Note: Descriptions are shown in the official language in which they were submitted.
FTZ-71315US05
AN ADJUSTABLE THERMOPLASTIC DENTAL APPLIANCE SYSTEM AND METHOD
CROSS-REFERENCE TO RELATED APPLICATIONS
[0001] The present application is a continuation-in-part of pending U.S.
Patent Application Serial No.
17/892,118 entitled "Thermoplastic Dental Appliance System and Method," filed
August 21, 2022, which is
hereby incorporated by reference in its entirety, which is a continuation of
U.S. Patent No. 11,419,751,
which was a non-provisional filing of U.S. Provisional Patent Application
Serial No.US 62/797,889, entitled
"Thermoplastic Dental Appliance System and Method," filed January 28, 2019,
which is hereby
incorporated by reference in its entirety.
BACKGROUND
[0002] Sleep apnea and obstructive sleep apnea treatments include surgery,
positive airflow machinery,
such as CPAP machines, and dental appliances. One known dental appliance is
the "Elastic Mandiblular
Advancement" (EMA ) and related appliances. The EMA appliance operates by
providing increased
airflow by forward mandibular advancement. One problem with the EMA appliance
is that each appliance
requires the specific dentition of a patient to create the appliance. What is
needed is a solution that avoids
the need for the specific dentition of a patient prior to formation of an
appliance.
SUMMARY
[0003] Some embodiments of a method may include forming an upper dental
appliance chassis
including at least two upper appliance button protrusions and an elongated
member protruding from the
upper dental appliance chassis, forming a lower dental appliance chassis
including at least two lower
appliance button protrusions, at least two vertical displacement bite pads,
and a second elongated member
protruding from the lower dental appliance chassis, injection overmolding a
first thermoplastic on the upper
dental appliance chassis to provide a first reformable layer integrated with
the upper dental appliance
chassis that exposes the at least two upper appliance button protrusions to
form an upper dental tray, and
injection overmolding a second thermoplastic on the lower dental appliance
chassis to provide a second
reformable layer integrated with the lower dental appliance chassis that
exposes the at least two lower
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appliance button protrusions and the at least two vertical displacement bite
pads to form a bottom dental
tray, wherein the at least two vertical displacement bite pads include a
gradient inclining from rear to fore.
[0004] The method further includes forming a dental appliance including the
upper dental appliance
chassis and the lower dental appliance chassis, wherein the at least two lower
appliance button
protrusions, and the at least two upper appliance button protrusions provide a
forward mandibular position
when two or more bands are attached to connect the upper dental tray and the
lower dental tray.
[0005] In one or more embodiments, the upper dental appliance chassis and the
lower dental appliance
chassis are injection molded from one or more of an Ethylene Propylene
Copolymer and a
Polyoxymethlene Copolymer.
[0006] In
one or more embodiments, the upper dental appliance chassis and the lower
dental appliance
chassis are injection molded using a thermoplastic olefin, thermoplastic
polyolefin, or olefinic thermoplastic
elastomer.
[0007] In one or more embodiments, the upper dental appliance chassis and the
lower dental appliance
chassis are injection molded using a polyethylene terephthalate.
[0008] In one or more embodiments, the upper dental appliance chassis and the
lower dental appliance
chassis are formed by three-dimensional (3D) printing of one or more of a
light polymerizable liquid
thermoset crosslinked polymer, a polyurethane, a methacrylate and a copolymer.
[0009] In one or more embodiments, the upper dental appliance chassis and the
lower dental appliance
chassis are formed by three-dimensional (3D) printing of a polymerizable resin
composition of a urethane
monomer of urethane dimethacrylate (UDMA), an acidic monomer, and one or more
hydrophobic
monomers.
[0010] In one or more embodiments, the first thermoplastic and the second
thermoplastic are comprised
of one or more of an E-caprolactone, caprolactam and one or more
polycaprolactone polymers.
[0011] In one or more embodiments, the first thermoplastic and the second
thermoplastic are comprised
of one or more of a caprolactone or polycaprolactone polymer material
overmolded on the upper dental
appliance chassis and the lower dental appliance chassis.
[0012] In one or more embodiments, the at least two vertical displacement bite
pads are configured to
be replaced with alternate vertical displacement bite pads of one or more
heights.
[0013] Another embodiment is directed to a mandibular advancement dental
appliance including a two-
layer upper tray including an upper dental appliance chassis layer including
at least two upper appliance
button protrusions and a first elongated member protruding from the upper
dental appliance chassis; and a
first reformable thermoplastic layer injection overmolded over a portion of
the upper dental appliance
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chassis layer formed of one or more of an E-caprolactone, caprolactam and one
or more polycaprolactone
polymers integrated with the upper dental appliance chassis via one or more
cavities in the surface of the
upper dental appliance chassis, the first reformable thermoplastic layer
configured to expose the at least
two upper appliance button protrusions; a two-layer lower tray including a
lower dental appliance chassis
layer including at least two lower appliance button protrusions and at least
two vertical displacement bite
pads, and a second elongated member protruding from the lower dental appliance
chassis; and a second
reformable thermoplastic layer injection overmolded over the lower dental
appliance chassis layer formed
of one or more of an E-caprolactone, caprolactam and one or more
polycaprolactone polymers integrated
with the lower dental appliance chassis via one or more cavities in the
surface of the lower dental appliance
chassis, the second reformable thermoplastic layer configured to expose the at
least two lower appliance
button protrusions and the at least two vertical displacement bite pads,
wherein the at least two vertical
displacement bite pads include a gradient inclining from rear to fore.
[0014] In one or more embodiments, the mandibular advancement dental appliance
includes a pair of
bands adapted to couple the two-layer lower tray with the two-layer upper tray
to provide mandibular
advancement. In other embodiments, the first elongated member and the second
elongated member
include marks to measure forward mandibular adjustment when worn by a patient.
Further, in one or more
embodiments, the first elongated member and/or the second elongated member
include a default 21
millimeter marking and at least one of the first elongated member and the
second elongated member
include marks that identify a displacement matching a length for the pair of
bands.
[0015] In one or more embodiments, the mandibular advancement dental appliance
of claim includes a
pair of bands adapted to couple the two-layer lower tray with the two-layer
upper tray to provide mandibular
advancement.
[0016] Some embodiments include a processor and a non-transitory computer-
readable storage
medium storing instructions operative when executed on the processor to
perform the methods herein
described.
BRIEF DESCRIPTION OF THE DRAWINGS
[0017] FIG. 1 illustrates a thermoplastic dental appliance including
straps, button protrusions and a
vertical displacement bite pads by overmolding manufacture in accordance with
one or more embodiments
of the present disclosure.
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[0018] FIG. 2 illustrates a top exploded view of a thermoplastic dental
appliance including straps, button
protrusions and bit pads illustrating the overmolded dentition layer in
accordance with one or more
embodiments of the present disclosure.
[0019] FIG. 3 illustrates a bottom exploded view of a thermoplastic dental
appliance including straps,
button protrusions and bit pads illustrating the overmolded dentition layer in
accordance with one or more
embodiments of the present disclosure.
[0020] FIG. 4 illustrates a method in accordance with one or more embodiments
of the present
disclosure.
[0021] FIG. 5 illustrates another method in accordance with one or more
embodiments of the present
disclosure.
[0022] FIG. 6 illustrates a system and network environment including a
computing device in accordance
with one or more embodiments of the present disclosure.
[0023] FIG. 7 illustrates a processor and a computing device in accordance
with one or more
embodiments of the present disclosure.
[0024] FIG. 8 illustrates a network environment in accordance with one or more
embodiments of the
present disclosure.
DETAILED DESCRIPTION
[0025] In the following detailed description, reference is made to the
accompanying drawings, which
form a part hereof. In the drawings, similar symbols typically identify
similar components, unless context
dictates otherwise. The illustrative embodiments described in the detailed
description, drawings, and
claims are not meant to be limiting. Other embodiments may be utilized, and
other changes may be made,
without departing from the spirit or scope of the subject matter presented
here.
[0026] Referring now to FIG. 1, a dental appliance in accordance with one or
more embodiments is
illustrated. Unlike other dental appliances, the illustrated dental appliance
provides a "boil and bite" type of
appliance that produces an elasto-mandibular advancement appropriate for
treating snoring and sleep
apnea. The dental appliance 100 is formed by having lower dental chassis 110
and upper dental chassis
120 overmolded with a reformable thermoplastic layers 130 and 140. Lower
dental chassis 110 and upper
dental chassis 120 can be injection molded or 3D printed of a non-reformable
material. The reformable
thermoplastic overmolded material in layers 130 and 140 couples to the layer
of non-reformable material by
virtue of a plurality of cavities within upper and lower chassis 110, 120.
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[0027] In one or more embodiments, the lower dental chassis 110 and the upper
dental chassis 120
include button protrusions, two on each of dental chassis 110, 120. Button
protrusions shown in FIG. 1
include upper button protrusions 150 and lower button protrusion 160. FIG. 1
further includes elongated
members 112 and 132, with elongated member 112 attached to upper dental
chassis 120, and elongated
member 132 attached to lower dental chassis 110. In one or more embodiments,
elongated members 112
and 132 include measurements, such as marks to enable proper titration and
choice of band 190 for a
patient.
[0028] More particularly, as shown in FIG. 1, lower dental chassis 110
includes elongated member 132
with measurement markings 134 which may be millimeter markings that function
to identify a length of band
that is appropriate for preventing sleep apnea and snoring of a patient. In an
embodiment, when the upper
dental chassis 120 and the lower dental chassis 110 are aligned one on top of
the other, the end of
elongated member 112, shown as end 114, aligns with measurement marking 132.
In one embodiment,
this mark may be a "21" to indicate that a 21 millimeter length band is
appropriate for a patient to achieve
forward mandibular advancement that aligns the teeth enough to prevent sleep
apnea.
[0029] Since not all patients have mandibles that achieve proper advancement
with a 21 millimeter
length band or strap, markings on the elongated members enable fitting of the
dental appliance to
determine a proper length of band. For example, if a patient inserts the
dental appliance after form fitting
the appliance to their dentition, the patient may then determine a proper
alignment and horizontal
advancement that is comfortable and achieves a forward mandibular advancement
appropriate for the
patients mouth. Next, the markings on the elongated members assist to
determine the size band that is
associated with that alignment. For example, where the end of the top
elongated member 112 sits relative
to the bottom elongated member 132 indicates the type of band required. Thus,
if a patient needs greater
advancement than where the upper elongated member 112 mark 114 aligns with
"21" then the
displacement is shown on measurement marks 132 in terms of millimeters. A one
millimeter displacement
of further mandibular advancement would indicate that a 20 millimeter band be
appropriate for the given
patient. Conversely, if a patient has an overbite, a longer band would be more
appropriate as indicated by
the amount by which the upper elongated member 112 mark 114 sits relative to
the mark "21" and would
indicate how many millimeters beyond a 21 millimeter band would be appropriate
for comfortable
advancement.
[0030] Referring now to FIG. 2 and 3, exploded views of the dental
appliance illustrate how different
components fit together to create a dental appliance appropriate for treating
sleep apnea.
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[0031] As shown, FIGs. 2 and 3 show lower dental chassis 110, and upper dental
chassis 120 and
illustrate cavities to enable secure coupling to reformable thermoplastic
layers 130 and 140 via injection
overmolding. Bottom lower dental chassis 110 further includes button
protrusions 160, bite pads 170, and
elongated member 130 with measurement markings 132 and marking "21" 136. In
one embodiment, bite
pads 170 includes alternate snap-on type bite pads to enable different heights
of vertical displacement as
appropriate for a patient. In another embodiment bite pads 170 include an
increasing gradient from rear to
fore to provide more comfort for a patient. More particularly, in one
embodiment, either the injection
molded bite pads or snap-on type bite pads include a one to two millimeter
gradient from rear to fore to
enable movement
[0032] FIGs.
2 and 3 further show elastic bands 190 configured to couple the lower dental
chassis 110
to upper dental chassis 120. As shown, upper dental chassis 120 includes
button protrusions 150 for
receiving elastic bands 190. FIGs. 2 and 3 further illustrate that upper
dental chassis 120 includes cavities
for receiving reformable thermoplastic layer 140 through injection
overmolding.
[0033] Referring now to FIG. 4, a flow diagram illustrates a method for
forming a dental appliance. As
shown, block 410 provides for forming an upper dental appliance chassis
including at least two upper
appliance button protrusions 150 and an elongated member 112. For example,
lower dental chassis 110
and upper dental chassis 120 are formed via one or more of injection molding
and 3D printing.
[0034] Block 420 provides for forming a lower dental appliance chassis 110
including at least two lower
appliance button protrusions 160, at least two lower appliance bite pads 170,
and an elongated member
132 with measurement marks 134 and 136. For example, both lower dental
appliance chassis 110 and
upper dental appliance chassis 120 can be formed by injection molding or 3D
printing a nonreformable
thermoplastic, nylon or other nonreformable material.
[0035] Block 430 provides for injection overmolding a first thermoplastic on
the upper dental appliance
chassis to provide a first reformable layer integrated with the upper dental
appliance chassis that exposes
the at least two upper appliance button protrusions. For example, both lower
dental appliance chassis 110
and upper dental appliance chassis 120 can be formed by injection molding or
3D printing a nonreformable
thermoplastic, nylon or other nonreformable material. In one or more
embodiments, the upper dental
appliance chassis and the lower dental appliance chassis are injection molded
from one or more of an
Ethylene Propylene Copolymer and a Polyoxymethlene Copolymer. In one or more
embodiments, the
upper dental appliance chassis and the lower dental appliance chassis can be
injection molded using a
thermoplastic olefin, thermoplastic polyolefin, or an olefinic thermoplastic
elastomer. In one or more
embodiments, the upper dental appliance chassis and the lower dental appliance
chassis are injection
molded using a polyethylene terephthalate.
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[0036] In other embodiments, the upper dental appliance chassis and the
lower dental appliance chassis
are formed by three-dimensional (30) printing of one or more of a light
polymerizable liquid thermoset
crosslinked polymer, a polyurethane, a methacrylate and a copolymer. In one or
more embodiments, the
upper dental appliance chassis and the lower dental appliance chassis can be
formed by three-dimensional
(3D) printing of a polymerizable resin composition of a urethane monomer of
urethane dimethacrylate
(UDMA), an acidic monomer, and one or more hydrophobic monomers.
[0037] Referring back to FIG. 4, block 440 provides for injection
overmolding a second thermoplastic on
the lower dental appliance chassis to provide a second reformable layer
integrated with the lower dental
appliance chassis that exposes the at least two lower appliance button
protrusions and the at least two
appliance bit pads. For example, referring to FIGs. 2 and 3, injection
overmolding a reformable
thermoplastic 130 over lower dental appliance chassis 110 enables integration
of the lower dental
appliance chassis 110 with reformable thermoplastic 130. In one or more
embodiments, lower dental
appliance chassis 110 includes cavities or deformations that provide a surface
for better adhesion of the
reformable thermoplastic 130 to the lower dental appliance chassis 110.
[0038] The materials appropriate for a three-dimensional printer can be
resin-type materials and
materials described in U.S. Patent No. 9,682,018 to Sadowsky et al., June 20,
2017, "Denture Tooth and
Material" which is hereby incorporated by reference in its entirety. As one of
skill in the art will appreciate,
materials appropriate for dental appliances must be FDA approved. Appropriate
materials for resins is
further described in Tanaka J, Hashimoto T., Stansbury JW, Antonucci JM,
Suzuki K., "Polymer Properties
of Resins Composed of UDMA an Methacrylates With the Carboxyl Group" Dental
Material Journal 2001;
10:206-215, which incorporated by reference herein in its entirety.
[0039] Three-dimensional printing, as referred to herein include, but is
not limited to, stereolithography
(SLA), micro-stereolithography (pSLA), DLP projection, 2PP (two photon
polymerization), continuous liquid
interface production and material jetting. In embodiments, three-dimensional
printing includes a layer-by-
layer printing with successive layers formed in discrete layers. For example,
a surface with a build plate
immersed in a reservoir of a formulation of a polymer/resin component can be
exposed to light at
wavelengths and intensity to activate a photoinitiator to cause
photopolymerization. As one of skill in the art
will appreciate, there are other methods of three-dimensional printing such as
continuous liquid interphase
printing, in which dental trays are built up from a reservoir of
photopolymerizable resin. Continuous liquid
interphase printing is described in U.S. Patent Publication Nos. 2015/0097315,
2015/0097316, and
2015/0102532, the disclosures of each of which are incorporated herein by
reference in their entirety.
[0040] Thus, as shown above, the upper and lower dental appliance chassis
portion of a dental
appliance can be directly manufactured using 3D technology. Material
appropriate for 3D printing
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technology include thermoset polymers such as light polymerizable liquid
materials. In one or more
embodiments, the material appropriate for 3D printing includes a crosslinked
polymer, such as a
polyurethane, a methacrylate or a copolymer. In some embodiments, 3D printing
materials can include
nylon materials.
[0041] In one or more embodiments, the materials used for milling and/or
injection molding of can be
provided by Myerson Tooth, Inc., including VisiClearTm, and DuraFlexTm, which
are Ethylene Propylene
Copolymers having the following properties as shown in Table 1:
[0042] Table 1
Test
Physical Nominal Value Unit
Method
Density-Specific Gravity (Method B) ASTM D792 .902 sp gr
23/23 C
Melt Mass-Flow M Rate
ASTM D1238 40 g/10 min
(FR)
Mechanical
Tensile Strength @ Yield ASTM D638 4060 psi
Tensile Elongation @ Yld ASTM D638 12.00%
Flexural Modulus (Procedure A) ASTM D790 1% Secant: 145000
psi
Impact
Notched lzod Impact
ASTM D256 .0899 ft lb/in
Thermal
DTUL @66psi ¨
ASTM D648 194 F
Unannealed
Optical
Haze ASTM D1003 6.00%
[0043] In another embodiment, the injection molding material for the chassis
components can be
provided by DuraCetalTM, also available from Myerson Tooth, Inc., which is a
Polyoxymethlene Copolymer
with the following properties shown in Table 2:
TABLE 2
Test
Physical Nominal Value Unit
Method
Specific Gravity ASTM D792 1.41
Melt Mass-Flow Rate ASTM
(MFR) D1238
Mechanical
Tensile Strength ASTM D638 8800 psi
Tensile Elongation ASTM D638 60.00%
Flexural Modulus ASTM D790 .38 psi x 106
Impact
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Impact Strength, lzod, ASTM D256 1 ft-lb/in
notched 1/8 in (3.18 mm) section
Thermal
Deflection
Temperature
ASTM 648
@264 psi
(1.82 Mpa)
Deflection
Temperature
ASTM D648 315 fC
@ 66psi
(0.45 Mpa)
[0044] Referring now to FIG. 5, a flow diagram illustrates another embodiment
is directed to a method
for a dental appliance. In particular, block 510 provides for heating the
dental appliance using elongated
members to submerge dental appliance. For example, on dental appliance 100,
without elastic straps 190,
can be heated by boiling or other heat process so that reformable
thermoplastic is heated to enable
reformation. In one or more embodiments, the dental appliance includes an
upper dental tray such as
upper dental appliance chassis 120 and lower appliance chassis 110, each with
a reformable thermoplastic
layer.
[0045] Block 520 provides for molding the first reformable thermoplastic
layer and the second
reformable thermoplastic layer according to dentition of a patient. For
example, first reformable
thermoplastic layer, such as reformable thermoplastic layer 130 and reformable
thermoplastic layer 140
can include a bond between hard lower and upper dental chassis coupled to
reformable thermoplastic
material. In some embodiments the bonding between the formable and reformable
layers can be a
combination of mechanical and chemical.
[0046] Block 530 provides for identifying a distance using marks on the
elongated members for
mandibular advancement. For example, marks 134 on elongated member 132
identify the distance, if any,
from "21136 mark where the upper mark 114 on elongated member 112 comfortably
advances a patient's
mandible. This identifies the length of a band for coupling the upper and
lower chassis of the dental
appliance.
[0047] Block 540 provides for attaching at least two bands identified by the
marks to couple the upper
portion of the dental appliance to a lower portion of the dental appliance,
wherein the upper portion
includes the first reformable thermoplastic layer, and the lower portion of
the dental appliance includes the
second reformable thermoplastic layer, wherein the at least two bands attach a
first pair of button
protrusions with a second pair of button protrusions to provide a forward
mandibular position when the two
bands are attached to connect the upper dental tray and the lower dental tray.
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[0048] Block 550 provides that if the dentition of the patient changes, the
method provides for reheating
the dental appliance to remold the first reformable thermoplastic layer and
the second reformable
thermoplastic layer.
[0049] In one or more embodiments, the heat process is a boil and bite heat
process wherein a patient
inserts a heated dental appliance to form the first and second reformable
thermoplastic layers according to
the dentition of the patient.
[0050] In one or more embodiments, the upper dental tray includes a first
non-reformable layer coupled
to the first reformable thermoplastic layer via injection overmolding and the
lower dental tray includes a
second non-reformable layer coupled to the second reformable thermoplastic
layer via injection
overmolding.
[0051] In one or more embodiments, the first reformable thermoplastic layer
and second reformable
thermoplastic layer are comprised of one or more of E-caprolactone,
caprolactam and one or more
polycaprolactone polymers. For example, in some embodiments, the reformable
thermoplastic layers can
be formed of CAPATM 6800 and/or CAPATM 6500 thermoplastics.
[0052] In one or more embodiments, the lower dental tray includes a pair of
vertical displacement bite
pads. For example, the pair of vertical displacement bite pads could be part
of the non-reformable chassis
components. In one or more embodiments, the vertical displacement bite pads
can be snap-on type bite
pads. For example, the non-reformable chassis components can include a base
enabling snap-on type bite
pads to be switched out.
[0053] Referring now to FIG. 6, the figure illustrates exemplary
environment 600 including a computing
device 610 connected to a scanner/camera 616, which in turn is connected to a
first user 620 connected to
a server/cloud computer servers 630 via network interface. As will be further
described herein the
illustrated computing device 610 and computer server 630 may employ the
computationally implemented
methods, systems, and articles of manufacture in accordance with various
embodiments. The computing
device 610 and computer server 630, in various embodiments, enable functions
of the computing device
610.
[0054] Computing device 610 illustrated in FIG. 6 can be a tablet computer,
in alternative embodiments,
the computationally implemented methods, systems, and articles of manufacture
in accordance with
various embodiments may be embodied in other types of computer systems having
other form factors
including other types of portable computing devices such as, for example,
mobile telephones, laptops,
smartphones, e-readers, and so forth. Computing devices can include
smartphones, client computers and
the like as possible computing devices. As illustrated, the computing device
610 can include a display, such
as a touchscreen as input/output of the computing device 610. Computing device
610 can further include a
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keyboard, either as a touch input/output keyboard or as an attached keyboard.
As further depicted, the
computing device 610 may also be connected to a scanner 616. In one
embodiment, scanner 616 can be a
scanning camera capable of creating a 3D image of dentition, and oral
characteristics of a patient.
[0055] Referring now to FIG. 7, computing device 610 is further illustrated
with logic modules 702,
network interface 704, user interface 710, processor 716, which can include
memory and computer
readable instructions 752. Logic modules 702 can be implemented using circuit
components such as an
ASIC. Logic modules 702 and other modules shown, may be implemented using a
combination of
specifically designed circuitry such as ASIC and one or more processors 716
(or other types of circuitry
such as field programmable gate arrays or FPGAs) executing computer readable
instructions 752. For
example, in some embodiments, at least one of the logic modules may be
implemented using specially
designed circuitry (e.g., ASIC) while a second logic module may be implemented
using a processor 716 (or
other types of programmable circuitry such as an FPGA) executing computer
readable instructions 752
(e.g., software and/or firmware). System requirements could dictate a
combination of software and
firmware and circuitry to meet the embodiments herein, for example, logic
modules could be designed to
use the most efficient combination of software/hardware/firmware in order to
quickly implement methods
and systems within the scope of the present disclosure.
[0056] In various embodiments, the memory 714 of the computing device 610 may
comprise of one or
more of mass storage device, read-only memory (ROM), programmable read-only
memory (PROM),
erasable programmable read-only memory (EPROM), cache memory such as random
access memory
(RAM), flash memory, synchronous random access memory (SRAM), dynamic random
access memory
(DRAM), and/or other types of memory devices. In various embodiments, the one
or more applications 764,
766 stored in memory may include, for example, an operating system 762, a
browser(s) 763, and one or
more productivity applications 764 such as a word processing application or an
imaging application,
scanning application and one or more communication applications 766.
[0057] Computing device 610 may also include access restricting module 706.
Access restricting
module 706 of the computing device 610 can be configured to restrict access
via the computing device 610
or preventing one or more actions by computing device 610. Computing device
610 may also include
appliance generation module 708 coupled to access restricting module 706 via a
bus.
[0058] Referring to FIG. 8, appliance generation module 708 may be configured
to determine that a first
user 620 is an authorized user attempting to operate computing device 610.
Appliance generation module
708 can also be configured to determine an established authorized user based
on network received data
while computing device 610 is connected to a network connection 650. In the
case of appliance generation
module 708, existing in a cloud computing setting or computer server 630,
appliance generation module
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708 may be configured to determine a network-based authorization for the first
user when first logging into
network 650 or cloud computing logging to computer server 630.
[0059] Appliance generation module 708 can be configured to receive inputs
from a scanner 616.
[0060] Computer server 630 connecting via network 650 to the computing device
610 of FIG. 6 and 7
can establish and/or determine a vertical displacement and a forward
mandibular position for treating sleep
apnea. For example, scanner 616 and/or molds of a patient's teeth can be
examined and used to
determine the adjustment needed for treating sleep apnea. Upper and lower
chassis including button
protrusions can be created from molds and injection molded prior to reformable
thermoplastic layers are
injection molded as an overmolding. For instance, a patient with malocclusion
and sleep apnea will require
a determination via scanner 616 or other method. Each patient, depending on
the results of scanned teeth
and soft tissue and patient feedback, may require a different placement of
horizontal and vertical
displacement for both treating sleep apnea. Vertical displacement can be by
way of lower bite pads or by
way of the thickness of a lower dental tray. In embodiments, the vertical
displacement is part of the mold,
milled appliance or 3D printed dental appliance.
[0061] In some embodiments, the elastic straps can be of different lengths and
strengths to enable a
gradual and incremental titration to advance the mandible forward, for example
some are 21 mm long but
may be softer or stronger elastic. In some embodiments, 9 different lengths
may be offered and four
different strengths may be offered for patient comfort and efficacy.
[0062] In one or more embodiments, bite pads 170 can be snap-on type bite pads
according to a
determined amount of vertical component required for a patient with sleep
apnea, or height of bite pads for
the dental appliance as a function of the shape of the soft palate. In other
embodiments, the vertical
displacement is determined by the soft tissue of the patient, such as the
hyoid shape. In one or more
embodiments, a scanner and/or camera such as scanner/camera 616 detects shape
of soft palate. The
data is collected as oral characteristic data and provided to a processor
which operates to classify the oral
characteristics for fabrication of the upper and lower dentition appliance
chassis.
[0063] In one or more embodiments, there are three classifications for a
soft palate: short, normal or
long. Thus, in one or more embodiments, a method includes determining if the
posterior edge of the soft
palate is short. For example, if there is 5 to 7 mm of space between the
posterior edge of the soft palate to
the posterior wall of the oral pharynx, the soft palate is determined to be
short, and a dental appliance will
need 5 to 7mm of vertical displacement. In some embodiments, to determine the
vertical displacement, a
scanner can measure the distance from the gingival-tooth crown juncture of the
maxillary central to the
gingival-tooth crown juncture of the mandibular central. If this distance is,
for example, 20mm and, thus,
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7mm of vertical is desired, in some embodiments, a vertical displacement can
be determined such that the
bite will have 7mm of vertical displacement.
[0064] In some embodiments, a method includes determining if the posterior
edge of the soft palate is
longer than a normal soft palate. If the soft palate is longer such that the
posterior edge of the soft palate
has 3 to 4mm of space between it and the posterior wall of the oral pharynx,
in some embodiments, a
dental appliance can be made to provide 8 to lOmm of vertical displacement to
keep the soft palate from
closing the airway when the patient in a supine position.
[0065] If the soft palate is very long and webbed shaped with just 2mm or less
of space between the
soft palate and the posterior wall of the oral pharynx, the appliance will
likely require 11 to 14mm of vertical.
displacement.
[0066] In one or more embodiments, a scanner determines whether a soft palate
is short, long or normal
and determines the placement of the uvula with respect to the palate.
[0067] Determining the placement and size of the lower dental tray bite
pads is a function of the length
of the palate of a patient. Additionally, in some embodiments, maxillary
button protrusions on an upper
dental tray are placed on each incisal edge, in the embrasure between the
right and left cuspids and first
bicuspids.
[0068] The placement of the mandibular button protrusions (lower dental tray
button protrustions) can be
determined by determining a patient's range of motion. In some embodiments, a
scanner detects maximal
range of motion by measuring before and after extension of the lower jaw. For
example, if the patient has
only 5-7mm of potential advancement, the buttons are placed 23mm apart with
the patient's teeth in
centric. If the patient has 7-10mm of potential advancement, the buttons are
placed 25mm apart, and if the
patient has 10-17mm of potential advancement, the buttons are placed 27mm
apart.
[0069] In one or more embodiments, a method includes determining the location
of the buttons on the
mandibular arch by occluding the patient's models in centric and placing the
center of the mandibular
button 23, 25, or 27mm from the center of the maxillary button.
[0070] As described above, a scanner/camera 616 takes images/scans of a
patient's mouth to
determine dentition data and/or soft palate data and a computer system coupled
to the scanner or
processor incorporated into a scanner/camera determines the placement of the
button protrusions and bite
pads on the upper and lower dental appliance chassis.
[0071] In one or more embodiments receiving oral characteristic data of the
patient includes scanning by
a scanner or camera a mold of the teeth; and transmitting the oral
characteristic data to a server.
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[0072] In one or more embodiments receiving oral characteristic data of a
patient includes scanning by a
scanner of an oral cavity of the patient; imaging the oral cavity to determine
the dentition data, wherein the
oral characteristic data includes dentition data as one or more images of
teeth and a gum line of the patient
and one or more images of a soft palate of the patient; and transmitting the
oral characteristic to a server.
[0073] In one or more embodiments determining the oral characteristic data
and vertical displacement is
a function of a shape of the soft palate of the patient.
[0074] In one or more embodiments the determining via the oral
characteristic the vertical displacement
as a function of the shape of the soft palate of the patient includes
determining a vertical displacement of
between 5 and 7 millimeters if the soft palate has between 5 to 7 millimeters
of space between a posterior
edge of the soft palate to a posterior wall of an oral pharynx of the patient.
[0075] In one or more embodiments, the determining via the oral
characteristic data the vertical
displacement as a function of the shape of the soft palate of the patient
includes processing the oral
characteristic data to measure a distance from a gingival-tooth crown juncture
of a maxillary central to a
gingival-tooth crown juncture of a mandibular central.
[0076] In one or more embodiments the determining via the oral
characteristic data the vertical
displacement as a function of the shape of the soft palate of the patient
includes determining if a posterior
edge of the soft palate is longer than a normal soft palate with between 3 and
5 millimeters of space
between a posterior edge of the soft palate to a posterior wall of an oral
pharynx of the patient; and
providing the vertical displacement of between 8 and 10 millimeters.
[0077] In one or more embodiments the determining via the oral
characteristic data the vertical
displacement as a function of the shape of the soft palate of the patient
includes determining if a posterior
edge of the soft palate is longer than a normal soft palate and webbed and
wherein two millimeters or less
of space exists between the soft palate and a posterior wall of an oral
pharynx, providing at least 11 to 14
millimeters for the vertical displacement.
[0078] In one or more embodiments the determining via the oral
characteristic data the vertical
displacement as a function of the shape of the soft palate of the patient
includes determining whether the
soft palate is one of short, normal, and long.
[0079] In one or more embodiments the lower dental tray is inclusive of a
first vertical displacement bite
pad on a left side of the lower dental tray and a second vertical displacement
bite pad on a right side of the
lower dental tray wherein a height of each of the first and second vertical
displacement bite pads is
determined according to the oral characteristic data, the oral characteristic
data providing soft tissue data of
the patient indicative of airway function.
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[0080] In one or more embodiments, the lower dental tray couples to the
upper dental tray via two
elastic bands coupled to either side of the dental appliance via the button
protrusions. The elastic bands
can include a plurality of pairs of elastic bands, each pair being of
different length and/or elasticity.
[0081] Some embodiments of a method may include, a method including forming an
upper dental
appliance chassis including at least two upper appliance button protrusions;
forming a lower dental
appliance chassis including at least two lower appliance button protrusions
and at least two vertical
displacement bite pads; injection overmolding a first thermoplastic on the
upper dental appliance chassis to
provide a first reformable thermoplastic layer integrated with the upper
dental appliance chassis that
exposes the at least two upper appliance button protrusions to form an upper
dental tray; and injection
overmolding a second thermoplastic on the upper dental appliance chassis to
provide a second reformable
thermoplastic layer integrated with the lower dental appliance chassis that
exposes the at least two lower
appliance button protrusions and the at least two vertical displacement bite
pads to form a bottom dental
tray.
[0082] In one or more embodiments, the method includes forming a dental
appliance including the lower
dental tray and an upper dental tray, each of the lower dental tray and the
upper dental tray, the lower
dental tray inclusive of the at least two vertical displacement bite pads and
at least two lower appliance
button protrusions, the upper dental tray inclusive of the at least two upper
appliance button protrusions,
the at least two lower appliance button protrusions and the at least two upper
appliance button protrusions
providing a forward mandibular position when two elastic bands are attached to
connect the upper dental
tray and the lower dental tray.
[0083] In one or more embodiments, the upper dental appliance chassis and
the lower dental appliance
chassis are injection molded from one or more of an Ethylene Propylene
Copolymer and a
Polyoxymethlene Copolymer.
[0084] In one or more embodiments, the upper dental appliance chassis and
the lower dental appliance
chassis are injection molded using a thermoplastic olefin, thermoplastic
polyolefin, or olefinic thermoplastic
elastomer.
[0085] In one or more embodiments, the upper dental appliance chassis and
the lower dental appliance
chassis are injection molded using a polyethylene terephthalate.
[0086] In one or more embodiments, the upper dental appliance chassis and the
lower dental appliance
chassis are formed by three-dimensional (3D) printing of one or more of a
light polymerizable liquid
thermoset crosslinked polymer, a polyurethane, a methacrylate and a copolymer.
[0087] In one or more embodiments, the upper dental appliance chassis and the
lower dental appliance
chassis are formed by three-dimensional (3D) printing of a polymerizable resin
composition of a urethane
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monomer of urethane dimethacrylate (UDMA), an acidic monomer, and one or more
hydrophobic
monomers.
[0088] In
one or more embodiments, the first thermoplastic and the second thermoplastic
are comprised
of one or more of an E-caprolactone, caprolactam and one or more
polycaprolactone polymers.
[0089] In one or more embodiments, the first thermoplastic and the second
thermoplastic are comprised
of one or more of a caprolactone or polycaprolactone polymer material
overmolded on the upper dental
appliance chassis and the lower dental appliance chassis.
[0090] In one or more embodiments, the first thermoplastic and the second
thermoplastic provide
bonded overshot dentition layers that are formable to a patient's dentition
via a heat process.
[0091] In one or more embodiments, the first thermoplastic and the second
thermoplastic provide
bonded overshot dentition layers that are reformable to altered dentition of
the patient via one or more
subsequent heat processes.
[0092] In one or more embodiments, the heat process includes a boil and bite
process.
[0093] In one or more embodiments, the at least two vertical displacement bite
pads are configured to
be replaced with alternate vertical displacement bite pads of one or more
heights.
[0094] Another embodiment is directed to a system comprising a processor and a
non-transitory
computer-readable storage medium storing instructions operative when executed
on the processor to form
a dental appliance including forming an upper dental appliance chassis
including at least two upper
appliance button protrusions; forming a lower dental appliance chassis
including at least two lower
appliance button protrusions and at least two vertical displacement bite pads;
injection overmolding a first
thermoplastic on the upper dental appliance chassis to provide a first
reformable thermoplastic layer
integrated with the upper dental appliance chassis that exposes the at least
two upper appliance button
protrusions to form an upper dental tray; and injection overmolding a second
thermoplastic on the upper
dental appliance chassis to provide a second reformable thermoplastic layer
integrated with the lower
dental appliance chassis that exposes the at least two lower appliance button
protrusions and the at least
two vertical displacement bite pads to form a bottom dental tray.
[0095] Another embodiment is directed to a method including heating a dental
appliance by a heat
process, the dental appliance including an upper dental tray with a first
reformable thermoplastic layer and
a lower dental tray with a second reformable thermoplastic layer; molding the
first reformable thermoplastic
layer and the second reformable thermoplastic layer according to dentition of
a patient; and attaching at
least two elastic straps to the dental appliance to couple an upper portion of
the dental appliance to a lower
portion of the dental appliance, wherein the upper portion includes the first
reformable thermoplastic layer,
and the lower portion of the dental appliance includes the second reformable
thermoplastic layer, the at
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least two elastic straps, the at least two elastic straps attaching a first
pair of button protrusions with a
second pair of button protrusions to provide a forward mandibular position
when the two elastic bands are
attached to connect the upper dental tray and the lower dental tray.
[0096] One or more embodiments further include, if the dentition of the
patient changes, reheating the
dental appliance to remold the first reformable thermoplastic layer and the
second reformable thermoplastic
layer.
[0097] In one or more embodiments, the heat process is a boil and bite heat
process wherein a patient
inserts a heated dental appliance into form the first and second reformable
thermoplastic layers according
to the dentition of the patient.
[0098] In one or more embodiments, the upper dental tray includes a first
non-reformable layer coupled
to the first reformable thermoplastic layer via injection overmolding and the
lower dental tray includes a
second non-reformable layer coupled to the second reformable thermoplastic
layer via injection
overmolding.
[0099] In one or more embodiments, the first reformable thermoplastic layer
and second reformable
thermoplastic layer are comprised of one or more of E-caprolactone,
caprolactam and one or more
polycaprolactone polymers.
[0100] In one or more embodiments, the lower dental tray includes a pair of
vertical displacement bite
pads with a gradient from rear to fore of at least 1 millimeter.
[0101] Another embodiment is directed to a mandibular advancement dental
appliance including a two-
layer lower tray including: a lower dental appliance chassis layer including
at least two lower appliance
button protrusions and at least two vertical displacement bite pads; and a
first reformable thermoplastic
layer injection overmolded over the lower dental appliance chassis layer
formed of one or more of an E-
caprolactone, caprolactam and one or more polycaprolactone polymers integrated
with the lower dental
appliance chassis via one or more cavities in the surface of the lower dental
appliance chassis, the first
reformable thermoplastic layer configured to expose the at least two lower
appliance button protrusions and
the at least two vertical displacement bite pads; and a two-layer upper tray
including: an upper dental
appliance chassis layer including at least two upper appliance button
protrusions; and a second reformable
thermoplastic layer injection overmolded over the upper dental appliance
chassis layer formed of one or
more of an E-caprolactone, caprolactam and one or more polycaprolactone
polymers integrated with the
upper dental appliance chassis via one or more cavities in the surface of the
upper dental appliance
chassis, the first reformable thermoplastic layer configured to expose the at
least two lower appliance
button protrusions.
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[0102] In one or more embodiments, the mandibular advancement dental appliance
includes a pair of
elastic straps adapted to couple the two-layer lower tray with the two-layer
upper tray to provide mandibular
advancement.
[0103] Some embodiments include a processor and a non-transitory computer-
readable storage
medium storing instructions operative when executed on the processor to
perform the methods herein
described.
[0104] Those having skill in the art will recognize that the state of the
art has progressed to the point
where there is little distinction left between hardware and software
implementations of aspects of systems;
the use of hardware or software is generally (but not always, in that in
certain contexts the choice between
hardware and software can become significant) a design choice representing
cost vs. efficiency tradeoffs.
Those having skill in the art will appreciate that there are various vehicles
by which processes and/or
systems and/or other technologies described herein can be effected (e.g.,
hardware, software, and/or
firmware in one or more machines or articles of manufacture), and that the
preferred vehicle will vary with
the context in which the processes and/or systems and/or other technologies
are deployed. For example, if
an implementer determines that speed and accuracy are paramount, the
implementer may opt for a mainly
hardware and/or firmware vehicle; alternatively, if flexibility is paramount,
the implementer may opt for a
mainly software implementation that is implemented in one or more machines or
articles of manufacture;
or, yet again alternatively, the implementer may opt for some combination of
hardware, software, and/or
firmware in one or more machines or articles of manufacture. Hence, there are
several possible vehicles by
which the processes and/or devices and/or other technologies described herein
may be effected, none of
which is inherently superior to the other in that any vehicle to be utilized
is a choice dependent upon the
context in which the vehicle will be deployed and the specific concerns (e.g.,
speed, flexibility, or
predictability) of the implementer, any of which may vary. Those skilled in
the art will recognize that optical
aspects of implementations will typically employ optically-oriented hardware,
software, and or firmware in
one or more machines or articles of manufacture.
[0105] The foregoing detailed description has set forth various embodiments of
the devices and/or
processes via the use of block diagrams, flowcharts, and/or examples. Insofar
as such block diagrams,
flowcharts, and/or examples contain one or more functions and/or operations,
it will be understood by those
within the art that each function and/or operation within such block diagrams,
flowcharts, or examples can
be implemented, individually and/or collectively, by a wide range of hardware,
software, firmware, or
virtually any combination thereof. In one embodiment, several portions of the
subject matter described
herein may be implemented via Application Specific Integrated Circuitry
(ASICs), Field Programmable Gate
Arrays (FPGAs), digital signal processors (DSPs), or other integrated formats.
However, those skilled in the
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art will recognize that some aspects of the embodiments disclosed herein, in
whole or in part, can be
equivalently implemented in integrated circuitry, as one or more computer
programs running on one or
more computers (e.g., as one or more programs running on one or more computer
systems), as one or
more programs running on one or more processors (e.g., as one or more programs
running on one or more
microprocessors), as firmware, or as virtually any combination thereof, and
that designing the circuitry
and/or writing the code for the software and or firmware would be well within
the skill of one of skill in the
art in light of this disclosure. In addition, those skilled in the art will
appreciate that the mechanisms of the
subject matter described herein are capable of being distributed as a program
product in a variety of forms,
and that an illustrative embodiment of the subject matter described herein
applies regardless of the
particular type of signal bearing medium used to actually carry out the
distribution. Examples of a signal
bearing medium include, but are not limited to, the following: a recordable
type medium such as a floppy
disk, a hard disk drive, a Compact Disc (CD), a Digital Video Disk (DVD), a
digital tape, a computer
memory, etc.; and a transmission type medium such as a digital and/or an
analog communication medium
(e.g., a fiber optic cable, a waveguide, a wired communications link, a
wireless communication link, etc.).
[0106] In a general sense, those skilled in the art will recognize that the
various aspects described
herein which can be implemented, individually and/or collectively, by a wide
range of hardware, software,
firmware, or any combination thereof can be viewed as being composed of
various types of "electrical
circuitry." Consequently, as used herein "electrical circuitry" includes, but
is not limited to, electrical circuitry
having at least one discrete electrical circuit, electrical circuitry having
at least one integrated circuit,
electrical circuitry having at least one application specific integrated
circuit, electrical circuitry forming a
general purpose computing device configured by a computer program (e.g., a
general purpose computer
configured by a computer program which at least partially carries out
processes and/or devices described
herein, or a microprocessor configured by a computer program which at least
partially carries out
processes and/or devices described herein), electrical circuitry forming a
memory device (e.g., forms of
random access memory), and/or electrical circuitry forming a communications
device (e.g., a modem,
communications switch, or optical-electrical equipment). Those having skill in
the art will recognize that the
subject matter described herein may be implemented in an analog or digital
fashion or some combination
thereof.
[0107] Those having skill in the art will recognize that it is common
within the art to describe devices
and/or processes in the fashion set forth herein, and thereafter use
engineering practices to integrate such
described devices and/or processes into data processing systems. That is, at
least a portion of the devices
and/or processes described herein can be integrated into a data processing
system via a reasonable
amount of experimentation. Those having skill in the art will recognize that a
typical data processing system
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generally includes one or more of a system unit housing, a video display
device, a memory such as volatile
and non-volatile memory, processors such as microprocessors and digital signal
processors, computational
entities such as operating systems, drivers, graphical user interfaces, and
applications programs, one or
more interaction devices, such as a touch pad or screen, and/or control
systems including feedback loops
and control motors (e.g., feedback for sensing position and/or velocity;
control motors for moving and/or
adjusting components and/or quantities). A typical data processing system may
be implemented utilizing
any suitable commercially available components, such as those typically found
in data
computing/communication and/or network computing/communication systems.
[0108] While particular aspects of the present subject matter described herein
have been shown and
described, it will be apparent to those skilled in the art that, based upon
the teachings herein, changes and
modifications may be made without departing from the subject matter described
herein and its broader
aspects and, therefore, the appended claims are to encompass within their
scope all such changes and
modifications as are within the true spirit and scope of the subject matter
described herein. Furthermore, it
is to be understood that the invention is defined by the appended claims.
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