阅读说明：本技术 用于监测口腔矫治器的传感器 (Sensor for monitoring oral appliance ) 是由 Y·尚亚尼 B·卡姆 佐藤淳 于 2018-11-30 设计创作，主要内容包括：检测口腔矫治器(例如,对准器、腭扩张器、下颌重新定位装置等)的状态,以确定口腔矫治器是否正常运行和/或是否已经出现缺陷。(The state of an oral appliance (e.g., aligner, palatal expander, mandibular repositioning device, etc.) is detected to determine whether the oral appliance is functioning properly and/or whether a defect has occurred.)

1. An orthodontic appliance system, the system comprising:

a first orthodontic appliance configured to receive a patient's teeth;

a sensor receiver disposed on or in a first appliance, wherein the sensor receiver is configured to detect a signal from a sensor transmitter on another portion of the first appliance or on a second orthodontic appliance worn by a subject; and

at least one processor configured to receive sensor data from the sensor receiver and determine a relative position, orientation, or position and orientation between the sensor receiver and the sensor transmitter.

2. The system of claim 1, wherein the sensor receiver comprises one or more of: an optical sensor, an electromagnetic sensor, a capacitive sensor, or a magnetic sensor.

3. The system of claim 1, wherein the at least one processor is disposed on or within an orthodontic appliance.

4. The system of claim 1, wherein the at least one processor is coupled via electrical traces on or in the first orthodontic appliance.

5. The system of claim 1, wherein the first orthodontic appliance is removable.

6. The system of claim 1, further comprising a second orthodontic appliance, wherein the sensor transmitter is on or in the second orthodontic appliance.

7. The system of claim 6, wherein the first orthodontic appliance includes a first mandibular repositioning feature and the second orthodontic appliance includes a second mandibular repositioning feature, wherein the processor is configured to determine a relative position, orientation, or position and orientation between the first mandibular repositioning feature and the second mandibular repositioning feature.

8. The system of claim 1, further comprising wireless communication electronics disposed on or within the first orthodontic appliance, the wireless communication electronics configured to communicate the sensor data to the at least one processor.

9. The system of claim 1, wherein the orthodontic appliance comprises a polymeric shell having a plurality of tooth receiving cavities.

10. The system of claim 1, further comprising a non-transitory computer-readable storage medium configured to store sensor data.

11. The system of claim 1, wherein the at least one processor is configured to indicate an orthodontic appliance deformation.

12. The system of claim 1, wherein the at least one processor is configured to indicate that an orthodontic appliance is defective.

13. The system of claim 1, wherein the at least one processor is configured to indicate a sensor transmitter in close proximity to a sensor receiver.

14. The system of claim 1, wherein the at least one processor is configured to indicate that an orthodontic appliance is applying force to a patient's teeth.

15. The system of claim 1, wherein the first orthodontic appliance comprises a palatal expander.

16. The system of claim 1, wherein the first orthodontic appliance comprises a tooth aligner.

17. An orthodontic appliance system, the system comprising:

an orthodontic appliance configured to receive a patient's teeth;

a sensor emitter disposed on or in the orthosis at a first location;

a sensor receiver disposed on or in the appliance at a second location, wherein the sensor receiver is configured to detect a signal from the sensor transmitter; and

at least one processor configured to receive sensor data from the sensor receiver and determine a relative position, orientation, or position and orientation between the sensor receiver and the sensor transmitter.

18. A method for monitoring an orthodontic appliance, the method comprising:

positioning a first orthodontic appliance in the mouth of the patient such that the first orthodontic appliance receives at least some of the teeth of the patient;

emitting a signal from a sensor emitter within a patient's mouth;

receiving a signal with a sensor receiver on or in the first orthodontic appliance;

sending the signal to at least one processor;

determining a relative position, orientation, or position and orientation between the sensor receiver and the sensor transmitter; and

an indicator relating to a relative position direction, or position and direction, between the sensor receiver and the sensor transmitter is output.

19. The method of claim 18, wherein positioning the first orthodontic appliance comprises positioning the first orthodontic appliance with the sensor receiver on or in the first underbite repositioning feature.

20. The method of claim 18, wherein emitting a signal from a sensor emitter comprises emitting an electromagnetic signal or an optical signal.

21. The method of claim 18, wherein the electromagnetic signal comprises one or more of: electrical, magnetic, electrical current.

22. The method of claim 18, further comprising positioning a second orthodontic appliance in the mouth of the patient, wherein the sensor transmitter is on or in the second orthodontic appliance.

23. The method of claim 18, wherein emitting the signal comprises emitting the signal from a sensor emitter, further wherein the sensor emitter is on or in the first orthodontic appliance.

24. The method of claim 18, wherein transmitting the signal comprises wirelessly transmitting the signal.

25. The method of claim 18, wherein determining the relative position, orientation, or position and orientation between the sensor receiver and the sensor transmitter comprises indicating an orthodontic appliance deformation, and further wherein outputting an indicator related to the relative position orientation or position and orientation comprises outputting an orthodontic appliance deformation.

26. The method of claim 18, wherein determining the relative position, orientation, or position and orientation between the sensor receiver and the sensor transmitter comprises indicating that the orthodontic appliance is defective, and further wherein outputting an indicator related to the relative position orientation or position and orientation comprises outputting that the orthodontic appliance is defective.

27. The method of claim 18, wherein determining the relative position, orientation, or position and orientation between the sensor receiver and the sensor emitter comprises indicating that the sensor receiver is in close proximity to the sensor emitter, and further wherein outputting the indicator related to the relative position orientation or position and orientation comprises outputting the proximity between the sensor receiver and the sensor emitter.

28. The method of claim 18, wherein determining the relative position, orientation, or position and orientation between the sensor receiver and the sensor transmitter comprises indicating that the orthodontic appliance is applying a force to the patient's teeth, and further wherein outputting the indicator related to the relative position orientation or position and orientation comprises outputting that the orthodontic appliance is applying a force or outputting an applied force to the patient's teeth.

29. A method for monitoring an orthodontic appliance, the method comprising:

positioning a first orthodontic appliance in the mouth of the patient such that the first orthodontic appliance receives at least some of the teeth of the patient;

positioning a second orthodontic appliance in the mouth of the patient, wherein the second orthodontic appliance receives at least some of the teeth of the patient;

sending a signal from a sensor transmitter on or in the second orthodontic appliance;

receiving a signal with a sensor receiver on or in the first orthodontic appliance;

sending the signal to at least one processor;

determining, in a processor, a relative position, orientation, or position and orientation between a sensor receiver and a sensor transmitter; and

the relative positional orientation, or position and orientation, between the sensor receiver and the sensor transmitter is output from the processor.

30. An orthodontic apparatus comprising:

an intraoral appliance configured to receive a patient's teeth;

a first sensor disposed on or in the intraoral appliance;

a second sensor disposed on or in the intraoral appliance; and

at least one processor configured to receive sensor data from the first sensor and the second sensor and indicate a state of the orthodontic apparatus based on the sensor data.

31. The apparatus of claim 30, wherein the first and second sensors comprise one or more of: capacitive sensors, magnetic sensors, force sensors, pressure sensors and optical sensors.

32. The apparatus of claim 30, wherein the at least one processor is disposed on or within an intraoral appliance.

33. The apparatus according to claim 30, wherein the at least one processor is disposed on or within an electronic device remote from the orthodontic apparatus.

34. The device of claim 33, further comprising wireless communication electronics disposed on or within the first or second oral appliance, the wireless communication electronics configured to communicate sensor data from the first and second sensors to the at least one processor.

35. The apparatus of claim 30, wherein the intraoral appliance comprises a polymeric shell having a plurality of tooth receiving cavities.

36. The apparatus of claim 30, further comprising a non-transitory computer-readable storage medium configured to store sensor data from the first sensor and the second sensor.

37. The apparatus according to claim 30, wherein the at least one processor is configured to indicate orthodontic apparatus deformation.

38. The apparatus according to claim 30, wherein the at least one processor is configured to indicate that an orthodontic apparatus has a defect.

39. The apparatus of claim 30, wherein the at least one processor is configured to indicate that a first sensor is in close proximity to a second sensor.

40. The apparatus of claim 30, wherein the at least one processor is configured to indicate that an orthodontic apparatus is applying force to a patient's teeth.

41. The apparatus of claim 30, wherein the at least one processor is configured to indicate a position of a first sensor relative to a position of a second sensor.

42. A method for monitoring an orthodontic device, the method comprising:

positioning an intraoral appliance in a mouth of a patient, the intraoral appliance configured to receive teeth of the patient and comprising a plurality of sensors, each sensor positioned on or in a different portion of the intraoral appliance;

receiving a sensed parameter from each of the plurality of sensors; and

determining a state of the orthodontic device based on the sensed parameter.

43. The method of claim 42, wherein the sensed parameter comprises one or more of: capacitance, magnetic field, force measurement, voltage, and impedance.

44. The method of claim 42, wherein the determining step comprises determining whether the first portion of the intraoral appliance is properly aligned relative to the second portion of the intraoral appliance.

45. The method of claim 42, wherein the determining step comprises determining whether the intraoral appliance is deformed.

46. The method of claim 42, wherein the determining step comprises determining whether the intraoral appliance has a defect.

47. The method of claim 42, wherein the determining step comprises determining whether the intraoral appliance is applying an appropriate force to the patient's teeth.

48. A mandibular repositioning system, the system comprising:

a first intraoral appliance configured to receive the upper teeth of the patient and including a first lower jaw repositioning feature;

a first sensor disposed on or in the first underbite repositioning feature;

a second intraoral appliance configured to receive the lower teeth of the patient and including a second mandibular repositioning feature;

a second sensor disposed on or in the second mandibular repositioning feature;

at least one processor configured to receive sensor data from one or both of the first sensor and the second sensor to detect contact between the first mandibular repositioning feature and the second mandibular repositioning feature.

49. The system of claim 48, wherein the first and second sensors comprise one or more of: capacitive sensors, magnetic sensors, force sensors, pressure sensors and optical sensors.

50. The system of claim 48, wherein the at least one processor is disposed on or within a first intraoral appliance or a second intraoral appliance.

51. The system of claim 48, wherein the at least one processor is disposed on or within an electronic system remote from the first and second oral appliances.

52. The system of claim 4, further comprising wireless communication electronics disposed on or within the first or second oral appliance, the wireless communication electronics configured to communicate sensor data from the first and second sensors to the at least one processor.

53. The system of claim 48, wherein the first and second oral appliances comprise a polymeric shell having a plurality of tooth receiving cavities.

54. The system of claim 48, further comprising:

a third sensor disposed on or in the first underbite repositioning feature;

a fourth sensor disposed on or in the second mandibular repositioning feature;

wherein the first sensor is disposed on a first side of the first mandible repositioning feature, the third sensor is disposed on a second side of the first mandible repositioning feature, the second sensor is disposed on a first side of the second mandible repositioning feature, and the fourth sensor is disposed on a second side of the second mandible repositioning feature; and is

Wherein the at least one processor is configured to receive sensor data from the first sensor, the second sensor, the third sensor, and the fourth sensor to detect a proper orientation when the first sensor contacts the second sensor and a reverse orientation when the third sensor contacts the fourth sensor.

55. The system of claim 48, further comprising a non-transitory computer-readable storage medium configured to store sensor data from the first and second sensors.

56. A method for monitoring a mandibular repositioning system, the method comprising:

receiving the sensed parameters from a plurality of first sensors of a first orthodontic appliance worn in the mouth of the patient and a plurality of second sensors of a second orthodontic appliance worn in the mouth of the patient, wherein the first orthodontic appliance is configured to receive the upper teeth of the patient and includes a plurality of first sensors on or adjacent to a first positioning feature of the first intraoral appliance, and further wherein the second orthodontic appliance is configured to receive the lower teeth of the patient and includes a plurality of second sensors on or adjacent to a second positioning feature of the second intraoral appliance; and

engagement between the first and second locating features is determined based on the sensed parameter.

57. A palatal expander device comprising:

a palatal expander body including a palatal region and a tooth receiving region configured to receive teeth of an upper dental arch of a patient;

a sensor disposed on or in a palatal region of the palatal expander body;

at least one processor configured to receive sensor data from the sensor and determine an expansion state of the patient's palatal region based on the sensor data.

58. The apparatus of claim 57, wherein the sensor comprises one or more of: force sensor, optical sensor, strain gauge, capacitive electrode.

59. An apparatus as in claim 57, wherein the at least one processor is disposed on or within the palatal expander body.

60. An apparatus as in claim 57, where the at least one processor is disposed on or within an electronic device remote from the palatal expander device.

61. The device of claim 60, further comprising wireless communication electronics disposed on or within the first or second oral appliance, the wireless communication electronics configured to communicate sensor data from the sensors to the at least one processor.

62. The apparatus of claim 57, wherein the palatal expander body comprises a polymeric shell having a plurality of tooth receiving cavities.

63. An apparatus as in claim 57, wherein the at least one processor estimates a size of a median palatal suture of the patient based on the sensor data.

64. The apparatus of claim 57, wherein the at least one processor determines a change in deformation of the palatal expander device based on sensor data.

65. The apparatus of claim 57, wherein the at least one processor determines an expansion force of the palatal expander device based on sensor data.

66. A method of monitoring palatal expansion, the method comprising:

receiving sensor data from one or more sensors on a palatal expander device when the patient wears the palatal expander device, wherein the palatal expander device comprises a palatal expander body comprising a palatal region and a teeth receiving region, wherein the one or more sensors are on or in the palatal region;

monitoring sensor data from the sensor in a processor to determine an expanded state of the patient's palate based on the sensor data; and

an indicator of the expanded state of the patient's palate is output.

67. A method according to claim 66, wherein receiving sensor data includes receiving sensor data from the one or more sensors, including receiving sensor data from a pair of sensors positioned opposite a median palatal suture of the patient.

68. The method of claim 66, wherein receiving sensor data comprises receiving sensor data from the one or more sensors, including receiving sensor data from one or more optical sensors.

69. The method of claim 66, wherein receiving sensor data comprises receiving sensor data from the one or more sensors, including receiving sensor data from one or more capacitive sensors.

70. The method of claim 66, wherein monitoring comprises monitoring over a period of time greater than one day.

71. The method of claim 66, further comprising wirelessly transmitting the sensor data to one or more processors.

Technical Field

Described herein are oral appliances having one or more sensors, and methods of using the same.

Background

Orthodontic surgery generally involves repositioning a patient's teeth into a desired arrangement in order to correct malocclusions and/or improve aesthetics. To accomplish these objectives, orthodontic practitioners may apply orthodontic appliances, such as braces, shell aligners, etc., to a patient's teeth. The appliance may be configured to exert a force on one or more teeth in order to achieve a desired tooth movement according to a treatment plan.

During orthodontic treatment with a patient removable appliance, the appliance may not function properly due to defects or defects may occur during use. In some cases, the appliance may be improperly installed, formed, or operated by the practitioner. There is a need for methods and devices that allow for monitoring the status of an intraoral appliance. Methods and apparatus for performing such monitoring are described herein.

Disclosure of Invention

The devices described herein include apparatus and systems, particularly including orthodontic appliances (e.g., oral appliances) and methods for monitoring orthodontic appliances, including but not limited to monitoring parameters or conditions of orthodontic appliances.

In particular, described herein are oral appliances configured to determine whether they are worn correctly and/or function correctly when worn in a user's mouth. Applicants note that these devices (e.g., devices and systems that may include orthodontic aligners, mandibular repositioning devices, arch/palatal expanders, etc.) may be used as compliance monitors, including, but not limited to, that the patient is wearing the device and/or following orthodontic treatment. In particular, these devices can monitor the degree of contact of the device with the patient's mouth (including teeth, gums, palate, etc.). Alternatively or additionally, these devices may be configured to detect and/or monitor wear and/or damage of the devices. The apparatus may include one or more sensors that provide data to a processor (where the sensors may include sensor receivers and/or sensor transmitter and sensor receiver pairs); the processor may analyze (including real-time analysis) the degree to which the device is worn, wear of the device, damage to the device, etc. The processor may be part of an oral appliance worn by the patient, or the processor may be in communication (wired or wireless communication, including real-time or near real-time communication) with the oral appliance. Thus, any of the devices and methods described herein may determine and may signal or otherwise indicate an operational condition of the device.

Alternatively or additionally, monitoring includes monitoring the status of the appliance, monitoring wear of the appliance, monitoring the geographic/spatial location of the appliance, and the like. In some embodiments, the orthodontic appliance includes one or more sensors configured to acquire sensor data; these sensors may include sensors that indicate the status of the appliance. As used herein, the condition of the appliance may include, for example, how well the appliance fits the patient when worn, whether any damage or wear has occurred to the appliance, whether the appliance is defective, and the like. The appliance may include one or more processors operatively coupled to the sensors and configured to process the sensor data to indicate a status of the appliance, thereby enabling electronic monitoring of the appliance prior to and/or during a prescribed orthodontic treatment procedure. Advantageously, the devices (e.g., apparatus, systems, etc.) and methods described herein can improve treatment efficacy and provide data useful to practitioners in designing and monitoring orthodontic treatments.

For example, any of the devices described herein can be configured to include one or more tooth contact regions. An apparatus for monitoring a condition of an intraoral appliance may include an appliance shell including a plurality of tooth receiving regions (e.g., cavities), one or more sensors operatively coupled to the appliance shell and configured to generate sensor data indicative of the condition of the appliance (e.g., how well the appliance is in contact with the teeth, such as any gaps between the appliance and the teeth, buckling of the appliance, defects in the appliance such as tears, cracks, and/or runs outside a predetermined range of parameter values), and a processor operatively coupled to the one or more sensors and configured to process the sensor data to determine and/or indicate the condition of the appliance. The sensors can be configured to determine the quality of fit of the appliance, for example, by measuring contact (pressure, position, etc.) between the appliance and the oral cavity (e.g., teeth, gums, palate, etc.). For example, the sensors may include one or more capacitive or other electronic sensors within or on the appliance that indicate contact between the appliance and the user's teeth. Signals from such contact sensors may be received (continuously and/or periodically) to determine when contact is made with the patient's teeth and which portion of the appliance. The processor may be configured to analyze sensed data from one or more such sensors to determine appropriate contact with the device (e.g., of all or a predefined subset of the sensors in/on the appliance). A poorly adapted device may not be in full contact with all sensors or may be in contact with a subset of sensors that indicate poor contact. The processor may also be configured to check the strength of the contact and may indicate that the level of the signal (indicating contact/non-contact) is outside a range or threshold indicating good contact. The processor may record and/or transmit this information. In some variations, this information may be recorded for later use by a dental professional and/or may be used to alert the patient (e.g., via a display on a smartphone, tablet, etc., and/or via SMS, text message, etc.) that the appliance should be adjusted.

Thus, the devices and methods described herein may be configured to detect ("intelligently detect") engagement of the positioning features of the mandibular repositioning device, determine the rate of expansion of the palatal expander, or identify defects in the intraoral appliance. For example, as will be described in greater detail herein, any of the devices described herein can be configured with one or more sensors that detect interactions between different portions of an oral appliance and/or between different oral appliances or components of an oral appliance. For example, the mandibular repositioning device can include contact regions that engage a first oral appliance (e.g., a lower dental appliance) and a second oral appliance (e.g., an upper dental appliance). The devices described herein can detect and determine the interaction between the first oral appliance and the second oral appliance. For example, such devices may monitor occlusal interactions (e.g., cusp anastomoses) between the upper and lower arches. Sensors on one or both occlusal surfaces of the appliance may detect interaction with the opposing dental appliance or, in certain variations, with teeth on the opposing arch.

As mentioned, the methods and devices described herein may generally be used with or as part of any monitoring device for monitoring an orthodontic appliance. Monitoring may be continuous (e.g., always on), or may be at a fixed frequency (e.g., between 0.001Hz and 1KHz, between 1 and 120 times/hour, between 1 and 24 times/day, etc.), or at discrete times after insertion of the device. For example, described herein are devices that may be configured to record sensor data from an appliance, such as an orthodontic aligner.

In particular, orthodontic devices using them are described herein, including one or more sensors (e.g., temperature sensors, capacitance sensors, pressure sensors, etc.), one or more processors (e.g., CPU, etc.), a communication module (e.g., NFC communication module), an antenna, and a power source (e.g., battery, etc.), a housing or holder may be used to enhance and/or relay signals from a small monitoring device to a handheld device such as a smartphone.

In some examples, an orthodontic device including (or configured as) an intraoral appliance may generally be configured to monitor a condition of the intraoral appliance, and may include a housing enclosing a power source and a monitoring circuit, the monitoring circuit including: a processor, a memory and one or more sensors, and an elastomeric overmolding (overmold) surrounding the housing. In general, any of the orthodontic devices described herein can be sized to fit against or to fit over a tooth. Thus, the sensor(s) and any associated electronics (memory, processor, power source, etc.) may be compact and configured to not substantially intrude into the patient's mouth. For example, the maximum diameter of the housing that surrounds a portion of the sensor or attached electronics can be 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 be generally 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, e.g., may include a plurality of data electrodes external to the housing.

Although the methods and apparatus described herein include many examples of Near Field Communication (NFC), including NFC-to-NFC communications, any of the methods and apparatus 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 B L E), magnetic field induction (including NFC), Wimax, Zigbee, ultrasound, etc.

For example, described herein are orthodontic appliance systems that include a sensor (e.g., a pair of sensor transmitter and sensor receiver) that detects a relative position and/or orientation between the sensor transmitter and the sensor receiver. The sensor transmitter and sensor receiver may be used to determine a status of the orthodontic appliance (such as deformation of the orthodontic appliance, defects in the orthodontic appliance, etc.) and/or compliance with use of, for example, the orthodontic appliance. These orthodontic appliance systems may also be used to track the effectiveness of the appliances, including tracking tooth and/or palate movement.

For example, described herein is an orthodontic appliance system comprising: a first orthodontic appliance configured to receive a patient's teeth; a sensor receiver disposed on or in the first appliance, wherein the sensor receiver is configured to detect a signal from a sensor transmitter on another portion of the first appliance or on a second orthodontic appliance worn by the subject; and at least one processor configured to receive the sensor data from the sensor receiver and determine a relative position, orientation, or position and orientation between the sensor receiver and the sensor transmitter.

For example, an orthodontic appliance system may include: an orthodontic appliance configured to receive a patient's teeth; a sensor emitter disposed on or in the orthosis at a first location; a sensor receiver disposed on or in the appliance at a second location, wherein the sensor receiver is configured to detect a signal from the sensor transmitter; and at least one processor configured to receive the sensor data from the sensor receiver and determine a relative position, orientation, or position and orientation between the sensor receiver and the sensor transmitter.

In any of these devices, the sensor receiver and sensor transmitter may be configured to transmit and detect electromagnetic energy (e.g., current, voltage, electric field, magnetic field, etc.) and/or optical energy (e.g., light). For example, the sensor receiver may be one or more of: an optical sensor, an electromagnetic sensor, a capacitive sensor, or a magnetic sensor. The sensor transmitter may be configured to transmit electromagnetic energy and/or optical energy for detection by the sensor receiver. In some variations, the same sensor may be configured to be both a sensor receiver and a sensor transmitter. For example, the sensor transmitter may be an electrode configured to receive and/or transmit electrical energy (e.g., for detecting voltage, current, capacitance, etc.).

As mentioned, any of these systems may include at least one processor, which may be disposed on or within the orthodontic appliance; alternatively, the processor may be remotely located. For example, one processor may be coupled via electrical wiring on or in the first orthodontic appliance and/or may be in wireless communication with the sensor receiver.

The first and second orthodontic appliances may be removable. For example, the orthodontic appliance may include a polymeric shell having a plurality of tooth receiving cavities.

Any of these systems may include a second orthodontic appliance; the sensor transmitter may be on or in the second orthodontic appliance. Alternatively, the sensor transmitter may be on the same (e.g., first) orthodontic appliance as the sensor receiver.

In some variations, the system is configured to monitor repositioning of the mandible. For example, a first orthodontic appliance can include a first mandibular repositioning feature and a second orthodontic appliance can include a second mandibular repositioning feature; the processor may be configured to determine a relative position, orientation, or position and orientation between the first mandibular repositioning feature and the second mandibular repositioning feature.

Any of these systems can include wireless communication electronics disposed on or within the first orthodontic appliance configured to transmit the sensor data to the at least one processor.

Any of these systems may include a non-transitory computer-readable storage medium configured to store sensor data.

The at least one processor may be configured to indicate that the orthodontic appliance is one or more of: the deformed, defective, in close proximity to the sensor receiver, and/or the orthodontic appliance is applying a force to the patient's teeth. For example, the processor may be configured to detect a change in the relative position and/or orientation of the sensor receiver and the sensor transmitter based on the received signals; these changes can be monitored over time. In some variations, the one or more processors monitor a rate of change of the relative positions of the sensor transmitter and the sensor receiver.

The processor may convert signals from a sensor transmitter/sensor receiver pair (e.g., a sensor receiver) to a distance and/or intensity. For example, in some variations, the processor includes a memory that stores one or more look-up tables for converting sensor values to distances.

Generally, the orthodontic appliance may be, for example, a palatal expander, a dental aligner, or the like.

Also described herein are methods of monitoring an orthodontic appliance using any of the devices described herein. For example, a method of monitoring an orthodontic appliance may include: positioning a first orthodontic appliance in the mouth of the patient such that the first orthodontic appliance receives at least some of the teeth of the patient; emitting a signal from a sensor emitter within a patient's mouth; receiving a signal with a sensor receiver on or in the first orthodontic appliance; sending the signal to at least one processor; determining a relative position, orientation, or position and orientation between the sensor receiver and the sensor transmitter; and outputting an indicator related to a relative position direction, or a position and direction, between the sensor receiver and the sensor transmitter.

For example, a method for monitoring an orthodontic appliance may include: positioning a first orthodontic appliance in the mouth of the patient such that the first orthodontic appliance receives at least some of the teeth of the patient; placing a second orthodontic appliance in the mouth of the patient, wherein the second orthodontic appliance receives at least some of the teeth of the patient; sending a signal from a sensor transmitter on or in the second orthodontic appliance; receiving a signal with a sensor receiver on or in the first orthodontic appliance; sending the signal to at least one processor; determining, in a processor, a relative position, orientation, or position and orientation between a sensor receiver and a sensor transmitter; and outputting from the processor a relative positional orientation, or a position and orientation, between the sensor receiver and the sensor transmitter.

Positioning the first orthodontic appliance can include positioning the first orthodontic appliance with the sensor receiver on or in the first underbite repositioning feature.

Emitting a signal from the sensor emitter may include emitting an electromagnetic signal or an optical signal. For example, the electromagnetic signal may include one or more of the following: electrical, magnetic, electrical current.

Any of these methods may further include positioning a second orthodontic appliance in the mouth of the patient, wherein the sensor transmitter is on or in the second orthodontic appliance.

Emitting the signal may include emitting a signal from a sensor emitter, further wherein the sensor emitter is on or in the first orthodontic appliance. The transmission signal may include a wireless transmission signal.

Determining the relative position, orientation, or position and orientation between the sensor receiver and the sensor transmitter may include indicating that the orthodontic appliance is deformed, and further wherein outputting the indicator related to the relative position orientation or position and orientation may include outputting that the orthodontic appliance is deformed. Determining the relative position, orientation, or position and orientation between the sensor receiver and the sensor transmitter may include indicating that the orthodontic appliance is defective, and further wherein outputting the indicator related to the relative position orientation or position and orientation may include outputting that the orthodontic appliance is defective. Determining a relative position, orientation, or position and orientation between the sensor receiver and the sensor emitter may include indicating that the sensor receiver is in close proximity to the sensor emitter, and further wherein outputting an indicator related to the relative position orientation or position and orientation may include outputting a proximity between the sensor receiver and the sensor emitter. In some variations, determining the relative position, orientation, or position and orientation between the sensor receiver and the sensor transmitter comprises indicating that the orthodontic appliance is applying a force to the patient's teeth, and further wherein outputting the indicator related to the relative position orientation or position and orientation comprises outputting that the orthodontic appliance is applying a force or outputting an applied force to the patient's teeth.

The indicators related to the relative position, orientation, or position and orientation between the sensor receiver and the sensor transmitter may include numerical indicators (e.g., position values, coordinates, rate of change over time, etc.) with or without units, and/or indicators that the position and/or orientation between the sensor transmitter and the sensor receiver (or a portion of the first and/or second orthodontic appliance to which they are connected) has not changed, has changed, or has changed to a certain extent or degree.

Methods, systems, and devices for indicating one or more conditions of an orthodontic appliance are also described herein. For example, described herein is an orthodontic device comprising: an intraoral appliance configured to receive a patient's teeth; a first sensor disposed on or in the intraoral appliance; a second sensor disposed on or in the intraoral appliance; and at least one processor configured to receive the sensor data from the first sensor and the second sensor and indicate a state of the orthodontic apparatus based on the sensor data. The first sensor and the second sensor comprise one or more of: capacitive sensors, magnetic sensors, force sensors, pressure sensors and optical sensors.

As described above, the at least one processor may be disposed on or within the intraoral appliance. The at least one processor may be disposed on or within the electronic device remote from the orthodontic device. For example, the devices may include wireless communication electronics disposed on or within the first or second oral appliance that are configured to communicate sensor data from the first and second sensors to the at least one processor.

The intraoral appliance may include a polymeric shell having a plurality of tooth receiving cavities. The apparatus may include a non-transitory computer-readable storage medium configured to store sensor data from a first sensor and a second sensor. The at least one processor may be configured to indicate that the orthodontic apparatus is deformed. The at least one processor may be configured to indicate that the orthodontic apparatus has a defect.

The at least one processor may be configured to indicate that the first sensor is in close proximity to the second sensor. The at least one processor is configured to indicate that the orthodontic apparatus is applying force to a tooth of a patient. The at least one processor may be configured to indicate a position of the first sensor relative to a position of the second sensor.

Methods for monitoring orthodontic devices are also described herein. For example, a method may include: positioning an intraoral appliance in a mouth of a patient, the intraoral appliance configured to receive teeth of the patient and comprising a plurality of sensors, each sensor positioned on or in a different portion of the intraoral appliance; receiving a sensed parameter from each of a plurality of sensors; and determining a state of the orthodontic device based on the sensed parameter. The sensed parameters may include one or more of the following: capacitance, magnetic field, force measurement, voltage, and impedance. The determining step can include determining whether the first portion of the intraoral appliance is properly aligned relative to the second portion of the intraoral appliance. The determining step can include determining whether the intraoral appliance is deformed.

The determining step can include determining whether the intraoral appliance has a defect. The determining step can include determining whether the intraoral appliance is applying an appropriate force to the patient's teeth.

As described above, any of these methods and apparatus may be configured to monitor the repositioning of the mandible using an orthodontic appliance. For example, the correct interaction between the mandibular repositioning features of the appliance is determined.

The mandibular repositioning system may include: a first intraoral appliance configured to receive the upper teeth of the patient and including a first lower jaw repositioning feature; a first sensor disposed on or in the first underbite repositioning feature; a second intraoral appliance configured to receive the lower teeth of the patient and including a second mandibular repositioning feature; a second sensor disposed on or in the second mandibular repositioning feature; at least one processor configured to receive sensor data from one or both of the first sensor and the second sensor to detect contact between the first mandibular repositioning feature and the second mandibular repositioning feature. The first and second sensors may include one or more of: capacitive sensors, magnetic sensors, force sensors, pressure sensors and optical sensors.

The at least one processor may be disposed on or within the first oral appliance or the second oral appliance. The at least one processor may be disposed on or within an electronic system remote from the first and second oral appliances. Any of these systems can include wireless communication electronics disposed on or within the first oral appliance or the second oral appliance that are configured to communicate sensor data from the first sensor and the second sensor to the at least one processor.

The first and second oral appliances may include a polymeric shell having a plurality of tooth receiving cavities.

In some variations, the system further comprises a third sensor disposed on or in the first underbite repositioning feature; a fourth sensor disposed on or in the second mandibular repositioning feature; wherein the first sensor is disposed on a first side of the first mandibular repositioning feature, the third sensor is disposed on a second side of the first mandibular repositioning feature, the second sensor is disposed on a first side of the second mandibular repositioning feature, and the fourth sensor is disposed on a second side of the second mandibular repositioning feature; wherein the at least one processor is configured to receive sensor data from the first sensor, the second sensor, the third sensor, and the fourth sensor to detect a proper orientation when the first sensor contacts the second sensor and a reverse orientation when the third sensor contacts the fourth sensor.

Also described herein is a method for monitoring a mandibular repositioning system, the method comprising: receiving the sensed parameters from a plurality of first sensors of a first orthodontic appliance worn in the mouth of the patient and a plurality of second sensors of a second orthodontic appliance worn in the mouth of the patient, wherein the first orthodontic appliance is configured to receive the upper teeth of the patient and includes a plurality of first sensors on or adjacent to a first locating feature of the first intraoral appliance, and further wherein the second orthodontic appliance is configured to receive the lower teeth of the patient and includes a plurality of second sensors on or adjacent to a second locating feature of the second intraoral appliance; and determining engagement between the first and second locating features based on the sensed parameter.

Also described herein are devices (apparatus and systems) for monitoring palatal expansion by detecting movement/separation of a palatal slit, including detection while applying a force to expand the palatal slit. For example, a palatal expander device as described herein includes: a palatal expander body including a palatal region and a tooth receiving region configured to receive teeth of an upper dental arch of a patient; a sensor disposed on or in a palatal region of the palatal expander body; at least one processor configured to receive sensor data from the sensor and determine an expansion state of the patient's palatal region based on the sensor data. The sensor may comprise one or more of the following: force sensor, optical sensor, strain gauge, capacitive electrode. The at least one processor may be disposed on or within the palatal expander body.

The at least one processor may be located on or within electronics remote from the palatal expander device. Any of these devices may include wireless communication electronics disposed on or within the first or second oral appliance that are configured to communicate sensor data from the sensors to the at least one processor. The palatal expander body may include a polymeric shell having a plurality of tooth receiving cavities. The at least one processor may estimate a size of a median palatal suture of the patient based on the sensor data. For example, the at least one processor can determine a change in deformation of the palatal expander device based on the sensor data. In some variations, the at least one processor determines an expansion force of the palatal expander device based on the sensor data.

Also described herein is a method of monitoring palatal expansion, the method comprising: receiving sensor data from one or more sensors on a palatal expander device while a patient wears the palatal expander device, wherein the palatal expander comprises a palatal expander body including a palatal region and a teeth receiving region, wherein the one or more sensors are on or in the palatal region; monitoring sensor data from the sensor in a processor to determine an expanded state of the patient's palate based on the sensor data; and outputting an indicator of the expanded state of the patient's palate.

Receiving sensor data may include receiving sensor data from one or more sensors, including receiving sensor data from a pair of sensors positioned opposite a median palatal suture of the patient. Receiving sensor data may include receiving sensor data from one or more sensors, including receiving sensor data from one or more optical sensors.

Receiving sensor data may include receiving sensor data from one or more sensors, including receiving sensor data from one or more capacitive sensors. Monitoring may include monitoring over a period of more than one day (e.g., more than 24 hours, 36 hours, 48 hours, 3 days, 4 days, 5 days, etc.). Monitoring may be continuous (e.g., at periodic intervals, such as 100Hz, 10Hz, 1/minute, every 2 minutes, every 3 minutes, every 5 minutes, every 10 minutes, every 30 minutes, every hour, etc.) or at discrete intervals (e.g., upon user demand, etc.). As described above, any of these methods may include wirelessly transmitting the sensor data to one or more processors.

Drawings

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

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

Fig. 1B-1D illustrate examples of tooth repositioning systems.

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

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

Fig. 4 illustrates a flow chart showing a method for monitoring an orthodontic device.

Fig. 5A illustrates a first example of an apparatus including an aligner appliance configured to determine and/or monitor a state of the aligner.

Fig. 5B shows a second example of an apparatus comprising a pair of aligners (upper, lower) configured to determine the state of the aligners.

Fig. 6A-6B illustrate one embodiment of an orthodontic apparatus including a mandibular repositioning apparatus.

Fig. 6C-6E show examples of mandibular repositioning devices that can detect both proper and reverse engagement of positioning features.

Fig. 7 is an example of a portion of a mandibular repositioning device that includes engagement features with pairs of sensors (e.g., capacitive sensors).

Fig. 7A-7B illustrate operation of the sensors of the mandibular repositioning device (exaggerated) shown in fig. 7 configured to assess the quality of the device.

FIG. 8 illustrates a dental appliance having sensors that can detect defects in the appliance.

FIG. 9A is an example of a scan made through a patient's head showing the thickness of the palatal mucosa at the slit in the palate; in some variations, the devices described herein may be configured as a palatal expander that includes one or more sensors. The sensor may be configured to determine the thickness of the palatal slit region and/or the state of the palatal expander.

Fig. 9B is an example of a palatal expander device that may be adapted to include one or more sensors for determining the nature of the palate and/or the state of the palatal expander, as described herein.

Figs. 10A-10F show examples of palatal expander devices that may include any number or type of sensors to determine the expansion state of the palatal expander device based on sensor data.

Detailed Description

The orthodontic devices described herein are configured to determine a state of the orthodontic device based on sensor data. The state of an orthodontic device generally refers to the operational condition of the device. For example, the state of an orthodontic device may refer to a state of patient contact of an orthodontic appliance, including the degree and/or duration of contact with a relevant portion of the patient's oral cavity (teeth, gums, palate, etc.) and/or the degree and/or duration of contact with another orthodontic device or another region of an orthodontic device. Alternatively or additionally, the state of the orthodontic device may refer to the state of the integrity of the orthodontic appliance, including detecting and/or monitoring any damage or defect (e.g., breakage, tear, cavity, etc.) in the device.

Any of the apparatuses described herein may be configured to monitor one or more of: the operation of the orthodontic appliance (including status, e.g., operational status), and/or monitoring compliance of the user with wearing the appliance, and/or monitoring the overall wear or condition of the orthodontic appliance, and/or monitoring the interaction between the appliance and the patient's anatomy (e.g., teeth, gums, palate, etc.).

Typically, these devices include one or more orthodontic appliances and one or more sensors on the orthodontic appliances configured to detect one or more parameters that can be used to determine the status of the orthodontic device. The one or more sensors may be configured based on their location on and/or in the orthodontic appliance and/or based on their shape and size, and/or based on the type of sensor. Any suitable type of sensor may be used, including: electrical sensors (e.g., detecting capacitance, conductance, etc.), force sensors (e.g., detecting pressure, strain, etc.), thermal sensors, and the like. Examples of sensors are provided herein. The sensor may be embedded within the orthodontic device and oriented to directly sense a characteristic of the orthodontic appliance rather than the patient. For example, the sensor may be oriented away from the patient and toward the body of the orthodontic appliance.

Any of these devices may include one or more processors configured to communicate with one or more sensors. The processor may be attached to and/or integral with the orthodontic appliance. For example, the processor may receive sensor input from one or more sensors and may send control commands to activate/deactivate and/or modulate the sensors. The processor may control the timing of the sensing. The processor may adjust the power. The processor may also include or be connected to a memory for storing data (raw data and/or processed data). The processor may also be functionally connected to a communication module (e.g., a wireless communication circuit, such as bluetooth, WiFi, etc.).

As will be described in greater detail below, the processor may analyze sensor data from the one or more sensors to determine a state of the orthodontic device. The analysis of the sensor data may be performed on one or more processors attached to (on or in) the orthodontic appliance, or one or more processors (including an off-apply processor) may be used to analyze or further analyze the data to determine the status of the orthodontic appliance.

For example, the orthodontic device may record sensor data from an intraoral appliance (such as a tooth/orthodontic aligner, including a shell aligner). Data recorded by the orthodontic device may be stored in physical memory on the device and may be retrieved by another device. In particular, the described data may be retrieved by a handheld electronic communication device, such as a smartphone, tablet, or the like. The handheld electronic device may include a user interface to enhance communication between the orthodontic device and the electronic device, and may provide feedback to a user (e.g., a patient) and/or a technician, physician, dentist, orthodontist, or other medical/dental practitioner. Once the data is transmitted to the handheld device, the data may be processed (or further processed) and/or transferred to a remote processor, memory, and/or server.

As mentioned, the apparatus and methods described herein for monitoring an orthodontic appliance (e.g., a removable intraoral appliance) can generate sensor data related to the intraoral appliance. The sensor data may be processed and analyzed to determine if the appliance is functioning properly or has a defect. Additionally, sensor data may be used to provide information about the status of the device. Advantageously, the devices and methods described herein may provide an integrated electronic sensing and recording system capable of generating more reliable and accurate patient compliance data that may be used by an attending physician to track the status of orthodontic devices and improve treatment efficacy. Additionally, the orthodontic devices described herein can provide high value sensory data useful for appliance design. In some embodiments, the sensed data provided by the orthodontic devices described herein can be used as feedback to modify parameters of the ongoing orthodontic treatment, also referred to as an adaptive closed-loop treatment plan. For example, information about contact between the appliance and the patient's mouth and/or information about defects or wear in the appliance may be used to determine whether a replacement or modified version of the appliance should be used.

As mentioned, in any of the methods and devices described herein, all or some of the sensor data of the state of the orthodontic device may be used as feedback to a treatment plan that includes the treatment plan of which the appliance is a part from which the sensor data is collected. For example, sensor data indicative of relative changes in position and/or orientation of one or more portions of the appliance may be used to estimate and/or approximate movement of all or part of the patient's dentition, and this information may be used to modify the treatment plan, including duration of one or more stages, modification of one or more current and/or future stages, and so forth. Any of these methods and apparatus may provide feedback to the patient and/or user (e.g., doctor, dentist, orthodontist, technician, etc.) regarding the performance of the appliance and/or treatment plan. The feedback may be reported and/or implemented in real time or after a time delay.

In any of the methods and devices described herein, one or more sensors for detecting the status of the orthodontic device can be used to refine the treatment plan. Refining the treatment plan may include reducing or eliminating the number of modifications to the original treatment plan and/or extending the duration of the treatment plan (the overall or progressive duration of one or more phases). For example, using one or more sensors to detect the state of the orthodontic device may provide feedback that may be used to adjust the treatment plan or one or more stages of the treatment plan on-the-fly, which may reduce the total number of adjustments needed. In some variations, the treatment plan may be adjusted based on sensor data of the state of the orthodontic device to further adjust a subsequently worn orthodontic appliance; if the sensor data indicates that, for example, a portion of the aligner is under strain or stress that exceeds an expected value, this may indicate that the teeth, groups of teeth, and/or palatal regions have not moved in response to the force being applied by the appliance. Thus, the system or apparatus may adjust the treatment plan accordingly, for example by: by wearing the appliance until the force on the appliance and/or the relative position or orientation (of all or regions) of the appliance is within a determined range, and/or by providing additional appliances that can account for the changes according to a desired value.

The orthodontic device may be any orthodontic device, system, etc., including, inter alia, an orthodontic appliance, such as an aligner, a palatal expander, and/or a mandibular repositioning device. The orthodontic devices described herein may be removable (e.g., by the patient), or they may be attachable (e.g., by a dental professional). The orthodontic device may include a plurality of orthodontic appliances, including an upper arch appliance and a lower arch appliance. In some variations, the devices and methods described herein may detect interactions between a plurality of individual orthodontic appliances. Examples of each of these variations are described in detail below.

The various embodiments described herein may be used as part of or in conjunction with various types of intraoral appliances worn in a patient's mouth. The intraoral appliance may be an orthodontic appliance, such as an aligner or an archwire-bracket appliance (wire-and-rack appliance), for repositioning one or more teeth of a patient to a desired alignment, for example, for correcting malocclusions. Alternatively or additionally, an intraoral appliance (e.g., a retainer) may be used to hold one or more teeth of the patient in the current arrangement. Other examples of intraoral appliances suitable for use in conjunction with embodiments herein include mouthguards, mandibular repositioning devices, and palatal expanders.

An appliance having tooth receiving cavities that receive and can reposition teeth, such as by applying force, is generally shown with respect to fig. 1A. Fig. 1A illustrates an exemplary tooth repositioning appliance or aligner 100 that can be worn by a patient to achieve progressive repositioning of individual teeth 102 in the jaw. The appliance may include a shell having tooth receiving cavities that receive and resiliently reposition the teeth. The appliance or a portion thereof may be manufactured indirectly using a physical model of the teeth. For example, an appliance (e.g., a polymeric appliance) may be formed using a physical model of the teeth and a suitable sheet of polymeric material. In some embodiments, the physical appliances are fabricated directly from digital models of the appliances, for example, using rapid prototyping techniques.

Although appliances such as those shown in fig. 1A-1D may be referred to as polymeric shell appliances, the embodiments disclosed herein are well suited for use with many appliances that receive teeth (e.g., appliances without one or more polymers or shells, or shells with partial tooth receiving regions). The orthosis may be manufactured from one or more of a number of materials, such as metal, glass, reinforced fibre, carbon fibre, composite, reinforced composite, aluminium, biomaterial and combinations thereof. The appliance may be configured in a variety of ways, such as by thermoforming or direct manufacturing (e.g., 3D printing, additive manufacturing). Alternatively or in combination, the orthosis can be manufactured by machining, for example from a block of material using computer numerical control machining.

Correction applianceIn some cases, only some of the teeth that the appliance houses will be repositioned by the appliance, while other teeth may provide a base or anchor region to hold the appliance in place when the appliance applies force against the teeth as repositioned [ in some cases, the portion, or even all of the teeth, that are moved may also be used as a base or anchor to hold the appliance when the appliance is worn on the patient's appliance [ in general, no line or other means is provided for holding the appliance in place on the teeth ] however, in some cases, it may be possible or provided on anchor portion 102 or other anchor portion that is provided on anchor portion 102 or other anchor portion that may be provided on a patient's appliance, such as found in the patent application Ser. No. 3, No. 10, No. 3, including the patent application for example Align appliance for patent application No. 100, No. 3, No. 4, No. 6, including the subject to include a listing for example, No. 100, No. 3, to include a listing for a listing of an appliance for purposes of an appliance including a person to include a person and a person to include an appliance for purposes of an appliance for example, and a person to include a person to hold anThose used in the System. Examples of tooth-mounted attachments suitable for use with orthodontic appliances are also described in patents and patent applications assigned to alaien technologies, inc, including, for example, U.S. patent nos. 6,309,215 and 6,830,450.

Appliances such as those shown in fig. 1A may also be used as platforms or supports for other oral appliances that do not move teeth (or move teeth in addition to other therapeutic effects), but may, for example, adjust the bite or reshape the palate. For example, the mandibular repositioning device may include pairs of body regions that also include tooth receiving cavities within shell-like structures (one for the upper jaw and one for the lower jaw) that are configured to be secured over or on the patient's teeth. The tooth receiving portion can provide support against which other areas, such as locating features, can be supported. Similarly, the palatal expander device may include one or more tooth receiving portions in addition to a palatal region configured to be adjacent to a patient's palate.

1B-1D illustrate an example of a tooth repositioning system 110 (configured as a series of aligners) that includes a plurality of appliances 112, 114, 116. Any of the appliances described herein can be designed and/or configured 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 the intermediate or final tooth arrangement intended for the appliance. The patient's teeth may be gradually repositioned from the initial tooth arrangement to the target tooth arrangement by placing a series of incremental position adjustment devices on the patient's teeth. For example, the tooth repositioning system 110 can 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 of the patient's teeth during orthodontic treatment, which may include a variety of different treatment scenarios, including but not limited to the following: proposed surgery situations, situations where interproximal stripping (IPR) is appropriate, situations where scheduled checks are made, situations where anchor placement is optimal, situations where palatal expansion is desired, situations involving restorative dentistry (e.g., inlays, onlays, crowns, bridges, implants, veneers, etc.), and the like. Thus, it will be appreciated that the target tooth arrangement may be the resultant arrangement of any planning of the patient's teeth following one or more progressive repositioning stages. Likewise, the initial tooth arrangement may be any initial arrangement of the patient's teeth followed by one or more progressive repositioning stages.

The various embodiments of the orthodontic appliances presented herein can be manufactured in a variety of ways. As an 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 an orthodontic appliance may involve the following steps: a male or female mold of the patient's dentition in the target arrangement is produced (e.g., by rapid prototyping, milling, etc.), and one or more pieces of material are thermoformed over the mold to produce the appliance shell. Alternatively or in combination, some embodiments of the appliances herein can be fabricated directly, e.g., using rapid prototyping, stereolithography, 3D printing, etc.

The configuration of the orthodontic appliances herein can be determined according to a treatment plan for the patient (e.g., a treatment plan that involves the sequential application of multiple appliances to incrementally reposition teeth). Computer-based therapy planning and/or appliance manufacturing methods may be used to facilitate appliance design and manufacture. For example, one or more of the appliance components described herein can be designed and manufactured digitally with the aid of a computer controlled manufacturing device (e.g., Computer Numerical Control (CNC) milling, computer controlled rapid prototyping (e.g., 3D printing), etc.). The computer-based methods 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, when properly worn, can apply a force to the crown of the tooth and/or an attachment located on the tooth at one or more points of contact between the tooth receiving cavity of the appliance and the received tooth and/or attachment. 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. Types of tooth movement include squeezing, intrusion, rotation, tipping, translation, and root movement, and combinations thereof, as discussed further herein. Tooth movement of the crown greater than the movement of the root may be referred to as tipping. Equal movement of the crown and root may be referred to as translation. A movement of the tooth root greater than a movement of the crown may be referred to as a tooth root movement.

Fig. 2 illustrates a method 200 of orthodontic treatment using multiple appliances, according to an embodiment. The method 200 may be practiced using any of the appliances or sets of appliances described herein. In step 210, a first orthodontic appliance is applied to the 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 can be repeated using any suitable number and combination of sequential appliances as desired to incrementally reposition the patient's teeth from the initial arrangement to the target arrangement. These appliances may be manufactured in groups or in batches (e.g., at the beginning of a treatment session) at the same stage or point in time, or one appliance may be manufactured at a time, and the patient may wear each appliance until the pressure of each appliance on the teeth is no longer felt or until the maximum amount of tooth movement exhibited for that given stage has been reached. A plurality of different appliances (e.g., a kit) can be designed or even manufactured before a patient wears any one 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 there are no more appliances. The appliance is typically not fixed to the teeth, and the patient can place and replace the appliance at any time during treatment (e.g., a patient-removable appliance). The final appliance or appliances in the series may have one or more geometries selected for overcorrected tooth alignment. For example, one or more of the appliances may have a geometry that, if fully implemented, would move individual teeth beyond the tooth arrangement that has been selected as the "final". Such overcorrection may be required in order to counteract potential recurrence after the repositioning method has ended (e.g., to allow individual teeth to move back toward their pre-corrected positions). Overcorrection can also be beneficial to speed up the correction (e.g., an appliance with a geometry that is placed beyond the desired intermediate or final position can move each tooth toward that position at a greater rate). In this case, the use of the appliance may be terminated before the teeth reach the positions determined by the appliance. In addition, over-correction may be intentionally made to compensate for any inaccuracies or limitations of the appliance.

However, predictable and effective tooth movement using an aligner such as those described above may implicitly depend on good contact between the patient's teeth and the aligner. Thus, the efficacy of treatment may depend at least in part on fit, the ability of the patient to correctly wear the device, and the integrity of the device itself. Thus, the methods and devices described herein that can detect and monitor these parameters can improve patient treatment and outcome.

The intraoral appliance may be operatively coupled to a monitoring device configured to provide data relating to the status of the intraoral appliance. Alternatively or in combination, the monitoring device may be configured to provide data indicative of one or more characteristics of the device, such as an electrical parameter, elasticity, a defect such as a bubble or crack, an appliance-applied force, or a deformation of an appliance. The characteristics of the intraoral appliance may determine the condition of the appliance.

The devices described herein may include an oral appliance (e.g., aligner, palatal expander, etc.) and a condition monitoring subsystem including one or more of the following: sensors, processors, memory, communication circuitry (including antennas), clocks, power sources (e.g., batteries, capacitors, inductors, etc.), and connections and/or circuitry for communicating and/or coordinating between these components. The condition monitoring subsystem may be at least partially integrated into the oral appliance. For example, the devices described herein may be configured for use in a patient's mouth by locating and sizing monitoring subsystems used within the mouth. For example, as described below, the size of the monitoring device may be limited to avoid patient discomfort and/or to facilitate integration into the intraoral appliance. In some embodiments, the height or thickness of the monitoring device is less than or equal to about 1.5mm, or less than or equal to about 2 mm. In some embodiments, the length or width of the monitoring device is 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 less than or equal to about 5 mm.

Fig. 3 schematically illustrates an orthodontic apparatus 300, the orthodontic apparatus 300 including an intraoral appliance configured to be worn on one or more of a patient's teeth, gums, and/or palate 301 and a condition monitoring subsystem 302. The condition monitoring subsystem may include an electronics module ("ECI") 303 that interfaces or interacts with one or more sensors on the appliance. The orthodontic device 300 can be used in conjunction with any embodiment of the systems and devices described herein, and the components of the orthodontic device 300 can be equally applicable to any other embodiment of the orthodontic device described herein. All or a portion of the status monitoring subsystem 303 of the orthodontic device 300, such as the electronic module 303, can be implemented as an Application Specific Integrated Circuit (ASIC) including one or more of the following: a processor 302, a memory 304, a clock 308, a communication unit 310, an antenna 312, a power management unit 314, or a power supply 316. The one or more sensors 306 may be included as part of (e.g., integrated with) the electronics, or they may be separate and may be connected by one or more electrical traces (e.g., wires or other traces). The 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 that are 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 orthodontic device 300 can include any number of sensors 306, for example, 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 in 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-related 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 moisture sensors, physiological sensors (e.g., electrocardiogram sensors, bioimpedance sensors, photoplethysmograph sensors, galvanic skin response sensors), or combinations thereof. In some embodiments, the sensors herein may be configured as switches that are enabled and/or disabled in response to certain types of signals (e.g., optical, electrical, magnetic, mechanical, etc.).

In any of the devices and methods described herein, the sensor can be configured to sense or detect a change in orientation of the appliance and/or one or more regions of the appliance relative to one or more other regions of the appliance. For example, the sensor may be a gyroscope (e.g., a microelectromechanical system ("MEMS") gyroscope or any other suitable gyroscope and/or accelerometer, and/or any other suitable movement sensor.

The sensors 306 can be located at any portion of the intraoral appliance, for example, at or near the distal portion, the mesial portion, the buccal portion, the lingual portion, the gingival portion, the occlusal portion, or combinations thereof. The sensors 306 may be embedded in the appliance, including in any of these regions or portions. In embodiments using multiple sensors 306, some or all of the sensors may be located at different portions of the appliance and/or the oral cavity. Alternatively, 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, the processor 302 can process sensor data obtained by the sensors 306 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 orthodontic device 300 can include a communication unit 310, the communication unit 310 configured to transmit data (e.g., sensor data and/or processing results) stored in the memory to a remote device. The communication unit 310 may utilize any suitable communication method, for example, a wired or wireless communication method (e.g., RFID, near field communication, bluetooth, ZigBee, infrared, etc.). The communication unit 310 may include a transmitter and antenna 312 for transmitting data 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 utilized by the communication unit 310 may also be used to power the apparatus 300, for example during data transfer or if the apparatus 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 ("in the cloud") a cloud computing system. The remote device may be associated with a patient, attending physician, researcher, etc. In some embodiments, the remote device is configured to process and analyze data from the monitoring device 300, for example, to monitor patient compliance and/or appliance usage, for research purposes, and the like.

The orthodontic device 300 can be powered by a power source 316, such as a battery. In some embodiments, 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 oxynitride battery. The use of printed and/or flexible batteries may be advantageous to reduce the overall size of the condition monitoring subsystem of the orthodontic device 300 and avoid patient discomfort. For example, the printed batteries may be manufactured in various shapes and may be stacked to produce a three-dimensional structure, for example to conform to the geometry of the appliances and/or teeth. Also, the flexible battery may be configured to be flush with the surface of the tooth and/or appliance. Alternatively or in combination, other types of batteries, such as supercapacitors, may be used. In some embodiments, the power source 316 can utilize a lower power energy harvesting method (e.g., thermodynamic, electrodynamic, piezoelectric) to generate power for the orthodontic device 300. Alternatively, the power supply 316 may be rechargeable, for example, using through-hole induction or wireless methods. In some embodiments, the patient may recharge the power source 316 when the appliance is not in use. For example, when brushing, the patient may remove the intraoral appliance and place the appliance on an inductive power hub to recharge the power supply 316.

Optionally, the orthodontic apparatus 300 can include a power management unit 314 connected to a power source 316. The power management unit 314 may be configured to control when a status monitoring subsystem of the apparatus 300 is active (e.g., using power from the power supply 316) and when the apparatus 300 is inactive (e.g., not using power from the power supply 316). In some embodiments, the orthodontic apparatus 300 is only active at certain times to reduce power consumption and reduce the size of the power supply 316, thereby allowing for a smaller condition monitoring subsystem 302. In some embodiments, the orthodontic apparatus 300 includes an activation mechanism (not shown) for controlling when the status monitoring subsystem of the orthodontic apparatus 300 is in an active state (e.g., powered on, monitoring appliance usage) and when the status monitoring subsystem of the orthodontic apparatus 300 is in a dormant state (e.g., powered off, not monitoring appliance usage). The activation mechanism may be provided as a separate component of the orthodontic apparatus 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 orthodontic apparatus 300, for example, by deactivating the apparatus 300 when not in use, which may facilitate reducing the size of the power source 316, and thus the size of the overall apparatus.

The sensors (or any other portion of the condition monitoring subsystem) can be operatively coupled to the intraoral appliance in a variety of ways. For example, the sensors can be physically integrated with the intraoral appliance by coupling the sensors to a portion of the appliance (e.g., using adhesives, fasteners, latches, lamination, molding, etc.) and/or embedding them within the device (e.g., either while or after forming the device). For example, the coupling may be a releasable coupling to allow removal of the monitoring device from the appliance, or may be a permanent coupling in which the monitoring device is permanently secured to the appliance. Alternatively or in combination, the sensors may be physically integrated with the intraoral appliance by encapsulating, embedding, printing, or otherwise forming the monitoring device with the appliance. In some embodiments, the orthosis includes a shell configured to receive the teeth of the patient, and the sensor may be physically integrated with the shell. The sensor may be located on an inner surface of the housing (e.g., a surface adjacent to the received tooth), on another 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 configured to receive the sensor, as discussed further herein.

The orthodontic device as described herein may include: an intraoral appliance configured to receive a patient's teeth; a first sensor disposed on or in the intraoral appliance; a second sensor disposed on or in the intraoral appliance; and at least one processor configured to receive sensor data from the first sensor and the second sensor and indicate a state of the orthodontic apparatus based on the sensor data.

In general, the processor may be adapted or otherwise configured to receive and process sensor data and use the sensor data to determine one or more parameters of a condition of the orthodontic appliance as part of the apparatus, e.g., a condition of contact of a patient of the orthodontic appliance and/or a condition of integrity of the orthodontic appliance. The processor may include a non-volatile memory containing instructions (e.g., software, firmware, etc.) for performing any of the steps described herein, including controlling the sensors and receiving sensor data, and/or processing the data to determine a status of the appliance (e.g., a status of the integrity of the appliance or a quality of contact with the patient). For example, the at least one processor may be configured to indicate that the orthodontic device has been damaged, worn, and/or deformed. Additionally, the processor may be configured to indicate that the orthodontic apparatus has a defect. In some examples, the at least one processor is configured to indicate that the orthodontic apparatus is applying the appropriate force to the patient's teeth. Additionally, the at least one processor may be configured to indicate a position of the first sensor relative to a position of the second sensor.

In any of the apparatuses described herein, the apparatus may determine whether the first region (corresponding to the first sensor) is within a predetermined distance of the second region (corresponding to the second sensor), indicating that the apparatus is properly worn and/or operated. For example, if the orthodontic apparatus is a mandibular repositioning apparatus, the processor may be configured to indicate that the first sensor is in close proximity to the second sensor to determine whether the positioning features of the apparatus are properly engaged.

Fig. 4 illustrates a flow chart 400, which flow chart 400 illustrates an example of a method for monitoring an orthodontic appliance to determine a status of an orthodontic appliance forming a portion of the appliance (e.g., a status of contact by a patient of the orthodontic appliance and/or a status of integrity of the orthodontic appliance). At step 402 of flowchart 400, the method may include positioning an intraoral device in a mouth of a patient. The intraoral appliance may include an appliance configured to receive a patient's teeth, and may include a plurality of sensors, each sensor positioned within the intraoral appliance to sense a characteristic of the appliance. In some examples, the intraoral appliance is a dental appliance. The apparatus may include an upper arch aligner configured to receive upper teeth of a patient and a lower arch aligner configured to receive lower teeth of the patient. In another example, the intraoral device may include a mandibular repositioning appliance (e.g., device). The mandibular repositioning device may include repositioning features that are configured to engage one another. In yet another example, the intraoral appliance may include a palatal dilator device.

At step 404 of flowchart 400, the method may further include receiving a sensed value from each of the plurality of sensors. The sensed value may be a parameter sensed by any of a number of different types of sensors. For example, a capacitive sensor may provide a capacitance value, a magnetic sensor may provide a direction or magnitude of a magnetic field, a light sensor may provide an output current corresponding to a sensed light intensity (at a particular frequency or range of frequencies), a force sensor or strain gauge may provide a force value, and an ultrasonic sensor may provide a duration of a return pulse. These sensed values may be sent to a processor in the appliance (or separate from the appliance) and used to determine parameters indicative of the condition of the appliance. For example, at step 406 of flowchart 400, the method can include determining a state of the orthodontic device based on the sensed values. For example, in one example, the determining step comprises determining whether a first portion of an intraoral appliance is properly aligned relative to a second portion of the intraoral appliance. In another example, the determining step includes determining whether the intraoral appliance is deformed. In yet another example, the determining step includes determining whether the intraoral appliance has a defect. In additional examples, the determining step includes determining whether the intraoral appliance is applying an appropriate force to the patient's teeth. In another variation, the determining includes determining whether the appliance is properly placed on the patient's teeth, gums, and/or palate. In any of the devices (apparatus and systems) described herein, one or more optical sensors may be used to detect movement and/or position of one or more areas of the device relative to other areas. For example, an optical sensor may be used to detect expansion of the palatal/arch expander.

Having determined one or more parameters indicative of the status of the device, the device may transmit the status 408 and/or parameters of the device to a remote device for display, storage, and/or further transmission. For example, the device may be sent to a mobile device (e.g., phone, smartphone, tablet, etc.) held by the patient and/or to a dental professional (dentist, orthodontist, etc.).

Fig. 5 illustrates a first example of an apparatus including an orthodontic apparatus configured to determine, monitor, and indicate a state of the orthodontic apparatus. In this example, the orthodontic device is an aligner (e.g., a shell aligner) configured to receive a patient's teeth. The aligner 550 includes a tooth receiving region 551. The tooth receiving area may be a channel configured to substantially conform to a patient's teeth. The channel may have communicating chambers, each chamber including a negative impression of one of the patient's teeth (buccal, lingual and occlusal). These chambers may be formed from scans or impressions of the patient's teeth and may be arranged to apply force to reposition one or more of the patient's teeth while worn. In this example, the apparatus may be configured to detect and/or monitor and/or indicate a status of the aligner, and more particularly, a status of contact by a patient of the orthodontic appliance. As shown in FIG. 5A, a plurality of sensors 553 are shown within the bite path of the tooth receiving area 551. These sensors are configured to detect contact or proximity to teeth housed in each region (e.g., chamber) of the aligner. For example, each sensor may include a capacitive sensor, or a pair of electrodes configured to detect capacitance; the sensors may detect proximity to the sensors, which may each return a value corresponding to the proximity of the teeth when the device is worn (e.g., a voltage or current level based on the detected capacitance). In operation, such an arrangement, as shown in fig. 5A, in which a sensor configured as a proximity sensor or a contact sensor is disposed in the deepest portion of the tooth receiving region 551, may provide a series of values that may be used to determine whether the aligner is fully and correctly positioned on all of the teeth of the patient. The sensors may be paired sensor transmitters and sensor receivers or may be combined transmitters/receivers. In some variations, the sensor transmitter may be adjacent to the sensor receiver.

The apparatus of fig. 5A may also include any subsystem for determining the status of an orthodontic appliance (e.g., aligner). For example, in fig. 5A, the device includes a plurality of sensors 553, each sensor 553 being connected (by conductive traces, wires, etc.) to a housing 555, the housing 555 enclosing one or more of: a processor, memory, communication circuitry (e.g., an antenna), a clock, a power source (e.g., a battery, a capacitor, an inductor, etc.). Although a capacitive sensor (touch sensor) is shown in fig. 5A, any suitable type of sensor may be used, or multiple types of sensors may be used.

In fig. 5A, the processor may be configured to receive a value (capacitance value) from the sensor and may control the application of energy to the sensor to determine the capacitance value. The processor may process each sensor for a number of different positions corresponding to different teeth and/or regions of the aligner. The plurality of values may be compared to a threshold value or series of values to determine the degree of seating of the tooth/teeth at each position. The values may be normalized by one or more normalization sensors 557 (e.g., additional contact sensors), the normalization sensors 557 being located more laterally on the aligner (e.g., lingual or buccal sides). Accordingly, the processor may be configured to receive sensor data from the first sensor and the second sensor and indicate a state of the orthodontic apparatus based on the sensor data. The state of the aligner may indicate that the aligner is well seated (above a threshold with a contact sensor), poorly seated (which may be a single value or a level of values depending on the depth of seating of the teeth in some or all of the cavities forming the tooth receiving areas), or not seated (when not worn). Thus, while the devices may provide compliance information (worn/not worn), the devices may also provide a host of additional information about the operating conditions of the device, including the placement or application of the device. In some variations, the parameter indicative of the state of the aligner may include a map showing the extent of placement of the appliance on the dental arch; the time course of placement of the information may be recorded and reviewed (e.g., single night/day use, etc.).

Fig. 5B is another example of an apparatus configured to determine a condition of one or more appliances forming the apparatus. In fig. 5B, the device includes pairs of aligners, an upper arch aligner 561 and a lower arch aligner 563. The apparatus may be configured to detect cusp anastomosis (interdiction) between the upper and lower aligners. In this example, the lower aligner 563 includes a plurality of sensors 565 that can detect contact with predetermined locations on the upper aligner. For example, the upper aligner may also include a plurality of sensors 565', which may return values when a particular specific cusp anastomosis is achieved. In some variations, the upper sensor 565' may be a sensor transmitter and the lower sensor 565 may be a sensor receiver (or vice versa); in some variations, a mixture of complementary sensor receivers and sensor transmitters may be distributed between the upper and lower appliances. In some variations, a composite sensor (e.g., both sensor transmitter/sensor receiver sensors) may be used. The values may be tracked (as an array, correlated to location) and may be determined over time. When wearing the aligner, the processor may analyze the values to determine the quality of contact between the upper and lower jaws. As shown in fig. 5A, one or both of the upper and lower aligners may include any subsystem for determining the status of an orthodontic appliance (in this example, the cusp anastomosis between the two appliances) that may be duplicated between the two aligners or possibly shared between the two aligners. In fig. 5B, separate housings 575, 575' may enclose separate processors, power supplies, etc., and the two subsystems may communicate with each other.

Fig. 6A-6B illustrate one embodiment of an orthodontic apparatus including a mandibular repositioning appliance 500 as described herein. The mandibular repositioning appliance 500 may include a first intraoral appliance 502 and a second intraoral appliance 504, which may be part of a shell aligner configured to be secured to teeth and/or may reposition teeth and may be configured to receive the upper and lower teeth, respectively, of a patient. Each intraoral appliance may include locating features 506, 506' configured to engage one another. The interaction between the positioning features can drive the jaw (e.g., the patient's lower jaw) to provide an orthodontic effect. The at least one locating feature in the device may include at least one sensor 508. In fig. 6A, both the upper and lower locating features include sensors. These sensors may detect contact and/or proximity between opposing locating features and provide information about the proper function of the device, e.g., engagement between locating features from the proper side/location. In fig. 6A, the orthodontic apparatus can further include any additional components of at least one processor and sensing subsystem, as described in more detail above.

Fig. 6B is an alternative view of a first or upper appliance 502 'of an intraoral device 500' that includes a locating feature 506. The locating features may include sensors 508; in this example, the sensor includes two portions (e.g., pairs of electrodes 518, 518'). The sensor may be any type of sensor described herein. For example, the sensor may be a capacitive sensor, a magnetic sensor, a force sensor, a button sensor, a resistive sensor. As mentioned above, these sensors may be configured as sensor emitters/sensor receivers or as pairs of sensor emitters/sensor receivers.

Referring back to fig. 6A, the sensors of the first and second oral appliances may provide sensor data to the processor. The processor may be configured to use the sensor data to determine a state of the mandibular repositioning device. For example, the sensor data can be used to determine whether the positioning features of the first and second oral appliances are properly engaged. A sensor on the mating face of the locating feature can detect contact between the upper and lower locating features. In addition to contact, more advanced sensors can also detect the distance between locating features.

Fig. 6C-6E show examples of mandibular repositioning device 500 "that can detect either the correct engagement of the positioning feature as described above (shown in fig. 6D) or the reverse engagement as shown in fig. 6E. In the example of fig. 6C, the sensors 528, 528', 538' are positioned on opposite sides of the locating feature 506. Fig. 6D and 6E illustrate the operation of the mandibular repositioning device. In fig. 6D and 6E, sensors 548, 548' and 558, 558' are located on either side of each locating feature 506, 506 '. The processor may then determine which sensors are in contact or in close proximity to determine whether the mandibular repositioning device is properly engaged (fig. 6D) or reversely engaged (fig. 6E).

The sensors of the mandibular repositioning device may also include additional sensors, such as sensors configured as compliance indicators (e.g., temperature sensors or accelerometers to give an indication of head position and whether an appliance is being worn, etc.). The processor may be configured to use the additional compliance indicator to determine that engagement is only assessed when the appliance is worn by the patient. Thus, the mandibular repositioning device 500 may be configured to detect compliance and correct use by detecting engagement of the positioning features while the patient is wearing the appliance.

Fig. 7 shows another example of a portion of a mandibular repositioning device that includes a sensor (configured as a pair of electrodes 708, 708'). Referring to fig. 7A-7B, sensors 708, 708' of the orthodontic device can also be used to assess device quality (e.g., structural integrity, defects, etc.). For example, large unsupported thermoformed features (similar to the mandibular positioning features of fig. 6A-6E) may deform during treatment. Sensors (e.g., capacitive sensors) can be used to detect deformation of the intraoral appliance. Referring to fig. 7A, the appliance may include one or more capacitive sensors 708, 708' that sense electrostatic field lines 710. In fig. 7B, the capacitive sensor is capable of detecting a change in the electric field, which the processor uses to determine whether the appliance is bent or deformed by sensing a change in the electrostatic field lines.

In addition, the sensors may be used to detect defects within the appliance, such as bubbles or cracks. Referring to fig. 8, the sensors 808 in the appliance may detect the relative permittivity; the processor receiving this value may detect changes in the relative dielectric constant of the appliance material over time due to bubbles or cracks in the appliance. The processor may include one or more thresholds indicative of usage and/or defects. In fig. 8, defect 712 is an inclusion (inclusion) or manufacturing defect; defects may occur during use and/or storage, including delamination of the different layers of the device, tearing of the device, entrapment of air bubbles, etc. These defects may negatively impact the performance and/or fit of the device. In some variations, the orthosis may comprise a material which may disadvantageously absorb water (saliva), particularly in the region where the seal should be maintained. For example, a sealed area for housing electrical components (batteries, wires, electronics, etc.) may be inadvertently opened to exposure to saliva; one or more sensors may detect the failure mode and alert the patient and/or caregiver. In variations that include mandibular repositioning features, for example, a cavity or region of the appliance (e.g., in the hollow region) may collect saliva, which may be undesirable (e.g., allowing bacteria to grow, etc.). One or more sensors may detect the collection of fluid. Alternatively or additionally, any of these devices may include one or more sensors configured to detect bacterial growth or other contamination.

In any of these variations, the appliance may include one or more temperature sensors, which may be used to monitor the storage temperature. A temperature sensor on the device may be configured to monitor the temperature of the device to indicate that the stored temperature is not outside of a safe storage range (e.g., greater than 120 degrees fahrenheit, greater than 125 degrees fahrenheit, greater than 130 degrees fahrenheit, greater than 140 degrees fahrenheit, greater than 150 degrees fahrenheit, greater than 160 degrees fahrenheit, greater than 170 degrees fahrenheit, etc., and/or less than 50 degrees fahrenheit, less than 40 degrees fahrenheit, less than 30 degrees fahrenheit, less than 20 degrees fahrenheit, less than 10 degrees fahrenheit, less than 5 degrees fahrenheit, less than 0 degrees fahrenheit, etc.).

Thus, the devices and methods described herein may be used with any one or more of the palatal and/or arch expanders. For example, the methods and apparatus described herein may generally utilize the patient's anatomy (e.g., teeth, gums, palate, etc.) for monitoring the operation (including, but not limited to, the state of operation) of appliances (including, but not limited to, palate expanders), and/or monitoring the compliance of a user wearing appliances (including, but not limited to, palate expanders), and/or monitoring the overall wear or condition of orthodontic appliances (including, but not limited to, palate expanders), and/or monitoring interactions between appliances (including, but not limited to, palate expanders).

Fig. 9A-9B illustrate palatal expanders that may be configured to monitor and/or determine compliance (e.g., compliance when a patient wears the device) and/or the status of the appliance. For example, FIG. 9A shows a scan through a patient's head showing mucosal tissue at the slit in the palate (arrows). In this region, the tissue may be very thin, and the devices described herein may be configured to determine the palatal slit opening stage using capacitive electrodes. For example, the electrostatic field may be formed by capacitive electrodes in the soft palate area. Using this technique, the palatal expander can be monitored during treatment without the need for CT. Fig. 9B shows an example of a palatal expander formed similar to an aligner, including tooth retention regions 903 (regions on either side of the device may be configured to conform to molars and/or premolars of a patient) and palatal regions 905, which palatal regions 905 may be configured to be adjacent to the palate and exert a force on the lingual and/or lateral palates of the teeth to expand the raphe.

Fig. 10A-10F illustrate examples of palatal expander devices 1000, which palatal expander devices 1000 may include any number or type of sensors 1008 for monitoring operation of the palatal expander, monitoring compliance of a user wearing the palatal expander, monitoring the overall wear or condition of the palatal expander, and/or monitoring interaction between the palatal expander and a patient's anatomy. Any of these sensors may be configured as the sensor transmitter and/or sensor receiver described herein.

For example, fig. 10A shows a cross-section through an exemplary palatal expander 1000 worn over a subject's dental arch 1009, including the area worn over the teeth 1011. In this example, sensors (two pairs of sensors 1007, 1008 are shown) can be used to determine the expansion state of the palatal expander device based on sensor data. In fig. 10A, the sensor pair can detect compliance with wearing the palatal expander; either or both of first sensor pair 1007 and second sensor pair 1007 can be capacitive sensors that can detect changes in the field between any of the sensors in the sensor pair. Thus, for example, when a patient wears a palatal expander, the sensor (which may be an electrode) may determine a change in capacitance of the paired capacitive sensor that is consistent with dental tissue as compared to air or water alone. Alternatively, in some variations, the palatal expander may detect a change in capacitance between the electrodes in the first pair 1007 and the electrodes in the second pair 1008, which may indicate a change in the structural integrity of the palatal expander. Any of the devices may include a data processing unit (e.g., an electronic module, not shown) that is connected to the sensors and may provide power and receive and/or process signals from the sensors. The electronic monitor may record data (e.g., configured as a data recorder), process the data, and/or transmit the data to a remote processor, e.g., including a remote server. The device comprising the data processing unit may store and/or monitor the use of the device over time, including alerting the user, caregiver and/or patient if the appliance is not being worn for a specified duration.

Fig. 10B shows an example of a palatal expander device including one or more sensors configured to monitor the interaction between the palatal expander and the anatomy of a patient. In fig. 10B, the sensor may include an optical sensor 1008' (e.g., including an emitter and a detector in some variations) that may determine one or more of the following based on the optical contrast between soft and hard tissue and/or blood flow: distance to tissue (e.g., palate), and/or a midline opening. In some variations, an ultrasonic sensor may be used. The device, including any data processing unit (not shown), may store and/or monitor changes in the patient's tissue versus the device over time. For example, the device may monitor the movement/expansion of the slit opening in the palate and/or the distance between the device and the palate as the palate dilator operates over time. This data may be analyzed locally (e.g., in a data processing unit) or remotely, and may be used as feedback to a patient, user, and/or caregiver and/or may be used as feedback to an orthodontic treatment plan, including modifying the orthodontic treatment plan.

The palatal expander device 1000 of FIG. 10C illustrates another example of a device that includes a sensor for detecting a relationship between the device and patient tissue. As described above, the sensor may include a plurality of capacitive electrodes, and/or in certain variations, the sensor may include an optical sensor (e.g., optical receiver 1008 "and optical transmitter 1008"'). The device may be configured to detect the extent of mucosal tissue at the palatal slit, allowing the processor to detect the palatal slit opening when the sensor applies an electrostatic field using capacitive electrodes on an appliance positioned opposite the soft palate region, as described in fig. 10B. Using this technique, palatal expansion can be monitored during treatment without the need for CT. In general, the devices and methods described herein, and in particular the palatal expander, may allow for direct monitoring of the midline in real time.

Fig. 10D is an example of a palatal expander device configured to monitor operation of the palatal expander. In fig. 10D, sensor 1018 can include one or more capacitive electrodes configured to provide a value that can be used by the processor to monitor changes in the deformation of the palatal expander; this information may be used, for example, to determine the degree and rate at which dilation occurs. This can be measured by tracking the change in capacitance measured between the capacitive sensor electrodes in the dilator device. The sensor may be positioned on the palatal expander in such a way that the distance between the capacitive electrodes changes as expansion occurs. For example, sensor 1018 may be placed at the midline of the palatal segment. The ultrasonic sensor can also be used as a replacement for capacitive electrodes to track the expansion of the palatal expander. Alternatively or additionally, in some variations, the sensor may be configured to measure operation of the device to determine whether the palatal expander includes a break, crack, wear, etc., and thus the overall wear or condition of the palatal expander may be monitored.

Thus, any of the devices described herein can be configured to detect a malfunction (e.g., a failure mode) of a device such as a palatal dilator device. For example, palatal expanders such as those described herein may fail if the palatal region deforms under the force (pressure) applied to the device when the device is inserted into the mouth of a patient. One or more sensors on the device (such as those described with reference to fig. 10D) may detect deformation based on, for example, the position of various regions of the device relative to each other (e.g., the position of the left half of the palatal region relative to the right half).

Fig. 10F shows another example of a palatal expander device configured to monitor operation of the palatal expander. For example, if no force is applied, or if the applied pressure is less than an expected threshold (e.g., less than 8N), the device shown in fig. 10F may be used to directly detect the force applied by the device. In fig. 10F, the apparatus includes a sensor 1028 (e.g., a strain gauge) that detects stress on the palatal expander or a region of the palatal expander (e.g., a region of the palate configured to be worn adjacent to the patient's palate). In some variations, the forces acting on the device may be stored, analyzed and/or transmitted by a data processing unit (not shown); for example, the device may be configured to monitor a force across the device, which may be representative of a force exerted by a patient's teeth and/or palate region when the device is worn; it is contemplated that these forces may be reduced in a desired manner (e.g., in a predictable manner) as the patient's teeth and palate adjust and adapt to the appliance. Accordingly, the sensor values may be analyzed to determine a change in the values over time to indicate the wearing of the appliance (e.g., compliance, when the device is worn in the mouth of a patient) and/or the operation of the appliance (e.g., when the appliance is moving the teeth and/or palate). The rate of change of the applied force may be within a predicted range indicating effective treatment, or outside of the predicted range (below and/or in some cases above) compared to expected, which may indicate that treatment is problematic, especially if the absolute force applied is higher than expected.

In some of these devices, one or more sensors may be configured to detect compliance (e.g., the patient wears the device) when: the sensor is used to infer the wearing of the device from changes in the sensor value when monitoring the sensor itself. This may be particularly beneficial in comparison to direct compliance measurements, where the relationship between the device and the patient, and in particular between the sensor and the patient, may be variable, making reliable contact difficult; the internal anatomy of the mouth (including the teeth, gums, and palate) can be complex, making certain sensors (e.g., flat electrodes) difficult to function reliably. The methods and apparatus described herein may avoid these problems. In general, variations described herein that may be used to monitor or measure compliance may also be configured to monitor the quality of compliance, including the degree of wear or fit of the device in the patient's mouth. If the sensor values are outside of the expected parameter range, an improper fit may be detected from the sensor values, particularly when the device is worn.

Referring to fig. 10E and 10F, the sensor may be, for example, a strain gauge or force sensor, and may be placed at a force application region (e.g., the lingual side of the crown or a palate contact region) to monitor the expansion force of the palatal expander device. Sensor data from strain gauges or force sensors may be used to determine the expanded state of the device.

In some of these devices, one or more sensors may be configured to detect compliance (e.g., the patient wears the device) when: the sensor is used to infer the wearing of the device from changes in the sensor value when monitoring the sensor itself. This may be particularly beneficial in comparison to direct compliance measurements, where the relationship between the device and the patient, and in particular between the sensor and the patient, may be variable, making reliable contact difficult; the internal anatomy of the mouth (including the teeth, gums, and palate) can be complex, making certain sensors (e.g., flat electrodes) difficult to function reliably. The methods and apparatus described herein may avoid these problems. In general, variations described herein that may be used to monitor or measure compliance may also be configured to monitor the quality of compliance, including the degree of wear or fit of the device in the patient's mouth. If the sensor values are outside of the expected parameter range, an improper fit may be detected from the sensor values, particularly when the device is worn. Any of the devices described herein can, for example, be configured to detect retention of an appliance (e.g., aligner, palatal expander, etc.) on a patient's teeth.

When a feature or element is referred to herein as being "on" another feature or element, it can be directly on the other feature or element, and/or intervening features and/or elements may also be present. In contrast, when a feature or element is referred to as being "directly on" another feature or element, there are no intervening features or elements present. It will also 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 also recognize that references to a structure or feature 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 invention. 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 "/".

For ease of description, spatially relative terms, such as "below," "lower," "above," and "upper," may be used herein to describe one element or feature's relationship to another element(s) or feature(s) as illustrated in the figures. 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 "below" or "beneath" other elements or features would then be oriented "above" the other elements or features. Thus, the exemplary term "below" can encompass both an orientation of above and below. 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 illustrative purposes only, 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 feature/element from another feature/element. 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 invention.

In this specification and the appended claims, unless the context requires otherwise, the word "comprise", and variations such as "comprises" and "comprising", mean that the various components may be used in combination in the process and article of manufacture (e.g., compositions and devices including the device and process). 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.

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

As used herein in the specification and claims, including as used in the examples, unless otherwise expressly specified, all numbers may be read as if prefaced by the word "about" or "approximately", even if the term does not expressly appear. The phrases "about" or "approximately" may be used when describing magnitude 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 may have a value that is +/-0.1% of the value (or range of values), +/-1% of the value (or range of values), +/-2% of the value (or range of values), +/-5% of the value (or range of values), +/-10% of the value (or range of values), and the like. Any numerical value given herein is also to be understood as encompassing approximately that value or approximately that value, unless the context dictates 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 is well understood by those skilled in the art, the values "less than or equal to," greater than or equal to, "and possible ranges between the values are also disclosed. 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 points 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 is understood that greater than, greater than or equal to, less than or equal to, and equal to 10 and 15 and between 10 and 15 are considered disclosed. It should also be 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 invention 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 apparatus 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. The term "invention" may be used herein, individually or collectively, to refer to these embodiments of the inventive subject matter for convenience only and is not intended to limit the scope of this application to any single invention or inventive 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.