U.S. patent application number 15/378162 was filed with the patent office on 2017-04-06 for oral appliance for treatment of snoring and sleep apnea.
The applicant listed for this patent is RIC INVESTMENTS, LLC.. Invention is credited to Lance BUSCH, Ronald B. KEMNITZER, Gary LOTZ, Robert Dale PARKS, Eugene Nelson SCARBERRY, Christopher STYGAR.
Application Number | 20170095951 15/378162 |
Document ID | / |
Family ID | 38832603 |
Filed Date | 2017-04-06 |
United States Patent
Application |
20170095951 |
Kind Code |
A1 |
SCARBERRY; Eugene Nelson ;
et al. |
April 6, 2017 |
ORAL APPLIANCE FOR TREATMENT OF SNORING AND SLEEP APNEA
Abstract
An oral appliance (1) is provided for the treatment of snoring
and obstructive sleep apnea. The oral appliance (1) includes an
upper tray (10) adaptable to conform to a user's maxillary
dentition and a plurality of lower trays (40), each of the lower
trays (40) adaptable to conform to the user's mandibular dentition.
At least some of the lower trays (40) are structured to engage the
upper tray (10), each of the lower trays (40) are structured to
impart a different fixed amount of mandibular advancement.
Inventors: |
SCARBERRY; Eugene Nelson;
(Trafford, PA) ; LOTZ; Gary; (Mars, PA) ;
BUSCH; Lance; (Trafford, PA) ; PARKS; Robert
Dale; (Pittsburgh, PA) ; STYGAR; Christopher;
(Pittsburgh, PA) ; KEMNITZER; Ronald B.;
(Blacksburg, VA) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
RIC INVESTMENTS, LLC. |
WILMINGTON |
DE |
US |
|
|
Family ID: |
38832603 |
Appl. No.: |
15/378162 |
Filed: |
December 14, 2016 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
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13468177 |
May 10, 2012 |
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15378162 |
|
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|
11801994 |
May 11, 2007 |
8205617 |
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13468177 |
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60813405 |
Jun 14, 2006 |
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Current U.S.
Class: |
1/1 |
Current CPC
Class: |
B29K 2023/083 20130101;
B29C 39/003 20130101; A61F 5/566 20130101; B29C 39/02 20130101;
B29C 33/3857 20130101; B29K 2067/00 20130101; B29C 39/38 20130101;
B29L 2031/753 20130101 |
International
Class: |
B29C 39/38 20060101
B29C039/38; B29C 39/02 20060101 B29C039/02; B29C 39/00 20060101
B29C039/00; A61F 5/56 20060101 A61F005/56; B29C 33/38 20060101
B29C033/38 |
Claims
1. A method of fitting an oral appliance, comprising: taking an
impression of a user's dentition; creating a casting of the user's
dentition using the impression; heating the casting to a
predetermined temperature; and placing the heated casting in an
oral appliance having a moldable material.
2. The method of claim 1, wherein the taking an impression includes
at least one of taking an impression of a user's maxillary
dentition and taking an impression of a user's mandibular
dentition.
3. The method of claim 1, wherein heating the casting comprises
heating the casting to at least 180 degrees Fahrenheit (82 degrees
Celsius).
4. The method of claim 1, wherein the placing the heated casting in
an oral appliance further comprises heating at least a portion of
the oral appliance material until the moldable material yields.
5. The method of claim 1, wherein the placing the heated casting in
an oral appliance comprises: inserting the heated casing within an
oral appliance tray, the oral appliance tray comprising: a moldable
material with a channel structured to align the heated casting
within the center thereof, the channel having a substantially
V-shaped portion structured to engage an anterior portion of the
heated casting and a substantially U-shaped portion structured to
engage a posterior portion of the heated casting; and a support
member structured to carry the moldable material thereon.
Description
PRIORITY CLAIM
[0001] This application is a Divisional of Ser. No. 13/468,177,
filed May 10, 2012 which is a Divisional of Ser. No. 11/801,994,
filed May 11, 2007, now U.S. Pat. No. 8,205,617, Issued Jun. 26,
2012 and claims priority under 35 U.S.C. .sctn.119(e) from
provisional U.S. patent application No. 60/813,405, filed Jun. 14,
2006 the contents of which are incorporated herein by
reference.
TECHNICAL FIELD
[0002] The present invention pertains to an oral appliance and more
particularly to an oral appliance for the treatment of snoring and
sleep apnea.
BACKGROUND OF THE INVENTION
[0003] Individuals suffering from sleep-related breathing
disorders, such as excessive snoring and sleep apnea, have an
increased risk of experiencing severe health problems. Studies have
shown, for instance, that individuals suffering from obstructive
sleep apnea (OSA) are more likely to have a stroke, heart failure,
hypertension, and depression, among others. OSA is characterized by
repetitive collapse of the upper airway during sleep. This yields
episodes of reduced airflow, hypoxemia (reduced oxygen level in the
blood), hypercapnia (elevated circulating carbon dioxide,
CO.sub.2), and arousal from sleep to reestablish a stable
airway.
[0004] Severe sleep-related breathing disorders may require
positive airway pressure (PAP) therapy. Less severe sleep-related
breathing disorders, however, may be treated with other therapies
or devices, such as an oral appliance. Generally, an oral appliance
includes upper and lower dental trays coupled together in such a
way as to impart forward advancement of the user's mandible (i.e.,
lower jaw) relative to the user's maxilla (upper jaw). Accordingly,
an oral appliance may also be referred to as a "mandibular
advancement device" or "MAD". Forward advancement of the mandible
helps prevent the soft tissue of the tongue and the throat from
collapsing into, and thus blocking, the user's airway during
sleep.
[0005] Achieving the correct amount of forward mandibular
advancement with an oral appliance is important. A user, for
example, may continue to suffer from a sleep-related breathing
disorder if the forward mandibular advancement imparted by the oral
appliance is inadequate (e.g., the soft tissue of the user's tongue
and throat are not prevented from collapsing into the user's
airway). On the other hand, if the forward mandibular advancement
imparted by the oral appliance is excessive, the user may
experience unnecessary discomfort. The discomfort may cause
undesirable arousal from sleep and/or cause the user to stop
wearing the oral appliance all together.
[0006] Some oral appliances, such as those described in U.S. Pat.
Nos. 5,829,441, 5,365,945, and 5,868,138, include mechanisms for
adjusting the amount of mandibular advancement provided by the oral
appliance. These and similar oral appliances, however, are
expensive, complicated to manufacture, and have adjustment
mechanisms are difficult to operate. Additionally, oral appliances
incorporating adjustment mechanisms tend to be bulky, thereby
adversely impacting the user's comfort level. Furthermore, known
oral appliances are difficult to properly fit, do not allow
sufficient vertical or horizontal movement of the jaw when worn,
and are not flexible enough to allow a "one size fits all"
application (e.g., the oral appliance may not be appropriate for
both a user having a relatively small dental arch and a user having
a relatively large dental arch).
[0007] Accordingly, a need exists for an improved oral appliance
for the treatment of snoring and sleep apnea which overcomes these
and other problems associated with known oral appliances.
DISCLOSURE OF THE INVENTION
[0008] In accordance with an aspect of the present invention, an
oral appliance system comprises an upper tray and a plurality of
lower trays. The upper tray is adaptable to conform to a user's
maxillary dentition and each of the lower trays is adaptable to
conform to the user's mandibular dentition. The lower trays are
structured to engage the upper tray and each of the lower trays is
structured to impart a different fixed amount of mandibular
advancement and/or different amount of vertical height.
[0009] According to another aspect of the present invention, an
oral appliance tray comprises a moldable material and a support
member. The moldable material includes a channel structured to
align a user's dentition within the center thereof. The channel has
a substantially V-shaped portion structured to engage an anterior
portion of a user's dentition and a substantially U-shaped portion
structured to engage a posterior portion of the user's dentition.
The support member is structured to carry the moldable material
thereon.
[0010] According to another aspect of the present invention, an
oral appliance tray comprises a moldable material and a support
member. The support member has a base, an outer wall, and an inner
wall, which define a region adapted to couple with the moldable
material. A portion of the moldable material may extend out of the
region.
[0011] According to another aspect of the present invention, an
oral appliance tray comprises a moldable material and a support
member structured to carry a portion of the moldable material. The
support member has a ramp adapted to promote alignment of a user's
dentition relative to the moldable material.
[0012] According to another aspect of the present invention, an
oral appliance assembly comprises an oral appliance tray adaptable
to conform to a user's dentition and a holding tray adapted to
promote proper insertion of the oral appliance tray into a user's
mouth. The holding tray comprises a generally U-shaped frame
structured to couple with the oral appliance tray and a handle
located substantially at the vertex of the holding tray frame.
[0013] According to another aspect of the present invention, a
method for effecting the patency of a user's airway comprises
providing an oral appliance assembly comprising an upper tray
adaptable to conform to a user's maxillary dentition and a
plurality of lower trays each adaptable to conform to the user's
mandibular dentition, wherein each of at least some of the lower
trays is structured to couple with the upper tray to impart a
different fixed amount of mandibular advancement, enabling a
selection of at least one of the plurality of lower trays, and
enabling coupling of the upper tray with a selected one of the
lower trays to form an oral appliance having a desired amount of
mandibular advancement.
[0014] According to another aspect of the present invention, an
oral appliance tray comprises a generally U-shaped support member
having a first width relative to a vertex thereof that is between
approximately 0.30 inches (7.62 millimeters) and approximately 0.53
inches (13.46 millimeters) and having a second width relative to at
least one of a first leg and a second leg thereof that is between
approximately 0.50 inches (12.7 millimeters) and approximately 0.73
inches (18.54 millimeters).
[0015] According to another aspect of the present invention, a
holding tray adapted to promote proper insertion of an oral
appliance into a user's mouth comprises a generally U-shaped frame
and a handle. The frame is structured to engage the oral appliance
and has a base with an outer wall extending therefrom. The handle,
projecting from a front surface of the outer wall, is substantially
located at the vertex of the U-shaped frame.
[0016] According to another aspect of the present invention, a
method for fitting an oral appliance comprises taking an impression
of a user's dentition, creating a casting of the user's dentition
using the impression, heating the casting to a predetermined
temperature, and placing the heated casting in an oral appliance
having a moldable material.
[0017] According to another aspect of the present invention, a
method for fitting an oral appliance comprises enabling an oral
appliance tray to couple with a holding tray, the oral appliance
tray having a moldable material and the holding tray having a
handle, enabling the oral appliance tray to be submerged within a
heating medium without submerging at least a portion of the handle,
enabling removal of the oral appliance tray from the heating medium
using the handle, enabling insertion of the oral appliance tray
into a user's mouth using the handle, and enabling the user to make
an impression of a portion of the user's dentition.
[0018] These and other objects, features, and characteristics of
the present invention, as well as the methods of operation and
functions of the related elements of structure and the combination
of parts and economies of manufacture, will become more apparent
upon consideration of the following description and the appended
claims with reference to the accompanying drawings, all of which
form a part of this specification, wherein like reference numerals
designate corresponding parts in the various figures. It is to be
expressly understood, however, that the drawings are for the
purpose of illustration and description only and are not intended
as a definition of the limits of the invention.
BRIEF DESCRIPTION OF THE DRAWINGS
[0019] FIG. 1 is a perspective view of an oral appliance according
to one embodiment.
[0020] FIG. 2 is a front plan view of the upper tray for the oral
appliance illustrated in FIG. 1.
[0021] FIG. 3 is a bottom plan view of the upper tray illustrated
in FIG. 2.
[0022] FIG. 4 is a top plan view of the upper tray illustrated in
FIG. 2.
[0023] FIG. 5 is a side plan view of the upper tray illustrated in
FIG. 2.
[0024] FIG. 6 is a top plan view of the upper support member
portion of the upper tray illustrated in FIG. 2.
[0025] FIG. 7 is a front plan view of the lower tray for the oral
appliance illustrated in FIG. 1.
[0026] FIG. 8 is a bottom plan view of the lower tray illustrated
in FIG. 7.
[0027] FIG. 9 is a top plan view of the lower tray illustrated in
FIG. 7.
[0028] FIG. 10 is a side plan view of the lower tray illustrated in
FIG. 7.
[0029] FIG. 11 is a top plan view of the lower support member
portion of the lower tray illustrated in FIG. 7.
[0030] FIG. 12 illustrates the engagement of the upper and lower
trays according to one embodiment.
[0031] FIG. 13 is a side plan view of a lower tray for the oral
appliance illustrated in FIG. 1 according to another
embodiment.
[0032] FIG. 14 is top perspective view of a holding tray engaged
with a lower tray according to one embodiment.
[0033] FIG. 15 is bottom perspective view of the holding tray and
lower tray of FIG. 14.
[0034] FIG. 16 is a bottom plan view of the holding tray
illustrated in FIG. 14 according to one embodiment.
[0035] FIG. 17 illustrates an operational process for effecting the
patency of a user's airway according to one embodiment.
[0036] FIG. 18 illustrates an operational process for fitting an
oral appliance according to one embodiment.
[0037] FIG. 19 illustrates operational process for fitting an oral
appliance according to another embodiment.
[0038] FIG. 20 illustrates a layered moldable material according to
one embodiment of the present invention.
[0039] FIG. 21 illustrates an embedded molded material according to
one embodiment of the present invention.
[0040] FIG. 22 illustrates the oral appliance of FIG. 1
schematically coupled with a patient interface device.
[0041] FIG. 23 illustrates the oral appliance of FIG. 1 with
electromyography electrodes according to one embodiment.
BEST MODE(S) FOR CARRYING OUT THE INVENTION
[0042] Directional phrases used herein, such as, for example, left,
right, clockwise, counterclockwise, top, bottom, up, down, and
derivatives thereof, relate to the orientation of the elements
shown in the drawings and are not limiting upon the claims unless
expressly recited therein.
[0043] As employed herein, the term "number" shall mean one or more
than one and the singular form of "a", "an", and "the" include
plural referents unless the context clearly indicates
otherwise.
[0044] As employed herein, the statement that two or more parts are
"connected" or "coupled" together shall mean that the parts are
joined together either directly or joined together through one or
more intermediate parts. Further, as employed herein, the statement
that two or more parts are "attached" shall mean that the parts are
joined together directly.
[0045] As employed herein, the term "mandibular advancement" and
derivatives thereof refer to the anterior movement of a user's
mandible (lower jaw) relative to the user's maxilla (upper jaw).
Lateral movement, as employed herein, refers to the left/right
movement of the mandible relative to a sagittal plane passing
through the interproximal space of the maxillary centrals. Vertical
movement, as employed herein, refers to an increase/decrease of the
spacing between the occlusal surfaces of the mandibular dentition
and the occlusal surfaces of the maxillary dentition.
[0046] An oral appliance 1 according to one embodiment is shown in
FIG. 1. The oral appliance 1 includes an upper tray 10 adaptable to
conform to a user's maxillary dentition and a lower tray 40
adaptable to conform to the user's mandibular dentition. Although
only one lower tray 40 is illustrated in FIG. 1, it is contemplated
that multiple lower trays 40 will be provided. As will be discussed
in more detail below, each of at least some of the multiple lower
trays 40 is structured to impart a different fixed amount of
mandibular advancement when engaged with upper tray 10. A lower
tray 40 may also be structured to provide, in combination with
upper tray 10, a fixed amount of vertical spacing between the
user's maxillary dentition and mandibular dentition. Accordingly, a
user and/or dental specialist may select the proper lower tray 40
to provide a desired amount of mandibular advancement and/or a
desired amount of vertical spacing.
[0047] FIGS. 2-5 are front, bottom, top, and side plan views of
upper tray 10 for oral appliance 1 of FIG. 1. Upper tray 10 is
generally U-shaped (e.g., having two legs 16b, 16c extending from a
vertex 16a). Upper tray 10 includes an upper support member 11 and
an upper moldable material 24.
[0048] A top plan view of upper support member 11 without upper
moldable material 24 coupled thereto, for one embodiment, is
illustrated in FIG. 6. Upper support member 11 has a base 12 with a
bonding surface 13 and an occlusal surface 14, an outer wall 15
with a front surface 16 and a rear surface 17, and an inner wall 18
with a front surface 19 and a rear surface 20. A single slotted
engagement member 22 (FIG. 3) extends from occlusal surface 14. A
ramp 30 slopes downwardly from the top of a portion of inner wall
18 to a shelf 31 on bonding surface 13. As will be discussed in
greater detail below, ramp 30 is structured to assist with
centering the user's dentition relative to tray 10 during fitting
while shelf 31 is structured to help provide the desired vertical
spacing between the patient's maxillary and mandibular dentition.
Upper support member 11 may include identification markings 62. In
the current embodiment, for example and without limitation, upper
support member 11 includes the letter "U" on occlusal surface 14
(FIG. 3).
[0049] Traveling from leg 16b to leg 16c along base 12, bonding
surface 13 generally lies on a single plane (i.e., bonding surface
13 is generally flat). In an alternative embodiment, however, it is
contemplated that bonding surface 13 may be somewhat curved in
order to better accommodate the Curve of Spee associated with a
user's dentition. Specifically, it is contemplated that bonding
surface 13 is somewhat concave to accommodate the convex Curve of
Spee associated with a user's maxillary dentition.
[0050] Generally, upper support member 11 has a first width (A) at
vertex 16a that is between approximately 0.30 inches (7.62
millimeters) and approximately 0.53 inches (13.46 millimeters).
Upper support member 11 also has, relative to at least one of first
leg 16b and second leg 16c, a second width (B) that is between
approximately 0.50 inches (12.70 millimeters) and approximately
0.73 inches (18.54 millimeters). The distance between the outer
portion of first leg 16b and the outer portion of second leg 16c is
a third width (C) that is between approximately 2.0 inches (50.8
millimeters) and approximately 2.80 inches (71.12 millimeters). In
the current embodiment, first width (A) is approximately 0.41
inches (10.41 millimeters), second width (B) is approximately 0.60
inches (15.24 millimeters), and third width (C) is approximately
2.27 inches (57.66 millimeters).
[0051] Upper support member 11 is sized such that the ratio between
first width (A) and second width (B) is between approximately 0.60
and approximately 0.73 and the ratio between first width (A) and
third width (C) is between approximately 0.17 and approximately
0.19. In the current embodiment, for example, the ratio between
first width (A) and second width (B) is approximately 0.68 and the
ratio between first width (A) and third width (C) is approximately
0.18.
[0052] Referring briefly to FIG. 5, upper support member 11 has,
relative to vertex 16a, a first height (D) that is between
approximately 0.30 inches (7.62 millimeters) and approximately 0.50
inches (12.70 millimeters), and has a second height (E) relative to
at least one of a first leg 16b and a second leg 16c that is
between approximately 0.025 inches (0.635 millimeters) and
approximately 0.42 inches (10.67 millimeters). In the current
embodiment, first height (D) and second height (E) are selected
such that the ratio between second height (E) and first height (D)
is between approximately 0.083 and approximately 0.125.
Furthermore, upper support member 11 has a maximum height (F) that
is approximately between 0.30 inches (7.62 millimeters) and 0.48
inches (12.19 millimeters).
[0053] In the current embodiment, first height (D) is approximately
0.31 inches (7.87 millimeters), second height (E) is approximately
0.032 inches (0.813 millimeters), the ratio between second height
(E) and first height (D) is approximately 0.10, and maximum height
(F) is approximately 0.37 inches (9.40 millimeters).
[0054] Upper support member 11 may be constructed of any rigid or
semi-rigid material suitable for dental use. In the current
embodiment, upper support member 11 has a density that is
approximately between 0.040 lb/in3 and 0.050 lb/in.sup.3, a volume
that is between approximately 0.12 in.sup.3 and 0.22 in.sup.3 and a
weight that is between approximately 0.0071 lbs and 0.0081 lbs. For
example, upper support member 11 is constructed of a polycarbonate
resin thermoplastic, such as LEXAN, and has a density of
approximately 0.045 lb/in.sup.3, a volume of approximately 0.17
in.sup.3, and a weight of approximately 0.0076 lbs.
[0055] Returning to FIG. 6, upper support member 11 defines an
upper region 21. Upper region 21 is generally defined, for example
and without limitation, by base bonding surface 13, outer wall rear
surface 17, and inner wall front surface 19. Upper region 21 is
adapted to carry a portion of upper moldable material 24 therein.
Upper moldable material 24 may be coupled to upper support member
11 in any suitable manner, for example and without limitation,
using an adhesive.
[0056] Upper moldable material 24 is not restricted within upper
region 21. As seen for example in FIGS. 2, 3, and 5, at least a
portion of moldable material 24 extends out of upper region 21. In
the current embodiment, it is contemplated that a portion of upper
moldable material 24 extends at least 0.00984 inches (0.25
millimeters) above outer wall rear surface 17, at least 0.0256
inches (0.65 millimeters) above inner wall front surface 19, and at
least 0.00394 inches (0.1 millimeters) from the end of bonding
surface 13 of base 12 (i.e., from the end of the legs 16b, 16c of
upper support member 11). It should be noted that the amount that
moldable material 24 extends out of any portion of upper region 21
may be varied while remaining within the scope of the present
invention.
[0057] A moldable material may be selected which yields when
heated, thereby conforming to the user's dentition during fitting,
and re-hardens when cooled, thereby retaining the shape of the
user's dentition imparted during fitting. Such a moldable material
is sometimes referred to as a "boil and bite" material. In the
current embodiment, for example, moldable material 24 is an
ethylene-vinyl acetate copolymer resin, such as ELVAX, having a
density of approximately 0.035 lb/in.sup.3, a volume of
approximately 0.75 in.sup.3, and a weight of approximately 0.0263
lbs.
[0058] Oral appliance 1 incorporating an upper tray 10 provides
benefits over other oral appliances which have an upper tray
comprised solely of a moldable material or comprised of a moldable
material which is substantially completely contained within a
support member. For example, upper support member 11 is smaller
than other upper support members which completely enclose their
moldable material. Furthermore, by allowing a portion of upper
moldable material 24 to extend out from upper support member 11,
upper tray 10 is better able to conform to the user's maxillary
dentition during the fitting process. More specifically, moldable
material 24 is afforded a greater range of flow allowing moldable
material 24 to conform to the user's dentition even if the user's
dentition includes one or more misaligned teeth. Moldable material
24, such as that extending from the end of bonding surface 13, can
be manipulated during the fitting process to conform to the user's
dentition. Additionally, unlike other oral appliances which are
comprised solely of a moldable material, upper support member 11
provides additional support to moldable material 24 during and
after the fitting process. For these and other reasons, upper
support member 11 provides increased patient comfort and allows
upper tray 10 to fit a greater range of dental arch sizes.
[0059] Referring now to FIG. 4, upper moldable material 24 has a
channel 25 structured to center a user's dentition therein. More
specifically, channel 25 includes a substantially V-shaped portion
26 structured to engage an anterior portion of the user's maxillary
dentition (e.g., the upper centrals, laterals, and cuspids) and a
substantially U-shaped portion 27 structured to engage a posterior
portion of the user's maxillary dentition (e.g., the upper
bicuspids and molars). By centering the user's upper dentition
within upper moldable material 24, the user or dental profession
can better achieve the desired amount of mandibular advancement
when upper tray 10 is engaged with a selected lower tray 40. In
addition to centering the user's teeth within channel 25, V-shaped
portion 26 and U-shaped portion 27 promote increased contact
between the user's dentition and upper moldable material 24.
Accordingly, an improved impression of the user's dentition is
obtained during the fitting process.
[0060] FIGS. 7-10 are front, bottom, top, and side plan views,
respectively, of lower tray 40 for oral appliance 1 of FIG. 1.
Lower tray 40 is generally U-shaped (e.g., with two legs 46b, 46c
extending from a vertex 46a). Lower tray 40 includes a lower
support member 41 and a lower moldable material 54.
[0061] A top plan view of lower support member 41 without lower
moldable material 54 coupled thereto, for one embodiment, is
illustrated in FIG. 11. Lower support member 41 has a base 42 with
a bonding surface 43 and an occlusal surface 44, an outer wall 45
with a front surface 46 and a rear surface 47, and an inner wall 48
with a front surface 49 and a rear surface 50. An elongated
engagement member 52 (FIG. 10) extends from occlusal surface 44. A
ramp 58 slopes downwardly from the top of a portion of inner wall
48 to a number of ribs 60 on bonding surface 43. As will be
discussed in greater detail below, ramp 58 is structured to assist
with centering the user's dentition relative to tray 40 during
fitting while ribs 60 are structured to help provide the desired
vertical spacing between the patient's maxillary and mandibular
dentition. Lower support member 41 may include identification
markings 62. In the current embodiment, for example and without
limitation, lower support member 41 includes the letter "L" and the
numeral "000" on occlusal surface 14 (FIG. 8).
[0062] Traveling from leg 46b to leg 46c along base 42, bonding
surface 43 generally lies on a single plane (i.e., bonding surface
43 is generally flat). In an alternative embodiment, however, it is
contemplated that bonding surface 43 may be somewhat curved in
order to better accommodate the Curve of Spee associated with a
user's dentition. Specifically, it is contemplated that bonding
surface 43 is somewhat convex to accommodate the concave Curve of
Spee associated with a user's mandibular dentition.
[0063] In the current embodiment, legs 46b, 46c of lower support
member 41 also include a number of bite pads 59 which are
structured to help provide the desired vertical spacing (e.g., 10
millimeters of vertical spacing). Bite pads 59 may be sized to
promote the proper bite angle during fitting such that of the
user's bite pressure is distributed across the entire occlusal
surface 44 of base 42 during the fitting process. In the current
embodiment, bite pads 59 are similarly sized, however, different
sized bite pads 59 are within the scope of the present
invention
[0064] Generally, lower support member 41 has a first width (A') at
vertex 46a that is between approximately 0.30 inches (7.62
millimeters) and approximately 0.53 inches (13.46 millimeters).
Lower support member 41 also has, relative to at least one of first
leg 46b and second leg 46c, a second width (B') that is between
approximately 0.50 inches (12.70 millimeters) and approximately
0.73 inches (18.54 millimeters). The distance between the outer
portion of first leg 46b and the outer portion of second leg 46c is
a third width (C') that is between approximately 2.0 inches (50.8
millimeters) and approximately 2.80 inches (71.12 millimeters). In
the current embodiment, first width (A') is approximately 0.41
inches (10.41 millimeters), second width (B') is approximately 0.60
inches (15.24 millimeters), and third width (C') is approximately
2.27 inches (57.66 millimeters).
[0065] In the current embodiment, lower support member 41 is sized
such that the ratio between first width (A') and second width (B')
is between approximately 0.60 and approximately 0.73 and the ratio
between first width (A') and third width (C') is between
approximately 0.17 and 0.19. In the current embodiment, for
example, the ratio between first width (A') and second width (B')
is approximately 0.68 and the ratio between first width (A') and
third width (C') is approximately 0.18.
[0066] Referring briefly to FIG. 10, lower support member 41 has,
relative to vertex 46a, a first height (D') that is between
approximately 0.30 inches (7.62 millimeters) and 0.5 inches (12.70
millimeters), and has a second height (E') relative to at least one
of a first leg 46b and a second leg 46c that is between
approximately 0.025 inches (0.635 millimeters) and approximately
0.42 inches (10.67 millimeters). In the current embodiment, first
height (D') and second height (E') are selected such that the ratio
between first height (D') and second height (E') is between
approximately 0.083 and approximately 0.125. Furthermore, lower
support member 41 has a maximum height (F') that is between
approximately 0.30 inches (7.62 millimeters) and 0.48 inches (12.19
millimeters).
[0067] In the current embodiment, first height (D') is
approximately 0.32 inches (8.13 millimeters), second height (E') is
approximately 0.032 inches (0.813 millimeters), the ratio between
second height (E') and first height (D') is approximately 0.1, and
maximum height (F') is approximately 0.42 inches (10.67
millimeters).
[0068] Lower support member 41 may be constructed of any suitable
rigid or semi-rigid material. In the current embodiment, lower
support member 41 has a density that is approximately between 0.040
lb/in.sup.3 and 0.050 lb/in.sup.3, a volume that is between
approximately 0.12 in.sup.3 and 0.22 in.sup.3 and a weight that is
between approximately 0.0071 lbs and 0.0081 lbs. For example, lower
support member 41 is constructed of a polycarbonate resin
thermoplastic, such as LEXAN, having a density of approximately
0.045 lb/in.sup.3, a volume of approximately 0.18 in.sup.3, and a
weight of approximately 0.0081 lbs.
[0069] As mentioned above, upper tray 10 includes a ramp 30 (see
FIG. 6) that slopes downwardly from the top of a portion of inner
wall 18 to a shelf 31 located on the bonding surface 13 of base 12
and lower tray 40 includes a ramp 58 (see FIG. 11) that slopes
downwardly from the top of a portion of inner wall 48 to a number
of ribs 60 located on the bonding surface 43 of base 42. Ramp 30 is
structured to assist in centering the user's maxillary dentition
relative to upper tray 10 and ramp 58 is structured to assist in
centering the user's mandibular dentition relative to lower tray 40
during fitting. Shelf 31 and ribs 60 are structured to help provide
the desired vertical spacing between the user maxillary and
mandibular dentition.
[0070] Returning to FIG. 11, lower support member 41 defines a
lower region 51. Lower region 51 is generally defined, for example
and without limitation, by base bonding surface 43, outer wall rear
surface 47, and inner wall front surface 49. Lower region 51 is
adapted to carry a portion of lower moldable material 54 therein.
Lower moldable material 54 may be coupled to lower support member
41 in any suitable manner, for example and without limitation,
using an adhesive.
[0071] Lower moldable material 54 is not restricted within lower
region 51. As seen for example in FIGS. 7, 8, and 10, at least a
portion of moldable material 54 extends out of lower region 51. In
the current embodiment, it is contemplated that a portion of lower
moldable material 54 extends at least 0.00984 inches (0.25
millimeters) above outer wall rear surface 47, at least 0.0256
inches (0.65 millimeters) above inner wall front surface 49, and at
least 0.00394 inches (0.1 millimeters) from the end of bonding
surface 43 of base 42 (i.e., from the end of the legs 46b, 46c of
lower support member 41). It should be noted that the amount that
moldable material 54 extends out of any portion of lower region 51
may be varied while remaining within the scope of the present
invention.
[0072] As discussed above in conjunction with upper moldable
material 24, a lower moldable material 54 may be selected which
yields when heated, thereby conforming to the user's dentition
during fitting, and re-hardens when cooled, thereby retaining the
shape of the user's dentition imparted during fitting (i.e., a
"boil and bite" material). In the current embodiment, for example,
lower moldable material 54 is an ethylene-vinyl acetate copolymer
resin, such as ELVAX, having a density of approximately 0.035
lb/in.sup.3, a volume of approximately 0.66 in.sup.3, and a weight
of approximately 0.0231 lbs.
[0073] Oral appliance 1 incorporating a lower tray 40 provides the
same benefits over other oral appliances which have a lower tray
comprised solely of a moldable material or comprised of a moldable
material which is substantially completely contained within a
support member as were discussed above in conjunction with upper
tray 10. Accordingly, for these and other reasons, lower support
member 41 provides increased patient comfort and allows lower tray
40 to fit a greater range of dental arch sizes.
[0074] Referring now to FIG. 9, lower moldable material 54 has a
channel 55 structured to center a user's dentition therein. More
specifically, channel 55 includes a substantially V-shaped portion
56 structured to engage an anterior portion of the user's
mandibular dentition (e.g., the lower centrals, laterals, and
cuspids) and a substantially U-shaped portion 57 structured to
engage a posterior portion of the user's mandibular dentition
(e.g., the lower bicuspids and molars). By centering the user's
lower dentition within lower moldable material 54, the user or
dental profession can better achieve the desired amount of
mandibular advancement when the selected lower tray 40 is engaged
with upper tray 10. In addition to centering the user's teeth
within channel 55, V-shaped portion 56 and U-shaped portion 57
promote increased contact between the user's dentition and lower
moldable material 54. Accordingly, an improved impression of the
user's dentition is obtained as a result of the fitting
process.
[0075] Although the prior discussion of upper moldable material 24
and lower moldable material 54 was directed to the use of ELVAX, it
should be noted that other materials and/or combinations of
materials may be employed. For example, it is contemplated that
upper moldable material 24 and/or lower moldable material 54 are
comprised of a polycaprolactone polymer or other aliphatic
polyester (for example and without limitation, TONE P-700, TONE
P-767 or TONE P-787 polycaprolactone polymers manufactured by Union
Carbide Corporation). U.S. Pat. Nos. 6,247,926 and 5,807,100,
incorporated herein by reference, provides examples of the use of
such materials.
[0076] As another example, it is contemplated that upper moldable
material 24 and/or lower moldable material 54 are comprised of a
combination of ELVAX and a polycaprolactone polymer or other
aliphatic polyester Both the ELVAX and the polycaprolactone yield
when heated. Accordingly, these materials are better able to flow
around the user's dentition during the fitting process thereby
providing a custom fit. After cooling, the ELVAX remains relatively
flexible and promotes retention of the oral appliance 1 within the
patient's mouth. The polycaprolactone, however, becomes relatively
rigid after cooling. Accordingly, the polycaprolactone provides
additional support to the ELVAX; support that may be lacking when
the ELVAX is used alone. U.S. Pat. No. 5,051,476, incorporated
herein by reference, provides one such example of the use of ELVAX
and polycaprolactone.
[0077] The specific arrangement of the ELVAX and polycaprolactone
may be varied while remaining within the scope of the present
invention. FIGS. 20-21, for instance, show cross sectional views of
upper trays 10', 10'' according to embodiments in which the
moldable material 24', 24'' includes a combination of ELVAX 86 and
polycaprolactone 85. Referring to FIG. 20, ELVAX 86 and
polycaprolactone 85 are arranged in alternating layers.
Specifically, moldable material 24' includes a layer of
polycaprolactone 85 sandwiched between two layers of ELVAX 86. As
shown in FIG. 20, moldable material 24' is carried by support
member 11', which in this instance, is constructed of
polycarbonate. The present invention also contemplates eliminating
one or more layers, for example and without limitation, eliminating
the layer of ELVAX adjacent to support member 11'. Referring to
FIG. 21, polycaprolactone 85 is suspended within and throughout
ELVAX 86. Moldable material 24'' is carried by support member 11'',
which in this instance, is also constructed of polycarbonate.
[0078] FIG. 12 illustrates the engagement of upper tray 10 and
lower tray 40. Typically, lower tray 40 is arranged approximately
perpendicular to upper tray 10. A leading edge 52a of elongated
engagement member 52 is brought into contact with a portion of
slotted engagement member 22 such that end 52b is inserted into a
bottom slot 33 of slotted engagement member 22. Lower tray 40 and
upper tray 10 are then rotated, relative to each other, as
indicated by directional arrows 34, such that end 52b enters front
slot 32 (see FIG. 1) and is "hooked". When engaged, as seen in FIG.
1, end 52b is capable of moving a predetermined amount laterally
(as indicated by directional arrow 35) and a predetermined amount
vertically (as indicated by directional arrow 36) within slotted
engagement member 22. In the current embodiment, for instance, end
52b can move between 10-13 millimeters laterally and between
0.8-1.2 millimeters vertically. It should be noted, however, that
the amount of predetermined lateral and vertical movement may be
altered while remaining within the scope of the present
invention.
[0079] Although the engagement of upper tray 10 with lower tray 40
are described in conjunction with slotted engagement member 22 and
elongated engagement member 52 (i.e., a hook and slot arrangement),
alternative engagement mechanisms may be employed while remaining
within the scope of the present invention. Furthermore, the
specific arrangement of the engagement members may be altered while
remaining within the scope of the present invention. For example,
slotted engagement member 22 may extend from lower support member
41 of lower tray 40 and the elongated support member 52 may extend
from upper support member 11. As further examples, and without
limitation, the length of elongated engagement member 52, the size
of hook end 52b, and the orientation of hook end 52b may be altered
while remaining within the scope of the present invention.
[0080] In the current embodiment, slotted engagement member 22
includes a frangible portion 23 (see FIG. 2) which is structured to
break when approximately 36 lbs of force are applied thereto.
Frangible portion 23, however, may be structured to break when a
different amount of predetermined amount of force is applied
thereto. Furthermore, the applied force at which frangible portion
23 breaks may vary depending upon the direction that the force is
applied. Additionally, or alternatively, elongated engagement
member 52 may include a frangible portion (not shown).
[0081] As discussed above, each of the multiple lower trays 40 is
structured to impart a different fixed amount of mandibular
advancement when engaged with upper tray 10. In the current
embodiment, the amount of mandibular advancement imparted by each
lower tray 40 is determined by the fixed placement of elongated
engagement member 52 relative to, for example, vertex 46a of the
outer wall front surface 46 at vertex 46a.
[0082] For lower tray 40 illustrated in FIGS. 7-10, for example,
leading edge 52a of elongated engagement member 52 is offset
approximately 1.70 millimeters from the outer wall front surface at
vertex 46a of the outer wall front surface 46. At this position,
lower tray 40 is structured to provide a fixed amount of mandibular
advancement which brings the user's lower central teeth into
alignment with the user's upper central teeth in the current
embodiment.
[0083] Lower tray 40' illustrated in FIG. 13, as another example,
is structured to provide a fixed amount of mandibular advancement
such that the user's lower central teeth extend approximately 0.098
inches (2.5 millimeters) out from the user's upper central teeth
(i.e., lower tray 40' imparts a Class III malocclusion or
"underbite"). Specifically, leading edge 52a' of elongated
engagement member 52' is offset approximately 4.20 millimeters
relative to the outer wall front surface 46' at vertex 46a'.
Although the current discussion was limited to lower tray 40 and
lower tray 40', it is contemplated that other lower trays which
impart different fixed amounts of mandibular advancement may be
provided. For example, it is contemplated that oral appliance 1
also includes an additional lower tray which provides fixed
mandibular advancement such that the user's lower central teeth
extend approximately 0.197 inches (5 millimeters) out from the
user's upper central teeth.
[0084] Because upper tray 10 and lower tray 40 are asymmetric, the
amount of mandibular advancement may also be varied by flipping
upper tray 10 and lower tray 40. For example, when upper tray 10 is
fitted to a user's maxillary dentition and lower tray 40 is fitted
to the user's mandibular dentition; oral appliance 1 imparts an
amount of mandibular advancement to cause the user's upper central
teeth to be aligned with the user's lower central teeth. However,
if upper tray 10 is fitted to the user's mandibular dentition and
lower tray 40 is fitted to the user's maxillary dentition; oral
appliance 1 imparts an amount of mandibular advancement to cause
the user's lower central teeth to extend approximately 0.197 inches
(5 millimeters) out from the user's central upper teeth (i.e., to
cause a Class III malocclusion or "underbite"). Accordingly, a
small number of lower trays may be needed to obtain a larger range
of mandibular advancement.
[0085] Oral appliance 1 may be part of an assembly/system which
includes a number of holding trays which are structured to couple
with the upper and lower trays. FIGS. 14 and 15, for example,
illustrate a holding tray 70 engaged with lower tray 40 and FIG. 16
is a bottom plan view of holding tray 70 according to one
embodiment. Holding tray 70 includes a generally U-shaped frame 71
which is sized to accept lower tray 40 therein. Frame 71 includes a
base 78 with an outer wall 79 extending therefrom.
[0086] In the current embodiment, base 78 includes a gate 77 which
is structured to accommodate elongated engagement member 52. An
ejector pin 76 is employed to maintain lower tray 40 in contact
with holding tray 70. In the current embodiment, ejector pin 76 is
located along the posterior side of gate 77. Accordingly, when
lower tray 40 and holding tray 70 are coupled, ejector pin 76
engages inner wall 48 such that lower tray 40 "snaps-into" holding
tray 70.
[0087] In the current embodiment, holding tray 70 also includes a
handle 72 which projects from a front surface 80 of outer wall 79
at vertex 73 of frame 71. Handle 70 may be employed by the user to
suspend lower tray 40 within a heating medium during the fitting
process. For "boil and bite" moldable materials, for example, a
user may grasp and hold handle 72 while moldable material 54 is
submerged within the boiling water. Once moldable material 54 has
yielded (e.g., has become soft enough to be reshaped or molded),
the user may remove lower tray 40 from the boiling water and insert
lower tray 40 into their mouth. Holding tray 70 promotes proper
insertion of lower tray 40 into a user's mouth during the fitting
process. Specifically, a user employing holding tray 70 has the
additional leverage provided by handle 72 to better align lower
tray 40 within their mouth.
[0088] An occlusal surface 81 of base 78 may include a number of
bite pads 75 located thereon. Bite pads 75 may be constructed of an
elastomeric material that increases the user's comfort during the
fitting process although other materials are contemplated.
Additionally, bite pads 75 may be sized to promote the proper bite
angle during fitting such that of the user's bite pressure is
distributed across the entire occlusal surface 81 of base 78 during
the fitting process. In the current embodiment, bite pads 75 are
similarly sized, however, different sized bite pads 75 are within
the scope of the present invention.
[0089] It should be apparent that modifications may be made to
holding tray 70 while remaining within the scope of the present
invention. For example and without limitation, holding tray 70 may
have an ejector pin 76 located along the anterior side of gate 77
and an inner wall which engages outer wall 45 such that lower tray
40 "snaps-into" holding tray 70. Although the discussion associated
with FIGS. 14-16 was generally limited to using holding tray 70 in
conjunction with lower tray 40, it should be apparent that holding
tray 70 may also be structured for use with other lower trays
and/or upper tray 10.
[0090] FIG. 17 illustrates operational process 90 for effecting the
patency of a user's airway according to one embodiment. Operational
process begins at operation 91 which provides an oral appliance
assembly including an oral appliance, such as oral appliance 1
shown in FIG. 1, having an upper tray and plurality of lower trays.
In the current embodiment, upper tray 10 is adaptable to conform to
a user's maxillary dentition and each of the plurality of lower
trays 40, 40' is adaptable to conform to the user's mandibular
dentition. Upper tray 10 and lower tray(s) 40, 40' may be fitted to
a user's maxillary dentition and mandibular dentition,
respectively, using for example, operational process 100 and
operational process 110 which will be described in more detail
below. Each of at least some of lower trays 40, 40' is structured
to couple with upper tray 10 to impart a different fixed amount of
mandibular advancement.
[0091] Operational control is passed to operation 92 after the oral
appliance assembly is provided in operation 91. At Operation 92, at
least one of the plurality of lower trays is selected. In the
current embodiment, a lower tray may be selected based upon the
particular amount of mandibular advancement that is desired. For
example and without limitation, lower tray 40 is structured to
provide a fixed amount of mandibular advancement to bring the
user's lower central teeth into alignment with the user's upper
central teeth, whereas lower tray 40' is structured to provide a
fixed amount of mandibular advancement such that the user's lower
central teeth extend approximately 2.5 millimeters out from the
user's upper central teeth (i.e., lower tray 40' imparts a Class
III malocclusion or "underbite"). The selection of the proper lower
tray may be made by a dental professional, a user, or others.
[0092] Operational control is passed to operation 93 after one of
the lower trays is selected. At Operation 93, the upper tray is
coupled with the selected lower tray to form an oral appliance
having a desired amount of mandibular advancement. In the current
embodiment, upper tray 10 includes a slotted engagement member 22
and lower trays 40, 40' include an elongated engagement member 52.
Upper tray 10 and selected lower tray 40, 40' may be coupled as
described above in conjunction with FIG. 12. After the upper and
lower trays are coupled, oral appliance may be inserted into the
user's mouth to effect the patency of a user's airway.
[0093] FIG. 18 illustrates operational process 100 for fitting an
oral appliance according to one embodiment. Operational process 100
begins with taking an imprint of a user's dentition at operation
101. An imprint is generally a negative likeness of the user's
dentition. Typically, the imprint is taken by a dental professional
using a plastic material which hardens or sets while in contact
with the user's dentition. In the current embodiment, two imprints
are taken: the first is an imprint of the user's maxillary
dentition and the second is an imprint of the user's mandibular
dentition.
[0094] After the imprint is completed, operational control is
passed to operation 102 at which a casting of the user's dentition
is created. The casting may be made, for example, by filling the
imprint with plaster of Paris or artificial stone. In the current
embodiment, castings of both the user's maxillary and mandibular
dentition are created. Once completed, the castings provide a
facsimile of the user's maxillary and mandibular dentition.
[0095] The casting is then heated to a predetermined temperature at
operation 103. In the current embodiment, each casting created at
operation 102 is placed in heating medium, for example and without
limitation, water. The temperature of the heating medium is
maintained between approximately 180.degree. and 220.degree.
Fahrenheit (between approximately 82.22.degree. and 104.4.degree.
Celsius). In addition, in the current embodiment, top tray 10 and a
selected lower tray 40 are also placed in the heating medium such
that moldable material 24 and moldable material 54 begin to yield
(i.e., soften). It should be noted that the manner of heating and
the value of the predetermined temperature may be altered while
remaining within the scope of the present invention.
[0096] After reaching the predetermined temperature, the casting is
pressed into the moldable material of an oral appliance. In the
current embodiment, the heated casting of the user's maxillary
dentition is placed within upper moldable material 24 of upper tray
10. The heat retained by this casting permits upper moldable
material 24 to remain in a yielded state for a longer period of
time, thereby allowing a more accurate impression of the user's
maxillary dentition to be formed within upper moldable material 24.
Once cooled, upper moldable material 24 has been fit to the user's
maxillary dentition. Likewise, the heated casting of the user's
mandibular dentition is placed within lower moldable material 54 of
lower tray 40. The heat retained by this casting permits lower
moldable material 54 to remain in a yielded state for a longer
period of time, thereby allowing a more accurate impression of the
user's mandibular dentition to be formed within lower moldable
material 54. Once cooled, lower moldable material 54 has been fit
to the user's mandibular dentition.
[0097] FIG. 19 illustrates operational process 110 for fitting an
oral appliance according to another embodiment. Operational process
110 begins when an oral appliance tray is coupled with a holding
tray at operation 111. In the current embodiment, the oral
appliance tray is at least one of an upper tray 10 with moldable
material 24 and a lower tray 40, 40' with moldable material 54, 54'
and holding tray 70 has a handle 72 attached thereto.
[0098] After the oral appliance tray and the holding tray are
coupled, operational control is passed to operation 112 at which
the oral appliance tray is submerged within a heating medium while
at least a least a portion of the handle remains out of the heating
medium. With reference to an upper tray 10, for example, a user can
grasp an end of handle 72 and submerge upper tray 10 within boiling
water. The user may continue to hold handle 72 (which is not
submerged in the boiling water) while upper tray 10 is
submerged.
[0099] Operational control is then passed to operation 113 at which
the oral appliance tray is removed from the heating medium with the
handle. Continuing the example above, a user can remove upper tray
10 from the boiling water (with handle 72) after upper moldable
material 24 reaches a yielded state.
[0100] Operational control is then passed to operation 114 at which
the oral appliance tray is inserted into a user's mouth using the
handle. Continuing with the same example, a user can insert upper
tray 10 into their mouth while maintaining a grip on handle 72.
Handle 72 provides additional leverage to the user such that proper
alignment of upper tray 72 within the user's mouth is facilitated.
Additionally, handle 72 eliminates the need for the user to touch
upper tray 10 which may still be somewhat hot from being submerged
within the boiling water.
[0101] After the oral appliance tray is inserted into the user's
mouth, operational control is passed to operation 115 at which an
impression of at least a portion of the user's dentition is made.
In the current example, the user is able to bite into upper
moldable material 24 which is in a yielded state. Upper moldable
material 24 then flows around the user's dentition to form the
impression.
[0102] Although both operational process 100 and operational
process 110 can be used for fitting oral appliance 1, operational
process 100 may provide more accurate results than operational
process 110. Generally, a casting retains more heat than the
moldable material. This heat is transferred from the casting to the
moldable material, thus causing the moldable material to remain in
the yielded state for an increase length of time as compared to
heating the moldable material alone (e.g., operational process
110). Because the moldable material is in the yielded state for a
longer length of time, the moldable material has a better
opportunity to flow around the casting and form the impression.
Furthermore, once placed in the moldable material, the casting
remains substantially stationary; whereas a user biting directly
into the moldable material (operational process 110) will move
his/her jaw.
[0103] Oral appliance 1 also may be adapted for use with a patient
interface device. A patient receiving treatment for sleep apnea,
for instance, may be required to wear a nasal mask, oral mask,
full-face mask, or other patient interface device. Examples of oral
appliances used in combination with a patient interface device are
found in U.S. Pat. Nos. 2,521,084; 4,470,413; 5,573,994; 5,752,510;
5,954,048; 6,012,455; 6,405,729; 6,789,543; and 7,021,312. The
content of each of these patents is incorporated herein by
reference.
[0104] FIG. 22 illustrates a system 90 for treating sleep apnea
and/or other respiratory ailments. In the current embodiment,
system 90 includes a pressure generating device 91, a nasal mask
92, a conduit 93, and oral appliance 1'. Oral appliance 1' is shown
schematically coupled with nasal mask 92 which is operatively
connected to pressure generating device 91 via conduit 93. Oral
appliance 1' is structured to stabilize nasal mask 92 relative to
the patient's face. Nasal mask 92 is structured to deliver, to the
patient's airway, a flow of pressurized breathing gas produced by
gas generating device 91. By coupling with oral appliance 1', nasal
appliance 92 is better secured to the patient's face and the
patient's sleep apnea and/or other respiratory aliments are treated
through both mandibular advancement and the application of positive
airway pressure. It is contemplated that oral appliance 1' may be
coupled with the patient interface device in any suitable
manner.
[0105] Oral appliance 1 may also be adapted to be used in
combination with a patient monitoring device and/or intraoral
electromuscular stimulation device. Examples of oral appliances
with electrodes extending therefrom for use with a patient
monitoring device and/or intraoral electromuscular stimulation
device are found in U.S. Pat. Nos. 6,618,627 and 5,190,053. The
content of each of these patents is incorporated herein by
reference. FIG. 23 illustrates oral appliance 1'' with electrodes
95, 95' extending therefrom according to one embodiment.
[0106] Electrodes 95, 95' may be structured, for example, to
capture electromyography (EMG) activity produced by one or more of
the patient's muscles (e.g., the masseter muscle). Measured EMG
activity may be employed, for example and without limitation, to
monitor bruxism and oral appliance wear compliance. EMG electrodes
95, 95' may be placed at any suitable location on oral appliance
1'' such that, after fitting oral appliance 1'', the EMG activity
of the targeted muscle may be captured. As shown in FIG. 23, for
example, EMG electrodes 95 are placed in upper moldable material
24'', and EMG electrodes 95' are placed on lower support member
41''. A monitoring system (not shown) wirelessly communicates with
EMG electrodes 95, 95'. The monitoring system may include a
processor for analyzing the EMG activity detected in the masseter
muscle.
[0107] Electrodes 95, 95' may be structured, as another example, to
provide intraoral electromuscular stimulation to reduce or minimize
the occurrence of a breathing disorder, such as obstructive sleep
apnea. Intraoral electromuscular stimulation may be employed, for
instance, to provide electrical stimulation to the muscles of the
upper airway responsible for maintaining the patency of the airway.
Generally, electromuscular stimulation induces contraction in the
muscles of the upper airway, thereby preventing or minimizing
blockage of a user's airway.
[0108] It should be apparent that the number, type, function, and
location of electrodes 95, 95' may be altered while remaining
within the scope of the present invention. For example, only upper
tray 10'' may have electrodes 95 located thereon and/or electrodes
95, 95' may include a wire for communicating with the monitoring
system. Electrodes 95, 95' may also be placed directly on the
surface of upper moldable material 24, lower moldable material 54,
or both. During the molding process the upper moldable material 24
or lower moldable material 54 is typically moved outward, i.e.,
toward the intraoral surfaces of the user's oral cavity as the
teeth engage the moldable material. This outward movement of upper
moldable material 24 and/or lower moldable material 54 serves to
contact the electrode with the intraoral surfaces of the user's
oral cavity so that no other electrode placement devices are
needed. Nevertheless, the present invention also contemplates using
electrode placement devices, such as springs and support members,
to ensure that the electrodes 95, 95' are engaged with the
intraoral surfaces of the user. Furthermore, it is contemplated
that other patient monitoring devices (e.g., vibration monitoring
devices, sound monitoring devices, etc.) and/or components may be
employed in conjunction with oral appliance 1''.
[0109] Although the invention has been described in detail for the
purpose of illustration based on what is currently considered to be
the most practical and preferred embodiments, it is to be
understood that such detail is solely for that purpose and that the
invention is not limited to the disclosed embodiments, but, on the
contrary, is intended to cover modifications and equivalent
arrangements that are within the spirit and scope of the appended
claims. For example, it is to be understood that the present
invention contemplates that, to the extent possible, one or more
features of any embodiment can be combined with one or more
features of any other embodiment.
* * * * *