Note: Descriptions are shown in the official language in which they were submitted.
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IMPROVED MAXILLARY EXPANDER AND PROTRACTION DEVICE
CONTINUITY INFORMATION
This application is related to and claims priority to U.S. Provisional
Application filed
6/15/2018 with serial number 62/685,801 and with confirmation number 5437,
U.S.
Provisional Application filed 11/24/2017 with serial number 62/590,363 and
with
confirmation number 3619, U.S. Provisional Application filed 5/26/2018 with
serial number
62/676,969 and with confirmation number 1055, U.S. Provisional Application
filed
07/17/2018 with serial number 62/699,264 and with confirmation number 7667,
and U.S.
Patent Application filed 08/29/2018 with serial number 16/115,564 and with
confirmation
number 6177; all of which are incorporated herein by reference for all
purposes.
BACKGROUND
Current maxillary skeletal anchorage expanders (hereafter in the background
called
"expander(s)") are devices that can be used to treat patients with transverse
maxillary as well
as anterior-posterior deficiency. With children, palatal expanders have been
used to expand
the maxillary arch to create room for the growth of permanent teeth or to
widen the upper jaw
so that the bottom and upper teeth will fit together better. In some cases,
the jaw is expanded
as a treatment to a compromised airway. Some known palatal expanders comprise
and
expand the maxillary arch by tooth (molar) borne anchorage means (bands)
bridged together
by an adjustable screw mechanism (see U55564920 Klapper). As the screw is
turned, a
bilateral force is generated against the teeth and jaws to cause displacement
of the teeth and
the maxillary arch. Once installed, the adjustable screw is rotated using a
tool. The screw
conventionally comprises two opposing halves, each half having a threaded
portion. The
force from the expanding screw is transferred through arms of the device to
the banded
molars and ultimately results in expansion of the maxillary dental arch and/or
growth from
the median palatine suture. The expander is left in for a therapeutically
effective period and
the patient, or patient's caregiver, activates the expander by rotating the
screw a
predetermined amount over a predetermined period appropriate to the expander
screw
configuration, age of the patient, and condition for which treatment is
applied (e.g., a 1/4 turn
producing 0.25 mm of movement once per week; a 1/4-1/2 turn a day producing
0.25-0.50 mm
of movement a day, etc.). Following a desired expansion, a holding phase is
performed,
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leaving the expander in place for 3-6 months for stabilization, during which
time the screw is
locked in place to prevent the screw from backing up. During the holding phase
the
tooth/jaw interface stabilizes in a new position and the palatine suture grows
back together
across the space, after which time the expander is removed. The expander
described above
expands the space across the palatine suture via forces that are directly
applied to only the
teeth.
Another known expander device is demonstrated in U.S. 9,351,810 (Moon). The
Moon expander uses four mini screws/temporary anchorage devices to mount a
pair of bodies
to the ceiling of the hard palate on either side of palatine suture. Each of
the bodies in Moon
also comprise a pair of extending arms and a pair of tooth anchorage bands
devices similar to
that used by Klapper as mentioned above. The Moon expander comprises a double
ended
screw located between the pair of bodies. When the double ended screw in Moon
is rotated,
forces are applied directly not only to the teeth, but also by the mini screws
to the hard palate
on either side of the palatine suture. Unlike the Klapper device, since force
is also applied
directly to the hard palate, a reduced amount of force can be applied to the
teeth, and a greater
amount of force on the bone, which reduced force means stresses on the
tooth/jaw interface
can be reduced. However, the Moon expander also has a number of disadvantages.
By
applying forces directly to the hard palate, the mini screws are put under
stress and thus are
subject to potential breakage, as is also the bone structure in the area where
the screws are
inserted. Further, although Moon applies less force to the teeth, it
nevertheless transmits
force to and causes movement of the teeth, which may not be desired. For
example, when
treating transverse maxillary deficiency in skeletally mature individuals,
transmitting force to
the teeth can result in undesired alveolar effects, such as alveolar
"bending," tooth root
resorption, and potentially even a "scissors bite." Furthermore, Moon's
expander is only
supported by two mini implants on each side of the median palatine suture,
which often times
in more skeletally mature individuals is insufficient and inefficient at
generating the desired
orthopedic effects, such that could occur with surgical osteotomy followed by
expansion. In
these skeletally mature cases, the limit of only two mini implants on each
side of the median
palatine suture (4 in total) not only is inefficient at generating a desired
orthopedic expansion,
but also results in increased stresses on each individual mini implant and the
bone around
those implants. This is evidenced by the fact Moon's expander often time
requires full
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activation of the expansion screw in skeletally mature individuals, which is 8-
12mm of
activation, just to achieve opening of the median palatine suture and achieve
1-2mm of
orthopedic expansion. As a consequence of this inefficient skeletal expansion
and as a
consequence of the design lacking the ability to interchangeably attach
different size
expansion screws to the anchor bodies, in many cases when treating mature
individuals, at
least two of Moon's devices are required to achieve satisfactory skeletal
expansion. Requiring
multiple uninstallations and installations of the device causes patients to be
subjected to
multiple surgical procedures, increased cost, and discomfort, and requires
greater effort by
the clinician. Also, while Moon's device can be used to apply protraction
forces to patients
with anterior-posterior maxillary deficiencies, the device's reliance on the
teeth for stability
necessitates that protractionary forces must be transmitted at least partially
to the teeth
instead of wholly to the bone structure.
One thing that is needed, therefore, is an expander that does not directly
affect
movement of teeth during expansion of the palatine suture, that enables the
attachment of
interchangeable expansion screws of different sizes, that reduces forces and
stress applied to
screws as well as the local bone supporting the screws and yet is able to more
effectively
distribute force along the median palatine suture, and that enables for true
skeletal
protraction. Stated in another way, what is needed is an expander that can
generate more
substantial and efficient orthopedic effects than the prior art, while at the
same time
eliminating alveolar and tooth effects, and, reducing discomfort and
inconvenience for the
patient and clinician. Maxillary deficiency can also occur in a forward
(sagittal) direction. An
orthodontic device known as the Keles Facemask includes both a palatal
expander and an
external worn orthodontic appliance such as a face bow that impart lateral and
protraction
forces via molar bands that are fixed to a patient's dentition. Jaw movement
imparted by the
Keles device causes forwardly directed downward growth of the maxilla. The
Keles device
relies on tooth borne forces that are then transferred to the maxilla, which
is less than ideal,
since movement that might otherwise be imparted to the maxilla bone is instead
imparted to
teeth.
Another device invented by De Clerck utilizes a bone anchor comprised of a
Bollard
miniplate to transfer forward protraction forces to the maxilla. The De Clerck
device can be
used for maxillary protraction, but it to causes rotation of the maxilla,
which causes
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movement and growth of the maxilla to be directed not just forward, but
downward, and as
well requires relatively invasive mucosal surgery for installation.
What is needed is an orthodontic device that is able to impart forward
movement and
growth of the maxillary skeletal complex and the 9 bones that articulate with
the maxilla in a
manner that improves upon the prior art.
FIGURES
Referring to Figs. la-c, there are seen representations of components of a
skeletal
anchorage device before being coupled intraorally to a patient's upper palate
on either side of
the median palatine suture.
Referring to Figs. 2a-b, there are seen representations of components of a
skeletal
anchorage expander device during their coupling to the hard palate on either
side of the
median palatine suture.
Referring to Figs. 3, there is seen a representation of components of a
skeletal
anchorage expander device after a pair of first bodies has been coupled to a
palate of a patient
and after a first fixed aligner is removed.
Referring now to Figs. 4a-j, there are seen representations of components of a
skeletal
anchorage expander device that comprised of an adjustable aligner and/or a
pair of first
bodies.
Referring to Figs. 5a-b, there are seen representations of components a
skeletal
anchorage expander device, including of a pair of first bodies and a pair of
appliances before
the appliances are coupled to the pair of first bodies.
Referring to Figs. 6a-d, there are seen representations of components of a
skeletal
anchorage expander device including a pair of appliances coupled to a pair of
first bodies
before and after an adjustable aligner is coupled to the pair of first bodies
and the appliances.
Referring to Figs. 7a-b, there are seen representations of components of a
skeletal
anchorage expander device comprised of appliances before and after a distance
between an
adjustable aligner is increased by an adjustment mechanism.
Referring to Fig. 8, there is seen a representation of a pair of first bodies
after a
distance between the adjustable aligner is increased by a clinically desired
amount the
adjustable aligner and appliances are removed.
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Referring to Fig. 9, there is seen a representation of a pair of first bodies
and a pair of
third bodies after the pair third bodies are coupled to the pair of first
bodies via respective
fifth fasteners.
Referring to Figs. 10a-d, there are seen representations of components of a
skeletal
anchorage expander device, including a second fixed aligner.
Referring to Figs. ha-b there are seen representations of a skeletal anchorage
expander device comprised of additional bodies.
Referring to Figs. 12a-c, there are seen representations of a skeletal
anchorage
expander device that does not necessarily rely on the use of a pair of first
bodies.
Referring to Fig. 13, there is seen a representation of another embodiment of
a
skeletal anchorage expander device that does not require use of first bodies
100a-b.
Referring to Fig. 14, there is seen a representation of a third fixed
fastener.
Referring to Figs. 15a-c, there is seen a representation of another third
fixed fastener.
Referring to Figs. 16a-c, there is seen another skeletal anchorage expander
device.
Referring to Figs. 17a-c, there are seen representation of an orthodontic
device
comprised of a pair of third bodies and an externally worn orthodontic
appliance coupled to
the pair of third bodies.
Referring to Fig. 18, there is seen a representation of a pair of first bodies
coupled to
an externally worn orthodontic appliance.
Referring to Figs. 19a-b, there are seen other representations of an
externally worn
orthodontic appliance.
Referring to Figs. 20a-b, there is seen a representation of external forces
applied to an
externally worn orthodontic appliance.
Referring to Figs. 21a-b, there is seen another representation of an
externally worn
orthodontic appliance and its use.
SUMMARY
In one embodiment the present invention is directed to a medical device,
comprising:
at least two bodies, wherein each of the at least two bodies are configured to
be coupled to a
maxilla of a patient and/or to an appliance that is at least in part extra-
oral, and wherein the at
least two bodies are configured to apply forces to the maxilla without any
coupling of the
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device to the teeth of a patient. In one embodiment the present invention
further comprises an
adjustment mechanism configured to variably maintain a distance between the at
least two
bodies. In one embodiment the present invention comprises couplers configured
to couple to
ends of the appliance. In one embodiment the present invention comprises the
appliance. In
one embodiment the present invention the adjustment mechanism comprises
threads. In one
embodiment with the at least two bodies coupled to the hard palate, the
adjustment
mechanism is configured to cause lateral movement of the hard palate. In one
embodiment
with the at least two bodies coupled to the maxilla, an extra-oral force
applied to the
orthodontic appliance causes forward or a combination of forward and upward
movement of
the maxilla. In one embodiment with the at least two bodies coupled to the
hard palate, an
extra-oral protraction force applied to the appliance causes forward or a
combination of
forward and upward movement of the maxilla. In one embodiment the external
protraction
force is applied to the appliance in a direction that is in-line to the at
least two bodies. In one
embodiment the at least two bodies are configured to be releasably coupled to
the orthodontic
appliance by a fastener. In one embodiment the fastener is configured to form
an interference
fit, snap fit, and/or a slip fit. In one embodiment the appliance comprises an
intra-oral
portion and an extra-oral portion, where the intra-oral portion and the extra-
oral portion are
releasably coupled. In one embodiment the at least two bodies are coupled by
an adjustment
mechanism configured to impart lateral movement to the maxilla. In one
embodiment the
adjustment mechanism comprises a body with two ends that have threads at only
one end. In
one embodiment a first of the at least two bodies comprise at a first aperture
and a second
aperture, each aperture disposed along a respective longitudinal axis, wherein
the axis of the
first aperture is not parallel to the axis of the second aperture. In one
embodiment each of the
at least two bodies comprise a plurality or threaded apertures configured to
receive a threaded
fastener. In one embodiment the device comprises the threaded fasteners,
wherein each of the
threaded fasteners comprise two sets of thread, wherein one of the two sets of
threads is
configured to mate with a respective threaded aperture of one of the at least
two bodies, and
wherein a second of the two sets of threads is configured to be threadably
inserted into a
maxilla. In one embodiment the maxilla is the hard palate. In one embodiment
each body of
the at least two bodies comprises a plurality of channels each configured to
receive a fastener
along a longitudinal axis, wherein the longitudinal axis of at least one
channel of the plurality
of channels is disposed in a non-parallel relationship to a longitudinal axis
of at least a second
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channel of the plurality of channels. In one embodiment the longitudinal axis
of the at least
one channel is disposed in an angular relationship with respect to the
longitudinal axis of the
at least a second channel that is between 1 and 60 degrees.
In one embodiment, the present invention includes a maxillary expander,
comprising:
a pair of bodies comprised of a first body and a second body, wherein each of
the pair of
bodies is configured to be fixed intraorally to a palate of a patient; and a
fixed aligner,
wherein the fixed aligner is configured to be fastened to the pair of bodies
to position the pair
of bodies a predetermined distance apart. In one embodiment the present
invention comprises
a plurality of fasteners; a plurality of apertures formed in the pair of
bodies; and a plurality of
matching apertures formed in the fixed aligner; the plurality of fasteners
configured to fasten
the fixed aligner to the pair of bodies via insertion in the plurality of
apertures in the pair of
bodies and the fixed aligner. In one embodiment the present invention
comprises the plurality
of apertures comprise four apertures formed in the fixed aligner and two
apertures formed in
each of the pair of bodies. In one embodiment the present invention comprises
a plurality of
apertures formed in each of the pair of bodies; and a plurality of fasteners
configured to
fasten each of the pair of bodies body to the hard palate via insertion of the
plurality of
fasteners within the plurality of apertures. In one embodiment the plurality
of apertures in
each of the pair of bodies comprises at least three apertures. In one
embodiment the fixed
aligner comprises two ends, and wherein each of the pair of bodies is
configured to be
coupled to a respective one of the two ends. In one embodiment the fixed
aligner is
comprised of a wire. In one embodiment the fixed aligner consists of a single
material. In one
embodiment the expander is configured to be fixed to the palate with a space
present between
the pair of bodies and the tissue covering the palate.
In one embodiment the present invention includes a maxillary expander
comprising: a
first pair of bodies, wherein each of the bodies is configured to be coupled
to a palate of a
patient; and an adjustable aligner, wherein the adjustable aligner is
configured to be
releasably fastened to the pair of first bodies to vary a first distance
between the first pair of
bodies by applying an expansionary force to the first pair of bodies. In one
embodiment the
adjustable aligner comprises a second pair of bodies and an expansion screw
disposed
between the second pair of bodies. In one embodiment the present invention
comprises a pair
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of appliances and at least two supports, wherein each support is comprised of
a first end and a
second end, wherein first ends of at least two of the supports are each
coupled to and extend
from a respective one of the first pair of bodies, and wherein second ends of
the at least two
of the supports are each coupled to an appliance. In one embodiment the
adjustable aligner
comprises a pair of appliances each coupled to a respective one of the second
pair of bodies,
wherein each of the appliances is configured to match a shape of the palate.
In one
embodiment the appliances comprises silicone or acrylic. In one embodiment the
appliances
are not configured to couple to any teeth of the patient. In one embodiment
each of the first
pair of bodies comprises three apertures configured to receive fasteners. In
one embodiment
the three apertures are threaded. In one embodiment each of the second pair of
bodies is
configured to be coupled to respective ones of the pair of first bodies by at
least two screws.
In one embodiment the present invention includes a method of applying forces
to an
maxilla of a patient without engagement of any teeth of the patient,
comprising the steps of:
providing at least two bodies; coupling the at least two bodies to locations
on the maxilla
coupling an adjustable expander to the at least two bodies; and using the
adjustable expander
to apply a force to the at least two bodies to cause movement of the at least
two bodies
relative to one another and to cause expansion of the maxilla. In one
embodiment the
adjustable expander comprises threads at opposing ends of the expander. In one
embodiment
the movement of the at least two bodies is used to bilaterally expand the
maxilla. In one
embodiment the adjustable expander comprises threads at only one end of the
expander. In
one embodiment the movement of the at least two bodies is used to unilaterally
expand the
maxilla. In one embodiment the locations are on either side of the mid-
palatine suture.
In one embodiment the present invention includes a maxillary expander
comprising: at
least one pair of bodies comprised of a first body and a second body, wherein,
each body of
the pair of bodies is configured to be coupled intraorally to a hard palate of
a patient; and an
aligner, wherein the aligner is coupled to the pair of bodies and configured
to position the pair
of bodies a distance apart to cause expansion of the palate without any
engagement of the
aligner or the at least one pair of bodies with any teeth of the patient. In
one embodiment the
aligner comprises a fixed aligner or an adjustable aligner. In one embodiment
the at least one
pair of bodies is selected from the group consisting of two appliances, two
wires, and two
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fasteners. In one embodiment each body of the pair of bodies is configured to
be coupled
intraorally to the palate with at least one fastener. In one embodiment each
fastener comprises
two parts. In one embodiment the two parts comprises threaded portions and the
two threaded
portions are separated by a non-threaded portion. In one embodiment the two
parts are
separable. In one embodiment each of the at least one pair of bodies comprises
apertures
configured to receive fasteners having a body with threads at a top end and a
bottom end,
wherein the counter sunk apertures comprise threads configured to threadably
mate with the
threads at the top end. In one embodiment the apertures are countersunk. In
one embodiment
the threads at the top end and the threads at the bottom end are separated by
a non-threaded
portion.
In one embodiment the present invention is directed to a method of treating a
maxillary
deficiency, comprising the steps of: providing a pair of first bodies;
coupling the pair of first
bodies to a hard palate of a patient; attaching an externally worn appliance
to the pair of first
bodies; and applying a protraction force to the appliance to cause forward
movement of the
pair of first bodies. In one embodiment the method provides an expander
between the pair of
first bodies; and causing the expander to move to cause lateral movement the
pair of first
bodies relative to one another. In one embodiment the protraction force is
aligned to cause
only forward or forward and upward movement of the patient's maxilla. In one
embodiment
the protraction force generates little or no moments at the pair of first
bodies. In one
embodiment protraction force is applied in a direction that passes through the
pair of first
bodies and a point on the appliance where the force is applied to.
In one embodiment the present invention is directed to a method of laterally
expanding a
maxilla of a patient, comprising the steps of: intraorally attaching a pair of
first bodies to the
maxilla while maintaining a first space between the first bodies; attaching an
adjustable
aligner to the pair of first bodies; adjusting the adjustable aligner to cause
an expansionary
force to be applied to the pair of first bodies such that the first space is
changed to a second
space change; removing the adjustable aligner from the pair of first bodies;
and affixing a
first fixed aligner to the pair of first bodies to maintain the second space
between the first
bodies. In one embodiment the step of creating a first space between the
bodies comprises
affixing a second first fixed aligner to the pair of first bodies to create
the first space; and
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subsequently removing the first fixed aligner from the pair of first bodies
before attaching the
adjustable aligner. In one embodiment the method comprise a step of affixing
an appliance to
each of the bodies. In one embodiment the method comprises a step of coupling
the appliance
to a hard palate and not to any of the teeth of the patient. In one embodiment
each of the pair
of first bodies is affixed to the palate on either side of the median palatine
suture. In one
embodiment the step of intraorally attaching the bodies includes a step of
inserting at least
three fasteners through each body and into the hard palate.
In one embodiment the present invention is directed to a method of expanding a
median
palatine suture, comprising the steps of: providing a pair of first bodies;
providing a pair of
acrylic appliances; intraorally coupling the pair of first bodies and the pair
of acrylic
appliances to a hard palate while maintaining a first distance between the
pair of first bodies;
and applying an expansionary force to the first bodies such to change the
first distance
between the first bodies to a second distance.
In one embodiment the present invention is directed to a method of expanding a
maxilla,
comprising the steps of: providing a pair of first bodies; coupling the pair
of first bodies to a
hard palate;,attaching an aligner to the pair of first bodies; maintaining the
pair of first bodies
a distance below and apart from the hard palate. In one embodiment the aligner
is an
adjustable aligner. In one embodiment the aligner is a first fixed aligner. In
one embodiment
the distance is between .1 to 3mm. In one embodiment the method comprises
providing a
spacer to between the pair of first bodies and the hard palate. In one
embodiment coupling
comprises use of threaded fasteners. In one embodiment the distance is
maintained via
locking of threads of the threaded fastener into the pair of first bodies.
In one embodiment, the present invention comprises a maxillary expander,
comprising:
at least two bodies, wherein each of the at least two bodies are configured to
be coupled to a
hard palate with a first distance between the at least two bodies and the
palate; and an
expander configured to maintain a second distance between the at least two
bodies. In one
embodiment the expander comprises ends that are threaded. In one embodiment
the expander
comprises only one end that is threaded. In one embodiment further comprises
an aligner. In
one embodiment the aligner comprises at least one body configured to be
attached to the at
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least two of the bodies. In one embodiment, the aligner comprises a fixed
aligner. In one
embodiment aligner comprises an adjustable aligner. In one embodiment the
aligner
comprises the expander. In one embodiment the at least two bodies are
configured to receive
fasteners. In one embodiment the fasteners are configured to be received by at
least one
lateral support extending from each of the at least two bodies. In one
embodiment the
fasteners comprise screws. In one embodiment the fasteners comprise two
threaded portions,
wherein an outermost diameter of one or the two threaded portions is smaller
than an
outermost diameter of a second of the two threaded portions. In one embodiment
the two
threaded portions are separated by a non-threaded portion. In one embodiment
the at least
two bodies are disposed in a parallel relationship with respect to each other.
In one embodiment the present invention comprises a method of laterally
expanding a
maxilla, comprising the steps of: providing at least two bodies; coupling the
at least two
bodies to a hard palate; and attaching at least one aligner to the at least
two bodies. In one
embodiment the at least one aligner comprises a fixed aligner and/or an
adjustable aligner. In
one embodiment attaching the at least one aligner comprises attaching a fixed
aligner and an
adjustable aligner. In one embodiment the at least two bodies comprise
fasteners. In one
embodiment fasteners comprise threaded fasteners.
In one embodiment the present invention includes a medical device, comprising:
at least
two bodies configured to be coupled to a patient's maxilla, wherein each of
the at least two
bodies are configured to be coupled to an appliance that is at least in part
extra-oral, wherein
the appliance is configured to apply an extra-oral protraction force to the at
least two bodies,
and wherein the two bodies are configured to transfer the extra-oral force to
the maxilla to
cause movement and growth of the maxilla. In one embodiment the at least two
bodies
further comprising couplers configured to couple to ends of the orthodontic
appliance. In one
embodiment the device comprises the appliance. In one embodiment the appliance
comprises
an orthodontic face bow. In one embodiment an adjustment mechanism, wherein
with the at
least two bodies coupled to the maxilla, the adjustment mechanism is
configured to transfer
forces to the at least two bodies to cause the at least two bodies to apply
forces to the maxilla
and to cause lateral movement of the maxilla. In one embodiment with the at
least two bodies
coupled to the maxilla, an extra-oral force applied to the at least two bodies
by the appliance
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causes forward or a combination of forward and upward movement of the maxilla.
In one
embodiment the external protraction force is applied to the appliance in a
direction that that
in-line to the at least two bodies. In one embodiment the at least two bodies
are configured to
be releasably coupled to the orthodontic appliance. In one embodiment the
releasable
coupling comprises an interference fit, snap fit, and/or a slip fit. In one
embodiment the
appliance comprises an intra-oral portion and an extra-oral portion, where the
intra-oral
portion and the extra-oral portion are releasably coupled. In one embodiment a
first of the at
least two bodies comprise at least a first aperture and a second aperture,
each aperture
disposed along a respective longitudinal axis, wherein the axis of the first
aperture is not
parallel to the axis of the second aperture. In one embodiment each of the at
least two bodies
comprise a plurality or threaded apertures configured to receive a threaded
fastener. In one
embodiment the device comprises the threaded fasteners, wherein each of the
threaded
fasteners comprise two sets of threads, wherein one of the two sets of threads
is configured to
mate with a respective threaded aperture of one of the at least two bodies,
and wherein a
second of the two sets of threads is configured to be threadably inserted into
a maxilla. In one
embodiment each body of the at least two bodies comprises a plurality of
channels each
configured to receive a fastener along a longitudinal axis, wherein the
longitudinal axis of at
least one channel of the plurality of channels is disposed in a non-parallel
relationship to a
longitudinal axis of at least a second channel of the plurality of channels.
In one embodiment
the longitudinal axis of the at least one channel is disposed in an angular
relationship with
respect to the longitudinal axis of the at least a second channel that is
between 1 and 60
degrees.
The above should not limit the present invention as other advantages, benefits
and
embodiments are also within the scope of the invention as described in the
detailed
description below.
DETAILED DESCRIPTION
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The figures referenced below refer to components and features of the present
invention with reference indicators. Although same components may be shown in
different
figures, it should be noted that cumulative use of indicators with same
components is not
used when their use would be superfluous and/or make components more difficult
to identify.
Referring to Figs. la-c, there are seen representations of components of a
skeletal
anchorage device before being coupled intraorally to a patient's maxilla on
either side of the
median palatine suture.
In one embodiment, a skeletal anchorage device of the present invention
comprises a
pair of first bodies 100a-b (only one body shown in Fig. la) configured for
intra-oral
attachment to the maxilla along the upper palate on either side of the median
palatine suture.
In one embodiment, each body comprises a side configured to face the hard
palate and an
opposite top side. In one embodiment, one or both sides are flat. In other
embodiments, the
sides are parallel to each other. In one embodiment, at least a portion of one
side is not
parallel to the other side. In one embodiment, each of the first bodies 100a-b
comprises a
plurality of first apertures 101 and a plurality of second apertures 102
disposed along a
longitudinal axis each first bodies. In one embodiment each first body
comprises three first
apertures 101 and two second apertures 102. In one embodiment, first apertures
101 extend
through a thickness of the first bodies 100a-b. In one embodiment, second
apertures 102
extend only a certain distance into the first bodies 100a-b and not all the
way through. In one
embodiment, the skeletal anchorage expander device also comprises a first
fixed aligner 106
having a plurality of third apertures 199 configured to receive threaded first
fasteners 110. In
one embodiment, first fasteners 110 comprise screws configured to be received
through the
third apertures 199 and threadably screwed into the second apertures 102. In
one
embodiment, an equal number of third apertures 199 are formed on a lateral
first left side of
the first fixed aligner 106 as are formed on an opposite lateral right second
side. In one
embodiment, fixed aligner 106 comprises four third apertures 199. In one
embodiment, fixed
aligner 106 comprises a single integral body. In one embodiment, first fixed
aligner 106
comprises a plate like structure. In one embodiment, the first fixed aligner
106 comprises an
H-shaped geometry. In other embodiments, first fixed aligner comprises a
geometry capable
of having apertures formed at 4 corners. In one embodiment, third apertures
199 of the first
fixed aligner 106 are configured with a longitudinal spacing "B" that enable
them to be
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coupled to respective second apertures 102 of the pair of first bodies 100a-b
with first
fasteners 110 inserted in the apertures. In one embodiment, when the pair or
first bodies
100a-b are coupled to the first fixed aligner 106 via fasteners, a lateral
spacing of the third
apertures 199 results in the pair of first bodies 100a-b being separated by a
distance "Z". In
one embodiment, first apertures 101 comprise a channel where the channel is
counter sunk
into first bodies 100a-b to a first depth that is less than a thickness of the
first bodies and such
that the channel is threaded along the first depth and configured to
threadably receive
threaded upper end of second fasteners 111 (Figs. 2b-c) during screwable
insertion of
threaded bottom ends of the second fasteners into the palate. In one
embodiment, first fixed
aligner 106 and each first body 100a-b are dimensioned with the dimensions
noted in Figs. la
and lb.
In one embodiment of use (see Fig. lc), a hard palate facing side of first
fixed aligner
106 is positioned over respective bodies 100a-b, respective first fasteners
110 are inserted
through the third apertures 199 of the first fixed aligner 106, and respective
fasteners 110 are
screwed into second apertures 102 to couple the first fixed aligner 106 to the
pair of first
bodies 100a-b. After first fixed aligner 106 and the pair of first bodies 100a-
b are coupled, the
combination is positioned over a hard palate of a patient such that one of
first bodies 100a-b
is positioned on one side of the median palatine suture of the patient and the
other of first
bodies 100a-b is positioned on the other side of the suture.
Referring to Figs. 2a-b, there are seen representations of components of a
skeletal
anchorage expander device during their coupling to the hard palate on either
side of the
median palatine suture.
In one embodiment of use, after the first fixed aligner 106 and the pair of
first bodies
100a-b are coupled to each other, they are positioned over the hard palate on
either side of the
median palatine suture and the combination is coupled to the hard palate via a
plurality of
threadable second fasteners 111. In one embodiment, each of the first bodies
comprises a
plurality of threaded first apertures 101 that extend between a hard palate
facing side and an
opposite side of the pair of first bodies. In one embodiment, each of the pair
of first bodies
100a-b comprises three threaded first apertures 101. In one embodiment,
threadable second
fasteners 111 comprise a bottom portion configured to screw into the hard
palate via a set of
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first threads and a top portion configured to screw into first apertures 101
via a second set of
threads. In one embodiment, the first and second set of threads are separated
by an
unthreaded portion. In one embodiment the first set of threads are defied by
an outer diameter
that is smaller than an outer diameter of the second set of threads. In one
embodiment, second
fasteners 111 are dimensioned with the dimensions given in Fig 2b. In one
embodiment of
use, bottom portions of second fasteners 111 are inserted through a respective
first apertures
101 in the pair of first bodies 100a-b, and after insertion, the bottom
portions of the second
fasteners 111 are screwably inserted into the hard palate. During insertion of
the bottom ends
of second fasteners into the hard palate, the top portions of second fasteners
111 are screwed
into respective threads of first apertures 101 in the pair of first bodies
100a-b until a surface
portion at a top of the second fasteners 111 becomes seated against a surface
portion of the
first apertures 111. In one embodiment, a torque between about .1 and .6 nm is
applied to the
second fasteners to cause them to be inserted into both cortical bones of the
palatal process of
the maxilla and to achieve seating against and in the first bodies. In one
embodiment, when
second fasteners 111 are seated against and in the first bodies 100a-b, a
fixed rigid structure is
formed, which rigid structure is made even more rigid via insertion of the
second fasteners
into the hard palate.
In one embodiment, before insertion of the bottom end of second fasteners 111
into a
hard palate, one or more spacer 50 is inserted between a hard palate facing
side of the pair of
first bodies 100a-b and the hard palate. The one or more spacer is intended to
define a
distance between the pair of first bodies 100a-b and tissue covering the hard
palate. In one
embodiment, the distance is .1-3 mm. In one embodiment of use, second
fasteners 111 are
screwed into the hard palate until the pair of first bodies 100a-b lightly
abut against the one or
more spacer 50 and such that the one or more spacer lightly abuts against
tissue of the hard
palate. In one embodiment, spacer 50 comprises soft silicon. In another
embodiment, spacer
50 is made of material that is capable of being dissolved by fluids in the
mouth. In one
embodiment, spacer 50 comprises a material comprising gluten free wheat,
yeast, salt and
water that is formed by baking into a thin wafer that is capable dissolving
very rapidly when
exposed to secretions within the mouth. In other embodiments the spacer
comprises resin or
polycarbonate. After insertion of one or more spacer 50 and coupling of a pair
of first bodies
100a-b to the hard palate, in one embodiment, the spacer is removed or is
allowed to dissolve
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to leave an open space/air gap between the first bodies and the hard palate.
In one
embodiment, the space/air gap enables that no, or very minimal contact, is
made between the
first bodies 100a-b and the hard palate, which reduces the potential for
tissue necrosis to
occur. In doing so, since contact with the hard palate by the first bodies
100a-b is reduced,
damage and irritation (necrosis) of the palatal soft tissue is reduced, and
forces to the maxilla
bone are maximized. The present invention should not be limited to formation
of a space/gap
via that use of the described spacer(s) as other methods can also be used, for
example, via
temporary anchorage of a pair of first bodies to teeth with a surgical guide
so as to create the
space/gap during insertion of second fasteners 111, where after creation of
the space, the
temporary anchorage can be removed. Further, while threadable insertion of the
top ends of
the second fasteners into a pair first bodies is described to rigidly couple
second fasteners 111
to the bodies in a position below the palate, the present invention should not
be limited to use
or threads to achieve such coupling, as in other embodiments, biocompatible
resins or
adhesives; or clamping, locking, and interference fit type coupling mechanisms
could be used
to couple second fasteners 111 to a pair of first bodies in addition to, or in
lieu of, the second
set of threads described above.
With reference to Figs. 3, there is seen a representation of components of a
skeletal
anchorage expander device after a pair of first bodies has been coupled to a
palate of a patient
and after a first fixed aligner is removed. In one embodiment of use, after
second fasteners
111 are coupled to a hard palate of a patient, first fasteners 110 are
uncoupled from first
bodies 100a-b, and first fixed aligner 106 is uncoupled from the pair of first
bodies 100a-b
and removed. After removal, it is identified that the pair of first bodies
100a-b will be
separated by a distance "D" as was determined by distance "B" of first fixed
aligner 106 (see
Fig. lb).
Referring now to Figs. 4a-j, there are seen a representations of components of
a
skeletal anchorage expander device comprised of an adjustable aligner and/or a
pair of first
bodies that are configured to effectuate movement and growth of the maxillary
skeletal
complex of a patient. In one embodiment, a skeletal anchorage expander device
of the present
invention comprises an adjustable aligner 150 (see Fig. 4a). In one
embodiment, the
adjustable aligner 150 comprises a pair of second bodies 151a-b, where each
body is coupled
by at least one adjustment mechanism formed therebetween. In one embodiment,
each of the
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second bodies 151a-b is elongated along an axis. In one embodiment, when
coupled by an
adjustment mechanism 152, each axis is generally parallel to the other axis.
In one
embodiment, the adjustment mechanism 152 comprises a double ended expansion
screw
having threads at both of its ends. In one embodiment, the adjustment
mechanism 152 is
configured to be rotated relative to the pair of second bodies 151a-b so as to
cause each of the
second bodies to move toward or away from each other via threaded interaction
of its ends
with threaded apertures in each of the second bodies. In one embodiment, each
pair of second
bodies 151a-b is configured with apertures dimensioned to slideably receive
ends of one or
more stabilizing rod 175 thereinto or therethrough. In one embodiment, each of
the second
bodies 151a-b comprise a plurality of threaded fourth apertures 198 configured
to extend
between a hard palate facing bottom side and a top side of the second bodies
151a-b. In one
embodiment, fourth apertures 198 are longitudinally spaced apart to match the
longitudinal
spacing between second apertures 102 of each of the pair of first bodies. In
one embodiment
of use, adjustment mechanism 152 is rotated to a position that enables
threadable first
fasteners 110 to be aligned to and easily inserted through respective fourth
apertures 198 of
adjustable aligner 150 and into respective apertures 102 of each of the pair
of bodies 100a-b.
After being coupled in this manner, the pair of second bodies 151a-b will be
spaced apart by
the same initial distance "D" as the first bodies 100a-b are spaced apart from
each other. After
coupling, adjustment mechanism 152 can be used to increase or decrease the
lateral distance
between the pair of second bodies 151a-b, the pair of first bodies 100a-b and
the first
fasteners 110, which change in distance can be used to treat a maxillary
deficiency of a
patient by bi-laterally expanding the maxillary skeletal complex and the 9
bones that
articulate with the maxilla. In one embodiment, instead of an adjustment
mechanism 152
comprised of a double ended expansion screw having threads at both of its ends
as described
above, an adjustment mechanism 162 comprises a unilateral expansion screw (see
Fig. 4d)
where one end of the unilateral expansion screw is threaded and the other is
not. In one
embodiment, the non-threaded end is inserted into and through an aperture of
one of the
second bodies 151a-b and left to spin freely within the aperture, while the
threaded end is
coupled via its threads to a threaded aperture within the other body. The non-
threaded end is
secured by retainer, for example a circle-clip, at its end to limit
longitudinal movement within
the aperture relative to the second body. When adjustment mechanism 162 is
rotated, one of
the second bodies 151a-b remains fixed and the other moves. In one embodiment
of use, it is
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identified that a skeletal anchorage expander device comprised of a unilateral
expansion
screw as described above can, thus, be used to treat maxillary asymmetry.
Although rotation
is described above to effect an increase in distance between second bodies
151a-b, it is
contemplated that other mechanisms capable of causing movements of the second
bodies
151a-b are within the scope of the present invention, for example a spring, a
micro-motor, or
some other passive or active actuator could be used to effect linear movement
between the
second bodies. In one embodiment, after coupling of each of the pair of first
bodies 100a-b
to the hard palate, a total of six fasteners will have been used, three per
each first body 100a-
b. Compared to use of two second fasteners per first body 100a-b, the present
invention's use
of three second fasteners per first body enables lessening of forces the
fasteners experience
during movements of the first bodies as well as lessening of forces experience
by local bone
supporting the fasteners. Use of more second fasteners 111 distributes the
force applied to
the fasteners by the resistance by the resistance of the palate to movement
generated of the
second bodies 151a-b and reduces the force experienced by any one fastener.
Accordingly, in
other embodiments, as needed or desired, to lessen forces experienced by
fasteners and/or
local bone supporting the fasteners, more than three second fasteners 111 and
more than three
apertures in first bodies to receive the fasteners are within the scope of the
invention.
With reference to Fig. 4e, although some embodiments above described use of a
fixed
aligner 106 to provide initial alignment to a pair of first bodies, in one
embodiment, such
alignment can be provided without use of aligner 106. In one embodiment of
use, threadable
first fasteners 110 are inserted through respective fourth apertures 198 of a
pair of second
bodies 151a-b and then screwed into respective second apertures 102 of a pair
of first bodies
100a-b. After being coupled in this manner, the pair of first bodies 100a-b
will be spaced
apart by an initial distance determined by how much expansion mechanism 152 or
162 will
have been rotated. The pair of first bodies 100a-b, can thereafter be coupled
to the upper
palate with this initial spacing by first inserting four second fasteners 111
into first apertures
101 at both ends of the pair of first bodies 100a-b. After coupling to the
upper palate, the pair
of second bodies 151a-b can be removed and as desired two additional second
fasteners 111
can be used to secure the pair of first bodies to the hard palate via
insertion into first apertures
101 in the middle of the pair of first bodies 100a-b to. Once the first bodies
100a-b are
coupled to the upper palate with a full complement of second fasteners 111,
the pair of second
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bodies 151a-b can be recoupled to the pair of first bodies 100a-b for use via
insertion of
threadable first fasteners 110 into fourth apertures 198 and then via further
insertion into
respective second apertures 102 of the pair of first bodies 100a-b.
Embodiments of adjustable aligner 150 described have been found useful when an
initial distance between second bodies 151a-b is desired to be minimized (see
adjustable
aligner 150 in Fig. 4f sans stabilizing rods 175), for example, when the first
100a-b or second
151a-b bodies are initially desired to be mounted as close to the palatal
suture as possible,
where in such an orientation force transmission to resisting sutural tissue is
maximized. As
seen in Fig. 4g, although in one embodiment adjustment mechanism 152 between
the second
bodies 151a-b enables a minimum distance of 2.5 mm between the second bodies
to be
achieved, it also determines a maximum distance 10 mm, and as well determines
how far
outward ends of adjustment mechanism 152 protrude outward from the second
bodies in the
minimized orientation in Fig. 4f. However, it is identified that in some
instances, when the
ends of adjustment mechanism protrude too far, the protrusion can cause
interference with the
anatomy of a patient's tongue or mouth. Further, when expansionary forces are
applied to the
second bodies 151a-b, in palates with minimal space, the bodies can begin to
dig into the
palatal wall tissue due to insufficient transverse space.
With reference to Fig. 4h, to minimize or eliminate interference with a
patient's oral
anatomy, in some embodiments, adjustable aligner 150 comprises an adjustment
mechanism
172. In one embodiment, adjustment mechanism 172 comprises a telescopic
expansion screw
mechanism. In one embodiment, the expansion screw mechanism comprises a
housing 172a
having two threaded apertures at opposite ends and two threaded rods 172b each
have a first
threadable end threadably mounted in a respective threaded aperture and a
second threaded
end mounted within a respective threaded aperture of a second body.
In one embodiment of use, rather than using only one of adjustment mechanisms
152
or 172 to achieve a desired expansion of a patient's maxilla/palate, it may be
desired to use
both. For example, where an initial close placement of first or second bodies
to a palatal
suture is desired and a subsequent expansion greater than capable of being
provided by
adjustment mechanism 152 without causing interference by the adjustment
mechanism is
desired, an adjustable aligner 150 comprised of adjustment mechanism 152 can
be used to
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achieve a first distance between second bodies (for example a distance of 10
mm), whereafter
the first distance is achieved, and the adjustable aligner can be removed and
replaced with an
adjustable aligner 150 comprised of an adjustment mechanism 172 to achieve a
second
distance (15 mm) between the second bodies. The initial and final distances
described above
with regard to use of adjustment mechanism's 152 and 172 are intended to be
exemplary as in
other embodiments adjustment mechanisms 152 and 172 can be configured enable
smaller or
larger distances, for example, via appropriate selection of their lengths
and/or modification of
the bodies.
Referring to Figs. 5a-b, there are seen representations of components a
skeletal
anchorage expander device, including of a pair of first bodies and a pair of
appliances before
the appliances are coupled to the pair of first bodies. In some cases, the
combination of
adjustable aligner 150, first bodies 100a-b, and fasteners 111 may be
insufficient to achieve a
clinically desired expansion of the maxilla due to very thin bone or very
thick bone anatomy.
Accordingly, to further reduce bone stresses by threaded fasteners, in one
embodiment, a
skeletal anchorage expander device of the present invention comprises a pair
of appliances
120a-b. In one embodiment each appliance comprises at least one extending
support 125 (see
Fig. 5b). In one embodiment of use, a first end 130 of each support 125 is
configured to be
coupled to a respective second aperture 102 of the pair of first bodies 100a-
b, and an opposite
second end 131 of the supports is embedded within a respective plate 132. In
one
embodiment, each plate comprises acrylic or other sufficiently rigid
biocompatible material
as is known to be used by those skilled in the dental appliance arts. In one
embodiment, when
embedded within plate 132, first ends 130 of each extending support 125 are
spaced apart by
the same distance "Y" as are second apertures 102 of each of the pair of first
bodies 100a-b.
In one embodiment, each first end 130 comprises an aperture configured to
receive a
respective fastener 110 therethrough. In one embodiment, plates 132 are made
and
dimensioned from a mold or digital scan made of the mouth so that when used
intraorally,
they comfortably abut against the palatal tissue without any direct contact
being made with
any teeth.
Referring to Figs. 6a-d, there are seen representations of components of a
skeletal
anchorage expander device including a pair of appliances coupled to a pair of
first bodies
before and after an adjustable aligner is coupled to the pair of first bodies
and the appliances.
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In one embodiment of use, threadable first fasteners 110 are inserted through
respective
fourth apertures 198 of adjustable aligner 150, through respective apertures
in first ends 130
of extending supports 125 of appliances 120a-b (see Figs. 6a-b), and then
screwed into
respective second apertures 102 of the pair of first bodies 100a-b to cause
the three coupled
components to form a structure that when coupled to a palate and expanded via
adjustment
screw 152 enables additional forces to be applied on either side of the
palatal suture. In one
embodiment (see Fig. 6c), rather than initially provide appliances 120a-b as
units separate
from that of adjustable aligner 150, each appliance is integrated to be part
of respective
second body 151a-b, such that the adjustable aligner 150 and each appliance
can be attached
to the pair of first bodies 100a-b as a single integral unit. Fig. 6d
represents one such
integration, where a set of first end of supports 125 is integrated into a
second body and
where the opposite set of ends can be molded over by a plate (not shown).
Referring to Figs. 7a-b, there are seen representations of components of a
skeletal
anchorage expander device comprised of appliances before and after a distance
between an
adjustable aligner is increased by an adjustment mechanism. In one embodiment
of use,
adjustable aligner 150 is coupled to a pair of first bodies 100a-b and a
distance between the
pair of second bodies 151a-b is increased via rotation of adjustment mechanism
152, which
increase causes a distance between the first bodies 100a-b and appliances 120a-
b to be
increased. In embodiments, the increase is effected via use of a spanner
wrench, activation
key, or other device configured to move or rotate adjustment mechanism
152/162. In one
embodiment, an incremental increase in a distance between second bodies 151a-b
causes
lateral expansion of the maxilla of a patient, where the amount of increase is
determinative of
the amount of potential expansion and that can be achieved. During use of
adjustable aligner
150, it is identified that portions of second fasteners 111 at their insertion
point into the hard
palate are exposed by the small space/gap created between the hard palate and
the pair of first
bodies 100a-b (see use of spacer 50 to create space/gap in discussion of Fig.
2 above).
Compared to if the small space did not exist, the existence of a space causes
an increase in
the amount of stress the second fasteners are subject too at their insertion
point into the hard
palate via the aforementioned resistance to movement by the palatine suture at
one end of the
second fasteners and the movement applied by the second bodies 151a-b at the
other end of
the fasteners. The stresses applied to the fasteners 111 implies the hard
palate at each of the
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insertion points will also be subject to the stress. A reduction of local
stresses applied to
fasteners 111 and the maxilla bone is thus identified as being desired. One
approach to
reduce fastener stress includes distributing the stress over more fasteners as
discussed above.
However, when appliances 120a-b are also used, since their plates 132 abut
against the palate,
expansion of the second bodies 151a-b will cause the plates to apply forces to
the soft palate
and thus the hard palate which forces can be used to at least partially
overcome the resistance
to expansion by the maxilla, which in turn can be used to further reduce
stresses experienced
by the fasteners. Threadable insertion of the top ends of the second fasteners
111 into
respective threaded apertures of the pair of first bodies 100a-b, the use of
more than two
second fasteners 111 per first body, and the use of appliances as described
above can be used
alone or in combination to provide stability of the pair of first bodies 100a-
b and second
bodies 151a-b such that molar and tooth borne anchorage devices do not
necessarily need to
be used. By eliminating force transmission to the teeth, many benefits are
derived, namely,
greater orthopedic effects occur relative to alveolar or tooth effects.
Greater orthopedic
effects are correlated with greater airway and aesthetic benefits. Moreover,
many risks are
eliminated by the non-involvement and contact with the teeth, including root
resorption, tooth
tipping, and potentially a scissors bite. Although non-involvement and contact
with teeth is
preferred, it should be understood that nothing precludes embodiments of the
present
invention described above or further below from being coupled to the teeth
when desired or
needed to achieve a particular clinical outcome.
Referring to Fig. 8, there are seen representation of a pair of first bodies
after a
distance between the adjustable aligner is increased by a clinically desired
amount the
adjustable aligner and appliances are removed. In one embodiment of use, after
a distance
between a pair of first bodies 100a-b is increased to a clinically desired
distance "D2", first
fasteners 110 are unscrewed, and adjustable aligner 150 and, if used,
appliances 120a-b are
removed. In one embodiment, to enable regrowth of the palatine suture while
distance "D2"
is maintained, a pair of third bodies 170a-b are positioned over the pair of
first bodies 100a-b.
In one embodiment, each of the third bodies 170a-b comprise a plurality of
fifth apertures
195 each being longitudinally spaced apart with the same spacing as the second
apertures 102
of each first body. In one embodiment, apertures 195 extend from a palatal
facing side to a
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top side of the pair of third bodies 170a-b and are configured to receive
fifth fasteners 191
therethrough.
Referring to Fig. 9, there are seen representations of a pair of first bodies
and a pair of
third bodies after the pair third bodies 170a-b are coupled to the pair of
first bodies via
respective fifth fasteners 191 being inserted into respective fifth apertures
195, and the
respective fifth fasteners being screwed into respective second apertures 102
of the pair of
first bodies 100a-b to couple the third bodies to the first bodies.
Referring to Figs. 10a-d, there are seen representations of components of a
skeletal
anchorage expander device, including a second fixed aligner. In one embodiment
of use, to
maintain distance "D2" while first bodies 100a-b and third bodies 170a-b are
coupled
together, a second fixed aligner 196 is used. In one embodiment second fixed
aligner 196
comprises a body configured with a shape that maintains distance "D2" over a
holding/stabilizing phase during which a palatine suture of a patient is
allowed to regrow with
bone and to maintain the distance "D2" on its own and without use of
embodiments of the
present invention. In one embodiment, second fixed aligner 196 is configured
to couple third
bodies 170a-b together. In one embodiment, second fixed aligner 196 comprises
a wire bent
into a shape that allows insertion of its ends 166 and 167 into respective
sixth apertures 197
formed in each of the pair of third bodies 170a-b. In one embodiment, second
fixed aligner
196 is manufactured as a single piece from stainless steel spring metal. In
one embodiment,
second fixed aligner 170a-b is manufactured of a material that is sufficiently
strong enough to
maintain distance `D2" during the holding/stabilizing phase. Use of fixed
aligner 196 during
the holding/stabilizing phase instead of an adjustable presents a far sleeker
and less bulky
apparatus that enables greater tongue volume and tongue posture during the
phase.
Furthermore, removal of the adjustable aligner after an achieved expansion
enables greater
hygiene and sanitation. In other embodiments, however, after an achieved
expansion, the
adjustable expander can be left in place with no further adjusts being made to
effectively
function as a fixed aligner.
Referring to Figs. ha-b there are seen representations of a skeletal anchorage
expander device comprised of additional bodies. In some embodiments, during
expansion of
a patient's maxillary complex, a patient's age, gender, bone density, or a
desired clinical
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outcome may require an amount of stability that some of the embodiments
described above
are not best suited to provide. Accordingly, in one embodiment, a skeletal
anchorage
expander is provided with at least two additional bodies 165. In embodiments,
bodies 165
comprise extending arms, rods, stiff wires or other structures configured to
provide additional
points of stability to the skeletal anchorage expander without reliance on
support of the teeth.
In one embodiment, at least one body extends laterally from each of first
bodies 100a-b (see
Fig. 11a) or from each of second bodies 151-a-b (see Fig. 11b). In one
embodiment, one end
of each body 165 is integrated with first bodies 100a-b or second bodies each
body 165, and
another end comprises an attachment mechanism 164 configured to provide a
coupling to the
hard palate. In one embodiment, each attachment mechanism is configured to
receive a
fastener 163 configured to provide releasable coupling of the attachment
mechanism to the
hard palate. In embodiments, fastener 163 can comprise screws, rivets, pins,
interference
type mechanism biocompatible adhesives or other dental fasteners known in the
arts. Use of
bodies 165 provides additional coupling points via which forces can be
distributed across
more points of attachment of a skeletal anchorage device to the palate.
Referring to Figs. 12a-c, there are seen representations of a skeletal
anchorage
expander device that does not necessarily rely on the use of a pair of first
bodies. In one
embodiment, a skeletal anchorage expander comprises an adjustable aligner 151
or a fixed
aligner 106. In one embodiment, a skeletal anchorage expander comprises a
plurality of sixth
fasteners 136. One bottom end of each sixth fastener 136 is configured to be
inserted into the
maxilla and an opposite top end is configured to receive and be coupled to a
fixed aligner 106
or an adjustable aligner 150. In one embodiment, a respective alignment and
spacing of each
sixth fastener 136 relative to other sixth fasteners that are coupled to a
patient's hard palate is
determined by spacings of apertures formed through fixed aligner 106. In one
embodiment,
top ends of sixth fasteners 136 are initially coupled to fixed aligner 106 via
interference
fitment with recesses formed in the bottom of the apertures formed in the
fixed aligner 106,
where after fitment each sixth fastener extend from and is aligned with the
apertures. In one
embodiment of use, the fixed aligner 106 and sixth fasteners 136 are aligned
to and
positioned against the palate so that an equal number of sixth fasteners 136
are positioned on
either side of the palatine suture. In one embodiment of use, each fastener is
subsequently
coupled to the hard palate. In one embodiment, the bottom end of each sixth
fastener 136
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comprises threads that are inserted into the hard palate via rotatable
interaction with the top
ends of each fastener thorough the apertures in fixed aligner 106. In one
embodiment of use,
after insertion of each sixth fastener 136 to a desired depth, fixed aligner
106 is decoupled
from sixth fasteners 136 via removal of the top ends of the sixth fasteners
from the recesses
in the apertures of fixed aligner. In one embodiment of use, an adjustable
aligner 150 is
coupled to the sixth fasteners 136. In one embodiment, attachment mechanisms
are provided
with or in each second body 151a-b and are dimensioned to be longitudinally
spaced apart
with the same longitudinal spacing as the apertures of fixed aligner 106. In
one embodiment,
before coupling sixth fasteners 136, the second bodies 151a-b are spaced apart
using an
adjustment mechanism 152 to provide the attachment mechanism in the second
bodies 151a-b
with the same lateral spacing as that of the apertures of fixed aligner 106.
In one
embodiment, each attachment mechanism in adjustable aligner 150 is configured
such that
when adjustable aligner 150 is placed over sixth fasteners 136, the attachment
mechanism
retains adjustable aligner 150. In embodiments, the attachment mechanisms
comprise,
apertures, snap fit mechanisms, interference type mechanisms, adhesive or
combinations
thereof that are configured to allow sixth fasteners 135 to be coupled and
decoupled to the
adjustable aligner 150. In one embodiment, attachment mechanisms comprise
apertures and
seventh fasteners 135 that are provided in and with each second body 151a-b,
where seventh
fasteners comprise fasteners and where top ends of sixth fasteners 136 are
provided with
apertures to receive bottom ends of seventh fasteners 135. In one embodiment
top ends of
sixth fasteners 136 and bottom ends of seventh fasteners 135 are threaded. In
one
embodiment of use, after adjustable aligner 150 is positioned over sixth
fasteners 136,
seventh fasteners 135 are inserted into apertures of adjustable aligner and
coupled to sixth
fasteners 136. Subsequently, adjustable aligner 151 can be used to generate
therapeutic
expansionary forces to alignably installed sixth fasteners 136, without the
need to use first
bodies 100 a-b described above. Further, in as much as sixth fasteners 135 can
be installed
into the palate to a desired depth, in one embodiment, installation may be
performed such that
the top ends of the sixth fasteners 135 can protrude a particular distance
below the palate, in
which case, one or more spacer 50 as described above may not be needed to
achieve a desired
mounting space/gap between adjustable aligner 150 and tissue of the palate.
Although four
sixth 136 and seventh 135 fasteners are represented by Figs. 12a-b, other
numbers of
fasteners and attachment mechanism are understood to be capable of
implementation and use,
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for example, six or more sixth and seventh fasteners, and respective six or
more attachment
mechanisms can used as may be desired or needed to distribute forces
experienced by the
fasteners.
Referring to Fig. 13, there are seen representations of another embodiment of
a
skeletal anchorage expander device that does not require use of first bodies
100a-b.
In another embodiment, where a pair of first bodies 100a-b discussed above
need not
be used, each of the second bodies 151a-b comprise a plurality of threaded
fourth apertures
198 that are configured to extend between a hard palate facing bottom side and
a top side of
the second bodies 151a-b. Although four threaded apertures 198 are discussed
herein, the
present invention contemplates other numbers of fourth apertures can be
implemented within
each of the second bodies 151a-b to better distribute forces and decrease
screw and bone
stress. In one embodiment of use, pair of second bodies 151a-b are first
coupled to the upper
palate by inserting bottom ends second fasteners 111 into fourth apertures
198, and after
insertion the bottom ends of the second fasteners 111 are screwably inserted
into the hard
palate. During insertion of the bottom end into the hard palate, the top end
of second
fasteners 111 are screwed into respective threaded fourth apertures 198 in the
pair of second
bodies 151a-b. In one embodiment, before full screwable insertion of the
second fasteners
111 into the palate, a spacer 50 may be used to create a distance between the
pair of second
bodies 151a-b and the palate. In one embodiment, when used without the pair of
first bodies
as described above, the pair of second bodies 151a-b can be coupled to or
comprise an
appliance, arm, rod, stiff wire or other structure configured to provide
additional points of
stability to the skeletal anchorage expander as described above.
Comparison of a prior art device against various embodiments of the present
invention were performed, including for:
= Prior Art device: an expander assembly coupled to the teeth via molar
bands and
to the palate via 4 fasteners each comprised of a single set of thread
configured to
be threadably inserted into the palate (i.e. Moon device referenced in
Background)
= Embodiment 1: An expander assembly using an adjustable aligner 150
coupled to
the palate via a pair of first bodies 100a-b and six fasteners 111, where each
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fastener comprises two sets of threads, and where one set of threads is
threadably
coupled to the pair of first bodies and the second set of threads is
threadably
coupled to the palate (see Fig. 2b).
= Embodiment 2: An expander assembly using an adjustable aligner 150
coupled to
the palate via a set of two bodies 120a-b (see Fig. 6b) and a pair of first
bodies
100a-b and six fasteners 111, where each fastener comprises two sets of
threads
(see Fig. 2b), and where one set of threads is threadably coupled to the pair
of first
bodies and the second set of threads is threadably coupled to the palate (see
Fig.
2b).
The following peak bone stresses were noted:
= Prior Art device: 98 MPa
= Embodiment 1: 84 MPa (provided reduced stresses to fasteners and bone
compared to prior art).
= Embodiment 2: 50 MPa (provided reduced stresses to fasteners and bone
compared to prior art).
The following peak palatine strains were noted:
= Prior Art device: 0.479
= Embodiment 1: 0.426 (provided more uniform strain to the palatine suture
compared to prior art).
= Embodiment 2: 0.397 (provided more uniform strain to the palatine suture
compared to prior art and embodiment 1).
Referring to Fig. 14, there is seen a representation of a third fixed
fastener. In one
embodiment, a third fixed aligner 1901 comprises a surgical guide that is
configured to
accurately position and fixate a pair of first bodies 100a-b to the palate on
either side of the
palatal suture.
In one embodiment, a cast of a patient's intra-oral geometry is obtained, a
mold is
made from the cast, and an appliance is made from the mold in the form of a
third fixed
aligner 1901 that has matching features of the patient's palate, jaw and/or
dentition formed in
its palate facing surface. In another embodiment, a digital scan (for example,
a palatal and/or
a CBCT scan of the upper jaw) is performed via a computer-controlled imaging
device and a
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representation of the patient's palate, jaw and/or dentition is obtained and
stored in memory
(for example, as an STL file). The stored representation can subsequently be
used by a 3d
printing or machining device to form a third fixed aligner 1901 that has
matching features of
the patient's plalate, jaw, and/or dentition formed in its palate facing side.
In one
embodiment, fixed aligner comprises bio-compatible material suitable for oral
use as is
known to those skilled in the art. In one embodiment, third fixed aligner 1901
comprises
apertures 1936 that are formed in the third fixed aligner 1901 to guide
insertion of second
fasteners 111 into the hard palate. In one embodiment, apertures 1936 are
formed along a
peripheral notch 1937 formed in the third fixed aligner that is configured to
receive first
bodies 100a-b. In one embodiment of use, after installation against a
patient's soft palate,
third fixed aligner 1901 is used to guide first bodies 100a-b and fasteners
111 into a position
on either side of a palatine suture and such that fasteners 111 can be rotated
into the hard
palate until threads at their top become fixed in and against the pair of
first bodies. In one
embodiment, insertion of dentition portions of third fixed aligner 111 against
dentition of a
patient can be used so that movement of the first bodies 100a-b with respect
to the maxilla is
minimized during insertion of fasteners 111. In one embodiment of use, third
fixed aligner
1901 is to define a space/gap between the first bodies 100a-b and the palate.
To achieve a
desired space/gap, third fixed aligner 1901 can be manufactured with a
thickness in the area
around apertures 1936 according to a particular desired space/or gap, for
example, with a
space/gap between about .1 mm and about 3 mm. Third fixed aligner 1901 can be
made from
a relatively rigid, but frangible material, for example, biocompatible
acrylic, resin, or
polycarbonate. In one embodiment, third fixed aligner 1901 is provided with
one or more
thinned region 1938 that enable removal of the fixed aligner via subsequent
breakage of the
aligner along of the thinned region(s) so that the broken pieces of the
aligner can be removed
from around the fasteners and under the pair of first bodies 100a-b and so the
aligner can be
removed without removing or loosening fasteners 111.
Referring to Figs. 15a-c, there is seen a representation of another third
fixed fastener.
In one embodiment, a third fixed aligner 2001 is manufactured using techniques
discussed
above with reference to third aligner 1901. In one embodiment, third fixed
aligner 2001
comprises alignment features 2117 configured to receive a pair of first bodies
2100a-b, and a
plurality of apertures 2119 configured to receive a plurality of fasteners,
including fasteners
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2116 and fasteners 2111. In one embodiment, the plurality of apertures 2119
comprise
apertures that are configured with a spacing that match spacings of respective
apertures 2115
in first fixed aligner 2106 and the first bodies 2100a-b. In one embodiment of
use, first
bodies 2100a-b are positioned against and/or in features 2117 on one side of
third fixed
aligner 2001, first fixed aligner 2106 is positioned against an opposite side
of the third fixed
aligner 2001, and fasteners 2116 are inserted in apertures 2115, through
apertures 2119, and
into apertures in the first bodies to join the first bodies and the first
fixed aligner together so
as to form an assembly where the third fixed aligner is sandwiched between the
pair of first
bodies and the first fixed aligner. In one embodiment of use, the assembly is
subsequently
positioned against the palate and a plurality of fasteners 2111 are used to
secure the assembly
to the palate. In one embodiment of use, third fixed aligner 2001 comprises a
thickness Ti in
an area configured to receive the first bodies 2100a-b in features 2117, where
the thickness
Ti is thicker than a thickness T2 of the pair of first bodies 2100a-b, and
such that a palatal
facing side of the first bodies 2100a-b in an assembly mounted to the palate
is spaced apart
from the palate by distance determined by a difference between the thickness
of the third
fixed aligner 2001 and the thickness of the pair of first bodies, for example,
a distance of
about .1mm and 3mm.
In one embodiment, third fixed aligner 2001 and first fixed aligner 2106
comprise
apertures 2139 that are configured with dimension that allows the plurality of
fasteners 2111
be received entirely therethrough and such that subsequently the second fixed
aligner 2106
and the third fixed aligner 2001 can be removed via removal of fasteners 2116
while leaving
the pair of first bodies 2100a-b secured to the hard palate via fasteners 2111
in a
configuration that the pair of first bodies are spaced apart from the palate
by a distance and
such that an adjustable aligner 150 can be coupled thereto. In one embodiment,
third fixed
aligner 2001 is configured to fixate to a patient's dentition, and to be
sandwiched between
first bodies 2100a-b and fixed aligner 2106 so as to position the bodies
against a particular
location in a patient's mouth. The thickness of and counterbores formed in
first bodies 2100a
act to further align fasteners 2111 to enable a precise mounting of first
bodies 2100a-b above
the palate and of fasteners 2111 into the hard palate.
Referring to Figs. 16a-d, there are seen representations of another skeletal
anchorage
device. In some embodiments, it may difficult to secure certain embodiments
described above
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in a patient's mouth due to a "v" shaped, narrow, or constricted palate, where
in palates of
these and other shapes, the vertical orientation of the threadable second
fasteners 111 with
respect to the palate may be difficult to secure in place due to the limited
flat surface area.
In one embodiment a skeletal anchorage device comprises a pair of first bodies
100c-
d (see Fig. 16b-c). In one embodiment (see Fig. 16a), the pair of first bodies
100c-d each
comprise second apertures 102 that define longitudinal channels that are
angled (instead of
being parallel) with respect to longitudinal channels that define first
apertures 101. This
allows the pair of first bodies 100c-d to be secured to a pair of second
bodies 151a-b in a
similar manner as described with other prior embodiments, but where the axis
of threadable
second fasteners 111 inserted within second apertures 102 of one of the pair
of first bodies
100c-d will be oriented at an angle with respect to the longitudinal axis of
second fasteners
inserted in the other of the pair of first bodies. In one embodiment,
extensions 173 may be
provided to the first bodies 100c-d to provide additional structural support
for second
apertures 102. In one embodiment, the pair of first bodies 100c-d with the
extensions 173
comprise a unitary element. In other embodiments, the first bodies 100c-d and
the extensions
may be coupled together through various attachment means. It should also be
noted that
inserting the screws at an angle may allow for more surface contact in the
bone than a
vertical screw. Moreover, an angled screw can be designed to insert through
the mid palatal
suture in a different way than a vertical screw, which may be desirable)
Although in the
embodiments of Figs 16a-c the first bodies are configured to mate with second
bodies along
extension portions 173 of a top surface that are not parallel to bottom
surface of the first
bodies, in other embodiments the extension portions can be eliminates such
that top surfaces
and bottom surfaces of first bodies are substantially flat and/or parallel to
each other (see Fig.
16 d).
In one embodiment, as may be determined by a particular patient's palate shape
and
anatomy the angle of the longitudinal axis of second apertures 102 with
respect to the
longitudinal axis of first apertures 101 in each body 100 c-d may comprise
between about
zero (0) and about ninety (90 degrees). In other embodiments, the angle of the
longitudinal
axis of second apertures 102 with respect to the longitudinal axis of first
apertures 101 is
between about one (1) and about sixty (60) degrees. In one embodiment, the
angle of the
longitudinal axis of second apertures 102 with respect to the longitudinal
axis of second
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apertures in one of the pair of second bodies 100c-d may be the same as the
angle in the
second of the pair of first bodies 100c-d. In one embodiment, the angle of the
longitudinal
axis of second apertures 102 with respect to the longitudinal axis of second
apertures in one
of the pair of second bodies 100c-d may be the different from that of the
angle in the second
of the pair of first bodies 100c-d.
Although the embodiments discussed and described above have so far been
directed
to devices and methods used to apply transverse forces to treat maxillary
deficiencies, the
present invention identifies that one or more of the embodiments can be used
to apply
forward protraction forces to treat maxillary deficiencies.
In embodiments above, it was identified that a pair of second 151a-b or third
bodies
170a-b can be coupled to a pair of first bodies 100a-b, where in one
embodiment, apertures
197 in the pair of third bodies 170a-b are configured to be coupled to a
spring wire 196 (see
Fig. 10b) that is used to maintain a lateral distance between palatine sutures
of the maxilla.
As seen in embodiments below, the second and third bodies can also be
configured to
comprise apertures that can be intraorally coupled to an externally worn
appliance, for
example an orthodontic face bow, that can be used to enable forward movement
and growth
to the maxilla. In one embodiment, the appliance transfers one or more extra-
oral protraction
force to bodies mounted intraorally to a patient's maxilla in a manner that
does not cause
downward forward directed movement and growth of the maxilla, or equivalently
only
forward growth, or a combination of forward and upward movement and growth.
Referring to Figs. 17a-c, there are seen representations of an orthodontic
device
comprised of a pair of third bodies and an externally worn appliance coupled
to the pair of
bodies. In one embodiment (Fig. 17a below), a pair of third bodies 2170a-b are
coupled to a
palate via a pair of intervening first bodies 2100a-b (not shown as they are
underneath third
bodies 2170a-b in Fig. 17a). In one embodiment, each of the pair of third
bodies 2170a-b is
configured to mate with each free end of appliance 2002 (represented by 2002a-
d). In one
embodiment, mating is achieved via insertion of free male ends of appliance
into female
apertures 2197 of the pair of third bodies. In embodiments, mating can be
maintained via a
fastener, an interference fit, snap fit, slip fit, and/or or other releasable
coupling formed
between the pair of third bodies 2170a-b and free ends of appliance 2002. In
some
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embodiments, apertures 2197 enable quick and simple coupling and removal of
appliance
2002 to and from the pair of first bodies 2100a-b. In some embodiments,
appliance 2002 is
manufactured from one or more stainless steel, ceramic, cobalt chrome or other
sufficiently
strong material.
In another embodiment, a pair of second bodies 2151a-b are coupled to a hard
palate
via intervening first bodies 2100a-b. In one embodiment, each of the pair of
second bodies
2151a-b is configured to mate with each free end of an appliance 2002. In
embodiments,
mating can be maintained via a fastener, interference fit, snap fit, slip fit,
or releasable
coupling formed between the pair of second bodies 2150a-b and the free ends of
appliance
2002. In one embodiment, mating is achieved via insertion of free male ends of
appliance
2002 to into female apertures 2197 formed in the second bodies.
Referring to Fig. 18, there is seen a representation of a pair of first bodies
coupled to
an externally worn appliance. In one embodiment, rather than couple an
appliance 2002 to
second 2151a-b or third bodies 2170a-b, the appliance is coupled to a pair of
first bodies
2100a-b via fasteners 2198 provided to or in the first bodies. In one
embodiment, first bodies
2100a-b comprise apertures similar to apertures 2197 described above.
Referring back to Fig. 17a, in one embodiment, appliance 2002 comprises two
first
portions 2002a that are configured in a shape that extends laterally away from
each free end
to behind each of a patient's most posterior teeth (for example, molars),
where after extending
past the posterior teeth, the two first portions 2002a are configured to join
to third portions
2002c by bent portions 2002b, where the third portions 2002c are configured in
a shape that
extends from the bent portions generally along and opposite outer surfaces of
a patient's teeth
and out the patient's mouth, where outside the patient's mouth, the two third
portions 2002
are configured to be joined together, either in the form of an integral or non-
integral fourth
portion 2002d, or directly. In another embodiment, instead of extending
laterally behind
distal teeth, first portions 2002a can be configured in a shape that allows
them to fit between
spaces present between the teeth. In other embodiments, the shape of one or
more portions of
appliance 2002 an be customized to match a patient's particular geometry.
Referring to Figs. 19a-b, there are seen other representations of an
externally worn
orthodontic appliance. In one embodiment, appliance 2002 comprises a fifth
portion 2002e.
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In one embodiment, the fifth portion is coupled to, and extends centrally from
fourth portion
2002d in a generally orthogonal and upward direction relative to the fourth
portion. In one
embodiment, fifth portion 2002e is coupled to fourth portion 2002d via a rigid
connection, for
example, via brazing, welding, or other fixed coupling mechanism know to those
skilled in
the art. In one embodiment, fifth portion 2002e is configured with two
branches that extend
upward from the fourth portion 2002d and that rejoin together above the fourth
portion 2002d
in a manner that an aperture is defined by and such that the two rejoined
branches extend to a
terminating end. In one embodiment, the fifth portion 2002e comprises at least
one force
application point 2002n in the form of a hook, ring (see Fig. 19a),
indentation (see Fig. 19b),
or other attachment mechanism to which elastics or other external force
applicators from
externally worn protraction frames or devices can be coupled. In one
embodiment, fifth
portion 2002e is configured such that it extends upward such that little or no
interference
occurs with a patient's nose during use.
Referring to Figs. 20a-b, there is seen a representation of external forces
applied to an
externally worn appliance. As identified by the present inventors, when
external protraction
forces are coupled to an appliance, and by the appliance to a pair of bone
anchors mounted to
the maxilla, application of forward or forward and upward forces to the
appliance may be
used to achieve substantially only forward growth, or forward and upward
growth, wherein
such forces preferably do not generate or minimally generate rotational
moments about the
attachment points of the bone anchors to the maxilla. The present invention
identifies that
when forward, or forward and upward protraction forces are applied to an
appliance that is
coupled to a pair of bodies coupled to a maxilla at a hard palate location,
forward or
substantially forward movement and growth of the maxilla can also be achieved
when
rotational moments at the pair of first bodies 2100a-b where they are coupled
to the maxilla
are eliminated or substantially minimized. The present invention identifies
that rotational
moments transferred to the pair of bodies and, thus, the maxilla can be
substantially
minimized or eliminated when extra-oral forces are applied to a appliance in a
direction that
passes through the force application points on the appliance (for example see
points A, B,
and/or C) and a pair of bodies (for example, see first bodies 2100a-b in Fig.
20a) coupled to
the maxilla (for example, the hard palate). In one embodiment, with reference
to a standing
patient whose skull face forward, and with 1588gm of force applied to an
appliance along an
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axis passing at an angle of 60 degrees with respect to the horizontal and
through an
application point "C" on the appliance and through a point "D" on a pair of
first bodies,
desired forward only growth and movement of a patient's maxillary complex can
be
achieved. Depending on a particular patient's skeletal geometry and/or a
particular amount of
desired movement or growth of a patient's maxilla, other forces, angles and
other locations on
the appliance are also within the scope of the invention as long the direction
of force(s)
applied to the appliance are aligned to a pair of bodies according to the
embodiments
described above. For example, as shown in Fig. 20b, protraction forces can
potentially be
applied to a fifth portion 2002e at other locations 2002n, as long as the
forces are applied in a
direction that passes generally centrally through the pair of first bodies and
the force
application point on the appliance.
Referring to Figs. 21a-b, there is seen another representation of an
externally worn
orthodontic appliance and its use. In one embodiment, each third portion 2002c
of appliance
2002 extends generally along and opposite outer surfaces of a patient's teeth
and is formed of
an intra-oral portion 2002p and an intraoral/extra-oral portion 2002q coupled
to intra-oral
portion 2002p by a releasable joint 2002f, for example, via a releasable joint
formed by one
or more of hooks, rings, snap fits, slip fits, interference fits, and/or other
similar interlockings
formed at ends of the intra-oral and intraoral/extra-oral portions. In one
embodiment, during
intra-oral use of appliance 2002, as needed or desired (for example, during
periods when an
external head gear and appliance may not be desired to be worn in public)
intraoral/extra-oral
portions can be decoupled from intra-oral portions via a releasable joint
2002f. Although,
Figs. 21a-b represent an appliance joined at one joint 2002f on each of its
sides, it is
understood that in other embodiments, an appliance could comprise more joints,
and thus
more releasable portions than are represented.
Thus, when using pairs of first 2100a-b, second 2151a-b or third bodies 2170a-
b with
an orthodontic appliance 2002, it identified that in addition to lateral
expansion and growth of
a maxilla, forward or a combination of forward and upward movement and growth
of a
patient's maxilla can also be achieved. In an embodiment where third bodies
2170a-b are
used, it is further identified that in addition to bilateral movement and
growth, unilateral
movement and growth of the maxilla can also be achieved. It is also identified
that use of
pairs of first 2100a-b, second 2151a-b and third bodies 2170a-b obviates the
need to perform
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invasive surgical procedures such as those needed by other devices. It is
further identified that
aspects of the present invention are well suited for use of an externally worn
appliance by a
sleeping patient since it can be configured with shapes that span only above
and across a
patient's frontal facial anatomy and that only minimally interferes sleeping
on the side.
The preceding embodiments have been described in some detail to facilitate
understanding, the described embodiments are to be considered illustrative and
not limiting.
It will be apparent to one of ordinary skill in the art that certain changes
and modifications
can be practiced within the scope of the appended claims.
For example, one or more features from any embodiment may be combined with one
or more features of any other embodiment without departing from the scope of
the disclosure.
Further, modifications, additions, or omissions may be made to any embodiment
without
departing from the scope of the disclosure. Additionally, other dimensions and
other materials
other than those disclosed can be used as long as they are compatible and
sufficiently robust
for human use. Also, although embodiments of the present invention are
described to enable
use without necessarily requiring coupling to dental or molar band, it should
be understood
that such use is not precluded and the present invention could, if desired, be
adapted for use
with such devices. Further, although embodiments of the present invention have
been
described with respect to use as a orthodontic device to treat orthodontic
conditions, their use
is much greater, for example as a medical device that can be used to treat non-
obese
obstructive sleep apnea caused by maxillary hypoplasia, or for use with other
surgical
procedures capable of being performed by a craniomaxillofacial surgeon, which
procedure
could be covered by medical insurance rather than just by dental insurance.
