Patent Application
20250090276
This invention relates to orthodontic aligners.
Like traditional braces, orthodontic aligners are designed to move the teeth a little at a time. The aligners are designed based on the particular oral geometry of a user and wearing the aligner puts gentle pressure on the teeth, slightly repositioning them over time.
Patient compliance can significantly impact the effectiveness of orthodontic alignment treatments, particularly in the case of removable aligners. Healthcare professionals are currently limited in their ability to monitor treatment compliance and progression, relying on techniques that do not allow problems to be identified in a timely manner, provide limited information and can easily be spoofed by the patient.
It would be desirable to incorporate sensing functionality to enable monitoring of compliance and/or monitoring the tooth movement.
However, orthodontic aligners are compact so that they provide the least discomfort when worn, and they are disposable items. These factors make it challenging to incorporate meaningful smart features such as sensing functionality.
WO 2017/218947 discloses an aligner which incorporates sensing functionality to detect wearing of the aligner and hence compliance. A sensor is provided at the aligner and it communicates using near field communication with an external monitoring unit.
The invention is defined by the claims.
According to examples in accordance with an aspect of the invention, there is provided an orthodontic aligner, comprising:
The invention in this way provides a smart aligner, which can be interrogated externally to determine if it is worn. In this way, aligner compliance (and optionally also tracking of the correct fit) is enabled. The deformation of the deformable region caused by the presence of the teeth results in a detectable change in the RFID response, in particular by changing the effective antenna structure of the RFID tag. The two portions of the RFID tag in particular define different portions e.g. halves of an RFID antenna. The aligner is entirely passive and hence low cost. For example the RFID tag is passive and simply responds to an interrogation signal without requiring a power supply; the energy for operation is harvested from the interrogation signal.
When the aligner is not being worn, the first and second portions remain separate, i.e. they do not form a complete RFID tag. However, when the aligner is worn correctly, the deformable region changes shape slightly such that the portions come into contact forming a working, passive RFID tag.
Information about how the aligner is being worn can then be detected based on the external interrogation, for example by sending an RF pulse to the aligner, and analyzing the backscattered signals for the signature of the RFID antenna. The system thereby allows wearing of the aligner to be monitored remotely and in real time, and the information gathered can be sent to the user (patient) or their dentist to improve orthodontic outcomes.
In this way, the system allows dental professionals and/or patients to gather new and advantageous information about how an orthodontic aligner treatment plan is progressing using cheap and readily-available technology.
The RFID technology used to implement the system is increasingly small, cheap and easy to manufacture.
The aligner may comprise a plurality of RFID tags, each comprising first and second portions coupled to the deformable region.
The correct fitting of the aligner can thereby be determined by verifying that the deformation has taken place at all required positions of the support structure.
There may even be a plurality of RFID tags associated with one or more individual teeth to be monitored. Thus, tooth movement of a tooth can be monitored based on the RFID tags out of a set that a currently active. There may be multiple teeth, each with a set of RFID tags to enable monitoring of tooth position and movement.
The relative position between the first and second portions is for example adjustable between a first state in which the RFID tag is non-functional and will not respond to an interrogation signal and a second state in which RFID tag is functional and will respond to an interrogation signal. Thus, the presence of a response is indicative that the aligner is worn (at the location of the RFID tag).
The RFID tag is for example functional when the first and second portions are brought into physical electrical contact with each other. The portions may have dedicated contacts with engage with each other.
The support structure for example comprises a guard (i.e. a shell aligner) that fits over the teeth of one jaw. There may then be two such guards.
The deformable region may include a surface which makes contact with occlusal tooth surfaces, and at least on RFID tag comprises upper and lower portions which move together when the aligner is worn.
Thus, when the guard is fitted, the biting surfaces of the teeth push down on the deformable region so that the RFID portions move together.
The deformable region may alternatively or additionally include a surface which faces the labial tooth surfaces, and at least one RFID tag comprises inner and outer portions which move together when the aligner is worn.
Thus, when the guard is fitted, the front surface of the front teeth push outwardly on the deformable region so that the RFID portions move together.
The invention also provides an aligner system, comprising:
The RFID interrogator and controller of the system are for example remote from the parts of the aligner which are worn in the mouth, for example implemented as a smartphone or other wireless electronic device.
The controller is for example also adapted to determine a level of fit of the aligner to the user from the received reflected responses.
By gathering information about how the aligner is fitting, orthodontic treatment plans can be adjusted dynamically to optimize the treatment and respond to patients' needs, improving the effectiveness of the alignment process by identifying and implementing interventions earlier.
The controller may be adapted to determine tooth position information from the received reflected response. By gathering information about how the teeth have moved over time, from position information at different times, orthodontic treatment plans can again be adjusted dynamically to optimize the treatment.
The invention also provides a method of detecting if an orthodontic aligner is currently being worn, comprising:
The full method thus comprises:
The invention also provides a computer program comprising computer program code which is adapted, when said program is run on a computer, to implement the method defined above.
These and other aspects of the invention will be apparent from and elucidated with reference to the embodiment(s) described hereinafter.
For a better understanding of the invention, and to show more clearly how it may be carried into effect, reference will now be made, by way of example only, to the accompanying drawings, in which:
The invention will be described with reference to the Figures.
It should be understood that the detailed description and specific examples, while indicating exemplary embodiments of the apparatus, systems and methods, are intended for purposes of illustration only and are not intended to limit the scope of the invention. These and other features, aspects, and advantages of the apparatus, systems and methods of the present invention will become better understood from the following description, appended claims, and accompanying drawings. It should be understood that the Figures are merely schematic and are not drawn to scale. It should also be understood that the same reference numerals are used throughout the Figures to indicate the same or similar parts.
The invention provides an orthodontic aligner which includes a passive RFID tag comprising first and second portions coupled to a deformable region of the aligner, each portion comprising a respective antenna portion which together define the antenna for the RFID tag. The relative position between the first and second portions is changed by deformation of the deformable region when the aligner is worn by the user, so that a response of the RFID tag (in particular the ability of the tag to respond) to an external interrogation is dependent on whether or not the aligner is being worn.
The first and second portions 14a, 14b each comprise a respective antenna portion, and these antenna portions together define the antenna for the RFID tag 14.
A relative position between the first and second portions 14a, 14b is adjustable by deformation of the deformable region between at least a first relative position when the orthodontic aligner is worn by the user and a second relative position when the orthodontic aligner is not being worn.
An RFID interrogator unit 20 uses a transmitter 22 to generate an external interrogation signal and receives a return signal via a receiver 24. The received signal is dependent on the relative position between the first and second portions 14a, 14b. In particular, the relative position between the first and second portions is adjustable between a first state in which the RFID tag is non-functional because the antenna is not connected so that the RFID tag will not respond to an interrogation signal, and a second state in which RFID tag is functional and will respond to an interrogation signal.
The invention makes use of RFID technology. Advances in RFID technologies mean that printed RFID tags can be used to passively indicate touch points. When the antenna portions are separate, they do not create backscatter from an incident signal, but when brought into electrical contact they reflect a distinctive signature and hence can be used to detect relative motion between the two portions.
Passive RFID tags can be embedded in harsh environments. They can be cheap and flexible by using printed electronics techniques. For example, RFID tags can be manufactured using inkjet printing and screen printing techniques.
The technology needed for the interrogator unit 20 is also widespread. 5G communications technology is being rolled out to consumers globally, which is expected to increase the number of devices with ultra-high frequency (UHF) antennae in the home (such as smartphones and routers). This advance will increase the number of devices in the home that are capable of interfacing with passive RFID technologies.
The deformable region of the support structure may comprise a soft layered structure whereby tooth-induced deformation may cause two layers to touch. A soft flap or hinged structure may instead be used, whereby tooth-induced deformation may cause the flap to make contact with another surface.
The aligner may have a plurality of RFID tags, each comprising first and second portions coupled to the deformable region of the support structure 12. Contact may be monitored at a set of points around the shape of the aligner. However, in addition, contact may be monitored using a plurality of RFID tags associated with one or more individual teeth to be monitored. Thus, different tooth positions may trigger different contacts to be made and broken and thereby activate and deactivate different RFID tags.
The RFID tag portions may for example be around 1 mm apart in the non-contact situation. There may be a single RFID chip and two antenna portions, but there could also be separate circuit portions in two separate chips, which only connect when the two portions connect. Thus, a first RFID tag portion may comprise a first chip and a first antenna portion and the second RFID tag portion then comprises a second chop and a second antenna portion.
The two antenna portions may be two portions of a dipole antenna.
The monitoring may therefore be used to monitor aligner wear compliance (i.e. monitor when the aligner is worn and when it is not), aligner fit (i.e. monitor that contact is made at the correct locations representing a correct placement of the aligner) and alignment progression (i.e., tooth movement).
Each RFID tag responds to an external interrogation by means of a unique code so that the responding RFID tags are identified. Multiple responding RFID tags can thus be identified.
The number, location and configuration of the RFID tags depend on the desired detection capability of the aligner. For example, a single RFID tag may be sufficient to indicate compliance (when the aligner is in the mouth, the single RFID tag is activated). An array of two or more RFID tags may be used to indicate aligner fit and/or tooth movement. The correct aligner fitting may for example be separately detected at different areas, for example at the front of the mouth and at the rear.
In order to design the placement of the RFID tags, a design algorithm may be used to design the geometry and behavior of the RFID tags on the aligner. The design algorithm for example takes as inputs:
The design algorithm then ensures that the locations and deformation properties of the support structure will be such that the extent and characteristics of deformation will actuate the RFID tags allowing meaningful measurements to be extracted.
In the design of the aligner, weights may be assigned to different aspects to prioritize critical features. Assigned weights may be on the basis of known dental best practice or customized to the patient's orthodontic goals and preferences.
For example, correct orthodontic alignment may be weighed with a maximum multiplier of 5. Effective placement of the RFID tags to record specific aligner usage properties may be weighed with a multiplier of 4. Minimal visibility of the RFID tags or support structure to onlookers may be weighed with a multiplier of 2, etc.
In use, with the designed aligner placed in the mouth over the teeth, correct contact with the teeth causes the support structure to deform, altering the passive response of the associated RFID tags. The characteristics of this deformation are determined by the relative positions of the patient's teeth and the aligner, the geometrical and material properties of the aligner (with constraint that the deformation does not impact on the rigidity required to provide orthodontic correction).
The RFID interrogator unit detects and analyzes the state of the aligner, and thereby deduces compliance and fit quality. The RFID interrogation unit may be embodied in a third-party device such as a smartphone.
In order to interpret the RFID signals that are received, the RFID interrogator unit 20 comprises a database 30 which stores information about the expected RFID signals depending on exactly how the aligner is placed relative to the patient's teeth. The database 30 for example comprises a look-up table describing how the RFID tag configurations map to different received signals. Simulations may be provided of how the RFID signals will look in various configurations.
The received RFID signals at the interrogator unit are analyzed using the database to deduce whether the aligner is in proper alignment with the patient's teeth. For example, each RFID tag will have an ID and a location (e.g. top aligner tray, rear right) is associated with each ID. The RFID tag signal (e.g. open signal X or closed signal Y) is used to determine an aligner condition (signal X: loose fit, signal Y: correct fit).
The analysis then deduces whether and in what localities the aligner fits, or where the fit has changed. A map is for example stored between the RFID tag information and the aligner geometry. Detecting which RFID tags are in the closed state can therefore be translated into knowledge of which localities of the aligner are properly aligned with the patient's teeth.
The analysis of the responses to the tags may use machine learning techniques. It may generate an alert to communicate relevant information to the patient or a relevant healthcare professional. The alert may comprise notifications (via a smartphone, wearable, the aligner itself or another device) provided to the patient. An alert may comprise a prompt to wear the aligner when it is found to not be in the mouth, or a prompt when the aligner is in the mouth but not fitted correctly giving instructions on where the fit should be adjusted.
Historical information may be shared with a healthcare professional detailing how long an aligner has been worn by a patient, and how the patient's teeth have moved in response.
The aligner patient and their orthodontic health professional may be informed of dental issues and progress in real time.
The top image shows the aligner before fitting to the teeth. Three RFID tags 14 are shown, where there is no contact between the two portions 14a, 14b of each RFID tag. The deformable region of the support structure includes a surface which makes contact with occlusal (biting) tooth surfaces. The RFID tags comprise upper and lower portions which move together when the aligner is worn.
The aligner in the worn state is shown in the bottom image. This is a side view of the mouth, showing (from left to right) two incisors (one in side view), the canine, the two premolars and two molars.
The top image again shows the aligner before fitting to the teeth. One RFID tags 14 is shown, and there is no contact between the two portions of the RFID tag. The deformable region includes a surface which faces the labial tooth surfaces (in particular of a front incisor), and the RFID tag comprises inner and outer portions which move together when the aligner is worn.
The aligner in the worn state is shown in the bottom image. This is again a side view of the mouth.
Instead of each RFID tag having independent antenna halves, there may an antenna portion associated with each RFID tag chip, but then a shared remaining antenna which spans the whole aligner.
The tag 46 has two circuit portions and two antenna portions and the tag 48 has two circuit portions and two antenna portions. However, the antenna portions are shared.
The top image shows a first tooth position in which one of the RFID tags is activated, and the bottom image shows how tooth movement means a second tooth position caused the other of the RFID tags to be activated.
The same antenna is used by the two RFID tags, but only one connected pair of circuit portions is connected, and these determine the response that is made to the interrogation signal.
The monitoring of tooth movement could be enabled by understanding which combinations of RFID chips in an array or string are in electrical contact at a given time, and how this evolves over the course of treatment. In an embodiment with this functionality, it is likely that each tooth (or a subset of teeth) would be associated with two half-antennae as shown in
In the preferred implementation, the two halves of an RFID antenna are not in electrical contact when the RFID tag is to be non-responsive, and the deformation of the support structure is such that two halves of the antenna are brought together, either directly or by means of their associated RFID circuit portions (as in
The interrogation signals may be generated at regular intervals or sporadically, and a detection system may additionally detect when the aligner is close to the patient's face through gesture recognition technologies that are known in the art. This can be used to save power. The signals are preferably of a form which prevent the patient from simulating compliance.
Where an array of RFID tags is used, a sequence of interrogation signals may be used with differing properties in order to apply unique tests to each RFID tag.
When an RFID tag is responsive, it will modulate an interrogation signal in a detectable way, typically encoding information on the transmitted signal with information identifying that particular RFID tag.
In the preferred implementation, a tag is either responsive or non-responsive. However, the deformation of the support structure may activate an additional component.
The data processing of the RFID tag signals may take place on a second device (such as the patient's smartphone) or in a cloud location.
The output (feedback information) may indicate whether the aligner is worn correctly or at all, whether the patient's teeth as moving as required over the course of treatment, historical details on how, when and for how long the aligner is being worn. The feedback may be by means of smartphone notifications to the patient, or by haptic feedback through the aligner to the patient. There may be communication to the healthcare professional under whose guidance the patient is undergoing treatment. The timing and frequency of feedback may be optimized, for example a patient may be notified immediately on detection of incorrect aligner wear, in order to remedy the problem in real time. A dentist may be notified of the patient's compliance with the orthodontic treatment at intervals of days or weeks, such that sufficient data has been gathered from the aligner to provide a useful temporal analysis of patient behavior.
The aligner 10 comprises the support structure 12, functioning as a physically deformable structure, and the array of RFID tags, functioning as a tooth-actuated signal modifier array.
The patient's teeth are represented by block 50, and patient data relating to the teeth is provided to the aligner design algorithm 60.
The interrogator unit 20 comprises the RF transmitter (emitter) 22, the RF receiver 24 and the database 30. The transmitter is controlled by a signal control algorithm 26 and the received signals are interpreted by a signal analysis algorithm 28. This analysis results in the feedback from the feedback system 70, providing aligner usage data.
The aligner is typically used for cosmetic treatment. The treatment is thus typically non-therapeutic. The method of detecting if the orthodontic aligner is currently being worn is thus preferably a non-therapeutic method and is not a method of treatment.
Variations to the disclosed embodiments can be understood and effected by those skilled in the art in practicing the claimed invention, from a study of the drawings, the disclosure and the appended claims. In the claims, the word “comprising” does not exclude other elements or steps, and the indefinite article “a” or “an” does not exclude a plurality.
The mere fact that certain measures are recited in mutually different dependent claims does not indicate that a combination of these measures cannot be used to advantage.
A computer program may be stored/distributed on a suitable medium, such as an optical storage medium or a solid-state medium supplied together with or as part of other hardware, but may also be distributed in other forms, such as via the Internet or other wired or wireless telecommunication systems.
If the term “adapted to” is used in the claims or description, it is noted the term “adapted to” is intended to be equivalent to the term “configured to”.
Any reference signs in the claims should not be construed as limiting the scope.
| Number | Date | Country | Kind |
|---|---|---|---|
| 21184167.1 | Jul 2021 | EP | regional |
| Filing Document | Filing Date | Country | Kind |
|---|---|---|---|
| PCT/EP2022/068502 | 7/5/2022 | WO |
