Patent Application
20170095204
The apparatus and methods relate to measuring mechanical forces on the human body, particularly for sports.
Mechanical forces involved with traumatic brain injury (TBI) and mild traumatic brain injury (mTBI) concussions in sports have been quantified using accelerometers embedded within helmets, mostly in football and hockey (e.g., Head Impact Telemetry or HITs system). However, there is a paucity of data regarding head impacts in non-helmeted sports, particularly at the youth level. This is in part due to unreliable results from wearable sensor technology. A sensor which sticks on the skin is uncomfortable, prone to inaccuracies and lack of precision, and potentially injurious to the athlete during an impact. Headband-based sensors tend to move/shift and do not provide reproducible results. Therefore, there is a need for development of improved configurations for “wearable” non-invasive sensors that can accurately and reliably quantify mechanical forces to the head to improve understanding of the primary injury profile of concussions and to aid in the early detection of concussive injuries in all contact sports (helmeted and non-helmeted).
The invention described herein comprises an oral apparatus for quantifying accelerations and velocities as experienced by a wearer's head. The oral apparatus can include a rigid or substantially rigid central component and a sensor, and it can couple the sensor to bony portions of the upper jaw and/or teeth. The measured accelerations and velocities may be specifically associated with the upper jaw (maxilla), as representative of the larger skull.
In some embodiments, the oral apparatus for coupling a sensor to bony portions of the upper jaw (maxilla) comprises a rigid central capture component and a sensor. The apparatus may further include a resilient outer component. In some embodiments, the rigid central component is a sensor capture component. In some embodiments, the rigid central capture component firmly couples the sensor to the maxilla and/or upper teeth. Some embodiments of the oral apparatus include aspects that allow the apparatus to apply forces with respect to the maxillary anatomy to better couple the sensor with the bony structures of the upper jaw. In some embodiments the rigid central component is custom-molded for the wearer's mouth. Such a custom mold may facilitate firmer coupling and stronger adherence, for example due to mechanical locking and surface tension associated with a layer of saliva between the sensor capture component and the user's upper jaw, maxilla, gums, or teeth.
Some embodiments of the oral apparatus include a plurality of sensor or other electronic components. Some embodiments include a power source. The component arrangement or configuration can allow for contact of the tongue with the central lingual surfaces of the upper jaw. A variety of attachments can be used to secure the oral apparatus against the upper jaw. Some embodiments can include a non-corrosive sealant to protect electronic components. Some embodiments include metal, acrylic, or other rigid materials.
Some oral apparatus embodiments further include a resilient outer component. The resilient component may be an overlay, and can be permanently adhered to the rigid central component or detachable. In some embodiments, the resilient overlay is a mouthguard.
The invention may also be embodied in a method for manufacturing a custom oral apparatus for coupling a sensor to bony portions of the upper jaw, comprising: making an inverse mold for player, setting a rigid or substantially rigid central capture component configuration in the mold, incorporating a sensor capture setting into the rigid or substantially rigid capture component, and connecting (e.g., by embedding) the sensor to the rigid central component or capture setting.
Aspects and features of the present disclosure are directed to an apparatus and method for measuring forces and impacts on the skull. Preliminary work from the iTAKL (Imaging Telemetry And Kinematic modeLing in youth football) study indicates that the “cumulative” impact exposure is much more predictive/informative about the child's clinical outcome and clinical state than the “individual” impacts alone. However, these results were obtained for football using a sensor instrumentation system which is useful only for football, embedded in a helmet. One of the main barriers to exploration and understanding of other sports is instrumentation systems. Preliminary and unpublished data from several groups as well as some published data indicates that skin-based or headband/skull cap based systems are subject to lag and acceleration measurements that are not representative of the skull motion. Mouthguard based systems, largely exploratory and prototype to this point, show some promise. However, preliminary and unpublished data as well as some published data from several groups has shown that soft (resilient) mouthguard materials with embedded sensors are prone to measurement errors associated with relative motion between the sensor and the adjacent anatomy. They are also prone to chewing by athletes, low durability, can interfere with speech, and cannot be worn in situations where an athlete does not want to wear a mouthguard. Moreover, they are often incompatible with developing mouthguard technology which needs to fit over a person's existing dentition. Therefore exploiting a wearable sensor that can accurately keep track of an athlete's head impact history but can reside in the mouth is useful for the identification and early detection of concussive injuries as well as subconcussive impact measurement and impact exposure measurement.
Quantification of head impacts in non-helmeted sports can serve as an early detection tool for concussive injuries and also allow for accurate quantification of subconcussive impact exposure. A major issue with measuring these data in non-helmeted sports is coupling with the skull, which is a separate innovation from advances in wireless sensors, etc. Optimized coupling allows more accurate measurements of the forces acting on the head (skull) and the resulting accelerations, which are important for understanding what is happening to the brain.
Surprisingly, placement of a sensor (having the technical requirements needed to accurately measure these data) in a rigid capture component which is coupled with bony portions of the upper jaw, as compared to other sensor configurations and/or positions associated with the skull, generated preliminary results suggesting more accurate velocity and acceleration measurements. Mouthguards designed with resilient but softer coupling components are used because soft materials are better for covering and protecting teeth. However, these can be associated with durability issues due to chewing by athletes, interference with speech and breathing, and also bulk when sensors are placed outside the teeth. The ability to speak well with a retainer style design instrumentation in the mouth is also an unexpected result, which is confirmed with preliminary data in children and adults. Although mouthguards provide close proximity to the dentition and the skull, embedding of sensor and electronic components in the soft material of a mouthguard is associated with an unexpected amount of sensor motion during impacts which creates some difficulties with accuracy and precision of acceleration measurements. The specific technique employed herein provided unexpectedly accurate measurements of velocity and acceleration associated with less oscillation and noise in the signal, providing better precision and accuracy.
In the interest of clarity, not all of the routine features of the examples described herein are shown and described. It will, of course, be appreciated that in the development of any such actual implementation, numerous implementation-specific decisions must be made in order to achieve the developer's specific goals, such as compliance with application and business-related constraints, and that these specific goals will vary from one implementation to another and from one developer to another.
Reference herein to an example or implementation means that a particular feature, structure, operation, or other characteristic described in connection with the example may be included in at least one implementation of the disclosure. The disclosure is not restricted to the particular examples or implementations described as such. The appearance of the phrases “in one example,” “in an example,” “in one implementation,” or “in an implementation,” or variations of the same in various places in the specification does not necessarily refer to the same example or implementation. Any particular feature, structure, operation, or other characteristic described in this specification in relation to one example or implementation may be combined with other features, structures, operations, or other characteristics described in respect of any other example or implementation.
Use herein of the word “or” is intended to cover inclusive and exclusive OR conditions. In other words, A or B or C includes any or all of the following alternative combinations as appropriate for a particular usage: A alone; B alone; C alone; A and B only; A and C only; B and C only; and all three of A and B and C.
As used herein, a “substantially rigid central component,” a “rigid central component” or a “central capture component” refers to a central unit of a hard or firm material in an oral apparatus. The component is made from a rigid material that couples well with the palate of the upper jaw, especially when a layer of saliva is present. The rigid central component comprises a sensor and optionally other components, such as electrical components.
As used herein, a “resilient outer component” or “resilient component” refers to an optional layer of a comparatively softer or more pliable material than the rigid component material. The resilient outer component can be an additional layer over the rigid central component.
As used herein, a “sensor capture space” refers to an open position in or on the rigid central component that is designed to accept a sensor. When the oral apparatus is in use, the sensor capture space is occupied by a sensor. The sensor capture space can be formed from a structural element that is separate from the rigid central component, or it can simply be an empty space within the rigid central component designed to accept the sensor.
Thus the invention comprises an apparatus, methods and systems for improved quantification of accelerations and velocities as experienced by a wearer's head. The measured accelerations and velocities may be specifically associated with the maxilla as representative of the larger skull. A strong coupling between the apparatus and the maxilla or upper jaw and/or upper teeth can provide better accuracy in detection of forces acting on the skull. The layer of saliva between the sensor capture component and the user's upper jaw, maxilla, or teeth facilitates stronger coupling via mechanical locking and surface tension.
In some embodiments, the invention includes a sensor or sensors to track the linear and rotational accelerations during a head impact (non-invasively). In some embodiments, a rigid central capture component facilitates coupling or attachment of the sensor to a bony aspect of the mouth such as the teeth or maxilla (or both). In some embodiments, the sensor is incorporated into an oral appliance or apparatus that can feature a rigid central component. In some embodiments, the oral apparatus is custom made for the wearer's mouth.
The oral apparatus can include various electronic components. Some embodiments include a sensor. Additional components related to the function of the sensor may also be included in the oral apparatus, or they may be remotely positioned to receive signals from the sensor. For example, a power source can be incorporated into a rigid central capture component, or into some other aspect of the oral apparatus. A wire may also be incorporated, for example to connect the sensor with the power source. Electronic components may be placed on a flexible substrate but embedded in the apparatus (or mounted on the apparatus). Or wireless technologies or other hardware or software may be employed. In some embodiments all electronic components may be placed together in or on the oral apparatus, while in other embodiments separate electronic components can occupy different capture spaces in (or on) the oral apparatus. For example, a sensor may be placed on one side of a rigid central component, while a power source is placed on the opposite side of the rigid central component, with a wire connecting the sensor to the power source. In some embodiments the design placement of elements in the capture component is intended to streamline the apparatus. That is, it may be desirable to reduce or minimize the profile, for example in a low-profile custom apparatus.
In one aspect, the invention comprises an apparatus or appliance with a rigid mechanical coupling between the teeth and a streamlined sensor. Coupling a sensor to the upper jaw (maxilla) can more accurately and precisely measure skull kinematics. A strong, rigid coupling mechanism, similar to a dental-appliance based approach (optionally using modified materials) can provide a better coupling. The coupling is facilitated by a rigid central component of the oral apparatus. The rigid central component may serve as a sensor capture component. An oral apparatus may further comprise a full or partial mouthguard.
Thus in some embodiments, the invention comprises an oral apparatus for rigidly coupling a sensor or plurality of sensors to the maxilla (bony upper jaw). The apparatus may be custom made for the mouth of a specific person (similar to a molded dental retainer).
In another aspect, the invention apparatus comprises a low profile to minimize discomfort and/or disruption of speech for the wearer. A low profile can also facilitate easier breathing for the user (as compared to a high profile mouthguard). Thus some embodiments comprise a smaller sensor than has previously been used in devices designed to measure impacts. A sensor may be smaller in any one dimension or multiple dimensions and may also be shaped optimally to minimize the profile of the apparatus in the mouth. As improvements in sensor technology allow for smaller sensors and better incorporation of wireless transmitters or other technologies, an oral apparatus can also have a lower profile and minimize interference with speech and other functions. Generally there are surface areas inside the mouth/palate for which contact with an oral apparatus can be minimized, so as to interfere less with speech, breathing, etc.
As sensor technology improves, sensors can be designed to occupy smaller spaces. Thus in some embodiments, the apparatus comprises a sensor that is shorter, narrower, and a good deal thinner than previously used sensors, so as to reduce the bulk of the oral appliance overall and allow more freedom and comfort.
The apparatus may further comprise a rigid central capture component, which serves as a custom unit for capturing the sensor. The central capture component can be a rigid material. The rigid central component of the oral apparatus may comprise at least a sensor. The rigid central component may partially or fully enclose the sensor in a capture space or provide an attachment point or mounting hardware for the sensor. The rigid central component may be formed in a variety of shapes, including custom-fit to an individual user's mouth, for example in a shape similar to a dental retainer configuration. The rigid central component may comprise acrylic or other rigid or non-resilient materials. For example, a rigid central component can comprise self-polymerizing acrylic. Thus, in some embodiments, the rigid central capture component may have custom dimensions to optimally fit a user's mouth.
In some embodiments of an oral apparatus, the sensor is incorporated by sliding or wedging it into a designated slot or space designed to accommodate the sensor. In some embodiments, a sensor capture space can be positioned laterally, to be coupled to the hard palate next to the upper rear teeth. In other embodiments, a sensor can be positioned centrally, anteriorly, or otherwise, to accommodate needs or preferences of the user.
The illustrative examples provided with this disclosure are given to introduce the reader to the general subject matter discussed here and are not intended to limit the scope of the disclosed concepts. The following sections describe various additional features and examples with reference to the drawings in which like numerals indicate like elements, and directional descriptions are used to describe the illustrative examples but, like the illustrative examples, should not be used to limit the present disclosure.
For example,
In this embodiment shown in
In other embodiments, an oral apparatus may include a hard or rigid central component, a sensor component incorporated into the rigid central component, and an outer component made of a more resilient material. The resilient outer component can be adhered or bonded to the rigid central component in a temporary or permanent manner.
A resilient outer component can be durable but resilient and may bond temporarily or permanently with a rigid central component. In some embodiments, a resilient outer component may be made of materials similar to traditional mouthguards, or it can be more or less resilient than traditional mouthguards. A stiffer mouthguard can discourage chewing which is detrimental to the sensor components. Lack of direct coverage with biting surface of teeth between resilient and nonresilient components can reduce inadvertent teeth impacts which lead to higher apparent accelerations and are thus associated with false impacts.
In some embodiments, a bite guard portion of the outer component may be made of various composite materials. A bite guard component may be an adhered or composite component or a piece that slips over like a separate sports mouthguard to cover the central rigid component of the apparatus. The oral apparatus generally may comprise hard and soft components for coupling but also for impact protection. In some embodiments, the outer component may include a small grab bar for the purpose of removing and inserting the mouthguard. In some embodiments, a grab bar can feature a ball clasp for firmer retention and to facilitate easier removal of the apparatus. A grab bar and ball clasp, or another mechanism to facilitate removal, can be necessary due to the strong coupling created between the apparatus and the upper jaw.
In some embodiments, a sensor may be mounted or placed in a medial position on the rigid central capture component. In other embodiments, a sensor may be in a lateral position on the rigid central component. Or a plurality of sensors may occupy various positions from medial to lateral on the rigid central component. The rigid central component may have a single cross-section profile (similar to
Various configurations are possible, for example to allow for removability or permanent placement of the sensor in the oral apparatus. In some oral apparatus embodiments, the sensor capture space may be altered such that it creates a spring loaded fit (slight interference fit) that grips and holds the sensor within the mouth, such that it does not fall out. Alternatively, the capture space may be altered so that it includes a tensioned soft component (similar to a rubber band) that holds the sensor in the hard part of the apparatus. Or other latching mechanisms are optional. In some embodiments a capture space can include a lip designed to prevent angular displacement and a tab designed to prevent distal migration. In some embodiments, a sensor may click into the capture space.
If the sensor does not need to be removable from the apparatus, it may be entirely encased within the rigid central component of the apparatus. Some oral apparatus embodiments can be disassembled and reassembled and therefore are reusable. Other embodiments can be considered disposable, for example if disassembly is needed but the oral apparatus is destroyed when it is disassembled. In some embodiments, an oral apparatus can be designed so that many of the surfaces adjacent to teeth are soft to avoid high frequency components from contact creating unrealistic accelerations in the sensor (also known as “clacking”).
Methods of using an oral apparatus include the user wearing the oral apparatus during sports or other activities. Methods for use also include data collection, which could be via wired download, wireless technologies, or other means. Power could be provided to the sensor via wired or inductive means, or other technologies.
Various configurations can also provide permanent or temporary coupling of a rigid central component to a resilient outer component. For example, an adhesive can be applied to permanently fix the two components together. Or the placement of a rigid central component into the mouth, followed by the further placement of a resilient outer component, can create a strong but detachable coupling by virtue of the saliva present in the mouth.
Embodiments of the oral apparatus can include a sealing aspect, for example to protect the electronic components from moisture and/or to prevent electronics from being impacted by flexing, biting, or chewing by the user. In some embodiments, the apparatus can be hermetically sealed with an additional hard non-corrosive material. In some embodiments, the electronic components can be housed in a capture space which is coated and sealed with a non-corrosive protective (e.g., silicone, acrylic) spray prior to embedding in (or otherwise attaching to) the rigid central capture component. Other methods for water-proofing with non-corrosive sealants are also possible.
In some embodiments, the apparatus may include a variety of resilient and/or non-resilient materials in a multitude of combinations. For example, a rigid central capture component of the apparatus may comprise metal, acrylic, or other non-resilient materials, while a surrounding portion of the apparatus may comprise ethylene vinyl acetate (EVA), gel compositions, or other resilient materials for a form and feel similar to a regular mouthguard.
Some embodiments can be prepared by injection molding (e.g., using an injection-molded elastomer). Other embodiments can be vacuum-formed or prepared using other technologies. Preferred embodiments avoid curing processes that involve heat (i.e., heat-cured materials), as the electronic components can be affected. In some cases, it can be desirable to limit the contact area with the palate to the surfaces anterior to the first molar. In some embodiments, a custom rigid central component can be compatible with existing commercially available so-called “boil-and-bite” mouthguards. That is, the rigid central component can be placed in the mouth prior to using the formative steps as instructed by the manufacturer for such mouthguards.
In some embodiments, a custom sensor capture component can provide optimal rigidity in an apparatus that applies consistent force to the sensor to maintain its position against the teeth. Pre-stressing the rigid capture component may provide a baseline force/dynamic reading when the mouth piece is in properly. In some embodiments, pre-stressing may also facilitate the ability of the apparatus to provide an alert if during the activity, the player stops wearing it properly, or if the sensor becomes damaged.
The sensor(s) may be capable of quantifying peak linear and rotational accelerations in three translational axes and about three rotational axes, similar to the HITS system in football, as well as complete time history of the linear and rotational accelerations measured about the three translational axes and three rotational axes. In some embodiments, for example where certain sports do not require a mouthpiece and the wearer desires reduced or no external visibility, an apparatus can be completely contained in the mouth such that it is not visible externally. Likewise, where a resilient outer component is included, the thickness and color of such an outer component can be varied to suit the activity and the wearer or user.
Reduced sensor size, streamlined shape, better placement, and configuration within a larger custom apparatus made of a combination of resilient and non-resilient materials can provide a more accurate measurement of the accelerations and velocities of the wearer's head.
The foregoing description of certain examples, including illustrated examples, has been presented only for the purpose of illustration and description and is not intended to be exhaustive or to limit the disclosure to the precise forms disclosed. Numerous modifications, adaptations, and uses thereof will be apparent to those skilled in the art without departing from the scope of the disclosure.
A small form factor sensor system is incorporated into a rigid central component, without an additional outer component, for head force and impact studies in sports not requiring mouth gear. The small form factor is shorter, narrower, and thinner than previous designs intended for use on the skin. Appliances are tested with variable placement of a mouth-based sensor into a mouthguard or other oral appliance so that it couples to the upper jaw, taking advantage of additional bonding strength provided by the layer of saliva between the appliance and the maxilla, for measurement of accelerations and velocities. A prototype is shown in
A small form factor sensor system is housed in a rigid central component, which is further overlayed with a resilient outer component, to simulate implementation into a mouthguard-based system for initial studies. This example can combine existing mouthguard systems with the rigid central component comprising a sensor. A prototype of this combination is shown in
The present application claims priority to U.S. Provisional Patent Application No. 62/189,820, filed Jul. 8, 2015. The disclosure of U.S. Provisional Patent Application No. 62/189,820 is hereby incorporated by reference in its entirety herein.
| Number | Date | Country | |
|---|---|---|---|
| 62189820 | Jul 2015 | US |
