U.S. patent application number 14/466079 was filed with the patent office on 2014-12-11 for full-face mask and mask cushion therefor.
The applicant listed for this patent is ResMed Limited. Invention is credited to Philip Rodney KWOK, Gregory Scott SMART, Robert Edward STYLES.
Application Number | 20140360506 14/466079 |
Document ID | / |
Family ID | 46276399 |
Filed Date | 2014-12-11 |
United States Patent
Application |
20140360506 |
Kind Code |
A1 |
KWOK; Philip Rodney ; et
al. |
December 11, 2014 |
FULL-FACE MASK AND MASK CUSHION THEREFOR
Abstract
A full-face cushion comprises a substantially triangularly
shaped frame from which extends a membrane. The frame has a
scalloped edge by which the cushion is affixed to a mask body to
form a full-face mask. The membrane has an aperture into which the
wearer's nose is received. The member is spaced away from the rim
of the frame, and its outer surface is of substantially the same
shape as the rim. Respective notches receive the bridge of the
wearer's nose. The wearer's nose and lips are received through the
aperture into the chamber within the mask body. The seal forming
portion thus contacts both the surface of the wearer's nose and a
portion of the wearer's face in the region between the bottom lip
and the chin, and around the sides and over the bridge of the nose.
The shape of the seal forming portion is particularly suited to
effectively seal the difficult region of the facial contour that is
the crease between the sides of the nose and the face.
Inventors: |
KWOK; Philip Rodney;
(Sydney, AU) ; STYLES; Robert Edward; (Sydney,
AU) ; SMART; Gregory Scott; (Sydney, AU) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
ResMed Limited |
Bella Vista |
|
AU |
|
|
Family ID: |
46276399 |
Appl. No.: |
14/466079 |
Filed: |
August 22, 2014 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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13293684 |
Nov 10, 2011 |
8813748 |
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14466079 |
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11432436 |
May 12, 2006 |
8056561 |
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13293684 |
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10704754 |
Nov 12, 2003 |
7069933 |
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11432436 |
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10166282 |
Jun 11, 2002 |
6701927 |
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10704754 |
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09316227 |
May 21, 1999 |
6513526 |
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10166282 |
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08791212 |
Jan 31, 1997 |
6112746 |
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09316227 |
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Current U.S.
Class: |
128/206.24 |
Current CPC
Class: |
A61B 5/097 20130101;
A61M 16/06 20130101; A61M 2016/0661 20130101; A61B 5/682 20130101;
A61M 2210/0618 20130101; A61M 16/0633 20140204; A61B 5/6819
20130101; A61M 16/0622 20140204; A61M 16/0616 20140204; A61M
16/0683 20130101 |
Class at
Publication: |
128/206.24 |
International
Class: |
A61M 16/06 20060101
A61M016/06 |
Foreign Application Data
Date |
Code |
Application Number |
Jul 26, 1996 |
AU |
PO 1265 |
Claims
1-25. (canceled)
26. A mask assembly for delivery of a supply of gas to an entrance
to the airways of a patient, said patient having a nasal bridge
region, a cheek region and a chin region, said mask assembly
comprising: a headstrap system to secure the mask assembly relative
to the patient's head; and a cushion adapted to confront a face of
a patient, said cushion comprising first and second membranes of
integrally formed elastomeric material, said first and second
membranes having respective first and second distal ends delimiting
respective first and second apertures adapted to receive the
patient's nose and mouth, said first distal end terminating
adjacent the second aperture, said second membrane defines a
seal-forming portion on an outer surface thereof, said seal-forming
portion being constructed and arranged to be positioned adjacent a
nasal bridge region, along sides of the nose, and below lips or on
a chin to effect a seal, the seal forming portion is structured
such that it is not required to turn in on itself to conform with
the patient's face, said first membrane provides a supporting
structure for the second membrane, and said second membrane
covering said first membrane.
27. The mask assembly of claim 26, wherein the second membrane is
substantially unsupported by the first membrane where the cushion
is adapted to seal with the nasal bridge region.
28. The mask assembly of claim 26, wherein, in a portion of the
cushion adapted to contact the chin region, the first and second
membranes extend a chin region distance towards the aperture, the
chin region distances of the rims being generally equal.
29. The mask assembly of claim 26, wherein, in a portion of the
cushion adapted to contact the cheek region, the second membrane
extends a cheek region distance towards the aperture that is
greater than the chin region distance of the second membrane.
30. The mask assembly of claim 28, wherein, in the nasal bridge
region, the second membrane extends a nasal bridge region distance
that is greater than the chin region distance of the second
membrane.
31. The mask assembly of claim 30, wherein in the nasal bridge
region, the second membrane extends towards the aperture to a
degree relative to the first membrane that is greater than that of
the second membrane relative to the first membrane in the cheek
region.
32. The mask assembly of claim 26, wherein, in the nasal bridge
region, the shape between the first and second membranes is
different from one another such that the nasal bridge is able to be
inserted into a space where there is substantially no first
membrane, with the second membrane stretching across a gap in the
first membrane.
33. The mask assembly of claim 26, further comprising a notch in
both the first and second membranes to receive the bridge of the
wearer's nose.
34. The mask assembly of claim 26, wherein the first membrane has a
thickness of about 1.5 mm and the second membrane has a thickness
of about 0.35 mm.
35. The mask assembly of claim 26, wherein the first membrane
extends a first distance towards the aperture in the nasal bridge
region, and a second distance towards the aperture in the chin
region, wherein said first distance is less than said second
distance.
36. A mask assembly for delivery of a supply of gas to an entrance
to the airways of a patient, said patient having a nasal bridge
region, a cheek region and a chin region, said mask assembly
comprising: a headstrap system to secure the mask assembly relative
to the patient's head; and a cushion adapted to confront a face of
a patient, said cushion comprising: first and second membranes of
integrally formed elastomeric material, each of said first and
second membranes having a proximal portion and a distal end, the
distal ends defining respective first and second apertures adapted
to receive the patient's nose and mouth, proximal portions
intersecting one another, and the first and second membranes
extending in spaced relation to one another toward the respective
distal ends; and a support portion from which the first and second
membranes extend, the support portion including an edge configured
to connect the cushion to a mask body, said second membrane defines
a seal-forming portion on an outer surface thereof, said
seal-forming portion being constructed and arranged to be
positioned adjacent a nasal bridge region, along sides of the nose,
and below lips or on a chin to effect a seal, the seal forming
portion is structured such that it is not required to turn in on
itself to conform with the patient's face, said first membrane
provides a supporting structure for the second membrane, and said
second membrane covering said first membrane.
37. The mask assembly of claim 36, wherein the second membrane is
substantially unsupported by the first membrane wherein the cushion
is adapted to seal with the nasal bridge region.
38. The mask assembly of claim 36, wherein, a portion of the
cushion adapted to contact in the chin region, the first and second
membranes extend a chin region distance towards the aperture, the
chin region distance of the second membrane being greater than the
chin region distance of the first membrane.
39. The mask assembly of claim 38, wherein, in a portion of the
cushion adapted to contact the cheek region, the second membrane
extends a cheek region distance towards the aperture that is
greater than the chin region distance of the second membrane.
40. The mask assembly of claim 38, wherein, in the nasal bridge
region, the second membrane extends a nasal bridge region distance
that is greater than the chin or cheek region distances of the
second membrane.
41. The mask assembly of claim 40, wherein in the nasal bridge
region, the second membrane extends towards the aperture to a
degree relative to the first membrane that is greater than that of
the second membrane relative to the first membrane in the cheek and
chin regions.
42. The mask assembly of claim 36, wherein, in the nasal bridge
region, the shape between the first and second membranes is
different from one another such that the nasal bridge is able to be
inserted into a space where there is substantially no first
membrane, with the second membrane stretching across a gap in the
first membrane.
43. The mask assembly of claim 36, further comprising a notch in
both the first and second membranes to receive the bridge of the
wearer's nose.
44. The mask assembly of claim 36, wherein the first membrane has a
thickness of about 1.5 mm and the second membrane has a thickness
of about 0.35 mm.
45. A mask assembly for delivery of a supply of gas to an entrance
to the airways of a patient, said patient having a nasal bridge
region, a cheek region and a chin region, said mask assembly
comprising: a headstrap system to secure the mask assembly relative
to the patient's head; and a cushion adapted to confront a face of
a patient, said cushion comprising: first and second membranes of
integrally formed elastomeric material, each of said first and
second membranes having an aperture adapted to receive the
patient's nose and mouth, each of the first and second membranes
having a distal end and a proximal end, the proximal ends
intersecting one another and the first and second membranes
extending in spaced relation to one another toward the respective
distal ends, said second membrane defines a seal-forming portion on
an outer surface thereof, said seal-forming portion being
constructed and arranged to be positioned adjacent a nasal bridge
region, along sides of the nose, and below lips or on a chin to
effect a seal, said first membrane provides a supporting structure
for the second membrane, and said second membrane covering said
first membrane, wherein the second membrane has a variable
dimension suited to the nasal bridge region, the cheek region and
the chin region, wherein the first membrane has a variable
dimension suited to the nasal bridge region, the cheek region and
the chin region, and/or the first and second membranes have
variable widths relative to one another suited to the nasal bridge
region, the cheek region and the chin region.
46. The mask assembly of claim 45, wherein the second membrane is
substantially unsupported by the first membrane where the cushion
is adapted to seal with the nasal bridge region.
47. A mask assembly for delivery of a supply of gas to an entrance
to the airways of a patient, said patient having a nasal bridge
region, a cheek region and a chin region, said mask assembly
comprising: a headstrap system to secure the mask assembly relative
to the patient's head; and a cushion adapted to confront a face of
a patient, said cushion comprising: first and second membranes of
integrally formed elastomeric material, each of said first and
second membranes having an end forming a respective rim defining an
aperture through which the patient's nose and mouth, said second
membrane defines a seal-forming portion on an outer surface
thereof, said seal-forming portion being constructed and arranged
to be positioned adjacent a nasal bridge region, along sides of the
nose, and below lips or on a chin to effect a seal, the seal
forming portion is structured such that it is not required to turn
in on itself to conform with the patient's face, said first
membrane provides a supporting structure for the second membrane,
said second membrane covering said first membrane, and wherein the
second membrane is substantially unsupported by the first membrane
where the cushion is adapted to seal with the nasal bridge region
in use.
48. The mask assembly of claim 47, wherein, a portion of the
cushion adapted to contact in the chin region, the first and second
membranes extend a chin region distance towards the aperture, the
chin region distance of the second membrane being greater than the
chin region distance of the first membrane.
49. The mask assembly of claim 48, wherein, in a portion of the
cushion adapted to contact the cheek region, the second membrane
extends a cheek region distance towards the aperture that is
greater than the chin region distance of the second membrane.
50. The mask assembly of claim 48, wherein, in the nasal bridge
region, the second membrane extends a nasal bridge region distance
that is greater than the chin or cheek region distances of the
second membrane.
51. The mask assembly of claim 50, wherein in the nasal bridge
region, the second membrane extends towards the aperture to a
degree relative to the first membrane that is greater than that of
the second membrane relative to the first membrane in the cheek and
chin regions.
52. The mask assembly of claim 47, wherein, in the nasal bridge
region, the shape between the first and second membranes is
different from one another such that the nasal bridge is able to be
inserted into a space where there is substantially no first
membrane, with the second membrane stretching across a gap in the
first membrane.
53. The mask assembly of claim 47, further comprising a notch in
both the first and second membranes to receive the bridge of the
wearer's nose.
54. The mask assembly of claim 47, wherein the first membrane has a
thickness at its rim of about 1.5 mm and the second membrane has a
thickness at its rim of about 0.35 mm.
55. A mask assembly for delivery of a supply of gas to an entrance
to the airways of a patient, said patient having a nasal bridge
region, a cheek region and a chin region, said mask assembly
comprising: a headstrap system to secure the mask assembly relative
to the patient's head; and a cushion adapted to confront a face of
a patient, said cushion comprising: first and second membranes of
integrally formed elastomeric material, each of said first and
second membranes having an aperture through which the patient's
nose and mouth are received, said second membrane defines a
seal-forming portion on an outer surface thereof, said seal-forming
portion being constructed and arranged to be positioned adjacent a
nasal bridge region, along sides of the nose, and below lips or on
a chin to effect a seal, said first membrane provides a supporting
structure for the second membrane, and said second membrane
covering said first membrane, wherein the second membrane has a
variable dimension suited to the nasal bridge region, the cheek
region and the chin region, the first membrane has a variable
dimension suited to the nasal bridge region, the cheek region and
the chin region, and/or the first and second membranes have
variable widths relative to one another suited to the nasal bridge
region, the cheek region and the chin region, and wherein the
second membrane is substantially unsupported by the first membrane
where the cushion is adapted to seal with the nasal bridge region
in use.
56. The mask assembly of claim 26, wherein first and second
membranes extend in spaced relation to one another.
57. The mask assembly of claim 26, wherein the cushion comprises a
support portion from which the first and second membranes extend,
the support portion including an edge configured to connect the
cushion to a mask body.
Description
[0001] This is a CIP of Ser. No. 08/791,212 filed Jan. 31,
1997.
FIELD OF THE INVENTION
[0002] The invention relates generally to a full-face (ie. nose and
mouth) mask and to a cushion therefor, for example, for use in the
treatment of respiratory conditions and in assisted
respiration.
BACKGROUND OF THE INVENTION
[0003] Full-face masks are commonly used in the treatment of
respiratory conditions and sleep disorders (e.g., obstructive sleep
apnea) by delivering a flow of breathable gas for, or to assist,
patient respiration. These masks typically receive a gas supply
line which delivers gas into a chamber formed by walls of the mask
The walls usually are semi-rigid and have a face contacting portion
including an aperture which is generally aligned with the wearer's
nostrils and mouth. The face contacting portion can comprise a
soft, resilient elastomeric material which may conform to various
facial contours. The mask normally is secured to the wearer's head
by straps. The straps are adjusted to pull the mask against the
face with sufficient force to achieve a gas tight seal between the
mask and the wearer's face. Gas is thus delivered to the mask and
through the aperture to the wearer's nasal passages and throat.
[0004] Problems often arise with masks of the above configuration.
For example, the mask may be dislodged, thereby breaking the seal
between the mask and wearer. This may occur if the wearer rolls
over when sleeping thereby creating a drag force on the gas supply
line which is transmitted to the mask, breaking the seal. In the
case of a mask being used for the administration of Continuous
Positive Airway Pressure (CPAP) treatment for the condition
obstructive sleep apnea, such a leak can result in the pressure
supplied to the entrance of the wearer's airway being below the
therapeutic value, and the treatment becoming ineffective.
[0005] Another problem is that the face contacting portion may
apply excessive pressure to the wearer's face resulting in
discomfort and possibly skin irritation. This can occur because the
face contacting portion has to distort beyond its normal range of
elasticity to conform to certain facial contours which requires the
application of excessive forces. In some cases these excessive
pressures and forces may cause the face to distort to conform with
the face contacting portion to increase wearer discomfort, facial
soreness and ulceration.
[0006] It is an object of the invention to overcome or at least
substantially ameliorate one or more of the foregoing
disadvantages.
SUMMARY OF THE INVENTION
[0007] In one broad form, the invention discloses a full-face mask
cushion to sealingly connect a mask to a wearer's face, the cushion
comprising: [0008] a nasal bridge region, a cheek region and a chin
region; [0009] a first membrane comprising a substantially
triangularly-shaped frame of resilient material having a first
molded inwardly curved rim; [0010] a second membrane of resilient
material, said second membrane being thinner than said first
membrane, said second membrane having a second molded inwardly
curved rim, said second membrane curved rim spaced a first distance
from said first membrane curved rim in said cheek region and said
second membrane curved rim spaced a second distance from said first
membrane curved rim in said nasal bridge region, said second
distance greater than said first distance, said distances measured
when the mask is not in use, a portion of said second membrane
curved rim forming a face contacting seal.
[0011] Preferably, the rim and seal portion are shaped to generally
match facial contours of the facial tissue around the sides and
over the bridge of the nose and between the bottom lip and the
chin.
[0012] In one particularly advantageous form, the membrane is
substantially saddle-shaped. The membrane further has a centrally
located aperture through which the wearer's nose and mouth pass to
enter said cavity.
[0013] It is preferred that the cushion and membrane each include a
co-located notch to accommodate the bridge of the nose of the
wearer. Typically, the seal portion contacts at least the wearer's
nose, and preferably, also the facial tissue around the sides and
over the bridge of the nose and between the bottom lip and the
chin.
[0014] The invention further discloses a full-face mask for
connection to a wearer's face comprising: [0015] a mask body for
connection with a supply of breathable gas; and [0016] a full-face
cushion secured to said mask body, the body and cushion forming a
nose and mouth-receiving cavity, said cushion including: [0017] a
nasal bridge region, a cheek region and a chin region; [0018] a
substantially triangularly-shaped first membrane of resilient
material having a first molded inwardly curved rim to surround
wearer's nose; [0019] a second membrane also of resilient material,
said second membrane being relatively more flexible than said first
membrane, said second membrane having a second molded inwardly
curved rim, said second molded rim being of the same general shape
as said first molded rim and fixed to and extending away from said
first membrane so as to have a second membrane inner surface spaced
a first distance from an outer surface of said first molded rim in
said cheek region and said second membrane inner surface spaced a
second distance from said first membrane outer surface of said
first molded rim in said nasal bridge region, said second distance
greater than said first distance, said distances measured when the
mask is not in use, a portion of said second molded rim forming a
face contacting seal; and [0020] wherein said seal portion is
substantially coterminous with respect to said second molded rim
and is resiliently deformable towards said first membrane in use of
said mask.
[0021] The mask body can further include attachment points from
which securing straps can be attached, and by which the mask can be
secured to the wearer's head. The nasal mask can yet further
comprise an arm depending from said body from which a further
securing strap(s) can be attached.
[0022] The invention further discloses a CPAP treatment apparatus
comprising: [0023] a flow generator for the supply of gas at a
pressure elevated above atmospheric pressure; [0024] a gas delivery
conduit coupled to said flow generator; and [0025] a full-face mask
in turn coupled to said conduit to said nasal mask including:
[0026] a mask body for connection with a supply of breathable gas;
and [0027] a full-face cushion secured to said mask body, the body
and cushion forming a nose and mouth-receiving cavity, the cushion
including: [0028] a nasal bridge region, a cheek region and a chin
region; [0029] a substantially triangularly-shaped first membrane
of resilient material having a first membrane having a molded
inwardly curved rim; [0030] a second membrane having a second
molded inwardly curved rim also of resilient material, said second
membrane being relatively more flexible than said first membrane,
and being of the same general shape as said first molded inwardly
curved rim and fixed to and extending away from said first membrane
so as to have an inner surface spaced a first distance from said
first molded rim in said cheek region and said second membrane
inner surface spaced a second distance from said first molded rim,
said second distance greater than said first distance, said
distances measured when the mask is not in use, a portion of said
second molded rim forming a face contacting seal; and [0031]
wherein said seal portion is generally coterminous with respect to
said second molded rim and is resiliently deformable towards said
first membrane in use of said mask.
[0032] In one particularly preferred form, a supply of gas can be
provided to said cavity, said supply of gas assisting, but not
solely causing maintenance of a seal by said seal forming portion
of said membrane to the face of the wearer in use of the
cushion.
[0033] Advantageously, because the membrane and the rim are
substantially shaped to the facial contour, and the membrane does
not need to turn in on itself, as in the prior art, thus contacting
the face without folds or creases. With the cushion/mask secured to
the wearer's head, the headstraps need only to be tensioned to
balance the force due to mask gas pressure that tends to lift the
mask off the face. Such relatively lower mask-to-face pressure
results in greater patient comfort, and a reduction in the
likelihood of skin irritation.
BRIEF DESCRIPTION OF THE DRAWINGS
[0034] An embodiment of the invention will now be described with
reference to the accompanying drawings, in which:
[0035] FIG. 1 is a rear perspective view of a nasal mask cushion
embodying the present invention;
[0036] FIG. 2 is a cross-sectional view of the cushion shown in
FIG. 1 along line 2-2;
[0037] FIG. 3 is a perspective view of a nasal mask including the
cushion of FIG. 1;
[0038] FIG. 4 is a perspective view of the nasal mask of FIG. 3
secured to a wearer's head;
[0039] FIG. 5 is a side view of the mask cushion shown in FIG.
1;
[0040] FIG. 6 is a front view of the mask cushion shown in FIG.
1;
[0041] FIG. 7 is a rear view of the mask cushion shown in FIG.
1;
[0042] FIG. 8 is a cross sectional view of the mask shown in FIG. 1
along line 8-8 of FIG. 7;
[0043] FIG. 9 is a cross sectional view of the mask shown in FIG. 1
along line 9-9 of FIG. 7;
[0044] FIG. 10 is a front perspective view of a full-face mask
cushion embodying the present invention;
[0045] FIG. 11 is a perspective view of a full-face mask including
the cushion of FIG. 10;
[0046] FIG. 12 is an underside view of the mask cushion shown in
FIG. 10;
[0047] FIG. 13 is a front view of the mask cushion shown in FIG.
10;
[0048] FIG. 14 is a rear view of the mask cushion shown in FIG.
10;
[0049] FIG. 15 is a cross sectional view of the mask cushion shown
in FIG. 10 along line 15-15 of FIG. 14;
[0050] FIG. 16 is a cross sectional view of the mask cushion shown
in FIG. 10 along line 16-16 of FIG. 14; and
[0051] FIG. 17 is a perspective view of the mask shown in FIG. 11
secured to a wearer's face.
DESCRIPTION OF THE PREFERRED EMBODIMENTS
[0052] FIGS. 1 to 9 show a nasal cushion 30A and a nasal mask 60A
embodying the present invention.
[0053] FIG. 1 is a perspective view of the nasal cushion 30A. FIG.
3 is a perspective view of the nasal cushion 30A attached to a mask
body 46 to form the nasal mask 60A.
[0054] The nasal cushion 30A comprises a substantially triazgularly
shaped frame 32 from which extends a membrane 34. The frame 32 has
a scalloped edge 36 by which the nasal cushion 30A is affixed to
the mask body 46, as presently will be described.
[0055] The membrane 34 has an aperture 38 into which the wearer's
nose is received in use of the nasal cushion 30A. The membrane 34
is spaced away from the rim 40 of the frame 32, and its outer
surface 41 is of substantially the same shape as the rim 40. The
outer surface 41 of the membrane 34 and the rim 40 of the frame 32
also can be described as generally saddle shaped. The shaping of
the outer surface 41 of the membrane 34 and the rim 40 of the frame
32 also include respective notches 42,44 that receive the bridge of
the wearer's nose in use of the nasal cushion 30A.
[0056] As is best seen in FIG. 2, the frame 32 and the membrane 34
are integrally formed, typically in a one-shot molding process. The
frame 32 and the membrane 34 are fabricated from a resilient
material. One suitable such material is SILASTIC.TM. silicone
elastomer manufactured by Dow Corning. The frame 32, in a preferred
embodiment, has a typical thickness at its rim 40 of 1.5 mm The
membrane 34, in a preferred embodiment, has a typical thickness of
0.35 mm. In this way, the membrane 34 is relatively more flexible
than the rim 40.
[0057] In use of the nasal cushion 30A, a wearer's nose will be
inserted in the aperture 38 to engage a seal forming portion 45
(formed between the dashed lines) of the outer surface 41 to cause
deformation of the membrane 34. Depending upon the securing force
supplied to the membrane 34, it may deform to a point where it
butts against the rim 40 of the frame 32. The frame 32 has a
rigidity sufficient to withstand usual securing pressures in use of
the nasal cushion 30A to tend to retain its shape and resist
deformation. It thus acts as a supporting structure.
[0058] Referring now to FIG. 3, the nasal cushion 30A is shown
attached to the mask body 46 by the edge 36 of the frame 32,
adhered or otherwise secured to a flange 48 of the mask body 46.
Only the outer surface 41 of the membrane 34 can be seen. The
flange 48 includes two lower slots 50 and 54 from which a first
tensioning strap 68 can be attached to secure the cushion 30 and
the mask body 46 (in combination) to the head of a wearer.
[0059] The mask body 46 forms a cavity that can receive the nose of
the wearer by the aperture 38. A port 56 is provided at the top of
the mask body 46 by which breathable gas can be supplied to the
chamber.
[0060] Referring now to FIG. 4, a coupling tube 62 is shown above
the nasal mask 60A. The coupling tube 62 is connected at one end
with the inlet port 56, and at the other to a socket 64 into which
can be received a gas delivery tube 65 for the supply of breathable
gas to the chamber internal of the mask body 46 from a flow
generator 67. The mask body 46 also has two vent openings 66 by
which expired gas is exhausted. The first fastening strap 68 is
fixed between the two lower slots 50,54. An upper slot 52 receives
an arm 70, the top end of which has a resilient pad 72 to engage
the forehead of the wearer. The arm 70 has two slots, only one slot
74 shown, along its side edges, by which a second fastening strap
78 is secured.
[0061] In fitting the nasal mask 60A, the wearer's nose is received
through the aperture 38 into the chamber within the mask body 46.
The seal forming portion 45 thus contacts both the surface of the
wearer's nose and a portion of the wearer's face in the region
between the base of the nose and the upper lip, and around the
sides and over the bridge of the nose. The shape of the seal
forming portion 45 is particularly suited to effectively seal the
difficult region of the facial contour that is the crease between
the sides of the nose and the face. Depending upon the tension
applied by the first and second fastening straps 68,78, a seal is
formed with the membrane 34 remaining spaced from the rim 40 of the
cushion frame 32. While the provision of pressurised gas to the
chamber of the mask body 46 assists in the maintenance of a seal
between the membrane 34 and the wearer's nose and face, it is not
essential in most cases, and an effective seal will be formed
absent any such pressurised gas. When relative movement of the
nasal mask 60A in relation to the wearer's head, the nose will be
restrained by contacting the frame 32. Thus only limited relative
motion between the nasal mask 60A and the wearer's nose and face
occurs.
[0062] The membrane 34 closely imitates the facial contour, and
because of its relatively lesser stiffness than the frame 32, can
conform to particular facial structures with minimum force, and
without a tendency to fold or crease.
[0063] If the fastening straps 68 and 78 are tensioned to excess,
the membrane 34 deforms to abut the rim 40 of the cushion 30A, the
frame 32 thus acting as an "end limit". In such a configuration,
almost zero relative movement can occur between the nasal mask 60A
and the wearer's head.
[0064] FIGS. 10 to 17 show a full-face cushion 30B and a full-face
mask 60B embodying the present invention. Like reference numerals
to those used in describing the "nasal" embodiment of FIGS. 1 to 9
shall be used to denote like features of the "full-face" embodiment
of FIGS. 10 to 17.
[0065] FIG. 10 is a perspective view of the full-face cushion 30B.
FIG. 11 is a perspective view of the full-face cushion 30B attached
to a mask body 46 to form the full-face mask 60B.
[0066] The full-face cushion 30B comprises a substantially
triangularly shaped frame 32 from which extends a membrane 34. The
frame 32 has a scalloped edge 36 by which the full-face cushion 30B
is affixed to the mask body 46, as presently will be described.
[0067] The membrane 34 has an aperture 38 into which the wearer's
nose and lips are received in use of the full-face cushion 30B. The
membrane 34 is spaced away from the rim 40 of the frame 32, and its
outer surface 41 is of substantially the same shape as the rim 40.
The outer surface 41 of the membrane 34 and the rim 40 of the frame
32 also can be described as generally saddle shaped. The shaping of
the outer surface 41 of the membrane 34 and the rim 40 of the frame
32 also include respective notches 42,44 that receive the bridge of
the wearer's nose in use of the full-face cushion 30B.
[0068] As is best seen in FIG. 16, the frame 32 and the membrane 34
are integrally formed, typically by in a one-shot molding process.
The frame 32 and the membrane 34 are fabricated from a resilient
material. One suitable such material is SILASTIC silicone elastomer
manufactured by Dow Corning. The frame 32, in a preferred
embodiment, has a typical thickness at its rim 40 of 1.5 mm. The
membrane 34, in a preferred embodiment, has a typical thickness of
0.35 mm. In this way, the membrane 34 is relatively more flexible
than the rim 40.
[0069] In use of the full-face cushion 30B, a wearer's nose and
lips will be inserted in the aperture 38 to engage a seal forming
portion 45 (formed inside the dashed line, see FIG. 13) of the
outer surface 41 to cause deformation of the membrane 34. Depending
upon the securing force supplied to the membrane 34, it may deform
to a point where it butts against the rim 40 of the frame 32. The
frame 32 has a rigidity sufficient to withstand usual securing
pressures in use of the full-face cushion 30B to tend to retain its
shape and resist deformation. It thus acts as a supporting
structure.
[0070] Referring now to FIG. 11, the full-face cushion 30B is shown
attached to the mask body 46 by the edge 36 of the frame 32,
adhered or otherwise secured to a flange 48 of the mask body 46.
Only the outer surface 41 of the membrane 34 can be seen. The mask
body 46 includes two lower slots 50 and 54 and two upper slots 74
and 76 from which first and second tensioning straps 68 and 78 can
respectively be attached to secure the cushion 30B and the mask
body 46 (in combination) to the head of a wearer.
[0071] The mask body 46 forms a cavity that can receive the nose
and lips of the wearer by the aperture 38. A port 56 is provided at
the front of the mask body 46 by which breathable gas can be
supplied to the chamber.
[0072] Referring now to FIG. 17, a coupling elbow 62 is shown
connected at one end with the inlet port 56, and at the other to a
socket 64 into which can be received a gas delivery tube 65 for the
supply of breathable gas to the chamber internal of the mask body
46 from a flow generator 67. The mask body 46 also a vent opening
66 by which expired gas is exhausted. The first fastening strap 68
is fixed between to the lower two slots 50 and 54. The second
fastening strap 78 is secured between the two upper slots 74 and
76. The first and second straps 68 and 78 are joined at each side
by a bridging portion 79.
[0073] In fitting the full-face mask 60B, the wearer's nose and
lips are received through the aperture 38 into the chamber within
the mask body 46. The seal forming portion 45 thus contacts both
the surface of the wearer's nose and a portion of the wearer's face
in the region between the bottom lip and the chin, and around the
sides and over the bridge of the nose. The shape of the seal
forming portion 45 is particularly suited to effectively seal the
difficult region of the facial contour that is the crease between
the sides of the nose and the face. Depending upon the tension
applied by the first and second fastening straps 68,78, a seal is
formed with the membrane 34 remaining spaced from the rim 40 of the
cushion frame 32. While the provision of pressurised gas to the
chamber of the mask body 46 assists in the maintenance of a seal
between the membrane 34 and the wearer's nose and face, it is not
essential in most cases, and an effective seal will be formed
absent any such pressurised gas. When relative movement of the
full-face mask 60B in relation to the wearer's head, the nose will
be restrained by contacting the frame 32. Thus only limited
relative motion between the full-face mask 60B and the wearer's
nose and face occurs.
[0074] The membrane 34 closely imitates the facial contour, and
because of its relatively lesser stiffness than the frame 32, can
conform to particular facial structures with minimum force, and
without a tendency to fold or crease.
[0075] If the fastening straps 68 and 78 are tensioned to excess,
the membrane 34 deforms to abut the rim 40 of the cushion 32, the
frame 32 thus acting as an "end limit". In such a configuration,
almost zero relative movement can occur between the full-face mask
60B and the wearer's head.
[0076] The nasal cushion 30A, the nasal mask 60A, the full-face
cushion 30B and the full-face mask 60B have been described with
reference to CPAP or assisted respiration treatment, however it is
to be understood that the invention generally is applicable to any
application where gas and/or atomised liquid is to be supplied to
the entrance of the airways. Such applications include nebulisers,
gas masks and anaesthetic machines.
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