U.S. patent application number 13/918592 was filed with the patent office on 2013-12-19 for article for stabilizing jaw joint relationships for treatment of sleep apnea.
The applicant listed for this patent is Duane C. Keller. Invention is credited to Duane C. Keller.
Application Number | 20130333707 13/918592 |
Document ID | / |
Family ID | 49754772 |
Filed Date | 2013-12-19 |
United States Patent
Application |
20130333707 |
Kind Code |
A1 |
Keller; Duane C. |
December 19, 2013 |
Article For Stabilizing Jaw Joint Relationships For Treatment Of
Sleep Apnea
Abstract
An oral appliance for treating sleep apnea of a patient
including a monolithic body having an upper tray with an upper
recess formed to conform to the maxillary teeth of the patient and
a lower tray having a lower recess formed to conform to the
mandibular teeth, the monolithic body defining a coupling of a rear
portion of the upper tray to a rear portion of the lower tray at an
angle forming a orifice between front mandibular teeth and front
maxillary teeth, the upper tray including a raised upper seal
surrounding the recess corresponding to the patient's upper gum
line and the lower tray including a raised lower seal surrounding
the recess corresponding to the patient's lower gum line each when
the patient's teeth are disposed in the recesses.
Inventors: |
Keller; Duane C.; (St.
Louis, MO) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
Keller; Duane C. |
St. Louis |
MO |
US |
|
|
Family ID: |
49754772 |
Appl. No.: |
13/918592 |
Filed: |
June 14, 2013 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
|
61661725 |
Jun 19, 2012 |
|
|
|
Current U.S.
Class: |
128/848 |
Current CPC
Class: |
A61F 5/566 20130101;
A61M 16/10 20130101; A61M 16/0495 20140204; A61M 16/0493
20140204 |
Class at
Publication: |
128/848 |
International
Class: |
A61F 5/56 20060101
A61F005/56 |
Claims
1. An oral appliance for treating sleep apnea of a patient, the
patient having maxillary teeth located on an upper jaw with
surrounding upper soft gum tissue and an upper gum line, mandibular
teeth located on a lower jaw with surrounding lower soft gum tissue
and a lower gum line, a mouth cavity formed by the upper jaw and
the lower jaw containing the maxillary teeth, the mandibular teeth,
a tongue and an airway defined by the throat passage comprising: a
monolithic body having an upper tray with an upper recess formed to
conform to the maxillary teeth of the patient and a lower tray
having a lower recess formed to conform to the mandibular teeth,
the monolithic body defining a coupling of a rear portion of the
upper tray to a rear portion of the lower tray at an angle forming
a orifice between front mandibular teeth and front maxillary teeth,
the upper tray including a raised upper seal surrounding the recess
corresponding to the patient's upper gum line and the lower tray
including a raised lower seal surrounding the recess corresponding
to the patient's lower gum line each when the patient's teeth are
disposed in the recesses.
2. The oral appliance of claim 1 wherein the recess of the upper
tray conforms to the upper soft gum tissue surrounding the upper
teeth and the recess of the lower tray conforms to the upper soft
gum tissue surrounding the lower teeth.
3. The oral appliance of claim 1 wherein the monolithic body
includes at least one tongue support customized to conform to the
tongue of the patient.
4. The oral appliance of claim 3 wherein the tongue support is
positioned and dimensioned for holding a back edge of the patient's
tongue in a forward position and inhibiting the backward movement
of the tongue when the oral appliance is placed within the mouth of
the patient and onto the teeth of the patient.
5. The oral appliance of claim 3 wherein the monolithic body
includes two tongue supports, one positioned on each side of the
monolithic body and positioned for engaging opposing sides of the
tongue when the oral appliance is placed within the mouth of the
patient.
6. The oral appliance of claim 3 wherein the tongue support is
coupled to an inner side portion of at least one of the upper tray
and the lower tray with an amount of ethylene vinyl acetate (EVA)
material.
7. The oral appliance of claim 3 wherein the tongue support is
coupled between the rear portion of the upper tray and the rear
portion of the lower tray with an amount of ethylene vinyl acetate
(EVA) material.
8. The oral appliance of claim 3 wherein the tongue support and
each of the upper and lower trays are formed from a moldable
resilient soft plastic elastomeric material.
9. The oral appliance of claim 3 wherein the tongue support is
positioned for preventing the tongue from obstructing the open
airway when the oral appliance is placed within the mount of the
patient.
10. The oral appliance of claim 1 wherein each of the upper and
lower trays are formed from a moldable resilient soft plastic
elastomeric material.
11. The oral appliance of claim 1 wherein the upper and lower trays
are coupled together with an amount of ethylene vinyl acetate (EVA)
material.
12. The oral appliance of claim 1 wherein the upper tray and lower
tray are coupled in a position relative to each other in a
determined best functional position of the lower jaw relative to
the upper jaw of the patient to open the airway defined by the
throat passage.
13. The oral appliance of claim 1 wherein the upper tray is coupled
to the lower tray in the region from about a first or second
premolar back to about a second molar.
14. The oral appliance of claim 1, further comprising an adaptive
interface of the orifice configured for selectively coupling to an
oral device associated with a sleep apnea positive pressure
machine.
15. A dental oral appliance assembly for treating sleep apnea of a
patient, the patient having maxillary teeth located on an upper jaw
with surrounding upper soft gum tissue and an upper gum line,
mandibular teeth located on a lower jaw with surrounding lower soft
gum tissue and a lower gum line, a mouth cavity formed by the upper
jaw and the lower jaw containing the maxillary teeth, the
mandibular teeth, a tongue and an airway defined by the throat
passage comprising: a monolithic body having an upper tray with an
upper recess formed to conform to the maxillary teeth of the
patient and a lower tray having a lower recess formed to conform to
the mandibular teeth, the monolithic body defining a coupling of a
rear portion of the upper tray to a rear portion of the lower tray
at an angle forming a orifice between front mandibular teeth and
front maxillary teeth, and the monolithic body includes at least
one tongue support customized to conform to the tongue of the
patient.
16. The oral appliance of claim 15 wherein the tongue support is
positioned and dimensioned for holding a back edge of the patient's
tongue in a forward position and inhibiting the backward movement
of the tongue when the oral appliance is placed within the mouth of
the patient and onto the teeth of the patient.
17. The oral appliance of claim 15 wherein the monolithic body
includes two tongue supports, one positioned on each side of the
monolithic body and positioned for engaging opposing sides of the
tongue when the oral appliance is placed within the mouth of the
patient.
18. The oral appliance of claim 15 wherein the tongue support is
coupled to an inner side portion of at least one of the upper tray
and the lower tray with an amount of ethylene vinyl acetate (EVA)
material.
19. The oral appliance of claim 15 wherein the tongue support is
coupled between the rear portion of the upper tray and the rear
portion of the lower tray with an amount of ethylene vinyl acetate
(EVA) material.
20. The oral appliance of claim 15 wherein the tongue support and
each of the upper and lower trays are formed from a moldable
resilient soft plastic elastomeric material.
21. The oral appliance of claim 15 wherein the tongue support is
positioned for preventing the tongue from obstructing the open
airway when the oral appliance is placed within the mouth of the
patient.
22. The oral appliance of claim 1 wherein each of the upper and
lower trays are formed from a moldable resilient soft plastic
elastomeric material.
23. The oral appliance of claim 1 wherein the upper and lower trays
are coupled together with an amount of ethylene vinyl acetate (EVA)
material.
24. The oral appliance of claim 1 wherein the upper tray and lower
tray are coupled in a position relative to each other in a
determined best functional position of the lower jaw relative to
the upper jaw of the patient to open the airway defined by the
throat passage.
25. The oral appliance of claim 1 wherein the upper tray is coupled
to the lower tray in the region from about a first or second
premolar back to about a second molar.
26. The oral appliance of claim 1, further comprising an adaptive
interface of the orifice configured for selectively coupling to an
oral device associated with a sleep apnea positive pressure
machine.
27. The oral appliance of claim 1 wherein the upper tray includes a
raised upper seal surrounding the recess corresponding to the
patient's upper gum line and the lower tray includes a raised lower
seal surrounding the recess corresponding to the patient's lower
gum line each when the patient's teeth are disposed in the
recesses.
28. The oral appliance of claim 27 wherein the recess of the upper
tray conforms to the upper soft gum tissue surrounding the upper
teeth and the recess of the lower tray conforms to the upper soft
gum tissue surrounding the lower teeth.
Description
CROSS-REFERENCE TO RELATED APPLICATIONS
[0001] This application claims the benefit of U.S. Provisional
Application No. 61/661,725, filed on Jun. 19, 2012, the disclosure
of which is incorporated herein by reference.
FIELD
[0002] The present disclosure relates to devices for treatment of
sleep apnea and, more specifically, to an oral tray for treatment
of sleep apnea.
BACKGROUND
[0003] The statements in this section merely provide background
information related to the present disclosure and may not
constitute prior art.
[0004] Sleep apnea is a sleep disorder characterized by abnormal
pauses in breathing or instances of abnormally low breathing,
during sleep. Each pause in breathing can last from a few seconds
to minutes, and may occur many times in an hour of sleep. Sleep
apnea is diagnosed in an overnight sleep test or study. Common
symptoms include loud snoring, interrupted breathing, restless
sleep, and sleepiness during the daytime. Sleep apnea is recognized
as a problem due the sufferer having daytime sleepiness and
fatigue, slower reaction time, vision problems and other cognitive
and behavioral effects, such as moodiness, belligerence, decreased
attentiveness and motivation.
[0005] Treatments for sleep apnea include lifestyle changes, such
as avoiding alcohol or muscle relaxants, losing weight, quitting
smoking, sleeping at a 30-degree elevation of the upper body,
sleeping in a lateral position (sleeping on a side as opposed to
supine positions such as sleeping on the back), surgical procedures
to remove and/or tighten tissue in the airway, and use of an oral
appliance that keeps the airway open during sleep, and/or positive
airway pressure systems to promote air transfer during sleep. These
oral appliances include both passive and positive airway pressure
devices/assemblies.
[0006] Presently, dental trays are used for multiple applications
in dentistry, including dental tooth movements, topical medication
delivery, mandibular positioning and intra-oral orthotics and
cosmetic purposes, as components of sleep apnea appliances to
advance the mandible and multiple other uses. Trays used for
periodontal treatment are affixed to the patient's teeth with
custom formed seals to provide a comfortable means of attachment to
the individual dental arch. Dental trays are often used as mouth
guards or other types of appliances to help manage bite
relationships, mandibular maxillary relationships or to serve for
tooth protection. Orthotics are a type of dental appliances used to
acquire the patient's ideal or best functional relationship for an
optimal joint, muscle, head/neck and upper quadrant association. A
dental tray can be used in conjunction or in place of an orthotic
once the best functional relationship is established, but dental
trays fabricated from EVA material are extremely difficult to
adjust if there is any change to the bite or other change to the
patient. The functional dental relationships are confirmed in
stone, plaster, computer generated or other means of reproducing
the dental conditions and the models or other reproduced means are
approximated at the orthotic determined best functional
relationship. Trays are fabricated and affixed to one another at
this relationship to maintain the best functional joint, muscle and
structural and functional positioning for patients when they sleep
so they will maintain the optimal functional relationships.
SUMMARY
[0007] The inventor hereof has succeeded at designing a dental
tray, the method of use and the method of manufacture for the
treatment of sleep apnea such as the treatment of restricted or
obstructive airway that occurs during sleep that results from a
decreased airway due to abnormal mandibular/maxillary relationships
and soft tissue alterations.
[0008] According to one aspect, an oral appliance for treating
sleep apnea of a patient includes a monolithic body having an upper
tray with an upper recess formed to conform to the maxillary teeth
of the patient and a lower tray having a lower recess formed to
conform to the mandibular teeth. The monolithic body defines a
coupling of a rear portion of the upper tray to a rear portion of
the lower tray at an angle forming a orifice between front
mandibular teeth and front maxillary teeth. The upper tray can
include a raised upper seal surrounding the recess corresponding to
the patient's upper gum line and the lower tray cam include a
raised lower seal surrounding the recess corresponding to the
patient's lower gum line, each of which when the patient's teeth
are placed or disposed with their respective recesses.
[0009] According to another aspect, an oral appliance for treating
sleep apnea of a patient is provided. The patient has maxillary
teeth located on an upper jaw with surrounding upper soft gum
tissue and an upper gum line and mandibular teeth located on a
lower jaw with surrounding lower soft gum tissue and a lower gum
line. A mouth cavity is formed by the upper jaw and the lower jaw
containing the maxillary teeth, the mandibular teeth, a tongue and
an airway defined by the throat passage. The oral appliance has a
monolithic body including an upper tray with an upper recess formed
to conform to the maxillary teeth of the patient and a lower tray
with a lower recess formed to conform to the mandibular teeth. The
monolithic body defines a coupling of a rear portion of the upper
tray to a rear portion of the lower tray at an angle forming an
orifice between front mandibular teeth and front maxillary teeth.
The upper tray also has a raised upper seal surrounding the recess
corresponding to the patient's upper gum line. The lower tray also
has a raised lower seal surrounding the recess corresponding to the
patient's lower gum line each when the patient's teeth are placed
in the recesses.
[0010] According to yet another aspect, a dental oral appliance
assembly is provided for treating sleep apnea of a patient. The
patient has maxillary teeth located on an upper jaw with
surrounding upper soft gum tissue and an upper gum line, mandibular
teeth located on a lower jaw with surrounding lower soft gum tissue
and a lower gum line, a mouth cavity formed by the upper jaw and
the lower jaw containing the maxillary teeth, the mandibular teeth,
a tongue and an airway defined by the throat passage. The appliance
has a monolithic body that includes an upper tray with an upper
recess formed to conform to the maxillary teeth of the patient and
a lower tray with a lower recess formed to conform to the
mandibular teeth. The monolithic body includes and/or defines a
coupling of a rear portion of the upper tray to a rear portion of
the lower tray at an angle forming an orifice between front
mandibular teeth and front maxillary teeth. In this aspect, the
monolithic body includes at least one tongue support customized to
conform to the tongue of the patient to the hold the tongue when
worn by the patient.
[0011] In other aspects, methods for treating sleep apnea are
provided through the use of one or more of the above described
aspects of an oral appliance. In yet another aspect, one or more of
these methods can include also treating gum disease such as
periodontal disease simultaneous with treating sleep apnea.
[0012] Further aspects of the present disclosure will be in part
apparent and in part pointed out below. It should be understood
that various aspects of the disclosure may be implemented
individually or in combination with one another. It should also be
understood that the detailed description and drawings, while
indicating certain exemplary embodiments, are intended for purposes
of illustration only and should not be construed as limiting the
scope of the disclosure.
BRIEF DESCRIPTION OF THE DRAWINGS
[0013] FIG. 1A is a cast formed from an impression of maxillary
teeth of a patient for formation of an upper tray and FIG. 1B is a
cast formed from an impression of mandibular teeth for formation of
a lower tray for forming the unified sleep apnea appliance
according to one exemplary embodiment. As shown herein, is the
option with the groove for forming the optional seal along the gum
line.
[0014] FIG. 2A is an upper tray formed from the cast of FIG. 1A and
FIG. 2B is a lower tray formed from the cast of FIG. 1B according
to one exemplary embodiment of the sleep apnea appliance.
[0015] FIG. 3A is a bottom view of the upper tray formed from the
cast of FIG. 1A and FIG. 3B is a bottom view of the lower tray
formed from the cast of FIG. 1B each showing the recess in which
the teeth will be placed and showing the optional gum line seals
according to one exemplary embodiment of the sleep apnea
appliance.
[0016] FIG. 4 is a top schematic view of a wax impression of a bite
registration and of a patient's tongue placed thereon for formation
of a tongue support for one exemplary embodiment of the sleep apnea
appliance.
[0017] FIG. 5 is a front schematic illustration of a sleep apnea
appliance according to one exemplary embodiment showing the tongue
support and the angle of opening for the orifice and the coupling
of the upper tray to the lower tray at angle beta and coupling
using the coupling compound for forming the monolithic
appliance.
[0018] FIG. 6 is a front schematic illustration from a photograph
of a sleep apnea appliance according to one exemplary embodiment
showing the EVA coupling material and without the tongue
support.
[0019] FIG. 7 is a side schematic illustration from a photograph of
a sleep apnea appliance according to one exemplary embodiment
showing the upper recess for the upper teeth and the tongue support
and the opening angle beta for forming the front orifice.
[0020] FIG. 8 is a schematic illustration from a photograph of a
sleep apnea appliance according to one exemplary embodiment showing
the best functional relationship with the lower tray being placed
forward of the upper tray by offset distance and the angle of
opening beta to form the orifice.
[0021] FIG. 9 is a schematic illustration from a photograph of a
sleep apnea appliance in use in the mouth of a patient according to
one exemplary embodiment.
[0022] FIG. 10 is a side diagram of a patient suffering from sleep
apnea with a closed airway.
[0023] FIG. 11 is a side diagram of the patient of FIG. 10 with the
appliance with tongue support in place showing the opening of the
mouth at angle beta to form orifice, with the lower jaw and
mandibular teeth moved forward of the maxillary teeth and the
tongue support holding the tongue forward, thereby opening the
airway of the patient as compared to that of FIG. 10.
[0024] FIG. 12 is a side diagram of a patient with an appliance
having a connector or adaptor for coupling to a positive airway
pressure machine for receiving positive pressure through the
orifice of the appliance during use by the patient.
[0025] It should be understood that throughout the drawings,
corresponding reference numerals indicate like or corresponding
parts and features.
DETAILED DESCRIPTION
[0026] The following description is merely exemplary in nature and
is not intended to limit the present disclosure or the disclosure's
applications or uses.
[0027] Before turning to the figures and the various exemplary
embodiments illustrated therein, a detailed overview of various
embodiments and aspects is provided for purposes of breadth of
scope, context, clarity, and completeness.
[0028] A oral appliance for treating sleep apnea of a patient
including a monolithic body having an upper tray with an upper
recess formed to conform to the maxillary teeth of the patient and
a lower tray having a lower recess formed to conform to the
mandibular teeth, the monolithic body defining a coupling of a rear
portion of the upper tray to a rear portion of the lower tray at an
angle forming a orifice between front mandibular teeth and front
maxillary teeth, the upper tray including a raised upper seal
surrounding the recess corresponding to the patient's upper gum
line and the lower tray including a raised lower seal surrounding
the recess corresponding to the patient's lower gum line each when
the patient's teeth are disposed in the recesses.
[0029] In another embodiment, an oral appliance for treating sleep
apnea of a patient, the patient having maxillary teeth located on
an upper jaw with surrounding upper soft gum tissue and an upper
gum line, mandibular teeth located on a lower jaw with surrounding
lower soft gum tissue and a lower gum line, a mouth cavity formed
by the upper jaw and the lower jaw containing the maxillary teeth,
the mandibular teeth, a tongue and an airway defined by the throat
passage. The appliance has a monolithic body having an upper tray
with an upper recess formed to conform to the maxillary teeth of
the patient and a lower tray having a lower recess formed to
conform to the mandibular teeth. The monolithic body defines a
coupling of a rear portion of the upper tray to a rear portion of
the lower tray at an angle forming an orifice between front
mandibular teeth and front maxillary teeth.
[0030] In some embodiments, the upper tray and the lower tray are
coupled together to form the monolithic body by an amount of
ethylene vinyl acetate (EVA) material positioned between the two
trays. The upper tray and lower tray are coupled in a position
relative to each other in a determined best functional position of
the lower jaw relative to the upper jaw of the patient to open the
airway defined by the throat passage as discussed herein.
[0031] In some embodiments, the upper tray is coupled to the lower
tray in the region from about a first or second premolar back to
about a second molar, however, such coupling can vary by patient
based on the determined best functional positioning of the
jaws.
[0032] In some embodiments, the recess of the upper tray conforms
to the upper soft gum tissue surrounding the upper teeth and the
recess of the lower tray conforms to the upper soft gum tissue
surrounding the lower teeth. In such embodiments, the upper tray
can include a raised upper seal surrounding the recess
corresponding to the patient's upper gum line. The lower tray
includes a raised lower seal surrounding the recess corresponding
to the patient's lower gum line each when the patient's teeth are
disposed in the recesses. In such embodiments, as will be
discussed, the appliance as described herein for treatment of sleep
apnea can also be used during sleep for application of a bleaching
or whitening agent for whitening of the teeth or of a medicament
for treatment of periodontal disease.
[0033] In some embodiments, the monolithic body includes at least
one tongue support customized to conform to the tongue of the
patient. By customized, generally this includes a tongue support
that has been formed from an impression of the patient's tongue,
but can be otherwise customized as necessary to adapt to the
particular tongue of the patient. The tongue support can be
positioned and dimensioned for holding a back edge of the patient's
tongue in a forward position. This can include positioning for
inhibiting the backward movement of the tongue when the oral
appliance is placed within the mouth of the patient and onto the
teeth of the patient. In this manner, not only is the monolithic
body holding the upper and lower jaw in a predefined relationship,
but the oral appliance further restricts the backward movement of
the tongue to further ensure that the throat airway is open during
sleep and that the tongue does not obstruct the open airway during
use of the appliance.
[0034] In some embodiments, there is a single tongue support, that
can be positioned between the right and left sides of the
appliance, or in other embodiments, there can be two tongue
supports, one positioned on each side of the monolithic body and
positioned for engaging opposing sides of the tongue when the oral
appliance is placed within the mouth of the patient. The tongue
support or supports can be coupled to either side between the upper
and lower trays or attached to an upper tray or to a lower tray
depending on the arrangement as determined to be necessary to
position the tongue support for the proper placement relative to
the tongue for holding the back edge of the tongue in a forward
position. As will be addressed below, the tongue support can be
coupled to an inner side portion of at least one of the upper tray
and the lower tray with an amount of ethylene vinyl acetate (EVA)
material during formation of the monolithic body and/or attachment
of the upper tray to the lower tray as will be discussed below.
This can include coupling between the rear portion of the upper
tray and the rear portion of the lower tray or to one or both of
the trays with a desired or necessary amount of ethylene vinyl
acetate (EVA) material that is added as a bonding agent. Generally,
as the tongue support is in constant contact with the tongue, as
with the upper and lower trays, each of these can be formed from a
moldable resilient soft plastic elastomeric material or other
suitable material. However, in one embodiment, each is formed from
the moldable resilient soft plastic elastomeric material so as to
be more pleasant and comfortable during use than a harder
plastic.
[0035] In some embodiments, the appliance can be further adapted by
the formation of an adaptive interface at the formed orifice
between the front mandibular teeth and the front maxillary teeth,
e.g., between the front of the upper tray and the lower tray, so as
to enable or provide for the selective coupling to an oral device
associated with a sleep apnea positive pressure machine. Such an
interface would be customized for attachment to the positive
pressure tube, hose, or mask, via an appropriate coupling mechanism
for such device as at the current time; there is no defined
standardized interface. However, if one is developed, this
embodiment could meet such standard and still be within the scope
of this disclosure.
[0036] In another embodiment, a dental oral appliance assembly for
treating sleep apnea of a patient, the patient having maxillary
teeth located on an upper jaw with surrounding upper soft gum
tissue and an upper gum line, mandibular teeth located on a lower
jaw with surrounding lower soft gum tissue and a lower gum line, a
mouth cavity formed by the upper jaw and the lower jaw containing
the maxillary teeth, the mandibular teeth, a tongue and an airway
defined by the throat passage. The appliance has a monolithic body
having an upper tray with an upper recess formed to conform to the
maxillary teeth of the patient and a lower tray having a lower
recess formed to conform to the mandibular teeth. The monolithic
body is defined by the coupling of a rear portion of the upper tray
to a rear portion of the lower tray at an angle forming an orifice
between front mandibular teeth and front maxillary teeth. The
monolithic body includes at least one tongue support customized to
conform to the tongue of the patient to the hold the tongue when
worn by the patient as discussed above in various embodiments
thereof. The other embodiments and variations and options as
described above would also be applicable to and with the present
embodiment.
[0037] Referring now to the drawings, FIG. 1A is a cast 100 formed
from an impression of maxillary teeth of a patient for formation of
an upper tray and FIG. 1B is a cast 102 formed from an impression
of mandibular teeth for formation of a lower tray for forming the
unified sleep apnea appliance according to one exemplary
embodiment. As shown, the casts 100, 102 include tooth castings 104
and 106 of the patient's maxillary teeth and mandibular teeth,
respectively. The casts 100, 102 Each cast 100, 102 is formed from
a base cast 103 to include the tooth castings 104, 106 and
surrounding soft gum tissue 108, 110 for the upper cast 100 and the
lower cast 102, respectively.
[0038] To create the casts 100, 102, a dentist can use any
conventional impression-taking technique for example having the
patient bite into a container filled with a suitable hardenable
material such as an alginate material. When the alginate hardens,
an accurate copy of the patient's teeth are formed as the tooth
castings 104, 106 along with the adjacent periodontal soft tissue
108, 110 is produced. A suitable hardenable material such as, for
example, plaster or dental stone is poured into the impression to
create a male casting 100, 102 that includes the tooth castings
104, 106 and the and soft gum tissue 108, 110 which are
representative of the patient's teeth and adjacent soft tissue. The
casts 100, 102 are made for all or a portion (less than all) of the
upper and/or lower teeth. The soft tissues of the oral environment,
specifically the tongue, can also be included in the impression and
casts 100, 102. Further, the casts 100, 102 can be formed to
include connections or adapter for connecting to other fixtures to
help control the position of the tongue and posture, or for
connecting to other devices such as a continuation positive airway
pressure (CPAP) machine.
[0039] Further, in embodiments where a gum line seal is desired or
required, an upper groove 112 and/or a lower groove 114 is formed
in the casts 100, 102, respectively for forming upper and lower
seals. The grooves 112, 114 can be formed in the casts 100, 102
after fully cured. The dentist or technician can use a hand-held
tool (e.g., a round dental bar of desired dimension in a dental
hand piece or laboratory engine) or a dental lathe device, or a
computer directed removal device (such as a CAD-CAM) to remove a
desired or predefined amount of the stone or plaster material from
the casts 100, 102 at locations corresponding to desired level at
the patient's gingival or gum line within the soft tissue 108, 110
portion of the casts 100, 102. The depth and magnitude of the
removed materials is done in a manner to correspond to the gum line
so that only portions of the hardenable material from the casts
100, 102 are removed to create the one or more trough-like recesses
or grooves 112, 114 of the desired depth and thickness formed
around the front and rear surfaces of the tooth casts 104, 106
within the gum line of the soft gum tissue. In this manner, the
grooves 112, 114 assists in subsequent forming of a thickened
lingual extension in the trays formed from the casts 100, 102,
which is resiliently deflected by the gum when the tray is
installed on the patient's upper and lower teeth.
[0040] As shown in FIGS. 1A and 1B, by way of example, the casts
100, 102 include most of the upper and lower teeth. However, it
should be understood that less the all teeth can be molded and
casts 100, 102 and the subsequently formed upper and lower trays
can be formed using less than all of the maxillary and mandibular
teeth. Further, the grooves 112, 114 do not need to be formed as
the tray seal is an optional feature of the upper and lower
trays.
[0041] FIGS. 2A (top view) and 3A (bottom view) are illustrations
of one embodiment of an upper tray 150 formed from the cast 100 of
FIG. 1A according to one exemplary embodiment for formation of a
sleep apnea appliance. As shown here, an upper tray 150 has a
molded body 152 the forms a concave cavity 154 that includes an
upper recess 156 that forms upper tray crown covers 158 of the
maxillary teeth of the patient by formation from the upper tooth
casts 104 of the upper cast 100. The molded body 152 includes upper
tray body extension 162 which is the portion of the molded body 152
surrounding and supporting the upper recess 156. In those
embodiments requiring such, an upper gum line seal 160 is formed
between the upper recess 156 and the upper tray body extension 162.
Further in some embodiments, as will be described in further detail
below, a portion of the molded body 152 and/or the upper tray body
extension 162 can be formed as a tongue support 164 or portion
thereof, or in the alternative, can be formed to provide a
physical/structural support for a tongue support that is
subsequently attached or coupled thereto.
[0042] Similarly, FIGS. 2B (top view) and 3B (bottom view)
illustrate one embodiment of a lower tray 170 formed from the cast
102 of FIG. 1B according to one exemplary embodiment for formation
of a sleep apnea appliance. As shown here, an lower tray 152 has a
molded body 172 the forms a concave cavity 174 that includes a
lower recess 176 that forms lower tray crown covers 178 of the
mandibular teeth of the patient by formation from the lower tooth
casts 106 of the lower cast 102. The lower molded body 172 includes
lower tray body extension 182 which is the portion of the lower
molded body 152 surrounding and supporting the lower recess 176. In
those embodiments requiring such, a lower gum line seal 180 is
formed between the lower recess 176 and the lower tray body
extension 182. Further in some embodiments, as will be described in
further detail below, a portion of the lower molded body 172 and/or
the upper tray body extension 182 can be formed as a tongue
suppressor 184 or portion thereof, or in the alternative, can be
formed to provide a physical/structural support for a tongue
support that is subsequently attached or coupled thereto.
[0043] The seal 160 and 180 are optional. As shown in these
figures, a full body 152, 172 is formed to cover the associated
gums, and such is not required in all embodiments. Each upper tray
150 and lower tray 170 is configured with recesses 156, 176 in
which the teeth of a sleep apnea patient will be placed so that
they are covered by the crown covers 158, 178. In these exemplary
embodiments, the optional gum line seals 160, 180 are shown, which
can aid in securing the appliance formed from trays 150, 170 to the
teeth, gums and jaws of the patient during sleep apnea treatment.
As shown, a substantial portion of the gums can be covered by the
trays 150, 170, but such is not required in all embodiments, and in
some embodiments, only the gum line proximate to the teeth are
covered by the trays 150, 170 and in other embodiments, the trays
only cover the teeth or the crowns of the teeth.
[0044] FIG. 4 is a top schematic view of a wax impression 188 of a
bite registration 192 and of a tongue registration 190 for
formation of a tongue support 164, 184 for one exemplary embodiment
of the sleep apnea appliance. As shown, there is a left bite
registration 192A formed from a left wax body 196A with left tooth
bite impressions 198A from the left teeth of the patient. There is
a right bite registration 192B formed from a right wax body 196B
with right tooth bite impressions 198B from the right teeth of the
patient. The tongue registration 190 is formed with a tongue wax
body 194 from an impression or modeling of the patient's tongue
during the bite and the registration thereof. While FIG. 4 is only
an top view of the wax impression 188 and showing only the right
and left tooth impressions 198A, 198B of the maxillary teeth, it
should be understood that the left bite registration 192A, the
right bite registration 192B, and the tongue registration 194 will
include not only the registration of the left and right maxillary
teeth and the upper or top of the tongue as shown in this top view,
but also the mandibular teeth and the lower or bottom of the tongue
that is similarly reflected on the opposing sides of the thereof,
but not shown in FIG. 4's top view. In this manner, not only is a
registration of the patient's maxillary and mandibular teeth taken
during a normal bite, the position of the maxillary teeth in
relation to the mandibular teeth, and therefore the jaws containing
the teeth, as well as the position of the tongue during a bite.
[0045] The wax bite impression 188 with the bite registration 192
and the tongue registration 190 is used to determining an angle
alpha a which is the angle between the maxillary/upper teeth and
the mandibular/lower teeth during a normal bit. This can be used to
determine an appliance angle beta .beta. which is the desired angle
for the position of the upper tray 150 relative to the lower tray
170 from back to front (towards the opening of the mouth) to form
the sleep apnea appliance for the particular patient for
appropriate sleep apnea treatment through the use thereof. The wax
bit impression 188 is also used to determine an amount of offset
.epsilon. between the lower jaw and the upper jaw during the normal
bite which can be used to determine a desired appliance offset a
for the upper tray 150 relative to the lower tray 170 of the sleep
apnea appliance. The amount of the appliance angle beta .beta. and
the amount of the appliance offset a can be determined by the
health care specialist during determining the appropriate relative
positions of the jaws for sleep apnea treatment and control
(minimization of restricted airways in the throat, jaws and mouth)
during treatment or use of the sleep apnea appliance. Further, the
tongue impression 190 can be used to determine the need for, design
of and placement of the tongue support 164, 184 or pair of opposing
supports 164, 184 for the sleep apnea appliance.
[0046] FIGS. 5 and 6 are front schematic illustration of a sleep
apnea appliance 200 according to one exemplary embodiment. In this
illustrated exemplary embodiment, the appliance 200 has a
monolithic body 202 that is formed by coupling the upper tray 150
to the lower tray 170 along a coupling interface 204 at the rear
portion of the upper tray 150 and the rear portion of the lower
tray 170 on both the left and right sides of each. As shown in this
example, a coupling compound 206 forms the coupling interface 204
when the coupling compound 206 is applied to the upper portion of
the lower tray 170 and the lower portion of the upper tray 150
during manufacture of the appliance 200. As shown in this example,
the coupling compound 206 can be an amount of ethylene vinyl
acetate (EVA) material that is positioned between the two trays
150, 170 and is then cured to form the monolithic body 202 of the
sleep apnea appliance 200. In designing and forming the monolithic
body 202, the determined appliance angle beta .beta. and the amount
of the appliance offset .sigma. (not labeled in FIG. 5's front
view) defines an airway cavity 208. The assembled appliance 200
having the monolithic body 202 includes both the upper recess 156
in the upper tray 150 for receiving the patient's maxillary teeth
and the lower recess 176 in the lower tray 170 for receiving the
patient's mandibular teeth when the patient places the appliance
200 on such for sleep apnea treatment. In the exemplary embodiment
of FIG. 6, as compared to FIG. 5, a portion of the upper tray 150
includes the tongue support 164 at a rear portion thereof for
supporting the patient's tongue during treatment.
[0047] FIGS. 7 and 8 are top side perspective schematic views of
sleep apnea appliances 200 according to two exemplary embodiments.
Theses illustrated embodiments is similar to that of FIGS. 5 and 6,
but as a perspective view, have been labeled to illustrate the
monolithic body 202 of the appliance 200 having the upper tray 150
is a predetermined position relative to the lower tray 170. Two
sets of relationship axis have been included. The axis XL is along
the longitudinal line from the back to the front of the lower tray
170 that can be approximated by a center between the left side and
right side thereof or can be two parallel lines one on each lateral
side thereof. The axis XU is along the longitudinal line from the
back to the front of the upper tray 150 similarly positioned. The
upper tray longitudinal axis XU intersects the lower tray
longitudinal axis XL at the rear or proximate the rear or back of
each of the upper tray 150 and lower tray 170, identified as
X.sub.O. As described herein, the appropriate appliance angle beta
.beta. is defined by the medical care provider and the upper tray
150 is coupled to the lower tray 170 to form the monolithic body
202 fixing the angle beta .beta. as the angular relationship
between the two trays 150, 170. This also defines the appliances'
airway cavity 208 as shown. FIG. 7 further includes vertical plane
or line Z.sub.U defining a front X.sub.UF of the upper tray 150 or
the maxillary teeth or jaw of the patient associated therewith. For
illustration purposes, the front X.sub.UF is the distance point
along longitudinal line X.sub.U from the intersection X.sub.O. The
vertical plane or line Z.sub.L defines a front X.sub.LF of the
lower tray 150 or the mandibular teeth or jaw of the patient
associated therewith. For illustration purposes, the front X.sub.LF
is the distance point along longitudinal line X.sub.L from the
intersection X.sub.O. The difference in the distance between the
two front positions X.sub.UF and X.sub.LF is the appliance offset
.sigma. that is specified by the medical care provider as
identified or defined for sleep apnea treatment for the particular
patient. FIG. 7 defines these two front positions X.sub.UF and
X.sub.LF and therefore the appliance offset .sigma. as related to a
lateral portion of both the upper and lower trays 150, 170 as they
may associate with a position of the jaw containing the upper and
lower canine, by way of example. FIG. 8 provides a different
exemplary determination by defining the two front positions
X.sub.UF and X.sub.LF and therefore the appliance offset .sigma. as
related to a front foremost portion of the mammalian such as the
front most positioning of the central incisor. As will be
understood to those of skill in the art, these are only two
examples of alignments and that others are also possible based on
the particular needs as determined during evaluation. Whatever
alignment points or placements is used during the preparation of
the wax impression 188 of the bit registration 192 and tongue
registration 190 (where provided) would be alignment points or
placements used herein.
[0048] FIG. 9 is a schematic illustration from a photograph of a
sleep apnea appliance 200 as in actual use in a mouth 302 of a
patient 300 according to one exemplary embodiment. The patient's
mouth 302 includes upper lips 304 and lower lips 306, as well as
mouth soft tissue 308 generally known as buccal mucosa or lip and
cheek lining. As shown, the appliance 200 is placed about the
patients teeth and the patient's tongue 310 is illustrated within
the airway cavity 208 of the appliance for illustration purposes.
FIG. 10 is a side view diagram of a patient 300 suffering from
sleep apnea with a closed airway 312. As shown and known in
anatomy, each patient has a nasal cavity 314, a palate 316 with
rear portion 316R, an oral cavity 318, a pharynx 320, a esophagus
322, maxillary/upper jaw 324 with maxillary/upper teeth 326, and
mandibular/lower jaw 328 with mandibular/lower teeth 330. As shown,
the air passage way or pharynx 320 in FIG. 10 is shown as largely
or substantially closes along with a portion of the oral cavity at
the rear of the tongue 310 proximate to the pharynx 320. In this
illustration, the patient 300 has restricted airways that can
result in sleep apnea.
[0049] FIG. 11 is a side view diagram of the patient of FIG. 10 but
with appliance 200 positioned within the mouth 302 of the patient
300 and applied or placed on the maxillary teeth 326 and mandibular
teeth 330. In this example, further the appliance 200 includes a
tongue support 164, 184. The appliance 200 includes the positioning
of the mouth 302 in an open position formed in place showing the
opening of the mouth at the angle beta .beta. to form airway cavity
208. Further, the appliance 200 include the appliance offset
.sigma. that was determined by the health care provider that in
this embodiment having the lower jaw 328 and mandibular teeth 330
moved forward relative to the maxillary jaw 324 and maxillary teeth
326 by the predetermined amount of the appliance offset a. In this
manner, the forward positioning of the lower jaw 328 opens the
pharynx 320 during appliance 200 use. Further, in this exemplary
embodiment, the optional tongue support 164, 184 is included and
configured to hold the tongue 310 in a forward position, thereby
further opening the airway 312 of the patient as compared to that
of FIG. 10. As noted, the tongue support 164, 184 is optional and
may not be required for all patients 300 or their sleep apnea
treatment.
[0050] In some cases, the patient may have also been prescribed a
continuous positive airway pressure (CPAP) treatment wherein a CPAP
machine provides air pressure to the airways during sleep. In such
cases, the appliance 200 can include a connector or adaptor 340
which is coupled to or attachable to the appliance 200 or for
attaching a CPAP coupler 342 for a mask or a tube 344 each of which
are connected to a CPAP machine 346. This is shown in FIG. 12 where
the CPAP machine 324 provides positive pressure airflow 348 to an
air tube 344 that is connected to the mask connector 342 which is
attached to the adaptor 340 of appliance 200. This results in the
patient 300 receiving at least a portion of positive air pressure
350 within the airways during use of the appliance 200. The
appliance 200 as addressed above benefits the use of the CPAP
machine 346 by moving the lower jaw 328 forward of the upper jaw
324 to physically open the air passage 312 while the received
positive air pressure 350 further opens air passage 312 as well as
other airways during sleep. The appliance 200 can be adapted to
include an adaptor 340 that directly attaches to the CPAP machine
346 rather than requiring the patient 300 to have a nasal mask over
the nose.
[0051] In other embodiments, a method of treating sleep apnea using
the above described oral appliances. The patient is analyzed to
determine the best fit as described herein, the appliance is
manufactured as described herein and the patient places the
prepared appliance is his mouth during sleep as described herein
for the treatment of sleep apnea. As noted above, the above various
appliances can be used to treat gum/periodontal disease
simultaneously while treating sleep apnea or for application of a
tooth whitening solution or compound.
[0052] Another embodiment includes a method of manufacturing an
oral appliance for treating sleep apnea of a patient, the patient
having maxillary teeth located on an upper jaw, mandibular teeth on
a lower jaw, a mouth cavity formed by the upper jaw and the lower
jaw containing the maxillary teeth, the mandibular teeth, a tongue
and an airway defined by the throat passage. The method includes
taking an upper impression of the maxillary teeth and a soft gum
tissue proximate to and surrounding the maxillary teeth of the
patient, and preparing a maxillary cast from the upper impression.
The method also includes taking a lower impression of the
mandibular teeth and a soft gum tissue proximate to and surrounding
the mandibular teeth of the patient and preparing a mandibular cast
from the lower impression.
[0053] The process of preparing the upper and lower trays can
include molding a resilient elastomeric material to the maxillary
cast and molding a resilient elastomeric material to the mandibular
cast. While this process can include any suitable material, a
moldable resilient soft plastic elastomeric material or similar
soft material is often preferred.
[0054] The method further includes determining a functional
position of the lower jaw relative to the upper jaw of the patient
to open the airway defined by the throat passage. Next the upper
tray from the maxillary cast is prepared and the method includes
preparing a lower tray from the mandibular cast. The method
includes embedding the upper tray in stone forming an upper tray
stone cast leaving only a portion of the upper tray exposed,
embedding the lower tray in stone forming a lower tray stone cast
and leaving only a portion of the lower tray exposed. The method
further includes placing the embedded upper tray and the embedded
lower tray in an articulator, positioning the embedded upper tray
and the embedded lower tray in the articulator for alignment in the
determined functional position and coupling the exposed portion of
the upper tray to the exposed portion of the lower tray forming an
oral appliance having a unified body. The method then includes
removing the stone in which oral appliance is embedded.
[0055] The method of manufacture of the appliance can also include
positioning the embedded upper tray and the embedded lower tray in
the articulator with alignment of the tongue support for
positioning the tongue to prevent the tongue from obstructing the
open airway resulting from the determining of the functional
position.
[0056] This process can include positioning the embedded upper tray
and the embedded lower tray and coupling the exposed portion of the
upper tray to the exposed portion of the lower tray each includes
forming a orifice between a front of the upper tray and a front of
the lower tray. As addressed above, this can include forming an
adaptive interface to the orifice for selectively coupling to an
oral device associated with a sleep apnea positive pressure
machine.
[0057] The method of manufacturing can include coupling the exposed
portion of the upper tray to the exposed portion of the lower tray
by heating of each with a torch or other suitable heating source,
or through use of an adhesive or similar attachment mechanism.
Where heat is applied, the method of coupling can include adding an
amount of a suitable bonding agent, such as ethylene vinyl acetate
(EVA) material, into a space between the exposed portion of the
upper tray and the exposed portion of the lower tray when they are
heated, and such that once they are cooled, the bonding agent
fixedly couples the upper tray to the lower tray to form the
monolithic or unibody of the appliance.
[0058] The method of manufacturing can also include taking an
impression of the tongue of the patient and preparing one or more
tongue support fixtures from the tongue impression. This can be by
any suitable method and can include, but is not limited to a wax
impression. This can also include taking the impression of a back
edge of the tongue and preparing the tongue support fixture
includes preparing a fixture for resting behind the back edge of
the tongue for holding the tongue in a forward position and
inhibiting the backward movement of the tongue when the oral
appliance is placed in the patient's mouth.
[0059] The tongue support fixture or fixtures can be coupled to at
least one of the exposed portion of the upper tray or between and
the exposed portion of the lower tray to form a unibody oral
appliance with integrated tongue support. As such this step of
attachment and formation of the tongue support into the monolithic
or unibody oral appliance can take place after the embedded upper
tray and the embedded lower tray is placed in the articulator.
[0060] A noted, there can be a single tongue support in which case
the tongue support could expand or extend across the interior of
the mouth between two opposing sides of the appliance. In other
embodiments, the tongue support fixture includes a right fixture
portion and a left fixture portion with the right fixture portion
extending towards the tongue from a right inner side of the
appliance to which it is coupled and a left fixture portion would
extend towards the tongue from a left inner side of the appliance
to which it is coupled.
[0061] The method of manufacture of the appliance can include
coupling the tongue support to the other portions of the appliance
either before or after coupling of the upper tray to the lower tray
by any suitable means. In one exemplary embodiment, the method
includes heating at least a portion of the exposed portion of the
upper tray or the lower tray with a torch and adding an amount
suitable material such as ethylene vinyl acetate (EVA) material, by
way of example, between the at least one of the exposed portion of
the upper tray and the exposed portion of the lower tray and the
tongue support.
[0062] In some embodiments of the method of manufacture, when
taking the upper impression of the maxillary teeth, this step can
include taking an impression of a soft gum tissue proximate to and
surrounding the maxillary teeth of the patient and the mandibular
teeth of the patient in forming the upper and lower trays. In this
manner the upper and lower trays can be formed to not only cover
the crowns of the teeth but also a portion of the soft gum tissue
proximate to each tooth. As such, in this method the process of
preparing a maxillary stone cast from the upper impression would
include the soft gum tissue proximate the maxillary teeth and the
process of preparing the mandibular stone case from the lower
impression includes soft gum tissue proximate the mandibular teeth.
In these embodiments, the process of preparing the upper tray would
include forming the upper tray to include a portion covering the
soft gum tissue proximate to and surrounding the maxillary teeth
and would include preparing the lower tray to include a portion
covering the soft gum tissue proximate to and surrounding the
mandibular teeth. In such embodiments, as the trays include a
portion of the soft gum tissue proximate the teeth, the process can
also include preparing the upper tray to forming a seal a portion
covering the soft gum tissue proximate to and surrounding the
maxillary teeth. Similarly, the process of preparing the lower tray
can include forming a portion of the lower tray to cover the soft
gum tissue proximate to and surrounding the mandibular teeth.
[0063] The method in this regard can include defining an upper
elongated seal groove along an upper gum line and defining a lower
elongated seal groove along a lower gum line. The processes of
preparing the upper tray and lower tray include forming a raised
seal on the along the gum lines as defined by the elongated seal
grooves in the maxillary cast and the mandibular cast.
[0064] The process includes determining a functional position of
the lower jaw relative to the upper jaw of the patient to open the
airway defined by the throat passage including positioning the
lower jaw forward and the downward to open the mouth from a closed
mouth position to produce a forward protrusion of the mandible
relative to the maxilla and an space between a portion of the front
maxillary teeth and the front mandibular teeth forming a orifice.
This can include determining the functional position includes
determining a best functional relationship of the lower jaw
relative to the upper jaw and a maxilla and a head of the patient
relative to the spine of the patient. This can include, but is not
limited to taking a bite registration at the time of taking the
upper impression and the lower impression and determining the
functional position is a function of the occlusion identified by
the bite registration balanced with a determination of muscles of
mastification and jaw joint relationship.
[0065] As disclosed herein, the present oral tray and method of
manufacture and use is for treating sleep disorders and sleep
apnea/hypopnea through the use of custom formed dental trays
affixed at the patient best functional mandibular/maxillary
relationship. Joint problems are first addressed to allow a patient
with TMJ dysfunction to correct the compromises in the function of
the mandibular/maxillary relationship so they are able to function
and have a better functional association. These problems include
internal and external joint compromises resulting in being unable
to open fully, and a mandibular position that is compromised and
unable to functional adequately or normally. These compromises make
it impossible for the structures to functional adequately and can
cause limitations in structural and functional dimensions,
including airway dimensions. It is possible to reestablish the
functional relationships with a combination of physical medicine
modalities, orthotics and patient cooperation to acquire a best
functional position. In some instances surgery, such as disc
repositioning or maxillary and mandibular surgery or tonsil,
adenoid removal may be required. The patient's best functional
mandibular/maxillary relationship is established with a combination
of intraoral orthotics, physical medicine or other means. This
relationship is evaluated to ascertain the structural and
functional interactions to be as ideal as possible. Patient's
casts, models, molds or other representations of the teeth are
related to one another at this functional posture. Custom formed
trays, such as a PerioTray.TM., are fabricated on the models, casts
or representations of the teeth at this relationship and are
combined into one appliance to maintain this association when
placed over the patient's teeth in the mouth.
[0066] The trays are fabricated for the upper and lower teeth.
These are made at the patient's best functional relationship
(joint, muscle, and upper quadrant function) and are made as one
appliance, instead of two. The tongue shows the airway in the front
region. Once the upper and lower trays are initially made, they are
coupled together as one appliance so that the patient's
mandibular/maxillary relationship is established at the best joint,
muscle and functional position. Then when the patient sleep with
the appliance in place these best functional associations are
maintained and our research is showing a decrease or elimination of
sleep apnea events, better oxygen blood levels, less muscle
hyperactivity, no grinding and the heart rates have fluctuated much
less.
[0067] A normal bite registration is a substance (in this case a
special bite registration wax) that fits between the teeth. That
does not allow us to observe where the tongue sits when the patient
is awake. This initial bite registration is different in we mold
the wax across the patient's palate so it is in one piece and will
serve as an impression tray for taking an impression of the tongue.
We added a second impression material (after the functional bite
was established) that gives us an impression of the dorsal side of
the tongue and we go as far back as the patient's gag reflex will
allow. (We can apply a 6% lidocaine gel to the tongue and override
some of the gag reflex). This gives us an impression of the tongue
and we are in particular looking for the most posterior and lateral
border. We make an EVA flange that will go around the lateral
border of the tongue much the same as your fingers may go around a
cantaloupe when you are picking it up with both hands. This flange
is positioned around the stone impression of the dorsal surface of
the tongue that we pour up and position with the teeth models so
the processed flanges serves to help hold the tongue in position
when the patient sleeps. All of the surfaces we do not want to
distort are imbedded in stone and the EVA material is then affixed
to the upper and lower trays with a heat process.
[0068] When describing elements or features and/or embodiments
thereof, the articles "a", "an", "the", and "said" are intended to
mean that there are one or more of the elements or features. The
terms "comprising", "including", and "having" are intended to be
inclusive and mean that there may be additional elements or
features beyond those specifically described.
[0069] Those skilled in the art will recognize that various changes
can be made to the exemplary embodiments and implementations
described above without departing from the scope of the disclosure.
Accordingly, all matter contained in the above description or shown
in the accompanying drawings should be interpreted as illustrative
and not in a limiting sense.
[0070] It is further to be understood that the processes or steps
described herein are not to be construed as necessarily requiring
their performance in the particular order discussed or illustrated.
It is also to be understood that additional or alternative
processes or steps may be employed.
* * * * *