U.S. patent application number 13/009580 was filed with the patent office on 2011-07-28 for mouth guard formation methods.
This patent application is currently assigned to X2IMPACT, INC.. Invention is credited to Christopher B. Doughty, Christoph Mack, Jed McCann, Robert Snook, Zachary Williams.
Application Number | 20110179851 13/009580 |
Document ID | / |
Family ID | 44307256 |
Filed Date | 2011-07-28 |
United States Patent
Application |
20110179851 |
Kind Code |
A1 |
Mack; Christoph ; et
al. |
July 28, 2011 |
MOUTH GUARD FORMATION METHODS
Abstract
A method for producing a mouth guard having an encapsulated
sensor module. The method includes vacuum forming a first sheet of
thermoplastic material using a mold to produce a first mouth guard
layer, attaching a sensor module to the first mouth guard layer
with a hot melt adhesive, vacuum forming a second sheet of
thermoplastic material over the sensor module to produce a second
mouth guard layer, storing a default threshold level in the sensor
module, and calibrating the sensor module to account for sensor
alignment. In an example embodiment, the first and second layers
are formed such that they define an open area that allows a user's
tongue to touch their upper palate after the mouth guard has been
inserted and such that the layers define a channel for accepting a
plurality of teeth, including the incisors of a user.
Inventors: |
Mack; Christoph; (Seattle,
WA) ; McCann; Jed; (Seattle, WA) ; Doughty;
Christopher B.; (Seattle, WA) ; Snook; Robert;
(Kenmore, WA) ; Williams; Zachary; (Seattle,
WA) |
Assignee: |
X2IMPACT, INC.
Seattle
WA
|
Family ID: |
44307256 |
Appl. No.: |
13/009580 |
Filed: |
January 19, 2011 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
|
61336429 |
Jan 22, 2010 |
|
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|
61409906 |
Nov 3, 2010 |
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Current U.S.
Class: |
73/1.79 ;
264/16 |
Current CPC
Class: |
A63B 2225/50 20130101;
G01L 1/26 20130101; A63B 71/085 20130101; A63B 2220/40 20130101;
A42B 3/046 20130101; A63B 2220/53 20130101; A63B 71/10
20130101 |
Class at
Publication: |
73/1.79 ;
264/16 |
International
Class: |
B29C 45/14 20060101
B29C045/14; A61C 5/14 20060101 A61C005/14; G01P 21/00 20060101
G01P021/00 |
Claims
1. A method comprising: forming a first mouth guard layer;
attaching a sensor module to the first mouth guard layer; and
encapsulating the sensor module between the first mouth guard layer
and a second mouth guard layer.
2. The method of claim 1, wherein the first mouth guard layer is
formed from ethylene vinyl acetate (EVA).
3. The method of claim 2, wherein the step of attaching the sensor
module to the first mouth guard layer is performed with an EVA
based hot melt adhesive.
4. The method of claim 1, further comprising storing a first
default threshold level in the sensor module.
5. The method of claim 4, further comprising storing a second
default threshold level in the sensor module.
6. The method of claim 1, further comprising calibrating the sensor
module to account for sensor alignment after the sensor module is
encapsulated.
7. The method of claim 6, wherein the step of calibration comprises
mounting the mouth guard on a turntable, rotating the turntable,
and recording information from the sensor module.
8. The method of claim 1, further comprising attaching a battery to
the first mouth guard layer, wherein the battery is also
encapsulated between the first and second mouth guard layers.
9. The method of claim 1, wherein the first and second layers are
formed such that they define an open area that allows a user's
tongue to touch an upper palate of the user after the mouth guard
has been inserted.
10. The method of claim 1, wherein the first and second layers are
formed such that they define a channel for accepting a plurality of
teeth, including the incisors of a user.
11. The method of claim 1, further comprising attaching a proximity
sensor to the first mouth guard layer, the proximity sensor also
being encapsulated between the first and second mouth guard
layers.
12. The method of claim 1, wherein the first layer is formed by
injection molding.
13. The method of claim 12, wherein the step of attaching the
sensor module and the step of encapsulating the sensor module are
performed substantially simultaneously with the step of forming the
first layer by injection molding.
Description
PRIORITY CLAIM
[0001] This application claims the benefit of U.S. Provisional
Application Ser. No. 61/336,429 filed Jan. 22, 2010 and U.S.
Provisional Application Ser. No. 61/409,906 filed Nov. 3, 2010, the
contents of both are hereby incorporated by reference.
BACKGROUND OF THE INVENTION
[0002] Participation in athletic activities is increasing at all
age levels. All participants may be potentially exposed to physical
harm as a result of such participation. Physical harm is more
likely to occur in athletic events where collisions between
participants frequently occur (e.g., football, field hockey,
lacrosse, ice hockey, soccer and the like). In connection with
sports such as football, hockey and lacrosse where deliberate
collisions between participants occur, the potential for physical
harm and/or injury is greatly enhanced. Approximately 300,000
athletes incur concussions in the United States each year. This may
be a conservative estimate because many minor head injuries go
unreported. Although most concussions occur in high-impact sports,
athletes in low-impact sports are not immune to mild traumatic
brain injury. Head injuries are caused by positive and negative
acceleration forces experienced by the brain and may result from
linear or rotational accelerations (or both). Both linear and
rotational accelerations are likely to be encountered by the head
at impact, damaging neural and vascular elements of the brain.
[0003] At the school level, school authorities have become
sensitive to the risk of injury to which student participants are
exposed, as well as to the liability of the school system when
injury results. Greater emphasis is being placed on proper training
and instruction to limit potential injuries. Some players engage in
reckless behavior on the athletic field or do not appreciate the
dangers to which they and others are subject by certain types of
impacts experienced in these athletic endeavors. Unfortunately, the
use of mouth guards and helmets does not prevent all injuries. One
particularly troublesome problem is when a student athlete
experiences a head injury, such as a concussion, of undetermined
severity even when wearing protective headgear. Physicians,
trainers, and coaches utilize standard neurological examinations
and cognitive questioning to determine the relative severity of the
impact and its effect on the athlete. Return to play decisions can
be strongly influenced by parents and coaches who want a star
player back on the field.
[0004] The same problem arises in professional sports where the
stakes are much higher for a team, where such a team loses a
valuable player due to the possibility of a severe head injury.
Recent medical data suggests that lateral and rotational forces
applied to the head and neck area (for example, flexion/extension,
lateral flexion, and axial rotation) are more responsible for
axonal nerve damage than previously thought. Previous medical
research had indicated that axially directed forces (such as spinal
compression forces) were primarily responsible for such
injuries.
[0005] Identifying the magnitude of acceleration that causes brain
injury may assist in prevention, diagnosis, and return-to-play
decisions. Most field measurements assess the acceleration
experienced by the player with accelerometers attached to the
helmet. The following show some attempts for measuring the impacts
to the skull and brain while the player is participating in a
sporting activity. U.S. Pat. No. 5,539,935, entitled "Sports
Helmet," issued on Jul. 30, 1996 and U.S. Pat. No. 5,621,922,
entitled "Sports Helmet Capable of Sensing Linear and Rotational
Forces," issued on Apr. 22, 1997 are examples of some of those
attempts. Both patents relate to impact sensors for linear and
rotational forces in a football helmet. These devices test the
impact to the skull of a player. If an athlete suffers a
concussion, for example, it will be possible to determine if the
relative magnitude of an impact is dangerously high relative to a
threshold to which each sensing device is adjusted, taking into
consideration the size and weight of the player.
[0006] Another attempt performs testing impact acceleration to the
head with an intraoral device which provides acceleration
information of the brain in various sports. Other attempts have
been made, however all these attempts can be costly to implement
and fail to provide full historical medical information to coaches,
trainers and medical professionals in real-time for dozens of
players at a time on one or more adjacent fields.
SUMMARY OF THE INVENTION
[0007] The present invention provides a wirelessly linked sports
impact sensing and reporting system. The system mainly includes one
or more player electronics modules, a sideline module, and a
remotely served and remotely accessible recording database module.
In one aspect of the invention, the player module is housed
independently within the volume of a set of an otherwise standard
mouth guard and chin strap assembly, the sideline module is housed
within the structure of an otherwise standard clipboard, and the
database module is accessible via a network, e.g., public or
private Internet.
[0008] In one version of the invention, the player module includes
a plurality of sensors capable of detecting impact events in
multiple axes, a battery, a data memory storage device, a
microprocessor and a LED status indicator array. Each player module
includes an RF transducer module and an antenna system, capable of
establishing a wireless mesh network for reporting the data
associated with an impact to the player. A zinc-air primary cell
battery is used with the present player module device, but may be
substituted by use of a lithium-polymer rechargeable battery or
similar.
[0009] In another version of the invention, the sideline module
includes a radio system capable of acting as a node on the wireless
network and receiving signals from any of the player modules
participating on the wireless mesh network in real-time. The
sideline module also includes a battery, a data memory storage
device, a microprocessor and a display capable of indicating impact
information per player on the wireless mesh network, severity of
impact, and recommended action in near real-time. The sideline
module also includes a loudspeaker capable of generating audible
alert tones to attract a coach's attention to incoming information
in real-time. A zinc-air primary cell battery is used with the
present player module device, but may be substituted by use of a
lithium-polymer rechargeable battery or similar.
[0010] In still another version of the invention, the database
module includes a database of players and associated impact data
arrangeable by name, team, date, severity of impact, frequency of
impact, and many other parameters. The database module is so
constructed to be accessible via the public or private data network
and is configured to provide various degrees of access to its
information contents. Access accounts may be configured according
to individual, team, division, league, physician, and administrator
levels. Each account will be granted access to the appropriate set
of data only, and password protection will ensure dissemination of
data only to authorized parties.
[0011] In yet an additional version of the invention, an example
system includes a mouth guard having a proximity sensor, an
accelerometer, a gyroscope, a processor in signal communication
with the accelerometer and gyroscope, a memory in data
communication with the processor, a transmitter in signal
communication with the processor, and a battery that provides power
to the processor, the memory, the accelerometer, and the gyroscope.
The processor is configured to allow power from a battery to flow
to the accelerometer and gyroscope when the proximity sensor
detects that the mouth guard has been inserted into a mouth. The
processor is also configured to instruct the transmitter to
transmit a signal if an acceleration above a predefined first
threshold is sensed and to continue transmitting if an acceleration
above a predefined second threshold is sensed before a first time
period is complete.
BRIEF DESCRIPTION OF THE DRAWINGS
[0012] Preferred and alternative embodiments of the present
invention are described in detail below with reference to the
following drawings:
[0013] FIG. 1 is a drawing showing an example of the invention in
context of a football player's head in profile, while wearing a
football helmet and the sensor-enabled mouth guard and chin strap
set, i.e. the player module;
[0014] FIG. 2 is a drawing showing the player module in context of
its positioning as worn within a human head;
[0015] FIG. 3 is a drawing in isometric view showing an example
mouth guard element of the player module and indicating the
positioning of embedded sensor elements and conductors;
[0016] FIG. 4 is a drawing in plan view showing the example mouth
guard element of the player module and indicating the positioning
of embedded sensor elements and conductors;
[0017] FIG. 5 is a drawing showing a side view of an example player
module, including the mouth guard element and chinstrap element,
and showing the relationship and connection between the two;
[0018] FIG. 6 is a drawing in isometric view showing the player
module, including mouth guard and chinstrap elements;
[0019] FIG. 7 is a drawing showing a portion of an example sideline
module embodied as a clipboard, with a display and input buttons in
the uppermost region;
[0020] FIG. 8 illustrates an exemplary system formed in accordance
with an embodiment of the present invention;
[0021] FIG. 9 is a perspective view of a mouth guard formed in
accordance with an embodiment of the invention;
[0022] FIG. 10 is a diagram of a sensing module in the mouth guard
shown in FIG. 9;
[0023] FIG. 11 is a top view of the mouth guard shown in FIG.
9;
[0024] FIG. 12 is a front view of the mouth guard shown in FIG.
9;
[0025] FIG. 13 is a side view of the mouth guard shown in FIG. 9;
and
[0026] FIG. 14 is a flowchart of a method of producing a mouth
guard having an encapsulated sensor module.
DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT
[0027] A preferred version of the present invention is a system for
the detection, measurement, characterization, transmission, and/or
reporting of events causing impact forces to be experienced by
players, for example football players. Thus, as shown in FIGS. 1
and 2, a preferred system is configured for use with a mouth guard
in a situation in which a player also uses a chinstrap and a
helmet. In other examples, various sensors may be incorporated into
other housings such as headbands, goggles, or other headgear. The
system conveys to an authority figure, preferably a coach or
trainer, useful information about the identity of the impacted
player, the severity of the impact, and suggested actions for
evaluating the condition of the player and for making decisions
about the players subsequent status vis-a-vis readiness to return
to play or referral to a physician's care.
[0028] An example of the player module includes an arrangement of a
plurality of low-cost, distributed sensors arranged between the
inside surface of the player shell and the bottom surface of a
padding elements that provide fit and cushioning to the player's
head. These sensors may alternatively be positioned intermediately
within the padding element, either at the interface of two
laminated elements, or by encapsulation directly within the mass of
the padding element. The sensors may also be situated within
cavities of the player or in the spaces between padding elements.
For example, these sensors may be MEMS type impact sensors, MEMS
accelerometers, miniature weighted cantilevers fitted with
miniature strain-gauge elements, piezoelectric membranes, or
Force-Sensitive-Resistors (FSR).
[0029] In one example, the sensors are incorporated into a sensor
unit that is configured as a mouth guard. Thus, as shown in FIGS. 3
and 4, various sensors may be encapsulated into the material formed
as a mouth guard. In the illustrated version, sensors are shown
being positioned at a lower surface of the mouth guard, beneath the
channel formed to receive a user's teeth. As also illustrated, the
exemplary mouth guard of FIGS. 3 and 4 includes a wire or tether,
preferably encapsulated in a protective covering, extending from a
forward portion of the mouth guard in order to send data to a base
unit or other device. In other versions, as described below, the
mouth guard includes an antenna for wirelessly transmitting the
data to an intermediate module or directly to a sideline receiving
unit.
[0030] The sensors employed in the player module are connected
electronically by means of wires or printed flex circuitry to an
electronics pod or other similar means, in some versions situated
within a primary shell of the player, and within the space
available between two or more padding elements. As illustrated in
FIGS. 5 and 6, in some versions the mouth guard sensors are
communicatively coupled to a receiving unit contained within a chin
strap or other such component external to the mouth. The chin strap
includes electronic components to transmit the data received from
the mouth guard and then pass it along to a sideline receiving
unit. Most preferably the data is passed along in real time,
although in some versions the data is stored in a memory and
downloaded at a later time.
[0031] The electronics pod (whether in the helmet, the mouth guard,
the chin strap, or another location) collects, processes,
evaluates, and if appropriate, transmits data pertaining to an
impact event via radio to one or more other participant nodes of
the wireless network to which the player module belongs. The
electronics pod contains electronic circuitry having components
such as a microprocessor, flash memory, radio module, antenna, and
status display LEDs. In the circuit's memory resides a database
lookup table for evaluation of sensor data and comparison to
combinations of impact levels that represent suspicious likelihood
of Mild Traumatic Brain Injury (MTBI) or concussion. The
electronics pod is also configured to monitor, evaluate, and/or
display system status information such as link to network, battery
charge status, and proper system functioning.
[0032] An example sideline module is an electronic data gathering
and display device incorporated into a portable enclosure that is
easy for a coach, trainer, or other such game official to carry,
consult, and interact with during the activities of the practice or
game. In one embodiment, the sideline module is embedded into the
topmost section of a clipboard, for example as illustrated in FIG.
7. Since the majority of coaches and trainers need to carry
clipboards anyway, this is perceived as the most natural and least
obtrusive way to provide impact information. However, many other
configurations of the sideline module are possible, including
building it into a wristband, a stopwatch-style fob with a neck
lanyard, a device similar to a mobile phone or pager, etc. The
sideline module may be in the form of any electronic receiving
device, including laptop computers, mobile phones, or any other
such device configurable to receive wireless information. Moreover,
the sideline module is described as receiving information directly
from the sensor unit, although in some versions of the invention
the sensor module may pass its data to an intermediate server or
other device which then forwards the information to the sideline
module.
[0033] The sideline module includes electronic components arranged
into a circuit that allows for participation in the wireless mesh
network established by a set of player modules, and specifically
for the receipt of data transmissions from the player modules, and
subsequently the display of impact event information on a visual
display in real-time. The sideline module also produces audible and
vibratory alert signals to call attention to the arrival of new
data messages in real-time, which are disabled by manual conscious
intervention of the coach or trainer, indicating acknowledgement of
receipt of impact event data.
[0034] In one embodiment, the sideline module performs the
classification of incoming impact data into one of three
categories, indicating differing levels of concern and differing
levels of urgency of response. The system employs a "GREEN LIGHT"
"YELLOW LIGHT" and "RED LIGHT" system, in which a GREEN LIGHT
status indicates the absence of significant impact events for a
given player, a YELLOW LIGHT indicates the need for immediate
sideline evaluation of the player, and RED LIGHT indicates a severe
enough impact that the player be removed from play and referred to
a physician immediately.
[0035] Upon registering a YELLOW LIGHT impact event, and upon
subsequent acknowledgement of receipt of the message by the coach
or trainer, the sideline module, in one embodiment, leads the coach
or trainer through a simple protocol for evaluation of the player's
condition. Through answering a series of simple Yes or No
questions, the sideline module guides the coach or trainer to a
limited number of possible suggested actions. These potential
outcomes could include immediate referral to a physician for
further examination, or a period of bench time observation followed
by a secondary guided evaluation before allowing the player to
return to play.
[0036] In one embodiment, a durable record of data transactions is
received in real-time and is kept independently of the sideline
module or modules. Such a database provides players, parents,
coaches, trainers, administrators and other stakeholders access to
a record of what impact event information was conveyed, when, to
whom and about which player. The sideline module is equipped with a
wide area network radio module for transmission of a record of all
data transactions on the system with time stamp and a record of the
actions by coaches and content of player evaluations. A standard 1
way or 2 way pager system is used, which has the benefit of being
inexpensive and nearly ubiquitous in availability throughout much
of the world. Alternatives to pager radio systems are cellular
radios of various kinds and other wide area network wireless
connections. The knowledge that this information will be available
to stakeholders provides accountability to all stakeholders in the
health and well being of the player.
[0037] In one embodiment, the database is populated by an automatic
interface to the wide area radio network accessed by the sideline
network, and is accessible to stakeholders by means of internet
based applications, equipped with password protected hierarchical
account structures. The system provides parents the ability to log
on to their account and review the totality of impact event data
and the record of coach responses associated with their player.
[0038] Each player module at the start of each season maps its
unique identifier code to a particular player's name and number. It
is possible that during the course of events players might
accidentally wear the wrong player number and potentially cause
confusion by users of the system. It is for this reason that each
player module has, in one embodiment, a visual indicator array of
LEDs, which will repeatedly flash a visible signal in case of
transmission of an impact event of concern. A yellow light flashes
to indicate the transmission of a YELLOW LIGHT event, and a red
light flashes to indicate the transmission of a RED LIGHT event.
When the player is called to the sidelines for evaluation, the
coach or trainer can disable the flashing indicator light by
simultaneously depressing a button on the player module and a
button on the sideline module. This provides positive confirmation
that the player who sustained the reported impact is in fact the
player being evaluated by the coach or trainer.
[0039] FIG. 8 illustrates an exemplary system 100 that performs
aggregation of head-acceleration information received from a
plurality of sensor units 102 and makes the acceleration
information available to relevant parties. The sensor units are the
mouth guards or other components as described above that
incorporate one or more sensors. The system 100 includes a base
unit 104 that is in wireless communication with one or more sensor
units 102 and is optionally in wired or wireless communication with
one or more devices 106. As described above, the sensor units may
be directly coupled to the base unit, or may alternatively pass
their data to the base unit indirectly, through a server, network,
or other electronic device. The base unit 104 includes a processor
112, a user interface 114, local memory 116, and a communication
component 120. The base unit 104 receives acceleration information
wirelessly from each of the sensor units 102 and optionally makes
that data available to the one or more additional devices 106.
[0040] In some versions, the base unit 104 or any of the devices
106 are in wired or wireless connection with a medical system 124
over a public or private data network 108. The medical system 124
receives acceleration, identification or other information from the
base unit 104 or the devices 106 for analysis with regard to stored
athlete information and/or storage into a database 126.
[0041] FIG. 9 is a perspective view of a mouth guard 400 formed in
accordance with an example embodiment of the invention. The mouth
guard 400 is an example of one of the types of sensor units 102
that may be used with the system 100 shown in FIG. 8. The mouth
guard 400 defines a channel 402 for receiving a plurality of teeth
of a user. In an example embodiment, the channel 402 is structured
such that it covers teeth that include the incisors of a user when
the mouthpiece is inserted. The mouth guard 400 also defines an
open area 404 that allows the user's tongue to touch their upper
palate after the mouth guard 400 has been inserted. This allows the
user to maintain verbal communication with others without the
additional effort required with other types of mouth guards having
a solid portion that covers the upper palate.
[0042] The mouth guard 400 also includes a first battery 406 and a
second battery 408. The batteries 406, 408 are electrically
connected to a sensing module 410 and may be recharged with a
wireless battery charger in some embodiments. In an example
embodiment, the sensing module 410 is located at a front portion of
the mouth guard 400 that covers the incisors of a user when the
mouth guard 400 is inserted. However, the sensing module 410 may be
located in a different area of the mouth guard in other
embodiments. The sensing module 410 includes a three axis
accelerometer 412 that senses acceleration along three orthogonal
linear axes, a three axis gyroscope 414, and an electronics module
416 that are attached to a flex-printed circuit 418 (FPC) in an
example embodiment. The accelerometer 412 preferably senses
accelerations of at least 90 g and the gyroscope is preferably
sensitive to at least 6000 degrees per second. In a preferred
version, the electronic components described above are all
positioned along an outer portion of the mouth guard where they
will be located outside the teeth of the user and encapsulated
within the material forming the mouth guard.
[0043] In accordance with preferred implementations of the
invention, the accelerometer and gyroscope sense attributes of the
environment of the mouth guard or other sensor unit 102 to
determine a rate of acceleration of the sensor unit and an
orientation of the sensor unit over time. Thus, by matching the
acceleration and the position, the sensor unit is able to determine
not only the fact of an event causing acceleration of a particular
magnitude, but also a direction of the acceleration based on the
direction of movement of the sensor unit. These data can be
coupled, either in the sensor unit, the base unit, or another
device, to calculate a vector representative of a combined
direction and magnitude of the acceleration experienced by the
sensor unit. In some instances the sensed event may be determined
to be a straight line vector, while in other instances the motion
of the sensor unit may be along an arc or otherwise rotational.
[0044] Although the sensing module 410 includes the three axis
accelerometer 412 and the three axis gyroscope 414 in this
embodiment, other sensor combinations may be used in other
embodiments. For example, a two axis gyroscope in combination with
a single axis gyroscope may be used rather than a three axis
gyroscope, or additional linear accelerometers may be used rather
than a gyroscope. In accordance with preferred implementations of
the invention, however, the sensing module includes components that
are capable of sensing both acceleration and position of the sensor
unit.
[0045] A proximity sensor 420 is also in signal communication with
the electronics module 416. The proximity sensor 420 includes a
capacitive touch sensor in an example embodiment, but may include
other types of sensors in other embodiments such as a temperature
sensor or an optical sensor, for example. Most preferably, the
proximity sensor is configured to indicate whether the mouth guard
or other sensor unit is positioned in the player's mouth or
otherwise engaged and in use. The sensing module 410 may also be
configured as an application specific integrated circuit (ASIC) in
some embodiments.
[0046] FIG. 10 is a diagram of the sensing module 410 showing
additional detail for the electronics module 416 in accordance with
an example embodiment of the invention. The electronics module 416
includes a processor 440 in data communication with a memory 442.
The electronics module 416 also includes a transceiver 444 in
signal communication with the processor 440.
[0047] In an example embodiment, the accelerometer block 412
includes three single axis accelerometers such as model AD22283
produced by Analog Devices, Inc. The gyroscope block 414 includes a
dual axis sensor such as model LPR5150AL produced by
STMicroelectronics and a single axis sensor such as model LY5150ALH
produced by STMicroelectronics. The processor block 440 includes a
microcontroller such as model MSP430F5522 produced by Texas
Instruments, the memory block 442 includes a memory module such as
model M25P32 produced by Numonyx, and the transceiver block 444
includes a transceiver such as model CC1101 produced by Texas
Instruments in an example embodiment. However, different components
may be used in other embodiments. For example, piezoelectric and/or
piezoresistor based sensors may be used in some embodiments.
[0048] FIGS. 11-13 show additional views of the mouth guard 400
shown in FIG. 9. FIG. 11 is a top view of the mouth guard 400. FIG.
12 is a front view of the mouth guard 400. FIG. 13 is a side view
of the mouth guard 400. As best seen in FIG. 11, the electronic
components are positioned on an outer portion of the channel formed
for receiving the teeth of the user.
[0049] FIG. 14 is a flowchart of a method 800 of producing a mouth
guard having an encapsulated sensor module. First, at a block 802,
a first sheet of ethylene vinyl acetate (EVA) is vacuum formed
using a mold to produce a first mouth guard layer. Next, at a block
804, a sensor module is attached to the first mouth guard layer
with an EVA based hot melt adhesive. In an example embodiment, the
sensor module is configured in a similar manner to the sensing
module 410 described with respect to FIGS. 9 and 10 and at least
one battery such as the batteries 406, 408 and a proximity sensor
such as sensor 420 are also attached to the first mouth guard
layer. Then, at a block 806, a second sheet of EVA is vacuum formed
over the sensor module to produce a second mouth guard layer. This
encapsulates the sensor module, the battery, and the proximity
sensor between the first and second mouth guard layers in an
example embodiment.
[0050] In alternate versions of the invention, different molding
techniques are used. Thus, for example, the sensors may be mounted
in position while an injection molding process forms the mouth
guard about the sensors and other components.
[0051] Next, at a block 808, a first default threshold level and a
second default threshold level are stored in the sensor module. The
default levels may be stored in a memory in data communication with
a processor in the sensing module, for example as described above.
The default levels are set such that the processor will instruct a
transceiver to transmit a signal to a base unit if an accelerometer
in the sensor module detects an acceleration greater than the first
default level and will further instruct the transceiver to continue
transmitting the signal if an acceleration greater than the second
default level is detected during a predefined time period after the
transceiver begins transmitting.
[0052] Next, at a block 810, the sensor module is calibrated to
account for sensor alignment. Depending on the sensor used and the
method of incorporation into the mouth guard, the sensors may or
may not be perfectly oriented with the desired axes of alignment.
In various versions of the invention, the mouth guard may include
one or more sensors such as included within a module 410 that may
include a three axis accelerometer 412 and gyroscope 414. Other
versions may have different individual sensors, though in most
preferred versions the sensors include an axial alignment to detect
impacts along one or more specific axes. It is useful to be able to
associate the axes of the sensors with those of the mouth guard for
better measurement and analysis of the data. Accordingly, the mouth
guard is preferably calibrated for alignment.
[0053] In one version, the calibration step includes use of a
turntable mounted for rotation about a spindle or other central
axis. The mouth guard is placed on the turntable in a known
orientation. The turntable is then rotated at a known speed,
thereby imparting centripetal forces on the mouth guard and sensors
that can be detected as acceleration or g forces. A receiver can
monitor the movement detected by the sensors and compare the
detected vectors against the true vectors applied by the turntable
in order to calibrate the mouth guard. The calibration adjustments
may be recorded in a table in a computer or server as desired so
that it can adjust sensed forces to account for the calibration.
Alternatively, the embedded memory in the mouth guard may be
programmed to store the calibration data for adjustment of sensed
information locally at the mouth guard. Most preferably the mouth
guard is calibrated in this fashion across three axes.
[0054] Although the steps above are described as occurring
sequentially in a particular order, it should be understood that
they may occur in a different order and that a subset of the steps
or additional steps may be present in some embodiments.
Additionally, enclosure of the sensor module in the mouth guard may
be performed in another manner such as by attaching the sensor
module to the second EVA sheet rather than to the first mouth guard
layer and then vacuum forming the combined sheet and sensor module
to the first mouth guard layer, for example.
[0055] While the preferred embodiment of the invention has been
illustrated and described, as noted above, many changes can be made
without departing from the spirit and scope of the invention. For
example, although the mouth guard is described as being produced
with sheets of EVA and an EVA based adhesive, other types of
materials and adhesives may be used in other embodiments.
Accordingly, the scope of the invention is not limited by the
disclosure of the preferred embodiment. Instead, the invention
should be determined entirely by reference to the claims that
follow.
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