U.S. patent application number 12/010034 was filed with the patent office on 2008-07-24 for system and method for treating a patient with obstructive sleep apnea.
This patent application is currently assigned to ResMed Limited. Invention is credited to Christopher John Baxter, Robert Edward Henry, Gregory Robert Peake, Gregory Scott Smart.
Application Number | 20080173312 12/010034 |
Document ID | / |
Family ID | 39640075 |
Filed Date | 2008-07-24 |
United States Patent
Application |
20080173312 |
Kind Code |
A1 |
Peake; Gregory Robert ; et
al. |
July 24, 2008 |
System and method for treating a patient with obstructive sleep
apnea
Abstract
A method for treating obstructive sleep apnea includes providing
MAD therapy via an adjustable mandibular advancement device
structured to advance the position of the patient's lower jaw,
providing CPAP therapy via a mask system structured to deliver a
supply of pressurized air to a patient, and selectively adjusting
the mask system and/or the mandibular advancement device to
alternate and/or balance between CPAP therapy and MAD therapy.
Inventors: |
Peake; Gregory Robert;
(Kingsford, AU) ; Smart; Gregory Scott; (Randwick,
AU) ; Henry; Robert Edward; (Roseville, AU) ;
Baxter; Christopher John; (Chatswood, AU) |
Correspondence
Address: |
NIXON & VANDERHYE, PC
901 NORTH GLEBE ROAD, 11TH FLOOR
ARLINGTON
VA
22203
US
|
Assignee: |
ResMed Limited
Bella Vista
AU
|
Family ID: |
39640075 |
Appl. No.: |
12/010034 |
Filed: |
January 18, 2008 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
|
60881156 |
Jan 19, 2007 |
|
|
|
Current U.S.
Class: |
128/845 ;
128/205.25; 5/644 |
Current CPC
Class: |
A61M 16/022 20170801;
A61F 5/566 20130101; A61M 16/00 20130101 |
Class at
Publication: |
128/845 ;
128/205.25; 5/644 |
International
Class: |
A61M 16/00 20060101
A61M016/00; A61F 5/00 20060101 A61F005/00; A47C 20/00 20060101
A47C020/00 |
Claims
1. A mandibular advancement device, comprising: a first anchor
provided to one or more of a patient's lower teeth; a second anchor
supported at a position spaced from the first anchor; and a biasing
arrangement to couple the first and second anchors and provide a
biasing force to advance the position of the patient's lower
jaw.
2. The mandibular advancement device according to claim 1, wherein
the biasing arrangement includes a spring or elastic member.
3. The mandibular advancement device according to claim 1, wherein
the first anchor is attached to one or more of the patient's lower
teeth.
4. The mandibular advancement device according claim 1, wherein the
second anchor is attached to one or more of the patient's upper
teeth.
5. The mandibular advancement device according to claim 1, wherein
the second anchor is an external anchor provided outside the
patient's mouth.
6. The mandibular advancement device according to claim 1, wherein
the biasing arrangement includes a magnetic arrangement.
7. The mandibular advancement device according to claim 6, wherein
the first anchor is a dental insert or mouthpiece and the second
anchor is an external device provided outside the patient's mouth,
the dental insert being magnetically coupled to the external
device.
8. A system for treating obstructive sleep apnea, comprising: a
mask system adapted to deliver a supply of pressurized air to a
patient; and a mandibular advancement device according to claim
1.
9. The system according to claim 8, wherein the mask system
includes a nasal mask, full-face mask, nasal and mouth mask, and/or
nasal prongs.
10. A method for treating obstructive sleep apnea, comprising:
providing a pillow; and positioning the pillow behind the patient's
neck to tilt the patient's head back to a position that opens the
patient's airway to facilitate breathing.
11. The method according to claim 10, further comprising: providing
one or more protrusions to the pillow; and positioning the pillow
so that the one or more protrusions push up against the back of the
patient's jaw in order to advance the position of the patient's
lower jaw.
12. The method according to claim 10, further comprising providing
an upper portion or cradle to the pillow to effectively cradle the
patient's head in use.
13. The method according to claim 10, further comprising providing
an inflatable bladder to the pillow and inflating the pillow to
force the patient to a specific position.
14. The method according to claim 10, further comprising delivering
CPAP therapy to the patient.
15. A method for treating obstructive sleep apnea, comprising:
providing a mask system with an air delivery conduit that extends
over the patient's head; fitting the mask system to the patient's
head; and adjusting the mask system to promote opening of the
patient's upper airways.
16. The method according to claim 15, wherein adjusting the mask
system includes adjusting the mask system to tilt the patient's
head back.
17. The method according to claim 16, further comprising reducing
the length of the air delivery conduit that extends over the
patient's head to tilt the patient's head back.
18. The method according to claim 15, wherein adjusting the mask
system includes forcing the mask system away from the patient's
lower jaw.
19. The method according to claim 15, further comprising adjusting
the position of the patient interface to cause the angle of the
patient's neck to change.
20. The method according to claim 19, further comprising raising
the patient interface to cause the upper airway to open.
21. A method for treating obstructive sleep apnea, comprising:
providing MAD therapy via an adjustable mandibular advancement
device structured to advance the position of the patient's lower
jaw; providing CPAP therapy via a mask system structured to deliver
a supply of pressurized air to a patient; and selectively adjusting
the mask system and/or the mandibular advancement device to
alternate and/or balance between CPAP therapy and MAD therapy.
22. The method according to claim 21, wherein selectively adjusting
includes manual and/or automatic adjustment.
23. The method according to claim 21, wherein selectively adjusting
includes selectively adjusting the position of the patient's lower
jaw provided by the adjustable mandibular advancement device based
on the delivery pressure provided by the mask system.
24. The method according to claim 21, wherein selectively adjusting
includes selectively adjusting the delivery pressure provided by
the mask system based on the position of the patient's lower jaw
provided by the adjustable mandibular advancement device.
25. A pillow for treating obstructive sleep apnea, comprising: a
main body adapted to be positioned behind the patient's neck to
tilt the patient's head back to a position that opens the patient's
airway to facilitate breathing in use.
26. The pillow according to claim 25, wherein the includes one or
more protrusions, the one or more protrusions adapted to push up
against the back of the patient's jaw in order to advance the
position of the patient's lower jaw in use.
27. The pillow according to claim 25, wherein the pillow includes
an upper portion or cradle adapted to effectively cradle the
patient's head in use.
28. The pillow according to claim 25, wherein the pillow includes
an inflatable bladder that is inflatable to force the patient to a
specific position in use.
29. A system for treating obstructive sleep apnea, comprising: a
mask system adapted to deliver a supply of pressurized air to a
patient; and a pillow according to claim 25.
30. The system according to claim 29, wherein the mask system
includes a nasal mask, full-face mask, nasal and mouth mask, and/or
nasal prongs.
31. A system for treating obstructive sleep apnea, comprising: a
mask system adapted to deliver a supply of pressurized air to a
patient; and an adjustment mechanism provided to the mask system
and adapted to promote opening of the patient's upper airways in
use.
32. The system according to claim 31, wherein the mask system
includes a nasal mask, full-face mask, nasal and mouth mask, and/or
nasal prongs.
33. The system according to claim 31, wherein the mask system
includes an air delivery conduit that extends over the patient's
head.
34. The system according to claim 33, wherein the adjustment
mechanism is coupled to the air delivery conduit, the adjustment
mechanism structured to reduce the length of the air delivery
conduit to tilt the patient's head back.
35. The system according to claim 31, wherein the adjustment
mechanism is structured to adjust the mask system to tilt the
patient's head back.
36. The system according to claim 31, wherein the adjustment
mechanism is structured force the mask system away from the
patient's lower jaw.
37. The system according to claim 31, wherein the adjustment
mechanism is structured to adjust the position of the mask system
to cause the angle of the patient's neck to change.
38. The system according to claim 37, wherein the adjustment
mechanism is structured to raise the mask system to cause the upper
airway to open.
39. A system for treating obstructive sleep apnea, comprising: an
adjustable mandibular advancement device to provide MAD therapy; a
mask system to provide CPAP therapy; and a control system to
selectively adjust the mask system and/or the mandibular
advancement device to alternate and/or balance between CPAP therapy
and MAD therapy.
40. The system according to claim 39, wherein control system
provides manual and/or automatic adjustment.
41. The system according to claim 39, wherein the control system is
structured to selectively adjust the position of the patient's
lower jaw provided by the adjustable mandibular advancement device
based on the delivery pressure provided by the mask system.
42. The system according to claim 39, wherein the control system is
structured to selectively adjusting the delivery pressure provided
by the mask system based on the position of the patient's lower jaw
provided by the adjustable mandibular advancement device.
43. The system according to claim 39, wherein the mask system
includes a nasal mask, full-face mask, nasal and mouth mask, and/or
nasal prongs.
Description
CROSS-REFERENCE TO APPLICATION
[0001] This application claims the benefit of U.S. Provisional
Application No. 60/881,156, filed Jan. 19, 2007, which is
incorporated herein by reference in its entirety.
FIELD OF THE INVENTION
[0002] The present invention relates to a system and method for
treating a patient with obstructive sleep apnea.
BACKGROUND OF THE INVENTION
[0003] Obstructive sleep apnea (OSA) is a common sleep-related
respiratory disorder, and many obstructive sleep apnea therapies
have been developed to treat the disorder. One such therapy is a
mandibular advancement device (MAD) that is used to adjust the
position of the patient's lower jaw, e.g., bringing it forward, in
an attempt to keep the patient's airway open.
[0004] The present invention provides alternative arrangements of
MADs to enhance the treatment of OSA.
SUMMARY OF THE INVENTION
[0005] One aspect of the present invention relates to a mandibular
advancement device including a first anchor provided to one or more
of a patient's lower teeth, a second anchor supported at a position
spaced from the first anchor, and a biasing arrangement to couple
the first and second anchors and provide a biasing force to advance
the position of the patient's lower jaw.
[0006] Another aspect of the present invention relates to a method
for treating obstructive sleep apnea including providing a pillow
and positioning the pillow behind the patient's neck to tilt the
patient's head back to a position that opens the patient's airway
to facilitate breathing.
[0007] Another aspect of the present invention relates to a method
for treating obstructive sleep apnea including providing a mask
system with an air delivery conduit that extends over the patient's
head, fitting the mask system to the patient's head, and adjusting
the mask system to promote opening of the patient's upper
airways.
[0008] Another aspect of the present invention relates to a method
for treating obstructive sleep apnea including providing MAD
therapy via an adjustable mandibular advancement device structured
to advance the position of the patient's lower jaw, providing CPAP
therapy via a mask system structured to deliver a supply of
pressurized air to a patient, and selectively adjusting the mask
system and/or the mandibular advancement device to alternate and/or
balance between CPAP therapy and MAD therapy.
[0009] Another aspect of the present invention relates to a pillow
for treating obstructive sleep apnea. The pillow includes a main
body adapted to be positioned behind the patient's neck to tilt the
patient's head back to a position that opens the patient's airway
to facilitate breathing in use.
[0010] Another aspect of the present invention relates to a system
for treating obstructive sleep apnea. The system includes a mask
system adapted to deliver a supply of pressurized air to a patient
and an adjustment mechanism provided to the mask system and adapted
to promote opening of the patient's upper airways in use.
[0011] Another aspect of the present invention relates to a system
for treating obstructive sleep apnea. The system includes an
adjustable mandibular advancement device to provide MAD therapy, a
mask system to provide CPAP therapy, and a control system to
selectively adjust the mask system and/or the mandibular
advancement device to alternate and/or balance between CPAP therapy
and MAD therapy.
[0012] Other aspects, features, and advantages of this invention
will become apparent from the following detailed description when
taken in conjunction with the accompanying drawings, which are a
part of this disclosure and which illustrate, by way of example,
principles of the invention.
BRIEF DESCRIPTION OF THE DRAWINGS
[0013] The accompanying drawings facilitate an understanding of the
various embodiments of this invention. In such drawings:
[0014] FIG. 1 is a schematic view of a mandibular advancement
device including a spring or elastic arrangement according to an
embodiment of the present invention;
[0015] FIG. 2 is a schematic view of a mandibular advancement
device including a spring or elastic arrangement according to
another embodiment of the present invention;
[0016] FIG. 3 is a schematic view of a mandibular advancement
device including a magnetic arrangement according to an embodiment
of the present invention;
[0017] FIG. 4 is a schematic view of a pillow according to an
embodiment of the present invention;
[0018] FIG. 5 is a schematic view of a pillow including jaw pushers
according to an embodiment of the present invention;
[0019] FIG. 6 is a schematic view of a pillow according to another
embodiment of the present invention;
[0020] FIG. 7 is a schematic view of a mandibular advancement
device incorporating a football-type helmet according to an
embodiment of the present invention;
[0021] FIG. 8 is a schematic view of clamping locations for a
mandibular advancement device according to an embodiment of the
present invention;
[0022] FIGS. 9A and 9B illustrate a mask system including an Adam's
Circuit according to an embodiment of the present invention;
[0023] FIG. 9C illustrates a half brace according to an embodiment
of the present invention;
[0024] FIGS. 10A and 10B are schematic views of a mask including a
pivotally mounted lower section according to an embodiment of the
present invention;
[0025] FIG. 11 is a schematic view of a mask including a portion
that extends into the patient's mouth according to an embodiment of
the present invention; and
[0026] FIG. 12 is a schematic view of a control system to alternate
the balance between CPAP and MAD therapy according to an embodiment
of the present invention.
DETAILED DESCRIPTION OF ILLUSTRATED EMBODIMENTS
[0027] One aspect of the present invention relates to the way in
which a mandibular advancement device may be used in the treatment
of obstructive sleep apnea. For example, the mandibular advancement
device may be used as a stand-alone device and adjust the position
of the patient's lower jaw in an attempt to keep the patient's
airway open. Alternatively, the mandibular advancement device may
be used in conjunction with a mask system, e.g., nasal mask,
full-face mask, nasal and mouth mask, nasal prongs, to enhance the
treatment of obstructive sleep apnea. That is, the mandibular
advancement device may adjust the position of the patient's lower
jaw while the mask system delivers a supply of pressurized air. The
mandibular advancement device may be selectively or incrementally
adjusted during and/or after a treatment period (e.g., based on
apnea severity), and the adjustment of the mandibular advancement
device may be coordinated with the mask system (e.g., adjustment
coordinated with the pressure level of the mask system).
[0028] The following includes descriptions of several embodiments
of the present invention, which may share common characteristics
and features. It is to be understood that one or more features of
any one embodiment may be combinable with one or more features of
the other embodiments. In addition, each single feature or
combination of features in any of the embodiments may constitute an
additional embodiment.
1. Mandibular Advancement Device
[0029] A mandibular advancement device is structured to advance the
position of the patient's lower jaw in an attempt to keep the
patient's airway open. For example, the mandibular advancement
device may be an internal device that is provided within the
patient's mouth, e.g., dental insert, in order to advance the
position of the patient's lower jaw. Alternatively, the mandibular
advancement device may be an external device that is provided
outside the patient's mouth, e.g., engaged with patient's neck and
external jaw, in order to advance the position of the patient's
lower jaw.
1.1 Internal Device
[0030] An "internal" mandibular advancement device includes a
portion provided within the patient's mouth to advance the position
of the patient's lower jaw. The internal mandibular advancement
device may be a fixed device having a fixed magnitude of
advancement or an adjustable device having an adjustable magnitude
of advancement. Adjustment of the device may be manual and/or
automatic, and may be continuously controlled for a patient during
changing sleep conditions as needed.
1.1.1 Constant Displacement
[0031] Exemplary embodiments of "internal" mandibular advancement
devices are disclosed in PCT Application No. PCT/AU2006/001095,
filed Aug. 2, 2006, the entirety of which is incorporated herein by
reference. In the exemplary embodiments, the mandibular advancement
device includes upper and lower members that are fitted to
respective upper and lower jaws of the patient. The upper and lower
members include flanges (which may be adjustable) that engage one
another to advance the position of the patient's lower jaw. Thus,
the position of the patient's lower jaw is advanced by a constant
displacement.
1.1.2 Constant Force
[0032] Instead of constant displacement, constant force may be used
to advance the position of the patient's lower jaw. For example, a
spring arrangement, an elastic arrangement, and/or a magnetic
arrangement may be used to force the position of the patient's
lower jaw.
[0033] FIG. 1 is a schematic view of a mandibular advancement
device including a spring or elastic arrangement 10 according to an
embodiment of the present invention. As illustrated, the spring or
elastic arrangement 10 includes a lower anchor 12 provided to the
patient's lower teeth (e.g., anchor attached to one or more lower
teeth), an upper anchor 14 provided to the patient's upper teeth
(e.g., anchor attached to one or more upper teeth), and a spring or
elastic member 16 (e.g., rubber band) provided or attached between
the lower and upper anchors 12, 14. In use, the spring or elastic
member 16 provides a biasing force to advance the position of the
patient's lower jaw.
[0034] In an alternative embodiment, as shown in FIG. 2, the spring
or elastic arrangement 10 may include a lower anchor 12, an
external anchor 15 provided outside the patient's mouth, and a
spring or elastic member 16 provided or attached between the lower
anchor 12 and the external anchor 15. In use, the spring or elastic
member 16 provides a biasing force to advance the position of the
patient's lower jaw.
[0035] FIG. 3 is a schematic view of a mandibular advancement
device including a magnetic arrangement 20 according to an
embodiment of the present invention. As illustrated, the magnetic
arrangement 20 includes a dental insert or mouthpiece 22 provided
to the patient's lower teeth and an external device 24 provided
outside the patient's mouth. The dental insert 22 is magnetically
coupled to the external device such that the external device
magnetically "pulls" and/or "pushes" the dental insert 22 and hence
the patient's lower jaw outwardly to advance the position of the
patient's lower jaw. That is, the magnetic coupling may be provided
by magnets with unlike poles that are attracted to one another to
"pull" the dental insert outwards at the front of the patient's jaw
and/or magnets with like poles that are repelled from one another
to "push" the dental insert from behind the patient's jaw. The
magnetic arrangement provides an arrangement that is non-invasive
and non-mechanical.
[0036] An advantage of constant force over constant displacement is
that constant displacement may cause a tremendous amount of force
on a patient's jaw if the patient's muscles are tight. But, if the
muscles are tight, then the patient's oral soft tissue will
probably not be blocking the airway, so little to no jaw
advancement may actually be necessary.
1.2 External Device
[0037] An "external" mandibular advancement device is provided
outside the patient's mouth to advance the position of the
patient's lower jaw. For example, the "external" mandibular
advancement device may engage the patient's head, neck, face,
and/or external jaw to advance the position of the patient's lower
jaw.
1.2.1 Pillow
[0038] In an embodiment, as shown in FIG. 4, the mandibular
advancement device may be in the form of a pillow 30 that is
positioned, e.g., behind the patient's neck, to tilt the patient's
head back. Similar to tilting a patient's head back for
administering CPR, the pillow 30 tilts the patient's head back in
order to open the patient's airway to facilitate breathing.
[0039] In an alternative embodiment, as shown in FIG. 5, the pillow
30 may incorporate one or more protrusions 32 (e.g., jaw pushers)
that are adapted to push up against the back of the patient's jaw
in order to advance the position of the patient's lower jaw.
[0040] In either embodiment, the pillow may have a crescent or wave
shape that extends between the shoulders and the base of the
patient's skull (e.g., as viewed from the top of the pillow). The
pillow can also be formed with an upper portion to effectively
cradle the patient's head. For example, FIG. 6 illustrates a pillow
70 having a crescent or wave shape and an upper portion or cradle
72. As illustrated, the pillow 70 may include an inflatable bladder
74 such as that described below in section 1.2.3.
1.2.2 Neck Brace with Jaw Pushers
[0041] In an embodiment, the mandibular advancement device may be
in the form of a neck brace that includes one or more protrusions
or jaw pushers adapted to push up against the back of the patient's
jaw in order to advance the position of the patient's lower
jaw.
1.2.3 Inflatable Mechanism
[0042] In an embodiment, the mandibular advancement device may be
in the form of an inflatable mechanism that is adapted to inflate
and force the patient to be in a specific position. For example,
the inflatable mechanism may be an inflatable pillow that is
adapted to inflate and force the patient to tilt his/her head back,
roll on his/her side, etc.
1.2.4 Helmet with Mouth Guard
[0043] In another embodiment, as shown in FIG. 7, a mouth guard or
dental insert 40 may be provided to the patient's lower teeth and
coupled with the face mask 42 of a football-type helmet 44 to
"pull" the patient's lower jaw forward. The mouth guard 40 may be
fixed to the face mask 42 or may include a spring, elastic, and/or
a magnetic arrangement with the face mask 42 such as the
arrangements described above in section 1.1.2.
2. Mandibular Advancement Device Used in Conjunction with Mask
System
[0044] In some mask systems, e.g., full-face masks, portions of the
mask system may push against the patient's lower jaw which may
cause obstructions. An aspect of the present invention relates to a
mandibular advancement device used in conjunction with a mask
system in order to advance the position of the patient's lower jaw
and/or counteract any potential obstructions caused by using the
mask system. The mandibular advancement device may be incorporated
into any suitable mask system, e.g., full-face, nasal, nasal
prongs, mouth mask and nasal prongs, etc.
[0045] The mandibular advancement device may be permanently or
removably attached to the mask system, e.g., selectively
attachable. In an embodiment, the mask system and mandibular
advancement device may be formed separately from another and then
connected with a lanyard. Also, the mandibular advancement device
may be controlled, at least in part, by the mask system, e.g., mask
pressure used to operate mandibular advancement device.
[0046] In an embodiment, the combination of a CPAP mask system with
a mandibular advancement device may allow a reduced CPAP pressure
to be used for treatment. For example, a CPAP mask system alone may
deliver pressurized gas at about 12 cmH.sub.2O for treatment, and a
CPAP mask system used with a mandibular advancement device may
deliver pressurized gas at about 10 cmH.sub.2O for treatment.
2.1 External Clamp
[0047] In an embodiment, the mandibular advancement device may be
in the form of an external clamp adapted to clamp or clasp the rear
of a patient's jaw (as indicated by arrow R in FIG. 8) or the front
of a patient's jaw (as indicated by arrow F in FIG. 8). For
example, the external clamp may be coupled to the mask system,
e.g., attached to the mask frame and/or mask headgear, and be
configured to clamp the rear of a patient's jaw to "push" the
patient's chin forward or clamp the front of a patient's jaw to
"pull" the patient's chin forward. Preferably, the clamp pushes or
pulls outside of the patient's jowls near the temporomandibular
joint.
2.2 Tilt Head Back
[0048] In an embodiment, the mask system may include a component
(e.g., air conduit or delivery tube) that extends over the
patient's head, e.g., Adam's Circuit, to promote opening of the
patient's upper airways, e.g., by tilting the patient's head back
and/or forcing the mask system away from the patient's lower jaw.
This prevents the mask system from pushing down against the
patient's lower jaw which may cause obstructions.
[0049] For example, a mask system including an Adam's Circuit 80
(e.g., a Puritan Bennet Adam.TM. Interface System) may be provided
to a patient's head to tilt the patient's head from a first
position (shown in FIG. 9A) to a second position (shown in FIG. 9B)
to prevent the mask system from pushing down against the patient's
lower jaw and/or to open the patient's airway to facilitate
breathing. As illustrated, the Adam's Circuit 80 may tilt the
patient's head such that the patient interface (e.g., prongs,
cushion, cannula, etc.) translates over a distance d, which may be
sufficient to straighten the upper airways, e.g., to thereby clear
an occlusion or fold 82 within the patient's airway if the
patient's neck is awkwardly angled. In an embodiment, the Adam's
Circuit may have a first length that is reduced, e.g., by an
adjustment mechanism, to a second length in order to tilt the
patient's head from the first position (shown in FIG. 9A) to the
second position (shown in FIG. 9B).
[0050] In another embodiment, the air delivery tube may be movably
positionable relative to the headgear. If the patient is slouching
and the neck is bent, the tube may be pulled upwardly relative to
the patient and the headgear, thus forcing the patient to raise
his/her head in order to properly engage the patient interface. In
the process, the patient's upper airways are straightened, thus
potentially reducing the chances for airway collapse. In this and
other embodiments, it may be helpful to provide a fixed reference
point on the patient to which the headgear and/or Adam's Circuit
are positioned. In one example, the headgear simply has a fairly
rigid, depending member braced against the back of the head and the
neck and/or shoulders of the patient to maintain the neck at a
predetermined angle. In an alternative embodiment, the member could
be built into clothes or constitute a separate member (e.g., in a
neck brace). For example, FIG. 9C illustrates a half brace 85 that
is open in the front of the patient's neck and extends below the
patient's jaw line and up behind the back of the patient's head. As
illustrated, the brace 85 may include side portions 87 to prevent
wobbling of the patient's head in use.
[0051] In another embodiment, a mandibular advancement device in
the form of a pillow, pillow with jaw pushers, or neck brace with
jaw pushers (as described above) may be provided to tilt the
patient's head back.
2.3 Facial Support
[0052] In embodiments, the mask system may be supported by portions
of the patient's face to prevent the mask system from pushing down
against the patient's lower jaw. For example, the mask system may
clamp onto sides of the patient's mid-bridge, e.g., like a G-clamp,
or use the patient's ears as support.
2.4 Inflatable Mechanism
[0053] As noted above, the mandibular advancement device may be in
the form of an inflatable mechanism that is adapted to inflate and
force the patient to be in a specific position. In an embodiment,
the inflatable mechanism may be incorporated into the headgear of
the mask system. For example, the headgear may include an
inflatable portion or bladder that is adapted to inflate and force
the patient to tilt his/her head, roll on his/her side, roll over,
etc. The pressure to inflate the bladder may be provided by the
flow generator of the mask system.
2.5 Magnetic Arrangement
[0054] As noted above, a magnetic arrangement may be provided to
"pull" and/or "push" the patient's lower jaw. In an embodiment, the
mask, e.g., full-face mask, may be magnetically coupled to the
headgear such that the headgear magnetically "pulls" and/or
"pushes" the mask to adjust the position of the patient's lower
jaw, e.g., mask provided with magnetic attraction and headgear
provided with magnetic repulsion.
2.5.1 Electromagnetic Arrangement
[0055] In an alternative embodiment, an electromagnetic arrangement
may be provided for force advancement of the patient's lower jaw.
The electromagnetic arrangement may include a permanent magnet,
e.g., provided to the mask, and an electromagnet, e.g., provide to
the headgear, to allow the headgear to "pull" and/or "push" the
mask to adjust the position of the patient's lower jaw. The
electromagnet allows adjustment of the force.
2.6 Updated Mask Structure
[0056] The mask, e.g., full-face mask, may include structure to
allow movement and/or counteract any potential obstructions to
movement of the patient's lower jaw.
[0057] For example, the lower jaw region of a full-face mask may be
structured to allow movement of the patient's lower jaw. In an
embodiment, as shown in FIGS. 10A and 10B, the mask may include a
pivotally mounted lower section 50 to allow movement of the
patient's lower jaw in use. The lower section 50 may be spring
biased. For example, the lower section 50 may incorporate one or
more springs 52, with the attachment points P for headgear straps
positioned above the springs 52. The springs 52 may be arranged to
bias the lower section 50 towards the patient's face to provide a
sealing force but allow sufficient movement of the patient's lower
jaw in use. Alternatively, the springs 52 may be arranged to bias
the lower section 50 away the patient's face to allow sufficient
movement of the patient's lower jaw in use.
[0058] In another exemplary embodiment, as shown in FIG. 11, a mask
60, e.g., mouth mask, may support a portion 62 that extends into
the patient's mouth and provides a distal end 64 adapted to engage
the patient's lower jaw and/or lower teeth to push the patient's
lower jaw forward. As illustrated, the portion 62 has no contact
with the upper jaw and/or upper teeth of the patient in use. In an
embodiment, the portion 62 may be supported by a frame of the
mask.
[0059] In another embodiment, a mouth guard or dental insert may be
provided to the patient's lower teeth and coupled with the back of
the patient's head and/or headgear of the mask system to "push" or
"pull" the patient's lower jaw forward.
[0060] In another embodiment, a portion of the pressurized gas may
be used to force the patient's lower jaw forward, e.g., inflatable
bladder to force patient's lower jaw forward.
[0061] 2.7 Coordinated with Mask Pressure Level
[0062] In an embodiment, displacement provided by the mandibular
advancement device may be coordinated with the pressure level of
the mask system. That is, a control system may be provided to
alternate and/or balance between CPAP therapy provided by the mask
system and MAD therapy provided by the mandibular advancement
device.
[0063] For example, a pressure level of 12 cmH.sub.2O provided by
the mask system may be suitable with 8 mm of advancement provided
by the mandibular advancement device, and a pressure level of 20
cmH.sub.2O provided by the mask system may be suitable with 12 mm
of advancement provided by the mandibular advancement device.
However, other suitable relations between the pressure level and
MAD setting may be provided, e.g., depending on the patient and/or
required treatment. It should be appreciated that controlling the
alternation and/or balance may be manual and/or automatic, e.g.,
automatically changed during the night.
[0064] FIG. 12 is a schematic view of a control system to alternate
and/or balance between CPAP and MAD therapy. As illustrated, the
control system 90 is communicated with blower 92 to control and/or
receive feedback regarding the delivery of pressurized air to mask
94 for CPAP therapy. The control system 90 is also communicated
with MAD 96 to control and/or receive feedback regarding MAD
therapy. Based on the patient and/or required treatment, the
control system 90 may automatically update and/or recommend
suggested settings to alternate and/or balance between CPAP therapy
provided by the mask system and MAD therapy provided by the
MAD.
3.0 Improvements to Prior Art Masks
[0065] One or more of the above-described embodiments of mandibular
advancement devices may be adapted for use and/or incorporated into
the masks described in PCT Publication WO 01/95965, which is
incorporated herein by reference in its entirety. For example, an
inflatable mechanism, e.g., inflatable pillow, may be adapted for
use with the disclosed masks.
[0066] While the invention has been described in connection with
what are presently considered to be the most practical and
preferred embodiments, it is to be understood that the invention is
not to be limited to the disclosed embodiments, but on the
contrary, is intended to cover various modifications and equivalent
arrangements included within the spirit and scope of the invention.
Also, the various embodiments described above may be implemented in
conjunction with other embodiments, e.g., aspects of one embodiment
may be combined with aspects of another embodiment to realize yet
other embodiments. Further, each independent feature or component
of any given assembly may constitute an additional embodiment. In
addition, while the invention has particular application to
patients who suffer from OSA, it is to be appreciated that patients
who suffer from other illnesses (e.g., congestive heart failure,
diabetes, morbid obesity, stroke, barriatric surgery, etc.) can
derive benefit from the above teachings. Moreover, the above
teachings have applicability with patients and non-patients
alike.
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