NZ761302B2 - Respiratory Apparatus - Google Patents
Respiratory Apparatus Download PDFInfo
- Publication number
- NZ761302B2 NZ761302B2 NZ761302A NZ76130214A NZ761302B2 NZ 761302 B2 NZ761302 B2 NZ 761302B2 NZ 761302 A NZ761302 A NZ 761302A NZ 76130214 A NZ76130214 A NZ 76130214A NZ 761302 B2 NZ761302 B2 NZ 761302B2
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- NZ
- New Zealand
- Prior art keywords
- foam
- cushion
- clip
- mask
- support component
- Prior art date
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Classifications
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- A61M16/0057—Pumps therefor
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- A61M16/021—Devices for influencing the respiratory system of patients by gas treatment, e.g. mouth-to-mouth respiration; Tracheal tubes operated by electrical means
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- A61M16/06—Respiratory or anaesthetic masks
- A61M16/0605—Means for improving the adaptation of the mask to the patient
- A61M16/0616—Means for improving the adaptation of the mask to the patient with face sealing means comprising a flap or membrane projecting inwards, such that sealing increases with increasing inhalation gas pressure
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- A61M16/0616—Means for improving the adaptation of the mask to the patient with face sealing means comprising a flap or membrane projecting inwards, such that sealing increases with increasing inhalation gas pressure
- A61M16/0622—Means for improving the adaptation of the mask to the patient with face sealing means comprising a flap or membrane projecting inwards, such that sealing increases with increasing inhalation gas pressure having an underlying cushion
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- A61M16/00—Devices for influencing the respiratory system of patients by gas treatment, e.g. mouth-to-mouth respiration; Tracheal tubes
- A61M16/0003—Accessories therefor, e.g. sensors, vibrators, negative pressure
- A61M2016/0027—Accessories therefor, e.g. sensors, vibrators, negative pressure pressure meter
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- A61M2016/003—Accessories therefor, e.g. sensors, vibrators, negative pressure with a flowmeter
- A61M2016/0033—Accessories therefor, e.g. sensors, vibrators, negative pressure with a flowmeter electrical
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- A61M2205/00—General characteristics of the apparatus
- A61M2205/02—General characteristics of the apparatus characterised by a particular materials
Abstract
mask cushion assembly for a patient interface of a respiratory treatment apparatus, the mask cushion assembly comprising a peripheral foam cushion and adapted to surround an entrance to the airways of the patient, the mask cushion assembly further comprising a flexible support component peripherally engaged with the foam cushion and a rigid support component coupled with the flexible support component, wherein the flexible support component is formed of an air impermeable material and wherein the flexible support component comprises an internal periphery of a plenum chamber of the mask cushion assembly, wherein the internal periphery of the flexible support component is adapted to respond to a treatment pressure provided at the mask cushion assembly to increase a sealing force of a seal of the foam cushion. ly engaged with the foam cushion and a rigid support component coupled with the flexible support component, wherein the flexible support component is formed of an air impermeable material and wherein the flexible support component comprises an internal periphery of a plenum chamber of the mask cushion assembly, wherein the internal periphery of the flexible support component is adapted to respond to a treatment pressure provided at the mask cushion assembly to increase a sealing force of a seal of the foam cushion.
Description
(12) Granted patent specificaon (19) NZ (11) 761302 (13) B2
(47) Publicaon date: 2021.12.24
(54) Respiratory Apparatus
(51) Internaonal Patent Classificaon(s):
A61M 16/06 A61F 5/56
(22) Filing date: (73) Owner(s):
2014.02.04 ResMed Pty Ltd
(23) Complete specificaon filing date: (74) Contact:
2014.02.04 JAMES & WELLS
(62) Divided out of 745260 (72) Inventor(s):
Henry, Robert Edward
(30) Internaonal Priority Data: SCHEINER, Rupert, Christian
AU 2013900348 2013.02.04 KLASEK, Paul Jan
AU 2013900349 2013.02.04 GOLDSPINK, Lachlan, Richard
EDWARDS, Craig, David
HUNG, Andrew
LAW, Kam Man
OVZINSKY, Grant Milton
PLASCOTT, Stuart, Norris
SUNG, James
SWIFT, Lance Ian
WELLS, Matthew Robin
(57) Abstract:
A mask cushion assembly for a paent interface of a respiratory treatment apparatus, the mask
cushion assembly comprising a peripheral foam cushion and adapted to surround an entrance
to the airways of the paent, the mask cushion assembly further comprising a flexible support
component peripherally engaged with the foam cushion and a rigid support component coupled
with the flexible support component, wherein the flexible support component is formed of an
air impermeable material and wherein the flexible support component comprises an internal
periphery of a plenum chamber of the mask cushion assembly, wherein the internal periphery of
the flexible support component is adapted to respond to a treatment pressure provided at the
mask cushion assembly to increase a sealing force of a seal of the foam cushion.
NZ 761302 B2
RESPIRATORY APPARATUS
1 CROSS REFERENCE TO RELATED APPLICATIONS
This application claims the benefit of the filing
dates of Australia Provisional Patent Application Nos.
2013900348 filed February 4, 2013, and 2013900349 filed
February 4, 2013, the disclosures of which are hereby
incorporated herein by reference.
2 BACKGROUND OF THE TECHNOLOGY
2.1 FIELD OF THE TECHNOLOGY
The present technology relates to one or more of the
detection, diagnosis, treatment, prevention and
amelioration of respiratory-related disorders. In
particular, the present technology relates to medical
devices or apparatus, and their use. Such devices may
include an interface for directing a treatment to a patient
respiratory system.
2.2 DESCRIPTION OF THE RELATED ART
The respiratory system of the body facilitates gas
exchange. The nose and mouth form the entrance to the
airways of a patient.
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 "Respiratory Physiology", by John B. West,
Lippincott Williams & Wilkins, 9th edition published 2011.
A range of respiratory disorders exist.
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. Patent No. 4,944,310 (Sullivan).
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.
Patent No. 6,532,959 (Berthon-Jones).
Obesity Hyperventilation Syndrome (OHS) is defined as
the combination of severe obesity and awake chronic
hypercapnia, in the absence of other known causes for
hypoventilation. Symptoms include dyspnea, morning
headache and excessive daytime sleepiness.
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: dyspnoea
on exertion, chronic cough and sputum production.
Neuromuscular Disease (NMD) may encompass 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, dyspnoea on
exertion and at rest, fatigue, sleepiness, morning
headache, and difficulties with concentration and mood
changes.
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: dyspnoea on exertion, peripheral oedema,
orthopnoea, repeated chest infections, morning headaches,
fatigue, poor sleep quality and loss of appetite.
Otherwise healthy individuals may take advantage of
systems and devices to prevent respiratory disorders from
arising.
2.2.1 Therapy
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.
Non-invasive ventilation (NIV) provides ventilator
support to a patient through the upper airways to assist
the patient in taking a full breath and/or maintain
adequate oxygen levels in the body by doing some or all of
the work of breathing. The ventilator support is provided
via a patient interface. NIV has been used to treat CSR,
OHS, COPD, MD and Chest Wall disorders.
Invasive ventilation (IV) provides ventilatory
support to patients that are no longer able to effectively
breathe themselves and is provided using a tracheostomy
tube.
Ventilators may control the timing and pressure of
breaths pumped into the patient and monitor the breaths
taken by the patient. The methods of control and monitoring
patients typically include volume-cycled and pressure-
cycled methods. The volume-cycled methods may include among
others, Pressure-Regulated Volume Control (PRVC), Volume
Ventilation (VV), and Volume Controlled Continuous
Mandatory Ventilation (VC-CMV) techniques. The pressure-
cycled methods may involve, among others, Assist Control
(AC), Synchronized Intermittent Mandatory Ventilation
(SIMV), Controlled Mechanical Ventilation (CMV), Pressure
Support Ventilation (PSV), Continuous Positive Airway
Pressure (CPAP), or Positive End Expiratory Pressure (PEEP)
techniques.
2.2.2 Systems
One known device used for treating sleep disordered
breathing is the S9 Sleep Therapy System, manufactured by
ResMed. Ventilators such as the ResMed Stellar™ Series of
Adult and Paediatric Ventilators may provide support for
invasive and non-invasive non-dependent ventilation for a
range of patients for treating a number of conditions such
as but not limited to NMD, OHS and COPD.
The ResMed Elisée™ 150 ventilator and ResMed VS III™
ventilator may provide support for invasive and non-
invasive dependent ventilation suitable for adult or
paediatric patients for treating a number of conditions.
These ventilators provide volumetric and barometric
ventilation modes with a single or double limb circuit.
A system may comprise a PAP Device/ventilator, an air
circuit, a humidifier, a patient interface, and data
management.
2.2.3 Patient Interface
A patient interface may be used to interface
respiratory equipment to its user, for example by providing
a flow of breathable gas. The flow of breathable gas may
be provided via a mask to the nose and/or mouth, a tube to
the mouth or a tracheostomy tube to the trachea of the
user. Depending upon the therapy to be applied, the patient
interface may form a seal, e.g. with a face region of the
patient, to facilitate the delivery of gas at a pressure
at sufficient variance with ambient pressure to effect
therapy, e.g. a positive pressure of about 10cmH2O. For
other forms of therapy, such as the delivery of oxygen, the
patient interface may not include a seal sufficient to
facilitate delivery to the airways of a supply of gas at a
positive pressure of about 10cm H2O.
The design of a patient interface presents a number
of challenges. The face has a complex three-dimensional
shape. The size and shape of noses varies considerably
between individuals. Since the head includes bone,
cartilage and soft tissue, different regions of the face
respond differently to mechanical forces. The jaw or
mandible may move relative to other bones of the skull. The
whole head may move during the course of a period of
respiratory therapy.
As a consequence of these challenges, some masks
suffer from being one or more of obtrusive, aesthetically
undesirable, costly, poorly fitting, difficult to use, and
uncomfortable especially when worn for long periods of time
or when a patient is unfamiliar with a system. For example,
masks designed solely for aviators, mask designed as part
of personal protection equipment (e.g. filter masks), SCUBA
masks, or for the administration of anaesthetics may be
tolerable for their original application, but nevertheless
be undesirably uncomfortable to be worn for extended
periods of time, e.g. several hours. This is even more so
if the mask is to be worn during sleep. An uncomfortable
mask may impact on patient compliance.
Nasal CPAP therapy is highly effective to treat
certain respiratory disorders, provided patients comply
with therapy. If a mask is uncomfortable, or difficult to
use a patient may not comply with therapy. Since it is
often recommended that a patient regularly wash their mask,
if a mask is not easily replaceable or difficult to clean
(e.g. difficult to assemble or disassemble), patients may
not replace or clean their mask and this may impact on
patient compliance.
For these reasons, masks for delivery of nasal CPAP
during sleep form a distinct field.
2.2.3.1 Seal-forming portion
Patient interfaces may include a seal-forming portion.
A patient interface may be partly characterised
according to the design intent of where the seal-forming
portion is to engage with the face in use. In one form of
patient interface, a seal-forming portion may comprise two
sub-portions to engage with respective left and right
nares. In one form of patient interface, a seal-forming
portion may comprise a single element that surrounds both
nares in use. Such single element may be designed to for
example overlay an upper lip region and a nasal bridge
region of a face. In one form of patient interface a seal-
forming portion may comprise an element that surrounds a
mouth region in use, e.g. by forming a seal on a lower lip
region of a face. In one form of patient interface, a seal-
forming portion may comprise a single element that
surrounds both nares and a mouth region in use. These
different types of patient interfaces may be known by a
variety of names by their manufacturer including nasal
masks, full-face masks, nasal pillows, nasal puffs and oro-
nasal masks.
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.
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.
Another type of seal-forming portion may comprise a
friction-fit element, e.g. for insertion into a naris.
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.
A range of patient interface seal-forming portion
technologies are disclosed in the following patent
applications, assigned to ResMed Limited: ,310;
,513; ,785.
2.2.3.2 Positioning and stabilising
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 sealing
relation with the appropriate portion of the face.
One technique is the use of adhesives. See for example
US Patent publication US 2010/0000534.
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
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.
ResMed Limited has developed a number of improved mask
vent technologies. See ,665; ,381;
US 6,581,594; US Patent Application; US 2009/0050156; US
Patent Application 2009/0044808.
Table of noise of prior masks (ISO 17510-2:2007, 10
cmH O pressure at 1m)
Mask name Mask A-weighted A-weighted Year
type sound power sound (appr
level dBA pressure dBA ox.)
(uncertainty) (uncertainty)
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 Activa nasal 32 (3) 24 (3) 2002
ResMed Mirage Micro nasal 30 (3) 22 (3) 2008
ResMed Mirage SoftGel nasal 29 (3) 22 (3) 2008
ResMed Mirage FX nasal 26 (3) 18 (3) 2010
ResMed Mirage Swift nasal 37 29 2004
(*) pillows
ResMed Mirage Swift nasal 28 (3) 20 (3) 2005
II pillows
ResMed Mirage Swift nasal 25 (3) 17 (3) 2008
LT pillows
ResMed Mirage series full 31.7 23.7 2000
I, II (*) face
ResMed UltraMirage full 35 (3) 27 (3) 2004
face
ResMed Mirage Quattro full 26 (3) 18 (3) 2006
face
ResMed Mirage Quattro full 27 (3) 19 (3) 2008
FX face
(* one specimen only, measured using test method
specified in ISO3744 in CPAP mode at 10cm H O)
Sound pressure values of a variety of objects are
listed below
Object A-weighted sound Notes
pressure dB(A)
Vacuum cleaner: 68 ISO3744 at 1m
Nilfisk Walter distance
Broadly Litter Hog:
B+ Grade
Conversational 60 1m distance
speech
Average home 50
Quiet library 40
Quiet bedroom at 30
night
Background in TV 20
studio
2.2.3.4 Nasal pillow technologies
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 US Patent 4,782,832 (Trimble
et al.), assigned to Puritan-Bennett Corporation.
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), U.S. Patent
Application 2009/0044808 (describing amongst other things
aspects of ResMed SWIFT LT nasal pillows); International
Patent Applications ,328 and ,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).
2.2.4 Respiratory Apparatus (PAP Device / Ventilator)
Examples of respiratory apparatuses include ResMed’s
S9 AutoSet PAP device and ResMed’s Stellar™ 150
ventilator. PAP devices or ventilators typically comprise
a flow generator, such as a motor-driven blower or a
compressed gas reservoir, and are configured to provide a
controlled supply of breathable gases (e.g., air) to the
airway of a patient. In some cases, the flow of air or
other breathable gases may be supplied to the airway of the
patient at positive pressure may be supplied to the airway
of a patient by a PAP device such as a motor-driven blower.
The outlet of the blower PAP device or the ventilator is
connected via a flexible delivery conduit an air circuit
to a patient interface such as those described above.
Ventilators or PAP devices typically include a flow
generator, an inlet filter, a patient interface, an air
circuit delivery conduit connecting the flow generator to
the patient interface, various sensors and a
microprocessor-based controller. The patient interface may
include a mask or a tracheostomy tube as described above.
The flow generator may include a servo-controlled motor,
volute and an impeller that forms a blower. In some cases
a brake for the motor may be implemented to more rapidly
reduce the speed of the blower so as to overcome the inertia
of the motor and impeller. The braking can permit the
blower to more rapidly achieve a lower pressure condition
in time for synchronization with expiration despite the
inertia. In some cases the flow generator may also include
a valve capable of discharging generated air to atmosphere
as a means for altering the pressure delivered to the
patient as an alternative to motor speed control. The
sensors measure, amongst other things, motor speed, mass
flow rate and outlet pressure, such as with a pressure
transducer or the like. The apparatus may optionally
include a humidifier and/or heater elements in the path of
the air delivery circuit. The controller may include data
storage capacity with or without integrated data retrieval
and display functions.
3 BRIEF SUMMARY OF THE TECHNOLOGY
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.
An aspect of the present technology relates to
apparatus used in the treatment or prevention of a
respiratory disorder.
Another aspect of the present technology may relate
to methods used in the treatment or prevention of a
respiratory disorder.
One form of the present technology involves an
interface that directs a treatment, such as a positive
pressure breathable gas, to a patient respiratory system.
Another aspect of one form of the present technology
involves such an interface that directs a treatment to the
nares of the patient respiratory system.
Another aspect of one form of the present technology
is such an interface that directs a treatment to the nares
and mouth of the patient respiratory system but maintaining
a minimal facial contact profile so as to avoid contact or
coverage of a majority of a nose of patient.
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 the face profile of an intended wearer.
Another aspect of some forms of the present technology
is a patient interface that employs a foam cushion. The
foam may optionally be part of a cushion assembly that may
further implement a flexible support clip. In some such
cases, the flexible support clip can be configured with
dimensions and material properties so as to both support
the foam cushion and complement the foam cushion’s
compliance. Thus, a relatively thin foam cushion may
provide compliance to account for the fine details on the
user's face, while the flexible clip can account for the
more coarse aspects of the facial structure. Such
configuration may reduce the amount of foam required for a
comfortable and efficient sealing of the mask. The reduced
amount of foam may minimise the overall size of the mask,
make it less obtrusive and improve its aesthetic appeal.
Another aspect of some forms of the present technology
is a patient interface that is implemented as a mouth and
nose mask with a substantially above the nose or under the
nose seal configuration.
For example, a mask apparatus for a respiratory
treatment may include a frame adapted to couple with a
respiratory treatment apparatus so as to permit
communication of a pressurized gas to a respiratory system
of a patient from the respiratory treatment apparatus; and
it may include a cushion adapted to couple with the frame,
the cushion configured as a substantially under nose seal
portion and a mouth seal portion, the under nose seal
portion comprising a sub-nasal ridge formed as a semi-
peripheral sealing boundary about both nares of the
patient.
In some cases, the cushion may comprise a triangular
ring having a common nasal and mouth aperture. The cushion
may be foam. The cushion and the frame may form a common
plenum chamber for sealing about the nares and mouth. The
cushion may include a protrusion configured to ply adjacent
to a nasal ala of the patient. The cushion may include
left and right nasal ala protrusions.
In some versions, the mask apparatus may further
include a cushion support clip configured to couple with
the cushion and couple with the frame. The cushion support
clip may include first and second opposing sides, wherein
the clip is configured to couple with the cushion on the
first opposing side and to couple with the frame on the
second opposing side. The cushion support clip may include
a nasal plateau region and a mouth periphery region. The
nasal plateau region may be approximately perpendicular to
the mouth periphery region.
The cushion support clip may include a bend region
between the nasal plateau region and the mouth periphery
region. The bend region may form an approximately
nasolabial angle between the nasal plateau region and the
mouth periphery region. The bend region may include a set
of inwardly directing nasal protrusions. The nasal
protrusions may be flexible.
In some versions, the cushion support clip may include
first and second cushion support portions, the first and
second cushion support portions may be configured to
provide different flexibility characteristics. The first
cushion support portion may be a nasal support region and
the second cushion support portion may be a lateral mouth
support region. The first cushion support portion may have
a higher rigidity characteristic with respect to the second
cushion support portion. Optionally, the sub-nasal ridge
includes a scalloped edge. In some cases, the cushion
comprises a generally flat sealing surface. The cushion may
include a generally curved sealing surface.
In some cases, such mask apparatus may further include
a respiratory treatment apparatus configured to generate a
controlled supply of breathable gas at a pressure above
atmospheric pressure, the respiratory treatment apparatus
including a gas delivery conduit coupled with the frame to
direct the breathable gas to the frame.
In some versions of the mask apparatus, a cushion
support clip may be flexible. The cushion support clip may
be inwardly concave. The cushion support clip may be made
of a material other than or different from foam. The
cushion may be foam externally attached to a flexible clip.
In some cases, a foam surface of the cushion may be
configured for direct contact with a patient's skin. A
foam of the cushion may be a semi-open cell foam with
limited permeability.
Some versions of the present technology may include
a respiratory mask for delivering a respiratory gas
treatment. The mask may include a frame and cushion. The
cushion may be adapted to couple with the frame. The cushion
may be configured as a substantially under nose seal
portion and a mouth seal portion. The cushion may further
define a centrally open lip superior region.
The cushion may include a nasal plateau region and a
mouth periphery region. The cushion may be configured with
an approximately nasolabial angle between the nasal plateau
region and the mouth periphery region. The cushion may be
a triangular ring having a common nasal and mouth aperture.
The cushion may be foam.
The cushion and the frame may form a common plenum
chamber for sealing about nares and mouth. The centrally
open lip superior region may be within the plenum chamber.
The cushion may include a protrusion configured to ply
adjacent to a nasal ala of a patient. The cushion may
include left and right nasal ala protrusions.
The respiratory mask may include a clip to removably
couple the cushion to the frame. The clip may include
flexible nasal protrusions. The clip may include first and
second cushion support portions, the first and second
cushion support portions being configured to provide
different flexibility characteristics.
In some versions of the present technology, such as
when a mask is configured for sealing with the mouth and
over the nasal bridge, a foam cushion may be implemented.
For example, a foam cushion assembly can be configured
to seal around the mouth and over the nasal bridge, and can
achieve a comfortable and effective seal. Such an assembly
may include a foam cushion portion, a flexible clip portion
and a rigid clip portion. The flexible clip may be arranged
to complement the compliance of the cushion so as to allow
a reduction in the size of the cushion. Whilst the rigid
clip portion is generally expected to be made of generally
hard material, the term "rigid" is relative with respect
to the softer "flexible" clip portion (also referred to a
soft clip or flexible clip). Thus the rigid portion (also
referred to a rigid clip) may have some level of
flexibility. Its hardness, however, should be sufficient
to facilitate attachment to the frame or to the headgear.
In terms of comfort, the force applied to the user's
face at the seal interface from headgear and treatment
pressure of a respiratory treatment can be distributed over
a larger surface area compared to traditional silicone
based seals, resulting in better comfort as well as an
improved perceived comfort. This may have a positive
effect on patient therapy acceptance and, hence,
compliance.
Any mask leak can be dispersed over a wider area
resulting in a more dispersed flow, which minimise
"jetting" that is attributable to conventional silicone
cushions. This is likely to improve patient engagement
with therapy and compliance verses that associated with
typical silicone sealing technology.
Some potential benefits of such a foam cushion or
assembly may include:
A breathable foam cushion assembly can serve as a
cooler skin contact region and reduce discomfort in sealing
areas.
The inclusion of an optional flexible clip allows a
reduced overall dimension in the foam component of the
cushion, compared to a foam mask without such a component.
This increases stability without a compromise in comfort
and sealing.
A foam cushion assembly can be relatively small in
size, unobtrusive, yet easily removable for cleaning and
replacement.
Some versions of the present technology include a foam
cushion assembly for a patient interface. The foam cushion
assembly may be adapted to couple with a patient interface
frame. The cushion assembly may include a substantially
above nose seal portion and a mouth seal portion. Such a
cushion assembly may include a foam cushion arranged to
form with the frame a common plenum chamber and for sealing
about the nose and mouth of the patient, and it may include
a cushion support clip arranged to couple to the foam
cushion, wherein the cushion support clip may be
characterised by a height to thickness ratio of at least
3, around an entire periphery of the cushion.
The cushion support clip may be flexible. The
flexible cushion support clip may be formed by a rigid
material and the flexibility may be induced by way of
introducing one or more compliance regions. The
compliance regions may be formed by introducing a line of
weakness or a region of weakness.
The cushion support clip may have an inwardly concave
shape, dimensions and material properties that, when
pressure is applied to the patient interface, facilitate
an air spring effect. The cushion support clip may be made
of a material other than foam and silicone. The foam
cushion may be externally attached to the cushion support
clip. A foam surface of the cushion may be configured for
direct contact with a patient's skin.
The foam cushion may be a semi-open cell foam with
limited permeability. The foam cushion may have a
permeability characteristic in a range of about 0 to 20
litters per minute. The foam cushion may have an
indentation hardness characteristic in a range of about
110.48 to 303.11 Newtons. The foam cushion may have a
compression stress strain characteristic in a range of
about 2.32 to 7.26 kilo-pascals. The foam cushion may have
an apparent density characteristic in a range of about 24.3
to 117.85 kilograms per meter cubed. The foam cushion may
have a compression set characteristic in a range of about
0.16 to 17.30 percent.
The cushion support clip may be L, C and/or Z-shaped.
The cushion support clip may include a foam cushion
coupling portion, providing a contact surface to which the
cushion is attached, a flexible support portion and a base
portion for attaching to a second support clip or to the
frame. The foam cushion assembly may have shape,
dimensions and material characteristics of the cushion
support clip selected so that at least a portion of the
clip acts as a cantilever spring.
The cushion assembly may also include a second support
clip configured to couple with the cushion support clip and
the frame. The second support clip may be more rigid than
the cushion support clip and the cushion support clip may
be more rigid than the foam cushion. The foam cushion and
the cushion support clip may be integrally connected. The
foam cushion, the cushion support clip and the second
support clip may be integrally connected.
The foam cushion assembly may be configured so that
different levels of support and compliance are provided in
at least some sections along a periphery of the cushion
assembly. In some versions, one or more parameters vary
in at least some sections of a periphery of the clip, the
parameters may include: spring constant of the clip and/or
the foam cushion; cross-sectional profile of the clip
and/or the foam cushion; wall thickness of the clip; angle
of a contact surface of the clip to which the cushion is
attached; overhang of the cushion with respect to the
supporting contact surface; and foam thickness.
The foam cushion assembly may further include a
protrusion being configured to be, when in use, depressed
by a headgear strap so as to apply pressure on a respective
region of the foam cushion.
Some versions of the present technology may include a
patient interface apparatus for a respiratory treatment.
The patient interface apparatus may include a frame adapted
to couple with a respiratory treatment apparatus so as to
permit communication of a pressurized gas to a respiratory
system of a patient from the respiratory treatment
apparatus. It may further include a cushion assembly
adapted to couple with the frame of any of the versions
described herein.
Some versions of the present technology may include a
mask cushion assembly for a patient interface of a
respiratory treatment apparatus. The mask cushion assembly
may include a peripheral foam cushion adapted as a seal for
a mouth portion. The peripheral foam cushion may be further
adapted as a seal for a nasal portion. The cushion assembly
may further include a flexible support component
peripherally engaged with the foam cushion and a rigid
support component coupled with the flexible support
component, wherein the flexible support component is formed
of an air impermeable material. The flexible support
component may be formed of a flexible material.
The flexible support component may be formed by a
rigid material, wherein the flexible support component
comprises one or more compliance regions inducing
flexibility. The compliance regions may be formed by
introducing a line of weakness or a region of weakness.
The rigid support component may include a mask frame.
The rigid support component may include a clip for coupling
with a mask frame. The clip may include at least one snap
element. The flexible support component may include an
internal periphery of a plenum chamber of the mask cushion
assembly, the internal periphery adapted to respond to a
treatment pressure provided at the mask to increase a
sealing force of a seal of the foam cushion.
The flexible support component may include an internal
periphery of a plenum chamber of the mask cushion, wherein
the flexible support component is configured to respond
with different reaction forces in at least some regions of
the periphery. The regions with different reaction forces
may include a side of nose region and a side of mouth
region. The flexible support component may be configured
to provide different roll-in responses in different regions
of the periphery of the flexible support component. The
different regions may include an upper cheek region and a
side of mouth region. The internal periphery may be formed
with different angles in the different regions, each angle
formed by a support portion and a foam cushion coupling
portion. The flexible support component may include one
or more of a 'C' cross sectional geometry and an 'L' cross
sectional geometry.
The foam cushion coupling portion may include a
peripheral lip to which the foam cushion may be mounted.
In some cases, the engagement of the peripheral lip and
foam cushion form an overhang foam portion in at least some
sections along the periphery of the lip. The foam cushion
may include a nasal bridge contact region. The nasal bridge
contact region of the foam cushion may include a nasal
recess.
The foam cushion may include a substantially under
nose seal portion, the under nose seal portion comprising
a sub-nasal ridge formed as a semi-peripheral sealing
boundary about both nares of the patient.
In some versions, the flexible support component may
include a shell of a plenum chamber and a connection port
for coupling to an air circuit of a respiratory treatment
apparatus, and the rigid support component may include a
headgear frame including a shell aperture configured for
fitting about the shell.
In some versions, a flexible skirt member of a mask
component moves to engage and cover an inner surface of the
foam cushion, the flexible skirt member may be air
impermeable.
In some versions, a peripheral foam cushion may be
generally planar and the flexible support component and/or
the rigid support component may impart a three dimensional
(3D) contour to the peripheral foam cushion, when attached
to the foam cushion. The foam may be a polyurethane semi-
open cell foam of limited permeability.
In some cases, a spring constant of a foam cushion
with a nasal recess and flexible support component in a
mouth region may be greater than a spring constant of the
foam cushion and flexible support component in a nasal
bridge region. Optionally, a spring constant of the foam
cushion and flexible support component in a cheek region
may be similar to the spring constant of the nasal bridge
region. A spring constant of a flexible clip only
configuration in a mouth region may be larger than a spring
constant in a cheek bone region and the spring constant in
the cheek bone region may be larger than a spring constant
in a nasal bridge region.
The foam cushion may have a compression stress strain
characteristic in a range of about 2.32 to 7.26
kilopascals. The foam cushion may have a coefficient of
friction characteristic in a range of about 1.86 to 19.12
CF. The foam cushion may have an elongation at break
characteristic in a range of about 72.3 to 369.05 percent.
The foam cushion may have a permeability characteristic in
a range of about 0 to 20 liters per minute. The foam
cushion may have an indentation hardness characteristic in
a range of about 110.48 to 303.11 Newtons. The foam cushion
may have a compression stress strain characteristic in a
range of about 2.32 to 7.26 kilo-pascals. The foam cushion
may have an apparent density characteristic in a range of
about 24.3 to 117.85 kilograms per meter cubed. The foam
cushion may have a compression set characteristic in a
range of about 0.16 to 17.30 percent. The foam cushion may
have a tensile strength characteristic in a range of about
0.03 to 0.27 MegaPascals.
The flexible support component may be inwardly
concave. The flexible support component may be made of a
material other than foam. The cushion may be made of foam
and be externally attached to flexible support component.
A foam surface of the cushion may be configured for direct
contact with a patient's skin. One or more parameters may
vary in at least some sections of the periphery of the
flexible support component, the parameters may include:
spring constant of the flexible support component and/or
the foam cushion; cross-sectional profile of the flexible
support component and/or the foam cushion; wall thickness
of the flexible support component; angle of a contact
surface of the flexible support component to which the
cushion is attached; overhang of the cushion with respect
to the supporting contact surface; and/or foam thickness.
Some versions of the mask cushion assembly may further
include a protrusion configured to be, when in use,
depressed by a headgear strap so as to apply pressure on a
respective region of the foam cushion.
Some versions of the present technology may include a
mask cushion for a mask frame that may include a foam
cushion. The mask cushion may include a peripheral portion
adapted as a seal for a mouth portion. The peripheral
portion may be further adapted as a seal for a nasal
portion. The foam cushion may further include a
stretchable engagement skirt, whereby the foam cushion may
be configured as a slip-over foam cover for a supporting
structure.
Some versions of the present technology may include a
mask cushion assembly for a mask frame. The assembly may
include a foam cushion, the foam cushion may include a
peripheral portion adapted as a seal for a mouth portion.
The peripheral portion may be further adapted as a seal for
a nasal portion. The mask cushion assembly may further
include an inner peripheral clip and outer peripheral clip.
The clips may be configured to engage with a foam support
component. The inner peripheral clip may engage on an
inner side of the foam cushion and the outer peripheral
clip may engage on an outer side of the foam cushion. The
clips may clamp the foam cushion to secure the foam cushion
to the foam support component. The clips may be configured
to clamp the foam so as to round a patient contact surface
of the foam cushion. The clips may further include an
over-clip portion configured to depress over a top side
portion of the foam cushion. The foam cushion may further
include a slit to receive an over-clip portion.
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.
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 DRAWINGS
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
Fig. 1a shows components of a system suitable for use
with examples of the present technology. A patient 1000
wearing a patient interface 3000, such as nasal prongs only
covering the patient's nose, 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;
Fig. 1b shows a PAP device 4000 in use on a
patient with a nasal mask type of patient interface;
Fig. 1c shows a PAP device in use on a patient
with a full-face mask type of patient interface;
4.2 THERAPY
4.2.1 Respiratory system
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;
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
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;
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;
Fig. 2e is a further side view of a head. The
approximate locations of the Frankfort horizontal and
nasolabial angle are indicated;
Fig. 2f shows a base view of a nose;
Fig. 2g shows a side view of the superficial
features of a nose;
Fig. 2h shows subcutaneal structures of the nose,
including lateral cartilage, septum cartilage, greater alar
cartilage, lesser alar cartilage and fibrofatty tissue;
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;
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;
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;
4.3 PAP DEVICE
Fig. 3 shows an example PAP device suitable for
implementation with examples of the present technology;
4.4 PATIENT INTERFACE
Fig. 4, 5 and 6 show a patient using an example
under the nose patient interface of the present technology;
Fig. 7 is a patient side or proximate view of the
cushion of the patient interface of Fig. 4;
Fig. 8 and 9 are cross sectional views of the
patient interface of Fig. 4, particularly showing the nasal
region of the patient interface of Fig. 7;
Fig. 10 illustrates facial contact regions of an
under the nose mask for some examples of the present
technology;
Fig. 11 shows an example frame, cushion support
clip and cushion components in some forms of a patient
interface of the present technology;
Fig. 12 is an illustration of the example frame
component of Fig. 11;
Fig. 13 is an illustration of the example cushion
support clip component of Fig. 11;
Fig. 14 is an illustration of another example
cushion support clip component;
Figs. 15, 16 and 17 show cross sectional views
of different cushion support regions for the cushion
support clip component;
Fig. 18 is a further illustration of another
example cushion support clip of the present technology;
Fig. 19 illustrations and example force profile
that may be achieved with some examples of the present
technology;
Figs. 20 and 21 show perspective views of a
cushion support clip component coupled with a frame
component;
Figs. 22 and 23 illustrate a side view and a
perspective view, respectively, of a cushion coupled to a
cushion support clip;
Fig. 24 illustrates an example flat contact
surface cushion suitable for implementation with some
embodiments of the present technology; the figure also
includes a callout showing a cross-sectional view of the
cushion. Notably, because of the square profile, the
surfaces for contacting the underlying supporting surface
and the patient’s face are both flat);
Fig. 25 illustrates an example curved surface
cushion suitable for implementation with some embodiments
of the present technology; the figure also includes a
callout showing a cross-sectional view of the cushion. The
flat surface of the cushion is for contacting the
underlying supporting surface and not the patient’s face;
Figs. 26 and 27 illustrate the assembly of the
cushions of Figs. 24 and 25 respectively with a frame;
Fig. 28 illustrates a scalloped nasal region of
a cushion in some examples of the present technology;
Fig. 29 illustrates a cushion having left and
right nasal support protrusions;
Figs. 30 and 31 show plan and side views
respectively of the cushion of Fig. 29 in a under-the-nose
mask assembly of the present technology;
Figs. 32A and 32B illustrate a clip and frame
connector for some examples of the present technology;
Figs. 33A and 33B illustrate another clip and
frame connector for some examples of the present
technology;
Figs. 34 illustrates a still further clip and
frame connector for some examples of the present
technology; and
Figs. 35A and 35B illustrate yet another clip and
frame connector for some examples of the present
technology.
Figs. 36 and 37 illustrate a foam mask, with
headgear, configured for sealing with the mouth and over
the nasal bridge.
Fig. 38 is another view of the foam mask of Fig.
36 without the headgear.
Fig. 39 is an illustration of separated
components of a foam cushion assembly such as for the foam
mask of Fig. 38.
Fig. 40 shows the foam cushion assembly with the
coupled components of Fig. 39.
Fig. 41 illustrates mask sealing with a foam
cushion in a nasal region with the mask of Fig. 39.
Fig. 42 shows regions of a clip component of the
mask of Fig. 39.
Figs. 43, 44 and 45 are cross sectional views a
portion of a foam cushion in some embodiments of the present
technology such as for a nasal bridge region, a side of
nose region and side of mouth region.
Fig. 46 illustrates several example cross
sectional geometries for a foam cushion of any of the foam
cushion patient interface embodiments of the present
technology.
Fig. 47 illustrates foam cushion and clip
components, as separate components, as well as in an
assembled configuration of the present technology.
Fig. 48 is a cross sectional view of a cushion
assembly in some versions of the present technology having
multiple clip components and a foam cushion.
Fig. 49 shows various regions of a flexible clip
component for a foam cushion mask.
Fig. 50 shows the clip component of Fig. 49 with
an optional foam location ridge.
Figs. 51, 52, 53 and 54 illustrate various cross
sectional geometries for various regions of the clip
component of Fig. 49 such as for a nasal bridge region, a
side of nose region, side of mouth region and a bottom of
mouth region.
Figs. 55 and 56 are cross sectional views of
several example cushion assemblies coupled with a mask
frame.
Fig. 57 illustrates several example retention
elements for coupling a foam mask cushion assembly with a
mask frame.
Fig. 58A is a side view of a cushion and clip
assembly in some versions of the present technology.
Fig. 58B is a cross sectional view of the cushion
assembly of Fig. 58A.
Fig. 59 is a cross section view of a mask and
foam cushion assembly in some versions of the present
technology.
Fig. 60 is a cross sectional view of a flexible
shell for a foam mask assembly.
Fig. 61 is an exploded view of components of a
foam mask assembly with the shell of Fig. 60.
Fig. 62 illustrates the foam mask assembly of
Fig. 61 on person.
Figs. 63A and 63B illustrate assembly of a foam
cushion and clip in some examples of the present
technology.
Figs. 64, 65, 66A and 66B illustrate assembly of
a foam cushion and mask frame with various clips.
Figs. 67 and 68 show a foam cushion and clip
assembly with some versions of the present technology.
Fig. 69 is an illustration of a foam cushion
suitable for some embodiments of the present technology;
Figs. 70, 71, 72 and 74 illustrate cross
sectional geometries of an example clip such as for the
foam cushion of Fig. 69.
Fig. 73 is a side view of a further example clip
assembly for a foam cushion.
Fig. 76 is a cross sectional view of portions of
a foam cushion mask assembly.
Fig. 77 is a perspective view of an example foam
cushion mask assembly of the present technology.
Fig. 78 is a bottom side view of the foam cushion
mask assembly of Fig. 77.
Fig. 79 is a perspective view of a mask frame
component of the foam cushion mask assembly of Fig. 77.
Fig. 80 is a perspective view of a cushion
assembly of the foam cushion mask assembly of Fig. 77.
Fig. 81 is a bottom side view illustrating
assembly of the mask frame component and cushion assembly
of Figs. 79 and 80.
Fig. 82 is a cross sectional view of portions of
a foam cushion mask assembly.
Fig. 83 illustrates various performance regions
of a foam cushion of the present technology.
Fig. 84 is a side view of a foam cushion assembly
illustrating a pivot point.
Fig. 85 illustrates cushion pressure performance
of example foam cushion assemblies of the present
technology.
Fig. 86 illustrates cushion roll-in performance
of example foam cushion assemblies of the present
technology.
DETAILED DESCRIPTION OF THE INVENTION
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.
.1 TREATMENT SYSTEMS
In one form, the present technology comprises
apparatus for treating a respiratory disorder. The
apparatus may include a flow generator or blower for
supplying pressurised respiratory gas, such as air, to the
patient 1000 via an air delivery conduit, such as a tube,
leading to a patient interface 3000.
.2 THERAPY
In one form, the present technology may involve
a method for treating a respiratory disorder by applying
positive pressure to the entrance of the airways of a
patient 1000.
.2.1 CPAP for OSA
In one example, the present technology may
involve a method of treating Obstructive Sleep Apnea in a
patient by applying continuous positive airway pressure to
the patient with a patient interface described herein.
Other positive pressure treatment therapies may also be
provided (e.g., bi-level CPAP, etc.)
.3 PAP DEVICE 4000
An example PAP device 4000 in accordance with one
aspect of the present technology may include mechanical and
pneumatic components 4100, electrical components 4200 and
is programmed to execute one or more control methodologies
or algorithms, such as to control providing the continuous
positive airway pressure or any one or more of the positive
pressure treatment therapies. The PAP device may include
an external housing 4010, which may be formed in two parts,
an upper portion 4012 of the external housing 4010, and a
lower portion 4014 of the external housing 4010. In
alternative forms, the external housing 4010 may include
one or more panel(s) 4015. The PAP device 4000 may include
a chassis 4016 that supports one or more internal
components of the PAP device 4000. In one form a pneumatic
block 4020 is supported by, or formed as part of the chassis
4016. The PAP device 4000 may include a handle 4018.
The pneumatic path of the PAP device 4000 may
include an inlet air filter 4112, an inlet muffler 4122, a
controllable source 4140 of air at positive pressure
(preferably a blower 4142), and an outlet muffler 4124. One
or more pressure sensors 4272 and flow sensors 4274 may be
included in the pneumatic path.
An example pneumatic block 4020 may include a
portion of the pneumatic path that is located within the
external housing 4010.
The PAP device 4000 may have an electrical power
supply 4210, one or more input devices 4220, a processor,
a pressure device controller, one or more protection
circuits, memory, transducers, data communication
interface and one or more output devices. Electrical
components 4200 may be mounted on a single Printed Circuit
Board Assembly (PCBA) 4202. In an alternative form, the PAP
device 4000 may include more than one PCBA 4202.
The processor of the PAP device 4000 may be
programmed to execute a series of algorithm modules in use,
preferably including pre-processing transducer signals
module, a therapy engine module 4320, a pressure control
module, and further preferably a fault condition module.
.4 PATIENT INTERFACE 3000
.4.0 FEATURES
A patient interface 3000 in any versions of the
present technology may typically include optional features
such as a seal forming structure 3100, a plenum chamber
3200, positioning and stabilizing structure 3300, vent
3400, decoupling structure 3510, connection port 3600,
forehead support 3700, anti-asphyxia valve 3800 and/or one
or more ports 3900. Such features may be considered in
reference at least to the examples of Figs. 4 and 36.
.4.0.1 Seal-forming structure 3100
In one form of the present technology, a seal-
forming structure 3100 provides a sealing-forming surface,
and may additionally provide a cushioning function.
A seal-forming structure 3100 in accordance with
the present technology may be constructed from a soft,
flexible, resilient material such as silicone or other
materials and structures described throughout this
specification.
In one form, the seal-forming structure 3100 may
include a sealing flange and may further include a support
flange. The sealing flange may be a relatively thin member
with a thickness of less than about 1mm, for example about
0.25mm to about 0.45mm, that extends around the perimeter
of the plenum chamber 3200. Support flange may be
relatively thicker than the sealing flange. The support
flange can be disposed between the sealing flange and the
marginal edge of the plenum chamber 3200, and extends at
least part of the way around the perimeter. The support
flange is or includes a spring-like element and functions
to support the sealing flange from buckling in use. In use
the sealing flange can readily respond to system pressure
in the plenum chamber 3200 acting on its underside to urge
it into tight sealing engagement with the face.
In one form the seal-forming portion of the non-
invasive patient interface 3000 comprises a pair of nasal
puffs, or nasal pillows, each nasal puff or nasal pillow
being constructed and arranged to form a seal with a
respective naris of the nose of a patient.
Nasal pillows in accordance with an aspect of the
present technology may include: a frusto-cone, at least a
portion of which forms a seal on an underside of the
patient's nose; a stalk, a flexible region on the underside
of the cone and connecting the cone to the stalk. In
addition, the structure to which the nasal pillow of the
present technology is connected includes a flexible region
adjacent the base of the stalk. The flexible regions can
act in concert to facilitate a universal joint structure
that is accommodating of relative movement- both
displacement and angular- of the frusto-cone and the
structure to which the nasal pillow is connected. For
example, the frusto-cone may be axially displaced towards
the structure to which the stalk is connected.
In one form of a non-invasive patient interface
3000, a seal-forming portion forms a seal in use on an
upper lip region (that is, the lip superior) of the
patient's face.
In one form the non-invasive patient interface 3000
comprises a seal-forming portion that forms a seal in use
on a chin-region of the patient's face.
Additional features of the seal-forming structure
may be further considered in reference to the additional
details of this specification.
.4.0.2 Plenum chamber 3200
Preferably the plenum chamber 3200 has a perimeter
that is shaped to be complementary to a 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. Preferably
the seal-forming structure 3100 extends in use about the
entire perimeter of the plenum chamber 3200.
.4.0.3 Positioning and stabilising structure 3300
Preferably 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.
.4.0.4 Vent 3400
In one form, the patient interface 3000 includes a
vent 3400 constructed and arranged to allow for the washout
of exhaled carbon dioxide.
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.
Preferably the vent 3400 is located in the plenum
chamber 3200. Alternatively, the vent 3400 is located in a
decoupling structure 3510, e.g. a swivel.
.4.0.5 Decoupling structure(s) 3510
In one form the patient interface 3000 includes at
least one decoupling structure 3510, for example a swivel
or a ball and socket.
.4.0.6 Connection port 3600
Connection port 3600 allows for connection to the
air circuit 4170.
.4.0.7 Forehead support 3700
In one form, the patient interface 3000 includes a
forehead support 3700.
.4.0.8 Anti-asphyxia valve 3800
In one form, the patient interface 3000 includes
an anti-asphyxia valve 3800.
.4.0.9 Ports 3900
In one form of the present technology, a patient
interface 3000 may optionally include one or more ports
that allow access to the volume within the plenum chamber
3200. In one form this allows a clinician to supply
supplemental oxygen. In one form this allows for the direct
measurement of a property of gases within the plenum
chamber 3200, such as the pressure.
.4.1 Sub Nasal Sealing
A non-invasive patient interface 3000 in
accordance with one example of the present technology may
be considered with reference to Figs. 4-7. The patient
interface may include any of the following features: a
seal-forming structure 3100, such as a cushion 3110, a
plenum chamber 3200, a positioning and stabilising
structure 3300, such as one or more headgear vectors, and
a connection port 3600 for connection to an air/gas circuit
4170. In some forms, one or more such features may be
provided by one or more physical components. In some forms,
one physical component may provide one or more functional
features. In use, the seal-forming structure 3100 may be
arranged to be in direct contact with the patient's skin
and surround an entrance to the airways of the patient so
as to facilitate the supply of air at positive pressure to
the airways.
For example, as shown in Figs. 4-7, the patient
interface may be configured as a mask to provide a sealed
interface with the mouth and nares of a patient so as to
direct a breathable gas under pressure to both the mouth
and nares. Such a mask may be configured to be a
substantially under-the-nose mask. As illustrated, the
plenum chamber 3200 may be formed by a frame 3500 and
cushion 3110. The cushion 3110 may also serve as the seal
forming structure 3100. The frame may be adapted for
coupling with a respiratory treatment apparatus so as to
permit communication of a pressurized gas to a respiratory
system of a patient from the respiratory treatment
apparatus. The cushion may then be adapted to couple with
the frame.
In some cases, as illustrated in the
cushion may form a seal with a substantially under nose
seal portion UNSP and a mouth seal portion MSP. Such a
configuration may be considered in reference to the
illustration of Fig. 10. The under nose seal portion may
be formed by a sub-nasal ridge 3131 that forms a semi-
peripheral sealing boundary about both nares of the
patient. In this regard, such a seal may be achieved with
both nares and the mouth while in some cases avoiding a
seal portion or other mask contact structure at a central
region of the lip superior LS. Such a mask may provide a
more open and comfortable feel for users such as when
compared to mouth masks that may be combined with nasal
prongs, while still providing an effective seal.
Obtaining a seal with a single cushion that seals
both over the mouth and under the nares of the nose can be
difficult to achieve with a nasal cradle design that uses
standard silicone cushion materials. It has been
discovered that the anthropometrical variations of facial
features are large. Some materials, such as standard
silicone, may have insufficient flex to achieve both seal
and comfort, especially with respect to the intricate
facial features surrounding the nose and the mouth.
In some cases, this problem may be overcome by
an implementation of foam, such as a semi-open (or semi
closed) cell foam. In some examples, the cushion may be a
foamed silicone material or a polyurethane foam, etc. In
some cases, a very low durometer thermoplastic elastomers
(TPE), thermoplastic polyurethane (TPU), thermoplastic
polyurethane (TPV), silicone or rubber material might be
implemented. The compliant nature of foam allows it to,
under relatively small tension force, compress into
intricate facial features and affect a good seal. This,
combined with the easy adaptability and softness
experienced by the patient, provides for a relative fast
and easy mask set-up. The porosity of the foam also
exhibits better breathability than silicone and may permit
wicking away of moisture from the face. Thus, the use of
foam may be associated with better cooling and reduced
discomfort in the areas of contact or sealing.
In some cases, the cushion and/or frame may
define a single chamber, such as the plenum chamber 3200
that is illustrated in which covers the patient's
mouth and the nares of the nose from underneath. As
discussed in more detail herein, the cushion may have a
substantially oval and/or triangular shape. The sealing
surface may continuously extend substantially in two plains
– one plane that allows it to seal with the mouth and a
second plane that facilitates the seal under the patient's
nostrils. The second plane may form an angle with respect
to the first plane. The angle may be approximately close
to ninety degrees or approximately perpendicular, but may
be slightly larger or slightly smaller. Such an angle may
approximate the nasolabial angle. Such a single chamber
foam cushion may be designed to attach to a frame directly
or by way of a clip as discussed in more detail herein.
The seal around the mouth and the nares of such
a mask can be produced through the interaction between the
patient's face and the combined reaction of the assembly
(e.g., frame, flexible clip, and/or cushion) and subject
to tension from headgear. The structures of the components
when assembled can work together to provide variable
amounts of compression around the nose and mouth so that
an effective seal is produced in these areas.
Figs. 8 and 9 show a cross sectional view of a
sub-nasal region of a portion of the seal including an
example sub-nasal ridge 3131. The figures illustrate a
mechanism for achieving the seal in the sub-nasal region.
When the nose is applied onto the cushion (e.g.,
foam) in the region of the sub-nasal ridge, the headgear
may be tightened. The headgear vectors help to enforce a
seal at the periphery of both of the nares through the
combination of the cushion (e.g., foam) and/or the cushion
support structure 8800 (e.g., clip 3535) rolling inwards
(illustrated by arrows RR in Fig. 9) and closing around the
periphery of the nares. The flexibility of the combination
of cushion and/or cushion support structure can enable the
cushion to align to the alar angle and to the Nasolabial
angle of the nose. As the headgear vectors are further
tightened, a greater sealing force can be applied to the
periphery of the nares. The reaction force in the cushion
and the cushion support (e.g., clip and/or frame), caused
by the rolling and compression of them, result in a reaction
vector that radiates (approximately perpendicularly) from
the frame support back towards the patient. Moreover, the
generated gas pressure (e.g., from a flow generator coupled
to the mask assembly) that accumulates inside the mask
plenum chamber can push the cushion (e.g., foam) outwards.
This can ensure an opening up of the air passage to the
nostrils and may also compress the cushion upwardly
(towards the patient's sub-nasal region), thus generating
sealing pressure around the nares.
In some cases, there may be a potential for
occlusion of the nares by some cushions during set-up or
use. When the seal around the nares is associated with the
compression of some foams, it can lead to nasal occlusion
occurring at mask set-up before pressure is applied to the
mask. In order to minimize the potential for occlusion, a
balance can be attained between the foam thickness, the
foam profile around the periphery of the nares and
cantilever spring characteristics of the support structure
(e.g., clip if used).
In the case of implementation of foam, a thin
foam section, such as in the nasal region may be suitable.
For example, a foam thickness of about 8 to 20 mm (e.g.,
13mm) may noticeably improve/prevent set-up occlusion. In
some cases, the foam internal profile may be aligned and/or
shaped to match the nares opening such as at their
periphery. A soft elastic material (such as silicone, TPE,
TPU etc.) may be implemented as a material such as for the
cushion support. Such a material can be configured to pass
on a light cantilever spring affect onto the nose.
During a pressure treatment, such as a CPAP
treatment, occlusion may be avoided at the nares. The
internal profile (as illustrated in Fig. 9) of the foam
cushion can provide relief around the nares. Generally,
the foam may be compressed around the periphery of the
nares by the internal CPAP pressure inflating the nostrils.
In order to achieve a suitable and comfortable seal, the
foam rigidity should be no greater than the reaction force
generated by the internal CPAP pressure inflating the
nostrils. This situation can hold the nares open during
CPAP and no occlusion will result.
The cantilever spring force of the cushion
support (e.g., clip and/or frame) can be soft enough to
allow the nose to press into the foam cushion at set ‐up
without occluding the nares. Conversely, the spring force
of the cushion support can provide enough reaction force
to press the foam cushion into all the sealing zones of the
mask. This may be significant for areas such as at the
corners of the nose.
Example components for a mask assembly of the
present technology are further illustrated in Figs. 11
through 23. In some cases, as shown in Fig. 11, the frame
3500 may be a separable component from the clip 3535 and
the cushion. As seen in Fig. 12, the frame may include a
set of fasteners 3537. The fasteners may be employed for
connection of head gear (not shown) to position and support
the mask assembly for use. The frame may also optionally,
include a vent 3400. In one form, the vent 3400 may be
constructed and arranged to allow for the washout of
exhaled carbon dioxide. The vent 3400 may be formed by 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. The vent 3400 may be located in the plenum chamber
3200. Alternatively, the vent 3400 may be located in a
decoupling structure, e.g. a swivel or other coupler.
The frame may typically include a connection port
3600. The connection port 3600 allows for connection to
an air circuit 4170, such as for a connection with a
respiratory treatment apparatus or flow generator. Such a
connection to an air circuit may be by way of a decoupling
structure as previously mentioned. In some cases, the
patient interface 3000 may include an anti-asphyxia valve
(not shown). Optionally, the frame may include one or more
additional ports. Such additional ports may permit access
to the volume within the plenum chamber 3200. For example,
such a port may permit introduction of a supply of
supplemental oxygen. Such a port may also serve as a coupler
or housing for a sensor for direct measurement of a property
of the gases within the plenum chamber 3200, such as
pressure.
The frame may contain a flange 3515 around its
rear (patient proximate side) periphery such as the one
illustrated in . This flange may vary in angle and
width around the periphery of the plenum chamber in order
to follow the curvature of the sections of the face where
a seal is to take place. The flange may extend generally
parallel to those areas near where the seal is to exist on
the patient's face. A varying angled flange can work
together with the headgear vectors to impart a desired
amount of cushion compression to the varying parts around
the mouth and the nares to achieve a comfortable and
effective seal.
In some cases, the mask assembly may employ a
clip 3535 as illustrated in Fig. 13 or Fig. 14. The clip
may be releasably attachable with the frame so as to permit
a convenient replacement of the cushion that may be applied
to the clip. In this regard, Figs. 20 and 21 illustrate
the clip (without a cushion) coupled to the frame. However,
any one or more of the features of the clip described herein
may optionally be integrated with the structure of the
frame itself and the cushion applied thereto.
In some cases, the clip's profile can assist in
imparting form to the cushion so as to configure the cushion
into its multi-dimensional shape (e.g., multi-plane)
suitable for conforming to the person's face so as to form
a good seal in an under-the-nose configuration. In this
regard, as seen in Fig. 13 and 14, the clip may be formed
with a bend or angled region ABR. The angled region ABR
permits an angle between a nasal plateau region NPR and a
mouth periphery region PR. An approximately nasolabial
angle ANA may be formed by a plane of the mouth periphery
region and a plane of the nasal plateau region. When the
cushion is applied to the clip (and/or frame) such as shown
in Figs. 22 and 23, the characteristics of these regions
may be imparted to the cushion in the case that the cushion
is not already formed with such regions.
Alternatively, a 2D flat clip may be used. In
this case the 3D shape is imparted to the flexible clip /
cushion combination by attachment onto a 3-D shaped frame.
Generally, the clip may be permanently coupled
to the frame or include connectors 3536, such as those
illustrated in FIGs. 13, 22 and 23 to facilitate its
removable coupling with the frame. These elements may be
formed around one side (e.g., the lower periphery or distal
side) of the clip where it interfaces with the frame.
Additional examples of such connection elements are
explained in more detail herein with reference to Figs. 32-
. The clip's opposing side (e.g., upper peripheral
surface or patient proximate side) provides a connection
or landing surface for attachment of the cushion (e.g., the
foam ring). In this regard, the features of the clip may
serve as a suspension for the cushion.
As the wall thickness of the clip is relatively
small (i.e. few millimeters) the clip's body may generally
be approximated with a curved surface. The cross-sectional
profile of the clip around the clip's periphery may differ
in different sections of the clip so as to provide different
regions of flexibility/rigidness to the cushion. Examples
may be considered with reference to the cross sectional
views of Figs. 15, 16 and 17. For example, the clip may
be formed so as to have an open or concave wall 3535W with
a cross-section along the clip's periphery that may vary
in geometric shape. These cross-sectional shapes may be,
for example, formed as a U-shape such as that shown in Fig.
, an L-shape such as that shown in Fig. 16, or a C-shape
such as that shown in Fig. 17. Other examples may include
I-shape or Z-shape cross sectional configurations. In some
cases it may be formed with some or all of these wall
formations. The opening of each shape (shown in Figs. 13,
, 16 and 17 with reference character SO) can be directed
inwardly towards the center or plenum chamber of the mask.
These different wall structures may have different
flexibility characteristics. Such cross-sectional
shape(s) can enable the clip to act as a spring or
cantilever-type spring. Such a spring configuration can
permit the foam cushion to further conform to the face and
compress towards it once alignment has been achieved,
improving cushion compliance to the face.
Accordingly, the clip (or frame) may be formed
with a flexible peripheral lip that variably supports the
foam cushion. Pressure within the plenum chamber formed
between the mask frame, clip, cushion and the face of the
patient, acts on the inside of the clip section (e.g., the
shape opening SO of the wall) and cushion and pushes the
peripheral lip and the cushion towards the patient’s face,
thereby reinforcing the seal created by the cushion. As
pressure increases, so does the force creating the seal.
As such, the wall of the clip may also be chosen to have
thickness and flexibility to allow the air pressure to
create an air spring effect, further contributing to the
compliance of the seal.
As previously mentioned, the wall geometry around
the periphery of the clip may vary in order to alter the
stiffness or flexibility around the nose and mouth sealing
regions. Different stiffness/rigidity may be achieved in
these different sections of the face to achieve a balance
between good seal, comfort and stability. For example,
around the nose, a softer seal can be achieved as the nose
is sensitive to pressure, whereas the sides of the mouth
can withstand larger sealing pressures without discomfort.
Thus, the flexibility of the clip (or frame) may impart
these different flexibility characteristics.
In some such examples, support for the cushion
in the nasal sealing area may be formed as the flexible
cross-section "U" geometry illustrated in Fig. 15. The
clip wall (concave wall 3535W) may then have a cushion
support surface 3538 and a frame coupling surface 3539 for
a connector as discussed herein. In some cases, support
for the cushion in the sealing area at the sides of the
mouth may be formed by a flexible wall having a cross
sectional shape resembling an "L" geometry as illustrated
in Fig. 16. Moreover, support for the cushion in the
sealing areal at the lower part of the mouth, may be formed
by a flexible wall having a cross sectional shape
resembling the "C" geometry as shown below in Fig. 17.
Similarly, with respect to at least the example
clip shown in Figs. 14, 18 and 19, two active portions of
the clip's structure are the peripheral lip 3540 that form
an effective cantilever over-hang portion and a middle
transverse portion 3541 of the clip's periphery between the
frame coupling surface 3539 and the cushion support surface
3538. Both of these components can act as springs and
provide a sealing reaction force through their deformation.
Distribution of the clip-contributed sealing force around
the mouth may be governed by the clip's material and
geometry. Moreover, the force may be controlled by the
user depending on the amount of tightening of the headgear
of the mask.
In this regard, the combination of a foam cushion
and the flexible support structure of the clip can provide
reasonable results. However, for achieving optimal seal
comfort, the flexible clip may be provided with an
oversized peripheral lip that increases the support of a
foam cushion width that may be larger than the support
surface of the peripheral lip. Such variations in the
width of the peripheral lip can produce different reaction
forces around the periphery of the mouth cushion. Beam and
bending principles may show that, in isolation, a shorter
peripheral lip will produce a stiffer mechanical system as
there will be less clip deflection for a certain unit force
than there will be for a longer peripheral lip.
Such a clip may be considered with reference to
the cushion support structures of Figs. 14, 18 and 19.
Sizing of the width (shown in Fig. 18 as arrow LW) of the
peripheral lip also allows for introducing variations in
the seal geometry. For example, different (e.g., narrower)
widths in the peripheral lip area proximate to the nose and
mouth may help to achieve different reaction sealing forces
in these areas. As illustrated in Fig. 18, the profile for
the clip's peripheral lip may be changed to that shown by
the dashed line. The resulting clip is illustrated in Fig.
19. As illustrated, a shorter lip width (shown at arrow
SLW) may be provided at the peak of the nasal plateau region
for less flexibility. A relatively longer lip width (shown
as arrows LL) may be provided proximate the centrally open
lip superior region COLS for more flexibility. As shown
in Fig. 19, the reaction force of such a clip can vary
around the periphery as a result of such changing widths
of the peripheral lip or cantilever arm. In some such
cases, the width of the cushion may be similarly varied.
However, the width of the cushion may be relatively
constant despite the change in support structure width
around its periphery such as shown in Fig. 23. In this
sense, the foam's geometry profile may not follow the
clip's geometry exactly. As a result, the final force
profile of the mask can be affected by the combination of
the clip and the compressing foam.
Adjustments to flexibility around the sealing
periphery may also be achieved by varying the thickness of
the lip. For example, a lip thickness value along the
sides of the mouth toward the nasal peak portion may be
approximately double that of the thickness along the bottom
of the mouth. Such a ratio can provide less flexibility
in the nasal region and relatively more flexibility in the
lip inferior region. In one such example, and depending
on the clip materials, peripheral lip thickness may be in
a range of about 1.5mm to 2.5 mm, such as about a 2.2mm
(+/-0.1mm) relatively constant thickness from the region
proximate to the sides of the mouth to the nasal peak
region. The region of the peripheral lip proximate to the
lip inferior (around the bottom of the mouth) may be in the
range of about 0.75mm to 1.25mm, such as about a relatively
constant 1.0mm (+/- 0.1mm) thickness.
Generally, the body depth (illustrated in Fig.
14 as arrow BD) may be relatively constant about the
periphery of the clip. In the example of Fig. 14, 18 and
19, the body depth of the clip (that portion that does not
connect to the cushion or the frame) may be in a range, for
example, from about 8mm to 15mm or for example a depth in
a range of about 11mm to 13mm.
In some cases, additional features may be formed
with or applied to the cushion support structure to further
affect the performance of the seal, such as flexible nasal
protrusions. Such an example is illustrated with respect
to the clip of Fig. 13, which is also shown applied to a
frame in Figs. 20 and 21. In the example of Fig. 13, the
clip also contains extra cantilever protrusions 3561 that
may further serve as cantilever springs. With these
elements, the clip can press the foam into hard-to-seal
areas such as the corners of the nose, effectively
providing a variable level of cushion compliance.
As previously mentioned, the cushion support
(clip or frame), or portions thereof, may be molded from
different grades of thermoplastic elastomers TPE. Grades
of different hardness may be used. Generally, a TPE
material may be more beneficial to silicone as it may be
more easily molded onto some cushions (e.g., foam) and its
processing time may be faster than silicone. However,
other elastic or flexible materials may be used such as
thermoplastic polyurethane (TPU), thermoplastic
polyurethane TPV or rubber, etc. By way of further
example, in some cases, the flexible support structure
(e.g., clip) may be formed with silicone, such as a room
temperature vulcanizing RTV silicone.
As mentioned previously, because of their
flexible nature, the cushion and cushion support structure
(e.g., clip) work in unison to respond to the compression
force imparted to the frame by the headgear vectors.
However, the cushion, such as when foam is used, may play
a greater part in conforming to the face of the user purely
because it is the softer component and therefore may
compress more. Eventually, when the headgear tension has
been applied and the frame is pulled towards the patient's
face, the foam and flexible support structure will reach
an equilibrium shape, in which a seal is created.
Example cushions for the mask assemblies of the
present technology are illustrated in Figs. 24 and 25. The
cushions may be foam and form a triangular or oval shaped
ring and may have a common nasal and mouth aperture. The
corners may be rounded. In the example of Fig. 24, the
cushion has a generally flat patient contact surface PCS.
In some such cases, the edges may be rounded. For example,
as illustrated in Fig. 25, the cushion profile along is
periphery may have a generally curved patient contact
surface PCS. Other cushion profiles may also be
implemented. The frame or clip contact side of the cushion
may be generally flat or otherwise conform to the contact
surface of the cushion support structure.
With these example generally uni-planar
cushions, when connected to the clip or frame as
illustrated in Figs. 26 and 27, the cushion may deform to
a multi-planar shape as previously discussed that is better
for sealing. The triangular shape, when so deformed,
enables the cushion to produce its seal around the outer
periphery of a portion of the nares, into the corners of
the nose and around the side and the bottom of the mouth
while maintaining a substantially under-the-nose
configuration and providing for a centrally open lip
superior region. Thus, the mask may have a substantially
non-contact area in the central lip superior region between
the upper vermillion and the columella in the sub-nasal
region. Moreover, this non-contact region may be within
the plenum chamber during use.
While the cushions of Figs. 26 and 27 are
generally uni-planar and are deformed by the frame or clip
to have their multi-planar use configuration (e.g., with
an nasolabial angle between the nasal plateau region and
the mouth periphery region), in some cases the cushion or
foam may be pre-formed or pre-cut in the multi-planar shape
consistent with the shape of the clip or frame.
Generally, there should be an air tight seal
between cushion and its support structure (e.g., the clip).
Various methods may be employed to implement such a joining
of the cushion. For example, the cushion may be adhered
to the support structure such as with glue, spray adhesives
or hotmelts, etc. In some cases, it may be adhered by
ultrasonic welding. In some cases, the cushion may be sewn
and adhered. The join may also be implemented with an
intermediary material such as a tape (e.g., a double sided
adhesive tape). In some cases, the support structure
(e.g., clip) may be over molded to the cushion.
Similarly, such methods may be employed for
joining the cushion to the frame, such as without an
interfacing clip. In this regard, the frame may provide
the shape forming structure and surface to hold the cushion
(e.g., foam) in the desired profile for patient sealing.
In such an embodiment, the cushion foam may provide some
or all of the necessary spring and softness to effect the
seal and provide comfort to the patient. Otherwise, some
of the previously described flexible features (e.g.,
cantilever components of the clip) may be formed with the
frame to assist with the seal and comfort effectiveness.
In some such clip-free cases, some of the flexible
properties of the clip may be imparted to the foam by using
a secondary layer of cushion rather than the clip. Such a
secondary cushion layer may be applied to the patient
contact foam layer and may have different
flexibility/rigidity properties when compared to the first
foam layer. In such a case, the second layer of the dual
cushion may be applied directly to the frame without the
clip.
In some cases the foam cushion may be a
replaceable item (in some embodiments the replaceable item
may include the cushion/clip combination). The cushion may
be directly attached to the frame through an adhesive
membrane located on the foam (or on a surface of the
respective clip (either flexible or rigid). In such a
case, the cushion may be simply removed, and a different
cushion, with a new adhesive strip, may then be attached
to the reusable frame (or reusable clip). In some cases,
the foam cushion and frame may be co-molded. In some such
cases, the cushion and frame unit may then be discarded
together.
In some examples, the cushion 3110 may include
additional features. For example, as shown in Fig. 28, the
cushion may include an indent, such as a scalloped notch
3763, such as in the nasal plateau region of the cushion
as an alternative to being a generally flat sealing
surface. The indent may be formed by a semi-peripheral cut
of an edge of the cushion in the nasal portion of the seal.
In some examples, the cut may form a rising edge from a
centrally lower position to a radially higher position.
Such a semi-peripheral area may provide a cupping support
around the nose. The cupping geometry may provide a greater
surface area (bearing surface). In this regard, the
scalloped edge shape feature may replicate the topography
under the user's nose. As such, the scalloped notch may
also improve sealing in the sub-nasal ridge area and may
provide improved nasal comfort. It may also serve to
minimize nose inflation. The feature may also provide a
perceptively distinct landing area for patients to place
their nose, resulting in a more intuitive set-up. In some
cases, the notched area or the nasal plateau region may be
marked to provide an indication of nasal location for user
installation. For example, the area may have a distinct
color with respect to the remaining areas of the cushion.
The shape of such a notch may be defined from any
of the following anthropometric features: width between the
labial insertions of the alar base; length of the ala;
nasal ala-slope angle; inclination of the columella; nasal
tip protrusion; width of nose. In some cases, the depth
of the indent detail may be based on any of: the inclination
of the columella; patient perception with respect to
providing sufficient indication as to where the under nose
section of the mask should be worn; sufficient surface to
seal around the edge curvature of the nose; sufficient
support around the periphery of the nose to prevent the
nose from blowing out such as due to pressure from a
pressure treatment.
Other versions of the geometry of the indent may
include a simple chamfered edge following the periphery of
the nose. When the foam has sufficient compliance for the
chamfer to fit the nose an improved seal can result.
Similarly, other variations in the overall triangular shape
of the scalloped nasal feature may be achieved since foam
has sufficient compliance to conform to facial features in
a range of sizes.
As previously mentioned, the indent, such as the
scalloped nasal detail, can effectively cup the lower
periphery of the nose and may provide additional surface
area for sealing and comfort. Thus, it may work in
conjunction with other components of the mask assembly
(clip and frame) during use to effectively serve as a seal.
In terms of sealing and depending on the specific
anthropology of the nose, the sealing interface may shift
or extend or both, from under the nose to under and/or
partially up the sides of the nose. In terms of comfort,
the force applied to the nose from the headgear and the
treatment pressure from the seal interface, may thereby be
distributed over a larger surface area, resulting in better
comfort.
The geometry of the indent in the foam cushion
can change to accommodate a range of nasal sizes. A nose
that is pressed into the scalloped detail, for example,
during set-up of the mask will displace foam until the foam
conforms to the nose. The flexible spring nature of the
cushion support structure (e.g., clip and/or frame) can
provide a resistive force at this stage to prevent the nose
from fully pushing through the foam. Under treatment
pressure, the foam can be pressed back against the nose
which helps to provide an effective seal.
In some cases, the indent may be manufactured as
part of a complete compression cutting process for the
cushion. Alternatively, the feature may be manufactured
by a secondary process such as thermoforming, ultrasonic
welding or cutting. In some cases, the whole cushion
including the scalloped nasal detail may be manufactured
from a single compression cutting or thermoforming process.
In some further examples, the cushion may also
include one or more protrusions. Such protrusion(s) may
be included on the surface of the cushion. For example,
one or more protrusions can be so disposed so that, when
the mask is fit on the patient's face, the protrusions
extend further out of the cushion into a portion of the
patient's face. As such, the protrusions may provide
additional structural support and a better seal. For
example, a set (e.g., pair) of protrusions 3764, such as
one or more approximately oval projections or of another
shape, are illustrated in the cushion and mask of Figs. 29,
and 31. These protrusions are disposed so as to extend
on the left and right sides of the nose (e.g., left and
right nasal ala protrusions). For example, each protrusion
may be configured to ply adjacent to a nasal ala of the
patient. As such, they may assist with buttressing the
cushion's seal at the difficult sealing areas on both sides
of the nose. The nasal protrusions, while useful, are
optional. An effective seal in these difficult regions may
also be achieved by other means, including increasing the
thickness and varying the shape of the foam cushion in
these areas. For example, a narrowing may be introduced
at the sides of the nasal area of the cushion to facilitate
a better seal.
As previously mentioned, the connection between
the clip and frame may be implemented with various
structures. Some examples are illustrated in Figs. 32
through 35. Generally, in the case of an implementation
of a clip, there should be an air tight seal between the
clip and the frame. The cushion/clip assembly can be
detachable from the frame so as to permit regular
replacement of the cushion in the case that the cushion may
have a shorter useful life when compared to the frame.
Some example connection structures for anchoring
the clip to the frame may include: tongue and groove
geometry; a stretchable periphery skirt to extend around
an edge of the frame; a peripheral edge that connects by
interference fit, such as one similar to air ‐tight food
containers; a tongue and slot interface with secondary lip
seal or gasket present. In some cases, the connection
structures of the clip may correspond to existing mask
frames to permit retrofitting of the cushion designs
described herein with existing mask frames.
In the connector example of Fig. 32A and 32B, the
clip and frame may be coupled together by a bulbous ridge
3572 and channel 3574. For example, the frame may be formed
with the channel and the clip may include the ridge. A
cross sectional view of the ridge and channel may appear
as a ball and socket. The soft flexible (e.g., TPE,
silicone or other flexible material) bulbous ridge may be
pressed into the rigid channel frame (e.g., plastic) to
provide a seal and mechanical retention. Optionally snap
fingers 3576 may also aid assembly and component de-
molding.
In the connector example of Fig. 33A and 33B, the
clip and frame may be coupled together by a skirt 3578 and
flange 3515 such as the flange extending continuously
around the plenum chamber of the frame 3500. In such a
case, the skirt 3578 of the clip may be a semi-rigid element
(e.g., TPE, polypropylene or other similar semi-rigid
material) continuously extending around the ring of the
clip. Plying the skirt so as to cup it over the flange may
then serve as a seal and provide mechanical retention.
In the connector example of Fig. 34, the clip and
frame may be coupled together by a snap shoulder 3580 and
engagement cavity 3582 continuously or semi-continuously
extending around the periphery of the clip and frame. Such
a snap may be formed on a rim of the clip 3535. The rim
and snap may be displaced by a more rigid frame upon
engagement, such as when the snap shoulder, which may be a
semi-rigid material (e.g., plypropylene) is plied into the
engagement cavity 3582. The surface engagement of the rim
and frame may provide a seal and the snap shoulder and
engagement cavity coupling can provide a mechanical
retention.
In the connector example of Fig. 35A and 35B, the
clip and frame may be coupled together by a taper lock
(shown in exploded view 3583). In such an example, a
peripheral rim 3702 of the frame, which may be rigid, may
be retained in a peripheral channel 3585 of the clip. A
taper element 3586 of the frame may couple with a taper
receiving channel 3587 of the clip, which may be flexible
(e.g., silicone, TPE, etc). The taper element and the
taper receiving channel may be formed so as to continuously
or semi-continuously extend around the periphery of the
clip and frame. The taper element and taper receiving
channel may then aid mechanical retention of the frame and
clip components.
.4.2 Supra Nasal Sealing
Traditional Full Face mask (also referred to as
a patient interface) obtains a seal with the user’s face
by way of a silicone cushion that seals both around the
mouth and over the bridge of the nose. The main issue with
this is that, due to the nature of the silicon material,
often comfort issues are experienced by the user (i.e.
facial markings or other skin irritations).
This problem may be overcome by the
implementation of foam such as the foam previously
discussed. In some embodiments, the foam cushion can be
in direct contact with the patient's skin. The compliant
nature of foam allows it to, under relatively small tension
force, compress into intricate facial features and affect
a good seal. This, combined with the easy adaptability and
softness experienced by the patient, provides for a
relative fast and easy mask set-up. The foam also exhibits
better breathability than silicone. Thus, the use of foam
is associated with better permeability (associated by many
users with a "different feeling on the face verses
silicone") and reduced discomfort in the areas of contact
in the sealing areas.
The comfort associated with the permeability of
the foam has to be balanced with the increased leak
associated with high permeability. As in the case of the
under nose mask configuration, the foam cushion may
generally be formed by open cell foam, in which the majority
of cells are open; by closed cell foam, in which the
majority of cells are open or by semi-open (or semi-closed)
cell foam, which is formed by a mixture of open and closed
cells. In one example, the discussed technology may use a
semi-open cell foam in which the number of open cells is
significantly higher than that of the closed cells. This
ensures limited permeability and a smaller leak through the
cushion. The specific range of permeability values having
such limited permeability and found suitable for the
disclosed technology is discussed later in the text. Other
ratios between the number of open and closed cells can also
be used. In the case of higher permeability, various
actions may have to be taken to mitigate the increased
permeability. As discussed elsewhere in the text, one such
action is extending the flexible clip or other non-
permeable membrane to cover the inner surfaces of the foam
cushion and reduce the overall permeability. It is
envisaged that open cell foams or closed cell foams may
also be used according to the discussed technology.
In order to achieve comfortable fit, a good seal
and stability, current Full Face foam masks are larger in
footprint when compared to masks with traditional silicone
seals.
In effort to achieve certain flow
characteristics, some foam cushions previously used are
either not permeable or may include a secondary layer over
the foam to stop air from passing through the foam. Both
options remove the breathability benefit of a foam seal.
Only traditional foam full face masks having sealed or non-
permeable foam cushions were compatible with current
respiratory therapy for obstructive sleep apnea (OSA).
Some prior foam masks also involve separate
individual components that together form the cushion. In
one example, a foam layer may be attached to a silicon
cushion to improve the sealing quality and the comfort
associated with the mask. In some circumstances, such
arrangements, may be large in size and less comfortable,
and may make it more difficult for the user to disassemble,
assemble and clean the mask.
In some versions of the present technology, such
as when a mask is configured for sealing with the mouth and
over the nasal bridge as shown in the example of Figs. 36
and 37, a foam cushion may be implemented.
For example, a foam cushion assembly can be
configured to seal around the mouth and over the nasal
bridge, and can achieve a comfortable and effective seal.
Such an assembly may include a foam cushion portion and a
cushion support structure (e.g., a support clip portion).
Here the expression "over the nasal bridge" should be
construed as "across" the nasal bridge and not as "above"
the nasal bridge. The support clip portion may be a flexible
(or soft) clip portion configured to complement the
compliance of the cushion so as to allow a reduction in the
size of the cushion. The foam cushion can be externally
attached to the cushion support clip. Such an external
attachment can permit the foam surface of the cushion to
be configured for direct contact with a patient's skin.
In one example, the cushion 3810, which may be
made with foam, defines a single area that peripherally
covers the patient's mouth and nose (approximately midway
up the nasal bridge, but this can vary depending on the
face anatomy of the specific patient). The foam cushion
may, for example, be made from any suitable material such
as one or more of the following example materials:
Polyethylene, Polyurethane, Ethylene vinyl acetate (EVA).
In some cases, the foam cushion may be a semi-open closed
cell foam, such as one made of polyurethane. The cushion
of semi-open cell foam may have a limited permeability such
as in the ranges described in more detail in this
specification.
The cushion 3810 may have a substantially
triangular or pear-like shape with a sealing face that
follows the contours of a user's face. The single chamber
foam cushion is designed to be attached to a first support
(e.g., flexible) clip 3812 that is itself attached to a
second, more rigid, clip 3814 (as shown in Fig. 38) or
directly to the mask frame 3816. In one embodiment, the
first support clip 3812 can be a flexible clip that is more
rigid than the foam cushion, but softer or more flexible
than the second clip 3814. It is the combination of the
foam and a flexible clip that defines the physical
properties of the overall sealing interface. The flexible
clip allows the interface to accommodate major variations,
and to successfully conform to the contours of the
patient's face. The compliant nature of the foam cushion
provides micro-adjustment and forms a comfort interface
layer that interacts with the patient's skin.
In some versions of the cushion assembly or
cushion mask may include a protrusion, or an alignment
protrusion, that may be configured, when in use, to be
depressed by a headgear strap so as to apply pressure on a
respective region of the foam cushion. For example, a
protrusion 3813 may optionally be included on the outer
surface of the first support clip 3812 (e.g., flexible
support clip) on both sides of the mouth (e.g., both
symmetrically located about the mouth), in such a manner
that a respective headgear strap may pass over each
protrusion, as shown in Fig. 37. Such an arrangement may
allow for better sealing at the sides of the mouth when
dealing with facial width variations. When tightened, the
headgear may depress the protrusion toward the patient's
face. Such a pressure will be transferred to the foam
cushion, depressing the cushion towards the patient's face
and enhancing the sealing in this region of the mouth. The
additional pressure can be modified by changing either the
height of the protrusion, the tension of the headgear or
both. A height of between 2mm and 6mm, 3mm to 5mm, and
preferably of about 4mm, is considered sufficient for such
modification. Instead of being located on the surface of
the flexible clip, the protrusion may be located on the
outer surface of the foam cushion or the rigid clip.
Protrusions of different height/thickness and located on
different components (i.e. one located on the rigid clip
and the other on the flexible clip) can also be used, e.g.
to create a gradient of inwardly directed pressure along
the side of the mask. In another embodiment, the projection
may extend across both the foam cushion and the flexible
clip. In yet a further embodiment, a flange may be formed
to extend from the frame to apply inwardly directed force
and enhance the seal in a similar manner.
In some examples, the flexible clip or even both
the flexible and the rigid clips may be omitted by directly
applying a foam-only cushion assembly to the frame. Such a
design, however, may require the cushion to be of a
substantial thickness and height. The implementation of a
clip, even of a rigid one, and especially of a flexible
clip or a combination of soft and rigid clips as described
here, allows reduction in the dimensions of the foam
cushion, without compromising on compliance, sealing and
comfort. One role of the rigid clip is to facilitate
removable attachment of the foam/clip assembly to/from the
frame for cleaning or replacement. Components of a foam
cushion assembly 3901 are shown in Fig. 39. An assembled
view of the foam cushion assembly 3901 is shown in Fig. 40.
As illustrated in Fig. 39 and 40, a frame
coupling side FCS of a rigid second clip 3814 may include
structures for removeably coupling the second clip to a
mask frame 3816. For example, a coupling ridge 4022 may
be provided to engage with a corresponding structure of the
mask frame. The coupling ridge 4022 may help to form a
seal, such as with an interference fit, to prevent escape
of treatment pressure at contact surface of the mask frame
and the second clip at the frame coupling side FCS. One or
more optional engageable snap elements 4024, may permit a
snap-fit or snap-lock of the second clip to the mask frame.
Such a snap element may be flexibly resilient so as to bend
against a corresponding receptacle of the mask frame until
a ridge stop 4025 may engage with an edge of the receptacle
or aperture of the mask frame. A taper 4027 at the top
edge of the snap element may induce the bending of the snap
element during coupling of the second clip to the mask
frame until the ridge stop 4025 passes into the receptacle
or aperture of the mask frame and thereby locks within the
receptacle or aperture of the mask frame. In some cases,
the snap element may be formed on the mask frame and a
corresponding receptacle may be formed on the second clip.
A manual bending of the snap element(s) may then permit the
removal of the second clip from the mask frame.
In one example implementation of the foam,
flexible clip and rigid clip are formed together or
permanently attached to each other, as shown in Fig. 40,
forming an integral cushion assembly. The foam and
flexible clip form the compliant portion of the assembly,
while the rigid clip provides the mechanism to attach the
cushion assembly to the mask frame. This allows the cushion
assembly to be removed for cleaning and/or replacement. A
rigid clip can enable a rigid connection between the
cushion assembly and the mask frame which makes the mask
more convenient for handling and more durable. Thus, the
components of the cushion assembly (e.g., the foam cushion,
the flexible clip and the more rigid clip) can be
permanently attached in one integral assembly. However,
alternatively they may be separable elements, as shown in
Fig. 39. These three elements may be arranged to be
separately formed, assembled together, but dissembled and
assembled again, if necessary. Alternatively, the foam
cushion and the flexible clip can be permanently attached
to each other, but detachably connected to the rigid clip.
In another example, the flexible clip and the more rigid
clip can be permanently attached to each other but
detachably connected to the foam cushion.
The mechanisms of such removable attachment may
be those known in the art and may include adhesive layers
(for attaching the foam to the flexible clip), interference
fits and snap-locking engagements. The periphery of the
more flexible components, such as the flexible clip, can
also be stretched over the periphery of the more rigid
component, such as the frame or the rigid clip.
Any combination of the three components is
possible and alternative design variants could include a
cushion assembly comprising only a foam cushion; a foam
cushion and a flexible clip or a foam cushion and a hard
clip.
In some cases, a foam cushion may itself be
formed as a slip-over foam cover component for other mask
components, assemblies or mask cushions. For example, a
foam cushion overlay may be formed as or with a stretchable
engagement skirt. The skirt or foam skirt may then be
stretched over an underlying structure defined by any mask
component, such as a frame, a clip or even a silicon
cushion. Once the foam cushion has been slipped on to fit
over an edge of an underlying component, it can serve as a
comfortable sealing layer contacting the patient's face.
As such, the slip-over foam cushion may even serve as an
easily replaceable cover component to improve comfort of
existing silicone or foam cushion masks.
.4.2.1 Sealing Mechanism
With the mask example of Figs. 36 and 37, the
foam cushion is arranged to be in direct contact with the
patient's skin. The seal around the mouth, the sides of
the nose and the nasal bridge is produced through the
interaction between the patient's face and the combined
reaction force of the frame (which may be applied to the
cushion assembly by way of the hard clip); the flexible
clip and the foam cushion, to the headgear tension. Each
of these three components is discussed in more detail
below. These components when assembled together can work
in unison to provide variable amounts of foam compression
around the nose and mouth so that an effective seal is
produced in these areas. In this regard, the illustration
of Fig. 41 shows the mechanism that is created to, through
the combination of these three components, achieve seal.
As illustrated in Fig. 41, by applying the foam
cushion onto the user's face and tightening the headgear
vectors (seen in Fig. 37) a seal is generated along the
foam's contact surface with the patient's face, such as
over the nasal bridge and around the sides of the nose and
mouth. The seal is caused by a combination of foam
compression and/or deflection and compression of the
flexible clip.
The flexibility in the combination of foam and
flexible clip can enable the foam mask to conform well to
the patient's facial profile.
As the headgear vectors are further tightened, a
greater sealing force SF will be applied.
The reaction forces in the cushion and the
flexible clip, caused by the deflection and compression of
the cushion and clip by the headgear, result in a reaction
vector that is directed from the frame support and towards
the patient.
The structure of the foam cushion and the
flexible clip is such that the treatment pressure (e.g.,
CPAP) accumulated inside the mask plenum chamber also acts
upon the inner surface of the flexible clip and the foam,
pushing them outwardly and compressing the foam against the
user's face. Thus, the arrangement utilizes further the
pressure in the plenum chamber and helps maintaining
sealing pressure. As mentioned above, because of their
flexible nature, the foam and clip work in unison to respond
to the compression force imparted to the frame by the
headgear vectors. Eventually, when the requisite headgear
tension has been applied and the frame is pulled towards
the patient's face, the foam and clip will reach an
equilibrium shape, in which a seal is created and retained.
In some examples, through its greater stiffness, the clip
may provide a reaction force that is substantially larger
than that provided by the foam cushion. The reactions
forces of both the clip and the foam cushion may vary along
their periphery.
Similarly, the compressed foam may provide
relatively small elastic reaction force in some sections
of the cushion periphery, and a larger force in other
sections.
Similar to the mask examples previously described
in this specification (e.g., sub-nasal mask), the flexible
clip may be peripherally and inwardly concave so as to have
a concave profile or inwardly concave shape. This can
allow for the pressure to act upon the inner surface of the
clip so as to enhance the sealing of the mask.
Different portions of the flexible clip can serve
different functions. For example, the spring constant
provided from the mid area of the shape (e.g., 'C') may act
as a support beam that creates the main reaction force in
response to the tension force applied by the headgear. A
peripheral lip for supporting the foam can serve as a
cantilever that presses the foam towards the patient's face
to strengthen the sealing engagement. Additionally, the
overall open (concave, C-shaped or L-shaped) structure of
the clip allows the air pressure in the mask to be applied
to the inside surface of the peripheral lip. This surface
is located opposite to the foam supporting (also sealing)
surface. Thus, the mask pressure pushes the peripheral
lip, and therefore compresses the foam cushion towards the
patient's face, thus further strengthening the sealing
engagement and potentially assisting with reducing any air
permeability of the foam. In the absence of the clip the
pressure will still be applied to the foam cushion.
However, because of the semi-open cell type of the used
foam, the applied pressure may leak through the foam. Thus,
the concave shape of the clip means that at least a portion
of the lower surface of the foam cushion 3810 is covered
by a non-permeable material of the flexible clip, as best
seen in Fig. 41. This can be used to control the leak
through the cushion and increase the pressure within the
mask plenum chamber. This concept can be taken further and
the clip can be extended to cover at least a portion of the
outer side wall of the cushion 3810, as long as it does not
get in contact with the patient's skin. On the other hand,
for various reasons, one may wish to leave some of the
surface of the foam exposed. As will be discussed later
in the text, one positive outcome of such a design may be
the fact that a portion of the foam is unsupported by the
flexible clip and, as a result, the foam may tend to "roll-
in" when the headgear is tightened. Such a roll-in effect
may be beneficial for the sealing in some areas of the
nose, for example.
.4.2.2 Foam Cushion
In the example of the cushion shown in Fig. 42,
the foam has a varying cross section from the bridge of the
nose to the bottom of the mouth, and is symmetric through
the center plane. During use, he the geometry of the foam
is affected by the anthropometric data used in the overall
design of the flexible clip as well as the specification
of the foam material (e.g., hardness, compression set,
permeability, compression stress strain, density etc.).
The cushion may be configured with a varying
cross section that can be divided into three regions, nasal
bridge MNBR, sides of nose region MSNR and sides of mouth
region MMR, with a smooth transition between each of the
regions. Each section may be configured with a profile
that is optimized for the specific area of the face with
which it seals.
The cross section of the foam is designed to take
into account of the following, and the geometry is design
to address each of the areas:
(a) Comfort
It was found with an increase in the amount of
foam (both height and width) there is an increase in overall
comfort. Depending on the specific cross section of the
first clip, the first clip becomes noticeable so as to be
felt through the foam for heights of about less than (<)
8.0 mm. (In the example of Fig. 42, the range for the height
of the foam is about 8 mm-16 mm. Similarly, the comfort
of the cushion was significantly impacted for widths less
than (<) about 12mm. For the foam of an example, the width
can be in the range of about 12mm to 30mm, and may be
desirable at about 15-20mm.
(b) Seal
It was found the seal is improved with an
increase in width for the surface of the foam that is
directly in contact with the patient.
(c) Stability
It was found the stability of the seal is
negatively impacted by an increase in the height of the
foam, whilst being positively impacted by an increase in
the width of the foam.
(d) Encroachment
The main risk of encroachment is the potential
for the cushion assembly to intrude/obstruct the user's
eyes. In some cases, the width of the foam may be reduced
in these areas of the eye.
By minimizing either one or both the height and
the width of the foam cushion in the noted ranges, one can
minimize the overall size of the mask.
.4.2.2.1 Foam Cross Sections
(a)Nasal Bridge Region MNBR – Fig. 43
In some examples a nasal bridge region of the
cushion, such as that illustrated in Fig. 43 may be
configured (in its cross section) with a trapezium shape.
This may provide good stability characteristics. The top
corners may be rounded for comfort and for a better
aesthetic appeal. For example, a width of about 12mm (or
in a range of 0-25mm) may be suitable for the surface
portion that contacts the user's nasal bridge. This may
be kept substantially higher than other regions in order
to increase the sealing surface in this region.
(b) Side of nose region MSNR – Fig. 44
In some versions, a side of the nose region of
the cushion, such as that illustrated in Fig. 44, may be
configured (in its cross section) with a trapezium shape.
This may provide stability characteristics. The top
corners may be rounded for comfort. The width of the
surface contact portion at the user's face may be about
6.35mm (in a range of about (0-14mm)) in order to avoid the
cushion intruding into the patient’s eyes.
(c) Mouth Region MMR - Fig. 45
In some versions, a mouth region of the cushion,
such as that illustrated in Fig. 45, may be configured (in
its cross section) with a trapezium shape. This may provide
good stability characteristics. The top corners may be
rounded for comfort. The width of about 9mm (within a
range of about 0-17mm) may be suitable for the surface
contact portion and may be a compromise between
comfort/seal and overall mask size.
Although these distinct regions have been
illustrated with trapezium cross sectional geometry, other
cross sectional geometries shown in Fig. 46. Such may
include; a rounded top geometry 4621-A, a straight edge
rounded top geometry 4621-B, a rectangular geometry 4621-C
and a rectangular with rounded edges geometry 4621-D. The
rounded top geometry 4621-A has a cross section with a
fully rounded top surface. This increases clearance
between the user and the foam and improves overall
stability. The rectangular geometry 4621-C has a
rectangular cross section, which may perform similarly to
the trapezium geometry, which for performance purposes is
similar to a rectangular cross section with rounded
corners. The rounded corner increases the overall comfort
of the cushion since, by removing the sharp corners, not
as much foam is compressed in these areas during use of the
mask.
In some examples of the cushion, a combination
of geometries can be implemented in a single foam cushion
within and/or between different regions. For example, the
foam may be configured with a transition of geometries
between regions. In one example, the cushion may
transition from a cross sectional geometry having a flat
top (e.g., rectangular top for comfort and a better seal)to
a round top to increase clearance around specific facial
areas.
The example cross sectional geometries shown in
Figs. 45 and 46 each have a foam height of about 12mm.
However, in some examples, the height of the foam may also
transition between and/or within regions with suitable
heights greater or lesser than 12mm. Suitable heights may
be chosen to change the performance as needed in the
individual sections of the cushion.
.4.2.2.2 Foam Manufacture
An example embodiment of the foam may be produced
by compression cutting, but it may be produced by, or with
a combination of, any of the following methods including,
die cutting, thermoforming, moulding, grinding,
compression cutting, etc. For example, the foam may be
compression cut to a flat profile as illustrated in Fig.
47. In this flat profile, the foam's shape is somewhat two
dimensional, as its shape is mainly defined in two
dimensions, but is planar in the third dimension. Once the
foam is attached to one or both of the clips (e.g.,
soft/flexible) clip, it not only changes its two-
dimensional shape, but also bends in the third plane
(dimension) and becomes truly 3-dimensional. Thus, the
clip(s) may impart contour (such as for variations to
improve facial contact) into the foam when assembled. In
the example of Fig. 47, the foam is held in a contoured
shape by the first clip. A better view of the 3-dimensional
(3D) aspect of the cushion, in an attached configuration,
is shown in Fig. 84. Also, instead of having the 3D shape
imparted on the cushion by one of the clips, the cushion
itself may be formed in a 3D shape, or such may be imparted
to any one or both of the clips and/or the cushion by the
frame.
.4.2.2.3 Assembly method
The foam can be assembled onto a clip or other
mask structure such as the soft/flexible clip by adhesive
(e.g., glue and/or tape); by flame lamination; by moulding
(e.g., moulding of foam onto the clip, or vice versa); by
welding; mechanical connection between foam and clip; by
sewing; etc. The foam may be formed or cut with a generally
flat or planar contour. Although it will have a facial
contour when used as a mask on a patient (see, e.g., facial
contours of cushions of Figs. 58A and Fig. 22.) In some
cases, the foam cushion of any of the masks described in
this specification may simply be bent or deformed to have
a facial contour that corresponds to the contour of the
clip on which it is installed. Thus, the foam may be
dependent on the clip to have a facial contour. However,
in some cases, the foam may be formed with the facial
contour such as by moulding or cutting the foam. In such
cases, the facial contour of the foam may be independent
of any clip or other structure.
.4.2.3 First flexible clip (e.g., also occasionally
referred to as a "soft" clip))
As shown in the cross-sectional view of the
cushion assembly illustrated in Fig. 48, the first
soft/flexible clip includes a cushion coupling portion
4840, a support portion 4842 and a base portion 4844. The
cushion coupling portion 4840 provides a contact surface
to which the cushion is attached. The supporting portion
4842 is flexible, but with a specific degree of rigidity
so as to provide appreciable reaction support to the
cushion when the headgear is tensioned and the mask is in
use. The base portion 4844 attaches to the rigid second
clip or, in some embodiments, to the frame. One or more
additional support portions 4842, for example having
different rigidity/flexibility characteristics, can be
included between the coupling portion 4840 and the base
portion 4844.
Again, because of the relative small thickness
of its walls (a few millimeters) the general shape of the
body of the clip is a curved concave surface with the
opening being directed inwardly towards the center of the
plenum chamber of the mask. The cross-sectional profile of
the flexible clip varies in shape, but can generally be
described as L or C, or even Z-shaped, a simple gusset, or
variations in wall section etc. The open or concave nature
of the clip allows the pressure inside the mask plenum
chamber to be applied to the cushion (illustrated by the
arrows P4 of Fig. 48) in a way that enhances the cushion-
to-patient seal. The support portion 4842 may be generally
perpendicular to the sealing plane SP-5 (for example – see
the C-shaped cross section and its respective support
portion 4842 in Fig. 56). The material properties of the
clip, the shape and the dimensions (in particular the
thickness and the height) of the support portion of the
clip can be chosen so that the flexible clip offers
appreciable support to the cushion, but at the same time
is also able to, when the mask is in use, change its
configuration and act as a cantilever spring. The reaction
force associated with the rigidity of the clip compresses
the attached foam cushion towards the patient's face,
improving the seal to the face, whilst the compliance
introduced (i.e., by the cantilever spring nature of the
clip) assists the foam cushion to conform to the face. The
rigidity of the clip, especially in a lateral direction (up
and down or sidewise with respect to the face) also provides
lateral stability of the mask. Such stability is
especially beneficial for wearing the mask at night, when
movements of the patient's head tend to disturb the mask
and compromise the sealing engagement.
A minimum height of about 5mm is desired in the
flexible clip to allow for sufficient movement during
usage, so the user does not "bottom out" on the flexible
clip. In this context, "bottoming out" can occur when the
flexible clip has reached its deflection limits or when
compressed completely flat to a stop and there is a sharp
rise in the tension force acting on the user's face and
experienced by the user. The height can be chosen to be a
height within a range of about 5mm to 30mm, depending on
the area of the face covered by the clip.
The entire flexible supporting clip or the middle
support portion 4842 may represent a curved surface having,
for example, a "Z", "C" or "L" cross sectional geometry.
The cushion coupling portion 4840 may be in the form of a
peripheral lip that connects to the foam to form an
effective cantilever over-hang portion. Depending on the
structure and the material characteristics of the various
section of the clip cross-sectional profile (shown in Fig.
48), the cantilever spring effect may be predominantly
confined to a specific portion of the flexible clip, such
as the overhanging lip formed by the cushion coupling
portion 4840 with respect to the top edge of support portion
4842, or the combination of portions 4840 and 4842, with
respect to the boundary between the flexible support
portion 4842 and the frame attached portion 4844.
When the headgear is tensioned, the support
portion 4842 of the clip deforms and creates a reaction
force that tries to return the clip to its original shape.
This force depresses the foam towards the patient's face,
enhancing the sealing engagement.
The configuration of the entire support clip is
configured to offer a balance between support and
flexibility. By varying the dimensions (mainly the wall
thickness and the height), the rigidity and the cross-
sectional shape along the perimeter of the clip, different
levels of support and flexibility are provided in the
different sections of the mask. Whilst support portion 4842
of the clip is generally perpendicular to the sealing plane
SP-5, as it can be seen in Fig. 48, in some embodiments,
the support portion and a perpendicular to the sealing
plane may form an angle α there between. In some examples
of the technology, the cross-sectional shape of the
flexible support clip is at least partially characterized
by the angle α and/or the relative length of the arms of
the L, C or Z shape. For example, as it will be discussed
later in relation to Figs. 51-54, where higher softness and
lower support is needed, such as in the sensitive area of
the nasal bridge, the clip may use one, or combination of
two or more of the following features: higher support
portion 4842, a thinner support portion 4842 or an
increased angle α. For example, angles between 20° and
50°, and more specifically between 30° and 40°, may be
suitable for such applications. Variations in the overall
physical structure of the first flexible clip, such as
changing the overall shape of the clip (i.e. from C to L-
shaped ) or changing the relative lengths of various
sections of the clip (e.g. changing the relative length of
cushion coupling portion 4840 or support portion 4842) can
also be implemented to achieve similar results.
The cantilever springe effect resulting from the
flexible nature of the clip was already described in
previous paragraphs. However, the flexible nature of the
clip may define a broader self-adjustment effect that may
be distributed along the length of the clip and that goes
beyond the cantilever springe effect. In particular, such
an adjustment occurs when the mask is in an operational
configuration – it is attached to the user, the headgear
straps are tightened and the plenum chamber of the mask is
pressurized. In this instance a certain balance is
established between the forces acting on the clip. For
example, in a direction perpendicular to the contact plane
SP-5, such forces include forces depressing the clip (such
as the tension force of the headgear applied via the mask
frame, the applied pressure P4 and the reaction force
applied by the foam cushion) and the clip's spring
constant, defined mainly by the supporting portion 4842.
However, the applied pressure in the plenum chamber acts
not only in the direction indicated as P1, but on the entire
inner surface of the clip. The overall balance of forces
and the flexibility of the clip may lead to a dynamic change
in the entire configuration of the cross-sectional profile
of the clip, once the mask is in its operational
configuration. Thus, the shape of the clip (such as the
generally L shape shown in Fig. 48) may undergo changes,
which may be different in the different peripheral sections
of the clip. Some of the changes may include any one of
the following: inwardly or outwardly directed bending in
any section of the supporting portion 4842, modification
of the angle between the portions 4840 and 4842 (not shown
in Fig. 48, but being complimentary to angle α) and change
of the angle of inclination of the cushion supporting
portion 4840. An inward rotation of the cushion coupling
portion 4840 (the cushion supporting surface) towards the
plenum chamber defines a roll-in effect for the cushion.
The changes may vary along the periphery of the clip. For
example, in some sections around the periphery of the clip,
the surface of the clip at cushion coupling portion 4840
(and therefore the cushion) may roll-in, whilst in others,
they may roll-out.
The direction and the extent of modification of
the configuration of the clip will depend on the above
discussed balance of forces, on the patient’s face profile
and on the material properties of the clip, such as its
rigidity/flexibility. These characteristics may be
modified by way of changing the clip's shape, dimensions
(e.g., thickness and/or height) and/or material properties.
The specific dimensions and material (more specifically the
mechanical) properties of at least some embodiments of the
clip that facilitate such a modification of the cross-
sectional profile of the clip, when in use, are described
further in the text. The modification represents a self-
adjustment mechanism that allows the flexible clip and the
attached foam cushion to accommodate a wide variety of face
geometries and features and provide comfortable and
reliable seal. The effect of such a self-adjustment
mechanism may be further enhanced by a purposeful change
of the mechanical properties and the general spatial
relationship (or angle) between the portions 4840 and 4842
around the periphery of the flexible clip, as will be
discussed in relation to Figs. 51-54.
In some instances, the support portion 4842 of
the clip may be chosen to have dimensions (height and
thickness) and mechanical properties (i.e., flexibility)
that would allow the air pressure to create an air spring
effect. This is to say that, as shown in Fig. 48, because
of the flexibility of the supporting clip, the pressure P4
in the plenum chamber may be used to assist the overall
sealing of the mask cushion by depressing the foam cushion
towards the patient's face. As pressure increases, so does
the force creating the seal. The spring effect may also
vary around the periphery of the clip.
All of the effects described in the previous
paragraphs allow the flexible clip to compliment the
flexibility of the supporting clip. Their effect, however,
is limited by the rigidity of the clip. The clip meeds to
have sufficient overall rigidity in order to provide
significant structural support to the foam.
In some specific embodiments, if for any reason
a substantial compliance and softness is required, the
dimensions and the material properties of the clip may be
selected so as to enable the clip to at least partially
expand in a balloon like manner, under the pressure applied
to the mask when in use. Such an arrangement will exhibit
increased compliance, but reduced stability.
In the example shown in Fig. 49, the
soft/flexible first clip has a varying cross section from
the bridge of the nose to the bottom of the mouth, and is
symmetric through the center plane. The geometry of the
flexible clip will largely be affected by the overall
design of the foam and the specification of the clip
material. For one particular embodiment, the thickness of
the flexible clip in both the coupling portion 4840 and
support portion 4842 may vary between about 1mm to 2mm.
However, other thicknesses may be implemented.
A location ridge 4845 shown in Fig. 48 and in
Fig. 50 may be included on an external periphery of the
surface of the flexible clip that contacts the foam. This
structure may then aid alignment in the manufacturing
process of the foam to the foam mounting surface provided
by the coupling portion 4840 of the flexible clip. The
location ridge is designed to be small and does not come
into contact with the user's face. For example, it may be
about 0.5mm in height and width with a full round on the
top. Other heights may be chosen and may be in a range of
about 0.2mm to 2mm.
.4.2.3.1 First Clip Regions
The first clip may be implemented with different
characteristics in different regions of the clip. For
example, different cross sectional geometries and/or
properties in the various portions of the clip is intended
to impart different properties to the associated sections
of the mask and allow efficient sealing with the respective
regions of the user's face, as described in detail below.
Example regions are illustrated in Fig. 49. The regions
may include a nasal bridge region FC-NBR, a sides of nose
region FC-SNR, a sides of mouth region FC-SMR and a bottom
of mouth region FC-BMR.
(a) Nasal Bridge Region – Fig. 51
The example of the cross sectional geometry in
this region shown in Fig. 51 may be 'C' shaped and allows
the foam cushion to move substantially perpendicularly to
the user's face to accommodate a wide range of nasal bridge
depth. It may be the softest/most flexible part of the
first clip and have a thickness in its support portion 4842
of about 1mm. However, this thickness in some versions may
be in a range of about 0.25mm – 1.5mm. The movement is
generated by the angle between the inner face (in this case
45°) (with a range 0° to 90°) and the overall size of the
'C' section.
The surface that attaches to the foam at cushion
coupling portion 4848 may be the largest in this area (e.g.,
about 15mm) but can be in a range of about 10mm – 25mm.
This sizing is done to reduce the likelihood of the seal
blowing out on the sides of the nose, since it restricts
the outward movement of the flexible clip in this region.
The height of the clip measured, as indicated in
Fig. 51, from the boundary of the area used to attach the
flexible clip to the rigid clip, to the boundary of the
area used for attachment to the foam, is indicated as 13
mm. However this may vary between 10 and 20 mm. For an
indicated thickness of the clip of about 0.25mm to 1.5mm,
this will define a height to thickness ratio of between 5
and 80.
The combination of these values may define the
overall sealing and comfort quality.
(b) Sides of Nose Region – Fig. 52
The example cross sectional shape of the first
clip in this region shown in Fig. 52 may also be 'C' shaped
and may allow the foam to pivot and match the facial
geometry at the sides of the user's nose. This allows the
foam contact surface to be parallel with the user's nose.
The flexible clip support portion 4842 in this region of
the flexible clip may have a thickness of about 1mm.
However, this thickness in some versions may be in a range
of about 0.25mm to 1.5mm. The height of about 12mm gives
the range of movement necessary to conform to the user's
nose. However, this height in some versions may be in a
range of about 8mm to 20mm.
The height of the clip is measured, as indicated
in Fig. 52, from the boundary of the area used to attach
the flexible clip to the rigid clip, to the boundary of the
area used for attaching the clip to the foam cushion. The
above noted thickness and height of this section of the
periphery of the clip define a height to thickness ratio
of between 5 and 80.
(c) Sides of Mouth Region – Fig. 53
The example clip cross sectional geometry
illustrated in Fig. 53 at the region on both sides of the
mouth may be 'L' shaped and can be the most rigid portion
of the clip, effectively forming an anchor point around the
sides of the mouth. The support portion and the cushion
coupling portion can also be angled with respect to each
other for increased stability and better sealing. The more
rigid configuration is suitable since these side of mouth
regions of the face are deemed to be the least pressure
sensitive. Furthermore this angled configuration allows
the foam to be pivoted into the user's face to allow for
varying facial profiles. The flexible clip and more
particularly its support portion 4842, can have a thickness
of about 2mm but other thickness in a range of about 1.5mm
to 3mm) may also be implemented to provide the increase in
stiffness. In some versions, a 'C' shaped geometry may
also be implemented for these regions of the flexible clip.
However, this may result in an increase in overall mask
footprint.
The height of the clip measured, as indicated in
Fig. 53, from the boundary of the area used to attach the
flexible clip to the rigid clip, to the boundary of the
area used for attachment to the foam cushion, is indicated
as 15 mm. However this may vary between 10 and 20 mm. For
an indicated thickness of the clip, this will define a
height to thickness ratio for this section of the periphery
of the clip of between 3 and 80.
(d) Bottom of Mouth Region – Fig. 54
The example clip cross sectional geometry for the
bottom of the mouth region illustrated in Fig. 54 is 'L'
shaped and is configured to allow the flexible clip to
roll-in. This permits the foam to move upwards and
downwards relative to the face (left and right with respect
to Fig. 54) and maintain a parallel top sealing surface
with respect to the user's face. This feature allows for
movement of the user's jaw without losing the cushion-to-
patient seal (i.e., jaw drop during usage). The flexible
clip can have a thickness in this region of 1mm (with a
range of 0.25 – 1.5mm). The roll-in action is possible
with the rounded inner surface RIS, this action is further
aided by having a sufficiently large radius (for example,
about 4mm, but may be any radius within a range of about 2
to 10mm) that prevents the lip surface attached to the foam
(the cushion coupling portion 4840) from folding inwards.
The flexible clip can have a height of about 17mm but may
be a height in a range of about 15 to 25mm) in this region.
This height range permits sufficient movement of the foam
cushion. The height of the clip is measured, as indicated
in Fig. 54, from the boundary of the area used to attach
the flexible clip to the rigid clip, to the boundary of the
area used for attachment to the foam. Although an 'L' cross
sectional geometry is illustrated, in some versions, a 'C'
shaped geometry may be configured in this area, but would
result in an increase in overall mask footprint.
The indicated thickness and height of the clip
will define a height to thickness ratio for this section
of the periphery of the clip of between 10 and 100.
.4.2.3.2 First Clip Interfacing
In some versions, the flexible clip may include
a lip seal 5550, such as the examples illustrated in Figs.
55 and 56. The lip seal serves as a portion of the flexible
clip that seals the flexible clip with the mask frame.
Thus, the lip seal 5550 is used between the flexible clip
and the mask frame to ensure a seal is maintained between
the two components. The lip seal may be part of the
flexible clip and may extend around an internal periphery
of the flexible clip. The lip seal can be flexible. For
example, when the flexible clip is coupled to the mask
frame, such as with the hard clip attachment features, a
more rigid portion of the mask frame may be depressed
against the more flexible lip seal to create a
tight/effective seal between them. This may result in some
movement or displacement of the more flexible lip seal
5550. In other configurations, the lip seal 5550 may be
part not of the first support clip 3812 (e.g., flexible
clip), but of the rigid second clip 3814 or the frame 3816.
The interfacing between the second clip (or more
rigid clip) and the mask frame is also shown in Figs. 55
and 56. The rigid clip can serve as a hard stop 5551 to
prevent the cushion assembly with the flexible clip from
being pushed too far into the mask frame. Thus, the rigid
clip may assist with ensuring proper alignment of the lip
seal 5550. An incorrectly assembled cushion could lead to
leaks through the lip seal, the mask frame protruding too
far and contacting the patient, move the headgear
attachments on the mask frame too far and causing contact
with the patient.
The performance characteristics (how it behaves
under load, e.g., increase/decrease in sealing force) can
be altered in the individual sections of the flexible clip
by modifying any one or more the following: material
properties, soft clip thickness, overall flexible clip
height and width and/or soft clip geometry.
.4.2.3.3 First Clip Materials
Generally, unlike the foam cushion which may be
permeable to air, the first clip is typically not made of
foam and can itself be air impermeable or impermeable to
air. The first clip is considered "flexible" or "soft" in
that it may be flexible in use or made from an elastic
material that will deform under load. This includes but
is not limited to, silicone, TPE, TPU and natural rubbers.
TPE material is desirable as it has a higher
potential to be adhered to/moulded to the foam and/or the
rigid clip.
.4.2.3.4 First Clip Manufacture
The manufacturing process for the flexible clip
may include injection moulding. It may be moulded with any
one or more of the following techniques. It may be moulded
as a separate component. It may be overmoulded onto another
component or components such as any one of the hard clip,
mask frame and foam cushion. For example, it may be moulded
to both the foam and the hard clip.
Depending on the manufacturing process, if the
flexible clip is manufactured as a separate component, it
could be assembled to the hard clip by one or more
techniques. For example, it may be adhered such as with
an adhesive, glue or tape. It may be assembled by flame
lamination, ultrasonic welding, injection moulding, such
as a 2K or two-shot injection molding process that employs
multiple (e.g., two) different polymers by a single
injection moulding process.
.4.2.4 Second Clip (e.g., hard clip)
As illustrated in Figs. 56 and 57, the optional
second clip 3814, which may be more rigid with respect to
the flexible clip, can allow for easy assembly and
disassembly of the cushion assembly to and from the mask
frame. This can permit ease of cleaning of the mask frame
and for the replacement of the cushion assembly. While
different structures may serve as the mechanism for
attachment of the rigid clip to the mask frame, Figs. 56
and 57 represent an example in which a plurality of
retaining features (e.g., snap elements 4024 or clips) lock
to respective surfaces of the frame and abbutingly support
the rigid clip (as well as the entire cushion assembly),
to the frame. These features of the retention mechanism
have been described with reference to Fig. 40. Alternative
assemblies are also possible.
Generally, the second clip 3814 allows for a
harder interface between the flexible clip/foam assembly
and the mask frame. Whilst the use of the hard clip may
increase usability, it is not essential for the operation
of the mask. Alternate attachment mechanisms can be used
to attach the cushion assembly to the mask frame.
Similarly, a mask assembly may be designed that may not
necessarily include a support clip that is not flexible.
As mentioned earlier in the text, the use of a larger amount
of foam will be necessary in such a case.
An alternative assembly mechanism between the
foam cushion and the mask frame, some of which do not
include rigid or even flexible clip, may include a tongue
and groove geometry between the flexible clip and the mask
frame.
In some versions, a portion of the flexible clip
may be configured to attach to the mask frame by stretching
and gripping a coupling edge of the mask frame. In some
examples, the he flexible clip may be configured for
coupling with the mask frame or rigid clip by an
interference fit similar to air-tight food containers. In
some versions, the flexible clip and the mask frame may
have a tongue and slot interface between them and a
secondary lip seal or gasket may be present to prevent
air/pressure leak. In some versions, the cushion assembly
may be permanently attached to the mask frame. In some
versions, an adhesive, such as an adhesive tape, may be
employed between the cushion assembly and the mask frame.
The rigid second clip can provide structural
integrity to the cushion assembly due to the soft/flexible
nature of the flexible clip and foam cushion. The rigid
clip can also allow the cushion assembly to maintain its
shape even when disassembled from the mask frame.
.4.2.4.1 Second Clip Materials
The hard clip can be made of any suitable rigid
material. For example, the second clip may be made from a
rigid thermoplastic material. Such materials may include,
for example, acrylonitrile butadiene styrene (ABS), Nylon
and/or Polycarbonate.
The second clip may, for example, be manufactured
by injection moulding.
.4.3 Supra Nasal Sealing Additional Examples
Another example foam mask of the present
technology may be considered with reference to Figs. 69 to
86. The mask may be suitable for sealing around the mouth
and over the nose. The foam cushion 3810 is illustrated
in Fig. 69. The cross section geometry of the cushion may
be generally trapezium in shape with the corners contacting
the patients face rounded for comfort. This generally
trapezium shape provides stability. As shown in Fig. 70,
the flat contact surface has been partially removed to form
a nasal recess 6912 adapted to receive a user's nose and
reduce the pressure applied by the mask to the nasal bridge
area. The height of the recess (in a vertical direction
parallel to the nose height) can be about 17mm. (See cross-
section of Fig. 70.) In some versions, it can optionally
be any height up to the width of the foam, e.g. 25mm).
Moving from vertical(the direction along the length of the
user's nose) to horizontal direction (the direction of the
width of the user's nose), the recess gradually decreases
until the recessed surface starting from point 6910A joins
the non–recessed surface at point 6910B. The width 6910C
of the recess in the horizontal direction is between about
and 35mm, but may be about 20-25mm. A well designed
recess allows for the user’s nose to be hugged by the foam.
This increases the mask stability in the region. An
increase in the width of the recess can provide additional
relief/comfort to the user, but it will have the adverse
effect for sealing and stability. The depth of the recess
is about 9mm but it can be in a range up to the full height
of the foam, e.g., 9mm). An increase in the depth of the
recess will provide improved visibility and additional
relief/comfort to the user, but may adversely affect the
overall durability of the foam cushion.
The cross sectional geometry of the foam in the
side of nose and mouth region may be that of any of the
cushion versions described in this specification. However,
there may also be a smooth transition between the new nasal
bridge and side of nose regions. The recess may be
manufactured concurrently with a compression cutting
process for the foam cushion, but it can also be formed
during a secondary process by, for example, additional
compression cutting, thermoforming and/or grinding.
.4.3.1 First Clip (e.g., flexible clip)
Similar to the prior examples, the mask may
include a first clip (e.g., soft/flexibe clip) having cross
sectional geometries that vary by region of the clip (e.g.,
nasal bridge region FC-NBR, sides of nose region FC-SNR,
sides of mouth region FC-SMR and bottom of mouth region FC-
BMR.) Example cross sectional geometries of each of these
regions are shown in Figs. 71, 72, 74 and 75 respectively.
A. Flexible Clip Nasal bridge region
The formation of a recess in the foam cushion can
be complemented with a reduction of the width of the
flexible clip surface supporting the foam cushion in the
nasal bridge region. The reduced support increases the
compliance and allows the cushion to roll-in, when a
pressure is applied, thus further improving the user's
comfort in the nasal bridge area.
The cross section shown in Fig. 71 of this region
of the periphery of the clip is generally 'L' shaped and
allows the foam to move substantially perpendicularly to
the user's face to accommodate a wide range of nasal bridge
depth. It forms the softest (i.e., most flexible) part of
the clip and has a thickness (support portion 4842) of
about 0.5mm (but may suitably be a thickness within a range
of about 0.25 – 1.5mm). The flexibility may be manifested
in the flexing of support portion 4842 and the angular
movement between support portion 4842 and the portion
having the foam contact surface. In this example, the
support portion has a height of about 11.44mm but may
suitably be a height within a range of about 8mm – 20mm.
Furthermore, the foam contact surface may be for example
about 6.5mm in width but may be a width in a range of about
of about 3 – 12mm. This can permit the foam cushion to
overlap the contact surface since the foam can be wider.
The unattached portion of the foam may the flex
independently from the clip. In some versions, this cross
sectional portion the clip may be 'c' shaped, but would
result in an increase in the overall mask footprint.
B. Flexible Clip Sides of nose region
As seen in Fig. 73, in the side of nose region
at location 7310H, there is an increased overall height of
the foam due to the supporting section of the clip on both
sides of the nose, compared to the surrounding areas. This
can provide better support and improve seal in this
specific region.
The cross section of the clip in this region of
the mask as shown in Fig. 72 is generally 'L' shaped and
allows the foam to more easily pivot and match the facial
geometry at the sides of the user's nose. The geometry
allows the foam contact surface to be parallel to the user's
nose. The flexible clip at the support portion 4842 may
have a thickness in this region of about 0.75mm but may be
a thickness in a range of about 0.25 – 1.5mm.
The height of about 9.46mm (but may suitably be
a height in a range of about 8mm – 20mm) can give a range
of movement necessary to conform to the user's nose. Such
a localized increased height in this region allows for,
without changing the shape or the thickness of the foam in
this region, additional sealing force to be applied to form
a better seal around this critical region.
Alternatively, or in addition by combination, to
the increased clip height, a similar effect can be achieved
through a localised increase at location 7310H in height
of the foam cushion in the region of the clip of Fig. 73.
Optionally, a 'c' shaped geometry may be
implemented in this region, but would result in an increase
in overall mask footprint.
C. Flexible Clip Sides of mouth region
A cross-sectional geometry as indicated in Fig.
74 may be implemented in the sides of mouth region. The
region can be configured to have an angle β between a
horizontal that is perpendicular to an axis of the
supporting portion 4842 and the foam contact surface
supporting the foam cushion. This angling permits a roll-
in of the foam contact surface inwardly to better hug this
region of the face when the foam cushion is applied. It
can also improve the overall stability of the system.
This clip cross sectional geometry on both sides
of the mouth shown in Fig. 74 is generally 'L' shaped. The
large angle β reduces the inward flexing range of the clip
and enhances the rigidity of the clip. This allows this
section of the mask to better hug the face, effectively
forming an anchor point around the sides of the mouth. The
rigidity of the flexible clip may be at its highest in this
region. Such decreased flexibility in this region of the
face may be suitable since it is the least pressure
sensitive region of a user. The cross geometry also allows
the foam to be pivoted into the user's face to allow for
varying facial profiles. The flexible clip and more
particularly its support portion 4842, can have a thickness
of about 1.2mm (but may be a suitable thickness in a range
of about 1mm to 2mm) to provide the desired stiffness. The
angle β can be about 37.1 degrees (but may be a suitable
angle in a range of about 20-60 degrees).
Optionally, a 'c' shaped geometry design could
be used in this area, but would result in an increase in
overall mask footprint.
D. Flexible Clip Bottom of mouth region
The clip cross sectional geometry shown in Fig.
75 for the bottom of the mouth region is generally 'L'
shaped and allows for the flexible clip to roll. The small
(close to zero) angle β allows the foam supporting surface
to flex. This allows the foam to move upwards and downwards
relative to the face (left and right with respect to the
illustration of Fig. 75) whilst maintaining a parallel top
sealing surface with respect to the user's face. This
feature allows for movement of the user's jaw without a
loss in seal (e.g., jaw drop during usage). The flexible
clip can have a thickness of 0.75mm (but can suitably have
a thickness in a range of about 0.25mm – 1.5mm). The roll-
in action is aided by the smooth rounded internal surface
RIS and a height of about 14.21mm (but may have a suitable
height in a range of about 12 – 25mm).
Optionally, a 'c' shaped geometry could be
implemented in this region, but would result in an increase
in overall mask footprint.
.4.3.2 Second Clip (e.g., rigid clip)
Similar to the other versions, the flexible clip
as shown in Fig. 76 has a lip seal 5550 that, when the
flexible clip is attached to the hard clip, overhangs an
edge 7660 of the hard clip (e.g., second clip 3814). The
overhanging engagement is such that this peripheral lip
seals against the hard clip edge. The angle G the lip seal
makes to the horizontal is can be small (e.g., about 5
degrees (with a suitable angle range of about 0 to 20
degrees). This ensures that, when the frame is assembled
to the cushion, the lip seal will always be under tension
as it is depressed against a more rigid mask frame portion
7662, which improves the sealing engagement and minimizes
the change of potential buckling in the lip seal.
The engagement of the soft and hard clips is such
that an engagement rib 7664 of the hard clip is received
in an engagement groove 7666 of the mask frame. There are
a number of points along the engagement groove where stop
points 7668 are formed to limit the insertion of the
engagement rib into the groove. The hard stop can be a
continuous ridge or a set of points localized to a number
of positions (e.g., 6) about the periphery of the frame.
They can be arranged such that, when the clips are in the
engaged configuration, the engagement rib abuts against
some or all of these stop points and is prevented from
entering the engagement groove any further. Apart from
limiting the insertion in a vertical direction, the hard
stop points may also constrain the horizontal movement of
the frame to cushion assembly. This is achieved by at
least one, preferably several, of the hard stop points
having a recess that receives the engagement rib. As the
width of the opening is arranged to tightly receive the rib
7664, the arrangement limits the movement of the clips in
horizontal direction.
As seen in Figs. 77 to 82, a top attachment snap
element 8010-1 can be engaged to the respective frame
opening 8012. One way is to pivot the entire clip assembly
so that the snap element 8010-1 at a top locking edge of
the clip is pivotably inserted in the respective frame
opening 8012. This requires minimal effort on behalf of
the user. The entire clip assembly is then pivoted back
to be parallel to the frame and the lower part of the
clip/cushion is depressed against the frame until the
bottom snap element 8010-2 clicks into engagement with the
respective frame engagement portion. Alternatively, the
entire clip assembly may be aligned in parallel and
depressed against the frame until both the top and the
bottom snap elements of the clip assembly engage with the
frame. The engagement of the top attachment in this case
requires a slightly larger force which is arranged to be
approximately equal to the top headgear tension. Because
of that, in the event the top attachment has not been fully
engaged during assembly, it will self-engage as the user
puts on the mask.
The bottom snap element 8010-2 forms the main
interface the user will manipulate during disassembly, and
it is sized so a finger can comfortably operate the
mechanism. As best seen in Fig. 81, the bottom snap element
8010-2 on the hard clip has two rounds leading to taper
edges which increases usability as that will act as lead
ins to the corresponding receiving slot 8014 on the mask
frame.
In this version, the engagement mechanism
(receiving slot 8014) in the frame does not run fully across
the bottom, this is specifically designed so during
disassembly the user can slide their finger downwards while
maintaining full contact with the hard clip.
.4.3.3 Foam Mask Assembly Operation
Operation/performance of the example masks may
be considered in reference to Figs. 83 to 86. The
performance areas around the periphery of the cushion
assembly of Fig. 83 include nasal bridge region ZA, Sides
of nose region ZB, upper cheek region ZC, sides of mouth
region ZD and bottom of mouth region ZE. The design intent
of the cushion in terms of how it reacts to a user's face
is further described herein.
The cushion is configured to apply a different
amount of load or reaction force to individual regions of
a user's face. The nasal bridge region ZA is the least
loaded as it is the most sensitive region. Then there is
an increase in loading in regions ZB and ZC as a more robust
seal in this region would decrease the likelihood of leak
into the user's eye. In comparison, region ZD and ZE is
the most heavily loaded and acts to anchor the cushion to
a user's face. There may be uniform loading across regions
ZD and ZE, but this can change due to individual user's
facial profile.
The cushion has a pivoting motion as the top and
bottom headgear straps are tightened or loosened. The
approximate pivot axis is shown with the arrow of Fig. 84.
By tightening the top head gear straps regions ZA, ZB and
ZC pivot into the user's face, and region ZD) and ZE pivot
away. When the bottom straps are tightened region ZA, ZB
and ZC pivot away from the user's face and region ZD and
ZE pivot into the user's face. The inverse will happen
with the loosening of the top and bottom headgear straps.
Fig. 85 provides an approximate indication of the
relative pressure/reaction force in the various respective
regions of the mask. The arrows indicate the
pressure/force applied by the mask to the user's face, when
the headgear is tensioned to support the mask on the user's
face. The different sizes of the arrows indicate the
relative pressure differences in each respective region.
Thus, the mask may be configured (for example by virtue of
the characteristics of the clip(s) and/or foam cushion) to
apply different reaction forces in different regions of its
patient contact surfaces. In the illustrated example of
Fig. 85, the mask is configured for smaller forces to be
applied in the upper regions of the mask (e.g. the sensitive
nasal bridge region ZA, sides of nose region ZB and/or
upper cheek region ZC). The mask may be configured for
greater forces to be applied in lower regions of the mask
(e.g., sides of mouth region ZD and/or bottom of mouth
region ZE). In this example, the mask is configured for the
smallest force at the nasal bridge region ZA. These forces
may typically be symmetric from side to side of the image
of Fig. 85 (e.g., approximately the same on the left side
as the right side in the respective regions). Other force
distributions/variations may also be applied.
As discussed earlier in the text, the cushion may
also exhibit a roll-in effect as it is applied to the user's
face. As region ZA is depressed by the user's nose bridge,
region ZB can roll into the sides of the user's nose, which
acts to increase the compliance of the cushion's seal to
the user’s face. As region ZE is depressed by the user's
chin, region ZD rolls into the sides of the user's mouth,
forming a more effective anchor as it wraps around the
user's face.
Fig. 86 shows approximate roll-in response in the
respective regions of the mask. The arrows indicate the
relative extent of the roll-in response when the headgear
is tensioned to support the mask on the user's face. The
difference in size of the arrows indicates the relative
difference in roll-in in each respective region.
Thus, the mask may be configured (for example by
virtue of the characteristics of the clip(s) and/or foam
cushion) with different degrees of roll-in in different
regions of its patient contact surfaces. In the
illustrated example of Fig. 85, the mask is configured for
greatest degrees of roll-in to be applied in the sides of
nose region ZB and/or sides of mouth region ZD, which may
be approximately the same. The mask may be configured for
smaller degrees of roll-in to be applied in other regions
(e.g., nasal bridge region ZA, upper cheek region ZC and/or
bottom of mouth region ZE) which may be approximately the
same. These roll-in forces may typically be symmetric from
side to side of the image of Fig. 85 (e.g., approximately
the same on the left side as the right side in the
respective regions) However, other force variations may
also be configured.
The degree of roll has been intentionally
modified to assist with the comfort and with the efficient
sealing of the mask. There are a number of ways to achieve
a specific degree of rolling.
Generally, around the periphery of the cushion
interface, the plane on which the foam cushion sits, may
be angled inwardly to the users face at different angles
in a manner to promote degrees of roll-in. Some areas
(such as sides of mouth) have a more significant angle in
order to facilitate a greater roll-in affect.
The flexibility of the soft (e.g. TPE/Silicone)
clip to which the foam cushion is assembled is, broadly,
shaped as a right angle beam, hence allowing for inward
roll (intended via the inwards angling as described above).
The flexible clip material is selected to be
flexible and compliant which can also allow for inwards
roll (per the intention and descriptions above).
The degree of support to the foam provided by the
underlying flexible clip surface can be changed by ensuring
that the supporting surface of the flexible clip extends
only partially under the foam surface. Thus, some of the
foam surface, usually on the inner side of the mask, can
be unsupported (i.e., the foam overhangs the flexible
clip). When pressure is applied to the foam, the
unsupported surfaces may give-in and facilitate the roll-
in effect.
Thus, in some examples, the foam cushion assembly
can have parameters that vary in at least some sections of
the periphery of the clip and/or assembly, such as:
Spring constant of the clip and/or the foam cushion;
Cross-sectional profile of the clip and/or the foam
cushion;
wall thickness of the clip;
The angle of the contact surface to which the
cushion is attached;
The overhanging of the cushion with respect to the
supporting contact surface; and/or
Foam thickness.
.4.4 Further Optional Foam Mask Features
As previously described, masks may be implemented
with a foam cushion whether they are above or below the
nose masks as previously described or even nasal only
masks. Generally it is desirable to achieve a mask with
maximum comfort and compliance/seal performance. Various
foam seal forming cushions configurations may be configured
to achieve this desire. However, when designing a
comfortable foam cushion, there are other trade-offs to
consider. One such trade-off is permeability, which is
closely associated with the foam's softness and compliance.
For achieving desired seal and comfort, a relatively thick
layer of foam on the mask can be implemented. Apart from
being more heavy and obtrusive, a large layer or foam, even
of limited permeability, could be associated with an
increased leak and compromise the provided pressure
therapy. To address the issues with size and permeability,
some versions of the present technology as previously
mentioned can employ a flexible intermediary structural
component (e.g., clip(s)) between the foam layer and the
frame. Such a structure, such as the above described
flexible clip(s), attaches to the foam seal forming layer.
The balance of rigidity and flexibility of such an
intermediary structure (e.g., a flexible clip) can be
chosen so that it can serve as a substitute for some of the
foam cushion. Thus, a less bulky foam layer can be used.
In addition, the clip is generally formed of a non-
permeable material. Because of that, and because of the
specific concave configurations, discussed earlier in the
text, a portion of the clip covers at least a portion of
the foam cushion and may reduce the overall leak associated
with the foam cushion. The flexible clip may then maintain
the benefits of support and compliance, while minimising
leak. Some additional optional features of the intermediary
structure(s) may be considered with respect to achieving
some of the goals of the previously described flexible
clips.
.4.4.1 Clip Flexibility
One disadvantage of simply providing a foam seal
forming layer to a hard clip or a frame/shell of a mask is
that it has a risk of bottoming out on the hard/rigid
portion. Bottoming out occurs when the foam is compressed
to such a degree that the patient starts to feel the
rigidity or hardness of the underlying clip or frame/shell
of the mask. To address this issue, some examples described
throughout this specification introduce a soft/flexible
clip that flexes under pressure applied to the mask. The
arrangement is such that the flexibility and the compliance
of the flexible clip compliments that of the foam layer to
improve the overall compliance of the mask.
However, the flexibility nature of these flexible
clips need not necessarily be a consequence of particularly
flexible materials. For example, the function of the
flexible clip may be achieved with a semi-rigid or even
rigid clip or mask frame/shell instead to which the foam
is applied. In such cases, the flexible response may be
introduced by structural features, such as locally thinned
or profiled sections, that may form a hinge or gusset on a
rigid clip or frame to which the foam is attached. Thus,
the foam seal forming layer may be directly attached to a
rigid clip that has been designed to have flexible sections
with structurally introduced compliance in locations where
compliance is needed. Thus, the flexible support clip may
be formed by a rigid material and the flexibility may be
induced by way of introducing one or more compliance
regions, such as by introducing one or more lines of
weakness or one or more regions of weakness.
Two different examples of such a configuration
are illustrated with respect to Figs. 58A and 58B. Fig.
58B shows a cross section of the foam cushion assembly of
Fig. 58A with a foam cushion 3810 and a rigid clip 5858.
The rigid clip 5858 may then attach to a frame (not shown
in Fig. 58). This rigid clip 5858 is flexible in that it
has structural features designed to promote flexing. As
shown in Fig. 58B, the wall of the clip includes a profile
to implement a gusset at 5859-A, but the thickness of the
wall has not been changed. The other example shown at
5859-B introduces one or more lines of weakness around the
periphery of the clip, where the wall is thinner. Each
line can be a continuous line or an interrupted one, e.g.,
a series of weak spots. In such cases, the result can be
an increased level of flexibility of wall of the rigid or
semi-rigid clip or frame. These structural features can
also be implemented to modify the flexibility and the
spring constant of an already flexible clip such as any of
the clips described throughout this specification.
Another example for imparting flexibility into
an otherwise rigid or semi-rigid mask plenum chamber can
be to implement flexing sections defined in the recessed
rigid clip 6758 or mask shell. For example, such a rigid
clip coupled to a foam cushion 3810 is illustrated in Figs.
67 and 68. As illustrated, the frame/clip can have one or
more regions of weakness introduced by having portions of
rigid material removed at one or more clip recess(es) 6770.
This allows the rigid clip/shell to compress easier under
load. Thus, these recess sections can be positioned at
regions of discomfort (such as near the nasal bridge or
sides of the nose) where more flexibility or compliance is
needed. The recesses may be filled with another flexible
(but impermeable) material such as a recess membrane 6772
made of, for example, silicone or TPE. Alternatively, the
recesses created by the removed sections may be covered by
a single flexible sheet. Such a sheet may, for example
represent a silicone membrane attached to the inside of the
rigid clip.
.4.4.2 Clip Alternatives
In various assemblies described herein, a clip
is described as an intermediary structure for applying foam
to a mask frame. For example, the foam mask design has
been described as having a foam seal forming layer,
attached to a flexible clip that is subsequently attached
to a hard clip. The hard clip is removably attachable to
the mask frame. The frame in this case may be a rigid part
of the mask that provides some level of shape and support
to the mask structure and allows for headgear tension to
be transferred to the seal forming portion to seal on the
face.
Another configuration of a foam mask may include
a flexible shell or chamber made from a flexible material
(such as TPE or Silicone). Such an assembly may be
considered with reference to Figs. 61, 60 and 60. A
flexible chamber or shell 6160 can serve, in part, as the
flexible clip, where the flexibility of the shell provides
compliance when pressure is applied to the mask. In this
case, a headgear frame 6162, which may include a shell
aperture 6163, is fit over the shell 6160 as a separate
removable structure made of a rigid material to provide
support. Whilst the concave silicone chamber of the shell
6160 can serve in part as the C-shaped flexible clip, one
substantial difference is that the flexible shell also more
completely forms a part of the mask chamber or plenum
chamber 3200. For example, it may optionally include a
connection port 3600 for coupling with a gas delivery
conduit or circuit 4170 and/or a vent 3400.
Although Fig. 60 shows the shell 6160 version of
the clip attached to the foam cushion, in some cases a
further intermediary may be implemented such as the
examples illustrated in Figs. 63A, 63B and 59. These
versions of the mask assembly implement a foam cushion
attached directly to a rigid clip 6314. The rigid clip
6314 may then couple with the shell 6160 or other mask
frame with engagement features 6319. The foam may be
semipermeable, which is correlated to its softness and
breathability. However, a permeable foam layer will leak
air and air pressure.
In this case, the shell 6160 or other mask frame,
can include an additional flexible member 6320 peripherally
positioned inside the mask plenum chamber and configured
to cover at least a portion of the foam cushion when the
rigid clip is assembled/coupled to the shell or mask frame
as shown in Fig. 63B. This flexible member 6320 can be an
air impermeable skirt, flap or layer positioned within the
mask chamber that moves to engage and cover the inner
surface of the foam cushion.
The flexible member 6320 may be a flexible
membrane made of, for example, TPE or silicone and may be
attached to the chamber forming walls of the mask
shell/frame, or to a rigid clip 6314 attached to the mask
shell/frame. This flexible membrane forms a flap that is
adapted to, at least when under pressure, interact with the
foam and cover at least partially the under-surface of the
foam layer when pressure is applied to the mask.
Preferably, the flap will not interact with the face of the
patient. The implementation of such a non-permeable layer
enhances the overall quality of the seal, which otherwise
may be at least partially compromised by the at least
partially permeable foam layer.
This sealing layer (flexible member 6320) can
also enhance the air-spring effect within the chamber. As
the foam sealing portion overhangs off the edge of the hard
clip or frame to which it is attached, any force applied
to the flap also acts on the foam sealing portion. Having
the non-permeable flexible flap cover the foam under-
surface (plenum chamber side of foam), will allow for
pressure to build up and push the foam into a better sealing
engagement when pressure from a flow generator is applied
to the mask chamber.
A variation of the flexible member 6320 is seen
further in Fig. 59. In this version, flexible member more
completely covers the foam cushion by extending internally
beyond the supporting surface of the underlying rigid clip.
As such, it also extends to at least partially cover the
inner lateral surface of the foam cushion. In this position
it may be more affected by the flow through the mask from
the flow generator so as to move as illustrated in Fig. 59.
The length of the flap may be selected on the basis of how
thick the foam layer is and whether contact of the flap
with the face is desirable. Thus, it may extend to contact
the face in some versions and not in others. Such a
membrane may be applied to any of the mask described in
this specification to reduce foam air leak (i.e, leak
through the foam seal forming layer).
As a general requirement, the contours on the
foam layer should maximise comfort and effect a seal by
matching a patient's facial profile or facial contour.
Thus, the foam seal forming layers may preferably be
configured into a desired 3-dimensional (3-D) or desired
facial profile.
In one example, the flexible clip is moulded to
the desired 3-D shape or facial profile so as to impart
this shape to a generally flat foam seal forming layer when
it is attached to the foam. Alternatively, a 3-D shaped
hard clip can impart 3D shape (e.g., a facial contour) to
the flexible clip and the foam sealing layer attached to
Figs. 64, 65, 66A and 66B illustrate additional
mask examples that show alternative methods to give the
foam a desired shape. One such example is to provide one
or more rigid over clips that squeeze or clamp the foam
cushion into a desired three-dimensional (3D) profile such
as when snapped or snap fit into a foam support component
such as a mask frame 3816 or shell with snap elements. For
example, it has been shown that a foam seal forming layer
with a rounded seal forming surface is desirable. Thus, as
shown in Figs. 64, 65, 66A and 66B, multiple clips (e.g.,
two separate over clips 6470-1, 6470-2) such as an inner
peripheral clip (clip 6470-1 and outer peripheral clip
(clip 6470-2), can depress or clamp the opposing peripheral
edges/sides of a foam body, to effectively round the
patient contacting edges of the foam layer. Alternatively,
only one of the illustrated clips can be used or the two
clips can be arranged in a single clip.
As shown in the example of Fig. 65, the clip 6470
may have one or more over-clip portions 6580 to squash not
only the edges, but also one or more top or internal
portions of the foam layer toward the mask frame 3816,
shell or other mask assembly structure. For example, as
illustrated in Fig. 65 at the nasal bridge and in the middle
of the lower lip area optional slits 6582 partially through
the top side portion of the foam serve as channels for the
clip 6470. As a result, the foam may bulge is certain
portions and be pressed down in other portions of the mask.
This may enhance the compliance and/or comfort of the foam
seal forming layer.
Alternatively, one or more of the illustrated
over-clip portions can have a 3-D shape (e.g., facial
contour), which can provide the same effect (allow the foam
to bulge in certain areas and press the foam down in other
areas).
.4.5 Further Foam Cushion Characteristics
Although the cushions described for masks herein
may be implemented with many different foam materials,
foams with certain performance properties may be
particularly well suited when implemented for respiratory
treatments given the critical need to promote patient
compliance and to ensure effective delivery of medical
treatments. In this regard, particularly suitable foams
may be characterized by any one or more of its permeability
(Liters/min), indentation hardness (Newtons (N)),
compression stress strain (Kilo-pascals (Kpa)), density
(kilograms per meters (kg/m )), dynamic coefficient of
friction (calculated friction (cf)), compression set
(percent (%)), tensile strength (Megapascal (Mpa)),
elongation @ break (Percent (%)) and/or tear strength
(Newtons/millimeter (N/mm)).
.4.5.1 Permeability
For example, the foam cushion may be configured
to have a particular permeability characteristic. The
permeability characteristic of the foam may be a measure
of the rate of air flowing through a given sample in
Liters/minute. Such permeability may be determined by the
following permeability test. A test piece can be cut from
a piece of foam with a die or a sharp knife into an annular
shape (i.e., a ring-shaped geometric foam sample or square
sectioned toroid). The test piece is cut nominal to the
cell rise direction from a foam sample manufactured at
least 72 hours prior. The ring has a height of 25mm (plus
or minus 1.0mm) from the bottom of the ring to the top in
the cell rise direction. The inner open cylinder of the
foam ring has that height and a diameter of 70 mm (plus or
minus 1.0mm). The outer edge of the foam ring has a
diameter of 110 mm (plus or minus 1.0mm). Test pieces are
free from skin voids and densification lines. The test
piece will be in good condition without any visible defects
such as burrs, delaminating, tears etc. The test then
measures the air flow through the annulus of the foam ring
having its constant cross section. The circular shape
ensures the pressure is evenly distributed and the foam
inflates uniformly. The foam test ring is conditioned,
undeflected and undistorted, for at least sixteen hours in
an atmosphere of temperature at 23 ±2°C and relative
humidity at 50 ±5% prior to testing. The ring may be
compressed between plates in a manner to reduce the height
of the ring from 25mm to 17.5mm during flow testing. A
constant air pressure of 20 cmH2O, such as from a flow
generator, is applied to the center of the foam ring. Air
flow through the ring from the center outward across the
foam is then measured with a flow meter in liters/minute.
Foam cushions suitable for the present technology may have
a permeability characteristic in a range of about 0 to 20
L/m and may preferably have a permeability characteristic
in a range of about 0 to 3 L/m.
.4.5.2 Indentation Hardness
The foam cushion may be configured to have a
particular indentation hardness (IDF) characteristic. This
characteristic relates to the firmness or stiffness of the
material. This characteristic has a significant
correlation to comfort, seal and stability needs.
Generally, the lower the IDF - the softer the material.
Testing may be in general accordance with BS EN ISO 2439:
2008 (method C) – determination of 40% indentation hardness
check by compression of samples by 40% of its thickness and
recoding the maximum force (N). Foam cushions suitable for
the present technology may have an indentation hardness
(IDF) characteristic in a range of about 110.48 to 303.11
N, and may preferably have an indentation hardness (IDF)
characteristic in a range of about 122.76 to 275.55 N, and
still further may more preferably have an indentation
hardness (IDF) characteristic in a range of about 143.1-
198.88 N.
.4.5.3 Compression Stress Strain
The foam cushion may be configured to have a
particular compression stress strain characteristic. This
characteristic relates to how the foam material deflects
under stress or load. This characteristic has a
significant correlation to comfort, seal and stability
needs. The compression stress-strain may be determined in
accordance with BS EN ISO 3386: 1997 +A1:210. The test
speed may be 100mm/minute. Stress at a compression of 40%
may be calculated. Foam cushions suitable for the present
technology may have a compression stress-strain
characteristic in a range of about 2.32 to 7.26 Kpa, and
may preferably have a compression stress-strain
characteristic in a range of about 2.574 to 6.6 Kpa, and
still further may more preferably have a compression
stress-strain characteristic in a range of about 3.15 to
4.29 Kpa.
.4.5.4 Apparent Density
The foam cushion may be configured to have a
particular density characteristic. This characteristic
relates to the weight, firmness, "plushness" or tactile
"feel" of the material. This characteristic has a
significant correlation to comfort, seal and stability
needs. The apparent density may be determined in accordance
with BS EN ISO 845:2009. Using measured dimensions (mm)
and the weight (g) the density (kg/m ) can be calculated.
Foam cushions suitable for the present technology may have
a density characteristic in a range of about 24.3 to 117.85
kg/m , and may preferably have a density characteristic in
a range of about 27 to 107.14 kg/m , and still further may
more preferably have a density characteristic in a range
of about 50.76 to 66.11 kg/m .
.4.5.5 Dynamic Coefficient of Friction
The foam cushion may be configured to have a
particular dynamic coefficient of friction characteristic.
This characteristic relates to comfort on face and
perception of comfort in the hand. This characteristic
has a significant correlation to the surface feel or
texture of the material. This characteristic has a
moderate correlation to seal and stability as a result of
relationship between the patient's skin and surface finish
of the material. The dynamic coefficient of friction may
be determined in accordance with BS EN ISO 8295:2004. Test
pieces may be tested under a load of 1.96 N and a speed of
mm/minute on a glass substrate at a temperature of 37C
to 39C. Force readings may be measured and friction
calculated. Foam cushions suitable for the present
technology may have a dynamic coefficient of friction
characteristic in a range of about 1.86 to 19.12 CF, and
may preferably have a dynamic coefficient of friction
characteristic in a range of about 2.07 to 17.38 CF, and
still further may more preferably have a dynamic
coefficient of friction characteristic in a range of about
2.43 to 2.97 CF.
.4.5.6 Compression Set
The foam cushion may be configured to have a
particular compression set characteristic. This
characteristic relates to the ability of the foam to
recover to its original state post compression and
conditioning. If the foam has high/poor compression set
it will no longer act as a dynamic seal. If the foam has
no compression set, coupled with a strong resilience to
deterioration, it will be useable for a long period. The
compression set may be determined in accordance with BS EN
ISO 1856:2001. Test spacers may be selected to give a
compression of nominally 50% and 75% to each specimen.
Compression may occur for a period of time (e.g., 22 hours)
at certain temperature and relative humidity (e.g., 22
hours at 23C (plus or minus 2C) and 10% R.H.; and 22 hours
at 70C (plus or minus 1C). After unclamping the test
specimens, they may be allowed to recover for 30 minutes
at 23C (plus or minus 2C) before being re-measured and the
compression set % being calculated. Foam cushions suitable
for the present technology may have a compression set
characteristic in a range of about 0.16 to 17.3 %, and may
preferably have a compression set characteristic in a range
of about 0.18 to 15.73 %, and still further may more
preferably have a compression set characteristic in a range
of about 3.06 to 4.4 %.
.4.5.7 Tensile Strength
The foam cushion may be configured to have a
particular tensile strength characteristic. This
characteristic relates to the force required to break the
foam. This has a moderate correlation to stability and
seal. If the cushion has poor tensile strength, it will
fail causing leak and poor stability. The tensile strength
may be determined in accordance with BS EN ISO 1798:2008
at a tensile test speed of 500 mm/minute. Load may be
recorded and the elongation may be determined by laser
extensometry. Foam cushions suitable for the present
technology may have a tensile strength characteristic in a
range of about 0.03 to 0.27 Mpa, and may preferably have a
tensile strength characteristic in a range of about 0.036
to 0.242 Mpa, and still further may more preferably have a
tensile strength characteristic in a range of about 0.117
to 0.143 Mpa.
.4.5.8 Elongation @ Break
The foam cushion may be configured to have a
particular elongation @ (at) break characteristic. This
characteristic relates the foams ability to elongate before
failing. This characteristic has a moderate correlation
to stability and seal, as per tensile strength. Foam
cushions suitable for the present technology may have an
elongation @ break characteristic in a range of about 72.9
to 369.05 %, and may preferably have a elongation @ break
characteristic in a range of about 81 to 335.5 %, and still
further may more preferably have a elongation @ break
characteristic in a range of about 243 to 335.5%.
.4.5.9 Tear Strength
The foam cushion may be configured to have a
particular tear strength characteristic. This
characteristic relates to the foams ability to resist tear
under tension. There is a moderate correlation of this
characteristic to stability and seal, as per tensile
strength and elongation at break. The tear strength may
be determined in accordance with BS EN ISO 8067:2008
(method A) at a test speed of 50 mm/minute. Foam cushions
suitable for the present technology may have a tear
strength characteristic in a range of about 0.07 to 0.69
N/mm, and may preferably have a tear strength
characteristic in a range of about 0.081 to 0.627 N/mm, and
still further may more preferably have a tear strength
characteristic in a range of about 0.225 to 0.297 N/mm.
.4.6 Further Clip Characteristics
Although the cushion assembly with the clip(s)
described for masks herein may be implemented with many
different materials, foam and clip combinations with
certain performance properties may be particularly well
suited when implemented for respiratory treatments given
the critical need to promote patient compliance and to
ensure effective delivery of medical treatments. In this
regard, particularly suitable cushion assemblies may be
characterized by a spring constant characteristic.
In this regard, the spring rate of the cushion
assemblies of the present technology, which may be
perceived as hardness of the cushion assembly, is more than
just a sum of its parts. The parts (e.g., flexible clip
and foam cushion) work together to produce a final
synergetic effect. Both the foam and the underlying
flexible clip can be tuned to each other. For example, if
the characteristics of one changes, performance of the
whole assembly/system changes. Moreover, the spring rate
characteristics of the cushion and the clip assembly (e.g.,
cushion and flexible clip) can be different at set
locations. The spring rate, also known as the spring
constant or "k value", may be the force produced per
millimeter of deformation of a linear spring and may be
determined by equation F = kX. For example, the spring
rate may be determined by aligning a probe to act at a
particular test location of the cushion/clip assembly, and
may be perpendicular to the surface of the frame. The
probe may be driven into the location (such as at 50mm/min).
The probe may be stopped when the force exceeds some limit
(e.g., 10N). The force/displacement results may be
recorded and graphed.
In relation to such a spring constant, example
mask assemblies of the present technology are illustrated
in the table below. These include a flexible clip + foam
cushion assembly, denoted with FC and similar to that of
Fig. 47; another flexible clip + cushion assembly, denoted
by FF, where the clip is being replaced with a contoured
block of foam identical to that of the cushion; a further
flexible clip + cushion assembly (labelled as K1) is
similar to assembly FF but has a sculpted nasal recess, as
illustrated in Fig. 69. These measurements were
complimented by the measurements of other mask components,
specifically, a flexible clip without foam SC, and a
reference 25mm thick foam slab, denoted in the table as
"Foam".
Spring constants were determined in various
places of the cushion including bottom center, side of
mouth region (points "corner 1" and "corner 2" are on the
same side of the mouth with about a 0.5cm offset from each
other in lateral direction), cheek bone region and three
vertically aligned points along the nasal bridge region
(points nasal bridge 1, nasal bridge 2 and nasal bridge 3
are offset with respect to each other with about 0.5cm in
vertical direction). The spring constant data in the table
is summarized in Newtons per millimeter (N/mm). The table
indicates for the (foam + clip) assembly with a sculpted
nasal recess, a greater spring constant in a mouth region
(e.g., side of mouth regions) than in a nasal region (e.g.,
nasal bridge region) and similar spring constants in a
nasal region and a cheek bone region. For the flexible
clip only configuration (SC), the table indicates similar
spring constants in a nasal region and the corners of the
mouth region. It further illustrates a greater spring
constant in a cheek region than a nasal region (e.g., nasal
bridge region) but a lesser spring constant in a cheek
region (e.g., cheek bone region) than a mouth region (e.g.,
sides of mouth region).
The average numbers in the table are averaged
over several samples. Each of the minimum and the maximum
numbers correspond to a single measurement shown the
smallest or the largest value for the particular location,
respectively.
Bottom Corner 1 Corner 2 Cheek Bone Nasal Bridge 1 Nasal Bridge 2 Nasal Bridge 3
FC Average 0.11 0.09 0.07 0.07 0.11 0.09 0.08
FF Average 0.13 0.07 0.08 0.1 0.18 0.14 0.1
K1 Average 0.09 0.09 0.08 0.06 0.06 0.05 0.05
SC Average 0.12 0.74 0.77 0.26 0.13 0.09 0.07
Min SC 0.11 0.51 0.58 0.18 0.11 0.08 0.06
Max SC 0.13 0.88 1.04 0.32 0.15 0.1 0.07
Foam Min 0.06 0.06 0.06 0.06 0.06 0.06 0.06
Foam Average 0.13 0.13 0.13 0.13 0.13 0.13 0.13
Foam Max 0.18 0.18 0.18 0.18 0.18 0.18 0.18
.5. Glossary
For the purposes of the present technology
disclosure, 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.
.5.1 General
Air: In certain forms of the present technology,
air supplied to a patient may be atmospheric air, and in
other forms of the present technology atmospheric air may
be supplemented with oxygen.
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.
.5.2 Anatomy of the face
Ala: the external outer wall or "wing" of each
nostril (plural: alar)
Alare: The most lateral point on the nasal ala.
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.
Auricula or Pinna: The whole external visible part
of the ear.
(nose) Bony framework: The bony framework of the
nose comprises the nasal bones, the frontal process of the
maxillae and the nasal part of the frontal bone.
(nose) Cartilaginous framework: The cartilaginous
framework of the nose comprises the septal, lateral, major
and minor cartilages.
Columella: the strip of skin that separates the
nares and which runs from the pronasale to the upper lip.
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.
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.
Glabella: Located on the soft tissue, the most
prominent point in the midsagittal plane of the forehead.
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 greater alar cartilage.
Greater 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.
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.
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.
Naso-labial angle: The angle between the columella
and the upper lip, while intersecting subnasale.
Otobasion inferior: The lowest point of attachment
of the auricle to the skin of the face.
Otobasion superior: The highest point of attachment
of the auricle to the skin of the face.
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.
Philtrum: the midline groove that runs from lower
border of the nasal septum to the top of the lip in the
upper lip region.
Pogonion: Located on the soft tissue, the most
anterior midpoint of the chin.
Ridge (nasal): The nasal ridge is the midline
prominence of the nose, extending from the Sellion to the
Pronasale.
Sagittal plane: A vertical plane that passes from
anterior (front) to posterior (rear) dividing the body into
right and left halves.
Sellion: Located on the soft tissue, the most
concave point overlying the area of the frontonasal suture.
Septal cartilage (nasal): The nasal septal
cartilage forms part of the septum and divides the front
part of the nasal cavity.
Subalare: The point at the lower margin of the alar
base, where the alar base joins with the skin of the
superior (upper) lip.
Subnasal point: Located on the soft tissue, the
point at which the columella merges with the upper lip in
the midsagittal plane.
Supramentale: The point of greatest concavity in
the midline of the lower lip between labrale inferius and
soft tissue pogonion.
.5.3 Anatomy of the skull
Frontal bone: The frontal bone includes a large
vertical portion, the squama frontalis, corresponding to
the region known as the forehead.
Mandible: The mandible forms the lower jaw. The
mental protuberance is the bony protuberance of the jaw
that forms the chin.
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.
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.
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.
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.
Orbit: The bony cavity in the skull to contain the
eyeball.
Parietal bones: The parietal bones are the bones
that, when joined together, form the roof and sides of the
cranium.
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.
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 Anatomy of the respiratory system
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.
Larynx: The larynx, or voice box houses the vocal
folds and connects the inferior part of the pharynx
(hypopharynx) with the trachea.
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.
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.
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 nasal part of the pharynx), the
oropharynx (mesopharynx) (the oral part of the pharynx),
and the laryngopharynx (hypopharynx).
.5.5 Materials
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
moulded 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
Polycarbonate: a typically transparent
thermoplastic polymer of Bisphenol-A Carbonate.
.5.6 Aspects of a patient interface
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
rebreathing by a patient.
Elbow: A conduit that directs an axis of flow of
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.
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.
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.
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.
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
pressurised 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.
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.
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.
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.
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.
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 delivery
conduit, 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.
Tie: A tie will be taken to be a structural
component designed to resist tension.
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 ) and supply of oxygen (O ).
.5.7 Terms used in relation to patient interface
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 said 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 said to have a positive curvature. A
flat surface will be taken to have zero curvature.
Floppy: A quality of a material, structure or
composite that is the combination of features of:
• Readily conforming to finger pressure.
• Unable to retain its shape when caused to support
its own weight.
• Not rigid.
• Able to be stretched or bent elastically with
little effort.
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.
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.
Rigid: Not readily deforming to finger pressure,
and/or the tensions or loads typically encountered when
setting up and maintaining a patient interface in sealing
relationship with an entrance to a patient's airways.
Semi-rigid: means being sufficiently rigid to not
substantially distort under the effects of mechanical
forces typically applied during positive airway pressure
therapy.
.6 OTHER REMARKS
A portion of the disclosure of this patent
document contains material which is subject to copyright
protection. The copyright owner has no objection to the
facsimile reproduction by anyone of the patent document or
the patent disclosure, as it appears in the Patent and
Trademark Office patent file or records, but otherwise
reserves all copyright rights whatsoever.
Unless the context clearly dictates otherwise and
where a range of values is provided, it is understood that
each intervening value, to the tenth of the unit of the
lower limit, between the upper and lower limit of that
range, and any other stated or intervening value in that
stated range is encompassed within the technology. The
upper and lower limits of these intervening ranges, which
may be independently included in the intervening ranges,
are also encompassed within the technology, subject to any
specifically excluded limit in the stated range. Where the
stated range includes one or both of the limits, ranges
excluding either or both of those included limits are also
included in the technology.
Furthermore, where a value or values are stated
herein as being implemented as part of the technology, it
is understood that such values may be approximated, unless
otherwise stated, and such values may be utilized to any
suitable significant digit to the extent that a practical
technical implementation may permit or require it.
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.
When a particular material is identified as being
preferably used to construct a component, obvious
alternative materials with similar properties may be used
as a substitute.
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.
All publications mentioned herein are
incorporated by reference to disclose and describe the
methods and/or materials which are the subject of those
publications. The publications discussed herein are
provided solely for their disclosure prior to the filing
date of the present application. Nothing herein is to be
construed as an admission that the present technology is
not entitled to antedate such publication by virtue of
prior invention. Further, the dates of publication provided
may be different from the actual publication dates, which
may need to be independently confirmed.
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.
The expressions "soft" and "flexible", as well
as their derivatives, when used in this specification to
describe the first support clip 3812 (Fig. 40), are
intended to have the meaning of the expression "resilient"
as specifically defined in section "Terms used in relation
to patient interface". This is to say, the flexible
supporting clip is able to deform substantially
elastically, and to quickly release substantially all of
the energy upon unloading.
The subject headings used in the detailed
description are included only for the ease of reference of
the reader and should not be used to limit the subject
matter found throughout the disclosure or the claims. The
subject headings should not be used in construing the scope
of the claims or the claim limitations.
Although the technology herein has been described
with reference to particular embodiments, it is to be
understood that these embodiments 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.
It is therefore to be understood that numerous
modifications may be made to the illustrative embodiments
and that other arrangements may be devised without
departing from the spirit and scope of the technology.
.7 Parts List
patient 1000
partner 1100
patient interface 3000
seal forming structure 3100
cushion 3110
nasal ridge 3131
plenum chamber 3200
positioning and stabilising structure 3300
vent 3400
frame 3500
decoupling structure 3510
flange 3515
clip 3535
concave wall 3535W
connector 3536
fastener 3537
cushion support surface 3538
frame coupling surface 3539
peripheral lip 3540
middle transverse portion 3541
extra cantilever protrusion 3561
bulbous ridge 3572
channel 3574
finger 3576
skirt 3578
snap shoulder 3580
engagement cavity 3582
exploded view 3583
peripheral channel 3585
taper element 3586
taper receiving channel 3587
connection port 3600
forehead support 3700
peripheral rim 3702
scalloped notch 3763
protrusion 3764
anti-asphyxia valve 3800
foam cushion 3810
first clip 3812
projection 3813
second clip 3814
mask frame 3816
ports 3900
foam cushion assembly 3901
pap device 4000
external housing 4010
upper portion 4012
lower portion 4014
panel 4015
chassi 4016
handle 4018
pneumatic block 4020
pneumatic block 4020
coupling ridge 4022
snap element 4024
ridge stop 4025
taper 4027
pneumatic component 4100
inlet air filter 4112
inlet muffler 4122
outlet muffler 4124
controllable source 4140
blower 4142
air / gas circuit 4170
electrical component 4200
PCBA 4202
electrical power supply 4210
input device 4220
pressure sensor 4272
flow sensor 4274
therapy engine module 4320
coupling portion 4840
support portion 4842
base portion 4844
location ridge 4845
cushion coupling portion 4848
humidifier 5000
lip seal 5550
flexible lip seal 5550
hard stop 5551
rigid clip 5858
shell 6160
headgear frame 6162
shell aperture 6163
rigid clip 6314
engagement feature 6319
flexible member 6320
clip 6470
clip portion 6580
slit 6582
rigid clip 6758
clip recess 6770
recess membrane 6772
point 6910A
point 6910B
width 6910C
nasal recess 6912
location 7310H
edge 7660
rigid mask frame portion 7662
engagement rib 7664
engagement groove 7666
point 7668
frame opening 8012
receiving slot 8014
cushion support structure 8800
JAWS REF: 505862DIV3
Claims (47)
1. A mask cushion assembly for a patient interface of a respiratory treatment apparatus, the mask cushion assembly comprising a peripheral foam cushion and adapted to surround an entrance to the airways of the patient, the mask cushion assembly further comprising a flexible support component peripherally engaged with the foam cushion and a rigid support component coupled with the flexible support component, wherein the flexible support component is formed of an air impermeable material and wherein the flexible support component comprises an internal periphery of a plenum chamber of the mask cushion assembly, wherein the internal periphery of the flexible support component is adapted to respond to a treatment pressure provided at the mask cushion assembly to increase a sealing force of a seal of the foam cushion.
2. The mask cushion assembly of claim 1, wherein the peripheral foam cushion is adapted as a seal for at least a nasal portion.
3. The mask cushion assembly of claim 1 or 2 wherein the flexible support component is formed of a flexible material.
4. The mask cushion assembly of any one of claims 1-3 wherein the flexible support component is formed by a rigid material, wherein the flexible support component comprises one or more compliance regions inducing flexibility.
5. The mask cushion assembly of claim 4 wherein the one or more compliance regions are formed by introducing a line of weakness or a region of weakness.
6. The mask cushion assembly of any one of claims 1-5 wherein the rigid support component comprises a mask frame.
7. The mask cushion assembly of any one of claim 1-5 wherein the rigid support component comprises a clip for coupling with a mask frame.
8. The mask cushion assembly of claim 7 wherein the clip comprises at least one snap element.
9. The mask cushion assembly of any one of claims 1 to 3 wherein the flexible support component comprises an internal periphery of a plenum chamber of the mask cushion, wherein the JAWS REF: 505862DIV3 flexible support component is configured to respond with different reaction forces in at least some regions of the internal periphery.
10. The mask cushion assembly of claim 9 wherein the at least some regions of the internal periphery with different reaction forces comprise a side of nose region and a side of mouth region.
11. The mask cushion assembly of claim 1 wherein the flexible support component is configured to provide different roll-in responses in different regions of the internal periphery of the flexible support component.
12. The mask cushion assembly of claim 11 wherein the different regions comprise an upper cheek region and a side of mouth region.
13. The mask cushion assembly of one of claims 9 and 11 wherein the internal periphery is formed with different angles in the different regions, each angle formed by a support portion and a foam cushion coupling portion.
14. The mask cushion assembly of any one of claims 1 to 13 wherein the flexible support component comprises one or more of a 'C' cross sectional geometry and an 'L' cross sectional geometry.
15. The mask cushion assembly of any one of claims 1 to 14 wherein the foam cushion coupling portion comprises a peripheral lip to which the foam cushion is mounted.
16. The mask cushion assembly of claim 15 wherein the engagement of the peripheral lip and foam cushion form an overhang foam portion in at least some sections along a periphery of the peripheral lip.
17. The mask cushion assembly of any one of claims 1 to 16 wherein the foam cushion comprises a nasal bridge contact region.
18. The mask cushion assembly of claim 17 wherein the nasal bridge contact region of the foam cushion comprises a nasal recess. JAWS REF: 505862DIV3
19. The mask cushion assembly of any one of claims 1 to 18 wherein the peripheral foam cushion is further adapted as a seal for a mouth portion.
20. The mask cushion assembly of any one of claims 1 to 9 and 11 wherein the foam cushion comprises a substantially under nose seal portion, the substantially under nose seal portion comprising a sub-nasal ridge formed as a semi-peripheral sealing boundary about both nares of the patient.
21. The mask cushion assembly of any one of claims 1 to 20, wherein the flexible support component comprises a shell of a plenum chamber and a connection port for coupling to an air circuit of a respiratory treatment apparatus, and wherein the rigid support component comprises a headgear frame including a shell aperture configured for fitting about the shell.
22. The mask cushion assembly of any one of claims 1 to 21 wherein a flexible skirt member of a mask component moves to engage and cover an inner surface of the foam cushion, the flexible skirt member being air impermeable.
23. The mask cushion assembly of any one of claims 1 to 22 wherein the peripheral foam cushion is generally planar and the flexible support component and/or the rigid support component impart a three dimensional (3D) contour to the peripheral foam cushion, when attached to the foam cushion.
24. The mask cushion assembly of any one of claims 1 to 23 wherein the foam comprises a polyurethane semi-open cell foam of limited permeability.
25. The mask cushion assembly of any one of claims 1 to 24 wherein a spring constant of a foam cushion with a nasal recess and flexible support component in a mouth region is greater than a spring constant of the foam cushion and flexible support component in a nasal bridge region.
26. The mask cushion assembly of claim 25 wherein a spring constant of the foam cushion and flexible support component in a cheek region is similar to the spring constant of the nasal bridge region.
27. The mask cushion assembly of any one of claims 1 to 24 wherein a spring constant of a flexible clip only configuration in a mouth region is larger than a spring constant in a cheek bone JAWS REF: 505862DIV3 region and the spring constant in the cheek bone region is larger than a spring constant in a nasal bridge region.
28. The mask cushion assembly of any one of claims 1 to 27 wherein the foam cushion comprises a compression stress strain characteristic in a range of about 2.32 to 7.26 kilopascals.
29. The mask cushion assembly of any one of claims 1 to 28 wherein the foam cushion comprises a coefficient of friction characteristic in a range of about 1.86 to 19.12 CF.
30. The mask cushion assembly of any one of claims 1 to 29 wherein the foam cushion comprises an elongation at break characteristic in a range of about 72.3 to 369.05 percent.
31. The mask cushion assembly of any one of claims 1 to 30 wherein the foam cushion has a permeability characteristic in a range of about 0 to 20 liters per minute.
32. The mask cushion assembly of any one of claims 1 to 31 wherein the foam cushion has an indentation hardness characteristic in a range of about 110.48 to 303.11 Newtons.
33. The mask cushion assembly of any one of claims 1 to 32 wherein the foam cushion has a compression stress strain characteristic in a range of about 2.32 to 7.26 kilo-pascals.
34. The mask cushion assembly of any one of claims 1 to 33 wherein the foam cushion has an apparent density characteristic in a range of about 24.3 to 117.85 kilograms per meter cubed.
35. The mask cushion assembly of any one of claims 1 to 34 wherein the foam cushion has a compression set characteristic in a range of about 0.16 to 17.30 percent.
36. The mask cushion assembly of any one of claims 1 to 35 wherein the foam cushion comprises a tensile strength characteristic in a range of about 0.03 to 0.27 MegaPascals.
37. The mask cushion assembly of any one of claims 1 to 36 wherein the flexible support component is inwardly concave.
38. The mask cushion assembly of any one of claims 1 to 37 wherein flexible support component is made of a material other than foam. JAWS REF: 505862DIV3
39. The mask cushion assembly of any one of claims 1 to 38 wherein the cushion is made of foam and is externally attached to flexible support component.
40. The mask cushion assembly of any one of claims 1 to 39 wherein a foam surface of the cushion is configured for direct contact with a patient's skin.
41. The mask cushion assembly of any one of claims 1 to 40, wherein one or more parameters vary in at least some sections of a periphery of the flexible support component, the one or more parameters including: • spring constant of the flexible support component and/or the foam cushion; • cross-sectional profile of the flexible support component and/or the foam cushion; • wall thickness of the flexible support component; • angle of a contact surface of the flexible support component to which the cushion is attached; • overhang of the cushion with respect to a supporting contact surface of the flexible support component; and • foam thickness.
42. The mask cushion assembly of any one of claims 1 to 41, wherein the mask cushion assembly includes a protrusion configured to be, when in use, depressed by a headgear strap so as to apply pressure on a respective region of the foam cushion.
43. A mask cushion assembly of claim 1 wherein the foam cushion further comprises a stretchable engagement skirt, whereby the foam cushion is configured as a slip-over foam cover for a supporting structure.
44. A mask cushion assembly of claim 1 wherein the mask cushion assembly comprises an inner peripheral clip and outer peripheral clip that are configured to engage with the flexible support component, the inner peripheral clip engaging on an inner side of the foam cushion and the outer peripheral clip engaging on an outer side of the foam cushion, such that the inner peripheral clip and outer peripheral clip clamp the foam cushion to secure the foam cushion to the flexible support component. JAWS REF: 505862DIV3
45. The mask cushion assembly of claim 44 wherein the inner peripheral clip and outer peripheral clip are configured to clamp foam of the foam cushion so as to round a patient contact surface of the foam cushion.
46. The mask cushion assembly of any one of claims 44 to 45 wherein the inner peripheral clip and outer peripheral clip further comprise an over-clip portion configured to depress over a top side portion of the foam cushion.
47. The mask cushion assembly of any one of claims 44 to 46 wherein the foam cushion further comprises a slit to receive an over-clip portion. æØ º Ø æØ º Ø æØ º Ø æØ ºæØ ŒæØ ØæØ ŁæØ æØ æØ æØ æØ º Ł º Œ æØ º Œ Ł º æØ ºæØ ŒæØ ¸ — ØæØ ¿›¿· ‚¿††»· ºº ºº ŁŁ ŁŁ –›» ·•»… º ‹– «›‚•–† º ºº ºº ŁŁ ŁŁ º º »¿…„»¿fi ˚»‰‹–fi —«›‚ ŁæØ ˝ æØ º ºº ¿›¿· ‰‚¿††»· fi¿· ‰‚¿††»· æØ ºØ ºº ºØ ºØ Œ ºØ æØ ºº ºŒ ºŒ ºŒ ºŒ ºŒ æØ º ºŁ º æØ ØæØ ºº ºŁ º ºŒ º º ºº ºŁ º ºŒ º º ºŁ ºº º ºŒ º º æØ ºº ºº º º º ºŁ ˝ ˝ ºæØ ºŒ ºŒ ºº º Œ ŒæØ Œ ºŒ ºº ºŒ º ØæØ ºº ºŒ ŁæØ ºŒ ºŒ ºŒ ºº æØ æØ æØ Œ Œ º º æØ Œ ØŒ º æØ ØŒ ØŒ º ØŒ ØŒ æØ ºº ØŒ º Œ ºæØ ºº ºº ºØŁ º º ºØ ºº ºØ ºº ºØŁ ºº ºØ ºØŒ ºº ºØŒ º ºØŒ ºØ º ŒæØ ºŁ ºº Ø ºŁº º Ø ºŁ ºŁ º ºŁŒ ºº ºŁØ ºŁº ºº Ø º ØæØ Ø Ł Ł Ł Œ ŁŒ º ŁæØ ˝»¿·› –“»fi †¿›¿· fi•…„» ˝»¿·› ¿fi–«†… ‡–«‹‚ Ł æØ Ł Ł ŁŒ Ł Ł æØ Ł Ł Ł æØ Ł Ø º Ł Ł º Ø æØ Ł Ł Ł æØ ˛ Ł ˝˛ æØ ºæØ Œ Œ Œ Œ ŒæØ Ł Ł Ł Ł ØæØ ˝—º Ł Łº Ł Ł Ł Ł Ł ŁæØ ˛ Ł ˝˛ ˝˛ ˛ æØ Ł Łº Łº Łº Łº ºæØ ºæØ Ł Ł Ł Ł Ł Ł ºæØ Ł Ł Ł ººº ººº ŁŒ ºæØ Ł Ł Ł Ł ŁŒ ºæØ Ł Ł Ł ººæØ ºŁºŁ Ł ºŁºŁ Ł ºŁºŁ ºŁº ºŁº ºŒæØ Œ ŒŒ Œ Œ Œ Œ Ł Œ Ł Œ Ł Œ Ł ŒŒ ºØæØ ŒŒ ŒŒ ŒŒ Ł Œ Ø ºŁæØ ŒŒ ŒŒ Ł Œ ºæØ Œ ŒŒ ŒŒ Œ Œ Œ Œ Ł Ł Œ ŒŒ ŒŒ Œ Œ Œ Œ Œ Œ Ł Ł ŒæØ ŒØ ŒØ Ł ŁŒ ŒæØ ŒºŁ ŒØ ŒºŁ ŒØ ŒºŁ ŒºŁ Ł ŁŒ ŒæØ ŒØ ŒØ Ł ŁŒ Ł ŒØ ŒØ ŁŒ ŒæØ ŒØºŁ ŒØØ Ł ŒØØ ŒØØ ŒØºŁ ŒØØ ŁŒ ŒØºŁ ŒØØ ŒæØ Œ Œ Œ Œ ¿‰•¿· –†‹¿‰‹ ›•…» Ł ¿‰» ›•…» –›» ›•…» Ł ·• ›•…» ŒºæØ –¿‡ ‰–†‹¿‰‹ ›«fi”¿‰» Ł Ł ·• ‰–†‹¿‰‹ ›«fi”¿‰» –¿‡ ‰–†‹¿‰‹ ›«fi”¿‰» Ł ·• ‰–†‹¿‰‹ Ł ›«fi”¿‰» ŒŒæØ Ł Ø Ł –¿‡ ‰–†‹¿‰‹ ›«fi”¿‰» Ł Ł ·• ‰–†‹¿‰‹ ›«fi”¿‰» ŒØæØ –¿‡ ‰–†‹¿‰‹ ›«fi”¿‰» Ł Ł ·• ‰–†‹¿‰‹ ›«fi”¿‰» Ł Ł ØŒŒ ººº Ł ØŒŒ ØŒŒ ØŒŒŒ ØŒŒŁ ŒŁæØ Ł ŁŒ Ł Ł Ł Ł Ł Ł ŁŒ Ł Ł Ł ŒæØ Ł ŁŒ Ł Ł Ł Ł Ł Ł ØæØ ŁŒ Ł Ł Ł Ł Ł ØæØ Ł Ł Ł Ł ŁŒ ŁŒ Ł ˘ ˘ —•“–‹ ¤•› ØæØ Ł Ł Ł Ł Ł ØæØ Ł Ł Ł Ł
Priority Applications (1)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
NZ777484A NZ777484A (en) | 2013-02-04 | 2014-02-04 | Respiratory apparatus |
Applications Claiming Priority (5)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
AU2013900349A AU2013900349A0 (en) | 2013-02-04 | Cushion Assembly | |
AU2013900348 | 2013-02-04 | ||
AU2013900348A AU2013900348A0 (en) | 2013-02-04 | Respiratory Apparatus | |
AU2013900349 | 2013-02-04 | ||
NZ745260A NZ745260A (en) | 2013-02-04 | 2014-02-04 | Respiratory apparatus |
Publications (2)
Publication Number | Publication Date |
---|---|
NZ761302A NZ761302A (en) | 2021-08-27 |
NZ761302B2 true NZ761302B2 (en) | 2021-11-30 |
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