NZ793286A - Humidifier reservoir - Google Patents
Humidifier reservoirInfo
- Publication number
- NZ793286A NZ793286A NZ793286A NZ79328617A NZ793286A NZ 793286 A NZ793286 A NZ 793286A NZ 793286 A NZ793286 A NZ 793286A NZ 79328617 A NZ79328617 A NZ 79328617A NZ 793286 A NZ793286 A NZ 793286A
- Authority
- NZ
- New Zealand
- Prior art keywords
- reservoir
- thin film
- base
- water reservoir
- water
- Prior art date
Links
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 claims abstract 28
- 239000007788 liquid Substances 0.000 claims abstract 6
- 239000007769 metal material Substances 0.000 claims abstract 3
- 239000010409 thin film Substances 0.000 claims 19
- 239000000463 material Substances 0.000 claims 4
- 210000000088 Lip Anatomy 0.000 claims 2
- 210000003437 Trachea Anatomy 0.000 claims 2
- 101710039266 AKR7A2 Proteins 0.000 claims 1
- 210000000621 Bronchi Anatomy 0.000 claims 1
- 210000003238 Esophagus Anatomy 0.000 claims 1
- 210000000867 Larynx Anatomy 0.000 claims 1
- 241000658540 Ora Species 0.000 claims 1
- 210000001584 Palate, Soft Anatomy 0.000 claims 1
- 210000000614 Ribs Anatomy 0.000 claims 1
- RZVAJINKPMORJF-UHFFFAOYSA-N p-acetaminophenol Chemical compound CC(=O)NC1=CC=C(O)C=C1 RZVAJINKPMORJF-UHFFFAOYSA-N 0.000 claims 1
- 229920000515 polycarbonate Polymers 0.000 claims 1
- 239000004417 polycarbonate Substances 0.000 claims 1
- 229920001296 polysiloxane Polymers 0.000 claims 1
- 229920001169 thermoplastic Polymers 0.000 claims 1
- 239000004416 thermosoftening plastic Substances 0.000 claims 1
- 238000007789 sealing Methods 0.000 abstract 2
Abstract
water reservoir for an apparatus for humidifying a flow of breathable gas includes a reservoir base including a cavity structured to hold a volume of liquid and a conductive portion provided to the base. The conductive portion is adapted to thermally engage with a heater plate to allow thermal transfer of heat from the heater plate to the volume of liquid. The conductive portion includes a film comprising a non-metallic material, and the film is secured so that the film sealing covers a hole in the reservoir base, and perimeter edges of the film extend beyond edges of hole. nsfer of heat from the heater plate to the volume of liquid. The conductive portion includes a film comprising a non-metallic material, and the film is secured so that the film sealing covers a hole in the reservoir base, and perimeter edges of the film extend beyond edges of hole.
Description
A water reservoir for an apparatus for humidifying a flow of breathable gas includes a reservoir
base including a cavity structured to hold a volume of liquid and a tive n provided
to the base. The conductive portion is adapted to thermally engage with a heater plate to allow
thermal transfer of heat from the heater plate to the volume of liquid. The conductive portion
includes a film comprising a non-metallic material, and the film is secured so that the film sealing
covers a hole in the reservoir base, and perimeter edges of the film extend beyond edges of hole.
NZ 793286
James & Wells Ref: 506262NZDIV4, ResMed Ref: P1311NZ4
FIER RESERVOIR
1 CROSS-REFERENCE TO D APPLICATIONS
This application claims the benefit of lian Provisional Application
No. 2016904769, filed er 22, 2016, which is incorporated herein by reference
in its entirety.
2 BACKGROUND OF THE TECHNOLOGY
2.1 FIELD OF THE TECHNOLOGY
The present technology relates to one or more of the detection, sis,
treatment, prevention and amelioration of respiratory-related disorders. The present
technology also relates to medical devices or apparatus, and their use.
2.2 DESCRIPTION OF THE RELATED ART
2.2.1 Human Respiratory System and its Disorders
The respiratory system of the body facilitates gas exchange. The nose and
mouth form the entrance to the airways of a patient.
The airways include 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 inhaled air into the
venous blood and carbon dioxide to move in the opposite direction. The trachea
divides into right and left main bronchi, which further divide eventually into terminal
bronchioles. The bronchi make up the ting 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 atory zone. See “Respiratory Physiology”,
by John B. West, Lippincott Williams & Wilkins, 9th edition published 2012.
A range of respiratory disorders exist. Certain disorders may be
characterised by particular events, e.g. apneas, hypopneas, and neas.
Examples of respiratory disorders include Obstructive Sleep Apnea
(OSA), -Stokes Respiration (CSR), atory insufficiency, Obesity
James & Wells Ref: 506262NZDIV4, ResMed Ref: Z4
Hyperventilation Syndrome (OHS), Chronic Obstructive Pulmonary Disease (COPD),
Neuromuscular Disease (NMD) and Chest wall disorders.
Obstructive Sleep Apnea (OSA), a form of Sleep Disordered Breathing
(SDB), is characterised by events including occlusion or obstruction 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 t to
stop breathing for periods typically of 30 to 120 seconds in duration, sometimes 200
to 300 times per night. It often causes ive daytime somnolence, and it may
cause vascular disease and brain damage. The syndrome is a common disorder,
particularly in middle aged overweight males, gh a person affected may have no
awareness of the problem. See US Patent No. 4,944,310 (Sullivan).
Cheyne-Stokes Respiration (CSR) is another form of sleep disordered
breathing. CSR is a disorder of a patient's respiratory controller in which there are
rhythmic alternating periods of waxing and waning ventilation known as CSR cycles.
CSR is characterised by 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 US
Patent No. 6,532,959 (Berthon-Jones).
Respiratory failure is an umbrella term for respiratory disorders in which
the lungs are unable to inspire sufficient oxygen or exhale sufficient CO2 to meet the
patient’s needs. Respiratory failure may encompass some or all of the following
A patient with respiratory insufficiency (a form of respiratory e) may
experience abnormal ess of breath on exercise.
y Hyperventilation Syndrome (OHS) is d as the combination
of severe obesity and awake chronic hypercapnia, in the e of other known
causes for hypoventilation. Symptoms e dyspnea, morning headache and
excessive daytime sleepiness.
James & Wells Ref: 506262NZDIV4, ResMed Ref: Z4
Chronic Obstructive Pulmonary Disease (COPD) encompasses any of a
group of lower airway diseases that have certain characteristics in . These
e 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), tional res, air pollution and genetic factors.
ms include: dyspnea on exertion, chronic cough and sputum production.
Neuromuscular Disease (NMD) is a broad term that encompasses many
diseases and ailments that impair the functioning of the muscles either directly via
intrinsic muscle pathology, or indirectly via nerve pathology. Some NMD patients are
characterised by progressive muscular impairment leading to loss of ambulation,
being wheelchair-bound, swallowing difficulties, respiratory muscle weakness and,
eventually, death from respiratory failure. Neuromuscular ers 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 ssive disorders:
Characterised by muscle impairment that worsens over years and only mildly reduces
life expectancy (e.g. Limb girdle, Facioscapulohumeral and Myotonic muscular
dystrophy). Symptoms of respiratory failure in NMD include: increasing generalised
weakness, dysphagia, dyspnea on exertion and at rest, fatigue, sleepiness, morning
headache, and ulties with tration and mood changes.
Chest wall disorders are a group of thoracic deformities that result in
inefficient coupling between the respiratory muscles and the ic cage. The
disorders are usually characterised by a restrictive defect and share the ial of
long term hypercapnic respiratory failure. Scoliosis and/or kyphoscoliosis may cause
severe respiratory failure. Symptoms of atory failure include: dyspnea on
exertion, eral , orthopnea, repeated chest infections, morning headaches,
fatigue, poor sleep quality and loss of appetite.
A range of therapies have been used to treat or ameliorate such conditions.
Furthermore, otherwise healthy individuals may take advantage of such therapies to
James & Wells Ref: 506262NZDIV4, ResMed Ref: P1311NZ4
prevent respiratory disorders from arising. However, these have a number of
shortcomings.
2.2.2 Therapy
Various therapies, such as Continuous Positive Airway Pressure (CPAP)
therapy, Non-invasive ventilation (NIV) and Invasive ventilation (IV) have been used
to treat one or more of the above atory disorders.
Continuous Positive Airway Pressure (CPAP) therapy has been used to
treat Obstructive Sleep Apnea (OSA). The mechanism of action is that continuous
positive airway pressure acts as a pneumatic splint and may prevent upper airway
occlusion, such as by pushing the soft palate and tongue forward and away from the
posterior oropharyngeal wall. Treatment of OSA by CPAP therapy may be voluntary,
and hence ts may elect not to comply with therapy if they find devices used to
provide such y one or more of: uncomfortable, difficult to use, expensive and
aesthetically unappealing.
Non-invasive ventilation (NIV) provides ventilatory support to a patient
through the upper airways to assist the patient breathing and/or maintain te
oxygen levels in the body by doing some or all of the work of breathing. The
ventilatory support is provided via a non-invasive patient ace. NIV has been
used to treat CSR and respiratory failure, in forms such as OHS, COPD, NMD and
Chest Wall disorders. In some forms, the comfort and effectiveness of these therapies
may be improved.
Invasive ventilation (IV) provides ventilatory support to patients that are
no longer able to ively breathe themselves and may be provided using a
tracheostomy tube. In some forms, the comfort and effectiveness of these therapies
may be improved.
2.2.3 Treatment Systems
These therapies may be ed by a treatment system or device. Such
systems and devices may also be used to se a condition without treating it.
A treatment system may comprise a atory Pressure y Device
(RPT ), an air circuit, a humidifier, a patient interface, and data management.
James & Wells Ref: 506262NZDIV4, ResMed Ref: P1311NZ4
Another form of treatment system is a mandibular repositioning device.
2.2.3.1 Patient Interface
A patient interface may be used to interface respiratory equipment to its
wearer, for example by providing a flow of air to an entrance to the s. The flow
of air may be ed via a mask to the nose and/or mouth, a tube to the mouth or a
tracheostomy tube to the trachea of a patient. Depending upon the therapy to be
applied, the patient interface may form a seal, e.g., with a region of the t's face,
to facilitate the delivery of gas at a pressure at ient ce with ambient
pressure to effect therapy, e.g., at a positive pressure of about 10 cmH2O relative to
ambient pressure. 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 10 cmH2O.
Certain other mask systems may be functionally unsuitable for the present
field. For e, purely ntal masks may be unable to maintain a suitable
pressure. Mask systems used for underwater swimming or diving may be ured
to guard t ingress of water from an external higher re, but not to maintain
air internally at a higher pressure than ambient.
Certain masks may be clinically unfavourable for the present technology
e.g. if they block airflow via the nose and only allow it via the mouth.
Certain masks may be uncomfortable or impractical for the present
technology if they require a t to insert a portion of a mask structure in their
mouth to create and maintain a seal via their lips.
Certain masks may be impractical for use while sleeping, e.g. for sleeping
while lying on one’s side in bed with a head on a pillow.
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 and heads
varies considerably between duals. 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.
James & Wells Ref: 506262NZDIV4, ResMed Ref: P1311NZ4
As a consequence of these challenges, some masks suffer from being one
or more of ive, aesthetically undesirable, costly, poorly fitting, difficult to use,
and uncomfortable ally when worn for long periods of time or when a patient is
unfamiliar with a system. Wrongly sized masks can give rise to reduced compliance,
reduced comfort and poorer patient outcomes. Masks designed solely for aviators,
masks ed 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 such masks may be undesirably uncomfortable to be
worn for extended periods of time, e.g., several hours. This discomfort may lead to a
reduction in patient compliance with therapy. This is even more so if the mask is to
be worn during sleep.
CPAP y 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 difficult to clean (e.g., difficult to assemble or
disassemble), patients may not clean their mask and this may impact on patient
compliance.
While a mask for other applications (e.g. aviators) may not be suitable for
use in treating sleep ered ing, a mask designed for use in treating sleep
disordered breathing may be suitable for other applications.
For these reasons, patient interfaces for delivery of CPAP during sleep
form a distinct field.
2.2.3.1.1 Seal-forming structure
Patient interfaces may include a seal-forming structure. Since it is in direct
t with the t’s face, the shape and configuration of the orming
structure can have a direct impact the effectiveness and comfort of the patient
interface.
A patient ace may be partly characterised according to the design
intent of where the seal-forming structure is to engage with the face in use. In one
form of patient interface, a orming structure may comprise a first sub-portion to
form a seal around the left naris and a second sub-portion to form a seal around the
James & Wells Ref: 506262NZDIV4, ResMed Ref: P1311NZ4
right naris. In one form of patient interface, a seal-forming structure may comprise a
single element that nds 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 ace a seal-forming structure may se 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 structure 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 y of names by their manufacturer
ing nasal masks, full-face masks, nasal pillows, nasal puffs and oro-nasal
masks.
A seal-forming structure that may be effective in one region of a patient’s
face may be inappropriate in another region, e.g. because of the ent shape,
structure, ility and sensitivity regions of the patient’s face. For example, a seal
on swimming goggles that overlays a patient’s ad may not be appropriate to use
on a patient’s nose.
Certain seal-forming structures may be designed for mass manufacture
such that one design fit and be comfortable and effective for a wide range of different
face shapes and sizes. To the extent to which there is a mismatch between the shape
of the patient’s face, and the seal-forming structure of the mass-manufactured patient
interface, one or both must adapt in order for a seal to form.
One type of orming structure extends around the periphery of the
patient interface, and is intended to seal t the patient's face when force is
applied to the patient interface with the seal-forming structure in confronting
engagement with the patient's face. The seal-forming structure may include an air or
fluid filled cushion, or a moulded or formed surface of a resilient seal element made
of an mer such as a rubber. With this type of seal-forming structure, if the fit is
not adequate, there will be gaps between the seal-forming structure 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 structure incorporates a flap seal of thin
material positioned about the periphery of the mask so as to provide a self-sealing
James & Wells Ref: 506262NZDIV4, ResMed Ref: Z4
action against the face of the patient when positive pressure is applied within the
mask. Like the previous style of seal g portion, if the match between the face
and the mask is not good, additional force may be required to achieve a seal, or the
mask may leak. Furthermore, if the shape of the orming structure does not match
that of the patient, it may crease or buckle in use, giving rise to leaks.
Another type of seal-forming structure may comprise a friction-fit
element, e.g. for insertion into a naris, however some patients find these
uncomfortable.
Another form of seal-forming structure may use adhesive to achieve 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 structure technologies are
disclosed in the following patent applications, ed to ResMed Limited: WO
1998/004,310;
One form of nasal pillow is found in the Adam Circuit ctured by
Puritan Bennett. Another nasal pillow, or nasal puff is the subject of US Patent
4,782,832 le et al.), assigned to Puritan-Bennett Corporation.
ResMed Limited has manufactured the ing products that
incorporate nasal pillows: SWIFTTM nasal pillows mask, SWIFTTM II nasal pillows
mask, M LT nasal pillows mask, SWIFTTM FX nasal pillows mask and
MIRAGE LIBERTYTM full-face mask. The following patent applications, assigned to
ResMed Limited, describe examples of nasal s masks: International Patent
Application WO2004/073,778 (describing amongst other things aspects of the
ResMed Limited SWIFTTM nasal pillows), US Patent Application 2009/0044808
(describing amongst other things aspects of the ResMed Limited M LT nasal
pillows); International Patent Applications
(describing amongst other things aspects of the ResMed d MIRAGE
LIBERTYTM full-face mask); International Patent Application
(describing amongst other things aspects of the ResMed Limited M FX nasal
pillows).
James & Wells Ref: 506262NZDIV4, ResMed Ref: P1311NZ4
2.2.3.1.2 Positioning and stabilising
A seal-forming structure of a patient interface used for positive air
pressure y 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
structure, 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
Application Publication No. US 2010/0000534. However, the use of adhesives may
be uncomfortable for some.
r technique is the use of one or more straps and/or stabilising
harnesses. Many such harnesses suffer from being one or more of ill-fitting, bulky,
uncomfortable and awkward to use.
2.2.3.2 Respiratory Pressure Therapy (RPT) Device
A respiratory pressure therapy (RPT) device may be used to r one or
more of a number of therapies bed above, such as by generating a flow of air for
delivery to an entrance to the airways. The flow of air may be pressurised. Examples
of RPT devices include a CPAP device and a ventilator.
Air pressure generators are known in a range of applications, e.g.
industrial-scale ventilation systems. However, air pressure generators for medical
applications have particular requirements not fulfilled by more generalised air
re generators, such as the reliability, size and weight requirements of medical
s. In addition, even devices designed for medical treatment may suffer from
shortcomings, pertaining to one or more of: comfort, noise, ease of use, efficacy, size,
weight, manufacturability, cost, and reliability.
An example of the special requirements of n RPT devices is acoustic
noise.
Table of noise output levels of prior RPT s (one specimen only,
measured using test method specified in ISO 3744 in CPAP mode at 10 cmH2O).
RPT Device name A-weighted sound Year (approx.)
pressure level dB(A)
James & Wells Ref: 506262NZDIV4, ResMed Ref: P1311NZ4
C-Series TangoTM 31.9 2007
C-Series TangoTM with Humidifier 33.1 2007
S8 TM II 30.5 2005
S8 EscapeTM II with H4iTM Humidifier 31.1 2005
S9 AutoSetTM 26.5 2010
S9 AutoSetTM with H5i Humidifier 28.6 2010
One known RPT device used for treating sleep disordered breathing is the
S9 Sleep Therapy System, manufactured by ResMed Limited. Another example of an
RPT device is a ventilator. Ventilators such as the ResMed r™ Series of Adult
and Paediatric Ventilators may provide support for invasive and non-invasive nondependent
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 ation modes with a single or double limb circuit.
RPT devices typically comprise a pressure generator, such as a driven blower
or a compressed gas reservoir, and are configured to supply a flow of air to the airway
of a patient. In some cases, the flow of air may be supplied to the airway of the patient
at positive pressure. The outlet of the RPT device is connected via an air circuit to a
patient ace such as those described above.
The designer of a device may be presented with an infinite number of
choices to make. Design ia often conflict, meaning that certain design choices
are far from routine or inevitable. Furthermore, the comfort and efficacy of certain
s may be highly sensitive to small, subtle changes in one or more ters.
2.2.3.3 Humidifier
Delivery of a flow of air without humidification may cause drying of
airways. The use of a humidifier with an RPT device and the patient interface
produces humidified gas that zes drying of the nasal mucosa and increases
James & Wells Ref: 506262NZDIV4, ResMed Ref: P1311NZ4
patient airway comfort. In addition in cooler es, warm air applied generally to
the face area in and about the patient ace is more comfortable than cold air.
A range of artificial humidification devices and systems are known,
however they may not fulfil the specialised requirements of a medical humidifier.
Medical humidifiers are used to se humidity and/or temperature of
the flow of air in relation to ambient air when required, typically where the patient
may be asleep or resting (e.g. at a hospital). A medical fier for bedside
placement may be small. A medical humidifier may be configured to only humidify
and/or heat the flow of air delivered to the patient without humidifying and/or heating
the patient’s surroundings. ased s (e.g. a sauna, an air conditioner, or
an evaporative cooler), for example, may also humidify air that is breathed in by the
patient, however those systems would also humidify and/or heat the entire room,
which may cause fort to the occupants. Furthermore medical humidifiers may
have more stringent safety constraints than industrial humidifiers.
While a number of medical fiers are known, they can suffer from
one or more shortcomings. Some medical humidifiers may provide inadequate
humidification, some are difficult or inconvenient to use by patients.
2.2.3.4 Data Management
There may be clinical reasons to obtain data to determine whether the
patient prescribed with respiratory therapy has been “compliant”, e.g. that the patient
has used their RPT device according to n a “compliance rule”. One example of a
compliance rule for CPAP therapy is that a patient, in order to be deemed compliant,
is required to use the RPT device for at least four hours a night for at least 21 of 30
consecutive days. In order to determine a patient's ance, a er of the RPT
device, such as a health care provider, may manually obtain data describing the
patient's therapy using the RPT device, calculate the usage over a predetermined time
period, and compare with the compliance rule. Once the health care provider has
determined that the patient has used their RPT device according to the ance
rule, the health care provider may notify a third party that the patient is compliant.
There may be other aspects of a patient’s therapy that would benefit from
communication of therapy data to a third party or external system.
James & Wells Ref: 506262NZDIV4, ResMed Ref: P1311NZ4
Existing processes to communicate and manage such data can be one or
more of costly, time-consuming, and error-prone.
2.2.3.5 Mandibular repositioning
A ular repositioning device (MRD) or ular advancement
device (MAD) is one of the treatment options for sleep apnea and snoring. It is an
adjustable oral appliance available from a t or other er that holds the
lower jaw (mandible) in a forward position during sleep. The MRD is a ble
device that a patient inserts into their mouth prior to going to sleep and removes
following sleep. Thus, the MRD is not designed to be worn all of the time. The
MRD may be custom made or produced in a standard form and includes a bite
impression portion designed to allow fitting to a patient’s teeth. This mechanical
protrusion of the lower jaw expands the space behind the tongue, puts tension on the
pharyngeal walls to reduce collapse of the airway and diminishes palate vibration.
In certain examples a mandibular advancement device may comprise an
upper splint that is intended to engage with or fit over teeth on the upper jaw or
maxilla and a lower splint that is intended to engage with or fit over teeth on the upper
jaw or mandible. The upper and lower splints are connected together laterally via a
pair of connecting rods. The pair of connecting rods are fixed symmetrically on the
upper splint and on the lower .
In such a design the length of the connecting rods is selected such that
when the MRD is placed in a patient’s mouth the mandible is held in an advanced
position. The length of the connecting rods may be adjusted to change the level of
protrusion of the mandible. A t may determine a level of protrusion for the
mandible that will ine the length of the connecting rods.
Some MRDs are structured to push the mandible d relative to the
maxilla while other MADs, such as the ResMed Narval CC™ MRD are designed to
retain the mandible in a forward position. This device also reduces or minimises
dental and temporo-mandibular joint (TMJ) side effects. Thus, it is configured to
minimises or prevent any movement of one or more of the teeth.
James & Wells Ref: 506262NZDIV4, ResMed Ref: P1311NZ4
2.2.3.6 Vent technologies
Some forms of treatment systems may e a vent to allow the washout
of d carbon dioxide. The vent may allow a flow of gas from an or space of
a patient interface, e.g., the plenum chamber, to an exterior of the patient interface,
e.g., to ambient.
The vent may comprise an orifice and gas may flow through the orifice in
use of the mask. Many such vents are noisy. Others may become blocked in use and
thus provide insufficient washout. Some vents may be disruptive of the sleep of a bed
partner 1100 of the patient 1000, e.g. h noise or focussed airflow.
ResMed Limited has developed a number of improved mask vent
technologies. See International Patent Application Publication No.
International Patent Application Publication No.
6,581,594; US Patent Application Publication No. US 2009/0050156; US Patent
Application Publication No. 2009/0044808.
Table of noise of prior masks (ISO 17510-2:2007, 10 cmH2O re at
Mask name Mask type A-weighted A-weighted Year (approx.)
sound power sound re
level dB(A) dB(A)
(uncertainty) (uncertainty)
Glue-on (*) nasal 50.9 42.9 1981
ResCare nasal 31.5 23.5 1993
standard (*)
ResMed nasal 29.5 21.5 1998
MirageTM (*)
ResMed nasal 36 (3) 28 (3) 2000
UltraMirageTM
ResMed nasal 32 (3) 24 (3) 2002
Mirage
ActivaTM
ResMed nasal 30 (3) 22 (3) 2008
Mirage
MicroTM
ResMed nasal 29 (3) 22 (3) 2008
MirageTM
James & Wells Ref: 506262NZDIV4, ResMed Ref: Z4
SoftGel
ResMed nasal 26 (3) 18 (3) 2010
MirageTM FX
ResMed nasal pillows 37 29 2004
Mirage SwiftTM
ResMed nasal pillows 28 (3) 20 (3) 2005
Mirage SwiftTM
ResMed nasal pillows 25 (3) 17 (3) 2008
Mirage SwiftTM
ResMed AirFit nasal pillows 21 (3) 13 (3) 2014
(* one specimen only, measured using test method specified in ISO 3744
in CPAP mode at 10 cmH2O)
Sound pressure values of a variety of objects are listed below
Object A-weighted sound pressure dB(A) Notes
Vacuum cleaner: Nilfisk 68 ISO 3744 at 1m
Walter Broadly Litter Hog: B+ distance
Grade
Conversational speech 60 1m distance
Average home 50
Quiet library 40
Quiet bedroom at night 30
Background in TV studio 20
2.2.4 Diagnosis and Monitoring Systems
Polysomnography (PSG) is a conventional system for diagnosis and
monitoring of cardio-pulmonary disorders, and typically involves expert clinical staff
to apply the . PSG typically es the placement of 15 to 20 contact sensors
on a t in order to record various bodily signals such as electroencephalography
(EEG), electrocardiography (ECG), electrooculograpy (EOG), electromyography
(EMG), etc. PSG for sleep ered breathing has involved two nights of
James & Wells Ref: 506262NZDIV4, ResMed Ref: P1311NZ4
observation of a patient in a clinic, one night of pure diagnosis and a second night of
titration of treatment parameters by a clinician. PSG is therefore expensive and
inconvenient. In particular it is unsuitable for home sleep g.
Clinical experts may be able to diagnose or monitor patients adequately
based on visual observation of PSG signals. However, there are circumstances where
a clinical expert may not be available, or a al expert may not be affordable.
ent clinical experts may disagree on a t’s condition. In addition, a given
clinical expert may apply a different standard at different times.
3 BRIEF SUMMARY OF THE TECHNOLOGY
The present technology is directed towards providing medical devices
used in the sis, amelioration, treatment, or prevention of respiratory disorders
having one or more of improved t, cost, efficacy, ease of use and
manufacturability.
A first aspect of the present technology relates to apparatus used in the
diagnosis, amelioration, ent or prevention of a atory er.
Another aspect of the present technology relates to methods used in the
diagnosis, amelioration, treatment or prevention of a respiratory disorder.
An aspect of certain forms of the present technology is to provide methods
and/or apparatus that improve the compliance of patients with respiratory therapy.
An aspect of the present technology relates to a humidifier including a
water reservoir comprising a non-metallic, thin film base adapted to thermally engage
with a heater plate. The thin film base of the water reservoir is ured to provide
an arrangement that reduces cost of production of the water reservoir, while retaining,
or improving, its heat transfer characteristics as well as its reliability. In an example,
the thin film base may be sufficiently thin and flat to provide good thermal contact
and good humidifier performance and allow a suitable material to be selected, e.g.,
depending on humidifier requirements and performance.
James & Wells Ref: 506262NZDIV4, ResMed Ref: P1311NZ4
An aspect of the present technology relates to a water oir for an
tus for humidifying a flow of breathable gas including a reservoir base
including a cavity structured to hold a volume of liquid and a conductive portion
provided to the base. The tive portion is adapted to thermally engage with a
heater plate to allow l transfer of heat from the heater plate to the volume of
liquid. The conductive portion includes a thin film comprising a non -metallic
al, and the thin film es a wall thickness less than about 1 mm.
In an example, the wall thickness of the thin film may be less than about
0.5 mm. In an example, the thin film may comprise ne, polycarbonate, or other
thermoplastic or elastomeric materials. In an example, the thin film may be provided
as a separate and distinct structure from the reservoir base. In an example, the thin
film comprises a pre-formed structure that is secured or otherwise provided to the
oir base. In an example, the reservoir base may include a hole structured to
receive the thin film. In an example, the thin film may include a shape that
corresponds to a shape of the hole. In an example, the thin film may be generally
planar. In an example, the thin film may include a first side adapted to form a bottom
interior surface of the water reservoir exposed to the volume of liquid and a second
side, opposite to the first side, adapted to form a bottom or surface of the water
reservoir exposed to the heater plate. In an example, the second side of the thin film
may provide a contact e structured and arranged to directly engage with the
heater plate. In an example, the non-metallic material of the thin film may be similar
to a material of the reservoir base. In an example, the wall thickness of the thin film
may be less than a wall ess of walls of the reservoir base. In an example, the
water reservoir may further comprise one or more ribs structured and arranged to
extend across the thin film so as to create a force d to push the thin film against
the heater plate. In an example, the reservoir base may include a base upper body, a
base bottom plate, and the thin film which together form the cavity. In an example,
the water reservoir may further comprise a reservoir lid movably connected to the
reservoir base to allow the water reservoir to be convertible between an open
configuration and a closed configuration.
Another aspect of the present technology relates to a water reservoir for an
apparatus for humidifying a flow of breathable gas including a reservoir base
James & Wells Ref: 506262NZDIV4, ResMed Ref: P1311NZ4
including a cavity structured to hold a volume of liquid and a conductive portion
provided to the base. The conductive portion is adapted to thermally engage with a
heater plate to allow thermal transfer of heat from the heater plate to the volume of
liquid. T he conductive portion includes a thin film comprising a non-metallic
material. The thin film is provided as a separate and distinct structure from the
oir base, and the thin film es a wall thickness that is less than a wall
thickness of walls of the reservoir base. In an example, the thin film may comprise a
pre-formed structure that is secured or ise provided to the reservoir base.
An aspect of one form of the present technology is a method of
manufacturing apparatus.
An aspect of certain forms of the present technology is a medical device
that is easy to use, e.g. by a person who does not have medical training, by a person
who has limited dexterity, vision or by a person with limited experience in using this
type of medical device.
An aspect of one form of the present technology is a patient interface that
may be washed in a home of a patient, e.g., in soapy water, without requiring
specialised ng equipment. An aspect of one form of the present technology is a
humidifier tank that may be washed in a home of a patient, e.g., in soapy water,
without requiring specialised cleaning equipment.
The methods, systems, devices and apparatus described herein can
provide improved oning in a sor, such as of a processor of a specific
purpose er, respiratory monitor and/or a atory therapy apparatus.
Moreover, the described methods, systems, devices and apparatus can provide
improvements in the technological field of automated management, monitoring and/or
ent of respiratory conditions, ing, for example, sleep disordered
breathing.
Of course, portions of the aspects may form sub-aspects of the present
technology. Also, s 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.
James & Wells Ref: 506262NZDIV4, ResMed Ref: P1311NZ4
Other features of the technology will be apparent from eration of
the information contained in the ing 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 a system including a patient 1000 wearing a patient
interface 3000, in the form of nasal pillows, receiving a supply of air at ve
pressure from an RPT device 4000. Air from the RPT device 4000 is humidified in a
humidifier 5000, and passes along an air circuit 4170 to the patient 1000. A bed
partner 1100 is also shown. The patient is sleeping in a supine sleeping position.
Fig. 1B shows a system including a patient 1000 g a patient
interface 3000, in the form of a nasal mask, receiving a supply of air at positive
pressure from an RPT device 4000. Air from the RPT device is fied in a
humidifier 5000, and passes along an air circuit 4170 to the patient 1000.
Fig. 1C shows a system including a patient 1000 wearing a t
interface 3000, in the form of a full-face mask, receiving a supply of air at positive
pressure from an RPT device 4000. Air from the RPT device is fied in a
humidifier 5000, and passes along an air circuit 4170 to the patient 1000. The patient
is sleeping in a side sleeping position.
4.2 ATORY SYSTEM AND FACIAL ANATOMY
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 ,
nasal bone, lateral nasal cartilage, greater alar cartilage, nostril, lip superior, lip
James & Wells Ref: NZDIV4, ResMed Ref: P1311NZ4
inferior, larynx, hard palate, soft palate, oropharynx, tongue, epiglottis, vocal folds,
oesophagus and a.
4.3 PATIENT INTERFACE
Fig. 3A shows a patient interface in the form of a nasal mask in
accordance with one form of the t technology.
Fig. 3B shows a schematic of a cross-section through a structure at a
point. An outward normal at the point is indicated. The curvature at the point has a
positive sign, and a relatively large ude when compared to the magnitude of the
curvature shown in Fig. 3C.
Fig. 3C shows a schematic of a cross-section through a structure at a
point. An outward normal at the point is ted. The curvature at the point has a
positive sign, and a relatively small magnitude when compared to the magnitude of
the curvature shown in Fig. 3B.
Fig. 3D shows a schematic of a cross-section through a structure at a
point. An outward normal at the point is indicated. The curvature at the point has a
value of zero.
Fig. 3E shows a schematic of a section through a ure at a
point. An outward normal at the point is indicated. The curvature at the point has a
negative sign, and a relatively small magnitude when compared to the magnitude of
the curvature shown in Fig. 3F.
Fig. 3F shows a schematic of a cross-section through a structure at a point.
An outward normal at the point is indicated. The curvature at the point has a negative
sign, and a relatively large magnitude when compared to the magnitude of the
curvature shown in Fig. 3E.
Fig. 3G shows a cushion for a mask that includes two pillows. An exterior
surface of the cushion is ted. An edge of the e is indicated. Dome and
saddle regions are indicated.
Fig. 3H shows a cushion for a mask. An exterior surface of the cushion is
indicated. An edge of the surface is indicated. A path on the surface between points A
James & Wells Ref: 506262NZDIV4, ResMed Ref: P1311NZ4
and B is indicated. A ht line ce between A and B is ted. Two saddle
regions and a dome region are indicated.
Fig. 3I shows the surface of a structure, with a one dimensional hole in the
surface. The illustrated plane curve forms the boundary of a one dimensional hole.
Fig. 3J shows a cross-section through the structure of Fig.3I. The
illustrated surface bounds a two dimensional hole in the structure of Fig. 3I.
Fig. 3K shows a perspective view of the ure of Fig. 3I, ing the
two dimensional hole and the one dimensional hole. Also shown is the surface that
bounds a two dimensional hole in the structure of Fig. 3I.
Fig. 3L shows a mask having an inflatable bladder as a cushion.
Fig. 3M shows a cross-section through the mask of Fig. 3L, and shows the
interior surface of the bladder. The interior surface bounds the two dimensional hole
in the mask.
Fig. 3N shows a further cross-section through the mask of Fig. 3L. The
interior surface is also indicated.
Fig. 3O illustrates a left-hand rule.
Fig. 3P illustrates a right-hand rule.
Fig. 3Q shows a left ear, including the left ear helix.
Fig. 3R shows a right ear, including the right ear helix.
Fig. 3S shows a right-hand helix.
Fig. 3T shows a view of a mask, including the sign of the torsion of the
space curve d by the edge of the sealing membrane in different regions of the
mask.
4.4 RPT DEVICE
Fig. 4A shows an RPT device in accordance with one form of the present
technology.
James & Wells Ref: 506262NZDIV4, ResMed Ref: P1311NZ4
4.5 HUMIDIFIER
Fig. 5 is a perspective view of an RPT device and an integrated humidifier
according to an example of the present technology, and demonstrating ment of
the fier with the air circuit according to an example of the present technology.
Fig. 6 is a perspective view of the RPT device and integrated humidifier
of Fig. 5 demonstrating ment of the humidifier reservoir with the reservoir
dock according to an example of the present technology.
Fig. 7 is another ctive view of the RPT device and integrated
humidifier of Fig. 5.
Fig. 8 is another perspective view of the RPT device and integrated
humidifier of Fig. 5 demonstrating engagement of the humidifier reservoir with the
oir dock according to an example of the present technology.
Fig. 9 to 12 show various views of a humidifier reservoir according to an
example of present technology, wherein Figs. 9 to 11 show the humidifier reservoir in
a closed configuration and Fig. 12 shows the humidifier reservoir in an open
configuration.
Fig. 13 is a top perspective view of a reservoir base of a humidifier
reservoir according to an example of present technology.
Fig. 14 is a bottom perspective view of the reservoir base of Fig. 13.
Fig. 15 is an exploded view of the reservoir base of Fig. 13.
Fig. 16 is a sectional view of a humidifier reservoir including the
reservoir base of Fig. 13 according to an example of present technology.
Fig. 17 is a cross-sectional view of a base bottom plate and conductive
n of the oir base of Fig. 13 according to an example of present
technology.
Fig. 18 is a top perspective view of a reservoir base of a fier
reservoir according to another example of present technology.
James & Wells Ref: 506262NZDIV4, ResMed Ref: P1311NZ4
Fig. 19 is a bottom perspective view of the reservoir base of Fig. 18.
Fig. 20 is a cross-sectional view of a base bottom plate and tive
portion of the reservoir base of Fig. 18 according to an e of present
technology.
Fig. 21 shows a schematic of a humidifier in accordance with one form of
the present technology.
DETAILED DESCRIPTION OF EXAMPLES OF THE
TECHNOLOGY
Before the present technology is described in further detail, it is to be
understood that the technology is not limited to the ular es described
, 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.
The following description is provided in relation to various examples
which may share one or more common characteristics and/or features. It is to be
tood that one or more features of any one example may be combinable with one
or more features of another example or other examples. In addition, any single
feature or combination of features in any of the examples may tute a further
example.
.1 THERAPY
In one form, the present technology comprises a method for treating a
respiratory disorder comprising the step of applying positive pressure to the entrance
of the airways of a patient 1000.
In certain examples of the present technology, a supply of air at positive
pressure is ed to the nasal passages of the patient via one or both nares.
In certain examples of the present technology, mouth breathing is limited,
restricted or prevented.
James & Wells Ref: 506262NZDIV4, ResMed Ref: P1311NZ4
.2 ENT SYSTEMS
In one form, the present technology comprises an apparatus or device for
treating a respiratory er. The apparatus or device may comprise an RPT device
4000 for ing rised air to the t 1000 via an air circuit 4170 to a
patient interface 3000, e.g., see Figs. 1A to 1C.
.3 PATIENT INTERFACE
As shown in Fig. 3A, a non-invasive patient interface 3000 in accordance
with one aspect of the present technology comprises the following onal aspects:
a seal-forming structure 3100, a plenum chamber 3200, a positioning and stabilising
structure 3300, a vent 3400, one form of connection port 3600 for connection to air
t 4170, and a forehead support 3700. In some forms a onal aspect may be
provided by one or more physical components. In some forms, one physical
component may provide one or more functional aspects. In use the seal-forming
structure 3100 is arranged to surround an entrance to the airways of the patient so as
to facilitate the supply of air at positive pressure to the airways.
If a patient interface is unable to tably deliver a minimum level of
positive pressure to the airways, the patient interface may be unsuitable for respiratory
pressure therapy.
The patient interface 3000 in accordance with one form of the present
technology is constructed and arranged to be able to provide a supply of air at a
positive pressure of at least 6 cmH2O with respect to ambient.
The patient interface 3000 in ance with one form of the present
technology is constructed and arranged to be able to provide a supply of air at a
positive pressure of at least 10 cmH2O with respect to ambient.
The patient interface 3000 in accordance with one form of the present
technology is constructed and arranged to be able to provide a supply of air at a
positive pressure of at least 20 cmH2O with respect to t.
.4 RPT DEVICE
An RPT device 4000 in accordance with one aspect of the present
technology comprises mechanical, pneumatic, and/or electrical components and is
James & Wells Ref: 506262NZDIV4, ResMed Ref: P1311NZ4
configured to execute one or more algorithms, e.g., see Fig. 4A. The RPT device 4000
may be configured to generate a flow of air for delivery to a patient’s airways, such as
to treat one or more of the respiratory conditions described ere in the present
document.
In one form, the RPT device 4000 is ucted and arranged to be
capable of delivering a flow of air in a range of -20 L/min to +150 L/min while
maintaining a positive pressure of at least 6 cmH2O, or at least 10cmH2O, or at least
cmH2O.
A power supply may be located internal or external of the external
housing of the RPT device 4000.
In one form of the t technology, power supply provides electrical
power to the RPT device only. In another form of the present technology, power
supply provides electrical power to both RPT device 4000 and fier 5000.
In one form of the present technology, the RPT device 4000 includes a
central controller including one or a ity of processors suitable to control an RPT
device 4000.
Suitable processors may include an x86 INTEL processor, a processor
based on ARM® Cortex®-M processor from ARM Holdings such as an STM32
series microcontroller from ST MICROELECTRONIC. In certain alternative forms of
the present technology, a 32-bit RISC CPU, such as an STR9 series microcontroller
from ST MICROELECTRONICS or a 16-bit RISC CPU such as a processor from the
MSP430 family of microcontrollers, manufactured by TEXAS INSTRUMENTS may
also be suitable.
In one form of the t technology, the central controller is a dedicated
electronic circuit.
In one form, the central controller is an application-specific integrated
circuit. In another form, the central controller ses te electronic
components.
James & Wells Ref: 506262NZDIV4, ResMed Ref: P1311NZ4
The central controller may be configured to receive input signal(s) from
one or more transducers, one or more input devices, and the humidifier 5000.
The central controller may be configured to provide output (s) to
one or more of an output device, a therapy device ller, a data communication
interface, and the humidifier 5000.
In some forms of the present technology, the central ller is
configured to ent the one or more ologies described herein, such as the
one or more algorithms expressed as computer programs stored in a non-transitory
computer readable storage medium, such as memory. In some forms of the present
technology, the central controller may be integrated with an RPT device 4000.
However, in some forms of the present technology, some methodologies may be
performed by a remotely located device. For example, the remotely located device
may determine control settings for a ventilator or detect respiratory related events by
is of stored data such as from any of the sensors described herein.
.5 AIR CIRCUIT
An air circuit 4170 in ance with an aspect of the present technology
is a conduit or a tube constructed and arranged to allow, in use, a flow of air to travel
n two components such as RPT device 4000 and the patient interface 3000.
In particular, the air circuit 4170 may be in fluid connection with the
outlet of the tic block and the patient interface. The air t may be referred
to as an air delivery tube. In some cases there may be separate limbs of the circuit for
inhalation and exhalation. In other cases a single limb is used.
In some forms, the air circuit 4170 may comprise one or more heating
elements configured to heat air in the air circuit, for example to maintain or raise the
ature of the air. The heating element may be in a form of a heated wire circuit,
and may comprise one or more transducers, such as temperature sensors. In one form,
the heated wire circuit may be helically wound around the axis of the air circuit 4170.
The heating element may be in communication with a controller such as a central
controller. One example of an air circuit 4170 comprising a heated wire circuit is
described in United States Patent 8,733,349, which is incorporated herewithin in its
entirety by reference.
James & Wells Ref: 506262NZDIV4, ResMed Ref: P1311NZ4
.6 FIER
.6.1 Humidifier overview
In one form of the present technology there is provided a fier to
change the absolute ty of air or gas for delivery to a patient relative to ambient
air. Typically, the humidifier is used to increase the absolute humidity and increase
the temperature of the flow of air (relative to ambient air) before delivery to the
patient’s airways.
Figs. 5 to 8 show a RPT device 4000 and an integrated humidifier 5000
according to an example of the t technology. In the illustrated example, the
humidifier 5000 includes a water reservoir dock 5130 structured to receive a water
reservoir 5110. As shown, the water reservoir dock 5130 es a cavity 5160
formed therein to receive the water reservoir 5110, e.g., the water oir 5110 may
be insertable/removable from the water reservoir dock 5110 in a lateral direction.
In the illustrated example, the RPT device 4000 is integrated with the
humidifier 5000. As this arrangement, the water reservoir dock 5130 is structured to
connect the water reservoir 5110 to the pneumatic path. As best shown in Figs. 5 and
8, the reservoir dock 5130 comprises a dock air outlet 5168 to deliver a flow of air to
the water reservoir 5110, a dock air inlet 5170 to receive the flow of air that has been
humidified in the water reservoir 5110, and a humidifier outlet 5172 to transfer the
flow of humidified air to the air circuit 4170. The cavity 5160 may include a top
portion configured to cover at least a portion of the lid of the water reservoir 5110 and
a bottom portion including a heater plate 5120.
r, it should be appreciated that the oir dock 5130 may be
provided separately to RPT device 4000 in an alternative arrangement. In such an
arrangement, additional interfaces may be used to connect the reservoir dock 5130 to
the RPT device 4000, e.g., ly coupled or coupled via an air circuit.
In another arrangement, the water reservoir dock 5130 may comprise an
opening in a substantially horizontal plane, so that the water reservoir 5110 may be
inserted from above or below the water reservoir dock 5130.
James & Wells Ref: 506262NZDIV4, ResMed Ref: P1311NZ4
Further examples and details of such RPT device 4000 and integrated
fier 5000 are described in PCT Publication No. WO 38804, published
September 18, 2014, which is orated herein by reference in its entirety.
.6.2 Humidifier components
.6.2.1 Water reservoir
Figs. 9 to 12 show one form of a water reservoir or tub 5110, which
comprises a reservoir base 5112, a reservoir lid 5114, and an ediate portion
including a ant portion 5116. The water reservoir 5110 includes a cavity (e.g.,
provided by the base) configured to hold, or retain, a volume of liquid (e.g. water) to
be evaporated for fication of the flow of air. The water reservoir 5110 may be
configured to hold a predetermined maximum volume of water in order to provide
adequate humidification for at least the on of a respiratory therapy session, such
as one evening of sleep. Typically, the reservoir 5110 is configured to hold several
hundred millilitres of water, e.g. 300 millilitres (ml), 325 ml, 350 ml or 400 ml. In
other forms, the humidifier 5000 may be configured to receive a supply of water from
an external water source such as a building’s water supply system.
According to one aspect, the water reservoir 5110 is configured to add
ty to a flow of air from the RPT device 4000 as the flow of air travels
therethrough. In one form, the water reservoir 5110 may be configured to encourage
the flow of air to travel in a tortuous path through the reservoir 5110 while in contact
with the volume of water therein.
The reservoir 5110 may also be configured to discourage egress of liquid
therefrom, such as when the reservoir 5110 is displaced and/or rotated from its
normal, working orientation, such as through any apertures and/or in between its subcomponents.
As the flow of air to be fied by the humidifier 5000 is typically
pressurised, the oir 5110 may also be configured to prevent losses in pneumatic
pressure h leak and/or flow impedance.
In the illustrated example, the reservoir lid 5114 comprises an inlet 5118
for receiving the flow of air into the reservoir 5110 and an outlet 5122 for delivering a
flow of air from the reservoir 5110. The reservoir lid 5114 is pivotably connected to
James & Wells Ref: 506262NZDIV4, ResMed Ref: Z4
the base 5112 by hinges 5158 to allow the reservoir 5110 to be converted between a
closed configuration, as shown in Figs. 9 to 11, and an open configuration, as shown
in Fig. 12. When the water reservoir 5110 is in its closed uration, the compliant
portion 5116 is put into sealing engagement between the base 5112 and the lid 5114
to seal the base 5112 and the lid 5114 and prevent egress of water from the reservoir
5110. The compliant portion 5116 may also perform other functions, such as to
e thermal contact n the reservoir 5110 and the heater plate 5120.
The reservoir base 5112 may be configured as a receptacle to retain the
given, maximum volume of liquid that the reservoir 5110 is configured to hold. In one
form, the base 5112 may comprise further features such as an overfill prevention
feature, e.g., at least one orifice 5138 in the water reservoir 5110 to indicate overfilling
as shown in Fig. 13
In one form, the reservoir base 5112 may further comprise an inner lip
5224 and/or an outer lip 5226, for e as shown in Fig. 13. According to one
aspect, the inner lip 5224 and/or outer lip 5226 may prevent egress of liquid from the
reservoir 5110 through the interface between an intermediate portion (e.g. the
compliant portion 5116) and the base 5112, for example when the intermediate
portion is ssed, or when the intermediate portion is under vibration.
In one form, the reservoir base 5112 includes a base upper body 5146, a
base bottom plate 5148, and a conductive portion 5152 which together form a
acle, e.g., see Fig 15. However, it should be appreciated that the reservoir base
5112 may be constructed in any number of parts.
In an example, the base upper body 5146, the base bottom plate 5148
and/or the lid 5114 may be constructed from a bio-compatible material suitable for
retaining the volume of liquid, such as a plastic or thermoplastic polymer, for
example, acrylonitrile butadiene styrene (ABS) or polycarbonate al.
In an e, a sealing element may be provided, e.g., between the base
upper body 5146 and the base bottom plate 5148, to prevent egress of water from the
water reservoir 5110, particularly from the base 5112.
James & Wells Ref: 506262NZDIV4, ResMed Ref: P1311NZ4
Further examples and details of such water reservoir are bed in PCT
ation No.
incorporated herein by reference in its entirety.
.6.2.2 tive portion
According to an example of the present technology, the reservoir 5110
comprises a conductive n 5152 configured to allow efficient transfer of heat
from the heater plate 5120to the volume of liquid in the reservoir 5110. The
conductive n 5152 comprises a heat conducting material structured and arranged
for thermal engagement or contact with the heater plate 5152 so as to allow thermal
transfer of heat from the heater plate to the volume of liquid.
In the illustrated example of Figs. 13 to 20, the conductive portion 5152
comprises a thin film (also referred to as a film base or a base conductor film)
comprising a thermally conductive, non-metallic material configured to thermally
couple with the heater plate 5120 of the humidifier 5000.
In an e, the heat conducting, non-metallic material of the thin film
5152 may comprise silicone, polycarbonate, or other thermoplastic or elastomeric
materials.
In an example, the thin film 5152 may comprise a thickness of about 0.05
mm to 1.5 mm, e.g., 0.10 mm to 0.125 mm. In an example, the thin film may
comprise a ess less than about 1 mm, e.g., less than about 0.5 mm. In one form
the film may comprise a silicone (LSR) film having a thickness of about 0.4 mm.
In the illustrated example, the base bottom plate 5148 includes side walls
5149.1 extending around the perimeter of the base bottom plate and a bottom wall
5149.2 that joins the side walls 5149.1, e.g., see Fig. 17. The thin film 5152 is
provided or otherwise incorporated into the bottom wall 5149.2 to form the receptacle
for retaining liquid. In the illustrated example, the bottom wall 5149.2 includes a hole
5149.3 structured to receive the thin film 5152, e.g., see Fig. 15. The thin film 5152 is
sealingly secured within and/or across the hole 5149.3 in an operative position so as
to form at least a portion of the base of the receptacle and prevent egress of water
from the water reservoir 5110.
James & Wells Ref: 506262NZDIV4, ResMed Ref: P1311NZ4
For example, the thin film 5152 may include a shape that corresponds to
the shape of the hole 5149.3 such that the or surface bounding the hole 5149.3 is
secured against edges at the perimeter of the thin film 5152. Alternatively, the thin
film 5152 may include a shape that is different than the shape of the hole 5149.3 such
that the edges at the perimeter of the thin film 5152 extend beyond edges of the hole
5149.3, e.g., thin film 5152 ps bottom wall 5149.2 of the base bottom plate
5148. In the illustrated example, the thin film 5152 includes a shape that generally
corresponds to a shape of the heater plate 5120, e.g., rectangular, however other
le shapes are possible, e.g., square, circular, oval.
As illustrated, the thin film 5152 includes a first side 5152.1 adapted to
form a bottom interior surface of the reservoir 5110 exposed to the water. The thin
film 5152 includes a second side 5152.2, te to the first side 5152.1, adapted to
form a bottom exterior surface of the reservoir 5110 exposed to the heater plate 5120,
e.g., second side 5152.2 of the thin film 5152 provides a contact surface structured
and arranged to directly engage with the heater plate 5120.
In the illustrated example, the thin film 5152 is lly planar and
provided at the bottom of the reservoir. r, the thin film 5152 may comprise a
non-planar shape and may be provided in other regions of the reservoir, e.g., provided
along a side wall of the reservoir exposed to the water. In an example, the thin film
5152 may overlap one or more walls of the base bottom plate 5148, e.g., thin film
extends across hole in the base bottom plate and shaped to conform and overlap with
bottom and/or side walls of the base bottom plate 5148.
In an example, the film 5152 is provided as a separate and ct
structure from the base bottom plate 5148 and then secured or otherwise provided to
the base bottom plate 5148 in an operative position, e.g., film 5152 comprises a preformed
structure that is secured to the base bottom plate 5148.
In an example, the film 5152 may be pre-formed, and then insert moulded
to the base bottom plate 5148. In another example, the film 5152 may be rmed
and then secured to the base bottom plate 5148, e.g., by adhesives or welding. In yet
another example, the film 5152 may be provided to the base bottom plate 5148 by
overmoulding the film 5152 to the base bottom plate 5148.
James & Wells Ref: 506262NZDIV4, ResMed Ref: P1311NZ4
In an example, the base bottom plate 5148 may be eliminated, or the film
may be supported or reinforced in other ways, e.g., at least one reinforcing strip of a
more rigid material compared to the film, embedded into or otherwise provided to the
film. In an example, the film may be provided to the base upper body 5146 such that
the film constitutes the entire bottom of the oir.
In arrangements where a pre-formed film 5152 is ed to the base
bottom plate 5148 (e.g., insert-moulded or adhered), the film may comprise a
thermoplastic polycarbonate film al (e.g., Makrofol DE 1-4 material of about
0.1 mm thickness), and the base bottom plate 5148 may comprise a plastic
polycarbonate material (e.g., Makrolon 2458 (or Makrolon 2258) material).
However, it should be appreciated that the pre-formed film and/or the base bottom
plate may comprise other suitable materials.
In an example, the film may be filled with one or more additives to
promote l conductivity, in which case the film may be thicker, e.g., for added
ical stability.
For example, the film may comprise ceramic powder or metallic powder
filled plastics, or the film may comprise multiple films or layers, e.g., sandwich
laminates ing a metallic film with a plastic film on one or both sides of the
metallic film.
In an example, powder-coating or spray painting with thermally
conductive materials (e.g., metals) may be applied to the second side 5152.2 of the
film facing the heater plate 5120 to improve thermal conductivity.
In an e, the film 5152 may comprise a thickness that is different
than a thickness of the bottom and/or side walls of the base bottom plate 5148, e.g.,
wall thickness of the film is less than the wall ess of the bottom and/or side
walls of the base bottom plate 5148. Such arrangement allows the thickness of the
film to be suitably selected to achieve desired performance characteristics, e.g.,
performance at high flows, humidification rate, heat-up time.
In an example, the film 5152 may comprise a material similar to the
material of the base upper body 5146 and/or the base bottom plate, with the film 5152
James & Wells Ref: 506262NZDIV4, ResMed Ref: P1311NZ4
comprising a wall thickness that is less than a wall thickness of walls of the base
upper body 5146 and/or the base bottom plate 5148.
In an example, as shown in Figs. 18 to 20, the reservoir 5110 may be
provided with one or more ribs 5175 structured and arranged to extend across the thin
film 5152 so as to create a force adapted to push the thin film 5152 t the heater
plate 5120.
Alternatively or in addition, the fier may be ed with a springlike
t structured and arranged to push the heater plate 5120 against the thin
film 5152.
The thin film base 5152 of the reservoir es an arrangement that
reduces cost of production of the reservoir, while retaining, or improving, its heat
transfer characteristics as well as its reliability. For example, the thin film base is
advantageous in that the thin film base may be sufficiently thin and flat to provide
good thermal contact and good humidifier performance and allow a suitable material
to be selected, e.g., depending on humidifier requirements and performance.
In an example, the thin film base may be advantageous in that the nonmetallic
properties of the thin film base (e.g., plastic or elastomeric al
properties) provides corrosion protection (e.g., protection due to exposure to water)
and a sealed connection with the base bottom plate 5148 (e.g., to form a sealed
reservoir for the humidification water). Also, the non -metallic properties of the thin
film base (e.g., thermoplastic or elastomeric material properties) may facilitate
manufacture of the thin film base to assume complex shapes, e.g., thin film base may
be molded into complex shapes if required to meet design requirements of the
fier. Further, the reduced cost of production of the reservoir is particularly
desirable in the case of a disposable reservoir in which the reservoir is intended only
for a limited product life where a hospital, a t or a user replaces the reservoir on
a regular basis.
.6.2.3 Humidifier reservoir dock
As described above, the fier 5000 may comprise a humidifier
reservoir dock 5130 (as shown in Figs. 5 to 8) ured to receive the humidifier
reservoir 5110. In some arrangements, the humidifier reservoir dock 5130 may
James & Wells Ref: 506262NZDIV4, ResMed Ref: P1311NZ4
comprise a locking feature configured to retain the reservoir 5110 in the humidifier
reservoir dock 5130.
.6.2.4 Water level indicator
The humidifier oir 5110 may comprise a water level indicator. In
some forms, the water level tor may provide one or more tions to a user
such as the patient 1000 or a care giver regarding a quantity of the volume of water in
the humidifier reservoir 5110. The one or more indications provided by the water
level indicator may include an indication of a maximum, predetermined volume of
water, any portions thereof, such as 25%, 50% or 75% or volumes such as 200 ml,
300 ml or 400ml.
Humidifier transducer(s)
As shown in Fig. 21, the humidifier 5000 may comprise one or more
humidifier ucers (sensors) 5210 instead of, or in addition to, transducers
provided in the RPT device 4000. Humidifier transducers 5210 may include one or
more of an air pressure sensor 5212, an air flow rate transducer 5214, a temperature
sensor 5216, or a ty sensor 5218 as shown in Fig. 21. A fier transducer
5210 may produce one or more output signals which may be communicated to a
controller such as a central controller of the RPT device 4000 and/or a central
humidifier ller 5250. In some forms, a fier transducer may be located
externally to the humidifier 5000 (such as in the air circuit 4170) while
communicating the output signal to the controller.
.6.2.5.1 Pressure transducer
One or more pressure transducers 5212 may be provided to the humidifier
5000 in addition to, or instead of, a pressure sensor provided in the RPT device 4000.
.6.2.5.2 Flow rate transducer
One or more flow rate transducers 5214 may be provided to the humidifier
5000 in addition to, or instead of, a flow rate sensor provided in the RPT device 4000.
.6.2.5.3 Temperature transducer
The fier 5000 may comprise one or more temperature transducers
5216. The one or more temperature transducers 5216 may be configured to measure
James & Wells Ref: 506262NZDIV4, ResMed Ref: P1311NZ4
one or more temperatures such as of the heating t 5240 and/or of the flow of
air downstream of the humidifier outlet. In some forms, the humidifier 5000 may
further comprise a temperature sensor 5216 to detect the ature of the ambient
.6.2.5.4 Humidity ucer
In one form, the humidifier 5000 may se one or more humidity
sensors 5218 to detect a humidity of a gas, such as the ambient air. The humidity
sensor 5218 may be placed towards the humidifier outlet in some forms to measure a
humidity of the gas red from the humidifier 5000. The humidity sensor may be
an absolute humidity sensor or a relative ty sensor.
.6.2.6 Heating element
A heating element 5240 may be provided to the humidifier 5000 in some
cases to provide a heat input to one or more of the volume of water in the humidifier
reservoir 5110 and/or to the flow of air. The heating element 5240 may comprise a
heat generating component such as an electrically resistive heating track. One suitable
example of a g t 5240 is a layered heating element such as one described
in the PCT Patent Application Publication No.
incorporated herewith by reference in its entirety.
In some forms, the g element 5240 may be provided in the
humidifier base where heat may be provided to the humidifier reservoir 5110
primarily by conduction.
7 Humidifier controller
According to one arrangement of the present technology, a humidifier
5000 may comprise a humidifier controller 5250 as shown in Fig. 21. In one form, the
humidifier ller 5250 may be a part of the central controller of the RPT device
4000. In another form, the humidifier controller 5250 may be a separate controller,
which may be in communication with the central controller.
In one form, the humidifier controller 5250 may receive as inputs
measures of properties (such as temperature, humidity, pressure and/or flow rate), for
example of the flow of air, the water in the reservoir 5110 and/or the humidifier 5000.
James & Wells Ref: 506262NZDIV4, ResMed Ref: P1311NZ4
The humidifier controller 5250 may also be configured to execute or implement
humidifier algorithms and/or deliver one or more output signals.
As shown in Fig. 21, the fier controller 5250 may comprise one or
more controllers, such as a central humidifier controller 5251, a heated air circuit
controller 5254 configured to control the temperature of a heated air circuit 4171
and/or a heating t controller 5252 configured to control the temperature of a
heating element 5240.
.7 GLOSSARY
For the es of the present technology disclosure, in certain forms of
the t technology, one or more of the following definitions may apply. In other
forms of the present technology, alternative definitions may apply.
.7.1 General
Air: In n forms of the present technology, air may be taken to mean
heric air, and in other forms of the present technology air may be taken to
mean some other combination of able gases, e.g. atmospheric air enriched with
oxygen.
Ambient: In certain forms of the present logy, the term ambient will
be taken to mean (i) external of the treatment system or patient, and (ii) ately
surrounding the ent system or patient.
For example, ambient humidity with respect to a humidifier may be the
humidity of air immediately surrounding the humidifier, e.g. the humidity in the room
where a patient is sleeping. Such ambient humidity may be different to the ty
outside the room where a patient is sleeping.
In another example, ambient pressure may be the pressure immediately
surrounding or external to the body.
In certain forms, ambient (e.g., acoustic) noise may be considered to be
the background noise level in the room where a patient is located, other than for
example, noise generated by an RPT device or emanating from a mask or patient
interface. Ambient noise may be generated by sources outside the room.
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Automatic Positive Airway Pressure (APAP) therapy: CPAP therapy in
which the treatment pressure is automatically adjustable, e.g. from breath to breath,
between minimum and m , depending on the presence or absence of
indications of SDB events.
Continuous Positive Airway Pressure (CPAP) therapy: Respiratory
pressure therapy in which the treatment pressure is approximately constant through a
respiratory cycle of a patient. In some forms, the pressure at the entrance to the
airways will be slightly higher during exhalation, and ly lower during tion.
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 ction.
Flow rate: The volume (or mass) of air delivered per unit time. Flow rate
may refer to an instantaneous quantity. In some cases, a nce to flow rate will be
a reference to a scalar quantity, namely a quantity having magnitude only. In other
cases, a reference to flow rate will be a reference to a vector quantity, namely a
ty having both magnitude and direction. Flow rate may be given the symbol Q.
‘Flow rate’ is sometimes shortened to simply ‘flow’ or ‘airflow’.
In the example of patient respiration, a flow rate may be nominally
positive for the inspiratory portion of a breathing cycle of a patient, and hence
negative for the expiratory portion of the breathing cycle of a patient. Total flow rate,
Qt, is the flow rate of air leaving the RPT device. Vent flow rate, Qv, is the flow rate
of air g a vent to allow washout of exhaled gases. Leak flow rate, Ql, is the flow
rate of leak from a patient interface system or ere. Respiratory flow rate, Qr, is
the flow rate of air that is received into the patient's atory system.
Humidifier: The word humidifier will be taken to mean a humidifying
tus constructed and arranged, or configured with a physical structure to be
capable of ing a therapeutically beneficial amount of water (H2O) vapour to a
flow of air to ameliorate a medical respiratory condition of a patient.
James & Wells Ref: NZDIV4, ResMed Ref: P1311NZ4
Leak: The word leak will be taken to be an nded flow of air. In one
example, leak may occur as the result of an incomplete seal between a mask and a
patient's face. In another example leak may occur in a swivel elbow to the ambient.
Noise, conducted (acoustic): Conducted noise in the present document
refers to noise which is carried to the patient by the pneumatic path, such as the air
circuit and the patient interface as well as the air therein. In one form, conducted noise
may be quantified by measuring sound pressure levels at the end of an air circuit.
Noise, radiated tic): Radiated noise in the present document refers
to noise which is carried to the t by the ambient air. In one form, radiated noise
may be quantified by measuring sound power/pressure levels of the object in question
according to ISO 3744.
Noise, vent (acoustic): Vent noise in the present document refers to noise
which is generated by the flow of air through any vents such as vent holes of the
patient interface.
Patient: A person, whether or not they are suffering from a respiratory
condition.
re: Force per unit area. Pressure may be expressed in a range of
units, including cmH2O, g-f/cm2 and hectopascal. 1 cmH2O is equal to 1 g-f/cm2 and
is approximately 0.98 hectopascal. In this specification, unless otherwise stated,
pressure is given in units of cmH2O.
The pressure in the patient ace is given the symbol Pm, while the
treatment pressure, which represents a target value to be achieved by the mask
pressure Pm at the current instant of time, is given the symbol Pt.
Respiratory Pressure Therapy (RPT): The application of a supply of air to
an entrance to the airways at a treatment pressure that is typically positive with
respect to here.
Ventilator: A ical device that provides pressure t to a
patient to perform some or all of the work of breathing.
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1 Materials
ne or Silicone Elastomer: A synthetic rubber. In this specification, a
reference to silicone is a reference to liquid ne rubber (LSR) or a ssion
moulded silicone rubber (CMSR). One form of commercially ble LSR is
SILASTIC ded in the range of products sold under this trademark),
manufactured by Dow g. r manufacturer of LSR is Wacker. Unless
ise specified to the contrary, an exemplary 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 thermoplastic polymer of Bisphenol-A Carbonate.
.7.1.2 Mechanical properties
Resilience: Ability of a material to absorb energy when deformed
elastically and to release the energy upon ing.
Resilient: Will release substantially all of the energy when unloaded.
Includes e.g. certain silicones, and thermoplastic mers.
Hardness: The ability of a material per se to resist deformation (e.g.
described by a Young’s Modulus, or an indentation hardness scale measured on a
standardised sample size).
• ‘Soft’ materials may include silicone or thermo-plastic elastomer (TPE),
and may, e.g. readily deform under finger pressure.
• ‘Hard’ materials may include polycarbonate, polypropylene, steel or
aluminium, and may not e.g. readily deform under finger pressure.
Stiffness (or rigidity) of a structure or component: The ability of the
structure or component to resist deformation in response to an applied load. The load
may be a force or a moment, e.g. compression, tension, bending or torsion. The
structure or component may offer different resistances in different directions.
Floppy structure or component: A structure or component that will
change shape, e.g. bend, when caused to support its own weight, within a relatively
short period of time such as 1 second.
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Rigid structure or ent: A structure or component that will not
substantially change shape when subject to the loads typically encountered in use. An
example of such a use may be setting up and maintaining a patient interface in sealing
relationship with an entrance to a patient's airways, e.g. at a load of approximately 20
to 30 cmH2O pressure.
As an example, an I-beam may comprise a different bending stiffness
tance to a bending load) in a first direction in comparison to a second,
orthogonal direction. In r example, a structure or component may be floppy in a
first direction and rigid in a second direction.
.7.2 t 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 CO2 rebreathing by a patient.
Elbow: An elbow is an e of a structure that directs an axis of flow
of air travelling therethrough to change direction through an angle. In one form, the
angle may be approximately 90 degrees. In another form, the angle may be more, or
less than 90 degrees. The elbow may have an approximately circular cross-section. In
another form the elbow may have an oval or a rectangular cross-section. In certain
forms an elbow may be rotatable with t to a mating component, e.g. about 360
s. In certain forms an elbow may be ble from a mating component, e.g.
via a snap connection. In certain forms, an elbow may be assembled to a mating
component via a one-time snap during manufacture, but not removable by a patient.
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. For example the headgear may
comprise a collection of one or more struts, ties and stiffeners configured to locate
and retain a patient interface in on on a patient’s face for delivery of respiratory
James & Wells Ref: 506262NZDIV4, ResMed Ref: P1311NZ4
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, ably, substantially no resistance to bending, but has resistance to being
stretched.
Plenum chamber: a mask plenum r will be taken to mean a portion
of a patient interface having walls at least partially 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.
Seal: May be a noun form ("a seal") which refers to a structure, or a verb
form (“to seal”) which refers to the effect. Two elements may be constructed and/or
arranged to ‘seal’ or to effect ‘sealing’ therebetween without requiring a separate
‘seal’ t per se.
Shell: A shell will be taken to mean a curved, relatively thin ure
having bending, tensile and compressive stiffness. For example, a curved structural
wall of a mask may be a shell. In some forms, a shell may be faceted. In some forms a
shell may be airtight. In some forms a shell may not be airtight.
Stiffener: A stiffener will be taken to mean a structural component
designed to increase the bending resistance of r component in at least one
direction.
Strut: A strut will be taken to be a structural component designed to
se the compression resistance of another component in at least one ion.
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 ucted 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. There may
be little or no leak flow of air from the swivel in use.
James & Wells Ref: 506262NZDIV4, ResMed Ref: P1311NZ4
Tie (noun): A structure designed to resist tension.
Vent: (noun): A structure that allows a flow of air from an interior of the
mask, or conduit, to ambient air for clinically effective washout of exhaled gases. For
example, a clinically effective washout may involve a flow rate of about 10 litres per
minute to about 100 litres per minute, depending on the mask design and treatment
pressure.
.7.3 Shape of structures
Products in accordance with the present technology may comprise one or
more three-dimensional mechanical structures, for example a mask cushion or an
impeller. The three-dimensional structures may be bounded by two-dimensional
es. These surfaces may be distinguished using a label to describe an ated
surface orientation, location, function, or some other characteristic. For example a
structure may comprise one or more of an anterior surface, a posterior surface, an
interior e and an exterior e. In another example, a seal-forming structure
may comprise a face-contacting (e.g. outer) surface, and a separate non-facecontacting
(e.g. underside or inner) surface. In another example, a structure may
comprise a first surface and a second surface.
To facilitate describing the shape of the dimensional structures and
the es, we first consider a cross-section through a surface of the structure at a
point, p. See Fig. 3B to Fig. 3F, which rate examples of cross-sections at point p
on a surface, and the resulting plane . Figs. 3B to 3F also illustrate an outward
normal vector at p. The outward normal vector at p points away from the surface. In
some examples we describe the surface from the point of view of an imaginary small
person standing upright on the surface.
.7.3.1 Curvature in one ion
The curvature of a plane curve at p may be described as having a sign
(e.g. ve, negative) and a magnitude (e.g. 1/radius of a circle that just touches the
curve at p).
Positive curvature: If the curve at p turns towards the outward normal, the
curvature at that point will be taken to be positive (if the imaginary small person
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leaves the point p they must walk uphill). See Fig. 3B (relatively large positive
curvature compared to Fig. 3C) and Fig. 3C (relatively small positive curvature
compared to Fig. 3B). Such curves are often referred to as concave.
Zero curvature: If the curve at p is a straight line, the curvature will be
taken to be zero (if the imaginary small person leaves the point p, they can walk on a
level, neither up nor down). See Fig. 3D.
ve curvature: If the curve at p turns away from the outward normal,
the curvature in that direction at that point will be taken to be negative (if the
imaginary small person leaves the point p they must walk downhill). See Fig. 3E
(relatively small negative curvature compared to Fig. 3F) and Fig. 3F (relatively large
negative curvature compared to Fig. 3E). Such curves are often referred to as .
.7.3.2 Curvature of two dimensional surfaces
A description of the shape at a given point on a two-dimensional e
in accordance with the present technology may e multiple normal crosssections.
The multiple cross-sections may cut the surface in a plane that includes the
outward normal (a “normal plane”), and each cross-section may be taken in a different
direction. Each cross-section results in a plane curve with a corresponding curvature.
The different curvatures at that point may have the same sign, or a different sign.
Each of the ures at that point has a magnitude, e.g. relatively small. The plane
curves in Figs. 3B to 3F could be examples of such multiple cross-sections at a
ular point.
Principal curvatures and directions: The directions of the normal planes
where the curvature of the curve takes its maximum and minimum values are called
the principal ions. In the examples of Fig. 3B to Fig. 3F, the maximum curvature
occurs in Fig. 3B, and the minimum occurs in Fig. 3F, hence Fig. 3B and Fig. 3F are
cross sections in the principal directions. The principal curvatures at p are the
curvatures in the principal directions.
Region of a surface: A connected set of points on a e. The set of
points in a region may have similar characteristics, e.g. curvatures or signs.
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Saddle region: A region where at each point, the principal ures have
opposite signs, that is, one is positive, and the other is negative (depending on the
direction to which the ary person turns, they may walk uphill or downhill).
Dome region: A region where at each point the principal curvatures have
the same sign, e.g. both positive (a “concave dome”) or both negative (a x
dome”).
Cylindrical region: A region where one principal curvature is zero (or, for
example, zero within manufacturing nces) and the other principal curvature is
Planar region: A region of a surface where both of the principal
curvatures are zero (or, for example, zero within manufacturing tolerances).
Edge of a surface: A boundary or limit of a surface or region.
Path: In certain forms of the present technology, ‘path’ will be taken to
mean a path in the mathematical – topological sense, e.g. a continuous space curve
from f(0) to f(1) on a surface. In certain forms of the present technology, a ‘path’ may
be described as a route or course, including e.g. a set of points on a surface. (The path
for the imaginary person is where they walk on the surface, and is analogous to a
garden path).
Path length: In certain forms of the present technology, ‘path length’ will
be taken to mean the distance along the surface from f(0) to f(1), that is, the distance
along the path on the surface. There may be more than one path between two points
on a e and such paths may have different path lengths. (The path length for the
imaginary person would be the distance they have to walk on the surface along the
path).
Straight-line distance: The straight-line distance is the distance between
two points on a surface, but t regard to the surface. On planar regions, there
would be a path on the surface having the same path length as the straight-line
ce between two points on the surface. On non-planar surfaces, there may be no
paths having the same path length as the straight-line ce between two points.
James & Wells Ref: 506262NZDIV4, ResMed Ref: P1311NZ4
(For the imaginary person, the straight-line distance would correspond to the distance
‘as the crow flies’.)
3 Space curves
Space curves: Unlike a plane curve, a space curve does not necessarily lie
in any particular plane. A space curve may be , that is, having no endpoints. A
space curve may be considered to be a one-dimensional piece of three-dimensional
space. An ary person walking on a strand of the DNA helix walks along a
space curve. A typical human left ear comprises a helix, which is a left-hand helix, see
Fig. 3Q. A typical human right ear comprises a helix, which is a right-hand helix, see
Fig. 3R. Fig. 3S shows a right-hand helix. The edge of a structure, e.g. the edge of a
membrane or impeller, may follow a space curve. In general, a space curve may be
described by a curvature and a torsion at each point on the space curve. Torsion is a
measure of how the curve turns out of a plane. Torsion has a sign and a magnitude.
The torsion at a point on a space curve may be characterised with reference to the
tangent, normal and binormal vectors at that point.
Tangent unit vector (or unit t vector): For each point on a curve, a
vector at the point specifies a direction from that point, as well as a magnitude. A
tangent unit vector is a unit vector pointing in the same direction as the curve at that
point. If an imaginary person were flying along the curve and fell off her vehicle at a
particular point, the direction of the tangent vector is the ion she would be
travelling.
Unit normal : As the imaginary person moves along the curve, this
tangent vector itself changes. The unit vector pointing in the same direction that the
tangent vector is changing is called the unit principal normal vector. It is
perpendicular to the tangent vector.
Binormal unit vector: The binormal unit vector is perpendicular to both
the tangent vector and the principal normal vector. Its direction may be determined by
a hand rule (see e.g. Fig. 3P), or alternatively by a left-hand rule (Fig. 3O).
Osculating plane: The plane containing the unit tangent vector and the
unit pal normal vector. See Figures 3O and 3P.
James & Wells Ref: 506262NZDIV4, ResMed Ref: Z4
Torsion of a space curve: The torsion at a point of a space curve is the
magnitude of the rate of change of the binormal unit vector at that point. It measures
how much the curve deviates from the osculating plane. A space curve which lies in a
plane has zero torsion. A space curve which deviates a relatively small amount from
the osculating plane will have a relatively small magnitude of torsion (e.g. a gently
sloping helical path). A space curve which deviates a relatively large amount from the
osculating plane will have a relatively large magnitude of torsion (e.g. a steeply
sloping helical path). With reference to Fig. 3S, since T2>T1, the magnitude of the
torsion near the top coils of the helix of Fig. 3S is greater than the magnitude of the
torsion of the bottom coils of the helix of Fig. 3S
With reference to the right-hand rule of Fig. 3P, a space curve turning
towards the direction of the right-hand binormal may be considered as having a righthand
positive n (e.g. a right-hand helix as shown in Fig. 3S). A space curve
turning away from the direction of the right-hand binormal may be ered as
having a right-hand negative torsion (e.g. a left-hand helix).
Equivalently, and with reference to a left-hand rule (see Fig. 3O), a space
curve turning towards the direction of the left-hand binormal may be considered as
having a left-hand positive torsion (e.g. a left-hand helix). Hence left-hand positive is
equivalent to right-hand negative. See Fig. 3T.
.7.3.4 Holes
A surface may have a one-dimensional hole, e.g. a hole bounded by a
plane curve or by a space curve. Thin structures (e.g. a membrane) with a hole, may
be bed as having a one-dimensional hole. See for example the one dimensional
hole in the surface of structure shown in Fig. 3I, bounded by a plane curve.
A structure may have a two-dimensional hole, e.g. a hole bounded by a
e. For e, an inflatable tyre has a two dimensional hole bounded by the
interior surface of the tyre. In another example, a bladder with a cavity for air or gel
could have a two-dimensional hole. See for example the cushion of Fig. 3L and the
example cross-sections therethrough in Fig. 3M and Fig. 3N, with the or surface
bounding a two dimensional hole ted. In a yet r example, a conduit may
comprise a one-dimension hole (e.g. at its entrance or at its exit), and a two-dimension
James & Wells Ref: 506262NZDIV4, ResMed Ref: P1311NZ4
hole bounded by the inside surface of the conduit. See also the two dimensional hole
through the structure shown in Fig. 3K, bounded by a surface as shown.
.8 OTHER REMARKS
A portion of the disclosure of this patent nt contains material
which is subject to ght protection. The copyright owner has no ion to the
facsimile reproduction by anyone of the patent document or the patent disclosure, as it
appears in Patent Office patent files 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 logy, it is understood that such values may be
approximated, unless ise 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 g of the
present technology, a limited number of the ary methods and materials are
bed herein.
When a particular material is identified as being used to construct a
ent, obvious alternative materials with similar properties may be used as a
tute. Furthermore, unless ied to the contrary, any and all components
James & Wells Ref: 506262NZDIV4, ResMed Ref: P1311NZ4
herein described are understood to be capable of being ctured and, as such,
may be manufactured together or separately.
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 herein by reference in
their entirety to disclose and describe the methods and/or materials which are the
subject of those ations. The publications discussed herein are ed 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.
The terms "comprises" and "comprising" should be interpreted as
ing to ts, 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 ts, components, or steps that are not expressly referenced.
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.
gh the technology herein has been described with reference to
particular examples, it is to be understood that these examples are merely illustrative
of the principles and applications of the technology. In some ces, 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 ed to indicate any order but may be
utilised to distinguish between distinct elements. Furthermore, gh process steps
in the methodologies may be described or illustrated in an order, such an ng is
not required. Those skilled in the art will recognize that such ordering may be
James & Wells Ref: 506262NZDIV4, ResMed Ref: P1311NZ4
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 rative examples and that other arrangements may be devised without
departing from the spirit and scope of the technology.
.9 REFERENCE SIGNS LIST
Feature Item Number
patient 1000
bed r 1100
patient interface 3000
seal-forming structure 3100
plenum chamber 3200
stabilizing structure 3300
vent 3400
connection port 3600
forehead support 3700
RPT device 4000
air circuit 4170
humidifier 5000
water reservoir 5110
reservoir base 5112
oir lid 5114
compliant portion 5116
inlet 5118
heater plate 5120
outlet 5122
water reservoir dock 5130
e 5138
base upper body 5146
base bottom plate 5148
side wall 5149.1
bottom wall 5149.2
hole 5149.3
thin film 5152
first side 5152.1
second side 5152.2
hinge 5158
cavity 5160
dock air outlet 5168
dock air inlet 5170
humidifier outlet 5172
rib 5175
humidifier transducer 5210
James & Wells Ref: 506262NZDIV4, ResMed Ref: P1311NZ4
air pressure sensor 5212
air flow rate transducer 5214
temperature sensor 5216
humidity sensor 5218
inner lip 5224
outer lip 5226
heating element 5240
humidifier controller 5250
central humidifier controller 5251
heating element controller 5252
air t controller 5254
James & Wells Ref: 506262NZDIV4, ResMed Ref: P1311NZ4
6
Claims (20)
1. A water reservoir for an apparatus for humidifying a flow of breathable gas, comprising: a reservoir base including a cavity ured to hold a volume of liquid; and a conductive portion provided to the base, the conductive portion adapted to thermally engage with a heater plate to allow thermal transfer of heat from the heater plate to the volume of , wherein the conductive portion includes a thin film comprising a nonmetallic material, and wherein the thin film includes a wall thickness less than about 1 mm.
2. The water reservoir according to claim 1, wherein the wall thickness is less than about 0.5 mm.
3. The water reservoir according to any one of claims 1 to 2, n the thin film comprises silicone, polycarbonate, or other thermoplastic or elastomeric materials.
4. The water reservoir according to any one of claims 1 to 3, n the thin film is provided as a separate and distinct structure from the reservoir base.
5. The water reservoir according to any one of claims 1 to 4, n the thin film comprises a pre-formed structure that is secured or otherwise provided to the oir base.
6. The water reservoir according to any one of claims 1 to 5, wherein the reservoir base includes a hole structured to receive the thin film.
7. The water reservoir according to claim 6, wherein the thin film es a shape that corresponds to a shape of the hole. James & Wells Ref: 506262NZDIV4, ResMed Ref: P1311NZ4
8. The water oir according to any one of claims 1 to 7, wherein the thin film is generally planar.
9. The water reservoir according to any one of claims 1 to 8, wherein the thin film includes a first side adapted to form a bottom interior surface of the water reservoir exposed to the volume of liquid and a second side, opposite to the first side, adapted to form a bottom exterior surface of the water reservoir exposed to the heater plate.
10. The water oir according claim 9, wherein the second side of the thin film provides a t surface structured and arranged to directly engage with the heater plate.
11. The water reservoir according to any one of claims 1 to 10, wherein the non-metallic material of the thin film is similar to a material of the reservoir base.
12. The water reservoir according to any one of claims 1 to 11, wherein the wall thickness of the thin film is less than a wall thickness of walls of the reservoir base.
13. The water oir according to any one of claims 1 to 12, further comprising one or more ribs structured and arranged to extend across the thin film so as to create a force adapted to push the thin film against the heater plate.
14. The water oir according to any one of claims 1 to 13, wherein the reservoir base includes a base upper body, a base bottom plate, and the thin film which together form the cavity.
15. The water reservoir according to any one of claims 1 to14, further comprising a reservoir lid movably ted to the reservoir base to allow the water reservoir to be convertible between an open uration and a closed configuration.
16. A water reservoir for an apparatus for humidifying a flow of breathable gas, comprising: James & Wells Ref: 506262NZDIV4, ResMed Ref: P1311NZ4 a reservoir base including a cavity ured to hold a volume of ; and a conductive portion provided to the base, the conductive portion adapted to thermally engage with a heater plate to allow thermal transfer of heat from the heater plate to the volume of liquid, wherein the conductive portion includes a thin film comprising a nonmetallic material, wherein the thin film is provided as a separate and distinct ure from the reservoir base, and wherein the thin film includes a wall thickness that is less than a wall thickness of walls of the reservoir base.
17. The water reservoir according to claim 16, wherein the thin film ses a pre-formed structure that is secured or otherwise provided to the reservoir base.
18. An apparatus for fying a flow of breathable gas, comprising: a water reservoir dock; and the water oir according to any one of claims 1 to 17 provided to the water reservoir dock.
19. The apparatus according to claim 18, wherein the water reservoir dock forms a cavity to receive the water oir.
20. The apparatus according to any one of claims 18 to 19, wherein the water reservoir dock includes the heater plate adapted to thermally engage the conductive portion provided to the water reservoir. WO 94452 WO 94452 WO 94452 Ora! cavity Larynx Vocai foids Alveolar sacs Oesophagus Trachea Bronchus Diaphragm Copyright 2012 ResMed Limited Laterai nasa‘ cartriage Greater aiar cartriage vvvvvvvvvvvvv Hard paiate Soft palate Lip superior Lip or Orgpharynx ”Tbngue Epigiotris Vecai foids Esophagus Trachea FIG. ZB Copyright 2012 ResMed Limited WO 94452 Relatively Large Positive ure Relatively Small Positive Curvature Zero Curvature Relatively Small Negative Curvature Relatively Large Negative Curvature Copyright 2015 ResMed Limited 8.28m A) JKH M 28 83555 8:555 EEEZ .2me 89:3 Im £9.38 w>Em0m w>zmmwz 995:0 ._®_n_ Ema wumtsm 220mm coawm $3wumtsm 299$ + 44m»tumWQin,.wmfl.mwmnfi.iflw.”mum. _, g.” 220mm $3wumtsm A) {M 83556 83556 EEEZ n_ w>zmmwz 99550 Om .2me 89:3 .~w__o_omm coawm ._®_n_ WO 94452 Interior surface Interior surface Copyright 2015 ResMed Limited WO 94452
Applications Claiming Priority (1)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
AU2016904769 | 2016-11-22 |
Publications (1)
Publication Number | Publication Date |
---|---|
NZ793286A true NZ793286A (en) | 2022-10-28 |
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