1. Field of the Invention
This invention relates generally to wearable detection and alert electronics that double as protective gear for the prevention of injurious concussive forces. More particularly, this invention relates to a sports mouth guard with built-in on-board electronics for sensing lateral and rotational forces, transforming such data, and communicating estimated risk levels.
2. Description of Related Art
At all levels, athletics are seen as constructive methods of exercise. Sports encourage robust competition and health. Men and women, boys and girls participate in a variety of sports and athletic activities on levels ranging from the personal to informal pick-up game, to the more organized and professional levels. Given the variety of individuals involved, there is a diverse number and range of sports that we play. Some of these games involve high speed running. More physical sports may even involve purposeful or incidental contact between players and/or fixed objects. Such contact raises the potential for harm, including head and brain injury. While football is seen as the primary cause of concussions and long-term brain injury, it is less known that players in other sports also experience a high-risk for head injury and brain trauma. The incidence of concussions in girls' soccer is second only to football, and the combined incidence of concussions for boys' and girls' soccer nearly matches that of football.
Virtually any forceful impact to the head or body involves some risk level for brain trauma. Head injury may occur from collision with another player, an object, or even from a fall. Impact and rotational forces to the head are the leading causes for injury. Brain injury manifests as either neural, or most often, vascular injury within the head.
It is also widely known that the risk and severity of brain injury is related to the frequency and severity of repeated head trauma. A first blow to the head may modify the risk factors for future injury. For instance, a first incidental hit may lower the threshold for injury by a later fall to the ground. Repeated blows and impacts have a greater impact on the risk of head trauma. Even a minor blow, below the normal threshold for injury, may cause catastrophic brain injury if it follows an earlier risk-elevating first impact. Furthermore, biometric data (i.e. gender, age, height, weight, etc.) provide a separate method to determine impact threshold for predicting brain injury.
During play, head injury may manifest as a temporary impairment or loss of brain function; more severe concussions may cause a variety of physical, cognitive, and emotional symptoms. Unfortunately, some injuries cause no immediate or obvious observable symptoms, while even minor symptoms may be overlooked during the excitement of a game. The unknown consequences of prior impacts further exacerbates the risks, by failing to diagnose an injury and take corrective action.
Given the high-risk of injury in all sports and activities, from team sports to personal fitness programs, prior art solutions have not provided a solution that is flexible and precise enough for use in a myriad of routines. For instance, given the extent of electronics and monitoring systems required for head injury assessment tools, products to be worn by players often involve a skull cap or complete helmet. A helmet, while welcomed in permissive contact sports such as football, hockey and motocross, might be out-of-place for tennis, interfere with play for a sport such as soccer, and even presents an added danger on the rugby pitch.
Other products include multiple part pieces that are deployed on the player and can be cumbersome and/or complicated to employ. Additionally, other products do not provide a simple customizable single-piece portable solution.
It is therefore an object of the present invention to provide a single-piece mouth guard for identifying the risk factor for traumatic head injury.
It is a further object of the present invention to provide a diagnostic device that can indicate the potential for injury.
It is another object of the present invention to provide a personalizable risk detector that can reflect the risk factors based upon impact thresholds of a unique user. It is yet another object of the present invention to provide an instrumented mouth guard that can be widely deployed to assess and indicate injury risk.
All these and other objects of the present invention will be understood through the detailed description of the invention below.
The present invention is a mouth guard for detecting, measuring and indicating impacts and calculating the magnitude thereof combining such impact data with preprogrammed user biometric data to display risk factor. The mouth guard includes a mouthpiece to be worn by the user while participating in an activity or situation in which there may be sudden force or movement that may lead to concussive head trauma. The mouthpiece is powered by a power source, which may be a battery, preferably one embedded in the mouthpiece for powering the on-board electronics. The mouth guard also includes an accelerometer, for measuring linear forces, and a gyroscope, for measuring rotational forces, preferably within the mouthpiece. The power source powers a processing unit in the mouth piece that receives data from the sensors. The processing unit may conduct a calculation to determine if a significant impact has occurred. The processing unit may have hard-coded levels for predetermining impact thresholds, or may be programmed by an individual user for a personal threshold scheme. When the sensors detect an actionable impact force, the processing unit caused a display indicator, preferably a light source, preferably on the mouthpiece, to display a light to indicator to the user and others around that a significant force has been sustained. This light display may warn of potential future head trauma, current head trauma, and indicate for the user to cease the activity and seek a safer venue free from a high risk of future sudden forces.
The display indicator may be a light, preferably a low-power required light, such as a light-emitting diode (LED) that can display a solid and/or blinking light in one or more colors; preferably the LED is a three-color light, allowing display of a myriad of color wavelengths. The display indicator may be embedded in the mouthpiece, preferably at the front or lower front, or may be attached or extending outwardly in front of the mouth guard. The display indicator may use a single color to show that it is on and functioning to detect impacts, and another color or lighting scheme once an actionable force is detected. Blinking and solid lights of various colors may be employed. For instance, the system may use a first color, such as blue, and blink to indicate a minor impact has occurred. A second minor impact may show a solid blue light. At any time, a major impact may trigger a red light display. Other displays may be available.
The calculation of impact thresholds may be dependent on personal or universal data. For instance, a personalized mouth guard for specific aged person of a certain gender may set thresholds specific to that person. Preferably, there will be various categories for each of these biometrics, including a range of weight, years, etc. The mouth guard may record past hits and use these in calculating or altering the threshold(s). For instance, one minor impact may lower the threshold for the next minor impact.
Preferably, the mouth guard will be able to sense an array of forces, and include multiple impact force thresholds. For instance, the mouth guard can distinguish between a major force and a minor force. In addition, information of past recent impacts may open new thresholds, or lower the threshold for minor or major impacts. The processing unit may have an on-board memory for temporarily or permanently recording past impacts. The processing unit memory may be reset either at a given time period, i.e. recording data for 24 hours, and/or may allow for a reset button to erase some or all past impact data.
Furthermore, the mouth guard may include an on-board data input system, such as a button key for input of various factors, such as biometrics of age, weight, height, and gender. The biometric data may set the impact thresholds for future use. The mouth guard may come equipped with an ON button that may also perform a shut down or send the mouth guard to a low-power stand-by mode. The processing unit memory may be power dependent, such as typical random-access memory (RAM) or may include hard coded memory that will persist after the mouth guard is shut off or the power source fails, such as flash memory. To avoid power failure, the power source may be on-board and be rechargeable such as through an inductive power recharge.
The present invention also includes various methods for detection, calculation and display of potential head trauma, preferably by use of a mouth guard with on-board sensors and diagnostic logic. The mouth guard is worn by the user and placed alongside the jaw or preferably molar teeth within the mouth. The user can preset a threshold scheme by putting or selecting a preferable predetermined biometric profile, preferably via on-board input button. The preset can be used to focus the diagnostic logic on particular thresholds of rotational and/or linear forces.
The may include on/off switch to conserve battery. Preferably off position option will allow any required memory to store attributes, such as biometrics, or previous shock instances. On/off switch may include an On button when pressed a first time to activate mouth guard until battery death, and a standby mode to allow low power mode between uses. Mouth guard in stand-by mode, preferably includes accelerometer function to allow automatic on-switching when sensing a major impact, or just even a minor motion indicating future use.
While powered on, the sensors continually monitor forces. Once the sensor experiences a force beyond the preset threshold, the logic function communicates with the mouth guard to cause the display function to illuminate in a predetermined scheme, such as a lighting scheme, preferable for an on-board LED lights.
A more complete understanding of the present invention may be derived by referring to the detailed description when considered in connection with the following illustrative figures.
The present invention may be further described and understood by a limited set of preferred embodiments. However, the embodiments described herein are intended for illustrative purposes only, and not to preclude other devices or embodiments that embody the invention herein.
A preferred embodiment uses a mouth guard to be placed into a user's mouth. The mouth guard is self-sufficient as a small portable useful item that can be used in a myriad of occasions and activities. It is anticipated that the user will be engaged in some sort of athletic activity. The mouth guard will be equipped with electronics that allow monitoring or sensing of forces, both linear and rotational. Preset thresholds, preferably personalized for the particular user, of combined rotational and linear forces will indicate various risk factors for brain injury. Furthermore, certain repeated hits of various or same intensity will indicate risk. Certain hit, or hits, may modify the risk threshold for future hits in the near term. When operating, the mouth guard may indicate status “ON” by lighting up an on-board display. Should a minor impact occur, the display may indicate so, for instance by blinking light, or light of another color. Should a major impact occur, the display would indicate, for instance in an alternative lighting scheme, i.e. color. The thresholds may be preset, and on-board memory may recall prior recent incidents to modify impact thresholds without further manual intervention.
A preferred embodiment of the present invention includes a mouth guard with on-board electronics and signaling, sensors and display lights. An LED indicates status of the system including powered status and risk factors. The use of on-board display alleviates the necessity for a third party device or extra component as is necessary in many competitive products on the market.
A first preferred embodiment of the present invention is presented in
Body 15 encapsulates flex board 70 and all components thereon. Flex board 70 may be limited to certain components, flex board may come in multiple pieces, each piece carrying one or more component, or all electronic may be including on a single flexible circuit board, preferably encapsulated within the mouth guard. Microcontroller 16 provides on-board preprogrammed logic to collect data from sensors, preferably including gyroscope 60 and accelerometer 50, transmitted along embedded wires 71. It is preferable that microcontroller also contains preprogrammed thresholds, and various sets of impact threshold data. The sensors, accelerometer and gyroscope, may alternatively be positioned intermediately within the body, or padding element, or at an interface between a hard section connected to such body. Alternatively, electronic components may be connected by wire, electronics pods, etc. instead of a flexible circuit board.
Mouth guard may be formed in three basic steps. First, the flex-board and all components are arranged. Once arranged, the electronics may be set within a bottom mold. The bottom mold is then filled to complete the lower portion of the mouth guard with a material to form the body. Finally, an upper chamber mold may be used (preferably once the lower portion is flipped) to complete the body portion. Once completed, the body is then cleaned, and the action/power buttons identified and ensured for indentation. Alternatively, the body may be formed in a single injection mold around the electronics, or any other method as known in the art. The electronics may be protected by a casing or shield to avoid overheating during production encapsulation. The casing may adhere to, or otherwise be absorbed into the body to form a tight fit between the electronics and body. The electronics, particularly sensors, must adhere strictly to the body to allow for precise measurements of force on the body. Therefore, outside surface of the sensors may be exceptionally thick to expose to the body during formation/injection, or the surface may be scored, pocked, or otherwise detailed to allow for snug tight fit with body.
Referring to
Side shields 4 and 5 may provide housing for on-board electronics and may also be made of deformable plastic or rubber, or other material or composite. Alternatively, side shields will be made of a more permanent solid material for the protection of the electronics, and may or may not be coated with the deformable material for better user sensory feel along users inside cheeks. Interior top ridge 12 of front shield 3 includes protection and front shield 3 provides for encapsulation of display 80. Display 80 may be set right along edge 3A or more centered within front shield 3. Front shield 3 preferably includes indent 8 at the top to accommodate the superior labial frenulum. Interior top ridge 12 should be soft enough to accommodate contact with user's soft gum or gingiva. In this embodiment, the bulk of the electronics are positioned on the sides and front of the mouth guard to avoid the risk of a hard bite to damage components. Alternatively, the electronics can be placed in the front, or below with a more solid bite pad, or in combination of the two, or elsewhere.
Microcontroller 16 preferably collects information from sensors, performs necessary calculation, and when impact data received from sensors indicates a hit beyond a threshold, microcontroller 16 sends signal along wire 71 to display 80 to cause display 80 to demonstrate a predetermined indication scheme. Most preferably, the data is passed along in real time, although in some versions the data is stored in a memory and accessed at a later time. Memory is preferably stored in or accessed by the microcontroller, but may also be included in a separate element (not shown) such as RAM chip(s), flash memory, etc.
Preferably display 80 includes light-emitting diode display. Action button 10 may serve as an on/off toggle switch for the mouth guard electronics. When in the off-position, the mouth guard should still serve the standard purpose of a simple mouth guard, but not collect or handle impact data. Input button 20 allows user to communicate and send direct data in predetermined signal language to the microcontroller to accomplish certain tasks such as setting a predetermined biometric set of thresholds, reset the device, reset the timer, or in some embodiments, set the device to standby mode.
Various demographic modes are contemplated for customizable programming of risk factors/thresholds. For instance, there may be a high, low, and average threshold category for weight. There may also, or instead, be a gender category, and/or an age category, etc. In one embodiment, to program the mouth guard, press the action button for 10 seconds. The indicator will blink white to indicate that programming is now available. Press the action button once for low mode, twice for medium/average mode, and three times for high threshold mode (weight). Each time the button press is activated, the display may change colors, i.e. turn red briefly to indicate acceptance of a button press. Holding the button an additional at least 10 seconds, will set into a second mode to indicate gender, i.e. once for male, twice for female. When inputting a second demographic data set, it is contemplated that a second color will blink in display, i.e. blue blinking. When inputting the third demographic set, i.e. age, the same rules will apply for age categories, i.e. under 12, 13-16, 17-22, 23-35, and 35+. The mouth guard is sold with an instruction manual to allow for activation and customization, as well as instructions to reset the customizable category. Depending on the customized demographic data of a user, the impact thresholds will be set. In the embodiment with RAM memory requiring power to retain information, it is contemplated that a low power source will maintain demographic data in standby mode. Impact thresholds will be set to raise or lower thresholds for minor and major hits, and/or modify the risk curves based on gender or age data, for instance see curve modification indicated in
Further, preferably on flex board, is power source 40, preferably a battery. Power source 40 preferably provides power as direct current to microcontroller 16, display 80, and preferably sensors 60 and 70. Battery voltage may be below 10V and preferably between 1V and 6V. A voltage regulator (not shown) may be included to allow a single power source to provide power for all components.
Power source 40 may be a simple coin cell battery. Alternatively, power source 40 uses inductive or wireless charging. Inductive charging allows a rechargeable guard while still not having any exposed ports. In a preferred embodiment, there may be a complementary charging station, i.e. pad or mouth guard container case, with built in inductive capability.
In an alternative embodiment, antenna 71 may be included along flex board 70 to allow for remote transmission from or to on-board electronics. For instance, remote data or instructions may be programmed to the mouth guard from a remote component, such as over wireless frequency Wi-Fi, or other electro-magnetic transmission, to communicate data to the on-board micro-controller. Another use may be as a source of information to communicate impact data and risk factors to an off-board monitor.
Microcontroller 16 preferably includes built-in memory capacity. Preferably, a portion of the data in memory will be hard coded. Preferably the predetermined biometric scales and impact threshold, as well as the logic equations for one or all of the biometric sets will be hard-coded into memory. The memory may be able to hold, and selectively erase, historical impact data. It is envisioned that through, input button, the memory may be reset to erase short term memory of historical impacts. It is also contemplated that the memory may have on-board clock timer that will be used by microcontroller to selectively erase historical impact data more than a predetermined time length, i.e. more than 24 hours, while using more recent data to help determine if an impact threshold has been met.
Embodiment shown in
As seen in
Thresholds for linear forces for an average adult male may be set as high as 100 to 300 G forces. Preferably the sensor is able to handle and distinguish forces at this great shock within a 10-20 G range. Lower shocks with impact G force of less than 100 will preferably be selected within 5 G. While the thresholds are listed in this specification and on the Figures, they are in no way intended to limit the threshold settings ranges for practice of the present invention. As studies, data, and even personal preferences evolve, various threshold levels of acceleration and rotation may be programmed into an embodiment of the present invention.
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Preferably a single 3-color LED capable of RGB colors, including ability to combine to provide virtually all colors and white. As seen in
An alternative display configuration is shown in
An alternative embodiment is shown in
In a preferred embodiment as shown in
As seen in
While linear acceleration is not a significantly worse predictor of concussion than the combined probability of linear and rotational acceleration for concussion for all data sets, and rotational acceleration alone is associated with the smallest predictability, the purpose is for a predictive capability with a low false-positive issue. Such accurate information with low false-positive indications should lead to greater adoption and continuing use of the product. Using rotational acceleration as a brain injury predictor results in the greatest false positive rate associated with high true positive rates, while using the combined probability of concussion produces lowest false positive rates in all head impact telemetry data sets. Findings clearly indicate the a combination of both linear and rotational forces add value to the safety of the device, particularly among young athletes, who will resist sitting out of a game due to a false positive. The goal is to prevent players staying on the field with a concussion, while simultaneously encouraging product adoption and use.
For illustration, using a “red” display might indicate that the risk threshold is met. Using rotational acceleration measurement leads to more often “going red” and the player not having a concussion, while simultaneously having a more hits that previous would not have “gone red” head only linear acceleration been used, resulting in a concussion. Additionally, the curve may be modified to include threshold of a single source, i.e. accelerometer or gyroscope, as shown in the intersection of the probability lines of
Plotted out, risk function predicts probability of concussive impact. As shown in
Typical procedure of risk factors, impact thresholds, are demonstrated in
The mouth guard will preferably be powered by on-board power source, such as a battery. It is compatible with an embodiment with out on/off switch could have on switch such as broken capsule that may be a one-time use as switch. The capsule may contain a resistor that, when broken, serves to transmit electrical power and thereby power on the device. If using RAM for memory, a low-power standby mode may be used to conserve power. Action button, i.e. 10 or 20 shown in
Various LED Display settings are contemplated. For instance, when the device is on and actively sensing forces, the display may show a solid blue light. This will indicate that the device is on and functioning. Before activity ensues, each player may check the status of the device, and players with a non-functioning mouth guard may be identified. A minor hit may cause a different display, i.e. blinking red/green or alternative colors. The differing display may be reset, should the player chose to resume play by either waiting a set amount of time, i.e. 5 minutes, or by resetting via the on-board action button. During play, if there is a first concussive shock that triggers the alternate (lower) thresholds, this may be reset by action button, i.e. holding it down. This may be done when the thresholds are not properly set, to avoid false positives, or to allow multiple users to use the device. When a major hit occurs, a solid red display light might indicate high risk of injury and alert player to be removed from play. Further advances with multiple LED may allow for a more detailed display, i.e. not only using color, but also a letter, symbol, or word, or percentage risk factor, etc. may be displayed. This advanced multi-LED display can also be used effectively when initially setting risk thresholds manually for better interactivity.
It is preferable that the power source include an on-board battery, preferably Nickel-Cadmium as known in the art, to provide necessary voltage power for all components. It is contemplated that in a preferred embodiment, the battery will be built into and integrated encapsulated within the mouth guard. In an alternative embodiment, the on-board battery will be rechargeable. The recharge may be accomplished by a hidden pug in accessory access port, preferably behind a flap section of the mouth guard material (not shown). In another alternative embodiment, the battery can be recharged remotely by induction, preferably through a complementary pad docking station, or alternatively within a mouth guard case.
In an alternative preferred embodiment, there will be a complimentary display function on a remote display piece. In this instance, the on-board, or integrated built-in, antenna transmits a preferably electro-magnetic signal to the remote receiver which is in turn connected to the display. An example might be a remote WiFi receiver, such as a common handheld device, i.e. cellular phone, or WiFi handheld tablet, etc.
The alert and indication are part of the present invention. An LED display is contemplated as a preferred embodiment of the alert method, but future and more advance device could integrate alternative indication, such as: text, email, push-notification, sending data to an external app, and that app then alters the individual risk factors. The present invention has been described in the above illustrative embodiments, but should not be considered to be limited in any way therein.