U.S. patent application number 17/301447 was filed with the patent office on 2021-10-14 for patient interfaces.
The applicant listed for this patent is Fisher & Paykel Healthcare Limited. Invention is credited to Roheet Patel.
Application Number | 20210316100 17/301447 |
Document ID | / |
Family ID | 1000005681429 |
Filed Date | 2021-10-14 |
United States Patent
Application |
20210316100 |
Kind Code |
A1 |
Patel; Roheet |
October 14, 2021 |
PATIENT INTERFACES
Abstract
An interface for positive pressure respiratory therapy includes
a mask assembly having a mask seal and a mask shell. The mask
assembly is positioned lower than and exposes a bridge of the
user's nose. The mask seal includes portions that contact opposing
sides of the user's nose. Each portion of the mask seal includes
supports that help maintain the mask seal's shape. Two covers can
be supported relative to the mask assembly and adjacent a
respective portion of the mask seal. The covers limit expansion of
the portions of the mask seal in response to pressurized air within
the mask seal. The supports can transfer load from the mask seal to
the covers. An interface system can include multiple size mask
seals, which can be designed with consideration of ethnic
variations in nose size and/or shape.
Inventors: |
Patel; Roheet; (Auckland,
NZ) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
Fisher & Paykel Healthcare Limited |
Auckland |
|
NZ |
|
|
Family ID: |
1000005681429 |
Appl. No.: |
17/301447 |
Filed: |
April 2, 2021 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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15757112 |
Mar 2, 2018 |
10994090 |
|
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PCT/IB2016/055212 |
Sep 1, 2016 |
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17301447 |
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62214463 |
Sep 4, 2015 |
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Current U.S.
Class: |
1/1 |
Current CPC
Class: |
A61M 16/0616 20140204;
A61M 16/0622 20140204; A61M 2210/0618 20130101; A61M 16/0683
20130101 |
International
Class: |
A61M 16/06 20060101
A61M016/06 |
Claims
1.-58. (canceled)
59. A mask seal for an interface for use in providing positive
pressure respiratory therapy, the mask seal comprising: a seal body
configured to be fully positioned lower than a bridge of a nose of
a face of a user and to provide an exposed bridge of the nose of
the user, the seal body comprising a nasal region comprising a
nasal opening, the seal body comprising a first paddle on a first
side of the nasal region and a second paddle on a second side of
the nasal region, the first paddle configured to contact one side
of the nose of the user and the second paddle configured to contact
the other side of the nose of the user; the seal being configured
to be provided in a range of sizes comprising: a first size
configured to fit users having a first range of nasal widths and a
first range of nasal lengths; a second size configured to fit users
having a second range of nasal widths and a second range of nasal
lengths; a third size configured to fit users having a third range
of nasal widths and a third range of nasal lengths; a fourth size
configured to fit users having a fourth range of nasal widths and a
fourth range of nasal lengths; the first range of nasal widths and
the second range of nasal widths are similar and the third range of
nasal widths and the fourth range of nasal width are similar, the
first range of nasal widths and the third range of nasal widths are
different.
60. The mask seal of claim 59, wherein the first range of nasal
lengths and the third range of nasal lengths are similar and the
second range of nasal lengths and the fourth range of nasal lengths
are similar.
61. The mask seal of claim 60, wherein the first range of nasal
lengths is different from the second range of nasal lengths.
62. The mask seal of claim 61, wherein the first range of nasal
lengths does not overlap with the second range of nasal
lengths.
63. The mask seal of claim 59, wherein the first range of nasal
widths does not overlap with the third range of nasal widths.
64. The mask seal of claim 59, wherein the first range of nasal
widths is different from the fourth range of nasal widths, and the
first range of nasal lengths is different from the fourth range of
nasal lengths.
65. The mask seal of claim 64, wherein the first range of nasal
widths does not overlap with the fourth range of nasal widths, and
the first range of nasal lengths does not overlap with the fourth
range of nasal lengths.
66. The mask seal of claim 64, wherein the first range of nasal
widths is less than the fourth range of nasal widths, and the first
range of nasal lengths is less than the fourth range of nasal
lengths.
67. The mask seal of claim 64, wherein the second range of nasal
widths is different from the third range of nasal widths, and the
second range of nasal lengths is different from the third range of
nasal lengths.
68. The mask seal of claim 67, wherein the second range of nasal
widths does not overlap with the third range of nasal widths, and
the second range of nasal lengths does not overlap with the third
range of nasal lengths.
69. The mask seal of claim 67, wherein the second range of nasal
widths is less than the third range of nasal widths, and the second
range of nasal lengths is greater than the fourth range of nasal
lengths.
70. A mask seal for an interface for use in providing positive
pressure respiratory therapy, the mask seal comprising: a seal body
configured to be fully positioned lower than a bridge of a nose of
a face of a user and to provide an exposed bridge of the nose of
the user, the seal body comprising a nasal region comprising a
nasal opening, the seal body comprising a first paddle on a first
side of the nasal region and a second paddle on a second side of
the nasal region, the first paddle configured to contact one side
of the nose of the user and the second paddle configured to contact
the other side of the nose of the user; the seal being configured
to be provided in a range of sizes comprising: a first size
configured to fit users having a first range of nasal widths and a
first range of nasal lengths; a second size configured to fit users
having a second range of nasal widths and a second range of nasal
lengths; a third size configured to fit users having a third range
of nasal widths and a third range of nasal lengths; a fourth size
configured to fit users having a fourth range of nasal widths and a
fourth range of nasal lengths; the first range of nasal lengths and
the third range of nasal lengths are similar and the second range
of nasal lengths and the fourth range of nasal lengths are similar,
the first range of nasal lengths and the second range of nasal
lengths are different.
71. The mask seal of claim 70, wherein the first range of nasal
lengths does not overlap with the second range of nasal
lengths.
72. The mask seal of claim 70, wherein the first range of nasal
widths is different from the fourth range of nasal widths, and the
first range of nasal lengths is different from the fourth range of
nasal lengths.
73. The mask seal of claim 72, wherein the first range of nasal
widths does not overlap with the fourth range of nasal widths, and
the first range of nasal lengths does not overlap with the fourth
range of nasal lengths.
74. The mask seal of claim 72, wherein the first range of nasal
widths is less than the fourth range of nasal widths, and the first
range of nasal lengths is less than the fourth range of nasal
lengths.
75. The mask seal of claim 72, wherein the second range of nasal
widths is different from the third range of nasal widths, and the
second range of nasal lengths is different from the third range of
nasal lengths.
76. The mask seal of claim 75, wherein the second range of nasal
widths does not overlap with the third range of nasal widths, and
the second range of nasal lengths does not overlap with the third
range of nasal lengths.
77. The mask seal of claim 75, wherein the second range of nasal
widths is less than the third range of nasal widths, and the second
range of nasal lengths is greater than the fourth range of nasal
lengths.
Description
INCORPORATION BY REFERENCE TO ANY PRIORITY APPLICATIONS
[0001] Any and all applications for which a foreign or domestic
priority claim is identified in connection with the present
application are hereby incorporated by reference herein and made a
part of the present disclosure.
BACKGROUND
Field
[0002] The present disclosure relates to interface assemblies for
respiratory therapy. In particular, the present disclosure relates
to under-nose interface assemblies that do not cover the bridge of
the user's nose.
Description of Related Art
[0003] In patients suffering from obstructive sleep apnea (OSA),
muscles that normally keep the upper airway open relax during
slumber to the extent that the airway is constrained or completely
closed off, a phenomenon often manifesting itself in the form of
snoring. When this occurs for a period of time, the patient's brain
typically recognizes the threat of hypoxia and partially wakes the
patient in order to open the airway so that normal breathing may
resume. The patient may be unaware of these waking episodes, which
may occur as many as several hundred times per session of sleep.
This partial awakening may significantly reduce the quality of the
patient's sleep, over time potentially leading to a variety of
symptoms, including excessive daytime sleepiness, chronic fatigue,
elevated heart rate, elevated blood pressure, weight gain,
headaches, irritability, depression and anxiety.
[0004] Obstructive sleep apnea is commonly treated with the
application of positive airway pressure (PAP) therapy. PAP therapy
involves delivering a flow of gas to a patient at a therapeutic
pressure above atmospheric pressure that will reduce the frequency
and/or duration of apneas, hypopneas, and/or flow limitations. The
therapy is often implemented by using a positive airway pressure
device to deliver a pressurized stream of air through a conduit to
a patient through a patient interface or mask positioned on the
face of the patient.
[0005] One common type of patient interface assembly used with PAP
therapy or other respiratory therapies involving the administration
of gas includes a seal that contacts the bridge of the nose of a
user of the interface assembly. The bride of the nose is sensitive
to pressure applied by the seal of the interface assembly. More
recently, interface assemblies have become available that do not
contact the bridge of the nose. Such interface assemblies can be
referred to as "under-nose" interface assemblies. A need exists to
provide improved under-nose interface assemblies with improved
comfort and/or sealing performance, or to provide the public with a
useful choice.
SUMMARY
[0006] The disclosed under-nose masks are full face masks that seal
below and around the nares of the user as opposed to full face
masks that go over the nose bridge. Typically, over-the-nose full
face masks sizing is determined by the length of the users face
from the Nasion to the Menton/Sublabial. An aspect of the present
disclosure involves the realization by the present inventors that
under-nose full face mask sizing is significantly different than
over-the-nose full face masks at least because the under-nose full
face masks seal around the underside and nares of a user's nose.
There is a large variation between nose shapes and sizes as well as
variations in ethnicities ranging from short, long, wide, narrow,
upward and downward facing as well as variations in nostril
shapes/sizes. The combinations of all these variations make for a
difficult task with regards to sizing. In addition to the
variations described above, there are also many other facial
dimensions to consider, such as face length, mouth width, head
shape, among others.
[0007] The systems, methods and devices described herein have
innovative aspects, no single one of which is indispensable or
solely responsible for their desirable attributes. Without limiting
the scope of the claims, some of the advantageous features will now
be summarized.
[0008] In some configurations, a seal for an interface for use in
providing positive pressure respiratory therapy includes a seal
body configured to be fully positioned lower than a bridge of a
nose of a face of a user and to provide an exposed bridge of the
nose of the user. The mask seal includes a nasal region comprising
a nasal opening. The mask seal includes a first paddle on a first
side of the nasal region and a second paddle on a second side of
the nasal region. The first paddle is configured to contact one
side of the nose of the user and the second paddle is configured to
contact the other side of the nose of the user. The nasal opening
has one or more of the following: a nasal opening maximum linear
distance between 5-10 mm, 6-8 mm or about 7.36 mm; a nasal
opening-oral opening spacing linear distance between 10-15 mm,
11-13 mm or about 12.7 mm; a nasal opening length between 5-10 mm,
6-9 mm or about 7.2 mm; and a nasal opening width between 15-25 mm,
18-22 mm or about 19.7 mm.
[0009] In some configurations, a seal for an interface for use in
providing positive pressure respiratory therapy includes a seal
body configured to be fully positioned lower than a bridge of a
nose of a face of a user and to provide an exposed bridge of the
nose of the user. The mask seal includes a nasal region comprising
a nasal opening. The mask seal includes a first paddle on a first
side of the nasal region and a second paddle on a second side of
the nasal region. The first paddle is configured to contact one
side of the nose of the user and the second paddle is configured to
contact the other side of the nose of the user. The nasal opening
has one or more of the following: a nasal opening maximum linear
distance between 5-10 mm, 6-8 mm or about 7.85 mm; a nasal
opening-oral opening spacing linear distance between 10-15 mm,
11-13 mm or about 12.2 mm; a nasal opening length between 5-10 mm,
6-9 mm or about 7.1 mm; and a nasal opening width between 18-28 mm,
20-26 mm or about 23.75 mm.
[0010] In some configurations, a seal for an interface for use in
providing positive pressure respiratory therapy includes a seal
body configured to be fully positioned lower than a bridge of a
nose of a face of a user and to provide an exposed bridge of the
nose of the user. The mask seal includes a nasal region comprising
a nasal opening. The mask seal includes a first paddle on a first
side of the nasal region and a second paddle on a second side of
the nasal region. The first paddle is configured to contact one
side of the nose of the user and the second paddle is configured to
contact the other side of the nose of the user. The nasal opening
has one or more of the following: a nasal opening maximum linear
distance between 3-7 mm, 4-6 mm or about 4.77 mm; a nasal
opening-oral opening spacing linear distance between 9-14 mm, 10-13
mm or about 11.5 mm; a nasal opening length between 2-7 mm, 3-6 mm
or about 3.85 mm; and a nasal opening width between 18-28 mm, 20-25
mm or about 22.3 mm.
[0011] In some configurations, a seal for an interface for use in
providing positive pressure respiratory therapy includes a seal
body configured to be fully positioned lower than a bridge of a
nose of a face of a user and to provide an exposed bridge of the
nose of the user.
[0012] The mask seal includes a nasal region comprising a nasal
opening. The mask seal includes a first paddle on a first side of
the nasal region and a second paddle on a second side of the nasal
region. The first paddle is configured to contact one side of the
nose of the user and the second paddle is configured to contact the
other side of the nose of the user. The nasal opening has one or
more of the following: a nasal opening maximum linear distance
between 2-6 mm, 3-5 mm or about 3.7 mm; a nasal opening-oral
opening spacing linear distance between 7-12 mm, 8-11 mm or about
9.5 mm; a nasal opening length between 0.5-3 mm, 1-2 mm or about
1.6 mm; and a nasal opening width between 25-45 mm, 30-40 mm or
about 32.9 mm.
[0013] In some configurations, the nasal opening has a height in a
vertical plane when the seal is oriented vertically between 6-12
mm, 7-10 mm or about 8.63 mm.
[0014] In some configurations, the seal includes outwardly
projecting portions on each side of the nasal region.
[0015] In some configurations, an interface includes a mask
assembly comprising any one of the seals described above. The
interface further includes a frame removably coupled to the mask
assembly.
[0016] In some configurations, the interface further includes a
pair of covers that are supported relative to the mask assembly
such that each of the covers is positioned adjacent a portion of a
respective one of the first and second paddles. The covers limit
expansion of at least the portion of the first and second
paddles.
[0017] In some configurations, the covers are supported by the
frame. In some configurations, the covers are unitarily formed with
the frame.
[0018] In some configurations, the covers are positioned adjacent
only a portion of the paddles leaving a portion of the paddles
exposed. In some configurations, a rearward portion of the paddles
are left exposed by the covers.
[0019] In some configurations, the paddles cover a substantial
entirety of a height of an adjacent portion of the paddles.
[0020] In some configurations, the paddles define a space
therebetween, which exposes a portion of an upper portion of the
mask seal.
[0021] In some configurations, the covers are formed as part of the
mask shell and extend upward along the mask seal adjacent the
paddles.
[0022] In some configurations, each of the paddles includes a
support in the form of a suspension member, which assists in
maintaining a desired shape of the paddles.
[0023] In some configurations, the suspension members include
elongate, thickened areas of the mask seal that extend toward the
frame from a patient side of the mask assembly. In some
configurations, the suspension members are thicker than other
portions of the mask seal in the paddles and the nasal region.
[0024] In some configurations, each of the suspension members is
aligned with a respective one of the covers and is configured to
transfer load from the seal to the covers via the suspension
member.
[0025] In some configurations, the suspension members are connected
to one another.
[0026] In some configurations, an interface system includes a frame
that interchangeably supports at least two mask assemblies, each
having a different one of the seals of paragraphs
[0008]-[0011].
[0027] In some configurations, the interface system includes all
four of the seals of paragraphs [0008]-[0011].
[0028] In some configurations, any one of the seals or interfaces
includes any single one or combination of the features of described
above.
[0029] In some configurations, an interface system is provided for
providing positive pressure respiratory therapy to users, the
system includes a mask frame; and a first seal and a second seal
that are interchangeably mountable to the mask frame, the first
seal having a first size and a second seal having a second size
different than the first size. The first seal is configured to fit
users having substantially the same nasal length and a smaller
nasal width than users fitted by the second seal.
[0030] In some configurations, the interface system includes a
third seal that is interchangeably mountable to the mask frame, the
third seal having a third size that is different than the first and
second sizes. The third seal is configured to fit users having
substantially the same nasal width and a smaller nasal length than
users fitted by the first seal.
[0031] In some configurations, the interface system includes a
fourth seal that is interchangeably mountable to the mask frame,
the fourth seal having a fourth size that is different than the
first, second and third sizes. The fourth seal is configured to fit
users having substantially the same nasal width and a smaller nasal
length than users fitted by the second seal.
[0032] In some configurations, an interface system is provided for
providing positive pressure respiratory therapy to users, the
system includes a mask frame; and a first seal and a second seal
that are interchangeably mountable to the mask frame, the first
seal configured to fit a first range of nasal widths and a first
range of nasal lengths, the second seal configured to fit a second
range of nasal widths and a second range of nasal lengths.
[0033] In some configurations, the first and second ranges of nasal
lengths are substantially equal.
[0034] In some configurations, the first and second ranges of nasal
lengths overlap.
[0035] In some configurations, the interface system includes a
third seal that is interchangeably mountable to the mask frame, the
third seal configured to fit a third range of nasal widths and a
third range of nasal lengths.
[0036] In some configurations, the first and third ranges of nasal
widths are substantially equal.
[0037] In some configurations, the first and third ranges of nasal
widths overlap.
[0038] In some configurations, the second and third ranges of nasal
widths overlap.
[0039] In some configurations, the first and third ranges of nasal
lengths overlap.
[0040] In some configurations, the second and third ranges of nasal
lengths overlap.
[0041] In some configurations, the interface system includes a
fourth seal that is interchangeably mountable to the mask frame,
the fourth seal configured to fit a fourth range of nasal widths
and a fourth range of nasal lengths.
[0042] In some configurations, the second and fourth ranges of
nasal widths are substantially equal.
[0043] In some configurations, the second and fourth ranges of
nasal widths overlap.
[0044] In some configurations, the second and fourth ranges of
nasal lengths overlap.
[0045] In some configurations, the first and fourth ranges of nasal
widths overlap.
[0046] In some configurations, the first and fourth ranges of nasal
lengths overlap.
[0047] In some configurations, the third and fourth ranges of nasal
lengths are substantially equal.
[0048] In some configurations, the third and fourth ranges of nasal
widths overlap.
[0049] In some configurations, the third and third ranges of nasal
lengths overlap.
[0050] In some configurations, a method for sizing seals that
provide positive pressure respiratory therapy is provided. The
method includes collecting data from a sample user population, the
data including at least a first facial measurement and second
facial measurement for each user; plotting the first and second
facial measurements on a scatter plot, the scatter plot having a
first axis corresponding to the first facial measurement and a
second axis corresponding to the second facial measurement; and
dividing the scatter plot into regions such that each region
corresponds to a discrete seal size that is configured to fit users
having facial measurements within a range along the first axis and
a range along the second axis.
[0051] In some configurations, dividing the scatter plot into
regions includes overlapping portions of two or more regions,
wherein users having facial measurements within overlapping regions
can be fitted to more than one seal size.
[0052] In some configurations, dividing the scatter plot into
regions includes aligning at least one of edges and endpoints of
two or more regions.
[0053] In some configurations, the first facial measurement
includes a nasal width measurement and the second facial
measurement includes a nasal breadth measurement.
[0054] In some configurations, the first facial measurement
includes a nasal width measurement and the second facial
measurement includes a mouth width measurement.
[0055] In some configurations, the first facial measurement
includes a nasal width measurement and the second facial
measurement includes a subnasal-to-sublabial length
measurement.
[0056] In some configurations, a PAP kit is provided and includes
an interface with a first seal having a first size and a second
seal having a second size that is different than the first size.
The first seal is configured to fit users within a first range of a
first facial measurement and a first range of a second facial
measurement, the second seal is configured to fit users within a
second range of the first facial measurement and a second range of
the second facial measurement.
[0057] In some configurations, a difference between average values
of the first and second ranges of the first facial measurement is
greater than a difference between average values of the first and
second ranges of the second facial measurement.
[0058] In some configurations, a difference between average values
of the first and second ranges of the first facial measurement is
less than a difference between average values of the first and
second ranges of the second facial measurement.
[0059] In some configurations, average values of each the first and
second ranges of the first facial measurement are offset by a
greater distance than average values of each the first and second
ranges of the second facial measurement.
[0060] In some configurations, average values of each the first and
second ranges of the first facial measurement are offset by a
smaller distance than average values of each the first and second
ranges of the second facial measurement.
[0061] In some configurations, the first and second ranges of the
first facial measurement overlap.
[0062] In some configurations, the first and second ranges of the
second facial measurement overlap.
[0063] In some configurations, the first facial measurement
includes a nasal width measurement and the second facial
measurement includes a nasal breadth measurement.
[0064] In some configurations, the first facial measurement
includes a nasal width measurement and the second facial
measurement includes a mouth width measurement.
[0065] In some configurations, the first facial measurement
includes a nasal width measurement and the second facial
measurement includes a subnasal-to-sublabial length
measurement.
BRIEF DESCRIPTION OF THE DRAWINGS
[0066] Throughout the drawings, reference numbers can be reused to
indicate general correspondence between reference elements. The
drawings are provided to illustrate example embodiments described
herein and are not intended to limit the scope of the
disclosure.
[0067] FIG. 1 is a front perspective view of an interface assembly
having certain features, aspects and advantages of the present
disclosure positioned on the head of a user.
[0068] FIG. 2 is a top view of the interface assembly of FIG. 1
positioned on the head of a user.
[0069] FIG. 3 is rear perspective view of an interface portion of
the interface assembly of FIG. 1 separated from the user and
without headgear.
[0070] FIG. 4 is a front perspective view of a mask assembly of the
interface assembly of FIG. 1.
[0071] FIG. 5 is a rear view of the mask assembly of FIG. 4
illustrating a thickened region of a mask seal of the mask
assembly.
[0072] FIG. 6 is a side view of the mask assembly of FIG. 4
illustrating the thickened region of the mask seal.
[0073] FIG. 7 is a top view of the mask seal of the mask assembly
of FIG. 4 illustrating regions of different thickness of the mask
seal.
[0074] FIG. 8 is a rear view of the mask seal of FIG. 7
illustrating regions of different thickness of the mask seal.
[0075] FIG. 9 is a side view of the mask seal of FIG. 7
illustrating regions of different thickness of the mask seal.
[0076] FIG. 10 is a front view of the mask seal of FIG. 7
illustrating regions of different thickness of the mask seal.
[0077] FIG. 11 is a rear view of the mask seal of FIG. 7.
[0078] FIG. 12 is a sectional view of the mask seal taken along
line 12-12 of FIG. 11.
[0079] FIG. 13 is a sectional view of the mask seal taken along
line 13-13 of FIG. 11.
[0080] FIG. 14 is a sectional view of the mask seal taken along
line 14-14 of FIG. 11.
[0081] FIG. 15 is a sectional view of the mask seal taken along
line 15-15 of FIG. 11.
[0082] FIG. 16 is a sectional view of the mask seal taken along
line 16-16 of FIG. 11.
[0083] FIG. 17 is a sectional view of the mask seal taken along
line 17-17 of FIG. 11.
[0084] FIG. 18 is a sectional view of the mask seal taken along
line 18-18 of FIG. 11.
[0085] FIG. 19 is a sectional view of the mask seal taken along
line 19-19 of FIG. 11.
[0086] FIG. 20 is a sectional view of the mask seal taken along
line 20-20 of FIG. 11.
[0087] FIG. 21 is a sectional view of the mask seal taken along
line 21-21 of FIG. 11.
[0088] FIG. 22 is a top view of the interface portion of the
interface assembly of FIG. 1 illustrating an example placement of
support structures of the mask seal.
[0089] FIG. 23 is a rear view of the interface portion of FIG.
22.
[0090] FIG. 24 is a rear view of a portion of the interface portion
of FIG. 22.
[0091] FIG. 25 is an illustration of three different nose
types.
[0092] FIG. 26 illustrates a displacement profile of a patient's
nose.
[0093] FIG. 27 is a side view of an under-nose seal in place on a
patient and illustrating a nasal displacement plane.
[0094] FIG. 28 is a rear view of the under-nose seal of FIG. 27
illustrating the nasal displacement plane projected as curves onto
the seal.
[0095] FIG. 29 is a view of the underside of the patient's nose
illustrating nasal breadth and nasal length dimension along with a
nasal perimeter length estimated curve.
[0096] FIG. 30 is a view of the underside of the patient's nose
similar to FIG. 29 illustrating a right triangle utilized to
estimate the nasal perimeter length.
[0097] FIG. 31 is a chart illustrating a method for estimating
nasal perimeter length using nasal dimensions in combination with a
scaling factor.
[0098] FIG. 32 is a rear view of the under-nose seal of FIG. 28
illustrating a maximum lateral dimension of the nasal region of the
seal.
[0099] FIG. 33 is a scatter plot of nose breadth versus nasal
perimeter length illustrating a theoretical population that will
fit the seal of FIGS. 28 and 32.
[0100] FIG. 34 is the scatter plot of FIG. 33 with linear
regressions for certain segments of the data.
[0101] FIG. 35 is the scatter plot of FIGS. 33 and 34 with proposed
sizing models represented.
[0102] FIG. 36 is a scatter plot of nose breadth versus nasal
perimeter length illustrating theoretical populations for two
different mask sizes.
[0103] FIG. 37 is an exploded view of a relatively larger mask size
and corresponding frame.
[0104] FIG. 38 is a rear view of the mask and frame of FIG. 37.
[0105] FIG. 39 is a scatter plot of nasal breadth versus nasal
length with four proposed sizing models represented.
[0106] FIG. 40A illustrates a top-down view of a first size of an
under-nose seal.
[0107] FIG. 40B illustrates a side cross-sectional view of the
first size of the under-nose seal in FIG. 40A.
[0108] FIG. 40C illustrates a rear view of the first size of the
under-nose seal in FIG. 40A.
[0109] FIG. 41A illustrates a top-down view of a second size of an
under-nose seal.
[0110] FIG. 41B illustrates a side cross-sectional view of the
second size of the under-nose seal in FIG. 41A.
[0111] FIG. 41C illustrates a rear view of the second size of the
under-nose seal in FIG. 41A.
[0112] FIG. 42A illustrates a top-down view of a third size of an
under-nose seal.
[0113] FIG. 42B illustrates a side cross-sectional view of the
third size of the under-nose seal in FIG. 42A.
[0114] FIG. 42C illustrates a rear view of the third size of the
under-nose seal in FIG. 42A.
[0115] FIG. 43A illustrates a top-down view of a fourth size of an
under-nose seal.
[0116] FIG. 43B illustrates a side cross-sectional view of the
fourth size of the under-nose seal in FIG. 43A.
[0117] FIG. 43C illustrates a rear view of the fourth size of the
under-nose seal in FIG. 43A.
[0118] FIG. 44 is a scatter plot of nose breadth versus nasal
length illustrating a theoretical ethnically diverse population
with proposed sizing models represented that will fit an under-nose
seal.
[0119] FIG. 45 is a scatter plot of nose breadth versus nasal
length illustrating a theoretical ethnically diverse population
with proposed sizing models represented that will fit an over-nose
seal.
[0120] FIG. 46 is a scatter plot of nose breadth versus nasal
length illustrating a theoretical ethnically diverse population
with alternative proposed sizing models represented that will fit
an over-nose seal.
[0121] FIG. 47 is a scatter plot of nose breadth versus nasal
length illustrating a theoretical ethnically diverse population
with alternative proposed sizing models represented that will fit
an over-nose seal.
[0122] FIG. 48 is a scatter plot of nose breadth versus Subnasal to
Sublabial length illustrating a theoretical ethnically diverse
population with proposed sizing models represented that will fit an
over-nose seal.
[0123] FIG. 49 is a scatter plot of nose breadth versus mouth width
illustrating a theoretical ethnically diverse population with
proposed sizing models represented that will fit an over-nose
seal.
DETAILED DESCRIPTION
[0124] Embodiments of systems, components and methods of assembly
and manufacture will now be described with reference to the
accompanying figures, wherein like numerals refer to like or
similar elements throughout. Although several embodiments, examples
and illustrations are disclosed below, it will be understood by
those of ordinary skill in the art that the inventions described
herein extends beyond the specifically disclosed embodiments,
examples and illustrations, and can include other uses of the
inventions and obvious modifications and equivalents thereof. The
terminology used in the description presented herein is not
intended to be interpreted in any limited or restrictive manner
simply because it is being used in conjunction with a detailed
description of certain specific embodiments of the inventions. In
addition, embodiments of the inventions can comprise several novel
features and no single feature is solely responsible for its
desirable attributes or is essential to practicing the inventions
herein described.
[0125] Certain terminology may be used in the following description
for the purpose of reference only, and thus are not intended to be
limiting. For example, terms such as "above" and "below" refer to
directions in the drawings to which reference is made.
[0126] Terms such as "front," "back," "left," "right," "rear," and
"side" describe the orientation and/or location of portions of the
components or elements within a consistent but arbitrary frame of
reference which is made clear by reference to the text and the
associated drawings describing the components or elements under
discussion. Moreover, terms such as "first," "second," "third," and
so on may be used to describe separate components. Such terminology
may include the words specifically mentioned above, derivatives
thereof, and words of similar import.
[0127] One or more of the embodiments described herein address
issues with stability that can be experienced with face masks. In
particular, at least some of the embodiments are directed toward
patient interfaces, such as face masks, which seal below the bridge
of the user's nose and around the nares. However, the embodiments
disclosed herein could also be adapted to other full face masks
(e.g., those that partially cover and/or seal on the bridge of the
user's nose). Most full face masks have a forehead rest, headgear
mount or `T` piece which extends upwardly from the remainder of the
mask and rests on the forehead and adds significant stability
compared to those full face masks without `T` pieces. Instability
can cause nose tip or septum pressure and/or seal leaks due to
forces applied by the breathing tube of the breathing circuit that
is attached to the mask or other patient interface. This force is
often referred to as "hose pull" and can originate from the
breathing circuit or tube or from movement of the user.
[0128] The embodiments illustrated herein have no T piece and seal
below the bridge of the nose, around the nares and under the nose.
In at least some configurations, the interface or mask also seals
around the user's mouth. The reduced foot print of an under-nose
combined nasal and oral mask on the user's face compared to
conventional full face masks that contact the nasal bridge and/or
have a T piece can have an adverse effect on stability. Similarly,
the reduced foot print of an under-nose nasal mask on the user's
face compared to conventional nasal mask that contact the nasal
bridge and/or have a T piece can also have an adverse effect on
stability. Sealing around and below the nose in this manner can
present challenges due to the variation seen in facial geometries
from user to user. In some circumstances, even small movements of
the seal can induce loss of contact of the seal with the user,
which can result in leaks.
1. Mask Assembly
[0129] FIGS. 1-24 illustrate a mask assembly 2100 both in position
on a face of a user and separated from the face of the user. The
illustrated mask assembly 2100 is a combined nasal and oral mask,
which can be referred to herein as a nasal-oral mask. The
illustrated mask assembly 2100 is designed to seal under the nose
of the user, along a portion of the face extending lateral to the
nose, as well as around the mouth of the user. The mask assembly
2100 advantageously does not require contact with the bridge of the
nose of the user. In the illustrated configuration, the mask
assembly 2100 does not extend over the bridge of the nose of the
user. More particularly, the illustrated mask assembly 2100 does
not contact the bridge of the nose of the user. Even more
particularly, the illustrated assembly 2100 does not contact a
forward facing portion of the bridge of the nose of the user. In
some configurations, the assembly 2100 does not contact the face in
a region vertically higher than a generally horizontal plane
extending along the lower edges of the eyes of the user. The mask
assembly 2100 may or may not extend over the tip of the nose of the
user. Thus, in some configurations, the mask assembly 2100 covers
the tip of the nose. In some configurations, the seal of the mask
assembly 2100 covers the tip of the nose. In some configurations,
the illustrated mask assembly 2100 preferably does not enshroud the
tip of the nose of the user. In some configurations or with some
facial geometries, the tip of the nose of the user extends over the
adjoining portion of the mask assembly 2100.
[0130] As illustrated, the mask assembly 2100 preferably is adapted
to extend around and seal over the wing or alar of the nose, which
flares out to form a rounded eminence around the nostril. The
illustrated mask assembly 2100 is adapted to seal around the
surfaces that define the opening to the nostril, which may include
a portion or entirety of the fleshy external end of the nasal
septum, sometimes called the columella. In some configurations, the
mask assembly 2100 is adapted to extend upwardly to seal along at
least a portion of the left and right dorsal side walls of the nose
of the user. In some configurations, the mask assembly 2100 is
adapted to extend upwardly along at least a portion of the left and
right dorsal side walls without extending upwardly to the region of
the bridge of the nose of the user. In some configurations, a
primary sealing surface of the mask assembly 2100 contacts the
underside of the nose of the user, possibly along with the upper
lip and/or a transition region between the underside of the nose
and the upper lip. A secondary sealing surface of the mask can
contact the side surfaces of the nose of the user, possibly along
with the cheeks at a location near the nose. Such primary and
secondary sealing surfaces may not make contact with the face of
all users; however, such an arrangement can provide a suitable seal
with a relatively large range of facial geometries. The mask
assembly 2100 preferably also seals around at least a portion of
the user's mouth. The mask assembly 2100 may or may not be adapted
to seal between the mouth and nose of the user.
[0131] As illustrated, the mask assembly 2100 comprises a mask
support, such as a base, housing or shell 2102 (see, for example,
FIG. 5), for example. A mask seal 2104 can be attached to the mask
shell 2102 such that the mask shell 2102 provides some amount of
support for the mask seal 2104. However, in other configurations,
the mask seal 2104 may not include a support and may be adapted for
direct assembly to another component of the associated interface
assembly. In some configurations, the mask support 2102 can be
substantially smaller than the illustrated shell. For example, the
mask support 2102 can define an opening that allows the mask
assembly 2100 to be attached to another component, such as a frame
and/or conduit connector (e.g., elbow) and the mask support 2102
can be localized to the opening without providing direct support to
other portions of the mask assembly 2100.
[0132] The mask assembly 2100 can be engaged with or otherwise
supported by a frame 2178 that allows for connection to a head
strap or headgear 2180 of any suitable arrangement. The mask
assembly 2100 can be keyed to the frame 2178 to permit assembly in
only the correct orientation. In some configurations, the head
strap or headgear 2180 could be coupled directly to the mask
assembly 2100 and the frame 2178 can be utilized for other purposes
or omitted. A conduit connector 2106 can also be attached to the
mask shell 2102, frame 2178 or otherwise supported relative to and
adapted to communicate with an interior space of the mask assembly
2100. Together, the frame 2178 and the headgear 2180 can support
the mask assembly 2100 in place on the user's face. Collectively,
the mask assembly 2100, frame 2178 and headgear 2180 can be
referred to as an interface assembly. The mask assembly 2100 or the
mask assembly 2100 in combination with the frame 2178 can be
referred to as an interface.
[0133] The illustrated conduit connector 2106 can be connected to
the frame 2178 and/or shell 2102 in any suitable manner, including
but not limited to any manner discussed elsewhere within this
application. For example, but without limitation, the connector
2106 can be connected to the shell 2102 such that the connector
2106 can swivel, pivot or rotate relative to the shell 2102 about a
single axis or about multiple axes. In some configurations, the
connector 2106 can define a portion of a ball joint with the frame
2178 and/or mask shell 2102, for example but without limitation,
defining the other portion. The ball joint can have any suitable
configuration. The connector 2106 facilitates connection to a gases
conduit, such as a supply conduit or the like for the supply of
pressurized breathing gases to an interior of the mask assembly
2100. Any suitable connector 2106 can be used, which in some cases
can include a swivel or rotational coupling that permits relative
rotation between the connector 2106 and the gases conduit.
[0134] In the illustrated configuration, the connector 2106
comprises an elbow, such as a polycarbonate elbow for example but
without limitation, that contains a vent. In the illustrated
arrangement, the vent comprises bias flow holes 2110. However, the
vent could comprise other geometries or arrangements, such as slots
or a controlled leak between components, for example. The vent
could also comprise diffuser materials to reduce noise and/or
draft. The bias flow holes 2110 are a collection of orifices that
are configured to exhaust air and flush CO2 to reduce the
likelihood of rebreathing expired carbon dioxide by the user. While
the bias flow holes 2110 are shown exclusively on the connector
2106, in some configurations, the bias flow holes 2110 can be
provided on the mask shell 2102, on the mask seal 2104 or on any
combination of the connector 2106, the shell 2102 and the seal 2104
or on any other component of the interface assembly or associated
breathing circuit. The bias flow holes 2110 can have any suitable
cross-section and can be cylindrical, hour-glass shaped, tapered in
either direction, fully or partially tapered, fully or partially
cylindrical, contoured to vary in cross-section or the like.
[0135] The mask shell 2102 provides a support structure of sorts
for the mask assembly 2100 in general and for the mask seal 2104
more specifically. The mask shell 2102 can be formed from any
suitable material. In some configurations, the mask shell 2102 is
formed from a fairly rigid material. In some configurations, the
mask shell 2102 is formed from a plastic material, such as a
polycarbonate material. In some configurations, the mask assembly
2100 can comprises a mask seal that includes a mask seal clip that
is separate from but attachable to a mask shell. In such a
configuration, the mask seal clip would connect the mask seal 2104
to the mask shell 2102. In such configurations, the mask seal and
mask seal clip can be formed separately and secured together or the
mask seal and the mask seal clip can be integrated into a single
component. In some configurations, the mask seal can be overmolded
onto the mask seal clip and, in some configurations, the mask seal
2104 can be overmolded directly onto the mask shell 2102, which can
comprise chemical and/or mechanical overmolding, for example.
[0136] In some configurations, the mask shell 2102 comprises a
substantial portion of a forward wall of the mask assembly 2100.
Such an arrangement provides an advantageous level of support to
the mask seal 2104. For example, the mask shell 2102 comprises a
substantial portion of an oral portion of the forward wall of the
mask assembly 2100. In some configurations, the mask shell 2102 is
generally limited to the oral portion of the mask assembly 2100 and
does not extend into the nasal portion of the mask assembly 2100,
at least to any significant extent. Such an arrangement can provide
support to the mask seal 2104, while advantageously permitting
movement or deformation of the nasal portion of the mask seal 2104.
In the illustrated configuration, the mask shell 2102 sweeps
rearward from a central portion 2112 toward opposing side portions
2116. The central portion 2112 contains an aperture 2114 for
receiving the connector 2106. The mask shell 2102 can have a
generally or substantially constant height throughout the central
portion 2112 and opposing side portions 2116. In other
arrangements, the mask shell 2102 can vary in height, such as by
forming a shape that generally mimics the frontal shape of the mask
seal 2104. The height of the mask shell 2102 can be substantially
equal to a height of the oral portion of the mask seal 2104. A
width of the mask shell 2102 can comprise a significant portion of
the overall width of the oral portion of the mask assembly 2100,
such as at least about three-quarters of the overall width of the
oral portion of the mask assembly 2100. Such an arrangement of the
mask shell 2102 can provide reinforcement to the central and
lateral portions of the mask seal 2104. In some configurations, the
mask shell 2102 could be minimal, such as an annular support ring
or frame, for example.
[0137] The mask seal 2104 is designed to seal against the face of
the user. The mask seal 2104 preferably is formed of a soft
material, such as silicone, for example but without limitation. In
some configurations, at least portions of the mask seal 2104 can be
textured to improve comfort to the user. For example, in some
configurations, at least portions of the mold used to form the
illustrated mask seal 2104 can be bead blasted to provide a surface
texture in at least the regions of the mask seal 2104 that will
contact the skin of the user. Other techniques for texturing one or
more surface of the mask seal 2104 can be used. In some
configurations, it may be desirable to avoid surface texturing and
provide at least the face-contacting surfaces of the mask seal 2104
with a smooth surface texture, which may increase grip of the mask
seal 2104 on the user's face and improve sealing
characteristics.
[0138] As described above, the illustrated mask seal 2104 comprises
a nasal-oral mask seal and, therefore, comprises at least one oral
opening 2122 and at least one nasal opening 2124. In some
configurations, the mask seal 2104 can comprise a combined
oral-nasal opening. In some configurations, the mask seal 2104 can
comprise more than one nasal opening 2124. In some configurations,
the mask seal 2104 can comprise nasal openings 2124 defined within
superstructures, such as pillows, prongs or the like. In some
configurations, the nasal opening 2124 can be defined by a nasal
cushion or insert, which can be overmolded or otherwise secured to
a base structure of the mask seal 2104. An example of such an
arrangement is disclosed in Applicant's publication no. WO
2014/062070, the entirety of which is incorporated by reference
herein.
[0139] The at least one oral opening 2122 and the at least one
nasal opening 2124 preferably communicate with a single chamber
2125 that is defined within the mask assembly 2100. The chamber
2125 of the illustrated mask assembly 2100 is at least partially
defined by the mask shell 2102 and the mask seal 2104. The at least
one oral opening 2122 is substantially opposed to the aperture 2114
that receives or communicates with the connector 2106. The at least
one nasal opening 2124 can be vertically above the at least one
oral opening 2122. The at least one nasal opening 2124 can be
positioned between the aperture 2114 for the connector 2106 and the
at least one oral opening 2122 in a fore-aft direction of the mask
assembly 2100. The at least one nasal opening can have an axis that
is inclined relative to vertical and that, in some arrangements,
can generally extend through the aperture 2114 for the connector
2106.
[0140] The mask seal 2104 preferably comprises a pair of paddles
2126 that extend upward above an upper surface 2130 (FIG. 8) of a
central portion of the mask seal 2104. The upper surface 2130 can
define a line that lies along a central surface of the nasal
surface of the mask seal 2104 in a fore-aft direction. Such a line
extends generally along the nasal septum in a direction away from
the user's face. The paddles 2126 are configured to extend upward
alongside, and in some configurations above, the nares. The paddles
2126 can contact the edges of the nares and/or sides of the nose.
The paddles 2126 or portions of the mask seal 2104 between the
paddles 2126 may or may not cover the tip of the user's nose. As
described herein, preferably the mask seal 2104 does not contact
the bridge of the user's nose.
[0141] In some configurations, the paddles 2126 each comprise an
air pocket that is in direct fluid communication with the air path
through the mask assembly 2100 from the connector 2106 to the at
least one nasal opening 2124 and the at least one oral opening
2122. The paddles 2126 can be configured to expand in volume in
response to elevated pressure within the mask seal 2104 and/or flex
inwardly to accommodate various facial and nasal geometries and
assist in creating a sealed contact with the user's face. Expansion
of the paddles 2126 can assist in sealing against the face of the
user, especially along the varying contours on and around the
user's nose. Inward flexing of the paddles 2126 allows the central
portion (e.g., upper surface 2130) to move downward with less
restriction or less stretching of the material of the mask seal
2104 so that the mask seal 2104 can better conform to various nasal
geometries.
[0142] The height of the paddles 2126 above the upper surface 2130
can be selected to provide a desired balance between stability of
the mask seal 2104 on the user's face (e.g., vertical stability)
and being able to accommodate a range of nasal geometries or
reducing visual disruption by the paddles 2126. In general, higher
paddles 2126 tend to provide additional vertical stability of the
mask assembly 2100, while lower paddles 2126 tend to provide a
better fit of a wider range of users and result in less visual
disruption. In some configurations, the paddle height 2126 is
between about 10 mm and about 30 mm or between about 15 mm and
about 25 mm. In some configurations, the paddle height 2126 is
between about 15 mm and about 22 mm or between about 18 mm and
about 20 mm, including an value or sub-range within the
above-described ranges. In some configurations, the paddle height
is about 18.5 mm.
[0143] The illustrated mask seal 2104 of the mask assembly 2100
comprises a fairly complex range and configuration of thicknesses,
as shown in FIGS. 7-21. The thicknesses are varied to take
advantage of or provide different characteristics in different
regions of the illustrated mask seal 2104. For example, the
thicknesses in the various regions can be selected to address a
desired characteristic for that region and/or the mask seal 2104 as
a whole. Such characteristics can include, for example, allowing
the mask seal 2104 to conform to the facial geometry of the user to
enhance sealing properties or comfort, supporting the shape of the
mask seal without significant internal gas pressure to facilitate
fitment and/or in response to internal gas pressure and/or external
pressure (e.g., caused by headgear forces) or providing strength or
durability.
[0144] FIGS. 7-10 illustrate views of the mask seal 2104 with
regions of different thickness outlined. In general, the outer
surface of the mask seal 2104 defines a relatively smoothly shaped
or curved surface without abrupt changes in direction. The
different thicknesses are created by changes in wall thickness that
are apparent on or created by changes in shape of an interior
surface of the mask seal 2104, as illustrated by the sectional
views of FIGS. 12-21. FIGS. 7-10 illustrate differences in
thicknesses of the mask seal 2104, such as those in the
above-described regions or portions. In some configurations,
support structures 2163 for the paddles are thicker than a nasal
region 2168 and an upper front portion 2150. In some
configurations, a relatively abrupt transition in thickness occurs
between the nasal region 2168 and upper front portion 2150 and the
supports 2163. In contrast, transitions in thickness between outer
peripheral portions 2162, the supports 2163 and an upper rear
portion 2156 are more gradual. In addition, in at least some
configurations, transitions in thickness between the outer
peripheral portions 2162, the upper rear portion 2156 and the oral
region 2166 are relatively gradual. The various portions of the
mask seal 2104 are described further below.
[0145] To reduce the incidence of wrinkling of at least some of the
face contacting regions of the mask seal 2104 during use, it has
been found that the outer peripheral portions 2162 of the mask seal
2104, which are generally adjacent to some or all of the face
contacting portions of the mask seal 2104, provide desirable
performance when the outer peripheral portions 2162 are fairly
rigid or relatively rigid compared to adjacent portions or other
portions of the mask seal 2104. In the illustrated arrangement, the
outer peripheral portions 2162 extend along the generally
vertically extending portions on the rear of the mask seal 2104 and
wrap slightly inward at a bottom of the rear of the mask seal 2104.
In addition, the outer peripheral portions 2162 wrap from a rear
facing side of the mask seal around to at least a portion of a
laterally facing side of the mask seal 2104.
[0146] In the illustrated arrangement, the outer peripheral
portions 2162 are located on each lateral side of the oral opening
2122. In some configurations, the outer peripheral portions 2162
extend along an entire height of the oral opening 2122. Upper ends
of the outer peripheral portions 2162 can extend at least to about
an upper end of the oral opening 2122. Lower ends of the outer
peripheral portions 2162 can extend below a lower end of the oral
opening 2122. As described above, in some configurations the outer
peripheral portions 2162 wrap inwardly below the oral opening 2122
such that portions of the outer peripheral portions 2162 are
positioned vertically below portions of the oral opening 2122.
[0147] The relatively increased thickness of the outer peripheral
portions 2162 can assist in resisting or preventing collapse of the
mask seal 2104 in the absence of significant internal gas pressure
to facilitate fitment and provide feedback to the user, such as in
response to applied forces (e.g., headgear forces). The outer
peripheral portions 2162 can help maintain the curved shape of the
lateral sides of the mask seal 2104 and/or help maintain a
separation between a rear wall of the mask seal 2104 (defining a
face contacting surface) and a front wall of the mask seal 2104 at
least in response to forces experience during normal use. In some
configurations, the thickness of a portion or an entirety of the
outer peripheral portions can be between about 1.0 mm and about 2.0
mm. In the illustrated configuration, a portion or an entirety of
the outer peripheral portions 2162 preferably have a thickness of
about 1.5 mm. The thicknesses of the outer peripheral portions 2162
can be consistent or varied within a boundary of the outer
peripheral portion 2162.
[0148] The illustrated mask seal 2104 also comprises the oral
region 2166. The oral region 2166 in the illustrated mask seal 2104
extends along at least a portion of the oral opening 2122.
Preferably, the oral region 2166 extends along at least a lower
portion of the oral opening 2122. The oral region 2166 can extend
along at least the sides and the bottom of the oral opening 2122.
In the illustrated arrangement, the oral region 2166 circumscribes
the oral opening 2122. The oral region 2166 can comprise a
relatively thin band that surrounds some or all of the oral opening
2122, such as the sides and upper portion in the illustrated
arrangement. The illustrated oral region 2166 comprises a lower
thickened band portion that extends downwardly away from the oral
opening 2122 and can extend toward or to a lower edge of the mask
seal 2104. The lower thickened portion of the oral region 2166 can
contact the area below the lower lip of the user and can allow the
mask seal 2104 to accommodate a range of chin geometries. The lower
thickened portion of the oral region 2166 can define a curved edge
opposite the edge adjacent the oral opening 2122.
[0149] The oral region 2166 provides a softer region that contacts
the face. Accordingly, the oral region 2166 can have a thinner
cross-section than the outer peripheral portions 2162 and/or other
regions of the mask seal 2104. In some configurations, the oral
region 2166 has the smallest thickness or is among the smallest
thicknesses of the mask seal 2104. For example, a portion or an
entirety of the oral region 2166 can have a thickness of between
about 0.2 mm and about 0.5 mm. In the illustrated configuration,
the thickness of a portion or an entirety the oral region 2166 is
about 0.3 mm. The thickness of the oral region 2166 can be
consistent or variable within the oral region 2166.
[0150] The mask seal 2104 can also include the nasal region 2168
located near the nasal opening 2124. The nasal region 2168 can
surround a portion or an entirety of the nasal opening 2124. In the
illustrated arrangement, the nasal region 2168 surrounds an
entirety of the nasal opening 2124 and has side portions that are
located at least partially on the paddles 2126. The nasal region
2168 can wrap from the rear of the mask seal 2104 toward the front.
In the illustrated arrangement, the nasal region 2168 is radially
spaced from the nasal opening 2124. Given a desire to gently seal
against the lower portion of the nose, the nasal region 2168 in the
illustrated configuration has a fairly small thickness. In some
configurations, the nasal region 2168 has the smallest thickness of
the mask seal 2104 or is equal to or among the smallest thickness
of the mask seal 2104. For example, a portion or an entirety the
nasal region 2168 can have a thickness that is equal to or slightly
larger than the thickness of the oral region 2166. In some
configurations, the thickness of a portion or an entirety the nasal
region 2168 is between about 0.3 mm and about 0.5 mm or 0.6 mm. In
some configurations, the thickness of a portion or an entirety the
nasal region 2168 is about 0.3 mm. The thickness of the nasal
region 2168 can be consistent or variable within the nasal region
2168. A portion or an entirety of the nasal region 2168 could have
a thickness that is less than about 0.3 mm. For example, the
thickness could be as low as about 0.15 mm. However, it has been
determined that lower thicknesses can result in or increase the
likelihood of creasing of the nasal region 2168 for some facial
geometries and/or under some operational gas pressures. Keeping the
thickness above about 0.3 mm in a substantial portion or an
entirety of the nasal region 2168 can reduce the incidence of
creasing over a substantial range of operational pressures, which
may comprise an entire range of normal operating pressures.
[0151] The mask seal 2104 can also include the upper front portion
2150 that is positioned above the mask shell 2102. In the
illustrated arrangement, the upper front portion 2150 extends in a
lateral direction across the front of the mask seal 2104 between
the mask shell 2102 and the nasal region 2168 in a vertical
direction. The upper front portion 2150 can extend any suitable
distance across the mask seal 2104, such as along a substantial
entirety of a width of the mask seal 2104 or the width of the mask
seal 2104 at least at the location of the upper front portion 2150.
An upper edge of the upper front portion 2150 can be curved and the
sides of the upper front portion 2150 can have a greater height
than a central portion of the upper front portion 2150 such that
the central portion defines a valley of the upper front portion
2150. In some configurations, the sides of the upper front portion
2150 can extend into the portion of the mask seal 2104 defining the
paddles 2126. In some configurations, a lower edge of the upper
front portion 2150 can be generally linear and extend in a
horizontal or lateral direction. The lower edge of the upper front
portion 2150 can have generally the same shape as an upper edge of
the mask shell 2102.
[0152] The upper front portion 2150 preferably has a fairly small
thickness to promote flexibility of the upper front portion 2150.
That is, preferably, the upper front portion 2150 is able to flex,
fold or otherwise deform in response to pressure acting on other
portions of the mask seal 2104, such as downward pressure on the
nasal region 2168, for example. Such an arrangement can assist the
mask seal 2104 in conforming to different facial geometries of
possible users. In addition, such an arrangement can facilitate
expansion or ballooning of the paddles 2126, at least in the
absence of external restraints on such expansion. In some
configurations, the upper front portion 2150 has the smallest
thickness of the mask seal 2104 or is equal to or among the
smallest thickness of the mask seal 2104. For example, a portion or
an entirety the upper front portion 2150 can have a thickness that
is equal to the thickness of one or both of the oral region 2166
and the nasal region 2168. In some configurations, the thickness of
a portion or an entirety the upper front portion 2150 is between
about 0.2 mm and about 0.5 mm. In some configurations, the
thickness of a portion or an entirety the upper front portion 2150
is about 0.3 mm. The thickness of the upper front portion 2150 can
be constant or variable within the upper front portion 2150. The
thickness of the upper front portion 2150 could be smaller or
larger depending on the desired properties of the mask seal 2104,
such as compliance of the nasal region 2168.
[0153] The mask seal 2104 can also comprise the support structures
or supports 2163 for the paddles 2126, which can be in the form of
suspension members or springs that provide mechanical rigidity and
structure to hold the shape of the paddles 2126 when the mask seal
2104 is worn by a user. The supports 2163 can comprise thickened
regions of the seal material. The supports 2163 preferably are
sized, shaped and/or otherwise configured to transfer force from a
rearward or user-contacting surface of the paddles 2126 toward or
to a forward surface of the paddles 2126. In some configurations,
the interface can include a support portion or cover for the
paddles 2126 and the supports 2163 can transfer force from the
rearward surface of the paddles 2126 to the forward surface or
other portion of the paddles 2126 or mask seal 2104 that contacts
or faces the support portion or cover. In some configurations, the
supports 2163 can transfer force from the rearward surface of the
paddles 2126 toward or to another support portion of the mask seal
2104 (e.g., the mask shell 2102) or interface. The supports 2163
can resist or prevent collapse of the paddles 2126 or other related
or adjacent portions of the mask seal 2104 to facilitate fitment
and provide feedback to the user, such as in response to applied
forces (e.g., headgear forces). In some configurations, the
supports 2163 can resist or prevent collapse of the paddles 2126 or
other related or adjacent portions of the mask seal 2104 in the
absence of significant internal gas pressure. The supports 2163 can
help maintain the shape of the paddles 2126 of the mask seal 2104
and/or help maintain a separation between a rear wall of the mask
seal 2104 (defining a face contacting surface) and a front wall of
the mask seal 2104 at least in response to forces experience during
normal use. In addition, the supports 2163 can provide support to
the nasal region or nasal seal portion 2168. In particular, the
supports 2163 can provide structure to and inhibit or prevent
creasing, wrinkling or collapsing of the nasal seal portion 2168
and/or the upper front portion 2150. As described above, the nasal
seal portion 2168 and/or the upper front portion 2150 preferably
are relatively thin to permit these portions of the mask seal 2104
to conform to the user's nose. The relatively thin nasal seal
portion 2168 and/or the upper front portion 2150 can expand and
seal around the user's nose. The supports 2163 provide rigid
portions or elements of the seal 2104 adjacent or near the
relatively thin nasal seal portion 2168 and/or the upper front
portion 2150 to inhibit or prevent collapse when a user engages his
or her nose into the mask assembly 2100. The upper rear portion
2156 can assist in preventing collapse of the nasal seal portion
2168 and/or the upper front portion 2150.
[0154] In some configurations, the supports 2163 help to reduce the
likelihood of wrinkling or creasing of the face contacting portions
of the paddles 2126 during use while allowing the laterally inner
portions to be as thin as desired within practical limitations,
such as those described above. The supports 2163 can assist in
inhibiting or preventing collapse of the paddles 2126 or
maintaining a desired shape of the paddles 2126. For example, the
supports 2163 can assist in maintaining a desired fore-aft shape of
the paddles 2126 and/or a lateral or side-to-side shape of the
paddles 2126. The level of support provided can vary in different
directions. In some configurations, the supports 2163 could be
formed as separate portions or separate components from the seal
material and could be the same or a different material. Such
separate supports 2163 could be coupled to the paddles 2126 or
other portion of the mask seal 2104 if desired. The supports 2163
disclosed herein can be particularly useful in under-nose type mask
assemblies, including both nasal masks and combined nasal-oral
masks. However, the supports 2163 can also be utilized in other
types of mask assemblies or interfaces, including those that cover,
contact or seal against the bridge of the user's nose and/or
include a T piece or other type of forehead support, for example
and without limitation. The supports 2163 can be utilized, or
modified for use, in any locations of an interface in which support
against collapsing and/or support against overexpansion may be
desirable. Such locations can be at or near the portion of the seal
that contacts or extends alongside the user's nose or can be at
other locations.
[0155] In the illustrated arrangement, at least a portion of the
supports 2163 extend generally in a fore-aft direction along the
paddles 2126. In particular, the supports 2163 can extend along the
upper edge of the paddles 2126 or the region or ridge that joins
the laterally outer surface portion and the laterally inner surface
portion along the upper edges of the paddles 2126. The supports
2163 can extend along a portion of the sides of the nasal region
2168. The supports 2163 can comprise a generally thin, elongate
shape. Viewed from above, the supports 2163 can comprise a
generally triangular shape with a base of the triangle positioned
rearwardly of the top or point of the triangle. Other shapes are
possible to achieve a desired level of support or for other design
considerations, such as the desired shape(s) of adjacent or nearby
structures. The supports 2163 can have additional portions to
provide other levels of support or to provide support in other
directions. For example, the supports 2163 could connect to one
another, such as along one or both of the forward or rearward sides
of the nasal opening 2124. In some configurations, the supports
2163 could extend completely through the paddles 2126, such as to
the mask shell 2102, for example.
[0156] The supports 2163 can have a different thickness than other
portions of the paddles 2126 and can have a greater thickness than
other portions of the paddles 2126. In some configurations, the
supports 2163 can have the largest thickness or among the largest
thicknesses of the mask seal 2104. In some configurations, a
portion or an entirety of the supports 2163 can have a thickness of
between about 1.5 mm and about 3.5 mm. In the illustrated
configuration, a portion or an entirety of the supports 2163 can
have a thickness of about 2.5 mm. The thickness of the supports
2163 can be constant or variable.
[0157] With reference to FIGS. 19-21, portions of the mask seal
2104 incorporating the paddles 2126 are shown in cross section. As
illustrated therein, and described above, the paddles 2126 can have
a relatively thin cross section, at least in those sections other
than the supports 2163. In some configurations, the paddles 2126
can be formed at least in part with a cross section sufficiently
thin to allow controlled inflation or controlled expansion at
typical treatment pressures (e.g., about 3 to about 25 cmH2O). In
some configurations, such a thickness might be equal to or lower
than about 0.5 or 0.6 mm, equal to or lower than 0.3 mm or equal to
or lower than about 0.2 mm depending upon the particular location
within the paddle 2126 and/or the material used. In some
configurations, the portion of the paddles 2126 that will contact
the face comprises a generally constant cross-sectional thickness.
As illustrated in FIGS. 16-21, the thickened portions can continue
to extend below the supports 2163 of the paddles 2126, such as into
a region of the mask seal 2104 below the paddles 2126.
[0158] In some configurations, the mask seal 2104 comprises an
upper rear portion 2156 that extends in a lateral direction along a
rear surface of the mask seal 2104 between the nasal region 2168
and the oral region 2166. In the illustrated arrangement, the upper
rear portion 2156 is an elongated strip region of the mask seal
2104 defined by an internal rib. In some configurations, the ends
of the upper rear portion 2156 can have a greater height or
vertical dimension than a center portion of the upper rear portion
2156. In some configurations, the upper and lower edges of the
upper rear portion 2156 can generally follow the curvature or shape
of the corresponding portions of the nasal region 2168 and oral
region 2166, respectively. The upper rear portion 2156 can extend
along a substantial width of the mask seal 2104. For example, the
upper rear portion 2156 can have a length that is at least one-half
of a width of the mask seal 2104 at the location of the upper rear
portion 2156 and/or a length that is longer than a width of the
nasal opening 2124. In some configurations, the upper rear portion
2156 can have a length that is greater than a width of the oral
opening 2122. The upper rear portion 2156 can be centered in a
lateral direction of the mask seal 2104. In some configurations,
the upper rear portion 2156 extends into or is connected with the
outer peripheral portions 2162. Such an arrangement assists in
maintaining the open shape of the rear surface of the mask seal
2104 to facilitate fitment to the user's face.
[0159] The upper rear portion 2156 can provide support to the mask
seal 2104 between the nasal region 2168 and the oral region 2166,
such as to limit, inhibit or prevent collapse of the mask seal 2104
in a lateral direction between the outer peripheral portions 2162
and/or in a vertical direction between the nasal region 2168 and
the oral region 2166 or to maintain a desired separation of those
portions 2162 or regions 2168, 2166. The upper rear portion 2156
can have a thickness that is sufficient to provide such support and
that can be greater than one or both of the nasal region 2168 and
the oral region 2166. The upper rear portion 2156 can have a
thickness that is smaller than one or both of the outer peripheral
portions 2162 and the supports 2163. In some configurations, the
upper rear portion 2156 has a thickness that is greater than both
the nasal region 2168 and the oral region 2166 and smaller than
both the outer peripheral portions 2162 and the supports 2163. In
some configurations, a portion or an entirety of the upper rear
portion 2156 can have a thickness that is between about 0.5 mm and
about 1.5 mm. In the illustrated configuration, a portion or an
entirety the upper rear portion 2156 has a thickness of about 1.0
mm. The thickness could be smaller or larger depending on the
desired characteristics of the support provided by the upper rear
portion 2156.
[0160] The mask seal 2104 can have other portions outside of those
described above. For example, the mask seal 2104 can have one or
more transition portions 2170 in the area(s) between the
above-described portions. The transition portion 2170 can be
referred to in the singular herein; however, the transition portion
2170 is not necessarily a single contiguous region, but may
comprise several discrete or non-contiguous regions. The transition
portion 2170 can define a transitioning thickness between any one
or more (including all) of the upper front portion 2150, the upper
rear portion 2156, the supports 2163, the outer peripheral portions
2162, the oral region 2166 and the nasal region 2168. The
transition portion 2170 can define a thickness that extends away
from or is positioned or transitions between two regions in any
suitable manner, such as a gradual or abrupt transition, for
example. A transition in thickness can occur within the transition
portion 2170 or along an edge of the transition portion 2170, for
example. In the illustrated configuration, the outer peripheral
portions 2162 are generally surrounded by the transitional portion
2170. The outer peripheral portions 2162 can make a relatively
smooth transition into the supports 2163 such that the outer
peripheral portions 2162, transition portion 2170 and supports 2163
comprise a generally continuous thickened region, as illustrated in
FIG. 5. The oral region 2166 can be separated from the outer
peripheral portions 2162 and/or the upper rear portion 2156 by a
transition portion 2170. Other configurations also are
possible.
[0161] The illustrated mask seal 2104 includes a connecting region
2160 that generally encircles an opening that receives the mask
shell 2102 and can be configured to join the mask seal 2104 to the
mask shell 2102. In the illustrated arrangement, the connecting
region 2160 is illustrated as forming a portion of or being
contained with the transition portion 2170. In some configurations,
the connecting region 2160 could have a specific construction
providing desirable characteristics, such as permitting connection
to the mask shell 2102 and/or providing durability. In some
configurations, the connecting region 2160 can be the thickest
portion of the seal member 2104. In some configurations, the
thickness of the connecting region can be between about 2 mm and
about 5 mm or between about 3 mm and about 3.5 mm. In other
configurations, the thickness could be smaller or larger depending
on the desired properties, such as type of connection with the mask
shell 2102 (e.g., overmolded connection). The thickness can vary
within the connecting region 2160, such as in the case of the mask
seal 2104 mechanically-engaging the mask shell 2102. For example,
the periphery of the mask shell 2102 can include recesses or
openings that are engaged or passed through by material of the mask
seal 2104.
[0162] The illustrated mask seal 2104 also includes a nasal opening
support 2158 that surrounds a portion or an entirety of the nasal
opening 2124. The nasal opening support 2158 can assist in
maintaining a desired shape of the nasal opening 2124 and/or limit,
inhibit or prevent collapse of the nasal opening 2124. In the
illustrated arrangement, the nasal opening support 2158 is
illustrated as forming a portion of the transition portion 2170.
The nasal opening support 2158 can have a variable or a relatively
constant thickness. The nasal opening support 2158 can have a
thickness that is larger than the thickness of the nasal region
2168. In some configurations, the nasal opening support 2158 can
have a thickness of between about 1.0 mm to about 2.5 mm, for
example and without limitation. As described above, the nasal
opening support 2158 can be an insert or cushion that is coupled to
the material of other portions of the mask seal 2104, such as a
substantial entirety of the mask seal 2104.
[0163] With additional reference to FIGS. 1-3 and 22-24, as
described above, the mask seal 2104 and mask shell 2102 (mask
assembly 2100) can form a portion of an interface assembly, which
can include the frame 2178 and the headgear 2180. The frame 2178
can be removably connected to the mask assembly 2100 by any
suitable arrangement. For example, the frame 2178 can be coupled at
or around the aperture 2114 of the mask shell 2102, such as by a
snap fit, friction fit or clip connection, among other
possibilities. The mask assembly 2100 can be keyed to the frame
2178 to permit assembly in only the correct orientation. The
conduit connector 2106 can also be attached to the mask shell 2102,
frame 2178 or otherwise supported relative to and adapted to
communicate with an interior space of the mask assembly 2100.
[0164] In the illustrated arrangement, the frame 2178 comprises one
or more portions that are positioned adjacent or contact a portion
of the paddles 2126. In some configurations, the frame 2178
comprises a pair of support portions or covers 2182, each of which
is associated with one of the paddles 2126 of the mask seal 2104.
References to covers 2182 herein can refer to other suitable
support structures for the paddles 2126 unless indicated otherwise.
The covers 2182 can provide a desirable level of support to the
paddles 2126, such as to inhibit or prevent over-expansion and/or
outward bulging of the paddles 2126, which can occur in response to
gas pressure within the mask seal 2104, for example.
[0165] As described above, portions of the mask seal 2104 can be
textured for purposes of user comfort. Texturing of a surface of
the paddles 2126 that contacts or faces the paddle covers 2182 can
allow or facilitate relative movement (e.g., sliding movement) of
the paddles 2126 and the paddle covers 2182. However, if it is
desired for the paddle covers 2182 to grip the paddles 2126 to
inhibit movement therebetween, the surface of the paddles 2126
facing or contacting the paddle covers 2182 can be non-textured or
have a smooth surface finish. Any suitable method for texturing the
mask seal 2104 can be utilized, such as bead blasting of the mold
for the mask seal 2104.
[0166] Although the illustrated covers 2182 are integrated with the
frame 2178, in other configurations, the covers 2182 could be
otherwise supported in a desired position relative to the paddles
2126 by any component of the interface assembly. For example, the
covers 2182 could be a separate component(s) coupled to the frame
2178 or other portion of the interface assembly, including the mask
shell 2102. Such separate covers 2182 can be glued, clipped, welded
or otherwise attached to an underlying support structure. In some
configurations, the covers 2182 could be integrated with the mask
shell 2102. In some configurations, the covers 2182 could be a
portion of the mask seal 2104, such as portion having greater
thickness or stiffness relative to the paddles 2126. In the
illustrated arrangement, the covers 2182 are unitarily formed with
the frame 2178. Similarly, the covers 2182 could be unitarily
formed with the mask shell 2102, mask seal 2104 or other portion of
the interface assembly.
[0167] In some configurations, the covers 2182 are positioned next
to or against a laterally outer surface of the paddles 2126, with
or without a gap, or a varying gap, therebetween, prior to the
paddles 2126 being pressurized. With such an arrangement, the
covers 2182 can contact the paddles 2126 to limit, inhibit or
prevent an undesirable amount of expansion or outward movement of
the paddles 2126, such as due to gas pressure within the mask seal
2104. While some expansion of the paddles 2126 may be desirable to,
for instance, control creasing of the paddles 2126 or upper portion
of the mask seal 2104 (e.g., the nasal region 2168), too much
expansion may be uncomfortable to the user, such as by causing the
nasal region to press against the underside of the user's nose,
and/or compromise the seal between the face of the user and the
paddles 2126 or other portions of the mask seal 2104. Thus,
characteristics (e.g., size, shape or location) of the covers 2182
can be selected to provide a desired level of support and/or allow
a desired level of expansion of the paddles 2126 or other portions
of the mask seal 2104. Preferably, the paddles 2126 or at least
upper portions of the paddles 2126 are not coupled to the covers
2182 such that the paddles 2126 can flex or pivot inwardly away
from the covers 2182. In some configurations, laterally outer
surfaces of the paddles 2126 can move inwardly away from the covers
2182. Such an arrangement can advantageously assist in maintaining
contact between the laterally inner surfaces of the paddles 2126
and the user's face when downward pressure is applied to the nasal
region 2168.
[0168] In some configurations, the covers 2182 cover only a portion
of the laterally-outward or forward-facing surfaces of the paddles
2126. With such an arrangement, the covers 2182 can provide a
desired balance between user comfort and providing support to the
paddles 2126. For example, the covers 2182 can cover only a portion
of the paddles 2126 in a fore-aft direction. In the illustrated
arrangement, the covers 2182 support a forward portion of the
paddles 2126 and leave at least a rearward portion of the paddles
2126 exposed. In the illustrated arrangement, the covers 2182 cover
substantially an entire height of the paddles 2126. In some
configurations, the covers 2182 could cover a substantial entirety
or an entirety of the length of the paddles 2126, while leaving
some of the height of the paddles 2126 exposed. In some
configurations, the covers 2182 could cover an intermediate portion
of the paddles 2126, leaving forward and rearward portions exposed.
In some configurations, the covers 2182 cover or overlap at least
about one-third or one-half of a laterally-outward or
forward-facing surface of the paddles 2126. In some configurations,
the covers 2182 cover or overlap at least about two-thirds or
three-quarters of a laterally-outward or forward-facing surface of
the paddles 2126.
[0169] In some configurations, the paddle covers 2182 can be
configured to provide localized support to a portion of the paddles
2126. For example, the paddle covers 2182 can be in the form of
elongate finger structures. Such finger structures can provide
support to a relatively small portion of the paddles 2126. The
finger structures can originate at any desired location relative to
the paddles 2126, such as a forward end, a rearward end or an
intermediate portion of the paddles 2126. In some configurations,
the finger structures are curved, such as curving toward a rearward
direction or curving toward a forward direction. For example, the
finger structures can curve to follow a portion or an entirety of
an upper peripheral edge of the paddles 2126. Such finger
structures can be located at, or spaced from, the peripheral edge
of the paddles 2126. In some configurations, the finger structures
can be configured to overlap support structures of the paddles
2126, such as the supports 2163 described further below.
[0170] Preferably, a space or valley 2184 is defined between the
covers 2182. In the illustrated arrangement, the valley 2184
exposes a portion of the mask seal 2104, such as a forward portion
of the nasal region 2168, to allow a desired amount of inflation of
the mask seal 2104. In addition, such an arrangement can
accommodate the tip of a user's nose or can provide space to
accommodate a portion of the mask seal 2104 that is deflected by
the user's nose.
[0171] With reference to FIG. 22, the covers 2182 can cooperate
with features of the mask seal 2104 to provide desirable
performance characteristics. For example, the supports 2163 for the
paddles 2126 can be positioned relative to the covers 2182 such
that a load applied to the paddles 2126 by the user's face is
transferred to the covers 2182 by the supports 2163. Thus, the
supports 2163 can end at or shortly after the portion of the mask
seal 2104 that contacts or is positioned adjacent the covers 2182
and may not extend into the upper front portion 2150 or all the way
to the mask shell 2102. The supports 2163 can extend in a direction
generally from the rearward or user-contacting surface of the mask
seal 2104 toward its respective cover 2182. In some configurations,
each of the supports 2163 extends generally or substantially in a
longitudinal direction of the mask seal 2104. The supports 2163 can
extend generally parallel to one another or can be closer at a
forward end in comparison to a rearward end. In other words, the
supports 2163 can converge in a direction moving from the rearward
or user-contacting surface of the mask seal 2104 toward a front
portion of the mask seal 2104. However, in other configurations,
the supports 2163 can diverge from rear to front.
[0172] As described above, the supports 2163 can be in the form of
or function in a manner similar to suspension members or springs to
provide a resistance force in response to attempted compression or
collapse of the paddles 2126 in a fore-aft direction. The
thickness, shape, orientation and/or location of the supports 2163
inhibits or prevents collapse because the supports 2163 transmit
force into the covers 2182. Because the force is transferred into
the covers 2182, collapse of the regions of the mask seal 2104 near
or surrounding the supports 2163 (e.g., the nasal region 2168
and/or the upper front portion 2150) is inhibited or prevented.
Portions of the mask seal 2104 can deform or stretch, but
preferably collapse is inhibited or prevented. Collapse of the seal
can involve a loss of shape that causes leaks or other detrimental
performance of the mask seal 2104. In some case, collapse involves
contact of normally spaced-apart wall portions of the mask seal
2104 (e.g., contact between a relatively rearward wall portion and
a relatively forward wall portion). The supports 2163 can also
inhibit or prevent collapse of the valley of the mask seal 2104. In
other words, the supports 2163 can assist in maintaining the
paddles 2126 in a laterally-spaced or separated orientation.
[0173] In at least some configurations, the covers 2182 can also
provide support for the paddles 2126 in the absence of supports
2163. Moreover, although the covers 2182 (or other similar support
structures) are particularly useful for under-nose type nasal masks
or combined nasal-oral masks, the covers 2182 or similar structures
can be utilized in other types of interfaces, as well. For example,
the covers 2182 can be utilized in nasal or combined nasal-oral
mask assemblies or interfaces that cover, contact or seal against
the bridge of the user's nose and/or include a T piece or other
type of forehead support, for example and without limitation. The
covers 2182 can be utilized, or modified for use, in any locations
of an interface in which support against collapsing and/or support
against overexpansion may be desirable. Such locations can be at or
near the portion of the seal that contacts or extends alongside the
user's nose or can be at other locations. As noted above, the
covers 2182 can be utilized with or without corresponding supports
2163.
[0174] Possible locations of the supports 2163 relative to the
covers 2182 are illustrated in FIG. 22. In some configurations, the
supports 2163 extend generally between the covers 2182 and rearward
surfaces of the paddles 2126 that contact the user's face. Such
surfaces can coincide with sides of the nasal region 2168, for
example. Forward ends of the supports 2163 can be aligned in a
lateral direction with the covers 2182. In some configurations,
forward ends of the supports 2163 could join one another, such as
with a semi-circular joining portion, for example, and/or could
extend all the way or substantially all the way to the mask shell
2102. Such an arrangement could provide greater shape-holding
functionality and feedback. However, it has been determined that
the covers 2182 allow the supports 2163 to terminate earlier while
still providing a desirable amount of shape-holding and feedback. A
shape of the supports 2163 can be selected to be complementary with
or otherwise provide desired interaction with the covers 2182. Such
an arrangement allows at least portions of the nasal region 2168
(e.g., the nasal tip region), if not the entire nasal region 2168,
to be relatively thin to provide comfort to the user and/or provide
desirable sealing characteristics.
[0175] If desired, a structure or structures similar to the
supports 2163 (e.g., spring or suspension structures) could be
provided in the nose tip area (or other areas of the nasal region
2168) to help maintain a desired shape of the mask seal 2104. It is
contemplated that the provision of covers 2182 can permit such
supports to have a smaller thickness than would otherwise be
provided in the absence of the covers 2182 thereby increasing
compliance to improve user comfort and sealing characteristics.
[0176] With reference to FIGS. 23 and 24, rearward or
user-contacting surface views of the mask seal 2104 and a portion
of the nasal region 2168 are illustrated, respectively. It has been
determined that an inner portion of the nasal region 2168 can be a
region of the mask seal 2104 that can impact performance and there
are certain features or properties that have been discovered to
improve seal comfort, leak and overall performance. For example, a
width 2186 of the nasal region 2168 or width between the spring
structures or supports 2163 can influence seal comfort, leak and
overall performance. In some configurations, this width is in the
region of about 45 mm to about 50 mm, but could be smaller or
larger, such as for different size mask seals 2104.
[0177] With reference to FIG. 24, in some configurations, the outer
geometry profile of the mask seal 2104 from the spring structure or
supports 2163 to the inner portion of the nasal region 2168 is a
convex profile. Such an arrangement allows the paddles 2126 to
displace away when the user's nose is fitted against the nasal
region 2168 and provides a desirable sealing profile around the
user's nostrils.
[0178] In addition, as described above, a portion or an entirety of
the nasal region 2168 has a thickness of between about 0.3 mm and
about 0.5 mm or 0.6 mm, in some configurations. In some
configurations, at least the inner portion (excluding the nasal
opening support 2158) of the nasal region 2168 has a thickness of
at least about 0.3 mm to provide a desirable level of compliance
while also inhibiting creasing over a range of facial geometries
and/or operational pressures. In some configurations, the inner
region of the nasal portion 2168 has a constant thickness. However,
the thickness could be variable within the inner region of the
nasal portion 2168. In some configurations, the thickness of the
inner region of the nasal portion 2168 can vary from about 0.3 mm
to slightly thicker values. In some configurations, the thickness
of a portion or an entirety of the nasal region 2168 could be less
than about 0.3 mm, which could provide increased compliance.
However, such a thickness can result in creasing with some facial
geometries and/or at lower operational pressures.
2. Sizing
[0179] As described above, sizing of over-the-nose full face seals
that go over the nose bridge can be based on determining an overall
height of the seal, which can be selected to accommodate a nasion
to menton/sublabial measurement range of the desired population of
users. Such a sizing methodology can result in multiple seal sizes
(e.g., small, medium, large, extra-large) that differ in overall
height. Such seal sizes can also differ in width; however, the
differences in height are generally more significant than the
differences in width because the nasion to menton/sublabial
measurement variation is greater than the lip length variation,
which can be used to determine seal width measurements. Because the
end or tip of the nose is positioned within the breathing chamber
and is not contacted to a significant extent by the sealing
surface, a particular over-the-nose full face seal can accommodate
a wide variety of nasal widths and nasal lengths (of the underside
of the nose--e.g., subnasal to pronasal).
[0180] However, because the under-nose full face seals disclosed
herein seal against an underside of the nose and along the sides of
the nose, nasal width and nasal length variations, among other
variations related to the underside of the nose (e.g.,
upward-facing and downward-facing) have a larger impact on seal fit
and sizing in comparison to over-the-nose full face seal.
Accordingly, in some configurations, the sizing methodology
utilized to create different sizes of under-nose full face seals
utilizes information on nasal width and/or nasal length variations,
possibly along with other variations related to these
characteristics.
[0181] It has been determined that nasal shape and/or size
generally correlates with ethnicity. That is, general trends or
characteristics emerge among the nasal shapes and/or sizes of
different ethnicities. By way of example, three ethnicities are
illustrated in FIG. 25 and discussed herein: Caucasian, Asian, and
African. In general, Caucasians tend to have a taller triangular
shape to the underside of the nose, Africans tend to have a shorter
triangular shape to the underside of the nose and Asians tend to
have a triangular shape having a height in between those of
Caucasians and Africans. Nasal Index and Tip Index can be used to
compare different nose shapes. The Nasal Index is defined as the
ratio of the nasal width between the piriform crests and the length
of the nose. The Tip Index is defined as the ratio of the width of
the nose at the nostril apex and the width at the widest part of
the ala. Caucasian nose shapes generally have a Nasal Index of 0.61
or below and a Tip Index of between 0.60 and 0.75. African nose
shapes generally have a Nasal Index of 0.65 or above and a Tip
Index of 0.80 or above. Asian nose shapes generally have a Nasal
Index of between 0.61 and 0.65 and a Tip Index of between 0.70 and
0.80. These variations have been considered for the purposes of
sizing at least some of the under-nose seals disclosed herein.
[0182] Anthropometric data has been gathered by the Applicant for
both OSA and non-OSA sufferers in the form of 3D facial scanning.
Measurements have been taken from the facial scans and the data
compiled for use in the designing of OSA interfaces. Although the
sample sizes are small in terms of the global population, these
measurements have been used to help with statistical analysis and
sizing information and have been used in the sizing of at least
some of the under-nose seals disclosed herein. For example, the
data has been utilized to develop theories or tools for development
of the sizing of under-nose seals, including a Nasal Displacement
theory or tool and a Nasal Perimeter Length theory or tool. These
are describe in turn below.
[0183] a. Nasal Displacement
[0184] The Nasal Displacement theory or tool determines the overall
size nose the under-nose seal or mask can accommodate or is
intended to accommodate taking into account width and length and
can be used as a design tool to generate a range of mask sizes. It
should be mentioned that with the complex nature of the problem of
determining accurate nasal displacement values, a number of
assumptions have been made for the purposes of simplification and
practicality. Therefore, the theory or tool in at least some cases
is used as a general guide only. The under-nose seal designs
generated from this theory typically will then be verified on
actual users to determine the exact parameters within which the
seal can work at an acceptable level of sealing, comfort or other
relevant factors.
[0185] The nasal areas of the illustrated under-nose nasal seals or
masks have a surface that displaces when the mask is worn cupping
the nares of the user and providing a seal around the nose. The
displacement profile 2200 of a patient's nose is shown in FIG. 26.
The actual position of the displacement profile 2200 can vary as a
result of variations in nasal geometry; however, it is presently
contemplated that it will generally lie within a plane 2202 running
through the lowest section of the nose, which is generally the
largest cross sectional area and outer profile. FIG. 27 illustrates
an under-nose seal 2104 on the face of the patient of FIG. 26 with
the plane 2202 also illustrated. As a result, it can be determined
approximately where the plane 2202 will intersect the seal 2104 in
the nasal area. In general, the intersection between the plane 2202
and the seal 2014 will be the location of maximum displacement that
the seal 2104 will experience to accommodate the user's nose.
[0186] FIG. 28 illustrates a projection of the plane 2202 onto the
surface of the seal 2104, which results in a projected curve 2204.
The length of the curve 2204 can be measured (by, for example,
utilizing CAD software) and the result can be or approximate the
largest nasal profile the seal 2104 can accommodate in the nasal
area. In the illustrated arrangement, two planes 2202 were used to
account for variation in nasal shapes. An average of the lengths of
the resulting curves 2204 was calculated. For an example of an
under-nose seal 2104 as disclosed herein, this average length of
the two curves 2204 was calculated to be 83 mm. Thus, preferably,
such a seal 2104 is intended to accommodate a nasal displacement
profile 2200 that is less than or equal to about 83 mm.
[0187] b. Nasal Perimeter Length
[0188] Because of its complex shape, the actual nasal perimeter
length is a difficult measurement to attain directly from a user's
face. The length could be measured in CAD software but would very
time consuming for each individual scan. Therefore, in at least
some configurations, the Applicant has utilized anthropometric data
to determine or approximate this measurement. Again, a number of
assumptions have been made for the purposes of simplification and
practicality. Therefore, the theory or tool in at least some cases
is used as a general guide only.
[0189] FIG. 29 illustrates the `approximate` nasal perimeter length
2210 on a user's nose. This perimeter length 2210 approximates a
parabolic curve. In some configurations, nose breadth 2212 and nose
length (subnasal to pronasal) 2214 dimensions are used to calculate
this length 2210. With reference to FIG. 30, for simplicity, in
some configurations, the length 2210 of the parabolic curve is
approximated to a right triangle 2218. If desired, a scaling factor
can be applied to better approximate the actual curve length 2210.
The scaling factor can be determined by measuring the actual nasal
perimeter (for example, in CAD software) for a range of nasal
geometries and relating this back to nasal dimensions that are
easier to measure or determine, such as nose breadth 2212 and nose
length 2214.
[0190] In some configurations, the scaling factor utilized for
design purposes can be an average of the individual scaling factors
for all of the actual samples used. For example, FIG. 31
illustrates a chart having data associated with five different
individuals. The first (left) column is a scan identification
number. The second column is nose breadth 2212. The third column is
nose length 2214. The fourth column is the calculated length of the
hypotenuse C of the right triangle 2218 based on the nose breadth
2212 and nose length 2214 dimensions. The fifth column is the
hypotenuse C length times the scan-specific scaling factor of the
sixth column. The seventh column is the calculated size determined
by the hypotenuse C length times the average or overall scaling
factor 2220. The last (right or eighth) column of the table is the
fifth column (result using the scan-specific scaling factor)
divided by the calculated size using the average scaling factor
2220 of the seventh column. Thus, the last column illustrates that
all of the calculated nasal perimeter lengths 2210 are within 8-9%
of the actual measurements (for example, taken from CAD). For the
purpose of this analysis, this is considered a reasonable
measurement and methodology for determining the overall nose size
of each subject utilizing relatively easy-to-measure or
readily-available nasal geometry data. The scaling factor 2220 was
then used across an entire database of nasal geometry data to
categorise and sort the data for overall nose size. The resulting
values were then used to determine whether each subject will fit
the design parameters of each seal size. Again, preferably, this
theory or tool will be verified once actual seals are produced and
tested on a range of nose sizes.
[0191] c. Under-Nose Full Face Seal Size Analysis
[0192] The above analysis and design theory/tool was applied to a
particular under-nose full face seal 2104 already under
development, which is illustrated in FIGS. 28 and 32. The seal 2104
is the same as or substantially similar to the seals 2104 described
above or elsewhere herein. In the illustrated arrangement, the seal
2104 comprises support structures or supports 2163 within the
paddles 2126 or portions of the seal 2104 positioned alongside the
user's nose. The maximum nose breadth 2212 that the seal 2104 is
configured to accommodate is determined by the maximum lateral
distance 2222 between inner edges of the supports 2163. For the
illustrated seal 2104, the value of the maximum lateral distance
2222 is 46 mm. Using the maximum nasal perimeter length 2204 of 83
mm as discussed in connection to FIG. 28, the portion of an overall
population of users the seal 2104 will accommodate was determined
using a scatter plot (FIG. 33).
[0193] FIG. 33 illustrates a scatter plot of nose breadth 2212
versus nasal perimeter length 2210 for a user population. An upper
limit 2230 is set on the nose breadth 2212 based on the maximum
lateral distance 2222 of 46 mm as illustrated in FIG. 32.
[0194] Similarly, an upper limit 2232 is set on the nasal perimeter
length 2210 based on the length of the projected curve 2204 of 83
mm as illustrated in FIG. 28. An area 2234 below the upper limits
2230 and 2232 captures and represents a theoretical portion of the
illustrated user population that can be accommodated by the seal
2104.
[0195] In some configurations, both nasal breadth 2212 and nasal
length 2214 dimensions are utilized as design inputs into the
selection of the overall geometry of the seal 2104 and, in
particular, the nasal geometry of the seal 2104. FIG. 34
illustrates a scatter plot of nose breadth 2212 versus nose length
2214 that provides a representation of the variation seen in nasal
geometry. The scatter plot data has also been split into different
Ethnic groups and shows graphically how nasal geometry also varies
between ethnicities.
[0196] FIG. 35 illustrates the same scatter plot data of FIG. 34,
but includes a number of different possible sizing models. The
sizing models address both nasal dimensions--nasal breadth or width
2212 and nasal length 2214. Assuming that a maximum number of seal
sizes is set to 3, for example, the size ranges could be provided
as follows: S/M=small-medium, M/L=medium-large, and W=wide. The
coverage of the particular sizes is illustrated by the oval
perimeters in FIG. 35. The S/M size covers a portion of the user
population having smaller nasal breadths 2212 and nasal lengths
2214. The M/L size covers a portion of the user population having
larger nasal breadths 2212 and nasal lengths 2214. As illustrated,
in some configurations, there can be some overlap between the S/M
size and the M/L size such that a portion of the user population
could use either size.
[0197] The W size covers a portion of the user population having
larger nasal breadths 2212 than either of the S/M and M/L sizes.
However, in the illustrated configuration, there is overlap in the
coverage of nasal breadths 2212 between the W size and one or both
of the S/M and M/L sizes. The W size covers a portion of the user
population having nasal lengths 2214 smaller than at least the M/L
size. In the illustrated arrangement, the uppermost point of the W
size is located at a smaller nasal length 2214 value than the
uppermost point of the S/M size. In addition, the lowermost point
of the W size is located at a larger nasal length 2214 than the
lowermost point of the S/M size; however, in other arrangements or
based on other population data, the coverage of the W size could
accommodate smaller nasal lengths 2214 than the S/M size or equally
small nasal lengths 2214. In addition, as discussed below,
additional sizes could also be provided.
[0198] With reference to the analysis of the small-medium S/M seal
2104 of FIGS. 28 and 32, along with the possible sizing model
discussed above, the parameters for the medium-large M/L seal were
set. FIG. 36 illustrates possible sizing limits for the M/L size.
For example, an upper limit 2236 is set on the nose breadth 2212
based on, for example, a maximum lateral distance 2222 of 56 mm as
illustrated in FIG. 38. Similarly, an upper limit 2238 is set on
the nasal perimeter length 2210 based on the length of a projected
curve of 94 mm (not shown in FIG. 38, but similar to that
illustrated in FIG. 28). Lower limits 2150, 2152 can be set on the
nose breadth 2212 and nasal perimeter length 2210, respectively,
based on the same or other relevant dimensions of the seal
2104.
[0199] In some configurations, the M/L size seal 2104 utilizes the
same mask shell (seal housing) 2102 and mask frame 2178 as the S/M
size seal 2104 to achieve efficiencies in tooling, inventory,
validation and manufacturing cost, for example. In some
configurations, to accommodate the extra width of the upper or
nasal portion of the M/L seal 2104, the M/L seal 2104 is provided
with a protrusion or an outward step 2240 in the outer surface of
the upper portion or nasal portion (e.g., in the paddles 2126). In
the illustrated arrangement, the outward step 2240 protrudes
outwardly toward, to or past a portion 2242 of the frame 2178, as
shown in FIG. 37. The portion 2242 of the frame 2178 can be
partially or completely defined by a cover 2182 that is configured
to provide support to the paddle 2126. Such an arrangement can
allow the supports 2163 to be spaced further outwardly from one
another than would otherwise be possible without the outward step
2240. Preferably, however, the supports 2163 remain suitably
positioned to transfer force to the covers 2182 of the frame 2178.
However, in other arrangements, the outward step 2240 can be
provided at other locations, can have other shapes, can have other
lengths or can have other projecting distances.
[0200] FIG. 39 illustrates a scatter plot nose breadth 2212 versus
nose length 2214 similar to that of FIG. 35; however, the scatter
plot of FIG. 39 includes four sizes of seal 2104 configured to
cover a substantial portion or a substantial entirety of the
relevant user population. For example, the size ranges could be
provided as follows: S/M=small-medium, M/L=medium-large, short-wide
S/W and long-wide L/W=wide. The coverage of the particular sizes is
illustrated by the generally circular or oval perimeters in FIG.
39. Similar to the size ranges illustrated in FIG. 35, the S/M size
covers a portion of the user population having smaller nasal
breadths 2212 and nasal lengths 2214 and the M/L size covers a
portion of the user population having larger nasal breadths 2212
and nasal lengths 2214. As illustrated, in some configurations,
there can be some overlap between the S/M size and the M/L size
such that a portion of the user population could use either
size.
[0201] The S/W size covers a portion of the user population having
larger nasal breadths 2212 than at least a portion of the S/M size.
In the illustrated configuration, there is overlap in the coverage
of nasal breadths 2212 between the S/W size and one or both of the
S/M and M/L sizes. In particular, the coverage of nasal breadths
2212 of the S/W size is subsumed within the coverage of the
combination of the S/M and M/L sizes. The S/W size covers a portion
of the user population having nasal lengths 2214 smaller than at
least the M/L size. In the illustrated arrangement, the uppermost
point of the S/W size is located at or near a lowermost point of
the M/L size and at a smaller nasal length 2214 value than the
uppermost point of the S/M size. In addition, the lowermost point
of the S/W size is located at a smaller nasal length 2214 than the
lowermost point of the S/M size.
[0202] The L/W size covers a portion of the user population having
larger nasal breadths 2212 than at least a portion of the S/M size
and/or the S/W size. In some configurations, there can be overlap
in the coverage of nasal breadths 2212 between the S/W size and the
L/W size. The L/W size covers a portion of the user population
having nasal lengths 2214 similar to those of the S/W size. In some
configurations, the L/W size can cover somewhat larger nasal
lengths 2214 than those of the S/W size; however, preferably, the
nasal length 2214 coverage of the L/W size is for significantly
smaller nasal lengths 2214 than a majority of one or both of the
S/M and M/L sizes. In the illustrated arrangement, the uppermost
point of the L/W size is located above a lowermost point of each of
the S/M size and the M/L size. The relevant dimensions of the seals
2104 (e.g., projected curve 2204, maximum lateral distance 2222,
etc.) can be selected to achieve the desired coverages of the
different sizes illustrated in FIGS. 35 and 39, among others.
[0203] FIGS. 40A-43C illustrate exemplary versions of the S/M, M/L,
S/W and L/W size seals 2104. In particular, FIGS. 40A-43C
illustrate exemplary dimensions of the nasal opening 2124 and the
spacing of the nasal opening 2124 from the oral opening 2122 to
illustrate differences between the sizes in addition to those
discussed above. The seals 2104 have a maximum linear distance 2250
between forward and rearward edges of the nasal opening 2124 taken
along a centreline of the seal 2104. With the seal 2104 oriented
substantially vertical in a position as worn by a user with his or
her head in an upright position, the maximum linear distance 2250
can be defined by a line that extends upwardly in a rearward to
forward direction. The orientation of the line and the upper
surface of the nasal portion of the seal 2104 can generally
correspond to a typical angle of the underside of the nose for the
intended user population.
[0204] The seals 2104 also have a linear distance 2252 between an
upper edge of the oral opening 2122 and a rearward or lower edge of
the nasal opening 2124 taken along a centreline of the seal 2104.
The seals 2104 further can have a fore-aft distance 2254 between a
forward edge and a rearward edge of the nasal opening 2124 taken
along a centreline of the seal 2104. This distance 2254 can be
referred to as a length of the nasal opening 2124. However, the
length 2254 is not a maximum linear distance between the forward
and rearward edges, but the distance as measured in a top view or
in a horizontal plane when the seal 2104 is oriented vertically.
The seals 2104 can also have a maximum width 2156 of the nasal
opening 2124.
[0205] The nasal opening maximum linear distance 2250 of the S/M
size can be between 5-10 mm, 6-8 mm or can be about 7.36 mm. The
nasal opening maximum linear distance 2250 of the M/L size can be
between 5-10 mm, 6-8 mm or can be about 7.85 mm. The nasal opening
maximum linear distance 2250 of the S/W size can be between 3-7 mm,
4-6 mm or can be about 4.77 mm. The nasal opening maximum linear
distance 2250 of the L/W size can be between 2-6 mm, 3-5 mm or can
be about 3.7 mm.
[0206] The nasal opening-oral opening spacing linear distance 2252
of the S/M size can be between 10-15 mm, 11-13 mm or can be about
12.7 mm. The nasal opening-oral opening spacing linear distance
2252 of the M/L size can be between 10-15 mm, 11-13 mm or can be
about 12.2 mm. The nasal opening-oral opening spacing linear
distance 2252 of the S/W size can be between 9-14 mm, 10-13 mm or
can be about 11.5 mm. The nasal opening-oral opening spacing linear
distance 2252 of the L/W size can be smaller than any of the other
sizes and, in some cases, can be between 7-12 mm, 8-11 mm or can be
about 9.5 mm.
[0207] The nasal opening length 2254 of the S/M size can be between
5-10 mm, 6-9 mm or can be about 7.2 mm. The nasal opening length
2254 of the M/L size can be between 5-10 mm, 6-9 mm or can be about
7.1 mm. The nasal opening length 2254 of the S/W size can be
between 2-7 mm, 3-6 mm or can be about 3.85 mm. The nasal opening
length 2254 of the L/W size can be between 0.5-3 mm, 1-2 mm or can
be about 1.6 mm.
[0208] The nasal opening width 2156 of the S/M size can be between
15-25 mm, 18-22 mm or can be about 19.7 mm. The nasal opening width
2156 of the M/L size can be between 18-28 mm, 20-26 mm or can be
about 23.75 mm. The nasal opening width 2156 of the S/W size can be
between 18-28 mm, 20-25 mm or can be about 22.3 mm. The nasal
opening width 2156 of the L/W size can be between 25-45 mm, 30-40
mm or can be about 32.9 mm.
[0209] Although not explicitly shown for all of the seals 2104, the
seals 2104 can also have a height 2158 of the nasal opening 2124
taken along the centreline of the seal 2104 in a vertical plane
when the seal is oriented vertically. The height 2158 of the L/W
size can be between 6-12 mm, 7-10 mm or can be about 8.63 mm.
[0210] The above-described dimensions are exemplary only. Other
dimensions are possible in view of the sizing methodology disclosed
herein. Moreover, the disclosure includes not only the particular
dimensions and ranges, but the proportions and relative dimensions
between the sizes. In addition, the oral openings 2122 can be
relatively constant across the various sizes.
[0211] FIG. 44 illustrates a seal sizing coverage arrangement based
on a scatter plot of nose breadth 2212 versus nose length 2214. The
data illustrated in the scatter plot is a collection of facial
measurements that provides a representation of the variation seen
in nasal geometry of a sample population. The data includes sizing
information of user from different Ethnic groups and shows
graphically the wide variance of facial or nasal geometry when
considering a population sample that includes different
ethnicities. The scatter plot data has been divided into different
possible sizing models for a nasal under-nose interface. The sizing
models address both nasal dimensions--nasal breadth or width 2212
and nasal length 2214. Assuming that a maximum number of seal sizes
is set to 4, for example, the seal size ranges could be provided as
follows: M=medium, L=large, short=S and W=wide. The coverage of the
particular seal sizes is illustrated by the rectangular perimeters,
as shown in FIG. 44.
[0212] To provide nasal under-the-nose interface sizing coverage of
a substantially majority of the sample population, the scatter plot
is divided into quadrants wherein each quadrant is covered by a
seal size. That is, each size (i.e., M, L, S and W) generally
corresponds to a quadrant. In other words, the boundaries of
coverage provided by each size are defined by the quadrants. The
scatter plot of the sample population is divided by a nasal length
crossover axis 2302 (i.e., also referred to as the short/wide
crossover axis) and a nasal width crossover axis 2304 (i.e., also
be referred to as the large/wide crossover axis). That is, the
quadrants are defined by a nasal length crossover axis 2302 and a
nasal width crossover axis 2304. The ranges of nasal widths covered
by the M and L sizes, respectively, are defined by the nasal width
crossover axis 2304. The ranges of nasal widths covered by the S
and W sizes, respectively, are also defined by the nasal width
crossover axis 2304. Similarly, the ranges of nasal lengths covered
by the S and M sizes, respectively, are defined by the nasal length
crossover axis 2302. The ranges of nasal lengths covered by the W
and L sizes, respectively, are also defined by the nasal length
crossover axis 2302. Accordingly, the M and L sizes cover
substantially the entire range of nasal widths of the sample
population. Similarly, the S and W sizes also cover substantially
the entire range of nasal widths of the sample population. Further,
the S and M sizes cover substantially the entire range of nasal
lengths of the sample population. Similarly, the W and L sizes
cover substantially the entire range of nasal lengths of the sample
population.
[0213] As shown in FIG. 44, the sample population provides a range
of nasal widths that spans from approximately 27.8 to 60.2 mm. The
sample population provide a range of nasal lengths that spans from
approximately 14.3 to 27.7 mm. The nasal width crossover axis 2304
is positioned at approximately a median of the range of nasal
widths. As shown, the nasal width crossover axis 2304 is positioned
at approximately 44.0 mm. The nasal length crossover axis 2302 is
positioned at a nasal length less than the median of the sample
population. As shown, the nasal length crossover axis 2302 is
positioned at approximately 20.0 mm or approximately 40% of the
range of nasal lengths (i.e., 40.sup.th percentile of the
population sample). The crossover axes 2302, 2304 may be positioned
according to the distribution of sizes of the sample population
such that a greater number of users are covered by a particular
size or sizes. For example, the positioning of each axis 2302, 2304
may be positioned according to the population distribution to
adjust the range of coverage such that a greater or smaller number
of users are covered by a particular size.
[0214] As illustrated in FIG. 44, the M size is configured to fit
users having the smallest nasal widths to users having nasal widths
substantially near the median. That is, as shown, the M size fits
users having nasal widths of approximately 27.8 to 44.0 mm. The L
size is configured to fit users having nasal widths substantially
near the median to users having the largest nasal widths. That is,
as shown, the L size fits users having nasal widths of
approximately 44.0 to 60.2 mm. Accordingly, the combination of M
and L sizes cover substantially the entire range of nasal
widths.
[0215] Similarly, the S size is configured to fit users having the
smallest nasal widths to users having nasal widths substantially
near the median. That is, as shown, the S size fits users having
nasal widths of approximately 27.8 to 44.0 mm. The W size is
configured to fit users having nasal widths substantially near the
median to users having the largest nasal widths. That is, as shown,
the W size fits users having nasal widths of approximately 44.0 to
60.2 mm. Accordingly, the combination of S and W sizes cover
substantially the entire range of nasal widths. Further, as shown,
the range of nasal widths covered by the S size is substantially
equal to or aligned with the range of nasal width covered by the M
size. Similarly, the range of nasal width covered by the L size is
substantially equal to or aligned with the range of nasal widths
covered by the W size.
[0216] The S size is configured to fit users having the smallest
nasal length to users having nasal lengths near the short/wide
crossover axis 2304 (i.e., 40.sup.th percentile). That is, as
shown, the S size fits users having nasal lengths of approximately
14.3 to 20.0 mm. The M size is configured to fit users having nasal
lengths near the short/wide crossover axis 2304 to users having the
largest nasal lengths. That is, as shown, the M size fits users
having nasal lengths of approximately 20.0 to 27.7 mm. Accordingly,
the S and M sizes cover substantially the entire range of nasal
lengths.
[0217] Similarly, the W size is configured to fit users having the
smallest nasal length to users having nasal lengths near the
short/wide crossover axis 2304 (i.e., 40.sup.th percentile). That
is, as shown, the W size fits users having nasal lengths of
approximately 14.3 to 20.0 mm. The L size is configured to fit
users having nasal lengths near the short/wide crossover axis 2304
to users having the largest nasal lengths. That is, as shown, the L
size fits users having nasal lengths of approximately 20.0 to 27.7
mm. Accordingly, the W and L sizes cover substantially the entire
range of nasal widths. Further, as shown, the range of nasal length
covered by the S size is substantially equal to or aligned with the
range of nasal length covered by the W size. Similarly, the range
of nasal length covered by the M size is substantially equal to or
aligned with the range of nasal widths covered by the L size.
[0218] Accordingly, the nasal opening maximum linear distance 2250
of the M size can be between 5-10 mm, 6-8 mm or can be about 7.36
mm. The nasal opening maximum linear distance 2250 of the L size
can be between 5-10 mm, 6-8 mm or can be about 7.85 mm. The nasal
opening maximum linear distance 2250 of the S size can be between
3-7 mm, 4-6 mm or can be about 4.77 mm. The nasal opening maximum
linear distance 2250 of the W size can be between 2-6 mm, 3-5 mm or
can be about 3.7 mm.
[0219] The nasal opening length 2254 of the M size can be between
5-10 mm, 6-9 mm or can be about 7.2 mm. The nasal opening length
2254 of the L size can be between 5-10 mm,6-9 mm or can be about
7.1 mm. The nasal opening length 2254 of the S size can be between
2-7 mm, 3-6 mm or can be about 3.85 mm. The nasal opening length
2254 of the W size can be between 0.5-3 mm, 1-2 mm or can be about
1.6 mm.
[0220] The nasal opening width 2156 of the M size can be between
15-25 mm, 18-22 mm or can be about 19.7 mm. The nasal opening width
2156 of the L size can be between 18-28 mm, 20-26 mm or can be
about 23.75 mm. The nasal opening width 2156 of the S size can be
between 18-28 mm, 20-25 mm or can be about 22.3 mm. The nasal
opening width 2156 of the W size can be between 25-45 mm, 30-40 mm
or can be about 32.9 mm.
[0221] As a result of the seal sizing coverage arrangement provided
by dividing the scatter plot into quadrants, users of a variety of
ethnicities may comfortably fit one of the M, L, S and W sizes.
Particularly, users of ethnicities having nasal measurements at the
outermost extents of the ranges may be comfortably fit by one of
the M, L, S and W sizes. As shown, the size S may cover users and
ethnicities having shorter nasal lengths and shorter nasal widths.
Similarly, the size W may cover users and ethnicities having
shorter nasal lengths and longer nasal widths. The size M may cover
users and ethnicities having longer nasal lengths and shorter nasal
widths. The size L may cover users and ethnicities having longer
nasal lengths and longer nasal widths. It should be understood to
one of ordinary skill in the art that the nasal length crossover
axis 2302 and nasal width crossover axis 2304 may be positioned
according to the distribution of sizes of the sample population
such that a greater number of users are covered by a particular
size or sizes.
[0222] FIGS. 45-47 also illustrate different sizing coverage
arrangements for a population sample that includes different
ethnicities. The population sample is represented by a scatter plot
of nose breadth 2212 versus nose length 2214. The sizing coverage
arrangements in FIGS. 45 divide the scatter plot data into
different possible sizing models for an over-nose interface. The
sizing models address both nasal dimensions--nasal breadth or width
2212 and nasal length 2214. Assuming that a maximum number of seal
sizes is set to 4, for example, the seal size ranges could be
provided as follows: S/M=small-medium, M/L=medium-large, Short and
Wide. The coverage of the particular seal sizes is illustrated by
the rectangular perimeters.
[0223] Similar to FIG. 44, the sizing coverage arrangement of FIG.
45 divides the sample population into quadrants. However, in
contrast to FIG. 44, the boundaries of coverage provided by each
size are not defined by the quadrants. That is, FIG. 45 shows the
sample population divided into quadrants by axes (illustrated in
dashed lines) but the axes do not define the extents or range of
nasal lengths/widths covered by each size. Instead, the extents or
range of nasal lengths/widths covered by each size are determined
based on the population intended to be accommodated by a given
size. Further, the boundaries of coverage provided by at least one
size may overlap the boundaries of coverage of another size.
Accordingly, it is possible for users that are between sizes to
comfortable fit multiple seal sizes. Further, the sizes may be
configured such that users having a common size may have the option
of wearing more than one size.
[0224] As shown in FIG. 45, the sample population provide a range
of nasal widths that spans from approximately 28.8 mm to 57.7 mm.
The sample population provide a range of nasal lengths that spans
from approximately 14.3 mm to 27.8 mm. FIG. 45 shows a Nose Breadth
Average Axis 2312 is positioned at the nose breadth average
(approximately 39.1 mm) and a Short/Wide Crossover Axis 2314
positioned at approximately 30% of the range of nasal lengths
(approximately 18.0 mm).
[0225] The S/M size is configured to fit users having substantially
the smallest nasal widths to users having nasal widths greater than
the average nasal width. That is, as shown, the S/M size fits users
having nasal widths of approximately 28.8 to 43.0 mm. The M/L size
is configured to fit users having nasal widths less than the
average nasal width to users having nasal widths greater than the
average nasal width. That is, as shown, the M/L size fits users
having nasal widths of approximately 37.2 to 51.5 mm. Accordingly,
S/M and M/L sizes provide overlapping coverage of a range of nasal
widths between approximately 37.2 to 43.0 mm. That is, the S/M and
M/L sizes provide overlapping coverage for users having a common
nasal width size. As shown, the overlapping coverage includes sizes
near the Nose Breadth Average Axis 2312. Therefore, as shown, a
large number of the sample population (i.e., who have average,
median or common nasal width) may be properly fitted with both the
S/M and M/L sizes. Also, as shown in FIG. 45, the combination of
the S/M and M/L sizes do not cover the entire range of nasal
widths.
[0226] Further, a difference between the average and/or median
values of the range of nose lengths covered by the S/M and M/L
sizes is less than the difference between the average values of the
range of nasal width covered by the S/M and M/L sizes. That is,
when comparing the S/M and M/L sizes, the average and/or median
nasal width of the M/L size is increased or offset by a greater
amount than the increase of average and/or median nose lengths. In
other words, a difference between the average and/or median nasal
width between the S/M and M/L sizes is greater than a difference
between the average and/or median nose length between the S/M and
M/L sizes. This is in contrast to a general scaling up of both the
nasal width and the nose lengths by the same factor or multiplier.
Accordingly, the ranges of nasal width and nose lengths between the
S/M and M/L sizes are each offset by different amounts and/or
percentages. It should be understood by one of ordinary skill in
the art that, in other configurations, the average and/or median
nasal width of the M/L size may be increased or offset by a smaller
amount than the amount of increase of the average and/or median
nose lengths.
[0227] The Short size is configured to fit users having
substantially the smallest nasal widths to users having nasal
widths greater than the average nasal width. That is, as shown, the
Short size fits users having nasal widths of approximately 28.8 to
45.5 mm. The Wide size is configured to fit users having nasal
widths less than the average nasal to users having nasal widths
greater than the average nasal width. That is, as shown, the Wide
size fits users having nasal widths of approximately 44.5 to 58.0
mm. Accordingly, the Short and Wide sizes provide overlapping
coverage of a range of nasal widths between approximately 44.5 to
45.5 mm. That is, the Short and Wide sizes provide overlapping
coverage for users having nasal widths greater than the average
nasal width. Further, the combination of the Short and Wide sizes
covers substantially the entire range of nasal widths. In contrast
to the nasal width range provided by the S/M and M/L sizes, the
Short and Wide sizes cover a broader or wider range of nasal
widths.
[0228] The Short size is configured to fit users having the
smallest nasal lengths to users having nasal lengths greater than
the Short/Wide Crossover Axis 2314 (i.e., at approximately 30% of
the range of nasal lengths). That is, as shown, the Short size fits
users having nasal lengths between approximately 14.0 to 19.2 mm.
The S/M size is configured to fit users having nasal lengths less
than the Short/Wide Crossover Axis 2314 to users having the largest
nasal lengths. That is, as shown, the S/M size fits users having
nasal lengths of approximately 17.0 to 28.0 mm. Accordingly, Short
and S/M sizes provide overlapping coverage of a range of nasal
lengths between approximately 17.0 to 19.2 mm. Further, the
combination of the Short and S/M sizes cover substantially the
entire range of nasal lengths.
[0229] The Wide size is configured to fit a range of users having
the smallest nasal lengths to users having nasal lengths greater
than the Short/Wide Crossover Axis 2314 (i.e., at approximately 30%
of the range of nasal lengths). That is, as shown, the Wide size
fits users having nasal lengths between approximately 14.0 to 20.4
mm. The M/L size is configured to fit users having nasal lengths
less than the Short/Wide Crossover Axis 2314 to users having the
largest nasal lengths. That is, as shown, the M/L size fits users
having nasal lengths of approximately 17.6 to 28.8 mm. Accordingly,
Wide and M/L sizes provide overlapping coverage of a range of nasal
lengths between approximately 17.6 to 20.4 mm. Further, the
combination of the Wide and M/L sizes cover substantially the
entire range of nasal lengths. Even further, the S/M and M/L sizes
provide overlapping coverage of a range of nasal length between
approximately 17.6 to 28.0 mm. That is, the S/M and M/L sizes
provide overlapping coverage for users having a common nasal length
size. Therefore, as shown, a large number of the sample population
(i.e., who have average, median or common nasal length) may be
properly fitted with both the S/M and M/L sizes.
[0230] Based on the sizing coverage illustrated in FIG. 45, the
nasal opening maximum linear distance 2250 of the S/M size can be
between 5-10 mm, 6-8 mm or can be about 7.38 mm. The nasal opening
maximum linear distance 2250 of the M/L size can be between 5-10
mm, 6-8 mm or can be about 7.75 mm. The nasal opening maximum
linear distance 2250 of the Short size can be between 3-7 mm, 4-6
mm or can be about 4.70 mm. The nasal opening maximum linear
distance 2250 of the Wide size can be between 2-6 mm, 3-5 mm or can
be about 3.60 mm.
[0231] Based on the sizing coverage illustrated in FIG. 45, the
nasal opening-oral opening spacing linear distance 2252 of the S/M
size can be between 10-15 mm, 11-13 mm or can be about 12.67 mm.
The nasal opening-oral opening spacing linear distance 2252 of the
M/L size can be between 10-15 mm, 11-13 mm or can be about 12.2 mm.
The nasal opening-oral opening spacing linear distance 2252 of the
Short size can be between 9-14 mm, 10-13 mm or can be about 11.46
mm. The nasal opening-oral opening spacing linear distance 2252 of
the Wide size can be smaller than any of the other sizes and, in
some cases, can be between 7-12 mm, 8-11 mm or can be about 8.67
mm.
[0232] Based on the sizing coverage illustrated in FIG. 45, the
nasal opening length 2254 of the S/M size can be between 5-10 mm,
6-9 mm or can be about 6.86 mm. The nasal opening length 2254 of
the M/L size can be between 5-10 mm, 6-9 mm or can be about 7.07
mm. The nasal opening length 2254 of the Short size can be between
2-7 mm, 3-6 mm or can be about 3.86 mm. The nasal opening length
2254 of the Wide size can be between 0.5-3 mm, 1-2 mm or can be
about 1.58 mm.
[0233] Based on the sizing coverage illustrated in FIG. 45, the
nasal opening width 2156 of the S/M size can be between 15-25 mm,
18-22 mm or can be about 19.7 mm.
[0234] The nasal opening width 2156 of the M/L size can be between
18-28 mm, 20-26 mm or can be about 23.72 mm. The nasal opening
width 2156 of the Short size can be between 18-28 mm, 20-25 mm or
can be about 22.28 mm. The nasal opening width 2156 of the Wide
size can be between 25-45 mm, 30-40 mm or can be about 32.30
mm.
[0235] In FIG. 46, the illustrated sizing coverage is similar to
the sizing coverage illustrated in FIG. 45 except that a maximum
number of seal sizes is set to 3. For example, the seal size ranges
could be provided as follows: S/M=small-medium, M/L=medium-large
and Short. That is, a fourth size (i.e., the Wide size in FIG. 45)
is not provided by the sizing coverage illustrated in FIG. 46. The
nasal lengths and widths covered by the S/M, M/L and Short sizes
are substantially similar to those described in reference to FIG.
45. Accordingly, the geometry and configuration of the nasal
opening for the S/M, M/L and Short seal sizes is also substantially
similar to those described in reference to FIG. 45.
[0236] FIG. 47 illustrates a seal sizing coverage arrangement
similar to FIG. 45. That is, the maximum number of seal sizes is
set to 4, for example, the seal size ranges could be provided as
follows: S/M=small-medium, M/L=medium-large, Short and Wide. The
sizing arrangement in FIG. 47 differs from FIG. 45 in that the
range of nasal width coverage of the S/M, M/L and Short sizes are
broadened. Further, the range of nasal width coverage of the Wide
size is narrowed compared to FIG. 45. Still further, the range of
nasal length coverage of the Short size is also narrowed compared
to FIG. 45.
[0237] More specifically, the S/M size is configured to fit users
having substantially the smallest nasal widths to users with nasal
widths greater than the average nasal width. That is, as shown, the
S/M size fits users having nasal widths of approximately 28.8 to
46.0 mm (compared to approximately 28.8 to 43.0 mm in FIG. 45). The
M/L size is configured to fit users having nasal widths
substantially equal to the average nasal breadth to users with
nasal widths greater than the average nasal width. That is, as
shown, the M/L size fits users having nasal widths of approximately
39.0 to 56.0 mm (compared to approximately 37.2 to 51.5 mm in FIG.
45). Accordingly, S/M and M/L provide overlapping coverage of a
range of nasal widths between approximately 39.0 to 46.0 mm
(compared to approximately 37.2 to 43.0 mm in FIG. 45). Further,
the combination of the S/M and M/L sizes substantially cover the
entire range of nasal widths.
[0238] The Short size is configured to fit users having
substantially the smallest nasal widths to users with nasal widths
greater than the average nasal width. That is, as shown, the Short
size fits users having nasal widths of approximately 28.8 to 46.0
mm. The Short size may fit a range of nasal widths similar to the
S/M size. The Wide size is configured to fit users having nasal
widths less than the average nasal width to users with nasal widths
greater than the average nasal width. That is, as shown, the Wide
size fits users having nasal widths of approximately 44.5 to 56.5
mm (compared to approximately 44.5 to 58.0 mm in FIG. 45).
Accordingly, Short and Wide sizes provide overlapping coverage of a
range of nasal widths between approximately 44.5 to 46.0 mm
(compared to approximately 44.5 to 45.5 mm in FIG. 45). Further,
the combination of Short and Wide sizes cover substantially the
entire range of nasal widths similar to the S/M and M/L sizes.
[0239] The Short size is configured to fit users having the
smallest nasal lengths to users with nasal lengths greater than the
Short/Wide Crossover Axis 2314 (i.e., at approximately 30% of the
range of nasal lengths). That is, as shown, the Short size fits
users having nasal lengths between approximately 14.0 to 18.4 mm
(compared to approximately 14.0 to 19.2 mm in FIG. 45). The S/M
size is configured to fit users having nasal lengths less than the
Short/Wide Crossover Axis 2314 to users having the largest nasal
lengths. That is, as shown, the S/M size fits users having nasal
lengths of approximately 17.0 to 28.0 mm (compared to approximately
17.0 to 28.0 mm in FIG. 45). Accordingly, Short and S/M sizes
provide overlapping coverage of a range of nasal lengths between
approximately 17.0 to 18.4 mm (compared to approximately 17.0 to
19.2 mm in FIG. 45). Further, the combination of the Short and S/M
sizes cover substantially the entire range of nasal lengths.
[0240] The Wide size is configured to fit users having the smallest
nasal lengths to users having nasal lengths greater than the
Short/Wide Crossover Axis 2314 (i.e., at approximately 30% of the
range of nasal lengths). That is, as shown, the Wide size fits
users having nasal lengths between approximately 14.0 to 20.4 mm
(compared to approximately 14.0 to 20.4 mm in FIG. 45). The M/L
size is configured to fit users having nasal lengths less than the
Short/Wide Crossover Axis 2314 to users having the largest nasal
lengths. That is, as shown, the M/L size fits users having nasal
lengths of approximately 17.6 to 28.8 mm (compared to approximately
17.6 to 28.8 mm in FIG. 45). Accordingly, Wide and M/L sizes
provide overlapping coverage of a range of nasal lengths between
approximately 17.6 to 20.4 mm (compared to approximately 17.6 to
20.4 mm in FIG. 45). Further, the combination of the Wide and M/L
sizes cover substantially the entire range of nasal lengths.
[0241] FIG. 48 illustrates a seal sizing coverage arrangement based
on a scatter plot of nose breadth versus subnasal to sublabial
distance that provides a representation of the variation seen in
facial geometry. The scatter plot data includes the sizing
information of user from different Ethnic groups and shows
graphically the wide variance of nasal geometry when considering a
population sample that includes different ethnicities. The scatter
plot data has been split into different possible sizing models for
a nasal under-nose interface. The sizing models address both nasal
dimensions--nasal breadth or width and subnasal to sublabial
distance. Assuming that a maximum number of seal sizes is set to 2,
for example, the seal size ranges could be provided as follows:
S/M=small-medium and M/L=medium-large. The coverage of the
particular seal sizes is illustrated by the rectangular perimeters,
as shown in FIG. 48.
[0242] As shown in FIG. 48, the S/M size is configured to fit users
having nasal widths between substantially the smallest nasal widths
to users having substantially the median nasal width. That is, as
shown, the S/M size fits users having nasal widths of approximately
28.5 to 44.0 mm. The M/L size is configured to fit users having
substantially the median nasal width to users with substantially
the largest nasal widths. That is, as shown, the M/L size fits
users having nasal widths of approximately 37.0 to 51.7 mm.
Accordingly, the combination of S/M and M/L sizes cover
substantially the entire range of nasal widths.
[0243] The S/M size is configured to fit users having substantially
the smallest measured subnasal to sublabial distance to
substantially the largest subnasal to sublabial distance. That is,
as shown, the S/M size fits users having subnasal to sublabial
distance of approximately 27.5 to 53.4 mm. The M/L size is
configured to fit users having the smallest measured subnasal to
sublabial distance to substantially the largest subnasal to
sublabial distance. That is, as shown, the M/L size fits users
having subnasal to sublabial distance of approximately 29.4 to 54.6
mm. Accordingly, the combination of S/M and M/L sizes cover
substantially the entire range of subnasal to sublabial
distance.
[0244] As shown in FIG. 48, as a result of sizing according to an
ethnically diverse user population, the S/M and M/L sizes each
provide coverage for a similar range of subnasal to sublabial
distances but differ in terms of their respective coverage of nasal
widths. That is, the ethnically diverse scatter plot indicates that
the range of subnasal to sublabial distance is substantially
consistent throughout the range to nasal breadth. A linear
regression of the scatter plot indicates that the range of subnasal
to sublabial distance varies approximately 25 mm throughout the
range of nasal widths while the average subnasal to sublabial
distance varies only 3 mm between a nasal width range of
approximately 35.3 to 44.6 mm. Accordingly, the S/M and M/L sizes
provide a similar range of subnasal to sublabial coverage while
varying in terms of nasal width coverage. Further, a difference
between the average values of the range of subnasal to sublabial
distance covered by the S/M and M/L sizes (3 mm) is less than the
difference between the average values of the range of nasal width
covered by the S/M and M/L sizes (9 mm). That is, when comparing
the S/M and M/L sizes, the nasal width of the M/L size is increased
or offset by a greater amount than the subnasal to sublabial
distance. In other words, a difference between the average and/or
median nasal width between the S/M and M/L sizes is greater than a
difference between the average and/or median subnasal to sublabial
distance between the S/M and M/L sizes. This is in contrast to a
general scaling up of both the nasal width and subnasal to
sublabial distance by the same factor or multiplier. Accordingly,
the ranges of nasal width and subnasal to sublabial distance
between the S/M and M/L sizes are each offset by different amounts.
It should be understood by one of ordinary skill in the art that,
in other configurations, the average and/or median nasal width of
the M/L size may be increased or offset by a smaller amount than
the amount of increase of the average and/or median subnasal to
sublabial distance.
[0245] Accordingly, the S/M and M/L sizes provide a similar range
of subnasal to sublabial distance coverage while varying to a
greater degree in terms of nasal width coverage. That is, the
difference (i.e., in terms of amount and/or percentage) between the
ranges of subnasal to sublabial distance coverage provided by the
S/M and M/L sizes is less than the difference (i.e., in terms of
amount and/or percentage) between the ranges of nasal width
coverage provided by the S/M and M/L sizes. Put another way, the
users that properly fit the S/M size generally have similar
subnasal to sublabial distances as the users that properly fit the
M/L size. However, the users that properly fit the S/M size have
smaller nose widths than the users that properly fit the M/L
size.
[0246] FIG. 49 illustrates a seal sizing coverage arrangement based
on a scatter plot of nose breadth versus mouth width that provides
a representation of the variation seen in facial geometry. The
scatter plot data includes the sizing information of user from
different Ethnic groups and shows graphically the wide variance of
nasal geometry when considering a population sample that includes
different ethnicities. The scatter plot data has been split into
different possible sizing models for a nasal under-nose interface.
The sizing models address both nasal dimensions--nasal breadth or
width and mouth width. Assuming that a maximum number of seal sizes
is set to 2, for example, the seal size ranges could be provided as
follows: S/M=small-medium and M/L=medium-large. The coverage of the
particular seal sizes is illustrated by the rectangular perimeters,
as shown in FIG. 49.
[0247] As shown in FIG. 49, the S/M size is configured to fit users
having substantially the smallest nasal widths to users having
substantially the median nasal width. That is, as shown, the S/M
size fits users having nasal widths of approximately 29.0 to 43.0
mm. The M/L size is configured to fit users having substantially
the median nasal width to users with substantially the largest
nasal widths. That is, as shown, the M/L size fits users having
nasal widths of approximately 37.0 to 52.0 mm. Accordingly, the
combination of S/M and M/L sizes cover substantially the entire
range of nasal widths.
[0248] The S/M size is configured to fit users having substantially
the smallest mouth widths to users having the largest mouth widths.
That is, as shown, the S/M size fits users having mouth widths of
approximately 41.8 to 79.0 mm. The M/L size is configured to fit
users having substantially the smallest mouth widths to users
having the largest mouth widths. That is, as shown, the M/L size
fits users having mouth widths of approximately 49.8 to 80.2 mm.
Accordingly, the combination of S/M and M/L sizes cover
substantially the entire range of mouth widths.
[0249] As shown in FIG. 49, as a result of sizing according to an
ethnically diverse user population, the S/M and M/L sizes each
provide coverage for a similar range of mouth widths but differ in
terms of their respective coverage of nasal widths. That is, the
ethnically diverse scatter plot indicates that the range of mouth
widths is substantially consistent throughout the range to nasal
breadth. A linear regression of the scatter plot indicates that the
range of mouth widths vary approximately 28 mm throughout the range
of nasal widths while the average mouth width varies only 4 mm
between a nasal width range of approximately 35.3 to 44.6 mm.
Accordingly, the S/M and M/L sizes provide a similar range of mouth
width coverage while varying to a greater degree in terms of nasal
width coverage. That is, the difference (i.e., in terms of amount
and/or percentage) between the ranges of mouth width coverage
provided by the S/M and M/L sizes is less than the difference
(i.e., in terms of amount and/or percentage) between the ranges of
nasal width coverage provided by the S/M and M/L sizes. Put another
way, the users that properly fit the S/M size generally have
similar mouth widths as the users that properly fit the M/L size.
However, the users that properly fit the S/M size have smaller nose
widths than the users that properly fit the M/L size. Further, a
difference between the average and/or median values of the range of
mouth widths covered by the S/M and M/L sizes (4 mm) is less than
the difference between the average values of the range of nasal
width covered by the S/M and M/L sizes (9 mm). That is, when
comparing the S/M and M/L sizes, the average and/or median nasal
width of the M/L size is increased or offset by a greater amount
than the increase of average and/or median mouth width. In other
words, a difference between the average and/or median nasal width
between the S/M and M/L sizes is greater than a difference between
the average and/or median nasal length between the S/M and M/L
sizes. This is in contrast to a general scaling up of both the
nasal width and the mouth width by the same factor or
multiplier.
[0250] Accordingly, the ranges of nasal width and mouth width
between the S/M and M/L sizes are each offset by different amounts
and/or percentages. It should be understood by one of ordinary
skill in the art that, in other configurations, the average and/or
median nasal width of the M/L size may be increased or offset by a
smaller amount than the amount of increase of the average and/or
median mouth width.
[0251] Unless the context clearly requires otherwise, throughout
the description and the claims, the words "comprise", "comprising",
and the like, are to be construed in an inclusive sense as opposed
to an exclusive or exhaustive sense, that is to say, in the sense
of "including, but not limited to". Conditional language used
herein, such as, among others, "can," "could," "might," "may,"
"e.g.," and the like, unless specifically stated otherwise, or
otherwise understood within the context as used, is generally
intended to convey that certain embodiments include, while other
embodiments do not include, certain features, elements and/or
states. Thus, such conditional language is not generally intended
to imply that features, elements and/or states are in any way
required for one or more embodiments or that one or more
embodiments necessarily include logic for deciding, with or without
author input or prompting, whether these features, elements and/or
states are included or are to be performed in any particular
embodiment.
[0252] The term "plurality" refers to two or more of an item.
Recitations of quantities, dimensions, sizes, formulations,
parameters, shapes and other characteristics should be construed as
if the term "about" or "approximately" precedes the quantity,
dimension, size, formulation, parameter, shape or other
characteristic. The terms "about" or "approximately" mean that
quantities, dimensions, sizes, formulations, parameters, shapes and
other characteristics need not be exact, but may be approximated
and/or larger or smaller, as desired, reflecting acceptable
tolerances, conversion factors, rounding off, measurement error and
the like and other factors known to those of skill in the art.
Recitations of quantities, dimensions, sizes, formulations,
parameters, shapes and other characteristics should also be
construed as if the term "substantially" precedes the quantity,
dimension, size, formulation, parameter, shape or other
characteristic. The term "substantially" means that the recited
characteristic, parameter, or value need not be achieved exactly,
but that deviations or variations, including for example,
tolerances, measurement error, measurement accuracy limitations and
other factors known to those of skill in the art, may occur in
amounts that do not preclude the effect the characteristic was
intended to provide.
[0253] Numerical data may be expressed or presented herein in a
range format. It is to be understood that such a range format is
used merely for convenience and brevity and thus should be
interpreted flexibly to include not only the numerical values
explicitly recited as the limits of the range, but also interpreted
to include all of the individual numerical values or sub-ranges
encompassed within that range as if each numerical value and
sub-range is explicitly recited. As an illustration, a numerical
range of "1 to 5" should be interpreted to include not only the
explicitly recited values of about 1 to about 5, but should also be
interpreted to also include individual values and sub-ranges within
the indicated range. Thus, included in this numerical range are
individual values such as 2, 3 and 4 and sub-ranges such as "1 to
3," "2 to 4" and "3 to 5," etc. This same principle applies to
ranges reciting only one numerical value (e.g., "greater than 1")
and should apply regardless of the breadth of the range or the
characteristics being described.
[0254] A plurality of items may be presented in a common list for
convenience. However, these lists should be construed as though
each member of the list is individually identified as a separate
and unique member. Thus, no individual member of such list should
be construed as a de facto equivalent of any other member of the
same list solely based on their presentation in a common group
without indications to the contrary. Furthermore, where the terms
"and" and "or" are used in conjunction with a list of items, they
are to be interpreted broadly, in that any one or more of the
listed items may be used alone or in combination with other listed
items. The term "alternatively" refers to selection of one of two
or more alternatives, and is not intended to limit the selection to
only those listed alternatives or to only one of the listed
alternatives at a time, unless the context clearly indicates
otherwise.
[0255] Reference to any prior art in this specification is not, and
should not be taken as, an acknowledgement or any form of
suggestion that that prior art forms part of the common general
knowledge in the field of endeavour in any country in the
world.
[0256] The invention may also be said broadly to consist in the
parts, elements and features referred to or indicated in the
specification of the application, individually or collectively, in
any or all combinations of two or more of said parts, elements or
features.
[0257] Where, in the foregoing description reference has been made
to integers or components having known equivalents thereof, those
integers are herein incorporated as if individually set forth.
[0258] It should be noted that various changes and modifications to
the presently preferred embodiments described herein will be
apparent to those skilled in the art. Such changes and
modifications may be made without departing from the spirit and
scope of the invention and without diminishing its attendant
advantages. For instance, various components may be repositioned as
desired. It is therefore intended that such changes and
modifications be included within the scope of the invention.
Moreover, not all of the features, aspects and advantages are
necessarily required to practice the present invention.
Accordingly, the scope of the present invention is intended to be
defined only by the claims that follow.
* * * * *