Note : Les descriptions sont présentées dans la langue officielle dans laquelle elles ont été soumises.
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OSTEOGENETIC-ORTHODONTIC DEVICE, SYSTEM, AND METHOD
FIELD OF THE INVENTION
The present invention relates to devices, systems, and treatment methods
directed at
aligning and correcting orthodontic or dentofacial abnormalities, including
both foundational
correction (a treatment that changes the skeletal and/or dental tissues) and
functional
correction (a treatment that changes the soft tissues and/or tissue spaces).
More specifically, the present invention relates to devices, systems, and
methods
incorporating osteogenetic-orthodontic appliances. Osteogenetic-orthodontic
appliances are
specialized orthopedic and/or orthodontic appliances that signal the genome of
the patient to
remodel tissues and spaces.
BACKGROUND
In contrast, the prior art teaches that common orthodontic and dentofacial
abnormalities are suitably corrected by using treatment methods and devices
that apply
continuous forces via brackets and wires (which translate to vectors that
apply force to teeth).
Traditional orthodontic or dentofacial treatments that address orthopedic
correction
are known as Phase I treatments and are characterized, typically, as using bio-
mechanical
systems. Examples known in the art include Twin Block appliances. After Phase
I treatments
for orthopedic correction, using brackets bonded to teeth, Phase II is
undertaken: Correcting,
leveling, aligning, and rotation of the teeth is undertaken using wires of
various shapes and
sizes.
The present invention, along with traditional methods and devices, attempts to
correct
common orthodontic and craniofacial abnormalities, which are undesired for
both esthetic and
medical reasons. For example, in the craniofacial region, a well-balanced face
is not only
perceived as beautiful, but it is also free of health problems such as: dental
malocclusions
and tooth wear; facial underdevelopment (including facial asymmetry and
craniofacial
obesity); temporo-mandibular joint dysfunction (TMD), and upper airway
difficulties, such as
snoring, sleep disordered breathing, and obstructive sleep apnea (OSA). These
conditions,
whether diagnosed or covert, represent major issues in this field of work.
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For example, traditional devices and treatments do not adequately address the
underlying causes of poor tooth alignment. Poor tooth alignment is commonly
accompanied
by several other clinically-observable signs and symptoms, such as facial
asymmetry,
according to the patient's genome. One major issue not adequately addressed in
the prior art
teachings and traditional methods and devices is the irregular alignment of
teeth as a result of
development compensation. For example, malocclusion, an obvious sign of which
is irregular
teeth, belies a more serious issue, and may require correction and/or
development of the
bone constituting the jaws during comprehensive orthodontic care.
The current art does not fully treat the underlying cause by adequately
interacting with
or naturally-manipulating the genome because the traditional methods and
devices do not
recognize the importance of the gene-environmental interactions and,
therefore, lack the
structural elements necessary to properly signal the genes, which results in
less than optimal
corrections despite the temporo-spatial pattern or genetic template of facial
development.
Examples of common but detrimental environmental stimuli include myofunctional
influences,
such as bottle-feeding, a lack of breast-feeding, pacifier use, thumb-sucking,
and other
childhood habits including a soft diet of refined foods. Thus, dysfunctional
features - such as
adverse tongue posture, abnormal swallowing patterns, and lip activity - lead
to further
craniofacial consequences as the child matures (such as malocclusion). Yet,
some of these
consequences (such as obstructive sleep apnea) may not manifest until
adulthood.
These consequences are the outcomes of gene-environmental factors that are
thought to perturb the genetic craniofacial foundation encoded by genes, and
include features
such as a high-vaulted palate with maloccluded teeth, and functional features,
such as a
submandibular pannus (double chin). However, the complexity of these gene-
environmental
interactions leads to heterogeneity in terms of patient presentation. Thus,
patients may
present with a single feature, such as a malocclusion, TMD, snoring, wear
facets on teeth,
aged facial appearance, or any combination of the above, even though the
underlying etiology
is similar. For any foundational correction to remain stable, it must be co-
provided with a
functional correction.
More recently, biomechanical loading is thought to be an important regulator
of
osteogenesis, as bone formation occurs in response to its functional
environment. Based on
this information, biophysical techniques of osteo-stimulation have been
successfully
introduced into clinical practice.
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These biophysical techniques include craniofacial distraction osteogenesis,
and the
application of ultrasound etc. to promote bone formation. As well, titanium
implants are
commonly used in orthopedics and dentistry. These implants integrate into the
host's bone
by a complex process known as osseo-integration. Data suggest that
micromechanical
forces may have anabolic effects on bone in-growth surrounding intra-osseous
titanium
implants.
For example, in one study micromechanical forces of 200 mN at 1 Hz were
delivered
axially to implants for 10 minutes per day for 12 consecutive days. The
average bone volume
near the mechanically loaded implants was significantly greater than the
unloaded control
side, and the average number of bone-producing osteoblast-like cells was
significantly greater
on the loaded side compared to the controls. There was also a significant
increase in mineral
apposition and bone-formation rate for the mechanically stressed implants
compared to the
controls. Therefore, modulation of bone in-growth can occur by in vivo
micromechanical
loading.
A considerable part of oral and maxillofacial surgery deals with bone healing.
Recently, low-intensity ultrasound treatment has been shown to reduce the
healing time of
bone fractures. To observe the clinical effects of low intensity ultrasound
after tooth extraction
in patients, the sockets on one side were treated with low intensity
ultrasound while the other
side underwent no treatment. It was found that clinical use of low intensity
ultrasound
reduced post-operative pain and the incidence dry socket, and it also
stimulated bone healing
after extraction of mandibular third molar teeth. Therefore, the potential of
ultrasound to
stimulate maxillofacial bone healing may be of value in other orthopedic
applications.
One study applied ultrasound to human gingival fibroblasts, mandibular
osteoblasts,
and monocytes. Ultrasound was found to induce cell proliferation in
fibroblasts and
osteoblasts by 35-50%. Collagen synthesis was also significantly enhanced (up
to 110%)
using a 45kHz ultrasound device with intensities of 15 and 30mW/cm2 (SA). In
addition,
angiogenesis-related cytokine production, such as IL-8, bFGF and VEGF were
also
significantly stimulated in osteoblasts. Therefore, therapeutic ultrasound
induces in vitro cell
proliferation, collagen production, bone formation, and angiogenesis.
Another known structure known in the prior art is sutures, which are fibrous
connective
tissue joints found between intramembranous craniofacial bones. They consist
of multiple
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connective tissue cell lines, such as mesenchymal cells, fibroblasts,
osteogenic cells, and
osteoclasts. Sutures are organized with osteogenic cells at the periphery,
producing a matrix
that is mineralized during bone growth and development; with fibroblastic
cells with their
matrices in the center. Cyclic loading of these sutures may have clinical
implications
including acting as mechanical stimuli for modulating craniofacial growth and
development in
patients. One study demonstrated that in vivo mechanical forces regulate
sutural growth
responses in rats. In that study, cyclic compressive forces of 300mN at 4Hz
were applied to
the maxilla for 20 minutes per day over 5 consecutive days. Computerized
analysis revealed
that cyclic loading significantly increased the average widths of the sutures
studied in
comparison with matched controls, and the amount of osteoblast-occupied
sutural bone
surface was significantly greater in cyclically loaded sutures. These data
demonstrate that
cyclic forces are potent stimuli for modulating postnatal sutural development,
potentially by
stimulating both bone formation (osteogenesis) and remodeling
(osteoclastogenesis).
In a similar study, static and cyclic forces with the same magnitude of 5N
were applied
to the maxilla in growing rabbits in vivo. Bone strain recordings showed that
the waveforms of
static force and 1 Hz cyclic force were expressed as corresponding static and
cyclic sutural
strain patterns. However, on application of repetitive 5N cyclic and static
forces in vivo for 10
minutes per day over 12 days, cyclic loading induced significantly greater
sutural widths than
controls and static loading. Cell counting also revealed significantly more
sutural cells on
repetitive cyclic loading than sham control and static loading.
Fluorescent labeling of newly formed sutural bone demonstrated more
osteogenesis
on cyclic loading in comparison with sham control and static loading. Thus,
the oscillatory
component of cyclic force, or more precisely the resulting cyclic strain
experienced in sutures,
is a potent stimulus for sutural growth. The increased sutural growth by
cyclic mechanical
strain suggests that both microscale tension and compression induce anabolic
sutural growth
response. Therefore, mechanical forces readily modulate bone growth, and
cyclic forces
evoke greater anabolic responses of craniofacial sutures and cartilage.
In another study, the premaxillo-maxillary sutures of growing rabbits received
in vivo
exogenous static forces with peak magnitudes of 2N, or cyclic forces of 2N
with frequencies
of 0.2Hz and 1 Hz. The static force and two cyclic forces did not evoke
significant differences
in the peak magnitude of static bone strain. However, cyclic forces at 0.2Hz
delivered to the
premaxillo-maxillary suture for 10 minutes per day over 12 days (120 cycles
per day) induced
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significantly more craniofacial growth, marked sutural separation, and islands
of newly formed
bone, in comparison with both sham controls and static force of matching peak
magnitude.
This data demonstrates that application of brief doses of cyclic forces
induces sutural
osteogenesis more effectively than static forces with matching peak magnitude.
Sutural
5 growth is accelerated upon small doses of oscillatory strain (600 cycles
delivered 10 minutes
per day over 12 days), and both oscillatory tensile and compressive strains
induce anabolic
sutural responses beyond natural growth. Oscillatory strain likely modulates
genes and
transcription factors that activate cellular developmental pathways via
mechanotransduction
pathways. And, sutural growth is determined by hereditary and mechanical
signals via gene-
environmental interactions or epigenetics. Therefore, small doses of
oscillatory mechanical
stimuli have the potential to modulate sutural growth for therapeutic
objectives.
The above data suggest that oro-facial sutures have capacities for mechanical
deformation. The elastic properties of sutures are potentially useful for
improving our
understanding of their roles in facial development. Current data on suture
mechanics suggest
that mechanical forces regulate sutural growth by inducing sutural mechanical
strain.
Therefore, various orthopedic therapies, including orthodontic functional
appliances, may
induce sutural strain, leading to modification of natural sutural growth.
Additionally, for example, Singh G. D., Diaz, J., Busquets-Vaello, C., and
Belfor, T. R.
in "Soft tissue facial changes following treatment with a removable
orthodontic appliance in
adults," Funct. Orthod., (2004) vol. 21 no. 3 at pp. 18 - 23 reported dental
and facial changes
in adults treated with a static removable orthodontic appliance (and as
disclosed in United
States Patent Application No. 2007/0264605 published on 15 November 2007 and
as
disclosed in United States Patent Nos. 7,314,372 issued on 01 January 2008 and
7,357,635
issued on 15 April 2008, the full disclosures of which are hereby incorporated
by reference as
if set out fully herein). The maxillary arch showed a 30-percent relative size
increase in the
mid-palatal region (corresponding to the mid-palatal suture) with shape
changes consistent
with improved dental alignment and maxillary expansion in the transverse
direction.
However, the treatment time was excessively long (up to 30 months in one
case).
Nevertheless, current orthodontic and dentofacial orthopedic therapies
exclusively utilize
static forces to change the shape of craniofacial bones via mechanically
induced bone
apposition and resorption, but cyclic forces capable of inducing different
sutural strain wave
forms may accelerate sutural anabolic or catabolic responses.
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Recently, it was shown that low intensity pulsed ultrasound enhances jaw
growth in
primates when combined with a mandibular appliance, and that orthodontically
induced root
resorption can be repaired using ultrasound in humans.
Thus, there remains a need for improved treatment methods, systems, and
devices
that utilize therapy that harness the underlying developmental mechanisms -
encoded at the
level of the gene. Further, such improved treatment methods, devices, and
systems should
utilize the application of brief doses of cyclic forces to induce sutural
osteogenesis.
Additionally, there remains a need for a removable orthopedic-orthodontic
appliance with
cyclic functionality and a system and method to bioengineer vibrational
orthopedic-orthodontic
devices.
Further, teeth are adept at adapting to axial stimuli preferentially through
physiologic
mechanisms. These developmental mechanisms include active tooth eruption,
passive tooth
eruption; and the tooth support phenomenon. For example, when a deciduous
tooth is lost,
the permanent successor will typically actively erupt in an axial direction
until it makes contact
with an opposing tooth or teeth. Similarly, when a tooth is extracted, the
opposing tooth can
passively erupt until it meets some hindrance.
In the tooth support phenomenon, teeth undergo an initial elastic intrusion
when an
axial force is applied; and a further visco-elastic intrusion if the force is
maintained, for
example during mastication. When the axial force is removed, the tooth
undergoes initial
elastic extrusion and further visco-elastic extrusion (recovery) so that the
tooth returns to its
original position, in balance or in equilibrium with the opposing tooth/teeth.
However, when
an orthodontic device is applied to a tooth these natural mechanisms of
homeostasis can be
overpowered.
In contrast, during the development of the dentition, commonly referred to as
tooth
eruption, it is now thought that inherited genes are transcribed and
expressed. The timing
and orderly eruption of teeth is genetically-encoded in a developmental
mechanism that is
part of a systemic phenomenon called temporo-spatial patterning. In other
words, specific
teeth develop at specific sites at specific times. Thus, there is an innate,
physiologic
mechanism of tooth alignment that can be overpowered by biomechanical
orthodontic
therapy.
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Moreover, current research in molecular genetics suggests that external
stimuli can
cause the expression of genes that are not normally expressed. Therefore, the
application of
appropriate external stimuli to teeth that have already completed their
eruptive phase can
cause these teeth to take up new positions in accord with the patient's genome
as determined
by temporo-spatial patterning, using the patient's own natural genome. Bearing
in mind that
teeth are adept at adapting to stimuli in the axial direction, the spring
design described herein
is orientated at an angle approximately parallel to the long axis of the
palatal/lingual surface of
the tooth, unlike all previous designs that contact the palatal/lingual
surface of the tooth in the
transverse plane.
Conventional orthodontic therapy is based on the premise that when a force is
applied
to a tooth, the tooth will move in response to the force. Thus, conventional
fixed orthodontic
approaches are primarily based upon the manipulation of teeth by exerting,
controlling and
maintaining forces, vectors and moments on teeth and/or roots. This torque
control can be
exerted on teeth either individually, segmentally or by the use of wires that
engage the entire
dental arch through the use of brackets.
In order to apply corrective forces, sophisticated systems of brackets and
wires are
commonly deployed. Brackets and/or bands of various designs are directly
bonded to the
surfaces of the teeth. The brackets have slots at various orientations that
can engage wires.
The wires are also of different materials, such as stainless steel and/or
other alloys such as
Nickel-Titanium; and of different cross-sectional shapes, such as round,
square or
rectangular; and of different sizes e.g. 0.016 inch round and 0.018 by 0.022
inch rectangular
etc.
The wires are ligated to the brackets in various ways to permit low-friction,
sliding
mechanics, for example. Typically, the first phase of this biomechanical
orthodontic
correction is leveling using round wires, followed by more detailed tooth re-
orientation using
rectangular or square wires. Other corrections, such as space closure, are
often
accomplished by using elastics attached to the brackets or coil springs along
the arch-wire to
pull or push teeth into positions as determined by the orthodontic clinician.
From the patients' viewpoint, apart from esthetic considerations, one of the
drawbacks
of conventional fixed appliances is the trauma that the metallic orthodontic
components
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and/or elastics may cause. The inside surface mucosa of the cheeks and lips,
as well as the
tongue, routinely contacts the metallic orthodontic components and/or elastics
during
swallowing, speech and mastication, which can cause cheek-biting, painful
mouth ulcers, etc.
In addition, inappropriate forces and moments that reach or exceed physiologic
blood
pressure during fixed orthodontic treatment can cause root resorption, by
producing stresses
in the periodontium. To avoid high pressures, the acting forces need to remain
below about
0.5N. These levels of forces can be achieved by using Nickel-Titanium (NiTi)
wires with a
diameter of 0.012-inches, for example. The use of NiTi wires ensures an almost
constant
moment (torque) based on its stiffness, spring-back, shape memory, and
elasticity. A
superior NiTi alloy wire was developed by the Furukawa Electric Co., Ltd.,
Japan. This
Japanese NiTi wire exhibits "super-elasticity" in that this particular wire
delivers a constant
force over an extended portion of its deactivation range. This Japanese NiTi
alloy wire
undergoes minimal permanent deformation during activation, and its stress
remains nearly
constant despite the change in strain within a specific range. This unique
feature is called
`super-elasticity'. Moreover, Titanium-Niobium-Aluminum (Ti-Nb-Al) springs
generate lighter
and more continuous forces. Thus, Ti-Nb-AI wire has superior mechanical
properties for
smooth, continuous tooth movement, and Ti-Nb-Al wire may be used as a nickel-
free, shape-
memory and super-elastic alloy wire for orthodontic tooth movement instead of
Ni-Ti wire.
Similarly, NiTi coil springs, used with elastic chains, can generate nearly
constant
forces over a wide range of activation due to low load deflection. Reducing
the load
deflection rates of orthodontic springs is important, as it provides relative
constancy of the
moment-to-force ratio applied to the teeth with concomitant, predictable tooth
movements.
Lower load deflection rate springs increase patient comfort and reduce the
number of office
visits, while lowering potential tissue damage.
Using 0.016" X 0.022" NiTi and multi-stranded arch wires employed in a 0.018"
slot
system, with power-hooks or up-righting springs, bodily tooth movements can be
achieved.
But, friction may increase if the up-righting torque is too strong and other
unwanted side
effects such as tooth extrusion, rotation and tipping can also occur.
Therefore, the load-
deflection rate of an orthodontic spring depends on the modulus of elasticity
of the utilized
alloy and the geometric configuration of the spring. Thus, it is usually
preferable to choose
springs with a low load-deflection rate of about 50 p/mm (50kN/mm2).
Nevertheless, it has
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been found that the force systems produced by straight wire and conventional
up-righting
springs can show severe extrusive force components, which may lead to occlusal
trauma.
Furthermore, intra-oral adjustment of up-righting springs is difficult because
of high
susceptibility to minor modifications of geometry.
Prior art had described the design and construction of the stainless steel
flap springs
utilized, including springs constructed of heat-treated alloy wire
transversely orientated
against the palatal/lingual surfaces of the pertinent teeth. Nevertheless,
palatal finger springs;
open springs; boxed springs; cranked palatal springs; re-curved springs,
double cantilever or
Z-springs, and T-springs etc. that are transversely orientated against the
palatalllingual or
mesial/distal surfaces of the pertinent teeth are commonly found in the
orthodontic literature
as known by those skilled in the art. Indeed, the use of acrylic buttons
attached to the
palatal/lingual surfaces of pertinent teeth has been commonly deployed to
prevent the
transversely orientated spring from riding up the palatal/lingual tooth
surface.
Thus, there remains a need for improved treatment methods, systems, and
devices
that utilize springs that harness the underlying developmental mechanisms -
encoded at the
level of the gene. Further, such improved treatment methods, devices, and
systems should
utilize cyclic intermittent forces to induce sutural osteogenesis.
Additionally, there remains a
need for a spring with cyclic functionality as a key component of a system and
method to
bioengineer vibrational orthopedic-orthodontic devices.
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SUMMARY OF THE INVENTION
The present invention provides a device, system, and treatment method for
correcting
common orthodontic and craniofacial abnormalities. In one preferred
embodiment, the
present invention includes a vibrational orthopedic-orthodontic appliance
adapted to induce
5 craniofacial homeostasis by triggering the patient's genome. One objective
of the invention is
to increase, enhance, optimize and augment craniofacial homeostasis,
equilibrium and
balance.
The present invention further contemplates a system comprising a device
including a
removable orthodontic appliance with active plates. Its framework is a base
plate made from
10 acrylic or a similar (thermoplastic) material. The appliance or device
comprises an acrylic
body that incorporates various components within its two halves as shown in
Fig. 1.
This component serves as a base in which the various components are embedded
and onto which clasps, bands or bonded brackets are attached directly or
indirectly (Fig. 2).
The active elements of the device can be vibrational, ultrasonic or
oscillatory
components with an actuator or other expansion mechanism that straddles the
two parts of
the body plate (Fig. 3).
The tooth-contacting material can be high-elasticity, pre-formed alloys that
are
custom-formed to adapt to the long axis of the palatal/lingual surfaces of the
teeth. These
materials can be adjusted as required by the clinician.
Alternatively, electrical ultrasonic/vibrational, meso-motors or micro-motors
can be
located between the two halves of the body plate. These ultrasonic/vibrational
motors can
have their characteristics varied manually or through the use of a
microprocessor, chip or
programmable integrated circuit.
In addition, these small electrical motors adjust the separation of the two
plate halves
automatically through the use of pressure sensors in contact with several
tooth surfaces to
ensure the device remains in contact with the tissues without having to
manually adjust the
appliance. These sensors can be used to monitor, download and measure the
pressure
applied to each tooth or groups of teeth. The sensors can be located in other
positions, such
as the body plate to record readings in the roof of the mouth or floor of the
mouth, and to
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provide soft tissue pressure measurements. In addition, by using a global
positioning system
changes in tooth position could be monitored, downloaded and measured for
calculations and
predictive modeling of changes using appropriate computer software.
Further adjustments can then be made by applying an electric current to the
micro-or
meso-motors, assisted by the readings of the output of the sensors and/or the
global
positioning system. For these reasons, a microprocessor will be provided
embedded within
the body plate.
To power the microprocessor, a battery or cell is also provided, similar to
those used
for hearing aids or bone conductors. The microprocessor is supplied via
conducting wires
with information from the pressure sensors, and its output can drive the
ultrasonic/vibrational,
micro-motors or meso-motors, via other conducting wires at least partially
embedded in the
plastic body, in order to automatically keep the vibrational pressure on the
teeth and tissues
at a pre-set level. Furthermore, the dental healthcare provider can create a
therapy profile
that will lead to a good outcome for each patient. For example, the force
vectors need to be
cyclic, intermittent, long-acting, low-level and consistent so as not to over
do the application of
force and produce an inferior result. This profile may be in the form of data
or digital codes
stored in a memory that is part of the microprocessor. Thus the microprocessor
would control
the motors based on the profile data and the readings from the sensors.
The intra-oral device is attached to at least two permanent or deciduous teeth
using
clasps, bands or direct bonding to the surfaces of the teeth with orthodontic
brackets. A labial
bow and other wires in the form of springs can also be provided as required.
The body of the
device lies in close approximation to the patient's tissues, especially in the
palate in the
maxillary version of the appliance; and on the lingual areas in the mandibular
version of the
appliance. In addition, extensions of the plate body symmetrically overlay the
biting (occlusal)
surfaces of at least two of the patient's teeth in the space where those teeth
would normally
contact the opposing teeth from the upper or lower jaw. The thickness of the
occlusal
coverage ranges from approximately 0.5 mm to approximately 5.0 mm, as
determined by
orthodontic equilibration, and may be absent in certain locations or spots, if
required. The
plate body itself has a thickness that varies, and ranges from about 1.0 mm to
about 5.0 mm,
depending upon the components embedded within it.
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Micromechanical, cyclic, tensile and/or compressive forces and/or doses of
oscillatory
strain will be applied using an ultrasonic/vibrational component similar to
that found in
ultrasonic dental scalers, electric toothbrushes, ultrasonic dental cleaning
appliances and
cellular telephones. The range of force applied will be very low and vary
between 0.1-10N
although forces of other magnitudes may be applied as required. The frequency
applied will
vary between 1-600Hz although other ranges of cycles may be applied as
required.
The device will be activated for 10-60 minutes per day although other
durations of
application may be used as required. The overall duration of the
ultrasonic/vibrational therapy
will last between 5-14 consecutive days or non-consecutive days e.g. alternate
days, although
other durations of therapy will be used as required, depending on the
patient's response, as it
is thought that frequent small activations of a midline screw-mechanism or
actuator are more
effective than a few large ones.
The device may be used in conjunction with conventional fixed orthodontic
appliances
(braces), if required. It may also be used as a component in a two-phase
orthopedic-
orthodontic treatment. The device should be equally applicable to child,
teenage and adult
dental patients.
One preferred embodiment includes two or more retentive (Adams or Delta or
Crozat)
clasps to hold the appliance in place while it is being worn. These Adams or
Delta or Crozat
clasps are attached to the molar teeth and provide good retention.
According to one aspect of the present invention there is provided an
orthopedic-
orthodontic appliance for inducing remodeling of craniofacial hard and soft
tissues including at
least one tooth, the appliance comprising:
a base plate comprising a first half and a second half, the base plate
further comprising at least two overlays adapted to overlay an occlusal
surface of posterior
teeth bilaterally wherein one overlay is adapted to overlay an occlusal
surface of a left-side of
a jaw and the second overlay is adapted to overly a second occlusal surface of
a right-side of
the jaw;
a contacting material comprising at least one axial spring adapted to contact
the
palatal/lingual surface of at least one tooth, the contacting material coupled
to the base plate,
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wherein the contacting material is adapted to produce and transmit
intermittent, cyclic forces
to the palatal/lingual surface of the tooth;
a midline medio-lateral actuator adapted to permit separation of the first
half and the second half, the midline media-lateral actuator being disposed
intermediate therebetween;
clasps coupled to the base plate, the clasps being adapted to bilaterally
contact a posterior of at least one tooth;
and wherein the at least one axial spring comprises a 3-D axial spring
comprising
a continuous spring body comprising an arm portion at a proximal end
and
a head portion at a distal end, the head portion being adapted to
contact the palatal/lingual surface of at least one tooth in an orientation
approximately parallel to the long axis of the tooth and anchored by a base-
plate
the head portion comprising at least one first minor sinusoidal-shaped
coil extending from the proximal end and having a first axis coincident with a
long axis of the axial spring, the head portion further comprising at least
one
first major sinusoidal-shaped coil extending from the proximal end and having
a second axis arranged about 90-degrees from the first axis.
According to a second aspect of the present invention there is provided a 3-D
axial
spring designed for and used within an orthopedic-orthodontic oral appliance
inducing
physiologic tooth movements in accord with the patient's genome, the spring
comprising:
a continuous spring body comprising an arm portion at a proximal end and
a head portion at a distal end, the head portion being adapted to contact the
palatal/lingual
surface of at least one tooth in an orientation approximately parallel to the
long axis of the
tooth and anchored by a base-plate;
the head further comprising three axes of movement, the three axes comprising
a
transverse axis, an antero-posterior axis, and a vertical axis;
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and wherein the spring body being further adapted to produce and transmit
intermittent, cyclic signals to said palatal/lingual surface of said at least
one tooth; and
wherein
the head portion comprising at least one first minor sinusoidal-shaped
coil extending from the proximal end and having a first axis coincident with a
long axis of the axial spring, the head portion further comprising at least
one
first major sinusoidal-shaped coil extending from the proximal end and having
a second axis arranged about 90-degrees from the first axis.
The 3-D axial spring may further comprise:
the head portion comprising a first minor sinusoidal-shaped coil extending
from the
proximal end, a second minor sinusoidal-shaped coil disposed adjacent to the
first minor
sinusoidal-shaped coil and a third minor sinusoidal-shaped coil adjacent to
the second minor
sinusoidal-shaped coil, each first, second, and third minor sinusoidal-shaped
coils being
arranged on the first axis coincident with a long axis of the axial spring,
and
the head portion further comprising a first major sinusoidal-shaped coil
extending from
the proximal end, a second major sinusoidal-shaped coil disposed adjacent to
the first major
sinusoidal-shaped coil and a third major sinusoidal-shaped coil adjacent to
the second major
sinusoidal-shaped coil, each first, second, and third major sinusoidal-shaped
coils being
arranged on the second axis, the second axis being disposed about 90-degrees
from the first
axis.
In one preferred embodiment the appliance includes a passive acrylic baseplate
connecting the two halves with an intervening midline jack-screw. In an
alternate preferred
embodiment the appliance includes a memory- or posture-pedic smart material
for the
baseplate. This active baseplate will help remodel the underlying bone as
tooth movement
proceeds.
Another preferred embodiment of the present invention includes a method for
achieving concurrent craniofacial correction, combining simultaneous
orthopedic and
orthodontic therapies without the use of typical biomechanical forces. The
method comprises:
(a) introducing appliances into the oral cavity that alter the spatial
relations or the bite
of the jaws and teeth;
CA 02675496 2011-02-23
(b) adjusting the appliances to achieve intimate contact with oral structures,
including
the teeth, but without the use of force that push or pull on the teeth;
(c) inducing an intermittent, non-continuous, cyclic stimulus or stimuli that
reach a
physiologic threshold to evoke mechanoreceptors present within craniofacial
sutures,
5 including the periodontium;
(d) permitting tissue remodeling to occur such that the appliances lose
intimate
contact with oral structures, including the teeth; and
(e) re-adjusting the appliance or appliances to re-establish intimate contact.
This method is further adopted to include adjusting the amount of correction
relative to
10 an individual patient's genome. Additionally, the time of correction
depends on the individual's
genome. Notably, this method does not require the application of orthodontic
brackets to the
teeth. However, in an alternative embodiment, the present method adapts to
cooperate with
orthodontic brackets applied to the teeth. In yet another alternative
preferred embodiment, the
method adapts to cooperate with orthodontic wires applied to orthodontic
brackets applied to
15 the teeth.
One possible device or appliance according to another preferred embodiment of
the
present invention includes an orthopedic-orthodontic appliance for inducing
remodeling of
craniofacial hard and soft tissues comprising:
(a) a removable oral appliance composed of a discontinuous hard acrylic base
plate
wherein the discontinuous hard acrylic includes extensions overlaying an
occlusal surface of
posterior teeth bilaterally;
(b) a tooth contacting material, which is anchored to the hard acrylic and
contacts the
palatal/lingual surface of at least one tooth; wherein the contacting material
has the ability to
produce and transmit intermittent, cyclic signals to said palatal/lingual
surface of said tooth;
and
(c) a midline medio-lateral actuator, which permits separation of said two
halves of
hard acrylic, wherein the hard acrylic includes clasps, which are anchored to
said hard acrylic
and attach to said posterior teeth bilaterally.
Further, this contacting material is a wire composed of a single strand of
alloy.
Alternatively, the contacting material is a braided wire composed of a
plurality of strands of
CA 02675496 2011-02-23
16
alloy. In yet another preferred embodiment, the contacting material is
orientated at an angle
approximately parallel to the long axis of said tooth.
In yet another preferred embodiment, the oral appliance includes a contacting
material
comprising a lever arm of a vibrational mesa-motor capable of producing
intermittent, cyclic
signaling.
In yet another preferred embodiment, the oral appliance further includes a
vibratory
signal contacting the palatal lingual surface of one tooth is produced by
ultrasonic technology.
Additionally, the acrylic overlay of posterior teeth bilaterally is about 5 mm
in thickness
or less. And, the vibratory signal is produced by intermittent contact of
opposing teeth in the
maxillary and mandibular dental arches, during sleep, swallowing, speech and
mastication,
for example.
In yet another preferred embodiment, a three-dimensional (3-D) axial spring
design is
described wherein said spring is orientated at an angle approximately parallel
to the long axis
of the palatal/lingual surface of the tooth and/or root (see Fig. 4). Said 3-D
axial spring lies on
palatal/lingual surface of the contiguous oral structures (mucosa) orientated
at an angle
approximately parallel to the long axis of the palatal/lingual surface of the
tooth and/or root
(see Fig. 4). Figures 5 illustrates the three axes, including transverse (from
side to side
across the tooth), antero-posterior (from the front biting edge of the tooth
back towards the
gum), and vertical (spring loops extending up away from the tooth, and down
towards the
tongue).
The 3-D axial spring design wherein the active (compression-extension) axis of
the
spring is orientated at an angle approximately parallel to the long axis of
the palatal/lingual
surface of the tooth and/or root, instead of it lying approximately parallel
to the transverse axis
of the palatal/lingual surface of the crown of said tooth is described. The
initial arm 30 of said
3-D axial spring is embedded in a discontinuous acrylic base-plate, and the
terminal arm 30 of
said 3-D axial spring is embedded in said acrylic base-plate, both arms 30
lying in
approximately the same vertical axis. Said initial arm 30 and said terminal
arm 30 are
connected by a plurality of undulating U-bends that comprise the body of said
3-D axial
spring. Said plurality of U-bends may vary in amplitude, being bigger or
smaller in size. Said
plurality of U-bends may vary in frequency, being many or few in number. Said
plurality of U-
bends may vary in characteristic, being differently shaped, such as a `Z'
formation or a square
CA 02675496 2011-02-23
17
waveform etc. Said plurality of U-bends in said initial and said terminal arms
30 of said body
of said 3-D axial spring lie in close approximation with respect to each other
for the entire
length of said active (compression-extension) axis of said 3-D axial spring.
Said 3-D axial
spring lies on palatal/lingual surface of the contiguous oral structures
(mucosa) orientated at
an angle approximately parallel to the long axis of the palatal/lingual
surface of the tooth
and/or root (see Fig. 4). The head of said 3-D axial spring intimately
contacts the long axis of
said palatal/lingual surface of said tooth (see Fig. 4).
The three-dimensional (3-D) axial spring design as in Figures 5A, 513, and 5C
whereby
a plurality of said 3-D axial springs are orientated approximately parallel to
the long axis of
said palatal/lingual surface of said tooth/root or a plurality of said
teeth/roots (see Fig. 3).
The 3-D axial spring design wherein one active (compression-extension) arm 30
of
said 3-D axial spring is orientated at an angle approximately parallel to the
long axis of the
palatal/lingual surface of the tooth and/or root, and the other active
(compression-extension)
arm 30 of said 3-D axial spring is lying approximately parallel to the
transverse axis of said
palatal/lingual surface of the crown of said tooth. The initial arm 30 of said
3-D axial spring is
partially or fully embedded in a discontinuous acrylic base-plate, and the
terminal arm 30 of
said 3-D axial spring is embedded in said acrylic base-plate, both arms 30
lying at
approximately 90-degrees or less with respect to each other (see Fig. 3). Said
initial arm 30
and said terminal arm 30 consist of and are connected by a plurality of
undulating U-bends
that comprise the body of said 3-D axial spring. Said plurality of U-bends may
vary in
amplitude, being bigger or smaller- Said plurality of U-bends may vary in
frequency, being
many or few. Said plurality of U-bends may vary in characteristic, being
differently shaped.
The arrangement of said plurality of U-bends is in an open configuration for
the entire length
of said active (compression-extension) arms 30 of said 3-D axial spring. Said
initial arm 30 of
said 3-D axial spring lies on palatal/lingual surface of the contiguous oral
structures (mucosa)
orientated at an angle approximately parallel to the long axis of the
palatal/lingual surface of
the tooth and/or root (see Fig. 4). Said terminal arm 30 of said 3-D axial
spring is orientated
at an angle approximately parallel to said transverse axis of said
palatal/lingual surface of
said tooth, not contacting any hard or soft tissues; however, head of said
active
(compression-extension) arm 30 of said 3-D axial spring orientated at an angle
approximately
parallel to said transverse axis of said palatal/lingual surface of crown of
said tooth, lies in
intimate contact with said palatal/lingual surface of crown of said tooth.
CA 02675496 2011-02-23
18
The 3-D axial spring design as in Figures 5A - 5C whereby a plurality of said
3-D axial
springs are interconnected by a plurality of U-bends approximately parallel to
the long axis of
said palatal/lingual surface of said tooth/root or a plurality of said
teeth/roots, said plurality of
U-bends lying on palatal/lingual mucosa of said teeth and/or roots (see Figs.
3 and 4).
CA 02675496 2011-02-23
19
DRAWING
Figure 1 is a bottom view of a device according to a preferred embodiment of
the
present invention.
Figure 2 is a top view of the device of Figure 1.
Figure 3 is a bottom view of an alternative embodiment according to the
present
invention.
Figure 4 is a partial side view showing the embodiment of Figure 3 in
relationship to a
tooth of a patient.
Figure 5A is an offset frontal view of a three-dimensional axial spring device
and
method according a preferred embodiment of the present invention.
Figure 5B is a side view of the 3-D axial spring of figure 5A.
Figure 5C is a top view of the 3-D axial spring of Figures 5A.
Figure 6 shows a device according to a preferred embodiment of the present
invention
used to treat the lower jaw and teeth of a patient.
Figure 7 illustrates a patient's teeth at the beginning of treatment according
to a
method of the present invention.
Figure 8 illustrates the patient of Figure 7 after one week of the treatment
method.
Figure 9 is a representational diagram of a computer system according to one
embodiment of the present invention.
Figure 10 is a "before" drawing of a patient.
Figure 11 is an "after" drawing representing the patient of Figure 10 after a
method
according to the present invention was applied.
Figure 12 illustrates a patient's teeth before the device and method of the
current
invention was applied.
Figure 13 illustrates a patient's corrected teeth after the device and method
of the
present invention was applied.
CA 02675496 2011-02-23
Figure 14 is a side view of a patient before the device and method of the
current
invention was applied.
Figure 15 is a side view of a patient after the device and method of the
present
invention was applied.
5
CA 02675496 2011-02-23
21
DESCRIPTION OF THE INVENTION
Possible preferred embodiments will now be described with reference to the
drawings
and those skilled in the art will understand that alternative configurations
and combinations of
components may be substituted without subtracting from the invention. Also, in
some figures
certain components are omitted to more clearly illustrate the invention.
The present invention, in a first preferred embodiment, includes a treatment
method
including the following procedures:
The clinician should first be able to visualize the effects of ideal facial
development for
a given patient. Next, a clinical examination of the head, neck and facial
area is performed
followed by a postural evaluation. Diagnostic imaging is then performed using
lateral
cephalographs, panoral radiography, computerized tomography, Cone-beam CT
scan, and/or
MRI. Photographic images are also taken intra-orally, extra-orally, and
posturally. Three-
dimensional techniques such as stereophotogrammetry or laser scan should also
be
performed.
Subsequent to medical imaging, an electro-diagnostic analysis is performed
using
Joint Vibrational Analysis (JVA), Electromyography (EMG), and
Electrognathology (EGN).
Impressions of the maxillary and mandibular arches should be taken to produce
study
models, which can be laser scanned to create digital study models.
Prior to the induction of craniofacial homeostasis, a treatment protocol is
developed
with the goal of visualizing the treatment objective.
The foregoing treatment plans need to be based on what is termed the
osteogenetic-
orthodontic concept, i.e., the growth and development of the craniofacial
region can be
influenced by signaling using an osteogenetic-orthodontic appliance. Data-
driven predictive
modeling with computer analyses may be utilized where available.
The following steps must be followed prior to the induction of craniofacial
homeostasis: Evaluation of facial features should include assessments of.
facial asymmetry,
intercanthal angle, sclera, venous pooling, and lower eyelid of the patient.
The vertical and
antero-posterior axes of the ears should be noted. Asymmetry of the nares,
morphology of
the dorsum, and relative size of the nose should be noted, including the depth
of the
CA 02675496 2011-02-23
22
nasolabial grooves. The form of the lips should be examined for: asymmetry,
thin upper lip,
dry and/or everted lower lip, and the depth of the labiomental groove.
Facial profile analysis should include: frontonasal angle, cranial base
length, facial
proportions, under-developed midface/maxilla with or without midfacial
retrognathia,
underdeveloped mandible with or without retrognathia (retruded position).
Esthetic Line of the face is assessed. This is the measurement of the midface
in
relation to the cranial base, and represents the fullness of the facial
profile. It is the distance
from the tip of the nose to the incisal edge of the upper incisor in the
midline. This
measurement should be approximately 38mm in adults.
Protocol for the induction of Craniofacial Homeostasis:
With the foregoing steps accomplished, the next step is the foundational
correction
treatment protocol by which facial development for maximum medical improvement
is
enhanced by achieving skeletal and dental balance, equilibrium and
homeostasis.
The desired results from a successful protocol are: 1) Correcting the size and
shape of
the maxilla; 2) Correcting the size, shape and position of the mandible; and,
3) Bringing the
mandible into occlusion with the maxilla, and maintaining the corrected
spatial relations
(including the posture of the tongue, lips etc.).
TREATMENT PLANNING:
Proper treatment planning will take into account the following: 1) Correcting
skeletal
midline to soft tissue midline; 2) Correcting occlusion to Class I
molar/cuspid relationship;
and, 3) Correcting condyles to symmetrical positions.
For patients having space less than 2mm (Class I Christiansen effect):
Step 1. Development of Maxilla
Insert upper osteogenetic-orthodontic appliance with snug or intimate fit;
Occlusal coverage should be adjusted to avoid open-bite; anterior teeth should
be
edge to edge;
Wear osteogenetic-orthodontic appliance at night-time, or additionally as
indicated;
CA 02675496 2011-02-23
23
Turn screw approximately once per week (abut 0.25 mm), or more or less as
required.
If maxilla is not ready for the turn, the patient should wait until it is
ready (i.e. when the
appliance feels loose).
Step 2. Development of Mandible
Upper appliance should be used for about 3 to about 6 months (or as required)
before
insertion of lower appliance.
Insert lower osteogenetic-orthodontic appliance with snug or intimate fit.
Stop developing the maxilla but have patient continue to wear the upper
appliance.
Mandible should be developed until it occludes with the maxillary arch.
Turn screw approximately once per week (about 0.25mm, or more or less as
required
in a particular patient's case). If mandible is not ready for the turn, the
patient should wait
until it is ready (i.e. when the appliance feels loose).
For steps 1 and 2:
Try to avoid complete buccal crossbite during development.
Anterior 3-D axial springs are activated to re-position teeth to ideal
esthetic line
measurement, approximately.
3-D axial springs are activated for tooth alignment, if needed.
Step 3. Finish treatment
Adjust upper and lower appliances simultaneously until optimally-desired
results are
reached.
Balance any facial asymmetries as far as possible
Step 4. Retention
Maintain balance;
Continue using osteogenetic-orthodontic appliance(s) at night only.
For steps 1-4:
Rate of development depends on individual; and
CA 02675496 2011-02-23
24
Time of treatment depends on rate of development.
For patients having space more than 2mm (Class II Christiansen effect):
Step 1. Development of Maxilla
Insert upper osteogenetic-orthodontic appliance with snug fit.
Patient continues using day-time orthotic repositioning appliance for day
wear,
including eating.
As maxilla develops, adjust day-time re-positioner appliance as required.
If patient wakes up with pain, construct an NTI appliance (night orthotic) for
use during
sleep.
Turn screw approximately about once per week (about 0.25 mm), or as required
(more
or less frequently). If maxilla is not ready for the turn, the patient should
wait until it is ready
(i.e. when the appliance feels loose).
When Christiansen effect is 2mm or less, construct lower osteogenetic-
orthodontic
appliance
Step 2. Development of Mandible
Insert lower osteogenetic-orthodontic appliance with snug fit.
Remove day-time re-positioner appliance.
Stop developing the maxilla.
Turn screw approx. once per week (0.25mm). If mandible is not ready for the
turn, the
patient should wait until it is ready (i.e. when the appliance feels loose).
Mandible should be developed until it occludes with the maxillary arch.
For steps 1-2.
Rate of development depends on individual.
Time of treatment depends on rate of development.
Avoid complete buccal crossbite.
Activate anterior 3-D axial springs for tooth alignment as needed.
CA 02675496 2011-02-23
Step 3. Finish treatment
Adjust upper and lower appliances simultaneously until optimally-desired
results are
reached.
Balance any facial asymmetries as far as possible.
5 Step 4. Retention
Maintain balance.
Continue using osteogenetic-orthodontic appliance(s) at night only.
The Functional Correction treatment protocol is directed toward enhancing
facial
development by achieving extra-oral (facial) and intra-oral soft tissue
balance, equilibrium and
10 homeostasis for maximum medical improvement. This is achieved through: 1)
Developing the
muscles of the face (muscles of facial expression); 2) Developing the muscles
of the jaws
(muscles of mastication); 3) Maintaining corrected spatial relations (posture
of tongue, lips
etc.); and, 4) Losing features of craniofacial obesity where indicated.
A treatment plan is developed which takes into account: 1) Correcting extra-
oral soft
15 tissues; 2) Correcting intra-oral soft tissues; and, 3) Correcting tongue
posture to enhance
functional airway space.
The method developed includes facial therapy to workout facial muscles
approximately 10 mins. per day and oral myofunctional therapy to correct oral
muscles,
including the tongue. This treatment method just described results in before
and after
20 conditions of the patient as exemplified in Figures 10-11, for example.
In a second preferred embodiment, and well-suited for use with the treatment
method
previously described, the present invention includes an orthodontic device or
appliance 10 of
Figures 1 - 6.
Figures 1, 2 and 3 show an orthodontic device or appliance 10 of the split
palate type
25 in accordance with one preferred embodiment of the present invention.
Device 10 includes a
plate body 12, preferably of plastic material, such as acrylic. The plate body
is preferably in
two halves 12A, 12B, but it can be in one piece or in several pieces of
unequal size. Plate
body 12 has overlay 14 extending from it to a position that would cover the
top of a tooth.
While it is shown with one such overlay 14A on the left side in Fig. 3, it
should be understood
CA 02675496 2011-02-23
26
that the overlay 14B is on the right side. The location and extent of the
overlay 14 is based on
a clinical determination by the dental health care provider to achieve the
desired equilibration
in an optimal way.
A first clasp 16 and a second clasp 18 are connected to the plate; preferably
by being
embedded in the plastic material of plate body 12. Each clasp 16, 18 includes
an archway
20, 22 for selectively permitting device 10 to be fitted about a tooth,
preferably one of the
posterior teeth, to hold the device or appliance in place. When fitted or
connected, overlay
14A may be positioned to extend over one of the archways (archway 20 is shown
in Figure 3,
with overlay 14B additionally extending over archway 22) so as to be in
contact with the teeth.
Overlay 14 is preferably placed on top of the teeth adjacent to archway 20 or
22 of the
respective clasp 18, 20, thereby preventing the jaw from fully closing.
The halves 12A, 12B of plate body 12 may be connected by an expansion jack
screw
24. While the screw 24 may be manually adjustable to control the separation of
the plate
halves, a small electrical micro-motor 25 may incorporate the screw 24 and be
used to adjust
the separation.
A labial bow 26, in the form of an arch wire, is also connected to the plate
body 12,
preferably by being embedded in the plastic material of the plate body 12.
Labial bow 26
wraps around the front of the teeth and additionally acts to keep device 10 in
place.
A plurality of 3-D axial springs 28, which are also known in the art as Singh
springs in
Figure 2, for example - or in an alternative preferred embodiment as the Singh
spring 29
shown in Figures 5A, 5B, and 5C , for example - are coupled or otherwise
connected to the
plate body, preferably by being embedded in the plastic material of the plate
body 12. Each 3-
D axial spring 29 includes an arm portion 30 and a head portion 32. As is
common, the head
portion 32 rests against the inside of the teeth and contacts the patient's
tissues at that
location. Typically, the amount of contact can be adjusted by manual bending
of the arm
portions 30.
As an alternative, small electrical motors 35 can be located between the body
plate 12
and one or more of the 3-D axial springs 28 to adjust the contact that the 3-D
axial springs
have to the patient's teeth and tissues without having to manually bend the
springs. In
addition, sensors can be located at the ends of the 3-D axial springs where
they meet the
teeth in order to measure the pressure applied to each tooth or group of teeth
by the 3-D axial
CA 02675496 2011-02-23
27
spring. The sensor can be located in other positions, but in such a case it
would not provide a
direct measurement of the pressure and some calculation would be necessary to
arrive at the
actual pressure.
During use of the device, as the jaw expands and other bones develop, it will
be
necessary to adjust the separation of the body plates 12A, 12B, as well as the
contact of the
3-D axial springs, in order to continue the development of the bones. This can
be
accomplished during periodic visits, e.g., once a week, to the dental health
care provider for
adjustments. Such adjustments can be manual or, where the motors 25, 35 are
present, they
can be made by applying an electric current to the motors. In part, the output
of sensors can
be read by the dental health care provider to better adjust the appliance.
A microprocessor 40 can be provided on or embedded within the body plate 12.
In
order to power the microprocessor, a battery 42 would also be provided. The
microprocessor
may be supplied via conducting wires with information from the sensors and its
output can
drive the micro-motors 25, 35, via other conducting wires at least partially
embedded in the
plastic body 12, in order to automatically keep the contact on the teeth at a
preset level. In
this way patient errors such as missed, over-zealous or reversed screw-turns
are eliminated,
and the visits to the dental healthcare provider are reduced to an optimized
level. Further, the
dental heathcare provider can create a force profile that will lead to a
desired outcome for the
patient. For example, the vectors need to be intermittent, cyclic, long-
acting, low-level and
consistent so as not to over do the application of force and produce an
inferior result. This
profile may be in the form of data or digital codes stored in a memory that is
part of the
microprocessor. Thus the microprocessor controls the motors based on the
profile data and
the readings from the sensors.
The plate body 12 does not include the clasps 16, 18, the labial bow 26, and
the 3-D
axial springs 28 or 29. The body 12 of device 10, except for the overlay 14,
is slightly spaced
from the patient's tissue, including the palate and mandibular lingual areas.
Therefore, the
only portion of the plate body 12 that touches the patient's tissues is the
overlay 14, which
contacts the biting (occlusal) surface of at least one of the patient's teeth
in the space where
that tooth would normally contact an opposing tooth from the opposite set of
teeth, i.e., upper
or lower jaw. The overlay 14 is sufficiently thick to prevent the jaws from
fully closing. The
thickness of the overlay, where it contacts the tooth preferably ranges from
approximately
about 0.5 mm to approximately about 2mm. But, the overlay can have a thickness
ranging
CA 02675496 2011-02-23
28
from approximately about 0mm to approximately about 5.0mm. The plate body 12
has a
thickness that varies and ranges from about 1 mm to about 5mm.
To change the form of the jaw and facial bones with device 10, the device is
placed
within the mouth of a patient so that overlay 14 contacts at least one tooth
and the remainder
of the plate body 12 is spaced from the patient's tissue, including the
palate. Overlay 14
prevents the patient's jaws from fully closing. It is believed that this
contact of the teeth with
the overlay causes intermittent forces to be applied to the body plate 12 and
through it to the
3-D axial springs 28, 29 to the teeth. This cyclic intermittent signaling
stimulates the patient's
genome during function, essentially each time the patient speaks, swallows,
smiles etc.,
which is estimated to be about 2,000 to 3,000 times per day/night. This
frequent cyclic
intermittent signaling on the facial and alveolar bones is believed to cause
development of the
facial and jaw bones where jaw development did not fully occur during
childhood. This bone
development may include a descent of the palate (i.e., remodeling of the vault
of the palate
downwardly toward the lower jaw); a widening of the palate; an upward and
outward
remodeling of the body of the maxilla; and an increase in palatal length, if
necessary.
Figures 7, 10, 12 and 14 show the teeth and mouth of a patient at the
beginning of
treatment prior to use of the device 10 of the present invention. Figures 8,
11, 13 and 15 is
the same patient after partial treatment (for one week) of the device 10. It
should be noted
that the teeth have been re-positioned more favorably in the "after" figures
of 8, 11, 13 and 15
when compared to the "before" figures (7, 10, 12, and 14). In effect the
jawbone has been
developed to accommodate the new position of the teeth. Notice that tooth X
and tooth Y are
now better aligned because of the effects of the device 10. This alignment was
brought about
by the application of intermittent cyclic signals to the patient's tissues.
During function, e.g.,
as the patient swallows while wearing the device, either while awake or
asleep, the teeth
come into contact with the overlay 14, which applies signals through the
device to the bones
of the jaw. This repetitive signaling causes stimulation of the genes that
encode the bones of
the jaw and face. While not wishing to be held to any theory of operation, it
is believed that
the symmetrical nature of the result of the reformation of the teeth and jaw
bones is not due
entirely to the application of force to specific areas of bone, but to the
developmental
mechanisms encoded at the genetic level of the patient, as predicted by the
Spatial Matrix
Hypothesis of Singh.
CA 02675496 2011-02-23
29
The vibrational signals from the 3-D axial springs (for example spring 28, 29
of Figures
1-6) stimulate the patient's jaw (alveolar) and facial bone genes while
wearing the device,
which is estimated to be for about 20-30 minutes per day and/or while sleeping
at night. This
frequent, cyclic, intermittent signaling of the facial and alveolar bones
causes development of
the facial and jaw bones that did not occur optimally during childhood. This
bone
development may include remodeling of the palate, eruption of the teeth,
remodeling of the
facial bones and jaws etc., according to the patient's genome. It should be
noted that the
teeth are expected to relocate outwards; in effect the jawbone will be
expanded to
accommodate the new positions of the teeth, without any new spacing occurring
between
individual teeth.
The spring 28 and 29 is also known as an orthodontic spring and comprises a
resilient
material. Suitable materials, well-understood in this art, include, for
example, a Titanium-
Niobium-Aluminum (Ti-Nb-Al) alloy, a Cobalt-Chromium-Nickel alloy, also known
under the
trade name "Elgiloy " available from Elgiloy Specialty Alloys of Elgin,
Illinois, USA, or a NiTi
wire that exhibits "super-elasticity".
Additionally, the spring 28 and 29 is further comprised of a wire composed of
a single
strand of alloy. Alternatively, this spring is constructed from a braided wire
composed of a
plurality of strands of a single alloy. In yet another embodiment, this spring
is constructed
from a braided wire composed of a plurality of strands of a plurality of
alloys. Other
contemplated alloys include a Nickel-free a-titanium alloy.
Further, the spring 28, 29 includes a spring body having an arm 30 and
oppositely
spaced head 32. The spring body further includes three axes of movement. The
three axes
include a transverse axis (from side to side across the tooth), an antero-
posterior axis (from
the front biting edge of the tooth back towards the gum), and a vertical axis
(spring loops
extending up away from the tooth, and down towards the tongue).
Although the invention has been particularly shown and described with
reference to
certain embodiments, it will be understood by those skilled in the art that
various changes in
form and detail may be made without departing from the spirit and scope of the
invention.
