Note : Les descriptions sont présentées dans la langue officielle dans laquelle elles ont été soumises.
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MAXILLARY AND MANDIBULAR DEVICES, CONTROLLER STATION
RELA __________________________________ IED APPLICATIONS
[0001] This application is a continuation-in-part of U.S.
Application No. 16/822,993, filed
March 18, 2020, which is a continuation-in-part of U.S. Application No.
16/784,758, filed
February 7, 2020, which claims the benefit of U.S. Provisional Patent
Application No.
62/936,032, filed November 15, 2019, the entirety of which are both
incorporated herein by
reference.
TECHNICAL FIELD
[0002] This application relates to maxillary and mandibular devices
and methods of
treating and/or diagnosing medical disorders and/or medical conditions using
the same, more
particularly, to a maxillary device that can provide electrical impulse
stimulation to the
muscle of the soft pallet and hard pallet, and/or the lateral pterygoid
muscles to move the jaw
forward.
BACKGROUND
[0003] Many individuals suffer from disordered breathing while
asleep. Some example
disorders include obstructive sleep apnea (OSA), snoring, snore arousals,
sleep-related
hypoxia, and other conditions dependent on and caused by snoring or OSA. OSA
is a
condition in which sleep is repeatedly interrupted by an inability to breathe,
which is
typically a results of intermittent obstruction of the airway by the tongue
and a general
relaxation of the muscles which stabilize the upper airway segment, which can
cause a lack
of oxygen, snoring, cardiovascular and neurological complications, such as
sleep-induced
hypertension, heart attacks, cardiac arrythmias, strokes, Alzheimer's disease,
hypertension,
sleep-induced hypertension, diabetes, weight gain, and depression.
[0004] Mandibular repositioning devices have been FDA-approved and used as a
treatment for sleep apnea when treatment by a CPAP (Continuous Positive Airway
Pressure)
machine has been ineffective for the particular patient, or when a patient is
unable to tolerate
a PAP (Positive Airway Pressure) device. Most oral appliances on the market
have only been
able to control approximately 50% of sleep apnea events. There are a large
number of
patients that are intolerant to PAP devices, some due to the PAP device or the
mask but most
due to excessive high air pressure that may be medically recommended for
keeping an open
airway. Repeated adjustments have to be performed in attempts to make
intolerant patients
tolerate a PAP device, most of which require manual adjustments by a
professional or require
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repeated sleep studies after a sleep study. Since a large number of patients
with OSA have
thus remained untreated due to various reasons, there is a serious need for a
new method of
treatment that can maintain an open airway during sleep using a combination of
j aw
stabilization and simultaneous advancement of the jaw and tongue, i.e., a
dynamic
mandibular and lingual repositioning device as disclosed herein.
100051 There is also a need for such a device that can continuously
learn (artificial
intelligence) a particular persons sleep-related breathing, blood pressure,
heart rate and
rhythm, body positioning, depth of sleep and oxygen levels, silent or
symptomatic acid reflux
during sleep and amount of bruxism (teeth grinding) over periods of days,
months and even
years while the person sleeps at home or elsewhere, thereby removing the need
of performing
expensive sleep studies. While using such a device it should lend itself to
continuously
making automatic, guided, algorithmic (SERVO) adjustments to the treatment of
these
medical conditions and continuously providing information related to
improvement in
oxygen levels, breathing, blood pressure, heart rate and rhythm, acid reflux
and bruxism and
sleep depth, quantity and quality to the controller, cloud-based server system
and to the
treating physician, providing a lifelong (life of the device) safe open airway
with reliable
normalization of oxygen, breathing and sleep.
SUNEVIARY
100061 In all aspects, mandibular repositioning devices are
disclosed that have a maxillary
piece with a tooth covering having a driver flange protruding laterally
outward on a right side
proximate a backmost teeth mold and/or on a left side proximate a backmost
teeth mold and a
mandibular piece with a tooth covering having a protrusive flange extending
cranially
therefrom positioned to have a posterior side engaged with the anterior side
of each driver
flange. Each driver flange has an anterior side with a convex curvature and
each protrusive
flange has a posterior side with a concave-to-convex curvature from its base
toward its most
cranial point. The posterior side of each protrusive flange has a convex
portion of the
concave-to convex curvature engaged with the convex curvature of the driver
flange in a rest
position. Downward movement of the mandibular piece moves the convex portion
of the
posterior side of the protrusive flange along the convex curvature of the
driver flange,
thereby moving a user's mandible forward. In all embodiment, the convex
portion of the
curvature of the protrusive flange can engage with the convex curvature of the
driver flange
at a point that is two thirds of the height of the driver flange
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100071 In all embodiments, the protrusive flange can be removably
replaceably attached to
the mandibular piece and/or the driver flange can be removably replaceably
attached to the
maxillary piece. The driver flange has a base that is positioned on the
maxillary piece.
100081 In all embodiments, the protrusive flange and the driver
flange can be positioned to
place an engagement point of the convex portion of the concave-to convex
curvature with the
convex curvature of the driver flange at a midpoint length that is at half the
lineal distance
from a vertical axis at the front of the incisors (incisor vertical axis) to a
point on a parallel
vertical axis aligned with the temporo-mandibular joint (TMJ) at rest (TMJ
vertical axis). The
majority of the convex curvature of the driver flange is defined by an arc
having a center at a
point on the TMJ vertical axis that is one third of the height of the driver
flange measured
from the horizontal dental axis and has a radius length equal to the midpoint
length The
convex curvature of the driver flange has a back-cut most proximate a base of
the driver
flange. The back-cut portion is determined by an arc from a center point
positioned on the
TMJ vertical axis at two thirds of the height of the driver flange measured
from the horizontal
dental axis. A convex curvature of the convex portion of the protrusive flange
is defined by
an arc having a center at a point on the incisor vertical axis that is at two
thirds the height of
driver flange measured from the horizontal dental axis and has a radius length
equal to the
midpoint length. A concave curvature of the concave portion of the protrusive
flange is
defined by an arc drawn from a point on the TMJ vertical axis that is one
third of the height
of the driver flange measured from the horizontal dental axis and has a radius
length equal to
the midpoint length.
100091 In all embodiments, the anterior side of the protrusive
flange has a convex
curvature.
100101 In another aspect, the mandibular repositioning devices have
a maxillary piece that
includes a housing proximate one or both of a left molar portion and a right
molar portion,
wherein each housing encloses a power source electrically connected to a motor
and to an on-
board circuit board and has a driver operatively connected to the motor and to
the driver
flange for anterior and posterior movements of the driver flange, and the
mandibular piece
has a housing proximate one or both of a left molar portion and a right molar
portion and the
mandibular device has a laterally inward extending protrusion extending from
each housing
toward the tongue at a position proximate a lingual muscle of the tongue,
wherein each
housing of the mandibular piece encloses a power source electrically connected
to an on-
board circuit board which is in electrical communication with one or more
sensors enclosed
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within the laterally inward extending protrusion, or the maxillary piece has a
palate housing
portion and/or a buccal housing portion extending from each housing thereof
and each palate
housing portion and buccal housing portion encloses therein a power source
electrically
connected to an on-board circuit board which is in electrical communication
with one or
more sensors. The one or more sensors are selected from the group consisting
of a pulse
oxygen sensor, a vibration and airflow sensor, a pH sensor, a doppler
ultrasound sensor, an
M-Mode ultrasound sensor, a 2D ultrasound sensor, 3D ultrasound sensor, a
pressure plate
sensor for measuring bruxism, a pulse transit time sensor, EEG, EMG, EOG,
lactic acid
sensor, hygroscopic/hydration sensor, video and audio recording, non-invasive
ventilation
systolic/diastolic blood pressure sensor, a carotid doppler (trans-oral)
sensor, and a cardiac
trans-oral echocardiography sensor.
100111 In one embodiment, when the mandibular piece houses the one or more
sensors,
each on-board circuit within housings of the maxillary piece include a
receiver and a
microprocessor having an instruction stored in nontransitory memory to
activate each motor
and each on-board circuit board within housings of the mandibular piece
include a receiver, a
transmitter, and a microprocessor having an instruction in nontransitory
memory to activate
each motor within housing of the maxillary piece simultaneously based on data
received from
the one or more sensors. In another embodiment, when the maxillary piece
houses the one or
more sensors, each on-board circuit within the housings of the maxillary piece
include a
microprocessor having an instruction in nontransitory memory to activate each
motor
simultaneously based on data received from the one or more sensors.
100121 In another aspect, the mandibular repositioning devices have
a mandibular piece
that has a motor housed within each housing thereof and has a cranial-to-
caudal driver
operatively connected to each motor. The cranial-to-caudal driver is
operatively engaged with
the maxillary piece for cranial and caudal adjustment of the device from
instructions stored in
the nontransitory memory of the on-board circuit board within each housing of
the
mandibular piece based on data received from the one or more sensors. In some
embodiments, one or both of the laterally inward extending protrusion house an
electrode
operatively connected to the on-board circuit board and the power source of
the housing from
which laterally inward extending protrusion extends; wherein the on-board
circuit board
within each housings of the mandibular piece include instructions that based
on data from the
one or more sensors activates each motor within housing of the maxillary piece
and the
electrode simultaneously or sequentially as needed to open an airway of a
user. The
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mandibular piece has a motor housed within each housing thereof and has a
cranial-to-caudal
driver operatively connected to each motor. The cranial-to-caudal driver is
operatively
engaged with the maxillary piece for cranial and caudal adjustment of the
device from
instructions stored in the nontransitory memory of the on-board circuit board
within each
housing of the mandibular piece based on data received from the one or more
sensors.
100131 In another aspect, the mandibular repositioning devices have
a mandibular piece
that has a housing proximate one or both of a left molar portion and a right
molar portion and
the mandibular device has a laterally inward extending protrusion extending
from each
housing toward the tongue at a position proximate a lingual muscle of the
tongue, wherein
each housing of the mandibular piece encloses a power source electrically
connected to an
on-board circuit board which is in electrical communication with one or more
sensors and
with an electrode, and wherein the on-board circuit board within each housings
include
instructions that based on data from the one or more sensors activates each
electrode as
needed to open an airway of a user.
100141 In yet another aspect, the mandibular repositioning devices
have a mandibular
piece that has a housing proximate one or both of a left molar portion and a
right molar
portion and the mandibular device has a laterally inward extending protrusion
extending from
each housing toward the tongue at a position proximate a lingual muscle of the
tongue,
wherein each housing of the mandibular piece encloses a power source
electrically connected
to an on-board circuit board and to a motor, wherein the on-board circuit
board is in electrical
communication with one or more sensors enclosed within the laterally inward
extending
protrusion and the motor has a cranial-to-caudal driver operatively connected
thereto. The
cranial-to-caudal driver is operatively engaged with the maxillary piece for
cranial and caudal
adjustment of the device from instructions stored in the nontransitory memory
of the on-
board circuit board based on data received from the one or more sensors.
100151 In all aspects, the tooth covering of each of the maxillary
piece and the mandibular
piece connects to or covers one or more teeth of a user or is a full bite mold
of a user's teeth.
100161 In all aspects, each housing of the mandibular piece and of
the maxillary piece is
removably attachable thereto.
100171 In yet another aspect, the mandibular repositioning devices
have a maxillary piece
that has a palate housing portion and/or a buccal housing portion extending
from one or both
of a left molar portion and a right molar portion, wherein each of the palate
housing portion
and buccal housing portion enclose a power source electrically connected to an
on-board
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circuit board which is in electrical communication with one or more sensors
and with an
electrode, and wherein the on-board circuit board within each housings include
instructions
stored in nontransitory memory that based on data from the one or more sensors
activates
each electrode to stimulate a preselected muscle that is in contact with the
palate housing
portion or buccal housing portion.
BRIEF DESCRIPTION OF THE DRAWINGS
100181 Many aspects of the disclosure can be better understood with
reference to the
following drawings. The components in the drawings are not necessarily to
scale, emphasis
instead being placed upon clearly illustrating the principles of the present
system.
100191 FIG. 1 is a left-side view of a first embodiment of a
mandibular lingual
repositioning device.
100201 FIG. 2 is a side, perspective view of the mandibular piece
of the mandibular
lingual repositioning device of FIG. 1.
100211 FIG. 3 is a side, perspective view of the maxillary piece as
it articulates and fits
with the mandibular lingual repositioning device of FIG. 1.
100221 FIG. 4 is a cross-sectional view of the mandibular lingual
repositioning device
along line 4-4 in FIG. 1.
100231 FIG. 5 is front, perspective view of a controller station
for use with the devices
disclosed herein.
100241 FIG. 6 is an enlarged view of the left movement mechanism of the
mandibular
lingual repositioning device of FIG. 1.
100251 FIG. 7 is a an enlarged view of an alternate embodiment of the left
movement
mechanism of the mandibular lingual repositioning device.
100261 FIG. 8 is an enlarged side view of an embodiment of a
protrusive flange.
100271 FIG. 9 is a side, perspective view of an embodiment of a
mandibular device having
at least a stimulator electrode therein.
100281 FIG. 10 is an enlarged cross-sectional view of the
mandibular device along line 9-9
in FIG. 9.
100291 FIG. 11 is a cross-sectional view of another embodiment of a
mandibular device
that is removable attachable to a teeth covering.
100301 FIG. 12 is a schematic illustration of a system in operative
communication with the
MRLD of FIG. 1 or the mandibular device of FIG. 8.
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[0031] FIG. 13 is a rear, perspective view of a maxillary device
having at least a
stimulator electrode therein.
[0032] FIG. 14 is a cross-sectional view along line 14-14 of FIG.
13.
[0033] FIG. 15 is an enlarged view of a second embodiment of a connecting
portion of the
maxillary device.
[0034] FIG. 16 is a longitudinal cross-sectional view of an
embodiment of a maxillary
device having a medicament dispenser.
[0035] FIG. 17 is a left-side view of the maxillary device of FIG.
2 modified to include a
digital camera or digital video recorder.
[0036] FIG. 18 is a side view of an embodiment of a mandibular
repositioning device that
provides Dynamic Continuous Open Airway Technology (DCOAT) to the user.
100371 FIG. 19 is a side perspective view of the mandibular piece
of the mandibular
repositioning device of FIG. 18.
[0038] FIG. 20 is a model comparing the movement of the mandible of a user
having the
mandibular repositioning device of FIG. 18 against a commercially available
mandibular
repositioning device.
[0039] FIG. 21 is a mathematical model of how to position and determine the
convex and
concave curvatures of the protrusive flange and the driver flange of a
mandibular reposition
device.
[0040] FIG. 22 is a side view of another embodiment of a mandibular
repositioning device
that provides Dynamic Continuous Open Airway Technology (DCOAT) to the user.
[0041] FIG. 23 is a front view of the device of FIG. 22 in a full-
open mouth position.
DETAILED DESCRIPTION
[0042] The following detailed description will illustrate the
general principles of the
invention, examples of which are additionally illustrated in the accompanying
drawings. In
the drawings, like reference numbers indicate identical or functionally
similar elements.
[0043] Referring now to FIGS. 1 to 4, a mandibular lingual repositioning
device (MLRD)
that is dynamic in its movement of the jaw(s) and tongue is represented
collectively in FIG. 3
by reference number 100. The MLRD 100 has a maxillary piece 102 seated on a
mandibular
piece 104 for operative communication of drivers built therein.
[0044] Turning to FIGS. 1 and 4, the mandibular piece 104 is shown,
which has a first
teeth covering 106 and has a housing 108 proximate each of a left molar
portion 110 and a
right molar portion 112. A protrusive flange 114 extends cranially from each
housing 108,
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and a stimulator 116 extends from each housing 108 toward the tongue at a
position to lie
under the tongue in contact with lingual muscles, in particular the
Genioglossus (GG), the
Geniohyoid (GH), sub-mentalis (SM), and Glossopharyngeal (GP). The stimulator
protrusion 116 of each housing 108 should be fitted to the user/custom made
for the user to
ensure proper contact with the lingual muscles. Each stimulator portion 116
while appearing
somewhat boxy-looking in the drawings, is more preferably molded of moldable
material
suitable for use in a human oral cavity and has smooth transitions to its
shape and is shaped
to match the shape of the user's mouth, especially to sit under the tongue in
contact with the
base of the tong and the floor of the mouth as shown in FIG. 4. The moldable
material may
be any of those commercially available or hereinafter developed for use in a
human oral
cavity.
100451 Referring now to the transverse cross-section of FIG. 4,
each housing 108 encloses,
in a fluid-tight manner, a power source 120 electrically connected to a motor
122, to a circuit
board 124, and to the stimulator 116. A first driver 130 is operatively
connected to each
motor 122 for cranial to caudal adjustments of the device 100. The first
driver 130 is linearly
translatable by linkages 134 operatively connected to the motor 122 within its
housing 108 as
shown in FIG. 3. The linkages 134 will be fluid-proof, heat-resistant and acid-
resistant and
thus able to withstand the conditions found within the oral cavity of a user.
100461 With reference to FIGS. 2 and 3, the maxillary piece 102 is
shown, which has a
second teeth covering 107 and has a housing 109 proximate each of a left molar
portion 111
and a right molar portion 113. Referring to the partial cross-sectional view
of FIG. 3, each
housing 109 encloses a power source 121 electrically connected to a motor 123
and to a
circuit board 125. A second driver 132 is operatively connected to each motor
123 for
anterior to posterior adjustments of the device 100. The second driver 132 is
linearly
translatable by linkages 135 operatively connected to the motor 123 within its
housing 109.
100471 In all embodiments, the housings 108 and 109 may be fixedly
attached to the
respective teeth covering, integral therewith, or removable attachable
thereto. When
removable attachable, the housings 108, 109 may be slid over a molar portion
of the teeth
covering, have a snap fit thereto, an interference fit thereto, may be a two-
piece compartment
that snaps together over a predetermined location of the teeth covering, may
be three-
dimensionally printed to cover or fit over a portion of the teeth covering. In
all embodiments,
while the teeth coverings 106, 107 are shown as full coverings for all teeth
in the mandible
and all teeth in the maxilla, the teeth coverings are not limited thereto.
Instead, each teeth
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covering may be a partial cover for one or more teeth, as such, the mandibular
piece 104 may
be a two-part configuration having a left and a right portion each with a
housing 108 and the
maxillary piece 102 may be a two-part configuration having a left and a right
portion each
with a housing 109.
100481 In all embodiments herein, each housing 108, 109 is
described herein as positioned
proximate a molar portion of a teeth covering, but is not limited to any
particular size, i.e., the
number of teeth to which it is associated. Each housing may be associated with
one tooth
region, a two-tooth region, a three-tooth region, or whatever number of teeth
is needed to
accommodate the size and position of the housing and its stimulator
protrusion.
100491 Referring to FIGS. 1, 3, and 4, the protrusive flange 114 of
the mandibular piece
104 is an elongate flange that is releasably, removably attached to or may be
integral with the
housing 108. A releasably, removably attachable protrusive flange 114 is shown
in FIGS. 6
and 7 to accommodate an interchangeability of protrusive flanges 114 of
different shapes and
sizes to provide the best fit for the user's mouth. In the embodiment of FIG.
1, the protrusive
flanges 114 are generally an elongate linear flange protruding cranially from
each of the
housing 108.
100501 Turning now to FIGS. 6 and 7, the protrusive flange 114' is
releasably attachable
to the housing 108 of the mandibular piece 104. The protrusive flange
terminates with a post
144 opposite a free end 142 thereof. The post 142 includes a releasably
attachable feature
146, such as a snap fit feature, a friction fit feature, or threaded holes as
shown in FIG. 7.
The housing 108 defines a receptacle 126 shaped to receive the post 144. The
receptacle 126
will have a releasably attachable mating feature 128 that mates with the
releasably attachable
feature 146 of the post 144. In FIG. 7, the releasably attachable mating
feature 128 is a set of
threaded holes and screws 129.
100511 As shown in FIGS. 6 and 7, the protrusive flange 114' can
have a bend 140 on the
anterior side of the flange, but this is not required. The new feature in this
embodiment is
that the posterior side 145 of the protrusive flange 114' is arcuately shaped
as best shown in
FIG. 8 as a concave surface, which mates with a driver 132 having a convex
surface shaped
to match the concavity of the posterior side 145. The midpoint 147, relative
to being the
middle or halfway point between the free end 142 and the opposing end 143, of
the arcuately
shaped posterior side 145 defines an arc of a circle having its center at the
temporomandibular joint (TMJ) in this illustration and the free end 142 has a
width that is
smaller than a width of the opposing end 143 of the flange. The arc of the
circle is one that
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defines 01 as being any angle with the range of 12 degrees to 15 degrees in
increments of
whole degrees, half degree, or 0.2 degree increments. The angle of the arc 01
defines the
amount of protrusion of the mandible with each degree of mouth opening. The
larger this
angle 01, the greater the protrusion with mouth opening. The larger the angle
of mouth
opening, the larger the protrusion of the mandible. The arcuate surface is
customizable to
provide a curvature that provides the best forward movement of the mandible
for the user in
relation to the individual user's mouth shape and size. Depending upon the
shape and size of
the user' s mouth and jaws, the radius defining the point of the arc may be
offset by moving
this point up or down relative to the midpoint 147, which may change the
widths of the free
end 142 and the opposing end 143.
100521 The advantage to the arcuately shaped side 145 of the
protrusive flange 114' is that
it will help protrude the mandible forward as the Temporo-Mandibular joint
(TMJ) relaxes
and the mouth falls open during sleep, wake or any other transitional state of
the human mind
(such as various Parasomnia create) thus allowing gradual smooth arcuate
incremental
forward mandibular movement to occur as convex surface 145 of protrusive
flange 114'
smoothly glides against concave surface 136 of driver 132'. The maximum
protrusive
distance (MPD) for anterior movement of the mandible is in a range of 6 mm to
10 mm.
Typically, the first 13 degrees of rotation of the mandible about the TMJ
during natural, un-
aided spontaneous mouth opening does not move the mandible anteriorly, i.e.,
this rotation
does not change or open the airway. Drivers 130, 132 will actively coordinate
simultaneous
desired amount of vertical and protrusive movements of the mandible
(controlled by
controller) during this first 13 degrees of mouth opening while the arcuate
opposing gliding
movements of convex surface 145 of protrusive flange 114' smoothly against
concave
surface 136 of driver 132' surfaces will passively create mild forward
movement of the
mandible. Driver 132 will ensure constant contact between surfaces 145 and 136
while driver
130 will adjust height of oral cavity and thus increase oral cavity volume
while
simultaneously stiffening the soft palate and Uvula. This entire process will
work in synergy
(keeping the person's sleep undisturbed) to increase cross-sectional area of
upper airway and
increase the cubic volume of the oral cavity which in turn allows 150L/R
(through the
controller) in 116 to appropriately incrementally protrude the base of tongue
forward into the
increased oral cavity volume utilizing electric stimulation of the tongue
nerves and muscles
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(details described elsewhere in this document), further increasing the cross-
sectional area of
the upper airway (the tongue forms the anterior wall of the upper airway).
[0053] In the natural state, the mandible must rotate beyond this
initial 13 degrees,
typically through another 7 to 13 degrees to have an effect on the airway
size. In an example,
where the arcuately shaped side 145 is based on a 15 degree jaw rotation (end
to end)
curvature, i.e., qi and q2 are 15 degrees each or they may be any combination
of two different
angles that add up to 30 degrees. The approximate midpoint 147 of the arc 145
is the point at
which transition between angle of wand qi occurs and is approximately the
point at which
the mandible (mouth) is expected to have opened or rotated to the first 13
degrees (12 to15
degree range). Total theta at the point of transition 147 = 180 - (qi + q2).
Surface 136 of
driver 132 should align with the lower part of surface 145 closer to 143 when
the mouth is
completely closed (Centric Occlusion CO with a Centric Relation CR between
mandibular
and maxillary incisor teeth). Angle of q2 can be different from angle of qi,
i.e. the arc may or
may not be one fixed radius from TMJ. Each of the qi and q2 should remain
between the
ranges of 12-15 degrees each although both qi or q2 or both could be zero
degrees each (0-15
degrees each). These angles could exceed 15 degrees each based on individual
needs of the
user/patient. Total of (qi + q2) will ordinarily be between 24-30 degrees but
could be 0-30
degrees or greater. Theta at point of transition 147 is (180 - (qi-F q2)) =
150 to 180 degrees
unless angles of qi and or q2 exceeded 15 degrees. A q of 0 degrees will
essentially create a
straight vertical posterior surface 145 and would require a similar angle for
surface13 6. An
angle of 180 would produce incremental forward protrusive movement of the
mandible
throughout the entire range of mandibular rotation (CR/C0 to MMO) during mouth
opening.
[0054] q2 is primarily useful to control neutral mandibular
protrusion during the initial 13
degrees of mandibular rotation (although protrusive flange can protrude the
mandible when
using MRD with motorized protrusive flange option) but can be adjusted to
produce
protrusive movement (the more q2 is, the less the radius of mandibular incisor
to TMJ, the
less protrusion of the mandible during early rotation or mouth opening and the
less q2 is the
more protrusion with each degree of mandibular rotation). On the other hand,
qi is used to
create the majority of the forward mandibular protrusion during the remainder
of the
mandibular rotation or mouth opening all the way to MMO (Maximum mouth
opening).
Resistance to mouth opening will also occur during this part of mandibular
rotation due to the
resistance from stretching the muscles of the TMJ as the mandible
incrementally protrudes
with every additional degree of mandibular rotation. Increasing qi will cause
even more
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protrusion of mandible and thus also cause incremental resistance to mouth
opening created
by forward jaw movement. Essentially, if the desired outcome is to keep the
mouth closed or
barely open (CR/C0 position), one could use only qi and remove q2 altogether.
This would
require an arcuate or non-arcuate straight posterior surface 145 with qi of 0-
15 degrees from
the vertical axis starting at base 143 all the way up to 142 as shown in FIG.
6 and FIG. 7 with
a corresponding surface 136 that is straight non-arcuate surface with a
corresponding angle
90 qi or a corresponding arcuate surface that leans back as shown in
FIG. 6 or combination
of arcuate and non-arcuate surfaces such as shown in FIG. 6. Under these
circumstances,
greater the qi greater the protrusion of the mandible with the least amount of
mandibular
rotation or mouth opening (mm of protrusion for each degree of mandibular
rotation) and
thus also ensure the highest resistance to mandibular rotation and mouth
opening to match the
needs of the user/patient. In an example, where the arcuately shaped side 145
is customized
with qi and q2 of 15 degrees each as well (total theta = 180-30 = 150) for the
sake of
simplicity of driving home the point, a mandibular rotation or mouth opening
of about 20
degrees will protrude the jaw anteriorly about 5 mm and a mandibular rotation
of about 24
degrees will protrude the jaw anteriorly about 11 mm. Since the MPD (Maximum
Protrusive
Distance with range of 6-10 mm) typically has an absolute maximum of 10 mm, 11
mm is
nearly impossible for most people and thus the mechanics of the device create
the
environment where the mouth will not open to MMO (Maximum mouth opening) of 24
degrees.
100551 The releasably attachable features of the flange 114'
accommodates the
interchangeability of protrusive flanges 114 of different shapes and sizes to
provide the best
fit for the user's mouth.
100561 Turning now to FIGS. 18-21, some people in need of Continuous Open
Airway
Technology (COAT) may suffer from dysfunction or abnormalities of the temporo-
mandibular joint (TMJ). These individuals may not have evidence of TMJ disease
but may
have mild restriction of the range of movement of the TMJ and mandibular
advancement. As
such, milder advancements of the mandible are needed for these individuals
when using a
mandibular repositioning device (MRD), such as the MRD 800 of FIG. 18. The WM
800
has Dynamic Continuous Open Airway Technology (DCOAT) because the mandible
will
follow Arc2 of FIG. 20 in which as the mandible drops to open the mouth, the
mandible will
move forward in small increments because of the shape of the protrusive flange
814 and the
driver flange 832, thereby opening the airway. Arc2 demonstrates that when the
mandible
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opens in 5 degree increments relative to the TMJ, the forward point of the
mandible changes
as shown in Table 1 below.
Table 1: Arc2Degrees of Travel corelated to Mandible position
Degrees of Mouth Opening Distance from the TMJ
(centimeters)
0 77/8
81/8
83/8
8 7/16
8 9/16
83/4
In comparison, Arci demonstrates the movement of commercially available COAT
MRDs,
which open the jaw, but allow the mandible to fall backward toward the throat.
100571 Turning back to FIGS. 18 and 19, the MRD 800 has a concave-to-convex
curvature
moving from the base 816 to the most cranial point 818 of the posterior side
815 (or trailing
edge) of the protrusive flange 814 of the mandibular piece 804 and a convex
curvature 835 of
the anterior side 833 (leading edge) of the driver flange 832. While FIG. 18
only shows the
left side of the MRD 800, it is understood that the right side can be the
same. The protrusive
flange 814 extends cranially from the mandibular piece 804 which has a teeth
covering 806
for the lower teeth. The driver flange 832 protrudes laterally outward from
the side of the
maxillary piece 802 a distance sufficient to engage the posterior side 815 of
the protrusive
flange 814 with the anterior side 833 thereof The driver flange 832 has a base
834 positioned
on the maxillary piece 802, i.e., the base of the driver flange does not
extend caudally in an
overlapping manner with the mandibular piece 804. The maxillary piece 802 has
a teeth
covering 807 for the upper teeth. The protrusive flange 814 and the driver
flange 832 are not
shown in this embodiment to have the housings with the motor and mechanism for
moving
the flanges to provide the movements described herein for the other
embodiment, but they are
equally usable with such mechanisms and all the systems described herein.
100581 The protrusive flange 814 may be molded as an integral
portion of the mandibular
piece 804, but is preferably a removably attachable flange as described above
for other
embodiments. When the flange is removable, it may include a hole or depression
860 to
receive a tool to activate a release of the fastener holding the removable
attachable flange in
place on the mandibular piece 804. Likewise, the drive flange 832 may be
molded as an
integral portion of the maxillary piece 802 or it may be removable attachable
thereto. The
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fasteners for holding the flanges to their respective pieces 802, 804 can be
any specifically
described herein, and commercially available, or any hereinafter developed.
100591 The concave-to-convex curvature of the posterior side 815 of
the protrusive flange
814 has a concave portion 850 most proximate the base of the protrusive
flange. Cranially
above the concave portion 850 is the convex section 852. The shape and
positions of the
concave and convex portions 850, 852 is described in more detail with
reference to FIG. 21.
The mathematical model in FIG. 21, was created using a scale of 1 cm = 10 mm.
Here, the
dental horizontal axis (AH) is represented by segment BC and runs horizontally
between the
mandibular teeth (crowns of the teeth) along the plane and the maxillary teeth
(crowns) above
the plane. Thus, the mandibular coverings part of the MRD lies below the
horizontal axis
while the maxillary coverings part lies above the horizontal axis. A vertical
axis (Av) is
drawn perpendicular to the dental horizontal axis at a position passing
between the protrusive
flange 814 and the driver flange 832 in the at rest position shown in FIG. 21.
The rest
position is a position of the mandible at which there is no stress on the TMJ.
This axis passes
between the mating point V/ of the protrusive flange 814 and the point 137 of
the driver flange
832. Point A represents the TMJ at rest and an axis parallel to the vertical
axis (Av) is drawn
through point A, called the TMJ axis (ATAu). Point B is the point where the
horizontal axis
and the angle of the mandible intersect. Point C is the point where the TMJH
vertical axis
and the horizontal axis intersect. Point D is a mid-point of the length of the
segment AC.
Point E is a point along the TMJ axis that is at 2/3 of the height (HDF) of
the driver flange
832. Point F is the mirror of point D along the TMJ axis and Point G is the
mirror of point A
along the TMJ axis, i.e., a negative value equal to point D and Point A,
respectively, below
the horizontal dental axis. Point El is the mirror of point E on a vertical
axis parallel to the
TMJ axis but positioned at the front of the incisors (Ai). Average dimensions
were used in
FIG. 21, and it is therefore understood that these dimensions may vary from
individual to
individual based on natural variations of body size, jaw size, head size and
variations created
by abnormalities of the human body as well.
100601 The primary concept is to use a tangent (T) that is parallel
to the lean of the Ramus
of the mandible (represented by line segment AB) in relationship to the
horizontal axis (AH)
that passes between the protrusive flange 814 and the driver flange 832 in the
at rest position
shown in FIG. 21. This creates an angle within the range of 100 to 50 with
the vertical axis
(Ay) on the maxillary side of the horizontal axis (An), which we call cp. For
the purpose of
the following description and simplicity, 10 was selected for qi and qi = q2.
However, qi can
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be any value within the 100 to 500 range. The tangent (T) defines the point V2
of the
protrusive flange 814 and the point P2 of the driver flange 832 on the convex
portions
thereof, which are aligned in the at rest position. This is referred to as
point V2P2 and is a
point where three tangents meet to create the tangent (T). These are designed
to meet at the
same point although they do not always have to, especially, if a design for
any individual
requires a variance from this concept. Also, if the Ramus angle is different
in each subject
from what we have used for this discussion, T may change.
[0061] The five points labeled in FIG. 21 for the protrusive flange
814 are identified in
this paragraph. Point Vi is the lowest point on the trailing edge 815 of the
protrusive flange
414 where it lands on the mandibular covering of the MRD. Point V) is where
the tangent
(T) coincides with point P2. Point V3 is the most cranial point of the
trailing edge 815 of the
protrusive flange 814. Point V4 is the lowest point of the leading edge 817 of
the protrusive
flange 814. Point V5 is the high point where V3 reflects and meets the leading
edge 817.
[0062] The three points labeled in FIG. 21 for the driver flange
832 are identified in this
paragraph. Point Pi is the lowest point of the leading edge 833 of the drive
flange 832. P2 is
the point where tangent (T) coincides with point V2. Point P3 is the most
cranial point of the
leading edge 833.
[0063] At T = 10o, the very front of the incisor part of the MRD to point C
(the
perpendicular dropped from A) appears to be 84 mm long. The midpoint of this
segment is
42 mm (referred to herein as the midpoint length) from either end is at point
V2. This is an
average distance and may vary on a case-by-case basis (as will all other
measurements).
About 4.6 mm above point C is a point that is one third of the height of
segment AC
measured from the horizontal dental plane, designated as point H. Using point
H as a center
point, a first arc Vi ¨ V2P2 defining the curvature of the concave portion 850
of the trailing
edge of protrusive flange 814 is drawn and a second arc Pi ¨ P2 ¨ P3 (the
entire leading edge
of protrusive drive 832 is drawn using a radius 1 (01) of 42 mm (equal to the
midpoint
length). The 42 mm length for the radius could vary on a case-by-case basis.
100641 The second arc Pi¨ P2¨ P3 defines almost the entire leading
edge of the driver
flange 832. The radius that will be used to draw the leading edge of the
driver flange is about
0.2-0.5 mm shorter than the radius used to draw the trailing edge 815 of the
protrusive flange
814 to allow a small play for the purpose of proper articulation. The leading
edge 833 of the
driver flange 832 has a back-cut portion 854 most proximate the point Pi. Pi
is described by
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a different radius, radius 4 (04) of 52 mm on average. The center point used
to draw the arc
for the back-cut portion 854 is point D such that segment EC = ED = 11 mm.
100651 Point E is created by drawing a horizontal line from the
point V?P2 such that the
angle created by V2P2¨ C ¨ Vi = 10- thus allowing the point V2P2to be the
point where the
tangent T = 100 from the vertical axis. Now extending the horizontal line that
passes through
the points V?P? and E further to the left allows creation of a point El, such
that segment V?P?
¨ Ei = 42 mm = segment V2P2¨ E. Extending the line H similarly will allow the
creation of
Hi. With Ei as center point using the same radius 02 = 42 mm another arch is
drawn that
starts at V2P2 and extends upwards to V3, thus completing the remainder of the
trailing edge
of the protrusive flange 814. Hi may similarly be used and any point between
Ei and Hi may
also be used for the same purpose depending on the amount of convexity
required at the top
of the protrusive flange 814 to create best mandibular advancement for each
individual
person.
100661 To build the leading edge 817 of the protrusive flange 814,
Point F was used as the
center to draw arc V4 ¨ V5. This was then smoothed out at the top for a smooth
transition to
the trailing edge 815 and to avoid creating pointed edges. The convex
curvature of the
leading edge 817 is oriented with its curvature tilted toward the TMJ such
that the most
cranial point 818 (point V5) is more proximate point V2 than point V4.
However, turning now
to FIGS. 22 and 23, an alternate embodiment 800Tor the MRD is shown in which
the leading
edge 817 of the protrusive flange 814 can be more linear, yet still oriented
tilted with the
most cranial point 818 pointed toward the TMJ. Additionally, FIG. 22 has a
back-cut portion
864 to the convex portion 852 most proximate the most cranial point 818, back-
cut toward
the most cranial point 818. FIG. 23 is a front view of the MRD 800'of FIG. 22
in a full-open
mouth position with the back-cut portion 864 of the protrusive flange 814
seated against the
back-cup portion 854 of the driver flange 832.
100671 A user in need of an open airway, most often during sleep,
but not limited thereto,
inserts the maxillary and mandibular device of any of the embodiments
disclosed herein into
their mouth and goes about with their activity or goes to sleep. With respect
to the shape of
the flanges in FIGS. 18-21, when the user moves the mandible downward, such as
normal
relaxation during sleep, the protrusive flange 814 of the mandibular piece 804
moves along
the convex curvature of the driver flange 832, which will move the mandible
forward, see the
increments of movement set forth in Table 1 above, and naturally opens the
airway. As such,
sleep apnea can be avoided, prevented or controlled.
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100681 Referring back to FIGS. 1 and 4, at least one stimulator
116, but preferably both
stimulators 116, include a first sensor 150L/R and/or a second sensor 152L/R,
but preferably
both sensors. 150L and 152L stands for the left side of the user and 150R and
152 R stands
for the right side of the user. The sensors 150L/R and 152L/R may be selected
from a variety
of sensors to create which every combination is the most likely to be useful
in diagnosing or
treating the user. The sensors are selected form the group consisting of a
pulse oximetry
sensor, a vibration sensor, an airflow sensor, a pH sensor, a combination
pulse
oximetry/vibration and airflow sensor, an EKG sensor, EEG sensor, EMG sensor,
EOG
sensor, lactic acid sensor, a pulse transit time (PTT) sensor, an ultrasound
sensor
(echocardiography), an electro-oculogram sensor, a temperature sensor, a body
position or
jaw position sensor (such as a potentiometer), an el ectromyogram sensor, a
pressure
measurement sensor, a hygrometer sensor, a microphone or sound recording
sensor, video
recording, and hygroscopic/hydration sensor. In one embodiment the first
sensor is a
combination pulse oximetry/vibration and airflow sensor and the second sensor
is a pH
sensor. In another embodiment, the first sensor is a pulse oximetry sensor and
the second
sensor is a vibration and airflow sensor. Any number of combinations of the
sensors listed
above is possible and can best be selected by a medical professional based on
data relative to
the pre-selected end user.
100691 The stimulator 116 may also be accompanied by a sensor or
sensors that can record
EEG (electro-encephalogram), EOG (electro-oculogram), electromyogram (EMG) for
the
tongue muscles and NC (Nerve conduction) data from the nerves of the tongue,
pharynx and
muscles of mastication (jaw muscles) and phonation (speech). These sensors may
transmit
these data to the controller 200 (described in more detail below) through
variety of industry
standard wireless protocols that are currently in use for wireless EMG, NC and
EEG
recordings in other skin surface applications in neurology and sleep
laboratories. Data from
such sensors will be useful for detection of various medical diseases as it
will be computed in
time-synchronized manner by the controller 200 and cloud based servers in
system 300
described in more detail below and will help to determine cause-effect of many
medical
diseases. The sensors will also provide feedback to controller 200 to gauge
effectiveness of
electric stimulation of the tongue or forward movement of the tongue and
mandible and thus
allowing the controller to make fine adjustments to all components of the
system.
100701 The length L of each stimulator 116 will be pre-selected to
fit the user's mouth and
tongue, in particular for adequate contact with the base of the tongue during
sleep. Each
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stimulator 116 has a single or dual electrode 154 connected to the power
source 120 and
generates an electrical impulse that travels through the electrode to one or
more of the lingual
muscles of the tongue identified above, which contracts the lingual muscle(s)
to create a
forward movement of the tongue. The forward movement of the tongue increases
the cross-
sectional open airway diameter in transvers, vertical and antero-posterior
dimensions, thus
increasing the aggregate volume of open airway and exponentially reducing air-
flow
resistance. The power source for the single or dual electrode can be a direct
current (DC)
power source or may employ any other technology such as electro-magnetic
energy, photon
energy among other forms of energy. The electrical impulses' power source will
be in volts
or microvolts and the current, likely in milli-Amps (usually 2-6 mA), will be
pre-selected on
a per patient basis. The power, current, and capacity will typically be within
a range suitable
for effective performance of mated hardware and safe for use with cardiac
pacemakers,
defibrillators, deep brain stimulators, or spinal cord stimulators.
[0071] The forward movement of the mandible (protrusion) is
performed by lateral
pterygoids, medial pterygoids and masseter muscles. These are stimulated by
the mandibular
branch of the trigeminal nerve. The neuronal firing rate drops during sleep
relaxing these
muscles causing the jaw to fall back (retrusion) and thus allowing the tongue
to fall back
(retro-glossal movement) into the airway as well creating a narrow airway
which is the cause
of obstructive sleep apnea, oxygen desaturation, elevated blood-pressure,
cardiac arrhythmia,
disruption in sleep and nocturnal acid reflux. The transverse stimulator 116
can specifically
target these muscle groups and their distributing nerve and stimulate and
sense electrical
activity of these various muscles individually or together inside the oral
cavity.
[0072] Also, the stimulators 116 can stimulate selected muscles to
improve their strength.
This can be a training or a retraining exercise, for example, after a stroke
(swallowing
difficulty or speech difficulty) or for children with speech pathologies. If
sensors are present
in the stimulators 116, the sensors can provide data to the controller station
200 and the
system 300 of FIG. 11 to determine which muscle and/or muscle group needs
attention.
Thus, the shape of exterior surface/housing of the stimulators 116 are shaped
and sized to
direct each and every sensor, stimulator or combination thereof to the
appropriate location
inside the oral cavity.
[0073] The pulse oximetry sensor 150 is positioned in one or both
stimulators 116 at a
position enabling direct contact with the base of the tongue from which data
will be collected.
The position of the pulse oximetry sensor 150 is generally antero-superiorly
positioned for
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measuring pulse-oximetry through the blood-flow of the tongue. The vibration
and airflow
sensor 152 is positioned in one or both stimulators 116 at a position suitable
for airflow
measurements, which can indicate when there is a restriction of airflow, and
vibration
measurements (sub-sonic and sonic) that are an indication of inaudible and
audible snores.
The vibration and airflow sensor 152 faces posteriorly to measure snores and
airflow
resistance/pressure from the airway.
100741 The power source 120, 121 in all embodiments may be a
rechargeable battery. In
one embodiment, the rechargeable battery is one or more micro-lithium ion
batteries in each
housing 108, 109. Solar/light charging energy source that can be recharged by
ambient
lighting (used in the watch maker industry) or solar power may also be
considered for a
rechargeable source of energy. The rechargeable battery may have a maximum
discharge
milli-amperage creating a mechanical mandibular protrusion or retrusion
ranging between 1-
mm in linear dimensions for the movement of the drivers 130, 132.
100751 As seen in FIGS. 1 and 2, each housing 108, 109 of the
mandibular and maxillary
pieces, respectfully, include a charging member 118, 119, such as a charging
plate, in an
exterior surface thereof In the figures, the charging plate is in a lateral
side of the housing
108, 109, but is not limited thereto.
100761 As best seen in FIG. 3, the first driver 130 may be a flat
plate connected to the
motor 122 by the linkages 134.
100771 The motor 122, 123 in all embodiments may be a single or
dual piezoelectric motor
having a linearly movable linkage(s). Micro motors based on piezo electric
materials are
commercially available from Piezo Motor, a company headquartered in Sweden and
may be
modified as needed for use in the disclosed devices. The motor 122, 123 may
include a
position sensor.
100781 As best seen in FIGS. 3 and 6, the maxillary piece 102 sits
on the mandibular piece
104 with the first driver 130 operatively engaged with the maxillary piece 102
and the second
driver 132 operatively engaged with the protrusive flange 114, 114', or 114¨
of the
mandibular piece 104. Each of the drivers 130, 132 can move the jaws in
increments of 0.1
mm up to 2 mm with each movement with a maximum of 12 mm in the respective
direction.
The protrusive flange 114, 114', 114¨, is moveable by the second driver 132 in
a range from
0.1 mm to 11 mm and the first driver 130 can lift the maxillary portion in a
range from 0.1
mm to 12 mm.
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[0079] Referring again to FIG. 6, the second driver 132 has a head
136 that is shaped to fit
the shape of the posterior side 145 of the protrusive flange 114'. The head
136 has a
convexly- shaped anterior side to press against the posterior side 145 of the
protrusive flange
114'.
[0080] Turning now to FIG. 9, a mandibular device 101 is
illustrated that has just the
stimulator 116 and a mandibular teeth covering 105. As such, the maxillary
piece can
comprise of a teeth covering 107 as shown in FIG. 2 without the housings 109
or be absent,
i.e., the user can just have the mandibular device 101 in their mouth during
use. Dual
housings 108' are present with one each proximate a left molar portion 110 and
a right molar
portion 112. A stimulator 116 extends from each housing 108' toward the tongue
at a
position to lie under the tongue in contact with lingual muscles, in
particular the
Genioglossus (GG), the Geniohyoid (GH), sub-mentalis (SM), and
Glossopharyngeal (GP).
Each housing 108' includes a charging feature 118 for recharging any
battery(ies) housed
therein, as described above.
[0081] Referring now to the cross-section of FIG. 10 through one of
the stimulators 116,
each stimulator 116 houses therein, in a fluid-tight manner, a first sensor
150, a second sensor
152, and a stimulator electrode 154. In FIG. 10, the first sensor 150, the
second sensor 152,
and the stimulator electrode 154 are each electrically connected to the power
source 120
within housing 108'. The electrical connections may be direct connections to
the power
source 120, which may be accomplished by a plug-n-play electrical connector
156, or, as
represented by the dashed lines, may be accomplished by a plug-in style
connector 157 to the
microprocessor 159 and thereby to the power source.
[0082] In one embodiment, the first sensor 150 is a pulse oxygen
sensor continually
measuring oxygen data at the base of the tongue and the second sensor 152 is a
vibration/air
flow sensor measuring snoring, turbulent flow, and vibrations from inside the
user's mouth.
As noted above with respect to FIG. 4, multiple other sensors and sensor
combinations are
possible that will provide data to the microprocessor 159. The circuit board
124 within the
housing 108' is in operative connection to the power source to be powered and
to control
activation of the stimulator electrode 154 in response to data received by the
circuit board
124, more particularly, the microprocessor 159, from the first sensor 150
and/or the second
sensor 152. As discussed the microprocessor 159 receives the sensor data,
processes the
sensor data, and determines whether the stimulator electrode 154 needs
activated.
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[0083] Each of the stimulators 116 may include a pH electrode too.
The pH electrode will
measure the acidity at the back of the tongue, which if too high is an
indication of chronic
high acid reflux.
[0084] Referring now to the FIG. 11, which is a transverse cross-
section through one of
the stimulator/sensor protrusions 117 and housings 108 'of a mandibular device
similar to the
mandibular device 101 of FIG. 9. In this embodiment, each housing 108' and
stimulator/sensor protrusion 117, rather than being built as part of the teeth
covering 160, are
removably attachable to the teeth covering 160. Each housing 108' defines a
groove 162
shaped to receive therein an end 161 of the teeth covering 160, such that one
housing 108' is
removably attached to a first end 161 defining a left molar portion and the
other housing
108'(not shown) is removably attached to a second end (not shown) of the teeth
covering 160
defining a right molar potion thereof. The groove 162 may have opposing
flanges 164
positioned at and parallel with a bottom surface 166 of its housing 108' and
extending toward
the open void defined by the groove 162. The groove 162 of each housing
108'may be slid
over and be received on the teeth covering, may have a snap fit to the teeth
covering, may
have an interference fit, or may be fabricated in two parts that can snap into
each other over a
predetermined location of the teeth covering or may be fabricated with three-
dimensional
printing over a teeth covering. The illustrated embodiment in FIG. 11 has the
housing 108'
slidingly received on the first end 161 of the teeth covering 160 with the
flanges 164 resting
against bottom surfaces of each of the sides of the teeth covering 160.
Regardless of the type
of attachment, each housing 108'is movable fore and aft to adjust the position
of the
stimulator/sensor portion under the correct position under the tongue of the
user.
[0085] Since the housings 108' are removably attachable to the
teeth covering 160, each
housing and or teeth covering may be disposable or reusable. When the housings
108' are
reusable, the housings are constructed of a material suitable for
sterilization between uses,
such as by autoclave sterilization. Housed within each housing 108', in a
fluid-tight manner,
is a first sensor 150, and an optional second sensor 152, and an optional
third sensor 153 or a
stimulator electrode 154 or even a high-pressure pellet discharge system. Each
of the first
sensor 150, the second sensor 152, and the third sensor 153 or the stimulator
electrode 154
are electrically connected to the power source 120. The electrical connections
may be direct
connections to the power source 120, which may be accomplished by a plug-n-
play electrical
connector 156, or may be accomplished by a plug-in style connector to the
microprocessor
159 and thereby to the power source 120. The housings 108'each include a
charging member
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118 in an exterior surface thereof for coordination with one of the charging
units 202, 204 of
the controller station 200 of FIG. 5.
100861 In one embodiment, only the first sensor 150 is present. The
first sensor 150 may
be, but is not limited to, a pulse oxygen sensor, a vibration and airflow
sensor, a pH sensor, a
doppler ultrasound, an M-Mode ultrasound, a 2D ultrasound, 3D ultrasound, a
pressure plate
for measuring bruxism, a pulse transit time sensor, non-invasive ventilation
systolic/diastolic
blood pressure sensor, a carotid doppler (trans-oral) sensor, or a cardiac
trans-oral
echocardiography sensor or a camera/videography system, or any other sensor
identified
herein. In one embodiment, the first sensor 150 is a pH sensor. In another
embodiment, the
first sensor 150 is a pulse oxygen sensor continually measuring oxygen data.
The mandibular
device 101 is used with the controller station 200 in a diagnostic mode.
100871 Since there are two housings 108'each having a
stimulator/sensor protrusion 117,
each housing 108'may have a different type of sensor for the first sensor 150
or one may
have a first sensor 150 and the other may have the stimulator 154. As such,
the mandibular
device 101 can be used in a diagnostic mode or a treatment mode depending upon
the
selection of sensors and/or stimulator in the housings 108', thereby providing
great versatility
in use. Furthermore, since the housings 108'are removable attachable to the
teeth covering
160, the housings 108'can be switched for housings having different sensors in
a sequence of
nights to assess various parameters of the user or during the day or both
night and day. The
mandibular or maxillary housings or teeth coverings, when used alone
(mandibular or
maxillary) should allow most speech functions and thus can be used during the
course of a
normal day. The data interfaces with standard Bluetooth functionality or WIFI
functionality
and the controller station may be used as a mobile unit with Bluetooth and
WIFI functionality
and as such may be carried to work or elsewhere since it has its own
rechargeable battery
operations. Controller station will be interfaced with proprietary or open
platform program
that can be securely loaded on variety of computer systems and hand-held smart
devices.
100881 In another embodiment, the first sensor 150 in a first of
the housings 108' is a
pulse oxygen sensor continually measuring oxygen data at the base of the
tongue and the
second sensor 152 is a vibration/air flow sensor measuring snoring, turbulent
flow, and
vibrations from inside the user's mouth; the second of the housings 108'has a
pH sensor as
the first sensor and includes the stimulator 154. Here, diagnostic and
treatment functions are
possible that are coordinated by the system 300 or any of its components such
as controller or
PC or smart device. The sensors 150, 152 provide data to the microprocessor
159. The
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circuit board 124 within the housing 108' is in operative connection to the
power source to be
powered and to control activation of the stimulator electrode 154 in response
to data received
by the circuit board 124, more particularly, the microprocessor 159, from the
first sensor 150
and/or the second sensor 152 and/or from instructions from the controller
station 200 and /or
the cloud server as shown in FIG. 12 (described in more detail below) to
effect a treatment.
For example, if the pH sensor senses an increasing acid condition as the user
sleeps and the
other sensors measure airflow resistance or decreased airflow, then the
stimulator will be
activated to open the airway and the system will then determine if the pH
decreases. Such a
causal relationship may help reduce/prevent significant nocturnal acid reflux
and thus
minimize or eliminate the use of acid reflux medications. Moreover, the
combination of
sensors can be selected to determine time synchronization of the pH to other
physiological
occurrences of the user, such as body position, inspiration, expiration, sleep
measurements,
oxygenation, bruxism, snoring, apnea, etc. Ideally, a link between acid reflux
and other
physiological occurrences can be determined and then used for treatment.
[0089] Moreover, using the controller station 200 and cloud server
of the system 300, it
will be possible to receive data regarding the user's input of food and time
consumed to act
proactively during sleep based on a correlation of digestion time and acid
reflux onset. This
capability may be extended to input of any and all medications, physiological
data such as
BP, EKG and blood sugar, and to administering of any and all medications
during the day
(prompted to the user through handheld device) or night (automatically
performed if pressure
pellet for medication is available to the system to discharge sub-lingually in
liquid form or
inhaled as micro-aerosol powder form.
[0090] The teeth covering 160 in the embodiment of FIG. 11 can be
as simple as a plastic
boil and bite mandibular device onto which the housings 108' are removably
attachable. In
this manner, the teeth covering 160 is disposable and are readily available.
Other teeth
coverings 160 are commercially available that are generally cheap and
disposable such as
ora-guard, sonabul, oral-b etc. However, the teeth covering 160 is not
required to be
disposable. Instead, the teeth covering 160 can be constructed of a material
that is
sterilizable such that the teeth covering is reusable by a user or users over
a preselected time
period while sterilizing the housings 108 'and utilizing any combination of
housings 108'
having a variety of sensors to monitor as many physiological parameters of the
user as
selected by administering expert.
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100911 Turning now to FIGS. 13 and 14, a maxillary device 400 that
is either integral with
a teeth covering 407 or removably attachable to the teeth covering 407 is
shown. A teeth
covering includes a palatal expander or retainer device as well as mouthpiece
covering the
teeth. Teeth covering 407 may have one maxillary device 400 at the left molar
portion and a
second maxillary device (the mirror image of the maxillary device 400 in FIG.
13) at the
right molar portion. Each maxillary device 400 has a housing 408 that defines
a tooth
connecting portion 409 one or both of a buccal housing 410 and a palate
housing 411 that
each define an internal cavities 412, 413, 415, respectively, in which is
housed, in a fluid-
tight manner, a stimulator electrode 454, 455 and/or one or more sensors 450,
452 and/or
other data collecting devices 456.
100921 The buccal housing 410, when present, is shaped to fit
between the user's teeth and
cheek and may extend anteriorly and/or posteriorly to collect data and/or
stimulate muscles
within the oral cavity. The buccal housing 410 can stimulate the lateral
pterygoid muscles to
move the jaw forward. The jaw may be moved forward during sleep or while
awake. While
awake, the stimulator 455 can coordinate muscles of mastication or swallowing.
100931 The palate housing 411 is shaped/contoured to rest against
the roof of the user's
mouth in contact with the hard palate and the soft palate and clings to the
surface of the
mucosa in the mouth in order to have good contact for purpose of stimulation
of the muscles
of swallowing and of the soft palate. The palate housing 411 extends in any
possible
direction to acquire physiological data from the oral cavity and to stimulate
the lateral
pterygoid muscles for protrusive movement of the mandible or stimulate muscles
of the soft
palate and uvula so as to stiffen these structures to reduce snoring or for
detection and
treatment of speech or swallowing pathologies. The speech or swallowing
pathologies may
include, for example, post-stroke recovery or reconstructive surgery of the
maxilla-facial
region recovery or short frenulum syndrome with associated speech defects or
micrognathi a
syndrome in children such as is seen in pediatric obstructive sleep apnea or
in Treacher-
Collins syndrome.
100941 Each housing 408 includes a charging feature 418 in an
exterior surface thereof for
recharging any on-board power source 420, such as battery(ies), housed within
the internal
cavities 413, 415 or in any portion of the maxillary or mandibular device,
even in remote
parts of the device, i.e., there is no requirement for the batteries to be
adjacent to the location
of sensors. The batteries may be any of those discussed above with respect to
other
embodiments.
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100951 In FIG. 14, the housing 408 includes a photography and/or
videography array 460
having photography and videography units 460a, 460b, 460c positioned to face
each side and
a bottom of a tooth, respectively, as shown in FIG. 14. The photography and/or
videography
array 460 can include, but is not limited to, unidirectional or
multidirectional collection using
single or multiple digital cameras to map dental structure, oral cavity
structure, airway
structure etc. and record sounds. When intended to map the oral cavity or
airway structure,
the unidirectional or multidirectional units are oriented outward toward the
oral cavity rather
than toward a tooth. These photography/videography arrays may be used to
create recordings
of teeth and gums (maxillary or mandibular) for use in general dentistry,
endodontic and
periodontal applications such as fabrication of enamel, measurement of enamel
wear in
bruxi sm, artificial teeth construction, crown construction, gum disease
detection and
treatment, and for 3-D printing of the mandibular and maxillary devices
disclosed herein.
When the photography/videography arrays face a tooth, the housing 408 may be
configured
to slide back and forth over the teeth to create a video or photo recording
thereof for dental
use. The housing 408 may attached to a wand or a fiberoptic flexible wand that
can be
manually moved along the teeth by the dentist or physician to help take images
of single or
multiple teeth or the complete dentition for dental applications or MRD
(mandibular
repositioning device) construction applications.
100961 The stimulator electrodes 454, 455 are as discussed above
for other embodiments.
The sensors 450, 452, 456, 568 include any and all of the sensors discussed
above for other
embodiments. One of the sensors can be a sound sensor to collect sounds such
as those
during sleep (e.g., snoring or grinding of the teeth) or those related to
speech and swallowing
that may be useful to define specific speech defects and swallowing defects.
All these
functions may be standalone or in synergy with stimulators, mandibular and/or
maxillary
movement devices, videography, photography, etc.
100971 In FIG. 14, the first sensor 450, the second sensor 452, and
the stimulator electrode
454 are each electrically connected to the power source 420 within the palate
housing 411.
Likewise, a third sensor 456, a fourth sensor 458, and the stimulator
electrode 455 are each
electrically connected to the power source 421 within the buccal housing 409.
The electrical
connections may be direct connections to the power source 420, 421 which may
be
accomplished by a plug-n-play electrical connector or may be accomplished by a
plug-in
style connector directly to the microprocessor 459 and thereby to the power
source 420, 421.
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[0098] In the removably attachable embodiment of FIG. 13, the
housing 408 defines a
groove 462 shaped to receive therein an end 461 of the teeth covering 407. A
first housing
408 is removably attached to a first end 461 defining a left molar portion and
a second
housing, if present, is removably attached to a second end (not shown) of the
teeth covering
407 defining a right molar potion thereof. The groove 462 may have opposing
flanges 464
positioned at and parallel with a bottom surface 466 of its housing 408 and
extending toward
the open void defined by the groove 462. The groove 462 of the housing 408 may
be slid
over and be received on the teeth covering, may have a snap fit to the teeth
covering, may
have an interference fit, or may be fabricated in two parts that can snap into
each other over a
predetermined location of the teeth covering or may be fabricated with three-
dimensional
printing over a teeth covering. The illustrated embodiment in FIG. 13 has the
housing 408
slidingly received on the first end 461 of the teeth covering 407 with the
flanges 464 resting
against bottom surfaces of each of the sides of the teeth covering. Regardless
of the type of
attachment, housing 408 can be movable fore and aft to adjust the position of
the
stimulator/sensor portion to engage the stimulator 454, 455 with a preselected
muscle.
100991 The housing 408 can be molded from suitable plastics or
built with 3-dimensional
printing, especially after photographic/video graphic impressions are made of
one or all teeth,
for example with a system such as Carestream dental imaging. These images can
be used to
make the housing 408 a single tooth just like putting on a temporary crown.
This would be a
removable, disposable or reusable option.
[00100] Turning now to FIG. 15, an alternate embodiment of the tooth
connecting portion
409 of housing 408 is shown. Here, the tooth connecting portion 409 defines a
clasp 500 that
is elastically deformable to fit over a single tooth or a plurality of teeth.
The clasp 500
defines an arcuate shaped opening 502 that receive a tooth or teeth therein
and has opposing
teeth side flanges 504 that seat against opposite sides of the tooth/teeth or
gums The clasp
500 is made of an elastic material that will stretch open as it is fitted over
a tooth/teeth and
will then return to its original position for a tight fit against the
tooth/teeth or gums. To
enhance the elastic flexibility of the clasp 500, the body defining the
arcuate shaped opening
502 can include a plurality of elongate, slightly arcuate bores 506 passing
through the body in
a juxtaposed arrangement to the arcuate shaped opening.
[00101] Turning now to FIG. 16, a maxillary device 600 is shown that includes
a
medicament dispenser 670, but it could just as easily be any of the mandibular
devices
disclosed herein. The maxillary device 600 has a housing 608 connectable to a
tooth of a
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user or connectable or integral with a teeth covering 607. The housing 608
encloses an on-
board circuit board 659 and a power source 620 and comprises a tooth
connecting portion
609, a palate housing portion 611 extending from the connecting portion, and a
charging
feature 618 in an exterior surface thereof for recharging the on-board power
source 620. The
palate housing portion 611 encloses therein a first sensor 650, and optional
second sensor
452, and a medicament dispenser 670 each in electrical communication with a
microprocessor of the on-bard circuit board 659. The on-board circuit board
659 receives
data from sensors 650, 652 and activates the medicament dispenser 670 to
dispense a
medicament to a user's oral cavity as needed under pre-selected conditions.
[00102] The medicament dispenser 670 includes a reservoir housing 672 the
medicament
(i.e., a plurality of doses), which can be in pellet, tablet, powder, or
liquid form, and a
dispenser head 674 open or openable for communication with the oral cavity.
The reservoir
672 is either refillable or removable replaceable with a filled reservoir. The
reservoir 672
may be manufactured separated and is insertable into the cavity of the housing
611. The
reservoir 672 can likely hold 1, or more doses, for example, 2, 3, or 4 doses
of a pre-selected
medicament. The total dose of all batches of medication would not exceed the
total FDA
approved dose for a specified period of time ,exemplified by an 8 hour period.
[00103] In one embodiment, the medicament is radiation pellets for treatment
of oral cancer
or immuno-therapy. In another embodiment, the medicament is trans-mucosal or
sublingual
drugs, for example, but not limited to, nitroglycerine, intermezzo, albuterol,
ADVAIR
medicine. In an embodiment where the medicament is intermezzo, the sensor is
an EEF,
EOG, or EMG sensor to detect insomnia and thereafter dispense the intermezzo.
In another
embodiment, the medicament is nitroglycerine and the sensor is an EKG monitor.
Additional
sensors are beneficial with this embodiment, including a blood pressure
sensor,
echocardiography and/or carotid doppler blood flow. In a third embodiment, the
medicament
is a dry powder micro-aerosol inhalation of insulin to treat diabetes and the
sensor is a non-
invasive continuous glucose sensor. In a fourth embodiment, the medicament is
a
bronchodilator and the sensor is a microphone to detect breathing difficulties
such as
wheezing, for example in asthmatics.
[00104] In one embodiment, the medicament is in pellet form and the pellet is
filled with a
liquid or aerosolized form under pressure therein. The pellet is rupturable,
meltable,
pierceable. or dissolvable A rupturable pellet ruptures upon application of
pressure, such as
being squeezed by a driver of a piezo electric motor. A meltable pellet open
upon application
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of heat, such as heat from the power source via a heating electrode. A
pierceable pellet is
opened by a micro-needle within housing 611. A dissolvable pellet is simply
ejected into the
oral cavity and dissolves in the saliva. Each pellet is a single dose unit of
the selected
medicament relative to the user.
[00105] As in the embodiment of FIGS. 1-3, up to four housings, a right and a
left
maxillary housing and a right and left mandibular housing, can be present and
each could
include a sensor and a medicament dispenser. As such, up to four or more
medicament
reservoirs 672 could be present and each can have a plurality of doses of a
medicament.
Different medications could be installed in different housing, each with an
appropriate sensor
for the medicament. If only one medication is installed in the user's device,
then the
medication and the sensor may be in the same housing or in different housings.
[00106] Turning now to FIG. 17, any of the maxillary devices disclosed herein
may
additionally include a forward facing photography/videography system 700,
which includes a
digital camera or video recorder 702 facing forward. The maxillary device here
is the one
from FIG. 2, modified to have an integrally molded recorder housing 704 which
houses the
digital camera or video recorder 702. The digital camera or video recorder 702
is electrically
connected to the on-board circuit board within housing 109 or includes its own
wireless
transmitting system to send the data to the on-board circuit board within
housing 109 or to an
off-board microprocessor discussed below. Each of the features disclosed with
respect to the
maxillary devices of FIGS. 13-17 are equally applicable to any of the
mandibular and
maxillary devices of FIGS. 1-12.
[00107] Turning now to FIGS. 5 and 12, a controller station 200 is illustrated
for
operatively controlling any of the mandibular lingual repositioning devices
100, 101
described above, which together define a system 300 schematically illustrated
in FIG. 12.
The controller station 200 has a housing 201 defining a first charging unit
202 for receipt of
the maxillary piece 102 and a second charging unit 204 for receipt of the
mandibular piece
104. The first and second charging units 202, 204 may be receptacles defined
in a surface of
the housing 201. In another embodiment, the first and second charging units
202, 204 may
be generally flat plates. The housing 201 has a display screen 203 for
displaying information
to a user and one or more ports 206 for connecting the charging station to
power, other
devices, and/or the internet. Alternately, instead of ports 206, the housing
201 can enclose
wireless communication technology for other devices 310, for example, but not
limited
thereto, a printer, speakers, tablets, laptops, cellular phones, smart
watches, and other cloud-
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based devices. The controller station 200 may include sensors to record
ambient room
conditions, such as light, temperature, humidity, noise/sound, etc. The
controller station 200
optionally is battery powered and may include a rechargeable battery. The
controller station
200 may be portable.
[00108] Alternately, rather than having the first and second charging units
202, 204
integrated into the controlling station 200, a separate charging station (not
shown) having a
first and second charging unit is possible. The charging station may be
portable.
[00109] When the charging station is separate from the controller station 200,
the controller
station may be incorporated into a hand-held smart device and such a smart
device would
share blue tooth, WIFI, Video, audio and communication capability with
sensors. In one
embodiment, the controller can be a proprietary software program for use with
or an App
(software application) having full functionality to function like the
controller station 200.
System 300 and controller station 200 in all its embodiments will be HIPPA and
HITECH
compliant for purpose of medical privacy. Interface with the wide variety of
electronic health
formats (EHR) would allow system 300 and controller station 200 and its
operated systems to
be available for real-time data download and upload, active health care worker
involvement
in user's health care needs and would permit the health care worker to operate
and alter any
treatment and access and interpret diagnostic information provided by the
system. As such
controller station 200 and system 300 would allow newer formats of health care
provisions
such as tele-medicine and others yet to be defined. System 300 may be
integrated into a full-
function health care software-hardware system for patient assessments (such as
telemedicine), tests, treatments and medications.
[00110] The controller station 200 encloses a circuit board having a
microprocessor,
including memory (non-transitory computer readable media) in which is stored
firmware and
learning algorithms, haying a receiver of electronic communications, and
having a transmitter
of electronic communications, including wireless communication capabilities to
electronically communicate with at least the MLRD 100, 101 for real-time
communications
with the sensors on board the MLRD. The MLRD 100, 101 has microprocessors on-
board
with a transmitter to transmit raw data from all sensors, stimulators and
pressure pellets
exemplified by the pulse oximetry sensor, the vibration and airflow sensor,
lingual
stimulator, lateral pterygoid stimulator, medial pterygoid or masseter
stimulator, EKG sensor,
sub-lingual nitroglycerine pellet discharge, etc. to the controller station
200 in real-time aided
by system 300 for processing into executional commands exemplified by
movements of the
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first driver and/or the second driver and activation of the stimulator for
tandem or
synchronized movements and activation thereof, i.e., simultaneous,
independent, or
sequential activation of the motors and the stimulator, training of muscles of
speech or
swallowing including the sequence of movement and strength and duration of
current or
release of a medication for sublingual or aerosolized use. The controller
station 200 can
simultaneously transmits the instructions to the MLRD 100, 101 microprocessors
in each
housing 108, 109, 108' which implement the instructions, exemplified by
synchronizing the
cranial to caudal adjustments, the anterior to posterior adjustments, and
activation of the
stimulator etc. The MLRD may also operate as a stand-alone mandibular
protrusive and
vertical advancement device or as a stand-alone lingual/pterygoid stimulator
device or a
timed-medication release device as preferred by treating health care provider.
[00111] The circuit board of the controller station 200 receives data from the
pulse
oximetry sensor and/or the vibration and air sensor and activates the motors
and the
stimulator as needed after a pre-selected number of breaths of the user. The
firmware and
algorithms, including learning algorithms as well as standard algorithms,
stored in the
memory of the circuit board may define the pre-selected number of breaths to
be every
breath, every other breath, every five breaths, or an absence of breath(s).
Since the
movements of the MLRD 100, 101 are done in real-time, the airway of the user
can be
opened without disturbing the sleep of the user.
[00112] The controller station 200 has a microprocessor configured to process
the data and
instruct the MLRD 100, 101. However, the controller station 200 can
communication with a
server, such as a cloud server, for further processing if desired, or for
additional memory
storage and/or communication of the data to authorized healthcare providers
and/or sleep
analysis experts, etc. and/or communicate with a database of said person. This
intercommunication of databases can create therapeutic interventions and
diagnostic testing
of a user while at home. This system 300 enables an authorized healthcare
provider to
monitor and record patient data in real time, learn the patient, and alter the
patient's treatment
in real-time. The communications to and from the server can be through a wired
or a
wireless connection. The system 300 can also be configured to send data to a
pharmacy.
[00113] The server can also send commands, configuration data, software
updates, and the
like to the controller station 200. The configuration data may include, but is
not limited to,
configuration parameters for the system 300, configuration parameters for a
particular user,
and/or notifications, feedback, instructions, or alerts for the user.
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[00114] The system 300, in addition to the MLRD 100, 101 can wirelessly
communicate
with additional sensors connected to the user to provide a broader data set
for a more
complete picture of the user's physiology. For example, electrocardiogram
(EKG),
electromyography (EMG), electrooculography (EOG), electroencephalography (EEG)
sensors, echocardiography, blood pressure monitoring systems, and sensors
sensing
environmental conditions, such as temperature, ambient light, and humidity.
The system may
include a camera for video recording through the controller station 200 to
evidence any
nocturnal seizures, sleep-walking, other movement or violent disorders during
sleep.
[00115] In operation, data from the sensors on the MLRD 100, 101, such as
oxygen
measurements and pulse data, is sent to the controller station 200 to be
processed by the
microprocessor to determine how much movement of the protrusive flange by
activation of
the second driver is needed, how much movement of the first driver is needed
to separate the
jaws of the user, and if and when to stimulate the transverse lingual muscle
of the tongue to
move the tongue forward. After some breaths, the controller station 200 may
determine to
stimulate the tongue and activate the second driver to move the mandibular
piece, and hence
the jaw of the user, forward (anterior) or backward (posterior) direction. In
other instances,
the controller station 200 may determine to stimulate the tongue and activate
both the first
driver and the second driver to separate the jaws and move the mandibular
piece forward in
order to adequately open the airway of the user.
[00116] The system 300 also creates three-dimensional images and videos of
breathing,
cardiac function, carotid blood flow data, eye-movements, jaw movements and
brain EEG
recordings for identification of medical conditions and interventions that may
be useful to
correct or treat those medical conditions.
[00117] A unique advantage of this system over any other existing systems is
that the jaw
and tongue can move synchronously, independently, or sequentially during sleep
in real-time
and in anticipation of impending airway closure and in a provision of a
measured response to
restriction of airflow as determined by the controller station 200 even before
the airway has
completely closed; thus, restoring unrestricted airflow even before the
patient has completely
stopped breathing. This system can see airway obstruction before it happens
and will keep
the airway constantly open in any body position or depth of sleep. This is a
distinct advantage
over CPAP/B1PAP or any other mechanical or electrical system that is
commercially
available in the market. In addition, there are distinct advantages just by
the breadth of
functionality that has been described above.
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[00118] The controller station 200 includes learning algorithms in the memory
of the
microprocessor that learns a user's sleep patterns and other physiological
events and
functions during sleep and wake, pathological events and activities during
wake and sleep
from the data collected over time and creates a "best response" for the
simultaneous,
independent, or sequential responses exemplified by tensing of the soft palate
or Uvula,
release of medication or stimulation of the stimulator and activation of the
first and second
drivers to open the airway or to train muscles of speech, and to synchronize
these best
responses such as exemplified by certain jaw movements that are associated
with particular
phases of respiration. The activation of the first and second drivers 130, 132
not only
includes advancements, but also retractions of the first and second drivers
130, 132 to relax
the jaws in between necessary advancements to open the airway to avoid
potential TMJ
problems. Any discussions herein directed to the mandibular component, with
respect to the
controller station 200 and the system 300, are equally applicable to the
maxillary component.
[00119] The controller station 200, in the memory of the microprocessor, may
include a
pre-programmed range for the movements of the first and second drivers 130,
132 based on
sleep study data for the user conducted by an authorized healthcare provider.
The pre-
programmed range can be used by the controller station 200 in a stand-alone or
auto servo
mode. The pre-programmed range may be determined by simple or multiple linear
regression models that employ data from inputs and from previous experiences,
which the
controller station 200 will be able to forecast ranges for the amount and
direction of
movements of the drivers 132, 134 and the amount or timing of energy discharge
through the
transverse stimulator(s). The controller station 200, in the memory of the
microprocessor,
may include data from tests previously performed on the user and/or the output
of algorithms
to set the MLRD 100, 101 each day for use just prior to sleep.
[00120] The controller station 200 can operate based on a standalone function
or a servo
function. In the standalone function, the controller station 200 operates the
MLDR 100, 101
based on set parameters for the movement of the drivers, such as repetitive
equal
advancement and retraction of the mandible that are not based on active
feedback. For
example, a set 2 mm movement anteriorly of the mandible during each breath and
a 2 mm
posterior movement of the mandible after each breath, with a fixed amount of
energy
discharge to the electrode of the stimulator. The set parameters for the
standalone function
may be based on data collected from the specific user or may be based on a
peer group of like
sleep attributes.
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[00121] In the servo function, the controller station 200 interactively
controls the MLRD
100, 101 during sleep or wake, at home or elsewhere, based on the data
collected from the
sensors on-board the MLRD in a feedback loop and based on data available from
the server.
During operation, the continual feedback loop allows incrementally accurate
interventions
followed by listening to observational inputs exemplified by airflow
measurements, video
recordings, pulse-oximetry, doppler flow in carotids or advancement of
mandible and
followed by more interventions exemplified by protrusive or vertical
adjustments based on
real-time data even after a previous advancement or incremental increase in
energy to
stimulate the tongue. The changes to the advancement or application of energy
to the
stimulator will be capable of producing positive and negative changes
regarding movement
of the mandible and tongue. For example, the energy applied to the stimulator
may be
reduced relative to the prior application of energy discharge if the previous
discharge of
energy caused teeth grinding or cough. In another example, the protrusive
movement of the
jaw may be reversed if the previous protrusion advancement caused a
deleterious change in
any of the monitored physiological parameters. In another example training of
muscles of
swallowing would be altered upon observing retrograde movement of food or
appearance of
cough or gag.
[00122] Also, in the servo function, data from all sources, server, MLRD, and
any other
sensors attached to the user that are communicating with the controller
station 200, are
continuously processed through algorithms that are stored in the memory of the
controller or
stored in the server. Examples of other sensors includes, but is not limited
to, wireless pulse-
transit time sensors, and wireless EKG sensor. These two additional sensors
would be
utilized in addition to the MLRD to diagnose and treat sleep-induced
hypertension and/or
cardiac arrhythmia such as lack of oxygen to the heart, especially by
collecting time
synchronized data from the EKG sensor and the pulse oximeter sensor. For
example, the
server may include data related to sleep attributes and alcohol consumption to
make
adjustments for the user during sleep after drinking alcohol. For example, it
may require a
change in current applied to the stimulators 116 after alcohol consumption to
effectively
stimulate the lingual muscles. The same may be true of a user taking certain
medications,
especially those that depress brain function. As another example, the server
may include data
on myriad patients correlating sleep attributes to weight loss. As such, if
the user loses 5 or
pounds, data from the server can be considered in the algorithm determining
how much
movement of the jaws is needed and/or whether to stimulate the tongue.
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[00123] The system 300 may be used to treat many medical diseases, including
but not
limited to any type of sleep apnea, bruxism, sleep related GERD, sleep-induced
hypertension,
snoring, etc.
[00124] The system 300 may be used to diagnose any possible medical conditions
related
to sleep or while awake, including sleep apnea or other sleep disorders
including sleep-
induced hypertension, sleep-related cardiac arrhythmia, sleep related
seizures, RLS and
periodic limb movement disorders and other medical diseases, even those
unrelated to sleep.
Here, the IVLLRD 100 or 101 is placed in the user's mouth during a sleep
period, such as at
night, with the controller station 200 in a -test mode" in which the on-board
sensors measure
and monitor the user's physiological parameters mentioned above. The test mode
is used for
multiple sleep periods of over two to 30 days, based on a time period set by a
medical
professional. For example, the user may have the controller station in "test
mode" for seven
days. Then, the seven days of data is reviewed by the medical professional to
deteonine
whether the user has sleep apnea or any other sleep disorder, and if so,
determines the
parameters for the standalone mode, which are then stored in the controller
station 200. The
same system may be used even during the day and outside of the home of the
user such as at
place of work.
[00125] The system 300 may have a therapeutic mode, which implements the servo
function. Here, the feedback loop is on for data from the on-board sensors,
which is
processed through an algorithm to determine the least amount of anterior and
caudal
movement to maintain an open airway and the least amount of energy discharge
to stimulate
the tongue and maintain an open airway and the order in which to take such
actions, i.e.,
simultaneously, sequentially, or individually.
[00126] The device and system disclosed herein have numerous advantages,
including
artificial intelligence utilizing data collected by the MLRD during use to
actively in real-time
adjust the 1VILRD in response to the phases of respiration, degree of
obstruction of the
airway, snore sounds and vibrations and amount of hypoxemia present relative
to each breath
irrespective of the stage of sleep of the user. The system is capable of
measuring a large
number of cardiac, neurological and endocrine sensory inputs as described
above exemplified
by continuous non-invasive glucose, oxygen, blood pressure, pH monitoring,
heart rhythm
and temperature etc. The system is capable of photography for creating dental
impressions,
dentures or to diagnose gum disease etc. The system is capable of executing a
large spectrum
of functions such as mandible protrusion, administering sub-lingual insomnia
medication like
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Intermezzio or cardiac medication like nitroglycerine or training muscle
groups for
swallowing or speech. The system is capable of communicating with user,
provider, EHR
(Electronic Health Record) and pharmacy etc. This system is capable of
determining
restriction to airflow, increase in velocity of air and turbulence, decreasing
levels of oxygen
and increasing levels of heart rate, pH monitoring and any other physiological
parameter that
could be installed in the future with constant inputs of physiological
parameters (unlike with
CPAP machine or oral appliances that are available in the industry), such as
those mentioned
above. This collection and processing of data allows the system to actually
make adjustments
exemplified by the movement of the mandible and tongue prior to closure of the
airway and
hence will work as a preventative form of treatment for sleep apnea.
[00127] Age and gender specific physiology of the airway and the mouth during
sleep are
known to affect sleep and cause sleep disorders. The system 300 and 310 will
collect data
that will enable the development of algorithms that are age and gender
specific, which can
improve treatment outcomes for future users. System 300 and 310 has ability to
create
database of all physiological and pathological events measured in real-time
and time
synchronized with each other in its users and develop algorithms for normal
and abnormal
manifestations of disease states during wake and sleep and develop new cause-
and-effect
understanding of these events that have never been observed before. Recording
and
correlation of these phenomenon with sensors, especially during sleep would
help understand
conditions such as `wake-up strokes' (occur during sleep) that account for 14%
of all strokes
and diagnose conditions like obstructive sleep apnea that occurs with almost
83% of
cardiovascular disease, 58% of heart failure and 53% of atrial fibrillation,
to name a few.
[00128] The system not only advances movement of the mandible (cranially and
anteriorly), but enables a relaxed movement of the mandible (caudally and
posteriorly),
which allows the temporomandibular joint to relax periodically to prevent jaw
discomfort,
temporomandibular joint strain and destabilization, morning stiffness of said
joint, and
alteration of the user's bite.
[00129] The system 300 can also be used for users that snore, but who do not
yet have
sleep apnea. The inclusion of the vibration and airflow sensor enables the
measurement of
the intensity of snoring and can open the airway before the sub-sonic snore
has become
audible. The inclusion of stimulators of soft palate and uvula can reduce or
eliminate snoring
in users that do not have sleep apnea yet. Also, the system 300 can be used
along with a
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CPAP machine and enable the CPAP machine to be used at a lower air pressure
than a
typical setting for user's that cannot tolerate CPAP machine at their typical
air pressure.
[00130] In one example, the devices disclosed herein are worn by a user at
nighttime and
includes sensors to monitor nocturnal silent angina or myocardial ischemia
(measured by
continuous EKG monitoring) that could cause sudden death or acute myocardial
infarction
during sleep or wake (especially silent ischemia). With the medical dispenser
present, an
incident could be treated with release of sublingual nitroglycerine from
medicament reservoir
while data such as continuous blood pressure recording, EKG, echocardiography
and carotid
doppler blood flow is continuously recorded and transmitted to the controller
station 200 or
cloud server 300. The cloud server 300 can then send the data to a monitoring
on-call
physician, a handheld device or computer to alert the patient, as well to the
nearest ER/ED
(emergency room) for early ambulance dispatch.
[00131] In other examples, the sensors selected for use in the maxillary and
mandibular
devices disclosed herein can be those that can diagnose cardiovascular,
gastrointestinal,
and/or neurological medical conditions. The devices can have sensors and
treatment methods
to treat the same medical conditions.
[00132] In an athletic environment, the sensors selected for use in the
maxillary and
mandibular devices disclosed herein can be the pulse-oximetry, heart rate and
EKG, PTT
with non-invasive blood pressure recording, carotid blood flow, airway
resistance and total
tidal volume (airflow measurement per breath), EEG recording, respiratory rate
measurement, and combinations thereof. Data from these sensors will allow
determination
of performance restrictions and methods to physiologically improve performance
such as
legal nutritional supplementation or medications for underlying medical
conditions or
increasing the size of airway to help improve oxygenation and reduce heart
rate during
exercise or athletic performance. Further, evaluation of concussion injuries
is possible with
maxillary and mandibular devices that have EEG sensors, carotid doppler blood
flow
ultrasound sensor, airway and airflow sensors. The protrusive aspect of the
devices can
improve airflow after a concussion by increasing the size of airway with
electrical
stimulation of the tongue when the athlete is unconscious, thereby reducing
brain injury from
loss of oxygen.
[00133] System 300 can be used for scheduled timed administration of
medication through
the mechanisms and devices discussed above, especially for those medications
best
administered while the user is asleep.
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[00134] When medicaments are being administered by the devices disclosed
herein, the
controller station 200 or system 300 would identify a physiological problem of
the user from
data received from the sensors and/or from data received from an external EKG
monitoring
system or external blood-glucose monitoring system of the user followed by
generation of an
executable instruction sent to the device's on-board microprocessor through
wireless data
system (blue tooth or other protocols) with back-up confirmation system for
dangerous
medications. The back-up may be the user themselves (smart phone or display
screen of
controller Station 200) or an on-call nurse or ER physician or authorized
health care provider
or tele-medicine through a smart handheld device or through videography/audio
from a
camera or video recorder in the mandibular or maxillary housing. Data related
to
administration of the medication would require a response the following day
prompting
replacement of discharged pellets or other forms of the medicament, a visit to
the health care
provider's office, or a tele-medicine visit.
[00135] It should be noted that the embodiments are not limited in their
application or use
to the details of construction and arrangement of parts and steps illustrated
in the drawings
and description. Features of the illustrative embodiments, constructions, and
variants may be
implemented or incorporated in other embodiments, constructions, variants, and
modifications, and may be practiced or carried out in various ways.
Furthermore, unless
otherwise indicated, the terms and expressions employed herein have been
chosen for the
purpose of describing the illustrative embodiments of the present invention
for the
convenience of the reader and are not for the purpose of limiting the
invention. Having
described the invention in detail and by reference to preferred embodiments
thereof, it will be
apparent that modifications and variations are possible without departing from
the scope of
the invention which is defined in the appended claims.
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