Mouthpiece for oral care device

Abstract

A technique for obtaining measurements of the mechanical properties of the grip performed by the chewing apparatus. The mouthpiece comprises a sensing component (for obtaining the measurements) and one or more oral contact elements for protecting, cleaning or treating the teeth / gums. In this way, measurements can be obtained that indicate potential abnormalities or physiological dysfunctions in the chewing apparatus using a mouthpiece that has a secondary function of protecting, cleaning and / or treating the elements of the oral cavity.

Description

[Technical field]

[0001] The present invention relates to the field of oral care, and in particular to a mouthpiece for an oral care device. [Background technology]

[0002] Occlusal disorders, which usually result from abnormalities of the jaw or masticatory apparatus (whether dental or skeletal in nature), are quite common throughout the world. These problems include (and can be caused by) malocclusion, misalignment of teeth, teeth grinding, tooth wear, facial muscle pain or temporomandibular joint (TMJ) disorders.

[0003] Early detection of abnormal occlusion problems can prevent serious complications. Individuals with abnormalities in the jaw or other chewing apparatus have both functional and aesthetic impairments. Misaligned teeth cause difficulties in head and neck function with regard to chewing, swallowing, breathing, speech intelligibility, and lip closure / posture. Affected individuals also experience TMJ pain and dysfunction that negatively impacts quality of life. Some affected individuals also have psychological problems.

[0004] One significant problem area involves TMJ disorders, which are usually detected too late for effective treatment. There is growing awareness of the prevalence of occlusal or masticatory disorders, such as temporomandibular joint muscle disorders, which can be as high as 50% in some populations. Recent studies have demonstrated that 25% of the U.S. population deals with occlusion-induced migraines, and 25-30% have some variant of TMJ disorder.

[0005] Uncommon as a chronic pain condition, the prevalence of TMJ disorders is higher among younger people. Furthermore, TMJ disorders are at least twice as prevalent in women as in men, and women who use either supplemental estrogen or oral contraceptives are more likely to seek treatment for these conditions. Summary of the Invention [Problem to be solved by the invention]

[0006] TMJ disorders and malocclusion dysfunctions are usually only examined by dentists during routine examinations, therefore there is a continuing need to enable self-testing in the home environment and to improve the ability to identify the presence of abnormalities or physiological dysfunctions in the masticatory apparatus, such as the presence of TMJ disorders. [Means for solving the problem]

[0007] The invention is defined by the claims.

[0008] According to an example according to one aspect of the invention, there is provided a mouthpiece comprising: a mount configured to be grasped between an upper and lower jaw of a subject, one or more oral cavity-contacting elements, each configured to contact one or more portions of the oral cavity of the subject when the mount is grasped between the upper and lower jaw to protect, treat, and / or clean the contacted one or more portions of the oral cavity, and a sensing arrangement located in or on the mount, the sensing arrangement configured to sense one or more measurements of a mechanical property of grasping by the upper and lower jaws of the subject during grasping of the mount by the upper and lower jaws, the one or more measurements of the mechanical property being responsive to one or more abnormalities or physiological dysfunctions in the masticatory apparatus of the subject.

[0009] The present disclosure proposes an approach for generating data useful for identifying the presence or effect of occlusal disorders (i.e. jaw abnormalities) in a subject, the abnormalities being present in the jaw muscles, teeth, and / or joints (i.e. the subject's chewing apparatus) and relating to misalignments (e.g. of teeth or jaw movement), variations (e.g. of teeth or bite), etc.

[0010] The present disclosure proposes integrating a sensor with a mouthpiece used to brush or clean a subject's teeth in order to collect data during the cleaning procedure. In other words, the present disclosure proposes using the cleaning mouthpiece as a carrier for a sensor used to collect data for occlusal analysis.

[0011] The sensing component collects data during gripping of the mouthpiece. A grip is the time during which the mouthpiece is held between the subject's jaws, and includes (for example) periods during which the subject squeezes the mouthpiece, maintains pressure on the mouthpiece, and / or releases pressure from the mouthpiece. Grips include a "loose" grip (where the mouthpiece is held loosely between the jaws) and a "tight" grip (where the mouthpiece is held tightly between the jaws), as well as movement between loose and tight grips.

[0012] Any suitable mechanical properties of the grip by the upper and lower jaws are measured. In particular, the mechanical properties are measured or sampled during a period of time when pressure is (increasingly) applied by the jaws to the mouthpiece, thus generating data representative of the gripping sequence.

[0013] By using a mouthpiece that is used to clean or brush a user's teeth, data can be collected over an extended period of time (e.g., at least twice daily) rather than just once (e.g., in a specialist clinic or using specialized devices). This can facilitate a long-term analysis of the nature of the grip by the upper and lower jaws, thereby facilitating more accurate identification of occlusal disorders. In particular, tracking measurements over time allows for increased accuracy in identifying those at risk.

[0014] The one or more measurements of the mechanical properties of the grasp include a force in one or more directions applied between a portion of the upper jaw and a portion of the lower jaw, and / or one or more components of a stress or pressure applied between a portion of the upper jaw and a portion of the lower jaw.

[0015] The force may be, for example, a vertical force, which is (a component of) a force applied in a direction perpendicular to the plane in which the upper jaw lies. In some instances, the force may be a lateral force, which is (a component of) a force applied in a direction parallel to the plane in which the upper jaw lies. Of course, it will be understood that the direction of the force may be between vertical and lateral.

[0016] In some examples, the sensing component comprises a first sensor configured to sense a force or pressure applied between a first side of the upper jaw and a first side of the lower jaw, and a second sensor configured to sense a force or pressure applied between a second side of the upper jaw and a second side of the lower jaw, where the first side of the upper jaw is opposite the second side of the upper jaw and the first side of the lower jaw is opposite the second side of the lower jaw.

[0017] Differences in pressure or force exerted by different sides of the jaw, i.e., uneven pressure, can indicate a possible TMJ disorder or jaw misalignment.

[0018] The sensing arrangement is configured to generate a difference measurement, which is the difference between the force or pressure generated by the first sensor and the force or pressure generated by the second sensor.

[0019] The sensing arrangement comprises a torque sensing arrangement configured to sense a torque applied to the lower jaw when the upper and lower jaws grip the mouthpiece.

[0020] The torque sensing arrangement is configured to generate a measurement of rotation as the upper and lower jaws come together and / or separate during gripping of the mouthpiece.

[0021] When the teeth are aligned (i.e., negligible torque is generated), i.e., when there is correct jaw alignment, jaw clamping or loosening movements essentially do not generate torque or rotation, but when the teeth are misaligned, for example resulting in upper and lower jaws crossing, it will induce torque or rotation. Monitoring the rotation of the mouthpiece using a torque sensor can therefore generate measurements that are useful for assessing potential crossing of the jaws and therefore can predict or identify whether the teeth are misaligned.

[0022] A pair of strain gauges arranged at right angles (90°) to each other provides one suitable example of a torque sensing arrangement; other torque sensing arrangements will be apparent to those skilled in the art.

[0023] In some examples, the torque sensing component includes a first torque sensor configured to sense a torque applied to a first side of the upper jaw when the upper and lower jaws are brought together, and a second torque sensor configured to sense a torque applied to a second side of the lower jaw when the upper and lower jaws are brought together, the first side of the lower jaw being opposite the second side of the lower jaw.

[0024] The difference in torque applied to the sides of the mandible may be indicative of a misalignment between the jaws and / or may more accurately identify the location of the misalignment between the jaws compared to a single torque sensor.

[0025] The sensing arrangement includes a motion sensor configured to generate a measurement of lateral movement, displacement or tilt of the mouthpiece as the upper and lower jaws come together and / or separate during gripping of the mouthpiece.

[0026] Side-to-side movement as the subject clenches (i.e., makes a clamping motion) or releases the bite indicates a misalignment or difference in size of the upper and lower jaws, i.e., a jaw abnormality. This lateral side-to-side movement can be measured using a torque sensing arrangement. Lateral movement is movement that is parallel to the plane in which the upper jaw lies.

[0027] In one example, the sensing arrangement comprises two strain gauges arranged at right angles to each other, facilitating measurement of torque and side-to-side motion, however, in a simplified embodiment, a single strain sensor is suitably positioned and configured to record only side-to-side motion.

[0028] Thus, in some examples, the torque sensing arrangement is adapted to sense side-to-side movement.

[0029] The one or more oral cavity-contacting elements comprise one or more sensing elements for the sensing arrangement, each sensing element configured to sense a mechanical property of gripping of the mount by the upper and lower jaws.

[0030] In particular, the oral cavity contact element or elements are formed or manufactured from a material that is capable of sensing changes in mechanical properties, such as dynamic (static) pressure or force, in other words, at least a portion of the sensing components are integrated into the oral cavity contact element.

[0031] In some examples, each sensing element comprises a conductive (e.g., elastomeric) element configured to act as both a sensing element (e.g., force or muscle activity) and as a bristles for cleaning the subject's teeth and / or gums.

[0032] The mouthpiece further comprises an electromyography electrode arrangement configured to provide one or more signals responsive to electrical activity in one or more muscles of the jaw to perform electromyography sensing.

[0033] One or more of the oral contact elements are further configured to function as one or more electrode elements for an electromyography electrode configuration. Thus, one or more of the oral contact elements are at least partially conductive, thereby acting as an electrode that generates a signal responsive to electrical activity in the jaw muscles. Suitable materials will be apparent to those skilled in the art, such as, for example, conductive silicone, conductive polymers, etc.

[0034] For example, the one or more oral contact elements comprise one or more brushing elements configured to clean / brush the subject's teeth and / or gums, and the one or more brushing elements are further configured to function as one or more electrode elements for an electromyography electrode configuration.

[0035] In other words, one or more of the brushing elements are at least partially conductive, thereby acting as electrodes that generate signals responsive to electrical activity in the jaw muscles. The brushing elements are formed, for example, from conductive silicone (or any other material) suitable for acting as an electrode and for brushing the teeth / gums.

[0036] In some examples, the sensing component is configured to include or function as one or more electrode elements for an electromyography electrode component, e.g., the electrode elements are integrated into the sensing component.

[0037] In a preferred example, the sensor or sensors for the sensing component and the electrode or electrodes for the electromyography electrode component form part of the oral contact element, e.g. a ((partially) conductive) brushing element serves as both a sensor for the sensing component and / or an electrode or electrodes for the electromyography component.

[0038] In some examples, a first set of one or more oral cavity contact elements are configured to serve as sensing elements for the sensing arrangement and a second set of one or more oral cavity contact elements are configured to serve as electrode elements for the electromyography electrode arrangement, the first and second sets of oral cavity contact elements being exclusive, partially overlapping, or fully overlapping.

[0039] One or more of the oral cavity contact elements are thereby configured to act as a sensing element for the sensing arrangement and as an electrode element for the electromyography electrode arrangement.

[0040] The one or more oral cavity-contacting elements include one or more brushing elements for brushing or cleaning at least one gum or tooth of the subject.

[0041] The one or more oral cavity contacting elements may include a mouth guard configured to cover and protect at least one portion of the subject's oral cavity, such as the gums and / or teeth, and / or a tooth alignment device configured to align or realign the position of the subject's teeth. The one or more oral cavity contacting elements may include a bite guard.

[0042] It will be appreciated that in some instances, the mount and the oral-contacting element are the same element, for example, the mount comprises a mouth guard for covering and protecting one or more portions of the subject's oral cavity.

[0043] Also proposed is a mouthpiece system comprising the mouthpiece described above and a processing component configured to receive one or more measurements of the mechanical properties of the grip from a sensing component of the mouthpiece and to process the received one or more measurements to generate an indicator of whether one or more abnormalities are present in the subject's maxilla and / or mandible.

[0044] The processing component receives one or more measurements at an input interface of the processing component.

[0045] The mouthpiece system further comprises a memory configured to repetitively store one or more measurements obtained by the sensing component, thereby forming stored measurements, and the processing component is configured to process the received one or more measurements and the stored one or more measurements to generate the indicator.

[0046] The processing component is configured to control the user interface to provide a visual representation of the one or more measurements and / or generated indicators (if generated), or a user perceptible output, and thus the processing component is configured to output (e.g., at an output interface) interface control signals for controlling operation of the user interface.

[0047] In some examples, the processing component is configured to control a user interface to instruct the subject to perform the guided occlusion action, for example in the form of a textual or visual output. This embodiment allows for well-controlled and predictable (un)gripping of teeth from mounts as part of the user workflow to increase consistency in taking measurements.

[0048] The mouthpiece system further comprises a user interface.

[0049] These and other aspects of the invention will be apparent from and elucidated with reference to the embodiments described hereinafter.

[0050] For a better understanding of the present invention, and to show more clearly how the same may be carried into effect, reference will now be made, by way of example only, to the accompanying drawings in which: [Brief description of the drawings]

[0051] [Figure 1] FIG. 2 illustrates a mouthpiece according to one embodiment. [Diagram 2] FIG. 2 illustrates a sensor for use in the sensing arrangement. [Diagram 3] FIG. 2 is a cross-sectional view of a mouthpiece according to one embodiment. [Figure 4] FIG. 1 illustrates a torque sensing arrangement for use in one embodiment. [Diagram 5] FIG. 1 illustrates a mouthpiece system according to one embodiment. [Figure 6] FIG. 1 illustrates a processing system for use in one embodiment. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0052] The present invention will now be described with reference to the drawings.

[0053] It should be understood that the detailed description and specific examples, while indicating exemplary embodiments of the devices, systems and methods, are intended for purposes of illustration only and are not intended to limit the scope of the invention. These and other features, aspects and advantages of the devices, systems and methods of the present invention will become better understood from the following description, appended claims and accompanying drawings. It should be understood that the figures are schematic only and are not drawn to scale. It should also be understood that the same reference numerals are used throughout the figures to denote the same or similar parts.

[0054] The present invention provides an approach for obtaining measurements of the mechanical properties of the grip performed by the chewing apparatus. The mouthpiece comprises a sensing component (for obtaining the measurements) and one or more oral contact elements for protecting, cleaning or treating the teeth / gums. In this way, measurements can be obtained that indicate potential abnormalities or physiological dysfunctions in the chewing apparatus using a mouthpiece with secondary or additional functions of protecting, aligning, cleaning and / or treating elements of the oral cavity.

[0055] It will be understood that a "secondary function" is in effect the primary intended use function for the mouthpiece, e.g., the advertised function of the mouthpiece, with features of the present disclosure forming additional useful functionality for the mouthpiece. The term "secondary function" is used to distinguish protection, cleaning, and / or treatment functionality from the mechanical property sampling functionality described in this disclosure.

[0056] An embodiment of the present invention advantageously recognizes that the integration of such sensing functionality into a mouthpiece with a secondary (oral care or oral hygiene) functionality facilitates improved ease and regularity of obtaining measurements. This is based on the recognition that the onset of abnormalities or physiological dysfunctions in the chewing apparatus can be detected by monitoring changes in the mechanical properties of gripping (e.g., biting) over a period of time. By using a mouthpiece with a secondary functionality, the likelihood that repeated measurements over a period of time will be obtained (by relying on the subject's regular use of the mouthpiece) may be increased.

[0057] The proposed concept may be employed in any mouthpiece that may be held between the upper and lower jaw, such as cleaning (e.g. brushing) appliances, orthodontic retainers / aligners, mouth guards, bite guards, mandibular advancement devices, etc.

[0058] In the context of this application, the masticatory apparatus refers to the upper and lower jaws (including teeth or dental implants) of a subject, together with other anatomical features that contribute to the movement of the upper and lower jaws (e.g., the jaw muscles and / or the temporomandibular joints).

[0059] 1 illustrates a mouthpiece 100 according to one embodiment of the present invention. The mouthpiece is designed or configured to be held in the oral cavity of a subject.

[0060] The mouthpiece 100 comprises a mount 110. The mount is configured to be gripped or grippable between the upper and lower jaws of a subject. The mount is therefore suitably shaped and / or sized to fit within the subject's oral cavity such that the subject can "bite" the mouthpiece to grip the mount 110 between the subject's jaws. For example, the mount has a (dental) arch-like shape, a chevron shape, a semicircular shape, etc. The mount is custom made, for example, from a scan of the subject's oral cavity or from a pre-defined shape / size that best fits the subject's dentition (i.e., a best-fitting mount taken from a set of pre-defined or fixed (and different) mount sizes).

[0061] In the example shown, the mount is in the shape of a semi-ring (ie, a sector of a ring with the dividing line passing through the diameter of the ring).

[0062] Gripping need not be caused by direct contact between the jaws and the mount, for example gripping may occur via one or more intermediate elements (such as those described below).

[0063] In the context of this application, a grip occurs when the mouthpiece (i.e., the mount) is held between the jaws of a subject. This does not have to be a tight or clamped grip, but can be a loose grip (e.g., the mouthpiece is held loosely). Any movements during gripping (e.g., clamping or unclamping, clenching or unclenching, clenching or releasing the bite) are either random or well controlled through instructions given to the user to perform a guided bite movement.

[0064] The mount 110 further comprises a stopper 115 configured to contact the front of the subject's teeth or lips to prevent or limit movement of the mouthpiece towards the back of the throat, which can help prevent accidental gagging on the mouthpiece and / or act as a guide for positioning the mouthpiece in the subject's oral cavity.

[0065] The mouthpiece 100 further comprises one or more oral cavity-contacting elements 120. The oral cavity-contacting elements are configured to perform one or more protective, cleaning and / or (dental) treatment tasks. In particular, the oral cavity-contacting elements are configured to contact one or more parts of the oral cavity and to perform protective, cleaning, alignment and / or (dental) treatment tasks on the contacted parts of the oral cavity. The parts of the oral cavity include teeth, gums, tongue and / or dental implants. The (dental) treatment includes any suitable treatment task, such as alignment tasks (e.g., using retainers or braces) and / or teeth whitening tasks. Thus, dental treatment includes cosmetic and non-cosmetic procedures.

[0066] In the illustrated example, each oral contact element 120 is / comprises a brushing element for brushing (i.e., cleaning) one or more teeth and / or gums of a subject. However, other types of oral contact elements may be used in addition to or instead of brushing elements, such as mouth guards, bite guards, mandibular advancement devices (MADs), (tooth) alignment devices, (orthodontic) retainers, etc.

[0067] The mouthpiece 100 further comprises a sensing arrangement 130. The sensing arrangement is disposed in or on the mount 110. During gripping of the mount by the upper and lower jaws (i.e., when the mouthpiece is held between the jaws), the sensing arrangement senses one or more measurements of a mechanical property of the gripping by the upper and lower jaws. In other words, the sensing arrangement senses one or more measurements of a mechanical property applied to the mouthpiece in response to or as a result of gripping by the upper and lower jaws, including measurements of changes in mechanical properties due to changes in gripping, for example, during clenching or releasing.

[0068] Suitable examples of mechanical properties include pressure (e.g., as a result of maxillary / mandibular abnormalities), stress, force, torque, strain, displacement, movement, orientation / tilt, etc. One skilled in the art can readily develop or use sensing components to detect such mechanical properties following the teachings of the present disclosure.

[0069] The mechanical property measurements of (the result of) gripping are measurements that are responsive to one or more abnormalities or physiological dysfunctions in the chewing apparatus of the subject, and therefore are measurements that have conventional or desired values ​​for the subject, or that should not (significantly) change over repeated use of the jaws and / or over time.

[0070] In particular, the sensing arrangement is configured to sense measurements of one or more mechanical properties of the grip during the subject's clamping movement (where the mandible exerts pressure on the upper jaw or increases the pressure exerted on the upper jaw) and the subject's loosening / unclamping movement (where the mandible stops exerting pressure on the upper jaw or decreases the pressure exerted on the upper jaw). It has been recognized that measurements during the clamping / unclamping process are responsive to and indicative of abnormalities or physiological dysfunctions in the chewing apparatus, particularly the TMJ, since such TMJ abnormalities or physiological dysfunctions may cause changes in the movement of the mandible during the clamping action.

[0071] The present invention recognizes that a sensing component for obtaining such measurements (suitable for identifying masticatory organ disorders or deterioration symptoms) can be integrated into a mouthpiece having a secondary function, such as a protective, cleaning or treatment function. This means that, for example, when the mouthpiece is used regularly for its secondary function over time, long-term data on the subject's measurements can be obtained, which means that such measurements can be obtained without the need for a dedicated measurement session.

[0072] The sensing component is capable of obtaining measurements of the mechanical properties of the grip at multiple positions of the mouthpiece (e.g. for different parts of the oral cavity). In this way, a mapping of measurements of the grip performed by the upper and lower jaws can be performed. The measurement map is useful in identifying areas of abnormal anatomical structures or grips between the upper and lower jaws and thus potential abnormalities or physiological dysfunctions in the chewing apparatus.

[0073] By way of example only, the measurements may be of the force applied between a particular portion of the upper jaw and a corresponding portion of the lower jaw, with multiple measurements / samples being taken (e.g. simultaneously) for different portions of the upper and lower jaw.

[0074] Preferably, the one or more measurements of the mechanical property of the grasp include a component of force, stress or pressure applied between a portion of the upper jaw and a portion of the lower jaw. Preferably, multiple measurements are taken / sampled, e.g. for different portions of the upper / lower jaw and / or at different times.

[0075] The sensing component 130 is at least partially integrated into the oral-contact element 120. For example, the brushing element comprises a material suitable to act as (part of) the sensing component. By way of example, the brushing element comprises conductive silicone pillars / elements that can be used as force / pressure measuring sensors, and bristles / tufts (mounted on the silicone pillars) for cleaning the teeth and / or gums.

[0076] However, (full) integration of the sensing component into the oral-contact element is not required and the sensing component may comprise one or more elements disposed elsewhere in / on the mount, for example using a thin, flexible pressure-sensitive film disposed in / on the mount of the mouthpiece (e.g. by overmolding) to obtain higher resolution force / pressure measurements.

[0077] The illustrated sensing arrangement 130 comprises a first sensor 131 configured to sense (a component of) a force, stress or pressure applied between a first side of the upper jaw and a first side of the lower jaw (e.g., a force / stress / pressure applied to the first side 101 of the mouthpiece). The sensing arrangement 130 also comprises a second sensor 131 configured to sense (a component of) a force, stress or pressure applied between a second side of the upper jaw and a second side of the lower jaw (e.g., a force, stress or pressure applied to the second side 102 of the mouthpiece 100). The first side of the upper jaw is opposite the second side of the upper jaw and the first side of the lower jaw is opposite the second side of the lower jaw.

[0078] Although only two sensors are shown, the sensing arrangement may include any number of sensors, e.g., only a single sensor (element), multiple sensors, four or more sensors, six or more sensors, etc. It is not necessary that each sensor measure / sense the same type of physical component of the grasp performed by the upper and lower jaws.

[0079] In the illustrated example, both the first sensor and the second sensor are integrated in the oral contact element. In particular, both sensors are formed from a force- or pressure-sensitive material (e.g., particle-filled conductive silicone or conductive polymer) of the brushing element of the oral contact element. Examples of sensors formed from suitable materials are described by US patent US10736528B2, which may be adapted for use with embodiments of the present disclosure. Thus, one or more brushing elements generate signals that respond to different amounts of force, pressure or stress applied thereto. The brushing elements are thus (partially) conductive bristles.

[0080] Due to its conductive nature, the brushing element can also be used as an inert electrode to measure electrophysiological signals in the oral cavity (eg, electromyography (EMG)), as described below.

[0081] FIG. 2 shows an example of a suitable sensor 200 that can serve as part of the oral contact element and sensing component.

[0082] The sensor 200 is in the form of a structured pin electrode having an electrode body 202 and an electrical coupling or snap 210. In some embodiments, a structured pin electrode 200 is used. In some embodiments, the structured pin electrode 200 includes a multi-pin design (e.g., with one or more pins 250) that allows the electrode 200 to establish good galvanic contact with the subject.

[0083] The (e.g., each) pin 250 is formed from a particle-filled conductive silicone material (or other suitable material, such as a conductive polymer) that is force-sensitive and / or pressure-sensitive, and can act as a brush for the subject's oral cavity. In other words, the pins 250 act as bristles or brushing elements for the oral cavity. Thus, the pins 250 are, in effect, conductive bristles.

[0084] In some embodiments, the electrode 200 has a diameter of 25 millimeters. In some embodiments, the pin 250 of the electrode 200 has a height of 5 millimeters. In some embodiments, the pin 250 of the electrode 200 has a diameter of 2 millimeters.

[0085] Returning to FIG. 1 , one skilled in the art will appreciate that the first and second sensors can be formed elsewhere, for example in a force / pressure / stress sensitive film disposed on top of mount 110, or can be integrated into mount 110, for example by overmolding.

[0086] The illustrated sensing component 130 is further configured to generate a difference measurement (which may alternatively be labeled a differential measurement). A difference measurement is the difference between a force, pressure or stress detected by a first sensor and a force, pressure or stress detected by a second sensor. The sensing component includes a difference measurement sensor 135 for performing this measurement.

[0087] Differential measurements effectively provide a measurement of the force / pressure difference between contralateral sites in the oral cavity. Differences in the force / pressure / stress being applied between contralateral sites have been identified as responsive to abnormalities or physiological dysfunctions in the masticatory apparatus, such as the presence of TMJ disorders. Such measurements therefore provide useful information.

[0088] In some other examples, the force or pressure obtained at the first sensor 131 and the second sensor 132 is determined relative to a reference measurement, e.g., a force or pressure measured at a third reference sensor (not shown).

[0089] The mouthpiece 100 further comprises an electromyography (EMG) electrode arrangement 140 configured to generate one or more signals responsive to electrical activity in (one or more muscles of) the jaw.

[0090] In one embodiment, EMG measurements are facilitated or performed by one or more of the oral contact elements, such as the brushing elements and / or sensing components. For example, EMG measurements are facilitated by the conductive nature of the brushing elements and / or sensing components previously described and may be performed using sensing components / elements 131 (which may also serve as a (lateral) brushing element integrated into mount 110).

[0091] By way of example, and referring to FIG. 2, the conductive support plate 200 and / or conductive bristles 250 of the illustrated sensor 200 can be used to measure EMG.

[0092] The EMG electrode configuration 140 includes one or more electrodes disposed on the mount 110. These electrodes may be dedicated electrodes (i.e., electrodes not used for other purposes) or may be integrated (at least partially) into the oral contact elements 120 and / or the sensing components 130. For example, the oral contact elements may include one or more brushing elements, at least one of which is at least partially conductive to serve as an electrode for the EMG electrode configuration.

[0093] In the illustrated example, the EMG system includes two electrodes configured to perform EMG measurements, however, any number of electrodes may be used, e.g., a single electrode, four electrodes, eight electrodes, two or more electrodes, etc.

[0094] Preferably, the one or more electrodes 140 are located at the distal end of the mouthpiece (i.e., at the end of the mouthpiece that is received towards the back of the throat) and / or facing the buccal side of the jaw. This aids in the collection of EMG measurements from the masseter muscles, which are identified herein as being indicative of abnormalities or physiological dysfunctions in the chewing apparatus, among other things. In particular, such EMG measurements are responsive to the presence of a TMJ disorder.

[0095] In some examples, the electrode or electrodes are attached to a side of the mount, such as a side on the periphery of the mount, which increases the likelihood that the electrode or electrodes will come into contact with a muscle to sense electrical activity of the muscle.

[0096] In a particularly preferred example, the one or more electrodes are positioned so that when the mouthpiece is received by the subject's oral cavity (such that the mount is grasped between the upper and lower jaw), the electrode(s) contact the subject's cheek.

[0097] It has been previously described how the EMG electrodes may be at least partially integrated into the oral cavity contact elements, in particular the oral cavity contact elements may include or be formed from a material that is sensitive to or responsive to electrical signals (i.e., a material suitable for forming an electrode).

[0098] FIG. 3 is a side view showing a cross-section of a mouthpiece 300 according to another embodiment.

[0099] Mouthpiece 300 comprises a mount 310 and one or more oral contact elements 320 supported by mount 310. Here, the oral contact elements again comprise one or more brushing elements, although other forms of oral contact elements for protecting, cleaning or treating teeth are envisioned.

[0100] The mouthpiece includes a sensing component 330 integrated in the mount, i.e., between a first portion 311 and a second portion 312 of the mount. In the illustrated example, a first set of oral cavity contact elements is coupled to an upper surface 311A ​​of the mount 310 and a second set of oral cavity contact elements is coupled to a lower surface 312A of the mount 310. One or more of these sets may be omitted.

[0101] In an alternative embodiment, the mount is formed from one continuous part (e.g., the second part 312 is omitted), the sensing element 330 is attached onto this part, and the second set of one or more oral contact elements is attached directly onto the sensing element.

[0102] Here, the sensing arrangement 330 comprises a torque sensing arrangement configured to detect torque applied to / by the mandible when the upper and lower jaws are brought together (or apart). In particular, the torque sensing arrangement is arranged to detect a lateral torque applied to the torque sensing arrangement. A lateral torque is a torque applied about an axis that is parallel to the plane in which the upper teeth lie and that runs from the rear of the oral cavity to the front of the oral cavity. The torque sensing arrangement is thus constructed and arranged such that if the teeth are aligned when the upper and lower jaws are brought together (or apart), no torque is detected, and if the teeth are not aligned when the upper and lower jaws are brought together (or apart), a torque is detected.

[0103] In this manner, the torque present during the clamping or unclamping process is detected. In particular, the torque sensing arrangement detects torque applied to the mouthpiece about an axis that is parallel to the plane in which the upper jaw lies, thereby detecting whether a jaw crossover or plane misalignment has occurred (i.e., resulting in misaligned teeth) or whether a dysfunction at the TMJ is present.

[0104] In some examples, torque measurements are taken during the clamping process (i.e., when the jaws come together) and during the unclamping process (i.e., when the jaws move apart). This feature makes it possible to check the quality of the torque measurements, as in the ideal case the signals upon occlusion and release should be equal in amplitude and opposite in sign.

[0105] Figure 4 shows an example of a suitable torque sensing arrangement 400 for use in the sensing arrangement of Figure 3. The torque sensing arrangement is formed from a first strain gauge 410 and a second strain gauge 420 arranged orthogonally to each other, which facilitates sampling and / or obtaining torque measurements.

[0106] The above examples give various techniques and systems for obtaining measurements of the physical / mechanical properties of the grasp performed by the masticatory apparatus (upper and lower jaws), which can be used, for example, automatically or by a clinician to assess the condition of the masticatory apparatus.

[0107] However, the described measurements of physical / mechanical properties should not be considered exhaustive, rather the sensing component is configured to obtain / sample measurements of any suitable property that is indicative of or responsive to the onset, worsening or change of an abnormality or physiological dysfunction in the subject's chewing apparatus.

[0108] As a further example, the sensing components of the mouthpiece include a motion sensor configured to sense side-to-side movement (e.g., sliding) of the mandible and / or mouthpiece during the jaw clamping or unclamping process. Side-to-side movement (i.e., lateral movement) is an example of a measurement that is indicative of either a misalignment or difference in size of the upper and lower jaws.

[0109] In the context of this application, side-to-side movement is movement in a plane parallel to the plane in which the upper jaw lies.

[0110] This sensing arrangement may, for example, comprise a separate torque sensing arrangement, for example comprising two strain gauges arranged at right angles (i.e. perpendicular) to each other, however, in less expensive embodiments a single strain sensor arranged to sense or record side to side movements may be sufficient.

[0111] As yet another example, the sensing components of the mouthpiece are configured to calculate, sense or measure the distance (or relative displacement / offset) between different portions of the upper and lower jaw during a clamping or unclamping movement. If the subject's occlusion is not uniform (indicating a potential abnormality or physiological dysfunction in the chewing apparatus), the distance between different portions of the upper and lower jaw will be different.

[0112] As yet another example, the sensing components of the mouthpiece are configured to calculate, sense or measure the orientation (e.g., tilt) of the upper and / or lower jaw (e.g., relative to one another) while gripping the mouthpiece, e.g., during a clamping or unclamping movement of the mouthpiece. In general, the upper and lower jaw should have the same or similar orientation when gripping the mouthpiece (i.e., the upper and lower jaw should be parallel to one another). Deviations from the same / similar orientation may indicate a potential abnormality or physiological dysfunction in the chewing apparatus.

[0113] As yet another example, the sensing arrangement of the mouthpiece is configured to calculate, sense or measure the angle between the upper and / or lower jaws (e.g. relative to each other) while gripping the mouthpiece, e.g. during a clamping or unclamping movement of the mouthpiece. The sensing arrangement thus comprises a (digital) goniometer, a (2D) gimbal angulation sensor and / or an accelerometer. Other suitable types of sensors will be apparent to the skilled person. As explained before, the jaws should be mostly parallel when gripping the mouthpiece, so that the presence or size of an angle between the jaws indicates a potential abnormality or physiological dysfunction in the chewing apparatus.

[0114] In another example, the sensing component is configured to calculate, sense or measure 3D force and momentum measurements using an integrated piezoelectric based force dynamometer that allows for capturing static and dynamic bite force or torque changes.

[0115] Those skilled in the art will appreciate that the sensing component is configured to detect any combination of previously described measurements and / or mechanical properties of gripping of the mouthpiece by the upper and lower jaws. Those skilled in the art will be able to modify the sensing component to include one or more of the previously described sensors (e.g., force sensing component, torque sensing component, etc.) as appropriate.

[0116] Any of the embodiments described herein may also include an electromyography (EMG) electrode arrangement configured to generate one or more signals responsive to electrical activity in the jaw (one or more muscles).

[0117] Although only a single mouthpiece has been described in the above examples, it will be apparent that a subject may hold multiple mouthpieces in the subject's oral cavity (e.g., one attached to the upper jaw and one attached to the lower jaw), one or more of which may be a mouthpiece as previously described.

[0118] 5 is a block diagram illustrating a mouthpiece system 500 according to one embodiment. The mouthpiece system includes a mouthpiece 510 (such as any of the previously described mouthpieces) and a processing component 520. Mouthpiece 510 is one of multiple mouthpieces for a subject.

[0119] The processing component is configured to receive one or more measurements of the mechanical properties of the grip from the sensing component of the mouthpiece, hi some examples, the processing component is configured to monitor the measurements provided by the sensing component and to (periodically) sample the measurements.

[0120] The processing component communicates with the sensing component via one or more wires and / or via a wireless communication mechanism. Suitable wireless communication mechanisms will be readily apparent to those skilled in the art. Suitable wireless communication protocols include infrared links, Zigbee, Bluetooth, wireless local area network protocols such as those according to the IEEE 802.11 standard, 2G, 3G or 4G telecommunications protocols, etc. Other formats will be readily apparent to those skilled in the art.

[0121] It will be appreciated that if mouthpiece 510 is one of multiple mouthpieces, each mouthpiece will provide one or more measurements of grip of the mouthpiece.

[0122] The processing component 520 is configured to process the received measurement(s) to generate an indicator of whether there is an abnormality or physiological dysfunction within the chewing apparatus.

[0123] The indicator is one or more of a binary indicator predicting whether there is an abnormality or physiological dysfunction in the chewing organ, a categorical indicator providing a predicted type or classification of the identified abnormality or physiological dysfunction in the chewing organ (if relevant), and / or a numerical indicator providing the likelihood of there being an abnormality or physiological dysfunction in the chewing organ (e.g. on a scale of 0-1, 0-100, 0-10, 1-10 or 1-100). In some embodiments, more than one indicator is generated, e.g. multiple different binary or numerical indicators for classification of different types of abnormality or physiological dysfunction.

[0124] The processing may include, for example, comparing the received measurements with one or more (predetermined) thresholds to determine or predict whether such an abnormality or physiological dysfunction exists and / or how severe the abnormality is.

[0125] Purely by way of example, consider a scenario in which the measurements obtained by the processing component are difference measurements indicative of the difference between a force applied between a first side of the upper jaw and a first side of the lower jaw and a force applied between a second, different side of the upper jaw and a second, different side of the lower jaw. In this scenario, if the difference measurement exceeds a certain predefined value (as uneven forces are indicative of an abnormality or physiological dysfunction), it is predicted that an abnormality or physiological dysfunction is present.

[0126] Another approach may be to process the received measurements using machine learning methods to generate an indicator, the machine learning indicator being trained to detect abnormalities or physiological dysfunctions in the chewing apparatus based on a set of one or more measurements received as input. Comparison with federated data may also enable classification of diseases.

[0127] Yet another approach may be to compare the received measurement value with previous measurements. An increase in a particular measurement value may indicate the onset of an abnormality and / or physiological dysfunction. Thus, processing may include determining whether a change in a particular measurement value (e.g., over time) exceeds a certain threshold, where the change is the difference between the previous measurement value and the most recently collected measurement value, and / or the ratio between such difference and the time difference between the time the previous measurement value was collected and the time the most recently collected measurement value was collected.

[0128] More generally, longitudinal measurements (ie, measurements over time) allow tracking of disease progression or response to therapy and / or natural healing.

[0129] Where appropriate, the processing component 520 also receives signals generated by an optional electromyography (EMG) electrode arrangement in the mouthpiece responsive to electrical activity in the jaw (one or more muscles). Processing the received measurement(s) to generate an indicator includes processing the received measurement(s) and the received signal to determine whether there is an abnormality or physiological dysfunction in the chewing apparatus.

[0130] It will be appreciated that the processing component 520 is configured to receive one or more other parameters or measurements as inputs when processing the received measurements to generate an indicator of whether there is an abnormality or physiological dysfunction in the chewing apparatus, including, for example, subject information such as age, sex, weight, medical history, signs, symptoms, diagnosis, etc.

[0131] In some examples, the mouthpiece system further comprises a user interface 530. The processing component 520 is configured to control the user interface to provide a visual representation or user-perceivable output of the one or more measurements and / or generated indicators (if generated).

[0132] In some examples, the mouthpiece arrangement further comprises a memory 540 configured to repeatedly store one or more measurements obtained by the sensing arrangement. In this way, measurements obtained over a period of time (e.g., in different sessions where a user uses the mouthpiece, or when a subject uses a new mouthpiece after a period of time) can be stored.

[0133] Various forms of memory are contemplated, such as any one or combination of volatile memory elements (e.g., random access memory (RAM), such as dynamic random access memory (DRAM), static random access memory (SRAM) etc.) and non-volatile memory elements (e.g., ROM, erasable programmable read only memory (EPROM), electronically erasable programmable read only memory (EEPROM), programmable read only memory (PROM), tape, compact disc read only memory (CD-ROM), disk, diskette, cartridge, cassette, etc.). Moreover, memory incorporates electronic, magnetic, optical, and / or other types of storage media. It should be noted that memory 540 may have a distributed architecture in which various components are located remotely from one another, but can be accessed by processing system 520.

[0134] The processing component 520 is configured to process the stored and acquired measurements to generate an indicator, such that the indicator is generated based on previous and current measurements of the mechanical properties of the grasp performed between the upper and lower jaws.

[0135] This embodiment recognizes that changes in mechanical properties can indicate the onset of an abnormality or physiological dysfunction in the masticatory apparatus, such as the presence of a TMJ disorder.

[0136] Thus, the processing performed by the processing component 520 includes comparing one or more current measurements (i.e., most recently collected) with previous or stored measurements, with deviations exceeding a predetermined amount (e.g., percentage or amount) indicating a potential abnormality or physiological dysfunction in the chewing apparatus.

[0137] Alternatively, the processing performed by the processing component 520 may include processing a time series or sequence of acquired measurements (including stored measurements and most recently acquired measurements) to generate the indicator. This embodiment recognizes that a change in the measurements over time may indicate a potential abnormality or onset of a physiological dysfunction in the chewing apparatus.

[0138] As a further example, Figure 6 illustrates an example processing system 60 for use in one embodiment. The various operations described above utilize the functionality of the processing system 60. For example, one or more portions of the system for obtaining and processing measurements from a mouthpiece described herein may be incorporated into any of the elements, modules, applications, and / or components described below. In this regard, it should be understood that the system functional blocks may be executed on a single processing system or distributed across several computers and locations (e.g., connected via the Internet).

[0139] The processing system 60 includes, but is not limited to, a PC, a workstation, a laptop, a PDA, a palm device, a server, storage, etc. In general, with respect to a hardware architecture, the processing system 60 includes one or more processors 61, a memory 62, and one or more I / O devices 67 communicatively coupled via a local interface (not shown). The local interface may be, for example, but is not limited to, one or more buses or other wired or wireless connections, as known in the art. The local interface has additional elements, such as controllers, buffers (caches), drivers, repeaters, and receivers, to enable communication. Additionally, the local interface includes address, control, and / or data connections to enable appropriate communication between the aforementioned components.

[0140] In some examples, the memory is external to the processing system, for example, as perhaps best shown in FIG.

[0141] 6, processor 61 is a hardware device for executing software that may be stored in memory 62. Processor 61 may be nearly any custom or commercially available processor, a central processing unit (CPU), a digital signal processor (DSP), or coprocessor, among other processors associated with processing system 60, and processor 61 may be a semiconductor-based microprocessor (in the form of a microchip) or a microprocessor.

[0142] The memory 62 may include any one or combination of volatile and non-volatile memory elements, such as dynamic random access memory. Suitable examples of such elements have been given above. Moreover, the memory 62 incorporates electronic, magnetic, optical, and / or other types of storage media. It should be noted that the memory 62 may have a distributed architecture in which various components are located remotely from each other, but can be accessed by the processor 61.

[0143] The software in memory 62 includes one or more separate programs, each of which includes an ordered listing of executable instructions for implementing logical functions. The software in memory 62, according to an exemplary embodiment, includes a suitable operating system (O / S) 65, a compiler 64, source code 63, and one or more applications 66. As shown, the applications 66 include a number of functional components for implementing the features and operations of the exemplary embodiments. The applications 66 of the processing system 60, according to an exemplary embodiment, are representative of various applications, computational units, logic, functional units, processes, operations, virtual entities, and / or modules, although the applications 66 are not limiting.

[0144] Operating system 65 controls the execution of other processing system programs and provides scheduling, input / output control, file and data management, memory management, and communication control and related services. It is contemplated by the inventors that applications 66 for implementing the exemplary embodiment are applicable on all commercially available operating systems.

[0145] The application 66 may be a source program, an executable program (object code), a script, or any other entity that includes a set of instructions to be executed. In the case of a source program, the program is typically translated via a compiler (such as compiler 64), assembler, interpreter, etc., which may or may not be included in memory 62, to operate properly with the O / S 65. Furthermore, the application 66 may be written as an object-oriented programming language having classes of data and methods, or a procedural programming language having routines, subroutines, and / or functions, such as, but not limited to, C, C++, C#, Pascal, BASIC, API call, HTML, XHTML, XML, ASP script, JavaScript, FORTRAN, COBOL, Perl, Java, ADA, .NET, etc.

[0146] The I / O devices 67 include input devices such as, but not limited to, a mouse, keyboard, scanner, microphone, camera, etc. Additionally, the I / O devices 67 also include output devices such as, but not limited to, a printer, device, etc. Finally, the I / O devices 67 further include devices that communicate both input and output such as, but not limited to, a NIC or modulator / demodulator (for accessing remote devices, other files, devices, systems, or networks), radio frequency (RF) or other transceivers, telephone interfaces, bridges, routers, etc. The I / O devices 67 also include components for communicating over various networks, such as the Internet or an intranet.

[0147] If the processing system 60 is a PC, workstation, intelligent device, etc., the software in memory 62 further includes a Basic Input / Output System (BIOS) (omitted for simplicity). The BIOS is a set of essential software routines that initializes and tests the hardware at power-up, starts the O / S 65, and supports the transfer of data between hardware devices. The BIOS is stored in some type of read-only memory, such as ROM, PROM, EPROM, EEPROM, etc., such that the BIOS may be executed when the processing system 60 is activated.

[0148] When processing system 60 is in operation, processor 61 is configured to execute software stored in memory 62 to communicate data to and from memory 62 and generally control the operation of processing system 60 in accordance with the software. Applications 66 and O / S 65 are read, in whole or in part, by processor 61, possibly buffered within processor 61, and then executed.

[0149] It should be noted that when the application 66 is implemented in software, the application 66 may be stored on nearly any processing system readable medium for use by or in connection with any processing system related system or method. In the context of this document, a processing system readable medium is an electronic, magnetic, optical, or other physical device or means that can contain or store a processing system program for use by or in connection with a processing system related system or method.

[0150] The application 66 may be embodied in any computer readable medium for use by or with an instruction execution system, apparatus, or device, such as a computer-based system, a system including a processor, or other system capable of fetching instructions from and executing instructions from an instruction execution system, apparatus, or device. In the context of this document, a "computer readable medium" may be any means that can store, communicate, propagate, or transport a program for use by or with an instruction execution system, apparatus, or device. A processing system readable medium may be, for example, but not limited to, an electronic, magnetic, optical, electromagnetic, infrared, or semiconductor system, apparatus, device, or propagation medium.

[0151] Variations to the disclosed embodiments can be understood and effected by those skilled in the art in practicing the claimed invention, from a study of the drawings, the disclosure, and the appended claims. In the claims, the word "comprising" does not exclude other elements or steps, and the word "a" or "an" does not exclude a plurality.

[0152] A single processor or other unit may fulfill the functions of several items recited in the claims.

[0153] The mere fact that certain measures are recited in mutually different dependent claims does not indicate that a combination of these measures cannot be used to advantage. It should be noted that, where the term "adapted for" appears in the claims or in the description, the term "adapted for" is equivalent to the term "configured for". Any reference signs in the claims should not be construed as limiting the scope.

Claims

1. a mount that is grasped between the upper and lower jaws of a subject; one or more oral cavity-contacting elements for contacting one or more portions of the subject's oral cavity when the mount is grasped between the upper jaw and the lower jaw to treat and / or clean the contacted one or more portions of the oral cavity; a sensing element located in or on the mount, the sensing element sensing one or more measurements of a mechanical property of the grip by the upper and lower jaws of the subject during gripping of the mount by the upper and lower jaws; wherein the sensing component comprises: a first sensor that senses a force or pressure applied between a first side of the upper jaw and a first side of the lower jaw; a second sensor that senses a force or pressure applied between a second side of the upper jaw and a second side of the lower jaw, the first side of the upper jaw being opposite the second side of the upper jaw and the first side of the lower jaw being opposite the second side of the lower jaw; and A mouthpiece comprising: the sensing arrangement generates a difference measurement that is the difference between the force or pressure generated by the first sensor and the force or pressure generated by the second sensor; 10. The mouthpiece of claim 9, wherein the sensing component comprises a movement sensor that generates a measurement of lateral movement of the mouthpiece when the upper and lower jaws are brought together and / or when the upper and lower jaws are separated during gripping of the mouthpiece.

2. The one or more measurements of the mechanical properties of the grip are: a force in one or more directions applied between a portion of the upper jaw and a portion of the lower jaw; and / or One or more components of stress or pressure applied between the portion of the upper jaw and the portion of the lower jaw The mouthpiece of claim 1 , comprising:

3. 3. The mouthpiece of claim 1 or 2, wherein the sensing arrangement comprises a torque sensing arrangement that senses torque applied to the lower jaw when the upper and lower jaws grip the mouthpiece.

4. 4. The mouthpiece of claim 3, wherein the torque sensing arrangement generates a measurement of rotation when the upper and lower jaws are brought together and / or when the upper and lower jaws are separated during gripping of the mouthpiece.

5. 5. The mouthpiece of claim 1, wherein the one or more oral-contact elements comprise one or more sensing elements for the sensing configuration, each sensing element sensing a mechanical property of the grip of the mount by the upper and lower jaws.

6. 6. The mouthpiece of claim 5, wherein each sensing element comprises a conductive element that acts as both a sensing element and a bristles for cleaning the subject's teeth and / or gums.

7. 7. The mouthpiece of any one of claims 1 to 6, further comprising an electromyography electrode arrangement that provides one or more signals responsive to electrical activity in one or more muscles of the jaw to perform electromyography sensing.

8. 8. The mouthpiece of claim 7, wherein the one or more oral contact elements comprise one or more brushing elements for cleaning / brushing the subject's teeth and / or gums, the one or more brushing elements further functioning as one or more electrode elements for the electromyography electrode configuration.

9. 9. The mouthpiece of claim 1, wherein the one or more oral-contact elements comprise one or more brushing elements for brushing or cleaning at least one gum or tooth of the subject.

10. 10. The mouthpiece of any one of claims 1 to 9, wherein the one or more oral-contact elements comprise a teeth alignment device for aligning or realigning the position of the subject's teeth.

11. A mouthpiece according to any one of claims 1 to 10; receiving the one or more measurements of the mechanical property of the grip from the sensing component of the mouthpiece; processing the one or more received measurements to generate an indicator of whether one or more abnormalities are present in the maxilla and / or mandible of the subject; and a processing component for performing the above; A mouthpiece system comprising:

12. a memory for repeatedly storing the one or more measurements obtained by the sensing arrangement to form stored measurements; 12. The mouthpiece system of claim 11, wherein the processing component processes the received measurement(s) and the stored measurement(s) to generate the indicator.

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