy for dentin sensitivity, also known as dentin hypersensitivity, works through a few different mechanisms:• Sealing Dentinal Tubules: Dentin, the layer beneath your tooth enamel, contains microscopic tubules that lead to the tooth's nerve. When these tubules are exposed(e.g., due to receding gums, enamel erosion, or the like), stimuli like hot, cold, sweet, or acidic foods can trigger pain signals in the nerve. Laser energy can help to seal these tubules, reducing their sensitivity.

[0093] Nerve Desensitization: monochromatic light (or other electromagnetic radiation) energy can have a direct effect on the nerve fibers within the tooth. It can alter their ability to transmit pain signals, making them less responsive to stimuli, and Stimulating Secondary Dentin Formation: In some cases, monochromatic light (or other electromagnetic radiation) therapy may stimulate the tooth to produce more secondary dentin. This is a natural repair process where the tooth creates additional dentin to protect itself, further reducing sensitivity.

[0094] Monochromatic light (or other electromagnetic radiation) therapy is a minimally invasive procedure, requiring no anesthesia for reducing dentin sensitivity, and often providing immediate relief. Studies have shown that monochromatic light (or other electromagnetic radiation) therapy can be long-lasting, although the duration varies from person to person. The dentist will generate a prescription for a toothbrush detachable head for the toothbrush device to apply the prescribed monochromatic light (or other electromagnetic radiation) energy to the sensitive areas of the teeth.

[0095] A toothbrush device of the invention can analyze toothpaste airborne chemicals and make personalized recommendations based on existing dental work, gums conditions, and other dental diagnoses and dental restorations (including the release of mercury vapor from Amalgam restorations) (resting and acrylic restorations, and prosthetic work.

[0096] A toothbrush device for analyzing airborne chemicals from the mouth can provide personalized dental health recommendations, and includes:• A communication module for transmitting sensor data to a data server.• A processing unit for analyzing sensor data and generating personalized recommendations based on a user's dental history, such as existing dental work identified through photographic Al processing and machine learning analysis of the teeth or teeth routine x-rays via a mobile app, trained to recognize features from dental x-rays (full mouth, bitewing, and CT scans) uploaded to the data server.• Supplemental user input regarding known dental work performed.

[0097] Gum conditions can be assessed through analysis of sensor data and user-reported history and / or symptoms. For example, dental restorations and prosthetic dental work can be identified through user input or integration with dental records. A device of the invention can employ Al and machine learning by the processing unit to analyze data and dental history tosuggest potential oral health issues, such as tooth decay, gum disease, halitosis (bad breath), or oral infections.

[0098] A device of the invention can further comprise a user interface for displaying personalized recommendations, such as suggested dietary changes to improve oral health, recommended oral hygiene practices, or guidance on seeking professional dental care. A method of use for such embodiment of the device can analyze oral health status and provide personalized recommendations, comprising the steps of:• Accessing a user's dental history through photo analysis of teeth via a mobile app trained to recognize features from dental x-rays uploaded to a data server, or user input regarding known dental work performed.• Combining sensor data analysis with dental history to generate personalized recommendations for improving oral health.

[0099] A method in accordance with the invention can further comprise the steps of:• Identifying potential oral health issues based on the combined analysis of sensor data and dental history.• Tailoring recommendations to address the identified oral health issues.

[0100] The analyses can employ the use of a computer program comprising non-transitory computer-readable instructions stored on a non-transitory computer-readable medium.

[0101] Sensors of a toothbrush device of the invention can detect, directly or indirectly, airborne chemical concentration of biomarkers for periodontitis, bleeding gums, blood, tooth abscess, liquor puris, tooth decay, plaque, and tartar. For example, a hexanal sensor can be useful for identifying periodontitis by detecting hexanal. Volatile sulfur compounds (VSCs) produced by certain bacteria can be responsible for the unpleasant "halitosis" or bad breath. But while VSCs are the primary culprits behind periodontitis-related bad breath, hexanal plays a supporting role. Specific bacteria associated with periodontitis, such as Porphyromonas gingivalis and Prevotella intermedia, possess enzymes that break down lipids (fats) present in food debris and dead cells accumulated in the periodontal pockets (gum pockets). This breakdown process, known as lipolysis, generates hexanal as one of the byproducts.

[0102] The presence of hexanal in the breath, along with VSCs, can provide additional clues to the severity and extent of periodontitis. Studies have shown that breath levels of hexanal correlate with the degree of gum inflammation and periodontal pocket depth. Therefore, measuring hexanal, along with other volatile compounds, could potentially aid in diagnosing and monitoring periodontitis.

[0103] A toothbrush device of the invention can analyze airborne chemicals in toothpaste and make personalized recommendations based on existing medical history, genetics, gum health, or other medical diagnoses, conditions, or prescribed medications. Sensors in a toothbrush device of the invention can detect airborne biomarkers from saliva differentiating types and concentration of proteins, electrolytes, minerals, buffers, and serum proteins that may be present.

[0104] Sensors in a toothbrush device of the invention can detect airborne biomarkers from bacteria that are present in the individual. For example, bacteria biomarkers in exhaled breath can be used in early diagnosis and treatment of respiratory infections. These biomarkers can be used to identify the presence of bacteria in the lungs, even before symptoms develop. This can help doctors to diagnose and treat infections in early stages when they are most treatable. There are a number of bacteria biomarkers that have been identified in exhaled breath, including Volatile Organic Compounds (VOCs), Volatile Sulphur Compounds (VSCs) and other lipid metabolites, and bacterial DNA.

[0105] In the event a sensor used in a device of the invention detects a potentially harmful biomarker or airborne chemical, the system can share analyzed data with medical or dental insurance scheduling team members for a medical in-person or telemedical consultation. If the patient does not have medical or dental insurance the system can browse the world wide web and a recommendation can be made to provider in proximity to the individual, based on geolocation or GPS information.

[0106] It will be understood that the volatile biomarker sensor described herein can be provided separately or together with a microprocessor for collecting or processing or analyzing or storing the information or data collected by the sensor. The sensor, or sensor portion of an integrated sensor-microprocessor, is used to identify and distinguish between different airborne chemicals, molecules, odors, or biomarkers and send such identifying and distinguishing data to the microprocessor. The microprocessor can process the data received from the sensor or can transmit such data to a remote processor or computer for further analysis, storage or the like. The transmission of the data can be by a wired connection or, preferably, a wireless connection, such as IF?, microwave, Bluetooth, cell phone connection of the like.

[0107] The sensor and microprocessor can be integrated into a medical or dental device, personal hygiene device, or accessory or can be provided separately and affixed to the device.

[0108] An advantageous aspect of a device or system or method of the invention is incorporating Artificial Intelligence and machine learning into the sensor or microprocessor so that the information gathered over time can provide a basis for refining the capabilities of the sensor or microprocessor so that health management is more precise, accurate, and predictive of health status or potential disease development over time by the user - either a health care specialist or individual.

[0109] A convenience and advantageous aspect of a device or system or method of the invention is incorporating Artificial Intelligence and machine learning into a seamless data- collection processes of the individual. Al and machine learning offer powerful tools for collecting and analyzing data from diverse sources and formats.

[0110] Al and machine learning can collect data from diverse sources and formats in several ways, including Automating Data Extraction through Optical Character Recognition (OCR), Speech-to-Text (STT), Natural Language Processing (NLP): Extracts key information and structure from unstructured text data like emails, social media posts, or surveys.

[0111] Data Cleaning and Standardization procedures include machine learning algorithms that identify and correct errors, inconsistencies, and missing values in datasets from various sources, Data normalization and standardization that convert diverse data formats into a unified format for easier analysis and comparison, or .Enhancing Data Quality used for anomaly detection: Identify, data imputation, or enriching existing data, all in real time.

[0112] The toothbrush device incorporates compact odor sensors utilizing highly integrated CMOS semiconductor technology, achieving both miniaturization and high odor resolution.

[0113] The toothbrush's design can integrate a CMOS semiconductor-type odor imaging sensor chip with a sensor element area preferably equal or less than 1 .2 x 1 .2 mm, complete with peripheral driver and A / D converter circuits. The chip itself within the toothbrush detachable head and handle preferably measures 3.5 mm x 3.5 mm or less and accommodates at least 1 -100,000 odor receptor membranes. By mounting the peripheral circuitry directly on the chip, seamless integration within the toothbrush handle and detachable heads is achieved.

[0114] The device incorporates a technology that enables the formation of 1 -100,0000 odorreceptor membranes within the chip's sensor area. This is accomplished preferably through SIJ technology's printing process, capable of single-micron-level fine dispensing for precise membrane deposition.

[0115] SIJ Technology, or Super Inkjet Technology, is a printing technology developed by the Nanotechnology Research Institute of AIST (National Institute of Advanced Industrial Science and Technology). It enables precise printing on various materials at the sub-micrometer scale, which is much smaller than traditional inkjet printing methods.

[0116] While our toothbrush device is part of manufacturing printing technology that enables precise microdeposition of various materials, it can also be part of microfabrication, which is a technology used to fabricate micro-scale structures and devices; bioprinting, a technology that has applications in printing biological materials for medical purposes; and 3D Printing, the precision and material versatility of precise microdeposition of various materials technology can be applied to 3D printing applications on the toothbrush device.

[0117] Besides incorporating SIJ Technology (Super Inkjet Technology) into our toothbrush device, several other technologies can be part of high-precision printing and fabrication such as: Aerosol Jet Printing, which uses a focused aerosol beam to deposit various materials onto surfaces and offers high resolution and can print on complex 3D shapes, making it suitable for electronics and biomedical applications; Nanoimprint Lithography (NIL), a high-resolution patterning technique that replicates patterns from a mold onto a substrate widely used in semiconductor manufacturing and offers excellent resolution for nanoscale structures; Two- Photon Polymerization (2PP), a 3D printing technique that uses focused laser beams to solidify liquid resins, enabling the creation of intricate 3D structures with high resolution, particularly useful for micro-optics and biomedical applications; Electron Beam Lithography (EBL), a high- resolution patterning technique that uses a focused beam of electrons to write patterns on a substrate, and is primarily used in semiconductor manufacturing and research settings due to its high cost and complexity.

[0118] As a result, our toothbrush device establishes a technology capable of configuring 1 - 100,000 odor-receptor membranes within a sensor element area preferably under the size of 1 .5 mm x 1 .5 mm. This realizes the world's highest density sensor element array for e-Nose type odor sensors on a personal device, facilitating easy sensor integration into toothbrush devices for cost-effective mass production.

[0119] Traditional odor measurement methods, such as gas chromatography and oxide semiconductor type odor sensors, either analyze odorant composition or measure overall odorant quantity, but cannot distinguish specific odors. Conversely, the e-nose type odor sensormimics the human nose's ability to discern odors. It achieves this by depositing multiple odor receptor membranes with varying chemical affinities on numerous sensor elements, generating a digital odor pattern.

[0120] Our toothbrush device preferentially utilizes e-Nose type odor sensors (quartz crystal microbalance or CMOS semiconductor type) and others to digitally output odor patterns. This is based on the same principle as human odor perception, achieved by mounting a number of odor receptor membrane films with different chemical affinities on numerous sensor elements.

[0121] Manufacturing high-performance e-Nose type odor sensors with enhanced odor resolution includes odor receptor membrane film materials and deposition technology employed in the toothbrush device handle and detachable head. By depositing multiple types of odorreceptor membranes on the transducer, the toothbrush device creates an odor sensor functioning as an e-Nose. The toothbrush device can deposit well over 100,000 odor-receptor membranes within 1 mm x 1 mm sensor area, utilizing various technologies, including super inkjet technology and a multi-layered perspective Al engine. Leveraging these technologies, the toothbrush can accommodate dozens, hundreds, and tens of thousands of different odor receptor membranes.

[0122] The toothbrush device can be used in conjunction with an odor identification application equipped with machine learning functions, enabling highly accurate odor identification and utilization of digital odor data. By utilizing this application, a highly precise odor identification function combining teacher data and judgment models can be implemented, allowing for the utilization of other digital odor data.

[0123] The toothbrush device incorporates a combination of techniques in microchips to increase surface area in the microchips, thereby improving performance and capabilities. For example, 3D Chip Stacking utilizes stacking of multiple chip layers on top of each other, available surface area is increased without increasing the chip's footprint. Multiple chip layers are stacked vertically, connected by tiny vertical conduits called through-silicon vias (TSVs). This drastically expands the usable surface for transistors and other components without increasing the chip's footprint. Benefits include higher transistor density, shorter signal paths (faster performance), and reduced power consumption.

[0124] Advanced Packaging Techniques, such as fan-out wafer-level packaging (FOWLP) can also be used to distribute components across a larger area, effectively increasing the usable surface of the chip. Packaging techniques for the toothbrush device involve combining multiple chips or dies into a single package to improve performance, power efficiency, and form factor. These techniques often use interposers, silicon bridges, or other methods to connect the chips together. These include 2.5D packaging, which involves placing multiple dies on an interposer, which acts as a communication bridge between them; 3D packaging, which involves stacking multiple dies vertically, which can greatly increase the density of components and improve performance; Fan-out wafer-level packaging (FOWLP), which involves extending the interconnections of a die beyond its edges, allowing for more efficient use of space and improved electrical performance; System-in-package (SiP), which involves integrating multiple components, such as a processor, memory, and sensors, into a single package.

[0125] By combining multiple chips into a single package, the toothbrush device can be made smaller, more powerful, and more energy-efficient.

[0126] In addition, innovative chip configurations or architectures can also be employed to optimize the layout of components, maximizing the use of available space and potentially increasing the surface area dedicated to specific functions. For example, chiplet-based designs utilize the technique of dividing a large chip into smaller, more manageable chiplets that can be manufactured and tested independently. Chiplets can be combined in different ways to create custom chips for specific applications.

[0127] Neuromorphic computing using neuromorphic chips employs artificial neurons and synapses to process information, and they are well-suited for tasks such as image recognition and natural language processing, and In-memory Computing combines memory and processing functions on the same chip, which can significantly reduce the time and energy required to transfer data between them.

[0128] Reconfigurable computing architecture can be used to allow the chip's functionality to be reprogrammed on the fly, making it more versatile and adaptable to different tasks.

[0129] Passive Components, such as capacitors, resistors, and inductors can also be integrated within the chip layers, freeing up surface area that would otherwise be used for discrete components.

[0130] By utilizing these layering techniques, chip manufacturers can achieve higher transistor density, shorter interconnects, reduced power consumption, and smaller chip size, enabling more functionality within a smaller footprint, which can be preferred for use in mobile devices and other space-constrained applications.

[0131] In conclusion, layering techniques are essential for maximizing the surface area of microchips, leading to significant advancements in performance, power efficiency, and miniaturization.

[0132]

[0133] The above disclosure generally describes the present invention and is provided for purposes of illustration and is not intended to limit the scope of the invention. The invention described herein may be practiced in the absence of any element or elements, limitation or limitations which is not specifically disclosed herein. Thus, for example, in each instance herein, any of the terms “comprising,” “consisting essentially of,” and “consisting of” may be replaced with either of the other two terms.

[0134] The terms and expressions are used as terms of description and not of limitation, and there is no intention in the use of such terms and expressions of excluding any equivalents of the features shown and described or portions thereof, but it is recognized that various modifications are possible within the scope of the invention claimed. Accordingly, it should be understood that although the present invention has been specifically disclosed by preferred embodiments and optional features, modification and variation of the concepts herein disclosed may be resorted to by those skilled in the art, and that such modifications and variations are considered to be within the scope of this invention as defined by the appended claims. While there has been shown and described the preferred embodiment of the instant invention it is to be appreciated that the invention may be embodied otherwise than is herein specifically shown and described and that, within said embodiment, certain changes may be made in the form without departing from the underlying ideas or principles of this invention as set forth in the claims appended herewith.

Claims

CLAIMS1 . A diagnostic device comprising at least one sensor and a microprocessor capable of detecting a volatile or airborne chemical, or a plurality or combination of chemicals, present in breath or personal odor cloud of an individual, wherein the volatile or airborne chemical, or a plurality or combination of chemicals produce a detectable odor or scent associated with a disease state or health condition of the individual.

2. The device of claim 1 , wherein the device is a dental implement.

3. The device of claim 2 wherein the dental implement is a low-speed handpiece.

4. The device of claim 2, wherein the dental implement is a prophy cup.

5. The device of claim 1 , wherein the device is a personal hygiene implement.

6. The device of claim 5, wherein the personal hygiene implement is a toothbrush.

7. The device of claim 5, wherein the personal hygiene implement is a hairbrush or comb.

8. The device of claim 5, wherein the personal hygiene implement is a tongue cleaner.

9. The device of claim 1 , wherein the device is an accessory worn by the individual.

10. The device of claim 9, wherein the accessory is a smartwatch.11 . The device of claim 9, wherein the accessory is a bracelet or wristband.

12. The device of claim 9, wherein the accessory is a necklace or pendant.

13. The device of claim 9, wherein the accessory is eyeglasses frames.

14. The device of claim 1 , wherein the device further comprises a visual image or video signal for communicating analysis results to a user or the device.

15. The device of claim 1 , wherein the device further comprises an audio signal for communicating analysis results to a user or the device.

16. The device of claim 1 , wherein the device further comprises electric charge forconverting data into numerical, image, audio or video values by using increase or decrease in the amount of electric charge that occurs when volatile or airborne chemicals are in contact with the sensor17. A system for detecting a volatile or airborne chemical, or a plurality or combination of chemicals, present in breath or personal odor cloud of an individual, said system comprising:- a device of claim 1 , and a remote database and computer program in communication with the device wherein the remote database and computer program are capable of analyzing data detected by the sensor and identifying a health condition or disease associated with the volatile or airborne chemical, or a plurality or combination of chemicals, present in the breath or personal odor cloud of the individual.

18. The system of claim 17, wherein the database is in wireless communication with the device.

19. The system of claim 17, wherein the remote database and computer program are capable of analyzing data detected by the sensor and diagnosing a health condition or disease associated with the volatile or airborne chemical, or a plurality or combination of chemicals, present in the breath or personal odor cloud of the individual.

20. A method for detecting a volatile or airborne chemical, or a plurality or combination of chemicals, present in the breath or personal odor cloud of an individual, said method comprising: a) providing a device of claim 1 , b) using the device in a conventional manner whereby the breath or personal odor cloud of the individual contacts a sensor in the device to detect a volatile or airborne chemical, or a plurality or combination of chemicals, present in the breath or personal odor cloud; c) transmitting or communicating data detected by the sensor to a database and computer program capable of analyzing the data and identifying a health condition or disease associated with the volatile or airborne chemical, or a plurality or combination of chemicals, present in the breath or personal odor cloud of the individual.

21. The method of claim 19, wherein the data detected by the sensor is transmitted or communication to a database and computer program capable of analyzing the data and diagnosing a health condition or disease associated with the volatile or airborne chemical, or a plurality or combination of chemicals, present in the breath or personal odor cloud of the individual.

2. The method of claim 19, wherein the data detected by the sensor is transmitted or communication to a database and computer program capable of analyzing the data, wherein the analyzed data is accessible by a physician for diagnosing the health condition or disease.

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