U.S. patent application number 17/079468 was filed with the patent office on 2021-02-11 for mask.
The applicant listed for this patent is ResMed Limited. Invention is credited to Philip Rodney KWOK, Steven John LUBKE, Eva NG, Andrew Martin PRICE, Rupert Christian SCHEINER, Lee James VELISS.
Application Number | 20210038847 17/079468 |
Document ID | / |
Family ID | 1000005170300 |
Filed Date | 2021-02-11 |
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United States Patent
Application |
20210038847 |
Kind Code |
A1 |
PRICE; Andrew Martin ; et
al. |
February 11, 2021 |
MASK
Abstract
A mask for delivery of respiratory therapy to a patient may
include one or more of the following improvements: rigidizer
provided to headgear strap, locking clip/clip receptacle headgear
connection, keyed headgear buckles, lotion dispenser on frame,
rotatable prongs to adjust orientation, alignment indicators
provided to prong, cushion and/or frame, chin flap with bellows
arrangement, vent holes positioned away from gas entry port, and
vent holes to direct washout gas at an angle.
Inventors: |
PRICE; Andrew Martin;
(Sydney, AU) ; SCHEINER; Rupert Christian;
(Sydney, AU) ; KWOK; Philip Rodney; (Sydney,
AU) ; LUBKE; Steven John; (Sydney, AU) ;
VELISS; Lee James; (Rotterdam, NL) ; NG; Eva;
(Sydney, AU) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
ResMed Limited |
Bella Vista |
|
AU |
|
|
Family ID: |
1000005170300 |
Appl. No.: |
17/079468 |
Filed: |
October 24, 2020 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
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15405829 |
Jan 13, 2017 |
|
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17079468 |
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Current U.S.
Class: |
1/1 |
Current CPC
Class: |
A61M 16/0816 20130101;
A61M 16/0666 20130101; A61M 16/0683 20130101; A61M 2210/0618
20130101; A61M 16/0825 20140204; A61M 16/0611 20140204; A61M
16/0875 20130101; A61M 16/06 20130101; A61M 2210/0625 20130101;
A61M 16/0057 20130101; A61M 16/0605 20140204; A61M 16/0633
20140204; A61M 16/0622 20140204 |
International
Class: |
A61M 16/06 20060101
A61M016/06; A61M 16/08 20060101 A61M016/08; A61M 16/00 20060101
A61M016/00 |
Claims
1. A mask comprising: a frame; a facial and nasal interface
provided to the frame; and headgear provided to the frame to
maintain the mask in a desired position on the patient's face, the
headgear including at least one strap and a buckle provided to the
strap, the buckle including an opening adapted to engage a post
provided on the frame, wherein the opening and/or the post includes
a keyed portion structured to prevent rotation of the buckle with
respect to the post when the buckle is engaged with the post.
2. A mask comprising: a frame; a facial and nasal interface
provided to the frame; and a lotion dispenser or moisturizer
provided to frame and adapted to dispense lotion for lubricating
and/or moisturizing the facial and/or nasal interface.
3. The mask according to claim 2, wherein the facial interface
includes a cushion adapted to form a seal around an exterior of the
patient's mouth in use.
4. The mask according to claim 2, wherein the nasal interface
includes nasal prongs adapted to from a seal with the patient's
nasal passages in use.
5. A mask comprising: a frame; a cushion provided to the frame and
adapted to form a seal around an exterior of the patient's mouth in
use; and nasal prongs provided to the cushion and adapted to from a
seal with the patient's nasal passages in use, wherein each of the
nasal prongs is adapted to rotate relative to the cushion to change
the angle at which the nasal prong extends with respect to the
cushion.
6. The mask according to claim 5, wherein each of the nasal prongs
includes a sloped end that engages a sloped base provided to the
cushion such that rotation of the nasal prong is adapted to rotate
the sloped end relative to the sloped base which changes the angle
at which the prong extends with respect to the cushion.
7. (canceled)
Description
CROSS-REFERENCE TO APPLICATION
[0001] This application claims the benefit of U.S. Provisional
Application No. 60/935,268, filed Aug. 2, 2007, which is
incorporated herein by reference in its entirety.
FIELD OF THE INVENTION
[0002] The present invention relates to a mask for delivery of
respiratory therapy to a patient. Examples of such therapies are
Continuous Positive Airway Pressure (CPAP) treatment, Non-Invasive
Positive Pressure Ventilation (NIPPV), and Variable Positive Airway
Pressure (VPAP). The therapy is used for treatment of various
respiratory conditions including Sleep Disordered Breathing (SDB)
such as Obstructive Sleep Apnea (OSA).
BACKGROUND OF THE INVENTION
[0003] A known mask is commercially sold under the name of
HYBRID.TM. by Respcare, Inc. and one or more portions of the mask
are described in U.S. Patent Publication No. 2006/0124131,
published Jun. 15, 2006, and/or at the website
www.hybrid-mask.com.
SUMMARY OF THE INVENTION
[0004] One aspect of the present invention relates to improvements
and/or alternative arrangements of HYBRID.TM. mask to enhance
respiratory therapy.
[0005] Another aspect of the invention relates to a mask including
a frame, a facial and nasal interface provided to the frame, and
headgear provided to the frame to maintain the mask in a desired
position on the patient's face. The headgear includes at least one
strap and a buckle provided to the strap. The buckle includes an
opening adapted to engage a post provided on the frame. The opening
and/or the post includes a keyed portion structured to prevent
rotation of the buckle with respect to the post when the buckle is
engaged with the post.
[0006] Another aspect of the invention relates to a mask including
a frame, a facial and nasal interface provided to the frame, and a
lotion dispenser or moisturizer provided to frame and adapted to
dispense lotion for lubricating and/or moisturizing the facial
and/or nasal interface.
[0007] Another aspect of the invention relates to a mask including
a frame, a cushion provided to the frame and adapted to form a seal
around an exterior of the patient's mouth in use, and nasal prongs
provided to the cushion and adapted to from a seal with the
patient's nasal passages in use. Each of the nasal prongs is
adapted to rotate relative to the cushion to change the angle at
which the nasal prong extends with respect to the cushion.
[0008] Another aspect of the invention relates to a mask including
a frame, a cushion provided to the frame and adapted to form a seal
around an exterior of the patient's mouth in use, and a chin
portion or chin flap provided to the cushion and adapted to engage
the patient's chin in use. The chin portion or chin flap includes a
bellows arrangement structured to allow movement of the patient's
chin in use.
[0009] 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
[0010] The accompanying drawings facilitate an understanding of the
various embodiments of this invention. In such drawings:
[0011] FIGS. 1-1 to 1-12 are various views of a known mask
commercially sold under the name of HYBRID.TM.;
[0012] FIGS. 2-1 to 2-9 illustrate headgear according to
alternative embodiments of the present invention;
[0013] FIGS. 3-1 to 3-4 illustrate headgear connection according to
alternative embodiments of the present invention;
[0014] FIGS. 4-1 to 4-2 illustrate frames according to alternative
embodiments of the present invention;
[0015] FIGS. 5-1 to 5-2 illustrate nasal prongs according to
alternative embodiments of the present invention;
[0016] FIG. 5-3-1 illustrates a nasal prong of the HYBRID.TM.
mask;
[0017] FIGS. 5-3-2 and 5-3-3 illustrate a nasal prong according to
an embodiment of the present invention;
[0018] FIGS. 5-4 to 5-8 illustrate nasal prongs according to
alternative embodiments of the present invention;
[0019] FIG. 6-1-1 illustrates a cushion profile of the HYBRID.TM.
mask;
[0020] FIG. 6-1-2 illustrates a cushion profile according to an
embodiment of the present invention;
[0021] FIGS. 6-2 to 6-3 illustrate cushions according to
alternative embodiments of the present invention;
[0022] FIGS. 7-1 to 7-3 illustrate elbow assemblies according to
alternative embodiments of the present invention; and
[0023] FIGS. 8-1 to 8-4 illustrate vent arrangements according to
alternative embodiments of the present invention.
DETAILED DESCRIPTION OF ILLUSTRATED EMBODIMENTS
[0024] The following includes descriptions of several illustrated
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.
[0025] Each illustrated embodiment includes features that may be
adapted for use and/or incorporated into the embodiments and/or
components of the HYBRID.TM. mask, the mask described in U.S.
Patent Publication No. 2006/0124131, published Jun. 15, 2006,
and/or at the website www.hybrid-mask.com, as would be apparent to
those of ordinary skill in the art. The HYBRID.TM. mask, U.S.
Patent Publication No. 2006/0124131, and the website
www.hybrid-mask.com are each incorporated herein by reference in
its entirety.
[0026] While each illustrated embodiment is described as being
implemented into a HYBRID.TM. mask, a mask of the type described in
U.S. Patent Publication No. 2006/0124131, and/or a mask of the type
described at the website www.hybrid-mask.com, each illustrated
embodiment may be implemented into other masks, e.g., full-face
mask, mouth mask, nasal mask, nasal prongs, nozzles, nare seals,
and/or cannulae.
1. Known Mask
[0027] FIGS. 1-1 to 1-12 illustrate a known mask 10 commercially
sold under the name of HYBRID.TM. and one or more portions of the
mask are described in U.S. Patent Publication No. 2006/0124131
and/or at the website www.hybrid-mask.com. As illustrated, the mask
10 includes a ventilation interface or frame 12, a cushioned facial
interface or cushion 14 provided to the frame 12 and adapted to
form a seal around an exterior of the patient's mouth in use, a
nasal interface or nasal prongs or nasal pillows 16 provided to the
cushion 14 and adapted to from a seal with the patient's nasal
passages or nares in use, an elbow assembly 18 provided to the
frame 12 and adapted to be connected to an air delivery tube that
delivers breathable gas to the patient, and headgear 20 removably
attached to the frame 12 to maintain the mask 10 in a desired
position on the patient's face.
2. Improvements to Known Mask
[0028] The following embodiments describe improvements and/or
alternative arrangements of the HYBRID.TM. mask to enhance
respiratory therapy.
2.1 Headgear
[0029] The headgear 20 of the HYBRID.TM. mask is constructed of a
soft, flexible material and includes upper side straps 22 that pass
over the patient's ear's, lower side straps 24 that pass below the
patient's ear's, a Velcro.RTM. adjustable overhead strap 26 that
passes over the top of the patient's head, and upper and lower rear
straps 28, 29 that pass behind the patient's head and neck (e.g.,
see FIGS. 1-1, 1-2, and 1-6).
2.1.1 Rigid Element
[0030] In an alternative embodiment, as shown in FIG. 2-1, a rigid
element or rigidizer 30 may be provided to each upper side strap 22
and/or each lower side strap 24 to improve stability of the mask 10
on the patient's face, e.g., vertical stability. In addition, the
rigid element 30 may be structured to orient force vectors in the
correct direction to provide comfortable sealing. The rigid element
30 may be constructed of a rigid or semi-rigid material, e.g.,
nylon or plastic, and may be attached to the strap 22, 24 in any
suitable manner, e.g., stitching, welding, gluing, or mechanically
fixed.
[0031] Exemplary embodiments of such a rigid element provided to a
headgear strap is disclosed in U.S. Pat. No. 6,907,882 and U.S.
application Ser. No. 10/781,929, filed Feb. 20, 2004, each of which
is incorporated herein by reference in its entirety.
2.1.2 Velcro.RTM. Removal
[0032] In an alternative embodiment, as shown in FIG. 2-2, the
Velcro.RTM. adjustment on the overhead strap 26 may be removed and
the respective headgear strap portions attached to one another,
e.g., sewn together, to create a one size fits all headgear. This
arrangement may simplify headgear adjustment.
[0033] An exemplary embodiment of such headgear is disclosed in PCT
Application No. PCT/AU2006/000770, filed Jun. 6, 2006, which is
incorporated herein by reference in its entirety.
2.1.3 Lower Rear Strap Positioning
[0034] In an alternative embodiment, the lower rear strap 29 (see
FIG. 1-6) that passes behind the patient's neck may be moved from
that location. That is, the lower rear strap 29 may be arranged to
pass behind a lower portion of the patient's head and above the
patient's neck, as shown in FIG. 2-3. This arrangement would
prevent the mask from pulling off in use, e.g., when the patient
looks upwards.
[0035] An exemplary embodiment of such lower strap arrangement is
disclosed in U.S. patent application Ser. No. 10/433,779, filed
Nov. 13, 2003, which is incorporated herein by reference in its
entirety.
2.1.4 Other Headgear Alternatives
[0036] In an alternative embodiment, one or more of the headgear
straps may be constructed of a more elastic material, e.g., the
upper and/or lower side straps 22, 24.
[0037] In another alternative embodiment, Velcro.RTM. joints may be
incorporated into one or more straps of the headgear 20 so that
different parts of the headgear 20 could be aligned in different
ways. For example, Velcro.RTM. joints 31 may be incorporated into
the upper and/or lower rear straps 28, 29 to allow adjustment of
the length and/or angle of the upper and/or lower rear straps 28,
29 as shown in FIG. 2-4.
[0038] In another alternative embodiment, the upper side straps 22
and/or the upper rear strap 28 may be configured such that there is
more space between the strap and the patient's ears, e.g., move
upper side straps 22 away from the patient's ears as shown in FIG.
2-5.
[0039] In another alternative embodiment, one or more straps of the
headgear 20 may include a relatively soft cover, sock, or pad,
e.g., constructed or foam or gel, to improve comfort and/or
aesthetics. The cover, sock, or pad may be attachable and
retrofittable to the headgear straps. In an embodiment, the cover,
sock, or pad is especially provided near the patient's eyes and/or
cheeks. For example, FIG. 2-6 illustrates covers 33 provided to
portions of the upper and lower side straps 22, 24.
[0040] In another alternative embodiment, as schematically shown in
FIG. 2-7, the headgear 20 may include a pair of side straps 32
adapted to connect to the frame 12, and each side strap 32 forks
into upper and lower side straps 22, 24 such as those described
above.
[0041] In another alternative embodiment, an outrigger may be
incorporated into the headgear 20 and/or frame 12 to help stabilize
the frame 12 on the patient's face.
[0042] In another alternative embodiment, as shown in FIG. 2-8, the
headgear strap vectors may be changed, e.g., move lower side straps
24 up towards upper side straps 22 to change strap vector of lower
side straps 24. In an embodiment, the strap vectors may be
adjustable such as those described in U.S. Pat. No. 6,907,882,
which is incorporated herein by reference in its entirety.
[0043] In another alternative embodiment, as shown in FIG. 2-9, a
strap or sling 34 may be attached to the frame 12 and adapted to
engage the patient's nose, e.g., nasal bridge region or tip, to
prevent downward movement of the mask in use.
2.2 Headgear Connection
[0044] The upper and lower side straps 22, 24 of the HYBRID.TM.
headgear 20 each include a Velcro.RTM. tab 40 that engages the
remainder of the strap 22, 24 to secure a buckle 42 in place. Each
buckle 42 is adapted to engage a respective post 44 (e.g.,
mushroom-shaped post) on the frame 12 to secure the headgear 20 to
the frame 12. Specifically, each buckle 42 is interlocked with a
respective post 44 by first moving the buckle 42 adjacent the
respective post 44 such that the respective post 44 extends through
a larger opening in the buckle 42, and then moving the buckle 42
into engagement with the post 44 to interlock the post 44 with a
smaller opening in the buckle 42 (e.g., see FIGS. 1-3, 1-7, and
1-8).
2.2.1 Quick Release
[0045] In an alternative embodiment, as shown in FIG. 3-1, a quick
release rip-cord mechanism, extension member, or finger tab 46 may
be provided on the end of one or more of the buckles 42 to
facilitate engagement and/or disengagement of each buckle 42 with
the respective post 44 on the frame 12. The finger tab 46 may be
rigid or flexible. In use, the finger tab 46 may be pulled to move
the respective post 44 into the larger opening in the buckle 42,
thereby allowing quick release or disengagement of the buckle 42
from the respective post 44. That is, the finger tab 46 allows the
buckle 42 to be levered out of the respective post 44. In an
embodiment, the free end of the finger tab 46 may include a
ball-like protrusion 47 to facilitate grip.
[0046] An exemplary embodiment of such a finger tab is disclosed in
U.S. patent application Ser. No. 10/584,711, filed Jun. 26, 2006,
which is incorporated herein by reference in its entirety.
2.2.2 Extended Buckle
[0047] In an alternative embodiment, as shown in FIG. 3-2, the
buckles 42 provided to the upper and/or lower side straps 22, 24
may be extended in length to improve stability of the mask 10 on
the patient's face.
2.2.3 Locking Clip and Clip Receptacle
[0048] In an alternative embodiment, the buckle/post headgear
connection of the HYBRID.TM. mask 10 may be replaced by locking
clips, e.g., spring-loaded clip, adapted to engage respective clip
receptacles provided to the frame. Exemplary clip arrangements are
described in PCT Application No. PCT/AU2006/000770, filed Jun. 6,
2006, and U.S. Pat. Nos. 6,374,826 and 6,907,882, each of which is
incorporated herein by reference in its entirety.
[0049] In an embodiment, the locking clip may be configured to lock
into at least one configuration or direction, e.g., lockable
angular adjustment.
[0050] In another embodiment, each side of the frame may include
only one clip/receptacle headgear connection (e.g., use with
headgear shown in FIG. 2-7).
[0051] In another embodiment, the locking clip and/or clip
receptacle may include a ratcheting arrangement to allow indexed
rotational adjustment.
[0052] In another embodiment, the clip receptacle regions of the
frame may be constructed of a malleable material to allow the clip
receptacles to be positioned at different angles. In yet another
embodiment, the clip receptacle regions of the frame may include a
lockable ball joint to provide limited movement of the clip
receptacles.
2.2.4 Other Headgear Connection Alternatives
[0053] In an alternative embodiment, the buckle and/or post may be
keyed to prevent rotation of the buckle when attached to the post.
This arrangement will maintain the headgear straps in a particular
orientation or direction. For example, FIG. 3-3 illustrates a
buckle 42 wherein the smaller opening includes a keyed portion 35
that is adapted to interlock with a keyed post 37 provided to the
frame, thereby allowed the buckle 42 to rotate and lock into a
desired position.
[0054] In an alternative embodiment, a peg or post may be provided
on a headgear strap that is adapted to engage within a respective
hole provided to the frame.
[0055] In an alternative embodiment, a press-button quick release
mechanism may be incorporated into the headgear connection, e.g.,
such as that described in Australian Patent Application No. AU
2005100738 A4, filed Sep. 8, 2005, which is incorporated herein by
reference in its entirety.
[0056] In an alternative embodiment, a spring-biased pull tab quick
release mechanism may be incorporated into the headgear
connection.
[0057] In an alternative embodiment, as shown in FIG. 3-4, a
rotatable buckle 45 may be coupled to both upper and lower side
straps 22, 24. The buckle 45 may engage a keyed post 49 having
protrusions 51 adapted to engage with corresponding recesses 48 in
the buckle 45 and provide indexed incremental rotational
adjustment.
2.3 Frame
[0058] The frame 12 of the HYBRID.TM. mask 10 includes a main body
50 having a gas entry port 52 adapted to connect to the elbow
assembly 18. The frame 12 also includes supplemental oxygen ports
54, vent holes 56, and posts 44 adapted to engage buckles 42
provided to the headgear 20 (e.g., see FIGS. 1-3 to 1-5 and
1-9).
2.3.1 Frame Alternatives
[0059] In an alternative embodiment, as shown in FIG. 4-1, the
frame 12 may include a lotion dispenser (e.g., pocket) or
moisturizer 58, e.g., positioned between the prongs 16 in use. The
lotion dispenser or moisturizer 58 may be adapted to dispense
lotion for lubricating and/or moisturizing the prongs 16 and/or the
cushion 14.
[0060] In an alternative embodiment, as shown in FIG. 4-2, the
frame 12 may include one or more chin grabbing flaps 59. The one or
more chin grabbing flaps may be retrofit to the frame 12. The one
or more chin grabbing flaps may be elastic to improve fit and/or
seal of the cushion 14, or the one or more chin grabbing flaps may
be configured to stop jaw-drop.
2.4 Prongs
[0061] The nasal prongs or nasal pillows 16 of the HYBRID.TM. mask
10 each include a single-wall head portion 60 adapted to provide a
seal with the patient's nasal passage and a base portion 62 adapted
to be mounted to the cushion 14. The base portion 62 is formed with
rings 64 defining at least one groove 66 therebetween. The cushion
14 includes two portals 68 that define flanges adapted to engage a
respective groove 66 to secure the prong 16 in position (e.g., see
FIGS. 1-4, 1-5, 1-11, and 1-12).
2.4.1 Dual Wall Prongs
[0062] In an alternative embodiment, as shown in FIG. 5-1, each
nasal prong 16 may include a dual or double wall head portion 60
(e.g., inner and outer walls 61, 63) to enhance the seal of the
head portion 60 against the patient's nare. An exemplary dual wall
nasal prong is described in U.S. patent application Ser. No.
10/584,711, filed Jun. 26, 2006, and PCT Application No.
PCT/AU2006/000770, filed Jun. 6, 2006, each of which is
incorporated herein by reference in its entirety.
[0063] In another alternative embodiment, the head portion 60 of
each prong may include more than two walls, e.g., three or more
walls.
2.4.2 Trampoline-Like Base
[0064] In an alternative embodiment, each nasal prong 16 may
include a trampoline-like base portion. Specifically, as shown in
FIG. 5-1, the wall section within the grooves 66 may be thinned,
e.g., thinned silicone, and the connecting bar 65 joining the
prongs 16 may removed or cut to allow each nasal prong 16 to rotate
and/or articulate about the base portion (as indicated by the
arrows). An exemplary trampoline-like base is described in U.S.
patent application Ser. No. 10/584,711, filed Jun. 26, 2006, and
PCT Application No. PCT/AU2006/000770, filed Jun. 6, 2006, each of
which is incorporated herein by reference in its entirety.
2.4.3 Alignment Indicators
[0065] In an alternative embodiment, one or more alignment
indicators may be added to the prongs 16 and/or cushion 14 to aid
alignment of the prongs 16 with respect to the cushion 14. For
example, alignment indicators 75 may be provided to the prongs 16
(see FIG. 5-7) that are adapted to be aligned with respective
alignment indicators 77 provided to the cushion 14 (see FIG. 6-3).
An exemplary alignment indicator is also described in U.S.
Provisional Patent Application No. 60/848,360, filed Oct. 2, 2006,
which is incorporated herein by reference in its entirety.
2.4.4 Prong Angle
[0066] In an alternative embodiment, the prong 16 may be configured
to extend at different prong angles as the prong 16 is rotated. For
example, as schematically shown in FIG. 5-2, the prong 16 may
include a cam arrangement or leveling device including an sloped
end 70 that is adapted to engage a sloped base 72, e.g., provided
to the cushion 14. When the prong 16 is rotated, the sloped end 70
moves relative to the sloped base 72 which changes the angle at
which the prong 16 extends.
[0067] As shown in FIG. 5-3-1, the grooves 66 in each HYBRID.TM.
prong 16 are aligned with a horizontal axis of the prong 16. In
another alternative embodiment, one or more grooves 66 in the base
portion of the prong 16 may be configured to position the prong 16
at an angle. For example, as shown in FIG. 5-3-2, a groove 66A may
be sloped with respect to a horizontal axis of the prong 16 which
is adapted to position the prong 16 at an angle when mounted to the
cushion 14 (see FIG. 5-3-3).
2.4.5 Other Prong Alternatives
[0068] In an alternative embodiment, the wall thickness of each
prong may be reduced, e.g., to about 0.5 mm.
[0069] In an alternative embodiment, each prong 16 may be rotatable
relative to the cushion 14, and the prong rotation may include
indexing or incremental stops.
[0070] In an alternative embodiment, as shown in FIG. 5-4, each
prong 16 may have a drinking straw style concertina configuration
74 along its stalk and/or base portion to provide angle adjustment
of the prong 16. Such an arrangement is disclosed in U.S. patent
application Ser. No. 10/584,711, filed Jun. 26, 2006, which is
incorporated herein by reference in its entirety.
[0071] In an alternative embodiment, as shown in FIG. 5-5, each
prong 16 may have one or more detents 76 to provide relatively
large angle adjustment of the prong 16.
[0072] In an alternative embodiment, the base of each prong 16 may
include a gimble or universal joint for adjustment.
[0073] In an alternative embodiment, each prong 16 may have a
preload to provide a sealing force with the patient's nare.
[0074] In an alternative embodiment, one or more of the rings 64 at
the base portion of each prong 16 may be sized such that the prong
16 cannot push through the respective portal in the cushion 14. For
example, FIG. 5-6 illustrates a prong 16 wherein the uppermost
rings 64 are sufficiently larger than the portals in the cushion
16.
[0075] In an alternative embodiment, as shown in FIG. 5-7, the
connecting bar 65 joining the prongs 16 may be provided at the
bottom edge of the prong base portions, e.g., to avoid patient's
septum. Such an arrangement is disclosed in PCT Application No.
PCT/AU2006/000770, filed Jun. 6, 2006, which is incorporated herein
by reference in its entirety.
[0076] In an alternative embodiment, as shown in FIG. 5-8, each
prong 16 may include one or more stiffening members 78.
2.5 Cushion
[0077] The cushion 14 of the HYBRID.TM. mask 10 includes a chin
portion or chin flap 80, an upper surface defining two portals 68
adapted to mount respective nasal prongs 16, a face-contacting
portion having a double wall configuration (e.g., membrane 82 and
undercushion 84), and a non-face-contacting portion having a
leading edge 86 adapted to engage a groove 88 provided to the frame
12 to secure the cushion 14 to the frame 12 (e.g., see FIGS. 1-9 to
1-11).
2.5.1 Cushion Profile
[0078] As shown in FIG. 6-1-1, the profile of the HYBRID.TM.
cushion 14 is generally J-shaped. In an alternative embodiment, as
shown in FIG. 6-1-2, the cushion profile may have a question-mark
or sickle shape. The question-mark or sickle shape may provide the
cushion with greater range of movement or flexibility towards the
patient's face in use. An exemplary cushion with a question-mark or
sickle shape profile is described in PCT Publication No. WO
2006/074513, published Jul. 20, 2006, which is incorporated herein
by reference in its entirety.
2.5.2 Gusset
[0079] In an alternative embodiment, as shown in FIG. 6-2, the
cushion 14 may include a gusset arrangement 85 to provide a reduced
height profile, increased stability, better fit to the patient's
face, and/or a reduced visual impact.
[0080] An exemplary cushion with a gusset is described in U.S.
patent application Ser. No. 10/655,622, filed Sep. 5, 2003, which
is incorporated herein by reference in its entirety.
2.5.3 Cushion to Frame Interface
[0081] The leading edge of the HYBRID.TM. cushion is a
substantially flat wall, which may easily disengage from the groove
in the frame, e.g., especially when greasy. In an alternative
embodiment, a lip, lug, bead, and/or or rib may be provided to the
leading edge of the cushion to better retain the cushion to the
frame. Such retaining structures are disclosed in U.S. patent
application Ser. No. 10/390,682, filed Mar. 19, 2003, which is
incorporated herein by reference in its entirety.
2.5.4 Other Cushion Alternatives
[0082] In an alternative embodiment, the face-contacting portion
may include more than two walls, e.g., membrane 82 and two or more
undercushions 84.
[0083] In an alternative embodiment, the cushion may have a preload
to provide a sealing force.
[0084] In an alternative embodiment, one or more alignment
indicators may be added to the cushion 14 and/or frame 12 to aid
alignment of the cushion 14 with respect to the frame 12. For
example, FIG. 8-2 illustrates an alignment indicator 87 provided to
the frame 12 that is adapted to be aligned with a respective
alignment indicator 89 provided to the cushion 14. Such alignment
indicators are also disclosed in U.S. patent application Ser. No.
10/390,682, filed Mar. 19, 2003, which is incorporated herein by
reference in its entirety.
[0085] In an alternative embodiment, the chin flap 80 may be
adjustable, e.g., indexed or incremental adjustment. In an
embodiment, as shown in FIG. 6-3, the chin flap may include a
bellows arrangement 85 to allow movement of the chin in use.
[0086] In an alternative embodiment, the chin flap 80 may include
multiple chin supports.
[0087] In an alternative embodiment, cheek supports may be provided
to the cushion 14, e.g., cheek wings, such as the cheek support
shown in FIG. 4-2.
[0088] In an alternative embodiment, the cushion may be configured
or shaped to accommodate the patient's septum and/or nasal bridge.
Such cushion arrangements are disclosed in U.S. patent application
Ser. No. 10/390,682, filed Mar. 19, 2003, and U.S. Pat. No.
6,112,746, each of which is incorporated herein by reference in its
entirety.
2.6 Elbow Assembly
[0089] The elbow assembly 18 of the HYBRID.TM. mask 10 includes an
elbow 90 and a swivel coupling 92 provided to the elbow 90. The
elbow 90 includes a first portion 94 attachable to the frame 12 and
a second portion 96 attachable to the swivel coupling 92. Also, the
elbow 90 includes a port 98 that is selectively closed by an
anti-asphyxia valve 99 (e.g., see FIGS. 1-3 to 1-5 and 1-9).
2.6.1 Shortened Length
[0090] As shown in FIGS. 1-3 to 1-5, the second portion 96 of the
HYBRID.TM. elbow 90 is substantially longer than the first portion
94. In an alternative embodiment, as shown in FIG. 7-1, the second
portion 96 of the elbow 90 may be shortened to improve
stability.
2.6.2 Tolerances
[0091] In the commercial embodiment of the HYBRID.TM. mask 10,
excessive noise is caused by significant leakage through the elbow
to frame interface. In an alternative embodiment, the manufacturing
tolerances of the elbow 90 and/or frame 12 may be improved to
reduce noise caused by leak through the elbow to frame
interface.
2.6.3 Other Elbow Assembly Alternatives
[0092] In an alternative embodiment, as shown in FIG. 7-2, a
relatively short swivel coupling 93 may be provided to each end of
the elbow 90 to allow greater flexibility.
[0093] In another alternative embodiment, a swivel coupling 92 may
be provided over the elbow 90 to reduce the size of the elbow
90.
[0094] In another alternative embodiment, the elbow to frame
connection may include a ball joint arrangement.
[0095] In another alternative embodiment, the frame 12 may include
two gas entry ports 53, e.g., one on each side of the frame as
shown in FIG. 7-3. In use, one of the ports may be provided with a
plug 95 and the other of the ports may be provided with an elbow
assembly 18. The positions of the plug and the elbow assembly may
be interchanged, according to preference. Thus, the mask 10 may be
configurable between two different configurations.
[0096] In another alternative embodiment, the elbow assembly may be
constructed of materials to prevent "squeaking" in use.
[0097] In another embodiment, the swivel coupling may permanently
attach to the elbow with a snap-fit, e.g., to prevent
separation.
[0098] In another embodiment, the elbow may be structured to
facilitate removal of the anti-asphyxia valve, e.g., for cleaning
so that the mask is suitable for use by multiple patients. For
example, the anti-asphyxia valve may be attached to a removable
clip member that is removably attachable to the elbow. Exemplary
anti-asphyxia valve assemblies are disclosed in PCT Publication No.
WO 2007/045008, published Apr. 26, 2007, which is incorporated
herein by reference in its entirety.
2.7 Vent Holes
[0099] The HYBRID.TM. frame 12 includes six vent holes 56 for
CO.sub.2 washout. The vent holes 56 are positioned above the gas
entry port 52 and aligned along a horizontal axis (e.g., see FIGS.
1-5 and 1-9).
2.7.1 Size and Number
[0100] In an alternative embodiment, the size of each vent hole 56
may be smaller and the number of vent holes 56 provided to the
frame 12 may be increased, e.g., greater than six vent holes (e.g.,
6-60 vent holes). Exemplary vent arrangements are disclosed in U.S.
Pat. No. 6,581,594 and PCT Application Nos. PCT/AU2006/000770,
filed Jun. 6, 2006, and PCT/AU2006/001507, filed Oct. 13, 2006,
each of which is incorporated herein by reference in its
entirety.
2.7.2 Positioning
[0101] In an alternative embodiment, as shown in FIG. 8-1, the vent
holes 56 may be moved away from the gas entry port 52 and elbow 90
connected thereto. This vent arrangement may provide less
interference with the elbow 90 and therefore less noise in use.
Such a vent arrangement is disclosed in PCT Application No.
PCT/AU2006/000770, filed Jun. 6, 2006, which is incorporated herein
by reference in its entirety.
2.7.3 Vent Hole Direction
[0102] In the commercial embodiment of the HYBRID.TM. mask 10, the
vent holes 56 direct washout gas along a generally horizontal plane
or axis of the frame 12. In an alternative embodiment, as shown in
FIG. 8-2, the vent holes 56 may be configured to direct washout gas
at an angle with respect to the horizontal axis of the frame 12. In
an embodiment, a grommet may be provided to one or more of the vent
holes to direct washout gas at an angle.
[0103] In another alternative embodiment, as shown in FIG. 8-3, the
vent holes 56 may be configured such that washout gas enters each
vent hole along one path and exits each vent hole along another
path.
2.7.4 Other Vent Alternatives
[0104] In an alternative embodiment, one or more vent holes for
CO.sub.2 washout may be provided in the base of each nasal prong 16
and/or in the cushion 14.
[0105] In another alternative embodiment, as shown in FIG. 8-4, one
or more vent holes for CO.sub.2 washout may be provided to the port
cap 55 that covers a respective supplemental oxygen port 54 of the
frame 12, e.g., vent and port cap integrated into one elastomeric
component.
[0106] In another alternative embodiment, the two port cap 55 may
be tethered to one another, e.g., double ports cap. Such an
arrangement is disclosed in U.S. Pat. No. 6,439,230, which is
incorporated herein by reference in its entirety.
2.8 Miscellaneous
[0107] The following embodiments describe additional improvements
and/or alternative arrangements of the HYBRID.TM. mask.
2.8.1 Forehead Support
[0108] In an alternative embodiment, as schematically shown in FIG.
8-4, a forehead support 99 may be provided to the HYBRID.TM. mask
10 to provide a support and stability mechanism between the mask
and the patient's forehead. Exemplary forehead support arrangements
are disclosed in U.S. Pat. Nos. 6,119,693 and 6,532,961 and PCT
Application No. PCT/AU2006/000037, filed Jan. 12, 2006, each of
which is incorporated herein by reference in its entirety.
[0109] In an embodiment, the forehead support may include forehead
pads that extend up and around the outside of the patient's eyes.
Exemplary forehead pads are disclosed in U.S. patent application
Ser. No. 10/655,595, filed Sep. 5, 2003, which is incorporated
herein by reference in its entirety.
[0110] In another embodiment, the forehead support may include a
nose support adapted to engage the nose and provide a support and
stability mechanism between the mask and the patient's nose.
[0111] In another embodiment, the forehead support may include a
cheek support adapted to engage the patient's cheeks and provide a
support and stability mechanism between the mask and the patient's
cheeks, e.g., such as the cheek support shown in FIG. 4-2.
2.8.2 Other Alternatives
[0112] In an alternative embodiment, the HYBRID.TM. mask 10 may
include an intra-oral bite or dental insert provided within the
patient's mouth. In an embodiment, the insert may constitute a
mandibular advancement device structured to advance the position of
the patient's lower jaw. An exemplary mandibular advancement device
is disclosed in PCT Application No. PCT/AU2006/001095, filed Aug.
2, 2005, which is incorporated herein by reference in its
entirety.
[0113] In another alternative embodiment, the frame 12, cushion 14,
nasal prongs 16, and/or headgear 20 of the HYBRID.TM. mask 10 may
be constructed of a malleable material to allow bending for
conformance to the patient's head and/or face, e.g., conform mask
to suit different faces.
[0114] In another alternative embodiment, the frame 12 and/or
cushion 14 may include an articulating feature that allows the jaw
to move in use. The articulating feature may be adjustable and
lockable.
[0115] 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, bariatric surgery, etc.) can
derive benefit from the above teachings. Moreover, the above
teachings have applicability with patients and non-patients
alike.
* * * * *
References