阅读说明：本技术 利用感测的口内器具 (Intraoral appliance with sensing ) 是由 亚瑟·尚贾尼 布鲁斯·卡姆 佐藤淳 约翰·Y·莫顿 维克托·陈 C·李 艾伦·R·鲍隆凯 于 2017-06-19 设计创作，主要内容包括：本公开涉及利用感测的口内器具。检测患者口中的牙齿矫正器在牙齿上的放置以用于指示佩戴依从性。本文描述了用于检测包括依从性的佩戴以及用于通过有线或无线将电子依从性信息直接或间接地传递到智能电话来可靠地传送数据。本文还描述了可以检测与呼吸和睡眠相关的生理参数的牙科器具。本文还描述了实现与电子依从性指示器(ECI)设备的NFC通信和与智能电话的蓝牙通信的矫正器壳体。(The present disclosure relates to intraoral appliances utilizing sensing. The placement of dental appliances in the mouth of a patient on teeth is detected for indicating wear compliance. Described herein are methods and systems for detecting wear including compliance and for reliably communicating data by directly or indirectly communicating electronic compliance information to a smartphone, either by wire or wirelessly. Dental appliances that can detect physiological parameters related to respiration and sleep are also described herein. An appliance housing that enables NFC communication with an Electronic Compliance Indicator (ECI) device and bluetooth communication with a smartphone is also described herein.)

1. An apparatus for monitoring use of an intraoral appliance, the apparatus comprising:

one or more deflectable structures formed with or coupled to the intraoral appliance, wherein the one or more deflectable structures are shaped to deflect when the intraoral appliance is worn on a patient's teeth;

a sensor configured to generate sensor data indicative of deflection of the one or more deflectable structures; and

a processor operably coupled to the sensor and configured to process the sensor data in order to determine whether the intraoral appliance is being worn on a patient's teeth.

2. The apparatus of claim 1, wherein the intraoral appliance comprises an appliance housing comprising a plurality of tooth receiving cavities.

3. The apparatus of claim 2, wherein the one or more deflectable structures are located proximate to a tooth receiving cavity of the plurality of tooth receiving cavities so as to be deflected outward when a tooth is positioned within the tooth receiving cavity.

4. The apparatus of claim 3, wherein the one or more deflectable structures are formed in a wall of the tooth-receiving cavity.

5. The apparatus of claim 3, wherein the one or more deflectable structures deflect outward by at least 25 μm when a tooth is positioned within the tooth-receiving cavity.

6. The apparatus of claim 1, wherein the one or more deflectable structures comprise a deflected state when the intraoral appliance is worn and a rest state when the intraoral appliance is not worn, and wherein the one or more deflectable structures interact with the sensor when in the deflected state.

7. The apparatus of claim 6, wherein the sensor comprises a mechanical switch and the one or more deflectable structures engage the mechanical switch when in the deflected state.

8. The apparatus of claim 6, wherein the sensor comprises an optical switch and the one or more deflectable structures activate the optical switch when in the deflected state.

9. The apparatus of claim 1, wherein the one or more deflectable structures comprise a cantilever, dimple, concave surface, tab, protrusion, or pop-up structure.

10. The device of claim 1, further comprising a communication unit operably coupled to the sensor and configured to transmit one or more of the sensor data or processed sensor data to a remote device.

11. The apparatus of claim 1, wherein the sensor is integrated with the intraoral appliance or coupled to a tooth.

12. The apparatus of claim 1, wherein the processor is integrated with the intraoral appliance or coupled to a tooth.

13. An apparatus for monitoring use of an intraoral appliance, the apparatus comprising:

an appliance housing comprising a plurality of tooth receiving cavities;

one or more proximity sensors operably coupled to the instrument housing and configured to generate sensor data upon proximity to intraoral tissue; and

a processor operably coupled to the one or more proximity sensors and configured to process the sensor data in order to determine whether the intraoral appliance is being worn on a patient's teeth.

14. The device of claim 13, wherein the one or more proximity sensors comprise one or more touch sensors.

15. The device of claim 14, wherein the one or more touch sensors comprise at least one capacitive touch sensor activated by an electrical charge associated with one or more of enamel, gums, oral mucosa, saliva, cheeks, lips, or tongue; or wherein the one or more touch sensors comprise at least one capacitive touch sensor configured to use one or more of enamel, gums, oral mucosa, saliva, cheek, lips, or tongue as a ground electrode.

16. The device of claim 13, wherein the one or more touch sensors comprise at least one capacitive touch sensor activated by positive charge associated with plaque or bacteria on a patient's teeth.

17. The apparatus of claim 16, wherein the processor is configured to process the sensor data in order to determine an amount of bacteria on a patient's teeth.

18. The device of claim 14, wherein the one or more touch sensors comprise at least one resistive touch sensor.

19. The apparatus of claim 13, wherein the one or more proximity sensors comprise one or more of: a capacitive sensor, an eddy current sensor, a magnetic sensor, an optical sensor, a photoelectric sensor, an ultrasonic sensor, a hall effect sensor, an infrared touch sensor, or a Surface Acoustic Wave (SAW) touch sensor.

20. The device of claim 13, wherein the one or more proximity sensors are configured to generate the sensing data when approaching one or more of the patient's enamel, gums, oral mucosa, cheek, lips, or tongue.

21. The apparatus of claim 13, wherein the one or more proximity sensors are integrated with the intraoral appliance, coupled to a tooth, or a combination of both.

22. The apparatus of claim 13, wherein the processor is integrated with the intraoral appliance or coupled to a tooth.

23. An apparatus for monitoring use of an intraoral appliance, the apparatus comprising:

an appliance housing comprising a plurality of tooth receiving cavities;

one or more vibration sensors operably coupled to the appliance housing and configured to generate sensor data of an intra-oral vibration mode; and

a processor operably coupled to the one or more vibration sensors and configured to process the sensor data in order to determine whether the intraoral appliance is being worn on a patient's teeth.

24. The apparatus of claim 23, wherein the one or more vibration sensors comprise one or more of: MEMS microphones, accelerometers, or piezoelectric sensors.

25. The apparatus of claim 23, wherein the intra-oral vibration mode is associated with one or more of: vibration, bruxism, speech, chewing, breathing or snoring transmitted to the patient's teeth via the patient's jaw.

26. The apparatus of claim 23, wherein the processor determines whether the intraoral appliance is worn by comparing the intraoral vibration pattern to a patient-specific intraoral vibration pattern.

27. The apparatus of claim 23, wherein the one or more vibration sensors are integrated with the intraoral appliance, coupled to a tooth, or a combination of both.

28. The apparatus of claim 23, wherein the processor is integrated with the intraoral appliance or coupled to a tooth.

29. A Near Field Communication (NFC) to bluetooth communication (BLE) signal coupler apparatus for relaying monitoring data from an orthodontic Electronic Compliance Indicator (ECI) device to a handheld processor, the apparatus comprising:

a housing;

a first antenna configured for NFC within the housing;

a second antenna configured for BLE within the housing;

a support on the housing, the support configured to hold the ECI apparatus in alignment with the first antenna; and

a NFC-to-BLE transmission circuit configured to receive data from the first antenna and transmit data from the second antenna.

30. A method of relaying monitoring data from an orthodontic Electronic Compliance Indicator (ECI) device to a handheld processor, the method comprising:

aligning the ECI with a first antenna within a housing of a Near Field Communication (NFC) to Bluetooth communication (BLE) signal coupler device;

transmitting, by NFC, the monitoring data from the ECI to the NFC-to-BLE signal coupler device; and

resending the monitoring data from the NFC-to-BLE signal coupler device to a handheld electronic device via a Bluetooth signal.

31. An apparatus for monitoring a physiological characteristic of a patient, the apparatus comprising:

an intraoral appliance shaped to receive a patient's teeth and comprising a plurality of electrodes, each electrode positioned to be in electrical contact with a patient's mouth when the intraoral appliance is worn by a patient; and

one or more processors configured to:

measuring electrical impedance using the plurality of electrodes, an

Determining the physiological characteristic based on the electrical impedance.

32. A device for monitoring a physiological characteristic of an airway of a patient, the device comprising:

an intraoral appliance shaped to receive a patient's teeth and comprising a plurality of electrodes, each electrode positioned to be in electrical contact with a patient's mouth when the intraoral appliance is worn by a patient; and

One or more processors configured to:

measuring the far-field electrical impedance using the plurality of electrodes, an

Determining, based on the far-field electrical impedance, one or more of: respiratory tract diameter, respiratory tract volume, respiratory tract resistance, lung fluid level, and respiratory rate.

33. A method for monitoring a physiological characteristic of a patient, the method comprising:

positioning an intraoral appliance in a patient's mouth, the intraoral appliance shaped to receive a patient's teeth and comprising a plurality of electrodes, each electrode positioned in electrical contact with a different portion of the patient's mouth;

measuring electrical impedance using the plurality of electrodes; and

determining the physiological characteristic based on the electrical impedance.

34. A device for monitoring a characteristic of a patient's oral or respiratory tract, the device comprising:

an intraoral appliance shaped to receive a patient's teeth and comprising a transmitter and a receiver; and

one or more processors configured to:

causing the transmitter to transmit a signal within the patient's oral cavity,

measuring a signal returned from the patient's oral cavity or respiratory tract in response to the transmitted signal using the receiver, an

Determining the characteristic of the oral cavity or respiratory tract of the patient based on the measured signal.

35. A method for monitoring a characteristic of an oral cavity or respiratory tract of a patient, the method comprising:

positioning an intraoral appliance in a patient's mouth, the intraoral appliance shaped to receive a patient's teeth and comprising a transmitter and a receiver;

causing the transmitter to transmit a signal within the patient's oral cavity;

measuring, using the receiver, a signal returned from the patient's oral cavity or respiratory tract in response to the transmitted signal; and

determining the characteristic of the oral cavity or respiratory tract of the patient based on the measured signal.

Background

Orthodontic procedures typically involve repositioning a patient's teeth into a desired arrangement in order to correct malocclusions and/or improve aesthetics. To accomplish these objectives, orthodontic appliances such as braces, shell aligners, and the like, may be applied to a patient's teeth by an orthodontist. The appliance may be configured to apply a force to one or more teeth in order to achieve a desired tooth movement according to a treatment plan.

During orthodontic treatment with patient-removable appliances, a physician may rely on the patient to comply with prescribed appliance usage. In some cases, the patient may not wear orthodontic appliances prescribed by the doctor. For any reason outside the recommended range, extended removal of the appliance may interrupt the treatment plan and extend the entire treatment session. There is a need for methods and devices that allow monitoring the fit and/or effect of an intraoral appliance. Methods and apparatus for performing such monitoring are described herein.

Obstructive sleep apnea (hereinafter "OSA") is a medical condition characterized by complete or partial obstruction of the upper airway during sleep. Obstruction may be associated with relaxation of soft tissues and muscles in or around the throat (e.g., soft palate, dorsum of tongue, tonsils, uvula, and pharynx) during sleep. OSA episodes may occur multiple times per night and may disrupt the patient's sleep cycle. Subjects with chronic OSA may experience sleep deprivation, excessive daytime sleepiness, chronic fatigue, headache, snoring, and hypoxia.

Existing methods and devices for monitoring physiological characteristics of a patient having a condition such as sleep disturbance may be less than ideal in at least some aspects. It would be desirable to provide a system for monitoring physiological characteristics without the need for sensors placed outside the oral cavity. For example, instead of a sensor on the patient's body, implanted in the patient's body, or placed in the mouth but connected to an external device, it is preferable to have a sensor that operates autonomously within the patient's mouth. It would be helpful to provide an intraoral appliance including an embedded intraoral sensor that allows for autonomous monitoring of physiological characteristics of a patient, thereby providing data useful for diagnosing sleep disorders and other oral and respiratory related diseases.

Summary of the disclosure

Described herein are devices including apparatus and systems, particularly including appliances (e.g., orthodontic appliances), and methods for monitoring orthodontic appliances, including, but not limited to, monitoring patient compliance with orthodontic treatment. Monitoring may alternatively or additionally include monitoring status, monitoring wear of the appliance, monitoring geographic/spatial location of the appliance, monitoring environment of the appliance, and the like. In some embodiments, an orthodontic appliance includes one or more sensors configured to obtain sensor data; these sensors may include sensors that indicate patient compliance (e.g., whether the patient is wearing the appliance). The appliance may include one or more processors operatively coupled to the sensors and configured to process the sensor data to generate patient compliance data, thereby enabling electronic monitoring of patient compliance with a prescribed course of orthodontic treatment. Advantageously, the systems, methods, and devices herein can increase patient compliance and improve treatment efficacy, and provide patient data useful to physicians for designing and monitoring orthodontic treatment.

Apparatus for monitoring use of an intraoral appliance may comprise: an appliance housing comprising a plurality of tooth receiving cavities; one or more sensors operably coupled to the appliance housing and configured to generate sensor data indicative of patient usage of the appliance; and a processor operatively coupled to the one or more sensors and configured to process the sensor data in order to determine whether the intraoral appliance is being worn on a patient's teeth.

The devices and methods described herein may be configured to detect ("smart detect") placement of an appliance on one or more teeth, and may be configured to distinguish from other similar events, such as water immersion. Methods and apparatus that allow direct communication with a cellular telephone for activating and retrieving data from a monitor are also described herein.

As noted above, the methods and apparatus described herein may generally be used with or as part of any monitoring device for monitoring orthodontic appliances. For example, described herein are Electronic Compliance Indicator (ECI) devices that may be configured to record sensor data of an object (e.g., a patient) wearing or intended to be/is about to wear an orthodontic appliance, such as a shell appliance. However, it should be understood that the methods and devices are not limited to monitoring compliance and compliance data only, but may be used with any type of data, and that the monitoring devices (including ECIs) may also be collectively referred to as data loggers or embedded data loggers. Thus, in any of the descriptions and examples provided herein, when describing an "ECI" device, the device may not be limited to compliance monitoring unless the context clearly indicates otherwise. Thus, for any of the descriptions, examples, methods, and devices described herein, the term "ECI" should be understood to refer more broadly to a monitoring device (MA) or a performance monitoring device (PMA), and not just an ECI.

For example, in any of these devices, the data may be stored in physical memory on the monitoring device (e.g., the ECI) and may be retrieved by another device in communication with the monitoring device. The retrieval may be done wirelessly, for example using Near Field Communication (NFC) and/or Bluetooth (BLE) technology to retrieve data using a smartphone or other handheld device. Described herein in particular are monitoring devices (including ECI devices) and orthodontic appliances using them, including temperature and capacitive sensors, CPUs, NFC communication modules, NFC antennas, PCBs, and batteries. Also described herein are housings or holders (holders) that can enhance and/or relay signals from a small monitoring device to a handheld device such as a smartphone; such a shell or holder may be referred to as an NFC-BLE enabled orthotic shell.

A monitoring device configured to monitor use of an intraoral appliance, such as an Electronic Compliance Indicator (ECI) device, may include a housing enclosing a power source and a monitoring circuit including a processor, memory, and one or more sensors; a removable mechanically-activated interrupt between the power source and the processor, wherein the mechanically-activated interrupt has a first position that breaks a connection between the power source and the monitoring circuit such that no current flows between the power source and the monitoring circuit and a second position in which there is an electrical connection between the monitoring circuit and the power source; and an elastomer overmold (elastomeric over mold) encapsulating the housing.

The removable mechanically activated interrupts may include magnetic switches, removable activation levers, pins, and the like. Any of these devices may include a dental appliance (e.g., an appliance, such as a shell appliance) to which a monitoring device (e.g., an ECI) may be permanently or removably coupled.

In general, any of the monitoring devices (e.g., ECI devices) may be sized to fit or exceed one tooth. For example, the housing can have a maximum diameter of 2cm or less, 1.5cm or less, 1.0cm or less, 0.9cm or less, 0.8cm or less, 0.7cm or less, 0.6cm or less, and the like. The monitoring device housing can generally be thin (e.g., 1.0cm or less, 0.9cm or less, 0.8cm or less, 0.7cm or less, 0.6cm or less, 0.5cm or less, 0.4cm or less, etc.). In any of these devices, the monitoring circuitry may be configured for wired connection, for example, may include a plurality of data electrodes external to the housing but encapsulated by the elastomer over-mold. The device may be configured to connect to a plurality of metal/conductive leads that pierce (e.g., self-healing) the overmold material to contact otherwise covered contacts.

Also described herein are methods of activating a monitoring device (such as an electronic compliance indicator or ECI) configured to monitor an intraoral appliance. For example, a method may include: moving the mechanically activated interrupt of the monitoring device from a first position to a second position, the first position breaking a connection between a power source of the monitoring device and the monitoring circuit such that no current flows between the power source and the monitoring circuit, the second position in which an electrical connection between the monitoring circuit and the power source exists; inserting a monitoring device coupled to an orthodontic appliance into a patient's mouth; and recording data from the one or more sensors with the monitoring device. The mobile mechanical activation interrupt may include: operating the magnetic switch by removing the monitoring device from the package with the permanent magnet; inserting or removing an activation rod; and/or inserting or removing pins. The method can also include coupling a monitoring device to the orthodontic appliance. The insertion monitoring device may include a monitoring device insertedly coupled to the shell appliance. Recording data may include recording data from two or more sensors of the monitoring device every 1 minute to every 30 minutes (e.g., every approximately 10 minutes).

Also described herein are monitoring devices (e.g., electronic compliance indicating devices) configured to monitor use of the intraoral appliance and provide an output via a removable wired connection. The monitoring device may include: a housing enclosing a power supply and monitoring circuitry, the monitoring circuitry including a processor, a memory, and one or more sensors; a self-healing elastomer rubber coating mold for encapsulating the shell; a plurality of data electrodes external to the housing but encapsulated by an elastic encapsulation mold; and an attachment configured to secure the monitoring device to an orthodontic appliance. The apparatus may include an orthodontic appliance (e.g., a shell appliance). Any suitable self-healing material may be used, including electrically insulating polymeric materials.

Also described herein are boosters and/or converters for transforming signals from monitoring devices, such as NFC signals, to signals that can be received by smartphones, which typically have much larger (and poorly/difficult to match) antennas for receiving NFC from monitoring device devices. For example, described herein are Near Field Communication (NFC) to bluetooth communication (BLE) signal coupler apparatuses for relaying monitoring data from orthodontic monitoring devices, such as ECI's, to handheld processors, such as smart phones. These devices may include: a housing; a first antenna configured for NFC within the housing; a second antenna configured for BLE within the housing; a support on the housing configured to hold the monitoring device in alignment with the first antenna; and NFC-to-BLE transmission circuitry configured to receive data from the first antenna and transmit data from the second antenna. The support may include a housing formed at least in part by the housing and configured to hold the monitoring device (or MA such as an appliance and dental appliance) within the housing such that the monitoring device is aligned with the first antenna. The NFC to BLE transmission circuit may include a power source within the housing. The support may comprise a recess in the housing. The first antenna may comprise an on-board antenna or a coil antenna; for example, the first antenna includes a loop antenna having a gap.

Although the devices and methods described herein include many examples of Near Field Communication (NFC), including NFC to NFC communication, any of the methods and devices described herein may be used with other types of wireless communication modes, including, but not limited to, Wi-Fi, radio (RF, UHF, etc.), Infrared (IR), microwave, bluetooth (including bluetooth low energy or BLE), magnetic field induction (including NFC), Wimax, Zigbee, ultrasound, and the like. In particular, the methods and apparatus described herein may include means for transitioning between these different wireless modes.

Also described herein are methods of relaying monitoring data from an orthodontic monitoring device (such as an electronic compliance indicating device) to a handheld processor. For example, a method may include: aligning a monitoring device with a first antenna within a housing of a Near Field Communication (NFC) to bluetooth communication (e.g., BLE) signal coupler apparatus; transmitting monitoring data from the monitoring device to the NFC-to-BLE signal coupler apparatus via the NFC; and re-transmitting the monitoring data from the NFC-to-BLE signal coupler device to the handheld electronic device via the bluetooth signal. The method may further include inserting the monitoring device into the NFC-to-BLE signal coupler apparatus, wherein the NFC-to-BLE signal coupler apparatus is configured as a housing configured to hold the monitoring device (or the MA and a dental appliance coupled to the monitoring device). The method may also include receiving a bluetooth signal in a handheld electronic device, wherein the handheld electronic device includes a smartphone. The method may further comprise modifying the monitoring data before retransmitting the data. Transmitting the monitoring data may include receiving an NFC signal including the monitoring data on a first antenna of the NFC-to-BLE signal coupler device; alternatively or additionally, the retransmitting the monitoring data may include transmitting the monitoring data as bluetooth data via a second antenna of the NFC-to-BLE signal coupler device configured for bluetooth communication.

Also described herein are improved systems, methods, and devices for monitoring physiological characteristics of a patient, including from the respiratory tract of the patient. In many embodiments, an orthodontic appliance is provided. The orthodontic appliance includes one or more intraoral sensors embedded within an appliance shell shaped to receive a tooth. In some embodiments, the intraoral sensor includes a transmitter and a receiver. In certain embodiments, the intraoral sensor may include a plurality of electrodes. One or more intraoral sensors are coupled to one or more processors. The processor is configured to determine a characteristic of the oral cavity or respiratory tract of the patient based on the measurements from the intraoral sensor. In some cases, the measurement includes an electrical impedance measurement. In some cases, the measurement includes a return signal from the patient's oral or respiratory tract in response to the transmitted signal from the transmitter. Monitoring a physiological characteristic of a patient using the apparatus disclosed herein allows for a more accurate diagnosis of a patient condition, such as OSA. Because symptoms of diseases such as OSA occur when the patient is unconscious, autonomous electronic monitoring with intraoral appliances may provide patient data that is otherwise difficult or impossible to obtain, thereby facilitating diagnosis and treatment of the underlying condition. The monitoring systems and methods disclosed herein may be combined with a treatment device such as an appliance that applies tooth movement forces or an appliance for increasing airway clearance (clearance) in the treatment of OSA.

In one aspect, a device for monitoring a physiological characteristic of a patient is provided. The apparatus includes an intraoral appliance shaped to receive a patient's teeth. The appliance includes a plurality of electrodes. The electrodes are positioned to make electrical contact with the patient's mouth when the patient wears the intraoral appliance. The appliance also includes one or more processors configured to measure electrical impedance using the electrodes. The processor uses the measured electrical impedance to determine a physiological characteristic of the patient.

In another aspect, a device for monitoring a characteristic of a patient's oral cavity or respiratory tract is provided. The apparatus includes an intraoral appliance shaped to receive a patient's teeth, and includes a transmitter and a receiver. The appliance may also include one or more processors configured to cause the transmitter to transmit a signal within the oral cavity of the patient; measuring a signal returned from the oral cavity or respiratory tract of the patient in response to the transmitted signal using the receiver; and determining a characteristic of the patient's oral cavity or respiratory tract based on the measured signal.

Other objects and features of the present disclosure will become apparent by a review of the specification, claims and appended figures.

The present application provides the following:

1) An apparatus for monitoring a physiological characteristic of a patient, the apparatus comprising:

an intraoral appliance shaped to receive a patient's teeth and comprising a plurality of electrodes, each electrode positioned to be in electrical contact with a patient's mouth when the intraoral appliance is worn by a patient; and

one or more processors configured to:

measuring electrical impedance using the plurality of electrodes, an

Determining the physiological characteristic based on the electrical impedance.

2) The apparatus of 1), wherein the physiological characteristic comprises one or more of: respiratory tract diameter, respiratory tract volume, respiratory tract resistance, lung fluid level, soft tissue crowding, respiratory rate, muscle activity, ionic composition of saliva or ionic composition of oral mucosa.

3) The apparatus of 1), wherein the physiological characteristic is associated with a sleep disorder of the patient, the sleep disorder including one or more of sleep apnea, snoring, or bruxism.

4) The apparatus of claim 3), wherein the sleep disorder comprises sleep apnea.

5) The apparatus of claim 4), wherein the intraoral appliance is configured to treat the sleep apnea, the one or more processors further configured to evaluate an effect of the intraoral appliance in treating the sleep apnea based on the determined physiological characteristic.

6) The apparatus of claim 4), wherein the intraoral appliance is configured to monitor sleep apnea.

7) The apparatus of 1), wherein the electrical impedance comprises a near-field impedance and the physiological characteristic comprises one or more of soft tissue crowding, ionic composition of saliva, or ionic composition of oral mucosa.

8) The apparatus of 1), wherein the electrical impedance comprises a far-field impedance and the physiological characteristic comprises one or more of lung fluid level or airway length.

9) The apparatus of claim 1), wherein the one or more processors are configured to measure the electrical impedance by measuring a waveform in response to an electrical signal transmitted from an electrode of the plurality of electrodes.

10) The apparatus of claim 1), wherein the plurality of electrodes comprises a first electrode located near a left side of the patient's mouth and a second electrode located near a right side of the patient's mouth when the intraoral appliance is worn by the patient.

11) The apparatus of claim 1), wherein the plurality of electrodes comprises a first electrode positioned on a patient's upper jaw and a second electrode positioned on a patient's lower jaw when the intraoral appliance is worn by the patient.

12) The apparatus of 11), wherein the intraoral appliance comprises a first shell shaped to receive teeth of the upper jaw and a second shell shaped to receive teeth of the lower jaw, and wherein the first electrode is coupled to the first shell and the second electrode is coupled to the second shell.

13) The apparatus of 1), wherein the one or more processors are disposed on or within the intraoral appliance.

14) The apparatus of claim 1), wherein the intraoral appliance comprises a polymeric shell having a plurality of tooth receiving cavities.

15) A device for monitoring a physiological characteristic of a respiratory tract of a patient, the device comprising:

an intraoral appliance shaped to receive a patient's teeth and comprising a plurality of electrodes, each electrode positioned to be in electrical contact with a patient's mouth when the intraoral appliance is worn by a patient; and

one or more processors configured to:

measuring the far-field electrical impedance using the plurality of electrodes, an

Determining, based on the far-field electrical impedance, one or more of: respiratory tract diameter, respiratory tract volume, respiratory tract resistance, lung fluid level, and respiratory rate.

16) A device for monitoring a characteristic of a patient's oral or respiratory tract, the device comprising:

an intraoral appliance shaped to receive a patient's teeth and comprising a transmitter and a receiver; and

one or more processors configured to:

causing the transmitter to transmit a signal within the patient's oral cavity,

measuring a signal returned from the patient's oral cavity or respiratory tract in response to the transmitted signal using the receiver, an

Determining the characteristic of the oral cavity or respiratory tract of the patient based on the measured signal.

17) The apparatus of claim 16), wherein the features include one or more of: respiratory tract diameter, respiratory tract volume, respiratory tract resistance, lung fluid level, soft tissue crowding, respiratory rate, muscle activity, ionic composition of saliva or ionic composition of oral mucosa.

18) The apparatus of claim 16), wherein the characteristic is related to a sleep disorder of the patient including one or more of sleep apnea, snoring, or bruxism.

19) The apparatus of claim 16), wherein the transmitted signal comprises electrical, acoustic, or mechanical energy.

20) The apparatus of 19), wherein the emitted signal comprises electrical energy and the determining step comprises determining an electrical impedance of the oral or respiratory tract of the patient based on the measured signal.

21) The apparatus of claim 16), wherein the transmitted signal comprises a first waveform, the measured signal comprises a second waveform, and the determining step comprises identifying a change between the first and second waveforms.

22) The apparatus of claim 16), wherein the one or more processors are disposed on or within the intraoral appliance.

23) The apparatus of claim 16), wherein the intraoral appliance comprises a polymeric shell having a plurality of tooth receiving cavities.

24) An apparatus for monitoring use of an intraoral appliance, the apparatus comprising:

one or more deflectable structures formed with or coupled to the intraoral appliance, wherein the one or more deflectable structures are shaped to deflect when the intraoral appliance is worn on a patient's tooth; and

a sensor configured to generate sensor data indicative of deflection of the one or more deflectable structures; and

A processor operably coupled to the sensor and configured to process the sensor data in order to determine whether the intraoral appliance is being worn on a patient's teeth.

25) The apparatus of claim 24), wherein the intraoral appliance comprises an appliance housing comprising a plurality of tooth receiving cavities.

26) The apparatus of 25), wherein the one or more deflectable structures are located proximate to a tooth receiving cavity of the plurality of tooth receiving cavities so as to be deflected outwardly when a tooth is positioned within the tooth receiving cavity.

27) The apparatus of claim 26), wherein the one or more deflectable structures are formed in a wall of the tooth-receiving cavity.

28) The apparatus of 26), wherein the one or more deflectable structures deflect outward by at least 25 μ ι η when a tooth is positioned within the tooth-receiving cavity.

29) The apparatus of 24), wherein the one or more deflectable structures comprise a deflected state when the intraoral appliance is worn and a rest state when the intraoral appliance is not worn, and wherein the one or more deflectable structures interact with the sensor when in the deflected state.

30) The device of 29), wherein the sensor comprises a mechanical switch and the one or more deflectable structures engage the mechanical switch when in the deflected state.

31) The apparatus of 29), wherein the sensor comprises an optical switch and the one or more deflectable structures activate the optical switch when in the deflected state.

32) The apparatus of 24), wherein the one or more deflectable structures comprise a cantilever, dimple, concave surface, tab, protrusion, or pop-up structure.

33) The device of 24), further comprising a communication unit operably coupled to the sensor and configured to transmit one or more of the sensor data or processed sensor data to a remote device.

34) The apparatus of 24), wherein the sensor is integrated with the intraoral appliance or coupled to a tooth.

35) The apparatus of 24), wherein the processor is integrated with the intraoral appliance or coupled to a tooth.

36) An apparatus for monitoring use of an intraoral appliance, the apparatus comprising:

An appliance housing comprising a plurality of tooth receiving cavities;

one or more proximity sensors operably coupled to the instrument housing and configured to generate sensor data upon proximity to intraoral tissue; and

a processor operably coupled to the one or more proximity sensors and configured to process the sensor data in order to determine whether the intraoral appliance is being worn on a patient's teeth.

37) The device of claim 36), wherein the one or more proximity sensors comprise one or more touch sensors.

38) The device of 37), wherein the one or more touch sensors comprise at least one capacitive touch sensor activated by an electrical charge associated with one or more of enamel, gums, oral mucosa, saliva, cheeks, lips, or tongue; or wherein the one or more touch sensors comprise at least one capacitive touch sensor configured to use one or more of enamel, gums, oral mucosa, saliva, cheek, lips, or tongue as a ground electrode.

39) The device of claim 36), wherein the one or more touch sensors comprise at least one capacitive touch sensor activated by positive charge associated with plaque or bacteria on the patient's teeth.

40) The device of 39), wherein the processor is configured to process the sensor data in order to determine an amount of bacteria on the patient's teeth.

41) The device of 37), wherein the one or more touch sensors comprise at least one resistive touch sensor.

42) The device of claim 36), wherein the one or more proximity sensors comprise one or more of: a capacitive sensor, an eddy current sensor, a magnetic sensor, an optical sensor, a photoelectric sensor, an ultrasonic sensor, a hall effect sensor, an infrared touch sensor, or a Surface Acoustic Wave (SAW) touch sensor.

43) The device of claim 36), wherein the one or more proximity sensors are configured to generate sensing data when in proximity to one or more of the patient's enamel, gums, oral mucosa, cheek, lips, or tongue.

44) The apparatus of 36), wherein the one or more proximity sensors are integrated with the intraoral appliance, coupled to a tooth, or a combination thereof.

45) The apparatus of claim 36), wherein the processor is integrated with the intraoral appliance or coupled to a tooth.

46) An apparatus for monitoring use of an intraoral appliance, the apparatus comprising:

an appliance housing comprising a plurality of tooth receiving cavities;

one or more vibration sensors operably coupled to the appliance housing and configured to generate sensor data of an intra-oral vibration mode; and

a processor operably coupled to the one or more vibration sensors and configured to process the sensor data in order to determine whether the intraoral appliance is being worn on a patient's teeth.

47) The apparatus of 46), wherein the one or more vibration sensors comprise one or more of: MEMS microphones, accelerometers, or piezoelectric sensors.

48) The apparatus of 46), wherein the intra-oral vibration mode is associated with one or more of: vibration, bruxism, speech, chewing, breathing or snoring transmitted to the patient's teeth via the patient's jaw.

49) The apparatus of 46), wherein the processor determines whether the intraoral appliance is worn by comparing the intraoral vibration pattern to a patient-specific intraoral vibration pattern.

50) The apparatus of 46), wherein the one or more vibration sensors are integrated with the intraoral appliance, coupled to a tooth, or a combination thereof.

51) The apparatus of 46), wherein the processor is integrated with the intraoral appliance or coupled to a tooth.

52) A Near Field Communication (NFC) signal coupler apparatus for relaying monitoring data from an orthodontic monitoring device (MA) to a handheld processor, the apparatus comprising:

a housing;

a first antenna configured for NFC within the housing;

a second antenna located within the housing;

a support on the housing, the support configured to hold the monitoring device in alignment with the first antenna; and

an NFC coupling transmission circuit configured to receive data from the first antenna and transmit data from the second antenna.

53) The device of 52), wherein the second antenna is configured for bluetooth communication (BLE), and wherein the NFC coupling transmission circuit is configured to receive data from the first antenna over NFC and to transmit data from the second antenna over BLE.

54) The apparatus of 52), wherein the monitoring device is an Electronic Compliance Indicator (ECI) device.

55) The device of 52), wherein the second antenna is larger than the first antenna and is configured for NFC with a phone placed in or on the housing.

56) The apparatus of 52), wherein the support comprises a housing formed at least in part from the housing and configured to retain the monitoring device within the housing such that the monitoring device is aligned with the first antenna.

57) The apparatus of 52), wherein the support comprises a shell formed at least in part from the housing and configured to hold a dental appliance coupled to the monitoring device within the shell such that the monitoring device is aligned with the first antenna.

58) The device of 52), further wherein the NFC coupling transmission circuit comprises a power source within the housing.

59) The apparatus of 52), wherein the support comprises a recess on the housing.

60) The device of 52), wherein the first antenna comprises an on-board antenna or a coil antenna.

61) The device of 52), wherein the first antenna comprises a loop antenna having a ferrite core comprising a gap.

62) The device of 52), wherein the second antenna is 2 times or more the size of the first antenna.

63) A Near Field Communication (NFC) to bluetooth communication (BLE) signal coupler apparatus for relaying monitoring data from an orthodontic Electronic Compliance Indicator (ECI) device to a handheld processor, the apparatus comprising:

a housing;

a first antenna configured for NFC within the housing;

a second antenna configured for BLE within the housing;

a support on the housing, the support configured to hold the ECI apparatus in alignment with the first antenna; and

a NFC-to-BLE transmission circuit configured to receive data from the first antenna and transmit data from the second antenna.

64) The apparatus of 63), wherein the support comprises a housing formed at least in part from the enclosure and configured to retain the ECI device within the housing such that the ECI device is aligned with the first antenna.

65) The apparatus of 63), wherein the support comprises a shell formed at least in part from the housing and configured to hold a dental appliance coupled to the ECI device within the shell such that the ECI device is aligned with the first antenna.

66) The device of 63), wherein the NFC-to-BLE transmission circuitry includes a power source within the housing.

67) The apparatus of 63), wherein the holder comprises a recess on the housing.

68) The device of 63), wherein the first antenna comprises an on-board antenna or a coil antenna.

69) The device of 63), wherein the first antenna comprises a loop antenna with a gap.

70) A method of relaying monitoring data from an orthodontic Electronic Compliance Indicator (ECI) device to a handheld processor, the method comprising:

aligning an ECI with a first antenna within a housing of a Near Field Communication (NFC) signal coupler device; transmitting the monitoring data from the ECI to the signal coupler device via NFC; and

retransmitting the monitoring data from the NFC signal coupler device to a handheld electronic device.

71) The method of 70), wherein retransmitting comprises retransmitting the monitoring data to the handheld electronic device via bluetooth communication.

72) The method of 70), further comprising inserting the ECI device into the NFC signal coupler apparatus, wherein the NFC signal coupler apparatus is configured as a housing configured to hold the ECI device.

73) The method of 70), further comprising inserting the ECI device into the NFC signal coupler apparatus, wherein the NFC signal coupler apparatus is configured as a housing configured to hold the ECI device and a dental appliance to which the ECI device is coupled.

74) The method of 70), further comprising receiving the monitoring data in the handheld electronic device, wherein the handheld electronic device comprises a smartphone.

75) The method of 70), further comprising modifying the monitoring data prior to resending the data.

76) The method of 70), wherein transmitting the monitoring data comprises receiving an NFC signal comprising the monitoring data on a first antenna of the NFC signal coupler device.

77) The method of 70), wherein retransmitting the monitoring data comprises transmitting the monitoring data in a bluetooth signal via a second antenna of the NFC signal coupler device configured for bluetooth communication.

78) A method of relaying monitoring data from an orthodontic Electronic Compliance Indicator (ECI) device to a handheld processor, the method comprising:

aligning the ECI with a first antenna within a housing of a Near Field Communication (NFC) to Bluetooth communication (BLE) signal coupler device;

transmitting, by NFC, the monitoring data from the ECI to the NFC-to-BLE signal coupler device; and

resending the monitoring data from the NFC-to-BLE signal coupler device to a handheld electronic device via a Bluetooth signal.

79) The method of 78), further comprising inserting the ECI device into the NFC-to-BLE signal coupler apparatus, wherein the NFC-to-BLE signal coupler apparatus is configured as a housing configured to hold the ECI device.

80) The method of 78), further comprising inserting the ECI device into the NFC-to-BLE signal coupler apparatus, wherein the NFC-to-BLE signal coupler apparatus is configured as a housing configured to hold the ECI device and a dental appliance coupled with the ECI device.

81) The method of 78), further comprising receiving the bluetooth signal in the handheld electronic device, wherein the handheld electronic device comprises a smartphone.

82) The method of 78), further comprising modifying the monitoring data prior to resending the data.

83) The method of 78), wherein transmitting the monitoring data comprises receiving an NFC signal comprising the monitoring data on a first antenna of the NFC-to-BLE signal coupler device.

84) The method of 78), wherein retransmitting the monitoring data comprises transmitting the monitoring data with the bluetooth data via a second antenna of the NFC-to-BLE signal coupler device configured for bluetooth communication.

Brief Description of Drawings

The novel features of the disclosure are set forth with particularity in the appended claims. A better understanding of the features and advantages of the present disclosure will be obtained by reference to the following detailed description that sets forth illustrative embodiments, in which the principles of the disclosure are utilized, and the accompanying drawings of which:

FIG. 1A shows an example of a tooth repositioning appliance.

FIGS. 1B-1D show examples of tooth repositioning systems.

Fig. 2 illustrates a method of orthodontic treatment using multiple appliances.

Fig. 3A schematically shows an example of a monitoring apparatus (shown as an ECI device).

Fig. 3B schematically illustrates a system including an intraoral appliance having one or more sensors described herein and digital scan data of the appliance and/or a patient's teeth. The analysis engine (which may be part of or separate from the intraoral appliance) may integrate the remote information and the sensor information and may use the digital scan data to associate the particular sensor information with the patient's teeth.

Figure 4A shows an example of an intraoral appliance including an integrated monitoring device.

Fig. 4B is a cross-sectional view of the appliance of fig. 4A.

Fig. 5 shows an example of a monitoring system comprising a first appliance and a second appliance.

Fig. 6A shows an example of a system comprising an intraoral appliance and a tooth-mounted attachment device.

Fig. 6B shows an example of a system comprising an intraoral appliance and a tooth-mounted attachment device.

Fig. 7A and 7B show examples of monitoring devices having deflectable structures.

Fig. 7C shows an example of a monitoring device having a deflectable structure.

Figure 7D illustrates an exemplary method for manufacturing an intraoral appliance having a deflectable structure.

Figure 8A shows an example of an intraoral appliance comprising a capacitive sensor.

Fig. 8B shows an example of a monitoring device integrated into an intraoral appliance.

Figure 8C illustrates an example of an intraoral appliance in which a majority of the appliance surface includes capacitive touch sensor material.

Fig. 8D shows an enlarged view showing a grid pattern of capacitive touch sensors distributed over the surface of the intraoral appliance of fig. 8C.

Fig. 9 shows an example of a monitoring system for detecting proximity between the jaws of a patient.

Fig. 10A shows an example of a monitoring device using optical sensing.

Fig. 10B shows an example of a monitoring device using optical sensing.

Fig. 10C shows an example of a monitoring device using optical sensing.

Fig. 11A and 11B illustrate operation of an example of a monitoring device using optical sensing.

Fig. 11C and 11D show examples of a monitoring device using optical sensing.

Fig. 12A and 12B show an example of a monitoring device using magnetic sensing.

Fig. 12C shows an example of a monitoring device using magnetic sensing.

Fig. 13A shows an example of a monitoring device using magnetic sensing.

Fig. 13B shows an example of a monitoring device using magnetic sensing.

Fig. 13C shows an example of a monitoring device using magnetic sensing.

Fig. 14A shows an example of a monitoring device using a plurality of magnets.

Fig. 14B is a cross-sectional view of the device of fig. 14A.

Fig. 15 shows an example of a monitoring device configured to measure force and/or pressure between an intraoral appliance and a patient's teeth.

Fig. 16A shows an example of a monitoring device configured to measure force and/or pressure between an intraoral appliance and one or more attachment devices on a patient's teeth.

Fig. 16B is a cross-sectional view of the device of fig. 16A.

Fig. 16C is an example of an intraoral device configured to measure mechanical impedance of one or more teeth.

Figure 16D graphically illustrates detection of acceleration at a particular tooth (or portion of an appliance corresponding to a particular tooth) over time. Figure 16E graphically illustrates the detection of force over time at the same tooth (or appliance region) for which acceleration is determined as shown in figure 16D. An intraoral device configured to measure mechanical impedance, such as the apparatus shown in fig. 16C, may correlate time-varying acceleration and time-varying force to estimate mechanical impedance to a tooth.

Figure 16F shows a portion of an intraoral appliance configured to measure mechanical impedance. In this example, one or more motion sensors (e.g., accelerometers) may be coupled to the teeth (as part of the attachment, as shown) and may communicate with electronic components (e.g., memory, processor, power source, wireless communication, etc.) on the intraoral appliance. The device may also include or be used with a mechanical actuator to provide a known (or measured) perturbation vibration, and the processor may use the known force input and the output from the accelerometer to determine the mechanical impedance for one or more teeth.

Fig. 17A shows an example of a monitoring device including an airflow sensor.

Fig. 17B shows an example of a monitoring device including an airflow sensor.

Fig. 17C shows an example of a monitoring device including an airflow sensor.

Fig. 18 shows an example of a monitoring device using motion sensing.

Figure 19 shows an example of a method for monitoring use of an intraoral appliance.

Fig. 20A-20D illustrate an exemplary method for manufacturing an intraoral appliance with an integrated monitoring device.

Fig. 21A-21C illustrate an example of a method for manufacturing an intraoral appliance with an integrated monitoring device.

FIG. 22 is a simplified block diagram of an example of a data management system.

Fig. 23 shows an example of a monitoring device.

Figure 24 illustrates one example of coupling an ECI device to an orthotic.

Fig. 25 shows an exemplary prototype of an ECI device coupled to an orthotic.

Figure 26 graphically illustrates the use of capacitive sensors to detect when the orthotic is worn by a user and/or submerged in a fluid (e.g., water).

Fig. 27 graphically illustrates mutual capacitance measurement (left side) and self capacitance measurement (right side).

Fig. 28 shows an example of an ECI device having a pair of capacitive electrodes.

FIG. 29A shows an enlarged view of the sensing electrodes on the ECI device. Fig. 29B illustrates the use of capacitance signals from different sensing electrodes to distinguish wear of an appliance including the described ECI apparatus.

FIG. 30A shows an example of an ECI apparatus including a pair of guard electrodes; FIG. 30B illustrates the complex impedance of the ECI apparatus shown in FIG. 30A when submerged in water; fig. 30C is an example of an ECI device that includes capacitive sensing electrodes at an end of an appliance. Fig. 30D shows an explanation of capacitive sensing electrodes to distinguish false positives when determining that an appliance having an ECI device such as that shown in fig. 30A is worn.

Fig. 31A-31D show views of one variation of an appliance housing configured for coupling a near field signal (NFC) from an ECI device for output as a bluetooth signal to an intermediary of a phone. Fig. 31A is a top view when the case cover is opened. Fig. 31B shows a rear view of the housing of fig. 31A, and fig. 31C is a side view of the housing of fig. 31A. Fig. 31D is a top view of a prototype of the housing shown in fig. 31A.

Fig. 32 illustrates one example of a system for sending data directly from an ECI to a smartphone.

Fig. 33A-33C illustrate an example of a system for sending data directly from an ECI to a smartphone using a holder/fixture tool to hold the ECI in alignment with the antenna of the phone.

Fig. 34A and 34B illustrate an on-board antenna and the use of an on-board antenna to read data from an ECI, respectively. Figure 34B shows an alternative variation of the antenna on the orthotic.

Fig. 35A and 35B illustrate a coil antenna and the use of a coil antenna as part of a data reader to read data from an ECI, respectively.

Fig. 36A shows a schematic diagram of a circuit diagram for an NFC coupler coupled between an ECI device and a smartphone. Fig. 36B shows an example of a loop antenna with a gap in a ferrite core that may be used as part of an NFC coupler such as that shown in fig. 36A, for example. Fig. 36C shows the overall system coupling between NFC antennas.

Fig. 37A and 37B schematically show an NFC coupling device.

Fig. 38 shows a prototype of an NFC coupling device such as that shown in fig. 37A.

Fig. 39 is an exemplary circuit diagram of an NFC coupling device.

FIG. 40 is an example of a user interface for an application that can coordinate data transformation and/or analysis and/or compliance monitoring.

FIG. 41 is a flow diagram of a communication protocol that may be part of an application.

Fig. 42 is a flow diagram for coordinating near field communication between a smartphone and an ECI device.

Fig. 43 is a flowchart of data processing for using an application program that processes EIC data.

Fig. 44 is a flowchart schematically showing an operation state of the ECI apparatus.

Fig. 45 is a flowchart showing communication control by a reception processor (for example, a smartphone) communicating with an ECI device.

FIG. 46 is an example of a process diagram for a data processing component/manager.

FIG. 47 shows an impedance model of a patient's respiratory tract.

Fig. 48A shows the change in airway width for patients with different malampati scores, and fig. 48B shows the corresponding change in airway resistance as a function of malampati scores.

Fig. 49A shows the patient's mouth along with points from which sensors, such as electrodes, may be placed to measure characteristics of the mouth and respiratory tract.

Figure 49B shows an alternative location where sensors such as electrodes can be placed to measure characteristics of the oral cavity and respiratory tract.

FIG. 50A shows an appliance wearable on a patient's teeth that includes sensors positioned at diametrically opposed points in the patient's mouth.

FIG. 50B illustrates an appliance that can be worn on a patient's teeth that includes sensors positioned in close proximity to each other.

Fig. 50C shows the interior of an appliance with an embedded measurement system that includes drive electronics and sensors.

Fig. 50D shows an example of alternative expansion positions for the sensor and drive electronics.

Fig. 50E shows an appliance including an upper shell fitting over the patient's upper teeth and a lower shell fitting over the patient's lower teeth, each shell including a sensor.

Fig. 50F shows an appliance configured to measure impedance between electrodes on opposite sides of the appliance housing.

Fig. 50G shows an appliance with corresponding sensors on the upper and lower shells, where the sensors are inductively coupled.

Fig. 51A shows a block diagram of a signal chain for impedance measurement with the appliances disclosed herein.

Fig. 51B shows a schematic diagram of an oral appliance including a plurality of electrodes for measuring impedance of a system, such as a patient's oral cavity or respiratory tract.

Fig. 52 illustrates a method of monitoring a physiological characteristic of a patient using the apparatus disclosed herein.

Fig. 53 illustrates a method for monitoring characteristics of a patient's oral or respiratory tract.

Fig. 54 illustrates a method of manufacturing an appliance including a sensor and control electronics.

Fig. 55 shows exemplary rotational speed data collected with a gyroscope accelerometer coupled to the patient's maxilla.

Detailed Description

The monitoring devices described herein may generally include an Electronic Compliance Indicator (ECI). The ECI may record sensor data from an object wearing one or more dental appliances (such as dental/orthodontic appliances, including shell appliances). Data recorded by the ECI may be stored in physical memory on the ECI and retrieved by another device. In particular, the described data may be retrieved by a handheld electronic communication device such as a smartphone, tablet computer, or the like. The handheld electronic device may include a user interface for enhancing communication between the ECI and the device, and may provide feedback to a user (e.g., a patient) and/or a technician, physician, dentist, odontologist, or other medical/dental practitioner. Once sent to the handheld device, the data may be processed (or further processed) and/or transferred to a remote processor, memory, and/or server.

In particular, described herein are devices for monitoring including ECIs that are very small and therefore use relays, such as appliance housings or holders configured to operate as relays. For example, described herein are devices that use NFC and BLE communications to transfer data between an ECI and a handheld electronic device (e.g., a smartphone). Using NFC and BLE technology may allow smartphones to retrieve data with a rather high accuracy and low power even from very small ECIs comprising only a small antenna.

The devices and methods described herein for monitoring treatment with a removable intraoral appliance may generate sensor data related to the use of the intraoral appliance. The sensor data may be processed and analyzed to determine whether the patient is wearing the appliance according to a prescribed treatment plan. Advantageously, the devices and methods described herein provide an integrated electronic sensing and recording (logging) system capable of generating more reliable and accurate patient compliance data that can be used by a treating physician to track patient behavior and improve treatment outcomes. In addition, the monitoring devices described herein can provide high value sensing data for appliance design. In some embodiments, the sensed data provided by the monitoring devices described herein may be used as feedback to modify parameters of the ongoing orthodontic treatment, also referred to as an adaptive closed-loop treatment plan.

The ECI devices described herein may use any suitable method including one or more of those described herein to detect when the device is worn on a subject's teeth. For example, a device for monitoring use of an intraoral appliance (ECI) may include one or more deflectable structures formed with or coupled to the intraoral appliance. The deflectable structure can be shaped to deflect when the oral appliance is worn on a patient's teeth. The device may include a sensor configured to generate sensor data indicative of a deflection of the deflectable structure. Optionally, the device may include a processor operatively coupled to the sensor and configured to process the sensor data in order to determine whether the intraoral appliance is being worn.

An intraoral appliance may include an appliance shell including a plurality of tooth receiving cavities. The deflectable structure may be located adjacent a tooth-receiving cavity of the plurality of tooth-receiving cavities so as to deflect outwardly when a tooth is positioned within the tooth-receiving cavity. The deflectable structure may be formed in a wall of the tooth-receiving cavity. The deflectable structure can deflect outward at least 25 μm when the tooth is positioned within the tooth-receiving cavity.

The deflectable structure may include a deflected state when the intraoral appliance is worn and a rest state when the intraoral appliance is not worn, and the deflectable structure interacts with the sensor when in the deflected state. The sensor may include a mechanical switch, and the deflectable structure may engage the mechanical switch when in the deflected state. The sensor may comprise an optical switch and the deflectable structure may activate the optical switch when in the deflected state.

The deflectable structure may comprise a cantilever, dimple, concavity, tab, protrusion or pop-up structure.

The apparatus may also include a communication unit operatively coupled to the sensor and configured to transmit the one or more sensor data or the processed sensor data to a remote device. The sensor may be integrated with the intraoral appliance or coupled to the tooth. The processor may be integrated with the intraoral appliance or coupled to the teeth. Alternatively or additionally, the processor may be located outside the patient's mouth.

Any of the devices for monitoring use of an intraoral appliance may include an appliance housing including a plurality of tooth receiving cavities and one or more proximity sensors operatively coupled to the appliance housing and configured to generate sensor data when in proximity to intraoral tissue. The apparatus may include a processor operatively coupled to the one or more proximity sensors and configured to process sensor data in order to determine whether the intraoral appliance is worn on a patient's teeth.

The one or more proximity sensors may include one or more touch sensors (similarly, the touch bed sensors described herein may be referred to as proximity sensors and/or proximity/touch sensors). The one or more touch sensors may include at least one capacitive touch sensor activated by an electrical charge associated with one or more of enamel, gum, oral mucosa, saliva, cheek, lips, or tongue. The one or more touch sensors can include at least one capacitive touch sensor activated by positive charge associated with plaque or bacteria on the patient's teeth. The processor may optionally be configured to process the sensor data in order to determine the amount of bacteria on the patient's teeth. The one or more touch sensors can include at least one resistive touch sensor.

The one or more touch sensors may include at least one capacitive sensor configured to use one or more of enamel, gums, oral mucosa, saliva, cheeks, lips, or tongue as a ground electrode.

The one or more proximity sensors may include one or more of: a capacitive sensor, an eddy current sensor, a magnetic sensor, an optical sensor, a photosensor, an ultrasonic sensor, a hall effect sensor, an infrared touch sensor, or a Surface Acoustic Wave (SAW) touch sensor. The one or more proximity sensors may be configured to generate the sensing data when in proximity to one or more of the patient's enamel, gums, oral mucosa, cheek, lips, or tongue. One or more proximity sensors may be integrated with the intraoral appliance, coupled to the tooth, or a combination thereof.

The processor may be integrated with the intraoral appliance or coupled to the teeth.

An apparatus for monitoring use of an intraoral appliance may include an appliance housing including a plurality of tooth receiving cavities and one or more vibration sensors operatively coupled to the appliance housing and configured to generate sensor data of an intraoral vibration mode. The apparatus may also include a processor operatively coupled to the one or more vibration sensors and configured to process the sensor data to determine whether the intraoral appliance is worn on a patient's teeth. The one or more vibration sensors include one or more of: MEMS microphones, accelerometers, or piezoelectric sensors. The intra-oral vibration mode may be associated with one or more of: vibration, bruxism, speech, chewing, breathing or snoring transmitted to the patient's teeth via the patient's jaw. The processor may determine whether the intraoral appliance is worn by comparing the intraoral vibration pattern to a patient-specific intraoral vibration pattern. One or more vibration sensors may be integrated with the intraoral appliance, coupled to the tooth, or a combination thereof. The processor is integrated with the intraoral appliance or coupled to the tooth.

The various embodiments described herein may be used in combination with various types of intraoral appliances worn in a patient's mouth. The intraoral appliance may be an orthodontic appliance, such as an appliance or a wire-and-bracket (wire-and-bracket) appliance, for repositioning one or more of a patient's teeth into a desired arrangement, for example, for correcting malocclusions. Alternatively or additionally, the intraoral appliance may be used to hold one or more of the patient's teeth in the current arrangement, such as a holder. Other examples of intraoral appliances suitable for use in conjunction with embodiments herein include sleep apnea treatment devices (e.g., mandibular protrusion devices or splints), night guards (e.g., for treating bruxism), braces (mouth guards), and palatal expanders.

With respect to fig. 1A, an appliance having a tooth-receiving cavity is generally shown that receives and repositions teeth, for example, via forces applied due to the appliance's elasticity. Fig. 1A illustrates an exemplary tooth repositioning appliance or appliance 100 that may be worn by a patient to effect incremental repositioning of individual teeth 102 in the jaw. The appliance may include a shell having a tooth-receiving cavity that receives and resiliently repositions the teeth. The appliance or portions thereof may be manufactured indirectly using a physical model of the teeth. For example, a physical model of the teeth and a sheet of a suitable polymeric material layer may be used to form a device (e.g., a polymeric device). In some embodiments, the physical appliance is directly manufactured from a digital model of the appliance, for example using rapid prototyping techniques.

Although reference is made to appliances that include a polymer shell appliance, the embodiments disclosed herein are well suited for use with many appliances that receive teeth, such as appliances that do not have one or more of a polymer or shell. The appliance may be made from one or more of a number of materials such as metal, glass, reinforced fibers, carbon fibers, composites, reinforced composites, aluminum, biomaterials, and combinations thereof, for example. The appliance may be shaped in a number of ways, such as, for example, using thermoforming or direct manufacturing (e.g., 3D printing, additive manufacturing). Alternatively or in combination, the appliance may be manufactured using machining, such as machining with computer numerical control of an appliance manufactured from a block of material.

The appliance may be mounted on all, or less than all, of the teeth present in the upper or lower jaw. The appliance may be specifically designed to accommodate a patient's teeth (e.g., the topology of the tooth receiving cavity matches the topology of the patient's teeth) and may be manufactured based on a positive or negative model of the patient's teeth generated from an impression, scan, or the like. Alternatively, the appliance may be a universal appliance configured to receive the teeth but not necessarily shaped to match the topology of the patient's teeth. In some cases, only some of the teeth received by the appliance will be repositioned by the appliance, while other teeth may provide a base or anchoring area for holding the appliance in place as it applies force against the repositioned tooth or teeth. In some embodiments, at some point during treatment, some, most, or even all of the teeth will be repositioned. The moved teeth may also serve as a base or anchor for holding the appliance when it is worn by the patient. Typically, no wire or other means for holding the appliance in place on the teeth will be provided. However, in some instances, it may be desirable or necessary to provide a separate attachment or other anchoring element 104 on the tooth 102 with a corresponding receptacle (receptors) or hole 106 in the appliance 100 so that the appliance can apply a selected force to the tooth. Comprises that Exemplary appliances for use in the system are described in a number of patents and patent applications assigned to Align Technology, inc (including, for example, U.S. patent nos. 6,450,807 and 5,975,893) and company websites that are accessible on the world wide web (see, for example, the URL "invisal. Examples of tooth-mounted attachments suitable for use with orthodontic appliances are also in patents and patent applications assigned to Align Technology, Inc(including, for example, U.S. patent nos. 6,309,215 and 6,830,450).

FIGS. 1B-1D illustrate an example of a tooth repositioning system 110 that includes a plurality of appliances 112, 114, 116. Any of the appliances described herein may be designed and/or provided as part of a set of multiple appliances for use in a tooth repositioning system. Each appliance may be configured such that the tooth-receiving cavity has a geometry corresponding to an intermediate or final tooth arrangement intended for that appliance. The patient's teeth may be incrementally repositioned from the initial tooth arrangement to the target tooth arrangement by placing a series of incremental position adjustment appliances on the patient's teeth. For example, the tooth repositioning system 110 may include a first appliance 112 corresponding to an initial tooth arrangement, one or more intermediate appliances 114 corresponding to one or more intermediate arrangements, and a final appliance 116 corresponding to a target arrangement. The target tooth arrangement may be a planned final tooth arrangement selected for the patient's teeth at the end of all planned orthodontic treatments. Alternatively, the target arrangement may be one of several intermediate arrangements for a patient's teeth during an orthodontic treatment procedure, which may include a variety of different treatment options, including but not limited to situations where surgery is recommended, situations where interproximal reduction (IPR) is appropriate, situations where a schedule check is scheduled, situations where anchoring locations are best, situations where palatal expansion is needed, situations where restorative dentistry is involved (e.g., inlays, patches, crowns, bridges, implants, veneers, etc.), and the like. Thus, it should be understood that the target tooth arrangement may be any planned resulting arrangement of the patient's teeth that follows one or more incremental repositioning stages. Similarly, the initial tooth arrangement may be any initial arrangement for the patient's teeth followed by one or more incremental repositioning stages.

The various embodiments of the orthodontic appliances presented herein can be manufactured in a variety of ways. By way of example, some embodiments of the appliances (or portions thereof) herein can be produced using indirect manufacturing techniques, such as by thermoforming on a male or female mold. Indirect manufacturing of orthodontic appliances may include creating a male or female mold of a patient's dentition in a target arrangement (e.g., by rapid prototyping, milling, etc.) and thermoforming one or more sheets of material on the mold to create an appliance shell. Alternatively or in combination, some embodiments of the apparatus herein may be manufactured directly, e.g. using rapid prototyping, stereolithography, 3D printing, etc.

The configurations of orthodontic appliances herein can be determined according to a treatment plan of a patient, e.g., a treatment plan involving the continuous administration of multiple appliances for incrementally repositioning teeth. Computer-based treatment planning and/or appliance manufacturing methods may be used to facilitate the design and manufacture of appliances. For example, one or more of the appliance assemblies described herein may be digitally designed and manufactured with the aid of computer controlled manufacturing equipment (e.g., Computer Numerical Control (CNC) milling, computer controlled rapid prototyping such as 3D printing, etc.). The computer-based approach presented herein may improve the accuracy, flexibility, and convenience of appliance manufacturing.

In some embodiments, an orthodontic appliance (such as the appliance shown in fig. 1A) applies a force to crowns and/or attachments of teeth located on the teeth at one or more points of contact between the tooth-receiving cavities of the appliance and the received teeth and/or attachments. The magnitude of each of these forces and/or their distribution over the tooth surface may determine the type of orthodontic tooth movement that results. Tooth movement may be in any direction in any plane of space and may include one or more of rotation or translation along one or more axes. As discussed further herein, types of tooth movement include squeezing, intrusion, rotation, tipping, translation, and root movement, and combinations thereof. Tooth movement of the crown greater than the movement of the root may be referred to as tipping. The equivalent movement of the crown and root may be referred to as translation. Movement of the root portion greater than the crown portion may be referred to as root movement.

Fig. 2 illustrates a method 200 of orthodontic treatment using a plurality of appliances, according to an embodiment. The method 200 may be implemented using any of the instruments or groups of instruments described herein. In step 210, a first orthodontic appliance is applied to a patient's teeth to reposition the teeth from a first tooth arrangement to a second tooth arrangement. In step 220, a second orthodontic appliance is applied to the patient's teeth to reposition the teeth from the second tooth arrangement to a third tooth arrangement. The method 200 may be repeated as desired using any suitable number and combination of successive appliances to incrementally reposition the patient's teeth from the initial arrangement to the target arrangement. The appliances may be generated all at the same stage or time, in groups or batches (e.g., at the beginning of one or more stages of treatment), or one at a time, and the patient may wear each appliance until the pressure of each appliance against the teeth is no longer felt, or until the maximum amount of expressed tooth movement for a given stage is reached. A plurality of different appliances (e.g., a set) may be designed and even manufactured before a patient wears any of the plurality of appliances. After wearing the appliance for an appropriate period of time, the patient may replace the current appliance with the next appliance in the series until no more appliances remain. Appliances are typically not fixed to the teeth, and the patient can place and replace appliances (e.g., patient-removable appliances) at any time during the surgical procedure. The final appliance or appliances in the series may have a geometry or geometries selected to overcorrect the tooth arrangement. For example, one or more appliances may have a geometry that will (if fully realized) move individual teeth beyond the tooth arrangement that has been selected as the "final". Such over-correction may be required in order to counteract potential recurrence after the repositioning method has terminated (e.g., to allow individual teeth to return to their pre-corrected positions). Overcorrection may also help to speed up the rate of correction (e.g., an appliance with a geometry that is located beyond a desired intermediate or final position may move an individual tooth toward that position at a greater rate). In this case, the use of the appliance may be terminated before the teeth reach the position defined by the appliance. Furthermore, an overcorrection may be applied on purpose in order to compensate for any inaccuracies or limitations of the appliance.

The intraoral appliance can be operably coupled to a monitoring device (also referred to herein as an "electronic compliance indicator") configured to provide data related to appliance use and/or patient compliance, such as data indicative of whether the appliance is worn, the amount of time the appliance is worn, and/or the interaction between the appliance and the oral cavity (e.g., contact between the appliance and intraoral tissue, force and/or pressure applied by the appliance to intraoral tissue). Alternatively or in combination, the monitoring device may be configured to provide data indicative of one or more characteristics of the patient's mouth or a portion thereof (e.g., teeth, gums, palate, lips, tongue, cheeks, saliva, respiratory tract), such as temperature, color, sound, vibration, motion, pH, conductivity, charge, resistance, capacitance, humidity, or airflow. Features of the patient's mouth may optionally be used to determine appliance usage and/or patient compliance, as discussed in more detail herein.

The monitoring devices described herein may be designed for use in the oral cavity of a patient. For example, the size of the monitoring device may be limited to avoid patient discomfort and/or to facilitate its integration into an intraoral appliance, as described below. In some embodiments, the monitoring device has a height or thickness of less than or equal to about 1.5mm, or less than or equal to about 2 mm. In some embodiments, the monitoring device has a length or width of less than or equal to about 4mm, or less than or equal to about 5 mm. The shape of the monitoring device may be varied as desired, e.g. circular, oval, triangular, square, rectangular, etc. For example, in some embodiments, the monitoring device may have a circular shape with a diameter of less than or equal to about 5 mm.

A relatively thin and flexible monitoring device may be used to provide a larger surface area while reducing patient discomfort. In some embodiments, the monitoring devices herein are sized to conform to a dental crown surface (e.g., facial, lingual, and/or occlusal surfaces of a dental crown). For example, a monitoring device having dimensions of about 10mm by about 5mm may be used to cover the facial surfaces of molar crowns. As another example, a monitoring device having dimensions of about 10mm by about 20mm may be used to cover the facial, occlusal, and lingual surfaces of a dental crown. The monitoring device may be in contact with the crown of a single tooth or the crowns of multiple teeth as desired.

Other properties of the monitoring device (e.g., volume, weight) may be designed to reduce patient discomfort. For example, the weight of the monitoring device may be selected to not exceed a level that would exert an undesirable force on the underlying teeth.

Fig. 3A schematically illustrates a monitoring device 300 (e.g., an ECI). The monitoring device 300 may be used in combination with any embodiment of the systems and devices described herein, and the components of the monitoring device 300 are equally applicable to any other embodiment of the monitoring device described herein. The monitoring device 300 may be implemented as an Application Specific Integrated Circuit (ASIC) including one or more of the following components: a processor 302, a memory 304, one or more sensors 306, a clock 308, a communication unit 310, an antenna 312, a power management unit 314, or a power supply 316. A processor 302 (e.g., a Central Processing Unit (CPU), microprocessor, Field Programmable Gate Array (FPGA), logic or state machine circuitry, etc.), also referred to herein as a controller, may be configured to perform the various methods described herein. The memory 304 includes various types of memory known to those skilled in the art, such as RAM (e.g., SRAM, DRAM), ROM (EPROM, PROM, MROM), or hybrid memory (e.g., flash memory, NVRAM, EEPROM), among others. The memory 304 may be used to store instructions executable by the processor 302 to perform the methods provided herein. Additionally, the memory may be used to store sensor data obtained by the sensors 306, as discussed in more detail below.

The monitoring device 300 may include any number of sensors 306, such as one, two, three, four, five, or more sensors. In some embodiments, multiple sensors are used to provide redundancy to increase the accuracy and reliability of the resulting data. Some or all of the sensors 306 may be of the same type. Some or all of the sensors 306 may be of different types. Examples of sensor types suitable for use with the monitoring devices described herein include: touch or tactile sensors (e.g., capacitive, resistive), proximity sensors, audio sensors (e.g., microelectromechanical system (MEMS) microphones), color sensors (e.g., RGB color sensors), electromagnetic sensors (e.g., reed sensors, magnetometers), light sensors, force sensors (e.g., force-based resistive materials), pressure sensors, temperature sensors, motion sensors (e.g., accelerometers, gyroscopes), vibration sensors, piezoelectric sensors, strain gauges, pH sensors, conductivity sensors, airflow sensors, gas detection sensors, humidity or humidity sensitive sensors, physiological sensors (e.g., electrocardiogram sensors, bioimpedance sensors, photoplethysmography sensors, galvanic skin response sensors), or combinations thereof. In some embodiments, the sensors herein may be configured as switches that are activated and/or deactivated in response to a particular type of signal (e.g., optical, electrical, magnetic, mechanical, etc.).

The sensor 306 may be located at any portion of the intraoral appliance, such as at or near a distal portion, a medial portion, a cheek, a tongue, a gingival portion, an occlusal portion, or a combination thereof. When the appliance is worn in the mouth of a patient, the sensor 306 may be positioned near a tissue of interest, such as near or adjacent to teeth, gums, palate, lips, tongue, cheeks, respiratory tract, or a combination thereof. For example, the sensor 306 may cover a single tooth or a portion of a single tooth when the appliance is worn. Alternatively, the sensor 306 may cover a plurality of teeth or portions thereof. In embodiments using multiple sensors 306, some or all of the monitoring devices may be located at different portions of the appliance and/or oral cavity. Optionally, some or all of the sensors 306 may be located at the same portion of the appliance and/or oral cavity.

Analog sensor data may be converted to digital format using an analog-to-digital converter (ADC) (not shown), if desired. As described herein, processor 302 may process sensor data obtained by sensor 306 in order to determine appliance usage and/or patient compliance. The sensor data and/or processing results may be stored in memory 304. Optionally, the stored data may be associated with a timestamp generated by a clock 308 (e.g., a real-time clock or counter).

The monitoring device 300 may include a communication unit 310 configured to transmit data (e.g., sensor data and/or processing results) stored in memory to a remote device. The communication unit 310 may utilize any suitable communication method, such as a wired or wireless communication method (e.g., RFID, near field communication, bluetooth, ZigBee, infrared, etc.). Communication unit 310 may include a transmitter for transmitting data and antenna 312 to a remote device. Optionally, the communication unit 310 comprises a receiver for receiving data from a remote device. In some embodiments, the communication channel used by the communication unit 310 may also be used to power the device 300, for example during data transmission or if the device 300 is used passively.

The remote device may be any computing device or system, such as a mobile device (e.g., a smartphone), a personal computer, a laptop computer, a tablet, a wearable device, and so forth. Alternatively, the remote device may be part of or connected to a cloud computing system ("in the cloud"). The remote device may be associated with a patient, treating physician, medical doctor, researcher, or the like. In some embodiments, the remote device is configured to process and analyze data from the monitoring device 300, e.g., in order to monitor patient compliance and/or appliance usage for research purposes, etc.

The monitoring device 300 may be powered by a power source 316, such as a battery. In some embodiments, the power source 316 is a printed and/or flexible battery such as a zinc-carbon flexible battery, a zinc-manganese dioxide printed flexible battery, or a solid state thin film lithium phosphorus oxynitride battery. The use of printed and/or flexible batteries is advantageous for reducing the overall size of the monitoring device 300 and avoiding patient discomfort. For example, printed batteries can be manufactured in a wide variety of shapes and can be stacked to form three-dimensional structures, for example, to conform to appliance and/or tooth geometry. Similarly, the flexible battery may be shaped to be flush with the surface of the appliance and/or teeth. Alternatively or in combination, other types of batteries, such as supercapacitors, may be used. In some embodiments, the power source 316 may utilize lower power energy harvesting methods (e.g., thermodynamics, electrodynamics, piezoelectricity) to generate power for the monitoring device 300. Alternatively, the power supply 316 may be recharged, for example, via inductive or wireless means. In some embodiments, the patient may recharge the power source 316 when the appliance is not being used. For example, the patient may remove the intraoral appliance while brushing and place the appliance on an inductive power hub to recharge the power supply 316.

Optionally, the monitoring device 300 may include a power management unit 314 connected to a power supply 316. Power management unit 314 may be configured to control when monitoring device 300 is in an active state (e.g., using power from power supply 316) and when device 300 is inactive (e.g., not using power from power supply 316). In some embodiments, the monitoring device 300 is only active during certain times in order to reduce power consumption and reduce the size of the power supply 316, allowing for a smaller monitoring device 300. In some embodiments, the monitoring device 300 includes an activation mechanism (not shown) for controlling when the monitoring device 300 is in an active state (e.g., powered on, monitoring appliance usage) and when the monitoring device 300 is in a dormant state (e.g., powered off, not monitoring appliance usage). The activation mechanism may be provided as a discrete component of the monitoring device 300 or may be implemented by the processor 302, the power management unit 314, or a combination thereof. The activation mechanism may be used to reduce the amount of power used by the monitoring device 300, for example, by deactivating the monitoring device 300 when not in use, which may be beneficial to reducing the size of the power supply 316, and thereby help reduce the overall device size.

In some embodiments, the monitoring device 300 is dormant (e.g., during storage, shipping, etc.) before being delivered to the patient and is only activated when ready for use. Such an approach may be beneficial to save electrical expenditure. For example, the components of the monitoring device 300 may be electrically coupled to the power source 316 when assembled, but may be in a dormant state until activated, e.g., by an external device such as a mobile device, personal computer, laptop, tablet, wearable device, power hub, or the like. The external device may send a signal to the monitoring device 300 causing the activation mechanism to activate the monitoring device 300. As another example, the activation mechanism may include a switch (e.g., mechanical, electrical, optical, magnetic, etc.) such that the power source 316 is not electrically coupled to other components of the monitoring device 300 until the switch is triggered. For example, in some embodiments, the switch is a reed switch or other magnetic sensor held open by a magnet. The magnet may be removably attached to the monitoring device 300, or may be integrated into a package for the device 300 or appliance, for example. When the monitoring device is separated from the magnet (e.g., by removing the magnet or removing the device and appliance from the package), the switch closes and connects the power supply 316. As another example, the monitoring device 300 may include a mechanical switch, such as a button, that is manually actuated to connect the power source 316. In some embodiments, the activation mechanism includes a locking function that locks the switch upon first actuation to maintain connection to the power source, thereby maintaining activation of the monitoring device 300. Optionally, the switch for the activation mechanism may be activated by a component in the patient's mouth (e.g., a magnet coupled to the patient's teeth) such that the monitoring device 300 is active only when the appliance is worn by the patient and is inactive when the appliance is removed from the patient's mouth. Alternatively or in combination, the switches may be activated by other types of signals, such as optical signals.

Fig. 23 illustrates a monitoring device 2300 having an activation mechanism, according to an embodiment. As with all other monitoring devices described herein, monitoring device 2300 may be similar to monitoring device 300 and may include some or all of the components described herein with respect to monitoring device 300. The apparatus 2300 is coupled to an intraoral appliance 2302 (e.g., via an encapsulation material 2304). Device 2300 may include an activation mechanism 2303, which includes a magnetic switch. Prior to use, device 2300 may be removably coupled to magnet 2306 (e.g., using tape 2308), and magnet 2306 may hold the magnetic switch in the open position, such that device 2300 is inactive. When the appliance 2302 is ready for use, a user can remove the magnet 2306, thereby closing the magnetic switch and connecting the components of the monitoring device 2300 to a power source. The intraoral appliances and monitoring devices described herein may be configured in many different ways. In some embodiments, an intraoral appliance as described herein is operably coupled to a single monitoring device. Optionally, the intraoral appliance may be operably coupled to a plurality of monitoring devices, such as at least two, three, four, five or more monitoring devices. Some or all of the monitoring devices may be of the same type (e.g., collect the same type of data). Alternatively, some or all of the monitoring devices may be of different types (e.g., collect different types of data). Any of the embodiments of the monitoring device described herein may be used in combination with other embodiments in a single intraoral appliance.

The monitoring device may be located at any portion of the appliance, such as at or near the distal portion, the intermediate portion, the cheek, the tongue, the gum portion, the bite portion, or a combination thereof. When the appliance is worn in the mouth of a patient, the monitoring device may be positioned near the tissue of interest, such as near or adjacent to the teeth, gums, palate, lips, tongue, cheeks, respiratory tract, or a combination thereof. For example, the monitoring device may cover a single tooth or a portion of a single tooth when the appliance is worn. Alternatively, the monitoring device may cover a plurality of teeth or portions thereof. In embodiments where multiple monitoring devices are used, some or all of the monitoring devices may be located at different parts of the appliance. Alternatively, some or all of the monitoring devices may be located at the same part of the appliance.

The monitoring device may be operatively coupled to the intraoral appliance in various ways. For example, the monitoring device may be physically integrated with the intraoral appliance by coupling the monitoring device to a portion of the appliance (e.g., using an adhesive, fastener, latch, laminate, molding, etc.). The coupling may be a releasable coupling allowing the monitoring device to be removed from the appliance, or may be a permanent coupling in which the monitoring device is permanently fixed to the appliance. Alternatively or in combination, the monitoring device may be physically integrated with the intraoral appliance by being encapsulated, embedded, printed or otherwise formed with the appliance. In some embodiments, the appliance includes a shell shaped to receive a patient's teeth, and the monitoring device is physically integrated with the shell. The monitoring device may be located on an inner surface of the housing (e.g., a surface adjacent to the received tooth), on an outer surface of the housing (e.g., a surface distal from the received tooth), or within a wall of the housing. Optionally, the housing may include a receptacle shaped to receive the monitoring device, as discussed further herein. Exemplary methods for manufacturing an appliance with a physically integrated monitoring device will be described in further detail herein (e.g., by incorporating some or all of the components of the monitoring device during direct manufacturing of the appliance).

In general, any of the devices described herein may be used in conjunction with a digital model or scan or a patient's teeth and/or intraoral appliance. For example, fig. 3B schematically illustrates a system 383 including intraoral appliances 377 having one or more sensors and digital scan data of appliances and/or a patient's teeth 379. Analysis engine 381 (which may be part of or separate from the intraoral appliance) may integrate the remote information and sensor information and may use the digital scan data to associate particular sensor information with the patient's teeth.

Fig. 4A and 4B illustrate an intraoral appliance 400 including an integrated monitoring device 402 according to an embodiment. The appliance 400 includes a housing 404 having a plurality of tooth receiving cavities, and a monitoring device 402 is coupled to an outer buccal surface of the housing 404 adjacent the tooth receiving cavities 406. In the depicted embodiment, the monitoring device 402 is coupled to the tooth receiving cavities 406 for molars. It should be appreciated that in alternative embodiments, the monitoring device 402 may be coupled to other portions of the shell 404, such as an interior surface, a lingual surface, an occlusal surface, one or more tooth receiving cavities for other types of teeth (e.g., incisors, canines, premolars), and the like. The monitoring device 402 may be shaped to conform to the geometry of the corresponding appliance portion (e.g., the wall of the cavity 306) in order to provide a lower surface profile and reduce patient discomfort. In some embodiments, the appliance 400 includes a receptacle 408 formed on an exterior surface of the housing 404, and the monitoring device 402 is positioned within the receptacle. An exemplary method for forming an instrument having a receptacle 408 and an integrated monitoring device 402 is described in detail below.

Monitoring device 402 may include any of the components previously described herein with respect to monitoring device 300 of fig. 3A. For example, the monitoring device 402 may include a sensor 410, a power source 412 (e.g., a battery), and/or a communication unit 414 (e.g., a wireless antenna). The arrangement of the components of the monitoring device 402 may be changed as desired. In some embodiments, the sensor 410 is located adjacent to the tooth receiving cavity 406. A gap may be formed in the housing 404 adjacent to the sensor 410 to allow direct access to the received teeth. The communication unit 414 (or components thereof, such as an antenna) may be located adjacent or on an outer surface of the receptacle 408 to facilitate data transmission.

In some embodiments, some components of the monitoring device may be packaged and provided separately from other components of the device. For example, the monitoring device may include one or more components physically integrated with the first intraoral appliance and one or more components physically integrated with the second intraoral appliance. For example, a first intraoral appliance and a second intraoral appliance may be worn on opposing jaws. Any of the components of the monitoring device (e.g., components of device 300 of fig. 3A) may be located on the appliance for the upper jaw, the appliance for the lower jaw, or a combination thereof. In some embodiments, it may be beneficial to distribute the components of the monitoring device across multiple appliances, for example, to accommodate space limitations, accommodate power limitations, and/or improve sensing. Further, some of the components of the monitoring device may serve as a substrate for other components (e.g., a battery serving as a substrate for an antenna). Fig. 5 shows a monitoring system 500 comprising a first fixture 502 and a second fixture 504 according to an embodiment. The first appliance 502 may be shaped to receive teeth of an upper arch of a patient and the second appliance 504 may be shaped to receive teeth of a lower arch of the patient. The system 500 may include a monitoring device separated into a first sub-unit 506 physically integrated with the first appliance 502 and a second sub-unit 508 physically integrated with the second appliance 504. In some embodiments, the first subunit 506 is a power supply subunit that includes a power supply 510, and the second subunit 508 is a sensing subunit that includes the remaining components of the monitoring device, such as a power management unit 512, a processor (e.g., CPU415), a sensor 516, memory (e.g., RAM518 such as SRAM or DRAM; ROM such as EPROM, PROM, or MROM; or hybrid memory such as EEPROM 520, flash memory, or NVRAM), a communication unit (e.g., antenna 522), or any other component 524 described herein (e.g., with respect to the monitoring device 300 of fig. 3A). The first and second subunits 506, 508 may be operably coupled to each other via an inductive coupling between the power supply 510 and the power management unit 512, for example, when the first and second appliances 502, 504 are brought into proximity with each other by closure of the patient's jaw.

The configuration of fig. 5 may be varied as desired. For example, first subunit 506 may be physically integrated with second appliance 504, while second subunit 508 may be physically integrated with first appliance 502. As another example, the distribution of monitoring device components between the first sub-unit 506 and the second sub-unit 508 may differ from the depicted embodiment.

Alternatively or in combination, the monitoring device may include one or more components physically integrated with the intraoral appliance and one or more components physically integrated with another device external to the patient's mouth. For example, the external device may be a wearable device (e.g., a headset, a smart watch, a wearable computer, etc.) that is worn on another part of the patient's body. As another example, the external device may be a power hub, a mobile device, a personal computer, a laptop, a tablet, and the like. Any of the components of the monitoring device (e.g., components of device 300 of fig. 3A) may be located on the external device. In some embodiments, the monitoring device includes an antenna and communication unit integrated into the intraoral appliance that transmits sensor data from the patient's oral cavity to, and optionally receives data from, an external device. The monitoring device assembly integrated into the external device may provide additional functionality (e.g., processing and/or analysis capabilities) that enhance the functionality of the monitoring device assembly within the intraoral appliance. The monitoring device assembly within the intraoral appliance is capable of operating with or without enhanced functionality.

Alternatively or in combination, the monitoring device may include one or more components physically integrated with the intraoral appliance and one or more components located in the patient's mouth separate from the appliance. The intraoral components may be positioned to interact with (e.g., physically contact, communicate with) integrated components in the appliance when the appliance is worn. In some embodiments, the intraoral assembly is coupled to a portion of the oral cavity, such as the crown of a patient's teeth. For example, the intraoral assembly may be physically integrated into an attachment device that is mounted on a patient's tooth. Alternatively or in combination, the monitoring device may be surgically implanted, for example in the jaw bone of a patient. Any of the components of the monitoring device (e.g., the components of the device 300 of fig. 3A) may be located in the mouth of the patient, rather than in an intraoral appliance. In some embodiments, the appliance and integrated assembly may be removed from the patient's mouth independently of the intraoral assembly. Advantageously, the method may reduce costs by allowing the same apparatus assembly to be used with a plurality of different appliances, for example when applying a series of shell appliances to reposition a patient's teeth.

Fig. 6A shows a system 600 comprising an intraoral appliance 602 and an attachment device 604 mounted on a tooth 606, according to an embodiment. The appliance 602 may include a housing having a tooth-receiving cavity shaped to receive a tooth 606 and a receptacle shaped to receive an attachment device 604 on the tooth 606. In some embodiments, the system 600 includes a monitoring device having a first subunit physically integrated into the appliance 602 (e.g., according to any of the methods described herein) and a second subunit physically integrated into the attachment device 604. In some embodiments, the second subunit integrated into the attachment device 604 includes relatively bulky components of the monitoring device, such as a power source, memory, and/or sensors. For example, the attachment device 604 may include a battery or other power source that is operably coupled to a monitoring device component integrated into the appliance 602, e.g., via inductive coupling or direct contact using the electrodes 608. In an alternative embodiment, the configuration may be reversed, with the power source installed in the appliance 602 and the remaining monitoring device components located in the attachment device 604. This approach may reduce costs when multiple appliances are used, as only the power source is replaced with each new appliance. As another example, the attachment device 604 may include a passive sensing element driven by one or more monitoring device components located in the appliance 602. In yet another example, the attachment device 604 may include a conductive element for triggering a switch integrated in the appliance 602.

Fig. 6B shows a system 650 comprising an intraoral appliance 652 and an attachment device 654 mounted on a tooth 656, according to an embodiment. Similar to appliance 600, appliance 652 may include a shell having a tooth-receiving cavity shaped to receive a tooth 656 and a receptacle shaped to receive an attachment device 654 on tooth 656. In some embodiments, system 650 includes a monitoring device having a first subunit physically integrated into fixture 652 (e.g., according to any of the methods described herein) and a second subunit physically integrated into attachment device 654. A first subunit in the appliance 652 may include a sensing target 658 and a second subunit in the accessory device 654 may include one or more sensors configured to detect the target. For example, the sensing target 658 may be a specular or opaque surface and the sensor may be a photodetector. As another example, the sensing target 658 may be a magnet and the sensor may be a magnetometer. In yet another example, the sensing target 658 can be a metal element (e.g., foil, coating), and the sensor can be a capacitive sensor. Alternatively, the sensing target 658 may be a live coil that generates an AC electromagnetic field, such that the sensor also obtains power from the sensing target 658. In an alternative embodiment, the positions of the first and second subunits may be reversed such that the sensing target 658 is located in the attachment device 654 and the sensor is located in the fixture 652.

The monitoring device of the present disclosure may utilize many different types and configurations of sensors. The following description of certain example monitoring devices is not intended to be limiting, and it should be recognized that features of various embodiments described herein can be used in combination with features of other embodiments. For example, the monitoring device discussed below may also include any of the components previously described with respect to the monitoring device 300 of fig. 3A. A single monitoring device may include any combination of the sensor types and sensor configurations described herein.

In some embodiments, the monitoring device includes a structure shaped to interact with the sensor when the oral appliance is worn on the patient's teeth. The monitoring device may include one or more deflectable structures (e.g., cantilevered arms, dimples, concavities, tabs, protrusions, pop-up structures, etc.) formed with or coupled to the implement. For example, the deflectable structure may be deflected outward by the patient's teeth or an attachment device coupled to the teeth when the appliance is worn. In some embodiments, the monitoring device includes a sensor (e.g., a mechanical switch such as a button), an electrical switch, an optical switch, a proximity sensor, a touch sensor, etc., configured to generate sensor data indicative of deflection of the deflectable structure (e.g., whether the structure is deflected, a deflection distance, etc.). The monitoring device may further comprise a processor operatively coupled to the sensor and configured to process the sensor data in order to generate appliance usage and/or compliance data (e.g. information about whether the appliance is worn or not). Alternatively, the sensors may provide more complex data (e.g., force and/or pressure data) regarding the interaction between the appliance and the patient's teeth. In some embodiments, the deflectable structure is in a deflected state when the appliance is worn and is in a resting state when the appliance is not worn, and the deflectable structure interacts (e.g., activates) with the sensor only when in the deflected state.

Fig. 7A and 7B illustrate a monitoring device 700 having a deflectable structure 702 according to an embodiment. In the depicted embodiment, the deflectable structure 702 is formed in a shell 704 of an intraoral appliance, such as in a wall of a tooth receiving cavity 706. The monitoring device 700 may include a sensor 708 (e.g., a button) configured to detect deflection of the deflectable structure 702. When the appliance is not worn on the patient's teeth (fig. 7A), the deflectable structure 702 may be in a resting state such that the sensor 708 is not activated. When the appliance is worn by a patient, the teeth 710 (e.g., the first molar or the second molar) can move the deflectable structures 702 outward to activate the sensing 708. The deflection distance can be varied as desired. For example, the structures 702 may be deflected outward by a distance of at least about 25 μm, at least about 30 μm, at least about 50 μm, at least about 100 μm, at least about 200 μm, at least about 300 μm, or a distance in the range from about 25 μm to about 300 μm. The monitoring device 700 may include other components for storing, processing, analyzing, and/or transmitting sensor data (e.g., as previously described with respect to fig. 3A).

Fig. 7C shows a monitoring device 720 having a deflectable structure 722 according to an embodiment. The deflectable structure 722 is formed in the shell of the oral appliance, for example in the wall of the tooth receiving cavity 724. The tooth-receiving cavity 724 is shaped to receive a tooth 726 that is coupled to an attachment device 728. In some embodiments, the attachment device 728 includes an activator structure 730 that deflects the deflectable structure 722 when the tooth 726 is received in the cavity 724. The monitoring device 720 includes a sensing subunit 732 mounted to the housing in proximity to the deflectable structure 722. Sensing subunit 732 includes a sensor 734 (e.g., a switch) that is activated by deflection of deflectable structure 722. Alternatively, the sensor 732 may be covered by a flexible membrane. Subunit 732 may also include any of the power supplies, processors, and/or any other monitoring device components described herein (e.g., with respect to the embodiment of fig. 3A).

Figure 7D illustrates a method for manufacturing an intraoral appliance having a deflectable structure, according to an embodiment. In a first step, a mold 750 of the patient's dentition is provided. The mold 750 may represent the patient's teeth, for example, in a current or target tooth arrangement. In a second step, the intraoral appliance 752 is formed by forming (e.g., thermoforming) a material over the mold 750. Alternatively, the intraoral appliance 752 may be formed by direct fabrication (e.g., stereolithography, 3D printing, etc.) without the use of the mold 750. The appliance may include a housing having a tooth-receiving cavity 754 with a dimple or concave surface 756 at a target location for the deflectable structure. In a third step, deflectable structure 758 is formed in implement 752 by cutting the walls of cavity 754 so as to form cantilever portions. The cutting of the tool 752 may be performed using methods known to those skilled in the art, such as laser cutting or milling. Subsequently, other components of the monitoring device may be coupled to the implement 752 adjacent or near the deflectable structure 758.

Alternatively or in combination, the monitoring device may include one or more proximity sensors configured to generate sensor data when in proximity to a sensing target. Examples of proximity sensors suitable for use with embodiments herein include capacitive sensors, resistive sensors, inductive sensors, eddy current sensors, magnetic sensors, optical sensors, photoelectric sensors, ultrasonic sensors, hall effect sensors, infrared touch sensors, or Surface Acoustic Wave (SAW) touch sensors. The proximity sensor may be activated when within a certain distance of the sensing target. The distance may be about less than 1mm, or in the range of about 1mm to about 50 mm. In some embodiments, the proximity sensor may be activated without direct contact between the sensor and the sensing target (e.g., the maximum sensing distance is greater than zero).

In some embodiments, the proximity sensor is activated when in direct contact with a sensing target (sensing distance is zero), also referred to as a touch or tactile sensor. Examples of touch sensors include capacitive touch sensors, resistive touch sensors, inductive sensors, pressure sensors, and force sensors. In some embodiments, the touch sensor is activated only by direct contact between the sensor and the sensing target (e.g., the maximum sensing distance is zero). Some of the proximity sensor types described herein (e.g., capacitive sensors) may also be touch sensors, such that they are activated by proximity to a sensing target and direct contact with the target.

One or more proximity sensors may be integrated in the intraoral appliance and used to detect whether the appliance is in proximity to one or more sensing targets. The sensing target may be intraoral tissue (e.g., teeth, gums, palate, lips, tongue, cheek, or a combination thereof). For example, proximity sensors may be positioned on buccal and/or lingual surfaces of the appliance to detect use of the appliance based on proximity and/or direct contact with the cheek and/or tongue of the patient. As another example, one or more proximity sensors may be positioned in the appliance to detect use of the appliance based on proximity and/or direct contact with enamel and/or gum. In some embodiments, multiple proximity sensors are located at different locations of the appliance in order to detect proximity and/or direct contact with different portions of the oral cavity.

Alternatively or in combination, one or more sensing targets may be coupled to the intraoral tissue (e.g., integrated in an attachment device on the teeth), or may be some other component located in the oral cavity (e.g., a metal filling). Alternatively or in combination, one or more proximity sensors may be located in the oral cavity (e.g., integrated in an attachment device on the teeth) and respective sensing targets may be integrated in the oral appliance. Alternatively, a proximity sensor integrated in a first appliance on the patient's upper or lower jaw may be used to detect a sensing target integrated in a second appliance on the opposing jaw or coupled to a portion of the opposing jaw (e.g., attached to a tooth), and thus detect proximity and/or direct contact between the patient's jaws.

The proximity sensor may be a capacitive sensor activated by a charge on the sensing target. Capacitive sensors can be activated by an electrical charge associated with an intraoral tissue or ingredient, such as enamel, gums, oral mucosa, saliva, cheek, lips, and/or tongue. For example, the capacitive sensor may be activated by an electrical charge (e.g., positive charge) associated with plaque and/or bacteria on a patient's teeth or other intraoral tissue. In such embodiments, the capacitance sensing data may be used to determine whether the appliance is worn, and optionally the amount of plaque and/or bacteria on the teeth. As another example, the capacitive sensor may be activated by a charge associated with the crown, for example due to the presence of a negative charge of ionized carboxyl groups covalently bonded to sialic acid.

Various configurations of capacitive sensors may be used with the monitoring devices described herein. In some embodiments, the charge on the surface of the intraoral tissue may interfere with the electric field of the capacitive sensor. Alternatively or in combination, the intraoral tissue may be used as a ground electrode for a capacitive sensor. Optionally, a shielding mechanism may be used to direct the electric field of the capacitive sensor in a particular position and/or direction for detecting contact with a particular tissue.

Fig. 8A shows an intraoral appliance 800 including a capacitive sensor 802 according to an embodiment. In some embodiments, the sensing target for the capacitive sensor 802 is the surface of the patient's tooth 804, and the capacitive sensor 802 is coupled to the inner surface of the tooth receiving cavity 806 of the intraoral appliance so as to be adjacent to the tooth 804 when the appliance is worn. The capacitive sensor 802 may be activated by proximity to the tooth 804 and/or direct contact with the tooth 804. In some embodiments, the capacitive sensor 802 is activated by a negative charge on the enamel of the crown. Alternatively or in combination, the capacitive sensor 802 may be activated by positive charges associated with plaque and/or bacteria on the crown of the tooth. Alternatively, the capacitive sensor 802 may be activated by an electrical charge associated with minerals in saliva on the surface of the patient's teeth, including but not limited to NH4+, Ca2+, PO43", HCO3-, and F.

Fig. 8B shows a monitoring device 850 integrated into an intraoral appliance 852, according to an embodiment. The monitoring device 850 may be located on any suitable portion of the appliance 852, such as a buccal surface and/or a lingual surface of the appliance 852 adjacent to the tooth receiving cavity. Device 850 can include capacitive sensor 854 (e.g., a capacitive touch sensor grid). The capacitive sensor 854 may be similar to the sensor 802 described with respect to fig. 8A. In some embodiments, capacitive sensor 854 is flexible and/or thermoformable so as to conform to the shape of instrument 852. The monitoring device 850 may also include a controller and power supply 856 coupled to the capacitive sensor 854, as well as any other components described herein with respect to the monitoring device 300 of fig. 3A. For example, the controller and power supply 856 can be used to power the capacitive sensor 854, process proximity and/or contact data obtained by the capacitive sensor 854, store the obtained data and/or processing results, and/or transmit the data and/or processing results to a remote device.

Although fig. 8B illustrates a single monitoring device 850 having a single capacitive sensor 854, other configurations may also be used. For example, in an alternative embodiment, the monitoring device 850 may include multiple capacitive sensors located at different locations on the implement 852 to detect proximity and/or contact with multiple locations in the oral cavity. Alternatively, multiple monitoring devices may be used, with each device coupled to one or more respective capacitive sensors.

In some variations, most (or all) of the intraoral appliances (shown as appliances in this example, but as noted above, may be configured as any other intraoral appliance) may include capacitive touch sensor material. As shown in fig. 8C, the orthotic 890 comprises a formed surface of capacitive touch sensor material 893. Figure 8D shows an enlarged view of a grid pattern of capacitive touch sensors that may be distributed over the surface of the intraoral appliance of figure 8C.

Capacitive touch sensors can relate to the strength and location of the touch information and can derive forces (moments and force directions) from the intraoral appliance on the patient's teeth. In some variations, an appliance may include one or more processors for receiving touch information from a grid of capacitive sensors, and may correlate that information with the force applied by the appliance on the teeth. For example, using a digital model of the patient's teeth and/or appliances (as generally discussed above in fig. 3B), capacitive touch data may be associated with a particular tooth.

Fig. 9 illustrates a monitoring system 900 for detecting proximity between a patient's jaws, according to an embodiment. The system 900 includes a first appliance 902 worn on the patient's upper teeth and a second appliance 904 worn on the patient's lower teeth. The system 900 also includes a monitoring device that includes a first sensing subunit 906 (e.g., a first board) integrated with the first appliance 902, a second sensing subunit 908 (e.g., a second board) integrated with the second appliance 904, and a controller 910 integrated with the first appliance 902 and coupled to the first sensing subunit 906. Optionally, the controller 910 may be integrated with the second appliance 904 and coupled to the second sensing subunit 908. In some embodiments, the monitoring device is used to measure the capacitance and/or charge between the first sensing subunit 906 and the second sensing subunit 908, and the measurement data can be used to determine whether the patient's jaws are in proximity to each other.

Alternatively or in combination, the monitoring device may include one or more vibration sensors configured to generate sensor data indicative of intra-oral vibration patterns. Examples of vibration sensors include audio sensors (e.g., MEMS microphones), accelerometers, and piezoelectric sensors. The intra-oral vibration mode may be associated with one or more of: vibration, bruxism, speech, chewing, breathing or snoring transmitted to the patient's teeth via the patient's jaw. In some embodiments, the intra-oral vibration pattern is derived from sound received by the eardrum of the patient's ear. The mode of intraoral vibration may also result from intraoral activity, such as bruxism, speech, chewing, breathing, snoring, and the like. Sensor data generated by the vibration sensor may be processed to determine appliance usage and/or patient compliance. For example, the monitoring device may include a processor that compares the detected intraoral vibration pattern to a patient-specific intraoral vibration pattern to determine whether the appliance is worn on the patient's teeth. In some embodiments, the processor is trained using previous data of patient-specific intra-oral vibration patterns, and then determines whether the appliance is worn by matching the measured pattern to the previous pattern. Alternatively or in combination, appliance usage may be determined by comparing the measured vibration pattern with a vibration pattern obtained when the appliance is not being worn.

Alternatively or in combination, the monitoring device may comprise one or more optical sensors configured to detect the use of the appliance based on the optical signal. For example, the optical sensor may be a color sensor configured to detect the color of the intraoral tissue (e.g., a single channel color sensor, a multi-channel color sensor such as an RGB sensor). In some embodiments, one or more color sensors may be integrated into the intraoral appliance so as to be positioned adjacent to particular intraoral tissue (e.g., enamel, gums, cheeks, tongue, etc.) when the appliance is worn in the mouth. The device may determine whether the appliance is currently being worn based on whether the color detected by the sensor matches an expected color of the tissue. In such embodiments, the monitoring device may include one or more light sources (e.g., LEDs) that provide illumination for the color sensor.

As another example, the monitoring device may include one or more emitters (e.g., LEDs) configured to generate optical signals and one or more optical sensors (e.g., photodetectors) configured to measure optical signals. For example, the emitters may be positioned such that when the appliance is worn, the optical signals are reflected from a surface (e.g., intraoral tissue, a portion of an intraoral appliance) to reach the respective optical sensors. In some embodiments, when the appliance is not worn, the optical signal is not reflected and does not reach the optical sensor. Thus, activation of the optical sensor may indicate that the appliance is currently being worn.

Fig. 10A shows a monitoring device 1000 utilizing optical sensing according to an embodiment. The device 1000 includes an emitter 1002 and an optical sensor 1004 integrated into an intraoral appliance 1006. In the depicted embodiment, the emitter 1002 and the sensor 1004 are both located on a cheek face of the appliance 1006 such that when the appliance 1006 is worn, the light signal from the emitter 1002 reflects off the cheek 1008 of the patient to reach the sensor 1004. In an alternative embodiment, the emitter 1002 and sensor 1004 may be located on the lingual surface of the implement 1006 such that the optical signal from the emitter 1002 is reflected from the patient's tongue to reach the sensor 1004.

Fig. 10B shows a monitoring device 1020 using optical sensing according to an embodiment. The device 1020 includes an emitter 1022 and an optical sensor 1024 integrated into a first oral appliance 1026 worn on the jaw (e.g., upper or lower jaw) of the patient. The emitter 1022 and sensor 1024 may be arranged such that when the first and second appliances 1026, 1028 are worn, an optical signal from the emitter 1022 is reflected off of the second intraoral appliance 1028 worn on the opposing jaw of the patient to reach the sensor 1024. Optionally, the second appliance 1028 can include a surface 1030 having optical characteristics selected to enhance and/or control the reflection of the optical signal.

As another example, the emitter may be positioned such that when the appliance is worn, the optical signal is transmitted directly to the optical sensor without requiring any reflection from another surface. In some embodiments, the optical signal does not reach the optical sensor when the appliance is not worn. Thus, activation of the optical sensor may indicate that the appliance is currently being worn.

Fig. 10C illustrates a monitoring device 1040 using optical sensing, according to an embodiment. The device 1040 includes a transmitter 1042 integrated into a first intraoral appliance 1044 worn on a jaw (e.g., upper or lower jaw) of a patient and an optical sensor 1046 integrated into a second intraoral appliance 1048 worn on an opposite jaw of the patient. The emitter 1042 and the sensor 1046 may be arranged such that an optical signal from the emitter 1042 is transmitted directly to the sensor 1046 when the first and second appliances 1044, 1048 are worn. In yet another example, the emitter may be positioned such that the optical signal is obscured by intraoral tissue (e.g., the patient's tongue) when the appliance is worn. In some embodiments, when the appliance is not worn, the optical signal is not blocked and reaches the optical sensor (e.g., via direct transmission or reflection from a surface). Thus, activation of the optical sensor may indicate that the appliance is not currently being worn. Alternatively, the optical signal may be infrared light so as to be less noticeable to the patient.

Fig. 11A and 11B illustrate a monitoring device 1100 using optical sensing according to an embodiment. The device 1100 includes an emitter 1102 and an optical sensor 1104 integrated into an intraoral appliance 1106. The emitter 1102 and the sensor 1104 may be positioned on opposite sides of the lingual surface of the appliance 1106 such that the optical signal passes directly from the emitter 1102 to the sensor 1104 (fig. 11A) when the appliance 1106 is not worn. When the appliance 1106 is worn (fig. 11B), the patient's tongue 1108 may obscure transmission of optical signals between the emitter 1102 and the sensor 1104.

Fig. 11C and 11D illustrate a monitoring device 1120 using optical sensing, according to an embodiment. The apparatus 1120 includes an emitter 1122 and an optical sensor 1124 integrated into an intraoral appliance 1126. The emitter 1122 and sensor 1124 may be located on the same side as the lingual surface of the appliance 1126 such that when the appliance 1126 is not worn (fig. 11C), optical signals generated by the emitter 1122 reflect off of the opposite lingual surface 1128 to reach the sensor 1124. Optionally, the optical properties of surface 1128 may be selected to enhance and/or control the reflection of the optical signal. When the appliance 1126 is worn (fig. 11D), the patient's tongue 1130 may obscure the transmission of optical signals between the emitter 1122 and the sensor 1124.

Furthermore, the optical sensing-based monitoring devices described herein may also be configured to detect changes in reflected and/or transmitted optical signals caused by breathing, chewing, or other patient movement. This information can be used to further improve the reliability and accuracy of compliance monitoring based on optical sensing.

Alternatively or in combination, the monitoring device of the present disclosure may comprise one or more magnetic sensors configured to detect appliance usage based on changes in the magnetic field. Examples of magnetic sensors suitable for use with embodiments herein include magnetometers, hall effect sensors, reed switches, and magnetoresistive sensors. In some embodiments, the characteristics (e.g., magnitude, direction) of the magnetic field vary based on whether the appliance is currently being worn, e.g., due to interference from intraoral tissue such as teeth. Thus, the device may determine appliance usage by processing and analyzing the magnetic field detected by the magnetic sensor.

Fig. 12A and 12B illustrate a monitoring device 1200 using magnetic sensing according to an embodiment. The device 1200 includes a magnet 1202 coupled to an intraoral appliance 1206 and a sensing subunit 1204. For example, the appliance 1206 may include a housing having a tooth-receiving cavity, and the magnet 1202 and sensing subunit 1204 may be coupled to an outer surface of the tooth-receiving cavity. The sensing subunit 1204 includes one or more magnetic sensors 1208 (e.g., three magnetometers) configured to measure characteristics (e.g., magnetism, orientation) of a magnetic field generated by the magnet 1202. In some embodiments, when the appliance 1206 is worn by a patient, the teeth 1210 received in the cavity interfere with the magnetic field (fig. 12B) such that the field characteristics are different than when the appliance is not worn (fig. 12A). Monitoring device 1200 may include a processor (not shown) configured to determine whether an appliance is worn based on sensed data generated by magnetic sensor 1208.

Fig. 12C shows a monitoring device 1220 using magnetic sensing, according to an embodiment. The device 1220 includes a magnetic sensor 1222 (e.g., a hall effect sensor or a magneto-resistive sensor) integrated into a first oral appliance 1224 worn on the patient's jaw (e.g., upper or lower jaw). The magnetic sensor 1222 is used to detect a magnetic field generated by a magnet 1226 in a second intraoral appliance 1228 worn on the opposite jaw. In some embodiments, the characteristics of the magnetic field vary based on whether the first appliance 1224 and the second appliance 1228 are worn on the patient's teeth. Monitoring device 1220 may include a processor (not shown) configured to determine whether an appliance is worn based on sensed data generated by magnetic sensor 1222.

The magnetic sensing based monitoring device may include a ferromagnetic target (e.g., a metal plate) that changes the magnetic field characteristics when the appliance is worn. The ferromagnetic target may be integrated into an intraoral appliance or tooth-mounted attachment device, or may be an existing element in the oral cavity (e.g., a metal filler, an implant, etc.). The monitoring device may detect whether the patient is using the appliance by sensing a characteristic of the magnetic field and detecting whether a ferromagnetic target is present.

Fig. 13A shows a monitoring device 1300 using magnetic sensing according to an embodiment. The monitoring device 1300 includes a sensing subunit 1302 integrated into a first oral appliance 1304 worn on a patient's jaw (e.g., upper or lower jaw) and a ferromagnetic target 1306 (e.g., a metal plate) integrated into a second oral appliance 1308 worn on the patient's opposite jaw. The sensing subunit 1302 may include a magnet 1310 and a magnetic sensor 1312, the magnetic sensor 1312 detecting a magnetic field generated by the magnet 1310. In some embodiments, the presence of the ferromagnetic target 1306 changes the characteristics of the generated magnetic field when the first and second appliances 1304, 1308 are worn by the patient. The monitoring device 1300 may include a processor (not shown) configured to determine whether the appliance is worn based on the sensed data generated by the magnetic sensor 1312.

Fig. 13B illustrates a monitoring device 1320 using magnetic sensing, according to an embodiment. The monitoring device 1320 includes a sensing subunit 1322 integrated into an attachment device coupled to a tooth 1324 in a jaw (e.g., upper or lower jaw) of the patient and a ferromagnetic target 1326 (e.g., a metal plate) integrated into an intraoral appliance 1328 worn on the opposite jaw. Optionally, a second intraoral appliance 1329 including a cavity shaped to receive the teeth 1324 and sensing subunit 1322 may also be worn. Sensing subunit 1322 may include a magnet 1330 and a magnetic sensor 1332, the magnetic sensor 1332 detecting a magnetic field generated by magnet 1330. In some embodiments, the presence of the ferromagnetic target 1326 changes the characteristics of the generated magnetic field when the appliance 1328 is worn by the patient. The monitoring device 1320 may include a processor (not shown) configured to determine whether the appliance 1328 is worn based on the sensed data generated by the magnetic sensor 1332. Optionally, the processor and other components of the monitoring device 1320 may also be integrated into the attachment device. This implementation may reduce the cost of the apparatus 1320, as only the relatively low cost ferromagnetic targets will be replaced with each new appliance. Fig. 13C shows a monitoring device 1340 using magnetic sensing, according to an embodiment. The monitoring device 1340 includes a sensing subunit 1342 integrated into an attachment device coupled to teeth 1344 in a jaw (e.g., upper or lower jaw) of a patient and a ferromagnetic target 1346 (e.g., a metal plate) integrated into an intraoral appliance 1348 worn on the same jaw. The appliance 1348 may include a cavity shaped to receive a tooth 1344 and a sensing subunit 1342. The sensing subunit 1342 may include a magnet and a magnetic sensor that detects a magnetic field generated by the magnet. In some embodiments, the presence of the ferromagnetic target 1346 changes the characteristics of the generated magnetic field when the appliance 1348 is worn by the patient. The monitoring device 1340 may include a processor (not shown) configured to determine whether the instrument 1348 is worn based on the sensed data generated by the magnetic sensor. Optionally, the processor and other components of the monitoring device 1340 may also be integrated into the attachment device, thereby reducing costs when multiple appliances are used.

Alternatively or in combination, the monitoring device may use a magnet to directly activate the magnetic sensor. For example, the magnet may be attached to intraoral tissue, such as a tooth surface. The monitoring device may include a magnetic sensor (e.g., a magnetic reed sensor or switch) that is integrated into the intraoral appliance such that the magnet activates the sensor when the appliance is worn. In an alternative embodiment, the position of the magnet and magnetic sensor may be switched such that the magnetic sensor is attached to the intraoral tissue and the magnet is integrated into the appliance. Alternatively, the magnet may be integrated into a first oral appliance worn on the patient's jaw (e.g., upper or lower jaw), and the magnetic sensor may be integrated into a second oral appliance worn on the opposite jaw, such that the magnet activates the sensor when both appliances are worn.

Alternatively or in combination, the monitoring device may utilize two or more magnets that interact with each other (e.g., by applying a magnetic force to each other) and a sensor that detects the interaction between the magnets. For example, the sensor may be a mechanical switch coupled to the magnet and actuated by a magnetic force exerted on the magnet. As another example, the sensor may be configured to detect a characteristic (e.g., magnitude, direction) of a magnetic force exerted on the magnet by the other magnet. The magnet and sensor may each be independently integrated in the appliance or coupled to teeth or other intraoral tissue.

Fig. 14A and 14B illustrate a monitoring device 1400 using multiple magnets according to an embodiment. The device 1400 includes a sensing subunit 1402 integrated in a first oral appliance 1404 worn on the jaw (e.g., upper or lower jaw) of the patient. The sensing subunit includes a first magnet 1406 coupled to a force sensor 1408. A second magnet 1410 is integrated into a second intraoral appliance 1412 worn on the opposite jaw. The force sensor 1408 may measure a magnetic force between the first magnet 1406 and the second magnet 1410, which varies according to the distance between the magnets. The monitoring device 1400 may include a processor (not shown) configured to determine whether the appliance is worn based on the measured force. In some embodiments, the magnetic force may also be used to generate power for the monitoring device 1400.

Alternatively or in combination, the monitoring device of the present disclosure may comprise one or more force and/or pressure sensors for detecting use of the appliance. For example, the monitoring device may comprise a force-dependent and/or pressure-dependent resistive material, such as a membrane or sheet. The resistive material may be located between two thin electrodes in an intraoral appliance, and the resistance of the material may increase or decrease when a force and/or pressure is exerted on the material, for example, by interaction between the tooth and the appliance. Other types of force and/or pressure sensors include strain gauges and piezoelectric crystal type sensors. In some embodiments, the monitoring device determines whether the patient is wearing the appliance based on force and/or pressure measurements obtained by the force and/or pressure sensors. The measurement data may be indicative of a force and/or pressure between the appliance and one or more of the intraoral tissues, such as a patient's teeth. Optionally, the measurement data may be based on force and/or pressure between the appliance and one or more attachment devices mounted on the patient's teeth. The monitoring device may process the data to determine whether the measured force and/or pressure is within an expected range corresponding to the patient wearing the appliance.

The monitoring device may comprise a single force and/or pressure sensor, or a plurality of force and/or pressure sensors. The sensor may be positioned at any location in the appliance, such as the inner surface, the outer surface, the buccal surface, the lingual surface, the occlusal surface, the intermediate portion, the distal portion, the gingival portion, or a combination thereof. In some embodiments, the sensors are positioned proximate to certain teeth when the appliance is worn. In embodiments where the appliance is an orthodontic appliance, the sensor may be positioned near the tooth to be repositioned, such as in a location where the appliance is expected to apply a force to the tooth. For example, if the appliance is shaped to engage an attachment device mounted on a tooth in order to apply a force to the tooth, the force and/or pressure sensor may be located at or near the location of the engagement between the appliance and the attachment device.

Fig. 15 shows a monitoring device 1500 configured to measure force and/or pressure between an intraoral appliance 1502 and a patient's teeth according to an embodiment. The device 1500 includes a plurality of pressure and/or force sensors 1504 (e.g., pressure-dependent resistive films) electrically coupled (e.g., via a printed line 1505 or other connecting element) to a controller 1506. A plurality of pressure and/or force sensors 1504 may be patterned on the inner surface of the appliance 1502 to generate sensor data indicative of the pressure and/or force between the appliance 1502 and the patient's teeth. In some embodiments, the appliance 1502 includes a plurality of tooth-receiving cavities, and the pressure and/or force sensors 1504 are located on buccal, lingual, and/or occlusal surfaces of the cavities. Controller 1506 may include components configured to process sensor data to determine whether implement 1502 is worn (e.g., as previously described with respect to fig. 3). Optionally, the controller 1506 may include a wireless antenna 1508 for transmitting sensed data and/or processing results to a remote device, as described herein.

Fig. 16A and 16B illustrate a monitoring device 1600 configured to measure force and/or pressure between an intraoral appliance 1602 and one or more attachment devices 1604 on a patient's tooth 1606, according to an embodiment. The device 1600 includes a plurality of pressure and/or force sensors 1608 (e.g., pressure-dependent resistive films) electrically coupled to a controller 1610. A plurality of pressure and/or force sensors 1608 may be patterned on the inner surface of the appliance 1602 to generate sensor data indicative of pressure and/or force between the appliance 1602 and the attachment devices 1604 on the patient's teeth 1606. In some embodiments, the appliance 1602 includes a plurality of tooth-receiving cavities shaped with one or more receptacles 1612 to receive corresponding attachment devices 1604 on a patient's teeth, and the pressure sensors and/or force sensors 1608 may be positioned on an interior surface of the one or more receptacles 1612. The controller 1610 may include components configured to process the sensor data to determine whether the appliance 1602 is worn (e.g., as previously described with respect to fig. 3A).

Any of the apparatuses described herein (e.g., monitoring devices) may be configured to determine mechanical impedance of a tooth and/or an intraoral appliance. For example, any of the apparatuses described herein may be configured to derive the mechanical impedance of a tooth, a plurality or group of teeth, and/or an appliance. In general, mechanical resistance may refer to the resistance to motion given an applied force:

Z(w)＝F(w)/v(w)

Where F is force, v is velocity, and w is angular frequency.

Fig. 16C shows one example of a cross section through an intraoral appliance 977 (shown in this example as an appliance) that includes a motion sensor 971 (such as an accelerometer) and one or more force sensors 969, 969', 969 ″. Alternatively or additionally, one or more of the motion sensors and force sensors may be positioned directly on the teeth (including on attachments suitable for securing the intraoral appliance to the teeth) and may be in communication with a processor/analysis engine, battery, communication circuitry, etc. on the appliance.

The processor/analysis engine may then use the time-varying motion (e.g., acceleration) data (an example of which is shown in fig. 16D) and the corresponding time-varying force data (an example of which is shown in fig. 16E), and may correlate the data to estimate the mechanical impedance.

Alternatively or additionally, the system may estimate the mechanical impedance based on the under-damped second order system (e.g., as a logarithmic decrement of the under-damped second order system). In this case, the apparatus may be configured to measure a tooth (and/or appliance) response to a perturbing force, such as an input vibration or force applied to the tooth. For example, the device may be configured to measure a free-running vibrational response to a mechanical impulse input. The device may then determine the peak-to-peak attenuation of the under-damped oscillations and the period of the system; from these values, the device can then derive the damping natural frequency, natural frequency and damping ratio. In a second order system, these values may define the impedance.

For linear systems, the apparatus can fit the parameters of a parametric model of the mechanical impedance to the measured bode plot. For non-linear systems, the apparatus may analyze the non-linear system using a generalized frequency response function (e.g., forced vibration response, sinusoidal frequency sweep, etc., including machine learning).

For example, fig. 16F illustrates a side view of another example of an apparatus for measuring mechanical impedance of one or more teeth. In this example, a plurality of attachments 982 are used to secure orthodontic appliances (e.g., appliances 989) to the teeth. The appliance includes a processor 991, wireless communication circuitry, and may include additional hardware, software, and/or firmware for detecting sensor data to determine mechanical impedance of the tooth and/or the appliance. The accessory may include one or more sensors, including motion (e.g., accelerometers) and/or force sensors; these one or more sensors may communicate directly (e.g., via electrical contacts) with the processor 991 on the orthotic.

In fig. 16F, this configuration may be used as described above and/or may be used to determine the frequency response to the applied input signal. For example, any of these devices may include an actuator (e.g., a vibration motor, a micro-piston, etc.) for applying a vibration or force input to the teeth. The force applied by the actuator may be measured or estimated and used along with the detected response (e.g., motion/acceleration data). Alternatively, the device may take into account naturally occurring force inputs (e.g., chewing forces), and may measure or estimate them; as described above, one or more force sensors are used. The force data as well as the responsive movement/acceleration data can be used to determine mechanical impedance.

The resulting mechanical impedance data can then be used to assess the health of the tooth movement.

Alternatively or in combination, the monitoring devices described herein may include one or more gas flow sensors configured to detect whether an intraoral appliance is being worn based on intraoral gas flow. For example, the gas flow sensor may be a hot wire anemometer configured to measure gas flow associated with breathing, chewing, speech, snoring, or the like. Embodiments herein may also incorporate microfluidic-based gas flow sensors as desired. Optionally, the gas flow sensor may also be used to measure gas flow to determine whether the patient is experiencing a sleep apnea event. For example, the monitoring device may determine whether the measured airflow pattern is similar to the airflow pattern that occurs when the patient experiences sleep apnea. For example, the method may be used in embodiments where the intraoral appliance is a sleep apnea treatment appliance (e.g., a mandibular protrusion device). Fig. 17A illustrates a monitoring device 1700 that includes a gas flow sensor 1702 in accordance with an embodiment. The sensor 1702 is integrated into the intraoral appliance 1704. In some embodiments, a sensing portion (e.g., a wire or conductor) of the sensor 1702 extends from the instrument 1704 (e.g., the lingual surface) for exposure to the intraoral airflow. The sensed data obtained by the sensors 1702 may be processed and analyzed by other components of the monitoring device 1700 (e.g., the controller 1706) to determine appliance usage and/or whether the patient is experiencing a sleep apnea event.

Fig. 17B illustrates a monitoring device 1720 that includes a gas flow sensor 1722, according to an embodiment. Apparatus 1720 may be substantially similar to apparatus 1700, except that sensor 1722 extends through the opposite side of appliance 1724, such that the sensing portion is located near the middle of the intraoral airflow. Such an approach may provide improved sensing accuracy.

FIG. 17C illustrates a monitoring device 1740 including an airflow sensor 1742 according to an embodiment. The apparatus 1740 may be substantially similar to the apparatus 1720, except that the sensor 1742 extends from only one side of the instrument 1744. This approach may reduce patient discomfort.

Alternatively or in combination, the monitoring device may include one or more motion sensors configured to detect appliance usage based on movement of one or both of the patient's jaws. Examples of such motion sensors include accelerometers, gyroscopes, piezoelectric film vibration sensors, gravity sensors, and microwave transmitters and receivers. The motion sensors may be integrated into the intraoral appliance worn on the patient's upper or lower jaw, or may be distributed across the appliances worn on the upper jaw and the appliances worn on the lower jaw. In some embodiments, the motion sensor is configured to generate data representative of the patient's jaw movement pattern, and the monitoring device processes and analyzes the motion pattern (e.g., using power spectroscopy and/or kinematic analysis) to determine whether the pattern indicates that the appliance is being worn. Optionally, the monitoring device may distinguish jaw movement patterns associated with different oral activities (e.g., chewing, grinding, speech, etc.).

Fig. 18 shows a monitoring device 1800 using motion sensing according to an embodiment. The apparatus 1800 includes one or more motion sensors 1802 integrated into a first oral appliance 1804 worn over a jaw (e.g., upper or lower jaw) of a patient. In some embodiments, the motion sensor 1802 comprises one or more magnetometers that detect magnetic fields generated by a magnet 1806 integrated into a second intraoral appliance 1808 worn on the opposite jaw. For example, the device 1800 may include two multi-axis magnetometers for obtaining six-axis measurements of relative movement of the upper and lower jaws. In an alternative embodiment, rather than using the magnet 1806, the magnetometer 1802 can be used to measure the angle of the patient's jaw relative to the earth's magnetic field, and the angle data can be used to determine whether the appliance is being worn. The motion data generated by motion sensor 1802 may be used to track jaw motion patterns in order to determine whether the appliance is currently being worn. Other types of motion sensors 1802 may also be used, such as accelerometers, gravity sensors, gyroscopes, or microwave transmitters and receivers.

Alternatively or in combination, the monitoring device may include one or more temperature sensors, such as infrared radiation-based sensors that detect temperature, conductive thermistor-based sensors, and the like. The motion detector may determine appliance usage based on whether the measured temperature is within a body temperature range (e.g., mouth temperature). Optionally, the determination may involve comparing the measured temperature with ambient temperature measurements obtained when the appliance is not being worn. In some embodiments, the temperature data is recorded as raw temperature values. Alternatively, the temperature data may be recorded in binary form (e.g., whether the temperature is within the body temperature range), for example, to save storage space.

Alternatively or in combination, the monitoring device may include one or more strain gauges (e.g., resistance-based or MEMS-based) to detect stress and/or strain at one or more locations in the intraoral appliance. The monitoring device may determine whether the measured stress and/or strain values are within an expected range for use of the appliance. The monitoring device may store actual stress and/or strain values, or may store only binary data indicating whether the appliance is worn.

Alternatively or in combination, the monitoring device may include one or more pH sensors configured to measure the pH of a fluid (e.g., saliva) in the ambient environment. The monitoring device may determine whether the appliance is worn based on, for example, whether the measured pH value is within an expected pH range of human saliva.

Alternatively or in combination, the monitoring device may comprise one or more conductivity sensors configured to measure the conductivity of a fluid (e.g. saliva) in the surrounding environment. For example, the monitoring device may determine whether the appliance is worn based on whether the measured conductivity is within an expected range of human saliva. In some embodiments, the conductivity over a period of time may be measured. This approach may be used to prevent monitoring devices from being spoofed by immersion in saliva mimicking fluids, as the electrical conductivity of human saliva may change over time based on the physiological activity of the body.

Alternatively or in combination, the monitoring device may comprise one or more moisture sensors configured to detect contact with an intraoral fluid (e.g. saliva). For example, the monitoring device may determine whether the appliance is worn based on whether the measured humidity is within an expected humidity range of the oral cavity.

The monitoring devices described herein may be used in place of or in conjunction with a test instrument to measure health information of a patient. Such monitoring devices may include one or more physiological sensors, such as an electrocardiogram sensor, a bioimpedance sensor, a photoplethysmography sensor, a galvanic skin response sensor, or a combination thereof. For example, a photoplethysmographic sensor may be used to measure blood volume changes of tissues within a patient's mouth, such as the cheek or gums. As another example, a galvanic skin response sensor may be used to measure the electrical conductivity of the intraoral tissue, which may vary based on, for example, minerals released from the gland onto the external tissue surface. In some embodiments, the monitoring devices described herein are configured to distinguish between sensor data indicative of appliance usage and sensor data generated by other types of patient interactions with the appliance (e.g., the appliance is held in a patient's hand). This differentiation may be achieved by training the monitoring device to differentiate between data patterns indicative of appliance usage and data patterns resulting from other interactions, e.g., based on training data sets prior to actual patient monitoring and/or data generated during monitoring. Alternatively or in combination, the differentiation may also be performed by devices thereof other than the monitoring device, for example by an external processor performing post-processing on data obtained by the monitoring device.

Fig. 19 shows a method 1900 for monitoring use of an intraoral appliance, according to an embodiment. Method 1900 may be performed using any of the embodiments of the systems and apparatus described herein. In some embodiments, some or all of the steps are performed using a processor of a monitoring device operatively coupled to the intraoral appliance. Alternatively or in combination, some or all of the steps may be performed by a processor of a device external to the patient's mouth (e.g., a separate computing device or system).

In step 1910, sensor data is received from one or more sensors operably coupled to an intraoral appliance. The one or more sensors may include any of the sensor types described herein, including but not limited to: touch or tactile sensors (e.g., capacitive, resistive), proximity sensors, audio sensors (e.g., microelectromechanical system (MEMS) microphone), color sensors (e.g., RGB color sensors), electromagnetic sensors (e.g., reed sensors, magnetometers), optical sensors, force sensors (e.g., force dependent resistive materials), pressure sensors, temperature sensors, motion sensors (e.g., accelerometers, gyroscopes), vibration sensors, piezoelectric sensors, strain gauges, pH sensors, conductivity sensors, gas flow sensors, gas detection sensors, humidity or humidity sensitive sensors, physiological sensors (e.g., electrocardiogram sensors, bioimpedance sensors, photoplethysmography sensors, galvanic skin response sensors), or combinations thereof. The sensor may be physically integrated with (e.g., coupled to, embedded in, formed with, etc.) the intraoral appliance, or may be positioned in the oral cavity (e.g., attached to the teeth) so as to interact with the intraoral appliance. According to embodiments described herein, the sensor data may indicate whether the appliance is currently being worn in the mouth of the patient.

In step 1920, the sensor data is processed to determine whether the appliance is worn. For example, the processing step may include determining whether the sensor data matches a pattern and/or falls within a range of values indicating that the appliance is being worn. Alternatively or in combination, the processing step may comprise determining whether the sensor data differs from the pattern and/or lies outside a range of values indicating that the appliance is not being worn. Optionally, the processing step may include associating the sensor data with a timestamp indicating when the data was obtained so that appliance usage information over time can be determined. The processed sensor data may include appliance usage information indicating whether the appliance is currently being worn, a duration of device usage, and/or a time of day when the appliance was used. In some embodiments, step 1920 can alternatively or additionally include processing the sensor data to determine patient health information, as discussed herein.

In step 1930, the sensor data generated in step 1910 and/or the processed sensor data generated in step 1920 are optionally sent to a remote device. The remote device may be a mobile device (e.g., a smartphone), a personal computer, a laptop computer, a tablet, a wearable device, a cloud computing server, and so forth. Step 1930 may be performed using wireless or wired communication methods as desired. Step 1930 can be performed automatically (e.g., at predetermined time intervals) or in response to instructions received from a remote device (e.g., commands to transmit sensor data and/or appliance usage).

The monitoring devices described herein may be physically integrated into an intraoral appliance in various ways. In some embodiments, the monitoring device is integrated into the appliance during or after manufacture of the appliance. For example, after the appliance has been manufactured, the monitoring device may be attached to the appliance using an adhesive, a fastener, a latching mechanism, or a combination thereof. Optionally, the instrument may be formed with complementary features or structures (e.g., recesses, receptacles, guides, apertures, etc.) shaped to receive and house the monitoring device or components thereof.

In some embodiments, the monitoring device is coupled to the appliance as a pre-fabricated unit during or after the appliance manufacturing process, such as by being inserted and sealed into a receptacle in the appliance, attached to the appliance (e.g., by a latching mechanism, adhesive, fastener). Alternatively, the monitoring device may be assembled in situ on the appliance during or after manufacture of the appliance. For example, in embodiments where the appliance is manufactured by direct manufacturing (e.g., 3D printing), the monitoring device may be printed, inserted into the appliance, simultaneously with the appliance, either during manufacturing or after the assembled appliance has been manufactured. Alternatively, some of the monitoring device components may be prefabricated and others may be assembled in situ. It should be appreciated that the various manufacturing methods described herein may be combined in various ways to make an appliance with an integrated monitoring device assembly.

Fig. 20A-20D illustrate a method for manufacturing an intraoral appliance with an integrated monitoring device according to an embodiment. The method may be applied to any of the embodiments of monitoring devices and appliances described herein, and may be used in combination with any of the other manufacturing methods described herein. In a first step (fig. 20A (top view) and 20B (side view)), a prefabricated monitoring device 2000 is coupled to a positive model (positive model)2002 of the patient's dentition. For example, the monitoring device 2000 may be attached using adhesives and/or mechanical fasteners. Alternatively, the monitoring device 2000 may be hermetically sealed prior to attachment to the model 2002. In a second step (fig. 20C), material is formed (e.g., thermoformed) over the monitoring device 2000 and the mold 2002 to fabricate the appliance housing 2004. In a third step (fig. 20D), the mold 2002 is removed, thereby creating a device housing 2004 with an embedded monitoring device 2000. Alternatively, the monitoring device 2000 may be encapsulated using a biocompatible adhesive 2006 (e.g., a UV cured glue), a layer of material, or other sealing element.

Fig. 21A-21C illustrate a method for manufacturing an intraoral appliance with an integrated monitoring device according to an embodiment. The method may be applied to any of the embodiments of monitoring devices and appliances described herein, and may be used in combination with any of the other manufacturing methods described herein. In a first step (fig. 21A), an appliance 2100 is formed (e.g., thermoformed) over a positive model 2102 of a patient's dentition. In a second step (fig. 21B), prefabricated monitoring device 2104 is attached to appliance 2100, for example using adhesive layer 2106 and/or fasteners, and thermoplastic material 2108 is attached to the outer surface of monitoring device 2104. In a third step (fig. 21C), thermoplastic material 2108 is thermoformed to form a cover that encapsulates monitoring device 2104 into appliance 2100. The positive model 2102 may be removed, for example, before or after the third step.

Alternatively or in combination, the method can include forming a positive geometry (e.g., by 3D printing, CNC milling, etc.) that corresponds to the geometry of the monitoring device 2104 on the positive model 2102 such that the appliance 2100 is thermoformed with a receptacle for the monitoring device 2104. The monitoring device 2104 may then be placed and sealed into the receptacle.

Alternatively or in combination, an intraoral appliance with an integrated monitoring device may be made by manufacturing the appliance (e.g., by indirect or direct manufacturing), and then attaching a pre-fabricated monitoring device to the manufactured appliance, for example, using adhesives, fasteners, locking mechanisms, and the like. Optionally, the monitoring device may be hermetically sealed (e.g., by molding) prior to attachment to the appliance.

Alternatively or in combination, an intraoral appliance with an integrated monitoring device may be manufactured by coupling the flexible and/or printed components of the monitoring device to the appliance during or after formation of the appliance. The components may be coupled in various ways, such as thermoforming, lamination, adhesives, coatings, and the like.

Alternatively or in combination, an intraoral appliance with an integrated monitoring device may be manufactured by 3D printing a base for the monitoring device and then building the electronic components for the monitoring device onto the base. In some embodiments, the base is shaped to conform to the geometry of the tooth-receiving cavity and/or the target tooth in which the monitoring device is to be positioned. The 3D printed portion of the monitoring device may be shaped flush with the surface of the appliance to facilitate integration of the monitoring device with the appliance. Alternatively or in combination, an intraoral appliance with an integrated monitoring device can be fabricated by etching the surface of the appliance (e.g., using a masking process) and then depositing conductive ink, stretchable material, etc. onto the etched portion to establish the electronic components (e.g., wires, connectors, electrodes, etc.) of the monitoring device on the appliance.

FIG. 22 is a simplified block diagram of a data processing system 2200 that may be used to perform the methods and processes described herein. The data processing system 2200 typically includes at least one processor 2202 that communicates with one or more peripheral devices via a bus subsystem 2204. These peripheral devices typically include a storage subsystem 2206 (memory subsystem 2208 and file storage subsystem 2214), a set of user interface input and output devices 2218, and an interface to an external network 2216. This interface is schematically illustrated as a "network interface" block 2216 and is coupled to corresponding interface devices in other data processing systems via communications network interface 2224. Data processing system 2200 may include, for example, one or more computers, such as personal computers, workstations, mainframes, laptops, and the like.

The user interface input devices 2218 are not limited to any particular device and may generally include, for example, a keyboard, pointing device (pointing device), mouse, scanner, interactive display, touch pad, joystick, or the like. Similarly, various user interface output devices can be used in the systems of the present disclosure and can include, for example, one or more of a printer, a display (e.g., visual, non-visual) system/subsystem, a controller, a projection device, an audio output, and so forth. Storage subsystem 2206 maintains the basic required programming, including computer-readable media having instructions (e.g., operational instructions, etc.) and data structures. Program modules discussed herein are typically stored in storage subsystem 2206. Storage subsystem 2206 generally includes a memory subsystem 2208 and a file storage subsystem 2214. Memory subsystem 2208 typically includes a number of memories (e.g., RAM 2210, ROM 2212, etc.), including a computer readable memory for storing fixed instructions, and data during program execution, a basic input/output system, etc. File storage subsystem 2214 provides persistent (non-volatile) storage for program and data files, and may include one or more removable or fixed drives or media, hard disks, floppy disks, CD-ROMs, DVDs, optical drives, and the like. One or more of the storage systems, drives, etc. may be located at remote locations, so coupled via a server on a network or via the internet/world wide web. In this case, the term "bus subsystem" is used generically to include any mechanism for bringing the various components and subsystems into communication with one another as intended, and may include various suitable components/systems that would be recognized or deemed suitable for use herein. It will be appreciated that the various components of the system may be, but are not necessarily, at the same physical location, but may be connected via various local or wide area network media, transmission systems, and the like.

Scanner 2220 includes any means for obtaining a digital representation (e.g., an image, surface topology data, etc.) of a patient's teeth (e.g., by scanning a physical model of the teeth, such as cast 2221, by scanning impressions obtained from the teeth, or by directly scanning the oral cavity), which may be obtained from the patient or from a treatment professional, such as an odontoscope, and includes means for providing the digital representation to data processing system 2200 for further processing. Scanner 2220 may be located at a remote location relative to the other components of the system and may transmit image data and/or information to data processing system 2200, for example, via network interface 2224. The manufacturing system 2222 manufactures the appliance 2223 based on a treatment plan including data set information received from the data processing system 2200. The manufacturing machine 2222 may, for example, be located at a remote location and receive data set information from the data processing system 2200 via the network interface 2224.

Examples of the invention

Any of the monitoring devices described herein, which may be referred to as ECIs and/or data loggers, may be connected wirelessly or by wires ("wired connection"), or both. For example, when using wired communication with a monitoring device, the device may be connected via one or more pins/contacts on an outer surface of the device, whether while wearing and/or attaching to an orthodontic appliance (such as an appliance), or after removal from the appliance. Data communication with the monitoring device may be achieved via a reader having one or more mechanical probes that may act as electrical contacts to electrodes/pads (pads) in or on the monitoring device. For example, the probe may be located in a housing or shell for holding an appliance, which may then communicate separately with a handheld electronic device (such as a smartphone) via bluetooth. Thus, for example, the monitoring device may be connected to the housing via a wired connection, and the housing may then transmit the data (raw or unmodified data or modified, analyzed, and/or formatted data) to a separate handheld device, such as a smartphone.

The monitoring device may include one or more (e.g., a plurality of) connection pads, which may be encapsulated in a self-healing polymer, which opens upon insertion of the probe and retracts to an original shape after removal of the probe, thereby providing a water-tight seal. Alternatively or additionally, the connection pads may be exposed outside of the ECI, but grounded/disabled when the appliance and/or ECI is in the mouth or in contact with water/saliva. Upon powering up the reader probe, the ECI pad may be switched to a communication mode.

Any of the monitoring devices described herein may also be configured to be stored in an inactive configuration, in which some or all of the internal contacts are disabled (e.g., by physically disconnecting, clearance, pins, barriers, etc. disabling the connection between the battery and the processor or other components), which may be removed manually or automatically (e.g., connecting/reconnecting the power source to the circuitry) prior to use, including prior to removal from the housing or packaging, prior to insertion of the apparatus into the mouth of a subject, prior to connection of the monitoring device to a dental appliance, etc. For example, the device may include mechanical activation of the monitoring device via removal of a tiny pin.

In any of the ECI devices described herein, a mechanical activation/deactivation connection as described above may be used. Any of these ECIs (e.g., "dataloggers") may be configured for wired (direct mechanical/electrical) connection with a reader. The ECI may include internal circuitry (e.g., an ASIC and/or any of the above) one or more sensors, memory, etc.) and a battery that is packaged or at least partially packaged in a housing. A plurality of data pads may be present on the exterior of the housing so that electrical connections can be made to the internal circuitry. As described above, the entire apparatus including the pad may be covered by a protective elastomer (e.g., a self-healing elastomer). The elastomer may be any suitable material, typically a biocompatible, electrically insulating material, which is self-healing or self-sealing after penetration.

Monitoring device (ECI) operation may be initiated by a user, such as a patient, dental technician, or the like, including mechanical activation using pins, rods, or the like. For example, the user may remove the activation lever prior to using the ECI. When in place, the lever may break the connection between the battery and the circuit, ensuring zero current for the ECI circuit (e.g., ASIC). When the activation lever is removed, the battery may be connected to the ECI ASIC, initiating a data recording sequence. During operation, the ECI ASIC may acquire raw sensor data, as described above. For example, the device may take raw capacitance and temperature data at 10 minute intervals and store each sample in memory (e.g., EEPPROM). The sampling interval may be counted as a separate event, converted by the intermediate interface device to the desired time interval display format. Thus, by eliminating the need for a real-time clock and associated EEPROM memory, any of the devices described herein may have a reduced size/footprint (footprint). The ECI may include an outer shell (packaging) composed of a rigid material that holds the internal circuitry and battery portions of the assembly, and may also include an elastomeric coating on the outer shell and the data pads. Data may be retrieved from the device even when the battery is completely depleted, such as if the patient fails to deliver an ECI back to a dental professional (e.g., orthodontist) within the life of the small battery. As an alternative variant, the operation of the mechanical actuation mechanism may be reversed from that described above, such that the ECI device is activated by insertion rather than removal of an activation rod, pin, or the like.

In other variations, a similar mechanical control or switch may be provided by including a spring contact held open by a magnetic field rather than using an activation lever/pin. In this example, the device may be activated by removing it from the packaging; zero current flow in the circuit is also ensured when a permanent magnet in the package (e.g., built into the package/housing) may hold the spring contact away from the circuit, disconnecting the battery from the rest of the circuit (e.g., ASIC), disconnecting the connection between the battery and the rest of the circuit. Removing the device from the package may allow the spring contacts to close, activating a data recording sequence so that the device can acquire data (e.g., capacitance and/or temperature data at consecutive 10 minute intervals and store the data in memory for later reading from the data pad).

Although mechanical activation may be used in the context of devices having data contact pads for wired connections, any of those devices including those configured for wireless operation may be configured for mechanical activation.

Further, any of the ECI devices described herein may be configured to be inserted/connected to an orthodontic appliance (such as an appliance) by a user or dental professional. For example, figure 24 illustrates an example of an ECI device 2500 that may be inserted into an appliance 2502. In this case, the illustrated ECI devices are configured for wired connection (via pad 2507), however wireless ECI devices may be similarly configured for connection to the orthotic 2502. Thus, as described above, the orthotic may include one or more retaining features (retaining features), including a pin 2503, as shown in fig. 24. In some variations, a retention feature on the orthotic may enable a mechanical connection between the battery and the circuit. In some variations, the pin may be connected to one or more sensors on the orthotic. The pins may penetrate the molding material that may be present on any variation, including wireless and wired connection devices.

As described above, data may be retrieved from any of these devices using an intermediate interface device such as a housing or shell. When the ECI apparatus is configured for wired connections, the intermediate device may be equipped with sharp probes to penetrate through the mold elastomer (over mold elastomer) and make electrical contact with any data pads on the PCB. The intermediate device may then retrieve, process, calibrate and encrypt the data as needed, and then transmit to a handheld device such as a smartphone, for example, via bluetooth. The data may then be displayed on a smart phone or other display medium using custom application software that the patient and/or orthodontist may be able to download for execution on the smart phone or other mobile device.

In any of the variations described herein, the same pin may be used for connection and as a conductivity sensing probe for detection of salivary media.

Although fig. 24 and 25 show the connection pads covered by the over-mold material, the connection pads may be exposed in some variations. For example, the connection pads may be exposed outside of the ECI, but grounded/disabled when the appliance and ECI are in the user's mouth or in contact with water/saliva. When the reader probe is powered on, the ECI pads may switch to a communication mode during which data may be transmitted.

Any of the devices described herein may also or alternatively be connected by a wireless connection. Fig. 25 shows one example of a prototype of an ECI constructed as described herein, including one or more temperature and capacitance sensors. In this example, the ECI 2603 is connected to an orthotic (shell 2601). In fig. 25, the prototype is relatively large; for example, by reducing the size of the processor, sensors, and other internal components, it may actually be much smaller. For example, the prototype shown in fig. 25 may include a Texas Instruments FDC1004 capacitance-to-digital converter (footprint 10x8 mm); this footprint may be significantly reduced in size, for example, using QFN instead of SOP packages. The data logger may comprise an on-chip temperature sensing data logger (e.g. of the NFC type, such as a THOR data logger). The exemplary prototype shown in fig. 25 may be wirelessly connected to an intermediate device and may thus be a handheld electronic device such as a smartphone.

In any of the devices described herein, the ECI may include a capacitive sensor that may be configured to accurately determine when the device is present on the tooth/teeth, rather than outside the mouth, even when immersed in water or other material that mimics saliva. For example, a prototype such as that shown in fig. 25 is used as a proof of concept to show that capacitive data can be used to determine when an oral appliance is present in a user's mouth, rather than merely being submerged (or outside the mouth). In fig. 26, the capacitance (and temperature) was recorded every 5 minutes using the apparatus of fig. 25 for fifty-four hours while subjecting the apparatus to different conditions and observing the capacitance. As shown, the device is able to distinguish between being worn ("touched" 2703) and being submerged in saline ("submerged 2705"). As described above, the capacitive sensor configuration may be configured as a mutual capacitance measurement or a self-capacitance measurement (see, e.g., the left and right diagrams of fig. 27, respectively). The capacitive sensor may saturate, but using the appropriate frequency range and/or ground size may allow the capacitive detector circuit to distinguish between saturation due to saturation in the mouth and saturation due to immersion in the fluid.

For example, fig. 28 and 29A-29B illustrate one example of an ECI configured to distinguish between other conditions worn and otherwise likely to provide a capacitance signal similar to that provided when in a fluid solution rather than worn. In fig. 28, the ECI 2901 is shown worn on a subject's teeth 2905 as part of an appliance 2903. The appliance in this case is shown with two sensing electrodes (a and B). The first electrode (a) is configured to be proximate to a crown of a tooth when the appliance is worn. The second (B) is configured to be "distal" to the crown when worn. FIG. 29A shows a schematic of an ECI including A and B sense electrodes. Fig. 29B shows how the capacitance signals from these sensing electrodes can be used to distinguish when the device is actually worn in the mouth from when the ECI is outside the mouth or submerged in a saliva-like environment. Logic for distinguishing between these conditions may be used to determine a more accurate "worn" or "unworn" metric (e.g., from application software running on a smartphone, etc.) that may be output by the ECI or by software/firmware/hardware in communication with the ECI. In fig. 29B, the signal from the a-touch sensor is shown aligned with the signal from the B-touch sensor. In this case, three conditions are shown, as well as a coarse signal amplitude. When ECI is out of the mouth, the signal on the A sense electrode is low; similarly, the signal on the B sense electrode is low. When the device is worn as shown in fig. 28, the signal on the a sensing electrodes is high (greater than the threshold amount ACR) and the signal on the B sensing electrodes is higher than when out of the mouth but below the threshold (BCR). However, when the device is submerged in water, the signals on both the a and B sense electrodes are high, above the ACR and BCR thresholds. Thus, by rejecting readings when a > ACR and B > BCR are false positives, the device can distinguish between intraoral, extraoral and submerged conditions. When both a and B are below their thresholds, the device is out of the mouth, and when the a signal is above the threshold but the B signal is below the threshold, the device may be determined to be in the user's mouth.

Fig. 30A-30C illustrate another example of a method for distinguishing between these conditions (intraoral, extraoral, and submerged). In this example, the apparatus may again include a pair of sensing electrodes "a" 3001 and "B" 3003, however they are located on either side of the tooth on the appliance and a complex impedance measurement Z between them may be taken. This "guard" electrode configuration can use short detection pulses to distinguish false positive readings. The signal may be used in conjunction with proximity sensing to increase the specificity of detection. The placement of the sensing electrodes may be optimized to minimize the likelihood of false negatives (e.g., saliva shorts). For example, the electrodes may be placed at the ends of the arch, as shown in fig. 30C. In this configuration, the complex impedance Z may be 0 when the electrode is placed in water rather than against a tooth. As shown in fig. 30D, when the proximity sensor shows that the actual capacitance is low, the device is out of the mouth; when the proximity sensor shows a high or medium height capacitance and the complex impedance measurements are low, the device may be submerged in a solution (e.g., water), and thus these measurements may be rejected as false positives.

When an ECI device described herein wirelessly transmits data (e.g., data output) to a handheld device such as a smartphone, an intermediary device such as a housing or case (container) may hold only an ECI module or device, and/or it may hold the ECI device and an appliance (such as an appliance) to which the ECI device is attached. Fig. 31A-31D show one example of a case acting as an intermediary, receiving near field communication signals from an ECI module and sending these signals over bluetooth to a smartphone or other handheld device. Because of the relatively small size of the ECI devices, any antenna assembly used to wirelessly transmit signals must also be small; this may lead to problems with direct communication with the smart phone or other device, as it may be difficult to align the antenna of the ECI device with the antenna of the smart phone or other handheld electronic device. In this case, a housing or holder such as that shown and described in fig. 31A-31D may be used to securely hold the appliance and the ECI and transfer any data recorded by the ECI from the ECI to the housing and then to a mobile device such as a smartphone, first transferring the data from the ECI to the middle housing as NFC and then from the middle housing to the smartphone as BLE. A housing or other intermediary device may hold the ECI in a predetermined position, including alignment with one or more antennas. Note that data may be transmitted in a continuous manner or sequentially between the ECI, the case, and the mobile device (e.g., delayed transmission between the case and the mobile device); delaying transmission may help determine when a receiving device (e.g., a mobile device) is ready to receive data, and an intermediary device may remain on the data until the receiving device indicates its readiness. In fig. 31A, the orthotic 3103 is fitted into the housing 3101 such that the ECI 3105 is aligned with the reader antenna 3107 for reliable transmission via NFC. An intermediary device such as a housing may be passive (e.g., communicating data) or it may be active, e.g., modifying, filtering, annotating, analyzing, averaging, etc., data.

Generally, when the ECI device is configured to wirelessly communicate data, the near field communication antenna (NFC antenna) may be a planar antenna, such as an on-board antenna, and/or it may be a coil antenna. Fig. 34A and 34B illustrate a planar (on-board) antenna and the transmission of data by a user of such an antenna from an appliance containing an ECI data recorder. In fig. 34A, an on-board antenna is formed on a substrate (e.g., a PCB substrate) and forms a loop 3404 (or multiple loops) and is connected to an antenna circuit 3402. The on-board antenna generates a field substantially transverse to the plane of the substrate. In fig. 34B, the braces 3407 may be aligned with the attached ECI 3406 adjacent to the antenna loop 3404. In fig. 34B, two separate NFC antennas are shown in an alternative view of the ECI. On the top, the ECI antenna is a coil antenna 3411; the antenna in the lower ECI is an on-board antenna 3413.

Fig. 35A shows an enlarged view of a general coil antenna (e.g., a coil wound around a ferrite rod) that may be used for NFC; fig. 35B shows an example of an ECI and a reader both using a coil antenna. In fig. 35B, the ECI antenna 3505 includes a ferrite core as does a coil antenna on the reader 3507. Any of the readers (including intermediate devices such as holders, etc.) may use any suitable antenna, including coil antennas and on-board antennas. In fig. 34B and 35B, the reader may be used while the appliance (shown as an orthotic) is attached to the ECI.

As noted above, there is often a size difference between NFC antennas in ECI devices and antennas in telephones (e.g., smart phones) and other handheld electronic devices. Thus, the energy transfer efficiency between a relatively large NFC loop antenna, such as may be present in a smart phone, and a much smaller ECI loop antenna (e.g., typically only tooth wide) can be very low, including less than 1% due to antenna size mismatch. Accordingly, it may be beneficial to use an energy coupler that is included as part of an intermediate device (e.g., a booster, etc.), which may be configured as a housing, stand, support, or other apparatus. Fig. 36A-36C illustrate a passive NFC energy coupler 3603 that can be used. In fig. 36A, a circuit diagram illustrates the use of an NFC coupler 3603 between an NFC antenna 3601 of an ECI device and an antenna of a smartphone 3605. Any suitable antenna may be used as part of the NFC coupler, including a toroidal coil ferrite coupler 3607 with an air gap 3609 in the ferrite core, as shown in fig. 36B; the ECI (or NFC antenna of the ECI) may be placed within the air gap. Fig. 36C shows the overall system coupling prediction using the NFC coupler.

Fig. 37A and 37B illustrate the use of NFC-to-NFC coupler prototypes that can be used as an intermediary. As shown in fig. 37A, an ECI device (shown schematically with a coil antenna) 3701 is located within range of an NFC antenna 3703, which in this example is shown with an air gap and ferrite coil (e.g., a 6mm loop antenna). The signal received from the NFC antenna is then retransmitted using the second antenna 3705 of the NFC coupler for transmission by NFC to the phone 3707 placed within range of the second larger antenna 3711. As will be described in fig. 39, the first antenna may be matched to an ECI antenna and the second antenna may be matched to an antenna in the phone. Further, the NFC coupler device may provide alignment between the phone antenna and the second antenna 3711 and the ECI antenna and the first antenna, and may securely hold the phone and/or ECI in this position. The prototype shown in fig. 37B also includes an indication that additional circuitry (e.g., amplifiers, filters, etc.) 3413 may be used to modify the data signals received from the ECI before they are passed to the phone. In general, any signal processing may be performed at this stage, or the signal may simply be passed on. In one example, a 3dB attenuator is located between the first antenna 3703 and the second antenna 3711.

Fig. 38 shows a prototype of an NFC coupler similar to that shown schematically in fig. 37A and 37B. In fig. 38, the orthotic with the ECI is placed over the NFC coupler such that the ECI antenna is aligned with the NFC antenna of the NFC coupler (not visible in fig. 38). A phone that receives signals passing over the NFC coupler is located over the phone antenna area of the NFC coupler. Fig. 39 shows a schematic circuit diagram of the device of fig. 38. In this example, a pair of shunts (C1, C2) and a series of capacitors (C3, C4) convert the inductive impedance of the two NFC coupler coils to a resistive impedance at the center of the circuit, largely eliminating impedance mismatch losses in the system.

In addition to transferring data from the ECI through an intermediary device (such as a housing or other relay device), in some variations, the ECI may be configured (in some variations, in combination with other system components, including hardware, software, and/or firmware) for transferring data directly from the ECI to a mobile handset, such as a smartphone (e.g., NFC to NFC communications, or alternatively NFC to bluetooth or other wireless protocol). For example, fig. 32 shows a first example of a system for sending data directly from an ECI to a mobile handset. In fig. 32, a mark or guide (e.g., sticker, decal, phone cover/housing, sleeve, etc.) may indicate a location 3201 or place for placing an ECI or orthotic/appliance on a phone 3203 to reliably transfer data from an ECI device to a smartphone (e.g., via NFC). In fig. 32, the guide mark is a part of the decal 3205.

In some variations, application software on the mobile device (e.g., phone) may also provide guidance for the alignment of the ECI, including on-screen indications where the ECI equipment and/or appliances and ECI are placed. The software may also indicate when the ECI is in good alignment, either visually, audibly, or both, allowing the user to correct/adjust the alignment. For example, fig. 33A illustrates another example of direct communication between an ECI and a smartphone. In this example, the application software for data transfer from the ECI to the phone 3301 indicates where to locate the ECI by displaying an alignment area 3303 on the screen of the phone. In fig. 33B-33C, additional supports or interfaces 3305 are shown that hold the ECI securely on the phone, and fig. 33C shows the use of support 3305 to hold the ECI on the best target for data transfer. In this example, the data receiver is a mobile/handheld device (e.g., a smartphone) that can help align the ECI to transfer data, as in fig. 33B and 33C. In these illustrations, a screen of the mobile device displays a target that can indicate the location of placement of the ECI relative to the mobile device for optimal communication between an antenna (e.g., such as an NFC antenna) in the smartphone and the ECI. In this example, a target (which is drawn as a bullseye, but may be any marker or indicator 3303) is displayed on the screen, and the user may manually align the target matching portion of the "clip" 3305 for locating the opposite side of the target 3303. This allows the ECI attached to or on the clip (see top of FIG. 33C) to maintain optimal alignment. The mobile device may determine the location of the target 3303 based on one or more criteria, including hardware (e.g., mobile device) configuration, model, etc., such as the known location of the antenna within a particular make and model of device, which may be determined by the application method (e.g., software) operating the mobile device (shown in fig. 33B and 33C as the "find my antenna" application method). In some variations, the application method may calculate the target 3303 position based on feedback between the receiver (mobile device) antenna and the ECI device.

Other alignment mechanisms and techniques may also be used to align and/or maintain the ECI devices in communication with the phone for wireless transmission of data from the ECI to the smartphone. For example, in some variations, magnetic forces may be used to attract the ECI to the target location. Other mechanical alignment mechanisms may be used to secure the ECI device in alignment with the antenna area of the phone. For example, a phone housing or cover (e.g., sleeve) that includes a depressed/retained area for aligning the ECI with the phone's antenna may be used. In some variations, the mount/cover/sleeve may include one or more pins to hold the ECI equipment in place.

As noted above, any of the apparatuses (including systems) described herein may communicate with a smartphone (or other handheld electronic device) via control software running on such a smartphone. The application software may interface with the electronic compliance indicator and may enhance wireless communication between the Electronic Compliance Indicator (ECI) using NFC and BLE protocols. The application may supplement or augment the ECI by incorporating mechanisms (e.g., stimulation, gaming, etc.) to encourage compliance, and may also provide data processing, visualization, and/or data sharing from the ECI. An ECI device may typically record sensor data from a patient wearing an orthodontic appliance, such as an appliance. The data may be stored in physical memory on the ECI and retrieved by another device, for example using NFC and BLE technology (or NFC and NFC) as described above, so that the smartphone can retrieve the data. A smartphone application (app) may be composed of several components, some of which are described in fig. 41, 42, and 43. For example, NFC/BLE communication control is schematically illustrated in fig. 41. In addition, fig. 44, 45 and 46 schematically show the operating state of the ECI device, and the control of communication between the device and a remote processor (e.g., a smartphone).

Processing wireless communications and data transfers with the ECI may be coordinated by application software. The application may publish events to other elements that may include the application, such as: a home screen or User Interface (UI) manager that may respond to an event (e.g., an "activate card" event, as shown in fig. 41-42, when the ECI is first opened and a confirmation return is received) to provide a notification to the user or to initiate a welcome or instruction screen; and/or a data analysis manager capable of responding to a data transfer (e.g., "upload successful" in fig. 43) event. The application software may generate a display including graphics and may look for patterns in the data to improve the accuracy/specificity/sensitivity of the compliance data. It may issue events such as "low compliance", "high compliance", etc. Referring to, for example, fig. 40 (middle), a user interface for an exemplary application software including intelligent compliance monitoring is shown.

Some components of the application software may not exist or run locally (on the smartphone) but may run on a remote server. For example, the data history and data analysis may be hosted on a remote server. In this case, the application may also have components to upload and download data to and from the server.

The application software may assist the user in managing the operation of the appliance and/or the ECI on the appliance, including start/stop timing/sensing/recording, and/or transferring data to/from the ECI, activating/deactivating the ECI, etc. Events published according to normal use can be used to supplement or augment the ECI system from application software. For example, the application software may manage notifications or reminders related to appliances and/or ECIs and/or may respond to an event (e.g., an "activate card" event) by starting a timer that may issue another event when it expires. One possible response to the event may be to push a notification to the user to remind the user to connect the ECI device to the phone. The notification may be an alarm, email, short message, etc. The service may also respond to "low compliance" by notifying other connected users (e.g., parents or doctors).

The application software may also coordinate the stimulation system in response to specific events related to wearing/using the orthodontic appliance described herein. For example, the application software may include or operate a game with virtual rewards (e.g., coins, trophies, RPG element "escalation"/promoting your smile, credits, etc.), monetary rewards (e.g., discounts, coupons, gift cards, etc.), and/or incentive information. For example, when an "activate card" event occurs, output- > "you activate your first orthotic! You are happy with a healthy smile in your way ". After the download event, a specific message may be displayed or transmitted to the user based on the data, such as, "wear your orthotic this week well", "only 2 more orthotics are needed! "and the like.

Fig. 42 shows a potential flow diagram of application software for controlling NFC as described herein, including detecting ECI. FIG. 43 shows a potential control diagram of application software for controlling data processing.

An example of the operational status for an ECI device is shown in FIG. 44, illustrating the interaction of communications between the device (e.g., an appliance with a monitoring sensor, as shown in the ECI) and a remote processor such as a smart phone. In fig. 44, the device transitions between various power down and recording states in which NFC is active or removed. Other possible states may include activity patterns in which logging is completed, and activity patterns with real-time measurements.

FIG. 45 illustrates management of communications by a receiving processor (such as a smartphone) on which control logic (e.g., software) operates; fig. 45 shows one example of how a phone/receiver application may behave and interact. For example, in figure 45, the smart phone may switch between waiting for BLE pairing, waiting for NFC and attempting to download, or waiting for NFC and attempting to download depending on the state of communication between the smart phone and the orthodontic appliance with the sensor (e.g., ECI). A communication manager (e.g., software/firmware on a smartphone) may be responsible for managing BLE or NFC-only communications. It may publish an event so that an external component or administrator may operate on it (e.g., a data manager may perform an operation on a "data download" event, while another component (not shown here) may operate on a "data upload" event). Similarly, FIG. 46 shows an example of a process diagram for a data processing component/manager.

The present disclosure provides improved systems, methods, and devices for monitoring physiological characteristics of the oral and respiratory tracts of a patient. The appliance is equipped with sensors configured to send and receive signals, and a processor that records these signals into memory. The signals may be analyzed to determine physiological characteristics of the patient. The intraoral appliance may also be a therapeutic appliance, treating an underlying disease and monitoring physiological characteristics to track the effectiveness of the treatment.

As used herein, the term "and/or" is used as a functional word to indicate that two words or expressions are to be used together or separately. For example, A and/or B includes A alone, B alone, and A and B together.

The present disclosure provides orthodontic systems, devices, and related methods for monitoring physiological characteristics of a patient and for assessing treatment parameters, such as appliance effectiveness.

In one aspect, a method for monitoring a physiological characteristic of a patient is provided. The method includes positioning an intraoral appliance within an oral cavity of a patient. An intraoral appliance is shaped to receive a patient's teeth and includes a plurality of electrodes, each electrode positioned to make electrical contact with a different portion of the patient's mouth. The method also includes measuring electrical impedance using the plurality of electrodes and determining a physiological characteristic based on the electrical impedance. In some embodiments, the measuring and determining steps are performed by one or more processors disposed on or within the intraoral appliance.

In some cases, the physiological characteristics include one or more of: respiratory tract diameter, respiratory tract volume, respiratory tract resistance, lung fluid level, soft tissue crowding, respiratory rate, muscle activity, ionic composition of saliva or ionic composition of oral mucosa. The physiological characteristic may be related to a sleep disorder of the patient, and the sleep disorder may include one or more of sleep apnea, snoring, or bruxism. In some embodiments, the sleep disorder comprises sleep apnea, and the intraoral appliance is configured to treat sleep apnea.

In some cases, the effectiveness of the intraoral appliance in treating sleep apnea is determined based on the determined physiological characteristic. The one or more processors may be configured to make this determination.

In some cases, the electrical impedance includes a near-field impedance, and the physiological characteristic includes one or more of soft tissue crowding, ionic composition of saliva, or ionic composition of oral mucosa. In some cases, the electrical impedance includes far-field impedance, and the physiological characteristic includes one or more of lung fluid level or airway length.

In another aspect, a method for monitoring a characteristic of a patient's oral cavity or respiratory tract is provided. The method includes positioning an intraoral appliance in an oral cavity of a patient. An intraoral appliance is shaped to receive a patient's teeth and includes a transmitter and a receiver. The method also includes causing the transmitter to transmit a signal within the patient's oral cavity, measuring a signal returned from the patient's oral cavity or airway using the receiver in response to the transmitted signal, and determining a characteristic of the patient's oral cavity or airway based on the measured signal. In some embodiments, the measuring and determining steps are performed by one or more processors disposed on or within the intraoral appliance.

Although reference is made to appliances that include a polymer shell appliance, the embodiments disclosed herein are well suited for use with many appliances that receive teeth, such as appliances that do not have one or more of a polymer or shell. For example, the implement may be made of one or more of a number of materials, such as metal, glass, reinforced fibers, carbon fibers, composites, reinforced composites, aluminum, biomaterials, and combinations thereof. For example, the appliance may be shaped in a number of ways, such as with thermoforming or direct manufacturing (e.g., 3D printing, additive manufacturing). Alternatively or in combination, the appliance may be manufactured using machining, such as using computer numerically controlled machining of appliances manufactured from blocks of material.

Fig. 47 shows an impedance model of a patient's respiratory tract 4700. The respiratory tract 4700 includes the oral cavity, which is bounded on the maxillary side by the hard and soft palate 4701 and 4702, on the mandibular side by the tongue 4703 and the maxilla, and on the lateral side by the cheeks. As the patient breathes, the airflow 4704 travels through the mouth and sinuses and down the upper airway 4705 towards the lungs. Obstruction of these passageways can cause sleep apnea and may be due to conditions such as soft tissue compression or narrowing of portions of the upper airway, for example. The patient's respiratory tract may be modeled as a substantially cylindrical passage between the mouth and lungs. In some embodiments, the patient's trachea approximates a cylinder 4710 of length L with an outer shell 4712 of soft tissue and a hollow core 4714 filled with air. The electrical conductivity of the soft tissue is much higher than that of air; thus, the impedance of the airway can be approximated as the resistance of a hollow cylinder having an outer radius R (the radius of the tissue surrounding the airway in the neck), an inner radius R (the airway radius), and a length L (the airway length). The resistivity p may be approximated as the resistivity of respiratory tract tissue, and the impedance 4720 may be estimated by the equation Z ═ pl/a, where a is the total conductive area — in this case the outer cylinder area minus the inner (substantially non-conductive) cylinder area. This gives a total impedance 4720 of about Z ═ ρ L/pi (R ^2-R ^ 2). More generally, in some embodiments, the impedance will be proportional to the resistivity of the soft tissue and the length of the airway, and inversely proportional to the cross-sectional area of the electrically conductive tissue of the airway. For electrical signals traveling between the oral cavity and the lower airway, the upper airway can therefore be considered a circuit element characterized by an impedance Z similar to this equation. The impedance Z depends on the inner radius r, in particular Z increases as r increases and Z decreases as r decreases. Thus, by measuring the change in impedance over time, the change in airway width can be determined from the corresponding change in impedance.

Changes in airway width are particularly important for patients suffering from sleep apnea and related illnesses because sleep disturbances and snoring can result from an insufficiently wide airway. Fig. 48A shows the variation in airway width for patients with different malampati scores. A patient with malampati score I has a large unobstructed airway in which the hard palate 201, soft palate 202, uvula 203 and struts 204 are visible; patients with mallamati score II have smaller airways where struts are no longer visible; patients with malampati score III have only the hard and soft palate and base of the uvula visible; and mallapati IV patients have only the hard palate visible. A higher Mallampati score may be associated with a greater likelihood of sleep apnea, with sleep apnea being particularly likely to occur at levels III and IV.

As can be seen in fig. 48A, in some embodiments, the unobstructed cross-sectional area of the patient's airway decreases as the malampati score increases such that a higher malampati score is associated with a smaller airway area. As discussed with respect to fig. 1, a smaller airway cross-section may correspond to a lower electrical impedance. FIG. 48B shows the correlation between Malampati scores and airway impedance, plotted versus inverse impedance 1/Z. Since increasing 1/Z corresponds to increasing the malampati score, the measurement of electrical impedance along the respiratory tract can be used to determine the malampati score. An appliance capable of continuously or continuously measuring impedance while worn by a patient allows for continuous monitoring of airway width, for example while the patient is sleeping. The data generated by such measurements can be used to diagnose and treat sleep apnea.

In some embodiments, the present disclosure provides systems, methods, and devices for measuring characteristics of the oral cavity and/or respiratory tract of a patient based on electrical impedance. Examples of characteristics that may be measured include respiratory tract diameter, respiratory tract volume, respiratory tract resistance, lung fluid level, soft tissue congestion, respiratory rate, muscle activity, ionic composition of saliva, or ionic composition of oral mucosa. The measurements may be based on near-field impedance, far-field impedance, or a combination thereof. As used herein, near field may refer to a measurement of impedance along or around the shortest path between two electrodes. For electrodes within the mouth, for example, the near field impedance may be a portion of the impedance, or a portion thereof, that depends on the resistivity and shape of the mouth tissue. The near field can be used to measure characteristics such as muscle activity, the ionic composition of saliva, or the ionic composition of the oral mucosa. As used herein, far field may refer to an impedance measurement that depends on a characteristic that is far from the shortest path between two electrodes. For intraoral electrodes, for example, far field impedance measurements may measure the effect on impedance due to changes in the shape or resistivity of tissue in the upper or lower respiratory tract or in the lungs. For example, the far field may be used to measure characteristics such as airway diameter, airway volume, airway resistance, lung fluid level, soft tissue crowding, respiratory rate, and the like. The impedance may be measured between two or more points in the patient's mouth. The location of the measurement points in the mouth can be varied as desired. For example, the electrodes may be placed on opposite sides of the mouth, at points on the upper and lower jaws, at points on the same jaw (upper or lower), or in contact with tissue, such as the cheek, palate, gums, teeth. The electrodes may be configured to separate the points in the contact opening, for example, by 1mm, 2mm, 4mm, 10mm, 20mm, 40mm, 100mm, or 200 mm. For example, a shorter separation may be more sensitive to near-field measurements, while a longer separation may be more sensitive to far-field measurements.

Fig. 49A shows a patient's oral cavity 4900 incorporating points where sensors such as electrodes can be placed to measure characteristics of the oral cavity and respiratory tract. A pair of contact points 4910 and 4920 are located in oral cavity 4900. One contact point is located on the lingual side along the gum of the upper arch 4912. Although shown on the right lingual side near the posterior of the mouth, as shown in fig. 49A, the location of the contact point 4910 may vary; for example, in some embodiments, contact point 4910 is located on the buccal side of the upper arch or on the left side of the mouth, or at any point along the upper or lower arch, including optionally on the same arch as contact point 4920. The contact point 4910 may also be at a point along the patient's cheek. Similarly, although contact point 4920 is shown along the gums of lower arch 4922 on the buccal side opposite tongue 4924, contact point 4920 may also vary in the same manner as contact point 4910 such that any effective contact point for one may be a contact point for another, including but not limited to contact points on the tongue and/or buccal side of one or more arches along the hard palate, along the cheek of the patient, or at any other point within the mouth. The position of each contact pair affects the sensitivity of the measurement performed with that pair.

For example, with reference to the particular selection of contact points shown in fig. 49A, as the patient's airway extends from the oral cavity, the airway passage may be substantially in the far field with respect to electrical impedance. Thus, in some embodiments, it is preferable to keep the near-field signal as small as reasonably possible in order to maximize the relative magnitude of the far-field signal. Thus, in some embodiments, points 4910 and 4920 are preferably located farther in the mouth and near the back of the mouth; in fig. 49A, there is shown a point 4910 located near the upper molars on one side of the mouth, while point 4920 is located near the lower molars on the other side of the mouth.

Currents may be induced to flow between contact points (such as points 4910 and 4920) by applying appropriate voltages, and these currents may be measured to determine electrical impedance. For example, the voltage may be an alternating voltage to induce an alternating current. A current pulse comprising a number of frequencies may be induced to allow the impedance to be measured simultaneously and/or sequentially at each of a number of different frequencies. In some embodiments, although a portion of the electrical impedance between contact points, such as points 4910 and 4920, is due to near-field impedance, a portion may also be due to far-field impedance (including respiratory tract impedance). More distant contact points may tend to be more sensitive to the far field relative to the near field, while points closer together may be more sensitive to the near field relative to the far field. The principles may also be applied to measurements made using sensors other than electrodes, such as the transmitter-receiver pairs disclosed herein: a close transmitter-receiver pair may be more sensitive to the near field, while a separate transmitter-receiver pair may be more sensitive to the far field.

The measurement results, such as impedance measurements, may be filtered to separate the portion of the measurement quantity and its variation due to the variable to be measured and its variation. For example, by applying a voltage pulse between points 4910 and 4920, a current pulse can be induced, then received, and then the return signal measured. The signal may be tracked as a function of time. The time required for the pulse to travel to the lungs and back may correspond to the round trip distance divided by the current speed, which may be a significant fraction of the speed of light. With sufficient time resolution, such as nanosecond resolution, it can be determined how far the pulse has traveled based on its round trip time; by measuring the signal strength at a delay time corresponding to the round trip through the respiratory tract, a direct measurement of the far-field impedance of the respiratory tract may be obtained. In some cases, the relative phase of the current pulses may be measured to determine the far-field impedance, as the phase may be affected by a time delay.

A portion of the near-field impedance will also depend on the airway width, as the available path between points 4910 and 4920 along the oral surface includes a path that travels near the airway opening. If the airway opening is small, a shorter path is available, which reduces the impedance of the near field. The impedance may also be measured repeatedly over a longer period of time to allow better filtering of noise sources and to isolate the effects of changes in airway width on the impedance. For example, the airway changes shape as the patient breathes, so changes in airway impedance associated with the patient's breathing can be used to isolate changes in impedance caused by changes in airway width. Similarly, for other measurements, a change in impedance or other measurement characteristic may be associated with the particular measurement; for example, changes in ionic saliva content may be determined from near-field impedance changes, and physical characteristics of the tooth or tooth PDL system may be determined from measured acceleration in response to the force applied by the actuator. It should be recognized that points 4910 and 4920 may vary throughout the oral cavity to alter measurement sensitivity and specificity; for example, to determine the appropriate position for the measurement sensor location, a plurality of point pairs may be tested in the patient's mouth, and the point pair with the highest signal-to-noise ratio for that measurement may be selected for that patient or other patients. Other measurements (such as transmitter-receiver measurements) may allow the same pattern to be followed for their respective measurement variables, and may likewise be placed at variable positions throughout the oral cavity to vary their sensitivity and specificity for their respective measurements.

Figure 49B shows an alternative location where sensors such as electrodes can be placed to measure characteristics of the oral cavity and respiratory tract. In the sensor configuration 350, a first sensor 360 is positioned along the maxilla near soft tissue 362 and the uvula 364. The second sensor is positioned along the mandibular jaw between the tongue 374 and the mandibular teeth (not shown). In this embodiment, the sensors are located on opposite sides of the airway, such that the airway is on the shortest path between the two sensors. In the case where sensors 360 and 370 are electrodes, for example, the impedance between the two sensors will depend in part on the width of the airway, with lower impedances corresponding to narrower (and thus more obstructed) airways.

In some embodiments, the impedance measurements described herein are performed using electrical sensors coupled to the oral appliance. Examples of such oral appliances include dental retainers, braces, and dental trays. In some embodiments, the oral appliance is used to treat sleep apnea, such as a mandibular protrusion device. In some embodiments, the patient wears a mandibular advancement device to displace the mandible forward relative to the upper jaw to treat sleep apnea. The mandibular protrusion device may be a patient removable appliance (e.g., the patient may place and remove the appliance without the assistance of a physician) that is inserted into the patient's mouth prior to sleep so as to maintain the mandible in the protruded position during sleep and removed from the patient's mouth while the patient is awake to allow normal activity. In alternative embodiments, the intraoral appliance may include one or more components that are not patient removable (e.g., an attachment or bracket secured to one or more teeth, an anchoring device positioned in oral tissue such as bone). In some embodiments, the intraoral appliance includes at least one appliance shell having a plurality of cavities shaped to receive teeth of a single jaw of a patient.

Any number of sensors may be used, such as electrodes, acoustic transducers, and accelerometers. The sensor may be located at any part of the appliance, such as lingual or buccal side adjacent to the gums, tooth surface adjacent to the teeth, cheek adjacent or along the top or bottom of the mouth. The sensor may be coupled to the appliance in various ways, such as by an adhesive, a fastener, embedded in the appliance material, or inserted into a cavity formed in the appliance. The measurements described herein may be obtained using sensors coupled to a single appliance worn on the upper or lower jaw of the patient. Alternatively, the sensors may be distributed between a pair of appliances worn on the upper and lower jaw, respectively. In some embodiments, the oral appliance and the sensor are completely contained within the patient's mouth when worn. For example, in some embodiments, the appliance may be operated without connection to an external power source, control electronics, or external sensor points. Appliance electronics may include a power source, such as a battery, to store energy for continuous operation. For example, the battery may be rechargeable, e.g. by plugging the appliance into a charger when not in use or by charging using wireless power transmission, in which case the appliance may include a suitable antenna for receiving the transmitted power from the base station. The oral appliance and sensor may be patient removable, allowing measurements to be performed without the need to implant the sensor device within the patient's tissue or to be secured to the patient's mouth or teeth.

Figures 50A-50G illustrate various oral appliances that include electrical sensors (such as electrodes placed in various configurations) to allow for measurement of impedance due to changes in airway width, as well as other physiological characteristics of a patient, including characteristics of the patient's mouth or airways. The electrodes may be used to monitor changes in resistance within the oral cavity, as in patients with abnormal soft tissue crowding, the conductive path between the electrodes may be shorter. Because stretching of soft tissue during a change in mandible position can alter the conductive path within the oral cavity, impedance measurements can be used to detect whether a patient has an open or closed mouth, for example, or whether the lower jaw is moving backwards or protruding. While in some embodiments, well-separated electrodes may be desirable to increase sensitivity to far-field impedance changes, closely positioned electrodes may also be used to monitor physiological characteristics of a patient. For example, the electrical potential generated by muscle cells during activation can be monitored by appropriately positioned electrodes. Among the physiological activities that can be detected by monitoring muscle movement in this way are temporomandibular articulation, increased biting muscle activity during dysfunctional activities such as molars or clenches, and upper airway relaxation, e.g. due to collapse or decline of the upper airway in activity, associated with hypopnea or apnea.

Although electrodes are used herein as exemplary sensors in the illustrated orthodontic appliances, sensors other than electrodes may also be used to sense physiological characteristics of the patient's oral and/or respiratory tract by, for example, measuring characteristics other than impedance, such as piezoelectric pulses, acoustic waves, and acceleration. In some embodiments, the physiological characteristic may be measured by transmitting a signal into the oral cavity and/or respiratory tract of the patient and measuring a response signal returned from the oral cavity and/or respiratory tract. The characteristics (e.g., amplitude, frequency, etc.) of the response signal may vary based on the characteristics of the patient's oral and/or respiratory tract.

In such an embodiment, the electrodes labeled in fig. 50A-50G may be replaced with appropriate pairs of sensors, serving as transmitters and receivers, respectively. For example, a transducer may be used to generate and receive acoustic waves (e.g., ultrasound), and phase and amplitude information of the response signals may be used to image the oral cavity or upper respiratory tract. An actuator (such as a piston, vibration motor or piezoelectric crystal) and an accelerometer may replace the respective electrodes. A pulse signal may be sent to the tooth via the actuator and a response signal may be recorded with an accelerometer in contact with the tooth. This response may be associated with different phases of tooth motion, such as motion due to orthodontic forces applied by the appliance shell, as the stiffness of the tooth-PDL structure will vary with different phases of tooth movement. This response may be related to tooth, root, and/or PDL health, even if tooth movement is not caused by the appliance shell. The actuator may also be positioned to generate a force capable of generating an electrical current in the mouth structure (e.g., via the piezoelectric effect). For example, the compression of bone and collagen causes movement of electrons in the lattice, and the application of force on the tooth may cause a short piezoelectric effect on the alveolar bone, which may be detected by a suitable receiving sensor (such as an electrode). Electrical signals generated by the alveolar and periodontal ligament (PDL) under load can stimulate changes in bone metabolism, and electrical sensors such as electrodes can also be used to detect these electrical signals, for example, by monitoring changes in voltage. These examples of measurements may be combined to perform simultaneous or interleaved measurements, including combinations with electrode measurements of impedance and other electrical characteristics. In some embodiments, multiple measurements are performed and their results compared or combined using sensor fusion techniques, thereby increasing the resolution of each measured quantity.

Fig. 50A shows a wearable appliance 5000 on a patient's teeth that includes sensors located at diametrically opposed points in the patient's mouth 5002. The appliance 5000 includes a housing 5004 in which tooth receiving cavities are configured to receive the patient's teeth when worn in the patient's mouth 5002. The appliance housing includes a protruding portion 5005 configured to extend along the cheek of the patient when the appliance is worn. For example, the projections may be configured to engage projections of an appliance worn on the opposing jaw to provide a force for mandibular protrusion. The appliance also includes a plurality of sensors, such as electrodes, where a first electrode 5006 is disposed on the protrusion and positioned to contact the right cheek of the patient when worn. A second electrode 5008 is disposed on the housing and positioned to contact the patient's left cheek when worn. The illustration of the patient's mouth 5002 shows the points contacted by each electrode when the appliance is worn. The electrodes are positioned to contact substantially opposite points near the back of the patient's mouth, providing electrical contact points in an area similar to that shown in fig. 49A. As a result, for example, the electrode position is well suited for measuring far field impedance. In alternative embodiments, the appliance 5000 may also be used to perform other types of measurements, as discussed herein.

Appliance 5000 also includes appropriate wiring disposed within housing 5004, providing electrical contact points between the sensors (shown as electrodes 5006 and 5008) and a processor disposed within the housing. The processor is also connected to a power source such as a battery that provides power. The processor is configured to control the voltage value at each electrode to allow the generation of current pulses, alternating current and/or direct current. The circuit connecting the processor to the electrodes also includes a current measurement unit, such as an ammeter, so that the impedance can be calculated by the processor from measurements of voltage and current as a function of time. The processor comprises a clock for time measurement and is connected to the memory to allow recording of sensor data and contains instructions to be executed by the processor. Optionally, the processor is also connected to a radio transmitter, allowing the recorded data to be sent to an external receiver for processing by an external computing device. The external receiver may be, for example, a mobile device or a WiFi antenna, and the receiver and transmitter may communicate using an appropriate communication protocol, such as bluetooth, cellular, WiFi, or other protocol. Fig. 50C provides more detail of the internal structure of an appliance such as that shown in fig. 50A.

Fig. 50B shows a wearable appliance 5010 on a patient's teeth 5012 that includes sensors positioned in close proximity to each other. The instrument includes an instrument housing 5014 and the sensor includes a plurality of electrodes 5016 in close proximity to each other. For example, when the shortest distance between sensors, such as electrodes, is small compared to the width of the respiratory tract, it may be very close. Sensors in close proximity may be more sensitive to near field measurements than sensors separated by greater distances. The electrodes are configured to contact a plurality of nearby points 5018 within the patient's oral cavity when the patient is wearing the appliance. In this example, the contact point is on the buccal gingiva; in other embodiments, the contact point may be on the cheek or lip, or on the lingual side contacting the tongue and lingual gums. The contact points may also contact the teeth on the tongue and/or buccal side (including one sensor on each side of the tooth). The proximate electrode is sensitive to near-field variations in impedance; thus, they can be used to measure characteristics such as intra-oral impedance caused by changes in saliva volume or content. For example, if the mouth of the patient becomes drier, the amount of saliva between the electrode 5016 and the surrounding point 5018 will decrease, which may increase impedance as saliva cannot be used to carry current. Similarly, changes in saliva content (such as pH changes) can be measured, for example, by a synthetic change in its saliva conductivity. These characteristics can also be measured by providing an appliance with a near-field and far-field electrode configuration in conjunction with far-field measurements, such as by adding a near-field electrode such as that shown in fig. 50B to an appliance with a far-field electrode such as that shown in fig. 50A. Each electrode pair may be individually connected to and controlled by the processor, or may be controlled by a separate processor.

Fig. 50C shows the interior of an appliance 430 with an embedded measurement system, which includes control electronics and sensors. The appliance 430 includes oral appliance layers 431 and 432 surrounding control electronics 433. The control electronics 433 include a power source such as a battery, drive electronics that generate voltage pulses for inducing current, and measurement electronics for measuring current and voltage as a function of time and then recording the resulting data to memory. The control electronics 433 includes a processor and a memory containing instructions that, when executed, cause the processor to control the drive and measurement electronics to generate electrical pulses and perform measurements, such as impedance measurements, according to the methods disclosed herein. The control electronics are electrically coupled to one or more sensors, such as electrodes 436 and 438, using wires 434. The wires 434 are preferably disposed within the layers of the appliance housing, but may include an open connection between the housings (see, e.g., fig. 50E). The electrodes are disposed to contact a surface of the patient's mouth when the appliance is worn. The electrodes perform current generation and electrical measurements under the direction of control electronics. The first schematic layout shown in fig. 50C may be used with appropriate changes in the positions of the electrodes, drive electronics, and measurement electronics in any of a variety of appliance housing configurations, including the configurations shown in fig. 50A, 50B, and 50D-50G.

Fig. 50D shows an example of alternative extended positions for sensors such as electrodes and drive electronics. The configuration of the appliance housing and electrodes as shown in fig. 50A, 50B and 50E-50G may be changed as desired to place the drive and measurement electronics and electrodes in alternative locations. For example, fig. 50D shows a device 440 with some variations of this type. The drive electronics 441 of the appliance 440 are located outside of the housing, allowing additional oral measurement devices to be connected. For example, the lead 442 may be connected to an external device while the patient is asleep, allowing the appliance to record impedance and other data without the need for an internal power source. The electrodes may be located in tabs (tab)443 extending from the gingival margin of the appliance, or even in a flexible wired connection such as electrode 444. For example, electrode 444 may be attached to a tool or dental attachment on the opposite side of the patient's mouth, such as tool 440. This allows for greater flexibility in electrode configuration for performing various measurements within the patient's oral cavity. The tab 443 may be a preloaded tab with electrodes on the inner surface to allow contact to be maintained. As shown in the cross-sectional view 445 of a portion of the appliance 440, the tabs 443 are configured to resiliently bend between a first configuration 446 away from the dentition and gingiva and a second configuration 447 pressing the electrodes against the patient's gingiva when the appliance is worn. The tabs 443 are configured to apply a preloaded inward force to retain the tabs in the second configuration 447 to maintain electrical contact between the electrodes and the patient's gums. Such electrode locations are useful, for example, in the measurement of the impedance and other electrical characteristics of the periodontal ligament (PDL).

Fig. 50E shows an appliance that includes an upper shell that fits over the patient's upper teeth and a lower shell that fits over the patient's lower teeth, each shell including a sensor, such as an electrode. The appliance 450 includes an upper housing 451 containing an upper electrode 453 and a lower housing 452 containing a lower electrode 454. For example, each electrode is located on a protrusion of the mandibular protrusion device for treating a condition such as OSA, and the protrusions are configured to contact to protrude the mandible when each appliance is worn over the respective upper and lower teeth of the patient. The interface 455 between the projections may include a conductive surface on each projection so that the projections form an electrical contact, allowing each electrode to be controlled by a processor in one of the two shells. It should be understood that electrodes 453 and 454 need not be located on the projections, but may be located elsewhere on their respective housings (e.g., on opposite sides of the patient's mouth). In this case, wires may be provided within the housing to connect the electrodes, processor, and interface 455 together.

Fig. 50F shows an appliance configured to measure physiological properties using electrodes on opposite sides of the appliance housing. The appliance 460 comprises an appliance housing 462 having two electrodes 464 and 466 on opposite sides of the housing. Impedance 468 may be measured between the electrodes as shown in partial circuit diagram form in fig. 50F. The appliance housing 462 includes control electronics including, for example, a processor and memory as shown in fig. 50C. The processor determines an impedance Z between the electrodes, which is then used to determine one or more physiological characteristics of the patient; such as the cross-sectional area of the airway.

Fig. 50G shows an appliance 470 with corresponding sensors on the upper and lower shells, where the electronics of the sensors are inductively coupled. The appliance 470 includes an upper housing 471 with a sensor 472 and a lower housing 472 with a sensor 474. The two housings each include respective control electronics, including respective processors, power supplies, and measurement and drive electronics. The two shells are not configured to form direct electrical contact; instead, the electronics of the upper and lower shells are inductively coupled so that each responds to transient electrical pulses emitted from the other. The sensor of fig. 50G may be configured with one sensor as a transmitter and one sensor as a receiver; for example, acoustic transmitters and receivers may be used. In this manner, measurements related to signals to and from the sensor can be performed in each housing without requiring electrical paths connecting the upper and lower housing electronics.

In case of an appliance in which the sensors are located in separate upper and lower appliance housings, the two housings may be coupled in various ways to achieve a coordinated measurement. For example, the conductive coupling may be achieved in various ways. A wired connection may be made between the opposing dental arches. In some embodiments, a single unitary appliance may be more practical than appliances for two dental arches. However, where intermittent sensing is acceptable, the conductive connectors may be placed on known contact points, such as shown in fig. 50E. In another example of coupling, a conductive hinge rod, such as a Herbst-type rod, may be included between the shells to provide a conductive path. Other methods of direct coupling include stretchable conductors that can work as between appropriate hooks or buttons, such as orthodontic elastics, or implanted wires within the mouth of the patient (such as subcutaneous wires in the cheek or adhesive wires attached on the inner surface of the mouth).

Fig. 51A shows a block diagram of a signal chain 5100 for impedance measurements with the appliances disclosed herein. Drive electronics provide current 5110 to the electrodes and is characterized by carrier frequency Fc. To eliminate DC current, the current transfer electrode is shielded from the current source by a high pass filter in the form of a capacitor 5120. The electrodes contact the patient's mouth, which provides a modulation 530 of low frequency corresponding to changes in electrical impedance. This impedance can be modeled as the baseline impedance RB plus the variable impedance ar. Modulation is due to changes in Δ R, for example, caused by changes in the cross-sectional area of the airway as the patient breathes. The modulated signal is received at the receive electrode, which is also shielded by a high pass filter in the form of a capacitor 540. The received signal is then amplified by gain stage 550. Thereafter, the signal is synchronously demodulated 560 to remove the carrier frequency Fc. The remaining high frequency components are removed with a low pass filter 570 to produce the final signal to be measured. Analog-to-digital converter 580 then converts the signal into a digital signal that is processed by a processor that records the resulting measurement data to a non-transitory computer readable medium.

When the signal chain 51A disclosed in fig. 51A is applied to monitoring physiological characteristics within the mouth of a patient, it is important to use signal frequencies and amplitudes that do not stimulate or harm the patient. For inductive measurements with electrodes, the safe range of current flow may be about 100 μ A or less. The carrier frequency used to modulate the signal may be selected to minimize noise as appropriate; for example, a carrier frequency of about 10kHz is useful for many applications. The signal chain disclosed in fig. 51A may be applied to systems using sensors other than electrodes, replacing the electrodes with suitable sensors such as transducers, piezoelectric crystals, or actuator/accelerometer pairs. The impedance modulation will be replaced accordingly by a modulation of the signal to which the particular sensor is sensitive. For systems that apply mechanical energy, the applied mechanical energy may remain less than about 1N for continuous forces. For transient forces, such as cyclic forces, a larger force may be applied; for example, an amplitude of about 5N or less may be applied for transient force measurements.

Fig. 51B shows a schematic diagram of an oral appliance including a plurality of electrodes for measuring impedance of a system, such as a patient's oral cavity or respiratory tract. The power supply 515 supplies an alternating current to the first electrode lead 525. The electrode lead 525 may be in contact with a system 535 to be measured, such as a patient's oral cavity. The voltage drop between lead 525 and lead 545 varies based on the impedance of system 535 in a manner approximating ohm's law (V ═ I × Z); thus, the relationship between the voltage drop and current flow between electrodes 525 and 545 can be used to determine the impedance of system 535. Each of the voltage and current may be measured using conventional methods, for example using a voltmeter and/or an ammeter. A pull-up or pull-down resistor 555 may be included to ensure that the incoming electrical signal has the proper voltage reference. The input AC signal from the electrode lead 545 is then demodulated at a signal conditioner 565, where gain is applied as needed to amplify the signal. The remaining high frequency elements are removed with a low pass filter and the signal is then recorded to memory 575 for analysis. As the data accumulates over time, a data plot 585 of impedance vs time may be generated for analysis by the processor. The data may also be transmitted to an external device such as a mobile device for e.g. display and analysis by e.g. a medical professional.

Fig. 52 illustrates a method 5200 for monitoring a physiological characteristic of a patient using the intraoral appliance disclosed herein.

In step 610, an appliance is positioned in the mouth of a patient. The appliance may comprise, for example, an appliance housing, or even a plurality of appliance housings, such as those disclosed herein. The appliance includes a plurality of electrodes disposed within one or more shells and is configured to be in electrical contact with the patient's oral cavity when the patient wears the intraoral appliance.

In step 620, an impedance measurement is performed by a processor coupled to the electrodes. The impedance measurement may be performed, for example, using a signal chain, such as signal chain 500. Changes in impedance due to physiological changes in the patient, such as changes in airway obstruction, result in modulation of the current signal. After amplifying and demodulating the carrier frequency of the current signal, the remaining signal may be sent through a low pass filter to obtain an analog signal. The change in the signal corresponds to a change in impedance. The analog-to-digital converter may generate the signal data readable by the processor as a sequence of time-varying signal values and the sequence contains information from which the impedance variation may be determined. For example, the impedance change caused by breathing may be determined by detecting a signal change at a frequency substantially similar to the breathing frequency.

In step 630, the processor records data corresponding to the impedance measurement into memory. Alternatively, the processor may cause the transmitter to transmit data to a remote receiver to be recorded in a memory external to the appliance. For example, a mobile device or other computing device may communicate with the processor using wired or wireless technology (e.g., bluetooth, WiFi, or cellular communications).

In step 640, a physiological characteristic is determined based on the impedance measurement data recorded in the memory. For example, the physiological characteristic may be respiratory tract diameter, respiratory tract volume, respiratory tract resistance, lung fluid level, soft tissue crowding, respiratory rate, muscle activity, ionic composition of saliva, or ionic composition of oral mucosa, or a combination thereof. Airway diameter, volume and resistance can be determined by measuring the change in far field impedance measured by the electrodes. These size changes can be used as indicators of soft tissue crowding. For example, the signal may be isolated by detecting impedance changes associated with patient breathing. The breathing frequency can be determined by detecting a slow periodic variation of the overall impedance over a time period in seconds. The lung level may be determined by measuring characteristics of the returned current pulse, in particular its delay time and phase. Muscle activity, ionic composition of saliva or ionic composition of oral mucosa can be measured with near field electrodes; changes in ionic composition alter the electrical impedance of the intervening fluid, and muscle activity generates a current that can be detected with the electrodes.

Fig. 53 illustrates a method 5300 of monitoring a characteristic of a patient's oral cavity or airway using a transmitter-receiver pair disposed within an intraoral appliance.

In step 5310, an appliance is positioned in the mouth of a patient. The appliance may comprise, for example, an appliance housing, or even a plurality of appliance housings, such as those disclosed herein. The appliance includes a transmitter and a receiver disposed within one or more housings. For example, the transmitter and receiver may be placed in place of electrodes in the appliance substantially as described in fig. 50A-50F. The transmitter and receiver may also be provided in a pair of housings with inductively coupled electronics, as shown in fig. 50G.

In step 5320, the transmitter sends a signal within the oral cavity. Examples of transmitters and corresponding transmit signals include electrodes that transmit electrical pulses, transducers that transmit acoustic waves, and actuators that transmit mechanical forces.

In step 5330, the response signal is received and processed by a processor and then recorded to a memory. For example, the response signal may result from an interaction between the transmitted signal and a portion of the patient's oral cavity and/or respiratory tract, such as scattering, reflection, or stimulation of tissue or fluid. The response signal is received by the receiving sensor. Examples of receiving sensors and corresponding receiving signals include electrodes that receive piezoelectric pulses, transducers that receive reflected sound waves, and accelerometers that detect acceleration. The received signals contain information about the tissue and/or fluid through which they travel, which can be analyzed to determine physiological characteristics; for example, modulation of the amplitude, frequency, and phase of the received signal may correspond to a corresponding change in the transmission medium of the patient's oral or respiratory tract.

In step 5340, a physiological characteristic is determined based on the sensor measurement data recorded in the memory. The determined physiological characteristic may be, for example, the compressive response of bone and collagen; temporomandibular joint occlusion; bruxism or tight bite; decreased upper airway muscle activity; stiffness of the tooth-PDL structure; tooth, root and/or PDL health; root structure based on acoustic response of surrounding tissue; oral or upper respiratory tract shape and size; soft tissue crowding; opening or closing the mouth; or the mandible extending or receding. These physiological characteristics can be determined using appropriate sensors and physiological relationships as described above with respect to fig. 50A-50G, respectively.

Fig. 54 shows a method of manufacturing an appliance comprising a sensor and control electronics 5400.

In step 5410, a dental structure of a patient is obtained. The structure may be in the form of a physical mold or model, or a 3D image of the patient's dentition, for example.

In step 5420, a first layer of device material is deposited. The deposition may be, for example, the application of a thermoformed plastic layer on the mold. Alternatively, the material may be deposited by direct fabrication, such as using a 3D printer, from a 3D model of the appliance for mounting the patient's teeth generated based on the 3D image of the patient's dentition in step 5410. In some embodiments, steps 5420 and 5440 may be combined into a single step in which the appliance housing is fabricated directly around the control electronics and sensors of step 5430.

In step 5430, the control electronics and sensors are placed in place on the first layer of the appliance. Wiring is provided as needed to connect each component of the sensing system. In this step, carbon fibers may be incorporated into the orthotic to create an antenna for wireless communication with an external receiver. Multiple electrodes or other sensors may be provided to enhance signal acquisition; for example, in a manner similar to neural electrodes used for electroencephalography measurements.

In step 5440, a second layer of tool material is deposited, as in step 5420. The second layer, in combination with the first layer, surrounds the control electronics and the sensor.

In step 5450, any material covering the sensor leads may be removed, if desired. For example, robotic milling or laser cutting machines may be used to remove instrument material covering electrodes, transducers, actuators, accelerometers, etc., in order to provide clear contact with the appropriate portion of the patient's mouth when the instrument is worn.

To better separate the signals related to the physiological characteristics to be measured, sensor fusion techniques may be used to combine multiple sensor systems. For example, as described above, airway width changes are associated with patient breathing. The patient breathing rate may be determined using an accelerometer located within the intraoral appliance. Fig. 55 shows exemplary rotational speed data collected with a gyroscope accelerometer coupled to the patient's maxilla. The grey spectrum shows the rotational speed data of the sensor loosely coupled to the body near the hip joint. The black spectrum shows the corresponding data from the sensor coupled to the patient's jaw via the appliance. The left spectrum shows the raw data in each of the x, y and z dimensions, while the right spectrum shows the same data converted to fourier space and displayed as a power spectrum. The power spectrum of the black curve measuring jaw movement shows a maximum value slightly below 1Hz, corresponding to the breathing frequency of the patient. In contrast, measurements at the hip of the patient only show a weak signal. Thus, intraoral measurements can be used to measure signals that are sensitive to the patient's respiratory rate. Using this measured respiratory rate, the effect of airway width changes on the impedance measurements from the electrodes can be isolated by detecting impedance changes with substantially matched frequencies. Since impedance measurements are also sensitive to the patient's breathing, impedance and acceleration signals can be measured by intraoral appliances and cross-validated to provide respiratory rate measurements with higher accuracy.

In some embodiments, an appliance including a sensor disclosed herein may be a therapeutic appliance, such as an orthodontic appliance or an appliance for treating sleep apnea. In such an appliance, monitoring of physiological conditions may include assessment of the effectiveness of the treatment. For example, an intraoral appliance may be used to treat sleep apnea and monitor effectiveness by tracking the resultant changes in airway diameter or volume. Tooth movement due to orthodontic forces can also be measured, such as by monitoring the stiffness of the tooth-PDL structure to which orthodontic forces are applied by the appliance.

Appliances having tooth-receiving cavities, such as those disclosed herein, include appliances that receive and reposition teeth, for example, via forces applied due to appliance elasticity. An example of such an appliance is shown generally with respect to fig. 1A. Fig. 1A illustrates an exemplary tooth repositioning appliance or appliance 1000 that may be worn by a patient to effect incremental repositioning of individual teeth 1002 in the jaw. The appliance may include a shell having a tooth-receiving cavity that receives and resiliently repositions the teeth. The appliance or portions thereof may be manufactured indirectly using a physical model of the teeth. For example, a physical model of the teeth and a sheet of a suitable polymeric material layer may be used to form a device (e.g., a polymeric device). In some embodiments, the physical appliance is directly manufactured from a digital model of the appliance, for example using rapid prototyping techniques.

Although reference is made to appliances that include a polymer shell appliance, the embodiments disclosed herein are well suited for use with many appliances that receive teeth, such as appliances that do not have one or more of a polymer or shell. For example, the implement may be made of one or more of a number of materials, such as metal, glass, reinforced fibers, carbon fibers, composites, reinforced composites, aluminum, biomaterials, and combinations thereof. For example, the appliance may be shaped in a number of ways, such as with thermoforming or direct manufacturing (e.g., 3D printing, additive manufacturing). Alternatively or in combination, the appliance may be manufactured using machining, such as machining an appliance made from a block of material with computer numerical control.

The appliance may be mounted on all, or less than all, of the teeth present in the upper or lower jaw. The appliance may be specifically designed to accommodate a patient's teeth (e.g., the topology of the tooth receiving cavity matches the topology of the patient's teeth) and may be manufactured based on a positive or negative model of the patient's teeth generated from an impression, scan, or the like. Alternatively, the appliance may be a universal appliance configured to receive the teeth but not necessarily shaped to match the topology of the patient's teeth. In some cases, only some of the teeth received by the appliance will be repositioned by the appliance, while other teeth may provide a base or anchor region for securing the appliance in place, As it applies a force against the repositioned tooth or teeth. In some embodiments, at some point during treatment, some, most, or even all of the teeth will be repositioned. The moved teeth may also serve as a base or anchor for securing the appliance when it is worn by the patient. Typically, no wires or other means for securing the appliance in place on the teeth are provided. However, in some instances, it may be desirable or necessary to provide a separate attachment or other anchoring element 1004 on the tooth 1002 with a corresponding receptacle or hole 1006 in the appliance 1000 so that the appliance can apply a selected force to the tooth. Comprises thatExemplary appliances for use in the system are described in a number of patents and patent applications assigned to Align Technology, inc, including, for example, U.S. patent nos. 6,450,807 and 5,975,893, as well as company websites that are accessible on the world wide web (see, e.g., the URL "invisal. Examples of tooth-mounted attachments suitable for use with orthodontic appliances are also described in patents and patent applications assigned to Align Technology, inc, including, for example, U.S. patent nos. 6,309,215 and 6,830,450.

Fig. 1B shows a tooth repositioning system 1010 including a plurality of appliances 1012, 1014, 1016. Any of the appliances described herein may be designed and/or provided as part of a set of multiple appliances for use in a tooth repositioning system. Each appliance may be configured such that the tooth-receiving cavity has a geometry corresponding to an intermediate or final tooth arrangement intended for that appliance. The patient's teeth may be incrementally repositioned from the initial tooth arrangement to the target tooth arrangement by placing a series of incremental position adjustment appliances on the patient's teeth. For example, tooth repositioning system 1010 may include a first appliance 1012 corresponding to an initial tooth arrangement, one or more intermediate appliances 1014 corresponding to one or more intermediate arrangements, and a final appliance 1016 corresponding to a target arrangement. The target tooth arrangement may be a planned final tooth arrangement selected for the patient's teeth at the end of all planned orthodontic treatments. Alternatively, the target arrangement may be one of several intermediate arrangements for a patient's teeth during an orthodontic treatment procedure, which may include a variety of different treatment options, including but not limited to situations where surgery is recommended, situations where interproximal reduction (IPR) is appropriate, situations where a schedule check is scheduled, situations where anchoring locations are best, situations where palatal expansion is needed, situations where restorative dentistry is involved (e.g., inlays, patches, crowns, bridges, implants, veneers, etc.), and the like. Thus, it should be understood that the target tooth arrangement may be any planned resulting arrangement of the patient's teeth that follows one or more incremental repositioning stages. Similarly, the initial tooth arrangement may be any initial arrangement for the patient's teeth followed by one or more incremental repositioning stages.

The various embodiments of the orthodontic appliances presented herein can be manufactured in a variety of ways. By way of example, some embodiments of the appliances (or portions thereof) herein can be produced using indirect manufacturing techniques, such as by thermoforming on a male or female mold. Indirect manufacturing of orthodontic appliances may include creating a male or female mold of a patient's dentition in a target arrangement (e.g., by rapid prototyping, milling, etc.) and thermoforming one or more sheets of material on the mold to create an appliance shell. Alternatively or in combination, some embodiments of the apparatus herein may be manufactured directly, e.g. using rapid prototyping, stereolithography, 3D printing, etc.

The configurations of orthodontic appliances herein can be determined according to a treatment plan of a patient, e.g., a treatment plan involving the continuous administration of multiple appliances for incrementally repositioning teeth. Computer-based treatment planning and/or appliance manufacturing methods may be used to facilitate the design and manufacture of appliances. For example, one or more of the appliance assemblies described herein may be digitally designed and manufactured with the aid of computer controlled manufacturing equipment (e.g., Computer Numerical Control (CNC) milling, computer controlled rapid prototyping such as 3D printing, etc.)). The computer-based approach presented herein may improve the accuracy, flexibility, and convenience of appliance manufacturing.

In some embodiments, an orthodontic appliance (such as the appliance shown in fig. 1A) applies a force to crowns and/or attachments of teeth located on the teeth at one or more points of contact between the tooth-receiving cavities of the appliance and the received teeth and/or attachments. The magnitude of each of these forces and/or their distribution over the tooth surface may determine the type of orthodontic tooth movement that results. Tooth movement may be in any direction in any plane of space and may include one or more of rotation or translation along one or more axes. As discussed further herein, types of tooth movement include squeezing, intrusion, rotation, tipping, translation, and root movement, and combinations thereof. Tooth movement of the crown greater than the movement of the root may be referred to as tipping. The equivalent movement of the crown and root may be referred to as translation. Movement of a tooth root larger than a crown may be referred to as root movement.

When a feature or element is described herein as being "on" another feature or element, it can be directly on the other feature or element or intervening features or elements may also be present. In contrast, when a feature or element is described as being "directly on" another feature or element, there are no intervening features or elements present. It will be understood that when a feature or element is referred to as being "connected," "attached," or "coupled" to another feature or element, it can be directly connected, attached, or coupled to the other feature or element or intervening features or elements may be present. In contrast, when a feature or element is referred to as being "directly connected," "directly attached" or "directly coupled" to another feature or element, there are no intervening features or elements present. Although described or illustrated with respect to one embodiment, the features and elements so described or illustrated may be applied to other embodiments. One skilled in the art will recognize that a structure or feature referred to as being disposed "adjacent" another feature may have portions that overlap or underlie the adjacent feature.

The terminology used herein is for the purpose of describing particular embodiments only and is not intended to be limiting of the disclosure. For example, as used herein, the singular forms "a", "an" and "the" are intended to include the plural forms as well, unless the context clearly indicates otherwise. It will be further understood that the terms "comprises" and/or "comprising," when used in this specification, specify the presence of stated features, steps, operations, elements, and/or components, but do not preclude the presence or addition of one or more other features, steps, operations, elements, components, and/or groups thereof. As used herein, the term "and/or" includes any and all combinations of one or more of the associated listed items, and may be abbreviated as "/".

Spatially related terms such as "under", "below", "lower", "over", "upper", and the like may be used herein to facilitate describing the relationship of one element or feature to another element or feature or elements or features as illustrated in the drawings. It will be understood that the spatially relative terms are intended to encompass different orientations of the device in use or operation in addition to the orientation depicted in the figures. For example, if the device in the figures is turned over, elements described as "under" other elements or features "and" under "the other elements or features would then be oriented" over "the other elements or features. Thus, the exemplary term "under" can encompass both directions that are under. The device may be otherwise oriented (rotated 90 degrees or at other orientations) and the spatially relative descriptors used herein interpreted accordingly. Similarly, the terms "upward", "downward", "vertical", "horizontal", and the like are used herein for the purpose of description, unless specifically stated otherwise.

Although the terms "first" and "second" may be used herein to describe various features/elements (including steps), these features/elements should not be limited by these terms unless the context dictates otherwise. These terms may be used to distinguish one element/component from another. Thus, a first feature/element discussed below could be termed a second feature/element, and similarly, a second feature/element discussed below could be termed a first feature/element, without departing from the teachings of the present disclosure.

In this specification and the claims which follow, unless the context requires otherwise, the word "comprise", and variations such as "comprises" and "comprising", mean that the various components (e.g., compositions and devices including devices and methods) may be used together in methods and articles of manufacture. For example, the term "comprising" will be understood to imply the inclusion of any stated elements or steps but not the exclusion of any other elements or steps.

Generally, any apparatus and methods described herein should be understood to be inclusive, but all or a subset of components and/or steps may optionally be exclusive, and may be represented as "consisting of" or "consisting of" substantially various components, steps, sub-components, or sub-steps.

As used herein in the specification and claims, including in the examples, unless otherwise expressly specified, all numbers may be read as if prefaced by the word "about" or "about", even if the term does not expressly appear. The phrases "about" or "approximately" may be used when describing amplitude and/or position to indicate that the described value and/or position is within a reasonably expected range of values and/or positions. For example, a numerical value can have a value that is +/-0.1% of the set point (or range of values), +/-1% of the set point (or range of values), +/-2% of the set point (or range of values), +/-5% of the set point (or range of values), +/-10% of the set point (or range of values), and the like. Any numerical value given herein is to be understood as including about that value or about that value unless the context indicates otherwise. For example, if the value "10" is disclosed, then "about 10" is also disclosed. Any numerical range recited herein is intended to include all sub-ranges subsumed therein. It is also understood that when a value is disclosed as "less than or equal to" the value, possible ranges between "greater than or equal to the value" and the value are also disclosed, as is well understood by those skilled in the art. For example, if the value "X" is disclosed, "less than or equal to X" and "greater than or equal to X" (e.g., where X is a numerical value) are also disclosed. It should also be understood that throughout this application, data is provided in a number of different formats and represents end and start points and ranges for any combination of data points. For example, if a particular data point "10" and a particular data point "15" are disclosed, it should be understood that greater than, greater than or equal to, less than or equal to, and equal to 10 and 15 are considered to be disclosed as being between 10 and 15. It is also understood that each unit between two particular units is also disclosed. For example, if 10 and 15 are disclosed, 11, 12, 13 and 14 are also disclosed.

While various illustrative embodiments have been described above, any of several variations may be made to the various embodiments without departing from the scope of the disclosure as described in the claims. For example, in alternative embodiments, the order in which the various described method steps are performed may generally be varied, and in other alternative embodiments, one or more of the method steps may be skipped altogether. Optional features of various device and system embodiments may be included in some embodiments and not in others. Accordingly, the foregoing description is provided primarily for the purpose of illustration and should not be construed as limiting the scope of the disclosure as set forth in the claims.

The examples and illustrations included herein show by way of illustration, and not by way of limitation, specific embodiments in which the subject matter may be practiced. As mentioned, other embodiments may be utilized and derived therefrom, such that structural and logical substitutions and changes may be made without departing from the scope of this disclosure. Such embodiments of the disclosed subject matter may be referred to herein, individually or collectively, by the term "disclosure" merely for convenience and without intending to voluntarily limit the scope of this application to any single disclosure or disclosed concept if more than one is in fact disclosed. Thus, although specific embodiments have been illustrated and described herein, any arrangement calculated to achieve the same purpose may be substituted for the specific embodiments shown. This disclosure is intended to cover any and all adaptations or variations of various embodiments. Combinations of the above embodiments, and other embodiments not specifically described herein, will be apparent to those of skill in the art upon reviewing the above description.