Note: Descriptions are shown in the official language in which they were submitted.
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HYGIENIC AND ORTHOTROPIC ORAL DEVICES
CLAIMS OF PRIORITY
The present application includes subject matter disclosed in and claims
priority
to U.S. patent application Serial No. 16/711,128, tiled December 11, 2019,
entitled
"Hygienic and Orthotropic Oral Devices"; and application Serial No.
16/183,223, filed
April 12, 2014, entitled "Pacifier with Cleaning Brush" (now U.S. Patent No.
10,555,876); and also provisional patent application entitled Improved
Pacifier and
Nipple" filed July 11, 2019 and assigned Serial Number 62/872,900,
incorporated
.. herein by reference, which describe inventions made by the present
inventor.
BACKGROUND OF THE INVENTION
1. Field of the Invention
The present invention relates to the general art of oral care. The present
invention more particularly relates to a pediatric dental oral hygiene and
orthotropic
development devices and uses thereof.
2. Description of Related Prior Art
Improvements to the BIN K! BRUSH, or pacifier with cleaning brush, may be
used on pacifiers, bottle nipples, or other devices intended for use in a
mouth. Children
from the age of zero to two years commonly use oral apparati, such as
pacifiers, bottle
nipples, teethers, etc. for numerous purposes. As may be understood from the
name
"pacifier", the tool may be used to calm or soothe a child. Additionally, the
tool may
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be used to exercise a child's tongue and cheek muscles., promote development
of the
maxilla, and otherwise serve to clean interior surfaces of the oral cavity via
friction
provided by the pacifier exterior surface(s). While newborns are often born
without
any erupted teeth, up to 15% of newborns in the United States have one or more
teeth
present The "baby" tooth or teeth may be compromised due to decay caused by
bakterial metabolic byproducts such as acids produced from substances in the
oral
cavity such as sugars. present in milk, formula, or otherwise the tooth/teeth
may be
susceptible to damage from bacterial and fungal biofilms that may develop on
the oral
surfaces. It is therefore advantageous to include an oral apparatus that acts
to clean, or
otherwise brush, the upper and lower gingival ridges and/or erupted teeth. In
addition,
it has been shown that in the year 20.14, approximately 40% of children under
the age
of 5 have some evidence of caries, often referred to as baby bottle caries.
Most oral apparati, such as pacifiers, binkies, soothies, etc., are often
symmetrical. Oftentimes, a binky, or surrogate nipple, may be uniformly
isometric,
such as including a cylindrical nub with hemispherical cap (imitating a
mother's
biological nipple). Advanced oral devices may be transversely symmetrical,
left to
right, however, may include longitudinal shape changes such as alternating
superior
and inferior sides to better mimic the shape and location of the tongue, and
the slight
overbite of a baby, newborn, inant, or toddler. The promotion of an ideal
Allotropic
development of the maxillary and mandibular arches leads to the better
development of
the airway spaces, and this contributes to the prevention of multiple chronic
maladies.
As known in the field of orthotropics, deficiencies in airway spaces
exacerbate these
chronic conditions.
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Prior attempts have been made to provide oral devices that achieve the dual
purpose of pacification and oral hygiene, however, they suffer the drawbacks
of
improperly accounting for the changing shape of the mouth during the suckling
exercise. Further, limited inventions have been directed to orthotropics and
improvement of the development of the upper palate andlor mandible in the
developing
mouth.. Nine out of ten children in the developed world may suffetsome level
of
obstructive sleep apnea(OSA), including symptom from sleep disorders, to
breathing
issues, to grOVIth retardation.
It is therefore a primary object of the present invention to provide an oral
device
that provides for friction activated cleansing and/or stimulation of interior
otul surfaces.
It is another object of the present invention to provide a pacifier to mate
with at
least one of the superior or inferior ridges (gingival and/or tooth).
It is yet another object of the present invention to foster proper development
of
the orthoanathic relationship of the upper and lower jaw bones.
It is as yet a timber object of the present invention to foster proper
development
of the upper palate and related bone structures.
It is a further object of the present invention to provide an easy to use oral
device useful for babies and/or small children.
These and other objects of the present invention will become apparent to those
skilled in the art as the description thereof proceeds.
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SUMMARY OF THE INVENTION
The present invention is also directed to an:Oral deviOeadapted to be
partially
inserted into the oral cavity. The present invention may take the form of a
pacifier,
bottle nipple, or otherwise. As a pacifier, the shield set on the outer
surface of the lips,
and the nipple., *ithflangestWingS eniplaced within. Witertkuctioning asa
bottle feed
asisingieniolded piece is prefen* to fit over an open end ofa. bottle.
In the preyiottS:veitiot4 the uppdpOrtiOrt atlit intra oral device intludes a
preferably solid andkr flexible padding With one or more #tat6ti* Bodo or
thicker
portions of the dome (Or pads) will be separable,:or at .leaStiChange their
Math,*
1,:a orientation, as the central material stretches:. A central bite block,
as well as shield
and/or:cap maybe made of one or more stiffer material(s). As the sucking
motion is
conducted, a tongue pressure pushes up on the bottom of the nipple (preferably
at the
tongue guide depression) and causes lateral stretching of the device, As the
device is
stretched, the harder/thicker portions at the top side resist stretching and
are thus thrust
15 against the upper palate and cause a slight upward and laterally outward
force. The
lower portion includes a tongue depression to better ensure proper alignment
of device
*ith the Ceuta:Oft-mufti and tongue. The outer surface :Of the device may
include
bristles, or a spiral shape foroleaning purposes ........................
,:often as rubbed against surfaces of the
mouth.
A nipple version of the present inyeritioninay include various undulations,
and/at ribs, to Cause proper turbulence offlo*Ing:fluids, to provide
stimulation/cleaning to the oral surfacOS and to prevent vacuum seals on the
mouth
surfaces, and avoid I tematomas. The angle of the pronation of the teeth
and/or alveolar
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ridges is prevented from exceeding certain thresholds, e.g. 20% pronation that
can
cause adverse deformation of the malleable (growing) jaws. Further, the
superior and
inferior edges of the device, preferably at the collar, are offset with the
superior set
slightly (e.g. 1-3mm) forward relative the inferior collar to promote proper
allotropic
aligurntnt of the maxilla and mandible relative the skull.
The present invention is directed to an oral pacification device adapted to be
partially inserted into the oral cavity, with the shield set on the outer
surface of the lips,
and the nipple, with flanges/wings emplaced within. There are two components
to the
device-- an extra-oral base piece and an intra-oral nipple. The inn-a-oral
part includes a
bladder formed within an exterior shell. The bladder includes an interior that
is a fluid-
filled chamber. The bladder forms the nipple that extends posteriorly with
flanges/wings set on the bladder outer surface at the anterior end. It is
contemplated
that the flanges be set against the anterior surfaces of the alveolar ridge(s)
and wings set
posterior the ridges. The chamber has a passage opening from the nipple bulb
and into
the flanges/ wings. Preferably the bladder is a single fluid filled chamber,
but it may be
sectioned_ The shell of the bladder includes an outer surface that has surface
features,
such as a texture, tinge/1, bristles, elle. The textured surface may be set in
direct contact
with the ridges (either bare gums (edentulous), ox with erupted teeth). in
alternative
embodiments. the 1-xtured surface may also extend along the inferior surface
of the
nipple and bulb to provide. fbr .:.teaning of the top of the tongue, and along
supetiOr
surface to clean the roof of the mouth/hard palate.
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BRIEF DESCRIPTION OF THE DRAWINGS
The present invention will be described with greater specificity and clarity
with
reference to the following drawings, in which:
Figure 1 illustrates a side cross-sectional view of a bottle embodiment in
passive state as applied into a human mouth.
Figure 2 illustrates :a side cross-sectional view of a bottle embodiment in a
compressed state.as applied into ..a human mouth.
Figure 3 illustrates a side eross-seetional view of the mouth portion in
passive
state of a bottle embodiment of the present invention,
Figure 4 illustrates a frontal view of a nipple in passive state of a bottle
embodiment of the present invention.
Figure 5 illustrates a side cross-sectional view of the mouth portion in
compressed state of a bottle embodiment of the present invention.
Figure 6 illustrates a frontal view of a nipple in compressed state of a
bottle
embodiment of the present invention.
Figure 7 illustrates a top view of a month portion in passive state of a
bottle
embodiment of the present invention.
Figure 8 illustrates a frontal view of a nipple and skin in passive state of
la:
bottle embodiment of the present invention.
Figure 9 illustrates a cross-sectional side view of a skirt and collar in
passive
state a bottle embodiment of the present in:11110M
Figure 10 illustrates a top view of a mouth portion in compressed state a a.
bottle embodiment of the present invention.
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Figure 11 illustrates a frontal view of a nipple and skirt in compressed state
of a
bottle embodiment of the present invention.
Figure 12 illustrates a cross-sectional side view of a skirt and collar in
compressed state a bottle embodiment of the present invention.
Figure 13 illustrates a side view of a bottle embodiment of the present
invention.
Figure 14 illustrates a perspective view of a bottle embodiment of the present
I/Went ion..
Figure 15 illustrates a top view of a rnouth portion of a bottle embodiment of
the present invention.
Figure 16 illustrates a frontal view of a mouth portion of a bottle embodiment
of the present invention.
Figure 17 illustrates a bottom view of a mouth portion of a bottle embodiment
of the present invention.
Figure 18 illustrates a perspective view of a mouth portion of a bottle
embodiment of the present invention.
Figure 19 illustrates a side cross-section view along lines A-A: of FIG, 16.
Figure 20 illustrates=a side cross-section view along lines B-B of FIG. 16.
Figure 21 illustrates a side cross-section view along lines BB of FIG. 16 as
when the mouth portion is in a compressed state.
Figure 22 illustrates a side view of a mouth portion of a bottle embodiment of
the present invention.
Figure 23 illustrates a front cross-sectional view along lines C-C of FIG. 22
in
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passive state.
Figure 24 illustrates a front cross-sectional view along lines CC of FIG. 22
in
compressed state.
Figure 25 illustrates a side cross-sectional vie* Oa bottle ietnbodiment in
compressed state WO Otte vectors Of flow and external pressures.
Figure ;6 illustrates a front view of a bottle embodiment in OasSiye state,
Figure 27 illasttates a partial Vanspatent side perspOgiVO:view 00:00rnativ.0
bottle embodiment in passive State as applied iittO *human mouth.
Figure 28 illastrateSt side croSS,SeCtional view 00 bottle embodiment in
passive, state.
Figure 28A illustrates a side cross-sectional view of a bottle embodiment in
passive state.
Figure 2813 illustrates a side cross-sectional view of a bottle embodiment in
compressed state.
15 Figure 29 illustrates a perspective view of a pacifier embodiment
of the present
invention.
Figure 30 illustrates a pei,spOtiVe :exploded **, of a pacifier enibodiment of
the present invention.
Figure 31 illustrates a side view of a pacifier embodiment of the present
2:0: invention:
Figure 32 illustrates a top view of a pacifier embodiment of the present
invention.
Figure 33 illustrates a front view of a pacifier embodiment of the present
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invention.
Figure 34 illustrates a cross-sectional side -View along lines C-C of FIG, 33.
Figure 35 illustrates a cross-sectional side view along lines B-B of FIG, 32
in
passive state.
Figure 36 illustrates a cross-sectional side view along lines BB of FIG. 33 in
compressed state.
Figure 37 illustrates a top view of= alternative pacifier embodiment of the
present invention.
Figure 38 illustrates a cross-sectional side view along lines AA of FIG. 32.
Figure 39 illustrates a cross-sectional side view along lines A-A of FIG. 37in
passive state.
Figure 40 illustrates a cross-sectional side view along lines A-A of FIG. 37
in
compressed state.
Figure 41 illustrates a cross-sectionat side view along lines A-A of FIG. 32
in
passive state.
Figure 42 illustrates a cross-sectional side view along lines A-A of Fla 32 in
compressed state.
Figure 43 illustrates a top view of an alternative bite block of the present
invention.
Figure 44 illustrates a top view of an alternative bite block of the present
invention.
Figure 45 illustrates a top view of an alternative bite block of the present
invention.
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Figure 46 illustrates a top view of an alternative bite block of the present
invention.
Figure 47 illustrates a top view of an alternative bite block of the present
invention.
Figure 48 illnstrotes amp view of an altOrnative bite block of the present
=ihvention.
Figure 49 illustrates a top,view of ait alteritative bite bloat of the
=ptes0t11
inVeritiott.
Figure 50 illastrate$A side cro!t$,Sectiottal view or a pacifier embodiment of
the
1.,0 present invention
Figure 51 illustrates a cross-sectional view of a pacifier embodiment of the
present invention.
Figure 52 illustrates a cross-sectional view of flanges along plane lines F-F
in
Figure 51.
15 Figure 53 illustrates a cross-sectional view of flanges along plane
lines EE in
Figure 52.
Figure 54 illustrates a 400-seetional side view of tOddler'i oral cavity in
first
position with an embodiment of the present invention applied.
Figure 55 illustrates a cross-sectional sidt7.00w. Ofa toddler's oral cavity
in
2fy keond positiOri with ail embodiment Of the present itIvOtio0 applied.
Figure 56 illustrates a cron-$eetional side view of a toddler's oral cavity in
third position with an embodiment of the present invention applied.
Figure 57 illustratesa top view of an embodiment of the present invention.
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Figure 58 illustrates a cross-sectional side view of an embodiment of the
present invention.
Figure 59 illustrates a side view of an embodiment of the present invention,
Figure 60 illustrates an exploded perspective view of an embodiment of the
present invention.
Figure 61 illustrates a detachable nipple section of an alternative embodiment
of the present invention.
Figure 62 illustrates a close-up cross-sectional side view of circle AA of
embodiment as shown in Figure 58.
Figure 63 illustrates a frontal view of an embodiment of the present invention
in first position.
Figure 64 illustrates a frontal view of an embodiment of the present invention
in third position.
Figure 65 illustrates a cross-sectional side view of a newborn's oral cavity
in
first position with an embodiment of the present invention applied.
Figure 66 illustrates a cross-sectional side view of a newborn's oral cavity
in
second position with an embodiment of the present invention applied.
Figure 67 illustrates across-sectional side view of a newborn's oral cavity in
third position with an embodiment of the present invention applied.
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DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS
With use of embodiments of the present invention, one may provide hygienic
and/or
orthotropic support to newborns, infants, children, adolescents (or even
adults). The present
invention maybe used to prevent adverse deformation of the tissues and bones
associated with
the mouth. When used in newborns and infants, the application of orthotropic
devices can guide
the eruption &teeth and position and orient the bones in an ideal position.
Further, via
application of rhythmic vibrational signaling, stem cells can be activated,
and causing phenotype
improvements via epigenetic expression guided via external stimulation of the
genotype.
Rhythmic vibrational signaling can increase or induce stem cell development in
the area of the
0 signal,
Proper orthotropic development may also have multiple other pathways for
providing a
healthier human, both aesthetically and for health factors. Obstructive sleep
apnea affects
millions of people of all ages. In children symptoms can range from bed
wetting, choking,
drooling, coughing, night sweats, behavioral problem, learning disabilities,
sluggishness,
snoring, teeth grinding, restlessness, attention deficit hyperactivity
disorder (ADD or AD-ID).
By forming an orthotropically aligned mouth (maxilla and mandible), a root
cause of
obstructive sleep apnea (OSA.) can be minimized, controlled, or even
eliminated. With the
present invention and embodiments thereof, we may control or prevent these
chronic and
debilitating diseases.
As can be seen in Figures 13-15, bottle I may. be equipped with cap 2. Bottle
I is shown
with cap 2. Mouth portion 3 is set thereon, and includes skirt 27 and nipple
5. Cap 2 may be
threadedly engaged to screw onto bottle I. Mouth portion 3, fits onto cap 2,
preferably via a
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channel lip fastening connection. It is preferable that cap may be removed
from bottle via
unscrewing, and nipple may be removed from cap, to facilitate cleaning of the
bottle and
components. Cap is preferably made of a hard plastic, while nipple is
preferably made of a
softer plastic, silicon, silicone, or other known material for nipples,
bottles, and pacifiers. Nipple
5 may include air vent 29, preferably set outside area of lips when in use.
With reference to bottle mouth portion 3 in use with a human mouth. Figures 1-
2
demonstrate two states of action. Figure 1 demonstrate the mouth portion 3,
including skirt 27
and nipple 5 applied to a human mouth prior to application of compressive
forces. This is termed
the passive state, as with equilibrium forces within and outside the mouth
portion, the structure,
0 shape, and orientation remain in passive form. Upper lip 10 and lower lip
11 of the user may fit
onto neck 4 as a lip hold along mouth portion of nipple. Major undulations 6
may be provided
opposite bottle along neck 4. Major undulations, including both superior major
undulation and
inferior major undulation 6A and 6B, are preferably set to fit into the
maxillary buccal vestibule
16 and mandibular buccal vestibule 17, respectively. Minor undulations 7, fit
along/between
1 $ major undulations (as shown) and join with the main nipple 5 at collar
S. Together, the major
and minor undulations form ribs.
When sucking, ribs encourage turbulence of fluid flowing within mouth part,
and further
prevent vacuum seal against oral surfaces. Ribs further allow expansion of the
flanges
(undulations) into the collar to fill in portions of the vestibules. Ribs,
allow for mechanical
20 cleaning of gums. Micro movements of the ribs may cause a rhythmic
vibration, and vibrational
signaling, on the oral surflices to stimulate vascular development, tooth
growth, and stem cell
growth in the bony membrane and bone development/production. Ribs may form a
skin 27,
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while major undulations help define a skirt edge 47, that provides for a
bumper to prevent excess
pronation of the alveolar ridges to go beyond twenty-degrees .from vertical
axis 30 (or seventy
degrees from horizontal plane so). Vertical axis 30 and horizontal plane 50
meet at vertex 55,
while skin 27 is intended to roughly rotate along vertex from a more acute
angle, as shown
below in FIG. 28A, to the wider acute angle, as shown below in FIG. 2813, when
exposed to
compressive forces toachieve the compressed state (discussed below with
reference to FIG. .2).
Mandible 15 may be enclosed around nipple for use of bottle. User chin 25 is
shown. Nipple 5
may include milk pore 26 at the proximal end of nipple. Milk pore can be one
or more apertures
in the nipple, dependent on the needed flow rate for feeding in relation to
the age/size of
infant/user.
As between undulations and nipple, a collar 8 is formed. Collar 8 provides
placement. for
maxillary alveolar ridge and mandibular alveolar ridge, respectively.
Maxillary alveolar ridge 12
fits onto superior nipple collar, While mandibular alveolar ridge 13 fits into
inferior nipple collar.
An inferior lingual ridge 9 may be set as between the undulations and a
depressed tongue guide
1$ 21. Tongue guide 21 provides for a depression to locate tongue 18. Tomae
guide also causes
tongue to provide upward force against maxilla, and otherwise exercise and
develop habits to
strengthen and encourage proper tongue placement when not feeding/using
device, and trains the
tongue positioning from an early age. Nipple 5 fits into vault 20 of user's
mouth.
As seen in Figure 2, the sucking action caused deformation of mouth portion 80
into a
.. compressed state. Force vectors are shown via arrows. Lips 10 and 11 press,
or otherwise
provide push vector compressive forces against superior and interior neck 4,
respectively (neck 4
providing a lip hold). Upper and lower skirt, 77 and 87, expand, rotate, and
move to fill
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maxillary and mandibular buccal vestibules, 16 and 17. Maxillary alveolar
ridge 12 and
mandibular alveolar ridge 13 engage collar 8 to bite down onto mouth portion
3. Tongue 18
further presses upwards and anteriorly into tongue depression guide 21 to
press on, or squeeze,
nipple 5. When feeding, the mouth serves to suck on nipple in a posterior
direction (e.g. as when
feeding) to pull nipple. As mouth portion is deformed, nipple 5 extends
posteriorly, and skirt 27
extends outwardly.
As can be seen in Figures 3-6, mouth portion 3 in passive (non-compressed)
state is
shown in Figures 3-4, while in compressed state in Figures 5-6. Air vent 29 is
set along neck 4
in proximity to cap 2 (not shown). Major undulations 6 are shown extending at
offset extending
'IC) .. lengths, with minor undulations 7 set between major undulations 6 and
collar S. As is shown,
superior and inferior collars 8 are offset by linear offset 33 which may be as
much as 1-3
millimeters to from an orthotropic collar to guide jaw relationships, to
optimize positioning as
known in natural breast feeding, and facilitate proper orthotropic jaw
development. It is
contemplated that positioning the superior maxilla., forward by 1-3
millimeters in relation to the
1$ inferior mandible, proper alignment of the jaw will be formed.
As can be seen, in Figures 28, 28A and 28B, vertical axis 30 designates a
twenty-degree
angular offset above 31. and below 32, and horizontal plane 50 designates a
seventy-degree
offset, as the threshold angle to which the pronating alveolar ridge is
abutted and stopped from
further pronation. It is contemplated that the angle of the alveolar ridges
when engaging the
20 collars will limit the forward pronating angle to twenty degrees as is
shown in angle 34. The
angle of twenty degrees from vertical, or seventy degrees from horizontal, is
preferred as the
maximum orthotropic angle fur forward extension of the alveolar ridges and
teeth as they
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emerge. This is in contrast to development of pronate teeth caused by
thumbsucking, etc. as is
known in the art of pediatric orthodontics. Angles less than twenty degrees
are preferable, while
an angle between fifteen and twenty degrees is most preferable. Angles beyond
twenty degrees
would indicate excessive pronate tooth/ridge growth and is prevented by the
extending
undulations.
Figures 28A-28B demonstrate an alternative embodiment of the present
invention. In
passive state, as shown in Figure 28A, skirt 27 .forms a more acute angle.
Additionally, collar 8 is
offset at a lower length &approximately 0-1 mm. As mouth portion 3 is exposed
to
compression forces, skirt 27 expands as minor undulations 7 flatten out to
allow major
undulations 6 to rotate and extend (so as to fill buccal vestibule). Skirt may
be outfitted with
surface features. Skirt 27 includes upper skirt 77, which extends to an angle
of approximately
twenty degrees from vertical, as defined from upper vertex 75 defining an
upper vertical axis 76,
and lower skirt 87, which extends to an angle of approximately twenty degrees
from vertical, as
defined from lower vertex 85 defining a lower vertical axis 86.
1.5 Referring to Figures 26- 27 frenum relief 28 is shown, the device
including both superior
and inferior frenum reliefs 28. Major undulation 6 are shown as are minor
undulation 7, to form
ribs 48.
Referring to Figures 4 and 6, nipple 5 may include obstructive sleep apnea.
(OSA) pads
24. OSA pads 24, both right 24a and left 24b, are adapted to engage the
maxilla of the user
mouth, and apply small forces to achieve ideal orthotropic growth of .maxilla.
Internal padding
of OSA pads provide for superior and lateral forces when engaging maxilla, and
provide
treatment for maxillary bone development to reduce risk and effects of
obstructive sleep apnea.
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OSA pads 24 may include two separate pads, as shown, and milk. pore 26 may
include
one or more holes, or separate openings, to allow for fluid passage from
bottle through nipple.
OSA pads 24 are preferably thicker pads that allow lateral expansion to aid in
orthotropic
development of the maxilla and nasal floor. OSA pads 24 press and separate to
force expansion
of the maxilla. Employing lateral outward pressure on the maxilla, encourages
broadening the
maxilla, thus causing opening the floor of the nose. This well-developed
maxilla and nasal floor
provide proper aeration through the nostrils, and increases ventilation
through the nose to
decrease harmful issues associated with asthma and allergies. Nose breathing
helps warm
incoming air, filter the air, and mixes nitric oxide (a potent vasodilator) to
he received by the
alveoli in the lungs. This in turn causes better oxygen absorption and raises
oxygen saturation in
the blood. further, with proper stretching/growth of the appropriately widened
maxilla through
orthotropics, the mandible will be induced to expand to a proper width as well
in accordance
with widening of upper teeth/ridge in maxilla. Further information on the
proper development of
the maxilla, oral and nasal structures can be found in article entitled Is it
Mental or Dental?
1.5 Cranial & Dental Impacts on Total Health by Dr. Raymond Silkman, DDS,
published March 30,
2006, published by the Weston A. Price Foundation, attached and incorporate by
reference.
Major undulations 6 provide for a skirt 24 surrounding nipple. Compressive
forces applied (by
the mouth) force down on roof of nipple as the infant feed. Compressive forces
are also applied
to the inferior side by the infant's tongue, and fluid is forced from pore.
Superior and lateral
forces on nipple/mouth portion are applied to create maxillary orthotropie
forces in resistance via
OSA. pads, and guide better maxillary bone development. The proper bone
development reduces
the risk of OSA. (Note: passive state shape is shown in broken lines to mark.
dynamic change in
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mouth portion shape.) Additionally, if the OSA pads are used to exert a
widening sideways
outwardly force that widens the maxilla, one may prevent or treat issues
wherein the vault is
widened and thereby lowered reducinR lift on the vomer and anterior nasal
spine, thus preventing
rising forces against the efinnoid bone
In all embodiments, the OSA pads may be a hard or soft solid, gel or otherwise
material
as known in the art for oral treatments, such as silicone, rubber, Plastic,
calcium, silver, zinc, or
otherwise. Further, the OSA pads may be self-contained fluid sacs filled with
a water, or more
viscous fluid to soften the impact on the maxilla, upper palate. The OSA pads
may be filled with
a fluid that contains non-dissolved particles that provide for minor
vibrations as the OSA pad sac
0 is manipulated (or changes shape). Further the OSA pads may be in -fluid
communication with a
fluid filled bladder, such that compression of the bladder forces fluid into
the OSA pad sacs.
As can be seen in Figure 3, mouth portion 3 is shown. Air vent 29 is
preferably placed
on superior side on the anterior edge of mouth portion 3, near where mouth
portion meets cap.
Minor undulations 7 provide for a zone of undulation that can stretch or
otherwise add to
1$ turbulence of flowing fluid. Nipple 5 extends posteriorly from
orthotropic collar 8, and further
include tongue guide 21. Collar 8 includes an offset, whereby skirt superior
rib 48a is set
forward (or anterior), approximately 1-3 mm relative skirt inferior rib 48h.
The offset of the
collar and ribs is associated with proper orthounathic alignment of the jaw.
As can be seen in Figure 5, a fluid flow design is shown. Multiple force
vectors induce
2 0 distortion and migration of major undulations 6 to create flaps that
fill the maxillary and
mandibular buccal vestibules. Air vent 29 is set outside of user lip to allow
a one-way valve flow
of air into the bottle so as to prevent vacuum within the bottle. Air vent is
positioned in a
1 8
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manner that is shall be preferably on the superior side of nipple, but may be
on the inferior side.
Both push and pull force vectors impact the mouth portion and nipple. Push
forces are provided
by the compressive motions, such as lips pursing and alveolar ridges/teeth
biting against the
upper and lower portions of the device. Further, the tongue pressing upwards
causes a push
force vector against the nipple, further distorting the shape. Pull vectors
are provided by the
sucking and. vacuum forces that draw fluid from the bottle through the pores
and air into the vent.
Further, pull vectors cause the nipple to extrude in a posterior direction,
and may meet the roof
of the mouth vault.
It is preferable that the one-way valve prevents fluid exiting, air vent. As
the force
0 vectors engage the nipple, the lips purse against collars 8 to squeeze
nipples at neck 4. Further,
maxillary and mandibular alveolar ridges engage collar 8 to further squeeze
nipple. Finally,
sucking force induces a pull or vector force towards the throat. Sucking is
supported by tongue
thrust from tongue 18, preferably at tongue guide 21 on the inferior side of
nipple. OSA pads 24
are forced up against the maxilla. Fluid flows out of bottle and through milk
pores 26. The path
1$ of flow is guided via the shape of the nipple as it is deformed.
Undulations 8 extend into
vestibules causing a broadening of the nipple. Fluid flows from bottle into
undulations and
causes turbulence within undulations_ This turbulence is preferred to prevent
solids from
forming, and otherwise as a hygienic cleaning function to prevent buildup of
residue, or
otherwise stagnant fluid. As the undulations are flushed, fluid continues to
flow into nipple, in
20 .. turbulent fashion until reaching release at milk pore 26. Both the
repetitive swallow action and
rhythmic vibrational signaling induce stem cell activity.
As can be seen in Figure 6, major undulations 6 form a skirt 41. Nipple 5
includes
9
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tongue depression guide. Here, the mouth portion is shown in full including
air vent 29 and
channel 39. Channel is set to allow screw cap 2 (not shown) to fit via
fastening method over
mouth portion. Preferably, cap includes an extending interior flange to fit.
into channel, while
mouth portion is made of a flexible material that can squeeze into cap. OSA
pads 24a and 24b
are set with a superior cleft 45 set therebetween. OSA pads are preferably of
a thicker material,
and cleft allows for relative movement of pads to defonn flex and bend as
the nipple is
deformed under pressure. Tongue depression guide 21 is shown along with a
simile milk pore.
The daring of the internal S.A. pads will, upon tongue compression, cause
lateral and superior
loading of the two maxillary membranous bony plates.
io
Various shapes of the mouth portion 3 are shown in Figures 7-12, 'Figures 7-9
show the
mouth portion in passive state (when equilibrium forces are set upon system).
Skirt 27 include
frenum relief 28 to engage with the user's mouth. Here' skirt 27 is closed,
and nipple 5 is
intruded. Major undulations 6 form skirt 27. Major undulations 6 and minor
undulations 7
forms ribs 48. Skirt forms a high angle. Figures 10-12 show the system in
compressed. form.
1 $ Nipple 5 is extended (posteriorly) forced by compressive forces andlor
sucking vacuum (ptill)
forces. Skin 27 flares out as neck 4 is squeezed by lips to provide lateral
opening of skirt.
Nipple 5 stretches and extrudes. Ribs 48 are also stretched and reach a low
angle profile. When
ribs and skirt flare out, skirt fills buccal vestibule. Skirt increases in
height, narrows (as minor
undulations flatten), and turns upright. Skirt 27 also provides a bumper of
sort to help guide
20 orthotropic angle of alveolar ridge - preventing excessive pronation.
Mouth portion 3 is shown in isolation for further detail of an embodiment of
the present
invention in Figures 15-24. Mouth portion -3 includes circumferential features
on anterior side,
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including edge flange 101 and secondary flange 102 forming channel 105.
Channel 105 mates
with interior flange in cap (not shown) to provide a flexible, yet water -
tight seal when mouth
portion applied to cap. Skirt 27 .forms With major undulations 6. It is
preferred that an. even
number of major undulations 6, and ribs 48, are formed with a center gap 46
set .therebetween on
both superior and inferior sides. Nipple 5 includes pore 26, or pores in
alternative embodiments.
Skin 27 defines, side edges 47, absent of undulations. Nipple 5 includes
tongue depression guide
21 on the underside of nipple. Further, OSA pads 24 are set preferably within
(as shown, or pan
of the features of the nipple shell, or less preferably on the exterior
surface of nipple shell (not
shown)). As shown in Figure 23-24, nipple 5 moves from passive state (Fig: 23)
to compressed
state (Fig. 24). Tongue guide 21 is forced upwards and further distorts nipple
to cause OSA pads
24a and 24b apart. (Superior) cleft 45 allows for mechanical separation and
rotation of OSA
pads. As shown in Figure 21, fluid flow path is indicated by arrows, fluid
entering mouth
portion 3, passing through skirt (causing interior flushing/cleaning and
causing vibrations)
around OSA pad 24 and out pore 26.
$
Figure 25 further demonstrated the multiple force vectors caused when in use
by user's
mouth to distort and reshape mouth portion 3 on cap 2. Force vectors induce
distortion and
migration of skirt (or flaps) and also produce turbulence of flow through
mouth portion 3.
Pursing of lips 10 and 11 around neck 4 cause compressive force. Alveolar
rictus 12 and 13 bite
down on collar 8. Tongue 18 provide thrust up against tongue guide 21 and
compresses against
maxilla vault 20.
Pacifier embodiments of the present invention are shown in Figures 29-4.2.
Pacifier 500
includes superior collar 5.1 and inferior collar 52. A side wall 53 may
separate superior and
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inferior collars. Shield 54 is shown as is known in the art to engage with the
outer lip of user.
Nipple 55 extends to the distal end, and may include a tongue depression 56.
Flanges 57 and
wings 58 are set on the upper and lower portion of the pacifier. Further,
maxillary frenum
indentation may be set along the center line to allow for relief for the
frenum. As between
flanges and wings, a textured surface 150 is placed and intended to make
contact with alveolar
ridges and otherwise contact vestibules for hygienic, cleaning, and
stimulation. Texture
provides for cleaning, and stimulation of the gains and alveolar ridges. In a
similar manner, in
the bottle embodiment, vibrational forces by flow cause undulations to
stimulate the vestibules
and alveolar ridges. OSA pads 59 may be set on the superior side of nipple,
opposite tongue
depression 56. Cleft, or ceiling gap 62 is set as between OSA pads 59a and
5911. Frenum relief
28 maybe present on superior and inferior sides. Collar 108 is set on both
superior and inferior
sides between flanges 57 and wings 58, with sides 151 set on each side.
Flanges (and wino) are
adapted to bulge and extend when fluid from nipple 55 passes into flanges. As
seen in Figure 30,
shield 54 is connect to bite block 40 with channel 39 set therein to allow for
fluid flow from
nipple 55 into flanges 57.
As can be seen in cross-sectional view Figures 34-36, nipple 55 includes OSA.
pads 59 on
right and left side with central ceiling gap 62 set therebetween within cavity
60. Pacifier is
preferably hollow, or filled with a fluid, or gas, or otherwise within cavity.
As the nipple is
under pressure, the nipple collapses forcing fluid in cavity to extend into
flanges, and in some
embodiments, wings. OSA pads move relative to one another and exert pressure
against maxilla.
is preferable that the interior side of OSA pads 59 include a filleted edge
with rounded corners.
Nipple 55 includes tongue depression 56. OSA pads 59 tit on superior side of
nipple 55
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over cavity 60. Flanges 57 and wings 58 are set therein-with a bite block 40
separating inferior
and superior sides. Bite block includes some aperture or gap to allow fluid to
flow from nipple
into flames when pressure is exerted from teeth or alveolar ridges. While
prior art has been
known to modify the shape or orientation of flanges within a pacifier, prior
art: is limited to
relying solely on pull vectors, or sucking to pull on the device to modify the
shape. In
embodiments of the present: invention, push vectors, such as squeezing of the
lips, alveolar
ridges, and pressing the tongue against the vault all may be used to cause
deformation of the
device so as to extend the flanges into the buccal vestibule(s). OSA pads 59
are of a thicker
cross-section, as opposed to the central ceiling gap 62.
1 0 As
can be seen in Figures 43-50, portions of pacifier embodiments, such as a bite
block
of preferred embodiment of the present invention are shown. Shield 54 is set
on distal end while
nipple extends towards proximal end. Flanges, or skirt 27, are provided and
shown for reference.
Bite block 40 is preferably made of a flexible yet, preferably somewhat
stiffer material than
nipple. in some embodiments, same material may be used. for both nipple and
bite block. An
1 $ alternative embodiment nipple may be flexible, While bite block may be
made of a much harder
plastic or other material. Bite block may include right bar 42 and left bar 43
with flow channel
set therebetween. In other embodiments, bite block may be made of a single
form with an.
aperture set therein. The aperture may be of any shape, here shown as a square
or circle.
Furthermore, right and left bars 42 and 43 may be of any shape so long as flow
channel remains
20 therebetween.
As can be seen in Figures 51-53, an alternative embodiment of a nipple, or
bottle, is
shown with articulating extending flanges. In this embodiment, multiple
chambers provide for an
23
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articulating extension of the flanges to extend both upward and
medially/internally towards the
vestibule and alveolar ridge to facilitate and encourage contact against the
teeth, and/or ridges.
The flanges may expand circumferentially, and the articulating movement causes
the flange to
approximate the mucosa more intimately. As the first, minor, chamber is
filled, overflow into
the major chamber will have the effect of better approximating the flange to
the angle of the
alveolar ridge which inclines .posteriorly/inwardly. Further, these extended
flanges provide a
bumper to prevent excessive pronation of the ridges/teeth beyond twenty-
degrees. Bite block 40
is set between chambers and extends into nipple 55. Lips provide a push force
vector from both
upper and lower surfaces. While tongue provides a anther push force vector
upwards, forcing
0 fluid anteriorly/forwards from cavity within nipple into chambers to
extend flanges. As can be
seen in Figure 23, when nipple 55 is compressed, fluid fills into flanges
including minor
maxillary chamber 72, major maxillary chamber 74, minor mandibular chamber 73,
and major
mandibular chamber 75. It is contemplated that the minor chambers fill first,
extending up and
down, while the major chambers fill second, being forced to extend in the
distal/internal
$ direction, diagonally both up and down at an angle to cause intimate
contact with ridges or
ridges/gums (with erupted teeth). Solid portions 7.1 within flanges are set
and do not accept
moving fluids but allow for manipulation and change of form, such as balloons.
As can be seen in Figure 52, sides 76 may provide a location wherein central
chamber
wall 77 meets superior chamber wall 78 and inferior chamber wall 79. Bite
block 40 is shown as
20 two separate bars. Frenum indentation is shown as both maxillary 63 and
mandibular 64. As
fluid is forced out of nipple and into flanges, fluid first enters minor
maxillary and mandibular
chambers 72 and 73 via fluid flow arrows shown. As the pressure in the minor
chambers rises,
24
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fluid is then directed, due to the lower pressure in the major chambers, into
the major maxillary
and mandibular chambers 74 and 75, causing the flanges to fill the forward
buccal vestibules. In
this manner, the flanges are articulated in a step-wise &shim so as to force
them to extend
outward and then distally towards the vaults, or alveolar ridges.
The present invention is intended to solve the issue of hygienic problems and
provide
caries management. The present invention may reduce baby bottle caries. As it
is known that
15% more or less of newborns have emerged teeth, caries has become a major
issue. The
benefits of the present invention are both health and hygiene as well as
aesthetics of the
development of the maxilla and mouth. By using early guidance of maxilla, one
may reverse
0 environmental trends to allow for ideal phenotypic expression of the
potential genotype so as to
create a healthier and more aesthetic environment. The present invention
provides potential dual
benefit of hygiene and orthotropics to aid decrease the risks of OSA.
The present invention is also directed to an orthoanathically corrected
pacifier that serves
multiple purposes. The device is orthognathically positioned to help nurture
the jaws grow into a
1$ better alignment. The device may be made up of two separable, or joined
parts: an extra-oral
casing preferably of hard plastic, (which may include a bite block., the bite
block fitting into an
intra-oral bladder, preferably made of an antibacterial material such as
silicone. Preferably, the
bladder material has shape-memory to revert to a resting position, and is
further free of latex,
BPA, and phthalate. The bladder may include a nipple and flange(s).
Preferably, the size of the
20 device is sealable to allow a variety of sizes (e.g. small, medium,
large or neonatal, infant,
toddler). Additionally, the relative size and positions of each feature may be
modified to
accommodate the changing shape of the human mouth as the child grows..
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it is preferred that a single chamber is shared between the flange(s)/wing(s)
and the
nipple. However, a flexible wall or walls may separate the bladder into two or
more chambers.
The bladder may be tilled with a fluid, such as air, gas, liquid, or a more
viscous liquid or gel, so
as to allow flanges/wings and nipple to modulate in size and shape based on
pressure exerted by
the position of various muscle movements of the user's oral cavity.
Alternatively, the bladder
may be filled with a flowing malleable solid or pressure-dependent solid, or
may. be a solid
feature. It is contemplated that the fluid may be a freezable liquid that can
be frozen to make the
bladder hard (and cold) to provide a soothing effect, such as the relief of
painful teething of
erupting teeth. Used in its frozen state, as an appliance to soothe and.
relieve the very painful
"I 0 eruption of primary teeth, such as a .teether, etc. freezing fluid
solutions may include water with
little to no soluble materials (e.g. salt, etc.).
Under standard operating, protocols, the invention provides a method for
maintaining oral
hygiene. As suckling is conducted, the nipple may be compressed by external
forces applied by
the patient's oral muscles. The suckling motion causes the nipple to compress,
and forces
1 $ .. transfer of fluid to engorge the flanges. The flanges are therefore
expanded. As the flanges
engorge, the textured surface or bristles set on the outer surface of the
bladder may contact, and
move against (or brush), surfaces of the oral cavity. 'The textured surflice
and/or bristles may be
of a rigid or softer material such as silicone to provide for the mechanical
brushing of the ridges.
Additionally, dentifrices, such as emulsified creams or foams or gels, or
tinctures, of oils,
20 minerals, natural cleansers, soothing formulae, analgesics, etc. as may
be known in the art to
provide for improved oral care, may be provided as a dentifrice in, along, and
between bristles or
ridges. All age appropriate manner of dentifrices known in the art for oral
care are contemplated
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for use on the textured exterior surface of the bladder. Essential oils
(emulsified, diluted, or
pure) are preferred, including peppermint, tea tree, lavender, eucalyptus,
oregano, palma rosa,
orange, lemongrass, geranium, citronella, etc. Alternatively, toothpastes may
be used, preferably
without fluoride (So as to be safe for use with babies). Currently, many such
products are
Available and useful, suchas glycerin, water, silica, algin, calendula
extract., prunus amygdalus
dulcis oil, clove oil, esculin, limonene, benzocaine, belladonna, xylitol,
WINK teething gel, olea
europaea oil, salix alba, eintenia caryophyllus flower oil, rebadiana leaf,
mentha viridis leaf oil,
tocepherol, and many other suitable products as may be known in the an. The
dentifrice is
applied to the exterior surface of the flanges of the bladder, over and
between the textured
.. surface features, such as on and between the bristles.
In order to provide proper orthocnathic alignment, the maxillary arch is
advanced
compared to the mandibular arch by approximately fifteen degrees to promote
correct
orthotmathic growth development. Each arch serves as a flange for placement in
front of the
teeth and/or gingival ridges.
$ Referring now to Figure 54, cross-section of a toddler's face and oral
cavity is shown.
Pacifier 10 is placed into the mouth with the shield 12 and mount 11 placed
outside the cavity.
Upper lip 53 and lower lip 55 fit around shaft 16 to hold pacifier 10 in
place. Superior gum
flange 30 and inferior flange 32 rest in front of teeth, such as superior
incisors 40 and inferior
incisors 42, thus facing superior incisor front 41A and inferior incisor front
43A. Teeth bite
down on prongs 20, wherein prongs 20 serve as a bite block to prevent the user
from biting
through pacifier 10 or otherwise compromising fluid flow by occluding bladder
27. Bristles (or
textured surfaces) 34 extend along flanges and further along nipple surface
(top and bottom).
27
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Nipple 14 is provided to interact with tongue 49 and to be compressed against
hard palate 48.
Nipple is comprised of a bulb 18 with shell 26 (preferably silicone or like
material) surrounding
an inferior bladder 27 filled with air, inert gas, liquid water, viscous
fluid, gel, or otherwise.
Bladder extends from nipple into flanges.
Moving from first position as shown in Figure 54 to second position as shown
in Figure
5.5, the toddler begins the suckling motion in mouth cavity 50. Tongue 49
depresses against
lower side of nipple to force nippleagainst hard palate 48. As tongue presses
against nipple 14,
exterior forces provided by the oral musculature provide higher pressure on
nipple and bladder,
thus forcing the fluid. into superior and inferior flanges 30 and 32. Superior
and inferior flanges
30 and 32 engorge and fill user's vestibule 56 to the front of superior and
inferior incisors 40 and
42. As flanges expand, bristles 34 are forted along tooth surface and
therefore provide
mechanical cleaning of tooth surfaces. Additionally, bristles 34 may extend
further on to nipple
(not shown) so as to provide cleaning of the rear gum, hard palate, and
tongue. In some
embodiments, bristles may extend over the entirety of bladder surface.
As seen in Figure 56, suckling motion is at maximum. Toddler oral cavity 50
moves into
third position. User's tongue provides a higher pressure pressing nipple 14
between tongue 49
and hard palate 48. With this pressure, fluid in the bladder migrates to
flanges, and the bladder is
forced to Change shape to fill both upper and lower vestibules 56 and mate
with forward and rear
surfaces of teeth 40 and 42. Additionally, bristles on bladder outer surface
brush up against the
gingival ridges 44 and 46. it is contemplated that in third position, bristled
portions of bladder
extend over superior gingiva forward surface 45A, superior incisors 40 and
front 41 A, superior
gingiva rear surface 45B of superior gingivae 44, as well as on the lower jaw
to cover. interior
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incisors 42 in both front and back 43A and 43B, as well as inferior gingivae
46 in front and back
47A and 47B. Tongue 49 depresses against nipple 14 to almost completely
evacuate nipple
section of the bladder. Interior surfaces Of shell 26 may resist sticking to
one another when
nipple bladder is completely exhausted. It is contemplated that nipple will
spring back to
memory position and resume the shape of first position once the muscular
forces have been
removed.
As Shown in Figure 57, a top view of the pacifier 10 of an embodiment of the
present
invention is shown. Handle 13 fits onto mount 11, preferably in a rotatable
fashion, through
tunnel 15. A shield 12 is provided to cover the front of the lips. Superior
gum flange 30 is
provided to initially set in front of the superior incisors. Teeth bite down
onto bristles 34 at
bristled section 35 against bite block 38 shown as an interior portion of the
product that would.
not be viewable unless transparent materials are used. Nipple 14 extends with
bulb 18 as is
known in the art.
As Shown in Figures 58-59, side views of the apparatus demonstrate further
aspects of the
present invention. Again, pacifier 10 includes handle 13 mounted onto mount 11
through tunnel
15. Shield 12 is not intended for insertion into the oral cavity. Bite block
38 is formed to prevent
teeth or gums from biting down on through or otherwise impeding movement of
fluid within
bladder. Shield and exterlior portions of the pacifier mate with the nipple
bladder via shaft 16.
Superior gum flange 30 is set slightly forward of inferior gum flange 32 by
approximately fifteen
degrees to provide for proper orthognathic positioning of the jaw. The offset
may be as little as
zero to five degrees, or as much as forty-five degrees, depending mostly on
the thickness of the
nipple and/or bite block, and the age/development of the child user.
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Bristles 34 extend onto flanges and onto nipple 14. Fluid 46 is shown within
AO 26 as
may be forced into flanges and otherwise to change the shape of nipple. It is
preferred that the
shape and dimensions of the flanges accommodate orthognathic placement of the
alveolar ridges.
For illustrative and general relative proportional understanding, a model size
is hereby
.. discussed. It is contemplated that in a preferred model size, the superior
flanges will be set
approximately imin anterior of similarly shaped inferior flanges. Flanges may
be set roughly
transversely extending from the nipple bulb approximately 3 mm, with the
longitudinal bulb
approximately 4 cm long. The textured area, including the bristles or fingers,
may be as extend
along nipple and one or both sides of flanges for as much as 1 cm (when
stretched out
0 longitudinally), to cover the teeth and reach the gums. The lip shield
may include a transverse
diameter of as much as 8 cm. The shield may be as thin as 5 mm, and may be the
bite block
5mm high. The prongs of the bite block may be set apart 8min (infant), 1 cm
(toddler), and 1,5
cm (older child) to create the fluid channel.
As can be seen in Figures 58-59, the shape of the nipple 14 may not be
completely round
1 $ and symmetrical, but in some embodiments may include a differing upper
and lower section. It
is helpful to have a shaped flange to provide for proper alignment of upper
and lower section to
ensure that the onhognathic nature of the present invention is properly
aligned with the front jaw
forward and lower jaw rear by approximately 3mm, .ranging widely I MITI to
7mm, or ranging
narrowly 2.5min to 4mm.
20 Bladder shell may include one or more wings, or a circumferential wing
(as shown in
Figure 6) along outer surface of shell. Upper wing 62 and lower wing 64 are
preferably placed
posterior of superior flange 30 and inferior flange 32, respectively, to form
superior valley 66
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and inferior valley 68, respectively. Superior valley 66 provides for a space
to allow superior
alveolar ridge to set in proper place along bladder surfiice. Similarly,
inferior valley 68 provides
for a space to allow iriftrior alveolar ridge to set in proper place along
bladder surface. In this
way, proper positioning of the ridges, and the jaw can be assured.
Furthermore, wings may be
hollowed (not shown) and share the common. chamber as the flanges shown,
wherein, the wings
may also expand to fill the vestibule upon sucking. Otherwise, the wings are
meant to be smaller
(or extend less) than the flanges so that When bristle surface 35 of bladder
27 extends into
vestibule, the wings do not interfere.
As seen in Figures 60-61, in one embodiment, the present invention includes
two
0 separable pieces. Two independent pieces may be attached to provide a
functional unit. A first
extra-oral piece, or base portion 1, and a second intra-oral nipple portion 2.
The nipple portion
may form a bladder with an open end to be affixed to the base portion to
provide a seal.
Alternatively, the nipple portion may form a complete continuous shell to
provide a sealed
bladder, the nipple portion including one or more cavity(ies) 80 (or recess on
flat facing mating.
1 $ surface) for the emplacement of the bite block.
The first piece, or base portion 1, includes handle 13, mount II, shield 12,
and prongs 20
of bite block 38. Base portion I may include a hollow portion (filled with
air), such as shaft and
lip shield, for comfort. Prongs 20 form the bite block 38 and have channel 21
set therebetween.
Channel allows for bladder to fit over prongs and allow movement of fluids
into flanges. In this
20 way, when the child bites down on the device, a channel is formed to
allow fluid to flow
anteriorly within bladder from the nipple into the flanges. Flanges may
include upper indent 57
and lower indent (not shown) centrally positioned on flange ridge to
accommodate a frenulum.
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The nipple portion 2 includes a bladder 27 that. is formed by shell 26.
Bladder provides both
nipple 14 and flanges 30 and 32. ftft is contemplated that the device may
include a nipple portion
that is completely sealed. In an alternative embodiment, when base portion 1
and nipple portion
2 are combined and mated, the nipple portion 2 will be filled with the fluid
and sealed against
base portion I thereby enclosing the fluid in the reservoir.
Figure 62 demonstrates a close-up of lines A-N in Figure 58. As can be seen,
bladder 27
is filled with a viscous fluid 36. Shell 26 includes a bristle section 35 with
bristles 34. Bristles
may be of a variety of shapes, including sharp and triangular ridges, nubs,
tubular, conical,
hemispherical bumps, rounded ridges, pyramids, etc. as may be known in the art
to provide for
"I 0 friction against an interior surface of an oral cavity. Such bristles
or bristle section makes up
surface features useful for mechanical brushing of oral tissues. Between
various sizes of the
product(s), bristles may be shorter for neonates without teeth, and longer for
older children with
erupted teeth. Superior gum flange 30 includes a filled portion 31 that is
filled with fluid 36
shared between bladder in nipple and bladder in flanges. Bite block 38 is
provided by prong 20.
$ As can be seen in Figures 63-64, the nipple bulb 18, shield 12, and
flanges 30 and 32 are
shown. In this embodiment, superior and inferior flanges form an entire
circumferential fill
around shaft /6. In an alternative embodiment, superior and inferior flanges
are separable.
Bristle section 35 is shown. In Figure 63, first position, bulb is filled with
fluid. Moving to third
position as shown in Figure 64, nipple bulb 18 is depressed and compressed
providing an
20 extension of bristles and bristle section towards flanges 30 and 32. As
can be seen, superior gum
flange 30 and inferior gum flange 32 include upper indent 57 and lower indent
58 to
accommodate fur superior labial frenulum and inferior labial .fienulum,
respectively.
32
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As can be seen in Figures 65-67 a new born in first, .second,.and.third
position,
respectively is shown. Pacifier 10 is placed partially into oral cavity 50,
with shield 12, or lip
guard, set against upper lip 53 and lower lip 55. Newborn lips are known to be
shorter than.
developed lips and enlarge as the child grows. The incisors, having yet to
emerge, are confined.
within superior ridge 140 and inferior ridge 142. Bristles 34 can be set
against the ridges 140
and 142 to provide for massaging or otherwise frictional cleaning of the
gingival surface along
the ridges. Similarly, as the suckling commences, the mouth mimics a set of
feeding postures.
As the tongue 49 depresses nipple 14 against hard palate 48, fluid 36 is
forced in bladder 27 from
bulb 18 into flange filled portions 31 and 33 of the superior 30 and. inferior
32 flanges. The
0 vestibules 56 are thus filled with the flanges to provide for frictional
cleaning of oral surfaces.
33
