U.S. patent application number 14/889034 was filed with the patent office on 2016-03-24 for oro-nasal patient interface.
The applicant listed for this patent is RESMED LIMITED. Invention is credited to Adam Francis BARLOW, Lachlan Richard GOLDSPINK, Lemmy NGA, Rupert Christian SCHEINER.
Application Number | 20160082214 14/889034 |
Document ID | / |
Family ID | 51897519 |
Filed Date | 2016-03-24 |
United States Patent
Application |
20160082214 |
Kind Code |
A1 |
BARLOW; Adam Francis ; et
al. |
March 24, 2016 |
ORO-NASAL PATIENT INTERFACE
Abstract
A patient interface to provide breathable gas to a patient,
comprising: a plenum chamber assembly, comprising: a nasal plenum
chamber at least partly defining an upper gas chamber; an oral
plenum chamber at least partly defining a lower gas chamber; and a
decoupling structure at least partly connecting the nasal plenum
chamber and the oral plenum chamber and at least party defining a
flow path; a top plate including at least one connection feature
configured to releasably retain a first portion of a positioning
and stabilising structure; and a faceplate configured to releasably
retain a second portion of a positioning and stabilising
structure.
Inventors: |
BARLOW; Adam Francis;
(Sydney, AU) ; SCHEINER; Rupert Christian;
(Sydney, AU) ; GOLDSPINK; Lachlan Richard;
(Sydney, AU) ; NGA; Lemmy; (Sydney, AU) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
RESMED LIMITED |
New South Wales |
|
AU |
|
|
Family ID: |
51897519 |
Appl. No.: |
14/889034 |
Filed: |
May 14, 2014 |
PCT Filed: |
May 14, 2014 |
PCT NO: |
PCT/AU2014/050036 |
371 Date: |
November 4, 2015 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
|
61823353 |
May 14, 2013 |
|
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61954201 |
Mar 17, 2014 |
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Current U.S.
Class: |
128/206.24 |
Current CPC
Class: |
A61M 16/208 20130101;
A61M 16/0683 20130101; A61M 2210/0625 20130101; A61M 16/0622
20140204; A61M 2205/42 20130101; A61M 16/0825 20140204; A61M
16/0816 20130101; A61M 2205/581 20130101; A61M 16/0611 20140204;
A61M 16/06 20130101; A61M 2210/0618 20130101 |
International
Class: |
A61M 16/06 20060101
A61M016/06 |
Claims
1.-104. (canceled)
105. A cushion assembly for a patient interface for treatment of
sleep disordered breathing of a patient, comprising: a nasal
cushion joined to a nasal plenum chamber, the nasal cushion
structured to seal around the lower periphery of the patient's
nose; an oral cushion joined to an oral plenum chamber, the oral
cushion structured to seal around the patient's mouth; a decoupling
structure connecting the nasal cushion and the nasal plenum chamber
to the oral cushion and the oral plenum chamber, the decoupling
structure configured to allow the nasal cushion and the nasal
plenum chamber to move relative to the oral cushion and the oral
plenum chamber; a pair of side supports, each of the pair of side
supports located on opposite sides of the nasal cushion and joining
respective lateral sides of the nasal cushion to the oral cushion;
a pair of undercushion support walls provided to support protruding
ends positioned posteriorly on the nasal cushion; and a pair of
pockets, each of the pair of pockets located on opposite sides of
the nasal cushion, each of the pair of pockets including an upper
surface defined by the nasal cushion and the nasal plenum chamber,
each of the pair of pockets including a lower surface defined by
the oral cushion and the oral plenum chamber, and each of the pair
of pockets including side surfaces defined by the decoupling
structure and respective ones of the pair of side supports, wherein
each of the pair of pockets is open in an anterior direction of the
cushion assembly when the patient interface is donned by the
patient.
106. The cushion assembly according to claim 105, wherein each of
the pair of side supports includes a notch to provide a pivot point
for relative movement between the nasal cushion and the oral
cushion.
107. The cushion assembly according to claim 106, wherein the notch
of each of the pair of side supports is open in a direction
opposite the face of the patient when the patient interface is
donned by the patient.
108. The cushion assembly according to claim 105, wherein the nasal
cushion comprises a pair of stiffened sections, each of the pair of
stiffened sections located at opposite lateral sides of the nasal
cushion, wherein the stiffened sections are stiffer than the
remainder of the nasal cushion.
109. The cushion assembly according to claim 108, wherein the pair
of stiffened sections comprise a thickness greater than other
portions of the nasal cushion.
110. The cushion assembly according to claim 108, wherein the pair
of stiffened sections extend internally relative to the nasal
cushion and the nasal plenum chamber such that an external surface
of the nasal cushion is not raised.
111. The cushion assembly according to claim 105, wherein the nasal
cushion comprises a nasal sling, the nasal sling being formed
in-plane with the nasal cushion, and the nasal sling being
structured to contact the patient's columella.
112. The cushion assembly according to claim 111, wherein the nasal
cushion and the nasal sling define a pair of nare ports, each of
the pair of nare ports structured to pneumatically communicate with
a respective one of the patient's nares.
113. The cushion assembly according to claim 111, wherein the nasal
sling is structured to prevent the tip of the patient's nose from
extending into a nasal gas chamber, the nasal gas chamber defined
at least in part by the nasal cushion and the nasal plenum
chamber.
114. The cushion assembly according to claim 105, wherein the
cushion assembly is formed from one piece of liquid silicone
rubber.
115. The cushion assembly according to claim 105, wherein each of
the protruding ends is structured to seal within the gap between
the respective alae and nasolabial sulci of the patient.
116. The cushion assembly according to claim 105, wherein each of
the pockets is structured to support a corresponding one of the
protruding ends in use.
117. The cushion assembly according to claim 105, wherein the nasal
cushion further comprises a recessed portion to receive the tip of
the patient's nose in use.
118. A patient interface system for treatment of sleep disordered
breathing of a patient, the patient interface system comprising:
the cushion assembly of claim 105; a positioning and stabilizing
structure to secure the patient interface system on the patient
during use; and a frame to attach the positioning and stabilizing
structure to the cushion assembly.
119. A cushion assembly for a patient interface for treatment of
sleep disordered breathing of a patient, comprising: a nasal
cushion joined to a nasal plenum chamber, the nasal cushion
structured to seal around the lower periphery of the patient's
nose; a pair of undercushion support walls provided to support
protruding ends positioned posteriorly on the nasal cushion; and a
pair of pockets, each of the pair of pockets located on opposite
sides of the nasal cushion, each of the pair of pockets including
an upper surface defined by the nasal cushion and the nasal plenum
chamber, each of the pair of pockets including a lower surface, and
each of the pair of pockets including side surfaces, wherein each
of the pair of pockets is open in an anterior direction of the
cushion assembly when the patient interface is donned by the
patient.
120. The cushion assembly according to claim 119, wherein the nasal
cushion comprises a pair of stiffened sections, each of the pair of
stiffened sections located at opposite lateral sides of the nasal
cushion, wherein the stiffened sections are stiffer than the
remainder of the nasal cushion.
121. The cushion assembly according to claim 120, wherein the pair
of stiffened sections comprise a thickness greater than other
portions of the nasal cushion.
122. The cushion assembly according to claim 120, wherein the pair
of stiffened sections extend internally relative to the nasal
cushion and the nasal plenum chamber such that an external surface
of the nasal cushion is not raised.
123. The cushion assembly according to claim 119, wherein the nasal
cushion comprises a nasal sling, the nasal sling being formed
in-plane with the nasal cushion, and the nasal sling being
structured to contact the patient's columella.
124. The cushion assembly according to claim 123, wherein the nasal
cushion and the nasal sling define a pair of nare ports, each of
the pair of nare ports structured to pneumatically communicate with
a respective one of the patient's nares.
125. The cushion assembly according to claim 123, wherein the nasal
sling is structured to prevent the tip of the patient's nose from
extending into a nasal gas chamber, the nasal gas chamber defined
at least in part by the nasal cushion and the nasal plenum
chamber.
126. The cushion assembly according to claim 119, wherein the
cushion assembly is formed from one piece of liquid silicone
rubber.
127. The cushion assembly according to claim 119, wherein each of
the protruding ends is structured to seal within the gap between
the respective alae and nasolabial sulci of the patient.
128. The cushion assembly according to claim 119, wherein each of
the pockets is structured to support a corresponding one of the
protruding ends in use.
129. The cushion assembly according to claim 119, wherein the nasal
cushion further comprises a recessed portion to receive the tip of
the patient's nose in use.
130. A patient interface system for treatment of sleep disordered
breathing of a patient, the patient interface system comprising:
the cushion assembly of claim 119; a positioning and stabilizing
structure to secure the patient interface system on the patient
during use; and a frame to attach the positioning and stabilizing
structure to the cushion assembly.
Description
1 CROSS-REFERENCE TO RELATED APPLICATIONS
[0001] This application claims the benefit of U.S. Provisional
Application No. 61/823,353, filed May 14, 2013, and U.S.
Provisional Application No. 61/954,201, filed Mar. 18, 2014, each
of which is incorporated by reference herein in its entirety.
2 BACKGROUND OF THE TECHNOLOGY
[0002] 2.1 Field of the Technology
[0003] The present technology relates to one or more of the
diagnosis, treatment and amelioration of respiratory disorders, and
to procedures to prevent respiratory disorders. In particular, the
present technology relates to medical devices, and their use for
treating respiratory disorders and for preventing respiratory
disorders.
[0004] 2.2 Description of the Related Art
[0005] The respiratory system of the body facilitates gas exchange.
The nose and mouth form the entrance to the airways of a
patient.
[0006] The airways consist of a series of branching tubes, which
become narrower, shorter and more numerous as they penetrate deeper
into the lung. The prime function of the lung is gas exchange,
allowing oxygen to move from the air into the venous blood and
carbon dioxide to move out. The trachea divides into right and left
main bronchi, which further divide eventually into terminal
bronchioles. The bronchi make up the conducting airways, and do not
take part in gas exchange. Further divisions of the airways lead to
the respiratory bronchioles, and eventually to the alveoli. The
alveolated region of the lung is where the gas exchange takes
place, and is referred to as the respiratory zone. See West,
Respiratory Physiology--the essentials.
[0007] A range of respiratory disorders exist.
[0008] Obstructive Sleep Apnoea (OSA), a form of Sleep Disordered
Breathing (SDB), is characterized by occlusion of the upper air
passage during sleep. It results from a combination of an
abnormally small upper airway and the normal loss of muscle tone in
the region of the tongue, soft palate and posterior oropharyngeal
wall during sleep. The condition causes the affected patient to
stop breathing for periods typically of 30 to 120 seconds duration,
sometimes 200 to 300 times per night. It often causes excessive
daytime somnolence, and it may cause cardiovascular disease and
brain damage. The syndrome is a common disorder, particularly in
middle aged overweight males, although a person affected may have
no awareness of the problem. See U.S. Pat. No. 4,944,310
(Sullivan).
[0009] Cheyne-Stokes Respiration (CSR) is a disorder of a patient's
respiratory controller in which there are rhythmic alternating
periods of waxing and waning ventilation, causing repetitive
de-oxygenation and re-oxygenation of the arterial blood. It is
possible that CSR is harmful because of the repetitive hypoxia. In
some patients CSR is associated with repetitive arousal from sleep,
which causes severe sleep disruption, increased sympathetic
activity, and increased afterload. See U.S. Pat. No. 6,532,959
(Berthon-Jones).
[0010] Obesity Hyperventilation Syndrome (OHS) is defined as the
combination of severe obesity and awake chronic hypercapnia, in the
absence of other known causes for hyperventilation. Symptoms
include dyspnea, morning headache and excessive daytime
sleepiness.
[0011] Chronic Obstructive Pulmonary Disease (COPD) encompasses any
of a group of lower airway diseases that have certain
characteristics in common. These include increased resistance to
air movement, extended expiratory phase of respiration, and loss of
the normal elasticity of the lung. Examples of COPD are emphysema
and chronic bronchitis. COPD is caused by chronic tobacco smoking
(primary risk factor), occupational exposures, air pollution and
genetic factors. Symptoms include: dyspnea on exertion, chronic
cough and sputum production.
[0012] Neuromuscular Disease (NMD) is a broad term that encompasses
many diseases and ailments that impair the functioning of the
muscles either directly via intrinsic muscle pathology, or
indirectly via nerve pathology. Some NMD patients are characterised
by progressive muscular impairment leading to loss of ambulation,
being wheelchair-bound, swallowing difficulties, respiratory muscle
weakness and, eventually, death from respiratory failure.
Neuromuscular disorders can be divided into rapidly progressive and
slowly progressive: (i) Rapidly progressive disorders:
Characterised by muscle impairment that worsens over months and
results in death within a few years (e.g. Amyotrophic lateral
sclerosis (ALS) and Duchenne muscular dystrophy (DMD) in
teenagers); (ii) Variable or slowly progressive disorders:
Characterised by muscle impairment that worsens over years and only
mildly reduces life expectancy (e.g. Limb girdle,
Facioscapulohumeral and Myotonic muscular dystrophy). Symptoms of
respiratory failure in NMD include: increasing generalised
weakness, dysphagia, dyspnea on exertion and at rest, fatigue,
sleepiness, morning headache, and difficulties with concentration
and mood changes.
[0013] Chest wall disorders are a group of thoracic deformities
that result in inefficient coupling between the respiratory muscles
and the thoracic cage. The disorders are usually characterised by a
restrictive defect and share the potential of long term hypercapnic
respiratory failure. Scoliosis and/or kyphoscoliosis may cause
severe respiratory failure. Symptoms of respiratory failure
include: dyspnea on exertion, peripheral oedema, orthopnoea,
repeated chest infections, morning headaches, fatigue, poor sleep
quality and loss of appetite.
[0014] Otherwise healthy individuals may take advantage of systems
and devices to prevent respiratory disorders from arising.
2.2.1 Systems
[0015] One known product used for treating sleep disordered
breathing is the S9 Sleep Therapy System, manufactured by
ResMed.
2.2.2 Therapy
[0016] Nasal Continuous Positive Airway Pressure (CPAP) therapy has
been used to treat Obstructive Sleep Apnea (OSA). The hypothesis is
that continuous positive airway pressure acts as a pneumatic splint
and may prevent upper airway occlusion by pushing the soft palate
and tongue forward and away from the posterior oropharyngeal
wall.
[0017] Non-invasive ventilation (NIV) has been used to treat OHS,
COPD, MD and Chest Wall disorders.
2.2.3 Patient Interface
[0018] The application of a supply of air at positive pressure to
the entrance of the airways of a patient is facilitated by the use
of a patient interface, such as a nasal mask, full-face mask or
nasal pillows. A range of patient interface devices are known,
however a number of them suffer from being one or more of
obtrusive, aesthetically undesirable, poorly fitting, difficult to
use and uncomfortable especially when worn for long periods of time
or when a patient is unfamiliar with a system. Masks designed
solely for aviators, as part of personal protection equipment or
for the administration of anaesthetics may be tolerable for their
original application, but nevertheless be undesirably uncomfortable
to be worn for extended periods, for example, while sleeping.
[0019] Traditional oro-nasal masks include full face masks or
ResMed LIBERTY full-face mask. Due to their size and bulk, they may
less comfortable and more intrusive than other masks due to
physiological reasons including claustrophobia or clithrophobia.
Oro-nasal masks are typically bulky and heavy and can interfere
with patient comfort and prevent wearing of eyeglasses.
2.2.3.1 Seal-Forming Portion
[0020] Patient interfaces typically include a seal-forming
portion.
[0021] One type of seal-forming portion extends around the
periphery of the patient interface, and is intended to seal against
the user's face when force is applied to the patient interface with
the seal-forming portion in confronting engagement with the user's
face. The seal-forming portion may consist of an air or fluid
filled cushion, or a moulded or formed surface of a resilient seal
element made of an elastomer such as a rubber. With this type of
seal-forming portion, if the fit is not adequate, there will be
gaps between the seal-forming portion and the face, and additional
force will be required to force the patient interface against the
face in order to achieve a seal.
[0022] Another type of seal-forming portion incorporates a flap
seal of thin material so positioned about the periphery of the mask
so as to provide a self-sealing action against the face of the user
when positive pressure is applied within the mask. Like the
previous style of seal forming portion, if the match between the
face and the mask is not good, additional force may be required to
effect a seal, or the mask may leak. Furthermore, if the shape of
the seal-forming portion does not match that of the patient, it may
crease or buckle in use, giving rise to leaks.
[0023] Another form of seal-forming portion may use adhesive to
effect a seal. Some patients may find it inconvenient to constantly
apply and remove an adhesive to their face.
[0024] A range of patient interface seal-forming portion
technologies are disclosed in the following patent applications,
assigned to ResMed Limited: WO 1998/004,310; WO 2006/074,513; WO
2010/135,785.
2.2.3.2 Positioning and Stabilising
[0025] A seal-forming portion of a patient interface used for
positive air pressure therapy is subject to the corresponding force
of the air pressure to disrupt a seal. Thus a variety of techniques
have been used to position the seal-forming portion, and to
maintain it in scaling relation with the appropriate portion of the
face.
[0026] One technique is the use of adhesives. See for example US
Patent publication US 2010/0000534.
[0027] Another technique is the use of one or more straps and
stabilising harnesses. Many such harnesses suffer from being one or
more of ill-fitting, bulky, uncomfortable and awkward to use.
2.2.3.3 Vent Technologies
[0028] Some forms of patient interface systems may include a vent
to allow the washout of exhaled carbon dioxide. Many such vents are
noisy. Others may block in use and provide insufficient washout.
Some vents may be disruptive of the sleep of a bed-partner 1100 of
the patient 1000, e.g. through noise or focussed airflow.
[0029] ResMed Limited has developed a number of improved mask vent
technologies. See WO 1998/034,665; WO 2000/078,381; U.S. Pat. No.
6,581,594; US Patent Application; US 2009/0050156; US Patent
Application 2009/0044808.
TABLE-US-00001 Table of noise of prior masks (ISO 17510-2: 2007, 10
cmH.sub.2O pressure at 1 m) A-weighted A-weighted sound power sound
Mask level dbA pressure dbA Year Mask name type (uncertainty)
(uncertainty) (approx.) Glue-on (*) nasal 50.9 42.9 1981 ResCare
standard (*) nasal 31.5 23.5 1993 ResMed Mirage (*) nasal 29.5 21.5
1998 ResMed UltraMirage nasal 36 (3) 28 (3) 2000 ResMed Mirage
nasal 32 (3) 24 (3) 2002 Activa ResMed Mirage Micro nasal 30 (3) 22
(3) 2008 ResMed Mirage nasal 29 (3) 22 (3) 2008 SoftGel ResMed
Mirage FX nasal 26 (3) 18 (3) 2010 ResMed Mirage nasal 37 29 2004
Swift (*) pillows ResMed Mirage nasal 28 (3) 20 (3) 2005 Swift II
pillows ResMed Mirage nasal 25 (3) 17 (3) 2008 Swift LT pillows
ResMed Mirage series full face 31.7 23.7 2000 I, II (*) ResMed
UltraMirage full face 35 (3) 27 (3) 2004 ResMed Mirage full face 26
(3) 18 (3) 2006 Quattro ResMed Mirage full face 27 (3) 19 (3) 2008
Quattro FX (* one specimen only, measured using test method
specified in ISO3744 in CPAP mode at 10 cmH.sub.2O)
[0030] Sound pressure values of a variety of objects are listed
below
TABLE-US-00002 A-weighted sound pressure dbA Object (uncertainity)
Notes Vacuum cleaner: Nilfisk 68 ISO1744 at 1 m Walter Broadly
Litter Hog: B+ distance Grade Conversational speech 60 1 m distance
Average home 50 Quiet library 40 Quiet bedroom at night 30
Background in TV studio 20
2.2.3.4 Nasal Pillow Technologies
[0031] One form of nasal pillow is found in the Adam Circuit
manufactured by Puritan Bennett. Another nasal pillow, or nasal
puff is the subject of U.S. Pat. No. 4,782,832 (Trimble et al.),
assigned to Puritan-Bennett Corporation.
[0032] ResMed Limited has manufactured the following products that
incorporate nasal pillows: SWIFT nasal pillows mask, SWIFT II nasal
pillows mask, SWIFT LT nasal pillows mask, SWIFT FX nasal pillows
mask and LIBERTY full-face mask. The following patent applications,
assigned to ResMed Limited, describe nasal pillows masks:
International Patent Application WO2004/073,778 (describing amongst
other things aspects of ResMed SWIFT nasal pillows), US Patent
Application 2009/0044808 (describing amongst other things aspects
of ResMed SWIFT LT nasal pillows); International Patent
Applications WO 2005/063,328 and WO 2006/130,903 (describing
amongst other things aspects of ResMed LIBERTY full-face mask):
International Patent Application WO 2009/052,560 (describing
amongst other things aspects of ResMed SWIFT FX nasal pillows).
3 BRIEF SUMMARY OF THE TECHNOLOGY
[0033] The present technology is directed towards providing medical
devices used in the diagnosis, amelioration, treatment, or
prevention of respiratory disorders having one or more of improved
comfort, cost, efficacy, ease of use and manufacturability.
[0034] An aspect of the present technology may be directed to a
patient interface to provide breathable gas to a patient. The
patient interface may comprise: a plenum chamber assembly,
comprising: a nasal plenum chamber at least partly defining a first
gas chamber, the nasal plenum chamber structured to contact the
patient's nose below the bridge of the nose and around the lower
periphery of the nose; an oral plenum chamber at least partly
defining a second gas chamber, the oral plenum chamber structured
to seal around the patient's mouth; and a decoupling structure at
least partly connecting the nasal plenum chamber and the oral
plenum chamber and at least partly defining a flow path between the
nasal plenum chamber and the oral plenum chamber, the decoupling
structure configured to decouple relative movement between the
nasal plenum chamber and the oral plenum chamber; a top plate
operatively connected to the plenum chamber assembly at the nasal
plenum chamber, including at least one connection feature
configured to releasably retain a first portion of a positioning
and stabilising structure; and a faceplate operatively connected to
the plenum chamber assembly at the oral plenum chamber, and
configured to releasably retain a second portion of the positioning
and stabilising structure, wherein the top plate and faceplate are
more rigid than the plenum chamber assembly.
[0035] In examples, (a) said flow path may pneumatically connect
the first gas chamber and the second gas chamber, (b) said top
plate and said faceplate may be releasably attachable to the plenum
chamber assembly, (c) said positioning and stabilising structure
may comprise a rigidiser arm assembly having a pair of rigidiser
arms, the rigidiser arm assembly may be connected to the top plate,
(d) each of the pair of rigidiser arms may be permitted to flex in
a plane parallel to the patient's transverse plane, and each of the
pair of rigidiser arms may be structured to resist flexing in a
plane perpendicular to the patient's transverse plane, resist
twisting, and/or resist stretching, (e) each of the rigidiser arms
may have an ellipsoidal profile to conform with the curvature of a
patient's cheek, (f) said nasal plenum chamber may comprise a nasal
flange defining a nasal opening, and said nasal flange may be
configured to form a seal with at least the nose of the patient,
(g) said nasal flange may include a recessed portion to receive the
tip of the nose of the patient, (h) said oral plenum chamber may
comprise an oral flange defining an oral opening, and said oral
flange may be configured to form a seal with at least the mouth of
the patient, (i) said oral flange may be formed around the entire
perimeter of the oral plenum chamber, or around two opposing sides
of the perimeter of the oral plenum chamber, or the majority of the
perimeter of the oral plenum chamber, (j) said oral plenum chamber
may comprise a pair of oral undercushion portions each disposed on
a respective side of said oral plenum chamber to support said oral
flange, (k) said oral plenum chamber may comprise an oral
undercushion portion disposed circumferentially about said oral
plenum chamber and extending radially from each end of the
decoupling structure to support said oral flange, (j) said
decoupling structure may connect the nasal flange and the oral
flange, (k) the decoupling structure may comprise an upper surface,
a lower surface, and a connecting surface, the connecting surface
having a greater stiffness than the upper surface and the lower
surface, (l) said decoupling structure may be stiffer at a portion
opposite the face of the patient than at a portion adjacent to the
face of the patient, (m) said decoupling structure may have a
stiffness that increases radially from a portion adjacent to the
face of the patient to a portion opposite the face of the patient,
(n) a nose-contacting portion of said nasal flange may be stiffer
at a portion that does not contact the nose of the patient than at
a portion of said nasal flange that does not contact the nose of
the patient, (o) said nasal flange may increase in stiffness
outwardly from said nasal opening, (p) said nasal flange may have a
varied stiffness around said nasal opening at predetermined
positions, (q) a lower portion of said nasal flange proximal to
said decoupling structure may be concave to seal against the upper
lip of the patient, (r) said nasal flange may comprise a pair of
protruding ends extending symmetrically about the nasal opening,
each protruding end configured to seal against a corresponding alae
of the nose of the patient, (s) said nasal plenum chamber may
comprise a pair of nasal undercushion sections, each of the pair of
nasal undercushion sections supporting one of the pair of
protruding ends, (t) each said nasal undercushion section may be
disposed on an upper portion of said oral plenum chamber, (u) the
patient interface may comprise headgear to releasably secure said
patient interface to the patient, said headgear including a pair of
upper straps configured to connect to the nasal plenum chamber and
a pair of lower straps configured to connect to the oral plenum
chamber, (v) the top plate may be permanently connected to the
nasal plenum chamber, (w) the top plate may be removably attachable
to a soft connection region of the nasal plenum chamber, (x) the
top plate may be removably attachable to a hard connection region
of the nasal plenum chamber, and/or (y) the top plate and the
rigidiser arms may comprise one piece and the rigidiser arms are
flexible relative to the top plate in a plane parallel to the
patient's transverse plane.
[0036] Another aspect of the present technology may be directed to
a patient interface to provide breathable gas to a patient. The
patient interface may comprise: a nasal cushion to at least
partially define a nasal gas chamber; an oral cushion to at least
partially define an oral gas chamber distinct from said nasal gas
chamber; a decoupling structure disposed between said nasal cushion
and said oral cushion; a top plate fixed to the nasal cushion and a
pair of upper attachment features configured to releasably attach a
pair of upper side straps of a positioning and stabilizing
structure to the top plate; and a faceplate fixed to the oral
cushion and a pair of lower attachment features configured to
releasably attach a pair of lower side straps of the positioning
and stabilizing structure.
[0037] In examples, (a) said decoupling structure may be adapted to
form a pneumatic connection between said nasal gas chamber and said
oral gas chamber, (b) the decoupling structure may comprise an
upper surface, a lower surface, and a connecting surface, the
connecting surface having a greater stiffness than the upper
surface and the lower surface, (c) said decoupling structure may
have a stiffness that is radially variable about its perimeter such
that a portion distal to the face of the patient is stiffer than a
portion proximal to the face of the patient, and the nasal cushion
may be structured to move independently of the oral cushion, (d) a
nose-contacting portion of the nasal cushion may be less stiff than
a portion of the nasal cushion that does not contact the patient's
nose, (e) said decoupling structure may be structured to support
the nasal cushion against the nose of the patient, (f) said nasal
cushion may be stiffer at a portion of said nasal cushion that does
not contact the nose of the patient than at a nose-contacting
portion, (g) said nasal cushion may comprise a concave portion to
seal against the upper lip of the patient, (h) said nasal cushion
may comprise a pair of protruding ends that are each configured to
form a seal between respective alae and nasolabial sulci of the
face of the patient, (i) said nasal cushion may comprise a pair of
nasal undercushion portions each disposed under each respective
protruding end to support each respective protruding end against
the face of the patient, (j) said nasal cushion may comprise a wing
on each side of the nasal cushion to seal against respective alae
of the nose of the patient, (k) said oral cushion may comprise an
oral undercushion portion extending radially about said oral
cushion from either side end said of decoupling structure to
support said oral cushion against the face of the patient, (l) said
oral cushion may comprise a pair of oral undercushion portions each
disposed on a respective side of said oral cushion to support said
oral cushion against the face of the patient, (m) said nasal
cushion may be shaped to include a recessed portion configured to
receive the tip of the nose of the patient, (n) said nasal cushion
may be configured to contact the inferior periphery of the nose of
the patient below the bridge of the nose, (o) said nasal cushion,
said oral cushion, and said decoupling structure may comprise one
piece, (p) the top plate may be permanently connected to the nasal
plenum chamber, (q) the top plate may be removably attachable to a
soft connection region of the nasal plenum chamber, (r) the top
plate may be removably attachable to a hard connection region of
the nasal plenum chamber, (s) the top plate and a rigidiser arm
assembly may comprise one piece and a pair of rigidiser arms of the
rigidiser arm assembly are flexible relative to the top plate in a
plane parallel to the patient's transverse plane, (t) the
positioning and stabilising structure may comprise a rigidiser arm
assembly releasably attachable to the top plate at the upper
attachment features, (u) the patient interface may comprising a
frame releasably attachable to the faceplate and the lower
attachment features may be disposed on the frame, (v) each of the
lower attachment features may comprise a mating portion having a
mating portion magnet to releasably connect to corresponding clips
of the positioning and stabilising structure and each of the
corresponding clips may include a clip magnet oriented such that
when each clip magnet is magnetically attracted to each mating
portion magnet the mating portion is joined to the corresponding
clip, (w) the patient interface may comprise a top plate buffer to
dampen the connection between the top plate and the rigidiser arm
assembly and a faceplate buffer to dampen the connection between
the faceplate and the frame, and/or (x) the frame may be shaped to
join around the periphery of the faceplate, the frame may comprise
catches and the faceplate comprises cutouts, and engagement between
the catches and the cutouts may join the frame to the
faceplate.
[0038] Another aspect of the present technology may be directed to
a patient interface to provide breathable gas to a patient. The
patient interface may comprising: a plenum chamber assembly,
comprising: a nasal plenum chamber at least partly defining an
first gas chamber, the nasal plenum chamber is adapted to seal
against the patient below the bridge of the nose and around the
inferior periphery of the patient's nose; and an oral plenum
chamber at least partly defining a second gas chamber operatively
connected to the nasal plenum chamber; and a unitary plate member
having an upper portion releasably attachable to the nasal plenum
chamber and a lower portion releasably attachable to the oral
plenum chamber; wherein the upper portion of the plate member
includes at least one connection feature configured to releasably
retain a first portion of a positioning and stabilising structure
having a pair of rigidiser arms, and the lower portion of the plate
member is configured to releasably retain a second portion of the
positioning and stabilising structure.
[0039] In examples, (a) the plenum chamber assembly may comprise a
decoupling structure at least partly connecting the nasal plenum
chamber and the oral plenum chamber, the decoupling structure at
least partly defining a flow path between the nasal plenum chamber
and the oral plenum chamber, (b) each of the pair of rigidiser arms
may be permitted to flex in a plane parallel to the patient's
transverse plane, and each of the pair of rigidiser arms may be
structured to resist flexing in a plane perpendicular to the
patient's transverse plane, resist twisting, and/or resist
stretching, (c) each said at least one connection feature may
comprise a hinge to allow a corresponding one of the pair of
rigidiser arms to rotate relative to the rigid top plate upper
portion of the unitary plate member in a plane parallel to the
patient's transverse plane, (d) the first portion of a positioning
and stabilising structure may include a hook to pivotably connect
with the connection feature of the upper portion of the unitary
plate member, (e) said nasal plenum chamber may comprise a nasal
flange defining a nasal opening, and said nasal flange may be
configured to form a seal with at least the nose of the patient,
(e) said nasal flange may include a recessed portion to receive the
tip of the nose of the patient, (f) said oral plenum chamber may
comprise an oral flange defining an oral opening, and said oral
flange may be configured to form a seal with at least the mouth of
the patient, (g) said oral flange may be formed around the entire
perimeter of the oral plenum chamber, or around two opposing sides
of the perimeter of the oral plenum chamber, or the majority of the
perimeter of the oral plenum chamber, (f) said oral plenum chamber
may comprise a pair of oral undercushion portions each disposed on
a respective side of said oral plenum chamber to support said oral
flange, (g) said oral plenum chamber may comprise an oral
undercushion portion disposed circumferentially about said oral
plenum chamber and extending radially from each end of the
decoupling structure to support said oral flange, (h) said
decoupling structure may connect the nasal flange and the oral
flange, (i) said decoupling structure may be stiffer at a portion
opposite the face of the patient than at a portion adjacent to the
face of the patient, (j) said decoupling structure may have a
stiffness that increases radially from a portion adjacent to the
face of the patient to a portion opposite the face of the patient,
(k) a nose-contacting portion of said nasal flange may be stiffer
at a portion that does not contact the nose of the patient than at
a portion of said nasal flange that does not contact the nose of
the patient, (l) said nasal flange may increase in stiffness
outwardly from said nasal opening, (m) said nasal flange may have a
varied stiffness around said nasal opening at predetermined
positions, (n) a lower portion of said nasal flange proximal to
said decoupling structure may be concave to seal against the upper
lip of the patient, (o) said nasal flange may comprise a pair of
protruding ends extending symmetrically about the nasal opening,
each protruding end configured to seal against a corresponding alae
of the nose of the patient, (p) said nasal plenum chamber may
comprise a pair of nasal undercushion sections each corresponding
to each protruding end to support each protruding end, (q) each
said nasal undercushion section may be disposed on an upper portion
of said oral plenum chamber, and/or (r) each of said pair of
rigidiser arms may have an ellipsoidal curvature between the first
end and the second end.
[0040] Another aspect of the present technology may be directed to
a cushion assembly for a patient interface for treatment of sleep
disordered breathing of a patient, comprising: a nasal cushion
joined to a nasal plenum chamber, the nasal cushion structured to
seal around the lower periphery of the patient's nose; an oral
cushion joined to an oral plenum chamber, the oral cushion
structured to seal around the patient's mouth; a decoupling
structure connecting the nasal cushion and the nasal plenum chamber
to the oral cushion and the oral plenum chamber, the decoupling
structure configured to allow the nasal cushion and the nasal
plenum chamber to move relative to the oral cushion and the oral
plenum chamber; a pair of side supports, each of the pair of side
supports located on opposite sides of the nasal cushion and joining
respective lateral sides of the nasal cushion to the oral cushion;
a pair of undercushion support walls provided to support protruding
ends positioned posteriorly on the nasal cushion; and a pair of
pockets, each of the pair of pockets located on opposite sides of
the nasal cushion, each of the pair of pockets including an upper
surface defined by the nasal cushion and the nasal plenum chamber,
each of the pair of pockets including a lower surface defined by
the oral cushion and the oral plenum chamber, and each of the pair
of pockets including side surfaces defined by the decoupling
structure and respective ones of the pair of side supports, wherein
an opening of each of the pair of pockets is positioned opposite
the face of the patient when the patient interface is donned by the
patient.
[0041] In examples, (a) each of the pair of side supports may
include a notch to provide a pivot point for relative movement
between the nasal cushion and the oral cushion, (b) the notch of
each of the pair of side supports may be open in a direction
opposite the face of the patient when the patient interface is
donned by the patient, (c) the nasal cushion may comprise a pair of
stiffened sections, each of the pair of stiffened sections may be
located at opposite lateral sides of the nasal cushion, and the
stiffened sections may be stiffer than the remainder of the nasal
cushion, (d) the pair of stiffened sections may comprise a
thickness greater than other portions of the nasal cushion, (e) the
pair of stiffened sections may extend internally relative to the
nasal cushion and the nasal plenum chamber such that an external
surface of the nasal cushion is not raised, (f) the nasal cushion
may comprises a nasal sling, the nasal sling being formed in-plane
with the nasal cushion, and the nasal sling being structured to
contact the patient's columella, (g) the nasal cushion and the
nasal sling may define a pair of nare ports, each of the pair of
nare ports structured to pneumatically communicate with a
respective one of the patient's nares, and/or (h) the nasal sling
may be structured to prevent the tip of the patient's nose from
extending into a nasal gas chamber, the nasal gas chamber defined
at least in part by the nasal cushion and the nasal plenum
chamber.
[0042] Another aspect of the present technology is directed to a
patient interface system to provide breathable gas to a patient.
The patient interface may comprise: a cushion assembly, the cushion
assembly may comprise: a nasal cushion to at least partially define
a nasal gas chamber; an oral cushion to at least partially define
an oral gas chamber distinct from said nasal gas chamber; and a
decoupling structure disposed between said nasal cushion and said
oral cushion; a positioning and stabilizing structure with a pair
of lower side straps; and a pair of lower attachment features
configured to releasably attach a corresponding one of the pair of
lower side straps of the positioning and stabilizing structure to
the cushion assembly, wherein each of the pair of lower attachment
features comprises a thermoplastic elastomer and each of the pair
of lower attachment features has a first magnet embedded
therein.
[0043] In examples, (a) the patient interface system may comprise:
a faceplate fixed to the oral cushion; and a frame releasably
attachable to the faceplate, wherein the pair of lower attachment
features are fixed to the frame, (b) the frame may comprise a
material more rigid than thermoplastic elastomer, (c) the pair of
lower attachment features may be molded onto the frame, (d) the
positioning and stabilizing structure may comprise a pair of clips
to attach a corresponding one of the pair of lower side straps to
corresponding one of the pair of lower attachment features, (e)
each of the pair of clips may comprise a second magnet to attach
each of the pair of clips to a corresponding one of the pair of
lower attachment features, (f) each of the pair of clips may
comprise a notch and each of the pair of lower attachment features
may comprise a protrusion, and the protrusion may engage with the
notch when each of the pair of clips are engaged with a
corresponding one of the pair of lower attachment features, (g)
each of the pair of lower attachment features may comprise a flex
point, each of the pair of the pair of lower attachment features
structured to flex at said flex point, and/or (h) each of the pair
of lower attachment features may include a region of reduced
thickness at the flex point.
[0044] Another aspect of the present technology is directed to a
patient interface to provide breathable gas to a patient. The
patient interface may comprise: a nasal cushion to at least
partially define a nasal gas chamber; an oral cushion to at least
partially define an oral gas chamber distinct from said nasal gas
chamber a decoupling structure disposed between said nasal cushion
and said oral cushion; a top plate fixed to the nasal cushion; and
a rigidiser arm assembly releasably attachable to the top plate,
wherein the rigidiser arm assembly and the top plate engage at at
least three points of contact.
[0045] In examples, (a) the top plate may comprise a pair of upper
attachment features and the rigidiser arm assembly may comprise a
pair of connection features, each of the pair of connection
features may be structured to engage with a corresponding one of
the pair of upper attachment features, (b) the rigidiser arm
assembly may comprise a rib to engage with the top plate when the
rigidiser arm assembly is engaged with the top plate, (c) the
patient interface may comprise a top plate buffer to dampen
engagement between the rigidiser arm assembly and the top plate,
the top plate buffer may be positioned on an anterior side of the
top plate to contact a posterior side of the rigidiser arm
assembly, (d) the top plate buffer and the nasal cushion may
comprise one piece, the top plate buffer extending through the top
plate from the nasal cushion, (e) the rigidiser arm assembly may
comprise a pair of rigidiser arms, each of the pair of rigidiser
arms may be structured to a receive an upper side strap of a
positioning and stabilizing structure, and/or (f) each of the pair
of rigidiser arms may comprise a pad to cushion the pair of
rigidiser arms against the patient's face.
[0046] Another aspect of the present technology is directed to a
patient interface to provide breathable gas to a patient. The
patient interface may comprise: a nasal cushion to at least
partially define a nasal gas chamber; an oral cushion to at least
partially define an oral gas chamber distinct from said nasal gas
chamber; and a decoupling structure disposed between said nasal
cushion and said oral cushion, wherein the decoupling structure
comprises an upper surface joining the decoupling structure to the
nasal cushion, a lower surface joining the decoupling structure to
the oral cushion, and a connecting surface joining the upper
surface and the lower surface, wherein the upper surface and the
lower surface are substantially equal in thickness, and wherein the
connecting surface is thicker than the upper surface and the lower
surface.
[0047] In examples, (a) the connecting surface may be about twice
as thick as the upper surface and the lower surface, (b) the
decoupling structure may be structured to be flexible such that the
upper surface and the lower surface can be positioned at up to
50.degree. relative to one another, and/or (c) the upper surface
and the lower surface may be about 0.5 mm thick and the connecting
surface is about 1.2 mm thick.
[0048] Another aspect of one form of the present technology is a
patient interface that is moulded or otherwise constructed with a
clearly defined perimeter shape which is intended to match that of
an intended wearer. The patient interface system may have a reduced
part count compared to currently available patient interface
systems. The patient interface system may provide a visible mouth
region of the patient if the faceplate is semi-transparent or
transparent. The patient interface system is an oro-nasal mask
meaning it covers the nasal airways and the mouth. It may not
obstruct the patient's line of sight, and may be considered
physiologically non-threatening and may increase patient selection
of the system and adherence to therapy. The patient interface
system may flex to adapt to changes in jaw movement and head
position throughout the night. The patient interface system may
provide a supply of pressurised air or breathable gas to a
patient's nasal passages and may prevent or reduce mouth leak by
providing an effective seal with both the patient's mouth and the
patient's nasal passages.
[0049] Another aspect of one form of the present technology is a
patient interface that may have a reduced skin contact area and
less total points of contact with the face, when compared to most
known full face masks. This may allow a far reduced headgear
tension to be applied, significantly improving patient comfort.
Patient comfort may be further enhanced since the patient is less
likely to feel claustrophobic, particularly with the removal of any
mass that is close to the eyes.
[0050] Another aspect of one form of the present technology is a
patient interface that may be quick and easy to fit by all customer
segments including patient, home medical equipment dealers and
clinicians. It may simplify mask selection for clinicians and
dealers due to its superior ease of use (fitting, sealing, size
selection, sometimes remotely) and intuitiveness to assemble and
fit allowing greater success in remote setups done in an unassisted
environment without instruction. The patient interface may have one
primary size fitting the majority of the general adult patient
population, and no more than two additional sizes. It is envisaged
that three sizes of the patient interface will fit at least 90% of
the general adult population.
[0051] Of course, portions of the aspects may form sub-aspects of
the present technology. Also, various ones of the sub-aspects
and/or aspects may be combined in various manners and also
constitute additional aspects or sub-aspects of the present
technology.
[0052] Other features of the technology will be apparent from
consideration of the information contained in the following
detailed description, abstract, drawings and claims.
4 BRIEF DESCRIPTION OF THE SEVERAL VIEWS OF THE DRAWINGS
[0053] The present technology is illustrated by way of example, and
not by way of limitation, in the figures of the accompanying
drawings, in which like reference numerals refer to similar
elements including:
4.1 Treatment Systems
[0054] FIG. 1a shows a system in accordance with the present
technology. A patient 1000 wearing a patient interface 3000,
receives a supply of air at positive pressure from a PAP device
4000. Air from the PAP device is humidified in a humidifier 5000,
and passes along an air circuit 4170 to the patient 1000. A bed
partner 1100 is also shown.
[0055] FIG. 1b shows a PAP device in use on a patient with a nasal
mask.
[0056] FIG. 1c shows a PAP device in use on a patient with a
full-face mask.
4.2 Therapy
4.2.1 Respiratory System
[0057] FIG. 2a shows an overview of a human respiratory system
including the nasal and oral cavities, the larynx, vocal folds,
oesophagus, trachea, bronchus, lung, alveolar sacs, heart and
diaphragm.
[0058] FIG. 2b shows a view of a human upper airway including the
nasal cavity, nasal bone, lateral nasal cartilage, greater alar
cartilage, nostril, lip superior, lip inferior, larynx, hard
palate, soft palate, oropharynx, tongue, epiglottis, vocal folds,
oesophagus and trachea.
4.2.2 Facial Anatomy
[0059] FIG. 2c is a front view of a face with several features of
surface anatomy identified including the lip superior, upper
vermillion, lower vermillion, lip inferior, mouth width,
endocanthion, a nasal ala, nasolabial sulcus and cheilion.
[0060] FIG. 2d is a side view of a head with several features of
surface anatomy identified including glabella, sellion, pronasale,
subnasale, lip superior, lip inferior, supramenton, nasal ridge,
otobasion superior and otobasion inferior. Also indicated are the
directions superior & inferior, and anterior &
posterior.
[0061] FIG. 2e is a further side view of a head. The approximate
locations of the Frankfort horizontal and nasolabial angle are
indicated.
[0062] FIG. 2f shows a base view of a nose.
[0063] FIG. 2g shows a side view of the superficial features of a
nose.
[0064] FIG. 2h shows subcutaneal structures of the nose, including
lateral cartilage, septum cartilage, greater alar cartilage, lesser
alar cartilage and fibrofatty tissue.
[0065] FIG. 2i shows a medial dissection of a nose, approximately
several millimeters from a sagittal plane, amongst other things
showing the septum cartilage and medial crus of greater alar
cartilage.
[0066] FIG. 2j shows a front view of the bones of a skull including
the frontal, temporal, nasal and zygomatic bones. Nasal concha are
indicated, as are the maxilla, mandible and mental
protuberance.
[0067] FIG. 2k shows a lateral view of a skull with the outline of
the surface of a head, as well as several muscles. The following
bones are shown: frontal, sphenoid, nasal, zygomatic, maxilla,
mandible, parietal, temporal and occipital. The mental protuberance
is indicated. The following muscles are shown: digastricus,
masseter sternocleidomastoid and trapezius.
[0068] FIG. 2l shows anterolateral view of the skull and tissue
structures.
4.3 Patient Interface
[0069] FIG. 3a shows a perspective view of a patient interface in
accordance with an example of the present technology.
[0070] FIG. 3b shows a front view of a patient interface in
accordance with an example of the present technology.
[0071] FIG. 3c shows a rear view of a patient interface in
accordance with an example of the present technology.
[0072] FIG. 3d shows a top view of a patient interface in
accordance with an example of the present technology.
[0073] FIG. 3e shows a bottom view of a patient interface in
accordance with an example of the present technology.
[0074] FIG. 3f shows a side view of a patient interface in
accordance with an example of the present technology.
[0075] FIG. 3g shows a perspective view of a patient interface
including a air circuit in accordance with an example of the
present technology.
[0076] FIG. 3h shows a rear view of a patient interface including a
air circuit in accordance with an example of the present
technology.
[0077] FIG. 3i shows a front view of a patient interface including
a air circuit in accordance with an example of the present
technology.
[0078] FIG. 3j shows a top view of a patient interface including a
air circuit in accordance with an example of the present
technology.
[0079] FIG. 3k shows a bottom view of a patient interface including
a air circuit in accordance with an example of the present
technology.
[0080] FIG. 3l shows a side view of a patient interface including a
air circuit in accordance with an example of the present
technology.
[0081] FIG. 3m shows a perspective view of a patient interface
including a air circuit donned on a patient in accordance with an
example of the present technology.
[0082] FIG. 3n shows a front view of a patient interface including
a air circuit donned on a patient in accordance with an example of
the present technology.
[0083] FIG. 3o shows a side view of a patient interface including a
air circuit donned on a patient in accordance with an example of
the present technology.
[0084] FIG. 3p shows a top view of a patient interface including a
air circuit donned on a patient in accordance with an example of
the present technology.
[0085] FIG. 3q shows a side cross-sectional view of a patient
interface according to an example of the present technology with
the patient interface located against the face of a patient. The
patient is shown with a cross-section of the airways.
[0086] FIG. 3r shows a detailed front perspective view of a portion
of a patient interface according to an example of the present
technology. The patient interface is shown in dashed lines and the
nose, mouth, and chin of the patient are shown in solid lines.
[0087] FIG. 3s shows an exploded perspective view of a patient
interface in accordance with an example of the present
technology.
[0088] FIG. 3t shows an exploded front view of a patient interface
in accordance with an example of the present technology.
[0089] FIG. 3u shows an exploded rear view of a patient interface
in accordance with an example of the present technology.
[0090] FIG. 4a shows a top view of a nasal cradle cushion of a
patient interface in accordance with an example of the present
technology.
[0091] FIG. 4b shows a bottom cross-sectional view taken through
line 4c-4c of FIG. 4a of a nasal cradle cushion of a patient
interface in accordance with an example of the present
technology.
[0092] FIG. 4c shows a side cross-sectional view taken through line
4c-4c of FIG. 4a of a nasal cradle cushion of a patient interface
in accordance with an example of the present technology. A
patient's nose is shown in dashed lines.
[0093] FIG. 5a shows a top view of another nasal cradle cushion of
a patient interface in accordance with another example of the
present technology.
[0094] FIG. 5b shows a bottom cross-sectional view taken through
line 5c-5c of FIG. 5a of another nasal cradle cushion of a patient
interface in accordance with another example of the present
technology.
[0095] FIG. 5c shows a side cross-sectional view taken through line
5c-5c of FIG. 5a of another nasal cradle cushion of a patient
interface in accordance with an example of the present technology.
A patient's nose is shown in dashed lines.
[0096] FIG. 6a shows a top view of another nasal cradle cushion of
a patient interface in accordance with another example of the
present technology.
[0097] FIG. 6b shows a bottom cross-sectional view taken through
line 6c-6c of FIG. 6a of another nasal cradle cushion of a patient
interface in accordance with another example of the present
technology.
[0098] FIG. 6c shows a side cross-sectional view taken through line
6c-6c of FIG. 6a of another nasal cradle cushion of a patient
interface in accordance with another example of the present
technology. A patient's nose is shown in dashed lines.
[0099] FIG. 7a shows a rear perspective view of a plenum chamber
assembly of a patient interface in accordance with an example of
the present technology.
[0100] FIG. 7b shows a side perspective view of a plenum chamber
assembly of a patient interface in accordance with an example of
the present technology.
[0101] FIG. 7c shows a front perspective view of a plenum chamber
assembly of a patient interface in accordance with an example of
the present technology.
[0102] FIG. 7d shows a rear view of a plenum chamber assembly of a
patient interface in accordance with an example of the present
technology.
[0103] FIG. 7e shows a front view of a plenum chamber assembly of a
patient interface in accordance with an example of the present
technology.
[0104] FIG. 7f shows a top view of a plenum chamber assembly of a
patient interface in accordance with an example of the present
technology.
[0105] FIG. 7g shows a bottom view of a plenum chamber assembly of
a patient interface in accordance with an example of the present
technology.
[0106] FIG. 7h shows a side view of a plenum chamber assembly of a
patient interface in accordance with an example of the present
technology.
[0107] FIG. 8a shows a top view of a plenum chamber assembly of a
patient interface in accordance with an example of the present
technology and includes several lines defining various
cross-sections.
[0108] FIG. 8b shows a side cross-sectional view taken through line
8b-8b of FIG. 8a of a plenum chamber assembly of a patient
interface in accordance with an example of the present
technology.
[0109] FIG. 8c shows a side cross-sectional view taken through line
8c-8c of FIG. 8a of a plenum chamber assembly of a patient
interface in accordance with an example of the present
technology.
[0110] FIG. 8d shows a side cross-sectional view taken through line
8d-8d of FIG. 8a of a plenum chamber assembly of a patient
interface in accordance with an example of the present
technology.
[0111] FIG. 8e shows a side cross-sectional view taken through line
8e-8e of FIG. 8a of a plenum chamber assembly of a patient
interface in accordance with an example of the present
technology.
[0112] FIG. 8f shows a side cross-sectional view taken through line
8f-8f of FIG. 8a of a plenum chamber assembly of a patient
interface in accordance with an example of the present
technology.
[0113] FIG. 8g shows a front cross-sectional view taken through
line 8g-8g of FIG. 8a of a plenum chamber assembly of a patient
interface in accordance with an example of the present
technology.
[0114] FIG. 8h shows a front cross-sectional view taken through
line 8h-8h of FIG. 8a of a plenum chamber assembly of a patient
interface in accordance with an example of the present
technology.
[0115] FIG. 8i shows a front cross-sectional view taken through
line 8i-8i of FIG. 8a of a plenum chamber assembly of a patient
interface in accordance with an example of the present
technology.
[0116] FIG. 8j shows a front perspective cross-sectional view taken
through line 8j-8j of FIG. 8a of a plenum chamber assembly of a
patient interface in accordance with an example of the present
technology.
[0117] FIG. 8k shows a side cross-sectional view taken through line
8k-8k of FIG. 8a of a plenum chamber assembly of a patient
interface in accordance with an example of the present
technology.
[0118] FIG. 8l shows a side cross-sectional view taken through line
8l-8l of FIG. 8a of a plenum chamber assembly of a patient
interface in accordance with an example of the present
technology.
[0119] FIG. 9a shows a front view of a plenum chamber assembly of a
patient interface in accordance with an example of the present
technology and includes several lines defining various
cross-sections.
[0120] FIG. 9b shows a side cross-sectional view taken through line
9b-9b of FIG. 9a of a plenum chamber assembly of a patient
interface in accordance with an example of the present
technology.
[0121] FIG. 9c shows a side cross-sectional view taken through line
9c-9c of FIG. 9a of a plenum chamber assembly of a patient
interface in accordance with an example of the present
technology.
[0122] FIG. 9d shows a side cross-sectional view taken through line
9d-9d of FIG. 9a of a plenum chamber assembly of a patient
interface in accordance with an example of the present
technology.
[0123] FIG. 9e shows a side cross-sectional view taken through line
9e-9e of FIG. 9a of a plenum chamber assembly of a patient
interface in accordance with an example of the present
technology.
[0124] FIG. 9f shows a side cross-sectional view taken through line
9f-9f of FIG. 9a of a plenum chamber assembly of a patient
interface in accordance with an example of the present
technology.
[0125] FIG. 9g shows a side cross-sectional view taken through line
9g-9g of FIG. 9a of a plenum chamber assembly of a patient
interface in accordance with an example of the present
technology.
[0126] FIG. 9h shows a side cross-sectional view taken through line
9h-9h of FIG. 9a of a plenum chamber assembly of a patient
interface in accordance with an example of the present
technology.
[0127] FIG. 9i shows a side cross-sectional view taken through line
9i-9i of FIG. 9a of a plenum chamber assembly of a patient
interface in accordance with one form of the present
technology.
[0128] FIG. 10a shows a top view of a nasal cushion of a patient
interface in accordance with an example of the present
technology.
[0129] FIG. 10b shows a top view of a nasal cushion of a patient
interface in accordance with another example of the present
technology.
[0130] FIG. 10c shows a top view of a nasal cushion of a patient
interface in accordance with another example of the present
technology.
[0131] FIG. 10d shows a top view of a nasal cushion of a patient
interface in accordance with another example of the present
technology.
[0132] FIG. 11a shows a cross-section of a nasal cushion taken
through line 11a-11a of FIG. 4a according to an example of the
present technology.
[0133] FIG. 11b shows a cross-section of a nasal cushion taken
through line 11b, c of FIG. 13 according to an example of the
present technology.
[0134] FIG. 11c shows a cross-section of a nasal cushion taken
through line 11b, c of FIG. 13 according to an example of the
present technology.
[0135] FIG. 12a shows a rear view of an oral cushion with an
undercushion of an exemplary seal-forming structure according to
the present technology.
[0136] FIG. 12b shows a rear view of an oral cushion with an
undercushion of another exemplary seal-forming structure according
to the present technology.
[0137] FIG. 12c shows a rear view of an oral cushion with an
undercushion of another exemplary seal-forming structure according
to the present technology.
[0138] FIG. 12d shows a rear view of an oral cushion with an
undercushion of another exemplary seal-forming structure according
to the present technology.
[0139] FIG. 13 shows a top view of a nasal cradle cushion of a
patient interface in accordance with an example of the present
technology.
[0140] FIG. 14 shows an exploded side view of a patient interface
in accordance with an example of the present technology.
[0141] FIG. 15a shows a front view of a seal-forming structure, top
plate, and rigidiser arms in accordance with an example of the
present technology.
[0142] FIG. 15b shows a front view of a seal-forming structure, top
plate, and rigidiser arms in accordance with another example of the
present technology.
[0143] FIG. 15c shows a front view of a seal-forming structure, top
plate, and rigidiser arms in accordance with an example of the
present technology.
[0144] FIG. 15d shows a front view of a seal-forming structure, top
plate, and rigidiser arms in accordance with an example of the
present technology.
[0145] FIG. 15e shows a front view of a seal-forming structure, top
plate, and rigidiser arms in accordance with an example of the
present technology.
[0146] FIG. 16a shows a top perspective view of a seal-forming
structure and plenum chamber according to an example of the present
technology.
[0147] FIG. 16b shows a bottom perspective view of a seal-forming
structure and plenum chamber according to an example of the present
technology.
[0148] FIG. 16c shows a further top perspective view of a
seal-forming structure and plenum chamber according to an example
of the present technology.
[0149] FIG. 16d shows a front view of a seal-forming structure and
plenum chamber according to an example of the present
technology.
[0150] FIG. 16e shows a rear view of a seal-forming structure and
plenum chamber according to an example of the present
technology.
[0151] FIG. 16f shows a top view of a seal-forming structure and
plenum chamber according to an example of the present
technology.
[0152] FIG. 16g shows a bottom view of a seal-forming structure and
plenum chamber according to an example of the present
technology.
[0153] FIG. 16h shows a side view of a seal-forming structure and
plenum chamber according to an example of the present
technology.
[0154] FIG. 16i shows a cross-sectional view of a seal-forming
structure and plenum chamber taken through line 16i-16i of FIG. 16d
according to an example of the present technology.
[0155] FIG. 16j shows a cross-sectional view of a seal-forming
structure and plenum chamber taken through line 16j-16j of FIG. 16f
according to an example of the present technology.
[0156] FIG. 16k shows a cross-sectional view of a seal-forming
structure and plenum chamber taken through line 16k-16k of FIG. 16h
according to an example of the present technology.
[0157] FIG. 16l shows a cross-sectional view of a seal-forming
structure and plenum chamber taken through line 16l-16l of FIG. 16d
according to an example of the present technology.
[0158] FIG. 16m shows a cross-sectional view of a seal-forming
structure and plenum chamber taken through line 16m-16m of FIG. 16g
according to an example of the present technology.
[0159] FIG. 16n shows a detailed front perspective view of a
seal-forming structure and plenum chamber according to an example
of the present technology.
[0160] FIG. 16o shows a cross-sectional view of a seal-forming
structure and plenum chamber taken through line 16o-16o of FIG. 16d
according to an example of the present technology.
[0161] FIG. 17a shows a perspective view of a patient interface
according to an example of the present technology.
[0162] FIG. 17b shows a front view of a patient interface according
to an example of the present technology.
[0163] FIG. 17c shows a rear view of a patient interface according
to an example of the present technology.
[0164] FIG. 17d shows a top view of a patient interface according
to an example of the present technology.
[0165] FIG. 17e shows a bottom view of a patient interface
according to an example of the present technology.
[0166] FIG. 17f shows a side view of a patient interface according
to an example of the present technology.
[0167] FIG. 18a shows a perspective view of a seal-forming
structure with a top plate and a faceplate according to an example
of the present technology.
[0168] FIG. 18b shows a front view of a seal-forming structure with
a top plate and a faceplate according to an example of the present
technology.
[0169] FIG. 18c shows a side view of a seal-forming structure with
a top plate and a faceplate according to an example of the present
technology.
[0170] FIG. 18d shows a top view of a seal-forming structure with a
top plate and a faceplate according to an example of the present
technology.
[0171] FIG. 18e shows a rear perspective view of a seal-forming
structure with a top plate and a faceplate according to an example
of the present technology.
[0172] FIG. 18f shows a cross-sectional view taken through line
18f-8f of FIG. 18d of a seal-forming structure with a top plate and
a faceplate according to an example of the present technology.
[0173] FIG. 19a shows a perspective view of a rigidiser arm
assembly according to an example of the present technology.
[0174] FIG. 19b shows a front view of a rigidiser arm assembly
according to an example of the present technology.
[0175] FIG. 19c shows a side view of a rigidiser arm assembly
according to an example of the present technology.
[0176] FIG. 19d shows a top view of a rigidiser arm assembly
according to an example of the present technology.
[0177] FIG. 19e shows a rear view of a rigidiser arm assembly
according to an example of the present technology.
[0178] FIG. 19f shows a top view of a rigidiser arm assembly
according to an example of the present technology.
[0179] FIG. 19g shows another top view of a rigidiser arm assembly
according to an example of the present technology.
[0180] FIG. 19h shows a rear view of a rigidiser arm assembly
according to an example of the present technology.
[0181] FIG. 20a shows a perspective view of a faceplate frame,
lower attachment features, and clips according to an example of the
present technology.
[0182] FIG. 20b shows a front view of a faceplate frame, lower
attachment features, and clips according to an example of the
present technology.
[0183] FIG. 20c shows a rear view of a faceplate frame, lower
attachment features, and clips according to an example of the
present technology.
[0184] FIG. 20d shows a side view of a faceplate frame, lower
attachment features, and clips according to an example of the
present technology.
[0185] FIG. 20e shows a top view of a faceplate frame, lower
attachment features, and clips according to an example of the
present technology.
[0186] FIG. 20f shows a partially exploded perspective view of a
faceplate frame, lower attachment features, and clips according to
an example of the present technology.
[0187] FIG. 20g shows another partially exploded perspective view
of a faceplate frame, lower attachment features, and clips
according to an example of the present technology.
[0188] FIG. 20h shows an exploded perspective view of a faceplate
frame, lower attachment features, and clips according to an example
of the present technology.
[0189] FIG. 20i shows a perspective view of a faceplate frame
according to an example of the present technology.
[0190] FIG. 20j shows a front view of a faceplate frame according
to an example of the present technology.
[0191] FIG. 20k shows a rear view of a faceplate frame according to
an example of the present technology.
[0192] FIG. 20l shows a side view of a faceplate frame according to
an example of the present technology.
[0193] FIG. 20m shows a top view of a faceplate frame according to
an example of the present technology.
[0194] FIG. 20n shows a rear view of a faceplate frame according to
an example of the present technology.
[0195] FIG. 20o shows another partially exploded perspective view
of a faceplate frame, lower attachment features, and clips
according to an example of the present technology.
[0196] FIG. 20p shows an exploded perspective view of a faceplate
frame, lower attachment features, and clips according to an example
of the present technology.
[0197] FIG. 20q shows a top view of a faceplate frame according to
an example of the present technology.
[0198] FIG. 20r shows a top view of a faceplate frame according to
an example of the present technology.
[0199] FIG. 20s shows a top view of a faceplate frame according to
an example of the present technology.
[0200] FIG. 21a shows a perspective view of a top plate according
to an example of the present technology.
[0201] FIG. 21b shows a front view of a top plate according to an
example of the present technology.
[0202] FIG. 21c shows a rear view of a top plate according to an
example of the present technology.
[0203] FIG. 21d shows a top view of a top plate according to an
example of the present technology.
[0204] FIG. 21e shows a side view of a top plate according to an
example of the present technology.
[0205] FIG. 22a shows a perspective view of a faceplate according
to an example of the present technology.
[0206] FIG. 22b shows a front view of a faceplate according to an
example of the present technology.
[0207] FIG. 22c shows a rear view of a faceplate according to an
example of the present technology.
[0208] FIG. 22d shows a side view of a faceplate according to an
example of the present technology.
[0209] FIG. 22e shows a top view of a faceplate according to an
example of the present technology.
[0210] FIG. 23a shows a front perspective view of a lower
attachment feature support according to an example of the present
technology.
[0211] FIG. 23b shows another front perspective view of a lower
attachment feature support according to an example of the present
technology.
[0212] FIG. 23c shows a rear view of a lower attachment feature
support according to an example of the present technology.
[0213] FIG. 23d shows a top perspective view of a lower attachment
feature support according to an example of the present
technology.
[0214] FIG. 23e shows a side perspective view of a lower attachment
feature support according to an example of the present
technology.
[0215] FIG. 23f shows another side perspective view of a lower
attachment feature support according to an example of the present
technology.
[0216] FIG. 24a shows a front perspective view of a connector of a
lower attachment feature according to an example of the present
technology.
[0217] FIG. 24b shows another front perspective view of a connector
of a lower attachment feature according to an example of the
present technology.
[0218] FIG. 24c shows a rear view of a connector of a lower
attachment feature according to an example of the present
technology.
[0219] FIG. 24d shows a top perspective view of a connector of a
lower attachment feature according to an example of the present
technology.
[0220] FIG. 24e shows a side perspective view of a connector of a
lower attachment feature according to an example of the present
technology.
[0221] FIG. 24f shows another rear perspective view of a connector
of a lower attachment feature according to an example of the
present technology.
[0222] FIG. 25a shows a front perspective view of a clip according
to an example of the present technology.
[0223] FIG. 25b shows another front perspective view of a clip
according to an example of the present technology.
[0224] FIG. 25c show a rear perspective view of a clip according to
an example of the present technology.
[0225] FIG. 25d shows a top perspective view of a clip according to
an example of the present technology.
[0226] FIG. 25e shows a side perspective view of a clip according
to an example of the present technology.
[0227] FIG. 25f shows another rear perspective view of a clip
according to an example of the present technology.
[0228] FIG. 25g shows a front perspective view of a clip according
to an example of the present technology.
[0229] FIG. 25h shows another front perspective view of a clip
according to an example of the present technology.
[0230] FIG. 25i show a rear perspective view of a clip according to
an example of the present technology.
[0231] FIG. 25j shows a top perspective view of a clip according to
an example of the present technology.
[0232] FIG. 25k shows a side perspective view of a clip according
to an example of the present technology.
[0233] FIG. 25l shows another rear perspective view of a clip
according to an example of the present technology.
[0234] FIG. 26a shows a perspective view of a tube decoupling
structure according to an example of the present technology.
[0235] FIG. 26b shows a front view of a tube decoupling structure
according to an example of the present technology.
[0236] FIG. 26c shows a rear view of a tube decoupling structure
according to an example of the present technology.
[0237] FIG. 26d shows a cross-sectional view of a tube decoupling
structure taken through line 26d-26d of FIG. 26c according to an
example of the present technology.
[0238] FIG. 27a shows a perspective view of a seal-forming
structure with a top plate and a faceplate according to an example
of the present technology.
[0239] FIG. 27b shows a front view of a seal-forming structure with
a top plate and a faceplate according to an example of the present
technology.
[0240] FIG. 27c shows a side view of a seal-forming structure with
a top plate and a faceplate according to an example of the present
technology.
[0241] FIG. 27d shows a top view of a seal-forming structure with a
top plate and a faceplate according to an example of the present
technology.
[0242] FIG. 27e shows a rear perspective view of a seal-forming
structure with a top plate and a faceplate according to an example
of the present technology.
[0243] FIG. 27f shows a cross-sectional view taken through line
27f-27f of FIG. 27d of a seal-forming structure with a top plate
and a faceplate according to an example of the present
technology.
[0244] FIG. 28a shows a perspective view of a top plate according
to an example of the present technology.
[0245] FIG. 28b shows a front view of a top plate according to an
example of the present technology.
[0246] FIG. 28c shows a rear view of a top plate according to an
example of the present technology.
[0247] FIG. 28d shows a top view of a top plate according to an
example of the present technology.
[0248] FIG. 28e shows a side view of a top plate according to an
example of the present technology.
[0249] FIG. 29a shows a perspective view of a patient interface
according to an example of the present technology.
[0250] FIG. 29b shows a front view of a patient interface according
to an example of the present technology.
[0251] FIG. 29c shows a rear view of a patient interface according
to an example of the present technology.
[0252] FIG. 29d shows a top view of a patient interface according
to an example of the present technology.
[0253] FIG. 29e shows a bottom view of a patient interface
according to an example of the present technology.
[0254] FIG. 29f shows a side view of a patient interface according
to an example of the present technology.
5 DETAILED DESCRIPTION OF EXAMPLES OF THE TECHNOLOGY
[0255] Before the present technology is described in further
detail, it is to be understood that the technology is not limited
to the particular examples described herein, which may vary. It is
also to be understood that the terminology used in this disclosure
is for the purpose of describing only the particular examples
discussed herein, and is not intended to be limiting.
[0256] The following description is provided in relation to various
examples which may share one or more common characteristics and/or
features. It is to be understood that one or more features of any
one example may be combinable with one or more features of another
example or other examples. In addition, any single feature or
combination of features in any of the examples may constitute a
further example.
5.1 Treatment Systems
[0257] In one form, the present technology comprises apparatus for
treating a respiratory disorder. In an example, the apparatus
comprises a flow generator or blower for supplying pressurised
respiratory gas, such as air, to the patient 1000 via an air
delivery tube leading to a patient interface 3000.
5.2 Therapy
[0258] In one form, the present technology comprises a method for
treating a respiratory disorder comprising the step of applying
positive pressure to the entrance of the airways of a patient
1000.
5.2.1 Nasal CPAP for OSA
[0259] In one form, the present technology comprises a method of
treating Obstructive Sleep Apnea in a patient by applying nasal
continuous positive airway pressure to the patient.
5.3 Patient Interface
[0260] A non-invasive patient interface in accordance with one
aspect of the present technology comprises the following functional
aspects: a seal-forming structure, a plenum chamber, a positioning
and stabilising structure and a connection port for connection to
an air circuit. In some forms a functional aspect may be provided
by one or more physical components. In some forms, one physical
component may provide one or more functional aspects. In use the
seal-forming structure is arranged to surround an entrance to the
airways of the patient so as to facilitate the supply of air at
positive pressure to the airways.
[0261] FIG. 3a shows a front perspective view of a patient
interface 3000 according to an example of the present technology.
The patent interface 3000 may include a seal-forming structure
3100, an oral plenum chamber 3200, a nasal plenum chamber 3202, and
components of a positioning and stabilising structure 3300.
5.3.1 Plenum Chamber and Seal-Forming Structure
[0262] Also shown in FIG. 3a, the upper portion of the seal-forming
structure 3100 may include a nasal cushion or flange 3112 to seal
around the lower portion of the nose of the patient, particularly
around the ala and tip of the nose. This nasal cushion 3112 may
define, at least in part, an upper gas chamber, which will be
discussed in greater detail below.
[0263] FIG. 3a also shows that the seal-forming structure 3100 may
also include an oral cushion or flange 3110 to seal around the
mouth of the patient. The oral cushion 3110 may be attached to the
oral plenum chamber 3200 around a perimeter 3210 of the oral plenum
chamber 3200.
[0264] The rear view in FIG. 3c shows the portions of the
seal-forming structure 3100 that may contact the face of the
patient during use. The nasal cushion 3112 is shown connected to an
upper portion of the oral cushion 3110 by a decoupling structure
3106. The decoupling structure 3106 may be understood to be an
intermediate structure that joins the nasal cushion 3112 and the
oral cushion 3110. The decoupling structure 3106 may allow the
nasal cushion 3112 and the oral cushion 3110 to move relative to
one another, while maintaining a pneumatic flow path therebetween.
The nasal cushion 3112 may define a nasal gas chamber 3104 and a
nasal gas chamber opening 3103 in the nasal cushion 3112 may
receive a portion of the nose of the patient in use. During
therapy, breathable gas may be provided to the patient from the
patient interface 3000 to the nose through the nasal gas chamber
3104. The oral cushion 3110 may also include an oral gas chamber
3102 and an oral gas chamber opening 3101 to provide breathable gas
to the patient's mouth during therapy. Through the oral gas chamber
3102 of the oral cushion 3110, the faceplate 3204 and the port 3600
can be seen. It should be understood that when the patient
interface 3000 is donned on a patient, the faceplate 3204, the
plenum chamber 3200, the oral cushion 3110, the nasal cushion 3112,
and the decoupling structure 3106 may at least partially, along
with the face of the patient, define the nasal gas chamber 3104 and
the oral gas chamber 3102 through which breathable gas may be
provided to the patient at positive pressure.
[0265] In FIG. 3d, a protruding end 3114 can be seen on either side
of the nasal cushion 3112. When donned on the patient each
protruding end 3114 may be shaped to extend from the patient
interface 3000 so as to seal within the gap between the respective
alae and nasolabial sulci of the patient. FIG. 2c, which depicts
superficial features of the face, indicates the location of the
alae and the nasolabial sulci. The details of the seal provided by
the protruding ends 3114 will be described in greater detail below.
The protruding ends 3114 may partially inflate and/or deform to
seal in this area.
[0266] FIG. 3r shows how the exemplary patient interface 3000 may
seal against a patient, particularly the nose. In this detailed
front perspective view, the nose, mouth, and chin of a patient are
shown in solid lines with the nasal cushion 3112 shown against the
nose in dashed lines. It should be understood that the nasal
cushion 3112 may be concave in shape to cradle the nose of the
patient. The recessed portion 3116 is shown receiving the tip of
the nose and the protruding end 3114 can be seen sealing in the
region of the ala and nasolabial sulcus. The nasal undercushion
support wall 3208 may support the nasal cushion 3112 in the region
of the protruding end 3114 to aid in maintaining the seal in this
region, and may function like an undercushion. The nasal plenum
chamber 3202 is also shown. The oral components of the patient
interface 3000 are not shown in this view for the sake of
clarity.
[0267] FIG. 3d also shows a recessed portion 3116 that may be
included on the nasal cushion 3112. This recessed portion 3116 may
comprise an inwardly shaped section that extends into the nasal gas
chamber 3104 to receive the tip of the nose of the patient when
donned by the patient. The recessed portion 3116 may provide
enhanced sealing around and under the tip of the nose of the
patient during therapy by allowing the shape of the nasal cushion
3112 to better conform to the patient's nose. The recessed portion
3116 will also be described in greater detail below.
[0268] In FIGS. 3m and 3n it can be seen that the oral cushion 3110
surrounds the perimeter of the mouth of the patient 1000. The oral
gas chamber 3102 may be formed by the oral cushion 3110 that
surrounds the mouth of the patient 1000, the oral plenum chamber
3200, and the faceplate 3204. In use, the air circuit 4170 may be
connected to a PAP device 4000 (not shown in this view) to provide
breathable gas to the patient 1000 via the oral gas chamber 3102 of
the patient interface 3000 through the patient's mouth.
[0269] This view also shows the nasal cushion 3112 surrounding a
portion of the nose, specifically the nose tip, of the patient
1000. The nasal gas chamber 3104 is thus formed by the nasal
cushion 3112 and the face of the patient. In this example,
breathable gas from the air circuit 4170 may pass through the oral
gas chamber 3102, then through the opening defined by the
decoupling structure 3106 and into the nasal gas chamber 3104. The
line B-B shown in FIG. 3m is intended to indicate the transition
between the nasal bone and the cartilaginous portion of the nose
extending from the bone structure of the nose of the patient 1000.
The nasal cushion 3112 depicted with this exemplary patient
interface 3000 is designed to seal about the periphery of the nose
of the patient and below the line B-B with respect to the nose. In
other words, the nasal cushion 3112 may seal below the bridge of
the nose.
[0270] The patient interface 3000, according to an example of the
present technology, has a 4896 mm.sup.2 surface area footprint on
the face which is less obtrusive than a conventional full face mask
(for example, the ResMed Quattro FX full face mask has a 7007.89
mm.sup.2 surface area footprint on the face) by about 30%. For some
patients, it may also feel less claustrophobic. Also, the specific
areas of reduced obstruction are important because these areas are
found to have significant beneficial psychological impact on a bed
partner when looking at the mask because it looks less medical and
"opens up" the face. From the patient's perspective, the exemplary
patient interface 3000 is not in, or significantly reduced from,
their field of vision because the nasal cushion 3112 seals below
the bridge of the nose. This allows the patient to wear spectacles
when reading a book or watching television after donning the
patient interface 3000 before they fall asleep. By sealing below
the nose bridge, irritation may be avoided in an area that has thin
skin, is pressure sensitive, and/or has high chance of skin
breakdown due to blood flow constriction. Another advantage may be
that anthropometric variations between patients above the nose
bridge do not need to be considered and focus for the mask fit
range can be directed towards anthropometric variations around the
upper lip area. Also, unlike some other full face masks, the
patient interface 3000 may not require a forehead support which is
required for providing pressure point relief. This may also avoid
the problem of the forehead support being a source of a pressure
point and/or skin break down.
[0271] Anatomically, FIGS. 2h and 2i may be referenced for an
indication as to the location of the transitional region between
the nasal bone and the cartilage. Thus, the exemplary nasal cushion
3112 is intended to seal about the periphery of the nose of the
patient in contact with the softer tissues of the nose, e.g., fatty
tissue and cartilage. By forming a seal with the nose on these
softer tissues it may be possible to avoid irritation of the skin
of the patient that would otherwise occur were the seal to be
formed around/over the harder nasal structures, i.e., bone. In
other words, patient discomfort may be minimised by sealing below
the bridge of the nose. Also, locating the seal of the nasal
cushion 3112 around this region of the nose may allow for a better
seal to be formed because the nasal tissues and the nasal cushion
3112 may conform to one another to form the seal. The nasal cushion
3112 should conform to the nose predominantly.
[0272] A sealing feature described above that may be seen in FIG.
3m is the location of the protruding end 3114 against the face of
the patient 1000. Specifically, the protruding end 3114 may be an
extended portion of the nasal cushion 3112 that seals in the region
between the nasolabial sulcus and ala. These anatomical features
may be seen in FIG. 2c. Depending on the individual facial
structure of the patient, this region may represent a recessed
portion 3116 such that an extension from the nasal cushion 3112 may
be necessary to form an adequate seal about the nose of the
patient. The protruding ends 3114, as depicted in FIG. 3m, may
advantageously serve this function.
[0273] Another sealing feature of the depicted exemplary patient
interface 3000 can be seen in FIG. 3p. The nasal cushion 3112
includes, as discussed above, a recessed portion 3116 to receive
the tip of the nose of the patient 1000 when donned by the patient.
Specifically, at the region where the recessed portion 3116 is
located, the tip of the nose of the patient 1000 can be seen in
dashed lines. This view also shows how the nasal cushion 3112 may
be shaped to seal against the perimeter of the nose at its
underside. In other words, the seal formed by the nasal cushion
3112 against the nose may be characterized as against an inferior
and peripheral portion of the nose. Thus, it may be understood from
this view that the sealing surface of the nasal cushion 3112, as a
whole, may be concave or form a pocket to receive the nose and it
may further include the recessed portion 3116 to receive the tip of
the nose.
[0274] FIG. 3q depicts the various points of contact that may be
made by the patient interface 3000 to seal against the face of a
patient. The patient interface 3000 is shown in a side
cross-sectional view. Specifically, the nasal cushion 3112, nasal
plenum chamber 3202, oral cushion 3110, and the oral plenum chamber
3200 are shown in cross-section. Reference may also be made to
FIGS. 2b-f for description of the relevant anatomical features. The
nasal cushion 3112 is shown sealing against the nose of the patient
at the tip. A connection region 3106.2 between the oral cushion
3110 and nasal cushion 3112 is shown sealing against the lip
superior of the patient. It should be noted that connection region
3106.2 may be arranged to seal against the lip superior of the
patient in a region that is below the naris and above the mouth so
as not block airflow into the airways. The connection region 3106.2
may connect the posterior portions of the oral cushion 3110 and the
nasal cushion 3112. The connection region 3106.2 may be structured
and positioned to maintain a seal against the lip superior of the
patient and below the naris, while allow for relative movement
between structures of the oral gas chamber 3102 and the nasal gas
chamber 3104 (e.g., the oral cushion 3110 and the nasal cushion
3112, respectively). The connection region 3106.2 may function
cooperatively with the decoupling structure 3106 to facilitate this
relative movement as well.
[0275] The nasal gas chamber 3104 may be seen defined, at least in
part, by the nasal cushion 3112, nasal plenum chamber 3202, and the
patient's nose to provide a sealed path for breathable gas to enter
the patient's airways via the naris or nostril. A gap 3106.1 can
also be seen between the oral plenum chamber 3200 and the nasal
plenum chamber 3202. The gap 3106.1 will be discussed in greater
detail below, however, it should be understood that the gap 3106.1
may facilitate, in part, maintenance of the seals against the nose
and mouth in spite of independent movement of the nasal cushion
3112 and the oral cushion 3110. It may be advantageous to maintain
the seal of the nasal cushion 3112 against the nose, the connection
region 3106.2 against the lip superior, and the oral cushion 3110
around the mouth while allowing these components to move
independently of one another and also to accommodate anthropometric
variance and a large range of patients.
[0276] As shown in FIG. 3q, the oral gas chamber 3102 may be seen
defined, at least in part, by the oral cushion 3110, oral plenum
chamber 3200, and the mouth of the patient to provide a sealed path
for breathable gas to enter the patient's airways via the mouth. A
seal and/or contact at the lip inferior of the patient may be made
by the oral cushion 3110. Although not shown in this view, it
should be understood that the oral undercushion 3120 may support
the thinner oral cushion 3110 against the lip inferior when a
positioning and stabilising 3300 structure urges the patient
interface 3000 against the face of the patient. In such a
situation, the oral undercushion 3120 would be urged into contact
with a corresponding portion of the oral cushion 3110.
[0277] In one form of the present technology, a seal-forming
structure 3100 provides a sealing-forming surface, and may
additionally provide a cushioning function.
[0278] In an example, a seal-forming structure 3100 in accordance
with the present technology is constructed from a soft, flexible,
resilient material such as silicone. In another example of the
present technology, the seal-forming structure 3100, e.g., the oral
cushion 3110, the nasal cushion 3112 and/or their respective
undercushions, may be formed from foam.
[0279] In an example, the plenum chamber 3200 has a perimeter 3210
that is shaped to be complementary to the surface contour of the
face of an average person in the region where a seal will form in
use. In use, a marginal edge of the plenum chamber 3200 is
positioned in close proximity to an adjacent surface of the face.
Actual contact with the face is provided by the seal-forming
structure 3100. The seal-forming structure 3100 may extend in use
about the entire perimeter 3210 of the plenum chamber 3200.
[0280] FIGS. 7a-h depict several views of the seal-forming
structure 3100 and the plenum chamber 3200. These views show the
seal-forming structure 3100 and the plenum chamber 3200 without the
top plate 3206 and the faceplate 3204, as well as without any of
the associated positioning and stabilising structure 3300.
[0281] FIG. 7a shows a rear perspective view of the seal-forming
structure 3100 and plenum chamber 3200. The exemplary seal-forming
structure 3100 shown in this view includes the oral cushion 3110
and the nasal cushion 3112. The connection region 3106.2 can be
seen in this view connecting the oral cushion 3110 and the nasal
cushion 3112. Also, the location of the decoupling structure 3106
is shown between the oral cushion 3110 and the nasal cushion
3112.
[0282] The oral cushion 3110 and the oral plenum chamber 3200 can
be seen partially defining the oral gas chamber 3102. The opening
3101 to the oral gas chamber 3102 defined by the oral cushion 3110
can also be seen.
[0283] Also visible in FIG. 7a is the nasal plenum chamber 3202
that partly defines the nasal gas chamber 3104 along with the nasal
cushion 3112. This exemplary nasal cushion 3112 can also be seen,
including the protruding ends 3114 at either side. The recessed
portion 3116 that receives the tip of the nose can also be seen. A
nasal undercushion support wall 3208 is shown in this view as well.
The nasal undercushion support wall 3208 is associated with a
respective protruding end 3114 and may provide support for the
protruding end 3114 as it seals against the ala and nasolabial
sulcus of the patient.
[0284] FIG. 7b shows a side perspective view of the exemplary
seal-forming structure 3100 and plenum chamber 3200. FIG. 7b
depicts similar features to those shown in FIG. 7a. This view,
however, also depicts that the connection region 3106.2 may have a
concave shape. In other examples, the connection region 3106.2 may
have a non-concave shape. By forming the connection region 3106.2
with a concave shape, the oral cushion 3110 may be able to better
seal around the mouth of the patient and the nasal cushion may be
able to better seal around and under the nose of the patient.
Alternatively, a fully convex cushion may also function similarly.
In this view, a portion of the perimeter 3210 of the oral plenum
chamber 3200 can also be seen. Also, the location of the decoupling
structure 3106 is indicated.
[0285] FIG. 7b shows the nasal undercushion support wall 3208
associated with the respective protruding end 3114 of the nasal
cushion 3112. The nasal undercushion support wall 3208 extends out
to beyond the perimeter of the nasal plenum chamber 3202. Such a
configuration may allow the nasal undercushion support wall 3208 to
provide sufficient support for the protruding end 3114 to seal
against the patient's face. The bottom half of the nasal
undercushion support wall 3208 may act as a hinge or pivot point
for the decoupling structure 3106. The top half of the nasal
undercushion support wall 3208 may help locate the top plate
3206.
[0286] FIG. 7c shows a front perspective view of the exemplary
seal-forming structure 3100 and plenum chamber 3200. This view
depicts particularly well the anterior portion of the nasal plenum
chamber 3202 as well as the nasal undercushion support wall 3208
that supports the protruding ends 3114 of the nasal cushion
3112.
[0287] FIG. 7d shows a rear view of the exemplary seal-forming
structure 3100 and plenum chamber 3200. This view shows features
similar to those shown in FIG. 7a. On either side of the nasal
cushion 3112 a portion of each nasal undercushion support wall 3208
can be seen. Also, this view shows how the connection region 3106.2
may connect the oral cushion 3110 to the nasal cushion 3112. Also,
the location of the decoupling structure 3106 is indicated.
[0288] FIG. 7e shows a front view of the exemplary seal-forming
structure 3100 and plenum chamber 3200. This view shows especially
well the oral cushion 3110 disposed about the perimeter 3210 of the
oral plenum chamber 3200. Further, the oral gas chamber 3102 can be
seen defined by the oral cushion 3110 and the oral plenum chamber
3200. Also, this view shows the anterior portion of the decoupling
structure 3106 that connects the nasal cushion 3112 to the oral
cushion 3110. Nasal undercushion support walls 3208 can be seen on
either side of the nasal cushion 3112. From this view, the oral
undercushion 3120 is also visible. This view also shows that the
oral undercushion 3120 may terminate at a tapered region 3122 near
either side of the nasal cushion 3112. Thus, there may be no
undercushion at the connection region 3106.2 (not shown in this
view) between the oral cushion 3110 and the nasal cushion 3112.
Advantageously, this may allow greater flexibility in the
connection region 3106.2 such that the seal against the lip
superior that is shown in FIG. 3q may be easily maintained despite
movement of the oral and nasal cushions 3110, 3112.
[0289] FIGS. 12a-d show further exemplary arrangements of the oral
undercushion 3120 in accordance with the present technology. These
Figures show the oral cushion 3110 and the opening 3101 to the oral
gas chamber 3102 with various configurations of the oral
undercushion 3120 shown in stippling. For the sake of simplicity
additional features associated with the seal-forming structure 3100
have been omitted from these drawings.
[0290] FIG. 12a depicts an example of the oral cushion 3110 where
the oral undercushion 3120 surrounds the entire perimeter of the
oral cushion 3110. FIG. 12b depicts an example of the oral cushion
3110 where there are two portions of oral undercushion 3120, one on
either side of the oral cushion. FIG. 12c depicts an example where
the oral undercushion 3120 surrounds the entire perimeter of the
oral cushion 3110 with the exception of a portion near an upper
region of the oral cushion 3110. FIG. 12d depicts a similar example
to FIG. 12c, however the portion of the oral cushion 3110 where
there is no oral undercushion 3120 is at a lower region of the oral
cushion 3110.
[0291] FIG. 7f shows a top view of the exemplary seal-forming
structure 3100 and plenum chamber 3200. This view shows nasal
cushion 3112 with its protruding ends 3114 and recessed portion
3116, as well as the nasal gas chamber 3104 defined, in part, by
the nasal cushion 3112. This view also partly shows the pneumatic
connection between the oral gas chamber 3102 and the nasal gas
chamber 3104 that is defined by the decoupling structure 3106.
[0292] FIG. 7g shows a bottom view of the exemplary seal-forming
structure 3100 and plenum chamber 3200. This view shows oral
cushion 3110 attached to the oral plenum chamber 3200. Also, the
protruding ends 3114 of the nasal cushion 3112 can be seen.
[0293] FIG. 8a shows another top view of the exemplary seal-forming
structure 3100 and plenum chamber 3200. This view also shows a
number of cross-section lines to indicate the cross-sections
depicted in subsequent drawings, FIGS. 8b-8l. This view is similar
to FIG. 7f and similar components are therefore depicted. However,
to avoid confusion, reference numerals and lead lines have been
excluded.
[0294] FIGS. 8b-d show cross-sectional views of the exemplary
seal-forming structure 3100 and plenum chamber 3200 taken along
line 8b, 8c, 8d, -8b, 8c, 8d. The nasal cushion 3112 can be seen
connected to the oral cushion 3110 by the connection region 3106.2.
The oral gas chamber 3102 can be seen defined, in part, by the oral
plenum chamber 3200 and the oral cushion 3110. The nasal gas
chamber 3104 can be seen defined, in part, by the nasal plenum
chamber 3202 and the nasal cushion 3112. The protruding end 3114
and the recessed portion 3116 of the nasal cushion 3112 are also
shown. This view also shows how the connection region 3106.2 in one
example of the technology may not include an undercushion, while
the oral cushion 3110 may include an oral undercushion 3120 and a
nasal undercushion support wall 3208 (not shown in these views) to
support the protruding end 3114. The gap 3106.1 formed by the
hinge-like arrangement of the oral plenum chamber 3200, nasal
plenum chamber 3202, and the decoupling structure 3106 can also be
seen. In another example of the present technology, the oral
undercushion 3120 may include two discontinuous side portions that
are present on either side of the oral cushion 3110, but there
would be no oral undercushion portion at the connection region
3106.2 or at the lower central portion of the oral cushion 3110.
Alternatively, as shown in FIG. 7e, the oral undercushion 3120 may
terminate near the nasal cushion 3112 at tapered regions 3122 on
either side thereof.
[0295] FIGS. 8b and 8c also show angles .alpha. and .beta.,
respectively, being swept out with respect to the connection region
3106.2. FIG. 8b shows that .alpha. is the angle from the nasal
cushion 3112 to a lower portion of the oral cushion 3110. Angle
.alpha. may be in the range of about 80.degree. to about
180.degree. and in one example of the technology .alpha. may be
about 142.degree.. FIG. 8c shows that .beta. is the angle from the
nasal cushion 3112 to an upper portion of the oral cushion 3110.
Angle .beta. may be in the range of about 80.degree. to about
170.degree. and in one example of the technology .beta. may be
about 120.degree.. The cushions 3110, 3112 and plenum chambers
3200, 3202 may be formed as one-piece.
[0296] FIG. 8e shows another cross-sectional view of the exemplary
seal-forming structure 3100 and plenum chamber 3200 taken along
line 8e-8e. Again in this view, it can be seen that the oral
cushion 3110 includes an oral undercushion 3120. The connection
region 3106.2 is shown without an undercushion in accordance with
this example of the technology. The gap 3106.1 formed by the
hinge-like arrangement of the oral plenum chamber 3200, nasal
plenum chamber 3202, and the decoupling structure 3106 can also be
seen. Also, the side portion 3106.3 of the decoupling structure
3106 can be seen.
[0297] FIG. 8f shows another cross-sectional view of the exemplary
seal-forming structure 3100 and plenum chamber 3200 taken along
line 8f-8f. This view shows features similar to the example
depicted in FIG. 8e. However, this view also shows a portion of the
nasal undercushion support wall 3208 positioned to support the
protruding end 3114 of the nasal cushion 3112. Here, the side
portion 3106.3 of the decoupling structure 3106 can be seen
proximal to the nasal undercushion support wall 3208.
[0298] FIG. 8g shows another cross-sectional view of the exemplary
seal-forming structure 3100 and plenum chamber 3200 taken along
line 8g-8g. FIG. 8g again shows similar features to FIGS. 8e and
8f. This view, however, also more clearly shows the nasal
undercushion support wall 3208 positioned under the protruding end
3114 of the nasal cushion 3112.
[0299] FIG. 8h shows another cross-sectional view of the exemplary
seal-forming structure 3100 and plenum chamber 3200 taken along
line 8h-8h. This view also shows features similar to those depicted
in FIG. 8g. In this view each protruding end 3114 can be seen with
a respective nasal undercushion support wall 3208 positioned
thereunder.
[0300] FIG. 8i shows another cross-sectional view of the exemplary
seal-forming structure 3100 and plenum chamber 3200 taken along
line 8i-8i. This view also shows features similar to those depicted
in FIG. 8h.
[0301] FIG. 8j shows another cross-sectional view of the exemplary
seal-forming structure 3100 and plenum chamber 3200 taken along
line 8j-8j. This view also shows features similar to those depicted
in FIG. 8f.
[0302] FIG. 8k shows another cross-sectional view of the exemplary
seal-forming structure 3100 and plenum chamber 3200 taken along
line 8k-8k. This view also shows features similar to those depicted
in FIG. 8d. FIG. 8k also shows particularly well that in this
depicted example of the technology that the connection region 3106
may have a concave shape to fit against the upper lip of the
patient.
[0303] FIG. 8l shows another cross-sectional view of the exemplary
seal-forming structure 3100 and plenum chamber 3200 taken along
line 8l-8l. This view also shows features similar to those depicted
in FIG. 8d.
[0304] FIG. 9a shows another front view of the exemplary
seal-forming structure 3100 and plenum chamber 3200. This view also
shows a number of cross-section lines to indicate the
cross-sections depicted in subsequent drawings, FIGS. 9b-9i. This
view is similar to FIG. 7e and similar components are therefore
depicted. However, to avoid confusion, reference numerals and lead
lines have been excluded.
[0305] FIG. 9b shows a cross-sectional view of the exemplary
seal-forming structure 3100 and plenum chamber 3200 taken along
line 9b-9b. FIG. 9b also depicts similar features to those shown in
FIGS. 8b-d.
[0306] FIG. 9c shows a cross-sectional view of the exemplary
seal-forming structure 3100 and plenum chamber 3200 taken along
line 9c-9c. This view shows particularly well a cross-section of
the nasal undercushion support wall 3208 that may be included to
support the protruding end 3114 of the nasal cushion 3112.
[0307] FIG. 9d shows a cross-sectional view of the exemplary
seal-forming structure 3100 and plenum chamber 3200 taken along
line 9d-9d. The cross-sectional view shown here is taken at an
angle such that no portion of the nasal cushion 3112 is shown. This
view also depicts particularly well the oral undercushion 3120 of
the oral cushion 3110. In the example shown in this view, the
tapered end 3122 of the oral undercushion 3120 can be seen as
well.
[0308] FIG. 9e shows a cross-sectional view of the exemplary
seal-forming structure 3100 and plenum chamber 3200 taken along
line 9e-9e. FIG. 9e is taken along a similar cross-section to FIG.
9d and, therefore, depicts similar features.
[0309] FIG. 9f shows a cross-sectional view of the exemplary
seal-forming structure 3100 and plenum chamber 3200 taken along
line 9f-9f. This view depicts particularly well the oral cushion
3110 and the oral undercushion 3120 and how these two cushions
3110, 3120 may share a similar profile to seal against the face of
the patient.
[0310] FIG. 9g shows a cross-sectional view of the exemplary
seal-forming structure 3100 and plenum chamber 3200 taken along
line 9g-9g. FIG. 9g is taken along a similar cross-section to FIG.
9f and, therefore, depicts similar features.
[0311] FIG. 9h shows a cross-sectional view of the exemplary
seal-forming structure 3100 and plenum chamber 3200 taken along
line 9h-9h. FIG. 9h depicts features similar to those shown in FIG.
9c, including the cross-section of the nasal undercushion support
wall 3208.
[0312] FIG. 9i shows a cross-sectional view of the exemplary
seal-forming structure 3100 and plenum chamber 3200 taken along
line 9i-9i. FIG. 9i depicts features similar to those shown in FIG.
9b.
[0313] FIGS. 16a to 16o show several views of another seal-forming
structure 3100 and plenum chamber 3200, according to an example of
the present technology.
[0314] The seal-forming structure 3100 and the plenum chamber 3200
according to this example includes pockets 3208.1 on either side of
the nasal cushion 3112 near the side portions 3106.3 and under the
protruding ends 3114. FIGS. 16a, 16d, 16i, 16k, and 16m-o. The
pockets 3208.1 may be defined, at least in part, by the decoupling
structure 3106, the undercushion support walls 3208, the side
portions 3106.3, the nasal plenum chamber 3202, and the side
supports 3207. The pockets 3208.1 may be open in an anterior
direction of the seal-forming structure 3100 and the plenum chamber
3200. The pockets 3208.1 may also provide resistance to deformation
of the nasal cushion 3112 in every direction. The pockets 3208.1
may provide compression resistance for the nasal cushion 3112. This
compression resistance may help to reduce leak at the corners of
nose area where the pockets 3208.1 may support the nasal cushion
3112 and/or the protruding ends 3114 when the nasal cushion 3112 is
in contact the patient's nose. According to an example of the
present technology, it may be advantageous for the nasal cushion
3112 to deform at regions other than at the protruding ends 3114
that may be supported by the pockets 3208.1. The pockets 3208.1 and
the decoupling structure 3106 may help to resist deformation of the
nasal cushion 3112 or may help to allow deformation to occur in
targeted areas.
[0315] The side supports 3207 shown in the examples depicted by
FIGS. 16a to 16o may be integrally formed with the seal-forming
structure 3100 and the plenum chamber 3200. Thus, in the example
where the seal-forming structure 3100 and the plenum chamber 3200
are formed from silicone, the side supports 3207 would likewise be
formed of silicone. The side supports 3207 may serve a stiffening
purpose to improve the seal between the seal-forming structure and
the patient's face. For example, the side supports 3207 may help to
support the nasal cushion 3112, at its sides, against the patient's
alae and/or the side supports may help to support the protruding
ends 3114 against the region of the patient's face where the alae
join near the nasolabial sulci. The side supports 3207 may also
control deformation of the nasal cushion 3112, so that certain
areas of the nasal cushion deform before others. The side supports
3207 may also control the extent of deformation in certain areas of
the nasal cushion 3112. The side supports 3207 may facilitate
controlled deformation of the nasal cushion 3112 because the side
supports 3207 may allow bending when compressed due to contact with
the patient's face. The side supports 3207 may also strengthen the
sides of the nasal cushion 3112 to decouple a compression force of
the face against the nasal cushion 3112 to prevent the nasal
cushion 3112 from collapsing into the decoupling structure
3106.
[0316] The side supports 3207 may each include a notch 3209. The
notches 3209 of the side supports 3207 may provide a pivot point
between the nasal cushion 3112 and the oral cushion 3110. The
pockets 3208.1 may also serve to control the location of the pivot
point.
[0317] The side supports 3207 may also provide attachment points
for the top plate 3206. The top plate 3206 may be integrally and/or
chemically bonded with the seal-forming structure 3100 and the
plenum chamber 3200. In an example, the silicone of the
seal-forming structure 3100 and the plenum chamber 3200 may be
formed and/or molded around the top plate 3206. No mechanical
interlock may be necessary, according to an example of the present
technology, between the top plate 3206 and the seal-forming
structure 3100 and the plenum chamber 3200. Alternatively, there
may be no chemical and/or integral bond, such that a mechanical
interlock between the top plate 3206 and the seal-forming structure
3100 and the plenum chamber 3200 would be necessary. The top plate
3206 may also define, at least in part, the pivot point between the
nasal cushion 3112 and the oral cushion 3110.
[0318] It may also be desirable to strengthen or stiffen the nasal
cushion 3112 to provide localized support so as to reduce or
control deformation in particular regions of the nasal cushion
relative other regions. Examples of stiffening may include
increasing the relative thickness of the nasal cushion 3112 that
are desired to be strengthened. Alternatively, reinforcement ribs
or other reinforcement structures may be formed on the nasal
cushion 3112 to provide the desired level and position of localized
support.
[0319] FIGS. 16i, 16k-m, and 16o show that the nasal cushion 3112
may also include thickened nasal cushion sections 3124 at the
sides. The thickened nasal cushion sections 3124 may be thickened
portions of the nasal cushion 3112 that extend in an internal
direction of the nasal cushion and generally into the nasal gas
chamber 3104. These thickened nasal cushion sections 3124 may
provide additional support for the nasal cushion 3112 when it is in
sealing engagement with the nose and the face of the patient. The
thickened nasal cushion sections 3124 may be located on opposite
sides of the nasal cushion 3112 in a position such that they are
proximal to the patient's nasolabial sulcus when the seal-forming
structure engages the patient's face. The thickened nasal cushion
sections 3124 may also help to seal around the alae of the
patient's nose by preventing collapse of the nasal cushion 3112 due
to sealing forces. The thickened nasal cushion sections 3124 may be
formed integrally with the nasal cushion 3112. Also, the thickened
nasal cushion sections 3124 may be located on the nasal cushion
3112 such that when the seal-forming structure engages the
patient's nose and face the thickened nasal cushion sections 3124
may be, at least partially, urged against respective undercushion
support walls 3208. The thickened nasal cushion sections 3124 may
have a constant thickness throughout that is greater than the
thickness of the remainder of the nasal cushion 3112.
Alternatively, the thickened nasal cushion sections 3124 may have a
thickness that is variable across its area.
[0320] In alternative examples of the present technology, the
thickened nasal cushion sections 3124 not be provided and other
structures may be provided to increase stiffness in these regions.
For examples, ribs or other reinforcing structures may be provided
to the nasal cushion 3112 in the regions where the thickened nasal
cushion sections 3124 are shown to accomplish the function of
stiffening the nasal cushion 3112 in these areas.
[0321] FIG. 16k also shows an example of the present technology
where the oral plenum chamber 3200 includes thickened oral plenum
chamber sections 3212. These thickened oral plenum chamber sections
3212 may provide additional support for the oral plenum chamber
3200 to help resist collapsing of the oral plenum chamber.
[0322] Also, FIGS. 16j and 16k show cross-sectional views through
the seal-forming structure 3100 and the plenum chamber 3200. These
views show that the connection region 3106.2 may be thicker in the
examples depicted in these views relative to the connection region
shown in FIGS. 8a to 8l and 9a to 9l. The thickness of the
connection region 3106.2 shown in FIGS. 16j and 16k may also be
consistent along its width and height. Tube torque from the air
circuit 4170 may cause the oral cushion 3110 to pull on the nasal
cushion 3112 via decoupling structure 3106 and extend the
connection region 3106.2 in a generally vertical direction.
Extension of the connection region 3106.2 may cause disruption of
the seal of the nasal cushion 3112. By thickening the connection
3106.2 and making the thickness consistent throughout, this
extension of the connection region 3106.2 may be resisted and
disruption of the seal at the nasal cushion 3112 may be prevented
and/or reduced.
[0323] FIGS. 16b, 16c, 16e. 16f, 16j, and 16o show views of the
nasal cushion 3112 that include a nasal sling 3119 that divides the
opening 3103 to the nasal gas chamber 3104 into nare ports 3105.
The nasal sling 3119 may seal along the columella of the patient's
nose (see FIG. 2f) so that each nare may be sealed individually.
Alternatively, the nasal sling 3119 may provide columella relief by
contacting the patient's columella without forming a seal. Also,
the nasal sling 3119 may prevent the tip of the patient's nose from
extending through the nasal cushion 3112 and into the nasal gas
chamber 3104. The nasal sling 3119 may also provide support for the
nasal cushion 3112 to prevent deformation of the nasal cushion 3112
in the direction of the longitudinal axis of the nasal sling
3119.
[0324] The seal-forming structure 3100 may include a compliant
region. The compliant region is not shown in these examples.
Description and depiction of further examples of the compliant
region is provided in PCT Application No. PCT/AU2014/000026. The
compliant region may be relatively soft, flexible, and/or compliant
relative to other portions of the seal-forming structure 3100. The
compliant region's relative flexibility may be advantageous in that
it may help to relieve discomfort to the patient in the regions of
the tip of the nose and the septum. The compliant region may be
relatively thin as compared to other portions of the seal-forming
structure 3100 and, as such, may function like a mechanical spring
to maintain an effective seal at the tip of the nose by wrapping
against and/or contacting the tip of the nose. The compliant region
may be located on the seal-forming structure 3100 at the upper apex
where the seal-forming structure 3100 transitions to the plenum
chambers 3200, 3202. The compliant region may be located on the
seal-forming structure 3100 above the recessed portion 3116. The
compliant region may also blend into the recessed portion 3116. The
compliant region may also be located substantially centrally on the
seal-forming structure 3100 in horizontal direction. The
seal-forming structure 3100 may have a thickness at the compliant
region that is about 0.35 mm according to an example of the present
technology and may be one of the thinnest regions of the
seal-forming structure 3100.
5.3.1.1 Exemplary Nasal Cushions
[0325] FIGS. 4a-c, 5a-c, and 6a-c depict various examples of the
nasal cushion 3112 in accordance with the present technology.
[0326] FIG. 4a shows a top view of an exemplary nasal cushion 3112.
The protruding ends 3114 can be seen at either side of the nasal
cushion 3112. The nasal gas chamber 3104 and the opening 3103
thereto can also be seen. The opening 3103 to the nasal gas chamber
3104 may generally have a rectangular, lozenge or trapezoidal shape
that may be curved at its respective minor and major sides 3104.2.
When placed against the nose of the patient the curved minor sides
3104.2 of the nasal opening 3103 will be proximal to the respective
alae of the nose. Also in this example, one of a pair of major
sides, specifically a distal side 3104.1 of the nasal opening 3103,
will be distal to the upper lip of the patient and near the tip of
the nose, while another of the pair of major sides, a proximal side
3104.3, will be proximal to the upper lip of the patient. The
recessed portion 3116 that is shaped to receive the tip of the nose
is also shown.
[0327] FIG. 4b shows a bottom view of the exemplary nasal cushion
3112 sectioned along line 4c-4c of FIG. 4a. This view also shows
the nasal gas chamber 3104 and its associated opening 3103.
[0328] FIG. 4c shows a side perspective view of the exemplary nasal
cushion 3112 sectioned along line 4c-4c of FIG. 4a. This view again
shows the nasal gas chamber 3104 and the opening 3103 thereto. The
recessed portion 3116 is also indicated. Of particular note in this
view is the profile of the nasal cushion 3112 along the section
line 4c-4c. The nasal cushion 3112 can be seen to curve slightly
upward as it approaches the distal side 3104.1 of the opening 3103
to the nasal gas chamber 3104 from the recessed portion 3116. Also,
it can be seen in this view, as well as FIG. 4b, that the anterior
upper portion of the nasal cushion 3112 that is near the recessed
portion 3116 includes a slight dip or concave region at its center
where line 4c-4c passes, such that the nasal cushion 3112 is higher
at its sides than in the middle. This view also shows the outline
of a nose in dashed lines to indicate how the nose of the patient
may be located relative to the nasal cushion 3112. The peak 3118 in
the cushion 3112 may be tasked with sealing the anterior of the
nares. The peak 3118 sits further toward the posterior but
transitions more gradually for creating the balloon effect. The
distal side 3104.1 may flick up from the cushion 3112 and may
improve the seal at the nose tip because it makes contact with the
nose sooner and causes both a compressive and pneumatic seal by
cradling the nose. The recessed portion 3116 that is shaped to
receive the tip of the nose is also shown.
[0329] FIG. 5a shows a top view of an exemplary nasal cushion 3112.
The protruding ends 3114 can be seen at either side of the nasal
cushion 3112. The nasal gas chamber 3104 and the opening 3103
thereto can also be seen. The shape of the opening 3103 to the
nasal gas chamber 3104 may also be similar to that which is shown
in FIG. 4a. The recessed portion 3116 that is shaped to receive the
tip of the nose is also shown.
[0330] FIG. 5b shows a bottom view of the exemplary nasal cushion
3112 sectioned along line 5c-5c of FIG. 5a. This view also shows
the nasal gas chamber 3104 and its associated nasal opening
3103.
[0331] FIG. 5c shows a side perspective view of the exemplary nasal
cushion 3112 sectioned along line 5c-5c of FIG. 5a. This view again
shows the nasal gas chamber 3104 and the opening 3103 thereto. The
recessed portion 3116 is also indicated. Of particular note in this
view is the profile of the nasal cushion 3112 along the section
line 5c-5c. As contrasted with the profile of the nasal cushion
3112 in FIG. 4c, it can be seen in this view that the nasal cushion
is sloped downwardly as it approaches the distal side 3104.1
opening 3103 to the nasal gas chamber 3104 from the recessed
portion 3116. It can also be seen that this example of the nasal
cushion 3112 lacks the dip in the anterior region near the recessed
portion 3116 that can be seen in the example shown in FIGS. 4b and
4c. In other words, this example shows that the nasal cushion 3112
may be more circular/rounder, relative to the example shown in FIG.
4c in the region from the recessed portion 3116 to the distal side
3104.1 of the opening 3103 to the nasal gas chamber 3104. This view
also shows the outline of a nose in dashed lines to indicate how
the nose of the patient may be located relative to the nasal
cushion 3112.
[0332] FIG. 6a shows a top view of an exemplary nasal cushion 3112.
The protruding ends 3114 can be seen at either side of the nasal
cushion 3112. The nasal gas chamber 3104 and the opening 3103
thereto can also be seen. The shape of the opening 3103 to the
nasal gas chamber 3104 may also be similar to that which is shown
in FIG. 4a. In FIGS. 4a to 4c, the shape is more balloon like and
rounder than the example shown in FIGS. 6a to 6c.
[0333] FIG. 6b shows a bottom view of the exemplary nasal cushion
3112 sectioned along line 6c-6c of FIG. 6a. This view also shows
the nasal gas chamber 3104 and its associated opening 3103.
Additionally, it can be seen in this view that the nasal cushion
3112 has straight sidewalls 3121, in contrast with the sidewalls
that curve smoothly from the upper surface of the nasal cushions
3112 shown in FIGS. 4a-c and 5a-c. The straight sidewalls 3121 may
have a defined top edge and assumed to increase stability and
strength of the nasal cushions 3112.
[0334] FIG. 6c shows a side perspective view of the exemplary nasal
cushion 3112 sectioned along line 6c-6c of FIG. 6a. This view again
shows the nasal gas chamber 3104 and the opening 3103 thereto. The
recessed portion 3116 is also indicated. Of particular note in this
view is the profile of the nasal cushion 3112 along the section
line 6c-6c. It can be seen, as in FIG. 5c that this example of the
nasal cushion 3112 lacks the dip in the anterior region near the
recessed portion that can be seen in the example shown in FIGS. 4b
and 4c. The straight sidewalls 3121 of this exemplary nasal cushion
3112 can also be seen in this view. This view also shows the
outline of a nose in dashed lines to indicate how the nose of the
patient may be located relative to the nasal cushion 3112.
[0335] Furthermore, it should also be understood that the exemplary
nasal cushions 3112 depicted in FIGS. 4a-4c, 5a-5c, and 6a-6c are
shown in substantially undeformed states. FIGS. 4c, 5c, and 6c may
indicate a small amount of deformation due to conformation with the
shape of the nose shown in dashed lines. Thus, the nasal cushions
3112 may have the concave shape as shown, when not deformed.
[0336] It should also be understood that the nasal cushion 3112 may
have a cross-section of variable thickness. Thus, the region of the
nasal cushion 3112 proximate to the opening 3103 to the nasal gas
chamber 3104 may be thinner than the region where the nasal cushion
3112 attaches to the nasal plenum chamber 3202. Advantageously,
this may afford more comfort for the patient by providing a thinner
and, thus, more compliant region of cushion material at the area
where a large amount of contact is made with the patient's
nose.
[0337] FIGS. 10a-d show further additional nasal cushions 3112
according to further examples of the present technology. These
views depict further variations of the possible shape of the
opening 3103 to the nasal gas chamber 3104.
[0338] FIGS. 11a-c depict various cross-sectional profiles of the
nasal cushion 3112 according to examples of the present technology.
The region 3112.1 may be proximal to the opening 3103 to the nasal
gas chamber 3104 and the region 3112.3 may be proximal to the
connection to the nasal plenum chamber 3202. The region 3112.2 may
be the most elevated region around the upper periphery of the nasal
cushion 3112.
[0339] FIG. 11a shows a cross-section of a nasal cushion 3112 taken
across line 11-11a of FIG. 4a. This cross-section shows a smoothly
variable thickness for the nasal cushion 3112 from region 3112.1 to
region 3112.3. Also, the thickness x may be less than the thickness
z.
[0340] FIG. 11b shows a cross-section of a nasal cushion 3112 taken
across line 11b, c-11b, c of FIG. 13. This cross-section shows that
the region 3112.2 may abruptly become thicker than the regions
3112.1 and 3112.3. Also, the thickness x may be less than the
thickness z and the thickness y may be greater than x and z.
[0341] FIG. 11c shows a cross-section of a nasal cushion 3112 taken
across line 11b, c-11b, c of FIG. 13. Region 3112.2 may be
stiffened relative to the other regions 3112.1 and 3112.3. This
cross-section shows that the region 3112.2 may abruptly become
thicker than the regions 3112.1 and 3112.3. Also, the thickness z
may be less than the thickness x and the thickness y may be greater
than x and z.
[0342] FIG. 13 shows a top view of another exemplary nasal cushion
3112 according to the present technology. The opening 3103 to the
nasal gas chamber 3104 and the protruding end 3114 are indicated to
allow for understanding of the orientation of the nasal cushion
3112. Regions of various thicknesses are hatched differently to
better indicate where the stiffness and/or thickness of the nasal
cushion 3112 may vary. Region 3113 may be the thinnest to allow for
ready conformation to the tip of the nose. Region 3113, according
to an example of the present technology, may have a thickness of
about 0.35 mm. Region 3115 may be thicker to provide more support
for the nasal cushion 3112. Region 3115, according to an example of
the present technology, may have a thickness of about 0.5 mm.
Region 3117 may be thicker than the other regions to provide
maximum support, resistance to deformation, and ensure an effective
seal at the ala of the patient. Region 3117, according to an
example of the present technology, may have a thickness of about 1
mm.
5.3.2 Decoupling Structure
[0343] The decoupling structure 3106 shown in FIG. 3c may provide a
connection between the nasal cushion 3112 and the oral cushion
3110. The decoupling structure 3106 may also define a pneumatic
connection between the oral gas chamber 3102 and the nasal gas
chamber 3104. Thus, during therapy when the patient is provided
with breathable gas at positive pressure the gas may enter the
patient interface via the port 3600 and flow directly into the oral
gas chamber 3102 defined at least in part by the plenum chamber
3200, the faceplate 3204, the oral cushion 3110, and the decoupling
structure 3106. The gas may then flow to the mouth of the patient.
The breathable gas may also be provided to the nose of the patient
via the nasal gas chamber opening 3103 and through the nasal gas
chamber 3104 that is defined at least partly by the nasal cushion
3112, the nasal plenum chamber 3202 and the decoupling structure
3106. To reach the nasal gas chamber 3104, the gas must flow from
the oral gas chamber 3102 and through the pneumatic pathway defined
by the decoupling structure 3106 and then into the nasal gas
chamber 3104. It should be understood, however, that a port may be
provided to the top plate 3206 or the nasal cushion 3112 to receive
breathable gas. In that case, the flow pattern through the patient
interface 3000 may simply be reversed.
[0344] As to the decoupling structure 3106 depicted in FIG. 3c,
this feature may also allow for the nasal cushion 3112 and the oral
cushion 3110 to move independently of one another when donned by
the patient. When worn by the patient with a positioning and
stabilising structure 3300 (e.g., headgear), as will be described
in greater detail below, the nasal cushion 3112 may be urged
against the face of the patient, particularly the nose, by forces
transferred along the rigidiser arms 3302 to the nasal cushion 3112
via the top plate 3206. Also, the oral cushion 3110 may be urged
against the face of the patient, particularly the mouth, by forces
transferred to the faceplate 3204 from headgear straps 3306.
Because different sets of headgear straps 3306 may urge different
portions of the patient interface 3000 (e.g., the nasal cushion
3112 and the oral cushion 3110) against different portions of the
patient's face (e.g., the nose and the mouth, respectively) it may
be advantageous to allow the nasal cushion 3112 and the oral
cushion 3110 to move independently of one another because of the
decoupling structure 3106.
[0345] The decoupling structure 3106 may be used to connect the
oral cushion 3110 and the nasal cushion 3112 to facilitate this
independent movement. Allowing independent movement of the cushions
3110, 3112 may allow for better sealing against a wider variety of
patient facial shapes and it may also aid in maintaining a seal
against the patient's face in spite of movement in different
regions of the face, movement of the air circuit 4170 or external
forces. Moreover, due to the fact that the patient interface 3000
may seal against two separate regions of the face, the nose and the
mouth, two separate openings must be provided to supply the
breathable gas to the patient. By allowing the sealing structures
(e.g., the oral cushion 3110 and the nasal cushion 3112) to move
independently a seal may be maintained around the nose
independently of the seal around the mouth to prevent undesired
leakage and therefore, pressure loss through one or both
openings.
[0346] The decoupling structure 3106 may also form part of a wall
of the oral plenum chamber 3200 and the nasal plenum chamber 3202
in an anterior direction. The decoupling structure 3106 may also be
resiliently flexible to allow for relative movement and/or length
extension between the structures that define the oral gas chamber
3102 and the nasal gas chamber 3104. Thus, the oral plenum chamber
3200 and the nasal plenum chamber 3202 may be extended away from
one another or compressed together, while a pneumatic connection is
maintained between the oral gas chamber 3102 and the nasal gas
chamber 3104. Moreover, the decoupling structure 3106 may also
allow these structures (e.g., the oral plenum chamber 3200 and the
nasal plenum chamber 3202) to be tilted relative to one another,
while a pneumatic connection is maintained between the oral gas
chamber 3102 and the nasal gas chamber 3104 and a seal is
maintained with the patient's face.
[0347] The decoupling structure 3106 may also comprise an upper
surface 3106.4, a connecting surface 3106.5, and a lower surface
3106.6. The connecting surface 3106.5 may be relatively stiffer
than the upper surface 3106.4 and the lower surface 3106.6. The
lower surface 3106.6 may be understood to be a separate surface
from the oral cushion 3110. The upper surface 3106.4 may be
understood to be a separate surface from the nasal cushion 3112.
The greater stiffness of the connecting surface 3106.5 may be
produced by reinforcement ribs or other reinforcement structures or
by making the connecting surface 3106.5 thicker than the upper
surface 3106.4 and the lower surface 3106.6. According to one
example, the upper surface 3106.4 and the lower surface 3106.6 may
each have a thickness of 0.5 mm and the connecting surface 3106.5
may have a thickness of 1.2 mm. According to further examples of
the present technology, the specific numerical value of the
thicknesses may be varied while maintaining the same ratio of
thickness as between the upper surface 3106.4, the connecting
surface 3106.5, and the lower surface 3106.6.
[0348] According to a further example of the present technology,
the relative thicknesses of the upper surface 3106.4, the
connecting surface 3106.5, and the lower surface 3106.6 may be
chosen to allow for a desired amount of flexibility of the
decoupling structure 3106. In examples, the decoupling structure
3106 may be able to flex such that the upper surface 3106.4 and the
lower surface 3106.6 are positioned at up to about 45.degree. to
about 50.degree. relative to each other.
[0349] Also, according to further examples of the present
technology, the angle between the upper surface 3106.4 and the
connecting surface 3106.5 may be between about 80.degree. and about
140.degree.. According to a still further example of the present
technology, the angle between the upper surface 3106.4 and the
connecting surface 3106.5 may be about 90.degree.. It should be
understood that the angle between the upper surface 3106.4 and the
connecting surface 3106.5 may vary across the length of the
decoupling structure 3106 due to its curved shape. If the angle
between the upper surface 3106.4 and the connecting surface 3106.5
is greater than 90.degree. in a given example, then it may be
easier to stretch or separate the nasal structures and the oral
structures from one another. If the angle between the upper surface
3106.4 and the connecting surface 3106.5 is less than 90.degree. in
a given example, then it may be easier to compress the nasal
structures and the oral structures toward one another.
[0350] According to further examples of the present technology, the
angle between the lower surface 3106.6 and the connecting surface
3106.5 may be between about 80.degree. and about 140.degree..
According to a still further example of the present technology, the
angle between the lower surface 3106.6 and the connecting surface
3106.5 may be about 90.degree.. If the angle between the lower
surface 3106.6 and the connecting surface 3106.5 is greater than
90.degree. in a given example, then it may be easier to stretch or
separate the nasal structures and the oral structures from one
another. If the angle between the lower surface 3106.6 and the
connecting surface 3106.5 is less than 90.degree. in a given
example, then it may be easier to compress the nasal structures and
the oral structures toward one another.
[0351] Another advantageous feature of this exemplary patient
interface 3000 may also be seen in FIG. 3m. This feature is the
ability of the nasal cushion 3112 and the oral cushion 3110 to each
independently form a seal about respective anatomical features of
the patient. As already discussed, the nasal cushion 3112 is
intended to seal about the nose of the patient and the oral cushion
3110 is intended to seal about the mouth of the patient. The
decoupling structure 3106, shown in FIG. 3c for example, may allow
the nasal cushion 3112 and the oral cushion 3110 to move
independently and seal independently of one another. By attaching
the pair of upper straps 3310 to the nasal cushion 3112 via the top
plate 3206, the nasal cushion 3112 may be urged against the nose of
the patient 1000 when the patient interface 3000 is donned. Also,
the pair of lower straps 3312, by their connection to the faceplate
3204, may urge the oral cushion 3110 around the mouth of the
patient.
[0352] It should be understood that each respective pair of straps,
upper 3310 and lower 3312, represent a separate pair of vectors
along which tension forces that are directed to retain respective
portions of the patient interface 3000 against the face of the
patient. In other words, the upper straps 3310 serve to retain the
nasal cushion 3112 against the nose and the lower straps 3312 serve
to retain the oral cushion 3110 against the mouth. The decoupling
structure 3106 allows for a pneumatic connection between the two
cushions 3110, 3112 although these cushions may be moved
independently of one another. Thus, a variety of different patient
head and face shapes may be accommodated by the patient interface
3000. Also, it should be understood that the ability to form
separate seals independently may allow the patient interface 3000
to maintain these seals in spite of movement by the patient.
[0353] FIG. 7h shows a side view of the exemplary seal-forming
structure 3100 and plenum chamber 3200. This view shows the nasal
cushion 3112 attached to the nasal plenum chamber 3202, as well as
the protruding end 3114 that is supported by the nasal undercushion
support wall 3208 that is proximal to the side portion 3106.3 of
the decoupling structure 3106. The oral plenum chamber 3200 is
shown with the oral cushion 3110 disposed about its perimeter 3210.
Also in this view the decoupling structure 3106 can be seen
connecting the oral cushion 3110 to the nasal cushion 3112. This
view shows particularly well the hinge-like arrangement the nasal
plenum chamber 3202 and the nasal cushion 3112 may take with
respect to the oral plenum chamber 3200 and the oral cushion 3110
by virtue of the connection via the decoupling structure 3106 and
the connection region 3106.2 (not shown in this view). It should be
understood that this hinge-like arrangement may allow the nasal
plenum chamber 3202 and nasal cushion 3112 to tilt depending on the
forces applied by the face of the patient when the complete patient
interface 3000 is placed on the patient. Thus, the oral plenum
chamber 3200 and the nasal plenum chamber 3202 may approach one
another in the gap 3106.1
[0354] By providing a gap 3106.1 between respective anterior
portions of the oral plenum chamber 3200 and the nasal plenum
chamber 3202, as shown in this view, it may be possible to allow
the components of the oral plenum chamber 3200 and the nasal plenum
chamber 3202 to move independently of one another with some amount
of freedom before coming into contact with one another. It should
also be understood that the ability of the nasal cushion 3112 and
the oral cushion 3110 to move independently of one another while
maintaining an effective seal may be furthered by providing the
decoupling structure 3106 with a radially variable thickness or
varied stiffness. Thus, the decoupling structure 3106 may be
thinnest, or least stiff, at the portion that contacts the upper
lip of the patient and its thickness/stiffness may increase
radially to the anterior portion of the decoupling structure 3106.
By this arrangement an effective seal against the upper lip may be
maintained while also providing sufficient support and structure to
the cushions 3110, 3112. The decoupling structure 3106 may be
thicker at its vertex at the closed end of the gap 3106.1 compared
to regions proximal to the open end of the gap 3106.1. This
variation may prevent distortion and to improve hinging because the
thicker portion of the decoupling structure 3106 at the closed end
of the gap 3106.1 may serve as a pivot point.
[0355] FIG. 14 shows another example of the present technology in a
partially exploded side view. This example may include the oral and
nasal cushions 3110, 3112 and the oral and nasal plenum chambers
3200, 3202 connected by the decoupling structure 3106 in similar
fashion to other examples disclosed herein. The upper portion or
top plate 3206 and the lower portion or faceplate 3204 can be seen
disconnected from the nasal plenum chamber 3202 and the oral plenum
chamber 3200, respectively. Also, the attachment feature 3252 can
be seen connected to the connection feature 3304 of the rigidiser
arm 3302, which has been partially cut off for clarity. This view
also shows a middle or connection portion 3205 that may connect the
top plate 3206 and the faceplate 3204 to form a unitary plate
member. The connection portion 3205 may be shaped and dimensioned
to substantially follow the shape of the decoupling structure 3106
such that when the unitary member of the top plate 3206, faceplate
3204, and connection portion 3205 are attached to the nasal plenum
chamber 3202 and the oral plenum chamber 3200 the connection
portion 3205 may be substantially flush with the decoupling
structure 3106. To allow the oral and nasal plenum chambers 3200,
3202 to move relative to one another as described elsewhere herein,
it may be advantageous to form the connection portion 3205 from
silicone or any other suitable material that is soft, flexible, air
impermeable, and biocompatible.
[0356] In another example of the present technology, a portion of
the decoupling structure 3106 proximal to the gap 3106.1 may be
eliminated such that only the undercushion support walls 3208
and/or the connection region 3106.2 connect the oral and nasal
plenum chambers 3200, 3202 and the oral and nasal cushions 3110,
3112. In such an example, the connection portion 3205 may also
perform a sealing function to provide a pneumatically sealed
connection between the oral gas chamber 3102 and the nasal gas
chamber 3104. In other words, the connection portion 3205 may
effectively replace the eliminated portion of the decoupling
structure 3106 when the unitary member of the top plate 3206,
connection portion 3205, and faceplate 3204 are attached to the
oral and nasal plenum chambers 3200, 3202. Again, in this example
it may be desirable to form the connection portion 3205 from
silicone or any other like material.
5.3.3 Top Plate and Faceplate Connection Features, Rigidiser Arms,
and Positioning and Stabilising Structure
[0357] On a anterior side of the nasal cushion 3112, which would be
opposite the face of the patient in use, a rigid top plate 3206 may
be attached to a nasal plenum chamber 3202. The top plate 3206 may
be made from a rigid material such as EMS-Grivory Grilamid.RTM. TR
90. The top plate 3206 may include at least one upper attachment
feature 3252. In one example, a pair of upper attachment features
3252 may be disposed at either side of the top plate 3206 to
releasably and rotatably connect respective rigidiser arms 3302 of
the positioning and stabilising structure 3300. UBE America Inc.'s
Ubesta.RTM. nylon, Hytrel.RTM. from DuPont.TM., TPE and
polypropylene and other flexible polymers and materials are
possible materials for the rigidiser arms 3302. Other materials may
also be used for the rigidiser arms 3302 that are substantially
inextensible, while allowing the rigidiser arms 3302 to flex. The
rigidiser arms 3302 may be flexible in a direction parallel to the
patient's coronal plane (see FIG. 2e), while not being
significantly flexible in other directions. The connection of the
rigidiser arms 3302 may be a hinge such that the connection
features 3304 of the rigidiser arms may rotate about the attachment
features 3252 of the top plate 3206. In one example of the
technology, the rigidiser arms 3302 may be rotatable about the
hinged upper attachment features 3252 up to about 90.degree.. In
examples, the rigidiser arms 3302 may be rotatable about the hinged
upper attachment features 3252 over 180.degree.. Rotation may also
be provided by a ball and socket connection, living hinge, freed
style gimble or overmolded with silicone, TPE or TPU. At respective
opposite ends of the rigidiser arms 3302, there may be an opening
3308 to receive respective headgear straps 3306 of the positioning
and stabilising structure 3300 to be discussed in greater detail
below. Between each end of the rigidiser arm 3302 there may also be
a curved portion that is shaped to substantially follow the
curvature of the face of the patient.
[0358] FIGS. 3s-u show further examples of the patient interface
3000 with the rigidiser arms 3302 exploded to depict an exemplary
hinge-like connection between respective attachment features 3252
and connection features 3304. As discussed above, it should be
understood that the rigidiser arms 3302 may be rotatable in a plane
parallel to the patient's coronal plane and up to about 90.degree.
or, in another example, over 180.degree..
[0359] On an opposite side of the oral cushion 3110, a faceplate or
lower plate 3204 may be attached to the oral plenum chamber 3200.
The means of attachment may include being overmolded, push fit with
soft material to hard material, or a cushion clip to rely on the
hoop stress of silicone. The faceplate 3204 may include a port 3600
that facilitates connection to a air circuit 4170 (not pictured in
this view). Also, the faceplate 3204 may include at least one lower
attachment feature 3250 to attach respective headgear straps of the
positioning and stabilising structure 3300 to be discussed in
greater detail below. The lower attachment features 3250 shown in
this example may be female clip receiving structures to receive
male clips attached to headgear straps 3306. Alternatively, the
configuration may include male structures to receive female
clips.
[0360] The exemplary patient interface 3000, shown in a front view
in FIG. 3b, includes the top plate 3206 connected to the nasal
cushion 3112 and having at least one upper attachment feature 3252
at either side. A rigidiser arm 3302 is shown connected to
respective upper attachment features 3252 via connection features
3304. Also in this view, the faceplate 3204 can be seen connected
to the anterior side of the oral plenum chamber 3200. The port 3600
shown on the faceplate 3204 is circular to pneumatically connect to
a air circuit 4170 (e.g., via a tube decoupling structure 3500
discussed further below). Lower attachment features 3252 can also
be seen on either side of the faceplate 3204. The decoupling
structure 3106 is shown in this view and side portions 3106.3 of
the decoupling structure can also be seen.
[0361] FIG. 3c shows a rear view of the exemplary patient interface
3000. In this view a pair of the rigidiser arms 3302 can be seen
extending from and connected to respective upper attachment
features 3252 at respective connection features 3304. An opening
3308 can be seen at each respective opposite end of the rigidiser
arms 3302 for connecting to headgear straps 3306 of the positioning
and stabilising structure 3300. The location of the decoupling
structure 3106 is indicated in this view, along with the connection
region 3106.2 of the oral cushion 3110 and the nasal cushion
3112.
[0362] FIG. 3d shows a top view of a patient interface 3000 in
accordance with an example of the present technology. From this top
view, the portion of the nasal cushion 3112 that contacts the nose
of the patient can be seen, as well as the opening 3103 into the
nasal gas chamber 3104. This top view also shows the connection
features 3304 of the rigidiser arms 3302 connected to the upper
attachment features 3252 on either side of the top plate 3206,
which cannot be seen in this particular view. The oral plenum
chamber 3200 can also be seen connected to the faceplate 3204
around the periphery 3210 of the plenum chamber. The lower
attachment features 3250 are shown on either side of the faceplate
3204. The port 3600 can also be seen on the faceplate 3204.
[0363] FIG. 3e shows a bottom view of the exemplary patient
interface 3000 in accordance with the present technology. This view
shows the oral plenum chamber 3200 connected about its perimeter
3210 to the faceplate 3204. The faceplate 3204 can be seen with the
lower attachment features 3250 extending therefrom. The port 3600
on the faceplate 3204 can also be seen. The oral cushion 3110 and
the nasal cushion 3112 are shown in this view, along with the
protruding ends 3114 of the nasal cushion 3112. The rigidiser arms
3302 are shown as well, however, the connection of the rigidiser
arms 3302 to the top plate 3206 is not visible in FIG. 3e.
[0364] FIG. 3f shows a side view of the exemplary patient interface
3000 according to the present technology. A rigidiser arm 3302 can
be seen extending from the connection feature 3304, which is
attached to the upper attachment feature 3252 of the top plate
3206. Also, FIG. 3f depicts the plenum chamber 3200 connected at
its perimeter 3210 to the faceplate 3204. On the faceplate 3204,
the lower attachment feature 3250 can be seen, as well as the
connection port 3600. The nasal cushion 3112 and the oral cushion
3110 can also be seen. This view also depicts the location of the
decoupling structure 3106 and one of its side portions 3106.3. The
gap 3106.1 between the nasal plenum chamber 3202 and the oral
plenum chamber 3200 that allows these components to flex or move
toward one another while staying connected is also shown. The gap
3106.1 may be understood to be the distance between the oral plenum
chamber 3200 and the nasal plenum chamber 3202 and, as such, the
gap 3106.1 may define the distance that these structures are
allowed to more toward one another. The gap 3106.1 may extend
laterally between the oral plenum chamber 3200 and the nasal plenum
chamber 3202 and the gap 3106.1 may face in an anterior
direction.
[0365] FIG. 3m shows a further front perspective view of an
exemplary patient interface 3000. This view depicts similar
features to those shown in FIG. 3g and also shows the patient
interface 3000 donned on a patient 1000. Headgear straps 3306 of
the positioning and stabilising structure 3300 are shown releasably
securing the patient interface 3000 to the patient 1000. The
headgear straps 3306 are shown with at least one upper strap 3310
connected to a corresponding rigidiser arm 3302 at its
corresponding opening 3308. In the depicted example, each upper
strap 3310 loops through the corresponding opening 3308, which in
this example is an opening in the rigidiser arm 3302. This example
also shows at least one lower strap 3312 connected to the lower
attachment feature 3250 by looping through a portion of a clip 3314
that is releasably attached to the corresponding lower attachment
feature 3250.
[0366] FIG. 3n depicts another front view of an exemplary patient
interface 3000 retained on a patient 1000. The patient interface
3000 in this view can be seen retained against the face of the
patient 1000 by upper straps 3310 and lower straps 3312. The upper
straps 3310 are attached to the rigidiser arms 3302 and the lower
straps 3312 are attached to the lower attachment features 3250 by
clips 3314. Again, it can be seen in this example that the nasal
cushion 3112 seals against the nose of the patient 1000 and the
oral cushion 3110 seals against the mouth of the patient 1000. The
decoupling structure 3106 is shown in this view and side portions
3106.3 of the decoupling structure 3106 can also be seen.
[0367] FIG. 3o depicts another side view of the patient interface
3000. In this view the patient interface 3000 is retained against
the face of the patient 1000 by the headgear straps 3306. The upper
strap 3310 is connected to the rigidiser arm 3302 to urge the nasal
cushion 3112 against the nose and the lower strap 3312 is connected
to the faceplate 3204 to urge the oral cushion 3110 against the
mouth of the patient 1000. In this view the lower strap 3312 can be
seen extending below the ear of the patient 1000 and the upper
strap 3310 can be seen extending above the ear and below the eye of
the patient. As discussed above, the rigidiser arms 3302 may be
made of a relatively stiff material such as nylon. As such, the
rigidiser arms 3302 may cause irritation to the face of the patient
if they rub against and/or directly contact the face of the patient
1000. Thus, FIG. 3o also depicts a sheath 3316 that may surround
the rigidiser arm 3302 to cushion the rigidiser arm against the
face of the patient 1000. This view also depicts the location of
the decoupling structure 3106. The rigidiser arms 3302 may
incorporate or be created with face pads 3305 instead of sheaths
being added.
[0368] FIG. 3p shows another top view of an exemplary patient
interface 3000. In this top view the patient interface 3000 can be
seen retained against the face of the patient 1000 by the headgear
straps 3306. The upper straps 3310 can be seen connected to
respective openings 3308 of the rigidiser arms 3302 and the lower
straps 3312 can be seen connected to the lower attachment features
3250 by the clips 3314.
[0369] In an example, the seal-forming structure 3100 of the
patient interface 3000 of the present technology is held in sealing
position in use by the positioning and stabilising structure
3300.
[0370] In one form of the present technology, the rigidiser arms
3302 discussed above may be comprised as a component of the
positioning and stabilising structure 3300. Alternatively, the
rigidiser arms 3302 may be comprised as a component of the patient
interface 3000.
[0371] The positioning and stabilising structure 3300 may comprise
headgear straps 3306. The headgear may include at least upper side
straps 3310, lower side straps 3312, and a rear portion. Also, the
headgear straps 3306 may comprise a one-piece composite of soft,
flexible material. One layer of the headgear, e.g., an outer layer
that does not contact the skin of the patient when donned, may
connect to tabs of material fixed to respective ends of the upper
and lower side straps 3310, 3312. This connection may include a
hook-and-loop connection and the outer layer may comprise the loop
material. This connection may allow the side straps 3310, 3312 to
loop through attachment features of the patient interface 3000 to
releasably and/or adjustably retain the patient interface to the
patient's head via the headgear straps 3306. Other connections may
include a ladder lock or sliders that are not hook-and-loop.
[0372] By including the rigidiser arms 3302 on the patient
interface 3000 and attaching them to the nasal plenum chamber 3202
by the top plate 3206, it may be possible to advantageously locate
the upper straps 3310 of the positioning and stabilising structure
3300. To effectively seal the nose of the patient, as described
above, it may be desirable to urge the nasal cushion 3112 in a
generally upward direction against the underside of the nose. The
rigidiser arms 3302 may allow for the proper direction of the
tension force vectors generated by the upper straps 3310 of the
positioning and stabilising structure 3300 while decoupling these
straps 3310 from the nasal plenum chamber 3202 such that the straps
3310 do not pass across the eyes of the patient. In other words,
sufficiently stiff rigidiser arms 3302 will allow the upper straps
3310 of the positioning and stabilising structure 3300 to
effectively pull the nasal cushion 3112 against the nose of the
patient while locating the straps 3310 away from the patient's face
so that the patient may be more comfortable, wear glasses, see more
easily, etc.
[0373] FIGS. 15a-e depict various top plate 3206 and rigidiser arm
3302 connections to the seal-forming structure 3100 according to
examples of the present technology.
[0374] FIG. 15a shows the seal-forming structure 3100 in stippling.
The rigidiser arms 3302 and the top plate 3206 are one piece
according to the depicted example. It can be seen that the
attachment features 3252 and the connection features 3304 are not
shown. Thus, the connection between the top plate 3206 and the
rigidiser arms 3302 may be flexible to allow the rigidiser arms
3302 to deflect due to tension from a positioning and stabilising
structure 3300. Additionally, according to this example, the top
plate 3206 is permanently connected to the seal-forming structure
3100 in this example.
[0375] It should be understood that the top plate 3206 may be
joined to the nasal plenum chamber 3202 and/or the faceplate 3204
may be joined to the oral plenum chamber 3200 by a permanent
connection. A permanent connection may be facilitated by molding to
form a mechanical interlock or the components may be joined by a
chemical bond. A permanent connection may be understood to mean a
connection where disconnecting the components is irreversible such
that the components cannot be returned to their connected state.
Disconnection of such a permanent connection may, for example,
entail tearing, damaging, or breaking one or more of the components
such that it cannot reconnected in an operative fashion.
[0376] Alternatively, the top plate 3206 may be joined to the nasal
plenum chamber 3202 and/or the faceplate 3204 may be joined to the
oral plenum chamber 3200 by a non-permanent connection. A
non-permanent connection may comprise a connection where the
components can be detached from one another and reattached in a
manner that is reversible. In other words, the separation of the
components does not necessitate, for example, tearing, damaging, or
breaking one or more of the components such that it cannot
reconnected in an operative fashion. In a non-permanent connection,
when detached components are reattached, the device is returned to
an operable state.
[0377] FIG. 15b shows a similar example to FIG. 15a. In this
example the top plate 3206 may be connectable to the seal-forming
structure 3100 by a hard to soft connection at a soft connection
region 3130. In other words, the top plate 3206 and the rigidiser
arms 3302 are removable.
[0378] FIG. 15c shows another variation of the example shown in
FIG. 15a. In FIG. 15c, this example includes the attachment
features 3252 on the top plate 3206 and the connection features
3304 on the rigidiser arms 3302. Thus, the top plate 3206 is
permanently fixed to the seal-forming structure 3100 but the
rigidiser arms 3302 may be rotatable and may be removed from the
top plate 3206.
[0379] FIG. 15d shows an example similar to FIG. 15b. In this
example there is a hard to hard connection of the top plate 3206 to
a hard connection region 3132.
[0380] FIG. 15e shows an example that includes the hard to hard
connection of the top plate 3206 to the hard connection region
3132. This example also includes the attachment features 3252 on
the top plate 3206 and the connection features 3304 on the
rigidiser arms 3302. Thus, the top plate 3206 is removable from the
seal-forming structure 3100 but the rigidiser arms 3302 may be
rotatable and may be removed or disconnected from the top plate
3206.
[0381] Another example of the present technology may include lower
attachment features 3250 that are magnetic and provided to a living
hinge, such as examples described in PCT Application No.
PCT/AU2014/000021. The living hinge allows for movement of the
lower attachment features 3250 in one plane (e.g., a plane parallel
to the patient's transverse plane) and the direction of movement
may be about an axis. Such an arrangement may provide for more
control of the attachment of the positioning and stabilising
structure 3300 to the lower attachment features 3250 and may
provide for more stability for the seal of the oral cushion 3110
against the patient's face.
[0382] FIGS. 17a to 17f and 19a to 19h show the components of a
rigidiser arm assembly 3301 according to another example of the
present technology. The rigidiser arm assembly 3301 may be
detachable from the top plate 3206. The connection features 3304 of
these examples of the rigidiser arm assembly 3301 may comprise
holes shaped to conform to respective ones of the upper attachment
features 3252.
[0383] The rigidiser arm assembly 3301 may comprise two components.
The rigidiser arms 3302 and a top plate cover 3303 may be formed in
one piece, with the connection features 3304 and the openings 3308
being molded thereon as well. Nylon or Hytrel.RTM. may be used to
form the rigidiser arms 3302 and the top plate cover 3303. A pad
3305 may be overmolded onto each rigidiser arm 3302 as well. The
pads 3305 may be formed from a thermoplastic elastomer. The pads
3305 may cushion the patient's face (e.g., the cheeks) against the
rigidiser arms 3302 and prevent marking of the patient's skin when
the patient interface 3000 is worn for several hours (e.g., during
therapy).
[0384] The rigidiser arms 3302 may also be formed with an
ellipsoidal curvature, as can be seen in FIG. 19d, for example.
Also, the rigidiser arms 3302 may be structured to be flexible only
in a direction parallel to the patient's coronal plane (see FIG.
2e), e.g., inwardly and outwardly relative to the patient's face.
In other words, the rigidiser arms 3302 may be flexible in
substantially a single plane that is parallel to the patient's
transverse plane. This may allow the rigidiser arms 3302 to
accommodate various patient face widths. Moreover, the rigidiser
arms 3302 may be resistant to stretching along their respective
longitudinal axes. The rigidiser arms 3302 may also be resistant to
twisting about their respective longitudinal axes. Additionally,
the rigidiser arms 3302 may also be resistant to bending upwardly
or downwardly, e.g., in the superior or inferior direction,
relative to the patient's face. The rigidiser arms' 3302 resistance
to deformation in these directions may be beneficial for stability
of the patient interface 3000 when it is worn by the patient.
[0385] According to examples of the present technology, it may be
advantageous to ensure that the rigidiser arm assembly 3301 is
secured to the top plate 3206 so as to minimize relative movement
between the top plate 3206 and the rigidiser arm assembly 3301 when
engaged with one another. To ensure that relative movement between
the top plate 3206 and the rigidiser arm assembly 3301 is
adequately controlled, these components may be structured to engage
one another at at least three points. The connection features 3304
may provide two of the points of contact and another structure
positioned on the rigidiser arm assembly 3301 between the
connection features 3304 may provide a third point of contact.
[0386] FIGS. 19d and 19e also show that the rigidiser arm assembly
3301 may include a rib 3307. When the rigidiser arm assembly 3301
is attached to the top plate 3206, the rib 3307 may help to reduce
relative movement between the nasal cushion 3112 and the top plate
3206 when engaged with the rigidiser arm assembly 3301. The rib
3307 may have a cross-sectional profile that is triangular in shape
to guide the rigidiser arm assembly 3301 into engagement with the
top plate 3206. The rib 3307 may also help to reduce flexing and/or
twisting between the rigidiser arm assembly 3301 and the top plate
3206 when they are engaged. Thus, the rib 3307 and the connection
features 3304 may provide the three points of contact on the
rigidiser arm assembly that engage with the top plate 3206.
[0387] According to further examples of the present technology,
structures other than the rib 3307 may be provided for a third
point of contact, in addition to the connection features. For
example, the top plate 3206 and the rigidiser arm assembly 3301 may
engage at a third point of contact with a rod inserted into a
hole.
[0388] FIGS. 19f to 19h show another example of the rigidiser arm
assembly 3301. According to this example, a claw 3309 may provided
on the posterior side of the rigidiser arm assembly 3301 near where
the top plate cover 3303 meets each of the rigidiser arms 3302. The
claw 3309 may engage with corresponding ones of the side supports
3207 to secure the rigidiser arm assembly 3301 to the nasal cushion
3112.
[0389] FIGS. 29a to 29f show views of another example of the
present technology. These views show features that are similar to
those shown in FIGS. 17a to 17f. However, the decoupling structure
3500 is not depicted in FIGS. 29a to 29f. It should be understood
though that a decoupling structure 3500 as described elsewhere
herein may be attached at the connection port 3600.
5.3.3.1 The Top Plate and the Faceplate
[0390] As to the faceplate 3204 and the top plate 3206 described
above, it may be advantageous to choose a material that is
relatively more rigid than the nasal cushion 3112, for example,
which may be formed from a flexible material such as silicone.
Choosing a relatively rigid material may provide for an effective
anchor point for the positioning and stabilising structure 3300
(e.g., the rigidiser arms 3302) so that the positioning and
stabilising structure 3300 may attach to the seal-forming structure
3100 at fixed positions. Were the positioning and stabilising
structure 3300 to be connected directly to the seal-forming
structure 3100, which may be made of a relatively flexible material
such as silicone, this arrangement may cause undesirable
deformation of the oral and nasal cushions 3110, 3112 when donned
by the patient and tension is applied by the positioning and
stabilising structure 3300. Tension may be particularly applied in
the anterior/posterior directions. Examples of the positioning and
stabilising structure 3300 may be made from Breathe-O-Prene.TM.,
Soft Edge.TM., and/or elastic cloth.
[0391] Also, by forming the faceplate 3204 and the top plate 3206
from relatively a rigid material, these components may be shaped to
have approximately the same curvature as the face of the patient,
which may in turn ensure a better seal by properly supporting the
seal-forming structure 3100. This may also ensure an effective seal
against the airways of the patient when the positioning and
stabilising structure 3300 generates a tension force vector V
substantially parallel to the Frankfort horizontal as indicated in
FIG. 3o.
[0392] Forming the faceplate 3204 and the top plate 3206 from a
relatively rigid material may also be beneficial in that such a
relatively rigid material may prevent the outer portions of the
seal-forming structure 3100 from deforming to the point that the
periphery folds inward to the face. This arrangement may also help
to ensure that sealing pressure is evenly applied over the face of
the patient by the seal-forming structure 3100. The headgear strap
3306 of the positioning and stabilising structure 3300 may generate
tension force vectors to seal the seal-forming structure 3100
against the patient's face, however, the faceplate 3204 and the top
plate 3206 may help to spread these sealing forces out over the
oral cushion 3110 and the nasal cushion 3112. By spreading these
sealing forces over a broader area, pressure and/or deformation may
not be localized to particular regions of the oral cushion 3110 and
the nasal cushion 3112, for example near where the headgear straps
3306 are connected.
[0393] Additionally, by forming the top plate 3206 from a
relatively rigid material this may prevent undesirable vertical
flexing of the rigidiser arms 3302 when the patient interface 3000
is donned, but still allow pivoting of the rigidiser arms 3302 in a
plane parallel to the patient's coronal plane. It should be
understood that a small amount of vertical flexing may be
tolerable.
[0394] Also, by making the faceplate 3204 from a relatively rigid
material it may be easier for the patient to attach the lower
straps 3312 of the positioning and stabilising structure 3100. This
is so because the lower attachment features 3250 may be held in a
relatively fixed position when the patient interface 3000 is donned
by the patient.
[0395] Furthermore, disassembly and assembly of the patient
interface 3000 and positioning and stabilising structure 3300
(e.g., for cleaning purposes) may be easier for the patient if the
positioning and stabilising structure 3300 is not directly
connected to the seal-forming structure 3100.
[0396] By providing separate attachment points for the upper straps
3310 and the lower straps 3312 through the top plate 3206 and the
faceplate 3204, respectively, it may be possible to better control
the sealing of the nasal cushion 3112 against the nose. For
example, decoupling the nasal cushion 3112 may allow the upper
straps 3310 to provide targeted pressure upward against the
underside of the nose and/or inward against the face. It may also
be possible to control the height of the nasal cushion 3112
relative to the nose as well as its lateral position (e.g., left
vs. right). Additionally, it may be possible to control the
rotation of the nasal cushion 3112 relative to the nose and about
an axis parallel to a longitudinal axis of the top plate 3206.
These features may provide these benefits which may not be possible
when all of the straps of a positioning and stabilising structure
3300 are connected to one common front plate. Thus, the examples
disclosed herein may provide for a more effective and stable seal
around the nose of the patient. It should also be understood that
by virtue of the connection of the nasal plenum chamber 3202 to the
oral plenum chamber 3200 by the decoupling structure 3106, the
relative height of the oral cushion 3110 may also be controlled by
the upper straps 3310 of the positioning and stabilising structure
3300.
[0397] In examples of the technology various headgear
configurations may be used with the exemplary patient interfaces
3000 described herein. One example of the technology may utilize
headgear similar to that disclosed in US Patent Application
Publication 2012/0138061. A further variation may include upper
straps 3310 that are shorter than those disclosed in the
aforementioned publication by virtue of their connection to the
rigidiser arms 3302.
[0398] In further examples of the technology, the positioning and
stabilising structure 3300 may include the features disclosed in
PCT Application No. PCT/AU2013/000830 or in US Patent Application
Publication No. 2014/0026890. The positioning and stabilising
structure 3300 disclosed in that reference may be used as the upper
straps 3310. The lower straps 3312 may be neoprene CommonLine
headgear straps.
[0399] According to a further example of the present technology,
one size of the top plate 3206 and the faceplate 3204 may be used
for a variety of sizes of seal-forming structure 3100 and plenum
chamber 3200. This may be advantageous to reduce the number of
parts needed to be produced to manufacture patient interfaces 3000
to accommodate various patient head/face sizes. Thus, only the
seal-forming structure 3100 and the plenum chamber 3200 may need to
be molded in different sizes according to this example of the
technology.
[0400] FIGS. 18a to 18f, 21a to 21e, 22a to 22e, and 28a to 28e
show examples of the top plate 3206 and the faceplate 3204
according to further examples of the present technology. FIGS. 18a
to 18f show the top plate 3206 and the faceplate 3204 attached to
the nasal plenum chamber 3202 and the oral plenum chamber 3200,
respectively. According to an example of the present technology,
the top plate 3206 and the faceplate 3204 may be formed from a
material that is relatively rigid as compared to silicone. The top
plate 3206 and the faceplate 3204 may be joined to the nasal plenum
chamber 3202 and the oral plenum chamber 3200, respectively, by
overmolding the nasal plenum chamber 3202 and the oral plenum
chamber 3200 to the top plate 3206 and the faceplate 3204. The
nasal plenum chamber 3202, the nasal cushion 3112, the oral plenum
chamber 3200, the oral cushion 3110, and the decoupling structure
3106 may be molded as one piece from silicone.
[0401] FIGS. 18a, 18b, 18c, and 18f also shows a top plate buffer
3214 and a faceplate buffer 3215. The top plate buffer 3214 may be
formed in one piece with the nasal plenum chamber 3202 and may be
formed from silicone. When the nasal plenum chamber 3202 is
overmolded onto the top plate 3206 the silicone may pass through a
hole 3217 and into or through core-outs 3216 of the top plate 3206
to form the top plate buffer 3214, as can be seen in FIGS. 21a to
21e. The hole 3217 and the core-outs 3216 together may provide a
smooth flow path for the silicone as it is overmolded onto the top
plate 3206. Alternatively, the core-outs 3216 may not be open to
provide a passage for the flow of silicone during overmolding, but
instead the core-outs 3216 may comprise recessed pockets that can
be filled with silicone to form a mechanical interlock and provide
cushioning. The top plate buffer 3214 may be pressed against the
posterior side of the top plate cover 3303 when the rigidiser arm
assembly 3301 is joined to the top plate 3206. The top plate buffer
3214 being made of a material that is relatively softer than the
top plate 3206 and the top plate cover 3303, e.g., silicone, may
dampen the hard-to-hard connection to reduce or eliminate rattling
of these components.
[0402] The top plate buffer 3214 being formed in one piece with the
nasal plenum chamber 3202 and connecting through the hole 3217 in
the top plate 3206 may also provide a retaining function to retain
the top plate 3206 in position against the nasal plenum chamber
3206.
[0403] The rib 3307 may also work in conjunction with the top plate
buffer 3214 to provide dampening and/or retention of the engagement
between the top plate 3206 and the rigidiser arm assembly 3301. The
engagement of the rib 3307 with the top plate buffer 3215 and the
top plate 3206 may provide the dampening and/or retention and the
relative dimensions of these components may be selected to ensure
the desired level of dampening and/or retention.
[0404] The faceplate buffer 3215 may extend from the periphery of
the oral plenum chamber 3200 in an anterior direction. The
faceplate buffer 3215 may be formed in one piece with the oral
plenum chamber 3200. The faceplate buffer 3215 may be formed from
silicone. The faceplate buffer 3215 may also dampen the
hard-to-hard connection between the faceplate 3204 and the frame
3251 to reduce or eliminate rattling that may result from the
connection.
[0405] FIGS. 21a to 21e show the top plate 3206 in isolation and
FIGS. 22a to 22e show the faceplate 3204 in isolation.
[0406] The upper attachment features 3252 of the top plate 3206 may
connect the rigidiser arm assembly 3301 at the connection features
3304, as shown in FIGS. 17a to 17f. The upper attachment features
3252 of these examples may comprise rigid pockets and/or undercuts
that engage with respective connection features 3304 to attach the
rigidiser arm assembly 3301.
[0407] The faceplate 3204 may also include a cutout 3213 on each
side to connect a frame 3251 to the faceplate. Each cutout 3213 may
extend laterally from the faceplate 3204. The cutouts 3213 may
facilitate a hard-to-hard connection (e.g., between two relatively
rigid components) between the faceplate 3204 and the frame 3251.
The hard-to-hard connection may take the form of a snap-fit and may
produce an audible click when the frame 3251 is attached to the
faceplate 3204. Also, the connection port 3600 can be seen formed
in the faceplate 3204. In FIGS. 17a to 17f, the frame 3251 can be
seen attached around the faceplate 3204.
[0408] FIGS. 28a to 28e show another example of the top plate 3206
similar to the views shown in FIGS. 21a to 21e. However, the
example shown in FIGS. 28a to 28e shows that a recess 3219 may be
provided to each core-out 3216 on a posterior side thereof. The
recess 3219 may provide more depth for the flow of silicone during
the molding of the seal-forming structure 3100 and plenum chamber
3200 to the top plate 3206. The recess 3219 may be hemispherical
and, as such, may also provide for more surface area for the
attachment of silicone to the top plate 3206, which according to an
example of the present technology, may be a self-adhesive liquid
silicone rubber (LSR).
[0409] FIGS. 27a to 27f show another example of the present
technology. In these views the seal-forming structure 3100 is shown
with the faceplate 3204 and the top plate 3204. The example shown
in these views is similar to the example shown in FIGS. 18a to 18f
in that the seal-forming structure 3100 may be formed from silicone
and may be overmolded to the top plate 3206 and the faceplate 3204
to join these components. FIGS. 27a to 27f depict an alternative
example in that the top plate 3206 may be nearly completely
embedded in the seal-forming structure 3100. In other words, the
seal-forming structure 3100, when overmolded to the top plate 3206,
may completely surround the top plate 3206 such that a minimal
amount of the top plate 3206 is exposed. Additionally, an extension
3218 may be formed to extend from the top plate 3206 and may be
formed in one-piece with the seal-forming structure 3100. The
extension 3218 may serve cushioning and/or dampening functions
similar to the top plate buffer 3214 when the rigidiser arm
assembly 3301 is joined to the top plate 3206. Also, the extension
3218 may be formed with a barb shape and thus may serve a retaining
function.
[0410] In a further alternative example, the extension 3218 may be
formed in one piece with the top plate 3206. In this example, the
barb shape of the extension 3218 may serve the retaining function
but due to being made from the same, relatively rigid material of
the top plate 3206 it may not serve the cushioning and/or dampening
functions. As such, the overmolded silicone of the seal-forming
structure 3100 that substantially surrounds the top plate 3206 may
serve the cushioning and/or dampening functions.
[0411] FIGS. 20a to 20s, 23a to 23f, 24a to 24f, and 25a to 25f
show several views of the frame 3251 with clips 3314 and lower
attachment features 3250, in addition to view of their respective
subcomponents.
[0412] The frame 3251 may also include a catch 3253 on each side to
engage with respective ones of the cutouts 3213 to facilitate
attachment to the faceplate 3204. The engagement of the catches
3253 with the cutouts 3213 may generate a hoop stress in the frame
3251 that holds the frame onto the faceplate 3204. The lower
attachment features 3250 may also be formed on the frame 3251. As
shown in FIG. 20f, for example, the lower attachment features 3250
may each include a mating surface 3254 to which each of the clips
3314 is joined. FIG. 20g shows that each mating surface 3254 may be
on a mating portion 3255 of the lower attachment features 3252.
Each lower attachment feature 3250 may include a wing portion 3257
to join the frame 3251 to each of the mating portions 3255.
[0413] The wing portions 3257 may be joined to the frame 3251 by
overmolding the wing portions 3257 onto frame extensions 3259 of
the frame such that a mechanical interlock is formed. The frame
extensions 3259 may then extend into respective recesses 3258 of
the wing portions 3257. The mating portions 3255 may also be joined
to the wing portions 3257 by simultaneous overmolding such that a
mechanical interlock is also formed between the wing portions 3257
and the mating portions 3255. Thus, mating portion extensions 3256
may also extend into the recesses 3258 of the wing portions
3257.
[0414] The wing portions 3257 may be formed from thermoplastic
elastomer. The wing portions 3257 may also be flexible such that
the lower attachment features 3250 function as living hinges. In
other words, the lower attachment features 3250 may be able to move
in an anterior/posterior direction due to their flexibility so that
the tension of the straps 3306 causes them to flex and retain the
patient interface 3000 on the patient when donned. The mating
portions 3255 may also be formed from a thermoplastic
elastomer.
[0415] The clip 3314 may include a bar 3315 around which the lower
strap 3312 is looped to attach the clip 3314 to the lower strap
3312.
[0416] To join the clips 3314 to the lower attachment features 3250
a magnetic connection may be provided. A clip magnet 3260 may be
provided to each of the clips 3314 in a clip pocket 3317 and a
mating portion magnet 3261 may be provided to each of the mating
portions 3255 of the lower attachment features 3250 within a mating
portion pocket 3262. The poles of each clip magnet 3260 and each
mating portion magnet 3261 may be aligned such that a magnetic
attraction is generated between these magnets to draw and retain
the clips 3314 to the lower attachment features 3250. Further
examples of these attachment arrangements are disclosed in PCT
Application No. PCT/AU2014/000021, which is incorporated herein by
reference in its entirety.
[0417] The mating portions 3255 of these examples may also include
a guide surface 3263 and a protrusion 3264 to position the clip
3314 as it is attached. Also, each of the clips 3314 may include a
receiving surface 3319 to engage with a respective guide surface
3263 and a notch 3318 to engage with a respective protrusion 3264.
When the clips 3314 are attached to respective mating portions 3255
of the lower attachment features 3250, the engagement of the notch
3318 and the protrusion 3264 may prevent rotation of the clip 3314
relative to the mating portion 3255 of the lower attachment feature
3250. This may help ensure that the direction of the tension force
vectors of the lower straps 3312 become and remain properly aligned
when the patient interface 3000 is donned by the patient.
[0418] The guide surface 3263 may have a curved profile. The guide
surface 3263 may also be shaped to form an overhang. The receiving
surface 3319 may be shaped to correspond to the shape of the guide
surface 3263. The shape of the guide surface 3263 may also have a
guiding and/or retaining function. The curved profile and slope of
the guide surface 3263 may allow the receiving surface 3319 to
slide along the guide surface 3263 and into position such that the
protrusion 3264 engages with the notch 3318. This may be
advantageous because it may be difficult for the patient to align
the clips 3314 with the lower attachment features 3250 when the
patient interface 3000 is being donned. Also, the patient may be in
a darkened environment, may have limited tactile ability, and/or
may have limited vision to align the clips 3314 with the lower
attachment features 3250. Thus, structuring the guide surface 3263
such that it guides the receiving surface 3315 and, therefore, the
clip 3314 into place may be helpful to ensure a proper and secure
fit of the patient interface 3000.
[0419] FIG. 20n shows a rear view of frame 3251 and lower
attachment features 3250. According to this example, each of the
lower attachment features 3250 may comprise a flex point which is
depicted as a reduced thickness section 3266 in this view. The
lower attachment features 3250, when subjected to tension by the
lower side straps 3312 of the positioning and stabilizing structure
3300, may be deformed and flex in a posterior direction at the flex
point. The lower attachment features may comprise thermoplastic
elastomer.
[0420] FIGS. 20q to 20s show further examples of the present
technology with a top view of the frame 3251 and the lower
attachment features 3250. FIG. 20q shows a notch 3265 at the flex
point on an anterior side of each of the lower attachment features
3250. The notch 3265 shown in FIG. 20q may allow the lower
attachment feature 3250 to flex through the notch 3265 in an
anterior direction. FIG. 20r shows a notch 3265 at the flex point
on a posterior side of each of the lower attachment features 3250.
The notch 3265 shown in FIG. 20r may allow the lower attachment
feature 3250 to flex through the notch 3265 in a posterior
direction. It should be understood that according to a further
example of the present technology a notch 3265 may be provided on
the posterior and anterior side of each lower attachment feature
3250.
[0421] FIG. 20s shows another top view of the frame 3251 and lower
attachment features 3250 according to an example of the present
technology. According to this example, the flex point may comprise
a reduced thickness section 3266 that reduces the thickness of the
lower attachment features 3250 from the posterior and anterior
sides to allow the lower attachment features to flex in both
directions.
[0422] FIGS. 20o and 20p show exploded views depicting features
similar to FIGS. 20g and 20h. However, FIGS. 20o and 20p also
depict mating portion magnet receivers 3267. Each of the mating
portion magnet receivers 3267 may be structured to receive a
corresponding mating portion magnet 3261. FIGS. 23g to 23m also
depict the mating portion magnet receivers 3267.
[0423] FIGS. 20p and 25g to 25l also show that the clips 3314 may
include a clip magnet receiver 3321 and a clip magnet cover 3320 to
secure the clip magnet 3260 within the clip 3314. The clip magnet
cover 3320 may secure the clip magnet 3260 in the clip magnet
receiver 3321 with a snap-fit.
5.3.4 Vent, Tube Decoupling Structure(s), Connection Port, and
Anti-Asphyxia Valve
[0424] In one form, the patient interface 3000 includes a vent 3400
constructed and arranged to allow for the washout of exhaled carbon
dioxide.
[0425] One form of vent 3400 in accordance with the present
technology comprises a plurality of holes, for example, about 20 to
about 80 holes, or about 40 to about 60 holes, or about 45 to about
55 holes. More than 80 holes is also envisaged.
[0426] In an example, the vent 3400 is located in the plenum
chamber 3200. Alternatively, the vent 3400 is located in a tube
decoupling structure 3500. e.g. a swivel 3510.
[0427] In another example of the present technology the vent 3400
may be located on the top plate 3206 and/or the faceplate 3204. In
such an example, the tube decoupling structure 3500 may not include
a vent.
[0428] The vent 3400 may be laser cut or made from a mesh material
or a linear array. The vent 3400 may also be made from a material
or textile of interlacing plastic fibers. The material of the
interlacing plastic fibers is a thermoplastic polymer including
polycarbonate, nylon, polyethylene and preferably polypropylene.
Specifically, the textile may be SEFAR material Tetex Mono
05-1010-K 080 woven polypropylene material. The textile is
typically provided in the form of a roll or ribbon. The weave of
the textile is preferably a satin weave. However, other weaves are
envisaged including plain weave, plain reverse dutch weave and
twill weave. The voids or holes defined by the weave of fibers
through the textile do not necessarily have a uniform dimension
since there is some variation between the positioning, spacing and
compression of the fibers in the weave of the textile. The voids
are preferably not straight through holes but rather define a
tortuous air flow path between adjacent fibers through the
thickness of the textile. A tortuous air flow path significantly
diffuses the air flow and thereby reduces noise. If the voids are
straight through holes, then the fibers of the textile may be
arranged in the form of a mesh grid.
[0429] In one example, the airflow rate of the vent portion of the
textile is first measured by an airflow meter. A determination is
made on whether there is a difference between the measured airflow
rate and a desired airflow rate. If the airflow rate through the
vent portion exceeds a predetermined range, the amount of porosity
of the vent portion is selectively reduced. The desired
predetermined range is about 42 to about 59 litres per minute at 20
cm H2O pressure, preferably, about 47 to about 53 litres per minute
at 20 cm H2O pressure. For example, the airflow rate through the
SEFAR material Tetex Mono 05-1010-K 080 woven polypropylene
material may be about 37 to about 64 litres at 20 cm H2O pressure,
preferably, about 42 to about 58 litres at 20 cm H2O pressure. The
variance over the length of the SEFAR textile may be sinusoidal
over the length of the textile ribbon. Different areas of the SEFAR
textile when first received from a textile manufacturer exhibit
different air flow rates. After the porosity has been reduced, the
airflow rate is measured again for verification to confirm it is
now within the predetermined range. The average diameter of the
opening of the voids is preferably less than 0.1 mm, and preferably
provide a total open area of approximately 1% to 10% of the
superficial area of the vent. For example, the total open area may
be 22 mm2 where the superficial area of the vent is 240 mm2.
[0430] If the desired air flow rate exists in the textile,
optionally, the holes in a peripheral edge region of a desired vent
portion are occluded. The peripheral edge region of the vent
portion is overmolded to the top plate 3206 and/or the faceplate
3204. Since the holes that existed at the peripheral edge region
have been occluded, the airflow rate of the vent portion should not
differ after overmolding.
[0431] In some examples, the airflow rate may be measured after the
vent portion is cut from the textile, and also the vents may be
measured after being overmolded to the top plate 3206 and/or the
faceplate 3204. This enables the airflow rate to be known and
determined to be within the desired predetermined range after each
step. This may prevent wastage so that the part may be discarded as
soon as it is known that it is not within the desired predetermined
range.
[0432] The porosity of the vent portion can be reduced by several
ways, including: heat staking, plastic deformation by compression,
ultrasonic welding, applying a sealant (e.g. hot melt adhesive) and
applying a thin film. Preferably, heat staking by a staking punch
is used to reduce porosity due to increased precision, greater
certainty of occlusion of holes in the textile, manufacturing
speed, good visual appeal after heat staking, and no additional
material is required. Some material shrinkage occurs when heating a
thermoplastic which is accounted for by having excess material
surrounding the specific physical dimension for the shape of the
vent. The porosity of the vent portion is reduced by partially
occluding or by fully occluding holes in the vent portion.
[0433] Any area or region of the vent portion may be selected to
reduce porosity. Preferably, the porosity of a continuous
peripheral edge region of the vent portion is reduced. This
provides good visual appeal because this is adjacent to or at the
location where the vent portion is overmolded to the top plate 3206
and/or the faceplate 3204. Any visual differences between the
continuous peripheral edge region and the rest of the vent portion
may be less noticeable to the human eye at this location since it
may appear to be a defined edge of the top plate 3206 and/or the
faceplate 3204 for receiving the vent 3400. Alternatively, the area
for porosity reduction may be in the form of a character/letter or
logo in a central region of the vent portion to enhance visual
impact and improve brand awareness.
[0434] Sound caused by exhaled carbon dioxide passing through the
vent 3400 is minimised because of greater air diffusion as it
passes through the textile, in particular, for nasal pillows when a
patient exhales out of their nose and the carbon dioxide flows out
through the vent. Diffusion of the exhaled carbon dioxide avoids
direct or focused airflow to a bed partner or the patient depending
on vent orientation and sleeping position.
[0435] The vent of the patient interface is easy to clean. A mild
cleaning solution or soapy water can be used for cleaning the vent.
Hot water can also be used to flow through the vent for cleaning.
The vent can be hand washed and rinsed without disassembly from the
top plate 3206 and/or the faceplate 3204 because it may be
permanently connected, for example, overmolded, to the top plate
3206 and/or the faceplate 3204. Less detachable parts for the
patient interface avoids the possibility of losing individual parts
and also reduces cleaning time by not having to detach and
re-attach each part from each other. Since the vent is formed with
plastic fibers, durability of the vent is maintained even after
repeated cleaning in contrast to a vent made from another less
durable material, for example, a cloth textile.
[0436] The vent is quiet. Sound energy generated by exhaled carbon
dioxide is spread evenly. Vibrations caused by the exhaled carbon
dioxide coming in contact with the top plate 3206 and/or the
faceplate 3204 may produce vibrations in the top plate 3206 and/or
the faceplate 3204. Such vibrations may be dampened by the
vent.
[0437] In one form the patient interface 3000 includes at least one
tube decoupling structure 3500, for example a swivel or a ball and
socket. The tube decoupling structure 3500 may also include an
elbow feature. The tube decoupling structure 3500 may be divided
between the hose and mouth.
[0438] A connection port 3600 may allow for connection to the air
circuit 4170. The air circuit 4170 may include a short tube
connected to a longer tube. Examples of the tubes may include the
tube features disclosed in PCT Application No. PCT/AU2013/000830. A
rotatable adapter may also be included to connect the short tube
and long tube.
[0439] In one form, the patient interface 3000 includes an
anti-asphyxia valve 3800.
[0440] FIG. 3g shows another front perspective view of an exemplary
patient interface 3000 according to the present technology. This
view depicts features similar to those shown in FIG. 3a, however,
this view also includes features to connect the patient interface
3000 to a PAP device 4000. These additionally depicted features
include at least one vent 3400 disposed radially about the port
3600. In the example depicted, the vent 3400 comprises a plurality
of vent holes around the port 3600. The features of the vent 3400
will be discussed in greater detail below. Also shown in this view
is a tube decoupling structure 3500 to connect the air circuit 4170
to the port 3600 on the faceplate 3204 of the patient interface
3000. The tube decoupling structure 3500 may be an elbow and it may
include a swivel 3510 to allow the tube decoupling structure 3500
and the air circuit 4170 to rotate relative to the patient
interface 3000 about the port 3600. The tube decoupling structure
3500 in this view also includes an anti-asphyxiation valve 3800
that will be described in greater detail below. Also, FIG. 3g shows
that the air circuit 4170 may include a cuff 4172 to attach the air
circuit to the decoupling structure 3500.
[0441] FIG. 3h depicts features of the exemplary patient interface
3000 in a rear view, similar to FIG. 3c. FIG. 3h, however, also
shows that the patient interface 3000 may include a vent 3400 in
the form of a plurality of vent holes disposed radially about the
port 3600. The cuff 4172 and the air circuit 4170 can also be seen.
The location of the decoupling structure 3106 is indicated in this
view, along with the connection region 3106.2 of the oral cushion
3110 and the nasal cushion 3112.
[0442] FIG. 3i shows a front view of an exemplary patient interface
3000, similar to FIG. 3b. Also shown in FIG. 3i, is the tube
decoupling structure 3500 attached to the port 3600 on the
faceplate 3204 of the patient interface 3000. This view also shows
the vent 3400 in the form of a plurality of vent holes disposed
radially about the port 3600. The anti-asphyxiation valve 3800 can
also be seen on the tube decoupling structure 3500. The cuff 4172
and the air circuit 4170 can also be seen connected to the tube
decoupling structure 3500. The decoupling structure 3106 is shown
in this view and side portions 3106.3 of the decoupling structure
3106 can also be seen.
[0443] FIG. 3j shows a top view of an exemplary patient interface
3000 with features similar to those shown in FIG. 3d. FIG. 3d
additionally depicts the vent 3400 in the form of a plurality of
vent holes disposed around the port 3600. Extending from the port
3600 is the tube decoupling structure 3500 with the anti-asphyxia
valve 3800 disposed thereon.
[0444] FIG. 3k shows a bottom view of an exemplary patient
interface 3000. This view is similar to FIG. 3e and thus depicts
similar features. Additionally, this view depicts the vent 3400
comprising a plurality of vent holes disposed radially about the
port 3600. The tube decoupling structure 3500 is shown extending
from the port 3600. The cuff 4172 and air circuit 4170 can be seen
as well.
[0445] FIG. 3l shows a side view of an exemplary patient interface
3000 that is similar to the view shown in FIG. 3f. Accordingly,
FIG. 3l depicts features similar to those shown in FIG. 3f.
However, FIG. 3l also shows the vent 3400 including a plurality of
vent holes disposed radially about the port 3600. The tube
decoupling structure 3500 is shown connected to the port 3600 at
one end and connected to the air circuit 4170 via the cuff 4172 at
the other end. This view also depicts the location of the
decoupling structure 3106 and one of its side portions 3106.3. The
gap 3106.1 between the nasal plenum chamber 3202 and the oral
plenum chamber 3200 that allows these components to flex or move
toward one another is also shown.
[0446] According to the examples shown in FIGS. 17a to 17f and
FIGS. 26a to 26d, the decoupling structure 3500 may be joined to
the faceplate 3204 and the connection port 3600. In these examples,
the vent 3400 may be formed on the tube decoupling structure 3500.
In these examples, the tube decoupling structure 3500 may comprise
an elbow that is rotatable at the connection with the connection
port 3600. The decoupling structure 3500 may also include a swivel
3510 to connect to a air circuit 4170. The decoupling structure
3500 may include a baffle 3520 to separate the flow path of
pressurized gas from the PAP device 4000 from the flow path of
exhaled gas (e.g., CO.sub.2) from the patient that exits through
the vent 3400. By separating these flow paths, the baffle 3520 may
improve washout of exhaled gas (e.g., CO.sub.2). The tube
decoupling structure 3500 may also include a quick release
mechanism 3530 that allows the patient to easily attach and detach
the tube decoupling structure 3500 to and from the connection port
3600 on the faceplate 3204. The quick release mechanism 3530 may
also be structured to provide a snap-fit connection between the
connection port 3600 and the tube decoupling structure 3500 and
engagement may result in an audible click that ensures the patient
that the connection has been made. The tube decoupling structure
3500 may also include an anti-asphyxiation valve 3800.
5.4 Glossary
[0447] In certain forms of the present technology, one or more of
the following definitions may apply. In other forms of the present
technology, alternative definitions may apply.
5.4.1 General
[0448] Air: Air will be taken to include breathable gases, for
example air with supplemental oxygen.
[0449] Continuous Positive Airway Pressure (CPAP): CPAP treatment
will be taken to mean the application of a supply of air or
breathable gas to the entrance to the airways at a pressure that is
continuously positive with respect to atmosphere, and preferably
approximately constant through a respiratory cycle of a patient. In
some forms, the pressure at the entrance to the airways will vary
by a few centimeters of water within a single respiratory cycle,
for example being higher during inhalation and lower during
exhalation. In some forms, the pressure at the entrance to the
airways will be slightly higher during exhalation, and slightly
lower during inhalation. In some forms, the pressure will vary
between different respiratory cycles of the patient, for example
being increased in response to detection of indications of partial
upper airway obstruction, and decreased in the absence of
indications of partial upper airway obstruction.
5.4.2 Aspects of PAP Devices
[0450] Air circuit: A conduit or tube constructed and arranged in
use to deliver a supply of air or breathable gas between a PAP
device and a patient interface. In particular, the air circuit may
be in fluid connection with the outlet of the pneumatic block and
the patient interface. The air circuit may be referred to as air
delivery tube. In some cases there may be separate limbs of the
circuit for inhalation and exhalation. In other cases a single limb
is used.
[0451] APAP: Automatic Positive Airway Pressure.
[0452] Blower or flow generator: A device that delivers a flow of
air at a pressure above ambient pressure.
[0453] Controller: A device, or portion of a device that adjusts an
output based on an input. For example one form of controller has a
variable that is under control--the control variable--that
constitutes the input to the device. The output of the device is a
function of the current value of the control variable, and a set
point for the variable. A servo-ventilator may include a controller
that has ventilation as an input, a target ventilation as the set
point, and level of pressure support as an output. Other forms of
input may be one or more of oxygen saturation (SaO2), partial
pressure of carbon dioxide (PCO2), movement, a signal from a
photoplethysmogram, and peak flow. The set point of the controller
may be one or more of fixed, variable or learned. For example, the
set point in a ventilator may be a long term average of the
measured ventilation of a patient. Another ventilator may have a
ventilation set point that changes with time. A pressure controller
may be configured to control a blower or pump to deliver air at a
particular pressure.
[0454] Therapy: Therapy in the present context may be one or more
of positive pressure therapy, oxygen therapy, carbon dioxide
therapy, control of dead space, and the administration of a
drug.
[0455] Positive Airway Pressure (PAP) device: A device for
providing a supply of air at positive pressure to the airways.
5.4.3 Anatomy of the Face
[0456] Ala: The external outer wall or "wing" of each nostril
(plural: alae)
[0457] Alar angle: The angle defined between the ala, from an
inferior view.
[0458] Alare: The most lateral point on the nasal ala.
[0459] Alar curvature (or alar crest) point: The most posterior
point in the curved base line of each ala, found in the crease
formed by the union of the ala with the cheek.
[0460] Auricula or Pinna: The whole external visible part of the
ear.
[0461] (nose) Bony framework: The bony framework of the nose
comprises the nasal bones, the frontal process of the maxillac and
the nasal part of the frontal bone.
[0462] (nose) Cartilaginous framework: The cartilaginous framework
of the nose comprises the septal, lateral, major and minor
cartilages.
[0463] Columella: the strip of skin that separates the nares and
which runs from the pronasale to the upper lip.
[0464] Columella angle: The angle between the line drawn through
the midpoint of the nostril aperture and a line drawn perpendicular
to the Frankfurt horizontal while intersecting subnasale.
[0465] Frankfort horizontal plane: A line extending from the most
inferior point of the orbital margin to the left tragion. The
tragion is the deepest point in the notch superior to the tragus of
the auricle.
[0466] Glabella: Located on the soft tissue, the most prominent
point in the midsagittal plane of the forehead.
[0467] Lateral nasal cartilage: A generally triangular plate of
cartilage. Its superior margin is attached to the nasal bone and
frontal process of the maxilla, and its inferior margin is
connected to the major alar cartilage.
[0468] Lip, lower (labrale inferius): A point where the boundary of
the vermilion border of the lower lip and the skin is intersected
by the median sagittal plane.
[0469] Lip, upper (labrale superius): The point on the upper lip
lying in the median sagittal plane on a line drawn across the
boundary of the vermilion border and skin.
[0470] Major alar cartilage: A plate of cartilage lying below the
lateral nasal cartilage. It is curved around the anterior part of
the naris. Its posterior end is connected to the frontal process of
the maxilla by a tough fibrous membrane containing three or four
minor cartilages of the ala.
[0471] Nares (Nostrils): Approximately ellipsoidal apertures
forming the entrance to the nasal cavity. The singular form of
nares is naris (nostril). The nares are separated by the nasal
septum.
[0472] Naso-labial sulcus or Naso-labial fold: The skin fold or
groove that runs from each side of the nose to the corners of the
mouth, separating the cheeks from the upper lip.
[0473] Naso-labial angle: The angle between the columella and the
upper lip, while intersecting subnasale.
[0474] Otobasion inferior: The lowest point of attachment of the
auricle to the skin of the face.
[0475] Otobasion superior: The highest point of attachment of the
auricle to the skin of the face.
[0476] Pronasale: the most protruded point or tip of the nose,
which can be identified in lateral view of the rest of the portion
of the head.
[0477] Philtrum: the midline groove that runs from lower border of
the nasal septum to the top of the lip in the upper lip region.
[0478] Pogonion: Located on the soft tissue, the most anterior
midpoint of the chin.
[0479] Ridge (nasal): The nasal ridge is the midline prominence of
the nose, extending from the Sellion to the Pronasale.
[0480] Sagittal plane: A vertical plane that passes from anterior
(front) to posterior (rear) dividing the body into right and left
halves.
[0481] Sellion: Located on the soft tissue, the most concave point
overlying the area of the frontonasal suture.
[0482] Septal cartilage (nasal): The nasal septal cartilage forms
part of the septum and divides the front part of the nasal
cavity.
[0483] Subalare: The point at the lower margin of the alar base,
where the alar base joins with the skin of the superior (upper)
lip.
[0484] Subnasal point. Located on the soft tissue, the point at
which the columella merges with the upper lip in the midsagittal
plane.
[0485] Supramentale: The point of greatest concavity in the midline
of the lower lip between labrale inferius and soft tissue
pogonion
5.4.4 Anatomy of the Skull
[0486] Frontal bone: The frontal bone includes a large vertical
portion, the squama frontalis, corresponding to the region known as
the forehead.
[0487] Mandible: The mandible forms the lower jaw. The mental
protuberance is the bony protuberance of the jaw that forms the
chin.
[0488] Maxilla: The maxilla forms the upper jaw and is located
above the mandible and below the orbits. The frontal process of the
maxilla projects upwards by the side of the nose, and forms part of
its lateral boundary.
[0489] Nasal bones: The nasal bones are two small oblong bones,
varying in size and form in different individuals; they are placed
side by side at the middle and upper part of the face, and form, by
their junction, the "bridge" of the nose.
[0490] Nasion: The intersection of the frontal bone and the two
nasal bones, a depressed area directly between the eyes and
superior to the bridge of the nose.
[0491] Occipital bone: The occipital bone is situated at the back
and lower part of the cranium. It includes an oval aperture, the
foramen magnum, through which the cranial cavity communicates with
the vertebral canal. The curved plate behind the foramen magnum is
the squama occipitalis.
[0492] Parietal bones: The parietal bones are the bones that, when
joined together, form the roof and sides of the cranium.
[0493] Temporal bones: The temporal bones are situated on the bases
and sides of the skull, and support that part of the face known as
the temple.
[0494] Zygomatic bones: The face includes two zygomatic bones,
located in the upper and lateral parts of the face and forming the
prominence of the cheek.
5.4.5 Anatomy of the Respiratory System
[0495] Diaphragm: A sheet of muscle that extends across the bottom
of the rib cage. The diaphragm separates the thoracic cavity,
containing the heart, lungs and ribs, from the abdominal cavity. As
the diaphragm contracts the volume of the thoracic cavity increases
and air is drawn into the lungs.
[0496] Larynx: The larynx, or voice box houses the vocal folds and
connects the inferior part of the pharynx (hypopharynx) with the
trachea.
[0497] Lungs: The organs of respiration in humans. The conducting
zone of the lungs contains the trachea, the bronchi, the
bronchioles, and the terminal bronchioles. The respiratory zone
contains the respiratory bronchioles, the alveolar ducts, and the
alveoli.
[0498] Nasal cavity: The nasal cavity (or nasal fossa) is a large
air filled space above and behind the nose in the middle of the
face. The nasal cavity is divided in two by a vertical fin called
the nasal septum. On the sides of the nasal cavity are three
horizontal outgrowths called nasal conchae (singular "concha") or
turbinates. To the front of the nasal cavity is the nose, while the
back blends, via the choanae, into the nasopharynx.
[0499] Pharynx: The part of the throat situated immediately
inferior to (below) the nasal cavity, and superior to the
oesophagus and larynx. The pharynx is conventionally divided into
three sections: the nasopharynx (epipharynx), the oropharynx
(mesopharynx), and the laryngopharynx (hypopharynx).
5.4.6 Materials
[0500] Silicone or Silicone Elastomer: A synthetic rubber. In this
specification, a reference to silicone is a reference to liquid
silicone rubber (LSR) or a compression molded silicone rubber
(CMSR). One form of commercially available LSR is SILASTIC
(included in the range of products sold under this trademark),
manufactured by Dow Corning. Another manufacturer of LSR is Wacker.
Unless otherwise specified to the contrary, a preferred form of LSR
has a Shore A (or Type A) indentation hardness in the range of
about 35 to about 45 as measured using ASTM D2240.
[0501] Polycarbonate: a typically transparent thermoplastic polymer
of Bisphenol-A Carbonate.
5.4.7 Aspects of a Patient Interface
[0502] Anti-asphyxia valve (AAV): The component or sub-assembly of
a mask system that, by opening to atmosphere in a failsafe manner,
reduces the risk of excessive CO.sub.2 rebreathing by a
patient.
[0503] Elbow: A conduit that directs an axis of flow or air to
change direction through an angle. In one form, the angle may be
approximately 90 degrees. In another form, the angle may be less
than 90 degrees. The conduit may have an approximately circular
cross-section. In another form the conduit may have an oval or
rectangular cross-section.
[0504] Frame: Frame will be taken to mean a mask structure that
bears the load of tension between two or more points of connection
with a headgear. A mask frame may be a non-airtight load bearing
structure in the mask. However, some forms of mask frame may also
be air-tight.
[0505] Functional dead space: The functional dead space refers to
at least one region within a breathing circuit where a patient's
exhalate may collect such that the normal flow of gas within the
breathing circuit cannot effectively flush the exhalate from the
breathing circuit.
[0506] Headgear: Headgear will be taken to mean a form of
positioning and stabilizing structure designed for use on a head.
Preferably the headgear comprises a collection of one or more
struts, ties and stiffeners configured to locate and retain a
patient interface in position on a patient's face for delivery of
respiratory therapy. Some ties are formed of a soft, flexible,
elastic material such as a laminated composite of foam and
fabric.
[0507] Membrane: Membrane will be taken to mean a typically thin
element that has, preferably, substantially no resistance to
bending, but has resistance to being stretched.
[0508] Plenum chamber: a mask plenum chamber will be taken to a
mean portion of a patient interface having walls enclosing a volume
of space, the volume having air therein pressurized above
atmospheric pressure in use. A shell may form part of the walls of
a mask plenum chamber. In one form, a region of the patient's face
forms one of the walls of the plenum chamber.
[0509] Seal: The noun form ("a seal") will be taken to mean a
structure or barrier that intentionally resists the flow of air
through the interface of two surfaces. The verb form ("to seal")
will be taken to mean to resist a flow of air.
[0510] Shell: A shell will preferably be taken to mean a curved
structure having bending, tensile and compressive stiffness, for
example, a portion of a mask that forms a curved structural wall of
the mask. Preferably, compared to its overall dimensions it is
relatively thin. In some forms, a shell may be faceted. Preferably
such walls are airtight, although in some forms they may not be
airtight.
[0511] Stiffener. A stiffener will be taken to mean a structural
component designed to increase the bending resistance of another
component in at least one direction.
[0512] Strut: A strut will be taken to be a structural component
designed to increase the compression resistance of another
component in at least one direction.
[0513] Swivel: (noun) A subassembly of components configured to
rotate about a common axis, preferably independently, preferably
under low torque. In one form, the swivel may be constructed to
rotate through an angle of at least 360 degrees. In another form,
the swivel may be constructed to rotate through an angle less than
360 degrees. When used in the context of an air circuit, the
sub-assembly of components preferably comprises a matched pair of
cylindrical conduits. Preferably there is little or no leak flow of
air from the swivel in use.
[0514] Tie: A tie will be taken to be a structural component
designed to resist tension.
[0515] Vent: (noun) the structure that allows a deliberate
controlled rate leak of air from an interior of the mask, or
conduit to ambient air, to allow washout of exhaled carbon dioxide
(CO.sub.2) and supply of oxygen (O.sub.2).
5.4.8 Terms Used in Relation to Patient Interface
[0516] Curvature (of a surface): A region of a surface having a
saddle shape, which curves up in one direction and curves down in a
different direction, will be taken to have a negative curvature. A
region of a surface having a dome shape, which curves the same way
in two principle directions, will be taken to have a positive
curvature. A flat surface will be taken to have zero curvature.
[0517] Floppy: A quality of a material, structure or composite that
is the combination of features of: [0518] Readily conforming to
finger pressure. [0519] Unable to retain its shape when caused to
support its own weight. [0520] Not rigid. [0521] Able to be
stretched or bent elastically with little effort.
[0522] The quality of being floppy may have an associated
direction, hence a particular material, structure or composite may
be floppy in a first direction, but stiff or rigid in a second
direction, for example a second direction that is orthogonal to the
first direction.
[0523] Resilient: Able to deform substantially elastically, and to
release substantially all of the energy upon unloading, within a
relatively short period of time such as 1 second.
[0524] Rigid: Not readily deforming to finger pressure, and/or the
tensions or loads typically encountered when setting up and
maintaining a patient interface in scaling relationship with an
entrance to a patient's airways.
[0525] Semi-rigid: means being sufficiently rigid to not
substantially distort under the effects of mechanical forces
typically applied during positive airway pressure therapy.
5.5 Other Remarks
[0526] Unless defined otherwise, all technical and scientific terms
used herein have the same meaning as commonly understood by one of
ordinary skill in the art to which this technology belongs.
Although any methods and materials similar or equivalent to those
described herein can also be used in the practice or testing of the
present technology, a limited number of the exemplary methods and
materials are described herein.
[0527] It must be noted that as used herein and in the appended
claims, the singular forms "a", "an", and "the" include their
plural equivalents, unless the context clearly dictates
otherwise.
[0528] Moreover, in interpreting the disclosure, all terms should
be interpreted in the broadest reasonable manner consistent with
the context. In particular, the terms "comprises" and "comprising"
should be interpreted as referring to elements, components, or
steps in a non-exclusive manner, indicating that the referenced
elements, components, or steps may be present, or utilized, or
combined with other elements, components, or steps that are not
expressly referenced.
[0529] Although the technology herein has been described with
reference to particular examples, it is to be understood that these
examples are merely illustrative of the principles and applications
of the technology. In some instances, the terminology and symbols
may imply specific details that are not required to practice the
technology. For example, although the terms "first" and "second"
may be used, unless otherwise specified, they are not intended to
indicate any order but may be utilised to distinguish between
distinct elements. Furthermore, although process steps in the
methodologies may be described or illustrated in an order, such an
ordering is not required. Those skilled in the art will recognize
that such ordering may be modified and/or aspects thereof may be
conducted concurrently or even synchronously.
[0530] It is therefore to be understood that numerous modifications
may be made to the illustrative examples and that other
arrangements may be devised without departing from the spirit and
scope of the technology.
TABLE-US-00003 6 REFERENCE NUMERAL LIST patient 1000 bed partner
1100 patient interface 3000 seal-forming structure 3100 nasal
opening 3101 oral gas chamber 3102 oral opening 3103 nasal gas
chamber 3104 distal major side 3104.1 minor side 3104.2 proximal
major side 3104.3 nare port 3105 decoupling structure 3106 gap
3106.1 connection region 3106.2 side portion 3106.3 upper surface
3106.4 connecting surface 3106.5 lower surface 3106.6 oral cushion
3110 nasal cushion 3112 region 3112.1 region 3112.2 region 3112.3
region 3113 protruding end 3114 region 3115 recessed portion 3116
region 3117 peak 3118 nasal sling 3119 oral undercushion 3120
straight sidewalls 3121 tapered region 3122 thickened nasal cushion
section 3124 soft connection region 3130 hard connection region
3132 oral plenum chamber 3200 nasal plenum chamber 3909 faceplate
3204 connection portion 3205 top plate 3206 side support 3207 nasal
undercushion support wall 3208 pocket 3208.1 notch 3209 perimeter
3210 oral plenum chamber section 3212 cutout 3213 top plate buffer
3214 faceplate buffer 3215 recess 3216 hole 3217 extension 3218
depression 3219 lower attachment feature 3250 frame 3251 upper
attachment feature 3252 catch 3253 mating surface 3254 mating
portion 3255 mating portion extension 3256 wing portion 3257 recess
3258 frame extension 3259 clip magnet 3260 mating portion magnet
3261 mating portion pocket 3262 guide surface 3263 protrusion 3264
notch 3265 reduced thickness section 3266 mating portion magnet
receiver 3267 positioning and stabilising structure 3300 rigidiser
arm assembly 3301 rigidiser arm 3302 top plate cover 3303
connection feature 3304 pad 3305 headgear straps 3306 opening 3308
claw 3309 upper strap 3310 lower strap 3312 clip 3314 bar 3315
sheath 3316 clip pocket 3317 notch 3318 receiving surface 3319 clip
magnet cover 3320 clip magnet receiver 3321 vent 3400 tube
decoupling structure 3500 swivel 3510 baffle 3520 quick release
mechanism 3530 connection port 3600 anti-asphyxiation valve 3800
pap device 4000 air circuit 4170 cuff 4172 humidifier 5000
* * * * *