Mouthpiece for oral care devices

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 more particularly to a mouthpiece for an oral care device.

Background Art

[0002] Occlusal disorders, which typically (regardless of whether they are tooth-related or skeletal-related) result from abnormalities in the jaws or the masticatory apparatus, are quite common worldwide. These problems include (and can be caused by) malocclusion, tooth disharmony, tooth grinding, tooth wear, facial muscle pain, or temporomandibular joint muscle (TMJ) disorders.

[0003] Early detection of abnormal occlusion problems can prevent serious complications. Individuals with abnormalities in the jaws or other masticatory apparatus have both functional and aesthetic impairments. Tooth disharmony causes difficulties in head and neck functions related to chewing, swallowing, breathing, speech intelligibility, and lip closure / posture position. Affected individuals also experience TMJ pain and dysfunction that negatively impact quality of life. Some affected individuals also have psychological problems.

[0004] One significant problem area relates to TMJ disorders that are detected too late for effective treatment. There is a 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 shown that 25% of the US population is dealing with occlusal dentition-induced migraines, and 25 - 30% have some variant of TMJ disorder.

[0005] Uncommon as a chronic pain symptom, the prevalence of TMJ disorders is higher among younger people. Moreover, TMJ disorders are at least twice as prevalent in women as in men, and women using either supplemental estrogen or oral contraceptives are more likely to seek treatment for these symptoms.

Summary of the Invention

Problems to be Solved by the Invention

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

[0007] The present invention is defined by the claims.

[0008] According to an example of one aspect of the present invention, a mouthpiece is provided. The mouthpiece comprises a mount configured to be gripped between the maxilla and mandible of a subject; one or more oral contact elements, each oral contact element configured to contact one or more parts of the subject's oral cavity when the mount is gripped between the maxilla and mandible, and to protect, treat, and / or clean the one or more parts of the oral cavity that are in contact; and a sensing component located in or on the mount, the sensing component configured to sense one or more measurements of the mechanical properties of the grip by the maxilla and mandible during the subject's grip of the mount, wherein one or more measurements of the mechanical properties respond to one or more abnormalities or physiological dysfunctions in the subject's masticatory organs.

[0009] This disclosure proposes a method for generating data useful for identifying the presence or impact of occlusal disorders (i.e., jaw abnormalities) in a subject. The abnormalities are present in the jaw muscles, teeth, and / or joints (i.e., the subject's masticatory organs) and relate to misalignment (e.g., movement of teeth or jaw) and variability (e.g., movement of teeth or bite).

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

[0011] The sensing component collects data during the gripping of the mouthpiece. Grip is the time during which the mouthpiece is held between the subject's jaws, and includes periods during which the subject tightens the mouthpiece, maintains pressure on the mouthpiece, and / or releases pressure from the mouthpiece. Grip includes 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 movements between a loose grip and a tight grip.

[0012] Any desirable mechanical properties of the grip by the maxilla and mandible are also measured. In particular, the mechanical properties are measured or sampled during the time period in which pressure is (increasingly) applied to the mouthpiece by the jaw, and thus data representing the gripping procedure is generated.

[0013] By using a mouthpiece designed for cleaning or brushing a user's teeth, data can be collected not just once (e.g., in a professional clinic or using a specialized device), but over a long period of time (e.g., at least twice daily). This facilitates long-term analysis of the nature of maxillary and mandibular gripping, thereby promoting more accurate identification of occlusal disorders. In particular, tracking measurements over time improves accuracy in identifying individuals at risk.

[0014] One or more measurements of the mechanical properties of the grip include one or more components of the force applied between the part of the maxilla and the part of the mandible in one or more directions, and / or the stress or pressure applied between the part of the maxilla and the part of the mandible.

[0015] A force is, for example, a normal force, which is the force (or its component) applied to the maxilla in a direction perpendicular to the plane in which it is contained. In some examples, a force is a lateral force, which is the force (or its component) applied to the maxilla in a direction parallel to the plane in which it is contained. Of course, it will be understood that the direction of a force can be between the vertical and the lateral.

[0016] In some examples, the sensing component includes a first sensor configured to sense a force or pressure applied between a first lateral portion of the maxilla and a first lateral portion of the mandible, and a second sensor configured to sense a force or pressure applied between a second lateral portion of the maxilla and a second lateral portion of the mandible, wherein the first lateral portion of the maxilla is on the opposite side of the second lateral portion of the maxilla and the first lateral portion of the mandible is on the opposite side of the second lateral portion of the mandible.

[0017] Differences in pressure or force applied by different sides of the jaw, i.e., non-uniform pressure, can indicate potential TMJ dysfunction or jaw misalignment.

[0018] The sensing component 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 component includes a torque sensing component configured to sense the torque applied to the lower jaw when the upper and lower jaws grip the mouthpiece.

[0020] The torque sensing component is configured to generate rotational measurements when the upper and lower jaws become one 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, the closing or opening movement of the jaw essentially does not generate torque or rotation. However, when the teeth are misaligned, for example, when the upper and lower jaws cross as a result, torque or rotation is induced. Monitoring the rotation of the mouthpiece using a torque sensor thus generates useful measurements for evaluating potential crossing of the jaws and can therefore predict or identify whether the teeth are misaligned.

[0022] A pair of strain gauges arranged perpendicular (90°) to each other provides one suitable example of a torque sensing component. Other torque sensing components 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 the torque applied to the first side of the upper jaw when the upper and lower jaws are integrated, and a second torque sensor configured to sense the torque applied to the second side of the lower jaw when the upper and lower jaws are integrated, where the first side of the lower jaw is on the opposite side of the second side of the lower jaw.

[0024] The difference in the torque applied to the sides of the lower jaw represents the misalignment between the jaws and / or can more accurately identify the location of the misalignment between the jaws compared to a single torque sensor.

[0025] The sensing component includes a movement sensor configured to generate measurements of the lateral movement, displacement or tilt of the mouthpiece when the upper and lower jaws become integrated and / or separate during gripping of the mouthpiece.

[0026] The left and right movements when the subject bites (i.e., makes a closing movement) or releases the bite indicate misalignment or size differences between the upper and lower jaws, i.e., jaw abnormalities. This lateral left and right movement can be measured using the torque sensing component. The lateral movement is a movement parallel to the plane in which the upper jaw is located.

[0027] In one example, the sensing component comprises two strain gauges arranged at right angles to each other, thereby facilitating the measurement of torque and lateral movement. However, in a simplified embodiment, a single strain sensor is appropriately arranged and configured to record only lateral movement.

[0028] Thus, in some examples, the torque sensing component is adapted to sense lateral movement.

[0029] One or more oral contact elements comprise one or more sensing elements for the sensing component, and each sensing element is configured to sense the mechanical properties of the mount grip by the upper and lower jaws.

[0030] In particular, one or more oral contact elements are formed or manufactured from a material capable of sensing mechanical properties, such as dynamic (static) pressure or force changes. In other words, at least a part of the sensing component is integrated into the oral 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 a bristle for cleaning the teeth and / or gums of the subject.

[0032] The mouthpiece further comprises an electromyography electrode configuration configured to supply 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 the electromyography electrode configuration. Thus, one or more of the oral contact elements are at least partially conductive and thereby act as electrodes that generate signals responsive to electrical activity in the jaw muscles. Suitable materials will be apparent to those skilled in the art, such as conductive silicone, conductive polymer, and the like.

[0034] For example, one or more oral contact elements comprise one or more brushing elements configured to clean / brush the subject's teeth and / or gums, and 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 in response to electrical activity in the jaw muscles. The brushing elements are formed from conductive silicone (or any other material) suitable for acting as electrodes and for brushing the teeth / gums, for example.

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

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

[0038] In some examples, a first set of one or more oral contact elements is configured to act as a sensing element for a sensing component, and a second set of one or more oral contact elements is configured to act as an electrode element for an electromyography electrode component. The first and second sets of oral contact elements are mutually exclusive, partially overlapping, or completely overlapping.

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

[0040] One or more oral contact elements include one or more brushing elements for brushing or cleaning at least one gum or tooth of the subject.

[0041] One or more oral contact elements include a mouthguard 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. One or more oral contact elements may include a bite guard.

[0042] In some examples, the mount and the oral contact element are the same element; for example, the mount may comprise a mouthguard designed to cover and protect one or more parts of the subject's oral cavity.

[0043] Furthermore, a mouthpiece system is proposed comprising the mouthpiece described above, and a processing component configured to receive one or more measurements of the mechanical properties of gripping from the sensing component of the mouthpiece, and to process the received one or more measurements in order to generate an indicator showing whether or not there is one or more abnormalities in the subject's upper and / or lower jaw.

[0044] The processing unit receives one or more measurement values ​​at its input interface.

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

[0046] The processing unit is configured to control the user interface to provide one or more measurements and / or (if generated) a visual representation of a generated indicator, or an output that can be perceived by the user. Accordingly, the processing unit is configured to output interface control signals (for example, in the output interface) to control the operation of the user interface.

[0047] In some examples, the processing unit is configured to control the user interface to instruct the subject to perform guided occlusal movements, for example, in the form of text output or visual output. In this embodiment, well-controlled and predictable gripping (and release) of teeth to the mount is possible as part of the user workflow to improve consistency when acquiring measurements.

[0048] The mouthpiece system features an even more advanced user interface.

[0049] These and other aspects of the present invention will become apparent from the embodiments described below, and will be clarified by referring to those embodiments.

[0050] For a better understanding of the present invention, and to more clearly illustrate how the present invention is carried out, the accompanying drawings are now referred to, simply as examples. [Brief explanation of the drawing]

[0051] [Figure 1] This figure shows a mouthpiece according to one embodiment. [Figure 2] This figure shows a sensor for use in the sensing component. [Figure 3] This is a cross-sectional view of a mouthpiece according to one embodiment. [Figure 4] This figure shows a torque sensing component for use in one embodiment. [Figure 5] This figure shows a mouthpiece system according to one embodiment. [Figure 6] This figure shows a processing system for use in one embodiment. [Modes for carrying out the invention]

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

[0053] The detailed descriptions and specific examples illustrate exemplary embodiments of the apparatus, system, and method, but should be understood to be illustrative only and not to limit the scope of the invention. These and other features, aspects, and advantages of the apparatus, system, and method of the invention will be better understood from the following description, the appended claims, and the appended drawings. It should be understood that the figures are schematic and not drawn to a specific scale. It should also be understood that the same reference numerals are used throughout the figures to indicate the same or similar parts.

[0054] This invention provides a method for obtaining measurements of the mechanical properties of gripping performed by the masticatory organs. The mouthpiece comprises a sensing component (for obtaining measurements) and one or more oral contact elements for protecting, cleaning, or treating teeth / gingiva. Thus, measurements indicating potential abnormalities or physiological dysfunctions within the masticatory organs can be obtained using a mouthpiece having secondary or further functions of protecting, aligning, cleaning, and / or treating oral elements.

[0055] "Secondary functions" will be understood to be the primary intended use function of the mouthpiece, e.g., the advertised function of the mouthpiece, accompanied by features of the disclosure that effectively form additional useful functionality for the mouthpiece. The term "secondary functions" is used to distinguish protective, cleaning, and / or therapeutic functions from the mechanical property sampling functions described in the disclosure.

[0056] Embodiments of the present invention advantageously recognize that integrating such sensing functions into a mouthpiece having a secondary (oral care or oral hygiene) function facilitates improved ease and regularity in obtaining measurements. This is based on the recognition that the onset of abnormalities or physiological dysfunctions in the masticatory organs can be detected by monitoring changes in the mechanical properties of gripping (e.g., biting) over a period of time. The use of a mouthpiece with a secondary function can increase the likelihood of repeated measurements being taken over a period of time (by relying on the subject's regular use of the mouthpiece).

[0057] The proposed concept can be applied to any mouthpiece that can be held between the upper and lower jaw, such as cleaning (e.g., brushing) devices, orthodontic retainers / aligners, mouthguards, bite guards, and mandibular advancement devices.

[0058] In the context of this application, the masticatory organs refer to the maxilla and mandible (including teeth or dental implants) of the subject, along with other anatomical features that contribute to the movement of the maxilla and mandible (e.g., the jaw muscles and / or temporomandibular joint).

[0059] Figure 1 shows 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 includes a mount 110. The mount is configured to be grasped or grippable between the subject's upper and lower jaws. Thus, the mount is appropriately molded and / or sized to fit the subject's oral cavity so that the subject can "bite down" on the mouthpiece so as to grasp the mount 110 between the subject's jaws. For example, the mount may have an 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 predetermined shape / size that best fits the subject's dentition (i.e., the best-fitting mount taken from a predetermined or fixed set of (and different) mount sizes).

[0061] In the illustrated example, the mount is semicircular in shape (i.e., a sector of the ring with dividing lines passing through the diameter of the ring).

[0062] Grasping does not necessarily have to be caused by direct contact between the jaw and the mount; for example, gripping can be achieved through one or more intermediate elements (such as those described later).

[0063] In the context of this application, gripping occurs when the mouthpiece (i.e., mount) is held between the jaws of the subject. This does not have to be a tight or constricting grip, and can be a loose grip (e.g., the mouthpiece is held loosely). Any movement during gripping (e.g., tightening or releasing, clenching or releasing, biting or releasing) is either random or well controlled through commands given to the user to perform guided occlusal movements.

[0064] Mount 110 further comprises a stopper 115 configured to contact the front of the subject's teeth or lips to prevent or limit the movement of the mouthpiece toward the back of the throat. This can help prevent accidental nausea 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 contact elements 120. The oral contact elements are configured to perform one or more protective, cleaning, and / or (dental) treatment tasks. In particular, the oral contact 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. Parts of the oral cavity include teeth, gums, tongue, and / or dental implants. (Dental) treatment includes any preferred treatment tasks, such as alignment tasks (e.g., using retainers or braces) and / or teeth whitening tasks. Therefore, 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 the subject. However, other types of oral contact elements may be used in addition to or instead of the brushing elements, such as mouthguards, bite guards, mandibular advancement devices (MADs), (dental) alignment devices, and (orthodontic) retainers.

[0067] The mouthpiece 100 further comprises a sensing component 130, which is positioned in or on the mount 110. During the gripping of the mount by the maxilla and mandible (i.e., when the mouthpiece is held between the jaws), the sensing component senses one or more measurements of the mechanical properties of the gripping by the maxilla and mandible. In other words, the sensing component senses one or more measurements of the mechanical properties applied to the mouthpiece in response to, or as a result of, the gripping by the maxilla and mandible, and these measurements include, for example, measurements of changes in mechanical properties due to changes in gripping during clenching or release.

[0068] Suitable examples of mechanical properties include pressure, stress, force, torque, strain, displacement, motion, orientation / tilt (e.g., as a result of maxillary / mandibular abnormalities). Those skilled in the art can easily develop or use sensing components for detecting such mechanical properties in accordance with the teachings of this disclosure.

[0069] Measurements of the mechanical properties of gripping (and its results) are measurements that respond to one or more abnormalities or physiological dysfunctions in the subject's masticatory organs. Therefore, the measurements of mechanical properties should be conventional or desired values ​​for the subject, or measurements that should not change (significantly) over repeated use of the jaw and / or over time.

[0070] In particular, the sensing component is configured to sense measurements of one or more mechanical properties of the grip during the subject's tightening movement (where the mandible applies pressure to the maxilla or increases the pressure applied to the maxilla) and the subject's loosening / releasing movement (where the mandible stops applying pressure to the maxilla or reduces the pressure applied to the maxilla). Measurements during the tightening / releasing process have been shown to respond to and indicate abnormalities or physiological dysfunctions in the masticatory organs, particularly the TMJ. This is because such TMJ abnormalities or physiological dysfunctions can cause changes in mandibular movement during the tightening motion.

[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 protection, cleaning, or treatment. This means that, for example, if the mouthpiece is used regularly over time for its secondary function, long-term data on the subject's measurements can be obtained, and that such measurements can be obtained without requiring dedicated measurement sessions.

[0072] The sensing component is capable of acquiring measurements of the mechanical properties of gripping at multiple positions of the mouthpiece (for example, in different parts of the oral cavity). In this way, a mapping of gripping measurements performed by the maxilla and mandible can be performed. The measurement map is useful in identifying abnormal anatomical structures or areas of gripping between the maxilla and mandible, and thus potential abnormalities or physiological dysfunctions in the masticatory organs.

[0073] As a simple example, the measurement is a measurement of the force applied between a specific part of the maxilla and the corresponding part of the mandible, and multiple measurements / samples are taken (for example, simultaneously) for different parts of the maxilla and mandible.

[0074] Preferably, one or more measurements of the mechanical properties of the grip include components of force, stress, or pressure applied between a portion of the maxilla and a portion of the mandible. Preferably, multiple measurements are taken / sampled, for example, for different portions of the maxilla / mandible and / or at different points in time.

[0075] The sensing component 130 is at least partially integrated into the oral contact element 120. For example, the brushing element includes a material suitable for acting as (part of) the sensing component. As an example, the brushing element includes a conductive silicone pillar / element that can be used as a force / pressure measuring sensor, as well as a bristle / tuft (mounted on the silicone pillar) for cleaning teeth and / or gums.

[0076] However, (complete) integration of the sensing component into the oral contact element is not required, and the sensing component may include one or more elements positioned elsewhere in / on the mount. For example, a thin, flexible pressure-sensitive film positioned in / on the mount of the mouthpiece (e.g., by overmolding) can be used to obtain force / pressure measurements with higher resolution.

[0077] The illustrated sensing component 130 includes a first sensor 131 configured to sense a force, stress, or pressure (for example, a force / stress / pressure applied to the first side 101 of the mouthpiece) applied between the first side of the maxilla and the first side of the mandible. The sensing component 130 also includes a second sensor 131 configured to sense a force, stress, or pressure (for example, a force, stress, or pressure applied to the second side 102 of the mouthpiece 100) applied between the second side of the maxilla and the second side of the mandible. The first side of the maxilla is opposite the second side of the maxilla, and the first side of the mandible is opposite the second side of the mandible.

[0078] Although only two sensors are shown, the sensing configuration may include any number of sensors, e.g., a single sensor (element), multiple sensors, four or more sensors, six or more sensors, etc. It is not necessary for each sensor to measure / sens the same type of physical component of the grip performed by the maxilla and mandible.

[0079] In the illustrated example, both the first and second sensors are integrated within the oral contact element. More specifically, both sensors are formed from a force-sensitive or pressure-sensitive material (e.g., particle-filled conductive silicone or conductive polymer) of the brushing element of the oral contact element. An example of sensors formed from a suitable material is described in U.S. 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 element is therefore a (partially) conductive bristle.

[0080] Due to its conductive properties, the brushing element can also be used as an inert electrode to measure electrophysiological signals in the oral cavity (e.g., electromyography (EMG)), as will be explained later.

[0081] Figure 2 shows an example of a suitable sensor 200 that can function as part of an oral contact element and a 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., having one or more pins 250) that allows the electrode 200 to establish good galvanic contact with the subject.

[0083] Each (for example) pin 250 is formed from a force-sensitive and / or pressure-sensitive, particle-filled conductive silicon material (or other suitable material such as a conductive polymer) and is capable of acting as a brush for the subject's oral cavity. In other words, the pin 250 acts as a bristle or brushing element for the oral cavity. Thus, the pin 250 is, in effect, a conductive bristle.

[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 Figure 1, those skilled in the art will understand that the first and second sensors can be formed in other locations, for example, in a force / pressure / stress-sensitive film located on top of the mount 110, or they can be integrated into the mount 110 by, for example, overmolding.

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

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

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

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

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

[0091] As an example, referring to Figure 2, the conductive support plate 200 and / or conductive bristle 250 of the illustrated sensor 200 can be used to measure EMG.

[0092] The EMG electrode configuration 140 includes one or more electrodes positioned on the mount 110. These electrodes are either dedicated electrodes (i.e., electrodes not used for any other purpose) or are (at least partially) integrated into the oral contact element 120 and / or sensing component 130. For example, the oral contact element includes one or more brushing elements, at least one of which is at least partially conductive to act as an electrode for the EMD electrode configuration.

[0093] In the illustrated example, the EMG system comprises two electrodes configured to perform EMG measurements. However, any number of electrodes can be used, such as one electrode, four electrodes, eight electrodes, two or more electrodes, etc.

[0094] Preferably, one or more electrodes 140 are positioned 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 helps in collecting EMG measurements from the masseter muscle, which are identified herein, in particular, as indicating abnormalities or physiological dysfunctions in the masticatory organs. In particular, such EMG measurements respond to the presence of TMJ dysfunction.

[0095] In some cases, one or more electrodes are attached to the side of the mount, for example, on the outer circumference of the mount. This increases the likelihood that one or more electrodes will come into contact with the muscle to sense its electrical activity.

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

[0097] The process by which EMG electrodes are integrated, at least partially, into oral contact elements has been described previously. In particular, oral contact elements contain, or are formed from, materials that can sense or respond to electrical signals (i.e., materials suitable for forming electrodes).

[0098] Figure 3 is a side view showing a cross-sectional view of the mouthpiece 300 according to another embodiment.

[0099] The mouthpiece 300 comprises a mount 310 and one or more oral contact elements 320 supported by the mount 310. Herein, the oral contact elements also comprise one or more brushing elements, but other forms of oral contact elements for protecting, cleaning or treating teeth are conceivable.

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

[0101] In an alternative example, the mount is formed from a single continuous section (for example, the second section 312 is omitted), the sensing component 330 is mounted on this section, and a second set of one or more oral contact elements is mounted directly on the sensing component.

[0102] Here, the sensing component 330 includes a torque sensing component configured to detect the torque applied to the lower jaw / torque applied to the torque sensing component by the lower jaw when the upper and lower jaws are joined together (or separated). In particular, the torque sensing component is arranged to detect the lateral torque applied to the torque sensing component. Lateral torque is the torque applied around an axis parallel to the plane in which the upper teeth are located, or extending from the posterior to the anterior part of the oral cavity. The torque sensing component is therefore configured and arranged so that no torque is detected when the teeth are aligned when the upper and lower jaws are joined together (or separated), and torque is detected when the teeth are not aligned when the upper and lower jaws are joined together (or separated).

[0103] In this way, torque present during the tightening or untightening process is detected. Specifically, the torque sensing component detects the torque applied to the mouthpiece around an axis parallel to the plane in which the maxilla resides, thereby detecting whether jaw crossing or plane misalignment has occurred (i.e., the teeth are not aligned as a result), or whether there is a malfunction in the TMJ.

[0104] In some cases, torque measurements are taken during the tightening process (i.e., when the jaws are joined together) and during the release process (i.e., when the jaws are separated). This feature allows for verification of the quality of the torque measurements, as in the ideal case where the amplitudes of the signals during occlusion and release should be equal and opposite in sign.

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

[0106] The above examples provide various methods and systems for obtaining measurements of the physical / mechanical properties of the gripping performed by the masticatory organs (maxilla and mandible), which can be used, for example, automatically or by clinicians to assess symptoms of the masticatory organs.

[0107] However, the measurements describing the physical / mechanical properties should not be considered exhaustive. Rather, the sensing component is configured to acquire / sample any measurements of a desirable nature that indicate, or respond to, the onset, exacerbation, or change of abnormalities or physiological dysfunction in the subject's masticatory organs.

[0108] As a further example, the sensing component of the mouthpiece includes a motion sensor configured to detect lateral movement (e.g., sliding) of the mandible and / or mouthpiece during the jaw tightening or loosening process. Lateral movement (i.e., lateral movement) is an example of a measurement indicating either a mismatch or size difference between the maxilla and mandible.

[0109] In the context of this application, lateral movement refers to movement of the maxilla within a plane parallel to the plane in which it is located.

[0110] This sensing component includes, for example, another torque sensing component comprising two strain gauges arranged perpendicular to each other (i.e., orthogonal). However, in less expensive embodiments, a single strain sensor arranged to sense or record lateral movement may suffice.

[0111] As another example, the sensing component of a mouthpiece is configured to calculate, sense, or measure the distance (or relative displacement / offset) between different parts of the maxilla and mandible during tightening or loosening movements. If the subject's occlusion is not uniform (indicating a potential abnormality or physiological dysfunction in the masticatory organs), the distances between different parts of the maxilla and mandible will differ.

[0112] As another example, the sensing component of the mouthpiece is configured to calculate, sense, or measure the orientation (e.g., tilt) of the maxilla and / or mandible (e.g., relative to each other) during the gripping of the mouthpiece, for example, during the tightening or loosening of the mouthpiece. Generally, the maxilla and mandible should have the same or similar orientation when gripping the mouthpiece (i.e., the maxilla and mandible should be parallel to each other). Deviation from the same / similar orientation may indicate a potential abnormality or physiological dysfunction in the masticatory organs.

[0113] As another example, the sensing component of the mouthpiece is configured to calculate, sense, or measure the angle between the maxilla and / or mandible (e.g., relative to each other) during the gripping of the mouthpiece, for example, during the tightening or loosening of the mouthpiece. The sensing component thus comprises a (digital) goniometer, a (2D) gimbal angulation sensor and / or accelerometer. Other suitable types of sensors will become apparent to those skilled in the art. As previously described, the jaws should be mostly parallel when gripping the mouthpiece, so that the presence or size of the interjaw angle indicates a potential abnormality or physiological dysfunction in the masticatory organs.

[0114] In another example, the sensing component is configured to calculate, sense, or measure 3D force and momentum measurements using an integrated pneumatic-based force-dynamometer that enables the capture of static and dynamic occlusal force or torque changes.

[0115] Those skilled in the art will understand that the sensing component is configured to detect any previously described combination of measurements and / or mechanical properties of the gripping of the mouthpiece by the maxilla and mandible. Those skilled in the art will also understand that, where appropriate, the sensing component may be modified to include one or more of the previously described sensors (e.g., force sensing component, torque sensing component, etc.).

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

[0117] Although the above example only described a single mouthpiece, it will become clear that a subject may hold multiple mouthpieces in their oral cavity (for example, one attached to the upper jaw and one to the lower jaw). One or more of these mouthpieces are the ones described previously.

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

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

[0120] The processing unit communicates with the sensing unit 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 IEEE® 802.11 standards, and 2G, 3G, or 4G telecommunications protocols. Other forms will be readily apparent to those skilled in the art.

[0121] If mouthpiece 510 is one of several mouthpieces, it will be understood that each mouthpiece provides one or more measurements of the mouthpiece grip.

[0122] The processing unit 520 is configured to process one or more received measurements in order to generate an indicator showing whether or not there is an abnormality or physiological dysfunction in the masticatory organs.

[0123] The indicator is one or more of the following: a binary indicator that predicts whether or not there is an abnormality or physiological dysfunction in the masticatory organs; a classification indicator that provides a predicted type or classification of the abnormality or physiological dysfunction identified in the masticatory organs (if relevant); and / or a numerical indicator that provides the likelihood of an abnormality or physiological dysfunction in the masticatory organs (e.g., on a scale of 0-1, 0-100, 0-10, 1-10, or 1-100). In some embodiments, two or more indicators are generated, for example, multiple different binary or numerical indicators for different classifications of abnormalities or physiological dysfunctions.

[0124] The process includes, for example, comparing the received measurements to 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] As a purely illustrative example, consider a scenario where the measurement obtained by the processing unit is a difference measurement, representing the difference between the force applied between the first lateral portion of the maxilla and the first lateral portion of the mandible and the force applied between the second different lateral portion of the maxilla and the second different lateral portion of the mandible. In this scenario, if the difference measurement exceeds a certain predefined value (since non-uniform forces indicate abnormality or physiological dysfunction), then abnormality or physiological dysfunction is predicted to be present.

[0126] Another approach could involve processing received measurements using machine learning methods to generate indicators, which are trained to detect abnormalities or physiological dysfunctions in the masticatory organs based on a set of one or more measurements received as input. Disease classification may also be possible through comparison with federated data.

[0127] Another approach may involve comparing the received measurement with previous measurements. An increase in a particular measurement may indicate the onset of an abnormality and / or physiological dysfunction. Therefore, the process may involve determining whether a change in a particular measurement (e.g., over time) exceeds a certain threshold, where the change is the difference between a previous measurement and a very recently collected measurement, and / or the ratio of such difference to the time difference between when the previous measurement was collected and when the very recently collected measurement was collected.

[0128] More generally, long-term measurements (i.e., measurements over time) allow for tracking the progression of the disease or the response to therapy and / or spontaneous healing.

[0129] Where appropriate, the processing unit 520 also receives generated signals in response to electrical activity in the jaw (or one or more muscles of the jaw) via a voluntary electromyography (EMG) electrode configuration of the mouthpiece. Processing the received one or more measurements to generate an indicator involves processing the received one or more measurements and the received signals to determine whether there is an abnormality or physiological dysfunction in the masticatory organs.

[0130] It will be understood that the processing unit 520 is configured to receive one or more other parameters or measurements as input when processing received measurements to generate an indicator of whether or not there is an abnormality or physiological dysfunction in the masticatory organs. These one or more other parameters or measurements include, for example, subject information such as age, sex, weight, medical history, signs, symptoms, and diagnosis.

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

[0132] In some examples, the mouthpiece configuration further includes a memory 540 configured to iteratively store one or more measurements acquired by the sensing component. In this way, measurements acquired over a period of time (for example, in different sessions in which the user uses the mouthpiece, or when the subject uses a new mouthpiece after some time has passed) can be stored.

[0133] Various forms of memory are envisioned, such as volatile memory elements (e.g., dynamic random access memory (DRAM), static random access memory (SRAM), and random access memory (RAM)) 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, floppy disk, cartridge, cassette, etc.), one or a combination thereof. Furthermore, the memory incorporates electronic, magnetic, optical, and / or other types of storage media. It should be noted that the memory 540 may have a distributed architecture in which various components are located remotely from one another, but can be accessed by the processing system 520.

[0134] The processing unit 520 is configured to process stored and acquired measurements in order to generate an indicator. In this way, the indicator is generated based on past and current measurements of the mechanical properties of the grip performed between the maxilla and the mandible.

[0135] This embodiment acknowledges that changes in mechanical properties can indicate the onset of abnormalities or physiological dysfunctions in the masticatory organs, such as the presence of TMJ disorders.

[0136] Therefore, the processing performed by the processing unit 520 includes comparing one or more current measurements (i.e., very recently collected) with previous or stored measurements. Deviations exceeding a predetermined amount (e.g., percentage or quantity) indicate a potential abnormality or physiological dysfunction in the masticatory organs.

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

[0138] As a further example, Figure 6 shows an example of a processing system 60 for use in one embodiment. The various operations described above utilize the functions of the processing system 60. For example, one or more parts of the system for acquiring and processing measurements from the mouthpiece described herein are incorporated into any of the elements, modules, applications, and / or components described below. In this regard, it should be understood that the system function blocks can run on a single processing system or be distributed across several computers and locations (connected, for example, via the Internet).

[0139] The processing system 60 includes, but is not limited to, PCs, workstations, laptops, PDAs, palm devices, servers, storage, etc. Generally, with respect to the hardware architecture, the processing system 60 includes one or more processors 61, memory 62, and one or more I / O devices 67, all communicably coupled via a local interface (not shown). The local interface may be, for example, one or more buses or other wired or wireless connections, as known in the art, but is not limited to. The local interface may have additional elements, such as controllers, buffers (caches), drivers, repeaters, and receivers, to enable communication. Furthermore, the local interface may include address, control, and / or data connections to enable proper communication between the aforementioned components.

[0140] In some cases, the memory is located outside the processing system, for example, perhaps best illustrated in Figure 5.

[0141] Returning to Figure 6, the processor 61 is a hardware device for executing software that can be stored in memory 62. The processor 61 can be almost any custom-made or commercially available processor, central processing unit (CPU), digital signal processor (DSP), or auxiliary processor among several processors associated with the processing system 60, and the processor 61 can be a semiconductor-based microprocessor or microprocessor (in the form of a microchip).

[0142] Memory 62 may include one or a combination thereof of volatile memory elements and non-volatile memory elements, such as dynamic random access memory. Preferred examples of such elements are given previously. Furthermore, memory 62 incorporates electronic, magnetic, optical, and / or other types of storage media. It should be noted that memory 62 may have a distributed architecture in which various components are located remotely from one another, but are accessible 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 performing a logical function. According to an exemplary embodiment, the software in memory 62 includes a preferred operating system (O / S) 65, a compiler 64, source code 63, and one or more applications 66. As shown, the application 66 includes a number of functional components for performing the features and operations of the exemplary embodiment. The application 66 of the processing system 60, according to an exemplary embodiment, represents various applications, computing units, logic, functional units, processes, operations, virtual entities, and / or modules, but the application 66 is not limited to these.

[0144] The operating system 65 controls the execution of other processing system programs and performs scheduling, input / output control, file and data management, memory management, and communication control and related services. The inventors intend that application 66 for implementing exemplary embodiments is applicable to all commercially available operating systems.

[0145] An application 66 is any other entity that includes a source program, an executable program (object code), a script, or a set of instructions to be executed. In the case of a source program, the program is usually translated through a compiler (such as a compiler 64), assembler, interpreter, etc., which may or may not be contained in memory 62, so that it can work properly with the OS 65. Furthermore, an application 66 can be written as an object-oriented programming language with classes of data and methods, or a procedural programming language with 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] I / O devices 67 include input devices, such as, but are not limited to, a mouse, keyboard, scanner, microphone, and camera. Furthermore, I / O devices 67 also include output devices, such as, but are not limited to, a printer and other devices. Finally, I / O devices 67 further include devices that communicate both input and output, such as, but are not limited to, a NIC or modulator / demodulator (for accessing remote devices, other files, devices, systems, or networks), a radio frequency (RF) or other transceiver, a telephone interface, a bridge, a router, and so on. I / O devices 67 also include components for communication 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 the Basic Input / Output System (BIOS) (omitted for simplicity). The BIOS is a set of essential software routines that initialize and test the hardware at startup, start the OS 65, and support the transfer of data between hardware devices. The BIOS is stored in some type of read-only memory, such as ROM, PROM, EPROM, or EEPROM, so that the BIOS can be executed when the processing system 60 is activated.

[0148] When the processing system 60 is operating, the processor 61 is configured to communicate data with the memory 62 and to execute software stored in the memory 62 in order to generally control the operation of the processing system 60 according to the software. The application 66 and the OS 65 are read whole or partially by the processor 61, possibly buffered within the processor 61, and then executed.

[0149] When Application 66 is implemented in software, it should be noted that Application 66 can be stored by any system or method relating to any processing system, or on virtually any processing system-readable medium for use with such systems. In the context of this document, a processing system-readable medium is an electronic, magnetic, optical, or other physical device or means that contains or can store a processing system program by any system or method relating to a processing system, or for use with such systems.

[0150] Application 66 may be implemented by or in use 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 and executing instructions from an instruction execution system, apparatus, or device. In the context of this document, “computer-readable medium” can be any means by which a program can be stored, communicated, propagated, or transferred by or in use with an instruction execution system, apparatus, or device. The 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 of the disclosed embodiments can be understood and implemented by those skilled in the art in carrying out the claimed invention, based on a review of the drawings, disclosures, and appended claims. In the claims, the word “equipped with” does not exclude other elements or steps, and singular elements do not exclude plural elements.

[0152] A single processor or other unit performs the functions of several items described in the claims.

[0153] The mere fact that several means are presented in different dependent claims does not imply that combinations of these means cannot be used to one's advantage. Note that where the term “adapted to” is used in the claims or specification, it is equivalent to the term “configured to.” No reference numeral in the claims should be construed as limiting the scope.

Claims

1. A mount that is held between the upper and lower jaws of the subject, When the mount is grasped between the upper jaw and the lower jaw, it comes into contact with one or more parts of the subject's oral cavity, and one or more oral contact elements for treating and / or cleaning the one or more parts of the oral cavity that are in contact, A sensing component located in or on the mount, wherein the sensing component senses one or more measured values ​​of the mechanical properties of the grip by the upper and lower jaws of the subject while the upper and lower jaws are gripping the mount. The sensing component is equipped with, A first sensor that senses force or pressure applied between the first side of the upper jaw and the first side of the lower jaw, A second sensor for sensing force or pressure applied between the second side of the upper jaw and the second side of the lower jaw, wherein the first side of the upper jaw is on the opposite side of the second side of the upper jaw, and the first side of the lower jaw is on the opposite side of the second side of the lower jaw. In a mouthpiece equipped with, The sensing component generates a difference measurement value, which is the difference between the force or pressure generated by the first sensor and the force or pressure generated by the second sensor. The sensing component is characterized by comprising a motion sensor that generates a measurement value of the lateral movement of the mouthpiece when the upper jaw and the lower jaw become one and / or separate while the mouthpiece is being held.

2. The one or more measured values ​​of the mechanical properties of the gripping are A force applied in one or more directions between the part of the upper jaw and the part of the lower jaw, and / or One or more components of the stress or pressure applied between the part of the upper jaw and the part of the lower jaw The mouthpiece according to claim 1, including the following:

3. The mouthpiece according to claim 1 or 2, wherein the sensing component includes a torque sensing component that senses the torque applied to the lower jaw when the upper jaw and the lower jaw grip the mouthpiece.

4. The mouthpiece according to claim 3, wherein the torque sensing component generates a measurement of rotation when the upper jaw and the lower jaw become one and / or separate while the mouthpiece is being held.

5. The mouthpiece according to any one of claims 1 to 4, wherein the one or more oral contact elements comprises one or more sensing elements for the sensing component, each sensing the mechanical properties of the gripping of the mount by the upper and lower jaws.

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

7. The mouthpiece according to any one of claims 1 to 6, further comprising an electromyography electrode component that supplies one or more signals in response to electrical activity in one or more muscles of the jaw in order to perform electromyography sensing.

8. The mouthpiece according to claim 7, wherein the one or more oral contact elements comprises one or more brushing elements for cleaning / brushing the teeth and / or gums of the subject, and the one or more brushing elements further function as one or more electrode elements for the electromyography electrode configuration.

9. The mouthpiece according to any one of claims 1 to 8, wherein the one or more oral contact elements comprises one or more brushing elements for brushing or cleaning at least one gum or tooth of the subject.

10. The mouthpiece according to any one of claims 1 to 9, wherein the one or more oral contact elements comprises a tooth alignment device that aligns or realigns the position of the subject's teeth.

11. A mouthpiece according to any one of claims 1 to 10, The sensing component of the mouthpiece receives one or more measured values ​​of the mechanical properties of the grip, To generate an indicator showing whether or not there is one or more abnormalities in the upper jaw and / or lower jaw of the subject, the received one or more measurements are processed. A processing configuration unit that performs the following: A mouthpiece system equipped with this feature.

12. The system further includes a memory for forming stored measurement values ​​by repeatedly storing the one or more measurement values ​​acquired by the sensing component, The mouthpiece system according to claim 11, wherein the processing unit processes the received one or more measured values ​​and the stored one or more measured values ​​in order to generate the indicator.

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