NZ748881B2 - Mask System - Google Patents
Mask System Download PDFInfo
- Publication number
- NZ748881B2 NZ748881B2 NZ748881A NZ74888109A NZ748881B2 NZ 748881 B2 NZ748881 B2 NZ 748881B2 NZ 748881 A NZ748881 A NZ 748881A NZ 74888109 A NZ74888109 A NZ 74888109A NZ 748881 B2 NZ748881 B2 NZ 748881B2
- Authority
- NZ
- New Zealand
- Prior art keywords
- mask system
- headgear
- frame
- shroud
- patient
- Prior art date
Links
- 210000003467 Cheek Anatomy 0.000 claims abstract description 18
- 239000000463 material Substances 0.000 claims description 40
- 239000012528 membrane Substances 0.000 claims description 29
- 210000001061 Forehead Anatomy 0.000 claims description 20
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- 210000000088 Lip Anatomy 0.000 claims description 10
- 210000000214 Mouth Anatomy 0.000 claims description 8
- 230000029058 respiratory gaseous exchange Effects 0.000 claims description 8
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- 241000726123 Acanthurus Species 0.000 description 4
- 208000000927 Sleep Apnea Syndrome Diseases 0.000 description 4
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- MYMOFIZGZYHOMD-UHFFFAOYSA-N oxygen Chemical compound O=O MYMOFIZGZYHOMD-UHFFFAOYSA-N 0.000 description 4
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- JHWNWJKBPDFINM-UHFFFAOYSA-N Laurolactam Chemical compound O=C1CCCCCCCCCCCN1 JHWNWJKBPDFINM-UHFFFAOYSA-N 0.000 description 1
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Abstract
respiratory mask system has a frame and a cushion attached to the frame. A shroud is attachable to the frame and has upper and lower pairs of headgear connectors. The upper pair extend across patient cheeks and under eyes. The connectors are attachable to upper and lower headgear straps.
Description
DIV22
MASK SYSTEM
CROSS-REFERENCE TO APPLICATION
This application claims the benefit of U.S. Provisional Application Nos.
61/064,406, filed March 4, 2008, 61/071,893, filed May 23, 2008, and 61/136,617, filed
September 19, 2008, each of which is incorporated herein by reference in its entirety.
FIELD OF THE INVENTION
The present invention relates to a mask system used for treatment, e.g., of
Sleep Disordered Breathing (SDB) with Continuous Positive Airway Pressure (CPAP) or
Non-Invasive Positive Pressure Ventilation (NIPPV).
BACKGROUND OF THE INVENTION
Patient interfaces, such as a full-face or nasal mask systems, for use with
blowers and flow generators in the treatment of sleep disordered breathing (SDB), typically
include a soft face-contacting portion, such as a cushion, and a rigid or semi-rigid shell or
frame. In use, the interface is held in a sealing position by headgear so as to enable a supply of
air at positive pressure (e.g., 2-30 cm H O) to be delivered to the patient's airways.
One factor in the efficacy of therapy and compliance of patients with therapy is
the comfort and fit of the patient interface.
The present invention provides alternative arrangements of mask systems to
enhance the efficacy of therapy and compliance of patients with therapy.
It is an object of the invention to provide an improved mask system, or parts
thereof, or at least to provide the public with a useful choice.
SUMMARY OF THE INVENTION
Preferred aspects of the invention are set forth in the appended claims.
Particular embodiments are described below in non-limiting terms.
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One embodiment of the invention relates to a mask system provided without a
forehead support adapted to engage the patient's forehead.
Another embodiment of the invention relates to a mask system including a
frame and a shroud removably connected to the frame and adapted to attach headgear.
Another embodiment of the invention relates to a mask system including a
frame defining a breathing chamber, a cushion provided to the frame and adapted to form a
seal with the patient's face, and a shroud provided to the frame. The shroud and the frame are
co-molded with one another. The frame is constructed of a first, relatively soft, elastomeric
material and the shroud is constructed of a second material that is more rigid than the frame.
At least a portion of the frame includes a concertina section having a plurality of folds. Each
of the folds has a side wall with the side walls of the folds becoming progressively longer away
from the patient's face.
Another embodiment of the invention relates to a cushion module including a
frame defining a breathing chamber and a cushion adapted to form a seal with the patient's
face. The frame and the cushion are co-molded with one another. The cushion is constructed
of a first, relatively soft, elastomeric material and the frame is constructed of a second material
that is more rigid than the cushion. At least a portion of the frame includes a concertina
section.
Another embodiment of the invention relates to a method for constructing a
cushion module. The method includes molding a first part of the cushion module with a first,
relatively soft, elastomeric material, co-molding a second part of the cushion module to the
first part with a second material that is more rigid than the first material, and molding at least a
portion of the second part to include a concertina section.
Another embodiment of the invention relates to a shroud for a mask system
including a retaining portion structured to retain a frame, a pair of upper headgear connectors
each including an elongated arm and a slot at the free end of the arm adapted to receive a
headgear strap, and a pair of lower headgear connectors each adapted to attach to a headgear
strap, wherein the retaining portion, the upper headgear connectors, and the lower headgear
connectors are integrally formed as a one piece structure.
Another embodiment of the invention relates to a mask system including a
frame defining a breathing chamber, a cushion provided to the frame and adapted to form a
504972DIV22
seal with the patient's face, a shroud provided to the frame and adapted to attach headgear,
and an elbow provided to the frame and adapted to be connected to an air delivery tube that
delivers breathable gas to the patient. The shroud includes a retaining mechanism structured
to establish a positive connection between the shroud and the frame.
Another embodiment of the invention relates to a mask system including a
frame defining a breathing chamber and a cushion provided to the frame. The cushion is
adapted to engage at least a portion of the patient’s face. The cushion includes a base wall
connected to an undercushion layer and a membrane, wherein the membrane extends around
the perimeter of the cushion and contacts the patient’s face. The undercushion layer is
positioned underneath the membrane and supports the membrane. The under cushion layer
provides differential support to the membrane at predetermined regions of the face.
Another embodiment of the invention relates to a mask assembly for use in
medical applications having a top and bottom ends defined by its position relative to a
patient’s face, wherein the mask assembly is connected to a plurality of flexible straps, which
are adapted to engage the patient’s head. The flexible straps engage at least two elongated
rigid arms integrally molded to a portion of the mask assembly, and wherein the elongated
arms are molded to the mask assembly proximal to the top end of the mask assembly.
Another embodiment of the invention relates to a mask assembly for use in
medical applications including a main body connected to a cushion adapted to cover nose
and/or mouth and wherein the mask assembly is attached by a force substantially perpendicular
towards the face and wherein the force is approximately constant along the length of the mask
and is balanced by a portion of the cushion engaging the patient’s cheeks.
Another embodiment of the invention relates to a cushion for use with a
medical mask including an outer membrane layer adapted to sealably engage a face and an
undercushion layer adapted to support the membrane layer. The membrane or undercushion
layer includes a surface positioned between the two layers adapted to allow the layers to slide
against the respective surface.
Another embodiment of the invention relates to a mask system including a
frame defining a breathing chamber, a cushion provided to the frame and adapted to form a
seal with the patient’s face, and a releasable shroud adapted to engage a portion of the outer
surface of the frame, wherein the shroud is connected to straps to position the mask system.
504972DIV22
Another embodiment of the invention relates to a mask assembly for use in
medical applications including an upper end and a lower end wherein the upper end is adapted
to cover the nose and the lower end is adapted to cover the mouth of a patient. The mask
assembly includes no forehead support and includes two stiffened members attached to the
upper end on opposed sides of the mask assembly, and wherein the stiffened members include
a general curved shape and adapted to avoid covering the patient’s field of vision.
Another embodiment of the invention relates to a cushion for attaching to a
medical mask, wherein the cushion is flexible and includes a membrane attached to the
circumference of the cushion adapted to seal against the face of a patient, and at least one
undercushion adapted to support the membrane and positioned underneath the membrane to
prevent collapse of the membrane, in use. The membrane is softer than the undercushion. The
undercushion in the regions of nasal bridge or chin is between 0mm and 30mm in height as
measured between the base and the tip of the undercushion.
Another embodiment of the invention relates to a mask assembly for use in
medical applications including an upper end and a lower end wherein the upper end is adapted
to cover the nose and the lower end is adapted to cover the mouth of a patient. The mask
assembly includes no forehead support and includes two stiffened members attached to the
upper end on opposed sides of the mask assembly, and wherein the stiffened members include
a general curved shape and adapted to avoid covering the patient’s field of vision.
In an alternative embodiment, the mask system may include a headgear
connector or rigidizer structured to attach to the frame with a snap-fit, mechanical interlock,
friction fit, and/or grommet arrangement (e.g., constructed of rubber).
In an alternative embodiment, the mask system may include headgear having an
arrangement of straps constructed of silicone and/or Breath-O-Prene™ material.
Other aspects, features, and advantages of this invention will become apparent
from the following detailed description when taken in conjunction with the accompanying
drawings, which are a part of this disclosure and which illustrate, by way of example,
principles of this invention.
BRIEF DESCRIPTION OF THE DRAWINGS
504972DIV22
The accompanying drawings facilitate an understanding of the various
embodiments of this invention. In such drawings:
Fig. 1 is a front perspective view of a mask system according to an embodiment
of the present invention;
Fig. 1B is a perspective view showing the mask system of Fig. 1 with headgear
positioned on a patient’s head;
Fig. 1C is a cross-sectional view through the mask system of Fig. 1;
Fig. 1D is another cross-sectional view through the mask system of Fig. 1;
Fig. 1E is a side view of the mask system of Fig. 1;
Fig. 2 is a front perspective view showing the frame and cushion of the mask
system of Fig. 1;
Fig. 3 is an exploded perspective view of the mask system of Fig. 1 showing
the frame, cushion, shroud, and elbow;
Fig. 4 is another exploded perspective view of the mask system of Fig. 1
showing the frame, cushion, and shroud;
Fig. 5 is an exploded perspective view of the mask system of Fig. 1 showing
the shroud and assembled frame/cushion;
Fig. 6 is a front perspective view showing the shroud of the mask system of
Fig. 1;
Fig. 7 is a front perspective view showing the cushion of the mask system of
Fig. 1;
Fig. 8 is a cross-sectional view showing a portion of the cushion of Fig. 7;
Fig. 8B is a cross-sectional view through nasal bridge and chin regions of the
cushion of Fig. 7;
Fig. 9 is a plan view of headgear laid out flat according to an embodiment of
the present invention;
Fig. 10 is a front perspective view of a mask system according to another
embodiment of the present invention;
Fig. 11 is a front perspective view showing the frame of the mask system of
Fig. 10;
Fig. 12 is a front view showing the frame of the mask system of Fig. 10;
504972DIV22
Fig. 13 is a side view showing the frame of the mask system of Fig. 10;
Fig. 14 is a front perspective view showing the shroud of the mask system of
Fig. 10;
Fig. 15 is a front view showing the shroud of the mask system of Fig. 10;
Fig. 16 is a side view showing the shroud of the mask system of Fig. 10;
Fig. 17 is a rear perspective view showing the shroud of the mask system of
Fig. 10;
Figs. 18-1 to 18-2 are cross-sectional views showing in sequential relation
attachment of the shroud to the frame of the mask system of Fig. 10;
Figs. 19-1 to 19-4 are cross-sectional views showing in sequential relation
attachment of the shroud to the frame of the mask system of Fig. 10;
Fig. 20 is a perspective view showing an alternative arrangement for attaching
the shroud to the frame;
Fig. 21 is a rear perspective view showing the shroud of the mask system of
Fig. 10;
Fig. 22 is a cross-sectional view showing attachment of the shroud to the frame
of the mask system of Fig. 10;
Fig. 23 is a cross-sectional view showing attachment of the shroud, frame, and
elbow of the mask system of Fig. 10;
Fig. 24 is a cross-sectional view showing an alternative arrangement for
attaching the shroud to the frame;
Fig. 25 is a front perspective view of a mask system according to another
embodiment of the present invention;
Fig. 26 is a rear perspective view of the mask system of Fig. 25;
Fig. 27 is a front perspective view of a mask system according to another
embodiment of the present invention;
Fig. 28 is an exploded view of the mask system shown in Fig. 27;
Fig. 29 is an enlarged front perspective view of the mask system shown in Fig.
Fig. 30 is a side view of the mask system shown in Fig. 27;
504972DIV22
Figs. 31-1 is a rear view of a cushion according to an embodiment of the
present invention;
Fig. 31-2 is a front view of the cushion shown in Fig. 31-1 with a partial cut-
away;
Fig. 31-3 is a cross-section view through line 3131-3 in Fig. 31-1;
Fig. 31-4 is a cross-section view through line 3131-4 in Fig. 31-1;
Fig. 31-5 is a cross-section view through line 3131-5 in Fig. 31-1;
Figs. 32-1 to 32-3 illustrate top, front, and side views respectively of a
concertina section according to an embodiment of the present invention;
Fig. 33 is a side view of a mask system according to a variation of the present
invention;
Fig. 34 illustrates a cushion including a concertina section according to an
embodiment of the present invention;
Figs. 35-1 to 35-3 are front, side, and rear views of a mask system according to
another embodiment of the present invention;
Fig. 36 is a perspective view of a shroud for a mask system according to an
embodiment of the present invention;
Figs. 37-1 to 37-3 are perspective, front, and side views of a mask system
according to another embodiment of the present invention;
Figs. 38-1 to 38-5 are perspective, front, top, side, and bottom views of a
shroud of the mask system shown in Figs. 37-1 to 37-3;
Figs. 39-1 to 39-6 are perspective, front, side, bottom, and top views of a mask
system according to another embodiment of the present invention;
Figs. 40-1 and 40-2 are perspective and side views of a mask system according
to another embodiment of the present invention;
Fig. 40-3 is a perspective view of the frame of the mask system shown in Figs.
40-1 and 40-2;
Figs. 40-4 and 40-5 illustrate a retaining member of the frame shown in Fig.
40-3;
Figs. 40-6 and 40-7 illustrate a clip-on upper headgear connector of the mask
system shown in Figs. 40-1 and 40-2;
504972DIV22
Figs. 41-1 and 41-2 are rear and front perspective views of a mask system
according to another embodiment of the present invention;
Figs. 41-3 and 41-4 are exploded views of the mask system shown in Figs. 41-1
and 41-2;
Figs. 41-5 to 41-12 are various views of a clip-on upper headgear connector of
the mask system shown in Figs. 41-1 and 41-2;
Fig. 42-1 is a rear perspective view of a mask system according to another
embodiment of the present invention;
Fig. 42-2 is an exploded view of the mask system shown in Fig. 42-1;
Figs. 42-3 to 42-7 are various views of a clip-on upper headgear connector of
the mask system shown in Fig. 42-1;
Figs. 43-1 to 43-4 are perspective, side, front, and rear views of a mask system
according to another embodiment of the present invention;
Fig. 44 illustrates a mask system according to another embodiment of the
present invention; and
Fig. 45 illustrates a mask system according to another embodiment of the
present invention.
DETAILED DESCRIPTION OF ILLUSTRATED EMBODIMENTS
The following description is provided in relation to several embodiments or
examples which may share common characteristics and features. It is to be understood that
one or more features of any one embodiment or example may be combinable with one or more
features of the other embodiments or examples. In addition, any single feature or combination
of features in any of the embodiments or examples may constitute additional embodiments or
examples.
In this specification, the word “comprising” is to be understood in its “open”
sense, that is, in the sense of “including”, and thus not limited to its “closed” sense, that is the
sense of “consisting only of”. A corresponding meaning is to be attributed to the
corresponding words “comprise", "comprised" and "comprises" where they appear.
The term "air" will be taken to include breathable gases, for example air with
supplemental oxygen.
504972DIV22
The term “shroud” will be taken to include components that partially or fully
cover a second component within the illustrated embodiments. In an embodiment, the shroud
may include the component that partially covers or is mounted on the frame components of the
illustrated embodiments.
The term “positive connection” will be taken to include connections between
components of the illustrated embodiments wherein connectors mounted on respective
components are adapted to engage each other respectively.
1. Mask System
Embodiments of the invention are directed towards a mask system provided
without a forehead support adapted to engage the patient's forehead. Such arrangement
provides the mask system with a less obtrusive arrangement which does not significantly affect
the patient's field of view. Although the system is designed such that a forehead support is not
required, such a forehead support can be added if desired.
As described in greater detail below, the mask system includes a frame, a
cushion provided to the frame and adapted to form a seal with the patient's face, a shroud
provided to the frame and adapted to attach headgear, and an elbow provided to the frame and
adapted to be connected to an air delivery tube that delivers breathable gas to the patient.
Headgear may be removably attached to the shroud to maintain the mask system in a desired
adjusted position on the patient's face. The mask system is intended for use in positive
pressure therapy for users with Obstructive Sleep Apnea (OSA) or another respiratory
disorder.
While each embodiment below is described as including a full-face or oro-nasal
interface type, each embodiment may be adapted for use with other suitable interface types.
That is, the interface type is merely exemplary, and each embodiment may be adapted to
include other interface types, e.g., nasal interface, nasal mask, nasal prongs, etc.
2. Stabilizing Mechanisms
The stabilizing mechanisms (e.g., frame, shroud, headgear with associated
headgear vectors) of a mask system according to embodiments of the invention are structured
to accommodate the elimination of a forehead support from a full-face type interface. For
504972DIV22
example, a forehead support typically eliminates rotation of the mask system in the sagittal and
coronal planes, so the mask system and headgear according to embodiments of the invention
are structured to take on these functions since there is no forehead support.
The headgear is connected to the top and bottom of the frame either directly or
via the shroud, which shroud provides headgear connection points for headgear positioned and
arranged to stably maintain the mask system in position on the patient's face.
2.1 Frame
As shown in Figs. 1, 1B-1E, and 2-5, the frame 1040 of the mask system 1010
is structured to maintain the cushion 1060, shroud 1020, and elbow 1070 in an operative
position with respect to the patient's face. The frame 1040 is constructed (e.g., injection
molded) from a more rigid material (e.g., polyurethane) than the cushion 1060 (made of, e.g.,
silicone), however other materials may function likely as well (e.g., polycarbonate). In an
embodiment, the frame has a general wall thickness of about 1-2 mm, e.g., 1.5 mm.
The frame 1040 defines a breathing chamber or cavity adapted to receive the
patient's nose and mouth and provide air communication to the patient. One or the lower
portion of the frame 1040 includes an opening 1046 adapted to receive or otherwise
communicate with the elbow 1070 (e.g., swivel elbow) and another or upper portion of the
frame 1040 includes a vent arrangement 1076 for gas washout. In addition, the upper portion
of the frame 1040 includes an interfacing structure 1048 adapted to interface or otherwise
removably connect to the shroud 1020.
Figs. 27-30 shows a mask system 10 including a frame 40 with a cushion 44
that provides a sealing portion or sealing ring adapted to form a seal with the patient's nose
and/or mouth. Also, the frame 40 includes an opening 46 that is adapted to communicate with
the elbow 70.
2.2 Shroud
As shown in Figs. 1 and 3-6, the shroud 1020 is connected to the frame 1040
and is structured to attach headgear to the mask system. In an embodiment, the shroud 1020
is constructed (e.g., injection molded) of a resilient material including but not limited to plastic
or nylon (e.g., Nylon 12). However, the shroud may be constructed of other suitable
504972DIV22
materials, e.g., polycarbonate, polypropylene, thermoplastic elastomer (TPE), Pocan®, etc. In
an embodiment, the shroud has a general wall thickness of about 1-2 mm, e.g., 1.3 mm.
The top end of the shroud 1020 is adapted to be positioned proximal to the
nasal bridge region or nose of the patient and the bottom end is adapted to be positioned
proximal to the mouth or chin of the patient. The top end includes an opening or vent
receiving hole 1021 to accommodate the vent arrangement 1076 that protrudes from the frame
1040, and the bottom end includes an opening or elbow hole 1032 to accommodate the elbow
1070 and elbow opening into the frame 1040 (e.g., shroud provides no contact with elbow
when assembled).
Upper headgear connectors 1024 extend from each side of the top end, and
lower headgear connectors 1025 extend from each side of the lower end. The headgear
connectors 1024, 1025 may be integrally molded or otherwise attached to the shroud.
2.2.1 Upper Headgear Connectors
Each upper headgear connector 1024 includes an elongated arm 1026 and a
slot or receiving hole 1027 at the free end of the arm 1026 adapted to receive a respective
headgear strap. In use, the arms 1026 extend around the face of the patient in a generally
concave angle below the eyes of the patient so as to avoid the patient's field of view, i.e.,
direct headgear away from the patient's eyes. For example, as shown in Fig. 1E, each arm
1026 may extend at an angle α between about 10-25° (e.g., 17°) with respect to horizontal.
That is, each arm 1026 is suitably formed, shaped, or contoured to follow the contours of the
patient's face and avoid line of sight in use. In an embodiment, the shape of the arms may be
generally arcuate and adapted to extend in a direction across the cheek of the patient, while
avoiding the eyes or limiting the field of vision. In an embodiment, the arms may be integrally
molded to the shroud of the mask system. One possible advantage of molding the arms onto
the shroud is that it greatly increases manufacturability and also the shroud may be easily
replaced in the case of accidental breakage of the arms rather than replacing the complete
mask system. Additionally, molding of the arms onto the shroud may greatly increase the
strength of the connection and reduce or limit the actual likelihood of breakage of the arms.
In an embodiment, the arms 1026 are at least semi-rigid (e.g., relatively rigid)
so as to prevent up and down movement or bending of the arms relative to the face of the
504972DIV22
patient. Thus, the arms 1026 may act as rigidizers to effectively act as a level arrangement and
generate a mechanical advantage wherein the pressure or force applied to top end of the mask
system is readjusted to a fulcrum point being about the center of balance between the top and
bottom ends of the mask system. In an embodiment, the arms are attached to the highest
possible point relative to the mask system to additionally stabilize the configuration. In an
embodiment, the fulcrum point or moment of pivoting is positioned between the upper and
lower connection points of the straps, and wherein the design, angle, length and/or
configuration of the arms 1026 may effectively adjust the fulcrum point. In the illustrated
embodiment, the fulcrum point is shown to be between the vent arrangement and elbow of the
mask system. Additionally, when positioned on the face, the mask system may have a fulcrum
point around or about the region between the bottom of the patient’s nose and lip area. This
feature effectively stabilizes the mask system on the patient's face without the traditional need
for a forehead support.
The net result of the arms 1026 mounted in a position extending from the top
end of the mask system around the face of the patient is that the mask system is more stable
and reduces the net torsional forces experiences about the x- axis 1001 (see Fig. 1) for the
mask system in use. Please note that the arms 1026 may be rigidly connected to the mask
system in other suitable positions to generate a similar result.
In an embodiment, the arms 1026 may be used to stabilize the mask system by
contacting the patient's face at the cheeks. A cheek pad may be provided to the inner surface
of the arm to support the arm on the patient's cheek in use. Also, the arms 1026 may be
enveloped in a soft fabric sleeve to act as additional padding against the cheeks of the patient.
The soft fabric sleeve may be in the configuration of an elastic tube covering a portion of the
arms 1026.
2.2.2 Lower Headgear Connectors
Each lower headgear connector 1025 includes an abbreviated arm and a clip
receptacle 1031 at the free end of the arm adapted to be removably interlocked with a
headgear clip associated with a respective headgear strap. The clips allow for easier
positioning or donning/removal of the mask system. In an embodiment, the abbreviated arms
504972DIV22
and clips are also relatively rigid so as to prevent lateral movement of the arms along the y-
axis 1002, relative to the mask system in use.
Figs. 27-30 illustrate an exemplary headgear clip 33 adapted to be removably
interlocked with a clip receptacle 31. As best shown in Fig. 28, each clip 33 includes two
spring arms 35 adapted to interlock with the respective clip receptacle 31 with a snap-fit and a
slot 37 adapted to receive a respective headgear strap in use.
2.2.3 Alternative Headgear Connectors
As shown in Figs. 27-30, the arm 26 may be removably coupled to the shroud,
e.g., arm 26 includes clip structure adapted to removably interlock with a clip receptacle
provided to the shroud. This arrangement allows different styles of upper and lower headgear
connectors to be used with the shroud, e.g., arms for both upper and lower headgear
connectors, clips for both upper and lower headgear connectors, different length arms for
upper and lower headgear connectors, etc.
However, the shroud may provide other suitable arrangements for attaching
headgear straps of headgear. Also, the shroud may include one or more additional
components, e.g., forehead support.
2.2.4 Headgear Connector Positioning
In the embodiment of Figs. 1-6, the upper and lower headgear connectors
1024, 1025 provide headgear connection points that are as far from each other as possible
(i.e., top and bottom of frame) to allow for greater adjustability (e.g., allows adjustment at the
top and bottom of the mask system) and stability (e.g., anchor points spread out around the
mask system so more secure on the patient's face). Also, the upper headgear connectors are
positioned as close to the top of the mask system as possible without obstructing the patient's
eyes in use.
2.2.5 Separate Shroud
In the embodiment of Figs. 1-6, the shroud 1020 is formed separately (e.g.,
molded) and attached to the frame 1040. Such arrangement facilitates molding of the shroud,
allows different materials to be used for the frame and shroud (e.g., frame can be semi-rigid or
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rigid for stability and shroud with headgear rigidizers can be flexible for adjustment, allows the
shroud to hide elbow retention features around elbow/frame opening for retaining elbow to
frame (e.g., provides visual shroud for aesthetics), allows frame to be free of lower clip
receptacles, allows shroud to be used with different size frames, and allows the shroud to be
designed or stylized to minimize obtrusiveness of the mask system. The separate shroud may
also allow the headgear, frame, cushion, and/or elbow to be replaced or washed independently.
2.2.6 Sleeves
In an embodiment, soft fabric sleeves may be mounted on the upper and/or
lower headgear connectors. For example, the sleeves may be elastic and adapted to slide over
the arms of the headgear connectors to form a tight fit. In an embodiment, the sleeves form
elastic tubes. The sleeves may be padded to increase the comfort of the mask system in use.
The sleeves may be particularly useful where the arms of the headgear connectors contact the
patient's skin, e.g., to protect the patient's skin from irritation.
2.2.7 Arm Extends Over the Patient's Ear
Figs. 35-1 to 35-3 and 36 illustrate a shroud 220 for mask system 210
according to another embodiment of the present invention. The shroud 220 includes an
annular retaining portion 222 structured to retain the frame 240 and upper and lower headgear
connectors 224, 225 on each side of the retaining portion 222. In the illustrated embodiment,
the shroud 220 is integrally formed in one piece (e.g., see Fig. 36).
In the illustrated embodiment, each upper headgear connector 224 includes an
elongated arm 226 and a slot 227 at the free end of the arm 226 adapted to receive a
respective rear strap 298 in use. As illustrated, the arm 226 is suitably contoured to extend
along the cheeks and over the patient's ear just anterior of the patient's temple and retain the
respective rear strap 298 in spaced relation over the patient's ear, e.g., to avoid the strap
rubbing or irritating the patient's ear in use.
Also, each arm 226 is structured to extend along and engage an upper strap
292 of the headgear in use. As illustrated, each arm 226 is secured to the upper strap 292 to
add rigidity to the strap and stabilize the mask system on the patient's face in use. In addition,
the strap 292 provides padding to the arm 226 on the patient's face in use. In an embodiment,
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the upper strap 292 may be fixed to the arm 226 by gluing or stitching for example.
Alternatively, the arms 226 may be encapsulated by or inserted into respective straps 292 so
that the arms 226 are substantially not visible.
Each lower headgear connector 225 includes an abbreviated arm 228 with a
slot 229 at the free end of the arm 229 adapted to receive a respective lower strap 294 in use.
As illustrated, the arm 228 is suitably oriented to retain the respective lower strap 294 in
spaced relation under the patient's ear, e.g., to avoid the strap rubbing or irritating the patient's
ear in use.
In an embodiment, each arm may be attached to the upper end of the mask
system and curves below the patient’s field of vision or eyes and curves upwards at an angle
between about 10 to 20 degrees away from the horizontal axis.
In an alternative embodiment, as shown in Fig. 36, each lower headgear
connector 225 may include a clip receptacle 231 adapted to be removably interlocked with a
headgear clip (not shown) associated with a respective lower strap 294. In an embodiment,
the headgear clip receptacle and clip may be similar to that on ResMed's Mirage Liberty™
mask. Exemplary clip arrangements are disclosed in U.S. Patent Publication Nos.
2007/0144525 and 2006/0283461, each of which is incorporated herein by reference in its
entirety.
2.2.8 Shroud Without Upper Headgear Connector
Figs. 37-1 to 37-3 illustrate a mask system 310 according to another
embodiment of the present invention. As illustrated, the mask system 310 includes a shroud
320, a frame 340, a cushion 344, and an elbow 370.
As best shown in Figs. 38-1 to 38-5, the shroud 320 includes an opening 322
structured to receive the elbow 370 and a headgear connector 325 on each side thereof. In the
illustrated embodiment, each headgear connector 325 includes a clip receptacle 331 adapted to
be removably interlocked with a headgear clip (not shown) associated with a respective lower
headgear strap.
The frame 340 is removably attached to the shroud 320, e.g., fingers and tabs
345 extending from opening 322 adapted to engage collar of frame 340.
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The frame 340 includes an upper headgear connector 324 on each upper side
thereof. Each headgear connector 324 includes a clip retainer 333 adapted to be removably
interlocked with a headgear clip (not shown) associated with a respective upper headgear
strap.
Figs. 39-1 to 39-6 illustrate an alternative version of the mask system 310,
which is indicated with similar reference numerals. As illustrated, the frame 340 is provided
without upper headgear connectors, and the each clip receptacle 331 includes an alternative
configuration (e.g., holes for snap-fit tabs on the clip). Also, the shroud 320 in Figs. 39-1 to
39-6 includes support bars 329 structured to wrap around respective auxiliary ports 343, while
the shroud 320 in Figs. 37-1 to 38-5 includes support bars 329 that extend in front of
respective auxiliary ports 343.
2.3 Headgear
Headgear may be removably attached to the headgear connectors 1024, 1025
of the shroud 1020 to maintain the mask system 1010 in a desired position on the patient's
face, e.g., see Fig. 1B.
As shown in Fig. 9, the headgear 1090 includes a pair of upper and lower
straps 1092, 1094 with the upper straps 1092 removably attached to respective upper
headgear connectors 1024 and the lower straps 1094 removably attached to respective lower
headgear connectors 1025. The free end of each strap may include a Velcro® tab structured
to engage the remainder of the strap to secure the strap in place. Such Velcro® attachment
also allows adjustment of the length of the straps. However, the upper and lower headgear
straps may be secured to the shroud in any other suitable manners, e.g., adjustable ladder-lock
arrangement, etc.
The upper straps 1092 split at the crown of the patient's head to top straps
1096 (e.g., connected to one another by a buckle) adapted to pass over the top of the patient's
head in use and rear straps 1098 adapted to pass behind the patient's head in use. In an
embodiment, the headgear 1090 is structured to be self-supporting.
In Fig. 9, the top straps 1096 are adapted to be connected to one another by a
buckle. In an alternative embodiment, as shown in Fig. 27-30, headgear 90 may include upper
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and lower straps 92, 94, top strap 96, and rear strap 98, with the top straps 96 integral with
one another.
The upper straps 1092 are designed to adjust the position of the mask in a
similar way that an adjustable forehead support would alter the position of the mask system,
i.e., move the top of the mask system closer or further away from the patient's nasal bridge.
Without the forehead support, the headgear is connected at the top and bottom
of the mask frame 1040 via the shroud 1020, and in order to avoid the eyes and ears, the arm
1026 of the upper headgear connector extends at an angle. In doing so, the headgear vectors
V1 and V2 (see Figs. 1 and 1B) are aligned such that the mask system may have a tendency to
ride up the patient's face (i.e., upper headgear connectors position upper headgear vectors
upwardly from horizontal and lower headgear connectors position lower headgear vectors
generally horizontal). By splitting the upper headgear strap 1092 at the crown of the patient's
head (i.e., top and rear straps 1096, 1098), the upper headgear vectors are realigned to
prevent the mask system from sliding up the patient’s face.
2.3.1 Headgear Adjustment
Figs. 35-1 to 35-3 illustrate headgear 290 attached to the headgear connectors
224, 225 of the shroud 220 to maintain the mask system in a desired position on the patient's
face.
In the illustrated embodiment, the headgear 290 includes a pair of upper or top
straps 292, a pair of lower or bottom straps 294, and a pair of rear straps 298. In use, the
upper straps 292 are secured to respective upper connectors or arms 226, the lower straps 294
are removably attached to respective lower connectors via slots 229/clip arrangement 231, and
the rear straps 298 are removably attached to respective upper connectors via slots 227. The
upper straps 292 may include upper strap portions adapted to pass over the top of the patient's
head and couple to one another, e.g., via a headgear buckle or adjustable ladder-lock
arrangement 299. In the illustrated embodiment, the lower straps 294 and rear straps 298 are
formed in one piece.
This headgear arrangement allows adjustment to occur at three positions, i.e.,
upper straps 292 at the headgear buckle 299, lower straps 294 at the slot 229/clip 231
connection, and rear straps 298 at the slot 227 connection.
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As illustrated, the free end of each strap may include a hook and loop tab 295
(e.g., Velcro®) structured to engage the remainder of the strap to removably secure the strap
in place. Such hook and loop attachment also facilitates adjustment of the length of the straps.
In the illustrated embodiment, the lower straps 294 and rear straps 298 are
adapted to join and pass behind the patient's head in use (e.g., see Fig. 35-3). As illustrated,
the lower straps 294 join at an angle α (e.g., similar to the bottom strap in ResMed's Mirage
Liberty mask) to prevent the strap from irritating the patient's neck and/or prevent movement
of the strap due to movement of the patient's neck in use.
In an embodiment, the headgear may be similar to that for ResMed's Mirage
Liberty mask, however the top straps have been modified and there is an added rigidizer
system. The top straps may be similar to ResMed's Swift style headgear, with the rigidizers
extending along the sides.
2.3.2 Alternative Headgear Material
Figs. 43-1 to 43-4 illustrate a mask system 610 including a mask 615 and
headgear 690 according to another embodiment of the present invention. In the illustrated
embodiment, the headgear 690 includes an arrangement of straps wherein some of the straps
are constructed of silicone and some of the straps are constructed of Breath-O-Prene™
material. However, the headgear may be constructed such that the straps are completely
constructed of silicone or completely constructed of Breath-O-Prene™.
As illustrated, the lower strap portion 692 of the headgear is constructed of
Breath-O-Prene™ and extends along the cheeks and around the back of the patient's head.
The upper strap portion 694 of the headgear is constructed of silicone and includes side straps
694(1) that extend along the upper cheek and over the patient's ear, a top strap 694(2) that
extends over the top of the patient's head, rear straps 694(3) that extend behind the patient's
head and connects to the lower strap portion 692 (see Fig. 43-4), and connecting portions
694(4) that extend from respective side straps 694(1) in front of the patient's ear and connect
to the lower strap portion 692.
The headgear straps may be connected to the mask in any suitable manner. For
example, in the illustrated embodiment, the lower strap portion 692 is connected to the mask
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by a headgear clip arrangement and the upper strap portion 694 is connected to the mask using
an elongated buckle 695 with buckle portions on each end thereof.
In an embodiment, the headgear straps are arranged such that the force vectors
applied by the headgear to the mask are substantially perpendicular to the mask and
substantially parallel to one another (e.g., as shown by the arrows in Fig. 43-2). This
arrangement enhances the mask seal as the headgear forces the mask directly into the patient's
face.
3. Seal
The seal (i.e., cushion) of the mask system is structured to accommodate the
elimination of a forehead support from a full-face type interface.
3.1 Cushion
As shown in Figs. 1-5 and 7-8, the cushion 1060 is structured to interface with
the frame 1040 and form a seal with the patient's nose and mouth in use. In the illustrated
embodiment, the cushion is a full-face cushion adapted to engage the patient’s face generally
along nasal bridge, cheek, and lower lip/chin regions of the patient’s face. However, other
cushion interfaces are possible, e.g., nasal.
The cushion 1060 is structured be more compliant or flexible (e.g., particularly
in the nasal bridge region) to accommodate more movement due to loss of some stability
without a forehead support.
The cushion 1060 is constructed of a soft and flexible biocompatible material,
e.g., such as silicone. In the illustrated embodiment, the cushion 1060 includes a dual wall
configuration wherein the cushion comprises an undercushion or support wall 1062
underneath a membrane 1064 as shown in Fig. 8.
The membrane 1064 is generally softer and less stiff than the undercushion
1062 and provides a seal against the patient’s face in use. The membrane may be relatively
thin to allow for wider fit range and better conformance to the patient's face in view of less
mask stability with a forehead support. The undercushion is structured to generally support
the membrane and prevents collapse of the membrane when the mask system is attached and
tightened using the headgear.
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The membrane 1064 is generally concave and curves inwards towards the
breathing chamber. The undercushion 1062 may also curve inwardly but is generally shorter,
thicker, and more rigid than the membrane.
In an embodiment, the undercushion 1062 at the regions of the nasal bridge
and/or chin of the patient is shorter in height or completely absent and the height from the tip
to base of the undercushion 1062 may be between about 0 mm and 30 mm. The membrane is
generally longer than the undercushion 1062 at any given cross-section and may be between
about 1 mm and 40 mm. For example, Fig. 8B illustrates a cross-section through nasal bridge
and chin regions of the cushion to illustrate the membrane 1064 without an undercushion in
these regions.
In an embodiment, the undercushion 1062 may only be provided in selected
regions of the mask system, e.g., where the mask system is to be pushed away from the
patient's face. Certain pre-determined regions of the patient’s face may be preferably avoided
for applying pressure by the tightening of the headgear. In the illustrated embodiment, the
nasal bridge and chin regions of the patient do not include an undercushion 1062. In these
regions, the undercushion is only provided along lateral sides of the cushion (e.g., see Fig. 7)
which press against the cheeks of a patient so as to more evenly distribute the force vectors
applied by the mask system in use. In an embodiment, the undercushion may be relatively stiff
along the cheek regions because these points of contact are acting as anchor points, i.e., holds
mask system in position to provide effective seal.
This configuration of avoiding the nasal bridge and chin of the patient may
increase the comfort of the mask system for patients by reducing the pressure or force applied
to sensitive areas or to protruding regions of the patient’s face that experience relatively higher
contact pressures. Additionally, this arrangement avoids the cushion pinching the nasal bridge
of the patient when the mask system is adjusted. Additionally, the cushion of this embodiment
may be noticeably softer in the regions of the nasal bridge and chin because of the absence of
the undercushion.
In an embodiment, the undercushion may include a variable height, stiffness,
and/or thickness to generate a variable softness in the aforementioned predetermined regions
of the face that require lighter support.
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In the illustrated embodiment, the cushion may be structured to seal lower
down on the patient's nasal bridge and the eye sockets so that the cushion is less obtrusive.
In an embodiment, the cushion may be generally frosted except at patient
contacting surfaces where it is polished. In an embodiment, the frosting of the cushion may
reduce restriction between the face and membrane and/or the membrane and undercushion.
The frosting allows the surface of the membrane and undercushion to slide against each
other’s respective surface without the same restriction of unfrosted silicone. This feature may
also prevent or limit sticking of the membrane to the undercushion components and also may
generally improve the overall comfort and sealing properties of the cushion. Additionally, the
frosting of the cushion may be easier to manufacture and may lead to a reduction of costs of
manufacturing. The cushion may be constructed of frosted silicone or other suitable materials.
3.2 Cushion Lower On Nasal Bridge
Figs. 31-1 to 31-5 illustrate various views of a cushion 44 (e.g., constructed of
silicone) according to an embodiment of the present invention. As illustrated, the cushion 44
includes a base wall 44(1) provided to the frame, an undercushion layer (UCL) 44(2)
extending away from the base wall 44(1), and a membrane 44(3) provided to substantially
cover the UCL 44(2) and provide a sealing structure. In the illustrated embodiment, the
cushion 44 is structured to sit lower on the nasal bridge to reduce mask obtrusiveness and
improve "line of sight" in use.
Also, as best shown in Figs. 31-3 and 31-5, the UCL 44(2) design in the nasal
bridge region is structured to provide improved stability across the nasal bridge in use. As
shown in Fig. 31-1 and 31-3, the UCL is not provided in the lower lip/chin region. However,
other arrangements of the UCL are possible, e.g., UCL around entire perimeter.
In an embodiment of the cushion shown in Figs. 31-1 to 31-5, D1 may be about
-20 mm, e.g., 18.2 mm, D2 may be about 53-59 mm, e.g., 55.8 mm, D3 may be about 88-
93 mm, e.g., 90 mm, D4 may be about 78-83 mm, e.g., 81.1, D5 may be about 58-63 mm,
e.g., 60 mm, D6 may be about 95-100 mm, e.g., 98.1 mm, D7 may be about 57-62 mm, e.g.,
59.7 mm, D8 may be about 77-82 mm, e.g., 79 mm, D9 may be about 88-93 mm, e.g., 90.7
mm, D10 may be about 30-35 mm, e.g., 33.1 mm, D11 may be about 14-19 mm, e.g., 16.4
mm, D12 may be about 8-13 mm, e.g., 9.6 mm, D13 may be about 0.3-0.5 mm, e.g., 0.35 mm,
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D14 may be about 0.4-0.6 mm, e.g., 0.5 mm, and D15 may be about 0.3-0.5 mm, e.g., 0.4
mm. Although specific dimensions and ranges are indicated, it is to be understood that these
dimensions and ranges are merely exemplary and other dimensions and ranges are possible
depending on application. For example, the exemplary dimensions may vary by 10-20% or
more or less depending on application.
3.3 Cushion Higher On Nasal Bridge
Figs. 35-1 and 35-2 illustrate a full-face cushion 244 adapted to engage the
patient’s face generally along nasal bridge, cheek, and lower lip/chin regions of the patient’s
face. In this embodiment, the cushion 244 is structured such that it is positioned higher on the
bridge of the nose for sealing and comfort (e.g., with respect to the cushion 44 described
above). The cushion 244 may also be better for anthropometrics, i.e., the cushion will fit more
people.
In an embodiment, the cushion 244 may include a concertina section as
described below (e.g., in the nasal bridge region) to enhance the flexibility of the cushion in
use.
3.4 Concertina Section
As best shown in Figs. 30 and 33, a concertina section 50 may be provided in a
nasal bridge region of the cushion and/or frame. As illustrated, the concertina section 50
includes a bellows structure with one or more folds 52 that provide a higher degree of
flexibility or increased movement. That is, the concertina section 50 provides a higher level of
adaptability or flexibility to the nasal bridge region of the cushion/frame which is a more
sensitive region of the patient's face in use. Moreover, the concertina section 50 provides
increased movement without compromising seal.
Figs. 32-1 to 32-3 illustrate various views of a concertina section 50 (isolated
from the remainder of the cushion/frame) with one or more folds 52 according to an
embodiment of the present invention. As best shown in Fig. 32-3, the folds may have different
lengths, depths, and/or contours with respect to one another to optimize the concertina effect,
e.g., provide sufficient degree of movement without compromising seal. For example, as
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shown in Fig. 32-3, each fold 52 includes a first side wall 52(1) and a second side wall 52(2)
that interconnects adjacent side walls 52(1).
In the illustrated embodiment, the first side walls 52(1) and/or the second side
walls 52(2) may become progressively longer away from the patient's face. For example, the
first side wall 52(1) and/or the second side wall 52(2) adjacent patient's face, or the
combination of side walls 52(1) and 52(2), may have a length that is longer than and in some
cases significantly longer than the adjacent side wall 52(1) and/or 52(2) (e.g., one side wall at
least 25% greater than and up to 5x as long as the other side wall, e.g., 1x, 2x, 3x, or 4x).
The folds may be constructed and arranged to provide a predetermined order
of movement or folding, e.g., folds structured to fold in a sequential or progressive manner
wherein one fold collapses before an adjacent fold collapses. For example, upon application of
force, the folds closest to the patient's face may fold or collapse before the folds furthest from
the patient's face. Also, the folds may be constructed and arranged to provide various degrees
of fold or collapse, e.g., folds may fold or collapse more than others.
In an embodiment of the concertina section shown in Figs. 32-1 to 32-3, D1
may be about 50-60 mm, e.g., 55.7 mm, D2 may be about 5-15 mm, e.g., 9.7 mm, and D3
may be about 0.3-0.5 mm, e.g., 0.4 mm. Although specific dimensions and ranges are
indicated, it is to be understood that these dimensions and ranges are merely exemplary and
other dimensions and ranges are possible depending on application. For example, the
exemplary dimensions may vary by 10-20% or more or less depending on application.
It should be appreciated that a concertina section 50 may be provided in other
regions of the cushion and/or frame, e.g., depending on patient comfort. For example, the
concertina section 50 may be provided around the entire perimeter of the cushion and/or frame
or may be provided in selected regions of the cushion and/or frame.
Also, the flexibility of the concertina section 50 may be varied and may be
varied in different regions of the cushion and/or frame, e.g., depending on patient comfort.
For example, the cushion and/or frame may include a concertina section in the nasal bridge
region with a relatively high degree of flexibility and a concertina section in the lower lip/chin
region with a relatively low degree of flexibility. The flexibility of the concertina section 50
may be varied by varying the number of folds 52 (e.g., 1-5 folds), the wall lengths, the wall
thickness of the folds 52, the depth of the folds 52, etc.
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As noted above, the cushion and frame may be co-molded of two parts with
different materials/rigidities or may be integrally formed of the same material. In both
embodiments, the concertina section may be provided in the frame and/or the cushion.
In Figs. 27-30, the cushion 44 and frame 40 are co-molded of two parts with
the concertina section 50 provided in the frame 40. The frame 40 and cushion 44 include
different rigidities in order to optimize the function of each part. For example, one part (i.e.,
cushion 44) may be constructed of a relatively soft, supple material to optimize the sealing
effect and the other part (i.e., frame 40) may be constructed of a more rigid material to
provide adequate support for the cushion while at the same time allowing a sufficient degree
of movement to optimize the concertina effect. While the frame is more rigid than the
cushion, the frame may be constructed of a flexible material to allow the concertina effect.
In Fig. 33, the frame 40 and cushion 44 are integrally formed in one piece with
the concertina section 50 provided in the frame 40. The material properties and/or dimensions
may be selectively modified to optimize sealing and concertina effects.
For both embodiments of Figs. 27-30 and 33, it should be appreciated that the
concertina section may be alternatively provided in the cushion 44 or in both the frame 40 and
cushion 44. For example, Fig. 34 illustrates a concertina section 50 integrally formed with the
cushion 44 in the nasal bridge region.
4. Elbow
As shown in Fig. 3, the elbow 1070 (e.g., constructed of a relatively hard
material such as polycarbonate or polypropylene) includes a first end portion 1074(1) and a
second end portion 1074(2). The first end portion 1074(1) provides an interfacing structure
structured to interface or otherwise attach to the frame 1040. The second end portion
1074(2) is adapted to be connected to an air delivery tube.
4.1 Elbow Connection to Frame
The frame 1040 is structured to maintain the elbow 1070 in an operative
position with respect to the patient's face. That is, the frame acts as a carrier and bearing
surface for the elbow. The frame and elbow may connect with a friction fit, snap-fit,
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mechanical interlock, or other suitable attachment mechanism. However, other suitable
arrangements for attaching the elbow to the frame are possible.
In the illustrated embodiment, the elbow 1070 includes a series of tangs 1075
adapted to releasably engage within the opening 1046 of the frame 1040, e.g., with a snap-fit.
The tangs 1075 hold the elbow in place (e.g., preferably a relatively airtight connection) and
permit rotation or swiveling of the elbow with respect to the frame.
That is, the elbow is rotatably attached to the frame so that the elbow may be
rotated relative to the frame in use, e.g., 360° rotation. This arrangement allows the elbow to
assume different orientations in use, e.g., depending on patient preference. For example, the
elbow may assume a first orientation so that the elbow extends generally downwardly from the
mask to direct the air delivery tube under the patient's head in use. Alternatively, the elbow
may be rotated and assume a second orientation so that the elbow extends upwardly from the
mask to direct the air delivery tube over the patient's head in use. In an embodiment, the
frame and elbow may be constructed of dissimilar materials to prevent or at least reduce
squeak between the components in use.
The second end portion of the elbow may be provided to a swivel joint adapted
to be connected to the air delivery tube. For example, Figs. 27-30 illustrate a swivel joint 80
provided to the second end portion 74(2) of elbow 70. In the illustrated embodiment, the
swivel joint 80 is provided to a short tube 82 (e.g., extendable and retractable tube) that
interconnects the elbow with the air delivery tube. In an embodiment, the swivel joint 80 may
be integrally formed in one piece with the short tube 82.
4.2 AAV
The elbow 1070 includes a slot 1081 to receive an anti-asphyxia valve (AAV),
a port 1079 that is selectively closed by a flap portion of the AAV (depending on the presence
of pressurized gas), and structure for attaching the AAV, e.g., with a snap-fit.
Figs. 27-30 illustrate an exemplary AAV 85 including a flap portion 86 to
selectively close port 79 in elbow 70. In this embodiment, a clip portion 88 is provided to the
flap portion 86 for attaching the AAV 85 to the elbow 70. In the illustrated embodiment, the
flap portion 86 and the clip portion 88 are co-molded with one another to form a one-piece,
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integrated component. However, the flap portion 86 and clip portion 88 may be secured to
one another in other suitable manners, e.g., mechanical interlock.
In an embodiment, the flap portion 86 may be constructed of a relatively soft
elastomeric material (e.g., silicone) and the clip portion 88 may be constructed of a more rigid
material (e.g., rigid plastic) for interfacing with the elbow 70.
The clip portion 88 of the AAV 85 includes structure for removably
interlocking with the elbow 70, e.g., with a snap-fit. For example, the clip portion 88 may
include tabs structured to interlock with respective recesses/protrusions provided to the
elbow.
Figs. 35-1 and 35-2 illustrate an elbow 270 including a port 279 that is
selectively closed by a flap portion 286 of the AAV 285 (depending on the presence of
pressurized gas). Also, Figs. 37-1 to 37-3 illustrate elbow 370 including a port 379 and a slot
381 to retain the AAV.
Alternative embodiments of the AAV are disclosed in PCT Application No.
, which is incorporated herein by reference in its entirety.
4.3 Large Diameter End Portion
As shown in Figs. 27-30, the first end portion 74(1) of the elbow 70 may
provide a relatively large diameter which allows the potential for cleaner/smoother lines
thereby contributing to the overall mask aesthetic and reduced obtrusiveness. In addition, the
relatively large diameter elbow offers the potential for the patient's nose to protrude into the
elbow cavity thereby permitting the mask to be brought closer to the patient's face (i.e.,
reduced obtrusiveness), less moment since center of gravity of mask is closer to the patient's
face, and/or improved line of sight.
. Modular Design
The mask system provides a modular design that allows different styles and/or
sizes of the frame (also referred to as a frame module), shroud (also referred to as a shroud
module), cushion (also referred to as a cushion module), and/or elbow (also referred to as an
elbow module) to be interchanged or mixed and matched with one another to provide a more
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customized mask system for the patient. In addition, such design allows selected modules to
be easily replaced, e.g., treatment requirements change, worn out or damaged, etc.
In an embodiment, the mask system may be provided with a number of
different cushions, e.g., each having cushions of different styles and/or sizes (e.g., depending
on patient preference and/or fit). For example, the non-face contacting side of each cushion
may include a common or universal configuration for interfacing with the frame, and the face-
contacting side of the cushion may include different styles and/or sizes. This provides a
modular arrangement that allows the frame to be selectively (e.g., and removably) coupled to
one of multiple cushion. For example, the different cushions may include different size
cushions (e.g., small, medium, and large) and may include a different cushion structures.
In an embodiment, the mask system may be provided with different shrouds,
e.g., each shroud having a different style and/or size (e.g., shroud with different
arrangement/style of headgear connectors, shroud with forehead support, different headgear
vectors, etc).
In an embodiment, the mask system may be provided with different frames,
e.g., each frame having a different style and/or size (e.g., frame with different vent
arrangement, small, medium, and large size frame, etc).
In an embodiment, the mask system may be provided with a number of
different elbows, e.g., each having a vent arrangement, AAV (in the case of an oro-nasal
mask), and/or elbow of different styles and/or sizes. In the illustrated embodiment of Figs. 27-
, the vent arrangement 76 and AAV 85 are structured to be removably attachable to the
elbow 70. This provides a modular arrangement that allows the elbow to be selectively and
removably coupled to one of multiple vent arrangements and/or AAVs. This also allows the
vent arrangement and AAV to be easily replaced, e.g., if damaged.
.1 Shroud to Frame Connection
The shroud is mounted on the outer surface of the frame, e.g., preferably with a
tight, conforming fit on the frame.
.1.1 Upper Retaining Mechanism
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In the illustrated embodiment of Figs. 1-5, the shroud 1020 is connected to the
frame 1040 by an upper retaining mechanism or interfacing structure 1048 located on the top
end of the frame and shroud.
As shown in Figs. 2 to 5, the upper retaining mechanism 1048 is in the form of
two taper locks structured to secure the shroud 1020 on the frame 1040 and prevent
unintentional disassembly particularly due to headgear forces. In this embodiment, opposing
sides of the frame include a female slot 1055 adapted to receive a respective tang protrusion
(which tapers along its length) on the underside of the shroud 1020. The tapered protrusion
engages within a respective female slot, e.g., with a friction fit.
Figs. 10 to 19-4 show another embodiment of a mask system 1110 which more
clearly illustrates an embodiment of the taper lock. Figs. 10 to 17 show various views of the
frame 1140, shroud 1120, and elbow 1170 of the mask system 1110.
As best shown in Figs. 11 to 13, opposing sides of the top end of the frame
1140 include a platform 1154 which provides a first female slot 1155(1). In addition, the
space between the platform 1154 and the outer surface of the frame 1140 defines a second
female slot 1155(2). As best shown in Fig. 17, opposing sides of the top end of the shroud
1120 include a tang protrusion 1156 on the underside of the shroud 1120. The tang
protrusion 1156 includes a first tang 1156(1) and a second tang 1156(2) that extends generally
transverse to the first tang 1156(1). As shown in Figs. 18-1 and 18-2, each tang may taper
along its length, i.e., thinner towards its free end.
Figs. 18-1 and 18-2 and 19-1 to 19-4 sequentially illustrate attachment of the
shroud 1120 to the frame 1140. As illustrated, the tangs 1156(1), 1156(2) of each tang
protrusion 1156 are structured to engage with respective slots 1155(1), 1155(2), e.g., with a
friction fit. As best shown in Figs. 19-1 to 19-4, each slot 1155(2) includes lead-ins or guides
1157 that curve along their length (i.e., extend in vertical and horizontal direction) so as to
guide the tang 1156(2) into the slot 1155(2) and aid assembly. Figs. 18-2 and 19-4 show the
tangs 1156(1), 1156(2) when fully inserted with respective slots 1155(1), 1155(2).
In an alternative embodiment, as shown in Fig. 20, the upper retaining
mechanism may include a clip-type arrangement. As illustrated, opposing sides of the top end
of the frame 1240 provide a shoulder 1255(1) and a tapered protrusion 1255(2). Opposing
sides of the top end of the shroud 1220 include a first tang 1256(1) and a second tang 1256(2)
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on the underside of the shroud 1220. In use, each first tang 1256(1) is engaged with the
respective shoulder 1255(1) and the second tang 1256(2) is engaged or clipped onto the
tapered protrusion 1255(2), e.g., with a snap-fit.
.1.2 Lower Retaining Mechanism
In an embodiment, the shroud may also be connected to the frame by a lower
retaining mechanism located on the bottom end of the frame and shroud. For example, a
retaining mechanism may be provided to the opening of the shroud which is structured to
interlock or otherwise engage with the opening of the frame.
For example, as shown in Figs. 14, 15, 17, and 21, the opening 1132 of the
shroud 1120 may include structure adapted to engage the collar 1149 surrounding the frame
opening 1146 with a snap-fit. As illustrated, the shroud 1120 includes snap fingers 1145(1)
(e.g., three snap fingers) and sandwich tabs 1145(2) (e.g., three sandwich tabs) that extend
from the opening 1132. The snap fingers and sandwich tabs are alternatively spaced about the
opening.
In use, the snap fingers 1145(1) resiliently deflect (e.g., 0.5 mm deflection) and
engage respective part-annular protrusions 1149(1) provided to the collar 1149 (e.g., see Figs.
22 and 23) to provide an initial retention of the shroud 1120 to the frame 1140 (e.g., with
allowable stresses), e.g., to facilitate assembly and disassembly. In addition, as the snap
fingers 1145(1) engage respective protrusions 1149(1), the sandwich tabs 1145(2) are
received in respective recesses 1149(2) provided to the end of the collar 1149 (e.g., see Figs.
22 and 23). When the elbow 1170 is engaged with the frame 1140 (e.g., see Fig. 23), an
annular protrusion 1171 on the elbow 1170 is positioned on an opposing side of the sandwich
tabs 1145(2) so that the sandwich tabs 1145(2) are sandwiched between the collar 1149 and
the elbow 1170. Thus, the sandwich tabs utilize elbow retention forces to retain the shroud on
the frame during use. The elbow 1170 has a distal shoulder 1173 adapted to extend under the
edge of the frame 1140 to retain the elbow to the frame. The snap fingers 1145(1) allow the
shroud to connect to the frame independent of the elbow.
In an alternative embodiment, as shown in Fig. 24, the shroud's lower section
may be structured to clip to a single point below the collar. As illustrated, the lower end of
the shroud 1320 includes a snap finger 1345 that is engaged or clipped onto a protrusion
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1349(1) spaced below the collar 1349 of the frame 1340, e.g., with a snap-fit. In this
embodiment, the protrusion 1349 extends from the cover enclosing auxiliary ports. This
arrangement may facilitate molding of the collar on the frame, e.g., uniform thickness of the
collar prevents molding distortions. In addition, removal of the protrusions 1149(1)/recesses
1449(2) from the collar may reduce the risk of leak.
.1.3 Finger Grip
In an embodiment, the outer surface of the frame 1040 may include finger grips
or recessed portions 1097, which are positioned to be exposed under the shroud 1020. The
finger grips are adapted to allow the patient an improved ability to grip the frame and/or
shroud which is particularly useful when disengaging the shroud from the frame.
.1.4 Alternative Interfacing Structure
In an alternative embodiment, as shown in Fig. 27-30, the shroud 20 includes
an open construction that provides an annular or part annular retaining portion 22 structured
to retain the frame 40 and the elbow 70. As illustrated, the annular retaining portion 22
includes an interfacing structure 23 along an inner edge that is adapted to interface with or
otherwise removably connect to an interfacing structure 48 along the outer perimeter of the
frame 40 (e.g., see Fig. 28). In the illustrated embodiment, the interfacing structure 23 is in
the form of opposed flanges 23(1) that are adapted to interlock with respective locking
structures 48(1) provided on opposing sides of the frame 40. However, other suitable
arrangements for attaching the frame 40 to the shroud 20 are possible, e.g., friction fit, snap-
fit, mechanical interlock, or other suitable attachment mechanism.
For example, the frame 40 may be coupled to the shroud 20 in a manner that
allows the frame 40 to be locked in different angular positions with respect to the shroud 20,
e.g., pivotally mounted.
.1.5 Alternative Upper Headgear Connector
Figs. 40-1 to 40-7 illustrate a frame and a clip-on upper headgear connector or
rigidizer according to another embodiment of the present invention.
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The frame 442 includes an opening 449 adapted to engage a frame shroud
and/or elbow. Around and under the opening 449 is the u-shaped slot 402 for gas washout
and auxiliary ports 443 on each side thereof.
In this embodiment, each upper side of the frame 442 includes a retaining
member 433 and an upper intermediate portion of the frame 442 includes retaining grooves
435, which are structured and arranged to retain an upper headgear connector or rigidizer 424.
As best shown in Figs. 40-6 and 40-7, the upper headgear connector 424
includes a pair of elongated arms or rigidizers 426 coupled by a pair of wire members 428.
Each rigidizer 426 includes a slot 427 at its free end adapted to receive a respective headgear
strap in use.
In use, the upper headgear connector 424 is adapted to clip onto the frame 442
(e.g., see Figs. 40-1 and 40-2). Specifically, intermediate portions of the wire members 428
are received in respective grooves 435 of the frame 442, and end portions of the wire members
428 extend through respective retaining members 433 with the rigidizers 426 providing a
shoulder to interlock with respective retaining members 433. Figs. 40-4 and 40-5 show an
upper portion of a retaining member 433 to illustrate the groove 433(1) adapted to receive a
respective wire. As illustrated, the end of the groove 433(1) includes tapered side walls
433(2) and drops off towards a rear side 433(3) to position the rigidizers 426 into interlocking
engagement with the retaining member 433.
Figs. 41-1 to 41-12 illustrate an upper portion of a frame and a clip-on upper
headgear connector or rigidizer according to another embodiment of the present invention.
As illustrated, the upper portion of the frame 542 includes a retaining member
533 on each side thereof and a retaining groove 535 along an intermediate portion thereof,
which are structured and arranged to retain an upper headgear connector or rigidizer 524.
As best shown in Figs. 41-5 and 41-12, the upper headgear connector 524
includes a pair of elongated arms or rigidizers 526 coupled by a connecting portion 528. Each
rigidizer 526 includes a slot 527 at its free end adapted to receive a respective headgear strap
in use. In addition, the upper headgear connector 524 includes a clip structure 525 on each
side of the connecting portion 528.
In use, the upper headgear connector 524 is adapted to clip onto the frame 542
(e.g., see Figs. 41-1 and 41-2). Specifically, the connecting portion 528 is received in the
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groove 535 of the frame 542, and the clip structures 525 releasably interlock with respective
retaining members 533. As best shown in Figs. 41-3 and 41-4, each retaining member 533
provides a cross-bar, and each clip structure 525 provides a v-shaped configuration that is
adapted to resiliently deflect through the cross-bar and provide a shoulder to releasably
interlock with the cross-bar.
Figs. 42-1 to 42-7 illustrate an alternative embodiment for engaging the upper
headgear connector with the frame. As illustrated, each retaining member 533 provides an
open-ended cross-bar, and each clip structure 525 provides an elongated arm. In this
embodiment, the cross-bar is structured to resiliently deflect to allow the clip structure 525 to
extend through the cross-bar and releasably engage the cross-bar, e.g., with a friction fit. In
addition, the upper headgear connector 524 of Figs. 42-1 to 42-7 includes a c-shaped clip
structure 529 adapted to interlock with a tab 549 provided to the frame 542 (see Figs. 42-1
and 42-2).
.1.6 Grommet Attachment
Figs. 44 and 45 illustrate an alternative mask arrangement in which the shroud
is attached to the frame via a grommet.
For example, as shown in Fig. 44, the frame 740 includes a grommet 745 (e.g.,
constructed of a rubber) and the shroud 720 includes an opening 725 adapted to receive the
grommet 745 to secure the shroud 720 to the frame 740. As illustrated, the shroud 720
includes elongated upper and lower arms 724, 726 each with a slot 727 at its free end adapted
to receive a respective headgear strap in use.
Fig. 45 illustrates an alternative shroud 820 which includes a single arm with a
slot 827 at each end adapted to receive a respective headgear strap in use. In addition, the
shroud 820 provides an elongated inner slot 825 adapted to receive the grommet 745 of the
frame 740. The elongated slot 825 allows the grommet 745 to be fixed in one of multiple
positions along the length of the slot 825, in contrast to the shroud 720 which provides a
single fixed position. In an embodiment, the shroud 820 may be slidable with respect to the
grommet 745 to allow an infinite number of positions with respect to the frame 740.
In each embodiment, the grommet 745 (e.g., constructed of a rubber) fixes the
shroud in position but the inherent flexibility of the grommet provides a flexible connection to
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decouple the shroud from the frame and allow a range of movement between the two
components, e.g., like a ball joint or gimbal. Such arrangement helps with fitting and sealing
of the mask to the patient's face. That is, the flexible connection allows the mask to selectively
adjust and/or self-fit with the patient's face.
.2 Cushion to Frame Connection
In Figs. 1-8, the non-face contacting side of the cushion 1060 is connected to
frame 1040 in a tongue and groove relationship. The tongue 1066 (see Figs. 1C, 1D, and 8)
of the cushion 1060 is inserted within a groove 1041 (see Figs. 1C and 1D) provided along the
perimeter of the frame 1040. The tongue and groove relationship may also include a locking
lip or sealing lip 1068 (see Figs. 1C, 1D, and 8) on the cushion that is adapted to interlock
with an undercut bead 1042 (see Figs. 1C and 1D) within the frame groove to fixably retain
the cushion to the frame.
In the illustrated embodiment, the cushion 1060 also includes one or more
positioning features located around its circumference to assist with proper alignment of the
cushion with the frame 1040. As shown in Fig. 7, the cushion 1060 includes notches and/or
protrusions (e.g., two notches 1067 and one protrusion 1069) adapted to engage with
complementary features in the frame, e.g., interlocking relationship.
.2.1 Co-Molding Frame and Cushion
In an embodiment, as shown in Figs. 27-30, the frame 40 and cushion 44 may
be co-molded with one another to form a one-piece, integrated component. For example, the
frame 40 may be molded of a first material adapted to interface with the shroud 20 and the
cushion 44 may be co-molded onto the frame 40 of a second material adapted to interface with
patient's face.
In such embodiment, the cushion 44 may be constructed of a relatively soft
elastomeric material (e.g., silicone) for sealing and the frame 40 may be constructed of a more
rigid material than the cushion 44 (e.g., polycarbonate, polypropylene) for interfacing with the
frame.
Co-molding the frame 40 to the cushion 44 provides a chemical bond without
necessarily forming a mechanical interlock. As a result, the connection includes no cracks, a
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gas tight seal, and clean interface. Moreover, such co-molded connection relaxes tolerances as
the mold materials are sufficiently flexible to fill in any gaps at the interface between the frame
40 and the cushion 44. Also, the co-molded frame/cushion provides a reduced part count
(reduced cost) and facilitates assembly/disassembly to the shroud 20.
In an alternative embodiment, as shown in Fig. 33, the frame 40 and cushion 44
may be integrally formed in one piece, e.g., of a silicone material. That is, the frame 40 may
have the same shape and structure as described above, but be integrally molded of the same
material, e.g., silicone.
In an embodiment, the integrally formed frame 40/cushion 44 may be co-
molded to the shroud 20, e.g., constructed of polycarbonate or polypropylene. For example,
the shroud 20 may be constructed of a relatively rigid material (e.g., polycarbonate or
polypropylene) and the frame 40/cushion 44 may be co-molded onto the shroud 20 of a
relatively soft elastomeric material (e.g., silicone).
.3 Vent Arrangement
In Figs. 1, 1B, 1C, 1D, and 2-5, the vent arrangement 1076 is provided to the
frame and includes a plurality of holes 1077 (e.g., 5-100 holes, e.g., 20-50 holes, or about 35
holes) oriented at an angle (e.g., 45°) on the outer surface of the frame so as ensure the
exhausted air is directed away from the patient and preferably their bed partner when the
patient is sleeping. As shown in Figs. 1C and 1D, each hole 1077 may include a contour or
taper along its length. However, it should be appreciated that the vent arrangement may
include other suitable arrangements, e.g., different number of holes, hole arrangement,
positioning on frame, vent provides part pf interlocking structure with shroud, etc.
Fig. 35-1 illustrates a vent arrangement 276 provided to the frame 240 for gas
washout. In the illustrated embodiment, the vent arrangement 276 is in the form of a vent
insert (e.g., elastomeric vent insert) that is adapted to be removably supported within an outlet
opening in the frame 240. The vent insert may be similar those described in U.S. Patent Nos.
6,561,190, 6,561,191, and 7,207,335, each of which is incorporated herein by reference in its
entirety. However, it should be appreciated that the vent arrangement may have other suitable
forms (e.g., vent holes in frame 40 (Fig. 28), etc.).
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Figs. 37-3, 39-2, and 39-4 illustrate a frame 340 that includes a u-shaped slot
302 that receives a u-shaped plug-type vent 305 for gas washout. As illustrated, the plug-type
vent 305 wraps around and under the opening in the frame 340 for the elbow 370. The plug-
type vent 305 includes a plurality of tracks or grooves 307 on each side thereof. In use, the
grooved plug-type vent 305 forms a seal with the slot 302 so that exhausted air can exit
between the slot walls and the grooves 307 on the plug-type vent 305. In an embodiment, the
port caps 347 may be integrated or incorporated into the plug-type vent 305 (e.g., integrally
formed in one piece). Further details of such a plug-type vent arrangement are provided in
U.S. Patent Application No. 12/230,120, filed August 22, 2008, which is incorporated herein
by reference in its entirety. Figs. 39-2 to 39-6 show the frame 340 with the grooved plug-type
vent 305 removed so as to more clearly illustrate the u-shaped slot 302 and auxiliary ports 343
on each side thereof.
Also, it should be appreciated that the vent arrangement may be provided to
the elbow. For example, a shown in Figs. 27-30, the vent arrangement 76 is in the form of a
vent insert that is adapted to be removably supported within an outlet opening in the elbow 70.
In an embodiment, the vent arrangement 76 includes a base adapted to be supported within the
outlet opening, one or more grill components or media (e.g., filter, membrane, or other porous
material) provided to the base and structured to diffuse vent flow, and a cover to maintain the
grill components/media within the base. Only the cover 77 of the vent arrangement 76 is
visible in Figs. 27-30.
Exemplary embodiments of such a vent arrangement are disclosed in U.S.
Patent Application No. 12/230,120, filed August 22, 2008, which is incorporated herein by
reference in its entirety.
However, it should be appreciated that the vent arrangement may include other
suitable arrangements, e.g., vent insert with one or more vent holes.
Also, the elbow may provide an alternative venting arrangement to the vent
insert. For example, as indicated in dashed lines in Fig. 30, the first end portion 74(1) of the
elbow 70 (e.g., along the interfacing structure 75) may include one or more vent holes 276 for
gas washout. The one or more holes 276 may be provided to a soft part (e.g., silicone seal as
described below) and/or a hard part (e.g., polycarbonate, polypropylene) of the elbow. The
holes 276 may extend around the entire perimeter of the first end portion 74(1) or may extend
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along one or more portions of the first end portion 74(1). It is noted that providing vent holes
along the entire perimeter of the elbow may help to disperse the vent flow in use. However,
other suitable hole arrangements, hole numbers, and/or hole shapes along the first end portion
74(1) and/or other portions of the elbow are possible.
.4 Ports
In Figs. 1-5, the base of the frame 1040 includes two ports 1043 positioned so
that in use, oxygen or other breathable gas can be delivered close to the patient's nares or
pressure monitoring equipment can be attached. The ports 1043 may also be used to attach
additional medical equipment such as pressure or flow sensors. The ports may be selectively
closable or sealable by a ports cap.
In an alternative embodiment, as shown in Figs. 25 and 26, the frame 1040 may
include a side port 1043.1, e.g., in addition to or as an alternative to the ports 1043.
Figs. 35-1 and 35-2 show a frame 240 that includes an auxiliary port or spigot
243 on an upper portion of the frame, e.g., for supplemental oxygen, measurement device, etc.
In Figs. 37-1 to 37-3 and 39-1 to 39-6, the frame 340 includes an auxiliary port
or spigot 343 on each side thereof, e.g., for supplemental oxygen, measurement device, etc.
Port caps 347 are provided to seal respective ports 343.
6. Interface Seal
In an embodiment, a seal may be provided at the interface between the elbow
and the shroud, at the interface between the frame and the shroud, and/or at the interface
between the elbow and the frame. For example, a seal (e.g., elastomeric, ring-shaped seal)
may be formed separately from the modules and attached at the interface (e.g., sandwiched
between modules, adhesive, etc.). Alternatively, a seal may be co-molded with one or more of
the modules. In an embodiment, a silicone lip seal may be provided to the frame to seal
against the elbow, thereby reducing leak.
In another embodiment, as shown in Fig. 27-30, the interfacing structure 75 of
the elbow 70 may be constructed of a relatively soft, sealing material (e.g., silicone, which may
be co-molded to the harder material of the elbow) that is structured to provide a seal at the
interface between the elbow 70 and the shroud 20. Also, the relatively soft interfacing
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structure 75 (e.g., silicone) provides a "soft" attachment to the relatively hard shroud 20 (e.g.,
polycarbonate, polypropylene) which may allow an interference type fit. As noted above, one
or more vent holes may be provided to the softer interfacing structure and/or the harder
elbow.
While the invention has been described in connection with what are presently considered to be
the most practical and preferred embodiments, it is to be understood that the invention is not
to be limited to the disclosed embodiments, but on the contrary, is intended to cover various
modifications and equivalent arrangements included within the spirit and scope of the
invention. Also, the various embodiments described above may be implemented in conjunction
with other embodiments, e.g., aspects of one embodiment may be combined with aspects of
another embodiment to realize yet other embodiments. Further, each independent feature or
component of any given assembly may constitute an additional embodiment. Furthermore,
each individual component of any given assembly, one or more portions of an individual
component of any given assembly, and various combinations of components from one or more
embodiments may include one or more ornamental design features. In addition, while the
invention has particular application to patients who suffer from OSA, it is to be appreciated
that patients who suffer from other illnesses (e.g., congestive heart failure, diabetes, morbid
obesity, stroke, bariatric surgery, etc.) can derive benefit from the above teachings. Moreover,
the above teachings have applicability with patients and non-patients alike in non-medical
applications.
JAWs Ref: 504972DIV22
Claims (39)
1. A mask system for use in delivering breathable gas to a patient, comprising: a breathing chamber at least partially defined by a frame and a cushion, wherein the cushion is attached to the frame, and further wherein the cushion in use forms a seal around the patient’s nose and mouth; a shroud structured to attach to the frame; wherein the shroud comprises a pair of upper headgear connectors and a pair of lower headgear connectors, and wherein the shroud is removable from the frame as a unit, wherein the pair of upper headgear connectors comprises a first upper arm and a second upper arm, the first upper arm being adapted to extend across a first cheek of the patient and under a first eye of the patient, and the second upper arm being adapted to extend across a second cheek of the patient and under a second eye of the patient, and wherein the pair of lower headgear connectors comprises a first lower arm and a second lower arm, and further wherein each of the pair of upper headgear connectors is configured to in use attach to a respective upper headgear strap and each of the pair of lower headgear connectors is configured to in use attach to a respective lower headgear strap.
2. The mask system according to claim 1, wherein the first upper arm and the second upper arm are each a stiffened member.
3. The mask system according to claim 2, wherein the stiffened members are flexible.
4. The mask system according to any one of claims 1 to 3, wherein the first upper arm and the second upper arm are semi-rigid.
5. The mask system according to claim 4, wherein the semi-rigid structure of the first upper arm and the upper second arm in use prevents up and down movement or bending of the first upper arm and the second upper arm relative to the patient’s face.
6. The mask system according to any one of claims 1 to 5, wherein the first lower arm and the second lower arm are sufficiently rigid to in use prevent lateral movement of the first lower arm and the second lower arm relative to the mask system. JAWs Ref: 504972DIV22
7. The mask system according to any one of claims 1 to 6, wherein the first upper arm and the second upper arm are each adapted to in use readjust force applied to a top end of the mask system to a fulcrum point located at approximately the centre of balance between the top end and a bottom end of the mask system.
8. The mask system according to any one of claims 1 to 7, wherein the pair of upper headgear connectors are configured to in use attach to a respective upper headgear strap at a pair of upper connection points, and wherein the pair of lower headgear connectors are configured to in use attach to a respective lower headgear strap at a pair of lower connection points, and further wherein the fulcrum point is located between the pair of upper connection points and the pair of lower connection points.
9. The mask system according to either one of claim 7 or claim 8 when dependent on claim 7, wherein the fulcrum point is located in use in a region between the patient’s nose and the patient’s lip area.
10. The mask system according to any one of claims 1 to 9, wherein each of the first upper arm and the second upper arm is shaped to accommodate and / or follow the contours of a respective one of the patient’s cheeks.
11. The mask system according to any one of claims 1 to 10, wherein each of the first upper arm and the second upper arm is shaped and / or arranged to be positioned in use below the patient’s field of vision.
12. The mask system according to any of the claims 1 to 11, wherein the shroud is configured to wrap around at least a portion of the frame.
13. The mask system according to any one of claims 1 to 12, wherein the shroud is shaped to have a tight, conforming fit on the frame.
14. The mask system according to any one of claims 1 to 13, wherein the shroud partially or fully covers the frame.
15. The mask system according to any one of claims 1 to 14, wherein a top end of the shroud is adapted to be positioned proximal to the patient’s nasal bridge region. JAWs Ref: 504972DIV22
16. The mask system according to any one of claims 1 to 15, wherein each of the pair of upper headgear connectors is integrally formed with the shroud.
17. The mask system according to any one of claims 1 to 16, wherein each of the pair of lower headgear connectors is integrally formed with the shroud.
18. The mask system according to any one of claims 1 to 17, wherein each of the pair of upper headgear connectors is configured to be releasably attached to a respective upper headgear strap.
19. The mask system according to claim 18, wherein each of the pair of upper headgear connectors includes a free end and a receiving hole or slot near the free end, and wherein the receiving hole or slot is adapted to in use receive an upper headgear strap of headgear to thereby releasably attach the pair of upper headgear connectors to the upper headgear straps.
20. The mask system according to claim 18, wherein each of the pair of upper headgear connectors includes a clip retainer adapted to in use be removably interlocked with a headgear clip attached to an upper headgear strap of headgear to thereby releasably attach the pair of upper headgear connectors to the respective upper headgear straps.
21. The mask system according to any one of claims 1 to 17, wherein each of the first upper arm and the second upper arm is permanently attached to a respective upper headgear strap.
22. The mask system according to any one of claims 1 to 21, wherein each of the lower headgear connectors is configured to be releasably attached to a respective lower headgear strap.
23. The mask system according to claim 22, wherein each of the first lower arm and the second lower arm includes a free end and a receiving hole or slot near the free end, wherein the receiving hole or slot is adapted to in use receive a lower headgear strap of headgear to thereby releasably attach the pair of lower headgear connectors to the respective lower headgear straps.
24. The mask system according to claim 22, wherein each of the pair of lower headgear connectors includes a clip receptacle adapted to in use be removably interlocked with a JAWs Ref: 504972DIV22 headgear clip attached to a lower headgear strap of headgear to thereby releasably attach the pair of lower headgear connectors to the respective lower headgear straps.
25. The mask system according to any one of claims 1 to 24, wherein the lower arms of each of the pair of lower headgear connectors is an abbreviated arm.
26. The mask system according to any of claims 1 to 25, further comprising soft fabric sleeves that are mounted on one or more of the pair of upper headgear connectors and the pair of lower headgear connectors.
27. The mask system according to claim 26, wherein the sleeves comprise elastic tubes.
28. The mask system according to any one of claims 1 to 27, further comprising a second shroud which is different to the shroud in at least one aspect.
29. The mask system according to any of the claims 1 to 28, wherein the shroud is adapted to selectively attach to multiple frames, the multiple frames being different from each other in at least one aspect.
30. The mask system according to any of the claims 1 to 29, wherein the shroud is made of a relatively rigid material and the cushion is made of a relatively soft elastomeric material.
31. The mask system according to any of the claims 1 to 30, wherein the frame is made of a rigid material and the cushion is made of a relatively soft elastomeric material.
32. The mask system according to any one of claims 1 to 31, wherein the shroud does not include a forehead support.
33. The mask system according to any one of claims 1 to 32, wherein the cushion is a full-face cushion.
34. The mask system according to any one of claims 1 to 33, wherein the cushion is adapted to engage the patient’s nasal bridge, cheek, chin and lower lip regions.
35. The mask system according to any one of claims 1 to 34, wherein the cushion includes a membrane configured to in use contact the patient, and an under cushion. JAWs Ref: 504972DIV22
36. The mask system according to any of the claims 1 to 35, further comprising headgear.
37. The mask system according to claim 36, wherein the headgear includes a pair of upper headgear straps and a pair of lower headgear straps.
38. The mask system according to claim 37, wherein each of the upper headgear connectors is configured to in use locate the rear strap in a spaced relation above the patient’s ear.
39. The mask system according to either one of the claims 37 or 38, wherein each of the lower headgear connectors is configured to in use retain the lower headgear straps in a spaced relation under the patient’s ear.
Priority Applications (3)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
NZ759105A NZ759105A (en) | 2008-03-04 | 2009-02-27 | Mask system |
NZ765880A NZ765880A (en) | 2008-03-04 | 2009-02-27 | Mask system |
NZ768736A NZ768736B2 (en) | 2008-03-04 | 2009-02-27 | Mask System |
Applications Claiming Priority (7)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US6440608P | 2008-03-04 | 2008-03-04 | |
US61/064,406 | 2008-03-04 | ||
US7189308P | 2008-05-23 | 2008-05-23 | |
US61/071,893 | 2008-05-23 | ||
US13661708P | 2008-09-19 | 2008-09-19 | |
US61/136,617 | 2008-09-19 | ||
NZ73041709 | 2009-02-27 |
Publications (2)
Publication Number | Publication Date |
---|---|
NZ748881A NZ748881A (en) | 2020-12-18 |
NZ748881B2 true NZ748881B2 (en) | 2021-03-19 |
Family
ID=
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