BACKGROUND

Clear tray aligners, also referred to as aligners, are a set of orthodontic appliances for incrementally moving teeth when worn by the user (patient). The user wears each aligner for a set amount of time, for example one to two weeks, before wearing the next aligner in the set, and this process is repeated until the completement of treatment. The success and time duration of treatment depends in part upon the compliance of the user in wearing the aligners as instructed. And the healthcare provider has to rely upon the user’s feedback concerning such compliance with the treatment plan. Accordingly, a need exists for a more objective way to measure compliance and to measure other factors concerning the aligners when worn by the user.

SUMMARY

A first aligner with an integrated data capture device includes an aligner configured to be worn over the teeth of a user and to move the teeth when worn by the user for a particular amount of time. A data capture device is located within or attached to the aligner, and the data capture device includes a temperature sensor, a battery, and a microcontroller electrically connected with the temperature sensor and battery. The microcontroller is configured to receive a temperature reading from the temperature sensor and wirelessly transmit the temperature reading.

A second aligner with an integrated data capture device includes an aligner configured to be worn over the teeth of a user and to move the teeth when worn by the user for a particular amount of time. A data capture device is located within or attached to the aligner, and the data capture device includes a plurality of strain sensors, a battery, and a microcontroller electrically connected with the plurality of strain sensors and battery. The microcontroller is configured to receive strain sensors data from the plurality of strain sensors when the aligner is worn by the user and wirelessly transmit the strain sensors data.

A mobile device can be used for receiving data from the first or second aligners. The mobile device is configured to wirelessly receive data, including temperature readings, from the first or second aligner. The mobile device uses the temperature readings to determine an amount of time the aligner was worn by the user and presents to the user a notification relating to the such time. The mobile device can also receive strain sensors data from strain sensors in the aligner, via the data capture device, and reconstruct the strain states of the aligner using the strain sensors data.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a block diagram of a system for use with an aligner having an integrated data capture device. FIG. 2 is a diagram an aligner having a first data capture device.

FIG. 3 is a block diagram of the first data capture device.

FIG. 4 is a flow chart of a method for using the first data capture device.

FIG. 5 is a diagram an aligner having a second data capture device.

FIG. 6 is a block diagram of the second data capture device.

FIG. 7 is a flow chart of a method for using the second data capture device.

DETAILED DESCRIPTION

Embodiments of this invention include adding sensors to orthodontic aligners for remote tracking of compliance and algorithms for determining aligner fit and treatment progress from the strain state of an aligner.

FIG. 1 is a block diagram of a system for use with an aligner 10 having an integrated data capture device. Aligner 10 includes an integrated data capture device that can wirelessly transmit data concerning the aligner to a mobile device 12 such as mobile phone, tablet computer, or other computing device. Mobile device 12 can transmit the data to a provider computer 16, such as a healthcare provider, optionally through a cloud computer 14.

FIG. 2 is a diagram an aligner 18 having a first data capture device. Aligner 18 includes a data capture device 20 having temperature sensor and typically being encapsulated or embedded within the material of aligner 18. Data capture device 20 can optionally be used with one or more other sensors 22 located in aligner 18 and electrically connected with data capture device 20 by, for example, a thin metal wire. Sensors 22 can be embedded within the material of aligner 18 in order to be exposed to the oral environment when aligner 18 is worn by a user in order to measure conditions within the oral environment. Sensors 22 can record one or more of the following within the oral environment: temperature; moisture level; pH; sugar/glucose content; normal flora count or bacteria; and discoloration of the aligner over time with exposure to the oral environment.

FIG. 3 is a block diagram of first data capture device 20. Device 20 includes a microcontroller 28 and a temperature sensor 24 and optional other sensors 26, corresponding with sensors 22, each electrically connected with microcontroller 28. A battery 34 provides power to microcontroller 28, optionally through a regulator 32 such as a voltage regulator to control the voltage provided to microcontroller 28 and conserve power. Microcontroller 28 is electrically connected with a radio/antenna 30 for wirelessly transmitting data from temperature sensor 24 and optional other sensors 26. Radio/antenna 30 can be implemented with, for example, BLUETOOTH technology for short range communications. An exemplary microcontroller is the nRF52832 product, which contains a microcontroller, radio, and antenna in one package. Microcontroller 28 and radio/antenna 30 can be implemented with other products or components for performing the recited functions. Temperature sensor 24 can be implemented with any sensor for taking a temperature reading and having a suitable form factor for the aligner. The other sensor(s) 26 can be implemented with any sensors for measuring the corresponding condition in the oral environment and having a suitable form factor for the aligner.

The components 24, 28, 30, 32, and 34 are typically encapsulated within the material of aligner 18, as represented by the dashed line, in order to protect and secure the components. The optional other sensors 26 are typically only embedded within aligner 18 so that other sensors 26 are exposed to the oral environment when aligner 18 is worn by a user in order to measure conditions within the oral environment. Alternatively, data capture device 20 and optional sensors 22 can be implemented as an attachment to aligner 18.

FIG. 4 is a flow chart of a method for using first data capture device 20. This method can be implemented, for example, in software or firmware for execution by a processor in mobile device 12. The software to execute this method can be available, for example, as a software application (“app”) that the user can download to mobile device 12.

The method of FIG. 4 includes mobile device 12 receiving a temperature reading and optionally other sensor data from data capture device 20 (step 40). In particular, microcontroller 28 wirelessly transmits the temperature and sensor data via radio/antenna 30 to mobile device 12. The temperature readings can be received by microcontroller 28 both when aligner 18 is worn by the user and when aligner 18 is not being worn. Using the temperature reading and optionally other sensor data, the method determines when the user was wearing the aligner and saves the compliance history (step 42). For instance, by monitoring and saving the temperature data over time, possibly including the date and time information, the method can determine an amount of time the aligner was worn by the user based upon changes in temperature. Mobile device 12 can send the compliance history, temperature reading, and other sensor data to provider computer 16 optionally through cloud computer or service 14 (step 44).

Tables 1-3 include exemplary data structures for storing, respectively, the temperature data, other sensor(s) data, and compliance history. These data structures or other storage methods can be used to electronically store the associated data in mobile device 12, provider computer 16, or both.

In return, mobile device 12 can receive aligner information from provider computer 16 (step 46). In particular, the healthcare provider can remotely monitor the user’s compliance and determine when the user should switch to their next aligner in the treatment plan. The healthcare provider can optionally provide other aligner information based upon data received from the other sensor(s) 26. Mobile device 12 presents one or more notifications to the user (step 48). For example, the method can present the user’s compliance history to the user and can present notifications to the user to encourage them to meet their wear time goals. The method can also be used to communicate to the user when it is time for them to switch to their next aligner. These notifications can be presented, for example, in visual form on a display device in mobile device 12, in audible form using a speaker in mobile device 12, or both.

Table 4 includes an exemplary data structure for storing notifications along with sample notifications as recited. This data structure or other storage methods can be used to electronically store the notifications in mobile device 12, provider computer 16, or both.

The method of FIG. 4 can be repeated to periodically receive the temperature reading and other sensors data from data capture device 20. Also, data capture device 20 can optionally store multiple temperature readings and other sensor data recorded at different times and transmit the stored readings and data to mobile device 12.

FIG. 5 is a diagram an aligner 50 having a second data capture device. Aligner 50 includes a data capture device 52 electrically connected with strain sensors 54, 56, and 58 by, for example, thin metal wires. Data capture device 52 and strain sensors 54, 56, and 58 are typically encapsulated within the material for aligner 50. Only three strain sensors are shown for illustrative purposes only; more or fewer strain sensors can be used. Each strain sensor can be associated with a particular tooth, as shown, or a set of teeth in order to measure strain states for the associated tooth or teeth. In some embodiments, strain sensors can be associated with the teeth on a two-to- one or more basis, two or more strain sensors for each tooth.

FIG. 6 is a block diagram of second data capture device 52. Device 52 includes a microcontroller 66 and strain sensors 60, 62, and 64, corresponding with strain sensors 54, 56, and 58, each electrically connected with microcontroller 66. A battery 72 provides power to microcontroller 66, optionally through a regulator 70 such as a voltage regulator to control the voltage provided to microcontroller 66 and conserve power. Microcontroller 66 is electrically connected with a radio/antenna 68 for wirelessly transmitting data from strain sensors 60, 62, and 64. Radio/antenna 68 can be implemented with, for example, BLUETOOTH technology for short range communications. An exemplary microcontroller is the nRF52832 product, which contains a microcontroller, radio, and antenna in one package. Microcontroller 66 and radio/antenna 68 can be implemented with other products or components for performing the recited functions. Strain sensors 60, 62, and 64, can be implemented with any sensor or strain gauge for taking a strain measurement and having suitable form factors for the aligner.

The components 60, 62, 64, 66, 68, 70, and 72 are typically encapsulated within aligner 50, as represented by the dashed line, in order to protect and secure the components. Alternatively, data capture device 50 and strain sensors 54, 56, and 58 can be implemented as an attachment to aligner 50.

FIG. 7 is a flow chart of a method for using second data capture device 52. This method can be implemented, for example, in software or firmware for execution by a processor in mobile device 12. The software to execute this method can be available, for example, as an app that the user can download to mobile device 12.

The method of FIG. 7 includes mobile device 12 receiving strain sensors data from data capture device 52 (step 80). In particular, microcontroller 66 wirelessly transmits the strain sensors data via radio/antenna 68 to mobile device 12. The method reconstructs strain states of aligner 50 from the strain sensors data (step 82). Using the strain sensors data, the method determines when the user was wearing the aligner and saves the compliance history and strain states history (step 84). For instance, by monitoring and saving the strain sensors data over time, possibly including the date and time information, the method can determine an amount of time the aligner was worn by the user based upon changes in strain states within the aligner.

The “strain states” are the set of measurements recorded from the strain sensors (e.g., a set of strain gauges) measuring the mechanical strain and percent elongation of the aligner at critical points around each tooth. A mechanical finite element analysis (FEA) model of the aligner and teeth (using associated geometry) could then be used to solve for the set of tooth positions and orientations that generate matching strain values in the aligner at the locations where the sensors were located. The following is an exemplary algorithm for this solve process, which can be implemented in software or firmware, for example, for execution by mobile device 12, provider computer 16, or both:

1. Start with assumption for tooth positions.

2. Solve for the strain state matching those tooth positions.

3. Compare the strain state to the measured strain state.

4. Perturb the tooth positions/orientations and solve for the new strain state.

5. Compare the new strain state to the measured strain state.

6. Use the differences between the original (n-1), new (n), and measured strain states to generate a new set of tooth positions/orientations (via either root-finding or other algorithms for finding solutions to a set of nonlinear equations).

7. Iterate until the difference between the “new” and “measured” strain states is within a tolerance value.

8. Result: tooth positions and orientations of the teeth in the user’s (patient’s) mouth.

As a side effect of solving this model, a map is generated of the stress in the aligner, which is useful to predict whether it will deform or break, as well as an idea of the forces applied to each tooth.

Table 5 includes an exemplary data structure for storing the strain sensors data. This data structure or other storage methods can be used to electronically store the strain sensors data in mobile device 12, provider computer 16, or both.

Mobile device 12 can send the compliance history, strain states history, and strain states to provider computer 16 optionally through cloud computer or service 14 (step 86). In return, mobile device 12 can receive aligner information from provider computer 16 (step 88). Using the strains states history, the healthcare provider can remotely monitor and provide to mobile device 12 as the aligner information one or more of the following: user compliance; when the user should switch to their next aligner; whether or not the aligner is seating correctly; whether treatment is tracking based upon the changes in the strain states over time; and which teeth are tracking well and which teeth are not moving as expected. The healthcare provider can use this information to determine when the user should switch to their next aligner and when a refinement in the treatment plan may be necessary or desired. The progress of each tooth can thus be measured and compared to the treatment plan. Mobile device 12 presents one or more notifications to the user (step 90). For example, the method can present the user’s compliance history to the user and can present notifications to the user to encourage them to meet their wear time goals. The method can also be used to communicate to the user when it is time for them to switch to their next aligner. These notifications can be presented, for example, in visual form on a display device in mobile device 12, in audible form using a speaker in mobile device 12, or both. The notifications can be stored, and include the sample notifications, as described with respect to Table 4.

The method of FIG. 7 can be repeated to periodically receive the strain sensors data from data capture device 52. Also, data capture device 52 can optionally store multiple strain sensors data recorded at different times and transmit the stored data to mobile device 12.