Orthodontic Appliance Performance Monitor

Abstract

The present application discloses an orthodontic appliance performance monitor. Apparatus and methods for monitoring the performance of an orthodontic appliance for repositioning a patient's teeth. An orthodontic appliance may include a plurality of tooth receiving cavities shaped to reposition the patient's teeth from an initial arrangement to a target arrangement, and one or more sensors configured to determine tooth movement (based on position and / or orientation) and / or forces applied to the teeth. The sensors may be distributed between an attachment and a aligner mated with the attachment.

Description

[0001] This application is a divisional application of an application filed on June 19, 2017, with application number 201710464543.2 and invention name “Orthodontic Appliance Performance Monitor”.

[0002] CROSS-REFERENCE TO RELATED APPLICATIONS

[0003] This patent application claims priority to U.S. Provisional Patent Application No. 62 / 351,408, filed on June 17, 2016, and which is incorporated herein by reference in its entirety.

[0004] Incorporated by Reference

[0005] All publications and patent applications mentioned in this specification are herein incorporated by reference in their entirety to the same extent as if each individual publication or patent application was specifically and individually indicated to be incorporated by reference. background

[0006] The orthodontic process generally involves repositioning a patient's teeth into a desired arrangement in order to correct a malocclusion and / or improve aesthetics. To achieve these goals, orthodontic appliances such as braces, shell aligners, etc. may be applied to the patient's teeth by an orthodontist. The appliance may be configured to apply a force to one or more teeth in order to achieve the desired tooth movement according to a treatment plan.

[0007] In some instances, the forces actually applied to a patient's teeth by an orthodontic appliance may differ from the forces intended to be used to treat the teeth. The difference between the planned repositioning forces and the achieved repositioning forces may result in incomplete or undesired tooth movement and deviation from the prescribed treatment plan. Therefore, there is a need for improved methods for monitoring orthodontic appliance properties and treatment progress.

[0008] Public Overview

[0009] The present disclosure provides improved apparatus (e.g., systems and devices) and methods for monitoring the performance of orthodontic appliances for repositioning patient teeth. In some embodiments, the apparatus described herein includes one or more sensors configured to generate sensor data associated with repositioning patient teeth by an orthodontic appliance. For example, the data may indicate the amount of tooth movement achieved, the amount of force and / or pressure actually applied to the teeth by the appliance, or a combination thereof. As used herein, the term force may include linear forces or angular / rotational forces, such as moments / torques (e.g., torque) or both. As used herein, deformations and displacements may be linear, angular, or both.

[0010] Advantageously, the embodiments described herein provide high-value data that allows a physician to quantitatively assess whether an orthodontic appliance is repositioning a patient's teeth as planned. Optionally, the appliance performance data can be used as feedback to adjust the patient's treatment plan, also known as "adaptive closed-loop treatment," and can also inform the design and planning of future appliance-based orthodontic procedures.

[0011] For example, described herein is a device for monitoring the performance of an orthodontic appliance for repositioning a patient's teeth. The device may include an orthodontic appliance comprising a plurality of tooth receiving cavities shaped to reposition the patient's teeth from an initial arrangement toward a target arrangement. Alternatively or in addition, the orthodontic device may include a brace and wire for attachment to the teeth. The device may include one or more sensors configured to generate sensor data associated with repositioning the patient's teeth by the orthodontic appliance. The device may also include a processor configured to process the sensor data so as to evaluate the performance of the orthodontic appliance when achieving repositioning of the patient's teeth.

[0012] Any of the devices described herein may include a motion sensor. A motion sensor may also be referred to as a position sensor or a position / orientation sensor because it may provide data indicating a relative position (e.g., two axes (such as x, y position), three axes (such as x, y, z position), etc.) or a relative orientation (e.g., two angular orientations (such as tilt, yaw), or three angular orientations (such as tilt, roll, yaw), etc.). For example, described herein are orthodontic devices for repositioning a patient's teeth and tracking tooth movement. These devices may include: an orthodontic body including a plurality of tooth receiving cavities shaped to reposition the patient's teeth from an initial arrangement toward a target arrangement; a plurality of motion sensors coupled to the orthodontic body or configured to couple with the orthodontic body, wherein each motion sensor is configured to generate motion sensor data indicating one or more of a position of the patient's teeth and an orientation of the patient's teeth; and a processor configured to receive and store the motion sensor data and determine tooth movement from the motion sensor data.

[0013] Any of the devices described herein may include motion sensors (e.g., position / orientation sensors) and force sensors. For example, an orthodontic device for repositioning a patient's teeth and tracking tooth movement may include: an orthodontic body including a plurality of tooth receiving cavities shaped to reposition the patient's teeth from an initial arrangement toward a target arrangement; a plurality of motion sensors coupled to the orthodontic body or to an attachment configured to couple the orthodontic body to the patient's teeth, wherein each of the plurality of motion sensors is configured to generate motion sensor data indicating one or more of: the position of the patient's teeth and the orientation of the patient's teeth; a plurality of force sensors coupled to the orthodontic body or to an attachment configured to couple the orthodontic body to the patient's teeth, wherein each of the plurality of force sensors is configured to generate force sensor data indicating one or more of: the amount of force applied to the patient's teeth and the direction of the force applied to the patient's teeth; and a processor configured to receive and store the motion sensor data and the force sensor data.

[0014] In any of the devices described herein, the device may include a motion sensor (e.g., a position sensor) that includes an electromagnetic target (e.g., a magnet, a coil, etc.) that can indicate the position and / or orientation of a tooth in the presence of an electromagnetic field. For example, an orthodontic device for repositioning a patient's teeth and tracking tooth movement may include: one or more aligner bodies, each of the one or more aligner bodies including a plurality of tooth receiving cavities shaped to reposition the patient's teeth from an initial arrangement toward a target arrangement; a plurality of motion sensors coupled to the one or more aligner bodies or on an attachment configured to couple the aligner bodies to the patient's teeth, wherein the plurality of motion sensors each include an electromagnetic target configured to generate motion sensor data indicating one or more of the following: the position of the patient's teeth and the orientation of the patient's teeth; an electromagnetic field generator coupled to one of the one or more aligner bodies; and a processor configured to receive and store the motion sensor data.

[0015] In any of these devices, the processor may be configured to repeatedly receive and store motion sensor data at intervals between 1 hour and 2 weeks (e.g., every hour, every two hours, every 3 hours, every four hours, every 5 hours, every 6 hours, every 7 hours, every 8 hours, every 9 hours, every 10 hours, every 11 hours, every 12 hours, every 24 hours, every 36 hours, every 48 hours, every 3 days, every 4 days, every 5 days, every week, etc.) Thus, the device may include a memory, a clock, a power supply, etc.

[0016] As described above, any of these devices may also include a plurality of force sensors coupled to the aligner body or on an attachment configured to couple the aligner body to the patient's teeth. The force sensors may be configured to generate force sensor data indicating one or more of: the amount of force applied to the patient's teeth and the direction of the force applied to the patient's teeth. The processor may be configured to receive and store the motion sensor data and the force sensor data.

[0017] As described above, each of the plurality of motion sensors may include an electromagnetic target configured to generate motion sensor data. For example, each of the plurality of motion sensors includes a magnet, a flat coil, or a cylindrical coil. Any of these devices may also include an electromagnetic field generator, which may be coupled to the body of the aligner or separate from the body of the aligner (e.g., on a second aligner worn simultaneously with the first aligner or external to the aligner). The motion sensor may be configured to measure the position of one or more teeth by measuring changes in an applied electromagnetic field.

[0018] Typically, the processor can be configured to track the movement of the patient's teeth relative to each other (e.g., relative to other teeth, the upper jaw, the lower jaw, etc.) based on the motion sensor data.

[0019] Typically, motion sensors (e.g., electromagnetic targets) can be positioned on the body of the braces, or they can be mounted directly to the patient's teeth. For example, these motion sensors can be used to detect the position / motion of the braces when they are displaced by the patient's teeth. Alternatively or in addition, the position (e.g., location and orientation) can directly track the movement of the teeth to which the motion sensor (e.g., the electromagnetic target portion of the sensor) is attached. Therefore, in any of the method and device variations described herein, it may be beneficial to include a sensor or a portion of a sensor on an attachment. For example, at least some of the plurality of motion sensors may be on an attachment configured to couple the braces body to the patient's teeth. Attachments are typically incorporated into teeth and can be used to keep the braces body in place and / or apply force to the teeth from the braces. In treatment planning, attachments can be used with multiple braces. When a sensor including, but not limited to, a motion sensor (including an electromagnetic target) is coupled to an attachment or a portion of an attachment, the attachment may include an electrical contact for communicating with the braces via an electrical connection for transmitting data from the sensor.

[0020] Any of these devices may also include a power source, wireless communication circuitry coupled to the processor and configured to wirelessly transmit motion sensor data, memory, timers, etc., which may be part of the processor or coupled to the processor.

[0021] Also described herein is a method for designing an orthodontic treatment plan for a patient using any of the devices described herein, the devices including (but not limited to) a device for detecting tooth movement. A method may include: receiving motion sensor data from a plurality of motion sensors of an orthodontic appliance having an orthodontic body, the orthodontic body having a plurality of tooth receiving cavities shaped to reposition the patient's teeth from an initial arrangement toward a target arrangement according to a first orthodontic treatment plan, wherein the plurality of motion sensors are coupled to the orthodontic body or to an attachment configured to couple the orthodontic body to the patient's teeth, wherein the motion sensor data indicates one or more of: the position of the patient's teeth and the orientation of the patient's teeth; determining tooth movement according to the motion sensor data; and modifying the first orthodontic treatment plan based on the determined tooth movement.

[0022] For example, a method for designing an orthodontic treatment plan for a patient may include: providing an orthodontic appliance comprising an orthodontic body having a plurality of tooth receiving cavities shaped to reposition the patient's teeth from an initial arrangement toward a target arrangement according to a first orthodontic treatment plan, wherein a plurality of motion sensors are coupled to the orthodontic body or to an attachment configured to couple the orthodontic body to the patient's teeth; periodically applying an electromagnetic field from an electromagnetic field generator coupled to the orthodontic body; receiving motion sensor data from the plurality of motion sensors in a processor, wherein the motion sensor data indicates one or more of: a position of the patient's teeth and an orientation of the patient's teeth; determining tooth movement based on the motion sensor data; and modifying the first orthodontic treatment plan based on the determined tooth movement by modifying one or more of: a configuration of the plurality of tooth receiving cavities of the orthodontic body of a second orthodontic appliance worn by the patient, or shortening or extending a duration that the orthodontic appliance is worn by the patient.

[0023] Thus, modifying the treatment plan may include adjusting the appliance design and / or adjusting the duration of appliance wear. For example, the modification may include modifying the configuration of the tooth receiving cavity of the appliance body of the second orthodontic appliance worn by the patient. The modification may include modifying the duration of the orthodontic appliance worn by the patient.

[0024] Any of the methods described herein can include providing an attachment configured to couple the aligner body to the patient's teeth. The aligner body can include an attachment point for coupling to the attachment.

[0025] Any of the methods described herein may also include periodically sampling the sensor and / or recording the sensor value. For example, receiving may include receiving motion sensor data at intervals between every hour and every 2 weeks. For motion / position sensors using electromagnetic targets, periodic sampling may include applying an electromagnetic field from an electromagnetic field generator coupled to the body of the brace. The method may include periodically applying an electromagnetic field from the electromagnetic field generator, including applying the electromagnetic field between every two hours and every two weeks.

[0026] The method may include receiving, in a processor, force sensor data from a plurality of force sensors coupled to the appliance body or on an attachment, wherein the force sensor data indicates one or more of: an amount of force applied to the patient's teeth and a direction of the force applied to the patient's teeth.

[0027] Any of these methods may include determining forces acting on the patient's teeth from the force sensor data.The modifying may include modifying the first orthodontic treatment plan based on the determined tooth movement and forces acting on the patient's teeth.

[0028] The data may be transmitted to the processor locally (e.g., on the aligner) or remotely. For example, any of these methods may include wirelessly transmitting the motion sensor data from the orthodontic appliance to the processor, where the processor comprises a remote processor. Receiving may include receiving the motion sensor data in the processor, where the processor is coupled to the orthodontic appliance when the orthodontic appliance is worn in the patient's mouth.

[0029] Providing may include providing a plurality of attachments configured to couple the aligner body to the patient's teeth, wherein the aligner body includes attachment points for coupling to the attachments.

[0030] Any of these methods can include receiving, in a processor, force sensor data from a plurality of force sensors coupled to an appliance body or on an attachment, wherein the force sensor data indicates one or more of: an amount of force applied to the patient's teeth and a direction of the force applied to the patient's teeth. Additionally, the method can include determining the forces acting on the patient's teeth based on the force sensor data. Modifying can mean modifying the first orthodontic treatment plan based on the determined tooth movement and forces acting on the patient's teeth.

[0031] Also described herein is an orthodontic device for repositioning a patient's teeth and tracking tooth movement, wherein a sensor is located on an attachment and / or an engagement site on an appliance body to which the attachment is coupled. For example, the device may include: an appliance body including a plurality of tooth receiving cavities shaped to reposition the patient's teeth from an initial arrangement toward a target arrangement, the appliance body having a plurality of engagement sites; a plurality of attachments configured to engage the engagement sites and couple the appliance body to the patient's teeth; wherein each of the plurality of attachments includes a sensor configured to generate sensor data associated with a force applied to the patient's teeth by an orthodontic appliance or a movement of the patient's teeth; and a processor coupled to the appliance body and configured to receive and store the sensor data.

[0032] An orthodontic device for repositioning a patient's teeth and tracking tooth movement may include: an orthodontic body comprising a plurality of tooth receptors shaped to reposition the patient's teeth from an initial arrangement toward a target arrangement, the orthodontic body having a plurality of engagement sites on one or more of the buccal or lingual sides of the orthodontic body; a plurality of attachments configured to engage the engagement sites and couple the orthodontic body to the patient's teeth; a plurality of sensors, wherein each sensor extends at least partially within each of the plurality of engagement sites, wherein each of the plurality of sensors is configured to generate sensor data related to forces applied to the patient's teeth or movement of the patient's teeth caused by the orthodontic appliance; and a processor coupled to the orthodontic body and configured to receive and store the sensor data.

[0033] The sensor of each of the plurality of attachments can be any type of sensor described herein, including a motion (position) sensor, a force or pressure sensor configured to measure the force or pressure applied by an orthodontic appliance to one or more teeth, and the like. Each of the plurality of attachments can include a force-sensitive or pressure-sensitive film, a resistive film, a capacitive film, or a piezoelectric tactile sensor. Each of the plurality of attachments can include an electromagnetic target configured to generate motion sensor data indicating one or more of: the position of the patient's teeth and the orientation of the patient's teeth; further, wherein the body of the appliance includes an electromagnetic field generator.

[0034] Any of these arrangements may include electrical contacts between the attachment and the body of the aligner.The plurality of engagement sites may include openings or recesses formed through the body of the aligner.

[0035] The plurality of engagement sites may be located on one or more of the lingual side of the appliance body or the buccal side of the appliance body.

[0036] In any of these methods, the processor can be configured to evaluate the performance of the orthodontic appliance, for example by determining one or more of the following using the sensor data: the amount of force or pressure applied to the patient's teeth, the distribution of the force or pressure on the patient's teeth, the amount of movement of the patient's teeth, or the rate of movement of the patient's teeth. The processor can be configured to evaluate the performance of the orthodontic appliance by determining whether the amount of force or pressure applied to the patient's teeth by the orthodontic appliance is within a target range.

[0037] The sensor of each of the plurality of attachments may include a motion sensor configured to measure the movement of one or more teeth. For example, the motion sensor may be configured to measure the movement of one or more teeth by measuring changes in an applied electromagnetic field. As described above, any of these devices may include a power source, a memory, and / or a wireless communication circuit coupled to the processor.

[0038] Methods of using the devices are also described. For example, a method of designing an orthodontic treatment plan for a patient may include: receiving sensor data from a plurality of sensors of an orthodontic appliance having an orthodontic appliance body having a plurality of tooth receiving cavities shaped to reposition the patient's teeth from an initial arrangement toward a target arrangement according to a first orthodontic treatment plan, wherein a plurality of attachments on the patient's teeth engage engagement sites on the orthodontic appliance body to couple the orthodontic appliance body to the patient's teeth, wherein the plurality of sensors are located on the attachments, determining in a processor one or more of: tooth movement and forces on the patient's teeth from the sensor data; and modifying the first orthodontic treatment plan based on the determined one or more of the tooth movement and forces on the patient's teeth from the sensor data.

[0039] A method for designing an orthodontic treatment plan for a patient may include: receiving sensor data from a plurality of sensors of an orthodontic appliance having an orthodontic appliance body, the orthodontic appliance body having a plurality of tooth receiving cavities shaped to reposition the patient's teeth from an initial arrangement toward a target arrangement according to a first orthodontic treatment plan, wherein a plurality of attachments on the patient's teeth each engage an engagement portion on the orthodontic appliance body to couple the orthodontic appliance body to the patient's teeth, wherein the plurality of sensors are at least partially within the engagement portion, determining in a processor one or more of: tooth movement and forces on the patient's teeth from the sensor data; and modifying the first orthodontic treatment plan based on one or more of the tooth movement and forces on the patient's teeth determined from the sensor data.

[0040] As described above, the modification may include modifying the configuration of a tooth receiving cavity of an appliance body of a second orthodontic appliance worn by the patient. The modification may include modifying the duration of the orthodontic appliance worn by the patient. The modification may include modifying the first orthodontic treatment plan based on one or more of tooth movement and forces on the patient's teeth determined from sensor data. In any of the methods described herein, modifying the treatment plan may include modifying any of the components of the treatment plan, including, in particular, modifying the appliance performing the treatment / therapy. For example, modifying the treatment plan may include modifying one or more features of one or more appliances in a series of appliances, including, for example, modifying one or more of appliance shapes and / or thicknesses.

[0041] Receiving sensor data may include receiving sensor data from a force-sensitive film or a pressure-sensitive film, a resistive film, a capacitive film, or a piezoelectric tactile sensor. Receiving sensor data may include receiving force or pressure data applied by the orthodontic appliance to the patient's teeth. Receiving may include receiving motion sensor data in a processor, wherein the processor is coupled to the orthodontic appliance when the orthodontic appliance is worn in the patient's mouth.

[0042] Any of the devices described herein can be modular appliances. Thus, sensing components (e.g., sensors, power supplies, processors, memory, and / or wireless transmission circuits, etc.) can be distributed between an orthodontic appliance (e.g., a brace) and an attachment that is directly coupled to the teeth of a subject to which the appliance is attachable. Electrical connections (along with mechanical connections) between the attachment and the appliance (e.g., a joint on the appliance) can be used to transmit power and / or sensor data. Thus, when wearing a series of braces, a patient can replace portions of the sensing subsystem of the device, including power supplies, memory, processors, etc.

[0043] For example, an orthodontic device for repositioning a patient's teeth and for sensing one or more features in the patient's mouth may include an orthodontic body comprising a plurality of tooth receiving cavities shaped to reposition the patient's teeth from an initial arrangement toward a target arrangement, the orthodontic body having an engagement portion; an attachment configured to be coupled to the patient's teeth and engage with the engagement portion on the orthodontic body and to receive forces to attach the orthodontic body to the patient's teeth and / or to secure it; a sensor configured to generate sensor data; a processor configured to receive sensor data from the sensor and to perform one or more of: storing, analyzing, and transmitting the received sensor data; and a first electrical contact on the attachment and a second electrical contact on the orthodontic body, wherein when the attachment engages with the engagement portion, the first electrical contact and the second electrical contact form an electrical connection; wherein the sensor is located on the attachment or the orthodontic, and wherein when the attachment engages with the engagement portion, the sensor is electrically connected to the processor via an electrical connection formed by the first electrical contact and the second electrical contact.

[0044] The sensor may be on the attachment and the processor on the body of the orthosis; alternatively, the processor is on the attachment and the sensor is on the body of the orthosis. In some variations, the power source is on the orthosis (e.g., the sensor is on the attachment and / or the memory or other processor components are on the attachment or the body of the orthosis). Alternatively, the power source may be on the attachment. The processor may include one or more of the following: memory, wireless communication circuitry, and a timer. As described above, these components may be distributed between the body of the orthosis and / or the attachment.

[0045] Any sensor may be used (e.g., temperature sensor, pH sensor, force sensor, pressure sensor, etc.). For example, the sensor may include a force or pressure sensor configured to measure the force or pressure applied by an orthodontic appliance to one or more teeth. The sensor may include, for example, a force-sensitive film or a pressure-sensitive film, a resistive film, a capacitive film, or a piezoelectric tactile sensor. The sensor may include an electromagnetic target configured to generate motion sensor data indicating one or more of: the position of the patient's teeth and the orientation of the patient's teeth; further, wherein the body of the appliance includes an electromagnetic field generator.

[0046] Typically, the engagement site may include an opening or recess formed through the body of the appliance. The engagement site may be located on one or more of the lingual side of the body of the appliance or the buccal side of the body of the appliance.

[0047] Any of these devices may include a plurality of additional engagement sites on the aligner body and a plurality of additional attachments configured to couple to the patient's teeth and engage with the additional engagement sites and to receive and / or secure the aligner body to the patient's teeth. Sensors, processors, memory, power supplies, and wireless communication circuits may be distributed between all attachments and the appliance body (e.g., the aligner body).

[0048] For example, an orthodontic device for repositioning a patient's teeth and for sensing one or more features in the patient's mouth may include: an orthodontic body comprising a plurality of tooth receiving cavities shaped to reposition the patient's teeth from an initial arrangement toward a target arrangement, the orthodontic body having an engagement portion; an attachment configured to be coupled to the patient's teeth and engage with the engagement portion on the orthodontic body; a sensor on the attachment configured to generate sensor data; a processor on the orthodontic device configured to receive sensor data from the sensor and perform one or more of: storing, analyzing, and transmitting the received sensor data; and a first electrical contact on the attachment and a second electrical contact on the orthodontic body, wherein when the attachment engages with the engagement portion, the first electrical contact and the second electrical contact form an electrical connection; wherein when the attachment engages with the engagement portion, the sensor is electrically connected to the processor through the electrical connection formed by the first electrical contact and the second electrical contact.

[0049] Also described herein is a method of operating any of these modular / distributed orthotics, including forming a mechanical and electrical connection between the orthotic body and the attachment such that the sensor is electrically coupled to a processor and / or memory and / or a power source via the electrical connection.

[0050] This application also provides the following:

[0051] 1) An orthodontic device for repositioning a patient's teeth and for sensing one or more features in the patient's mouth, the device comprising:

[0052] an appliance body including a plurality of tooth receiving cavities shaped to reposition the patient's teeth from an initial arrangement to a target arrangement, the appliance body having an engagement portion;

[0053] an attachment configured to be coupled to a patient's tooth and to engage with the engagement site on the appliance body;

[0054] a sensor configured to generate sensor data;

[0055] a processor configured to receive sensor data from the sensor and to perform one or more of: storing, analyzing, and transmitting the received sensor data; and

[0056] a first electrical contact on the attachment and a second electrical contact on the aligner body, wherein the first electrical contact and the second electrical contact form an electrical connection when the attachment is engaged with the engagement site;

[0057] wherein the sensor is on the attachment or on the orthotic body, and wherein when the attachment is engaged with the engagement site, the sensor is in electrical communication with the processor through an electrical connection formed by the first electrical contact and the second electrical contact.

[0058] 2) The device of 1) wherein the sensor is on the attachment and the processor is on the aligner body.

[0059] 3) The device of 1) wherein the processor is on the attachment and the sensor is on the aligner body.

[0060] 4) The device according to 1) also includes a power supply on the corrector body.

[0061] 5) The device according to 1) further includes a power source on the attachment.

[0062] 6) The apparatus according to 1), wherein the processor comprises one or more of a memory, a wireless communication circuit, and a timer.

[0063] 7) The device according to 1), wherein the sensor comprises a force or pressure sensor configured to measure the force or pressure applied by the orthodontic device to one or more teeth.

[0064] 8) The device according to 1), wherein the sensor comprises a force-sensitive film or a pressure-sensitive film, a resistive film, a capacitive film or a piezoelectric tactile sensor.

[0065] 9) The apparatus of 1) wherein the sensor comprises an electromagnetic target configured to generate motion sensor data indicative of one or more of: a position of the patient's teeth and an orientation of the patient's teeth; and further wherein the appliance body comprises an electromagnetic field generator.

[0066] 10) The device of 1) wherein the engagement site comprises an opening or depression formed through the aligner body.

[0067] 11) The device according to 1), wherein the engagement site is located on one or more of the lingual side of the orthodontic body or the buccal side of the orthodontic body.

[0068] 12) The device according to 1) further includes a plurality of additional engagement sites on the aligner body and a plurality of additional attachment members, wherein the plurality of additional attachment members are configured to be coupled to the patient's teeth and engage with the plurality of additional engagement sites.

[0069] 13) A device according to 1), wherein the processor is configured to evaluate the performance of the orthodontic device by using the sensor data to determine one or more of: the amount of force or pressure applied to the patient's teeth, the distribution of the force or pressure on the patient's teeth, the amount of movement of the patient's teeth, or the rate of movement of the patient's teeth.

[0070] 14) The device of 1), wherein the processor is configured to evaluate the performance of the orthodontic device by determining whether the amount of force or pressure applied by the orthodontic device to the patient's teeth is within a target range.

[0071] 15) An orthodontic device for repositioning teeth of a patient and for sensing one or more features in the patient's mouth, the device comprising:

[0072] an appliance body including a plurality of tooth receiving cavities shaped to reposition the patient's teeth from an initial arrangement to a target arrangement, the appliance body having an engagement portion;

[0073] an attachment configured to be coupled to a patient's tooth and to engage with the engagement site on the appliance body;

[0074] a sensor on the attachment, the sensor configured to generate sensor data;

[0075] a processor on the orthotic body, the processor configured to receive the sensor data from the sensor and to perform one or more of: storing, analyzing, and transmitting the received sensor data; and

[0076] a first electrical contact on the attachment and a second electrical contact on the aligner body, wherein the first electrical contact and the second electrical contact form an electrical connection when the attachment is engaged with the engagement site;

[0077] Wherein, when the attachment is engaged with the engagement portion, the sensor is electrically connected to the processor through an electrical connection formed by the first electrical contact and the second electrical contact.

[0078] 16) An orthodontic device for repositioning a patient's teeth and tracking tooth movement, the device comprising:

[0079] an appliance body including a plurality of tooth receiving cavities shaped to reposition the patient's teeth from an initial arrangement to a target arrangement;

[0080] a plurality of motion sensors coupled to or configured to be coupled with the aligner body, wherein each motion sensor is configured to generate motion sensor data indicative of one or more of a position of a patient's teeth and an orientation of the patient's teeth; and

[0081] A processor is configured to receive and store the motion sensor data and determine tooth movement based on the motion sensor data.

[0082] 17) The apparatus of 16), wherein the motion sensor data generated by each of the plurality of motion sensors indicates one or more of: two or more spatial positions of the patient's teeth and two or more angular positions of the patient's teeth.

[0083] 18) The apparatus of 16), wherein the processor is configured to repeatedly receive and store the motion sensor data at intervals between 1 hour and 2 weeks.

[0084] 19) The device according to 16) further includes a plurality of force sensors, which are coupled to the brace body or to an attachment configured to couple the brace body to the patient's teeth, and are configured to generate force sensor data indicating one or more of the amount of force applied to the patient's teeth and the direction of the force applied to the patient's teeth, and further, wherein the processor is configured to receive and store the motion sensor data and the force sensor data.

[0085] 20) The apparatus of 16), wherein each of the plurality of motion sensors comprises an electromagnetic target configured to generate the motion sensor data.

[0086] 21) The device according to 20), wherein each of the plurality of motion sensors comprises a magnet, a flat coil or a cylindrical coil.

[0087] 22) The device according to 20) also includes an electromagnetic field generator coupled to the corrector body.

[0088] 23) The apparatus according to 16), wherein each of the plurality of motion sensors is configured to measure the position of one or more teeth by measuring changes in an applied electromagnetic field.

[0089] 24) The apparatus of 16) wherein the processor is configured to track movement of the patient's teeth relative to each other based on the motion sensor data.

[0090] 25) The device of claim 16), wherein at least some of the plurality of motion sensors are configured to couple the aligner body to an attachment to the patient's teeth.

[0091] 26) The apparatus of 16) further comprising a power supply and a wireless communication circuit coupled to the processor and configured to wirelessly transmit the motion sensor data.

[0092] 27) The device according to 16) also includes a second brace body, and the second brace body includes a plurality of tooth receiving cavities.

[0093] 28) The apparatus of 16) wherein each of the plurality of motion sensors is coupled to the orthotic body.

[0094] 29) An orthodontic device for repositioning a patient's teeth and tracking tooth movement, the device comprising:

[0095] an appliance body including a plurality of tooth receiving cavities shaped to reposition the patient's teeth from an initial arrangement to a target arrangement;

[0096] a plurality of motion sensors coupled to the aligner body or on an attachment configured to couple the aligner body to the patient's teeth, wherein the plurality of motion sensors are each configured to generate motion sensor data indicative of one or more of: a position of the patient's teeth and an orientation of the patient's teeth;

[0097] a plurality of force sensors coupled to the aligner body or to an attachment configured to couple the aligner body to the patient's teeth, wherein the plurality of force sensors are each configured to generate force sensor data indicative of one or more of: an amount of force applied to the patient's teeth and a direction in which the force is applied to the patient's teeth; and

[0098] A processor is configured to receive and store the motion sensor data and the force sensor data.

[0099] 30) The apparatus of claim 29), wherein the motion sensor data generated by each of the plurality of motion sensors indicates one or more of: two or more spatial positions of the patient's teeth and two or more angular positions of the patient's teeth.

[0100] 31) The apparatus of 29), wherein the processor is configured to repeatedly receive and store the motion sensor data and the force sensor data at intervals between 1 hour and 2 weeks.

[0101] 32) The apparatus of 29), wherein each of the plurality of motion sensors comprises an electromagnetic target configured to generate the motion sensor data.

[0102] 33) The device according to 32), wherein each of the plurality of motion sensors comprises a magnet, a flat coil or a cylindrical coil.

[0103] 34) The device according to 32) also includes an electromagnetic field generator coupled to the corrector body.

[0104] 35) The apparatus according to 29), wherein each of the plurality of motion sensors is configured to measure the position of one or more teeth by measuring changes in an applied electromagnetic field.

[0105] 36) An apparatus according to claim 29), wherein the processor is configured to determine one or more of: a rate of movement of the patient's teeth, a rate of change of force applied to the patient's teeth, and a force vector acting on the patient's teeth.

[0106] 37) An apparatus according to 29), wherein the processor is configured to track the movement of the patient's teeth relative to each other based on the motion sensor data.

[0107] 38) The apparatus of 29) further comprises a power supply and a wireless communication circuit coupled to the processor and configured to wirelessly transmit the motion sensor data.

[0108] 39) An orthodontic device for repositioning a patient's teeth and tracking tooth movement, the device comprising:

[0109] one or more aligner bodies, each aligner body including a plurality of tooth receiving cavities shaped to reposition the patient's teeth from an initial arrangement to a target arrangement;

[0110] a plurality of motion sensors coupled to the one or more aligner bodies or on an attachment configured to couple the one or more aligner bodies to the patient's teeth, wherein the plurality of motion sensors each include an electromagnetic target configured to generate motion sensor data indicative of one or more of: a position of the patient's teeth and an orientation of the patient's teeth;

[0111] an electromagnetic field generator coupled to an orthotic body of the one or more orthotic bodies; and

[0112] A processor is configured to receive and store the motion sensor data.

[0113] 40) The apparatus of claim 39), wherein the motion sensor data generated by each of the plurality of motion sensors indicates one or more of: two or more spatial positions of the patient's teeth and two or more angular positions of the patient's teeth.

[0114] 41) The apparatus of 39), wherein the processor is configured to repeatedly receive and store the motion sensor data at intervals between 1 hour and 2 weeks.

[0115] 42) The device according to 39) further includes a plurality of force sensors, which are coupled to the one or more aligner bodies or to attachments configured to couple the one or more aligner bodies to the patient's teeth, and are configured to generate force sensor data indicating one or more of the amount of force applied to the patient's teeth and the direction of the force applied to the patient's teeth, and further, wherein the processor is configured to receive and store the motion sensor data and the force sensor data.

[0116] 43) The apparatus of claim 39), wherein each electromagnetic target of the plurality of motion sensors comprises one or more of a magnet, a flat coil, or a cylindrical coil.

[0117] 44) The apparatus of claim 39), wherein each of the plurality of motion sensors is configured to measure the position of one or more teeth by measuring changes in an applied electromagnetic field.

[0118] 45) An apparatus according to claim 39), wherein the processor is configured to track the movement of the patient's teeth relative to each other based on the motion sensor data.

[0119] 46) An orthodontic device for repositioning a patient's teeth and tracking tooth movement, the device comprising:

[0120] an appliance body including a plurality of tooth receiving cavities shaped to reposition the patient's teeth from an initial arrangement to a target arrangement, the appliance body having a plurality of engagement sites;

[0121] a plurality of attachments configured to engage the plurality of engagement sites and couple the appliance body to the patient's teeth;

[0122] wherein each of the plurality of attachments comprises a sensor configured to generate sensor data related to a force applied by the orthodontic device to a patient's teeth or a movement of the patient's teeth; and

[0123] A processor is coupled to the orthotic body and is configured to receive and store the sensor data.

[0124] 47) A device according to 46), wherein the sensor of each of the plurality of attachments comprises a force or pressure sensor configured to measure the force or pressure applied by the orthodontic device to one or more teeth.

[0125] 48) The device according to 46), wherein each of the plurality of attachments comprises a force-sensitive film or a pressure-sensitive film, a resistive film, a capacitive film or a piezoelectric tactile sensor.

[0126] 49) The device of 46) wherein each of the plurality of attachments comprises an electromagnetic target configured to generate motion sensor data indicative of one or more of: a position of the patient's teeth and an orientation of the patient's teeth; and further wherein the appliance body comprises an electromagnetic field generator.

[0127] 50) The device according to 46) also includes electrical contacts between the attachment and the corrector body.

[0128] 51) The device of 46) wherein the plurality of engagement locations comprise openings or recesses formed through the body of the orthotic device.

[0129] 52) The device of claim 46), wherein the plurality of engagement sites are located on one or more of the lingual side of the brace body or the buccal side of the brace body.

[0130] 53) A device according to 46), wherein the processor is configured to evaluate the performance of the orthodontic device by using the sensor data to determine one or more of the following: the amount of force or pressure applied to the patient's teeth, the distribution of the force or pressure on the patient's teeth, the amount of movement of the patient's teeth, or the rate of movement of the patient's teeth.

[0131] 54) A device according to 46), wherein the processor is configured to evaluate the performance of the orthodontic device by determining whether the amount of force or pressure applied to the patient's teeth by the orthodontic device is within a target range.

[0132] 55) The device of claim 46), wherein the sensor of each of the plurality of attachments comprises a motion sensor configured to measure movement of one or more teeth.

[0133] 56) The device according to 55), wherein the motion sensor is configured to measure the movement of the one or more teeth by measuring changes in the applied electromagnetic field.

[0134] 57) The device according to 46) also includes a power supply, a memory and a wireless communication circuit coupled to the processor.

[0135] 58) An orthodontic device for repositioning a patient's teeth and tracking tooth movement, the device comprising:

[0136] an appliance body including a plurality of tooth receiving cavities shaped to reposition the patient's teeth from an initial arrangement to a target arrangement, the appliance body having a plurality of engagement sites on one or more of a buccal or lingual side of the appliance body;

[0137] a plurality of attachments configured to engage the plurality of engagement sites and couple the appliance body to the patient's teeth;

[0138] a plurality of sensors, wherein each sensor extends at least partially within each engagement location of the plurality of engagement locations, wherein each sensor of the plurality of sensors is configured to generate sensor data related to forces applied to a patient's teeth or movement of a patient's teeth by the orthodontic device; and

[0139] A processor is coupled to the orthotic body and is configured to receive and store the sensor data.

[0140] 59) A device according to 58), wherein each of the plurality of sensors comprises a force or pressure sensor configured to measure a force or pressure applied by the orthodontic device to one or more teeth.

[0141] 60) The device according to 58), wherein each of the plurality of sensors comprises a force-sensitive film or a pressure-sensitive film, a resistive film, a capacitive film or a piezoelectric tactile sensor.

[0142] 61) The apparatus of 58) wherein each of the plurality of sensors comprises a motion sensor configured to measure movement of one or more teeth.

[0143] 62) The apparatus according to 61), wherein the motion sensor is configured to measure the movement of the one or more teeth by measuring changes in an applied electromagnetic field.

[0144] 63) The device of 58) wherein the plurality of engagement locations comprise openings or recesses formed through the body of the orthotic device.

[0145] 64) A device according to 58), wherein the processor is configured to evaluate the performance of the orthodontic device by using the sensor data to determine one or more of the following: the amount of force or pressure applied to the patient's teeth, the distribution of the force or pressure on the patient's teeth, the amount of movement of the patient's teeth, or the rate of movement of the patient's teeth.

[0146] 65) A device according to 58), wherein the processor is configured to evaluate the performance of the orthodontic device by determining whether the amount of force or pressure applied to the patient's teeth by the orthodontic device is within a target range.

[0147] 66) The device according to 58) also includes a power supply, a memory and a wireless communication circuit coupled to the processor. BRIEF DESCRIPTION OF THE DRAWINGS

[0148] The novel features of the present disclosure are particularly set forth in the appended claims. A better understanding of the features and advantages of the present disclosure will be obtained by referring to the following detailed description, which sets forth illustrative embodiments utilizing the principles of the present disclosure and the accompanying drawings, in which:

[0149] Figure 1A A tooth repositioning appliance is shown.

[0150] Figure 1B A tooth repositioning system is shown.

[0151] Figure 2 A method of orthodontic treatment using multiple appliances is shown.

[0152] Figure 3A A monitoring device is schematically shown.

[0153] Figure 3B A system including an intraoral appliance having one or more sensors described herein and digital scan data of the appliance and / or a patient's teeth is schematically illustrated. An analysis engine (which may be part of the intraoral appliance or separate from the intraoral appliance) may integrate the distal information and the sensor information and may use the digital scan data to associate specific sensor information with the patient's teeth.

[0154] Figure 4 A monitoring device having an activation mechanism is shown.

[0155] Figure 5A An orthodontic appliance including an integrated monitoring device is shown.

[0156] Figure 5B yes Figure 5A A cross-sectional view of an apparatus.

[0157] Figure 6 A monitoring system is shown that includes a first appliance and a second appliance.

[0158] Figure 7A-7C A system comprising an intraoral appliance and an attachment mounted on a tooth is shown.

[0159] Fig.7D is an example of an intraoral device configured to measure the mechanical impedance of one or more teeth.

[0160] Fig. 7E The detection of acceleration at a particular tooth (or portion of an appliance corresponding to a particular tooth) over time is shown graphically. Figure 7F The diagram shows the Fig. 7E The detection of time-varying forces at the same tooth (or appliance area) for which the acceleration is determined is shown in FIG. Fig.7D An intraoral device of the apparatus shown in FIG. 1 configured to measure mechanical impedance can correlate time-varying acceleration and time-varying force to estimate the mechanical impedance to the tooth.

[0161] Figure 7G A portion of an intraoral appliance configured to measure mechanical impedance is shown. In this example, one or more motion sensors (e.g., accelerometers) can be coupled to the teeth (as part of an attachment, as shown) and can communicate with electronic components on the intraoral appliance (e.g., memory, processor, power supply, wireless communication, etc.). The device can also include or can be used with a mechanical actuator to provide a known (or measured) disturbance vibration, and the processor can use the known force input and the output from the accelerometer to determine the mechanical impedance for one or more teeth.

[0162] Fig. 8A A monitoring device configured to measure forces and / or pressures between an orthodontic appliance and a patient's teeth is shown.

[0163] Figure 8B An example of an intraoral appliance is shown in which a majority of the aligner surface includes capacitive touch sensor material. Figure 8C A zoomed in view is shown, showing the distribution in Figure 8B A grid pattern of capacitive touch sensors on the surface of an intraoral appliance.

[0164] Fig. 9A A monitoring device configured to measure forces and / or pressures between an orthodontic appliance and one or more attachments on a patient's teeth is shown.

[0165] Fig. 9Byes Fig. 9A Cross-sectional view of the device.

[0166] Fig. 10A A monitoring device for electromagnetic tooth tracking is shown.

[0167] Fig. 10B Shows Fig. 10A An alternative to a monitoring device in which a handheld reader device can be used by a physician or patient to read the position and / or orientation of teeth.

[0168] Fig.11 A method for monitoring the performance of an orthodontic appliance for repositioning teeth of a patient is shown.

[0169] FIG. 12A to FIG. 12D A method for manufacturing an orthodontic appliance with an integrated monitoring device is shown.

[0170] FIG. 13A to FIG. 13C A method for manufacturing an orthodontic appliance with an integrated monitoring device is shown.

[0171] Fig.14 It is a simplified block diagram of a data processing system.

[0172] Fig.15A is an example of an appliance having an array of multiple force and / or pressure sensors corresponding to each tooth to provide intra-tooth patterns of force and / or pressure that can be used by the devices described herein to determine accurate estimates of tooth movement and modify treatment accordingly (adaptive treatment). Fig.15A The intraoral appliances shown in are braces, but any appliance may be used, and although only a single tooth is shown with an array, it may include an orthodontic appliance. Figures 8B-8C Multiple arrays (on multiple teeth) similar to the example shown in , such as a capacitive touch sensor array.

[0173] Fig. 15B A device similar to the one worn on the teeth of a subject is shown. Fig.15A A portion of an orthosis showing an array of force sensors shown in FIG. 4 ; in this example, multiple arrays are shown (at least one array of n sensors per tooth).

[0174] Fig.16A An example of a device including electrical traces that are directly bonded to a subject's teeth and configured to interact with circuitry and / or electricity on a wearable orthodontic piece (e.g., an aligner). In this example, properly wearing the aligner on the teeth completes a circuit in the aligner that can accurately track compliance and / or activate a sensor (e.g., a biosensor). Fig. 16BAn open circuit is shown between the appliance (eg, the aligner on the left) and the conductive traces on the teeth when the appliance is not worn on the teeth or is not worn properly. Fig. 16C A closed circuit is shown causing a node on the tooth to couple to a node on the appliance when the appliance is worn.

[0175] Fig.17A An orthosis including multiple articulation sites is shown. Fig. 17B The patient's teeth are shown and configured with Fig.17A The sensor subsystem can be distributed between the aligner and one or more of the attachments that secure the aligner to the teeth; and electrical contact can be made between the attachment and the aligner, and the sensor can communicate electrically with a memory, a processor, etc. (e.g., transmit sensor data) through the electrical contacts. For example, referring to Fig. 17C , showing an enlarged view of the attachment point, the sensor is integrated into the attachment, which also includes electrical contacts. Fig.17D The connection between the attachment and the interface of the orthosis is shown, which also includes the electrical contact points.

[0176] Fig.17E An alternative configuration is shown in which a portion of the sensor subsystem (e.g., a processor and / or battery) is located on the attachment rather than the sensor. This portion can be electrically connected to the processor via electrical contacts between the attachment and a bonding site on the orthosis, such as Fig.17F shown. Detailed Description

[0177] Generally, described herein are devices (e.g., systems and apparatus) and methods for monitoring the progress of appliance-based orthodontic treatment. The devices and methods described herein are exemplified in the context of one or a series of orthodontic appliances, however it should be understood that the principles described herein and in particular the devices and methods described herein can be applied to any orthodontic appliance, including but not limited to: orthodontic appliances, palatal expanders, retainers, mouth guards, etc.

[0178] The devices described herein are configured to monitor treatment. Therefore, any of these devices can be considered a monitoring device. In some embodiments, the monitoring device includes one or more sensors configured to generate sensor data related to the repositioning of the patient's teeth using an orthodontic appliance. The sensor data can be processed and analyzed to determine whether the appliance successfully repositioned the teeth according to a prescribed treatment plan. Advantageously, the embodiments described herein provide an integrated electronic sensing and logging system that is capable of generating more reliable and accurate appliance performance data that can be used by a treating physician to track treatment progress and adjust the patient's treatment plan as needed. The monitoring device of the present disclosure can provide high-value sensing data for adaptive closed-loop treatment planning and appliance design.

[0179] In one aspect, a device for monitoring the performance of an orthodontic appliance for repositioning teeth of a patient is provided. The device may include an orthodontic appliance including a plurality of tooth receiving cavities shaped to reposition the teeth of the patient from an initial arrangement toward a target arrangement. The device may include one or more sensors configured to generate sensor data related to repositioning the teeth of the patient by the orthodontic appliance. The device may include a processor configured to process the sensor data so as to evaluate the performance of the orthodontic appliance in achieving the repositioning of the teeth of the patient.

[0180] The performance of an orthodontic appliance can be measured in a variety of ways. For example, in some embodiments, the processor is configured to evaluate the performance of an orthodontic appliance by using the sensor data to determine one or more of the following: the amount of force or pressure applied to the patient's teeth, the distribution of the force or pressure on the patient's teeth, the amount of movement of the patient's teeth, or the rate of movement of the patient's teeth.

[0181] In some embodiments, one or more sensors include a force or pressure sensor configured to measure the force or pressure applied by the orthodontic appliance to one or more teeth. The force or pressure sensor may include a force-sensitive film or a pressure-sensitive film, a resistive film, a capacitive film, or a piezoelectric tactile sensor. For example, the processor may be configured to evaluate the performance of the orthodontic appliance by determining whether the amount of force or pressure applied by the orthodontic appliance to the patient's teeth is within a target range.

[0182] In some embodiments, one or more sensors include a motion sensor configured to measure the movement of one or more teeth. The motion sensor may include an electromagnetic field generator configured to generate an electromagnetic field. The motion sensor may be configured to measure the movement of one or more teeth by measuring changes in the electromagnetic field. For example, the motion sensor may include one or more electromagnetic targets arranged to move in response to the movement of one or more teeth, so that the movement of the one or more electromagnetic targets produces a change in the electromagnetic field.

[0183] In some embodiments, the one or more sensors include a plurality of different sensors operably coupled to different portions of the orthodontic appliance. The one or more sensors may be integrated with the orthodontic appliance, coupled to the teeth, or a combination thereof.

[0184] In some embodiments, the processor is integrated with the orthodontic appliance or coupled to the teeth. Optionally, the processor can be located outside the patient's oral cavity. In some embodiments, the device also includes a communication module, which is configured to transmit one or more of the sensor data or processed sensor data to a remote device.

[0185] In another aspect, a method for monitoring the performance of an orthodontic appliance for repositioning teeth of a patient is provided. The method may include receiving sensor data from one or more sensors related to the repositioning of the patient's teeth by the orthodontic appliance. The orthodontic appliance may include a plurality of tooth receiving cavities shaped to reposition the patient's teeth from an initial arrangement toward a target arrangement. The sensor data may be processed to evaluate the performance of the orthodontic appliance in achieving the repositioning of the patient's teeth.

[0186] In some embodiments, the performance of an orthodontic appliance is evaluated by using sensor data to determine one or more of: the amount of force or pressure applied to the patient's teeth, the distribution of the force or pressure on the patient's teeth, the amount of movement of the patient's teeth, or the speed of movement of the patient's teeth.

[0187] In some embodiments, one or more sensors include a force or pressure sensor configured to measure the force or pressure applied by the orthodontic appliance to the patient's teeth. For example, the force or pressure sensor may include a force-sensitive film or a pressure-sensitive film, a resistive film, a capacitive film, or a piezoelectric tactile sensor. The performance of the orthodontic appliance can be evaluated by determining whether the amount of force or pressure applied by the orthodontic appliance to the patient's teeth is within a target range.

[0188] In some embodiments, the one or more sensors include a motion sensor configured to detect movement of a patient's teeth. The motion sensor may include an electromagnetic field generator configured to generate an electromagnetic field. The motion sensor may be configured to measure the movement of one or more teeth by measuring changes in the electromagnetic field. Optionally, the motion sensor includes one or more electromagnetic targets arranged to move in response to the movement of the one or more teeth, such that the movement of the one or more electromagnetic targets produces changes in the electromagnetic field.

[0189] In some embodiments, the one or more sensors include a plurality of different sensors operably coupled to different portions of the orthodontic appliance. For example, the one or more sensors may be integrated with the orthodontic appliance, coupled to the teeth, or a combination thereof.

[0190] In some embodiments, the processing step is performed by a processor integrated with orthodontic appliances or coupled to the teeth.Alternatively, the processor may be located outside the patient's mouth.

[0191] In some embodiments, the method further includes transmitting one or more of the sensor data or the processed sensor data to a remote device.

[0192] Various embodiments of the present disclosure can be used in conjunction with various types of orthodontic appliances. Figure 1A Appliances are generally shown having tooth receiving cavities that receive and reposition teeth, such as via forces applied due to the resiliency of the appliance. Figure 1A An exemplary tooth repositioning appliance or aligner 100 that can be worn by a patient to achieve incremental repositioning of individual teeth 102 in a jaw is shown. The appliance may include a shell having a tooth receiving cavity that receives and resiliently repositions the teeth. The appliance or portions thereof may be indirectly manufactured using a physical model of the teeth. For example, an appliance (e.g., a polymer appliance) may be formed using a physical model of the teeth and a thin sheet of a suitable polymer material layer. In some embodiments, the physical appliance is directly manufactured from a digital model of the appliance, for example using rapid prototyping techniques.

[0193] Although reference is made to appliances comprising polymer shell appliances, the embodiments disclosed herein are well suited for use with many appliances that receive teeth, such as appliances that do not have one or more of a polymer or shell. The appliance can be made of one or more of many materials such as metal, glass, reinforced fibers, carbon fibers, composite materials, reinforced composite materials, aluminum, biomaterials, and combinations thereof. The appliance can be formed in many ways, for example, such as by thermoforming or direct manufacturing (e.g., 3D printing, additive manufacturing). Alternatively or in combination, the appliance can be manufactured by machining, such as an appliance manufactured from a block of material using computer numerical control machining.

[0194] The appliance can be mounted on all teeth present in the maxillary or mandibular, or less than all teeth. The appliance can be specially designed to accommodate the patient's teeth (e.g., the topology of the tooth receiving cavity matches the topology of the patient's teeth), and can be manufactured based on a positive or negative model of the patient's teeth generated by an impression, a scan, etc. Alternatively, the appliance can be a universal appliance configured to receive teeth but not necessarily shaped to match the topology of the patient's teeth. In some cases, only some teeth received by the appliance will be repositioned by the appliance, while other teeth can provide a base or anchoring area for keeping the appliance in place because it applies force to one or more teeth for repositioning. In some embodiments, at certain moments during treatment, some, most, or even all teeth will be repositioned. The teeth that are moved can also be used as a base or anchor for keeping the appliance when it is worn by the patient. Typically, wires or other devices for keeping the appliance in place on the teeth will not be provided. However, in some circumstances, it may be desirable or necessary to provide separate attachments or other anchoring elements 104 on the tooth 102 with corresponding receptacles or holes 106 in the appliance 100 so that the appliance can apply a selected force to the tooth. Exemplary appliances used in the system are described in a number of patents and patent applications assigned to Align Technology, including, for example, U.S. Patent Nos. 6,450,807 and 5,975,893, and in the company's website accessible on the World Wide Web (see, for example, URL "invisalign.com"). Examples of tooth-mounted attachments suitable for use with orthodontic appliances are also described in patents and patent applications assigned to Align Technology, including, for example, U.S. Patent Nos. 6,309,215 and 6,830,450.

[0195] Figure 1BAn example of a tooth repositioning system 110 including a plurality of appliances 112, 114, 116 is shown. Any of the appliances described herein may be designed and / or provided as part of a set of a plurality of appliances for use in a tooth repositioning system. Each appliance may be configured so that a tooth receiving cavity has a geometry corresponding to an intermediate or final tooth arrangement intended for the appliance. The patient's teeth may be incrementally repositioned from an initial tooth arrangement to a target tooth arrangement by placing a series of incremental position adjustment appliances on the patient's teeth. For example, the tooth repositioning system 110 may include a first appliance 112 corresponding to an initial tooth arrangement, one or more intermediate appliances 114 corresponding to one or more intermediate arrangements, and a final appliance 116 corresponding to a target arrangement. The target tooth arrangement may be a planned final tooth arrangement selected for the patient's teeth at the end of all planned orthodontic treatment. Alternatively, the target arrangement may be one of a number of intermediate arrangements for the patient's teeth during the course of orthodontic treatment, which may include a variety of different treatment scenarios, including but not limited to situations where surgery is recommended, situations where interproximal reduction (IPR) is appropriate, situations where a progress check is scheduled, situations where anchorage positions are best, situations where palatal expansion is required, situations where restorative dentistry (e.g., inlays, veneers, crowns, bridges, implants, veneers, etc.) is involved, etc. Thus, it should be understood that the target tooth arrangement may be any planned resulting arrangement of the patient's teeth followed by one or more incremental repositioning stages. Similarly, the initial tooth arrangement may be any initial arrangement for the patient's teeth followed by one or more incremental repositioning stages.

[0196] 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 thermoforming on a male or female mold. The indirect manufacture of an orthodontic appliance can include producing a male or female mold of the patient's dentition in a target arrangement (e.g., by rapid prototyping, milling, etc.), and thermoforming one or more thin sheets of material on the mold to generate an appliance shell. Alternatively or in combination, some embodiments of the appliances herein can be manufactured directly, for example using rapid prototyping, stereolithography, 3D printing, etc.

[0197] The configuration of the orthodontic appliance herein can be determined according to the patient's treatment plan, for example, a treatment plan involving the sequential application of multiple appliances for incrementally repositioning teeth. Computer-based treatment plans and / or appliance manufacturing methods can be used to facilitate the design and manufacture of appliances. For example, one or more appliance assemblies described herein can be digitally designed and manufactured with the aid of computer-controlled manufacturing equipment (e.g., computer numerical control (CNC) milling, computer-controlled rapid prototyping (such as 3D printing, etc.). The computer-based method proposed herein can improve the accuracy, flexibility, and convenience of appliance manufacturing.

[0198] In some embodiments, an orthodontic appliance (such as Figure 1A The device shown) applies forces to the crown of the tooth and / or attachment located on the tooth at one or more contact points between the tooth receiving cavity of the device and the received tooth and / or attachment. The magnitude of each of these forces and / or its distribution on the tooth surface can determine the type of orthodontic tooth movement that results. Tooth movement can be in any direction in any plane in space and can include one or more of rotation or translation along one or more axes. As further discussed herein, types of tooth movement include extrusion, intrusion, rotation, tipping, translation, and root movement, and combinations thereof. Tooth movement of the crown that is greater than movement of the root can be referred to as tipping. Equivalent movement of the crown and root can be referred to as translation. Movement of the root that is greater than the crown can be referred to as root movement.

[0199] Figure 2A method 200 of orthodontic treatment using multiple appliances is shown. The method 200 can be implemented using any of the appliances or appliance groups described herein. In step 210, a first orthodontic appliance is applied to the patient's teeth so as 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 so as to reposition the teeth from the second tooth arrangement to a third tooth arrangement. The method 200 can be repeated as needed using any suitable number and combination of consecutive appliances so as to incrementally reposition the patient's teeth from an initial arrangement to a target arrangement. The appliances can all be generated at the same stage or time, in groups or batches (e.g., at the beginning of one or more stages of treatment), or one at a time, and the patient can wear each appliance until the pressure of each appliance on the teeth can no longer be felt, or until the maximum amount of tooth movement represented for a given stage is reached. Multiple different appliances (e.g., a set) can be designed and even manufactured before the patient wears any of the multiple appliances. After wearing the appliance for an appropriate period of time, the patient can replace the current appliance with the next appliance in the series until there are no more appliances remaining. The appliance is usually not fixed to the teeth, and the patient can place and replace the appliance at any time during the surgical procedure (i.e., the patient can remove the appliance). The final appliance or several appliances in the series may have a geometry or multiple geometries selected to overcorrect the tooth arrangement. For example, one or more appliances may have a geometry that will (if fully implemented) move individual teeth beyond the tooth arrangement that has been selected as the "final". This overcorrection may be required to offset potential recurrence (e.g., allowing individual teeth to return to their pre-corrected positions) after the repositioning method has been terminated. Overcorrection may also help to speed up the correction rate (e.g., an appliance with a geometry that is located beyond the desired intermediate position or final position can move a single tooth to a position at a greater rate). In this case, the use of the appliance can be terminated before the tooth reaches the position defined by the appliance. In addition, overcorrection may be deliberately applied to compensate for any inaccuracies or limitations of the appliance.

[0200] An orthodontic appliance can be operably coupled to a monitoring device configured to provide data related to tooth repositioning, such as tooth movement data (e.g., amplitude and / or direction of tooth movement, rate of tooth movement, etc.) and / or interaction between the appliance and the patient's teeth (e.g., contact between the appliance and the teeth, the amount of force and / or pressure applied by the appliance to the teeth, the distribution of force and / or pressure on the teeth, etc.). Such data can be used to evaluate the performance of an orthodontic appliance used to reposition a patient's teeth, as discussed in more detail herein. For example, appliance performance information as described herein can include information regarding whether the forces, pressures, and / or tooth movements generated by the orthodontic appliance are associated with expected values ​​for a planned orthodontic treatment.

[0201] The monitoring device described herein can be designed for use in the patient's oral cavity. For example, the size of the monitoring device can be limited to avoid patient discomfort and / or facilitate its integration into an orthodontic appliance, as described below. In some embodiments, the monitoring device has a height or thickness less than or equal to about 1.5 mm, or less than or equal to about 2 mm. In some embodiments, the monitoring device has a length or width less than or equal to about 4 mm, or less than or equal to about 5 mm. The shape of the monitoring device can be changed as needed, such as circular, oval, triangular, square, rectangular, etc. For example, in some embodiments, the monitoring device can have a circular shape with a diameter less than or equal to about 5 mm.

[0202] A relatively thin and flexible monitoring device can be used to provide a larger surface area while reducing patient discomfort. In some embodiments, the monitoring device herein is sized to conform to the crown surface (e.g., the buccal, lingual, and / or occlusal surfaces of the crown). For example, a monitoring device having a size of approximately 10 mm by approximately 5 mm can be used to cover the buccal surface of a molar crown. As another example, a monitoring device having a size of approximately 10 mm by approximately 20 mm can be used to cover the buccal, occlusal, and lingual surfaces of the crown. The monitoring device can contact the crown of a single tooth or the crowns of multiple teeth as needed.

[0203] Other attributes of the monitoring device (e.g., volume, weight) can be designed to reduce patient discomfort. For example, the weight of the monitoring device can be selected to not exceed a level that would exert undesirable forces on the underlying teeth.

[0204] In alternative embodiments, the monitoring device may be used primarily for research and characterization purposes rather than for patient treatment, and therefore may not be subject to size constraints to reduce patient discomfort. For example, in embodiments where the monitoring device is used outside of the oral cavity (e.g., benchtop testing of aligner performance), the size of the monitoring device may be relatively large compared to a device designed for intraoral use.

[0205] Figure 3A A monitoring device 300 according to an embodiment is schematically shown. The monitoring device 300 can be used in combination with any embodiment of the systems and devices described herein, and the components of the monitoring device 300 are equally applicable to any other embodiment of the monitoring device described herein. The monitoring device 300 can be implemented as an application specific integrated circuit (ASIC) including one or more of the following components: a processor 302, a memory 304, one or more sensors 306, a clock 308, a communication unit 310, an antenna 312, a power management unit 314, or a power supply 316.

[0206] The processor 302 (e.g., a central processing unit (CPU), a microprocessor, a field programmable gate array (FPGA), a logic or state machine circuit, etc.), also referred to herein as a controller, can 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), etc. The memory 304 can be used to store instructions executable by the processor 302 to perform the methods provided herein. In addition, the memory can be used to store sensor data obtained by the sensor 306, as discussed in more detail below.

[0207] The monitoring device 300 may include any number of sensors 306, such as one, two, three, four, five or more (e.g., fourteen, fifteen, sixteen, etc.) 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 the monitoring device described herein include touch or tactile sensors (e.g., capacitive, resistive), proximity sensors, motion sensors (e.g., electromagnetic field sensors), force sensors (e.g., force-sensitive resistors or capacitive materials), pressure sensors (e.g., piezoresistors or capacitive materials), strain gauges (e.g., based on resistors or MEMS), electrical sensors, optical sensors (e.g., LED / photodetectors), or combinations thereof.

[0208] The sensor 306 can be operably coupled to and / or located at any part of the orthodontic appliance, such as at or near the distal portion, the middle portion, the cheek, the tongue, the gum portion, the occlusal portion, or a combination thereof. When the appliance is worn in the patient's mouth, the sensor 306 can be positioned near the tissue of interest, such as near or adjacent to the teeth, gums, palate, lips, tongue, cheeks, respiratory tract, or a combination thereof. For example, when the appliance is worn, the sensor 306 can cover a single tooth or a portion of a single tooth. Optionally, the sensor 306 can cover multiple teeth or portions thereof. In an embodiment using multiple sensors 306, some or all of the monitoring devices can be located at different parts of the appliance and / or oral cavity. Optionally, some or all of the sensors 306 can be located at the same part of the appliance and / or oral cavity.

[0209] If desired, the analog sensor data may be converted to a digital format using an analog-to-digital converter (ADC) (not shown). As described herein, the processor 302 may process the sensor data obtained by the sensor 306 to determine appliance usage and / or patient compliance. The sensor data and / or processing results may be stored in the 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).

[0210] In some embodiments, the monitoring device 300 includes a communication unit 310 configured to send data stored in the memory (e.g., sensor data and / or processing results) to a remote device. The communication unit 310 can utilize any suitable communication method, such as a wired or wireless communication method (e.g., RFID, near field communication, Bluetooth, ZigBee, infrared, etc.). The communication unit 310 may include a transmitter for sending data to the remote device and an antenna 312. Optionally, the communication unit 310 includes a receiver for receiving data from the remote device. In some embodiments, the communication channel used by the communication unit 310 can also be used to power the device 300, such as during data transmission or if the device 300 is used passively.

[0211] The remote device can be any computing device or system, such as a mobile device (e.g., a smart phone), a personal computer, a laptop, a tablet, a wearable device, etc. Optionally, the remote device can be part of a cloud computing system or connected to a cloud computing system ("in the cloud"). The remote device can be associated with a patient, a treating physician, a medical practitioner, a researcher, etc. In some embodiments, the remote device is configured to process and analyze data from the monitoring device 300, for example, to evaluate instrument performance, for research purposes, etc.

[0212] The monitoring device 300 can be powered by a power source 316 such as a battery. In some embodiments, the power source 316 is a printed and / or flexible battery such as a zinc-carbon flexible battery, a zinc-manganese dioxide printed flexible battery, or a solid-state thin film lithium phosphorus nitrogen oxide battery. The use of printed and / or flexible batteries is advantageous for reducing the overall size of the monitoring device 300 and avoiding patient discomfort. For example, printed batteries can be manufactured in a variety of shapes and can be stacked to form a three-dimensional structure, for example to conform to the geometry of the appliance and / or tooth. Similarly, flexible batteries can be shaped to be flush with the surface of the appliance and / or tooth. Alternatively or in combination, other types of power sources or power storage (such as batteries, capacitors, etc.) can be used. In some embodiments, the power source 316 can utilize a lower power energy collection method (e.g., thermodynamics, electrodynamics, piezoelectricity) to generate power for the monitoring device 300. Optionally, the power source 316 can be recharged, for example, via induction or wirelessly. In some embodiments, the patient can recharge the power source 316 when the appliance is not in use. For example, a patient may remove an orthodontic appliance while brushing their teeth and place the appliance on the inductive power hub to recharge the power supply 316 .

[0213] Optionally, the monitoring device 300 may include a power management unit 314 connected to the power supply 316. The power management unit 314 may be configured to control when the monitoring device 300 is active (e.g., using power from the power supply 316) and when the device 300 is inactive (e.g., not using power from the power supply 316). In some embodiments, the monitoring device 300 is active only during certain times in order to reduce power consumption and reduce the size of the power supply 316, thereby allowing for a smaller monitoring device 300.

[0214] In some embodiments, the monitoring device 300 includes an activation mechanism (not shown) for controlling when the monitoring device 300 is in an active state (e.g., powered on, monitoring appliance use) and when the monitoring device 300 is in a dormant state (e.g., powered off, not monitoring appliance use). The activation mechanism can be provided as a discrete component of the monitoring device 300, or can be implemented by the processor 302, the power management unit 314, or a combination thereof. The activation mechanism can be used to reduce the amount of power used by the monitoring device 300, for example, by making the monitoring device 300 inactive when not in use, which can be beneficial in reducing the size of the power supply 316 and thereby helping to reduce the overall device size.

[0215] In some embodiments, the monitoring device 300 is dormant before being delivered to the patient (e.g., during storage, shipment, etc.) and is activated only when ready for use. This approach can be beneficial in saving power expenditures. For example, the components of the monitoring device 300 can be electrically coupled to the power supply 316 when assembled, but can be in a dormant state until activated, for example, by an external device, such as a mobile device, a personal computer, a laptop computer, a tablet computer, a wearable device, a power hub, etc. The external device can send a signal to the monitoring device 300 so that the activation mechanism activates the monitoring device 300. As another example, the activation mechanism can include a switch (e.g., mechanical, electronic, optical, magnetic, etc.) so that the power supply 316 is not electrically coupled to other components of the monitoring device 300 until the switch is triggered. For example, in some embodiments, the switch is a reed switch or other magnetic sensor that is held open by a magnet. The magnet can be removably attached to the monitoring device 300, or, for example, can be integrated into the packaging for the device 300 or the appliance. When the monitoring device is separated from the magnet (e.g., by removing the magnet or removing the device and appliance from packaging), the switch closes and connects the power source 316. As another example, the monitoring device 300 may include a mechanical switch, such as a button, that is manually actuated to connect the power source 316. In some embodiments, the activation mechanism includes a locking function that locks the switch upon initial actuation to maintain connection to the power source, thereby maintaining activation of the monitoring device 300. Optionally, the switch for the activation mechanism can be activated by a component in the patient's mouth (e.g., a magnet coupled to the patient's teeth) such that the monitoring device 300 is active only when the appliance is worn by the patient and is inactive when the appliance is removed from the patient's mouth. Alternatively or in combination, the switch can be activated by other types of signals, such as optical signals.

[0216] In general, any of the devices described herein can be used in conjunction with a digital model or scan or a patient's teeth and / or intraoral appliances. For example, Figure 3B Schematically illustrated is a system 383 including an intraoral appliance 377 having one or more sensors and digital scan data of the appliance and / or patient's teeth 379. An analysis engine 381 (which may be part of the intraoral appliance or separate from the intraoral appliance) may integrate the distal information and the sensor information and may use the digital scan data to correlate specific sensor information to the patient's teeth.

[0217] Figure 4 A monitoring device 400 having an activation mechanism according to an embodiment is shown. As with all other monitoring devices described herein, the monitoring device 400 may be similar to the monitoring device 300 and may include the monitoring devices described herein with respect to Figure 3AThe monitoring device 300 may include some or all of the components described in the description of the monitoring device 300 in the embodiment of the present invention. The device 400 is coupled to an orthodontic appliance 402 (e.g., via packaging material 404). The device 400 may include an activation mechanism 403, which includes a magnetic switch. Prior to use, the device 400 may be removably coupled to a magnet 406 (e.g., using tape 408), and the magnet 406 may hold the magnetic switch in an open position so that the device 400 is inactive. When the appliance 402 is ready for use, the user can remove the magnet 406, thereby closing the magnetic switch and connecting the components of the monitoring device 400 to a power source.

[0218] The orthodontic appliances and monitoring devices described herein can be configured in many different ways. In some embodiments, an orthodontic appliance as described herein is operably coupled to a single monitoring device. Optionally, an orthodontic appliance can be operably coupled to multiple monitoring devices, such as at least two, three, four, five or more monitoring devices. Some or all of the monitoring devices can be of the same type (e.g., collecting the same type of data). Optionally, some or all of the monitoring devices can be of different types (e.g., collecting different types of data). Any of the embodiments of the monitoring devices described herein can be used in combination with other embodiments in a single orthodontic appliance.

[0219] The monitoring device can be located at any part of the appliance, such as at or near the distal portion, the middle portion, the cheek, the tongue, the gum portion, the occlusal portion, or a combination thereof. When the appliance is worn in the patient's mouth, the monitoring device can be positioned near the tissue of interest, such as near or adjacent to the teeth, gums, palate, lips, tongue, cheeks, respiratory tract, or a combination thereof. For example, when the appliance is worn, the monitoring device can cover a single tooth or a portion of a single tooth. Optionally, the monitoring device can cover multiple teeth or portions thereof. In an embodiment using multiple monitoring devices, some or all of the monitoring devices can be located at different portions of the appliance. Optionally, some or all of the monitoring devices can be located at the same portion of the appliance.

[0220] The monitoring device can be operably coupled to the orthodontic appliance in various ways. For example, the monitoring device can be physically integrated with the orthodontic appliance by coupling the monitoring device to a portion of the appliance (e.g., using adhesives, fasteners, closures, laminations, molding, etc.). The coupling can be a releasable coupling that allows the monitoring device to be removed from the appliance, or it can be a permanent coupling in which the monitoring device is permanently fixed to the appliance. Alternatively or in combination, the monitoring device can be physically integrated with the orthodontic appliance by encapsulating, embedding, printing, or otherwise forming the monitoring device with the appliance. In some embodiments, the appliance includes a shell shaped to receive the patient's teeth, and the monitoring device is physically integrated with the shell. The monitoring device can be located on an inner surface of the shell (e.g., a surface adjacent to the received teeth), on an outer surface of the shell (e.g., a surface away from the received teeth), or within a wall of the shell. Optionally, as further discussed herein, the shell can include a receptacle shaped to receive the monitoring device. Exemplary methods for manufacturing an appliance with a physically integrated monitoring device (e.g., by combining some or all of the components of the monitoring device during direct manufacture of the appliance) will be further described in detail herein.

[0221] Figure 5A and Figure 5B An orthodontic appliance 500 including an integrated monitoring device 502 is shown according to an embodiment. The appliance 500 includes a shell 504 having a plurality of tooth receiving cavities, and the monitoring device 502 is coupled to an outer buccal surface of the shell 504 adjacent to the tooth receiving cavity 506. In the depicted embodiment, the monitoring device 502 is coupled to the tooth receiving cavity 506 for the molar. It should be appreciated that in alternative embodiments, the monitoring device 502 can be coupled to other portions of the shell 504, such as an inner surface, a lingual surface, an occlusal surface, one or more tooth receiving cavities for other types of teeth (e.g., incisors, canines, premolars), and the like. The monitoring device 502 can be shaped to conform to the geometry of a corresponding appliance portion (e.g., a wall of the cavity 306) so as to provide a low surface profile and reduce patient discomfort. In some embodiments, the appliance 500 includes a receptacle 508 formed on an outer surface of the shell 504, and the monitoring device 502 is positioned within the receptacle. An exemplary method for forming an appliance having a receptacle 508 and an integrated monitoring device 502 is described in detail below.

[0222] Monitoring device 502 may include Figure 3AAny of the components described for the monitoring device 300 of the present invention. For example, the monitoring device 502 may include a sensor 510, a power source 512 (e.g., a battery), and / or a communication unit 514 (e.g., a wireless antenna). The arrangement of the components of the monitoring device 502 may be changed as desired. In some embodiments, the sensor 508 is located adjacent to the tooth receiving cavity 506. A gap may be formed in the shell 504 adjacent to the sensor 510 to allow direct access to the received tooth. The communication unit 514 (or a component thereof, such as an antenna) may be located adjacent to or on an outer surface of the receptor 508 to facilitate data transmission.

[0223] In some embodiments, some components of the monitoring device may be packaged and provided separately from other components of the device. For example, the monitoring device may include one or more components physically integrated with a first orthodontic appliance and one or more components physically integrated with a second orthodontic appliance. For example, the first orthodontic appliance and the second orthodontic appliance may be worn on opposing jaws. Any of the components of the monitoring device (e.g., Figure 3A The components of the device 300 of the present invention can be located on an appliance for the upper jaw, an appliance for the lower jaw, or a combination thereof. In some embodiments, it is beneficial to distribute the components of the monitoring device across multiple appliances, for example, to accommodate space limitations, to accommodate power limitations, and / or to improve sensing. In addition, some of the components of the monitoring device can serve as a substrate for other components (e.g., a battery serves as a substrate for an antenna).

[0224] Figure 6 A monitoring system 600 including a first appliance 602 and a second appliance 604 is shown according to an embodiment. The first appliance 602 can be shaped to receive teeth of an upper dental arch of a patient, and the second appliance 604 can be shaped to receive teeth of a lower dental arch of a patient. The system 600 can include a monitoring device separated into a first subunit 606 physically integrated with the first appliance 602 and a second subunit 608 physically integrated with the second appliance 608. In some embodiments, the first subunit 606 is a power subunit including a power supply 610, and the second subunit 608 is a sensing subunit including the remaining components of the monitoring device, such as a power management unit 612, a processor (e.g., a CPU 614), a sensor 616, a memory (e.g., a RAM 618 such as an SRAM or DRAM; a ROM such as an EPROM, a PROM, or an MROM; or a hybrid memory such as an EEPROM 620, flash memory, or NVRAM), a communication unit (e.g., an antenna 622), or any other component 624 described herein (e.g., with respect to Figure 3AThe first subunit 606 and the second subunit 608 may be operably coupled to each other via inductive coupling between the power source 610 and the power management unit 612, for example when the first device 602 and the second device 604 are brought into proximity with each other by closing of the patient's jaw.

[0225] It should be understood that Figure 6 The configuration of can be varied as desired. For example, the first subunit 606 can be physically integrated with the second appliance 604, and the second subunit 608 can be physically integrated with the first appliance 602. As another example, the distribution of monitoring device components between the first subunit 606 and the second subunit 608 can be different from the depicted embodiment.

[0226] Alternatively or in combination, the monitoring device can include one or more components physically integrated with the orthodontic appliance and one or more components physically integrated with another device external to the patient's mouth. For example, the external device can be a wearable device worn on another part of the patient's body (e.g., headgear, a smartwatch, a wearable computer, etc.). As another example, the external device can be a power hub, a mobile device, a personal computer, a laptop computer, a tablet computer, etc. Any of the components of the monitoring device (e.g., Figure 3A The monitoring device 300 may be positioned on an external device. In some embodiments, the monitoring device includes an antenna and a communication unit integrated into the orthodontic appliance that transmits sensor data from the patient's mouth to the external device and optionally receives data from the external device. The monitoring device component integrated into the external device may provide additional functionality (e.g., processing and / or analysis capabilities) that enhances the functionality of the monitoring device component within the orthodontic appliance. The monitoring device component within the orthodontic appliance may be capable of operating with or without the enhanced functionality.

[0227] Alternatively or in combination, the monitoring device can include one or more components physically integrated with the orthodontic appliance and one or more components located in the patient's mouth separate from the appliance. The intraoral component can be positioned so as to interact (e.g., physically contact, communicate) with an integrated component in the appliance when the appliance is worn. In some embodiments, the intraoral component is coupled to a portion of the oral cavity, such as the crowns of the patient's teeth. For example, the intraoral component can be physically integrated into an attachment mounted on the patient's teeth. Alternatively or in combination, the monitoring device can be surgically implanted, for example, in the patient's jawbone. Any of the components of the monitoring device (e.g., Figure 3AThe device 300 of the present invention can be located in the patient's mouth instead of in the orthodontic appliance. In some embodiments, the appliance and integrated assembly can be removed from the patient's mouth independently of the intraoral assembly. Advantageously, the method can reduce costs by allowing the same device assembly to be used with multiple different appliances, such as when a series of shell appliances are applied to reposition the patient's teeth.

[0228] Figures 7A-7C A system 700 including an orthodontic appliance 702 and an attachment 704 mounted on a tooth 706 according to an embodiment is shown. The appliance 702 may include a shell having a tooth receiving cavity shaped to receive the tooth 706 and a receptacle shaped to accommodate an attachment (attachment 704) on the tooth 706. In some embodiments, the system 700 includes a monitoring device having a first subunit (e.g., according to any of the methods described herein) physically integrated into the appliance 702 and a second subunit physically integrated into the attachment 704. In some embodiments, the second subunit integrated into the attachment 704 includes relatively bulky components of the monitoring device, such as a power source, a memory, and / or a sensor. For example, the attachment 704 may include a battery or other power source that is operably coupled to a monitoring device component integrated into the appliance 702, for example, via inductive coupling or direct contact using electrodes 708. In an optional embodiment, the configuration may be reversed, with the power source installed in the appliance 702 and the remaining monitoring device components located in the attachment 704. This approach can reduce costs when multiple appliances are used because only the power supply is replaced with each new appliance. As another example, the attachment 704 can include a passive sensing element driven by one or more monitoring device components located in the appliance 702. In yet another example, the attachment 704 can include a conductive element for triggering a switch integrated in the appliance 702.

[0229] The monitoring devices of the present disclosure may utilize many different types and configurations of sensors. The following description of certain exemplary monitoring devices is not intended to be limiting, and it should be recognized that features of various embodiments described herein may be used in conjunction with features of other embodiments. For example, the monitoring devices discussed below may also include the previously described Figure 3A Any of the components described for monitoring device 300. A single monitoring device may include any combination of sensor types and sensor configurations described herein.

[0230] The monitoring device herein may include one or more force and / or pressure sensors for evaluating the performance of the appliance. For example, the monitoring device may include a force-sensitive and / or pressure-sensitive material, such as a membrane or sheet. The force and / or pressure sensor described herein may be a resistive sensor, a capacitive sensor, a strain gauge, a piezoelectric crystal sensor, or a combination thereof. In some embodiments, the force and / or pressure sensor includes a resistive material located between two thin electrodes in the orthodontic appliance, and when force and / or pressure is applied to the material, such as through interaction between the teeth and the appliance, the resistance of the material may increase or decrease.

[0231] The monitoring device may include a single force and / or pressure sensor, or multiple force and / or pressure sensors. The sensors may be positioned at any location in the appliance, such as on an inner surface, an outer surface, a buccal surface, a lingual surface, an occlusal surface, a middle portion, a distal portion, a gingival portion, or a combination thereof. In embodiments where the orthodontic appliance includes a shell having a plurality of tooth receiving cavities, the sensors may be positioned on the inner surfaces of the tooth receiving cavities. Optionally, at least some of the sensors may be located on an outer surface of the appliance, such as an occlusal surface, so as to measure the forces and / or pressures generated by contact between the upper teeth and the lower teeth.

[0232] The sensors can be positioned near certain teeth when the appliance is worn, for example, near the teeth to be repositioned and / or at locations where the appliance is expected to apply force to the teeth. For example, force and / or pressure sensors can be located at or near the buccal, lingual and / or occlusal surfaces of the teeth to be repositioned so as to provide a graph of force and / or pressure values ​​on the crowns. In some embodiments, the monitoring device is configured to obtain data from the buccal, lingual and occlusal sensors in a predetermined order and at a desired frequency so as to provide a graph of forces and / or pressures on the buccal, lingual and occlusal surfaces. Alternatively or in combination, if the appliance is shaped to engage an attachment mounted on a tooth so as to apply force to the tooth, the force and / or pressure sensor can be located at or near the engagement location between the appliance and the attachment.

[0233] The force and / or pressure sensor can be configured to generate measurement data indicating the contact force and / or pressure (e.g., amount, size, direction, distribution, etc.) between the appliance and one or more of the patient's teeth. Optionally, the force and / or pressure sensor can be configured to generate measurement data indicating the contact force and / or pressure between the appliance and an attachment coupled to the tooth. The measurement data can be processed (e.g., by a monitoring device or a remote device) to determine whether the measured force and / or pressure value is within a target range, such as for repositioning teeth, producing anchors, etc. In some embodiments, the measurement data is used to calculate the rate of change of the pressure and / or force applied to the tooth, which may be related to the rate of tooth movement. The rate of change of force and / or pressure can also be used to determine the stress relaxation of the appliance over time. Optionally, the measurement data can be used to calculate other biomechanical parameters related to tooth repositioning, such as one or more torques applied to the tooth, one or more force couples applied to the tooth, and / or the ratio between the force and torque applied to the tooth by the appliance (torque ratio).

[0234] Any of the devices described herein (e.g., monitoring devices) can be configured to determine the mechanical impedance of a tooth and / or an intraoral appliance using the forces applied to the tooth and / or appliance. For example, any of the devices described herein can be configured to derive the mechanical impedance of a tooth, a plurality of teeth, or a group of teeth and / or an appliance. In general, mechanical impedance can refer to the resistance to motion given an applied force:

[0235] Z(w) = F(w) / v(w), where F = force, v = velocity, and w = angular frequency.

[0236] Fig.7D An example of a cross-section of an intraoral appliance 977 (shown in this example as an orthotic device) is shown that includes a motion sensor 971 (such as an accelerometer) and one or more force sensors 969, 969', 969". Alternatively or in addition, one or more of the motion sensor and force sensor can be positioned directly on the teeth (including on an attachment adapted to receive forces from the intraoral appliance and / or forces to secure the intraoral appliance to the teeth) and can communicate with a processor / analysis engine, battery, communication circuitry, etc. on the orthotic device.

[0237] The processor / analysis engine can then use the time-varying motion (e.g., acceleration) data (an example of which is shown in Fig. 7E ) and the corresponding force data over time (an example of which is shown in Figure 7F ), and this data can be correlated to estimate mechanical impedance.

[0238] Alternatively or additionally, the system can estimate the mechanical impedance based on an underdamped second-order system (e.g., as the logarithmic decrement of the underdamped second-order system). In this case, the device can be configured to measure the tooth (and / or appliance) response to a perturbation force, such as an input vibration or force applied to the tooth. For example, the device can be configured to measure the free vibration response to a mechanical pulse input. The device can then determine the peak-to-peak decay of the underdamped oscillations and the period of the system; from these values, the device can then derive the damped natural frequency, the natural frequency, and the damping ratio. In a second-order system, these values ​​can define the impedance.

[0239] For linear systems, the device can fit the parameters of a parametric model of mechanical impedance to the measured Bode plots. For nonlinear systems, the device can use generalized frequency response functions to analyze nonlinear systems (e.g., forced vibration response, sinusoidal frequency sweeps, etc., including machine learning).

[0240] For example, Figure 7G A side view of another example of an apparatus for measuring the mechanical impedance of one or more teeth is shown. In this example, multiple attachments 982 are used to secure an orthodontic appliance (e.g., an orthodontic appliance 989) to the teeth. The orthodontic appliance includes a processor 991, wireless communication circuitry, and may include additional hardware, software, and / or firmware for detecting sensor data to determine the mechanical impedance of the teeth and / or the orthodontic appliance. The attachment may include one or more sensors, including motion (e.g., accelerometers) and / or force sensors; these one or more sensors may communicate directly (e.g., via electrical contact) with the processor 991 on the orthodontic appliance.

[0241] exist Figure 7G In, this configuration can be used as described above, and / or can be used to determine the frequency response to an applied input signal. For example, any of these devices can include an actuator (e.g., a vibration motor, a micropiston, etc.) for applying a vibration or force input to the tooth. The force applied by the actuator can be measured or estimated and used in conjunction with the detected response (e.g., motion / acceleration data). Optionally, the device can take into account naturally occurring force inputs (e.g., chewing forces) and can measure or estimate them; as described above, using one or more force sensors. The force data and the response motion / acceleration data can be used to determine the mechanical impedance.

[0242] The resulting mechanical impedance data can then be used to assess the health of tooth movement.

[0243] Fig. 8AA monitoring device 800 is shown that is configured to measure forces and / or pressures between an orthodontic appliance 802 and a patient's teeth. The device 800 includes a plurality of force and / or pressure sensors 804 (e.g., pressure-dependent resistive films) that are electrically coupled (e.g., via printed wires 805 or other connecting elements) to a controller 806. The plurality of force and / or pressure sensors 804 can be patterned on an inner surface of the appliance 802 to generate sensor data indicative of forces and / or pressures between the appliance 802 and the patient's teeth. In some embodiments, the appliance 802 includes a plurality of tooth receiving cavities, and the force and / or pressure sensors 804 are located on buccal, lingual, and / or occlusal surfaces of the cavities. As described herein, the controller 806 may include components configured to process force and / or pressure data in order to evaluate the performance of the appliance 802 in repositioning teeth (e.g., as previously described with respect to Figure 3A Optionally, controller 806 may include a wireless antenna 808 for transmitting sensor data and / or processing results to a remote device, as described herein.

[0244] In some variations, most (or all) of the intraoral appliances (shown as braces in this example, but as described above, may be configured as any other intraoral appliance) may include capacitive touch sensor material. Figure 8B As shown, the aligner 890 includes a formed surface of a capacitive touch sensor material 893. Figure 8C It shows that it can be distributed in Figure 8B A magnified view of the grid pattern of the capacitive touch sensor on the surface of the intraoral appliance.

[0245] The capacitive touch sensor can relate the intensity and location of the touch information, and can derive the forces (torque and force direction) on the patient's teeth from the intraoral appliance. In some variations, the appliance can include one or more processors for receiving touch information from a grid of capacitive sensors, and can correlate this information with the forces applied by the appliance on the teeth. For example, a digital model of the patient's teeth and / or braces (as described above, generally in Figure 3B ), to associate capacitive touch data with a specific tooth.

[0246] Fig. 9A and Fig. 9BA monitoring device 900 is shown that is configured to measure force and / or pressure between an orthodontic appliance 902 and one or more attachments 904 on a patient's teeth 906. The device 900 includes a plurality of force and / or pressure sensors 908 (e.g., a pressure-dependent resistive film) electrically coupled to a controller 910. The plurality of force and / or pressure sensors 908 may be patterned on an inner surface of the appliance 902 to generate sensor data indicative of force and / or pressure between the appliance 902 and the attachments 904 on the patient's teeth 906. In some embodiments, the appliance 902 includes a plurality of tooth receiving cavities formed with one or more receptors 912 to receive corresponding attachments 904 on the patient's teeth, and the pressure sensors and / or force sensors 908 may be positioned on the inner surface of the one or more receptors 912. The controller 910 may include a component configured to process the sensor data to determine whether the appliance 902 is being worn (e.g., as previously described with respect to Figure 3A described).

[0247] In some embodiments, the monitoring device is configured to evaluate the performance of the appliance by measuring the response signal to the force and / or pressure pulse signal delivered to the oral cavity. For example, the monitoring device can include an actuator (e.g., a micro piston, a vibration motor, or a piezoelectric crystal) configured to deliver force and / or pressure pulse signals to the patient's teeth. The vibration response signal can be recorded with a motion sensor (e.g., an accelerometer) in contact with the tooth. Model fitting and system identification methods can be used to derive the mechanical properties of the tooth periodontal ligament (PDL)-alveolar bone system based on the response signal. Statistical and experimental methods can be used to associate the response signal reaction with different stages of tooth movement (such as due to the movement of orthodontic forces applied by the appliance shell), because the stiffness of the tooth PDL can change with different stages of tooth movement. The response can also be related to tooth, root and / or PDL health and used to evaluate tooth, root and / or PDL health.

[0248] Alternatively or in combination, other types of sensors can be used to indirectly measure the force and / or pressure applied to the teeth by the appliance. For example, in some embodiments, applying force and / or pressure to the patient's teeth generates an electric current in the oral structure (e.g., via the piezoelectric effect). Compression of bone and collagen can cause movement of electrons in the lattice, and applying force on the teeth can result in a short piezoelectric effect on the alveolar bone, which can be detected by appropriate receiving sensors (such as electrodes). The electrical signals generated by the alveolar and periodontal ligament (PDL) under load can stimulate changes in bone metabolism. This piezoelectric effect can be measured to determine when the appliance loads or overloads the teeth. Electrical sensors such as electrodes can also be used to detect these electrical signals, for example by monitoring changes in voltage.

[0249] Alternatively or in combination, the monitoring device herein may include one or more tactile sensors responsive to direct contact with the patient's teeth. The tactile sensors described herein may be, for example, capacitive sensors, resistive sensors, inductive sensors, or piezoelectric sensors. For example, the tactile sensor may be a piezoelectric sensor comprising one or more materials exhibiting piezoelectric properties, such as quartz, ceramics, or polymers (e.g., polyvinylidene fluoride (PVDF)).

[0250] In some embodiments, the tactile sensor may be an array of sensors capable of detecting contact over a two-dimensional surface area. Alternatively, the tactile sensor may be provided as a transparent, thermoformable screen or film that can conform to the shape of the appliance. Some types of tactile sensors may be capable of providing only contact data (e.g., binary data indicating the presence or absence of direct contact), while other types of tactile sensors may also be capable of providing other types of data in addition to contact data (e.g., resistive tactile sensors capable of providing force and / or pressure data).

[0251] The monitoring device may include a single tactile sensor or a plurality of tactile sensors. The sensors may be positioned at any location in the appliance, such as an inner surface, an outer surface, a buccal surface, a lingual surface, an occlusal surface, a middle portion, a distal portion, a gingival portion, or a combination thereof. In embodiments where the orthodontic appliance includes a shell having a plurality of tooth receiving cavities, the sensors may be positioned on the inner surfaces of the tooth receiving cavities. Optionally, at least some of the sensors may be located on an outer surface of the appliance, such as an occlusal surface, to detect contact between upper and lower teeth.

[0252] The sensors can be positioned near certain teeth when the appliance is worn, for example, near the teeth to be repositioned and / or at locations where the appliance is expected to apply force to the teeth. For example, the tactile sensors can be located at or near the buccal, lingual and / or occlusal surfaces of the teeth to be repositioned so as to provide a map of the contact points on the crowns. In some embodiments, the monitoring device is configured to obtain data from the buccal, lingual and occlusal sensors in a predetermined order and at a desired frequency so as to provide contact maps on the buccal, lingual and occlusal surfaces. Alternatively or in combination, if the appliance is shaped to engage an attachment mounted on the teeth, the tactile sensors can be located at or near the engagement location between the appliance and the attachment.

[0253] The tactile sensor can be configured to generate measurement data indicating contact between the appliance and one or more of the patient's teeth. Optionally, the tactile sensor can be configured to generate measurement data indicating contact between the appliance and an attachment coupled to the tooth. The measurement data can be processed (e.g., by a monitoring device or a remote device) to determine whether the contact between the patient's teeth and the appliance is consistent with a prescribed treatment plan.

[0254] Alternatively or in combination, the monitoring device may include one or more motion sensors for measuring movement (e.g., translational and / or rotational movement) of one or more teeth. For example, a motion sensor may be used to track movement of one or more teeth relative to a mandibular portion (e.g., mandibular or maxillary). As another example, a motion sensor may be used to track movement of a first group of one or more teeth relative to a second group of one or more teeth, such as when tracking movement of opposite sides of a single dental arch during arch or palate expansion. Alternatively, a motion sensor may be used to track movement of an upper and lower dental arch relative to each other, such as when correcting the relative positioning of the dental arches to address an overbite or underbite.

[0255] Various types of motion sensors can be used. In some embodiments, the motion sensor includes an electromagnetic field generator (e.g., an electromagnetic coil, a generator antenna) integrated into an orthodontic appliance or attachment mounted on the patient's teeth. The generator can be configured to generate an electromagnetic field (e.g., an electric field, a magnetic field, or a combination thereof) within the oral cavity. The motion sensor can also include one or more electromagnetic targets (e.g., a cylindrical or flat coil, a magnet, etc.) integrated into the orthodontic appliance (e.g., the same appliance as the generator, a different appliance worn on the opposite jaw, or a combination thereof). The electromagnetic target can be positioned in an appliance at or near the location where tooth movement is expected to occur (e.g., coupled to a tooth receiving cavity of a tooth to be repositioned) so that movement of the tooth produces corresponding movement of the electromagnetic target. Alternatively or in combination, the monitoring device can include one or more electromagnetic targets integrated into an attachment coupled to the patient's teeth so that the movement of the tooth and the associated target is directly related.

[0256] In some embodiments, the electromagnetic target passively affects the electromagnetic field generated by the generator, and the motion sensor is configured to detect changes in the spatial deployment of the target by measuring changes in the electromagnetic field caused by the movement (e.g., using one or more electromagnetic sensors or the field generator itself). Alternatively or in combination, the electromagnetic target can actively generate an electromagnetic signal that is detected by the monitoring device and used to determine changes in the spatial deployment of the target (e.g., using one or more electromagnetic sensors or the field generator itself). The spatial deployment of the target can be measured with respect to up to three degrees of freedom in position and three degrees of freedom in orientation and with sufficient accuracy to enable the monitoring device to determine the corresponding movement of the patient's teeth. The determined movement can be compared with the planned movement of the teeth in order to evaluate the performance of the appliance.

[0257] Fig. 10AA monitoring device 1000 for electromagnetic tooth tracking is shown according to an embodiment. The device 1000 includes an electromagnetic field generator 1002 (e.g., a coil) coupled to a first orthodontic appliance 1004 worn on the patient's jaw and a plurality of electromagnetic targets (e.g., a cylindrical coil 1006, a flat coil 1008) coupled to a second orthodontic appliance 1010 worn on the opposite jaw. In an optional embodiment, some or all of the targets may also be coupled to the first appliance 1004. Optionally, the field generator 1002 and the targets may be located on both appliances 1004, 1010. The device 1000 may include a first controller subunit 1012 located on the first appliance 1004 and a second controller subunit 1014 located on the second appliance 1010. The first controller subunit 1012 and the second controller subunit 1014 may each include a controller, a power source, and / or other components as described herein (e.g., with respect to Figure 3A ) and any of the other monitoring device components described herein. The first controller subunit 1012 can be electrically coupled to the field generator 1002 and configured to control the operation of the field generator 1002, while the second controller subunit 1014 can be electrically coupled to the electromagnetic target and configured to control the operation of the electromagnetic target. In some embodiments, when the first device 1004 and the second device 1010 are worn by the patient, the movement of the patient's teeth produces a deflection in the second device 1010, which in turn causes a change in the spatial deployment of the electromagnetic target, which affects the characteristics (e.g., size, direction) of the magnetic field generated by the field generator 1002. These changes can be detected by the field generator 1002 and analyzed by the monitoring device 1000 (e.g., by the first controller subunit 1012 and / or the second controller subunit 1014) to determine the movement of the patient's teeth.

[0258] Alternatively or additionally, the electromagnetic target may be positioned on one or more attachments coupled to the respective teeth.Alternatively or additionally, one or more electromagnetic targets may be positioned directly on one or more teeth, and movement may be tracked directly.

[0259] Alternatively or in combination, the monitoring device may include one or more strain gauges (e.g., resistor-based or MEMS-based) to detect stress and / or strain at one or more locations in the orthodontic appliance. In some embodiments, changes in tooth position result in corresponding changes in stress and / or strain on the orthodontic appliance. Optionally, the amount of strain produced by changes in tooth position may fall within the linear behavior of the appliance material. Thus, the monitoring device can process and analyze stress and / or strain data in order to detect and track the movement of the patient's teeth.

[0260] Alternatively or in combination, the monitoring device may include one or more electrical sensors (e.g., electrodes) for measuring the surface charge of the teeth. Alveolar bone remodeling during orthodontic tooth movement may be regulated by stress-induced biopotentials on the tooth surfaces. For example, a force applied to the labial surface of a lower incisor may displace the tooth in its socket, deforming the alveolar bone convexly toward the root at the leading edge and creating a concave surface toward the root at the trailing edge. In some embodiments, the concave bone surface characterized by osteoblast activity is negatively charged, while the convex bone surface characterized by osteoclast activity is positively charged or neutrally charged. Thus, the monitoring device may measure changes in charge on the tooth surface in order to determine the rate and / or direction of tooth movement.

[0261] Alternatively or in combination, the monitoring device may include one or more conductivity sensors configured to measure the conductivity of a fluid (e.g., saliva) in the surrounding environment. In some embodiments, bone remodeling during orthodontic tooth movement results in changes in saliva content, and these changes can be measured based on the ionic charge of minerals in the saliva. Examples of minerals that can affect saliva conductivity include, but are not limited to, NH4+, Ca2+, PO43-, HCO3-, and F-.

[0262] As Fig. 10A An alternative or additional approach to determining the orientation of teeth as shown in , in which a sensing coil ("main coil") is located on the opposing dental arch, Fig. 10B An example is shown where the coils that can be used for sensing are on a handheld device 1055 that a doctor or patient can insert into the mouth to read the position and orientation of the teeth, and then the reader 1055 can be removed. As described, the reader can include one or more coils and / or field generators.

[0263] In general, the coils described herein can be passive (e.g., no battery or chip required) or active (e.g., attached to a battery or other power source). Passive coils can be charged via induction. When desired, individual coils or multiple coils can be connected to a tag or data logger for recording data.

[0264] In any of the variations described herein, a 3D configuration of capacitive sensing electrodes may be detected.

[0265] Fig.11A method 1100 for monitoring the performance of an orthodontic appliance for repositioning a patient's teeth is shown according to an embodiment. The method 1100 can be performed using any embodiment of the systems and devices described herein. In some embodiments, some or all of the steps are performed using a processor of a monitoring device operably coupled to the orthodontic appliance. Alternatively or in combination, some or all of the steps can be performed by a processor of a device external to the patient's mouth (e.g., a separate computing device or system).

[0266] In step 1110, sensor data is received from one or more sensors operably coupled to the orthodontic appliance. The one or more sensors may include any of the sensor types described herein, including but not limited to: a touch or tactile sensor (e.g., capacitive, resistive), a proximity sensor, a motion sensor (e.g., an electromagnetic field sensor), a force sensor (e.g., a force-sensitive film), a pressure sensor (e.g., a pressure-sensitive film), a strain gauge (e.g., resistive-based or MEMS-based), an electrical sensor, or a combination thereof.

[0267] As described herein, an orthodontic appliance may be worn by a patient as part of a treatment plan for gradually repositioning the patient's teeth. In some embodiments, the orthodontic appliance includes a tooth receiving cavity that is shaped to reposition one or more teeth according to a prescribed treatment plan, and a sensor may be physically integrated (e.g., coupled, embedded, formed, etc.) with the orthodontic appliance at a location adjacent to or proximate to the teeth to be repositioned. According to embodiments described herein, sensor data may be related to repositioning of the patient's teeth by the orthodontic appliance. For example, the sensor data may provide information about the movement (e.g., rotation, translation) of one or more teeth. As another example, the sensor data may provide information about the interaction between the orthodontic appliance and the patient's teeth or attachments mounted thereon, such as forces and / or pressures applied by the appliance to the teeth and / or attachments.

[0268] In some embodiments, sensor data is continuously generated and recorded. Optionally, to reduce power consumption, sensor data may be obtained at predetermined time intervals, such as every 15 minutes, 30 minutes, 1 hour, 2 hours, 5 hours, 12 hours, or 24 hours. The timing of sensor data collection may vary based on the tooth movement expected to be produced by the orthodontic appliance. For example, in some embodiments, tooth tipping is expected to occur relatively quickly after the patient begins wearing the appliance, such that monitoring of tooth tipping is performed during the first 12 hours of appliance use.

[0269] In step 1120, the sensor data is processed to evaluate the performance of the orthodontic appliance in repositioning the patient's teeth. For example, the sensor data may include measurements of force and / or pressure applied by the appliance to the teeth, and the processing step may involve determining whether the force and / or pressure measurements fall within, for example, a target value range for repositioning the teeth. Alternatively or in combination, the sensor data may include measurements of changes in the spatial deployment (e.g., position and / or orientation) of one or more teeth, and the processing step may involve determining whether the changes in the spatial deployment correspond to planned movement of the patient's teeth. Optionally, the processing step may involve associating the sensor data with a timestamp indicating when the data was obtained so that appliance performance information can be measured over time.

[0270] The processed sensor data may include appliance performance information, such as whether the forces, pressures, and / or tooth movements generated by the appliance correlate well with expected values ​​for the planned orthodontic treatment. The expected values ​​for the planned treatment may be determined by computer simulation. For example, an orthodontic appliance may be considered to be performing satisfactorily if: (1) the measured force and / or pressure values ​​are within the expected range of these values, or within 70% of the target values; (2) the pattern of force and / or pressure application on the teeth matches or is similar to the planned pattern for force and / or pressure application; (3) the amount of tooth movement achieved is within 70% of the planned movement; (4) the direction of tooth movement matches or is similar to the planned direction of tooth movement; or a combination thereof. An orthodontic appliance may be considered to be implemented unsatisfactorily if: (1) the measured force and / or pressure values ​​are outside the expected range of such values, or deviate from the target values ​​by more than 30%; (2) the pattern of force and / or pressure applied to the teeth is different from the planned pattern of force and / or pressure application; (3) the amount of tooth movement achieved deviates from the planned movement by more than 30%; (4) the direction of tooth movement is different from the planned direction of tooth movement; or a combination thereof.

[0271] In step 1130, the sensor data generated in step 1110 and / or the processed sensor data generated in step 1120 are optionally sent to a remote device. The remote device may be a mobile device (e.g., a smart phone), a personal computer, a laptop, a tablet, a wearable device, a cloud computing server, etc. Step 1130 may be performed using wireless or wired communication methods as desired. Step 1130 may be performed automatically (e.g., at predetermined time intervals) or in response to instructions received from the remote device (e.g., a command to transmit sensor data and / or appliance usage).

[0272] In step 1140, the orthodontic treatment plan prescribed for the patient is optionally modified based on the sensor data generated in step 1110 and / or the processed sensor data generated in step 1120. The modification step can be performed by a processor outside the patient's mouth (such as a remote device in step 1130). Modifying the treatment plan can involve modifying a planned intermediate or final arrangement of the patient's teeth, modifying the geometry of a tooth receiving cavity of an orthodontic appliance corresponding to the planned intermediate or final arrangement of teeth, modifying the time for wearing one or more appliances, modifying the order for wearing a series of appliances, or a combination thereof. For example, if the appliance performance information indicates that the tooth repositioning achieved by the orthodontic appliance is unsatisfactory and the teeth are off track, the treatment plan can be modified to move the patient's teeth back on track (e.g., mid-course correction). As another example, if the appliance performance information indicates that the appliance does not produce a desired force and / or pressure pattern on the teeth, the geometry of subsequent appliances can be adjusted accordingly to provide more accurate force and / or pressure application. By using appliance performance information as feedback, the systems, methods, and apparatus of the present disclosure allow for adaptive closed-loop orthodontic treatment based on the actual response of the patient's teeth to treatment.

[0273] The monitoring devices described herein can be physically integrated into orthodontic appliances in various ways. In some embodiments, the monitoring device is integrated into the appliance during or after manufacture of the appliance. For example, after the appliance has been manufactured, the monitoring device can be attached to the appliance using an adhesive, fastener, locking mechanism, or a combination thereof. Optionally, the appliance can be formed with complementary features or structures (e.g., recesses, receptacles, guides, holes, etc.) that are shaped to receive and accommodate the monitoring device or components thereof.

[0274] In some embodiments, the monitoring device is coupled to the appliance as a prefabricated unit during or after the appliance manufacturing process, such as by being inserted and sealed into a receptacle in the appliance, attached to the appliance (e.g., by a locking mechanism, adhesive, fastener). Optionally, the monitoring device can be assembled in situ on the appliance during or after the manufacture of the appliance. For example, in an embodiment in which the appliance is manufactured by direct manufacturing (e.g., 3D printing), the monitoring device can be printed simultaneously with the appliance and inserted into the appliance during manufacturing or after the assembled appliance has been manufactured. Optionally, some of the monitoring device components can be prefabricated and other components can be assembled in situ. It should be recognized that the various manufacturing methods described herein can be combined in various ways to make an appliance with an integrated monitoring device component.

[0275] FIG. 12A to FIG. 12DA method for manufacturing an orthodontic appliance with an integrated monitoring device according to an embodiment is shown. The method can be applied to any embodiment of the monitoring device and appliance described herein, and can be used in combination with any of the other manufacturing methods described herein. In a first step ( Fig. 12A (top view) and Fig. 12B (side view)), a prefabricated monitoring device 1200 is coupled to a positive model 1202 of a patient's dentition. For example, the monitoring device 1200 may be attached using adhesives and / or mechanical fasteners. Optionally, the monitoring device 1200 may be hermetically sealed prior to attachment to the model 1202. In a second step ( Fig. 12C ), material is formed (e.g., thermoformed) on the monitoring device 1200 and the model 1202 to make the device shell 1204. In the third step ( Fig.12D ), the mold 1202 is removed, thereby producing a device shell 1204 with an embedded monitoring device 1200. Optionally, the monitoring device 1200 can be encapsulated using a biocompatible adhesive 1206 (e.g., UV curable glue), a material layer, or other sealing element.

[0276] FIG. 13A to FIG. 13C A method for manufacturing an orthodontic appliance with an integrated monitoring device according to an embodiment is shown. The method can be applied to any embodiment of the monitoring device and appliance described herein, and can be used in combination with any of the other manufacturing methods described herein. In a first step ( Fig.13A ), the appliance 1300 is formed (e.g., thermoformed) on a positive model 1302 of the patient's dentition. In a second step ( Fig. 13B ), the prefabricated monitoring device 1304 is attached to the apparatus 1300, for example using an adhesive layer 1306 and / or fasteners, and the thermoplastic material 1308 is attached to the outer surface of the monitoring device 1304. In the third step ( Fig. 13C ), the thermoplastic material 1308 is thermoformed to form a cover that encapsulates the monitoring device 1304 into the appliance 1300. The positive model 1302 may be removed, for example, before or after the third step.

[0277] Alternatively or in combination, the method may include forming a positive geometry corresponding to the geometry of the monitoring device 1304 on the positive model 1302 (e.g., by 3D printing, CNC milling, etc.) such that the appliance 1300 is thermoformed with a receptacle for the monitoring device 1304. The monitoring device 1304 may then be placed and sealed into the receptacle.

[0278] Alternatively or in combination, an orthodontic appliance with an integrated monitoring device may be fabricated by manufacturing the appliance (e.g., by indirect or direct manufacturing) and then attaching a prefabricated monitoring device to the fabricated appliance, e.g., using adhesives, fasteners, locking mechanisms, etc. Optionally, the monitoring device may be hermetically sealed (e.g., by molding) prior to attachment to the appliance.

[0279] Alternatively or in combination, an orthodontic appliance with an integrated monitoring device can be manufactured by coupling a flexible and / or printed component of the monitoring device to the appliance during or after forming the appliance. The components can be coupled in various ways, such as thermoforming, lamination, adhesives, coatings, etc.

[0280] Alternatively or in combination, an orthodontic appliance with an integrated monitoring device can be manufactured by 3D printing a base for the monitoring device and then building the electronic components for the monitoring device onto the base. In some embodiments, the base is shaped to conform to the geometry of the tooth receiving cavity and / or target tooth in which the monitoring device will be positioned. The 3D printed portion of the monitoring device can be shaped flush with the surface of the appliance to facilitate integration of the monitoring device with the appliance.

[0281] Alternatively or in combination, an orthodontic appliance with an integrated monitoring device can be manufactured by etching the surface of the appliance (e.g., using a masking process) and then depositing a conductive ink, stretchable material, etc. onto the etched portion to establish the electronic components of the monitoring device on the appliance (e.g., wires, connectors, electrodes, etc.).

[0282] Fig.14 14 is a simplified block diagram of a data processing system 1400 that can be used to perform the methods and processes described herein. The data processing system 1400 typically includes at least one processor 1402 that communicates with one or more peripheral devices via a bus subsystem 1404. These peripheral devices typically include a storage subsystem 1406 (a memory subsystem 1408 and a file storage subsystem 1414), a set of user interface input and output devices 1418, and an interface to an external network 1416. The interface is schematically shown as a "network interface" block 1416 and is coupled to corresponding interface devices in other data processing systems via a communication network interface 1424. The data processing system 1400 may include, for example, one or more computers, such as personal computers, workstations, mainframes, laptop computers, etc.

[0283] The user interface input devices 1418 are not limited to any particular device, and may generally include, for example, a keyboard, a pointing device, a mouse, a scanner, an interactive display, a touch pad, a joystick, etc. Similarly, a variety of user interface output devices may be used in the systems of the present disclosure, and may include, for example, one or more of a printer, a display (e.g., visual, non-visual) system / subsystem, a controller, a projection device, an audio output, etc.

[0284] The storage subsystem 1406 maintains the basic required programming, including computer readable media and data structures with instructions (e.g., operating instructions, etc.). The program modules discussed herein are generally stored in the storage subsystem 1406. The storage subsystem 1406 generally includes a memory subsystem 1408 and a file storage subsystem 1414. The memory subsystem 1408 generally includes a number of memories (e.g., RAM 1410, ROM 1412, etc.), including computer readable memory for storing fixed instructions, instructions and data during program execution, a basic input / output system, etc. The file storage subsystem 1414 provides persistent (non-volatile) storage for program and data files, and may include one or more removable or fixed drives or media, hard disks, floppy disks, CD-ROMs, DVDs, optical drives, etc. One or more of the storage systems, drives, etc. may be located at a remote location, so coupled via a server on a network or via the Internet / World Wide Web. In this case, the term "bus subsystem" is used generically to include any mechanism for enabling the various components and subsystems to communicate with each other as intended, and may include various suitable components / systems that will be recognized or deemed suitable for use herein. It will be recognized that the various components of the system may be, but not necessarily, at the same physical location, but may be connected via various local or wide area network media, transmission systems, etc.

[0285] The scanner 1420 includes any means for obtaining a digital representation (e.g., image, surface topology data, etc.) of a patient's teeth (e.g., by scanning a physical model of the teeth, such as casts 1421, by scanning impressions obtained from the teeth, or by directly scanning the oral cavity), which may be obtained from the patient or from a treating professional (such as an orthodontist), and includes means for providing the digital representation to the data processing system 1400 for further processing. The scanner 1420 may be located at a remote location relative to the other components of the system, and may transmit image data and / or information to the data processing system 1400, for example, via a network interface 1424. The manufacturing system 1422 manufactures the appliance 1423 based on a process plan including data set information received from the data processing system 1400. The manufacturing machine 1422 may, for example, be located at a remote location and receive the data set information from the data processing system 1400 via a network interface 1424.

[0286] Any of the devices and methods described herein may include a plurality of sensors (including force sensors) arranged in an array on each tooth; a plurality of teeth may each be covered by an array of sensors. These sensors may be used to determine a force or pressure pattern on one or more teeth of a subject. The force or pressure pattern may be associated with a scan of the subject's teeth, for example, as described above with reference to Figure 3B and Fig.14 As mentioned. Thus, the sensor information can be combined with digital scan information of the morphology of the patient's teeth. The spatial distribution pattern of force / pressure on one or more of the subject's teeth can be used to determine the orientation of the force applied by the dental appliance relative to the tooth, and can be used to determine a prediction for tooth movement based on the current and / or proposed forces applied to the tooth.

[0287] Any number of sensors may be arranged on each tooth. For example, each tooth may be covered by two, three, four, or more (e.g., n) force sensors (e.g., on an appliance, on a dental attachment configured to couple with the tooth, or directly on the tooth and configured to couple with an orthodontic appliance). In some variations, the sensors are otherwise similar or identical, but are arranged in an array (e.g., an array of n sensors, l by w). This is, for example, in Fig.15A , a dental appliance 1500 (configured as an orthodontic appliance) is shown to be worn on the teeth of a subject. The appliance is configured as an orthodontic appliance having a body having a plurality of tooth receiving cavities shaped to receive the patient's teeth and to apply forces to reposition the patient's teeth from an initial arrangement toward a target arrangement. Fig.15A, the sensor array is shown on only a single tooth 1503 corresponding to a portion of the appliance. In some variations, it may be beneficial to include only a single tooth or a few teeth in the appliance, including teeth that are specifically targeted for movement. Alternatively, an array of force sensors may be used to monitor any number (including all) of the teeth to be retained in the device, such as Fig. 15B shown.

[0288] Fig. 15B Shown as Fig.15A An enlarged view of a portion of an orthodontic appliance is shown, including multiple arrays 1505, 1507, 1509 of force sensors configured to be arranged on the surface of each tooth. In this example, the appliance also includes a processor 1591 that receives input from the multiple sensors and can analyze, store and / or transmit signals from the sensors. The processor may include memory, communication circuitry (e.g., wireless communication circuitry, etc.), a power source (e.g., a battery), etc. Fig.15A and Fig. 15B In the embodiment, the array of sensors is shown as regularly spaced force sensors; alternatively or in addition, the force sensors may be spaced differently and may be spaced, for example, on the front (buccal), back (lingual), or sides of the teeth coupled to the appliance. Each sensor may be electrically connected to a processor on the appliance and / or held on an attachment on one or more teeth.

[0289] As described above, any of the devices described herein may include a portion of a sensor, sensor processor, power supply, memory, etc., on the appliance and / or directly connected to the tooth via an attachment or other tooth coupling technology (e.g., bonding, etc.). Thus, a component on a tooth / teeth may be integrated with a portion of an orthodontic appliance worn by a patient. For example, Figures 16A-16C An example is shown that includes a device that is directly bonded to at least a portion of a subject's tooth 1600 (shown as traces 1601, 1603) that is integrated with a portion of an orthodontic appliance (e.g., shown as an aligner in this example). Fig.16A In the example, the device includes one or more traces (e.g., stretchable conductive traces 1601, 1603) that are directly attached to the teeth. In this example, the traces connect nodes A and B to power supply nodes C and D that can be on the aligner (e.g., aligner 1605). This configuration can eliminate leakage current from the battery to component (X) when the aligner is not in the mouth. In one example, Figures 16A-16CThe components generally referred to as "X" in the figure may include one or more sensors, electronic devices (e.g., controller, memory, power supply, wireless communication, etc.). For example, the device can be configured to transmit a BLE signal every few minutes (e.g., every minute, 2 minutes, 3 minutes, 5 minutes, 10 minutes, 15 minutes, etc., or a variable interval / time) when the aligner is worn. A receiver (e.g., a smart phone and / or a dedicated receiver) can track the BLE pulses and monitor when the appliance is in the mouth.

[0290] exist Fig.16A , the traces 1603, 1601 shown on the tooth 1600 can be used to connect to a rigid component on the braces. Different electronic circuits can be used when the braces are in the mouth and when the braces are outside the mouth. For example, the traces shown above can be used as a performance measure for the movement of the braces or teeth. Nodes 1607 can be placed at known locations on the braces and compared to the node locations on the teeth. In some variations, printed potentiometers can be applied to the teeth. As in Fig. 16B As shown in FIG. 1 , before the brace is worn, the contact points (A, B) or nodes 1607 are not connected to a power source that may be on the brace (nodes D and C on the left). Fig. 16C ), the circuit is complete because nodes A and D are connected and nodes B and C are connected through the conductive traces on the teeth. At a minimum, this complete circuit can be used to indicate compliance because it will only complete the circuit when the appliance is worn and worn correctly. Optionally, additional sensors including one or more sensors may also be connected to traces on the subject's teeth (on a tooth / teeth or on the braces) and activated when the appliance is worn. In some variations, the use of conductive traces on the teeth that may interact with contact points on the braces may also be used to check the fit of the braces.

[0291] In some variations, such as Figures 16A-16C The traces shown may be magnetic, which may allow for self-healing of the traces, or may also be used for other purposes including detection (eg, via a reed switch or Hall effect sensor, etc.) including detection of teeth.

[0292] Distributed monitoring / sensing devices

[0293] As mentioned above, and in Figure 7D-7G As shown in , 9A-9B and 16A-16C, any of the methods and devices described herein can be a distributed device, in which an orthodontic appliance including multiple components (e.g., an orthodontic body and attachments) and a sensor subsystem are distributed among the components.

[0294] like Figures 17A-17BAs shown in FIG. 1 , the device may include an orthodontic body 1700 having a plurality of tooth receiving cavities 1705 shaped to reposition the patient's teeth from an initial arrangement toward a target arrangement. The orthodontic body may include a plurality of tooth receiving cavities 1705 for attachment to an attachment member 1707 ( Fig. 17B As shown, the attachment can be coupled to the patient's tooth / teeth and can engage with an engagement site on the aligner body to secure the aligner body to the patient's teeth (arrow 1719).

[0295] Generally, any portion of the sensor subassembly of the device may be on the attachment and the aligner, and may be distributed between them. This may allow portions on the aligner that are periodically removed to be recharged, downloaded / uploaded, etc., while other portions remain attached to the teeth. For example, the processor, memory, and / or battery may be on the aligner, and the sensor may be on the attachment. Alternatively, the processor, memory, and / or battery may be on the attachment, and the sensor may be on the aligner.

[0296] For example, in Fig. 17C and Fig.17D In the embodiment, the sensor is connected to the attachment. Fig. 17C An example of a sensor 1722 coupled to an attachment 1707 (e.g., any suitable sensor configured to generate sensor data) is shown. The sensor 1722 in this example is embedded in or attached to the attachment 1707, and the attachment 1707 is bonded to (or configured to be bonded to) a tooth 1719. For example, a dental cement or adhesive 1721 can secure the attachment to the tooth 1719. The attachment 1707 can include a surface that protrudes from the tooth and engages with an engagement site on the body of the appliance. In some variations, the sensor is part of the surface between the attachment and the engagement site.

[0297] The attachment may also include electrical contacts 1718 for establishing an electrical connection with complementary electrical contacts 1728 on the body of the aligner. Fig. 17C In the embodiment, the first electrical contact point 1718 is included on the sensor 1722 or on the attachment 1707 that is in electrical contact therewith. Fig.17D As shown, when the aligner is held by the attachment, the first electrical contact 1718 on the attachment 1707 can form an electrical connection with the second electrical contact 1728 on the aligner body. When the attachment 1707 is engaged with the engagement portion on the aligner 1700, the first electrical contact 1718 and the second electrical contact 1728 can form an electrical connection, and the sensor data can be transmitted through the connection.

[0298] Alternatively, the sensor may be on the orthosis and other components (e.g., battery, processor, and / or memory) may be on an attachment. Fig.17E , the processor 1732 and / or the battery are shown in the attachment 1707. In this example, when the attachment is engaged with the engagement site, the sensor can be in electrical communication with the processor and / or the battery through the electrical connection formed by the first electrical contact 1718 on the attachment and the second electrical contact 1728 on the aligner body. Fig.17E In the embodiment of the present invention, the sensor is not on the attachment 1707, but at least a portion of the processor 1732 is on the attachment (e.g., the processor and / or memory, timer, etc.) and / or the battery is part of the attachment and can be connected to the rest of the sensing subsystem (including the sensor) via an electrical connector 1718, which is in electrical contact with another electrical connector 1728 on the aligner when the aligner is worn on the teeth and over the attachment, as shown in FIG. Fig.17F shown.

[0299] Any of the methods described herein (including the user interface) may be implemented as software, hardware, or firmware, and may be described as a non-transitory computer-readable storage medium (e.g., a computer, tablet, smart phone, etc.) storing a set of instructions executable by a processor, which, when executed by the processor, causes the processor to perform any of the steps, including but not limited to: displaying, communicating with a user, analyzing, modifying parameters (including timing, frequency, intensity, etc.), determining, alerting, etc.

[0300] When a feature or element is described as "on another feature or element" in this article, it may be directly on other features or elements, or there may also be intermediate features or elements. On the contrary, when a feature or element is described as "directly on" another feature or element, there is no intermediate feature or element. It should be understood that when a feature or element is described as "connected", "attached" or "coupled" to another feature or element, it may be directly connected, attached or coupled to other features or elements, or there may be intermediate features or elements. On the contrary, when a feature or element is referred to as "directly connected", "directly attached" or "directly coupled" to another feature or element, there is no intermediate feature or element. Although described or shown with respect to one embodiment, the features and elements described or shown in this way can be applied to other embodiments. Those skilled in the art will recognize that the structure or feature set with reference to "adjacent" another feature may have a portion overlapping or below an adjacent feature.

[0301] The terms used herein are only used for the purpose of describing specific embodiments and are not intended to limit the present disclosure. For example, unless the context clearly indicates, as used herein, the singular forms "a", "an", and "the" are intended to include the plural forms as well. It should 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 exclude 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 " / ".

[0302] Spatially relative terms, such as "under," "below," "lower," "over," "upper," and the like, may be used herein to facilitate describing the relationship of one element or feature to another element or feature or multiple elements or features as illustrated in the accompanying drawings. It will be understood that the spatially relative terms are intended to encompass different orientations of the device in use or operation in addition to the orientation depicted in the accompanying drawings. For example, if the device in the accompanying drawings were reversed, such as elements being described as "under," "beneath" other elements or features, the elements would then be positioned "over" the other elements or features. Thus, the exemplary term "under" can encompass both orientations of over and under. The device may be otherwise oriented (rotated 90 degrees or at other orientations), and the spatially relative descriptors used herein interpreted accordingly. Similarly, the terms "upwardly," "downwardly," "vertical," "horizontal," etc. are used herein for descriptive purposes unless specifically stated otherwise.

[0303] 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 indicates otherwise. These terms may be used to distinguish one component / element from another component / element. Therefore, without departing from the teachings of the present disclosure, the first feature / element discussed below may be referred to as the second feature / element, and similarly, the second feature / element discussed below may be referred to as the first feature / element.

[0304] In this specification and the appended claims, unless the context requires otherwise, the word "comprises," and variations such as "comprises" and "comprising" mean that various components (e.g., compositions and devices including apparatus and methods) can be used together in methods and articles. 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.

[0305] In general, any apparatus and method described herein should be understood to be inclusive, but all or a subset of components and / or steps may optionally be exclusive and may be expressed as "consisting of" or "consisting essentially of" the various components, steps, subcomponents or sub-steps.

[0306] As used herein in the specification and claims, including in the examples, unless otherwise expressly stated, all numbers may be read as if beginning with the word "about" or "approximately", even if the term does not appear explicitly. The phrase "about" or "approximately" may be used when describing an amplitude and / or position to indicate that the value and / or position described is within a reasonable expected range of the value and / or position. For example, a numerical value may have a value of + / -0.1% of a set value (or range of values), + / -1% of a set value (or range of values), + / -2% of a set value (or range of values), + / -5% of a set value (or range of values), + / -10% of a set value (or range of values), etc. Any numerical value given herein should be understood to include about that value or about that value, unless the context indicates otherwise. For example, if the value "10" is disclosed, "about 10" is also disclosed. Any numerical range described herein is intended to include all subranges contained therein. It should also be understood that when a value is disclosed as "less than or equal to" the value, "greater than or equal to the value" and possible ranges between values ​​are also disclosed, as appropriately understood by those skilled in the art. For example, if a 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 the application, data is provided in a variety of different formats, and that the data represents end points and starting points and ranges for any combination of data points. For example, if a specific data point "10" and a specific data point "15" are disclosed, it should be understood that greater than, greater than or equal to, less than, less than or equal to, and equal to 10 and 15 are considered to be disclosed as being between 10 and 15. It should also be understood that every unit between two specific units is also disclosed. For example, if 10 and 15 are disclosed, 11, 12, 13, and 14 are also disclosed.

[0307] Although various illustrative embodiments are described above, any of several changes may be made to the various embodiments without departing from the scope of the present disclosure as described in the claims. For example, in optional embodiments, the order in which the various described method steps are performed may generally be changed, and in other optional embodiments, one or more method steps may be skipped altogether. Optional features of the various device and system embodiments may be included in some embodiments and not included in other embodiments. Therefore, the foregoing description is provided primarily for exemplary purposes and should not be construed as limiting the scope of the present disclosure as set forth in the claims.

[0308] The examples and descriptions included herein show specific embodiments in which the subject matter can be practiced by way of illustration and not limitation. As mentioned, other embodiments can be utilized and derived therefrom so that structural and logical replacements and changes can be made without departing from the scope of the present disclosure. For convenience only, such embodiments of the public subject matter may be referred to individually or collectively by the term "disclosure" herein, and it is not intended that the scope of the present application is actively limited to any single disclosure or public concept, if in fact more than one is disclosed. Therefore, although specific embodiments have been illustrated and described herein, any arrangement calculated to achieve the same purpose can replace the specific embodiments shown. The present disclosure is intended to cover any and all modifications or variations of various embodiments. After reading the above description, those skilled in the art will understand the combination of the above embodiments and other embodiments not specifically described herein.

Claims

1. An orthodontic device for repositioning a patient's teeth and tracking tooth movement, the device comprising: an appliance body including a plurality of tooth receiving cavities shaped to reposition the patient's teeth from an initial arrangement to a target arrangement, the appliance body having a plurality of engagement sites on one or more of a buccal side or a lingual side of the appliance body, wherein each engagement site is configured to couple the appliance body to an attachment coupled to the patient's teeth; a plurality of motion sensors coupled to or configured to be coupled with the aligner body, wherein each motion sensor extends at least partially within each engagement site of the plurality of engagement sites, wherein each motion sensor is configured to generate motion sensor data indicative of one or more of a position of a patient's teeth and an orientation of the patient's teeth; as well as A processor is configured to receive and store the motion sensor data and determine tooth movement based on the motion sensor data.

2. The device according to claim 1, wherein: The motion sensor data generated by each of the plurality of motion sensors indicates one or more of: two or more spatial positions of a patient's teeth and two or more angular positions of a patient's teeth.

3. The device according to claim 1, wherein: The processor is configured to repeatedly receive and store the motion sensor data at intervals between 1 hour and 2 weeks.

4. The apparatus of claim 1 , further comprising a plurality of force sensors coupled to the aligner body or to an attachment configured to couple the aligner body to the patient's teeth and configured to generate force sensor data indicative of one or more of an amount of force applied to the patient's teeth and a direction of the force applied to the patient's teeth, wherein, The processor is configured to receive and store the motion sensor data and the force sensor data.

5. The device according to claim 1, wherein: Each motion sensor of the plurality of motion sensors includes an electromagnetic target configured to generate the motion sensor data.

6. The device according to claim 5, wherein: Each of the plurality of motion sensors includes a magnet, a flat coil, or a cylindrical coil.

7. The apparatus of claim 5, further comprising an electromagnetic field generator coupled to the aligner body.

8. The device according to claim 1, wherein: Each motion sensor is configured to measure the position of one or more teeth by measuring changes in an applied electromagnetic field.

9. The device according to claim 1, wherein: The processor is configured to track movement of the patient's teeth relative to each other based on the motion sensor data.

10. The apparatus of claim 1, further comprising a power source and wireless communication circuitry coupled to the processor and configured to wirelessly transmit the motion sensor data.

11. The apparatus of claim 1 further comprising a second aligner body comprising a plurality of tooth receiving cavities.

12. The device according to claim 1, wherein: Each motion sensor of the plurality of motion sensors is coupled to the aligner body.

13. An orthodontic device for repositioning a patient's teeth and tracking tooth movement, the device comprising: an appliance body including a plurality of tooth receiving cavities shaped to reposition the patient's teeth from an initial arrangement to a target arrangement, the appliance body having a plurality of engagement sites on one or more of a buccal side or a lingual side of the appliance body, wherein each engagement site is configured to couple the appliance body to an attachment coupled to the patient's teeth; a plurality of motion sensors coupled to the aligner body, wherein each motion sensor extends at least partially within each engagement site of the plurality of engagement sites, wherein each of the plurality of motion sensors is configured to generate motion sensor data indicative of one or more of: a position of a patient's teeth and an orientation of the patient's teeth; a plurality of force sensors coupled to the aligner body, wherein each force sensor extends at least partially within each engagement location of the plurality of engagement locations, wherein each of the plurality of force sensors is configured to generate force sensor data indicative of one or more of: an amount of force applied to a patient's teeth and a direction of the force applied to the patient's teeth; as well as A processor is configured to receive and store the motion sensor data and the force sensor data.

14. The device according to claim 13, wherein: The motion sensor data generated by each of the plurality of motion sensors indicates one or more of: two or more spatial positions of a patient's teeth and two or more angular positions of a patient's teeth.

15. The device according to claim 13, wherein: The processor is configured to repeatedly receive and store the motion sensor data and the force sensor data at intervals between 1 hour and 2 weeks.

16. The device according to claim 13, wherein: Each motion sensor of the plurality of motion sensors includes an electromagnetic target configured to generate the motion sensor data.

17. The device according to claim 16, wherein: Each of the plurality of motion sensors includes a magnet, a flat coil, or a cylindrical coil.

18. The apparatus of claim 16, further comprising an electromagnetic field generator coupled to the aligner body.

19. The device according to claim 13, wherein: Each motion sensor is configured to measure the position of one or more teeth by measuring changes in an applied electromagnetic field.

20. The device according to claim 13, wherein: The processor is configured to determine one or more of: a rate of movement of a patient's tooth, a rate of change of a force applied to the patient's tooth, and a force vector acting on the tooth.

21. The device according to claim 13, wherein: The processor is configured to track movement of the patient's teeth relative to each other based on the motion sensor data.

22. The apparatus of claim 13, further comprising a power source and wireless communication circuitry coupled to the processor and configured to wirelessly transmit the motion sensor data.

23. An orthodontic device for repositioning a patient's teeth and tracking tooth movement, the device comprising: one or more aligner bodies, each aligner body including a plurality of tooth receiving cavities shaped to reposition the patient's teeth from an initial arrangement to a target arrangement; a plurality of motion sensors coupled to the one or more aligner bodies or on an attachment configured to couple the aligner bodies to the patient's teeth, wherein the plurality of motion sensors each include an electromagnetic target configured to generate motion sensor data indicative of one or more of: a position of the patient's teeth and an orientation of the patient's teeth; an electromagnetic field generator coupled to an orthotic body of the one or more orthotic bodies; as well as A processor is configured to receive and store the motion sensor data.

24. The device according to claim 23, wherein: The motion sensor data generated by each of the plurality of motion sensors indicates one or more of: two or more spatial positions of a patient's teeth and two or more angular positions of a patient's teeth.

25. The device according to claim 23, wherein: The processor is configured to repeatedly receive and store the motion sensor data at intervals between 1 hour and 2 weeks.

26. The apparatus of claim 23, further comprising a plurality of force sensors coupled to the aligner body or to an attachment configured to couple the aligner body to the patient's teeth and configured to generate force sensor data indicative of one or more of an amount of force applied to the patient's teeth and a direction of the force applied to the patient's teeth, and wherein, The processor is configured to receive and store the motion sensor data and the force sensor data.

27. The device according to claim 23, wherein: Each electromagnetic target of the plurality of motion sensors includes one or more of a magnet, a flat coil, or a cylindrical coil.

28. The device according to claim 23, wherein: Each motion sensor is configured to measure the position of one or more teeth by measuring changes in an applied electromagnetic field.

29. The device according to claim 23, wherein: The processor is configured to track movement of the patient's teeth relative to each other based on the motion sensor data.

30. A method of designing an orthodontic treatment plan for a patient, the method comprising: receiving motion sensor data from a plurality of motion sensors of an orthodontic appliance having an appliance body having a plurality of tooth receiving cavities shaped to reposition the patient's teeth from an initial arrangement toward a target arrangement according to a first orthodontic treatment plan and a plurality of engagement sites on one or more of a buccal side or a lingual side of the appliance body, wherein the plurality of motion sensors are coupled to the appliance body and are at least partially located within each of the plurality of engagement sites, wherein the motion sensor data indicates one or more of: a position of the patient's teeth and an orientation of the patient's teeth; determining tooth movement based on the motion sensor data; as well as The first orthodontic treatment plan is modified based on the determined tooth movement.

31. The method according to claim 30, wherein: The modification includes modifying the configuration of a tooth receiving cavity of an appliance body of a second orthodontic appliance worn by the patient.

32. The method of claim 30, wherein: The modification includes modifying the duration that the orthodontic appliance is worn by the patient.

33. The method of claim 30, wherein: Also included is providing an attachment anchor configured to couple the aligner body to a patient's tooth.

34. The method of claim 30, further comprising periodically applying an electromagnetic field from an electromagnetic field generator coupled to the aligner body.

35. The method of claim 30, further comprising receiving, in a processor, force sensor data from a plurality of force sensors coupled to the appliance body or on an attachment anchor, wherein the force sensor data indicates one or more of: an amount of force applied to the patient's teeth and a direction of the force applied to the patient's teeth.

36. The method of claim 35, further comprising determining forces acting on the patient's teeth based on the force sensor data.

37. The method of claim 36, wherein modifying comprises modifying the first orthodontic treatment plan based on the determined tooth movements and forces acting on the patient's teeth.

38. The method of claim 30, wherein receiving comprises receiving the motion sensor data at intervals between every hour and every 2 weeks.

39. The method of claim 30, further comprising wirelessly transmitting the motion sensor data from the orthodontic appliance to a processor, wherein the processor comprises a remote processor.

40. The method of claim 30, wherein receiving comprises receiving the motion sensor data in a processor, wherein the processor is coupled to the orthodontic appliance when the orthodontic appliance is worn in the patient's mouth.

41. A method of designing an orthodontic treatment plan for a patient, the method comprising: Providing an orthodontic appliance including an appliance body having a plurality of tooth receiving cavities shaped to reposition teeth of a patient from an initial arrangement toward a target arrangement according to a first orthodontic treatment plan, wherein a plurality of motion sensors are coupled to the appliance body or to attachment anchors configured to couple the appliance body to the teeth of the patient; periodically applying an electromagnetic field from an electromagnetic field generator coupled to the body of the orthosis; receiving, in a processor, motion sensor data from the plurality of motion sensors, wherein the motion sensor data indicates one or more of: a position of a patient's teeth and an orientation of the patient's teeth; determining tooth movement based on the motion sensor data; as well as The first orthodontic treatment plan is modified based on the determined tooth movement by modifying one or more of: a configuration of a plurality of tooth receiving cavities of an appliance body of a second orthodontic appliance worn by the patient, or shortening or lengthening a duration that the orthodontic appliance is worn by the patient.

42. The method according to claim 41, wherein: Providing includes providing a plurality of attachment anchors configured to couple the aligner body to the patient's teeth, wherein the aligner body includes attachment points for coupling to the attachment anchors.

43. The method of claim 41, wherein: Periodically applying the electromagnetic field from the electromagnetic field generator includes applying the electromagnetic field between every two hours to every two weeks.

44. The method of claim 41 further comprising receiving, in the processor, force sensor data from a plurality of force sensors coupled to the appliance body or to the attachment anchor, wherein the force sensor data indicates one or more of: an amount of force applied to the patient's teeth and a direction of the force applied to the patient's teeth.

45. The method of claim 44, further comprising determining forces acting on the patient's teeth based on the force sensor data.

46. ​​The method of claim 45, wherein modifying comprises modifying the first orthodontic treatment plan based on the determined tooth movements and forces acting on the patient's teeth.

47. The method of claim 41, wherein receiving comprises receiving the motion sensor data at intervals between every hour and every 2 weeks.

48. The method of claim 41 further comprising wirelessly transmitting the motion sensor data from the orthodontic appliance to the processor, wherein the processor comprises a remote processor.

49. The method of claim 41, wherein receiving comprises receiving the motion sensor data in the processor, wherein the processor is coupled to the orthodontic appliance when the orthodontic appliance is worn in the patient's mouth.

50. An orthodontic device for repositioning a patient's teeth and tracking tooth movement, the device comprising: an appliance body including a plurality of tooth receiving cavities shaped to reposition the patient's teeth from an initial arrangement to a target arrangement, the appliance body having a plurality of engagement sites; a plurality of attachments configured to engage the plurality of engagement sites and couple the appliance body to the patient's teeth; wherein each of the plurality of attachments comprises a sensor configured to generate sensor data related to a force applied by the orthodontic device to a patient's teeth or a movement of the patient's teeth; as well as A processor is coupled to the orthotic body and is configured to receive and store the sensor data.

51. The apparatus of claim 50, wherein: The sensor of each of the plurality of attachments comprises a force or pressure sensor configured to measure a force or pressure applied by the orthodontic device to one or more teeth.

52. The apparatus of claim 50, wherein: Each of the plurality of attachments includes a force-sensitive film or a pressure-sensitive film, a resistive film, a capacitive film, or a piezoelectric tactile sensor.

53. The apparatus of claim 50, wherein: Each of the plurality of attachments includes an electromagnetic target configured to generate motion sensor data indicative of one or more of: a position of a patient's teeth and an orientation of the patient's teeth; In addition, the corrector body includes an electromagnetic field generator.

54. The device of claim 50 further comprising electrical contacts between the attachment and the orthotic body.

55. The apparatus of claim 50, wherein: The plurality of engagement locations include openings or recesses formed through the aligner body.

56. The apparatus of claim 50, wherein: The plurality of engagement sites are located on one or more of a lingual side of the appliance body or a buccal side of the appliance body.

57. The apparatus of claim 50, wherein: The processor is configured to evaluate the performance of the orthodontic device by using the sensor data to determine one or more of: an amount of force or pressure applied to the patient's teeth, a distribution of the force or pressure on the patient's teeth, an amount of movement of the patient's teeth, or a rate of movement of the patient's teeth.

58. The apparatus of claim 50, wherein: The processor is configured to evaluate the performance of the orthodontic device by determining whether an amount of force or pressure applied by the orthodontic device to a patient's teeth is within a target range.

59. The apparatus of claim 50, wherein: The sensor of each of the plurality of attachments includes a motion sensor configured to measure movement of one or more teeth.

60. The apparatus of claim 59, wherein: Each motion sensor is configured to measure movement of the one or more teeth by measuring changes in an applied electromagnetic field.

61. The apparatus of claim 50, further comprising a power source, a memory, and wireless communication circuitry coupled to the processor.

62. An orthodontic device for repositioning a patient's teeth and tracking tooth movement, the orthodontic device comprising: an appliance body including a plurality of tooth receiving cavities shaped to reposition the patient's teeth from an initial arrangement to a target arrangement, the appliance body having a plurality of engagement sites on one or more of a buccal or lingual side of the appliance body; a plurality of attachments configured to engage the plurality of engagement sites and couple the appliance body to the patient's teeth; a plurality of sensors, wherein each sensor extends at least partially within each engagement site of the plurality of engagement sites, wherein each sensor of the plurality of sensors is configured to generate sensor data related to a force applied to a patient's tooth or a movement of a patient's tooth by the orthodontic device; as well as A processor is coupled to the orthotic body and is configured to receive and store the sensor data.

63. The device according to claim 62, wherein Each sensor of the plurality of sensors comprises a force or pressure sensor configured to measure a force or pressure applied by the orthodontic device to one or more teeth.

64. The apparatus of claim 62, wherein: Each of the plurality of sensors includes a force-sensitive film or a pressure-sensitive film, a resistive film, a capacitive film, or a piezoelectric tactile sensor.

65. The apparatus of claim 62, wherein: Each sensor of the plurality of sensors includes a motion sensor configured to measure movement of one or more teeth.

66. The apparatus of claim 65, wherein: Each motion sensor is configured to measure movement of the one or more teeth by measuring changes in an applied electromagnetic field.

67. The apparatus of claim 62, wherein: The plurality of engagement locations include openings or recesses formed through the aligner body.

68. The apparatus of claim 62, wherein: The processor is configured to evaluate the performance of the orthodontic device by using the sensor data to determine one or more of: an amount of force or pressure applied to the patient's teeth, a distribution of the force or pressure on the patient's teeth, an amount of movement of the patient's teeth, or a rate of movement of the patient's teeth.

69. The apparatus of claim 62, wherein: The processor is configured to evaluate the performance of the orthodontic device by determining whether an amount of force or pressure applied by the orthodontic device to a patient's teeth is within a target range.

70. The apparatus of claim 62, further comprising a power source, a memory, and wireless communications circuitry coupled to the processor.

71. A method of designing an orthodontic treatment plan for a patient, the method comprising: receiving sensor data from a plurality of sensors of an orthodontic appliance having an appliance body having a plurality of tooth receiving cavities shaped to reposition teeth of a patient from an initial arrangement toward a target arrangement according to a first orthodontic treatment plan, wherein a plurality of attachment anchors on the patient's teeth engage engagement sites on the appliance body to couple the appliance body to the patient's teeth, wherein the plurality of sensors are on the plurality of attachment anchors, determining, in a processor, from the sensor data, one or more of: tooth movement and forces on the patient's teeth; as well as The first orthodontic treatment plan is modified based on one or more of tooth movement and forces on the patient's teeth determined from the sensor data.

72. The method of claim 71, wherein: The modification includes modifying the configuration of a tooth receiving cavity of an appliance body of a second orthodontic appliance worn by the patient.

73. The method of claim 71, wherein: The modification includes modifying the duration that the orthodontic appliance is worn by the patient.

74. The method of claim 71, wherein receiving sensor data comprises receiving sensor data from a force-sensitive or pressure-sensitive film, a resistive film, a capacitive film, or a piezoelectric tactile sensor.

75. The method of claim 71, wherein: Also included is providing the orthodontic appliance and the plurality of attachment anchors.

76. The method of claim 71 further comprising periodically applying an electromagnetic field from an electromagnetic field generator coupled to the aligner body.

77. The method of claim 71 , wherein receiving comprises receiving in the processor.

78. The method of claim 71, wherein receiving sensor data comprises receiving force or pressure data applied by the orthodontic appliance to the patient's teeth.

79. The method of claim 71, wherein receiving comprises receiving the sensor data at intervals between every hour and every 2 weeks.

80. The method of claim 71 further comprising wirelessly transmitting the sensor data from the orthodontic appliance to the processor, wherein the processor comprises a remote processor.

81. The method of claim 71, wherein receiving comprises receiving the sensor data in the processor, wherein the processor is coupled to the orthodontic appliance when the orthodontic appliance is worn in the patient's mouth.

82. A method of designing an orthodontic treatment plan for a patient, the method comprising: receiving sensor data from a plurality of sensors of an orthodontic appliance having an appliance body having a plurality of tooth receiving cavities shaped to reposition teeth of a patient from an initial arrangement toward a target arrangement according to a first orthodontic treatment plan, wherein a plurality of attachment anchors on the patient's teeth each engage an engagement site on the appliance body to couple the appliance body to the patient's teeth, wherein the plurality of sensors are at least partially located within the engagement sites, determining, in a processor, from the sensor data, one or more of: tooth movement and forces on the patient's teeth; as well as The first orthodontic treatment plan is modified based on one or more of tooth movement and forces on the patient's teeth determined from the sensor data.

83. The method of claim 82, wherein: The modification includes modifying the configuration of a tooth receiving cavity of an appliance body of a second orthodontic appliance worn by the patient.

84. The method of claim 82, wherein: The modification includes modifying the duration that the patient wears the orthodontic appliance.

85. The method of claim 82, wherein receiving sensor data comprises receiving sensor data from a force-sensitive or pressure-sensitive film, a resistive film, a capacitive film, or a piezoelectric tactile sensor.

86. The method of claim 82, wherein: Also included is providing the orthodontic appliance and the plurality of attachment anchors.

87. The method of claim 82, further comprising periodically applying an electromagnetic field from an electromagnetic field generator coupled to the aligner body.

88. The method of claim 82, wherein receiving comprises receiving in the processor.

89. The method of claim 82, wherein receiving sensor data comprises receiving force or pressure data applied by the orthodontic appliance to the patient's teeth.

90. The method of claim 82, wherein receiving comprises receiving the sensor data at intervals between every hour and every 2 weeks.

91. The method of claim 82 further comprising wirelessly transmitting the sensor data from the orthodontic appliance to the processor, wherein the processor comprises a remote processor.

92. The method of claim 82, wherein receiving comprises receiving the sensor data in the processor, wherein the processor is coupled to the orthodontic appliance when the orthodontic appliance is worn in the patient's mouth.

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