+

WO2018183514A2 - Systems including removable oral devices - Google Patents

Systems including removable oral devices Download PDF

Info

Publication number
WO2018183514A2
WO2018183514A2 PCT/US2018/024864 US2018024864W WO2018183514A2 WO 2018183514 A2 WO2018183514 A2 WO 2018183514A2 US 2018024864 W US2018024864 W US 2018024864W WO 2018183514 A2 WO2018183514 A2 WO 2018183514A2
Authority
WO
WIPO (PCT)
Prior art keywords
mouth
removable oral
oral device
user
palatal
Prior art date
Application number
PCT/US2018/024864
Other languages
French (fr)
Other versions
WO2018183514A3 (en
Inventor
William H. Longley
Richard P. Schneider
Anthony R. Tremaglio
Marc M. GIBELEY
Original Assignee
Scientific Intake Limited Co.
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Scientific Intake Limited Co. filed Critical Scientific Intake Limited Co.
Publication of WO2018183514A2 publication Critical patent/WO2018183514A2/en
Publication of WO2018183514A3 publication Critical patent/WO2018183514A3/en

Links

Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/145Measuring characteristics of blood in vivo, e.g. gas concentration or pH-value ; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid or cerebral tissue
    • A61B5/14507Measuring characteristics of blood in vivo, e.g. gas concentration or pH-value ; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid or cerebral tissue specially adapted for measuring characteristics of body fluids other than blood
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/103Measuring devices for testing the shape, pattern, colour, size or movement of the body or parts thereof, for diagnostic purposes
    • A61B5/11Measuring movement of the entire body or parts thereof, e.g. head or hand tremor or mobility of a limb
    • A61B5/1113Local tracking of patients, e.g. in a hospital or private home
    • A61B5/1114Tracking parts of the body
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/103Measuring devices for testing the shape, pattern, colour, size or movement of the body or parts thereof, for diagnostic purposes
    • A61B5/11Measuring movement of the entire body or parts thereof, e.g. head or hand tremor or mobility of a limb
    • A61B5/1123Discriminating type of movement, e.g. walking or running
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/45For evaluating or diagnosing the musculoskeletal system or teeth
    • A61B5/4538Evaluating a particular part of the muscoloskeletal system or a particular medical condition
    • A61B5/4542Evaluating the mouth, e.g. the jaw
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/48Other medical applications
    • A61B5/4866Evaluating metabolism
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/68Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient
    • A61B5/6801Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient specially adapted to be attached to or worn on the body surface
    • A61B5/6813Specially adapted to be attached to a specific body part
    • A61B5/6814Head
    • A61B5/682Mouth, e.g., oral cavity; tongue; Lips; Teeth
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F5/00Orthopaedic methods or devices for non-surgical treatment of bones or joints; Nursing devices ; Anti-rape devices
    • A61F5/0003Apparatus for the treatment of obesity; Anti-eating devices
    • A61F5/0006Diet or mouth appliances
    • GPHYSICS
    • G09EDUCATION; CRYPTOGRAPHY; DISPLAY; ADVERTISING; SEALS
    • G09BEDUCATIONAL OR DEMONSTRATION APPLIANCES; APPLIANCES FOR TEACHING, OR COMMUNICATING WITH, THE BLIND, DEAF OR MUTE; MODELS; PLANETARIA; GLOBES; MAPS; DIAGRAMS
    • G09B19/00Teaching not covered by other main groups of this subclass
    • G09B19/0092Nutrition
    • GPHYSICS
    • G16INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR SPECIFIC APPLICATION FIELDS
    • G16HHEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA
    • G16H20/00ICT specially adapted for therapies or health-improving plans, e.g. for handling prescriptions, for steering therapy or for monitoring patient compliance
    • G16H20/10ICT specially adapted for therapies or health-improving plans, e.g. for handling prescriptions, for steering therapy or for monitoring patient compliance relating to drugs or medications, e.g. for ensuring correct administration to patients
    • G16H20/17ICT specially adapted for therapies or health-improving plans, e.g. for handling prescriptions, for steering therapy or for monitoring patient compliance relating to drugs or medications, e.g. for ensuring correct administration to patients delivered via infusion or injection
    • GPHYSICS
    • G16INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR SPECIFIC APPLICATION FIELDS
    • G16HHEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA
    • G16H20/00ICT specially adapted for therapies or health-improving plans, e.g. for handling prescriptions, for steering therapy or for monitoring patient compliance
    • G16H20/30ICT specially adapted for therapies or health-improving plans, e.g. for handling prescriptions, for steering therapy or for monitoring patient compliance relating to physical therapies or activities, e.g. physiotherapy, acupressure or exercising
    • GPHYSICS
    • G16INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR SPECIFIC APPLICATION FIELDS
    • G16HHEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA
    • G16H20/00ICT specially adapted for therapies or health-improving plans, e.g. for handling prescriptions, for steering therapy or for monitoring patient compliance
    • G16H20/60ICT specially adapted for therapies or health-improving plans, e.g. for handling prescriptions, for steering therapy or for monitoring patient compliance relating to nutrition control, e.g. diets
    • GPHYSICS
    • G16INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR SPECIFIC APPLICATION FIELDS
    • G16HHEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA
    • G16H30/00ICT specially adapted for the handling or processing of medical images
    • G16H30/20ICT specially adapted for the handling or processing of medical images for handling medical images, e.g. DICOM, HL7 or PACS
    • GPHYSICS
    • G16INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR SPECIFIC APPLICATION FIELDS
    • G16HHEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA
    • G16H40/00ICT specially adapted for the management or administration of healthcare resources or facilities; ICT specially adapted for the management or operation of medical equipment or devices
    • G16H40/60ICT specially adapted for the management or administration of healthcare resources or facilities; ICT specially adapted for the management or operation of medical equipment or devices for the operation of medical equipment or devices
    • G16H40/63ICT specially adapted for the management or administration of healthcare resources or facilities; ICT specially adapted for the management or operation of medical equipment or devices for the operation of medical equipment or devices for local operation
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B1/00Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopes; Illuminating arrangements therefor
    • A61B1/24Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopes; Illuminating arrangements therefor for the mouth, i.e. stomatoscopes, e.g. with tongue depressors; Instruments for opening or keeping open the mouth
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B2503/00Evaluating a particular growth phase or type of persons or animals
    • A61B2503/12Healthy persons not otherwise provided for, e.g. subjects of a marketing survey
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B2560/00Constructional details of operational features of apparatus; Accessories for medical measuring apparatus
    • A61B2560/02Operational features
    • A61B2560/029Operational features adapted for auto-initiation
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B2562/00Details of sensors; Constructional details of sensor housings or probes; Accessories for sensors
    • A61B2562/02Details of sensors specially adapted for in-vivo measurements
    • A61B2562/0204Acoustic sensors
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B2562/00Details of sensors; Constructional details of sensor housings or probes; Accessories for sensors
    • A61B2562/02Details of sensors specially adapted for in-vivo measurements
    • A61B2562/0219Inertial sensors, e.g. accelerometers, gyroscopes, tilt switches
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B2562/00Details of sensors; Constructional details of sensor housings or probes; Accessories for sensors
    • A61B2562/12Manufacturing methods specially adapted for producing sensors for in-vivo measurements
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/0002Remote monitoring of patients using telemetry, e.g. transmission of vital signals via a communication network
    • A61B5/0015Remote monitoring of patients using telemetry, e.g. transmission of vital signals via a communication network characterised by features of the telemetry system
    • A61B5/0024Remote monitoring of patients using telemetry, e.g. transmission of vital signals via a communication network characterised by features of the telemetry system for multiple sensor units attached to the patient, e.g. using a body or personal area network
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/02Detecting, measuring or recording for evaluating the cardiovascular system, e.g. pulse, heart rate, blood pressure or blood flow
    • A61B5/021Measuring pressure in heart or blood vessels
    • A61B5/02141Details of apparatus construction, e.g. pump units or housings therefor, cuff pressurising systems, arrangements of fluid conduits or circuits
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/02Detecting, measuring or recording for evaluating the cardiovascular system, e.g. pulse, heart rate, blood pressure or blood flow
    • A61B5/024Measuring pulse rate or heart rate
    • A61B5/02438Measuring pulse rate or heart rate with portable devices, e.g. worn by the patient
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/05Detecting, measuring or recording for diagnosis by means of electric currents or magnetic fields; Measuring using microwaves or radio waves
    • A61B5/053Measuring electrical impedance or conductance of a portion of the body
    • A61B5/0537Measuring body composition by impedance, e.g. tissue hydration or fat content
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/08Measuring devices for evaluating the respiratory organs
    • A61B5/0816Measuring devices for examining respiratory frequency
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/145Measuring characteristics of blood in vivo, e.g. gas concentration or pH-value ; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid or cerebral tissue
    • A61B5/1468Measuring characteristics of blood in vivo, e.g. gas concentration or pH-value ; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid or cerebral tissue using chemical or electrochemical methods, e.g. by polarographic means
    • A61B5/1473Measuring characteristics of blood in vivo, e.g. gas concentration or pH-value ; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid or cerebral tissue using chemical or electrochemical methods, e.g. by polarographic means invasive, e.g. introduced into the body by a catheter
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/68Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient
    • A61B5/6801Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient specially adapted to be attached to or worn on the body surface
    • A61B5/683Means for maintaining contact with the body
    • A61B5/6838Clamps or clips
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B8/00Diagnosis using ultrasonic, sonic or infrasonic waves
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F5/00Orthopaedic methods or devices for non-surgical treatment of bones or joints; Nursing devices ; Anti-rape devices
    • A61F5/0003Apparatus for the treatment of obesity; Anti-eating devices
    • A61F5/0013Implantable devices or invasive measures
    • A61F2005/0016Implantable devices or invasive measures comprising measuring means
    • A61F2005/002Implantable devices or invasive measures comprising measuring means for sensing mechanical parameters

Definitions

  • This application is directed to systems which use, at least in part, one or more removable oral devices. More particularly, certain configurations described herein are directed to systems which use a removable oral device in combination with one or more other separate devices or components comprising a processor or other electrical component.
  • a system configured to produce a removable oral device comprises an oral imager and a printer.
  • the oral imager comprises an image head configured to be inserted into a user's mouth and provide an oral cavity image.
  • the printer is configured to receive the oral cavity image from the oral imager and print a removable oral device using a first material,.
  • the printed removable oral device comprising a printed palatal element coupled to a clasping element, in which the printed palatal element is configured to contact a roof of a user's mouth at a palatal surface, and wherein the printed palatal element comprises a body comprising a thickness configured to lower a vaulted area of the roof of the mouth to decrease an overall oral volume of the mouth to a first oral volume.
  • the clasping element when present, can be configured to assist in removal of the removable oral device from the mouth and to retain the palatal surface of the palatal element against the roof of the user's mouth when the removable oral device is inserted into the user's mouth.
  • a system for monitoring intake of material into a mouth of a user comprises a removable oral device configured to removably insert into a mouth of the a user, wherein the removable oral device comprises a camera configured to capture images of the material in the mouth of the user.
  • the removable oral device can be present in combination with an external device separate from the removable oral device, in which the external device comprises a processor configured to couple to the removable oral device to transfer captured images from the camera of the removable oral device to the external device.
  • a system for monitoring athletic performance comprises a removable oral device configured to removably insert into a mouth of the user and comprising at least one electrode positioned within the body of a palatal element and exposed to fluid entering and exiting the mouth of the user.
  • the at least one electrode can be configured to measure athletic performance from fluid entering and exiting the mouth of the user.
  • the removable oral device can be present in combination with an external device that is separate from the removable oral device, in which the external device comprises a processor configured to couple to the removable oral device to transfer the measured athletic performance from the removable oral device to the external device.
  • a system for monitoring intake of material into a mouth of a user comprises a removable oral device comprising a bar code reader, and an external device that is separate from the removable oral device, in which the external device comprises a processor configured to couple to the removable oral device to transfer the measured bar code from the removable oral device to the external device.
  • a system comprises a removable oral device configured to removably insert into a mouth of the a user and comprises a memory unit configured to receive and store an electronic medical record of the user, and an external device that is separate from the removable oral device, in which the external device comprises a processor configured to couple to the removable oral device to read and update the electronic medical record on the removable oral device.
  • the removable oral device can be present with an external device that is separate from the removable oral device, in which the external device comprises a processor configured to couple to the removable oral device to transfer the measured physiological parameter from the removable oral device to the external device.
  • a system configured to monitor head tremor comprises a removable oral device configured to removably insert into a mouth of a user and comprising an accelerometer, and an external device that is separate from the removable oral device, in which the external device comprises a processor configured to couple to the removable oral device to transfer detected head movement measured by the accelerometer to the external device.
  • a system for monitoring head impact comprises a removable oral device configured to removably insert into the mouth of the user and comprising an accelerometer, and an external device that is separate from the removable oral device, in which the external device comprises a processor configured to couple to the removable oral device to transfer the detected head movement measured by the accelerometer to the external device to determine head impact.
  • a system configured to monitor chewing comprises a removable oral device configured to removably insert into a mouth of the user and comprising a piezoelectric sensor, and an external device that is separate from the removable oral device, in which the external device comprises a processor configured to couple to the removable oral device to transfer the measured pressure changes to the external device.
  • a system configured to monitor chewing comprises a removable oral device configured to removable insert into a mouth of a user and comprising a microphone configured to monitor chewing by measuring a change in decibel levels within the mouth, and an external device that is separate from the removable oral device, in which the external device comprises a processor configured to couple to the removable oral device to transfer the measured change in decibel levels within the mouth to the external device.
  • a system comprises monitoring chewing a removable oral device configured to removably insert into the mouth of the user and comprising a proximity sensor configured to monitor chewing by measuring a distance change between the proximity sensor and a sensor coupled to a lower tooth of the user, and an external device that is separate from the removable oral device, in which the external device comprises a processor configured to couple to the removable oral device to transfer the measured distance change to the external device.
  • the system may also comprise an external device separate from the removable oral device, in which the external device comprises a processor configured to couple to the removable oral device to transfer the measured nutrient species in the material to the external device.
  • the system may also comprise an external device separate from the removable oral device, in which the external device comprises a processor configured to couple to the removable oral device to receive the transmitted, recorded material intake.
  • the system may also comprise a case configured to receive and store the removable oral device, wherein the case comprises a transmitter/receiver to receive the information from the transmitter/receiver of the oral device to transfer the information present on the removable oral device when the removable oral device is inserted into the case.
  • a system configured to determine a body fat percentage of a human, the system comprises a removable oral device comprising an electrode, and an external device separate from the removable oral device, in which the external device that is separate from the removable oral device and comprises a processor configured to couple to the removable oral device to receive electrical measurements from the electrode and determine the body fat percentage using the received electrical measurements.
  • a system comprises a removable oral device comprising a processor, and a wearable device separate from the removable oral device and comprising a processor configured to receive information from the processor of the palatal element.
  • the printer can be configured to print a removable oral device using the three dimensional coordinates.
  • the printed removable oral device comprises a palatal element coupled to a clasping element, in which the palatal element is configured to contact a roof of a user's mouth at a palatal surface, and wherein the palatal element comprising a body comprising a thickness configured to lower a vaulted area of the roof of the mouth to decrease an overall oral volume of the mouth to a first oral volume.
  • the clasping element which may or may not be printed, is configured to assist in removal of the removable oral device from the mouth and to retain the palatal surface of the palatal element against the roof of the user's mouth when the removable oral device is inserted into the user's mouth.
  • a system comprises an oral imager comprising an image head configured to be inserted into a user's mouth and provide an oral cavity image, and a printer configured to receive the oral cavity image from the oral imager and print an impression tray using the received oral cavity image.
  • a system comprises an oral imager comprising an image head configured to be inserted into a user's mouth and provide an oral cavity image.
  • the system may also comprise a printer configured to receive the oral cavity image from the oral imager and print an impression tray using the received oral cavity image.
  • the system may also comprise a mold material configured to insert into the printed impression tray to provide an oral cavity impression.
  • the system may also comprise a first material configured to provide a removable oral device comprising a palatal element coupled to a clasping element.
  • a system comprises a first removable oral device comprising an embedded camera configured to capture an image or images of the oral cavity, and an external device comprising a processor configured to receive the captured image from the first removable oral device.
  • the system may also comprise a printer that is used to provide a second removable oral device using the captured image or images.
  • a system comprises a removable oral device in combination with a weight management schedule or program.
  • a system comprises a removable oral device in combination with a nutrition management schedule or program.
  • a system comprises a removable oral device in combination with an exercise management schedule or program.
  • a system comprises a coaching platform configured for use with a removable oral device to assist in weight management of the user.
  • FIG. 1A is an illustration of a removable oral device
  • FIG. IB is a schematic of various components which may be present on the removable oral device, in accordance with certain configurations
  • FIG. 2 is an illustration of a system comprising a removable oral device and an external device, in accordance with certain embodiments
  • FIG. 3 is an illustration of a system comprising a removable oral device comprising a camera and its use in combination with an external device, in accordance with certain examples;
  • FIG. 4 is an illustration of a system comprising a removable oral device comprising an electrode and its use in combination with an external device, in accordance with certain examples;
  • FIG. 5 is an illustration of a system comprising a removable oral device comprising a bar code reader and its use in combination with an external device, in accordance with certain examples;
  • FIG. 6 is an illustration of a system comprising a removable oral device comprising a memory unit and its use in combination with an external device, in accordance with certain examples;
  • FIG. 7 is an illustration of a system comprising a removable oral device comprising a sensor and its use in combination with an external device, in accordance with certain examples
  • FIG. 8 is an illustration of a system comprising a removable oral device comprising an accelerometer and its use in combination with an external device, in accordance with certain examples;
  • FIG. 9 is another illustration of a system comprising a removable oral device comprising an accelerometer and its use in combination with an external device, in accordance with certain examples;
  • FIG. 10 is an illustration of a system comprising a removable oral device comprising a piezoelectric sensor and its use in combination with an external device, in accordance with certain examples;
  • FIG. 11 is an illustration of a system comprising a removable oral device comprising a microphone and its use in combination with an external device, in accordance with certain configurations
  • FIG. 12 is an illustration of a system comprising a removable oral device comprising a proximity sensor and its use in combination with an external device, in accordance with certain configurations
  • FIG. 13 is an illustration of a system comprising a removable oral device comprising a chewing sensor and its use in combination with an external device, in accordance with certain configurations;
  • FIG. 14 is an illustration of a system comprising a removable oral device comprising a food sensor and its use in combination with an external device, in accordance with certain configurations;
  • FIG. 15 is an illustration of a system comprising a removable oral device comprising a processor and a sensor and their use in combination with an external device, in accordance with certain configurations;
  • FIG. 16 is an illustration of a system comprising a removable oral device comprising a multi-plexing sensor and its use in combination with an external device, in accordance with certain configurations;
  • FIG. 17 is an illustration of a system comprising a removable oral device comprising a transmitter/receiver and its use in combination with an external device, in accordance with certain configurations;
  • FIG. 18 is an illustration of a system comprising a removable oral device comprising a pressure sensor and its use in combination with an external device, in accordance with certain configurations;
  • FIG. 19 is an illustration of a system comprising a removable oral device comprising a transmitter/receiver and its use in combination with an external device, in accordance with certain configurations;
  • FIG. 20 is an illustration of a system comprising a removable oral device comprising an electrode and its use in combination with an external device, in accordance with certain configurations;
  • FIG. 21 is an illustration of a system comprising a removable oral device comprising a processor and its use in combination with an external device, in accordance with certain configurations;
  • FIG. 22 is an illustration of a system comprising a removable oral device comprising a processor and its use in combination with a wearable device, in accordance with certain configurations;
  • FIG. 23 is an illustration of a system comprising a printer configured to print a removable, in accordance with certain configurations;
  • FIG. 24 is an illustration of an oral imager system, in accordance with certain examples;
  • FIG. 25 is an illustration of a system comprising an oral imager and a printer, in accordance with certain embodiments.
  • FIG. 26 is an illustration of a system comprising a removable oral device and a remote coaching platform, in accordance with certain configurations.
  • a removable oral device in combination with a wearable device, e.g., a watch, spectacles, contact lenses, etc., or a local or remote system comprising a processor.
  • a wearable device e.g., a watch, spectacles, contact lenses, etc.
  • a local or remote system comprising a processor.
  • the systems described herein may comprise a removable oral device with an on-board sensor, processor or other electrical component in combination with one or more external devices which comprise a sensor, processor or other electrical component.
  • Other configurations of the systems include systems which can be used to produce a removable oral device, e.g., a scanner, printer, etc. and/or systems which can be used with a removable oral device, e.g., on-demand, remote or live coaching platforms.
  • the removable oral device can be used with a weight management plan or schedule, a nutrition plan or schedule and/or an exercise plan or schedule.
  • An optional clasping element 110 comprises a wire 115 and associated material 120 on some portion of the wire.
  • Another optional clasping element 130 comprises a wire 135 and associated material 140 on some portion of the wire 135.
  • Some portion of the wires 115, 1355 is embedded within a body of a palatal element 105.
  • the material 120, 140 generally rests against outer surfaces of the teeth when the palatal element 105 is engaged to the roof of the mouth.
  • the wires 115, 135 can assist in removal of the removable oral device from the mouth and/or may assist in retaining the removable oral device in place.
  • palatal element 105 may also comprise one or more electrical components such as a processor 160 and a memory unit 170 coupled to the processor.
  • the electrical component can take many forms including electrodes, sensors, pressure membranes, cameras, microphones or other devices.
  • the palatal element 105 may also comprise one or more on-board transmitters/receivers to send and/or receive information to and from the removable oral device.
  • the palatal element can be configured to contact a roof of a user's mouth at a palatal surface and comprises a body comprising a thickness configured to lower a vaulted area of the roof of the mouth to decrease an overall oral volume of the mouth to a first oral volume.
  • the body comprises a variable hardness across a tongue surface of the body.
  • the clasping element when present, can be configured to assist in removal of the removable oral device from the mouth and to retain the palatal surface of the palatal element against the roof of the user's mouth when the removable oral device is inserted into the user's mouth.
  • a removable oral device comprises a palatal element coupled to a clasping element and a camera.
  • the camera can be within the body of the palatal element.
  • the camera can be configured to capture images of material placed in the mouth of the user.
  • a removable oral device comprises a palatal element coupled to a clasping element and at least one electrode.
  • the at least one electrode can be positioned within the body and exposed to fluid entering and exiting the mouth of the user.
  • the at least one electrode can be configured to measure athletic performance from the fluid entering and exiting the mouth of the user.
  • a removable oral device comprises a palatal element coupled to a clasping element and a bar code reader.
  • a bar code reader can be within the body of the palatal element.
  • the bar code reader is configured to read a bar code present on a material placed in the mouth of the user, e.g., food, a drug or other material.
  • a removable oral device comprises a palatal element coupled to a clasping element and a processor.
  • a processor and an optional memory unit may be within the body of the palatal element. If desired, the memory unit may comprise desired information such as a nutrition plan or an updatable electronic medical record of the user.
  • a removable oral device comprises a palatal element coupled to a clasping element and a piezoelectric sensor.
  • a piezoelectric sensor within the body of the palatal element can be present.
  • the piezoelectric sensor can be configured to measure movement of the upper jaw during chewing.
  • a removable oral device comprises a palatal element coupled to a clasping element and an accelerometer.
  • the accelerometer can be within the body of the palatal element. The accelerometer can be used for many different uses, e.g., the accelerometer can be configured to measure impact force.
  • a removable oral device comprises a palatal element coupled to a clasping element and an electrode.
  • the electrode can within the body of the palatal element and may be configured, for example, to measure bioelectrical impedance to determine a body fat percentage of the user.
  • a removable oral device comprising a palatal element and a clasping element
  • the clasping element may not include any supporting wires or other structures.
  • a removable oral device comprises a palatal element coupled to a clasping element, where the clasping element comprises a continuous wire structure terminating in the body of the palatal element, and wherein the continuous wire structure has a smaller outer wire diameter at termini of the wire structure within the clasping element than an outer wire diameter within the palatal element is described.
  • a clasping element can be coupled to each side of the palatal element.
  • the palatal element comprises a lower thickness at a front section adjacent to inner surfaces of the anterior teeth to reduce lisping compared to a thickness at an apex section of the palatal element.
  • a removable oral device comprises a palatal element coupled to a clasping element, wherein the palatal element comprises a thermally expandable material configured to increase its volume with increasing temperature to decrease the overall oral volume to a second oral volume less than the first oral volume.
  • a removable oral device may comprise a first palatal element and a second palatal element.
  • the first palatal element can be configured to reversibly couple to the second palatal element to decrease the overall oral volume of the mouth to a second oral volume less than the first oral volume.
  • a removable oral device comprises a palatal element coupled to a clasping element and a chewing sensor.
  • the chewing sensor can be configured to provide sensory feedback to the user between swallowing of food in the user's mouth.
  • the removable oral devices described herein can be used in combination with one or more separate external devices.
  • Various illustrations of separate external devices which can be used with a removable oral device are shown in FIG. 2.
  • the removable oral device 210 can be used with a computer system 220.
  • the removable oral device 210 can be used with a mobile device 230.
  • the removable oral device 210 can be used with wearable devices such as, for example, a fitness tracker 240, e.g., a watch based fitness tracker, a chest based fitness or heart rate tracker, spectacles 250 such as, for example, Google® glass or smart glasses or spectacles, or body sleeves, wrist sleeves, jewelry or other devices which can be worn by a user.
  • a fitness tracker 240 e.g., a watch based fitness tracker, a chest based fitness or heart rate tracker
  • spectacles 250 such as, for example, Google® glass or smart glasses or spectacles, or body sleeves, wrist sleeves, jewelry or other devices which can be worn by a user.
  • the removable device 210 can be used with case 260, e.g., one which can store, charge and/or transfer information to and/or from the removable oral device 210.
  • the removable oral device 210 can be used with a body composition monitor 270 to measure weight, body fat composition, etc.
  • Other external devices which can be used with the removable oral devices will be readily selected by the person of ordinary skill in the art, given the benefit of this disclosure.
  • the various external devices typically comprise common components such as a processor, one or more memory units and/or an operating system.
  • the external device typically is separate from the removable oral device, but a processor, memory chip or other device may be integrated into some component of the removable oral device as desired.
  • At least one processor can be electrically coupled to one or more memory units to receive input data and/or store any data.
  • the processor may be, for example an Intel PENTIUM- type processor, Motorola PowerPC, Sun UltraSPARC, Hewlett-Packard PA-RISC processors, or any other type of processor.
  • Various aspects of the systems and external device which include an on-board processor may be implemented as specialized software.
  • a processor can be, if desired, connected to one or more memory devices, such as a disk drive, memory, or other device for storing data. Memory is typically used for storing programs and data during use of the removable oral device. Electrical components of the external device and/or the systems described herein may be coupled by an interconnection device, which may include one or more buses (e.g., between components that are integrated within a same component) and/or a network (e.g., between components that reside on separate discrete components). The interconnection device provides for communications (e.g., signals, data, instructions) to be exchanged between components of the system. The processor and other components are electrically coupled to a power source.
  • an interconnection device may include one or more buses (e.g., between components that are integrated within a same component) and/or a network (e.g., between components that reside on separate discrete components).
  • the interconnection device provides for communications (e.g., signals, data, instructions) to be exchanged between components of the system.
  • the processor and other components
  • system or external device may comprise one or more interfaces that connect the processor to a separate device or system such as, for example, a communication network (in addition or as an alternative to the interconnection device).
  • interfaces include, but are not limited to, a serial ATA interface, ISA interface, PCI interface or the like or one or more wireless interfaces, e.g., a Bluetooth device, a Wi-Fi device, a Near Field Communication device, a cellular device or other wireless protocols and/or interfaces.
  • the storage system of the external device or the system typically includes a readable and writeable nonvolatile recording medium in which data can be stored.
  • the medium may, for example, be a solid state memory chip, solid state drive or flash memory.
  • the processor causes data to be read from the nonvolatile recording medium into another memory that allows for faster access to the information by the processor than does the medium.
  • This memory is typically a volatile, random access memory such as a dynamic random access memory (DRAM) or static memory (SRAM). It may be located in the storage system or in the memory system.
  • DRAM dynamic random access memory
  • SRAM static memory
  • a variety of mechanisms are known for managing data movement between the medium and the integrated circuit memory element and the technology is not limited thereto.
  • the technology is also not limited to a particular memory system or storage system.
  • the system or external device may also include specially-programmed, special- purpose hardware, for example, an application-specific integrated circuit (ASIC) or a field programmable gate array (FPGA).
  • ASIC application-specific integrated circuit
  • FPGA field programmable gate array
  • Aspects of the technology may be implemented in software, hardware or firmware, or any combination thereof.
  • the external device or system may use or include a high-level computer programming language or specially programmed, special purpose hardware.
  • the processor and any associated sensors or components of the external device or the system may together define a computer platform for which application programs in high-level programming languages may be written. It should be understood that the technology is not limited to a particular computer system platform, processor, operating system, or network. Also, it should be apparent to those skilled in the art, given the benefit of this disclosure, that the present technology is not limited to a specific programming language or computer system. Further, it should be appreciated that other appropriate programming languages and other appropriate electrical components could also be used. In certain examples, the hardware or software can be configured to implement cognitive architecture, neural networks or other suitable implementations.
  • various configurations may be programmed using an object-oriented programming language, such as SmallTalk, Basic, Java, C++, Ada, or C# (C-Sharp). Other obj ect-oriented programming languages may also be used. Alternatively, functional, scripting, and/or logical programming languages may be used.
  • Various configurations may be implemented in a non-programmed environment (e.g., documents created in HTML, XML or other format that, when viewed in a window of a browser program, render aspects of a graphical-user interface (GUI) or perform other functions). Certain configurations may be implemented as programmed or non-programmed elements, or any combination thereof.
  • object-oriented programming language such as SmallTalk, Basic, Java, C++, Ada, or C# (C-Sharp).
  • Other obj ect-oriented programming languages may also be used.
  • functional, scripting, and/or logical programming languages may be used.
  • Various configurations may be implemented in a non-programme
  • the external device may be configured as a mobile device, e.g., a phone or a tablet, that is configured to control use of (or monitor use of) the removable oral device.
  • the mobile device may wirelessly communicate with the removable oral device to send signals and receive signals or data from the removable oral device or can communicate with the removable oral device in a hard-wired manner.
  • the mobile device can be preprogrammed or pre-configured to implement certain operations that can automatically load from the mobile device onto the removable oral device. If desired, the mobile device can be designed for use with two or more different removable oral devices to permit a single mobile device to implement the same or different operations on the two or more removable oral devices.
  • the mobile device can couple to the removable oral device in a wired or wireless manner, e.g., using near field communication, Bluetooth, USB cables, Lighting cables, or other wireless devices or wired methods and protocols, to send and receive information from the mobile device to the removable oral device.
  • One or more menus can be present on the mobile device to permit the user to select the particular methodology of using the removable oral device.
  • the removable oral device itself may comprise any one or more of those components mentioned herein in connection with external devices and systems.
  • the removable oral device can be configured to transmit information remotely to an external device or system located in a distant position from the removable oral device. For example, as noted in more detail below, information from the removable oral device can be sent to a remote coach or user which can provide feedback to the user of the removable oral device. Such feedback may include a weight management schedule, exercise schedule, nutrition schedule or other guidance. The particular schedule can be personalized for the user based on the user's weight, weight goals, use of the removable oral device, etc.
  • a customized Diabetes Prevention program customized nutrition programs such as those offered by Jenny Craig, Nutri System and Weight Watchers or customized exercise plans or schedules can be prepared based on information from the user and/or information received from the removable oral device.
  • the schedule can be altered as the body mass index and/or body fat composition of the user decreases.
  • caloric intake can be reduced gradually, e.g., 1-5% each week, until the user starts to observe weight loss.
  • caloric consumption by way of exercise can be increased gradually, until the user starts to observe weight loss.
  • Such weight management schedules, nutrition schedules and exercise schedules can be provided in an automated format based on user selections from a graphical user interface or may be provided from a coach or human during in-office or remote sessions.
  • a mobile device based application can be used to guide the user in using the removable oral device, to guide weight management, nutrition, exercise and/or other features which can assist in the user losing weight and/or reducing the body mass index or body fat percentage.
  • Information from the application can be transferred to a remote device or a remote coach to further assist in monitoring weight loss.
  • the application can be configured to provide notifications, reminders, etc. regarding usage of the removable oral device and/or eating times and durations. If desired, videos, e-mails, webinars, etc., may also be available by way of the application or through an external device to assist the user in losing weight and/or maintaining a desired weight using the removable oral device.
  • a system 300 for monitoring intake into a mouth of a user comprises a removable oral device 310 with a camera 312 in combination with an external device 320.
  • the removable oral device 310 can be configured to removably insert into a mouth of a user and may comprise a palatal element coupled to a clasping element.
  • the palatal element is configured to contact a roof of a user's mouth at a palatal surface, the palatal element comprising a body comprising a thickness configured to lower a vaulted area of the roof of the mouth to decrease an overall oral volume of the mouth to a first oral volume.
  • the clasping element when present, can be configured to assist in removal of the removable oral device from the mouth and/or to retain the palatal surface of the palatal element against the roof of the user's mouth when the removable oral device is inserted into the user's mouth.
  • the palatal element comprises the camera 312 which is configured to capture images of the material in the mouth of the user.
  • the external device 320 is typically separate from the removable oral device and comprises a processor configured to couple to the removable oral device to transfer captured images from the camera 312 of the removable oral device 310 to the external device 320.
  • the removable oral device 310 comprises a variable hardness across the tongue surface of the body.
  • the removable oral device 310 comprises a rechargeable power source electrically coupled to the camera 312.
  • the removable oral device 310 comprises a transmitter.
  • the external device 320 is configured to wirelessly couple to the camera 312 of the removable oral device 310.
  • the camera 312 is configured to automatically switch on in response to a sensed temperature change. For example, insertion of the removable oral device 310 into the mouth can increase its temperature and cause the camera 312 to switch on. In other examples, the camera 312 is configured to automatically switch off in response to a second sensed temperature change.
  • removal of the removable oral device 310 from the mouth can decrease its temperature and cause the camera 312 to switch off.
  • the removable oral device 310 may comprise a memory unit configured to store the captured image.
  • the body of the palatal element comprises an optical window and the camera 312 is configured to capture the image through the optical window. While the removable oral device 310 can be used to assist in weight loss, the removable oral device 310 is configured to not alter a position of the user's teeth and/or is configured to not retain a position of the user's teeth.
  • a system 400 for monitoring athletic performance comprises a removable oral device 410 and an external device 420.
  • the removable oral device 410 is configured to removably insert into a mouth of the user.
  • the removable oral device 410 comprises a palatal element coupled to a clasping element.
  • the palatal element is configured to contact a roof of a user's mouth at a palatal surface and comprises a body comprising a thickness configured to lower a vaulted area of the roof of the mouth to decrease an overall oral volume of the mouth to a first oral volume.
  • the clasping element when present, can be configured to assist in removal of the removable oral device from the mouth and/or to retain the palatal surface of the palatal element against the roof of the user's mouth when the removable oral device is inserted into the user's mouth.
  • the palatal element comprises at least one electrode 412 positioned within the body of the palatal element and exposed to fluid entering and exiting the mouth of the user, the at least one electrode 412 configured to measure athletic performance from fluid entering and exiting the mouth of the user.
  • the electrode 412 can be configured as a selective electrode to measure one or more of oxygen, carbon dioxide, humidity in the oral cavity or other parameters.
  • the tip of the electrode 412 can be exposed to fluid in the mouth to measure the athletic performance parameter.
  • the external device 420 is typically separate from the removable oral device 410 and comprises a processor configured to couple to the removable oral device to transfer the measured athletic performance from the removable oral device 410 to the external device 420.
  • the body comprises a memory unit configured to store the measured athletic performance.
  • the electrode 412 is configured to measure one or more of oxygen, carbon dioxide and water as the measure of athletic performance.
  • the removable oral device 410 comprises a rechargeable power source electrically coupled to the at least one electrode 412.
  • the body comprises a transmitter configured to transmit the measured athletic performance wirelessly to the external device 420.
  • the electrode 412 is configured to automatically switch on in response to a sensed temperature change. For example, insertion of the removable oral device 410 into the mouth can increase its temperature and cause the electrode 412 to switch on.
  • the electrode 412 is configured to automatically switch off in response to a second sensed temperature change. For example, removal of the removable oral device 410 into the mouth can decrease its temperature and cause the electrode 412 to switch off.
  • the removable oral device 410 is configured to not alter a position of the user's teeth.
  • the removable oral device 410 is configured to not retain a position of the user's teeth. In further examples, the removable oral device 410 comprises a variable hardness across the tongue surface of the body.
  • a system 500 for monitoring intake of material into a mouth of a user comprises a removable oral device 510 comprising a bar code reader 512 and an external device 520.
  • the removable oral device 510 comprises a palatal element coupled to a clasping element.
  • the palatal element can be configured to contact a roof of a user's mouth at a palatal surface.
  • the palatal element comprises a body comprising a thickness configured to lower a vaulted area of the roof of the mouth to decrease an overall oral volume of the mouth to a first oral volume.
  • the clasping element when present, can be configured to assist in removal of the removable oral device from the mouth and/or to retain the palatal surface of the palatal element against the roof of the user's mouth when the removable oral device is inserted into the user's mouth.
  • the palatal element comprises the bar code reader within the body of the palatal element, wherein the bar code reader is configured to read a bar code on the material entering the mouth of the user.
  • the external device 520 is typically separate from the removable oral device 510 and comprises a processor configured to couple to the removable oral device 510 to transfer the measured bar code from the removable oral device 510 to the external device 520.
  • the material is configured as an opioid pill or tablet comprising a bar code on at least one surface.
  • the material is configured as narcotic pill or tablet comprising a bar code on at least one surface.
  • the material is configured as food comprising a bar code on at least one surface.
  • the removable oral device 510 is configured to not alter a position of the user's teeth.
  • the removable oral device 510 is configured to not retain a position of the user's teeth.
  • the removable oral device 510 comprises a variable hardness across the tongue surface of the body.
  • a system 600 comprises a removable oral device 610 with a memory unit 612 and an external device 620.
  • the removable oral device 610 comprises a palatal element coupled to a clasping element.
  • the palatal element can be configured to contact a roof of a user's mouth at a palatal surface.
  • the palatal element comprises a body comprising a thickness configured to lower a vaulted area of the roof of the mouth to decrease an overall oral volume of the mouth to a first oral volume.
  • the clasping element when present, can be configured to assist in removal of the removable oral device from the mouth and/or to retain the palatal surface of the palatal element against the roof of the user's mouth when the removable oral device is inserted into the user's mouth.
  • the palatal element comprises the memory unit 612 configured to receive and store an electronic medical record of the user.
  • the external device 620 is typically separate from the removable oral device 610 and comprises a processor configured to couple to the removable oral device 610 to read and update the electronic medical record on the removable oral device 610.
  • the processor is configured to couple to the removable oral device 610 wirelessly to update the electronic medical record.
  • the removable oral device 610 is configured to not alter a position of the user's teeth.
  • the removable oral device 610 is configured to not retain a position of the user's teeth.
  • the removable oral device 610 comprises a variable hardness across the tongue surface of the body.
  • the removable oral device 710 comprises a palatal element coupled to a clasping element, wherein the palatal element is configured to contact a roof of a user's mouth at a palatal surface.
  • the palatal element comprises a body comprising a thickness configured to lower a vaulted area of the roof of the mouth to decrease an overall oral volume of the mouth to a first oral volume.
  • the clasping element when present, can be configured to assist in removal of the removable oral device from the mouth and/or to retain the palatal surface of the palatal element against the roof of the user's mouth when the removable oral device 710 is inserted into the user's mouth.
  • the palatal element comprises at least one sensor 712 positioned within the body of the palatal element and exposed to fluid entering and exiting the mouth of the user.
  • the at least one sensor 712 can be configured to measure a physiological parameter from fluid entering and exiting the mouth of the user.
  • the system 700 also comprises an external device 720 separate from the removable oral device 710, in which the external device 720 comprises a processor configured to couple to the removable oral device 710 to transfer the measured physiological parameter from the removable oral device 710 to the external device 720.
  • the senor 712 is configured to measure electrolyte levels in the fluid, e.g., the sensor 712 can be configured as an ion selective electrode to measure one or more ions in the fluid. In other embodiments, the sensor 712 is configured to measure ketone bodies in the fluid, e.g., the sensor 712 can be configured to cause release of colorimetric reagents to detect the ketone bodies. In some examples, the sensor 712 is configured to measure salivary insulin levels in the fluid, e.g., the sensor 712 can be measured using glucose oxidase in the sensor or other enzymatic or colorimetric methods.
  • the senor 712 is configured to measure a gas other than oxygen in the fluid, e.g., can measure carbon dioxide or nitrogen.
  • the sensor is configured to measure carbohydrate levels in the fluid, e.g., the sensor 712 can be configured to use enzymatic or colorimetric methods to measure sugars.
  • the sensor 712 is configured to measure oxygen levels in the fluid, e.g., using an oxygen sensor or oxygen sensitive electrode.
  • the sensor 712 is configured to measure carbon dioxide levels in the fluid.
  • sensor 712 is configured to measure a respiration rate, e.g., by monitoring air currents and/or oxygen levels.
  • the sensor 712 is configured to measure fluid intake, e.g., using a humidity sensor. In other examples, the sensor 712 is configured to measure heart rate, e.g., by monitoring the heart beat in the roof of the mouth using a piezoelectric sensor, electrocardiograph or other devices.
  • the removable oral device 710 comprises a second sensor configured to measure a different physiological parameter than the sensor 712. In certain examples, the removable oral device 710 is configured to not alter a position of the user's teeth. In other examples, the removable oral device 710 is configured to not retain a position of the user's teeth. In some embodiments, the removable oral device 710 comprises a variable hardness across the tongue surface of the body.
  • the removable oral device 810 comprises a palatal element coupled to a clasping element, wherein the palatal element is configured to contact a roof of a user's mouth at a palatal surface, and wherein the palatal element comprises a body comprising a thickness configured to lower a vaulted area of the roof of the mouth to decrease an overall oral volume of the mouth to a first oral volume.
  • the clasping element when present, can be configured to assist in removal of the removable oral device from the mouth and/or to retain the palatal surface of the palatal element against the roof of the user's mouth when the removable oral device is inserted into the user's mouth.
  • the palatal element comprises the accelerometer 812 within the body of the palatal element, the accelerometer 812 being configured to detect head movement to monitor the head tremor.
  • the external device 820 is separate from the removable oral device 810 and comprises a processor configured to couple to the removable oral device 810 to transfer the detected head movement measured by the accelerometer 812 to the external device 820.
  • the accelerometer 812 is configured to measure head movement at selected intervals. In some examples, the accelerometer 812 is configured to automatically switch off between the selected intervals where the accelerometer measures head movement. In other examples, the accelerometer 812 is configured to automatically switch on when the accelerometer measures head movement.
  • the removable oral device 810 comprises a second accelerometer. In some examples, the removable oral device 810 is configured to not alter a position of the user's teeth. In other examples, the removable oral device 810 is configured to not retain a position of the user's teeth. In some configurations, the removable oral device 810 comprises a variable hardness across the tongue surface of the body.
  • a system 900 for monitoring head impact comprises a removable oral device 900 comprising an accelerometer 912 and an external device 920.
  • the removable oral device 910 comprises a palatal element coupled to a clasping element, wherein the palatal element is configured to contact a roof of a user's mouth at a palatal surface, and wherein the palatal element comprises a body comprising a thickness configured to lower a vaulted area of the roof of the mouth to decrease an overall oral volume of the mouth to a first oral volume.
  • the clasping element when present, can be configured to assist in removal of the removable oral device from the mouth and/or to retain the palatal surface of the palatal element against the roof of the user's mouth when the removable oral device is inserted into the user's mouth.
  • the palatal element comprises the accelerometer 912 within the body of the palatal element.
  • the accelerometer 912 is configured to detect head movement, e.g., head movement rates, to monitor the head impact.
  • the external device 920 is separate from the removable oral device and comprises a processor configured to couple to the removable oral device to transfer the detected head movement measured by the accelerometer to the external device.
  • the removable oral device 910 can be configured for wear during athletic activities such as football, soccer, rugby, automotive racing or other sports where participant impact with each other or another object may occur.
  • the accelerometer 912 is configured to measure head impact at selected intervals. In certain examples, the accelerometer 912 is configured to automatically switch off between the selected intervals where the accelerometer measures head impact. In some examples, the accelerometer 912 is configured to automatically switch on when the accelerometer measures head impact. In other embodiments, the removable oral device 910 comprises a second accelerometer to measure head impact. In some examples, the removable oral device 910 comprises a motion sensor, wherein the accelerometer 912 is automatically switched on when the motion sensor senses user motion. In some embodiments, the removable oral device 910 is configured to not alter a position of the user's teeth. In certain examples, the removable oral device 910 is configured to not retain a position of the user's teeth. In other examples, the removable oral device 910 comprises a variable hardness across the tongue surface of the body.
  • a system 1000 configured to monitor chewing comprises a removable oral device 1010 comprises a piezoelectric sensor
  • the removable oral device 1010 comprises a palatal element coupled to a clasping element, wherein the palatal element is configured to contact a roof of a user's mouth at a palatal surface, and wherein the palatal element comprises a body comprising a thickness configured to lower a vaulted area of the roof of the mouth to decrease an overall oral volume of the mouth to a first oral volume.
  • the clasping element when present, can be configured to assist in removal of the removable oral device from the mouth and/or to retain the palatal surface of the palatal element against the roof of the user's mouth when the removable oral device is inserted into the user's mouth.
  • the palatal element comprises the piezoelectric sensor 1012 within the body of the palatal element.
  • the piezoelectric sensor 1012 is configured to measure pressure changes to monitor chewing.
  • the external device 1020 is separate from the removable oral device 1010 and comprises a processor configured to couple to the removable oral device 1010 to transfer the measured pressure changes to the external device 1020.
  • the piezoelectric sensor 1012 is configured to automatically switch on when the palatal element reaches a selected temperature.
  • the palatal element is configured with a device configured to provide the user sensor feedback after the piezoelectric sensor 1012 measures a selected number of chews.
  • the sensory feedback is configured as an audible alert or as a vibration.
  • the palatal element is configured with a second piezoelectric sensor.
  • the removable oral device 1010 is configured to not alter a position of the user's teeth.
  • the removable oral device 1010 is configured to not retain a position of the user's teeth.
  • the removable oral device 1010 comprises a variable hardness across the tongue surface of the body.
  • the removable oral device 1110 comprises a palatal element coupled to a clasping element, wherein the palatal element is configured to contact a roof of a user's mouth at a palatal surface, and wherein the palatal element comprises a body comprising a thickness configured to lower a vaulted area of the roof of the mouth to decrease an overall oral volume of the mouth to a first oral volume.
  • the clasping element when present, can be configured to assist in removal of the removable oral device from the mouth and/or to retain the palatal surface of the palatal element against the roof of the user's mouth when the removable oral device 1110 is inserted into the user's mouth.
  • the palatal element comprises the microphone 1112 configured to monitor chewing by measuring a change in decibel levels within the mouth.
  • the external device 1120 is separate from the removable oral device 1110 and comprises a processor configured to couple to the removable oral device 1110 to transfer the measured change in decibel levels within the mouth to the external device.
  • the microphone 1112 is configured with a speaker to provide a sensory feedback after the change in decibel levels has been measured for a selected period.
  • the microphone can be used to monitor the duration of chewing and after a selected time an audible or other sensory cue can be provided through the speaker.
  • the sensory feedback is configured as an audible alert or as a vibration.
  • the palatal element is configured with a second microphone.
  • the palatal element is configured with a recording medium to record audio, e.g., a memory unit.
  • the removable oral device 1110 is configured to not alter a position of the user's teeth.
  • the removable oral device 1110 is configured to not retain a position of the user's teeth.
  • the removable oral device 1110 comprises a variable hardness across the tongue surface of the body.
  • a system 1200 configured to monitoring chewing comprises a removable oral device 1210 comprising a proximity sensor 1212 and an external device 1220 (see FIG. 12).
  • the removable oral device 1210 comprises a palatal element coupled to a clasping element, wherein the palatal element is configured to contact a roof of a user's mouth at a palatal surface, and wherein the palatal element comprises a body comprising a thickness configured to lower a vaulted area of the roof of the mouth to decrease an overall oral volume of the mouth to a first oral volume.
  • the clasping element when present, can be configured to assist in removal of the removable oral device from the mouth and/or to retain the palatal surface of the palatal element against the roof of the user's mouth when the removable oral device 1210 is inserted into the user's mouth.
  • the palatal element comprises a proximity sensor 1212 configured to monitor chewing by measuring a distance change between the proximity sensor 1212 and a sensor coupled to a lower tooth of the user (not shown).
  • the sensor coupled to the lower tooth may be a sensor, contact or other device which can be used with the sensor 1212 to measure a distance change between the two components.
  • the external device 1220 external device is separate from the removable oral device and comprises a processor configured to couple to the removable oral device to transfer the measured distance change to the external device.
  • the proximity sensor 1212 is configured to measure contact of the proximity sensor 1212 to the sensor coupled to the lower tooth of the user. In some examples, the proximity sensor 1212 is configured to detect a radio wave emitted by the sensor coupled to the lower tooth of the user. In other examples, the proximity sensor 1212 is configured to detect light emission emitted by the sensor coupled to the lower tooth of the user. In certain examples, the proximity sensor 1212 is configured to detect an ultrasound wave emitted by the sensor coupled to the lower tooth of the user. In some examples, the removable oral device 1210 is configured to not alter a position of the user's teeth. In other examples, the removable oral device 1210 is configured to not retain a position of the user's teeth. In further examples, the removable oral device 1210 comprises a variable hardness across the tongue surface of the body.
  • the removable oral device 1310 comprises a palatal element coupled to a clasping element, wherein the palatal element is configured to contact a roof of a user's mouth at a palatal surface, and wherein the palatal element comprises a body comprising a thickness configured to lower a vaulted area of the roof of the mouth to decrease an overall oral volume of the mouth to a first oral volume.
  • the clasping element when present, can be configured to assist in removal of the removable oral device 1310 from the mouth and/or to retain the palatal surface of the palatal element against the roof of the user's mouth when the removable oral device 1310 is inserted into the user's mouth.
  • the palatal element comprises the vibratory device 1312 configured to vibrate after the user has chewed a selected number of times to provide feedback to the user to swallow the chewed material. If desired, the vibratory element 1312 can be used in combination with a motion sensor to monitor the number of chews
  • the external device 1320 is separate from the removable oral device 1310 and comprises a processor configured to couple to the removable oral device 1310 to transfer the selected number of times to the external device 1320.
  • the palatal element is configured with a chewing sensor electrically coupled to the vibratory device 1312, e.g., a motion sensor, piezoelectric sensor, etc.
  • the clasping element is configured with a chewing sensor electrically coupled to the vibratory device.
  • the removable oral device 1310 is configured to not alter a position of the user's teeth. In other instances, the removable oral device 1310 is configured to not retain a position of the user's teeth. In some examples, the removable oral device 1310 comprises a variable hardness across the tongue surface of the body.
  • the removable oral device 1410 comprises a palatal element coupled to a clasping element, wherein the palatal element is configured to contact a roof of a user's mouth at a palatal surface, and wherein the palatal element comprises a body comprising a thickness configured to lower a vaulted area of the roof of the mouth to decrease an overall oral volume of the mouth to a first oral volume.
  • the clasping element when present, can be configured to assist in removal of the removable oral device 1410 from the mouth and/or to retain the palatal surface of the palatal element against the roof of the user's mouth when the removable oral device 1410 is inserted into the user's mouth.
  • the palatal element comprises the food sensor 1412 that is configured to sense presence of the food in the user's mouth and absence of the food in the user's mouth as an indicator the food has been swallowed.
  • the palatal element is configured to provide feedback to the user once a selected number of swallows has been reached.
  • the external device 1420 is separate from the removable oral device and comprises a processor configured to couple to the removable oral device to transfer the number of swallows to the external device.
  • the food sensor 1412 is configured to use light, ultrasound waves, radio waves or other energy to sense whether or not food is present or absent in the mouth. For example, diffracted light can be used as a measure of food being present or absent.
  • the removable oral device 1410 is configured to not alter a position of the user's teeth. In other examples, the removable oral device 1410 is configured to not retain a position of the user's teeth. In some embodiments, the removable oral device 1410 comprises a variable hardness across the tongue surface of the body.
  • the removable oral device 1510 comprises a palatal element coupled to a clasping element, wherein the palatal element is configured to contact a roof of a user's mouth at a palatal surface, and wherein the palatal element comprises a body comprising a thickness configured to lower a vaulted area of the roof of the mouth to decrease an overall oral volume of the mouth to a first oral volume.
  • the clasping element when present, can be configured to assist in removal of the removable oral device 1510 from the mouth and/or to retain the palatal surface of the palatal element against the roof of the user's mouth when the removable oral device 1510 is inserted into the user's mouth.
  • the palatal element comprises a processor 1514 and a memory unit 1515 electrically coupled to the processor 1514, and wherein the palatal element comprises a sensor 1512 electrically coupled to the processor 1514.
  • the external device 1520 is separate from the removable oral device, in which the external device comprises a processor configured to couple to the removable oral device 1510 to transfer the measured nutrient species in the material to the external device 1520.
  • the senor 1512 is configured to measure carbohydrate content of the material. In other examples, the sensor is configured to measure protein content of the material. In some examples, the sensor is configured to measure fat content of the material. In some embodiments, the sensor 1512 is configured to measure water content of the material. In other examples, the removable oral device 1510 is configured to not alter a position of the user's teeth. In some embodiments, the removable oral device 1510 is configured to not retain a position of the user's teeth. In some examples, the removable oral device 1510 comprises a variable hardness across the tongue surface of the body.
  • the removable oral device 1610 comprises a palatal element coupled to a clasping element, wherein the palatal element is configured to contact a roof of a user's mouth at a palatal surface, and wherein the palatal element comprises a body comprising a thickness configured to lower a vaulted area of the roof of the mouth to decrease an overall oral volume of the mouth to a first oral volume.
  • the clasping element when present, can be configured to assist in removal of the removable oral device 1612 from the mouth and/or to retain the palatal surface of the palatal element against the roof of the user's mouth when the removable oral device 1612 is inserted into the user's mouth.
  • the palatal element comprises a processor and a memory unit electrically coupled to the processor, and wherein the palatal element comprises the multiplexing sensor 1612 electrically coupled to the processor and configured to simultaneously measure caloric content of all the material entering into the user's mouth, e.g., the sensor 1612 can measure and sum the calories entering the user's mouth.
  • the external device 1620 separate from the removable oral device 1610.
  • the external device comprises a processor configured to couple to the removable oral device 1610 to transfer the measured caloric content from the removable oral device 1610 to the external device 1620.
  • the multi-plexing sensor 1612 may comprise an electrode, a colorimetric sensor, an optical sensor and/or combinations thereof to measure protein, fat and carbohydrate caloric content of material entering into the user's mouth.
  • the palatal element is configured with a sensory feedback device configured to provide a sensory cue once the measured caloric content reached a selected level.
  • the sensory cue is configured as an audible noise or a vibration.
  • the removable oral device 1610 is configured to not alter a position of the user's teeth.
  • the removable oral device 1610 is configured to not retain a position of the user's teeth.
  • the removable oral device 1610 comprises a variable hardness across the tongue surface of the body.
  • the removable oral device 1710 comprises a palatal element coupled to a clasping element, wherein the palatal element is configured to contact a roof of a user's mouth at a palatal surface, and wherein the palatal element comprises a body comprising a thickness configured to lower a vaulted area of the roof of the mouth to decrease an overall oral volume of the mouth to a first oral volume.
  • the clasping element when present, can be configured to assist in removal of the removable oral device 1710 from the mouth and/or to retain the palatal surface of the palatal element against the roof of the user's mouth when the removable oral device 1710 is inserted into the user's mouth.
  • the palatal element comprises a processor, a memory unit electrically coupled to the processor and the transmitter/receiver 1712 electrically coupled to the processor, in which the processor is configured to transmit the recorded material intake to a site outside of the mouth of the user.
  • the external device 1720 is separate from the removable oral device, in which the external device comprises a processor configured to couple to the removable oral device to receive the transmitted, recorded material intake.
  • the transmitter/receiver 1712 comprises one or more of a
  • the transmitter/receiver 1712 is configured to be in an off state when the removable oral device 1710 is inserted into the mouth of the user. In other examples, the transmitter/receiver 1712 is configured to automatically switch from the off state to an on state when the removable oral device is removed from the mouth of the user.
  • the removable oral device is configured with a temperature sensor configured to determine when the removable oral device is removed from the mouth of the user. In certain examples, the removable oral device is configured to not alter a position of the user's teeth. In some embodiments, the removable oral device is configured to not retain a position of the user's teeth. In certain examples, the removable oral device comprises a variable hardness across the tongue surface of the body.
  • the removable oral device 1810 comprises a palatal element coupled to a clasping element, wherein the palatal element is configured to contact a roof of a user's mouth at a palatal surface, and wherein the palatal element comprises a body comprising a thickness configured to lower a vaulted area of the roof of the mouth to decrease an overall oral volume of the mouth to a first oral volume.
  • the clasping element when present, can be configured to assist in removal of the removable oral device 1810 from the mouth and/or to retain the palatal surface of the palatal element against the roof of the user's mouth when the removable oral device is inserted into the user's mouth.
  • the palatal element comprises a processor, a memory unit electrically coupled to the processor and the pressure sensor 1812 electrically coupled to the processor.
  • the external device 1820 is separate from the removable oral device 1810, in which the external device 1820 comprises a processor configured to couple to the removable oral device 1810 to receive pressure measurements from the pressure sensor 1812.
  • the pressure sensor 1812 is configured as a piezoelectric sensor or a device comprising a pressure sensitive membrane.
  • the removable oral device 1810 is configured to not alter a position of the user's teeth.
  • the removable oral device 1810 is configured to not retain a position of the user's teeth.
  • the removable oral device 1810 comprises a variable hardness across the tongue surface of the body.
  • a system 1900 configured to transfer information present on a removable oral device 1910 comprises a removable oral device 1910 comprising a transmitter/receiver 1912 and a case 1920.
  • the removable oral device 1910 comprises a palatal element coupled to a clasping element, wherein the palatal element is configured to contact a roof of a user's mouth at a palatal surface, and wherein the palatal element comprises a body comprising a thickness configured to lower a vaulted area of the roof of the mouth to decrease an overall oral volume of the mouth to a first oral volume.
  • the clasping element when present, can be configured to assist in removal of the removable oral device 1910 from the mouth and/or to retain the palatal surface of the palatal element against the roof of the user's mouth when the removable oral device 1910 is inserted into the user's mouth.
  • the palatal element comprises a processor, a memory unit electrically coupled to the processor and a transmitter/receiver 1912 electrically coupled to the processor.
  • the case 1920 is configured to receive and store the removable oral device 1910.
  • the case 1920 comprises a transmitter/receiver to receive the information from the transmitter/receiver 1912 of the removable oral device 1910 to transfer the information present on the removable oral device 1910 when the removable oral device 1910 is inserted into the case 1920.
  • the removable oral device 1910 is configured to transfer the information to the case 1920 wirelessly. In other embodiments, the removable oral device 1910 is configured to transfer the information to the case 1920 in a wired manner, e.g., through a cable or other hard-wired connection. In some examples, the case 1920 is configured to recharge the removable oral device 1910 when the removable oral device 1910 contacts the case 1920 or is within the case 1920. In certain examples, the case 1920 is configured to wirelessly recharge the removable oral device 1910 when the removable oral device 1910 contacts the case
  • the removable oral device 1910 is configured to not alter a position of the user's teeth. In some instances, the removable oral device 1910 is configured to not retain a position of the user's teeth. In other examples, the removable oral device 1910 comprises a variable hardness across the tongue surface of the body.
  • the removable oral device comprises a palatal element coupled to a clasping element, wherein the palatal element is configured to contact a roof of a user's mouth at a palatal surface, and wherein the palatal element comprises a body comprising a thickness configured to lower a vaulted area of the roof of the mouth to decrease an overall oral volume of the mouth to a first oral volume.
  • the clasping element when present, can be configured to assist in removal of the removable oral device 2010 from the mouth and/or to retain the palatal surface of the palatal element against the roof of the user's mouth when the removable oral device 2010 is inserted into the user's mouth.
  • the palatal element comprises the electrode 2012.
  • the external device 2020 is separate from the removable oral device and comprises a processor configured to couple to the removable oral device 2010 to receive electrical measurements from the electrode 2012 and determine the body fat percentage using the received electrical measurements. If desired, the external device 2020 may comprise its own electrode and power source to permit measurement of a current or voltage provided from the electrode of the external device 2020 by the electrode 2012 of the removable oral device 2010.
  • the removable oral device 2010 is configured to not alter a position of the user's teeth. In other examples, the removable oral device 2010 is configured to not retain a position of the user's teeth. In some examples, the removable oral device 2010 comprises a variable hardness across the tongue surface of the body.
  • the removable oral device 2110 comprises a palatal element coupled to a clasping element, wherein the palatal element is configured to contact a roof of a user's mouth at a palatal surface, and wherein the palatal element comprises a body comprising a thickness configured to lower a vaulted area of the roof of the mouth to decrease an overall oral volume of the mouth to a first oral volume.
  • the clasping element when present, can be configured to assist in removal of the removable oral device 2110 from the mouth and/or to retain the palatal surface of the palatal element against the roof of the user's mouth when the removable oral device 2110 is inserted into the user's mouth.
  • the palatal element comprises the processor 2112.
  • the mobile device 2120 is separate from the removable oral device 211 and is configured to receive information from the processor 2112 of the removable oral device 2110.
  • the exact configuration of the mobile device may vary from, for example, a cellular phone, a tablet, a laptop computer, a wearable device or other mobile devices.
  • the mobile device 2120 is configured to monitor usage duration of the removable oral device. In other examples, the mobile device 2120 is configured to monitor usage frequency of the removable oral device. In further examples, the removable oral device 2120 is configured to not alter a position of the user's teeth. In some examples, the removable oral device 2120 is configured to not retain a position of the user's teeth. In some instances, the removable oral device 2120 comprises a variable hardness across the tongue surface of the body.
  • a system 2200 comprises a removable oral device 2210 comprising a processor 2212 and a wearable device 2220.
  • the removable oral device 2210 comprises a palatal element coupled to a clasping element, wherein the palatal element is configured to contact a roof of a user's mouth at a palatal surface, and wherein the palatal element comprises a body comprising a thickness configured to lower a vaulted area of the roof of the mouth to decrease an overall oral volume of the mouth to a first oral volume.
  • the clasping element when present, can be configured to assist in removal of the removable oral device 2210 from the mouth and to retain the palatal surface of the palatal element against the roof of the user's mouth when the removable oral device 2210 is inserted into the user's mouth.
  • the palatal element comprises the processor 2212.
  • the wearable device 2220 is separate from the removable oral device 2210 and comprises a processor configured to receive information from the processor 2212 of the palatal element.
  • the wearable device 2220 is configured as a wrist device, e.g., a Fitbit device, Apple Iwatch, etc.
  • the wearable device is configured as spectacles, e.g., Google glass or other spectacles or eyeglasses which comprise a processor and/or on-board power source or other electrical components.
  • the wearable device is configured as a contact lens, e.g., a contact lens comprising a processor.
  • the wearable device is configured as a belt, a garment, footwear, jewelry, a necklace, wristband, ankle band, head band or other devices which are worn by a user.
  • the removable oral device 2210 is configured to not alter a position of the user's teeth. In other examples, the removable oral device 2210 is configured to not retain a position of the user's teeth. In some examples, the removable oral device 2210 comprises a variable hardness across the tongue surface of the body.
  • a system configured to produce a removable oral device comprises a three-dimensional printer 2310 comprising a processor configured to receive three-dimensional coordinates from an image of an oral cavity of a human mouth.
  • the printer 2310 can be configured to print a removable oral device using the three dimensional coordinates.
  • the printed removable oral device comprises a palatal element coupled to a clasping element, in which the palatal element is configured to contact a roof of a user's mouth at a palatal surface, and wherein the palatal element comprises a body comprising a thickness configured to lower a vaulted area of the roof of the mouth to decrease an overall oral volume of the mouth to a first oral volume.
  • the clasping element when present, can be configured to assist in removal of the removable oral device from the mouth and/or to retain the palatal surface of the palatal element against the roof of the user's mouth when the removable oral device is inserted into the user's mouth.
  • the printer 2310 is configured to print areas of the body adjacent to the clasping element using a second material softer than the first material. In other examples, the printer 2310 is configured to three-dimensionally print the palatal element using a photo-curable material. In some configurations, the printer 2310 is configured to print the photo-curable material onto a printer support comprising the one or more wires to provide the removable oral device. In some examples, the system is configured to photo-cure the printed palatal element using UV/Visible light. In other examples, the printer 2310 is configured to print each of the palatal element and the clasping element using a photo-curable material. In further examples, the printer 2310 is configured as an inkjet three-dimensional printer.
  • the printer 2310 is configured to use digital light processing. In further examples, the printer 2310 is configured to three-dimensionally print the removable oral device from a digital image of the user's mouth. In other examples, the printer 2310 is configured to print the palatal element of the digital image using a photo-curable material. In some embodiments, the printer 2310 is configured to print a photo-curable material onto a printer support comprising the one or more wires to provide the removable oral device. In further examples, the printed removable oral device is configured to not alter a position of the user's teeth. In other examples, the printed removable oral device is configured to not retain a position of the user's teeth. In other configurations, the printed removable oral device comprises a variable hardness across the tongue surface of the body.
  • three-dimensional printing used to produce the components of the removable oral device may vary.
  • Illustrative three- dimensional printing technologies include, but are not limited to, selective laser sintering (SLS), fused deposition molding (FDM), laminate object manufacturing (LOM), rapid prototyping, and three-dimensional inkjet printing.
  • SLS selective laser sintering
  • FDM fused deposition molding
  • LOM laminate object manufacturing
  • Three-dimensional printing methods using digital light processing (DLP) or an injection through a series of tiny nozzles or a single nozzle may use photo-curable materials which can be cured by UV/Vis light. These two methods are rapid, low cost, high resolution, and east to use.
  • Three-dimensional articles can be produced using ink-jet printing techniques that can use several different materials, e.g., from different reservoirs or cartridge, to provide a photo-curable liquid compositions which can be cured by exposure to UV/Vis light.
  • the photo-curable "ink" in the ink-jet printing process is provided through one or more nozzles on a support stage with a pattern defined by a computer aided design file or other three-dimensional coordinates.
  • successive layers of the palatal element can be "built up" by placing individual layers on the printer support and curing, at least to some degree, the printed layer prior to addition of successive layers. Layers can be added in individual areas until a desired final shape is reached.
  • the final three-dimensionally printed removable oral device can then be washed or treated with one or more other materials if desired.
  • the photo-curable liquid can be placed in a reservoir. Exposure of certain areas to the curing light can provide layers which can be used to build up the removable oral device. Once a layer has been cured by UV/Vis light, a building platform moves in the z-direction depending on the thickness of the layer. This process is repeated until all layers are formed and/or a desired shape is formed.
  • Illustrative three-dimensional printers include, but are not limited to, those commercially available from Objet or Master supplied by Carima and The Form 1 supplied by Formlabs.
  • the materials used by the three-dimensional printer may be photo-curable, heat curable, UV curable or cured by adding one or more external curing agents to the printed palatal element to harden the materials.
  • the exact materials uses include, but are not limited to, acrylates, methacrylates, acrylic polymers and co-polymers, functionalized bisphenol A methacrylates such as a monofunctional bisphenol A dimethacrylate or a difunctional bisphenol A dimethacrylate, a diglycidyl methacrylate ester of bisphenol-A or a bisphenol-A diglycidyl ether and other materials.
  • the printed palatal element of the removable oral device may comprise one or more of ethylene glycol dimethacrylate, diethylene glycol dimethacrylate, triethylene glycol dimethacrylate, polyethylene glycol dimethacrylate, 2,2 bis[4-(methacryloxy ethoxy)phenyl]propane, tricyclodecane dimethanol dimethacrylate, 1, 10-decanediol dimethacrylate, 1,6-hexanediol dimethacrylate, 1,9-nonanediol dimethacrylate, neopentyl glycol dimethacrylate, 2-hydroxy 1-3 dimethacryloxy propane, trimethylolpropane trimethacrylate, ethoxylated trimethylol propane trimethacrylate, ditrimethyolpropane tetramethacrylate, tris (2-hydroxy ethyl)isocyanurate trimethacrylate, dipentaerythritol pen
  • the exact material used or combinations of the materials used can be selected to provide a palatal element which provides sufficient hardness to permit chewing but is not so hard as to be uncomfortable in the mouth.
  • the material can be cured to provide a feel similar to the native roof of the mouth.
  • the clasping element of the removable oral device may also be printed or the palatal element can be printed with the clasping element or elements present on the printer support.
  • a clasping element in the form of a metal wire can be present on the printer stage, and the palatal element can be printed onto the clasping element to provide the removable oral device with an embedded wire as a clasping element.
  • the printed palatal element can be heat cured by placing it in an oven to harden the body of the palatal element. If desired, heat tape or other materials can be placed at the edges of the palatal element to prevent hardening of these areas to the same degree as an apex portion of the body. In other examples, one or more curing agent can be deposited onto the entire body of the palatal element or just at apex areas to provide softer edges when the palatal element is cured.
  • one or more photo-curing agents can be added to the printed palatal element (or clasping element or both) or may be present in the "ink" used to print the palatal element.
  • the polymeric material of the palatal element can be mixed with a photo-curing agent and the mixture is deposited in additive layers to form the palatal element.
  • Illustrative photo-curing agents include, but are not limited to, acetophenone, anisoin, anthraquinone, (benzene)tricarbonylchromium, benzil, benzoin, benzoin ethyl ether, benzoin isobutyl either, benzoin methyl ether, benzophenone, 3,3',4,4'-benzophenonetetracarboxylic dianhydride, 4-benzoylbiphenyl, 2-benzyl-2-(dimethylamino)-4'-morpholinobutyrophenone, 4,4'-bis(diethylamino)benzophenone, 4,4'-bis(dimethylamino)benzophenone, camphorquinone, 2-chlorothioxanthen-9-one, (cumene)cyclopentadienyliron(II)hexafluorophosphate, dibenzosuberenone, 2,2-diethoxyacetophenone, 4,4
  • 2,6-dichlorobenzoyldiphenylphosphine oxide 2,4,6-trimethylbenzoylmethoxyphenylphosphine oxide, 2,4,6-trimethylbenzoylethoxyphenylphosphine oxide, 2,3,5,6- tetramethylbenzoyldiphenylphosphine oxide, and benzoyl di-(2,6-dimethylphenyl)phosphonate.
  • bisacylphosphine oxides include bis-(2,6-dichlorobenzoyl)phenylphosphine oxide, bis-(2,6-dichlorobenzoyl)-2,5-dimethylphenylphosphine oxide, bis-(2,6-dichlorobenzoyl)- 4-prophylphenylphosphine oxide, bis-(2,6-dichlorobenzoyl)-l-naphthylphosphine oxide, bis- (2,6-dimethoxybenzoyl)-2,4,4-trimethylpentylphosphine oxide, bis-(2,6-dimethoxybenzoyl)-2,5- dimethylphenylphosphine oxide, bis-(2,4,6-trimethylbenzoyl)phenylphosphine oxide, (2,5,6- trimethylbenzoyl)-2,4,4-trimethylpentylphosphine oxide and those compounds commercially available from Dow Chemical Company as UVI 6
  • the printed palatal element may comprise fillers, particles, powders, reinforcing materials, etc. to impart overall desired physical properties to the removable oral device.
  • fillers particles, powders, reinforcing materials, etc.
  • silica based powders, fillers, fibers, etc. can be added to the removable oral device.
  • carbon fibers or particles can be added to the palatal element to alter its overall strength and/or weight.
  • Pigments, colorants, dyes, texturizing agents, UV stabilizers, or other materials may also be present.
  • the printer may include a reader which can read or scan a prescription or bar code specifying the removable oral device parameters. The read parameters can then be used to print some or all of the removable oral device.
  • a system 2400 comprises a kiosk or housing 2410 which comprises an oral imager 2420 electrically coupled to the system 2400.
  • the oral imager 2420 may take the form of a wand with an image head which can be inserted into the mouth of the user. If desired, the image head may receive a disposable cover to permit many different users to use the system 2400 without sterilizing the imager 2420.
  • the system 2400 may also comprise a scale 2430 which can measure the weight of the user and print a removable oral device based on the measured weight.
  • the user can enter their height into the system 2400, the system 2400 can measure the weight of the user and print a suitable removable oral device from the images and from the user parameters.
  • user's with a body mass index of about 25 to about 30 may be particularly suited to using the removable oral devices.
  • the system can be designed to alter the thickness of the palatal element based on the user parameters. For example, users with a BMI of 30 or above, may receive a removable oral device with a printed palatal element which reduces the oral volume by about 35-40%. Users with a BMI of 25-30 may receive a removable oral device with a printed palatal element which reduces the oral volume by about 30-35%.
  • the system 2400 may comprise an integral printer which can print the removable oral device and dispense it through opening 2450.
  • a graphic user interface may be present on the screen 2440 to permit the user to interact with the system 2400.
  • a system 2500 is configured to produce a removable oral device and comprises an oral imager 2510 comprising an image head configured to be inserted into a user's mouth and provide an oral cavity image, and a printer 2520 configured to receive the oral cavity image from the oral imager and print a removable oral device using a first material.
  • the printed removable oral device comprises a printed palatal element coupled to a clasping element, in which the printed palatal element is configured to contact a roof of a user's mouth at a palatal surface, and wherein the printed palatal element comprising a body comprising a thickness configured to lower a vaulted area of the roof of the mouth to decrease an overall oral volume of the mouth to a first oral volume.
  • the clasping element when present, can be configured to assist in removal of the removable oral device from the mouth and to retain the palatal surface of the palatal element against the roof of the user's mouth when the removable oral device is inserted into the user's mouth.
  • the printer 2520 is configured to use a second material softer than the first material to print areas of the body adjacent to the clasping element.
  • the image head of the oral imager 2510 is configured to receive a disposable cover configured to reversibly couple to the image head.
  • an oral imager can capture pictures, measure distances using light, ultrasound, sound waves, etc.
  • the disposable cover can be transparent to the particular energy or means used to perform the imaging while at the same time permitting multiple uses of the image head without the need to sterilize it.
  • the disposable cover can slide over or engage the image head through a friction fit and, if desired, the cover may be heat shrinkable so the cover engages the image head in a tight manner.
  • the printer 2520 is configured to wirelessly couple to the oral imager to receive the oral image cavity. In other examples, the printer 2520 is configured to couple to the oral imager to receive the oral image cavity through a hard wired connection. In some embodiments, the removable oral device is configured to not alter a position of the user's teeth. In other embodiments, the removable oral device is configured to not alter a retain a position of the user's teeth. In further examples, the removable oral device comprises a variable hardness across the tongue surface of the body.
  • a system comprises an oral imager comprising an image head configured to be inserted into a user's mouth and provide an oral cavity image, and a printer configured to receive the oral cavity image from the oral imager and print an impression tray using the received oral cavity image.
  • the system comprises a mold material configured to insert into the printed impression tray to provide an oral cavity impression.
  • the oral imager is configured to image the oral cavity impression.
  • the printer can be configured to use the imaged, oral cavity impression to print a removable oral device using a first material.
  • the printed removable oral device comprises a printed palatal element coupled to a clasping element, in which the printed palatal element is configured to contact a roof of a user's mouth at a palatal surface, and wherein the printed palatal element comprising a body comprising a thickness configured to lower a vaulted area of the roof of the mouth to decrease an overall oral volume of the mouth to a first oral volume.
  • the clasping element when present, can be configured to assist in removal of the removable oral device from the mouth and to retain the palatal surface of the palatal element against the roof of the user's mouth when the removable oral device is inserted into the user's mouth.
  • the image head is configured to receive a disposable cover to image the oral cavity.
  • the system is configured to inject a material into the printed mold to provide the removable oral device.
  • the system is configured to extrude material from the mold to provide the removable oral device.
  • the system is configured to place a gasket in the mold prior to providing the removable oral device, wherein the gasket is present between the body of the palatal element and the clasping element.
  • the printer is configured to three -dimensionally print the palatal element using a photo-curable material.
  • the printer or the system is configured to print the photo-curable material onto the printer support comprising one or more wires to provide the removable oral device.
  • the system is configured to cure the printed palatal element using UV/Visible light.
  • the printer is configured to print each of the palatal element and the clasping element using a photo- curable material.
  • the printer is configured as an inkjet three-dimensional printer.
  • the printer is configured to use digital light processing.
  • the removable oral device is configured to not alter a position of the user's teeth.
  • a system comprises an oral imager comprising an image head configured to be inserted into a user's mouth and provide an oral cavity image, and a printer configured to receive the oral cavity image from the oral imager and print an impression tray using the received oral cavity image.
  • the system also comprises a mold material configured to insert into the printed impression tray to provide an oral cavity impression.
  • the system also comprises a first material configured to provide a removable oral device comprising a palatal element coupled to a clasping element.
  • the palatal element is configured to contact a roof of a user's mouth at a palatal surface, and wherein the palatal element comprises a body comprising a thickness configured to lower a vaulted area of the roof of the mouth to decrease an overall oral volume of the mouth to a first oral volume.
  • the clasping element when present, can be configured to assist in removal of the removable oral device from the mouth and to retain the palatal surface of the palatal element against the roof of the user's mouth when the removable oral device is inserted into the user's mouth.
  • the image head is configured to receive a disposable cover to image the oral cavity.
  • the system is configured to inject a material into the impression of the oral cavity to provide the removable oral device.
  • the system is configured to use a gasket with the removable oral device, wherein the gasket is present between the body of the palatal element and the clasping element.
  • the printer is configured to use a photo-curable material.
  • the system can be configured to photo-cure the printed impression tray using UV/Visible light.
  • the system is configured to scan the impression to provide a digital image of the impression.
  • the system is configured to use the digital image to print the removable oral device.
  • the printer is configured as an inkjet three- dimensional printer. In other examples, the printer is configured to use digital light processing. In some embodiments, the removable oral device is configured to not alter a position of the user's teeth. In other embodiments, the removable oral device is configured to not retain a position of the user's teeth. In further embodiments, the removable oral device comprises a variable hardness across the tongue surface of the body.
  • a system comprises a first removable oral device comprising a palatal element coupled to a clasping element.
  • the palatal element of the first removable oral device comprises a body comprising an embedded camera configured to capture an image of the oral cavity, and wherein
  • the clasping element when present, can be configured to assist in removal of the removable oral device from the mouth and to retain the palatal surface of the palatal element against the roof of the user's mouth when the removable oral device is inserted into the user's mouth.
  • the system also comprises an external device comprising a processor configured to receive the captured image from the first removable oral device.
  • the system further comprises a printer configured to use the received captured image to print a second removable oral device.
  • the second removable oral device may comprise a palatal element coupled to a clasping element.
  • the palatal element of the second removable oral device comprises a body comprising a thickness configured to lower a vaulted area of the roof of the mouth to decrease an overall oral volume of the mouth to a first oral volume.
  • the clasping element of the second removable oral device is configured to assist in removal of the second removable oral device from the mouth and to retain the palatal surface of the palatal element against the roof of the user's mouth when the second removable oral device is inserted into the user's mouth.
  • the palatal element comprises a processor electrically coupled to the camera and configured to control the camera. In some examples, the palatal element comprises a memory unit electrically coupled to the processor. In further examples, the second removable oral device is configured to not alter a position of the user's teeth. In some embodiments, the second removable oral device is configured to not retain a position of the user's teeth. In other embodiments, the second removable oral device comprises a variable hardness across the tongue surface of the body.
  • a system comprises a removable oral device in combination with a weight management schedule or weight management program.
  • the removable oral device may comprise a palatal element coupled to a clasping element, in which the palatal element of the removable oral device comprises a body comprising a thickness configured to lower a vaulted area of the roof of the mouth to decrease an overall oral volume of the mouth to a first oral volume.
  • the clasping element when present, can be configured to assist in removal of the removable oral device from the mouth and/or to retain the palatal surface of the palatal element against the roof of the user's mouth when the removable oral device is inserted into the user's mouth.
  • the weight management schedule can be provided based on interaction of the user with an application software program, a live coach (which may be remotely located), based on user "weigh-ins" or other parameters.
  • the weight management schedule is designed to modify behavior, using the removable oral device, to assist in achieving weight loss in a controlled and health manner.
  • the system further comprises a nutrition schedule and/or an exercise schedule.
  • These schedules can also be configured based on user interaction with an application program or with a coach. For example, any one or more of the schedules can be managed by an external device such as a computer, an internet chat session, a mobile device, a wearable device, etc.
  • the weight management schedule is configured to reduce caloric intake by about 1-5% or 1-10% each week starting from when the user first inserts the removable oral device into the mouth until a desired lower level of daily calories (or target level of daily calories) is reached for weight loss.
  • the system may also comprise a body composition monitor configured to provide body information to the external device, wherein the weight management schedule is configured to alter caloric intake based on the provided body information.
  • the removable oral device is configured to not alter a position of the user's teeth.
  • the removable oral device is configured to not retain a position of the user's teeth.
  • the removable oral device comprises a variable hardness across the tongue surface of the body.
  • a system comprises a nutrition schedule or program in combination with a removable oral device.
  • the removable oral device comprises a palatal element coupled to a clasping element.
  • the palatal element of the removable oral device comprises a body comprising a thickness configured to lower a vaulted area of the roof of the mouth to decrease an overall oral volume of the mouth to a first oral volume.
  • the clasping element when present, can be configured to assist in removal of the removable oral device from the mouth and to retain the palatal surface of the palatal element against the roof of the user's mouth when the removable oral device is inserted into the user's mouth.
  • the nutrition schedule or program may consist of provided food of a selected caloric content similar to those programs and foods provided from Jenny Craig, Weight Watchers or other commercial companies.
  • the exact caloric content can be tailored based on weight loss goals, desired per week weight loss and other factors.
  • the nutrition schedule is managed by an external device, e.g., by an application program on a computer, mobile device, wearable device, etc.
  • the system comprises a body composition monitor configured to provide body information to the external device, wherein the nutrition schedule is configured to alter caloric intake based on the provided body information.
  • the nutrition schedule can be configured to reduce caloric intake by about 1-5% or 1-10% each week starting from when the user first inserts the removable oral device into the mouth until a desired lower level of daily calories (or target level of daily calories) is reached for weight loss.
  • the system may comprise an exercise schedule or program. If desired, both of the nutrition schedule and the exercise schedule are managed by an external device, e.g., by an application program on a computer, mobile device, wearable device, etc.
  • the nutrition schedule is configured to reduce caloric intake by about 1-5% orl-10% each week starting from when the user first inserts the removable oral device into the mouth and wherein the exercise schedule is configured to increase caloric consumption by the body by about 1-5% or 1-10% each week starting from when the user first inserts the removable oral device into the mouth.
  • the removable oral device is configured to not alter a position of the user's teeth. In other examples, the removable oral device is configured to not retain a position of the user's teeth.
  • the removable oral device comprises a variable hardness across the tongue surface of the body.
  • a system comprises a removable oral device in combination with an exercise schedule or program.
  • the removable oral device comprises a palatal element coupled to a clasping element, in which the palatal element of the removable oral device comprises a body comprising a thickness configured to lower a vaulted area of the roof of the mouth to decrease an overall oral volume of the mouth to a first oral volume.
  • the clasping element when present, can be configured to assist in removal of the removable oral device from the mouth and to retain the palatal surface of the palatal element against the roof of the user's mouth when the removable oral device is inserted into the user's mouth.
  • the exercise schedule or program is managed by an external device, e.g., by an application program on a computer, mobile device, wearable device, etc.
  • the system comprises a body composition monitor configured to provide body information to the external device, wherein the exercise schedule is configured to alter caloric intake based on the provided body information.
  • the exercise schedule is configured to increase caloric consumption by about 1 -5% each week starting from when the user first inserts the removable oral device into the mouth.
  • the removable oral device is configured to not alter a position of the user's teeth.
  • the removable oral device is configured to not retain a position of the user's teeth.
  • the removable oral device comprises a variable hardness across the tongue surface of the body.
  • the removable oral device can be used in combination with another device designed to be temporarily or permanently inserted into the oral cavity.
  • a sensor can be present in a crown or filling of a tooth and used in combination with one or more devices embedded or in the removable oral device.
  • dentures or a replacement tooth comprising a sensor may also be used in combination with the removable oral device.
  • a dental post may comprise a sensor which can be used in combination with the removable oral device.
  • a temporary device can be applied or adhered to one or more teeth and used with the removable oral device.
  • a sensor can be cemented to some surface of a lower tooth and used in combination with the removable oral device.
  • a sensor can be present in a piercing present in the oral cavity, e.g., a tongue piercing or the like.
  • the piercing can be removed to periodically recharge the sensor present in the piercing.
  • combinations of the devices and systems described herein may also be used.
  • the removable oral devices can be used in combination with two or more of wearable devices such as FitBit® fitness trackers, weight loss diet & exercise programs such as Weight Watchers, weight loss foods such as those provided by Weight Watched, Jenny Craig and Nutri System, digital weight loss programs such as Omada, and weight loss application software programs such as MyFitnessPal.
  • the removable oral devices can be used in combination with medical devices such as, for example, insulin injectors, blood glucose test strips & monitors, blood pressure monitors, cholesterol measuring devices, weight scales, body composition devices, sleep apnea devices, orthopedic devices that improve mobility, prostheses that improve mobility and physical therapy devices & procedures.
  • medical devices such as, for example, insulin injectors, blood glucose test strips & monitors, blood pressure monitors, cholesterol measuring devices, weight scales, body composition devices, sleep apnea devices, orthopedic devices that improve mobility, prostheses that improve mobility and physical therapy devices & procedures.
  • a system can be configured to provide a coaching platform configured for use with the removable oral device to assist in weight management, e.g., weight control and/or weight loss, of the user.
  • the coaching platform may be configured to monitor food intake, monitor use of a removable oral device, provide feedback based on the user's weight management plans, etc.
  • a coaching platform can be remotely located at a facility 2610 which is separate from a removable oral device 2605.
  • the remote coaching platform may be based on personal feedback from a coach or automated feedback using routines or application software.
  • the coaching platform can be based on in-person or in-office sessions where the user provides answers to various questions asked by a coach.
  • the coach may read or transfer information from the removable oral device to facilitate coaching of the user.
  • the coaching platform can be present as application software, e.g., present on a mobile device or a computer.
  • a removable oral device can be used with a mobile device comprising coaching application software.
  • the mobile device may be, for example, a cellular phone, a laptop computer, a tablet, a wearable device such as a Fitbit® device, an Apple Iwatch device or the like.
  • the coaching application software comprises menus or prompts to permit a user to navigate through the software based on the user's use of the removable oral device.
  • the coaching platform may be used in combination with a nutrition plan, an exercise plan or other schedules or plans.
  • the removable oral device can be provided along with the coaching platform or may be provided separately from the coaching platform.

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Medical Informatics (AREA)
  • Biomedical Technology (AREA)
  • Physics & Mathematics (AREA)
  • Biophysics (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Veterinary Medicine (AREA)
  • Animal Behavior & Ethology (AREA)
  • Molecular Biology (AREA)
  • Surgery (AREA)
  • Pathology (AREA)
  • Epidemiology (AREA)
  • Primary Health Care (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Dentistry (AREA)
  • Business, Economics & Management (AREA)
  • Physiology (AREA)
  • Obesity (AREA)
  • Orthopedic Medicine & Surgery (AREA)
  • Nutrition Science (AREA)
  • Physical Education & Sports Medicine (AREA)
  • Medicinal Chemistry (AREA)
  • Radiology & Medical Imaging (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Entrepreneurship & Innovation (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Educational Administration (AREA)
  • Educational Technology (AREA)
  • General Physics & Mathematics (AREA)
  • Theoretical Computer Science (AREA)
  • Chemical & Material Sciences (AREA)
  • General Business, Economics & Management (AREA)
  • Vascular Medicine (AREA)
  • Nursing (AREA)
  • Rheumatology (AREA)
  • Optics & Photonics (AREA)

Abstract

Certain configurations of systems which include a removable oral device are described. In some configurations, the system comprises a removable oral device which is coupled in some manner to a separate external component. The removable oral device can be used in combination with various additional external devices and components in weight control, athletic performance, and other applications.

Description

SYSTEMS INCLUDING REMOVABLE ORAL DEVICES
[0001] PRIORITY APPLICATIONS
[0002] This application claims priority to and the benefit of US 62/477,766 filed on March 28, 2017 and entitled "SYSTEMS INCLUDING REMOVABLE ORAL DEVICES" and claims priority to U.S. Provisional Application No. 62/521,498 filed on June 18, 2017 and entitled "METHODS OF USING REMOVABLE ORAL DEVICES." The entire disclosure of each of these applications is hereby incorporated herein by reference for all purposes.
[0003] CROSS-REFERENCE TO RELATED APPLICATIONS
[0004] This application is related to, and incorporates by reference herein, each of the following patent applications: U.S. Provisional Application 62/477,752 filed on March 28, 2017 and entitled "REMOVABLE ORAL DEVICES," U.S. Provisional Application No. 62/477,760 filed on March 28, 2017 and entitled "METHODS OF USING REMOVABLE ORAL DEVICES," U.S. Provisional Application No. 62/477,764 filed on March 28, 2017 and entitled "METHODS OF PRODUCING REMOVABLE ORAL DEVICES," and U.S. Provisional Application No. 62/477,768 filed on March 28, 2017 and entitled "REMOVABLE ORAL DEVICES AND THEIR USE IN COMBINATION WITH PHARMACOLOGICAL AGENTS, IMPLANTS AND OTHER DEVICES."
[0005] TECHNOLOGICAL FIELD
[0006] This application is directed to systems which use, at least in part, one or more removable oral devices. More particularly, certain configurations described herein are directed to systems which use a removable oral device in combination with one or more other separate devices or components comprising a processor or other electrical component.
[0007] BACKGROUND
[0008] Many methods for controlling weight exist. Most existing methods do not provide long term weight loss or health benefits.
[0009] SUMMARY
[0010] Certain illustrative configurations are directed to various systems which include a removable oral device. As noted in more detail below, the systems can include a removable oral device in combination with one or more other devices or systems. [0011] In one aspect, a system configured to produce a removable oral device comprises an oral imager and a printer. The oral imager comprises an image head configured to be inserted into a user's mouth and provide an oral cavity image. The printer is configured to receive the oral cavity image from the oral imager and print a removable oral device using a first material,. The printed removable oral device comprising a printed palatal element coupled to a clasping element, in which the printed palatal element is configured to contact a roof of a user's mouth at a palatal surface, and wherein the printed palatal element comprises a body comprising a thickness configured to lower a vaulted area of the roof of the mouth to decrease an overall oral volume of the mouth to a first oral volume. The clasping element, when present, can be configured to assist in removal of the removable oral device from the mouth and to retain the palatal surface of the palatal element against the roof of the user's mouth when the removable oral device is inserted into the user's mouth.
[0012] In another aspect, a system for monitoring intake of material into a mouth of a user comprises a removable oral device configured to removably insert into a mouth of the a user, wherein the removable oral device comprises a camera configured to capture images of the material in the mouth of the user. The removable oral device can be present in combination with an external device separate from the removable oral device, in which the external device comprises a processor configured to couple to the removable oral device to transfer captured images from the camera of the removable oral device to the external device.
[0013] In an additional aspect, a system for monitoring athletic performance comprises a removable oral device configured to removably insert into a mouth of the user and comprising at least one electrode positioned within the body of a palatal element and exposed to fluid entering and exiting the mouth of the user. The at least one electrode can be configured to measure athletic performance from fluid entering and exiting the mouth of the user. The removable oral device can be present in combination with an external device that is separate from the removable oral device, in which the external device comprises a processor configured to couple to the removable oral device to transfer the measured athletic performance from the removable oral device to the external device.
[0014] In another aspect, a system for monitoring intake of material into a mouth of a user comprises a removable oral device comprising a bar code reader, and an external device that is separate from the removable oral device, in which the external device comprises a processor configured to couple to the removable oral device to transfer the measured bar code from the removable oral device to the external device.
[0015] In an additional aspect, a system comprises a removable oral device configured to removably insert into a mouth of the a user and comprises a memory unit configured to receive and store an electronic medical record of the user, and an external device that is separate from the removable oral device, in which the external device comprises a processor configured to couple to the removable oral device to read and update the electronic medical record on the removable oral device.
[0016] In another aspect, a system configured to monitor human health comprises a removable oral device configured to removably insert into a mouth of the user and comprising at least one sensor configured to measure a physiological parameter from fluid entering and exiting the mouth of the user. The removable oral device can be present with an external device that is separate from the removable oral device, in which the external device comprises a processor configured to couple to the removable oral device to transfer the measured physiological parameter from the removable oral device to the external device.
[0017] In an additional aspect, a system configured to monitor head tremor comprises a removable oral device configured to removably insert into a mouth of a user and comprising an accelerometer, and an external device that is separate from the removable oral device, in which the external device comprises a processor configured to couple to the removable oral device to transfer detected head movement measured by the accelerometer to the external device.
[0018] In another aspect, a system for monitoring head impact comprises a removable oral device configured to removably insert into the mouth of the user and comprising an accelerometer, and an external device that is separate from the removable oral device, in which the external device comprises a processor configured to couple to the removable oral device to transfer the detected head movement measured by the accelerometer to the external device to determine head impact.
[0019] In an additional aspect, a system configured to monitor chewing comprises a removable oral device configured to removably insert into a mouth of the user and comprising a piezoelectric sensor, and an external device that is separate from the removable oral device, in which the external device comprises a processor configured to couple to the removable oral device to transfer the measured pressure changes to the external device.
[0020] In another aspect, a system configured to monitor chewing comprises a removable oral device configured to removable insert into a mouth of a user and comprising a microphone configured to monitor chewing by measuring a change in decibel levels within the mouth, and an external device that is separate from the removable oral device, in which the external device comprises a processor configured to couple to the removable oral device to transfer the measured change in decibel levels within the mouth to the external device.
[0021] In an additional aspect, a system comprises monitoring chewing a removable oral device configured to removably insert into the mouth of the user and comprising a proximity sensor configured to monitor chewing by measuring a distance change between the proximity sensor and a sensor coupled to a lower tooth of the user, and an external device that is separate from the removable oral device, in which the external device comprises a processor configured to couple to the removable oral device to transfer the measured distance change to the external device.
[0022] In another aspect, a system configured to monitor chewing of material entering a user's mouth comprises a removable oral device configured to removably insert into the mouth of the user and comprising a vibratory device configured to vibrate after the user has chewed a selected number of times to provide feedback to the user to swallow the chewed material, and an external device that is separate from the removable oral device, in which the external device comprises a processor configured to couple to the removable oral device to transfer the selected number of times to the external device.
[0023] In an additional aspect, a system configured to monitor food intake volume entering a user's mouth comprises a removable oral device configured to removal insert into the mouth of the user and comprising a palatal element configured to sense presence of the food in the user's mouth and absence of the food in the user's mouth as an indicator the food has been swallowed, and an external device that is separate from the removable oral device, in which the external device comprises a processor configured to couple to the removable oral device to transfer the number of swallows to the external device.
[0024] In another aspect, a system configured to monitor material entering into a user's mouth to measure nutrient species in the material comprises a removable oral device configured to removably insert into the mouth of the user and comprising a palatal element that comprises a processor and a memory unit electrically coupled to the processor, and wherein the palatal element comprises a sensor electrically coupled to the processor. The system may also comprise an external device separate from the removable oral device, in which the external device comprises a processor configured to couple to the removable oral device to transfer the measured nutrient species in the material to the external device.
[0025] In an additional aspect, a system configured to monitor material entering into a user's mouth to measure nutrient species in the material comprises a removable oral device configured to removably insert into the mouth of the user and comprising a multi-plexing sensor, and an external device that is separate from the removable oral device, in which the external device comprises a processor configured to couple to the removable oral device to transfer the measured caloric content from the removable oral device to the external device.
[0026] In another aspect, a system configured to provide real time measurements of material intake into a user's mouth comprises a removable oral device configured to removably insert into the mouth of the user, and comprising a processor, a memory unit electrically coupled to the processor and a transmitter/receiver electrically coupled to the processor, in which the processor is configured to transmit the recorded material intake to a site outside of the mouth of the user. The system may also comprise an external device separate from the removable oral device, in which the external device comprises a processor configured to couple to the removable oral device to receive the transmitted, recorded material intake.
[0027] In an additional aspect, a system configured to monitor blood pressure in a human by measuring blood pressure from a roof of the mouth of the human comprises a removable oral device configured to removably insert into the mouth of the human and comprising a pressure sensor, and an external device that is separate from the removable oral device, in which the external device comprises a processor configured to couple to the removable oral device to receive pressure measurements from the pressure sensor.
[0028] In another aspect, a system configured to transfer information present on a removable oral device comprises a removable oral device configured to removably insert into the mouth of the user and comprising a processor, a memory unit electrically coupled to the processor and a transmitter/receiver electrically coupled to the processor. The system may also comprise a case configured to receive and store the removable oral device, wherein the case comprises a transmitter/receiver to receive the information from the transmitter/receiver of the oral device to transfer the information present on the removable oral device when the removable oral device is inserted into the case.
[0029] In an additional aspect, a system configured to determine a body fat percentage of a human, the system comprises a removable oral device comprising an electrode, and an external device separate from the removable oral device, in which the external device that is separate from the removable oral device and comprises a processor configured to couple to the removable oral device to receive electrical measurements from the electrode and determine the body fat percentage using the received electrical measurements.
[0030] In another aspect, a system configured to transfer information from a removable oral device comprises a removable oral device comprising a processor, and a mobile device separate from the removable oral device, in which the mobile device is configured to receive information from the processor of the removable oral device.
[0031] In an additional aspect, a system comprises a removable oral device comprising a processor, and a wearable device separate from the removable oral device and comprising a processor configured to receive information from the processor of the palatal element.
[0032] In another aspect, a system configured to produce a removable oral device comprises a three-dimensional printer comprising a processor configured to receive three-dimensional coordinates from an image of an oral cavity of a human mouth. The printer can be configured to print a removable oral device using the three dimensional coordinates. The printed removable oral device comprises a palatal element coupled to a clasping element, in which the palatal element is configured to contact a roof of a user's mouth at a palatal surface, and wherein the palatal element comprising a body comprising a thickness configured to lower a vaulted area of the roof of the mouth to decrease an overall oral volume of the mouth to a first oral volume. The clasping element, which may or may not be printed, is configured to assist in removal of the removable oral device from the mouth and to retain the palatal surface of the palatal element against the roof of the user's mouth when the removable oral device is inserted into the user's mouth.
[0033] In another aspect, a system comprises an oral imager comprising an image head configured to be inserted into a user's mouth and provide an oral cavity image, and a printer configured to receive the oral cavity image from the oral imager and print an impression tray using the received oral cavity image.
[0034] In an additional aspect, a system comprises an oral imager comprising an image head configured to be inserted into a user's mouth and provide an oral cavity image. The system may also comprise a printer configured to receive the oral cavity image from the oral imager and print an impression tray using the received oral cavity image. The system may also comprise a mold material configured to insert into the printed impression tray to provide an oral cavity impression. The system may also comprise a first material configured to provide a removable oral device comprising a palatal element coupled to a clasping element.
[0035] In another aspect, a system comprises a first removable oral device comprising an embedded camera configured to capture an image or images of the oral cavity, and an external device comprising a processor configured to receive the captured image from the first removable oral device. The system may also comprise a printer that is used to provide a second removable oral device using the captured image or images.
[0036] In an additional aspect, a system comprises a removable oral device in combination with a weight management schedule or program.
[0037] In another aspect, a system comprises a removable oral device in combination with a nutrition management schedule or program.
[0038] In an additional aspect, a system comprises a removable oral device in combination with an exercise management schedule or program.
[0039] In another aspect, a system comprises a coaching platform configured for use with a removable oral device to assist in weight management of the user.
[0040] Additional aspects, examples, embodiments and configurations are described further below. [0041] BRIEF DESCRIPTION OF THE SEVERAL VIEW OF THE DRAWINGS
[0042] Certain configurations of methods using removable oral devices are described below with reference to the accompanying figures in which:
[0043] FIG. 1A is an illustration of a removable oral device, and FIG. IB is a schematic of various components which may be present on the removable oral device, in accordance with certain configurations;
[0044] FIG. 2 is an illustration of a system comprising a removable oral device and an external device, in accordance with certain embodiments;
[0045] FIG. 3 is an illustration of a system comprising a removable oral device comprising a camera and its use in combination with an external device, in accordance with certain examples;
[0046] FIG. 4 is an illustration of a system comprising a removable oral device comprising an electrode and its use in combination with an external device, in accordance with certain examples;
[0047] FIG. 5 is an illustration of a system comprising a removable oral device comprising a bar code reader and its use in combination with an external device, in accordance with certain examples;
[0048] FIG. 6 is an illustration of a system comprising a removable oral device comprising a memory unit and its use in combination with an external device, in accordance with certain examples;
[0049] FIG. 7 is an illustration of a system comprising a removable oral device comprising a sensor and its use in combination with an external device, in accordance with certain examples;
[0050] FIG. 8 is an illustration of a system comprising a removable oral device comprising an accelerometer and its use in combination with an external device, in accordance with certain examples;
[0051] FIG. 9 is another illustration of a system comprising a removable oral device comprising an accelerometer and its use in combination with an external device, in accordance with certain examples;
[0052] FIG. 10 is an illustration of a system comprising a removable oral device comprising a piezoelectric sensor and its use in combination with an external device, in accordance with certain examples;
[0053] FIG. 11 is an illustration of a system comprising a removable oral device comprising a microphone and its use in combination with an external device, in accordance with certain configurations; [0054] FIG. 12 is an illustration of a system comprising a removable oral device comprising a proximity sensor and its use in combination with an external device, in accordance with certain configurations;
[0055] FIG. 13 is an illustration of a system comprising a removable oral device comprising a chewing sensor and its use in combination with an external device, in accordance with certain configurations;
[0056] FIG. 14 is an illustration of a system comprising a removable oral device comprising a food sensor and its use in combination with an external device, in accordance with certain configurations;
[0057] FIG. 15 is an illustration of a system comprising a removable oral device comprising a processor and a sensor and their use in combination with an external device, in accordance with certain configurations;
[0058] FIG. 16 is an illustration of a system comprising a removable oral device comprising a multi-plexing sensor and its use in combination with an external device, in accordance with certain configurations;
[0059] FIG. 17 is an illustration of a system comprising a removable oral device comprising a transmitter/receiver and its use in combination with an external device, in accordance with certain configurations;
[0060] FIG. 18 is an illustration of a system comprising a removable oral device comprising a pressure sensor and its use in combination with an external device, in accordance with certain configurations;
[0061] FIG. 19 is an illustration of a system comprising a removable oral device comprising a transmitter/receiver and its use in combination with an external device, in accordance with certain configurations;
[0062] FIG. 20 is an illustration of a system comprising a removable oral device comprising an electrode and its use in combination with an external device, in accordance with certain configurations;
[0063] FIG. 21 is an illustration of a system comprising a removable oral device comprising a processor and its use in combination with an external device, in accordance with certain configurations;
[0064] FIG. 22 is an illustration of a system comprising a removable oral device comprising a processor and its use in combination with a wearable device, in accordance with certain configurations;
[0065] FIG. 23 is an illustration of a system comprising a printer configured to print a removable, in accordance with certain configurations; [0066] FIG. 24 is an illustration of an oral imager system, in accordance with certain examples;
[0067] FIG. 25 is an illustration of a system comprising an oral imager and a printer, in accordance with certain embodiments; and
[0068] FIG. 26 is an illustration of a system comprising a removable oral device and a remote coaching platform, in accordance with certain configurations.
[0069] DETAILED DESCRIPTION
[0070] Various components are described below in connection with systems that use or include a removable oral device. The exact configuration of the system may vary and may include, for example, a removable oral device in combination with a wearable device, e.g., a watch, spectacles, contact lenses, etc., or a local or remote system comprising a processor.
[0071] In certain examples, the systems described herein may comprise a removable oral device with an on-board sensor, processor or other electrical component in combination with one or more external devices which comprise a sensor, processor or other electrical component. Other configurations of the systems include systems which can be used to produce a removable oral device, e.g., a scanner, printer, etc. and/or systems which can be used with a removable oral device, e.g., on-demand, remote or live coaching platforms. In additional systems, the removable oral device can be used with a weight management plan or schedule, a nutrition plan or schedule and/or an exercise plan or schedule.
[0072] In certain embodiments and referring to FIG. 1A, an illustration of a removable oral device is shown. An optional clasping element 110 comprises a wire 115 and associated material 120 on some portion of the wire. Another optional clasping element 130 comprises a wire 135 and associated material 140 on some portion of the wire 135. Some portion of the wires 115, 1355 is embedded within a body of a palatal element 105. The material 120, 140 generally rests against outer surfaces of the teeth when the palatal element 105 is engaged to the roof of the mouth. The wires 115, 135 can assist in removal of the removable oral device from the mouth and/or may assist in retaining the removable oral device in place. For example, surface tension between a palatal surface of the palatal element 105 and the roof of a user's mouth can "lock" the palatal element to the roof of the mouth. The wires 115, 135 can provide leverage to assist in breaking of the surface tension and removal of the device from the mouth. An optional sensor or other device 145 (discussed in more detail below) is also shown as being present in the palatal element 105. While two clasping elements 110, 130 are shown in FIG. 1 A, only a single clasping element may be present if desired or no clasping elements may be present. As shown in FIG. IB, the palatal element 105 may also comprise one or more electrical components such as a processor 160 and a memory unit 170 coupled to the processor. As noted in more detail below, the electrical component can take many forms including electrodes, sensors, pressure membranes, cameras, microphones or other devices. The palatal element 105 may also comprise one or more on-board transmitters/receivers to send and/or receive information to and from the removable oral device.
[0073] In certain configurations, the palatal element can be configured to contact a roof of a user's mouth at a palatal surface and comprises a body comprising a thickness configured to lower a vaulted area of the roof of the mouth to decrease an overall oral volume of the mouth to a first oral volume. If desired, the body comprises a variable hardness across a tongue surface of the body. In certain examples, the clasping element, when present, can be configured to assist in removal of the removable oral device from the mouth and to retain the palatal surface of the palatal element against the roof of the user's mouth when the removable oral device is inserted into the user's mouth.
[0074] In some instances, a removable oral device comprises a palatal element coupled to a clasping element and a camera. For example, the camera can be within the body of the palatal element. For example, the camera can be configured to capture images of material placed in the mouth of the user.
[0075] In other examples, a removable oral device comprises a palatal element coupled to a clasping element and at least one electrode. For example, the at least one electrode can be positioned within the body and exposed to fluid entering and exiting the mouth of the user.
[0076] In some examples, the at least one electrode can be configured to measure athletic performance from the fluid entering and exiting the mouth of the user. In other instances, a removable oral device comprises a palatal element coupled to a clasping element and a bar code reader. For example, a bar code reader can be within the body of the palatal element. In certain instances, the bar code reader is configured to read a bar code present on a material placed in the mouth of the user, e.g., food, a drug or other material.
[0077] In certain examples, a removable oral device comprises a palatal element coupled to a clasping element and a processor. In certain configurations, a processor and an optional memory unit may be within the body of the palatal element. If desired, the memory unit may comprise desired information such as a nutrition plan or an updatable electronic medical record of the user.
[0078] In additional configurations, a removable oral device comprises a palatal element coupled to a clasping element and a piezoelectric sensor. For example, a piezoelectric sensor within the body of the palatal element can be present. In some examples, the piezoelectric sensor can be configured to measure movement of the upper jaw during chewing. [0079] In other configurations, a removable oral device comprises a palatal element coupled to a clasping element and an accelerometer. For example, the accelerometer can be within the body of the palatal element. The accelerometer can be used for many different uses, e.g., the accelerometer can be configured to measure impact force.
[0080] In some embodiments, a removable oral device comprises a palatal element coupled to a clasping element and an electrode. For example, the electrode can within the body of the palatal element and may be configured, for example, to measure bioelectrical impedance to determine a body fat percentage of the user.
[0081] In other examples, a removable oral device comprising a palatal element and a clasping element is provided. For example, the clasping element may not include any supporting wires or other structures.
[0082] In other embodiments, a removable oral device comprises a palatal element coupled to a clasping element, where the clasping element comprises a continuous wire structure terminating in the body of the palatal element, and wherein the continuous wire structure has a smaller outer wire diameter at termini of the wire structure within the clasping element than an outer wire diameter within the palatal element is described. If desired, a clasping element can be coupled to each side of the palatal element.
[0083] In some examples, wherein the palatal element comprises a lower thickness at a front section adjacent to inner surfaces of the anterior teeth to reduce lisping compared to a thickness at an apex section of the palatal element.
[0084] In other configurations, a removable oral device comprises a palatal element coupled to a clasping element, wherein the palatal element comprises a thermally expandable material configured to increase its volume with increasing temperature to decrease the overall oral volume to a second oral volume less than the first oral volume.
[0085] In additional examples, a removable oral device may comprise a first palatal element and a second palatal element. For example, the first palatal element can be configured to reversibly couple to the second palatal element to decrease the overall oral volume of the mouth to a second oral volume less than the first oral volume.
[0086] In other embodiments, a removable oral device comprises a palatal element coupled to a clasping element and a chewing sensor. For example, the chewing sensor can be configured to provide sensory feedback to the user between swallowing of food in the user's mouth.
[0087] In other configurations, the removable oral devices described herein can be used in combination with one or more separate external devices. Various illustrations of separate external devices which can be used with a removable oral device are shown in FIG. 2. For example, the removable oral device 210 can be used with a computer system 220. The removable oral device 210 can be used with a mobile device 230. The removable oral device 210 can be used with wearable devices such as, for example, a fitness tracker 240, e.g., a watch based fitness tracker, a chest based fitness or heart rate tracker, spectacles 250 such as, for example, Google® glass or smart glasses or spectacles, or body sleeves, wrist sleeves, jewelry or other devices which can be worn by a user. The removable device 210 can be used with case 260, e.g., one which can store, charge and/or transfer information to and/or from the removable oral device 210. The removable oral device 210 can be used with a body composition monitor 270 to measure weight, body fat composition, etc. Other external devices which can be used with the removable oral devices will be readily selected by the person of ordinary skill in the art, given the benefit of this disclosure.
[0088] In certain configurations, the various external devices typically comprise common components such as a processor, one or more memory units and/or an operating system. The external device typically is separate from the removable oral device, but a processor, memory chip or other device may be integrated into some component of the removable oral device as desired. At least one processor can be electrically coupled to one or more memory units to receive input data and/or store any data. The processor may be, for example an Intel PENTIUM- type processor, Motorola PowerPC, Sun UltraSPARC, Hewlett-Packard PA-RISC processors, or any other type of processor. Various aspects of the systems and external device which include an on-board processor may be implemented as specialized software. A processor can be, if desired, connected to one or more memory devices, such as a disk drive, memory, or other device for storing data. Memory is typically used for storing programs and data during use of the removable oral device. Electrical components of the external device and/or the systems described herein may be coupled by an interconnection device, which may include one or more buses (e.g., between components that are integrated within a same component) and/or a network (e.g., between components that reside on separate discrete components). The interconnection device provides for communications (e.g., signals, data, instructions) to be exchanged between components of the system. The processor and other components are electrically coupled to a power source. In addition, the system or external device may comprise one or more interfaces that connect the processor to a separate device or system such as, for example, a communication network (in addition or as an alternative to the interconnection device). Illustrative interfaces include, but are not limited to, a serial ATA interface, ISA interface, PCI interface or the like or one or more wireless interfaces, e.g., a Bluetooth device, a Wi-Fi device, a Near Field Communication device, a cellular device or other wireless protocols and/or interfaces.
[0089] In certain embodiments, the storage system of the external device or the system typically includes a readable and writeable nonvolatile recording medium in which data can be stored. The medium may, for example, be a solid state memory chip, solid state drive or flash memory. Typically, in operation, the processor causes data to be read from the nonvolatile recording medium into another memory that allows for faster access to the information by the processor than does the medium. This memory is typically a volatile, random access memory such as a dynamic random access memory (DRAM) or static memory (SRAM). It may be located in the storage system or in the memory system. The processor generally manipulates the data within the integrated circuit memory and then copies the data to the medium after processing is completed. A variety of mechanisms are known for managing data movement between the medium and the integrated circuit memory element and the technology is not limited thereto. The technology is also not limited to a particular memory system or storage system. In certain embodiments, the system or external device may also include specially-programmed, special- purpose hardware, for example, an application-specific integrated circuit (ASIC) or a field programmable gate array (FPGA). Aspects of the technology may be implemented in software, hardware or firmware, or any combination thereof. The external device or system may use or include a high-level computer programming language or specially programmed, special purpose hardware.
[0090] In certain examples, the processor and any associated sensors or components of the external device or the system may together define a computer platform for which application programs in high-level programming languages may be written. It should be understood that the technology is not limited to a particular computer system platform, processor, operating system, or network. Also, it should be apparent to those skilled in the art, given the benefit of this disclosure, that the present technology is not limited to a specific programming language or computer system. Further, it should be appreciated that other appropriate programming languages and other appropriate electrical components could also be used. In certain examples, the hardware or software can be configured to implement cognitive architecture, neural networks or other suitable implementations. In some instances, various configurations may be programmed using an object-oriented programming language, such as SmallTalk, Basic, Java, C++, Ada, or C# (C-Sharp). Other obj ect-oriented programming languages may also be used. Alternatively, functional, scripting, and/or logical programming languages may be used. Various configurations may be implemented in a non-programmed environment (e.g., documents created in HTML, XML or other format that, when viewed in a window of a browser program, render aspects of a graphical-user interface (GUI) or perform other functions). Certain configurations may be implemented as programmed or non-programmed elements, or any combination thereof.
[0091] In certain embodiments, the external device may be configured as a mobile device, e.g., a phone or a tablet, that is configured to control use of (or monitor use of) the removable oral device. The mobile device may wirelessly communicate with the removable oral device to send signals and receive signals or data from the removable oral device or can communicate with the removable oral device in a hard-wired manner. In addition, the mobile device can be preprogrammed or pre-configured to implement certain operations that can automatically load from the mobile device onto the removable oral device. If desired, the mobile device can be designed for use with two or more different removable oral devices to permit a single mobile device to implement the same or different operations on the two or more removable oral devices. The mobile device can couple to the removable oral device in a wired or wireless manner, e.g., using near field communication, Bluetooth, USB cables, Lighting cables, or other wireless devices or wired methods and protocols, to send and receive information from the mobile device to the removable oral device. One or more menus can be present on the mobile device to permit the user to select the particular methodology of using the removable oral device.
[0092] In some examples, the removable oral device itself may comprise any one or more of those components mentioned herein in connection with external devices and systems. In some embodiments, the removable oral device can be configured to transmit information remotely to an external device or system located in a distant position from the removable oral device. For example, as noted in more detail below, information from the removable oral device can be sent to a remote coach or user which can provide feedback to the user of the removable oral device. Such feedback may include a weight management schedule, exercise schedule, nutrition schedule or other guidance. The particular schedule can be personalized for the user based on the user's weight, weight goals, use of the removable oral device, etc. For example, a customized Diabetes Prevention program, customized nutrition programs such as those offered by Jenny Craig, Nutri System and Weight Watchers or customized exercise plans or schedules can be prepared based on information from the user and/or information received from the removable oral device. Depending on the user's body make-up, the schedule can be altered as the body mass index and/or body fat composition of the user decreases. For example, caloric intake can be reduced gradually, e.g., 1-5% each week, until the user starts to observe weight loss. Similarly, caloric consumption by way of exercise can be increased gradually, until the user starts to observe weight loss. Such weight management schedules, nutrition schedules and exercise schedules can be provided in an automated format based on user selections from a graphical user interface or may be provided from a coach or human during in-office or remote sessions. For example, a mobile device based application can be used to guide the user in using the removable oral device, to guide weight management, nutrition, exercise and/or other features which can assist in the user losing weight and/or reducing the body mass index or body fat percentage. Information from the application can be transferred to a remote device or a remote coach to further assist in monitoring weight loss. The application can be configured to provide notifications, reminders, etc. regarding usage of the removable oral device and/or eating times and durations. If desired, videos, e-mails, webinars, etc., may also be available by way of the application or through an external device to assist the user in losing weight and/or maintaining a desired weight using the removable oral device.
[0093] In certain configurations and referring to FIG. 3, a system 300 for monitoring intake into a mouth of a user comprises a removable oral device 310 with a camera 312 in combination with an external device 320. For example, the removable oral device 310 can be configured to removably insert into a mouth of a user and may comprise a palatal element coupled to a clasping element. The palatal element is configured to contact a roof of a user's mouth at a palatal surface, the palatal element comprising a body comprising a thickness configured to lower a vaulted area of the roof of the mouth to decrease an overall oral volume of the mouth to a first oral volume. The clasping element, when present, can be configured to assist in removal of the removable oral device from the mouth and/or to retain the palatal surface of the palatal element against the roof of the user's mouth when the removable oral device is inserted into the user's mouth. The palatal element comprises the camera 312 which is configured to capture images of the material in the mouth of the user. The external device 320 is typically separate from the removable oral device and comprises a processor configured to couple to the removable oral device to transfer captured images from the camera 312 of the removable oral device 310 to the external device 320.
[0094] In certain examples, the removable oral device 310 comprises a variable hardness across the tongue surface of the body. In other examples, the removable oral device 310 comprises a rechargeable power source electrically coupled to the camera 312. In some examples, the removable oral device 310 comprises a transmitter. In other configurations, the external device 320 is configured to wirelessly couple to the camera 312 of the removable oral device 310. In some examples, the camera 312 is configured to automatically switch on in response to a sensed temperature change. For example, insertion of the removable oral device 310 into the mouth can increase its temperature and cause the camera 312 to switch on. In other examples, the camera 312 is configured to automatically switch off in response to a second sensed temperature change. For example, removal of the removable oral device 310 from the mouth can decrease its temperature and cause the camera 312 to switch off. If desired the removable oral device 310 may comprise a memory unit configured to store the captured image. In some examples, the body of the palatal element comprises an optical window and the camera 312 is configured to capture the image through the optical window. While the removable oral device 310 can be used to assist in weight loss, the removable oral device 310 is configured to not alter a position of the user's teeth and/or is configured to not retain a position of the user's teeth.
[0095] In other configurations and referring to FIG. 4, a system 400 for monitoring athletic performance comprises a removable oral device 410 and an external device 420. The removable oral device 410 is configured to removably insert into a mouth of the user. For example, the removable oral device 410 comprises a palatal element coupled to a clasping element. The palatal element is configured to contact a roof of a user's mouth at a palatal surface and comprises a body comprising a thickness configured to lower a vaulted area of the roof of the mouth to decrease an overall oral volume of the mouth to a first oral volume. The clasping element, when present, can be configured to assist in removal of the removable oral device from the mouth and/or to retain the palatal surface of the palatal element against the roof of the user's mouth when the removable oral device is inserted into the user's mouth. The palatal element comprises at least one electrode 412 positioned within the body of the palatal element and exposed to fluid entering and exiting the mouth of the user, the at least one electrode 412 configured to measure athletic performance from fluid entering and exiting the mouth of the user. For example, the electrode 412 can be configured as a selective electrode to measure one or more of oxygen, carbon dioxide, humidity in the oral cavity or other parameters. The tip of the electrode 412 can be exposed to fluid in the mouth to measure the athletic performance parameter. The external device 420 is typically separate from the removable oral device 410 and comprises a processor configured to couple to the removable oral device to transfer the measured athletic performance from the removable oral device 410 to the external device 420.
[0096] In certain embodiments, the body comprises a memory unit configured to store the measured athletic performance. In other examples, the electrode 412 is configured to measure one or more of oxygen, carbon dioxide and water as the measure of athletic performance. In some instances, the removable oral device 410 comprises a rechargeable power source electrically coupled to the at least one electrode 412. In certain examples, the body comprises a transmitter configured to transmit the measured athletic performance wirelessly to the external device 420. In some examples, the electrode 412 is configured to automatically switch on in response to a sensed temperature change. For example, insertion of the removable oral device 410 into the mouth can increase its temperature and cause the electrode 412 to switch on. In other examples, the electrode 412 is configured to automatically switch off in response to a second sensed temperature change. For example, removal of the removable oral device 410 into the mouth can decrease its temperature and cause the electrode 412 to switch off. In some examples, the removable oral device 410 is configured to not alter a position of the user's teeth.
In other examples, the removable oral device 410 is configured to not retain a position of the user's teeth. In further examples, the removable oral device 410 comprises a variable hardness across the tongue surface of the body.
[0097] In another configuration and referring to FIG. 5, a system 500 for monitoring intake of material into a mouth of a user comprises a removable oral device 510 comprising a bar code reader 512 and an external device 520. For example, the removable oral device 510 comprises a palatal element coupled to a clasping element. The palatal element can be configured to contact a roof of a user's mouth at a palatal surface. The palatal element comprises a body comprising a thickness configured to lower a vaulted area of the roof of the mouth to decrease an overall oral volume of the mouth to a first oral volume. The clasping element, when present, can be configured to assist in removal of the removable oral device from the mouth and/or to retain the palatal surface of the palatal element against the roof of the user's mouth when the removable oral device is inserted into the user's mouth. The palatal element comprises the bar code reader within the body of the palatal element, wherein the bar code reader is configured to read a bar code on the material entering the mouth of the user. The external device 520 is typically separate from the removable oral device 510 and comprises a processor configured to couple to the removable oral device 510 to transfer the measured bar code from the removable oral device 510 to the external device 520.
[0098] In certain examples, the material is configured as an opioid pill or tablet comprising a bar code on at least one surface. In other examples, the material is configured as narcotic pill or tablet comprising a bar code on at least one surface. In some examples, the material is configured as food comprising a bar code on at least one surface. In further embodiments, the removable oral device 510 is configured to not alter a position of the user's teeth. In some examples, the removable oral device 510 is configured to not retain a position of the user's teeth. In other examples, the removable oral device 510 comprises a variable hardness across the tongue surface of the body.
[0099] In another configuration and referring to FIG. 6, a system 600 comprises a removable oral device 610 with a memory unit 612 and an external device 620. The removable oral device 610 comprises a palatal element coupled to a clasping element. The palatal element can be configured to contact a roof of a user's mouth at a palatal surface. The palatal element comprises a body comprising a thickness configured to lower a vaulted area of the roof of the mouth to decrease an overall oral volume of the mouth to a first oral volume. The clasping element, when present, can be configured to assist in removal of the removable oral device from the mouth and/or to retain the palatal surface of the palatal element against the roof of the user's mouth when the removable oral device is inserted into the user's mouth. The palatal element comprises the memory unit 612 configured to receive and store an electronic medical record of the user. The external device 620 is typically separate from the removable oral device 610 and comprises a processor configured to couple to the removable oral device 610 to read and update the electronic medical record on the removable oral device 610.
[00100] In certain examples, the processor is configured to couple to the removable oral device 610 wirelessly to update the electronic medical record. In some embodiments, the removable oral device 610 is configured to not alter a position of the user's teeth. In other embodiments, the removable oral device 610 is configured to not retain a position of the user's teeth. In other examples, the removable oral device 610 comprises a variable hardness across the tongue surface of the body.
[00101] In another configuration and referring to FIG. 7, a system 700 configured to monitor human health comprises a removable oral device 710 configured to removably insert into a mouth of the user. The removable oral device 710 comprises a palatal element coupled to a clasping element, wherein the palatal element is configured to contact a roof of a user's mouth at a palatal surface. The palatal element comprises a body comprising a thickness configured to lower a vaulted area of the roof of the mouth to decrease an overall oral volume of the mouth to a first oral volume. The clasping element, when present, can be configured to assist in removal of the removable oral device from the mouth and/or to retain the palatal surface of the palatal element against the roof of the user's mouth when the removable oral device 710 is inserted into the user's mouth. The palatal element comprises at least one sensor 712 positioned within the body of the palatal element and exposed to fluid entering and exiting the mouth of the user. The at least one sensor 712 can be configured to measure a physiological parameter from fluid entering and exiting the mouth of the user. The system 700 also comprises an external device 720 separate from the removable oral device 710, in which the external device 720 comprises a processor configured to couple to the removable oral device 710 to transfer the measured physiological parameter from the removable oral device 710 to the external device 720.
[00102] In certain examples, the sensor 712 is configured to measure electrolyte levels in the fluid, e.g., the sensor 712 can be configured as an ion selective electrode to measure one or more ions in the fluid. In other embodiments, the sensor 712 is configured to measure ketone bodies in the fluid, e.g., the sensor 712 can be configured to cause release of colorimetric reagents to detect the ketone bodies. In some examples, the sensor 712 is configured to measure salivary insulin levels in the fluid, e.g., the sensor 712 can be measured using glucose oxidase in the sensor or other enzymatic or colorimetric methods. In other instances, the sensor 712 is configured to measure a gas other than oxygen in the fluid, e.g., can measure carbon dioxide or nitrogen. In some examples, the sensor is configured to measure carbohydrate levels in the fluid, e.g., the sensor 712 can be configured to use enzymatic or colorimetric methods to measure sugars. In certain examples, the sensor 712 is configured to measure oxygen levels in the fluid, e.g., using an oxygen sensor or oxygen sensitive electrode. In some examples, the sensor 712 is configured to measure carbon dioxide levels in the fluid. In other examples, sensor 712 is configured to measure a respiration rate, e.g., by monitoring air currents and/or oxygen levels. In some embodiments, the sensor 712 is configured to measure fluid intake, e.g., using a humidity sensor. In other examples, the sensor 712 is configured to measure heart rate, e.g., by monitoring the heart beat in the roof of the mouth using a piezoelectric sensor, electrocardiograph or other devices. In some examples, the removable oral device 710 comprises a second sensor configured to measure a different physiological parameter than the sensor 712. In certain examples, the removable oral device 710 is configured to not alter a position of the user's teeth. In other examples, the removable oral device 710 is configured to not retain a position of the user's teeth. In some embodiments, the removable oral device 710 comprises a variable hardness across the tongue surface of the body.
[00103] In another configuration and referring to FIG. 8, a system 800 configured to monitor head tremor comprises a removable oral device 810 comprising an accelerometer 812 and an external device 820. The removable oral device 810 comprises a palatal element coupled to a clasping element, wherein the palatal element is configured to contact a roof of a user's mouth at a palatal surface, and wherein the palatal element comprises a body comprising a thickness configured to lower a vaulted area of the roof of the mouth to decrease an overall oral volume of the mouth to a first oral volume. The clasping element, when present, can be configured to assist in removal of the removable oral device from the mouth and/or to retain the palatal surface of the palatal element against the roof of the user's mouth when the removable oral device is inserted into the user's mouth. The palatal element comprises the accelerometer 812 within the body of the palatal element, the accelerometer 812 being configured to detect head movement to monitor the head tremor. The external device 820 is separate from the removable oral device 810 and comprises a processor configured to couple to the removable oral device 810 to transfer the detected head movement measured by the accelerometer 812 to the external device 820.
[00104] In certain examples, the accelerometer 812 is configured to measure head movement at selected intervals. In some examples, the accelerometer 812 is configured to automatically switch off between the selected intervals where the accelerometer measures head movement. In other examples, the accelerometer 812 is configured to automatically switch on when the accelerometer measures head movement. In some embodiments, the removable oral device 810 comprises a second accelerometer. In some examples, the removable oral device 810 is configured to not alter a position of the user's teeth. In other examples, the removable oral device 810 is configured to not retain a position of the user's teeth. In some configurations, the removable oral device 810 comprises a variable hardness across the tongue surface of the body.
[00105] In an additional configuration, a system 900 for monitoring head impact comprises a removable oral device 900 comprising an accelerometer 912 and an external device 920. The removable oral device 910 comprises a palatal element coupled to a clasping element, wherein the palatal element is configured to contact a roof of a user's mouth at a palatal surface, and wherein the palatal element comprises a body comprising a thickness configured to lower a vaulted area of the roof of the mouth to decrease an overall oral volume of the mouth to a first oral volume. The clasping element, when present, can be configured to assist in removal of the removable oral device from the mouth and/or to retain the palatal surface of the palatal element against the roof of the user's mouth when the removable oral device is inserted into the user's mouth. The palatal element comprises the accelerometer 912 within the body of the palatal element. The accelerometer 912 is configured to detect head movement, e.g., head movement rates, to monitor the head impact. The external device 920 is separate from the removable oral device and comprises a processor configured to couple to the removable oral device to transfer the detected head movement measured by the accelerometer to the external device. If desired, the removable oral device 910 can be configured for wear during athletic activities such as football, soccer, rugby, automotive racing or other sports where participant impact with each other or another object may occur.
[00106] In some examples, the accelerometer 912 is configured to measure head impact at selected intervals. In certain examples, the accelerometer 912 is configured to automatically switch off between the selected intervals where the accelerometer measures head impact. In some examples, the accelerometer 912 is configured to automatically switch on when the accelerometer measures head impact. In other embodiments, the removable oral device 910 comprises a second accelerometer to measure head impact. In some examples, the removable oral device 910 comprises a motion sensor, wherein the accelerometer 912 is automatically switched on when the motion sensor senses user motion. In some embodiments, the removable oral device 910 is configured to not alter a position of the user's teeth. In certain examples, the removable oral device 910 is configured to not retain a position of the user's teeth. In other examples, the removable oral device 910 comprises a variable hardness across the tongue surface of the body.
[00107] In another configuration and referring to FIG. 10, a system 1000 configured to monitor chewing comprises a removable oral device 1010 comprises a piezoelectric sensor
(PES) 1012 and an external device 1020. The removable oral device 1010 comprises a palatal element coupled to a clasping element, wherein the palatal element is configured to contact a roof of a user's mouth at a palatal surface, and wherein the palatal element comprises a body comprising a thickness configured to lower a vaulted area of the roof of the mouth to decrease an overall oral volume of the mouth to a first oral volume. The clasping element, when present, can be configured to assist in removal of the removable oral device from the mouth and/or to retain the palatal surface of the palatal element against the roof of the user's mouth when the removable oral device is inserted into the user's mouth. The palatal element comprises the piezoelectric sensor 1012 within the body of the palatal element. The piezoelectric sensor 1012 is configured to measure pressure changes to monitor chewing. The external device 1020 is separate from the removable oral device 1010 and comprises a processor configured to couple to the removable oral device 1010 to transfer the measured pressure changes to the external device 1020.
[00108] In certain examples, the piezoelectric sensor 1012 is configured to automatically switch on when the palatal element reaches a selected temperature. In some examples, the palatal element is configured with a device configured to provide the user sensor feedback after the piezoelectric sensor 1012 measures a selected number of chews. In certain examples, the sensory feedback is configured as an audible alert or as a vibration. In some examples, the palatal element is configured with a second piezoelectric sensor. In further examples, the removable oral device 1010 is configured to not alter a position of the user's teeth. In other examples, the removable oral device 1010 is configured to not retain a position of the user's teeth. In some embodiments, the removable oral device 1010 comprises a variable hardness across the tongue surface of the body.
[00109] In another configuration and referring to FIG. 11, a system 1100 configured to monitor chewing comprises a removable oral device 1110 comprising a microphone 1112 and an external device 1120. The removable oral device 1110 comprises a palatal element coupled to a clasping element, wherein the palatal element is configured to contact a roof of a user's mouth at a palatal surface, and wherein the palatal element comprises a body comprising a thickness configured to lower a vaulted area of the roof of the mouth to decrease an overall oral volume of the mouth to a first oral volume. The clasping element, when present, can be configured to assist in removal of the removable oral device from the mouth and/or to retain the palatal surface of the palatal element against the roof of the user's mouth when the removable oral device 1110 is inserted into the user's mouth. The palatal element comprises the microphone 1112 configured to monitor chewing by measuring a change in decibel levels within the mouth. The external device 1120 is separate from the removable oral device 1110 and comprises a processor configured to couple to the removable oral device 1110 to transfer the measured change in decibel levels within the mouth to the external device. [00110] In certain examples, the microphone 1112 is configured with a speaker to provide a sensory feedback after the change in decibel levels has been measured for a selected period. For example, the microphone can be used to monitor the duration of chewing and after a selected time an audible or other sensory cue can be provided through the speaker. In some examples, the sensory feedback is configured as an audible alert or as a vibration. In other examples, the palatal element is configured with a second microphone. In some embodiments, the palatal element is configured with a recording medium to record audio, e.g., a memory unit. In further examples, the removable oral device 1110 is configured to not alter a position of the user's teeth. In other examples, the removable oral device 1110 is configured to not retain a position of the user's teeth. In some examples, the removable oral device 1110 comprises a variable hardness across the tongue surface of the body.
[00111] In another configuration, a system 1200 configured to monitoring chewing comprises a removable oral device 1210 comprising a proximity sensor 1212 and an external device 1220 (see FIG. 12). The removable oral device 1210 comprises a palatal element coupled to a clasping element, wherein the palatal element is configured to contact a roof of a user's mouth at a palatal surface, and wherein the palatal element comprises a body comprising a thickness configured to lower a vaulted area of the roof of the mouth to decrease an overall oral volume of the mouth to a first oral volume. The clasping element, when present, can be configured to assist in removal of the removable oral device from the mouth and/or to retain the palatal surface of the palatal element against the roof of the user's mouth when the removable oral device 1210 is inserted into the user's mouth. The palatal element comprises a proximity sensor 1212 configured to monitor chewing by measuring a distance change between the proximity sensor 1212 and a sensor coupled to a lower tooth of the user (not shown). For example, the sensor coupled to the lower tooth may be a sensor, contact or other device which can be used with the sensor 1212 to measure a distance change between the two components. The external device 1220 external device is separate from the removable oral device and comprises a processor configured to couple to the removable oral device to transfer the measured distance change to the external device.
[00112] In certain examples, the proximity sensor 1212 is configured to measure contact of the proximity sensor 1212 to the sensor coupled to the lower tooth of the user. In some examples, the proximity sensor 1212 is configured to detect a radio wave emitted by the sensor coupled to the lower tooth of the user. In other examples, the proximity sensor 1212 is configured to detect light emission emitted by the sensor coupled to the lower tooth of the user. In certain examples, the proximity sensor 1212 is configured to detect an ultrasound wave emitted by the sensor coupled to the lower tooth of the user. In some examples, the removable oral device 1210 is configured to not alter a position of the user's teeth. In other examples, the removable oral device 1210 is configured to not retain a position of the user's teeth. In further examples, the removable oral device 1210 comprises a variable hardness across the tongue surface of the body.
[00113] In another configuration and referring to FIG. 13, a system 1300 configured to monitor chewing of material entering a user's mouth comprises a removable oral device 1310 comprising a vibratory element 1312 and an external device 1320. The removable oral device 1310 comprises a palatal element coupled to a clasping element, wherein the palatal element is configured to contact a roof of a user's mouth at a palatal surface, and wherein the palatal element comprises a body comprising a thickness configured to lower a vaulted area of the roof of the mouth to decrease an overall oral volume of the mouth to a first oral volume. The clasping element, when present, can be configured to assist in removal of the removable oral device 1310 from the mouth and/or to retain the palatal surface of the palatal element against the roof of the user's mouth when the removable oral device 1310 is inserted into the user's mouth. The palatal element comprises the vibratory device 1312 configured to vibrate after the user has chewed a selected number of times to provide feedback to the user to swallow the chewed material. If desired, the vibratory element 1312 can be used in combination with a motion sensor to monitor the number of chews The external device 1320 is separate from the removable oral device 1310 and comprises a processor configured to couple to the removable oral device 1310 to transfer the selected number of times to the external device 1320.
[00114] In certain examples, the palatal element is configured with a chewing sensor electrically coupled to the vibratory device 1312, e.g., a motion sensor, piezoelectric sensor, etc. In other examples, the clasping element is configured with a chewing sensor electrically coupled to the vibratory device. In some instances, the removable oral device 1310 is configured to not alter a position of the user's teeth. In other instances, the removable oral device 1310 is configured to not retain a position of the user's teeth. In some examples, the removable oral device 1310 comprises a variable hardness across the tongue surface of the body.
[00115] In another configuration and referring to FIG. 14, a system 1400 configured to monitor food intake volume entering a user's mouth comprises a removable oral device 1410 comprising a food sensor 1412 and an external device 1420. The removable oral device 1410 comprises a palatal element coupled to a clasping element, wherein the palatal element is configured to contact a roof of a user's mouth at a palatal surface, and wherein the palatal element comprises a body comprising a thickness configured to lower a vaulted area of the roof of the mouth to decrease an overall oral volume of the mouth to a first oral volume. The clasping element, when present, can be configured to assist in removal of the removable oral device 1410 from the mouth and/or to retain the palatal surface of the palatal element against the roof of the user's mouth when the removable oral device 1410 is inserted into the user's mouth. The palatal element comprises the food sensor 1412 that is configured to sense presence of the food in the user's mouth and absence of the food in the user's mouth as an indicator the food has been swallowed. The palatal element is configured to provide feedback to the user once a selected number of swallows has been reached. The external device 1420 is separate from the removable oral device and comprises a processor configured to couple to the removable oral device to transfer the number of swallows to the external device.
[00116] In certain examples, the food sensor 1412 is configured to use light, ultrasound waves, radio waves or other energy to sense whether or not food is present or absent in the mouth. For example, diffracted light can be used as a measure of food being present or absent. In some examples, the removable oral device 1410 is configured to not alter a position of the user's teeth. In other examples, the removable oral device 1410 is configured to not retain a position of the user's teeth. In some embodiments, the removable oral device 1410 comprises a variable hardness across the tongue surface of the body.
[00117] In another configuration and referring to FIG. 15, a system 1500 configured to monitor material entering into a user's mouth to measure nutrient species in the material comprises a removable oral device 1510 comprising a sensor 1512 and an external device 1510. The removable oral device 1510 comprises a palatal element coupled to a clasping element, wherein the palatal element is configured to contact a roof of a user's mouth at a palatal surface, and wherein the palatal element comprises a body comprising a thickness configured to lower a vaulted area of the roof of the mouth to decrease an overall oral volume of the mouth to a first oral volume. The clasping element, when present, can be configured to assist in removal of the removable oral device 1510 from the mouth and/or to retain the palatal surface of the palatal element against the roof of the user's mouth when the removable oral device 1510 is inserted into the user's mouth. The palatal element comprises a processor 1514 and a memory unit 1515 electrically coupled to the processor 1514, and wherein the palatal element comprises a sensor 1512 electrically coupled to the processor 1514. The external device 1520 is separate from the removable oral device, in which the external device comprises a processor configured to couple to the removable oral device 1510 to transfer the measured nutrient species in the material to the external device 1520.
[00118] In certain examples, the sensor 1512 is configured to measure carbohydrate content of the material. In other examples, the sensor is configured to measure protein content of the material. In some examples, the sensor is configured to measure fat content of the material. In some embodiments, the sensor 1512 is configured to measure water content of the material. In other examples, the removable oral device 1510 is configured to not alter a position of the user's teeth. In some embodiments, the removable oral device 1510 is configured to not retain a position of the user's teeth. In some examples, the removable oral device 1510 comprises a variable hardness across the tongue surface of the body.
[00119] In another configuration and referring to FIG. 16, a system 1600 configured to monitor material entering into a user's mouth to measure nutrient species in the material comprises a removable oral device 1610 comprising a multi-plexing sensor 1612 and an external device 1620. The removable oral device 1610 comprises a palatal element coupled to a clasping element, wherein the palatal element is configured to contact a roof of a user's mouth at a palatal surface, and wherein the palatal element comprises a body comprising a thickness configured to lower a vaulted area of the roof of the mouth to decrease an overall oral volume of the mouth to a first oral volume. The clasping element, when present, can be configured to assist in removal of the removable oral device 1612 from the mouth and/or to retain the palatal surface of the palatal element against the roof of the user's mouth when the removable oral device 1612 is inserted into the user's mouth. The palatal element comprises a processor and a memory unit electrically coupled to the processor, and wherein the palatal element comprises the multiplexing sensor 1612 electrically coupled to the processor and configured to simultaneously measure caloric content of all the material entering into the user's mouth, e.g., the sensor 1612 can measure and sum the calories entering the user's mouth. The external device 1620 separate from the removable oral device 1610. The external device comprises a processor configured to couple to the removable oral device 1610 to transfer the measured caloric content from the removable oral device 1610 to the external device 1620. As noted herein, the multi-plexing sensor 1612 may comprise an electrode, a colorimetric sensor, an optical sensor and/or combinations thereof to measure protein, fat and carbohydrate caloric content of material entering into the user's mouth.
[00120] In certain embodiments, the palatal element is configured with a sensory feedback device configured to provide a sensory cue once the measured caloric content reached a selected level. In some examples, the sensory cue is configured as an audible noise or a vibration. In other examples, the removable oral device 1610 is configured to not alter a position of the user's teeth. In some examples, the removable oral device 1610 is configured to not retain a position of the user's teeth. In some examples, the removable oral device 1610 comprises a variable hardness across the tongue surface of the body.
[00121] In another configuration and referring to FIG. 17, a system 1700 configured to provide real time measurements of material intake into a user's mouth comprises a removable oral device 1710 comprising a transmitter/receiver 1712 and an external device 1720. The removable oral device 1710 comprises a palatal element coupled to a clasping element, wherein the palatal element is configured to contact a roof of a user's mouth at a palatal surface, and wherein the palatal element comprises a body comprising a thickness configured to lower a vaulted area of the roof of the mouth to decrease an overall oral volume of the mouth to a first oral volume. The clasping element, when present, can be configured to assist in removal of the removable oral device 1710 from the mouth and/or to retain the palatal surface of the palatal element against the roof of the user's mouth when the removable oral device 1710 is inserted into the user's mouth. The palatal element comprises a processor, a memory unit electrically coupled to the processor and the transmitter/receiver 1712 electrically coupled to the processor, in which the processor is configured to transmit the recorded material intake to a site outside of the mouth of the user. The external device 1720 is separate from the removable oral device, in which the external device comprises a processor configured to couple to the removable oral device to receive the transmitted, recorded material intake.
[00122] In certain examples, the transmitter/receiver 1712 comprises one or more of a
Bluetooth device, a cellular chip, a Wi-Fi chip, an optical transmitter/receiver. In some examples, the transmitter/receiver 1712 is configured to be in an off state when the removable oral device 1710 is inserted into the mouth of the user. In other examples, the transmitter/receiver 1712 is configured to automatically switch from the off state to an on state when the removable oral device is removed from the mouth of the user. In some embodiments, the removable oral device is configured with a temperature sensor configured to determine when the removable oral device is removed from the mouth of the user. In certain examples, the removable oral device is configured to not alter a position of the user's teeth. In some embodiments, the removable oral device is configured to not retain a position of the user's teeth. In certain examples, the removable oral device comprises a variable hardness across the tongue surface of the body.
[00123] In another configuration, a system 1800 configured to monitor blood pressure in a human by measuring blood pressure from a roof of the mouth of the human comprises a removable oral device 1810 comprises a pressure sensor 1812 and an external device 1820. The removable oral device 1810 comprises a palatal element coupled to a clasping element, wherein the palatal element is configured to contact a roof of a user's mouth at a palatal surface, and wherein the palatal element comprises a body comprising a thickness configured to lower a vaulted area of the roof of the mouth to decrease an overall oral volume of the mouth to a first oral volume. The clasping element, when present, can be configured to assist in removal of the removable oral device 1810 from the mouth and/or to retain the palatal surface of the palatal element against the roof of the user's mouth when the removable oral device is inserted into the user's mouth. The palatal element comprises a processor, a memory unit electrically coupled to the processor and the pressure sensor 1812 electrically coupled to the processor. The external device 1820 is separate from the removable oral device 1810, in which the external device 1820 comprises a processor configured to couple to the removable oral device 1810 to receive pressure measurements from the pressure sensor 1812.
[00124] In certain examples, the pressure sensor 1812 is configured as a piezoelectric sensor or a device comprising a pressure sensitive membrane. In some examples, the removable oral device 1810 is configured to not alter a position of the user's teeth. In other examples, the removable oral device 1810 is configured to not retain a position of the user's teeth. In some examples, the removable oral device 1810 comprises a variable hardness across the tongue surface of the body.
[00125] In an additional configuration and referring to FIG. 19, a system 1900 configured to transfer information present on a removable oral device 1910 comprises a removable oral device 1910 comprising a transmitter/receiver 1912 and a case 1920. The removable oral device 1910 comprises a palatal element coupled to a clasping element, wherein the palatal element is configured to contact a roof of a user's mouth at a palatal surface, and wherein the palatal element comprises a body comprising a thickness configured to lower a vaulted area of the roof of the mouth to decrease an overall oral volume of the mouth to a first oral volume. The clasping element, when present, can be configured to assist in removal of the removable oral device 1910 from the mouth and/or to retain the palatal surface of the palatal element against the roof of the user's mouth when the removable oral device 1910 is inserted into the user's mouth. The palatal element comprises a processor, a memory unit electrically coupled to the processor and a transmitter/receiver 1912 electrically coupled to the processor. The case 1920 is configured to receive and store the removable oral device 1910. The case 1920 comprises a transmitter/receiver to receive the information from the transmitter/receiver 1912 of the removable oral device 1910 to transfer the information present on the removable oral device 1910 when the removable oral device 1910 is inserted into the case 1920.
[00126] In certain embodiments, the removable oral device 1910 is configured to transfer the information to the case 1920 wirelessly. In other embodiments, the removable oral device 1910 is configured to transfer the information to the case 1920 in a wired manner, e.g., through a cable or other hard-wired connection. In some examples, the case 1920 is configured to recharge the removable oral device 1910 when the removable oral device 1910 contacts the case 1920 or is within the case 1920. In certain examples, the case 1920 is configured to wirelessly recharge the removable oral device 1910 when the removable oral device 1910 contacts the case
1920. In other examples, the removable oral device 1910 is configured to not alter a position of the user's teeth. In some instances, the removable oral device 1910 is configured to not retain a position of the user's teeth. In other examples, the removable oral device 1910 comprises a variable hardness across the tongue surface of the body.
[00127] In an additional configuration and referring to FIG. 20, a system 2000 configured to determine a body fat percentage of a human comprises a removable oral device 2010 comprising an electrode 2012 and an external device 2020. The removable oral device comprises a palatal element coupled to a clasping element, wherein the palatal element is configured to contact a roof of a user's mouth at a palatal surface, and wherein the palatal element comprises a body comprising a thickness configured to lower a vaulted area of the roof of the mouth to decrease an overall oral volume of the mouth to a first oral volume. The clasping element, when present, can be configured to assist in removal of the removable oral device 2010 from the mouth and/or to retain the palatal surface of the palatal element against the roof of the user's mouth when the removable oral device 2010 is inserted into the user's mouth. The palatal element comprises the electrode 2012. The external device 2020 is separate from the removable oral device and comprises a processor configured to couple to the removable oral device 2010 to receive electrical measurements from the electrode 2012 and determine the body fat percentage using the received electrical measurements. If desired, the external device 2020 may comprise its own electrode and power source to permit measurement of a current or voltage provided from the electrode of the external device 2020 by the electrode 2012 of the removable oral device 2010.
[00128] In certain examples, the removable oral device 2010 is configured to not alter a position of the user's teeth. In other examples, the removable oral device 2010 is configured to not retain a position of the user's teeth. In some examples, the removable oral device 2010 comprises a variable hardness across the tongue surface of the body.
[00129] In another configuration and referring to FIG. 21, a system 2100 configured to transfer information from a removable oral device 2110 comprises a processor 2112 and a mobile device 2120. The removable oral device 2110 comprises a palatal element coupled to a clasping element, wherein the palatal element is configured to contact a roof of a user's mouth at a palatal surface, and wherein the palatal element comprises a body comprising a thickness configured to lower a vaulted area of the roof of the mouth to decrease an overall oral volume of the mouth to a first oral volume. The clasping element, when present, can be configured to assist in removal of the removable oral device 2110 from the mouth and/or to retain the palatal surface of the palatal element against the roof of the user's mouth when the removable oral device 2110 is inserted into the user's mouth. The palatal element comprises the processor 2112. The mobile device 2120 is separate from the removable oral device 211 and is configured to receive information from the processor 2112 of the removable oral device 2110. The exact configuration of the mobile device may vary from, for example, a cellular phone, a tablet, a laptop computer, a wearable device or other mobile devices.
[00130] In certain examples, the mobile device 2120 is configured to monitor usage duration of the removable oral device. In other examples, the mobile device 2120 is configured to monitor usage frequency of the removable oral device. In further examples, the removable oral device 2120 is configured to not alter a position of the user's teeth. In some examples, the removable oral device 2120 is configured to not retain a position of the user's teeth. In some instances, the removable oral device 2120 comprises a variable hardness across the tongue surface of the body.
[00131] In another configuration and referring to FIG. 22, a system 2200 comprises a removable oral device 2210 comprising a processor 2212 and a wearable device 2220. The removable oral device 2210 comprises a palatal element coupled to a clasping element, wherein the palatal element is configured to contact a roof of a user's mouth at a palatal surface, and wherein the palatal element comprises a body comprising a thickness configured to lower a vaulted area of the roof of the mouth to decrease an overall oral volume of the mouth to a first oral volume. The clasping element, when present, can be configured to assist in removal of the removable oral device 2210 from the mouth and to retain the palatal surface of the palatal element against the roof of the user's mouth when the removable oral device 2210 is inserted into the user's mouth. The palatal element comprises the processor 2212. The wearable device 2220 is separate from the removable oral device 2210 and comprises a processor configured to receive information from the processor 2212 of the palatal element.
[00132] In certain examples, the wearable device 2220 is configured as a wrist device, e.g., a Fitbit device, Apple Iwatch, etc. In other examples, the wearable device is configured as spectacles, e.g., Google glass or other spectacles or eyeglasses which comprise a processor and/or on-board power source or other electrical components. In some instances, the wearable device is configured as a contact lens, e.g., a contact lens comprising a processor. In some embodiments, the wearable device is configured as a belt, a garment, footwear, jewelry, a necklace, wristband, ankle band, head band or other devices which are worn by a user. In some examples, the removable oral device 2210 is configured to not alter a position of the user's teeth. In other examples, the removable oral device 2210 is configured to not retain a position of the user's teeth. In some examples, the removable oral device 2210 comprises a variable hardness across the tongue surface of the body.
[00133] In another configuration and referring to FIG. 23, a system configured to produce a removable oral device comprises a three-dimensional printer 2310 comprising a processor configured to receive three-dimensional coordinates from an image of an oral cavity of a human mouth. The printer 2310 can be configured to print a removable oral device using the three dimensional coordinates. The printed removable oral device comprises a palatal element coupled to a clasping element, in which the palatal element is configured to contact a roof of a user's mouth at a palatal surface, and wherein the palatal element comprises a body comprising a thickness configured to lower a vaulted area of the roof of the mouth to decrease an overall oral volume of the mouth to a first oral volume. The clasping element, when present, can be configured to assist in removal of the removable oral device from the mouth and/or to retain the palatal surface of the palatal element against the roof of the user's mouth when the removable oral device is inserted into the user's mouth.
[00134] In certain configurations, the printer 2310 is configured to print areas of the body adjacent to the clasping element using a second material softer than the first material. In other examples, the printer 2310 is configured to three-dimensionally print the palatal element using a photo-curable material. In some configurations, the printer 2310 is configured to print the photo-curable material onto a printer support comprising the one or more wires to provide the removable oral device. In some examples, the system is configured to photo-cure the printed palatal element using UV/Visible light. In other examples, the printer 2310 is configured to print each of the palatal element and the clasping element using a photo-curable material. In further examples, the printer 2310 is configured as an inkjet three-dimensional printer. In some embodiments, the printer 2310 is configured to use digital light processing. In further examples, the printer 2310 is configured to three-dimensionally print the removable oral device from a digital image of the user's mouth. In other examples, the printer 2310 is configured to print the palatal element of the digital image using a photo-curable material. In some embodiments, the printer 2310 is configured to print a photo-curable material onto a printer support comprising the one or more wires to provide the removable oral device. In further examples, the printed removable oral device is configured to not alter a position of the user's teeth. In other examples, the printed removable oral device is configured to not retain a position of the user's teeth. In other configurations, the printed removable oral device comprises a variable hardness across the tongue surface of the body.
[00135] In certain examples, the exact nature and type of three-dimensional printing used to produce the components of the removable oral device may vary. Illustrative three- dimensional printing technologies include, but are not limited to, selective laser sintering (SLS), fused deposition molding (FDM), laminate object manufacturing (LOM), rapid prototyping, and three-dimensional inkjet printing. Three-dimensional printing methods using digital light processing (DLP) or an injection through a series of tiny nozzles or a single nozzle may use photo-curable materials which can be cured by UV/Vis light. These two methods are rapid, low cost, high resolution, and east to use. Three-dimensional articles can be produced using ink-jet printing techniques that can use several different materials, e.g., from different reservoirs or cartridge, to provide a photo-curable liquid compositions which can be cured by exposure to UV/Vis light. The photo-curable "ink" in the ink-jet printing process is provided through one or more nozzles on a support stage with a pattern defined by a computer aided design file or other three-dimensional coordinates. In one exemplary illustration, successive layers of the palatal element can be "built up" by placing individual layers on the printer support and curing, at least to some degree, the printed layer prior to addition of successive layers. Layers can be added in individual areas until a desired final shape is reached. The final three-dimensionally printed removable oral device can then be washed or treated with one or more other materials if desired. In a three-dimensional printing technique using digital light processing, the photo-curable liquid can be placed in a reservoir. Exposure of certain areas to the curing light can provide layers which can be used to build up the removable oral device. Once a layer has been cured by UV/Vis light, a building platform moves in the z-direction depending on the thickness of the layer. This process is repeated until all layers are formed and/or a desired shape is formed. Illustrative three-dimensional printers include, but are not limited to, those commercially available from Objet or Master supplied by Carima and The Form 1 supplied by Formlabs.
[00136] In some examples, the materials used by the three-dimensional printer may be photo-curable, heat curable, UV curable or cured by adding one or more external curing agents to the printed palatal element to harden the materials. The exact materials uses include, but are not limited to, acrylates, methacrylates, acrylic polymers and co-polymers, functionalized bisphenol A methacrylates such as a monofunctional bisphenol A dimethacrylate or a difunctional bisphenol A dimethacrylate, a diglycidyl methacrylate ester of bisphenol-A or a bisphenol-A diglycidyl ether and other materials. In some examples, the printed palatal element of the removable oral device may comprise one or more of ethylene glycol dimethacrylate, diethylene glycol dimethacrylate, triethylene glycol dimethacrylate, polyethylene glycol dimethacrylate, 2,2 bis[4-(methacryloxy ethoxy)phenyl]propane, tricyclodecane dimethanol dimethacrylate, 1, 10-decanediol dimethacrylate, 1,6-hexanediol dimethacrylate, 1,9-nonanediol dimethacrylate, neopentyl glycol dimethacrylate, 2-hydroxy 1-3 dimethacryloxy propane, trimethylolpropane trimethacrylate, ethoxylated trimethylol propane trimethacrylate, ditrimethyolpropane tetramethacrylate, tris (2-hydroxy ethyl)isocyanurate trimethacrylate, dipentaerythritol pentamethacrylate, ethoxylated pentaerythritol tetramethacrylate, propoxylated glyceryl trimethacrylate, propoxylated trimethylolpropane trimethacrylate, and a polyester dendrimer. The exact material used or combinations of the materials used can be selected to provide a palatal element which provides sufficient hardness to permit chewing but is not so hard as to be uncomfortable in the mouth. For example, the material can be cured to provide a feel similar to the native roof of the mouth.
[00137] In certain examples, the clasping element of the removable oral device may also be printed or the palatal element can be printed with the clasping element or elements present on the printer support. For example, a clasping element in the form of a metal wire can be present on the printer stage, and the palatal element can be printed onto the clasping element to provide the removable oral device with an embedded wire as a clasping element.
[00138] In some examples, the printed palatal element can be heat cured by placing it in an oven to harden the body of the palatal element. If desired, heat tape or other materials can be placed at the edges of the palatal element to prevent hardening of these areas to the same degree as an apex portion of the body. In other examples, one or more curing agent can be deposited onto the entire body of the palatal element or just at apex areas to provide softer edges when the palatal element is cured.
[00139] In certain examples, one or more photo-curing agents can be added to the printed palatal element (or clasping element or both) or may be present in the "ink" used to print the palatal element. For example, the polymeric material of the palatal element can be mixed with a photo-curing agent and the mixture is deposited in additive layers to form the palatal element. Illustrative photo-curing agents include, but are not limited to, acetophenone, anisoin, anthraquinone, (benzene)tricarbonylchromium, benzil, benzoin, benzoin ethyl ether, benzoin isobutyl either, benzoin methyl ether, benzophenone, 3,3',4,4'-benzophenonetetracarboxylic dianhydride, 4-benzoylbiphenyl, 2-benzyl-2-(dimethylamino)-4'-morpholinobutyrophenone, 4,4'-bis(diethylamino)benzophenone, 4,4'-bis(dimethylamino)benzophenone, camphorquinone, 2-chlorothioxanthen-9-one, (cumene)cyclopentadienyliron(II)hexafluorophosphate, dibenzosuberenone, 2,2-diethoxyacetophenone, 4,4'-dihydroxybenzophenone, 2,2-dimethoxy-2- phenyl acetophenone, 4-(dimethylamino)benzophenone, 4,4'-dimethylbenzyl, 2,5- dimethylbenzophenone, 3,4-dimethylbenzophenone, 4'-ethoxyacetophenone, 2- ethylanthraquinone, ferrocene, 3'-hydroxyacetophenone, 4' -hydroxy acetophenone, 3- hydroxybenzophenone, 4-hydroxybenzophenone, 1 -hydroxy cyclohexyl phenyl ketone, 2- hydroxy-2-methylpropiophenone, 2-methylbenzophenone, 3 -methylbenzophenone, methylbenzoylformate, 2-methyl-4'-(methylthio)-2-morpholinopropio-phenone, phenanthrenequinone, 4'-phenoxyacetophenone, thioxanthen-9-one, triacrylsulfonium hexafluoroantimonate salts, triarylsulfonium hexafluorophosphate salts, ,4,6- trimethylbenzoyldiphenylphosphine oxide, 2,6-dimethyoxybenzoyldiphenylphosphine oxide,
2,6-dichlorobenzoyldiphenylphosphine oxide, 2,4,6-trimethylbenzoylmethoxyphenylphosphine oxide, 2,4,6-trimethylbenzoylethoxyphenylphosphine oxide, 2,3,5,6- tetramethylbenzoyldiphenylphosphine oxide, and benzoyl di-(2,6-dimethylphenyl)phosphonate. Examples of the bisacylphosphine oxides include bis-(2,6-dichlorobenzoyl)phenylphosphine oxide, bis-(2,6-dichlorobenzoyl)-2,5-dimethylphenylphosphine oxide, bis-(2,6-dichlorobenzoyl)- 4-prophylphenylphosphine oxide, bis-(2,6-dichlorobenzoyl)-l-naphthylphosphine oxide, bis- (2,6-dimethoxybenzoyl)-2,4,4-trimethylpentylphosphine oxide, bis-(2,6-dimethoxybenzoyl)-2,5- dimethylphenylphosphine oxide, bis-(2,4,6-trimethylbenzoyl)phenylphosphine oxide, (2,5,6- trimethylbenzoyl)-2,4,4-trimethylpentylphosphine oxide and those compounds commercially available from Dow Chemical Company as UVI 6950, UVI 6970, UVI 6974, UVI 6976, and UVI 6990.
[00140] In certain examples, the printed palatal element (or the clasping element or both) may comprise fillers, particles, powders, reinforcing materials, etc. to impart overall desired physical properties to the removable oral device. For example, silica based powders, fillers, fibers, etc. can be added to the removable oral device. In other instanced, carbon fibers or particles can be added to the palatal element to alter its overall strength and/or weight. Pigments, colorants, dyes, texturizing agents, UV stabilizers, or other materials may also be present.
[00141] In some instances, the printer may include a reader which can read or scan a prescription or bar code specifying the removable oral device parameters. The read parameters can then be used to print some or all of the removable oral device.
[00142] In certain examples, the three-dimensional printer can be used with an oral imager which can capture images and/or oral coordinates from a user's mouth and use those images or coordinates to print the removable oral device. Referring to FIG. 24, a system 2400 comprises a kiosk or housing 2410 which comprises an oral imager 2420 electrically coupled to the system 2400. The oral imager 2420 may take the form of a wand with an image head which can be inserted into the mouth of the user. If desired, the image head may receive a disposable cover to permit many different users to use the system 2400 without sterilizing the imager 2420. In some instances, the system 2400 may also comprise a scale 2430 which can measure the weight of the user and print a removable oral device based on the measured weight. For example, the user can enter their height into the system 2400, the system 2400 can measure the weight of the user and print a suitable removable oral device from the images and from the user parameters. In some examples, user's with a body mass index of about 25 to about 30 may be particularly suited to using the removable oral devices. In certain instances, the system can be designed to alter the thickness of the palatal element based on the user parameters. For example, users with a BMI of 30 or above, may receive a removable oral device with a printed palatal element which reduces the oral volume by about 35-40%. Users with a BMI of 25-30 may receive a removable oral device with a printed palatal element which reduces the oral volume by about 30-35%. If desired, more than a single removable oral device can be printed with varying thicknesses for the palatal elements to permit the user to select which device should be used. If desired, the system 2400 may comprise an integral printer which can print the removable oral device and dispense it through opening 2450. A graphic user interface may be present on the screen 2440 to permit the user to interact with the system 2400.
[00143] In another configuration and referring to FIG. 25, a system 2500 is configured to produce a removable oral device and comprises an oral imager 2510 comprising an image head configured to be inserted into a user's mouth and provide an oral cavity image, and a printer 2520 configured to receive the oral cavity image from the oral imager and print a removable oral device using a first material. For example, the printed removable oral device comprises a printed palatal element coupled to a clasping element, in which the printed palatal element is configured to contact a roof of a user's mouth at a palatal surface, and wherein the printed palatal element comprising a body comprising a thickness configured to lower a vaulted area of the roof of the mouth to decrease an overall oral volume of the mouth to a first oral volume. The clasping element, when present, can be configured to assist in removal of the removable oral device from the mouth and to retain the palatal surface of the palatal element against the roof of the user's mouth when the removable oral device is inserted into the user's mouth.
[00144] In certain configurations, the printer 2520 is configured to use a second material softer than the first material to print areas of the body adjacent to the clasping element. In other examples, the image head of the oral imager 2510 is configured to receive a disposable cover configured to reversibly couple to the image head. For example, an oral imager can capture pictures, measure distances using light, ultrasound, sound waves, etc. The disposable cover can be transparent to the particular energy or means used to perform the imaging while at the same time permitting multiple uses of the image head without the need to sterilize it. Generally, the disposable cover can slide over or engage the image head through a friction fit and, if desired, the cover may be heat shrinkable so the cover engages the image head in a tight manner. The cover can be peeled away or removed and discarded once the imaging operation is complete. In some embodiments, the printer 2520 is configured to wirelessly couple to the oral imager to receive the oral image cavity. In other examples, the printer 2520 is configured to couple to the oral imager to receive the oral image cavity through a hard wired connection. In some embodiments, the removable oral device is configured to not alter a position of the user's teeth. In other embodiments, the removable oral device is configured to not alter a retain a position of the user's teeth. In further examples, the removable oral device comprises a variable hardness across the tongue surface of the body.
[00145] In another configuration, a system comprises an oral imager comprising an image head configured to be inserted into a user's mouth and provide an oral cavity image, and a printer configured to receive the oral cavity image from the oral imager and print an impression tray using the received oral cavity image.
[00146] In some examples, the system comprises a mold material configured to insert into the printed impression tray to provide an oral cavity impression. In other examples, the oral imager is configured to image the oral cavity impression. The printer can be configured to use the imaged, oral cavity impression to print a removable oral device using a first material. The printed removable oral device comprises a printed palatal element coupled to a clasping element, in which the printed palatal element is configured to contact a roof of a user's mouth at a palatal surface, and wherein the printed palatal element comprising a body comprising a thickness configured to lower a vaulted area of the roof of the mouth to decrease an overall oral volume of the mouth to a first oral volume. The clasping element, when present, can be configured to assist in removal of the removable oral device from the mouth and to retain the palatal surface of the palatal element against the roof of the user's mouth when the removable oral device is inserted into the user's mouth. In some examples, the image head is configured to receive a disposable cover to image the oral cavity. In other examples, the system is configured to inject a material into the printed mold to provide the removable oral device. In further examples, the system is configured to extrude material from the mold to provide the removable oral device. In some configurations, the system is configured to place a gasket in the mold prior to providing the removable oral device, wherein the gasket is present between the body of the palatal element and the clasping element. In other configurations, the printer is configured to three -dimensionally print the palatal element using a photo-curable material. In some embodiments, the printer or the system is configured to print the photo-curable material onto the printer support comprising one or more wires to provide the removable oral device. In other embodiments, the system is configured to cure the printed palatal element using UV/Visible light. In some examples, the printer is configured to print each of the palatal element and the clasping element using a photo- curable material. In other configurations, the printer is configured as an inkjet three-dimensional printer. In some examples, the printer is configured to use digital light processing. In some examples, the removable oral device is configured to not alter a position of the user's teeth. In other examples, the removable oral device is configured to not retain a position of the user's teeth. In certain examples, the removable oral device comprises a variable hardness across the tongue surface of the body. [00147] In an additional configuration, a system comprises an oral imager comprising an image head configured to be inserted into a user's mouth and provide an oral cavity image, and a printer configured to receive the oral cavity image from the oral imager and print an impression tray using the received oral cavity image. The system also comprises a mold material configured to insert into the printed impression tray to provide an oral cavity impression. The system also comprises a first material configured to provide a removable oral device comprising a palatal element coupled to a clasping element. The palatal element is configured to contact a roof of a user's mouth at a palatal surface, and wherein the palatal element comprises a body comprising a thickness configured to lower a vaulted area of the roof of the mouth to decrease an overall oral volume of the mouth to a first oral volume. The clasping element, when present, can be configured to assist in removal of the removable oral device from the mouth and to retain the palatal surface of the palatal element against the roof of the user's mouth when the removable oral device is inserted into the user's mouth.
[00148] In certain examples, the image head is configured to receive a disposable cover to image the oral cavity. In other examples, the system is configured to inject a material into the impression of the oral cavity to provide the removable oral device. In further examples, the system is configured to use a gasket with the removable oral device, wherein the gasket is present between the body of the palatal element and the clasping element. In additional examples, the printer is configured to use a photo-curable material. For example, the system can be configured to photo-cure the printed impression tray using UV/Visible light. In some examples, the system is configured to scan the impression to provide a digital image of the impression. In other examples, the system is configured to use the digital image to print the removable oral device. In additional examples, the printer is configured as an inkjet three- dimensional printer. In other examples, the printer is configured to use digital light processing. In some embodiments, the removable oral device is configured to not alter a position of the user's teeth. In other embodiments, the removable oral device is configured to not retain a position of the user's teeth. In further embodiments, the removable oral device comprises a variable hardness across the tongue surface of the body.
[00149] In another configuration, a system comprises a first removable oral device comprising a palatal element coupled to a clasping element. The palatal element of the first removable oral device comprises a body comprising an embedded camera configured to capture an image of the oral cavity, and wherein The clasping element, when present, can be configured to assist in removal of the removable oral device from the mouth and to retain the palatal surface of the palatal element against the roof of the user's mouth when the removable oral device is inserted into the user's mouth. The system also comprises an external device comprising a processor configured to receive the captured image from the first removable oral device.
[00150] In certain examples, the system further comprises a printer configured to use the received captured image to print a second removable oral device. For example, the second removable oral device may comprise a palatal element coupled to a clasping element. The palatal element of the second removable oral device comprises a body comprising a thickness configured to lower a vaulted area of the roof of the mouth to decrease an overall oral volume of the mouth to a first oral volume. The clasping element of the second removable oral device is configured to assist in removal of the second removable oral device from the mouth and to retain the palatal surface of the palatal element against the roof of the user's mouth when the second removable oral device is inserted into the user's mouth. In other instances, the palatal element comprises a processor electrically coupled to the camera and configured to control the camera. In some examples, the palatal element comprises a memory unit electrically coupled to the processor. In further examples, the second removable oral device is configured to not alter a position of the user's teeth. In some embodiments, the second removable oral device is configured to not retain a position of the user's teeth. In other embodiments, the second removable oral device comprises a variable hardness across the tongue surface of the body.
[00151] In another configuration, a system comprises a removable oral device in combination with a weight management schedule or weight management program. For example, the removable oral device may comprise a palatal element coupled to a clasping element, in which the palatal element of the removable oral device comprises a body comprising a thickness configured to lower a vaulted area of the roof of the mouth to decrease an overall oral volume of the mouth to a first oral volume. The clasping element, when present, can be configured to assist in removal of the removable oral device from the mouth and/or to retain the palatal surface of the palatal element against the roof of the user's mouth when the removable oral device is inserted into the user's mouth. The weight management schedule can be provided based on interaction of the user with an application software program, a live coach (which may be remotely located), based on user "weigh-ins" or other parameters. The weight management schedule is designed to modify behavior, using the removable oral device, to assist in achieving weight loss in a controlled and health manner. In some examples, the system further comprises a nutrition schedule and/or an exercise schedule. These schedules can also be configured based on user interaction with an application program or with a coach. For example, any one or more of the schedules can be managed by an external device such as a computer, an internet chat session, a mobile device, a wearable device, etc. If desired, the weight management schedule is configured to reduce caloric intake by about 1-5% or 1-10% each week starting from when the user first inserts the removable oral device into the mouth until a desired lower level of daily calories (or target level of daily calories) is reached for weight loss. In some examples, the system may also comprise a body composition monitor configured to provide body information to the external device, wherein the weight management schedule is configured to alter caloric intake based on the provided body information. In certain instances, the removable oral device is configured to not alter a position of the user's teeth. In other instances, the removable oral device is configured to not retain a position of the user's teeth. In further examples, the removable oral device comprises a variable hardness across the tongue surface of the body.
[00152] In another configuration, a system comprises a nutrition schedule or program in combination with a removable oral device. The removable oral device comprises a palatal element coupled to a clasping element. The palatal element of the removable oral device comprises a body comprising a thickness configured to lower a vaulted area of the roof of the mouth to decrease an overall oral volume of the mouth to a first oral volume. The clasping element, when present, can be configured to assist in removal of the removable oral device from the mouth and to retain the palatal surface of the palatal element against the roof of the user's mouth when the removable oral device is inserted into the user's mouth. The nutrition schedule or program may consist of provided food of a selected caloric content similar to those programs and foods provided from Jenny Craig, Weight Watchers or other commercial companies. The exact caloric content can be tailored based on weight loss goals, desired per week weight loss and other factors. In some examples, the nutrition schedule is managed by an external device, e.g., by an application program on a computer, mobile device, wearable device, etc. In some examples, the system comprises a body composition monitor configured to provide body information to the external device, wherein the nutrition schedule is configured to alter caloric intake based on the provided body information. If desired, the nutrition schedule can be configured to reduce caloric intake by about 1-5% or 1-10% each week starting from when the user first inserts the removable oral device into the mouth until a desired lower level of daily calories (or target level of daily calories) is reached for weight loss. In some embodiments, the system may comprise an exercise schedule or program. If desired, both of the nutrition schedule and the exercise schedule are managed by an external device, e.g., by an application program on a computer, mobile device, wearable device, etc. In some examples, the nutrition schedule is configured to reduce caloric intake by about 1-5% orl-10% each week starting from when the user first inserts the removable oral device into the mouth and wherein the exercise schedule is configured to increase caloric consumption by the body by about 1-5% or 1-10% each week starting from when the user first inserts the removable oral device into the mouth. In some examples, the removable oral device is configured to not alter a position of the user's teeth. In other examples, the removable oral device is configured to not retain a position of the user's teeth. In certain examples, the removable oral device comprises a variable hardness across the tongue surface of the body.
[00153] In another configuration, a system comprises a removable oral device in combination with an exercise schedule or program. For example, the removable oral device comprises a palatal element coupled to a clasping element, in which the palatal element of the removable oral device comprises a body comprising a thickness configured to lower a vaulted area of the roof of the mouth to decrease an overall oral volume of the mouth to a first oral volume. The clasping element, when present, can be configured to assist in removal of the removable oral device from the mouth and to retain the palatal surface of the palatal element against the roof of the user's mouth when the removable oral device is inserted into the user's mouth.
[00154] In certain examples, the exercise schedule or program is managed by an external device, e.g., by an application program on a computer, mobile device, wearable device, etc. In some examples, the system comprises a body composition monitor configured to provide body information to the external device, wherein the exercise schedule is configured to alter caloric intake based on the provided body information. In additional examples, the exercise schedule is configured to increase caloric consumption by about 1 -5% each week starting from when the user first inserts the removable oral device into the mouth. In some examples, the removable oral device is configured to not alter a position of the user's teeth. In further examples, the removable oral device is configured to not retain a position of the user's teeth. In some configurations, the removable oral device comprises a variable hardness across the tongue surface of the body.
[00155] In certain embodiments, the removable oral device can be used in combination with another device designed to be temporarily or permanently inserted into the oral cavity. For example, a sensor can be present in a crown or filling of a tooth and used in combination with one or more devices embedded or in the removable oral device. In some examples, dentures or a replacement tooth comprising a sensor may also be used in combination with the removable oral device. In other examples, a dental post may comprise a sensor which can be used in combination with the removable oral device. In further examples, a temporary device can be applied or adhered to one or more teeth and used with the removable oral device. For example, a sensor can be cemented to some surface of a lower tooth and used in combination with the removable oral device. If desired, a sensor can be present in a piercing present in the oral cavity, e.g., a tongue piercing or the like. The piercing can be removed to periodically recharge the sensor present in the piercing. [00156] In some examples, combinations of the devices and systems described herein may also be used. For example, the removable oral devices can be used in combination with two or more of wearable devices such as FitBit® fitness trackers, weight loss diet & exercise programs such as Weight Watchers, weight loss foods such as those provided by Weight Watched, Jenny Craig and Nutri System, digital weight loss programs such as Omada, and weight loss application software programs such as MyFitnessPal. Further, the removable oral devices can be used in combination with medical devices such as, for example, insulin injectors, blood glucose test strips & monitors, blood pressure monitors, cholesterol measuring devices, weight scales, body composition devices, sleep apnea devices, orthopedic devices that improve mobility, prostheses that improve mobility and physical therapy devices & procedures.
[00157] In certain configurations, a system can be configured to provide a coaching platform configured for use with the removable oral device to assist in weight management, e.g., weight control and/or weight loss, of the user. For example, the coaching platform may be configured to monitor food intake, monitor use of a removable oral device, provide feedback based on the user's weight management plans, etc. Referring to FIG. 26, a coaching platform can be remotely located at a facility 2610 which is separate from a removable oral device 2605. The remote coaching platform may be based on personal feedback from a coach or automated feedback using routines or application software. In some examples, the coaching platform can be based on in-person or in-office sessions where the user provides answers to various questions asked by a coach. In other examples, the coach may read or transfer information from the removable oral device to facilitate coaching of the user. In some examples, the coaching platform can be present as application software, e.g., present on a mobile device or a computer. For example, a removable oral device can be used with a mobile device comprising coaching application software. The mobile device may be, for example, a cellular phone, a laptop computer, a tablet, a wearable device such as a Fitbit® device, an Apple Iwatch device or the like. In some examples, the coaching application software comprises menus or prompts to permit a user to navigate through the software based on the user's use of the removable oral device. Based on a user's desired weight loss and/or weight control, different feedback may be provided by the coaching platform to assist the user in obtaining their weight management goals. If desired, the coaching platform may be used in combination with a nutrition plan, an exercise plan or other schedules or plans. In some instances, the removable oral device can be provided along with the coaching platform or may be provided separately from the coaching platform.
[00158] When introducing elements of the examples disclosed herein, the articles "a," "an," "the" and "said" are intended to mean that there are one or more of the elements. The terms
"comprising," "including" and "having" are intended to be open-ended and mean that there may be additional elements other than the listed elements. It will be recognized by the person of ordinary skill in the art, given the benefit of this disclosure, that various components of the examples can be interchanged or substituted with various components in other examples.
[00159] Although certain aspects, examples and embodiments have been described above, it will be recognized by the person of ordinary skill in the art, given the benefit of this disclosure, that additions, substitutions, modifications, and alterations of the disclosed illustrative aspects, examples and embodiments are possible.

Claims

What is claimed is:
1. A system configured to produce a removable oral device, the system comprising:
an oral imager comprising an image head configured to be inserted into a user's mouth and provide an oral cavity image;
a printer configured to receive the oral cavity image from the oral imager and print a removable oral device using a first material, the printed removable oral device comprising a printed palatal element coupled to a clasping element, in which the printed palatal element is configured to contact a roof of a user's mouth at a palatal surface, the printed palatal element comprising a body comprising a thickness configured to lower a vaulted area of the roof of the mouth to decrease an overall oral volume of the mouth to a first oral volume, and wherein the clasping element is configured to assist in removal of the removable oral device from the mouth when the removable oral device is inserted into the user's mouth.
2. The system of claim 1, wherein the printer is configured to use a second material softer than the first material to print areas of the body adjacent to the clasping element.
3. The system of claim 1, wherein the image head is configured to receive a disposable cover configured to reversibly couple to the image head.
4. The system of claim 1, wherein the printer is configured to wirelessly couple to the oral imager to receive the oral image cavity.
5. The system of claim 1, wherein the printer is configured to couple to the oral imager to receive the oral image cavity through a hard wired connection.
6. The system of claim 1, wherein the removable oral device is configured to not alter a position of the user' s teeth.
7. The system of claim 1, wherein the removable oral device is configured to not retain a position of the user's teeth.
8. The system of claim 1, wherein the tongue surface of the printed palatal element comprises a softer material at an edge of the printed palatal element and is substantially non-compressible at an area adjacent to the roof of the user's mouth.
9. The system of claim 1, further comprising a sensor embedded in the printed palatal element.
10. The system of claim 9, wherein the sensor is one or more of a camera, an electrode, a bar code reader, a processor, a memory unit, an optical transmitter, a RFID tag, a piezoelectric sensor, an accelerometer, and a chewing sensor.
11. A system for monitoring intake of material into a mouth of a user, the system comprising: a removable oral device configured to removably insert into a mouth of the a user, the removable oral device comprising a palatal element coupled to a clasping element, in which the palatal element is configured to contact a roof of a user's mouth at a palatal surface, the palatal element comprising a body comprising a thickness configured to lower a vaulted area of the roof of the mouth to decrease an overall oral volume of the mouth to a first oral volume, and wherein the clasping element is configured to assist in removal of the removable oral device from the mouth when the removable oral device is inserted into the user's mouth, wherein the palatal element comprises a camera configured to capture images of the material in the mouth of the user; and
an external device separate from the removable oral device, in which the external device comprises a processor configured to couple to the removable oral device to transfer captured images from the camera of the removable oral device to the external device.
12. The system of claim 11, wherein the removable oral device comprises a variable hardness across the tongue surface of the body.
13. The system of claim 11, wherein the removable oral device comprises a rechargeable power source electrically coupled to the camera.
14. The system of claim 11, wherein the removable oral device comprises a transmitter.
15. The system of claim 11, wherein the external device is configured to wirelessly couple to the camera of the removable oral device.
16. The system of claim 11, in which the camera is configured to automatically switch on in response to a sensed temperature change.
17. The system of claim 16, in which the camera is configured to automatically switch off in response to a second sensed temperature change.
18. The system of claim 11, wherein the removable oral device further comprising a memory unit configured to store the captured image.
19. The system of claim 11, wherein the body of the palatal element comprises an optical window and the camera is configured to capture the image through the optical window.
20. The system of claim 11, wherein the removable oral device is configured to not alter a position of the user's teeth.
21. A system for monitoring athletic performance, the system comprising:
a removable oral device configured to removably insert into a mouth of the user, the removable oral device comprising a palatal element coupled to a clasping element, in which the palatal element is configured to contact a roof of a user's mouth at a palatal surface, the palatal element comprising a body comprising a thickness configured to lower a vaulted area of the roof of the mouth to decrease an overall oral volume of the mouth to a first oral volume, and wherein the clasping element is configured to assist in removal of the removable oral device from the mouth when the removable oral device is inserted into the user's mouth, and wherein the palatal element comprises at least one electrode positioned within the body of the palatal element and exposed to fluid entering and exiting the mouth of the user, the at least one electrode configured to measure athletic performance from fluid entering and exiting the mouth of the user; and
an external device separate from the removable oral device, in which the external device comprises a processor configured to couple to the removable oral device to transfer the measured athletic performance from the removable oral device to the external device.
22. The system of claim 21, wherein the body comprises a memory unit configured to store the measured athletic performance.
23. The system of claim 21, wherein the electrode is configured to measure one or more of oxygen, carbon dioxide and water as the measure of athletic performance.
24. The system of claim 21, wherein the removable oral device comprises a rechargeable power source electrically coupled to the at least one electrode.
25. The system of claim 21, wherein the body comprises a transmitter configured to transmit the measured athletic performance wirelessly to the external device.
26. The system of claim 21, wherein the electrode is configured to automatically switch on in response to a sensed temperature change.
27. The system of claim 26, wherein the electrode is configured to automatically switch off in response to a second sensed temperature change.
28. The system of claim 21, wherein the removable oral device is configured to not alter a position of the user's teeth.
29. The system of claim 21, wherein the removable oral device is configured to not retain a position of the user's teeth.
30. The system of claim 21, wherein the removable oral device comprises a variable hardness across the tongue surface of the body.
31. A system for monitoring intake of material into a mouth of a user, the system comprising a removable oral device comprising a bar code reader and configured to removably insert into a mouth of the a user, the removable oral device further comprising a palatal element coupled to a clasping element, wherein the palatal element is configured to contact a roof of a user's mouth at a palatal surface, wherein the palatal element comprises a body comprising a thickness configured to lower a vaulted area of the roof of the mouth to decrease an overall oral volume of the mouth to a first oral volume, and wherein the clasping element is configured to assist in removal of the removable oral device from the mouth when the removable oral device is inserted into the user's mouth, and wherein the palatal element comprises the bar code reader within the body of the palatal element, the bar code reader configured to read a bar code on the material entering the mouth of the user; and
an external device separate from the removable oral device, in which the external device comprises a processor configured to couple to the removable oral device to transfer the measured bar code from the removable oral device to the external device.
32. The system of claim 31, wherein the material is configured as an opioid pill or tablet comprising a bar code on at least one surface.
33. The system of claim 31, wherein the material is configured as narcotic pill or tablet comprising a bar code on at least one surface.
34. The system of claim 31, wherein the material is configured as food comprising a bar code on at least one surface.
35. The system of claim 31, wherein the removable oral device is configured to not alter a position of the user's teeth.
36. The system of claim 31, wherein the removable oral device is configured to not retain a position of the user's teeth.
37. The system of claim 31, wherein the removable oral device comprises a variable hardness across the tongue surface of the body.
38. The system of claim 31, wherein the tongue surface of the palatal element comprises a softer material at an edge of the palatal element and is substantially non-compressible at an area adjacent to the roof of the user's mouth.
39. The system of claim 31, further comprising a sensor embedded in the palatal element.
40. The system of claim 39, wherein the sensor is one or more of a camera, an electrode, a bar code reader, a processor, a memory unit, an optical transmitter, a RFID tag, a piezoelectric sensor, an accelerometer, and a chewing sensor.
41. A system comprising
a removable oral device configured to removably insert into a mouth of the a user, the removable oral device comprising a palatal element coupled to a clasping element, the palatal element configured to contact a roof of a user's mouth at a palatal surface, wherein the palatal element comprises a body comprising a thickness configured to lower a vaulted area of the roof of the mouth to decrease an overall oral volume of the mouth to a first oral volume, and wherein the clasping element is configured to assist in removal of the removable oral device from the mouth when the removable oral device is inserted into the user's mouth, and wherein the palatal element comprises memory unit configured to receive and store an electronic medical record of the user; and
an external device separate from the removable oral device, in which the external device comprises a processor configured to couple to the removable oral device to read and update the electronic medical record on the removable oral device.
42. The system of claim 41, wherein the processor is configured to couple to the removable oral device wirelessly to update the electronic medical record.
43. The system of claim 41, further comprising configuring the removable oral device to not alter a position of the user's teeth.
44. The system of claim 41, further comprising configuring the removable oral device to not retain a position of the user's teeth.
45. The system of claim 41, wherein the removable oral device comprises a variable hardness across the tongue surface of the body.
46. A system configured to monitor human health, the system comprises:
a removable oral device configured to removably insert into a mouth of the user, in which the removable oral device comprises a palatal element coupled to a clasping element, wherein the palatal element is configured to contact a roof of a user's mouth at a palatal surface, the palatal element comprising a body comprising a thickness configured to lower a vaulted area of the roof of the mouth to decrease an overall oral volume of the mouth to a first oral volume, and wherein the clasping element is configured to assist in removal of the removable oral device from the mouth when the removable oral device is inserted into the user's mouth, and wherein the palatal element comprises at least one sensor positioned within the body of the palatal element and exposed to fluid entering and exiting the mouth of the user, the at least one sensor configured to measure a physiological parameter from fluid entering and exiting the mouth of the user;
an external device separate from the removable oral device, in which the external device comprises a processor configured to couple to the removable oral device to transfer the measured physiological parameter from the removable oral device to the external device.
47. The system of claim 46, wherein the sensor is configured to measure electrolyte levels in the fluid.
48. The system of claim 46, wherein the sensor is configured to measure ketone bodies in the fluid.
49. The system of claim 46, wherein the sensor is configured to measure salivary insulin levels in the fluid.
50. The system of claim 46, wherein the sensor is configured to measure a gas other than oxygen in the fluid.
51. The system of claim 46, wherein the sensor is configured to measure carbohydrate levels in the fluid.
52. The system of claim 46, wherein the sensor is configured to measure oxygen levels in the fluid.
53. The system of claim 46, wherein the sensor is configured to measure carbon dioxide levels in the fluid.
54. The system of claim 46, wherein the sensor is configured to measure a respiration rate or heart rate.
55. The system of claim 46, wherein the sensor is configured to measure fluid intake.
56. A system configured to monitor head tremor, the system comprising:
a removable oral device configured to removably insert into a mouth of a user, the removable oral device comprising a palatal element coupled to a clasping element, wherein the palatal element is configured to contact a roof of a user's mouth at a palatal surface, wherein the palatal element comprises a body comprising a thickness configured to lower a vaulted area of the roof of the mouth to decrease an overall oral volume of the mouth to a first oral volume and wherein the clasping element is configured to assist in removal of the removable oral device from the mouth when the removable oral device is inserted into the user's mouth, and wherein the palatal element comprises an accelerometer within the body of the palatal element, the accelerometer configured to detect head movement to monitor the head tremor; and
an external device separate from the removable oral device, in which the external device comprises a processor configured to couple to the removable oral device to transfer the detected head movement measured by the accelerometer to the external device.
57. The system of claim 56, wherein the accelerometer is configured to measure head movement at selected intervals.
58. The system of claim 57, wherein the accelerometer is configured to automatically switch off between the selected intervals where the accelerometer measures head movement.
59. The system of claim 58, wherein the accelerometer is configured to automatically switch on when the accelerometer measures head movement.
60. The system of claim 56, wherein the removable oral device comprises a second
accelerometer.
61. The system of claim 56, wherein the removable oral device is configured to not alter a position of the user's teeth.
62. The system of claim 56, wherein the removable oral device is configured to not retain a position of the user's teeth.
63. The system of claim 56, wherein the removable oral device comprises a variable hardness across the tongue surface of the body.
64. The system of claim 56, wherein a tongue surface of the palatal element comprises a softer material at an edge of the palatal element and is substantially non-compressible at an area adjacent to the roof of the user's mouth.
65. The system of claim 56, further comprising a sensor embedded in the palatal element.
66. A system for monitoring head impact, the system comprising a removable oral device configured to removably insert into the mouth of the user, the removable oral device comprising a palatal element coupled to a clasping element, wherein the palatal element is configured to contact a roof of a user's mouth at a palatal surface, wherein the palatal element comprises a body comprising a thickness configured to lower a vaulted area of the roof of the mouth to decrease an overall oral volume of the mouth to a first oral volume, and wherein the clasping element is configured to assist in removal of the removable oral device from the mouth when the removable oral device is inserted into the user's mouth, and wherein the palatal element comprises an accelerometer within the body of the palatal element, the accelerometer configured to detect head movement to monitor the head impact; and
an external device separate from the removable oral device, in which the external device comprises a processor configured to couple to the removable oral device to transfer the detected head movement measured by the accelerometer to the external device.
67. The system of claim 66, wherein the accelerometer is configured to measure head impact at selected intervals.
68. The system of claim 67, wherein the accelerometer is configured to automatically switch off between the selected intervals where the accelerometer measures head impact.
69. The system of claim 68, wherein the accelerometer is configured to automatically switch on when the accelerometer measures head impact.
70. The system of claim 66, wherein the removable oral device comprises a second
accelerometer to measure head impact.
71. The system of claim 66, wherein the removable oral device comprises a motion sensor, wherein the accelerometer is automatically switched on when the motion sensor senses user motion.
72. The system of claim 66, wherein the removable oral device is configured to not alter a position of the user's teeth.
73. The system of claim 66, wherein the removable oral device is configured to not retain a position of the user's teeth.
74. The system of claim 66, wherein the removable oral device comprises a variable hardness across the tongue surface of the body.
75. The system of claim 66, wherein a tongue surface of the palatal element comprises a softer material at an edge of the palatal element and is substantially non-compressible at an area adjacent to the roof of the user's mouth.
76. A system configured to monitor chewing, the system comprising
a removable oral device configured to removably insert into a mouth of the user, the removable oral device comprising a palatal element coupled to a clasping element, wherein the palatal element is configured to contact a roof of a user's mouth at a palatal surface, wherein the palatal element comprises a body comprising a thickness configured to lower a vaulted area of the roof of the mouth to decrease an overall oral volume of the mouth to a first oral volume, wherein the clasping element is configured to assist in removal of the removable oral device from the mouth when the removable oral device is inserted into the user's mouth, and wherein the palatal element comprises a piezoelectric sensor within the body of the palatal element, wherein the piezoelectric sensor is configured to measure pressure changes to monitor chewing; and
an external device separate from the removable oral device, in which the external device comprises a processor configured to couple to the removable oral device to transfer the measured pressure changes to the external device.
77. The system of claim 76, wherein the piezoelectric sensor is configured to automatically switch on when the palatal element reaches a selected temperature.
78. The system of claim 76, wherein the palatal element is configured with a device configured to provide the user sensory feedback after the piezoelectric sensor measures a selected number of chews.
79. The system of claim 78, wherein the sensory feedback is configured as an audible alert or as a vibration.
80. The system of claim 76, wherein the palatal element is configured with a second
piezoelectric sensor.
81. A system configured to monitor chewing, the system comprising:
a removable oral device configured to removable insert into a mouth of a user, the removable oral device comprising a palatal element coupled to a clasping element, wherein the palatal element is configured to contact a roof of a user's mouth at a palatal surface, wherein the palatal element comprises a body comprising a thickness configured to lower a vaulted area of the roof of the mouth to decrease an overall oral volume of the mouth to a first oral volume, and wherein the clasping element is configured to assist in removal of the removable oral device from the mouth when the removable oral device is inserted into the user's mouth, and wherein the palatal element comprises a microphone configured to monitor chewing by measuring a change in decibel levels within the mouth; and
an external device separate from the removable oral device, in which the external device comprises a processor configured to couple to the removable oral device to transfer the measured change in decibel levels within the mouth to the external device.
82. The system of claim 81, wherein the microphone is configured with a speaker to provide a sensory feedback after the change in decibel levels has been measured for a selected period.
83. The system of claim 82, wherein the sensory feedback is configured as an audible alert or as a vibration.
84. The system of claim 81, wherein the palatal element is configured with a second
microphone.
85. The system of claim 81, wherein the palatal element is configured with a recording medium to record audio.
86. The system of claim 81, wherein the removable oral device is configured to not alter a position of the user's teeth.
87. The system of claim 81, wherein the removable oral device is configured to not retain a position of the user's teeth.
88. The system of claim 81, wherein the removable oral device comprises a variable hardness across the tongue surface of the body.
89. The system of claim 81, wherein a tongue surface of the palatal element comprises a softer material at an edge of the palatal element and is substantially non-compressible at an area adjacent to the roof of the user's mouth.
90. The system of claim 81, further comprising a sensor embedded in the palatal element.
91. A system configured to monitoring chewing, the system comprising:
a removable oral device configured to removably insert into the mouth of the user, the removable oral device comprising a palatal element coupled to a clasping element, wherein the palatal element is configured to contact a roof of a user's mouth at a palatal surface, wherein the palatal element comprises a body comprising a thickness configured to lower a vaulted area of the roof of the mouth to decrease an overall oral volume of the mouth to a first oral volume, and wherein the clasping element is configured to assist in removal of the removable oral device from the mouth when the removable oral device is inserted into the user's mouth, and wherein the palatal element comprises a proximity sensor configured to monitor chewing by measuring a distance change between the proximity sensor and a sensor coupled to a lower tooth of the user; and
an external device separate from the removable oral device, in which the external device comprises a processor configured to couple to the removable oral device to transfer the measured distance change to the external device.
92. The system of claim 91, wherein the proximity sensor is configured to measure contact of the proximity sensor to the sensor coupled to the lower tooth of the user.
93. The system of claim 91, wherein the proximity sensor is configured to detect a radio wave emitted by the sensor coupled to the lower tooth of the user.
94. The system of claim 91, wherein the proximity sensor is configured to detect light emission emitted by the sensor coupled to the lower tooth of the user.
95. The system of claim 91, wherein the proximity sensor is configured to detect an ultrasound wave emitted by the sensor coupled to the lower tooth of the user.
96. The system of claim 91, wherein the removable oral device is configured to not alter a position of the user's teeth.
97. The system of claim 91, wherein the removable oral device is configured to not retain a position of the user's teeth.
98. The system of claim 91, wherein the removable oral device comprises a variable hardness across the tongue surface of the body.
99. The system of claim 91, wherein a tongue surface of the palatal element comprises a softer material at an edge of the palatal element and is substantially non-compressible at an area adjacent to the roof of the user's mouth.
100. The system of claim 91, further comprising a sensor embedded in the palatal element.
101. A system configured to monitor chewing of material entering a user's mouth, the system comprising:
a removable oral device configured to removably insert into the mouth of the user, the removable oral device comprising a palatal element coupled to a clasping element, wherein the palatal element is configured to contact a roof of a user's mouth at a palatal surface, wherein the palatal element comprises a body comprising a thickness configured to lower a vaulted area of the roof of the mouth to decrease an overall oral volume of the mouth to a first oral volume, and wherein the clasping element is configured to assist in removal of the removable oral device from the mouth when the removable oral device is inserted into the user's mouth, and wherein the palatal element comprises a vibratory device configured to vibrate after the user has chewed a selected number of times to provide feedback to the user to swallow the chewed material; and an external device separate from the removable oral device, in which the external device comprises a processor configured to couple to the removable oral device to transfer the selected number of times to the external device.
102. The system of claim 101, wherein the palatal element is configured with a chewing sensor electrically coupled to the vibratory device.
103. The system of claim 101, wherein the clasping element is configured with a chewing sensor electrically coupled to the vibratory device.
104. The system of claim 101, wherein removable oral device is configured to not alter a position of the user's teeth or to not retain a position of the user's teeth.
105. The system of claim 101, wherein the removable oral device comprises a variable hardness across the tongue surface of the body.
106. A system configured to monitor food intake volume entering a user's mouth, the system comprising:
a removable oral device configured to removal insert into the mouth of the user, the removable oral device comprising a palatal element coupled to a clasping element, wherein the palatal element is configured to contact a roof of a user's mouth at a palatal surface, wherein the palatal element comprises a body comprising a thickness configured to lower a vaulted area of the roof of the mouth to decrease an overall oral volume of the mouth to a first oral volume, and wherein the clasping element is configured to assist in removal of the removable oral device from the mouth when the removable oral device is inserted into the user's mouth, and wherein the palatal element is configured to sense presence of the food in the user's mouth and absence of the food in the user's mouth as an indicator the food has been swallowed, and wherein the palatal element is configured to provide feedback to the user once a selected number of swallows has been reached;
an external device separate from the removable oral device, in which the external device comprises a processor configured to couple to the removable oral device to transfer the number of swallows to the external device.
107. The system of claim 106, wherein the removable oral device is configured to not alter a position of the user's teeth.
108. The system of claim 106, wherein the removable oral device is configured to not retain a position of the user's teeth.
109. The system of claim 106, wherein the removable oral device comprises a variable hardness across the tongue surface of the body.
110. The system of claim 106, wherein a tongue surface of the palatal element comprises a softer material at an edge of the palatal element and is substantially non-compressible at an area adjacent to the roof of the user's mouth.
111. A system configured to monitor material entering into a user's mouth to measure nutrient species in the material, the system comprising:
a removable oral device configured to removably insert into the mouth of the user, the removable oral device comprising a palatal element coupled to a clasping element, wherein the palatal element is configured to contact a roof of a user's mouth at a palatal surface, wherein the palatal element comprises a body comprising a thickness configured to lower a vaulted area of the roof of the mouth to decrease an overall oral volume of the mouth to a first oral volume, and wherein the clasping element is configured to assist in removal of the removable oral device from the mouth when the removable oral device is inserted into the user's mouth, and wherein the palatal element comprises a processor and a memory unit electrically coupled to the processor, and wherein the palatal element comprises a sensor electrically coupled to the processor; and
an external device separate from the removable oral device, in which the external device comprises a processor configured to couple to the removable oral device to transfer the measured nutrient species in the material to the external device.
112. The system of claim 111, wherein the sensor is configured to measure carbohydrate content of the material.
113. The system of claim 111, wherein the sensor is configured to measure protein content of the material, fat content of the material or water content of the material.
114. The system of claim 111, wherein the removable oral device is configured to not alter a position of the user's teeth or to not retain a position of the user's teeth.
115. The system of claim 111, wherein the removable oral device comprises a variable hardness across the tongue surface of the body.
116. A system configured to monitor material entering into a user's mouth to measure nutrient species in the material, the system comprising:
a removable oral device configured to removably insert into the mouth of the user, the removable oral device comprising a palatal element coupled to a clasping element, wherein the palatal element is configured to contact a roof of a user's mouth at a palatal surface, wherein the palatal element comprises a body comprising a thickness configured to lower a vaulted area of the roof of the mouth to decrease an overall oral volume of the mouth to a first oral volume, and wherein the clasping element is configured to assist in removal of the removable oral device from the mouth when the removable oral device is inserted into the user's mouth, and wherein the palatal element comprises a processor and a memory unit electrically coupled to the processor, and wherein the palatal element comprises a multi-plexing sensor electrically coupled to the processor and configured to simultaneously measure caloric content of all the material entering into the user's mouth; and
an external device separate from the removable oral device, in which the external device comprises a processor configured to couple to the removable oral device to transfer the measured caloric content from the removable oral device to the external device.
117. The system of claim 116, wherein the palatal element is configured with a sensory feedback device configured to provide a sensory cue once the measured caloric content reached a selected level.
118. The system of claim 117, wherein the sensory cue is configured as an audible noise or a vibration.
119. The system of claim 116, wherein the removable oral device is configured to not alter a position of the user's teeth or to not retain a position of the user's teeth.
120. The system of claim 116, wherein the removable oral device comprises a variable hardness across the tongue surface of the body.
121. A system configured to provide real time measurements of material intake into a user's mouth, the system comprising:
a removable oral device configured to removably insert into the mouth of the user, the removable oral device comprising a palatal element coupled to a clasping element, wherein the palatal element is configured to contact a roof of a user's mouth at a palatal surface, wherein the palatal element comprises a body comprising a thickness configured to lower a vaulted area of the roof of the mouth to decrease an overall oral volume of the mouth to a first oral volume, and wherein the clasping element is configured to assist in removal of the removable oral device from the mouth when the removable oral device is inserted into the user's mouth, and wherein the palatal element comprises a processor, a memory unit electrically coupled to the processor and a transmitter/receiver electrically coupled to the processor, in which the processor is configured to transmit the recorded material intake to a site outside of the mouth of the user. an external device separate from the removable oral device, in which the external device comprises a processor configured to couple to the removable oral device to receive the transmitted, recorded material intake.
122. The system of claim 121, wherein the transmitter/receiver comprises one or more of a Bluetooth device, a cellular chip, a Wi-Fi chip, an optical transmitter/receiver,
123. The system of claim 122, wherein the transmitter/receiver is configured to be in an off state when the removable oral device is inserted into the mouth of the user.
124. The system of claim 123, wherein the transmitter/receiver is configured to automatically switch from the off state to an on state when the removable oral device is removed from the mouth of the user.
125. The system of claim 124, wherein the removable oral device is configured with a temperature sensor configured to determine when the removable oral device is removed from the mouth of the user.
126. The system of claim 121, wherein the removable oral device is configured to not alter a position of the user's teeth.
127. The system of claim 121, wherein the removable oral device is configured to not retain a position of the user's teeth.
128. The system of claim 121, wherein the removable oral device comprises a variable hardness across the tongue surface of the body.
129. The system of claim 121, wherein a tongue surface of the palatal element comprises a softer material at an edge of the palatal element and is substantially non-compressible at an area adjacent to the roof of the user's mouth.
130. The system of claim 121, further comprising a sensor embedded in the palatal element.
131. A system configured to monitor blood pressure in a human by measuring blood pressure from a roof of the mouth of the human, the system comprising:
a removable oral device configured to removably insert into the mouth of the human, the removable oral device comprising a palatal element coupled to a clasping element, wherein the palatal element is configured to contact a roof of a user's mouth at a palatal surface, wherein the palatal element comprises a body comprising a thickness configured to lower a vaulted area of the roof of the mouth to decrease an overall oral volume of the mouth to a first oral volume, wherein the clasping element is configured to assist in removal of the removable oral device from the mouth when the removable oral device is inserted into the user's mouth, and wherein the palatal element comprises a processor, a memory unit electrically coupled to the processor and a pressure sensor electrically coupled to the processor; and
an external device separate from the removable oral device, in which the external device comprises a processor configured to couple to the removable oral device to receive pressure measurements from the pressure sensor.
132. The system of claim 131, wherein the pressure sensor is configured as a piezoelectric sensor.
133. The system of claim 131, wherein the removable oral device is configured to not alter a position of the user's teeth.
134. The system of claim 131, wherein the removable oral device is configured to not retain a position of the user's teeth.
135. The system of claim 131, wherein the removable oral device comprises a variable hardness across the tongue surface of the body.
136. A system configured to transfer information present on a removable oral device, the system comprising:
a removable oral device configured to removably insert into the mouth of the user, the removable oral device comprises a palatal element coupled to a clasping element, wherein the palatal element is configured to contact a roof of a user's mouth at a palatal surface, wherein the palatal element comprises a body comprising a thickness configured to lower a vaulted area of the roof of the mouth to decrease an overall oral volume of the mouth to a first oral volume, wherein the clasping element is configured to assist in removal of the removable oral device from the mouth when the removable oral device is inserted into the user's mouth, wherein the palatal element comprises a processor, a memory unit electrically coupled to the processor and a transmitter/receiver electrically coupled to the processor; and
a case configured to receive and store the removable oral device, wherein the case comprises a transmitter/receiver to receive the information from the transmitter/receiver of the oral device to transfer the information present on the removable oral device when the removable oral device is inserted into the case.
137. The system of claim 136, wherein the removable oral device is configured to transfer the information to the case wirelessly.
138. The system of claim 137, wherein the removable oral device is configured to transfer the information to the case in a wired manner.
139. The system of claim 136, wherein the case is configured to recharge the removable oral device when the removable oral device contacts the case or is within the case.
140. The system of claim 136, wherein the case is configured to wirelessly recharge the removable oral device when the removable oral device contacts the case.
141. The system of claim 136, wherein the removable oral device is configured to not alter a position of the user's teeth.
142. The system of claim 136, wherein the removable oral device is configured to not retain a position of the user's teeth.
143. The system of claim 136, wherein the removable oral device comprises a variable hardness across the tongue surface of the body.
144. The system of claim 136, wherein a tongue surface of the palatal element comprises a softer material at an edge of the palatal element and is substantially non-compressible at an area adjacent to the roof of the user's mouth.
145. The system of claim 136, further comprising a sensor embedded in the palatal element.
146. A system configured to determine a body fat percentage of a human, the system comprising:
a removable oral device comprising a palatal element coupled to a clasping element, wherein the palatal element is configured to contact a roof of a user's mouth at a palatal surface, wherein the palatal element comprises a body comprising a thickness configured to lower a vaulted area of the roof of the mouth to decrease an overall oral volume of the mouth to a first oral volume, wherein the clasping element is configured to assist in removal of the removable oral device from the mouth when the removable oral device is inserted into the user's mouth, and wherein the palatal element comprises an electrode; and
an external device separate from the removable oral device, in which the external device comprises a processor configured to couple to the removable oral device to receive electrical measurements from the electrode and determine the body fat percentage using the received electrical measurements.
147. The system of claim 146, wherein the removable oral device is configured to not alter a position of the user's teeth.
148. The system of claim 146, wherein the removable oral device is configured to not retain a position of the user's teeth.
149. The system of claim 146, wherein the removable oral device comprises a variable hardness across the tongue surface of the body.
150. The system of claim 146, wherein a tongue surface of the palatal element comprises a softer material at an edge of the palatal element and is substantially non-compressible at an area adjacent to the roof of the user's mouth.
151. A system configured to transfer information from a removable oral device, the system comprising:
a removable oral device comprising a palatal element coupled to a clasping element, wherein the palatal element is configured to contact a roof of a user's mouth at a palatal surface, wherein the palatal element comprises a body comprising a thickness configured to lower a vaulted area of the roof of the mouth to decrease an overall oral volume of the mouth to a first oral volume, wherein the clasping element is configured to assist in removal of the removable oral device from the mouth when the removable oral device is inserted into the user's mouth, wherein the palatal element comprises a processor; and
a mobile device separate from the removable oral device, the mobile device configured to receive information from the processor of the removable oral device.
152. The system of claim 151, wherein the mobile device is configured to monitor usage duration of the removable oral device.
153. The system of claim 151, wherein the mobile device is configured to monitor usage frequency of the removable oral device.
154. The system of claim 151, wherein the removable oral device is configured to not alter a position of the user's teeth or to not retain a position of the user's teeth.
155. The system of claim 151, wherein the removable oral device comprises a variable hardness across the tongue surface of the body.
156. A system comprising:
a removable oral device comprising a palatal element coupled to a clasping element, wherein the palatal element is configured to contact a roof of a user's mouth at a palatal surface, wherein the palatal element comprises a body comprising a thickness configured to lower a vaulted area of the roof of the mouth to decrease an overall oral volume of the mouth to a first oral volume, wherein the clasping element is configured to assist in removal of the removable oral device from the mouth when the removable oral device is inserted into the user's mouth, the palatal element comprising a processor; and
a wearable device separate from the removable oral device and comprising a processor configured to receive information from the processor of the palatal element.
157. The system of claim 156, wherein the wearable device is configured as a wrist device, spectacles, a contact lens, a belt, a garment, footwear or jewelry.
158. The system of claim 156, wherein the removable oral device is configured to not alter a position of the user's teeth.
159. The system of claim 156, wherein the removable oral device is configured to not retain a position of the user's teeth.
160. The system of claim 156, wherein the removable oral device comprises a variable hardness across the tongue surface of the body.
161. A system configured to produce a removable oral device, the system comprising:
a three-dimensional printer comprising a processor configured to receive three- dimensional coordinates from an image of an oral cavity of a human mouth, the printer configured to print a removable oral device using the three dimensional coordinates, the printed removable oral device comprising a palatal element coupled to a clasping element, in which the palatal element is configured to contact a roof of a user's mouth at a palatal surface, the palatal element comprising a body comprising a thickness configured to lower a vaulted area of the roof of the mouth to decrease an overall oral volume of the mouth to a first oral volume, and wherein the clasping element is configured to assist in removal of the removable oral device from the mouth when the removable oral device is inserted into the user's mouth.
162. The system of claim 161, wherein the printer is configured to print areas of the body adjacent to the clasping element using a second material softer than the first material.
163. The system of claim 161, wherein the printer is configured to three-dimensionally print the palatal element using a photo-curable material.
164. The system of claim 163, wherein the printer is configured to print the photo-curable material onto a printer support comprising the one or more wires to provide the removable oral device.
165. The system of claim 164, wherein the system is configured to photo-cure the printed palatal element using UV/Visible light.
166. The system of claim 161, wherein the printer is configured to print each of the palatal element and the clasping element using a photo-curable material.
167. The system of claim 161, wherein the printer is configured as an inkjet three-dimensional printer.
168. The system of claim 161, wherein the printer is configured to use digital light processing.
159. The system of claim 161, wherein the printer is configured to three-dimensionally print the removable oral device from a digital image of the user's mouth.
170. The system of claim 169, wherein the printer is configured to print the palatal element of the digital image using a photo-curable material.
171. The system of claim 161, wherein the printer is configured to print a photo-curable material onto a printer support comprising the one or more wires to provide the removable oral device.
172. The system of claim 161, wherein the removable oral device is configured to not alter a position of the user's teeth.
173. The system of claim 161, wherein the removable oral device is configured to not retain a position of the user's teeth.
174. The system of claim 161, wherein the removable oral device comprises a variable hardness across the tongue surface of the body.
175. The system of claim 161, wherein a tongue surface of the palatal element comprises a softer material at an edge of the palatal element and is substantially non-compressible at an area adjacent to the roof of the user's mouth.
176. A system comprising:
an oral imager comprising an image head configured to be inserted into a user's mouth and provide an oral cavity image; and
a printer configured to receive the oral cavity image from the oral imager and print an impression tray using the received oral cavity image.
177. The system of claim 176, further comprising a mold material configured to insert into the printed impression tray to provide an oral cavity impression.
178. The system of claim 177, in which the oral imager is configured to image the oral cavity impression, and wherein the printer is configured to use the imaged, oral cavity impression to print a removable oral device using a first material, the printed removable oral device comprising a printed palatal element coupled to a clasping element, in which the printed palatal element is configured to contact a roof of a user's mouth at a palatal surface, the printed palatal element comprising a body comprising a thickness configured to lower a vaulted area of the roof of the mouth to decrease an overall oral volume of the mouth to a first oral volume, and wherein the clasping element is configured to assist in removal of the removable oral device from the mouth when the removable oral device is inserted into the user's mouth.
179. The system of claim 176, wherein the image head is configured to receive a disposable cover to image the oral cavity.
180. The system of claim 176, wherein the system is configured to inject a material into the printed mold to provide the removable oral device.
181. The system of claim 176, wherein the system is configured to extrude material from the mold to provide the removable oral device.
182. The system of claim 176, wherein the system is configured to place a gasket in the mold prior to providing the removable oral device, wherein the gasket is present between the body of the palatal element and the clasping element.
183. The system of claim 176, wherein the printer is configured to three-dimensionally print the palatal element using a photo-curable material.
184. The system of claim 183, wherein the printer is configured to print the photo-curable material onto the printer support comprising one or more wires to provide the removable oral device.
185. The system of claim 184, wherein the system is configured to cure the printed palatal element using UV/Visible light.
186. The system of claim 176, wherein the printer is configured to print each of the palatal element and the clasping element using a photo-curable material.
187. The system of claim 176, wherein the printer is configured as an inkjet three-dimensional printer.
188. The system of claim 176, wherein the printer is configured to use digital light processing.
190. The system of claim 176, wherein the removable oral device is configured to not alter a position of the user's teeth or to not retain a position of the user's teeth.
191. A system comprising
an oral imager comprising an image head configured to be inserted into a user's mouth and provide an oral cavity image; and
a printer configured to receive the oral cavity image from the oral imager and print an impression tray using the received oral cavity image;
a mold material configured to insert into the printed impression tray to provide an oral cavity impression; and
a first material configured to provide a removable oral device comprising a palatal element coupled to a clasping element, in which the palatal element is configured to contact a roof of a user's mouth at a palatal surface, the palatal element comprising a body comprising a thickness configured to lower a vaulted area of the roof of the mouth to decrease an overall oral volume of the mouth to a first oral volume, and wherein the clasping element is configured to assist in removal of the removable oral device from the mouth when the removable oral device is inserted into the user's mouth.
192. The system of claim 191, wherein the image head is configured to receive a disposable cover to image the oral cavity.
193. The system of claim 191, wherein the system is configured to inject a material into the impression of the oral cavity to provide the removable oral device.
194. The system of claim 191, wherein the system is configured to use a gasket with the removable oral device, wherein the gasket is present between the body of the palatal element and the clasping element.
195. The system of claim 191, wherein the printer is configured to use a photo-curable material.
196. The system of claim 195, wherein the system is configured to photo-cure the printed impression tray using UV/Visible light.
197. The system of claim 191, wherein the system is configured to scan the impression to provide a digital image of the impression.
198. The system of claim 192, wherein the system is configured to use the digital image to print the removable oral device.
199. The system of claim 198, wherein the printer is configured as an inkjet three-dimensional printer or to use digital light processing.
200. The system of claim 191, wherein the removable oral device is configured to not alter a position of the user's teeth or to not retain a position of the user's teeth.
201. A system comprising:
a first removable oral device comprising a palatal element coupled to a clasping element, in which the palatal element of the first removable oral device comprises a body comprising an embedded camera configured to capture an image of the oral cavity, and wherein the clasping element is configured to assist in removal of the removable oral device from the mouth when the removable oral device is inserted into the user's mouth; and
an external device comprising a processor configured to receive the captured image from the first removable oral device.
202. The system of claim 201, further comprising a printer configured to use the received captured image to print a second removable oral device comprising a palatal element coupled to a clasping element, in which the palatal element of the second removable oral device comprising a body comprising a thickness configured to lower a vaulted area of the roof of the mouth to decrease an overall oral volume of the mouth to a first oral volume, and wherein the clasping element of the second removable oral device is configured to assist in removal of the second removable oral device from the mouth and to retain the palatal surface of the palatal element against the roof of the user's mouth when the second removable oral device is inserted into the user' s mouth.
203. The system of claim 201, wherein the palatal element comprises a processor electrically coupled to the camera and configured to control the camera.
204. The system of claim 203, wherein the palatal element comprises a memory unit electrically coupled to the processor.
205. The system of claim 201, wherein the second removable oral device is configured to not alter a position of the user's teeth.
206. The system of claim 201, wherein the second removable oral device is configured to not retain a position of the user's teeth.
207. The system of claim 201, wherein the second removable oral device comprises a variable hardness across the tongue surface of the body.
208. The system of claim 201, wherein a tongue surface of the palatal element comprises a softer material at an edge of the palatal element and is substantially non-compressible at an area adjacent to the roof of the user's mouth.
209. The system of claim 201, further comprising a sensor embedded in the palatal element.
210. The system of claim 209, wherein the sensor is one or more of a camera, an electrode, a bar code reader, a processor, a memory unit, an optical transmitter, a RFID tag, a piezoelectric sensor, an accelerometer, and a chewing sensor.
211. A system comprising:
a removable oral device comprising a palatal element coupled to a clasping element, in which the palatal element of the removable oral device comprises a body comprising a thickness configured to lower a vaulted area of the roof of the mouth to decrease an overall oral volume of the mouth to a first oral volume, and wherein the clasping element is configured to assist in removal of the removable oral device from the mouth when the removable oral device is inserted into the user' s mouth; and a weight management schedule.
212. The system of claim 21 1, further comprising a nutrition schedule.
213. The system of claim 21 1, further comprising an exercise schedule.
214. The system of claim 21 1, wherein the weight management schedule is managed by an external device.
215. The system of claim 21 1, wherein the weight management schedule is configured to reduce caloric intake by about 1-5% each week starting from when the user first inserts the removable oral device into the mouth.
216. The system of claim 21 1, wherein the weight management schedule is managed by an external device.
217. The system of claim 216, further comprising a body composition monitor configured to provide body information to the external device, wherein the weight management schedule is configured to alter caloric intake based on the provided body information.
218. The system of claim 21 1, wherein the removable oral device is configured to not alter a position of the user's teeth.
219. The system of claim 21 1, wherein the removable oral device is configured to not retain a position of the user's teeth.
220. The system of claim 21 1, wherein the removable oral device comprises a variable hardness across the tongue surface of the body.
221. A system comprising:
a removable oral device comprising a palatal element coupled to a clasping element, in which the palatal element of the removable oral device comprises a body comprising a thickness configured to lower a vaulted area of the roof of the mouth to decrease an overall oral volume of the mouth to a first oral volume, and wherein the clasping element is configured to assist in removal of the removable oral device from the mouth when the removable oral device is inserted into the user' s mouth; and
a nutrition schedule.
222. The system of claim 221, wherein the nutrition schedule is managed by an external device.
223. The system of claim 222, further comprising a body composition monitor configured to provide body information to the external device, wherein the nutrition schedule is configured to alter caloric intake based on the provided body information.
224. The system of claim 221, wherein the nutrition schedule is configured to reduce caloric intake by about 1-5% each week starting from when the user first inserts the removable oral device into the mouth.
225. The system of claim 221, further comprising an exercise schedule.
226. The system of claim 226, wherein the nutrition schedule and the exercise schedule are managed by an external device.
227. The system of claim 226, further comprising a body composition monitor configured to provide body information to the external device, wherein the nutrition schedule is configured to alter caloric intake based on the provided body information and wherein the exercise schedule is configured to increase caloric consumption based on the provided body information.
228. The system of claim 227, wherein the nutrition schedule is configured to reduce caloric intake by about 1-5% each week starting from when the user first inserts the removable oral device into the mouth and wherein the exercised schedule is configured to increase caloric consumption by about 1-5% each week starting from when the user first inserts the removable oral device into the mouth.
229. The system of claim 221, wherein the removable oral device is configured to not alter a position of the user's teeth or to not retain a position of the user's teeth.
230. The system of claim 221, wherein the removable oral device comprises a variable hardness across the tongue surface of the body.
231. A system comprising:
a removable oral device comprising a palatal element coupled to a clasping element, in which the palatal element of the removable oral device comprises a body comprising a thickness configured to lower a vaulted area of the roof of the mouth to decrease an overall oral volume of the mouth to a first oral volume, and wherein the clasping element is configured to assist in removal of the removable oral device from the mouth when the removable oral device is inserted into the user' s mouth; and
an exercise schedule.
232. The system of claim 231, wherein the exercise schedule is managed by an external device.
233. The system of claim 232, further comprising a body composition monitor configured to provide body information to the external device, wherein the exercise schedule is configured to alter caloric intake based on the provided body information.
234. The system of claim 233, wherein the exercise schedule is configured to increase caloric consumption by about 1-5% each week starting from when the user first inserts the removable oral device into the mouth.
235. The system of claim 231, wherein the removable oral device is configured to not alter a position of the user's teeth.
236. The system of claim 231, wherein the removable oral device is configured to not retain a position of the user's teeth.
237. The system of claim 231, wherein the removable oral device comprises a variable hardness across the tongue surface of the body.
238. The system of claim 231, wherein a tongue surface of the palatal element comprises a softer material at an edge of the palatal element and is substantially non-compressible at an area adjacent to the roof of the user's mouth.
239. The system of claim 231, further comprising a sensor embedded in the palatal element.
240. The system of claim 239, wherein the sensor is one or more of a camera, an electrode, a bar code reader, a processor, a memory unit, an optical transmitter, a RFID tag, a piezoelectric sensor, an accelerometer, and a chewing sensor.
241. A system comprising a coaching platform for weight management use with a removable oral device.
242. The system of claim 241, wherein the coaching platform comprises application software.
243. The system of claim 242, wherein the application software is present on a mobile device.
244. The system of claim 241, further comprising a removable oral device comprising a palatal element coupled to a clasping element, in which the palatal element of the removable oral device comprises a body comprising a thickness configured to lower a vaulted area of the roof of the mouth to decrease an overall oral volume of the mouth to a first oral volume, and wherein the clasping element is configured to assist in removal of the removable oral device from the mouth when the removable oral device is inserted into the user's mouth.
245. The system of claim 244, wherein the removable oral device is configured to not retain a position of the user's teeth.
246. The system of claim 244, wherein the removable oral device comprises a variable hardness across the tongue surface of the body.
PCT/US2018/024864 2017-03-28 2018-03-28 Systems including removable oral devices WO2018183514A2 (en)

Applications Claiming Priority (4)

Application Number Priority Date Filing Date Title
US201762477766P 2017-03-28 2017-03-28
US62/477,766 2017-03-28
US201762521498P 2017-06-18 2017-06-18
US62/521,498 2017-06-18

Publications (2)

Publication Number Publication Date
WO2018183514A2 true WO2018183514A2 (en) 2018-10-04
WO2018183514A3 WO2018183514A3 (en) 2018-12-06

Family

ID=63676967

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/US2018/024864 WO2018183514A2 (en) 2017-03-28 2018-03-28 Systems including removable oral devices

Country Status (1)

Country Link
WO (1) WO2018183514A2 (en)

Family Cites Families (10)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5924422A (en) * 1997-11-03 1999-07-20 Gustafson; Lynn Oral device to aid weight control
US7939003B2 (en) * 2004-08-11 2011-05-10 Cornell Research Foundation, Inc. Modular fabrication systems and methods
US20070282226A1 (en) * 2006-06-05 2007-12-06 Longley William H Apparatuses, Systems and Methods for Monitoring Conditions in an Oral Cavity
US20070283973A1 (en) * 2006-06-05 2007-12-13 Longley William H Apparatuses, Systems and Methods for Confirming Use of an Oral Appliance
US8291912B2 (en) * 2006-08-22 2012-10-23 Sonitus Medical, Inc. Systems for manufacturing oral-based hearing aid appliances
WO2011150282A2 (en) * 2010-05-26 2011-12-01 Robert Collins Harrell Devices, methods, and kits for taste modification and controlling food intake
US20120037168A1 (en) * 2010-08-16 2012-02-16 Jackson Terry L Dental device for weight control
JP2016501592A (en) * 2012-11-28 2016-01-21 アポロ オーラル スキャナー, エルエルシー Dental scanner device
US9610141B2 (en) * 2014-09-19 2017-04-04 Align Technology, Inc. Arch expanding appliance
FR3039984B1 (en) * 2015-08-10 2021-03-19 Lyra Holding MANDIBULAR CORRECTION ORTHESIS

Also Published As

Publication number Publication date
WO2018183514A3 (en) 2018-12-06

Similar Documents

Publication Publication Date Title
US20230111811A1 (en) Hearing and monitoring system
CN103828252B (en) Sense of touch biological feedback method, device and system in the mouth of speech and speech training
US20160220175A1 (en) Apparatus and method for range of motion tracking with integrated reporting
US20200093436A1 (en) Wearable apparatus attaching on tooth and the sensing device fixing at tooth
US20210282650A1 (en) Intraoral sensing system and intraoral sensing method
US11998407B2 (en) Methods of producing removable oral devices
US20220202602A1 (en) Methods of using removable oral devices
EP3656343B1 (en) Wearable apparatus attaching on tooth and the sensing device fixing at tooth
JP2014514032A (en) Wearable personal body-related devices with various physical configurations
JP7187466B2 (en) System and method with user interface for monitoring physical therapy and rehabilitation
CA2654301A1 (en) Apparatuses, systems and methods for confirming use of an oral appliance
EP4088287A1 (en) Systems and methods including ear-worn devices for vestibular rehabilitation exercises
WO2018183514A2 (en) Systems including removable oral devices
US11998470B2 (en) Removable oral devices for use in weight management and other applications
CN210158883U (en) Tongue training device
US20230372146A1 (en) Intraoral speech devices, methods, and systems
KR20110119999A (en) Wired and wireless U-Healthcare devices using a portable momentum sensor
de Almeida e Bueno et al. Evaluating the potential of an oral-based bioguard to estimate heart rate using photoplethysmography
Badnjević et al. MEDICON’23 and CMBEBIH’23: Proceedings of the Mediterranean Conference on Medical and Biological Engineering and Computing (MEDICON) and International Conference on Medical and Biological Engineering (CMBEBIH), September 14–16, 2023, Sarajevo, Bosnia and Herzegovina—Volume 2: Bio-innovations, Sustainable Practices, and Multidisciplinary Applications in Healthcare
US20240335260A1 (en) Mandibular or maxillary devices having a polymeric nanocomposite actively controlled for hard palate or mandibular growth
CN109907934A (en) Tongue Trainer
US20240358327A1 (en) Intra-oral devices and methods for making and using them
US20220301685A1 (en) Ear-wearable device and system for monitoring of and/or providing therapy to individuals with hypoxic or anoxic neurological injury
KR20220163350A (en) Accessories for Mandibular Advancement
Tomback The Oral User Interface Controller (O-UIC): An Assistive Communication Device

Legal Events

Date Code Title Description
121 Ep: the epo has been informed by wipo that ep was designated in this application

Ref document number: 18774518

Country of ref document: EP

Kind code of ref document: A2

NENP Non-entry into the national phase in:

Ref country code: DE

122 Ep: pct application non-entry in european phase

Ref document number: 18774518

Country of ref document: EP

Kind code of ref document: A2

点击 这是indexloc提供的php浏览器服务,不要输入任何密码和下载