EP4642502A1 - Appareil de régulation de débit de gaz pour traitement respiratoire - Google Patents

Appareil de régulation de débit de gaz pour traitement respiratoire

Info

Publication number
EP4642502A1
EP4642502A1 EP24736936.6A EP24736936A EP4642502A1 EP 4642502 A1 EP4642502 A1 EP 4642502A1 EP 24736936 A EP24736936 A EP 24736936A EP 4642502 A1 EP4642502 A1 EP 4642502A1
Authority
EP
European Patent Office
Prior art keywords
movable member
vent
flow regulating
patient interface
patient
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Pending
Application number
EP24736936.6A
Other languages
German (de)
English (en)
Inventor
Luke Andrew STANISLAS
Liam Holley
Karena NGUYEN
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Resmed Pty Ltd
Original Assignee
Resmed Pty Ltd
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Resmed Pty Ltd filed Critical Resmed Pty Ltd
Publication of EP4642502A1 publication Critical patent/EP4642502A1/fr
Pending legal-status Critical Current

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M16/00—Devices for influencing the respiratory system of patients by gas treatment, e.g. ventilators; Tracheal tubes
    • A61M16/20—Valves specially adapted to medical respiratory devices
    • A61M16/201—Controlled valves
    • A61M16/202—Controlled valves electrically actuated
    • A61M16/203—Proportional
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M16/00—Devices for influencing the respiratory system of patients by gas treatment, e.g. ventilators; Tracheal tubes
    • A61M16/021—Devices for influencing the respiratory system of patients by gas treatment, e.g. ventilators; Tracheal tubes operated by electrical means
    • A61M16/022—Control means therefor
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M16/00—Devices for influencing the respiratory system of patients by gas treatment, e.g. ventilators; Tracheal tubes
    • A61M16/06—Respiratory or anaesthetic masks
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M16/00—Devices for influencing the respiratory system of patients by gas treatment, e.g. ventilators; Tracheal tubes
    • A61M16/20—Valves specially adapted to medical respiratory devices
    • A61M16/201—Controlled valves
    • A61M16/202—Controlled valves electrically actuated
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M16/00—Devices for influencing the respiratory system of patients by gas treatment, e.g. ventilators; Tracheal tubes
    • A61M16/20—Valves specially adapted to medical respiratory devices
    • A61M16/201—Controlled valves
    • A61M16/207—Membrane valves with pneumatic amplification stage, i.e. having leader and follower membranes
    • A—HUMAN NECESSITIES
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    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M16/00—Devices for influencing the respiratory system of patients by gas treatment, e.g. ventilators; Tracheal tubes
    • A61M16/0057—Pumps therefor
    • A61M16/0066—Blowers or centrifugal pumps
    • A—HUMAN NECESSITIES
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    • A61M16/0057—Pumps therefor
    • A61M16/0066—Blowers or centrifugal pumps
    • A61M16/0069—Blowers or centrifugal pumps the speed thereof being controlled by respiratory parameters, e.g. by inhalation
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    • A61M16/0611—Means for improving the adaptation of the mask to the patient with a gusset portion
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    • A61M16/0825—Joints or connectors with ball-sockets
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    • A61M16/0875—Connecting tubes
    • A—HUMAN NECESSITIES
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    • A61M16/00—Devices for influencing the respiratory system of patients by gas treatment, e.g. ventilators; Tracheal tubes
    • A61M16/10—Preparation of respiratory gases or vapours
    • A61M16/14—Preparation of respiratory gases or vapours by mixing different fluids, one of them being in a liquid phase
    • A61M16/16—Devices to humidify the respiration air
    • A—HUMAN NECESSITIES
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    • A61M16/00—Devices for influencing the respiratory system of patients by gas treatment, e.g. ventilators; Tracheal tubes
    • A61M16/20—Valves specially adapted to medical respiratory devices
    • A61M16/208—Non-controlled one-way valves, e.g. exhalation, check, pop-off non-rebreathing valves
    • A61M16/209—Relief valves
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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    • A61M16/00—Devices for influencing the respiratory system of patients by gas treatment, e.g. ventilators; Tracheal tubes
    • A61M16/22—Carbon dioxide-absorbing devices ; Other means for removing carbon dioxide
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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    • A61M16/00—Devices for influencing the respiratory system of patients by gas treatment, e.g. ventilators; Tracheal tubes
    • A61M16/0003—Accessories therefor, e.g. sensors, vibrators, negative pressure
    • A61M2016/0015—Accessories therefor, e.g. sensors, vibrators, negative pressure inhalation detectors
    • A61M2016/0018—Accessories therefor, e.g. sensors, vibrators, negative pressure inhalation detectors electrical
    • A61M2016/0021—Accessories therefor, e.g. sensors, vibrators, negative pressure inhalation detectors electrical with a proportional output signal, e.g. from a thermistor
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    • A61M16/00—Devices for influencing the respiratory system of patients by gas treatment, e.g. ventilators; Tracheal tubes
    • A61M16/0003—Accessories therefor, e.g. sensors, vibrators, negative pressure
    • A61M2016/0027—Accessories therefor, e.g. sensors, vibrators, negative pressure pressure meter
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    • A61M2016/003—Accessories therefor, e.g. sensors, vibrators, negative pressure with a flowmeter
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    • A61M16/00—Devices for influencing the respiratory system of patients by gas treatment, e.g. ventilators; Tracheal tubes
    • A61M16/0003—Accessories therefor, e.g. sensors, vibrators, negative pressure
    • A61M2016/003—Accessories therefor, e.g. sensors, vibrators, negative pressure with a flowmeter
    • A61M2016/0033—Accessories therefor, e.g. sensors, vibrators, negative pressure with a flowmeter electrical
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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    • A61M2202/00—Special media to be introduced, removed or treated
    • A61M2202/02—Gases
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    • A61M2205/3653—General characteristics of the apparatus related to heating or cooling by Joule effect, i.e. electric resistance
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    • A61M2230/43—Composition of exhalation
    • A61M2230/432—Composition of exhalation partial CO2 pressure (P-CO2)

Definitions

  • the present technology relates to one or more of the screening, diagnosis, monitoring, treatment, prevention and amelioration of respiratory-related disorders.
  • the present technology also relates to medical devices or apparatus, and their use.
  • 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 conducting airways, and do not take part in gas exchange. Further divisions of the airways lead to the respiratory bronchioles, and eventually to the alveoli.
  • the alveolated region of the lung is where the gas exchange takes place, and is referred to as the respiratory zone. See “Respiratory Physiology” , by John B. West, Lippincott Williams & Wilkins, 9th edition published 2012.
  • a range of respiratory disorders exist. Certain disorders may be characterised by particular events, e.g. apneas, hypopneas, and hyperpneas.
  • respiratory disorders include Obstructive Sleep Apnea (OSA), Cheyne-Stokes Respiration (CSR), respiratory insufficiency, Obesity Hypoventilation Syndrome (OHS), Chronic Obstructive Pulmonary Disease (COPD), Neuromuscular Disease (NMD) and Chest wall disorders.
  • OSA Obstructive Sleep Apnea
  • CSR Cheyne-Stokes Respiration
  • OOS Obesity Hypoventilation Syndrome
  • COPD Chronic Obstructive Pulmonary Disease
  • NMD Neuromuscular Disease
  • Chest wall disorders include Obstructive Sleep Apnea (OSA), Cheyne-Stokes Respiration (CSR), respiratory insufficiency, Obesity Hypoventilation Syndrome (OHS), Chronic Obstructive Pulmonary Disease (COPD), Neuromuscular Disease (NMD) and Chest wall disorders.
  • Obstructive Sleep Apnea 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 patient to stop breathing for periods typically of 30 to 120 seconds in duration, sometimes 200 to 300 times per night. It often causes excessive daytime somnolence, and it may cause cardiovascular disease and brain damage. The syndrome is a common disorder, particularly in middle aged overweight males, although a person affected may have no awareness of the problem. See US Patent No. 4,944,310 (Sullivan).
  • CSR Cheyne-Stokes Respiration
  • CSR cycles 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 disorders.
  • a patient with respiratory insufficiency (a form of respiratory failure) may experience abnormal shortness of breath on exercise.
  • Obesity Hypoventilation Syndrome is defined as the combination of severe obesity and awake chronic hypercapnia, in the absence of other known causes for hypoventilation. Symptoms include dyspnea, morning headache and excessive daytime sleepiness.
  • COPD Chronic Obstructive Pulmonary Disease
  • COPD encompasses any of a group of lower airway diseases that have certain characteristics in common. These include increased resistance to air movement, extended expiratory phase of respiration, and loss of the normal elasticity of the lung. Examples of COPD are emphysema and chronic bronchitis. COPD is caused by chronic tobacco smoking (primary risk factor), occupational exposures, air pollution and genetic factors. Symptoms include: dyspnea on exertion, chronic cough and sputum production.
  • Neuromuscular Disease 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.
  • NMD patients are characterised by progressive muscular impairment leading to loss of ambulation, being wheelchair-bound, swallowing difficulties, respiratory muscle weakness and, eventually, death from respiratory failure.
  • Neuromuscular disorders can be divided into rapidly progressive and slowly progressive: (i) Rapidly progressive disorders: Characterised by muscle impairment that worsens over months and results in death within a few years (e.g. Amyotrophic lateral sclerosis (ALS) and Duchenne muscular dystrophy (DMD) in teenagers); (ii) Variable or slowly progressive disorders: Characterised by muscle impairment that worsens over years and only mildly reduces life expectancy (e.g. Limb girdle, Facioscapulohumeral and Myotonic muscular dystrophy).
  • Symptoms of respiratory failure in NMD include: increasing generalised weakness, dysphagia, dyspnea on exertion and at rest, fatigue, sleepiness, morning headache, and difficulties with concentration and mood changes.
  • Chest wall disorders are a group of thoracic deformities that result in inefficient coupling between the respiratory muscles and the thoracic cage.
  • the disorders are usually characterised by a restrictive defect and share the potential of long term hypercapnic respiratory failure.
  • Scoliosis and/or kyphoscoliosis may cause severe respiratory failure.
  • Symptoms of respiratory failure include: dyspnea on exertion, peripheral oedema, 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 prevent respiratory disorders from arising. However, these have a number of shortcomings.
  • CPAP Continuous Positive Airway Pressure
  • NMV Non-invasive ventilation
  • IV Invasive ventilation
  • HFT High Flow Therapy
  • Respiratory pressure therapy is the application of a supply of air to an entrance to the airways at a controlled target pressure that is nominally positive with respect to atmosphere throughout the patient’s breathing cycle (in contrast to negative pressure therapies such as the tank ventilator or cuirass).
  • Non-invasive ventilation provides ventilatory support to a patient through the upper airways to assist the patient breathing and/or maintain adequate 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 interface.
  • 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.
  • These respiratory therapies may be provided by a respiratory therapy system or device. Such systems and devices may also be used to screen, diagnose, or monitor a condition without treating it.
  • a respiratory therapy system may comprise a Respiratory Pressure Therapy Device (RPT device), an air circuit, a humidifier, a patient interface, an oxygen source, and data management.
  • RPT device Respiratory Pressure Therapy Device
  • 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 airways.
  • the flow of air may be provided via a mask to the nose and/or mouth, a tube to the mouth or a tracheostomy tube to the trachea of a patient.
  • the patient interface may form a seal, e.g., with a region of the patient's face, to facilitate the delivery of gas at a pressure at sufficient variance with ambient pressure to effect therapy, e.g., at a positive pressure of about 10 cmHiO relative to ambient pressure.
  • 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 cmHiO.
  • the patient interface is configured to insufflate the nares but specifically to avoid a complete seal.
  • a nasal cannula is a nasal cannula.
  • 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 patient 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.
  • Certain masks may cause some patients a feeling of claustrophobia, unease and/or may feel overly obtrusive.
  • 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 individuals. Since the head includes bone, cartilage and soft tissue, different regions of the face respond differently to mechanical forces.
  • the jaw or mandible may move relative to other bones of the skull. The whole head may move during the course of a period of respiratory therapy.
  • masks suffer from being obtrusive, aesthetically undesirable, costly, poorly fitting, difficult to use, and/or uncomfortable especially when worn for long 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 designed as part of personal protection equipment (e.g. filter masks), SCUBA masks, or for the administration of anaesthetics may be tolerable for their original application, but nevertheless 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, especially if the mask is to be worn during sleep.
  • CPAP therapy is highly effective to treat certain respiratory disorders, provided patients comply with therapy. If a mask is uncomfortable, or difficult to use a patient may not comply with therapy. Since it is often recommended that a patient regularly wash their mask, if a mask is difficult to clean (e.g., difficult to assemble or disassemble), patients may not clean their mask and this may impact on patient compliance.
  • a mask for other applications may not be suitable for use in treating sleep disordered breathing
  • a mask designed for use in treating sleep disordered breathing may be suitable for other applications.
  • patient interfaces for delivery of CPAP during sleep form a distinct field.
  • Patient interfaces may include a seal-forming structure. Since it is in direct contact with the patient’ s face, the shape and configuration of the seal-forming structure can have a direct impact the effectiveness and comfort of the patient interface.
  • a patient interface may be partly characterised according to the design intent of where the seal-forming structure is to engage with the face in use.
  • a seal-forming 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 right naris.
  • a seal-forming structure may comprise a single element that surrounds both nares in use. Such single element may be designed to for example overlay an upper lip region and a nasal bridge region of a face.
  • a seal-forming structure may comprise an element that surrounds a mouth region in use, e.g. by forming a seal on a lower lip region of a face.
  • 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 variety of names by their manufacturer including 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 different shape, structure, variability and sensitivity regions of the patient’s face. For example, a seal on swimming goggles that overlays a patient’s forehead 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 is able to 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.
  • seal-forming structure extends around the periphery of the patient interface, and is intended to seal against 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 elastomer such as a rubber.
  • 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 action against the face of the patient when positive pressure is applied within the mask.
  • a flap seal of thin material positioned about the periphery of the mask so as to provide a self-sealing action against the face of the patient when positive pressure is applied within the mask.
  • additional force may be required to achieve a seal, or the mask may leak.
  • the shape of the seal-forming 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.
  • nasal pillow is found in the Adam Circuit manufactured by Puritan Bennett. Another nasal pillow, or nasal puff is the subject of US Patent 4,782,832 (Trimble et al.), assigned to Puritan-Bennett Corporation.
  • ResMed Limited has manufactured the following products that incorporate nasal pillows: SWIFTTM nasal pillows mask, SWIFTTM II nasal pillows mask, SWIFTTM LT nasal pillows mask, SWIFTTM FX nasal pillows mask and MIRAGE LIBERTYTM full-face mask.
  • a seal-forming structure of a patient interface used for positive air pressure therapy is subject to the corresponding force of the air pressure to disrupt a seal.
  • 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.
  • Several factors may be considered when comparing different positioning and stabilising techniques. These include: how effective the technique is at maintaining the seal-forming structure in the desired position and in sealed engagement with the face during use of the patient interface; how comfortable the interface is for the patient; whether the patient feels intrusiveness and/or claustrophobia when wearing the patient interface; and aesthetic appeal.
  • a flow of pressurised air is provided to a patient interface through a conduit in an air circuit that fluidly connects to the patient interface at a location that is in front of the patient’s face when the patient interface is positioned on the patient’s face during use.
  • the conduit may extend from the patient interface forwards away from the patient’s face.
  • Another type of treatment system comprises a patient interface in which a tube that delivers pressurised air to the patient’s airways also functions as part of the headgear to position and stabilise the seal-forming portion of the patient interface at the appropriate part of the patient’s face.
  • This type of patient interface may be referred to as having “conduit headgear” or “headgear tubing”.
  • Such patient interfaces allow the conduit in the air circuit providing the flow of pressurised air from a respiratory pressure therapy (RPT) device to connect to the patient interface in a position other than in front of the patient’s face.
  • RPT respiratory pressure therapy
  • One example of such a treatment system is disclosed in US Patent Publication No. US 2007/0246043, the contents of which are incorporated herein by reference, in which the conduit connects to a tube in the patient interface through a port positioned in use on top of the patient’s head.
  • patient interfaces incorporating headgear tubing it is desirable for patient interfaces incorporating headgear tubing to be comfortable for a patient to wear over a prolonged duration when the patient is asleep, form an air-tight and stable seal with the patient’ s face, while also able to fit a range of patient head shapes and sizes.
  • 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 minimizes drying of the nasal mucosa and increases patient airway comfort.
  • warm air applied generally to the face area in and about the patient interface is more comfortable than cold air.
  • Some forms of treatment systems may include a vent to allow the washout of exhaled carbon dioxide.
  • the vent may allow a flow of gas from an interior space of a patient interface, e.g., the plenum chamber, to an exterior of the patient interface, e.g., to ambient.
  • ResMed Limited has developed a number of improved mask vent technologies. See International Patent Application Publication No. WO 1998/034665; International Patent Application Publication No. WO 2000/078381; US Patent No. 6,581,594; US Patent Application Publication No. US 2009/0050156; US Patent Application Publication No. 2009/0044808.
  • the present technology is directed towards providing medical devices used in the screening, diagnosis, monitoring, amelioration, treatment, or prevention of respiratory disorders having one or more of improved comfort, cost, efficacy, ease of use and manufacturability.
  • a first aspect of the present technology relates to apparatus used in the screening, diagnosis, monitoring, amelioration, treatment or prevention of a respiratory disorder.
  • Another aspect of the present technology relates to methods used in the screening, diagnosis, monitoring, 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.
  • One form of the present technology comprises a positioning and stabilising structure configured to provide a force to hold the seal-forming structure in a therapeutically effective position on the patient’s head.
  • the positioning and stabilising structure includes at least one strap.
  • One form of the present technology comprises a patient interface comprising a plenum chamber, a seal-forming structure, and a positioning and stabilising structure.
  • One form of the present technology comprises patient interface comprising a plenum chamber pressurisable to a therapeutic pressure of at least 4 cmH20 above ambient air pressure.
  • the plenum chamber includes at least one plenum chamber inlet port sized and structured to receive a flow of air at the therapeutic pressure for breathing by a patient.
  • the patient interface also comprises a seal-forming structure that is constructed and arranged to form a seal with a region of the patient’s face surrounding an entrance to the patient’s airways.
  • the seal-forming structure has a hole therein such that the flow of air at said therapeutic pressure is delivered to at least an entrance to the patient’s nares.
  • the seal-forming structure is constructed and arranged to maintain said therapeutic pressure in the plenum chamber throughout the patient’s respiratory cycle in use.
  • the patient interface also comprises a positioning and stabilising structure to provide a force to hold the seal-forming structure in a therapeutically effective position on the patient’s head.
  • Another aspect of one form of the present technology is a series of modular elements that may be interconnected in order to form different styles of patient interfaces.
  • each modular element there are at least two versions or styles of each modular element.
  • the versions or styles may be interchangeably used with one another in order to form different modular assemblies.
  • One form of the present technology comprises a flow regulating gas washout vent configured to vent respiratory gas from a patient interface.
  • Another form of the present technology comprises a flow regulating gas washout vent configured to vent respiratory gas from a patient interface that includes a base configured to anchor the gas washout vent to the patient interface; a movable member that opposes the base and forms a variable conduit with the base, the movable member being configured to move toward the base to narrow the variable conduit and move away from the base to widen the variable conduit; and a cantilevered biasing mechanism attached to the movable member and configured urge the movable member away from the base, the cantilevered biasing mechanism comprising a stationary anchored end and a movable free end.
  • the gas washout vent may be a spiral- shaped spring.
  • the anchored end of the cantilevered biasing mechanism may be located at a perimeter of the cantilevered biasing mechanism and the free end of the cantilevered biasing mechanism may be located radially inward from the perimeter of the cantilevered biasing mechanism.
  • the free end may be at a central region of the cantilevered biasing mechanism.
  • the cantilevered biasing mechanism may be configured so that when the cantilevered biasing mechanism is in a neutral position, the anchored end and the free end are coplanar.
  • the movable member may be attached to the cantilevered biasing mechanism at the free end of the cantilevered biasing mechanism.
  • a flexibility of the cantilevered biasing mechanism may be greatest at a central region of the cantilevered biasing mechanism.
  • the base, the movable member, and the cantilevered biasing mechanism may be formed unitarily.
  • the gas washout vent may be formed by way of a 3D-printing process.
  • variable conduit may include an inlet configured to receive gas washout from the base, the inlet of the variable conduit being located at a central region of the variable conduit.
  • variable conduit may include an outlet configured to discharge gas washout to atmosphere, the outlet of the variable conduit being located at a perimeter of the gas washout vent.
  • the movable member may be configured to move toward the base when a pressure of the gas washout in the variable conduit is less than a biasing force of the cantilevered biasing mechanism.
  • the cantilevered biasing mechanism may be connected to the housing at the perimeter of the gas washout vent.
  • the base may be configured to be removably secured to the patient interface.
  • the base may be permanently secured to the patient interface.
  • the patient interface configured to deliver pressurized respiratory gas to a patient’s airways.
  • the patient interface may include a seal-forming structure configured to sealingly engage a patient’s face and a gas washout vent including any of the features disclosed above.
  • the patient interface may further include a positioning and stabilizing structure configured to secure the seal-forming structure and the gas washout vent to the patient’s face.
  • the anchored end of the cantilevered biasing mechanism may be attached to the base and the free end of the cantilevered biasing mechanism is attached to the shaft.
  • the cantilevered biasing mechanism may be configured to be located inside the patient interface and the movable member is configured to be located outside the patient interface.
  • the cantilevered biasing mechanism may be a spiral-shaped spring.
  • the anchored end of the cantilevered biasing mechanism may be located at a perimeter of the cantilevered biasing mechanism and the free end of the cantilevered biasing mechanism is located radially inward from the perimeter of the cantilevered biasing mechanism.
  • the free end may be at a central region of the cantilevered biasing mechanism.
  • the cantilevered biasing mechanism may be configured so that when the cantilevered biasing mechanism is in a neutral position, the anchored end and the free end are coplanar. [0099] A flexibility of the cantilevered biasing mechanism may be greatest at a central region of the cantilevered biasing mechanism.
  • the base, the movable member, and the cantilevered biasing mechanism may be formed unitarily.
  • the gas washout vent may be formed by way of a 3D-printing process.
  • the variable conduit may include an inlet configured to receive gas washout from the base, the inlet of the variable conduit being located at a central region of the variable conduit.
  • variable conduit may include an outlet configured to discharge gas washout to atmosphere, the outlet of the variable conduit being located at a perimeter of the movable member.
  • the base may be configured to be removably secured to the patient interface.
  • FIG. 1 Another aspect of one form of the present technology is a patient interface configured to deliver pressurized respiratory gas to a patient’s airways.
  • the patient interface includes a seal-forming structure configured to sealingly engage a patient’s face; and a gas washout vent including any of the features discussed above.
  • the base may be a wall of the patient interface.
  • the patient interface may include a positioning and stabilizing structure configured to secure the seal-forming structure and the gas washout vent to the patient’s face.
  • the gas washout vent includes a base configured to anchor the gas washout vent to the patient interface; a movable member that opposes the base and forms a variable conduit with the base, the movable member being configured to move toward the base to narrow the variable conduit and move away from the base to widen the variable conduit; and a cantilevered biasing mechanism pivotably attached to the movable member so that the movable member is pivotable relative to the cantilevered biasing mechanism, the cantilevered biasing mechanism being configured urge the movable member away from the base.
  • the cantilevered biasing mechanism includes a stationary anchored end and a movable free end.
  • the cantilevered biasing mechanism may be connected to the movable member by way of a living hinge. [0110] The cantilevered biasing mechanism may be connected to the movable member by way of a ball and socket connection.
  • the movable member may be configured so that a pivoting movement of the movable member relative to the cantilevered biasing mechanism causes a width of the variable conduit to become inconsistent along a flow path of the gas washout.
  • the cantilevered biasing mechanism may be a spiral-shaped spring.
  • the anchored end of the cantilevered biasing mechanism may be located at a perimeter of the cantilevered biasing mechanism and the free end of the cantilevered biasing mechanism is located radially inward from the perimeter of the cantilevered biasing mechanism.
  • the free end may be at a central region of the cantilevered biasing mechanism.
  • the movable member may be attached to the cantilevered biasing mechanism at the free end of the cantilevered biasing mechanism.
  • the base, the movable member, and the cantilevered biasing mechanism may be formed unitarily.
  • the gas washout vent may be formed by way of a 3D-printing process.
  • the gas washout vent may further include housing that encloses the movable member and the cantilevered biasing mechanism.
  • the housing may be connected to the base by way of one or more spacers so that the variable conduit is between the housing and the base.
  • the anchored end of the cantilevered biasing mechanism may be rigidly connected to the housing at the perimeter of the gas washout vent.
  • FIG. 1 Another aspect of one form of the present technology is a patient interface configured to deliver pressurized respiratory gas to a patient’s airways.
  • the patient interface includes a seal-forming structure configured to sealingly engage a patient’s face; and a gas washout vent with any of the elements disclosed above.
  • the patient interface may further include a positioning and stabilizing structure configured to secure the seal-forming structure and the gas washout vent to the patient’s face.
  • the gas washout vent includes a base configured to anchor the gas washout vent to the patient interface; a movable member that opposes the base and forms a variable conduit with the base, the movable member being configured to move toward the base to narrow the variable conduit and move away from the base to widen the variable conduit; at least one sensor attached to the base and/or the movable member, the at least one sensor being configured to generate a signal indicative of a condition inside the variable conduit; and a cantilevered biasing mechanism attached to the movable member, the cantilevered biasing mechanism being configured urge the movable member away from the base.
  • the cantilevered biasing mechanism comprises a stationary anchored end and a movable free end.
  • the at least one sensor may include a flow sensor and the condition inside the variable conduit is a flow rate of gas washout flowing through the variable conduit.
  • the at least one sensor may include a pressure sensor and the condition inside the variable conduit is a pressure of gas washout flowing through the variable conduit.
  • the at least one sensor may be imbedded within the movable member and/or the base.
  • the at least one sensor may be positioned on a surface of the movable member and/or the base.
  • the cantilevered biasing mechanism may be a spiral-shaped spring.
  • the anchored end of the cantilevered biasing mechanism may be located at a perimeter of the cantilevered biasing mechanism and the free end of the cantilevered biasing mechanism is located radially inward from the perimeter of the cantilevered biasing mechanism.
  • the free end may be at a central region of the cantilevered biasing mechanism.
  • the movable member may be attached to the cantilevered biasing mechanism at the free end of the cantilevered biasing mechanism.
  • the base, the movable member, and the cantilevered biasing mechanism may be formed unitarily.
  • the gas washout vent may be formed by way of a 3D-printing process.
  • the housing may be connected to the base by way of one or more spacers so that the variable conduit is between the housing and the base.
  • the anchored end of the cantilevered biasing mechanism may be rigidly connected to the housing at the perimeter of the gas washout vent.
  • the cantilevered biasing mechanism may be pivotably attached to the movable member so that the movable member is pivotable relative to the cantilevered biasing mechanism.
  • the controller may include a user interface and the controller is configured to send a signal indicative of the level of fatigue of the gas washout vent to the user interface.
  • the fatigue detection system may further include a patient interface to which the gas washout vent is anchored, the patient interface being configured to deliver pressurized respiratory gas to a patient’s airways.
  • the patient interface may further include a positioning and stabilizing structure configured to secure the patient interface and the gas washout vent to the patient’s face.
  • the gas washout flow regulating system may include a flow regulating vent.
  • the flow regulating vent may include a base configured to anchor the gas washout vent to the patient interface and a movable member that opposes the base and forms a variable conduit with the base.
  • the movable member is configured to move toward the base to narrow the variable conduit and move away from the base to widen the variable conduit.
  • the flow regulating vent may also include an electrical actuator configured to move the movable member toward and away from the base.
  • the electrical actuator may include coil windings and a magnet movable relative to the coil windings.
  • a housing may enclose the movable member and the electrical actuator.
  • a controller may be configured to supply an electrical current to the coil windings to regulate a flow rate of gas washout through the flow regulating vent.
  • the controller may adjust a magnitude of the electrical current being supplied to the coil windings in response to a detection of a leak at a patient interface.
  • the controller may be configured to reduce the flow of gas washout in response to the detection of a leak at the patient interface.
  • the movable member may be configured to move toward and away from the base in response to a flow rate of gas flowing through the variable conduit.
  • the controller may be configured to supply electrical current to the coil windings to override the movement of the movable member caused by the gas washout flowing through the variable conduit in response to the detection of the leak at the patient interface.
  • the gas washout flow regulating system may further include a biasing mechanism.
  • the movable member may be attached to the housing by way of the biasing mechanism.
  • the coil windings may be located on the housing and the magnet may be located on the movable member. Alternatively, the windings may be located on the movable member and the magnet may be located on the housing.
  • the coil windings may include a recess configured to receive at least a portion of the magnet.
  • the magnet may include a recess configured to receive at least a portion of the coil windings.
  • the gas washout flow regulating system may further include a patient interface configured to sealingly engage the patient’ s face, an RPT device configured to pressurize a flow of respiratory gas, and an air delivery tube configured to convey the pressurized gas to the patient interface.
  • the flow regulating vent may be mounted to the patient interface.
  • the RPT device comprises a first leak detection sensor, and wherein the patient interface comprises a second leak detection sensor.
  • the gas washout flow regulating system may include a flow regulating vent.
  • the flow regulating vent may include a base configured to anchor the gas washout vent to the patient interface and a movable member that opposes the base and forms a variable conduit with the base.
  • the movable member is configured to move toward the base to narrow the variable conduit and move away from the base to widen the variable conduit.
  • the flow regulating vent may also include an electrical actuator configured to move the movable member toward and away from the base.
  • the electrical actuator may include coil windings and a magnet movable relative to the coil windings.
  • a housing may enclose the movable member and the electrical actuator.
  • a controller may be configured to supply an electrical current to the coil windings to regulate a flow rate of gas washout through the flow regulating vent.
  • the controller may adjust a magnitude of the electrical current being supplied to the coil windings in response to a detected level of CO2 in a patient interface.
  • the controller may be configured to reduce the flow of gas washout through the flow regulating vent in response to a determination that the level of CO2 in the patient interface is below a predetermined threshold.
  • the controller may be configured to increase the flow of gas washout through the flow regulating vent in response to a determination that the level of CO2 in the patient interface is above a predetermined threshold.
  • the movable member may be configured to move toward and away from the base in response to a flow rate of gas flowing through the variable conduit
  • the controller may be configured to supply electrical current to the coil windings to override the movement of the movable member caused by the gas washout flowing through the variable conduit in response to the detection of the leak at the patient interface.
  • the flow regulating valve may further include a biasing mechanism, and the movable member may be attached to the housing by way of the biasing mechanism.
  • the coil windings may be located on the housing and the magnet is located on the movable member.
  • the windings may be located on the movable member and the magnet is located on the housing.
  • the coil windings may include a recess configured to receive at least a portion of the magnet.
  • the magnet may include a recess configured to receive at least a portion of the coil windings.
  • the gas washout flow regulating system may further include a patient interface configured to sealingly engage the patient’ s face, an RPT device configured to pressurize a flow of respiratory gas, and an air delivery tube configured to convey the pressurized gas to the patient interface.
  • the flow regulating vent may be mounted to the patient interface.
  • the RPT device may include a first leak detection sensor, and the patient interface may include a second leak detection sensor.
  • the gas washout flow regulating system includes a flow regulating vent that includes a base configured to anchor the gas washout vent to the patient interface; a movable member that opposes the base and forms a variable conduit with the base, the movable member being configured to move toward the base to narrow the variable conduit and move away from the base to widen the variable conduit; an electrical actuator configured to move the movable member toward and away from the base, the electrical actuator comprising a motor with a movable component attached to the movable member and configured to move the movable member; and housing that encloses the movable member and the electrical actuator; and a controller configured to supply an electrical current to the motor to regulate a flow rate of gas washout through the flow regulating vent, wherein the controller adjusts a magnitude of the electrical current being supplied to the motor in response to a detection of a leak at a patient interface.
  • the controller of the gas washout flow regulating system may be configured to reduce the flow of gas washout in response to the detection of a leak at the patient interface.
  • the movable member may be configured to move toward and away from the base in response to a flow rate of gas flowing through the variable conduit, and the controller may be configured to supply electrical current to the motor to override the movement of the movable member caused by the gas washout flowing through the variable conduit in response to the detection of the leak at the patient interface.
  • the gas washout flow regulating system may further include a biasing mechanism, wherein the movable member is attached to the housing by way of the biasing mechanism.
  • the motor may include a linear actuator and a shaft, and the linear actuator may be secured to an outer surface of the housing and the shaft may be movable through the housing and is attached to the movable member.
  • the linear actuator may be configured to move the shaft in discrete steps.
  • the linear actuator may be configured to move in continuously.
  • the shaft may be configured so that rotation of the shaft causes the shaft and the movable member to move toward and away from the base.
  • the gas washout flow regulating system may further include a patient interface configured to sealingly engage the patient’s face; an RPT device configured to pressurize a flow of respiratory gas; and an air delivery tube configured to convey the pressurized gas to the patient interface.
  • the flow regulating vent may be mounted to the patient interface.
  • the RPT device may include a first leak detection sensor
  • the patient interface may include a second leak detection sensor.
  • gas washout flow regulating vent configured to vent respiratory gas from a patient interface
  • the gas washout flow regulating vent includes a base configured to anchor the gas washout vent to the patient interface; a movable member that opposes the base and forms a variable conduit with the base, the movable member being configured to move toward the base to narrow the variable conduit and move away from the base to widen the variable conduit; a sealing member; and housing that encloses the movable member and the sealing member and comprises an inlet port.
  • the sealing member is positioned between the movable member and the housing, and the sealing member is sealingly attached to the housing to form a chamber pneumatically isolated from the movable member.
  • the chamber may be configured so that gas is only allowed to enter or exit the chamber through the inlet port.
  • the sealing member may be configured to exert a biasing force on the movable member. The biasing force may urge the movable member away from the base.
  • the chamber may be configured so that relatively greater pressure in the chamber urges the movable member toward the base.
  • the chamber may be configured so that relatively lower pressure in the chamber allows the movable member to move away from the base.
  • the chamber may be configured to be pneumatically connected to a pressurized supply of respiratory gas being supplied to the patient interface.
  • the chamber may be configured to be pneumatically connected to a pump and/or a valve.
  • gas washout flow regulating system configured to vent respiratory gas from a patient interface
  • the gas washout flow regulating system including: a flow regulating vent including: a base configured to anchor the gas washout vent to the patient interface; a movable member that opposes the base and forms a variable conduit with the base, the movable member being configured to move toward the base to narrow the variable conduit and move away from the base to widen the variable conduit; an electrical actuator configured to move the movable member toward and away from the base, the electrical actuator comprising coil windings and a magnet movable relative to the coil windings; housing that encloses the movable member and the electrical actuator; and a flexible suspension member attached to the housing and the movable member, the flexible suspension member being configured to suspend the movable member from the housing and decouple movement of the movable member from the housing.
  • the suspension member may be configured to bias the movable member toward a predetermined direction.
  • the suspension member may be formed from foam.
  • the magnet may be attached to the movable member so that the movable member moves with the magnet.
  • the magnet may be surrounded by the windings.
  • the gas washout flow regulating system may include a controller configured to supply an electrical current to the coil windings to regulate a flow rate of gas washout through the flow regulating vent The controller may adjust a magnitude of the electrical current being supplied to the coil windings in response to a detected level of CO2 and/or pressure inside the patient interface.
  • a gas washout flow regulating system including: a patient interface configured to sealingly engage the patient’s face; an RPT device configured to pressurize a flow of respiratory gas; and an air delivery tube configured to convey the pressurized gas to the patient interface, wherein the flow regulating vent is mounted to the patient interface.
  • Another aspect of one form of the present technology is a patient interface that is moulded or otherwise constructed with a perimeter shape which is complementary to that of an intended wearer.
  • An aspect of one form of the present technology is a method of manufacturing apparatus.
  • Another aspect of one form of the present technology is a method of assembling a modular system comprising selecting a positioning and stabilising structure, and connecting the positioning and stabilising structure to either a first cushion or a second cushion.
  • 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 portable RPT device that may be carried by a person, e.g., around the home of the person.
  • 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 cleaning 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 may be implemented so as to improve the functionality of a processor, such as a processor of a specific purpose computer, respiratory monitor and/or a respiratory therapy apparatus. Moreover, the described methods, systems, devices and apparatus can provide improvements in the technological field of automated management, monitoring and/or treatment of respiratory conditions, including, for example, sleep disordered breathing.
  • portions of the aspects may form sub-aspects of the present technology.
  • various ones of the sub-aspects and/or aspects may be combined in various manners and also constitute additional aspects or sub-aspects of the present technology.
  • 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 positive 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. IB shows a system including a patient 1000 wearing 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 humidified 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 patient 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 humidified in a humidifier 5000, and passes along an air circuit 4170 to the patient 1000. The patient is sleeping in a side sleeping position.
  • 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. 2C is a front view of a face with several features of surface anatomy identified including the lip superior, upper vermilion, lower vermilion, lip inferior, mouth width, endocanthion, a nasal ala, nasolabial sulcus and cheilion. Also indicated are the directions superior, inferior, radially inward and radially outward.
  • Fig. 2E is a further side view of a head. The approximate locations of the Frankfort horizontal and nasolabial angle are indicated. The coronal plane is also indicated.
  • Fig. 2H shows subcutaneal structures of the nose, including lateral cartilage, septum cartilage, greater alar cartilage, lesser alar cartilage, sesamoid cartilage, nasal bone, epidermis, adipose tissue, frontal process of the maxilla and fibrofatty tissue.
  • Fig. 21 shows a medial dissection of a nose, approximately several millimeters from the midsagittal plane, amongst other things showing the septum cartilage and medial crus of greater alar cartilage.
  • Fig. 2J shows a front view of the bones of a skull including the frontal, nasal and zygomatic bones. Nasal concha are indicated, as are the maxilla, and mandible.
  • Fig. 2K shows a lateral view of a skull with the outline of the surface of a head, as well as several muscles.
  • the following bones are shown: frontal, sphenoid, nasal, zygomatic, maxilla, mandible, parietal, temporal and occipital. The mental protuberance is indicated.
  • the following muscles are shown: digastricus, masseter, sternocleidomastoid and trapezius.
  • Fig. 2L shows an anterolateral view of a nose.
  • FIG. 3A shows a patient interface in the form of a nasal mask in accordance with one form of the present 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 magnitude 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 indicated. 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 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 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 indicated. An edge of the surface 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 and B is indicated. A straight line distance between A and B is indicated. Two saddle regions and a dome region are indicated.
  • Fig. 31 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.31.
  • the illustrated surface bounds a two dimensional hole in the structure of Fig. 31.
  • Fig. 3K shows a perspective view of the structure of Fig. 31, including 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. 31.
  • 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. 30 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 defined by the edge of the sealing membrane in different regions of the mask.
  • Fig. 3U shows a view of a plenum chamber 3200 showing a sagittal plane and a mid-contact plane.
  • Fig. 3V shows a view of a posterior of the plenum chamber of Fig. 3U. The direction of the view is normal to the mid-contact plane.
  • the sagittal plane in Fig. 3V bisects the plenum chamber into left-hand and right-hand sides.
  • Fig. 3W shows a cross-section through the plenum chamber of Fig. 3V, the cross-section being taken at the sagittal plane shown in Fig. 3V.
  • a ‘mid-contact’ plane is shown.
  • the mid-contact plane is perpendicular to the sagittal plane.
  • the orientation of the mid-contact plane corresponds to the orientation of a chord 3210 which lies on the sagittal plane and just touches the cushion of the plenum chamber at two points on the sagittal plane: a superior point 3220 and an inferior point 3230.
  • the mid-contact plane may be a tangent at both the superior and inferior points.
  • Fig. 3X shows the plenum chamber 3200 of Fig. 3U in position for use on a face.
  • the sagittal plane of the plenum chamber 3200 generally coincides with the midsagittal plane of the face when the plenum chamber is in position for use.
  • the mid-contact plane corresponds generally to the ‘plane of the face’ when the plenum chamber is in position for use.
  • the plenum chamber 3200 is that of a nasal mask, and the superior point 3220 sits approximately on the sellion, while the inferior point 3230 sits on the lip superior.
  • FIG. 3Y shows a patient interface having conduit headgear, in accordance with one form of the present technology.
  • Fig. 3Y-1 shows forces acting on the patient interface of Fig. 3Y, while in use.
  • Fig. 4A shows an RPT device in accordance with one form of the present technology.
  • Fig. 4B is a schematic diagram of the pneumatic path of an RPT device in accordance with one form of the present technology.
  • the directions of upstream and downstream are indicated with reference to the blower and the patient interface.
  • the blower is defined to be upstream of the patient interface and the patient interface is defined to be downstream of the blower, regardless of the actual flow direction at any particular moment. Items which are located within the pneumatic path between the blower and the patient interface are downstream of the blower and upstream of the patient interface.
  • Fig. 4C is a schematic diagram illustrating the interconnection of various electrical components of the RPT device. 3.5 HUMIDIFIER
  • Fig. 5A shows an isometric view of a humidifier in accordance with one form of the present technology.
  • Fig. 5B shows an isometric view of a humidifier in accordance with one form of the present technology, showing a humidifier reservoir 5110 removed from the humidifier reservoir dock 5130.
  • Fig. 6A shows a perspective view of a cushion of a patient interface configured to be worn by a patient and convey pressurized air to the patient’s nose and the patient’s mouth.
  • Fig. 6B shows a perspective view of a cushion of a patient interface configured to be worn by a patient and convey pressurized air to the patient’s nose.
  • Fig. 6C shows a perspective view of tubes usable with either the cushion of Fig. 6A of the cushion of Fig. 6B.
  • Fig. 6D shows a perspective view of rigidiser arms usable with either the cushion of Fig. 6A of the cushion of Fig. 6B.
  • Fig. 6E shows a perspective view of headgear straps usable with the cushion of Fig. 6A.
  • Fig. 6F shows a perspective view of headgear straps usable with the cushion of Fig. 6B.
  • Fig. 6G shows a front view of a pair of sleeves that is removably fitted to either the tubes of Fig. 6C or the rigidiser arms of Fig. 6D.
  • Fig. 6H shows a front view of a full sleeve that is removably fitted to the rigidiser arms of Fig. 6D.
  • Fig. 61 shows a front perspective view of yet another alternate form of a full sleeve that is removably fitted to the rigidiser arms of Fig. 6D.
  • Fig. 6J is a front view of a patient wearing the cushion of Fig. 6A connected to the tubes of Fig. 6C, the headgear straps of Fig. 6E, and the sleeves of Fig. 6G.
  • Fig. 6K is a front view of a patient wearing the cushion of Fig. 6A connected to the rigidiser arms of Fig. 6D, the headgear straps of Fig. 6E, and the sleeve of Fig. 6H.
  • Fig. 6L is a front view of a patient wearing the cushion of Fig. 6B connected to the conduit headgear of Fig. 6C, and the headgear straps of Fig. 6F.
  • Fig. 6M is a front view of a patient wearing the cushion of Fig. 6B connected to the rigidisier arms of Fig. 6D, the headgear straps of Fig. 6F, and the sleeve of Fig. 61.
  • Fig. 6N is a perspective view of a vent.
  • Fig. 60 is a perspective view of an air circuit with a vented elbow and an air delivery conduit.
  • Fig. 6P exemplary ways different elements can be combined in order to form different patient interfaces.
  • Fig. 7A shows a schematic view of a flow regulating valve.
  • Fig. 7B shows a schematic view of another flow regulating valve.
  • Fig. 7C shows a schematic view of another flow regulating valve.
  • Fig. 7D shows a schematic view of another flow regulating valve.
  • Fig. 7E shows a shows an experimentally derived flow curve of a flow regulating vent according to one form of the present technology.
  • Fig. 7G shows a plurality of experimentally derived flow curves for differently dimensioned flow regulating vents according to other forms of the present technology.
  • Fig. 8A shows a perspective view of a flow regulating vent attached to a seal-forming structure.
  • Fig. 8C shows a perspective view of the flow regulating vent in isolation.
  • Fig. 8D shows a cross-section view of the flow regulating vent.
  • Fig. 8E shows a perspective view of a movable member of a flow regulating vent.
  • Fig. 8F shows a perspective view of a biasing mechanism of a flow regulating vent.
  • Fig. 8G shows a perspective view of a flow regulating vent without the housing.
  • Fig. 8H shows another perspective view of the flow regulating vent without the housing.
  • Fig. 81 shows another perspective view of the flow regulating vent without the housing.
  • Fig. 8J shows a cross-section view of another flow regulating vent.
  • Fig. 8K shows a schematic diagram of a system for sensing vent failure.
  • Fig. 8L shows a perspective view of another flow regulating vent.
  • Fig. 8M shows a cross-section view of the flow regulating vent of Fig. 8L.
  • Fig. 8N shows another perspective view of the flow regulating vent of Fig.
  • Fig. 80 shows a perspective view of another flow regulating vent.
  • Fig. 8P shows a cross-section view of the flow regulating vent of Fig. 80.
  • Fig. 8Q shows another perspective view of the flow regulating vent of Fig.
  • Fig. 8R shows a schematic diagram of a system for sensing vent failure.
  • Fig. 9A illustrates a control system for regulating a flow rate of gas washout.
  • Fig. 9B shows a vent response to a flow signal
  • Fig. 9C shows an exemplary flow regulating vent.
  • Fig. 9D shows an exemplary flow regulating vent.
  • Fig. 9E shows an exemplary flow regulating vent.
  • Fig. 9F shows an exemplary flow regulating vent.
  • Figs. 9G-9K show an exemplary flow regulating vent.
  • Fig. 9L shows an exemplary circuit diagram for control of the flow regulating vent of Figs. 9G-9K.
  • Fig. 9M is a flow diagram showing a method of using the flow regulating vent of Figs. 9G-9K.
  • Fig. 9N is another flow diagram showing a method of using the flow regulating vent of Figs. 9G-9K.
  • Fig. 90 shows an exemplary flow regulating vent.
  • Fig. 10A shows an exemplary flow regulating vent.
  • Fig. 10B shows an exemplary flow regulating vent.
  • Fig. 10C shows an exemplary flow regulating vent.
  • Fig. 10D shows an exemplary flow regulating vent.
  • the present technology comprises a method for treating a respiratory disorder comprising applying positive pressure to the entrance of the airways of a patient 1000.
  • a supply of air at positive pressure is provided to the nasal passages of the patient via one or both nares.
  • mouth breathing is limited, restricted or prevented.
  • the present technology comprises a respiratory therapy system for treating a respiratory disorder.
  • the respiratory therapy system may comprise an RPT device 4000 for supplying a flow of air to the patient 1000 via an air circuit 4170 and a patient interface 3000 or 3800.
  • a non-invasive patient interface 3000 such as that shown in Fig. 3A, in accordance with one aspect of the present technology comprises the following functional 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 circuit 4170, and a forehead support 3700.
  • a functional aspect may be provided by one or more physical components.
  • one physical component may provide one or more functional aspects.
  • the seal-forming structure 3100 is arranged to surround an entrance to the airways of the patient so as to maintain positive pressure at the entrance(s) to the airways of the patient 1000.
  • the sealed patient interface 3000 is therefore suitable for delivery of positive pressure therapy.
  • a non-invasive patient interface 3000 in accordance with another aspect of the present technology comprises the following functional aspects: a seal-forming structure 3100, a plenum chamber 3200, a positioning and stabilising structure 3300, a vent 3400 and one form of connection port 3600 for connection to an air circuit (such as the air circuit 4170 shown in Figs. 1A-1C).
  • the plenum chamber 3200 may be formed of one or more modular components in the sense that it or they can be replaced with different components, for example components of a different size.
  • a patient interface is unable to comfortably 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 above the ambient, for example at least 2, 4, 6, 10, or 20 cmH20 with respect to ambient.
  • a seal-forming structure 3100 provides a target seal-forming region, and may additionally provide a cushioning function.
  • the target seal-forming region is a region on the seal-forming structure 3100 where sealing may occur.
  • the region where sealing actually occurs- the actual sealing surface- may change within a given treatment session, from day to day, and from patient to patient, depending on a range of factors including for example, where the patient interface was placed on the face, tension in the positioning and stabilising structure and the shape of a patient’s face.
  • the target seal-forming region is located on an outside surface of the seal-forming structure 3100.
  • the seal-forming structure 3100 is constructed from a biocompatible material, e.g. silicone rubber.
  • a seal-forming structure 3100 in accordance with the present technology may be constructed from a soft, flexible, resilient material such as silicone.
  • a system comprising more than one a seal-forming structure 3100, each being configured to correspond to a different size and/or shape range.
  • the system may comprise one form of a seal-forming structure 3100 suitable for a large sized head, but not a small sized head and another suitable for a small sized head, but not a large sized head.
  • the seal-forming structure includes a sealing flange utilizing a pressure assisted sealing mechanism.
  • the sealing flange can readily respond to a system positive pressure in the interior of the plenum chamber 3200 acting on its underside to urge it into tight sealing engagement with the face.
  • the pressure assisted mechanism may act in conjunction with elastic tension in the positioning and stabilising structure.
  • the seal-forming structure 3100 comprises a sealing flange and a support flange.
  • the sealing flange comprises a relatively thin member with a thickness of less than about 1mm, for example about 0.25mm to about 0.45mm, which extends around the perimeter of the plenum chamber 3200.
  • Support flange may be relatively thicker than the sealing flange.
  • the support flange is disposed between the sealing flange and the marginal edge of the plenum chamber 3200, and extends at least part of the way around the perimeter.
  • the support flange is or includes a springlike element and functions to support the sealing flange from buckling in use.
  • the seal-forming structure may comprise a compression sealing portion or a gasket sealing portion.
  • the compression sealing portion, or the gasket sealing portion is constructed and arranged to be in compression, e.g. as a result of elastic tension in the positioning and stabilising structure.
  • the seal-forming structure comprises a tension portion.
  • the tension portion is held in tension, e.g. by adjacent regions of the sealing flange.
  • the seal-forming structure comprises a region having a tacky or adhesive surface.
  • a seal-forming structure may comprise one or more of a pressure-assisted sealing flange, a compression sealing portion, a gasket sealing portion, a tension portion, and a portion having a tacky or adhesive surface.
  • the seal-forming structure includes a saddle-shaped region constructed to form a seal in use on a nose bridge region or on a nose-ridge region of the patient's face.
  • the non-invasive patient interface 3000 comprises a sealforming structure that forms a seal in use on an upper lip region (that is, the lip superior) of the patient's face.
  • the seal-forming structure includes a saddle-shaped region constructed to form a seal in use on an upper lip region of the patient's face.
  • the non-invasive patient interface 3000 comprises a sealforming structure that forms a seal in use on a chin-region of the patient's face.
  • the seal-forming structure includes a saddle-shaped region constructed to form a seal in use on a chin-region of the patient's face.
  • the seal-forming structure of the non-invasive patient interface 3000 comprises a pair of nasal puffs, or nasal pillows, each nasal puff or nasal pillow being constructed and arranged to form a seal with a respective naris of the nose of a patient.
  • the patient interface 3000 comprises a seal-forming structure 3100 configured to seal around an entrance to the patient’s nasal airways but not around the patient’s mouth.
  • the seal-forming structure 3100 may be configured to seal to the patient’s lip superior.
  • the patient interface 3000 may leave the patient’s mouth uncovered.
  • This patient interface 3000 may deliver a supply of air or breathable gas to both nares of patient 1000 and not to the mouth.
  • This type of patient interface may be identified as a nose-only mask.
  • the sealforming structure 3100 may be configured to seal around the patient’s nares at an inferior periphery of the patient’s nose including to an inferior and/or anterior surface of a pronasale region of the patient’s nose and to the patient’s nasal alae.
  • the sealforming structure 3100 may seal to the patient’s lip superior.
  • the shape of the seal- forming structure 3100 may be configured to match or closely follow the underside of the patient’s nose and may not contact a nasal bridge region of the patient’s nose or any portion of the patient’s nose superior to the pronasale.
  • the seal-forming structure 3100 comprises a bridge portion dividing the opening into two orifices, each of which, in use, supplies air or breathable gas to a respective one of the patient’s nares.
  • the bridge portion may be configured to contact or seal against the patient’s columella in use.
  • the seal-forming structure 3100 may comprise a single opening to provide a flow or air or breathable gas to both of the patient’s nares.
  • a nose-only mask may comprise nasal pillows, described above.
  • the patient interface 3000 comprises a seal-forming structure 3100 configured to seal around an entrance to the patient’s nasal airways and also around the patient’s mouth.
  • the seal-forming structure 3100 may be configured to seal to the patient’s face proximate a chin region.
  • This patient interface 3000 may deliver a supply of air or breathable gas to both nares and to the mouth of patient 1000.
  • This type of patient interface may be identified as a nose and mouth mask.
  • One form of nose-and-mouth mask according to the present technology is what has traditionally been identified as a “full-face mask”, having a seal-forming structure 3100 configured to seal on the patient’s face around the nose, below the mouth and over the bridge of the nose.
  • a nose-and-mouth mask may be generally triangular in shape.
  • the patient interface 3000 comprises a seal-forming structure 3100 that forms a seal in use to a patient’s chin-region (which may include the patient’s lip inferior and/or a region directly inferior to the lip inferior), to the patient’s nose bridge or at least a portion of the nose ridge superior to the pronasale, and to cheek regions of the patient's face.
  • the patient interface 3000 shown in Fig. 1C is of this type.
  • This patient interface 3000 may deliver a supply of air or breathable gas to both nares and mouth of patient 1000 through a single orifice.
  • This type of sealforming structure 3100 may be referred to as a “nose-and-mouth cushion”.
  • the patient interface 3000 comprises a seal-forming structure 3100 that forms a seal in use on a patient’s chin region (which may include the patient’s lip inferior and/or a region directly inferior to the lip inferior), to an inferior and/or an anterior surface of a pronasale portion of the patient’s nose, to the alae of the patient’s nose and to the patient’s face on each lateral side of the patient’s nose, for example proximate the nasolabial sulci.
  • the seal-forming structure 3100 may also form a seal against a patient’s lip superior.
  • a patient interface 3000 having this type of seal-forming structure may have a single opening configured to deliver a flow of air or breathable gas to both nares and mouth of a patient, may have an oral hole configured to provide air or breathable gas to the mouth and a nasal hole configured to provide air or breathable gas to the nares, or may have an oral hole for delivering air to the patient’s mouth and two nasal holes for delivering air to respective nares.
  • This type of patient interface 3000 may have a nasal portion and an oral portion, the nasal portion sealing to the patient’ s face at similar locations to a nasal cradle mask.
  • the patient interface 3000 may comprise a seal-forming structure 3100 having a nasal portion comprising nasal pillows and an oral portion configured to form a seal to the patient’s face around the patient’s mouth.
  • the plenum chamber 3200 has a perimeter that is shaped to be complementary to the surface contour of the face of an average person in the region where a seal will form in use. In use, a marginal edge of the plenum chamber 3200 is positioned in close proximity to an adjacent surface of the face. Actual contact with the face is provided by the seal-forming structure 3100.
  • the seal-forming structure 3100 may extend in use about the entire perimeter of the plenum chamber 3200. In some forms, the plenum chamber 3200 and the seal-forming structure 3100 are formed from a single homogeneous piece of material.
  • the plenum chamber 3200 does not cover the eyes of the patient in use. In other words, the eyes are outside the pressurised volume defined by the plenum chamber. Such forms tend to be less obtrusive and / or more comfortable for the wearer, which can improve compliance with therapy.
  • the plenum chamber 3200 is constructed from a transparent material, e.g. a transparent polycarbonate.
  • a transparent material can reduce the obtrusiveness of the patient interface, and help improve compliance with therapy.
  • the use of a transparent material can aid a clinician to observe how the patient interface is located and functioning.
  • the plenum chamber 3200 is constructed from a translucent material.
  • the use of a translucent material can reduce the obtrusiveness of the patient interface, and help improve compliance with therapy.
  • the plenum chamber 3200 is constructed from a rigid material such as polycarbonate. The rigid material may provide support to the sealforming structure.
  • the plenum chamber 3200 is constructed from a flexible material (e.g., constructed from a soft, flexible, resilient material like silicone, textile, foam, etc.). For example, in examples then may be formed from a material which has a Young's modulus of 0.4 GPa or lower, for example foam. In some forms of the technology the plenum chamber 3200 may be made from a material having Young's modulus of 0.1 GPa or lower, for example rubber. In other forms of the technology the plenum chamber 3200 may be made from a material having a Young's modulus of 0.7MPa or less, for example between 0.7MPa and 0.3MPa. An example of such a material is silicone.
  • different plenum chambers 3200-1, 3200-2 may be formed as part of a multi-opening cushion 3050-1, 3050-2.
  • the cushions 3050-1, 3050-2 each include three openings, although an alternate cushion may be formed with greater or fewer openings.
  • the different openings may serve different functions. For example, some openings may be exclusively inlet openings, while other openings may be exclusively outlet openings.
  • At least one opening may serve two different functions.
  • one opening may operate as both an inlet and an outlet during the same breathing cycle.
  • the plurality of openings may allow for a variety of configurations of air delivery to the plenum chamber 3200-1, 3200-2.
  • the patient may use a given cushion 3050-1, 3050-2 in a “tube-up” configuration (e.g., using conduit headgear - described below) or a “tubedown” configuration (e.g., using a single conduit in front of the patient’s face).
  • the plenum chamber 3200-1 includes a pair of plenum chamber inlet ports 3254-1, which may be used to convey gas into and/or out of the plenum chamber 3200-1.
  • the plenum chamber inlet ports 3254-1 may be disposed on opposite sides (e.g., left and right sides) of the plenum chamber 3200-1.
  • the plenum chamber 3200-1 may also include at least one vent opening 3402-1 (see e.g., Fig. 6A).
  • the vent opening 3402-1 may be disposed in a center of the plenum chamber 3200-1.
  • the vent opening 3402-1 may be disposed between the plenum chamber inlet ports 3254-1.
  • the plenum chamber 3200-1 may include a pair of grooves 3266-1. Each groove 3266-1 may be disposed proximate to one of the plenum chamber inlet ports 3254-1. Each groove 3266-1 may form a partially recessed surface.
  • the plenum chamber 3200-2 of a nasal only cushion 3050-2 may be similar to the plenum chamber 3200-1 of the mouth and nose cushion 3050-1. Only some similarities and differences between the plenum chambers 3200-1, 3200-2 may be described below.
  • the plenum chamber 3200-2 includes a pair of plenum chamber inlet ports 3254-2, which may be used to convey gas into and/or out of the plenum chamber 3200-2.
  • the plenum chamber inlet ports 3254-2 may be disposed on opposite sides (e.g., left and right sides) of the plenum chamber 3200-2.
  • the plenum chamber 3200-2 may also include at least one vent opening 3402-2 (see e.g., Fig. 6B).
  • the vent opening 3402-2 may be disposed in a center of the plenum chamber 3200-2.
  • the vent opening 3402-2 may be disposed between the plenum chamber inlet ports 3254-2.
  • the plenum chamber 3200-2 may include a pair of grooves 3266-2. Each groove 3266-2 may be disposed proximate to one of the plenum chamber inlet ports 3254-2. Each groove 3266-2 may form a partially recessed surface.
  • the seal-forming structure 3100 of the patient interface 3000 of the present technology may be held in sealing position in use by the positioning and stabilising structure 3300.
  • the positioning and stabilising structure 3300 may comprise and function as “headgear” since it engages the patient’s head in order to hold the patient interface 3000 in a sealing position. Examples of a positioning and stabilising structure may be shown in Figs. 3A and 3A-1.
  • the positioning and stabilising structure 3300 provides a retention force at least sufficient to overcome the effect of the positive pressure in the plenum chamber 3200 to lift off the face (i.e., Fpienum).
  • the positioning and stabilising structure 3300 provides a retention force to overcome the effect of the gravitational force on the patient interface 3000.
  • the positioning and stabilising structure 3300 provides a force Fpss that assists in maintaining the plenum chamber 3200 in the sealing position on the patient’s face.
  • the positioning and stabilising force Fpss may be the resultant force from the various forces of the different elements of the positioning and stabilising structure 3300.
  • headgear straps may individually provide a strap force F s tra P in order to hold the seal-forming structure 3100 against the patient’s face.
  • the force F s tra P may also be directed at least partially in the superior direction in order to overcome the gravitational force F g .
  • the gravitational force F g may be specifically shown for the seal-forming structure 3100 and the plenum chamber 3200, but gravity would act on the entirely of the patient interface 3000 (i.e., in the same direction as the illustrated gravitational force F g ).
  • the gravitational force F g may be opposed by a frictional force Ff, which may act in a direction directly opposite of the gravitational force F g .
  • the frictional force Ff would act in the superior direction (e.g., against a patient’s face).
  • the patient may experience the frictional force Ff against his lip superior (and/or other surfaces of the patient’ s face in contact with the seal-forming structure 3100) in order to oppose the motion in the inferior direction (which may help to stabilising the cushion in place).
  • the frictional force Ff is shown specifically opposing the gravitational force F g of the seal-forming structure 3100 and the plenum chamber 3200, components of an overall frictional force (not shown) would also oppose the gravitational force F g associated with the positioning and stabilising structure 3300 and any other portions of the patient interface 3000.
  • a force of friction can act along any place where the patient interface 3000 contacts the patient’s skin (or hair).
  • the frictional force Ff extends in the opposite direction of the gravitational force F g and along the patient’s skin (or hair).
  • the gravitiational force F g may also be countered by vertical components of the reaction force from the patient’s face acting on the seal-forming structure 3100, for example at the nose ridge and chin regions of the patient’s face, for example.
  • the sum of the various forces may equal zero so that the patient interface 3000 is at equilibrium (e.g., not moving along the patient’s face while in use).
  • the gravitational force F g and the blowout force Fpienum tend to move the seal-forming structure 3100 away from the desired sealing position.
  • the positioning and stabilising force Fpss is applied in order to counteract the gravitational force F g and the blowout force Fpienum (as well as any frictional forces Ff) and keep the seal-forming structure 3100 properly situated.
  • the positioning and stabilising force Fpss may exceed the sum of the gravitational force F g and the blowout force Fpienum (with any additional positioning and stabilising force Fpss being balanced by reaction force from the patient’s head acting on the portions of patient interface 3000) and still maintain the seal-forming structure 3100 in an appropriate sealing position, patient comfort may be sacrificed. Maximum patient comfort may be achieved when the net force on the patient interface 3000 is zero and the positioning and stabilising force Fpss is exactly strong enough to achieve this.
  • the positioning and stabilising structure 3300 may be adjustable such that when fitted the positioning and stabilising force Fpss is greater than required to exactly balance the gravitational force F g and the blowout force Fpienum to hold the patient interface 3000 against the patient’s head tightly enough that disruptive forces which may be experienced in use (such as tube drag or lateral shunting of the plenum chamber 3200 during side sleeping) do not disrupt the seal.
  • disruptive forces which may be experienced in use (such as tube drag or lateral shunting of the plenum chamber 3200 during side sleeping) do not disrupt the seal.
  • various positions of the patient’s head while using the patient interface 3000 may determine the positioning and stabilising force Fpss necessary to achieve equilibrium.
  • the positioning and stabilising structure 3300 provides a retention force as a safety margin to overcome the potential effect of disrupting forces on the patient interface 3000, such as from tube drag, or accidental interference with the patient interface.
  • a positioning and stabilising structure 3300 is provided that is configured in a manner consistent with being worn by a patient while sleeping.
  • the positioning and stabilising structure 3300 has a low profile, or cross-sectional thickness, to reduce the perceived or actual bulk of the apparatus.
  • the positioning and stabilising structure 3300 comprises at least one strap having a rectangular cross-section.
  • the positioning and stabilising structure 3300 comprises at least one flat strap.
  • a positioning and stabilising structure 3300 is provided that is configured so as not to be too large and bulky to prevent the patient from lying in a supine sleeping position with a back region of the patient’s head on a pillow.
  • a positioning and stabilising structure 3300 is provided that is configured so as not to be too large and bulky to prevent the patient from lying in a side sleeping position with a side region of the patient’s head on a pillow.
  • a positioning and stabilising structure 3300 is provided with a decoupling portion located between an anterior portion of the positioning and stabilising structure 3300, and a posterior portion of the positioning and stabilising structure 3300.
  • the decoupling portion does not resist compression and may be, e.g. a flexible or floppy strap.
  • the decoupling portion is constructed and arranged so that when the patient lies with their head on a pillow, the presence of the decoupling portion prevents a force on the posterior portion from being transmitted along the positioning and stabilising structure 3300 and disrupting the seal.
  • a positioning and stabilising structure 3300 comprises a strap constructed from a laminate of a fabric patientcontacting layer, a foam inner layer and a fabric outer layer.
  • the foam is porous to allow moisture, (e.g., sweat), to pass through the strap.
  • the fabric outer layer comprises loop material to engage with a hook material portion.
  • a positioning and stabilising structure 3300 comprises a strap that is extensible, e.g. resiliently extensible.
  • the strap may be configured in use to be in tension, and to direct a force to draw a seal-forming structure into sealing contact with a portion of a patient’s face.
  • the strap may be configured as a tie.
  • the positioning and stabilising structure comprises a first tie, the first tie being constructed and arranged so that in use at least a portion of an inferior edge thereof passes superior to an otobasion superior of the patient’s head and overlays a portion of a parietal bone without overlaying the occipital bone.
  • the positioning and stabilising structure includes a second tie, the second tie being constructed and arranged so that in use at least a portion of a superior edge thereof passes inferior to an otobasion inferior of the patient’s head and overlays or lies inferior to the occipital bone of the patient’s head.
  • the positioning and stabilising structure includes a third tie that is constructed and arranged to interconnect the first tie and the second tie to reduce a tendency of the first tie and the second tie to move apart from one another.
  • a positioning and stabilising structure 3300 comprises a strap that is bendable and e.g. non-rigid.
  • An advantage of this aspect is that the strap is more comfortable for a patient to lie upon while the patient is sleeping.
  • a positioning and stabilising structure 3300 comprises a strap constructed to be breathable to allow moisture vapour to be transmitted through thestrap.
  • a system comprising more than one positioning and stabilising structure 3300, each being configured to provide a retaining force to correspond to a different size and/or shape range.
  • the system may comprise one form of positioning and stabilising structure 3300 suitable for a large sized head, but not a small sized head, and another, suitable for a small sized head, but not a large sized head.
  • the positioning and stabilising structure 3300 comprises one or more headgear tubes 3350 that deliver pressurised air received from a conduit forming part of the air circuit 4170 from the RPT device to the patient’s airways, for example through the plenum chamber 3200 and sealforming structure 3100.
  • the positioning and stabilising structure 3300 comprises two tubes 3350 that deliver air to the plenum chamber 3200 from the air circuit 4170.
  • the tubes 3350 are configured to position and stabilise the seal-forming structure 3100 of the patient interface 3000 at the appropriate part of the patient’s face (for example, the nose and/or mouth) in use. This allows the conduit of air circuit 4170 providing the flow of pressurised air to connect to a connection port 3600 of the patient interface in a position other than in front of the patient’s face, for example on top of the patient’s head.
  • the positioning and stabilising structure 3300 comprises two tubes 3350, each tube 3350 being positioned in use on a different side of the patient’s head and extending across the respective cheek region, above the respective ear (superior to the otobasion superior on the patient’s head) to the elbow 3610 on top of the head of the patient 1000.
  • This form of technology may be advantageous because, if a patient sleeps with their head on its side and one of the tubes 3350 is compressed to block or partially block the flow of gas along the tube 3350, the other tube 3350 remains open to supply pressurised gas to the patient.
  • the patient interface 3000 may comprise a different number of tubes, for example one tube, or two or more tubes.
  • the single tube 3350 is positioned on one side of the patient’s head in use (e.g. across one cheek region) and a strap forms part of the positioning and stabilising structure 3300 and is positioned on the other side of the patient’s head in use (e.g. across the other region) to assist in securing the patient interface 3000 on the patient’s head.
  • the tube 3350 and the strap may each be under tension in use in order to assist in maintaining the seal-forming structure 3100 in a sealing position.
  • the tube 3350 may be at least partially extensible so that the tube 3350 and the strap may adjust substantially equal lengths when worn by a patient. This may allow for substantially symmetrical adjustments between the tube 3350 and the strap so that the seal-forming structure remains substantially in the middle.
  • the two tubes 3350 are fluidly connected at superior ends to each other and to the connection port 3600.
  • the two tubes 3350 are integrally formed while in other examples the tubes 3350 are formed separately but are connected in use and may be disconnected, for example for cleaning or storage.
  • they may be indirectly connected together, for example each may be connected to a T-shaped connector.
  • the T-shaped connector may have two arms/branches each fluidly connectable to a respective one of the tubes 3350.
  • the T-shaped connector may have a third arm or opening providing the connection port 3600 for fluid connection to the air circuit 4170 in use.
  • the opening may be an inlet 3332 (see e.g., Fig. 6C) for receiving the flow of pressurized air.
  • the third arm of the T-shaped connector may be substantially perpendicular to each of the first two arms.
  • the third arm of the T-shaped connector may be obliquely formed with respect to each of the first two arms.
  • a Y-shaped connector may be used instead of the T-shaped connector.
  • the first two arms may be oblique with respect to one another, and the third arm may be oblique with respect to the first two arms.
  • the angled formation of the first two arms may be similar to the shape of the patient’ s head in order to conform to the shape.
  • At least one of the arms of the T-shaped connector may be flexible. This may allow the connector to bend based on the shape of the patient’s head and/or a force in the positioning and stabilising structure 3300.
  • At least one of the arms of the T-shaped connector may be at least partially rigidised. This may assist in maintaining the shape of the connector so that bending of the connector does not close the airflow path.
  • the tubes 3350 may be formed from a flexible material, such as an elastomer, e.g. silicone or TPE, and/or from one or more textile and/or foam materials.
  • the tubes 3350 may have a preformed shape and may be able to be bent or moved into another shape upon application of a force but may return to the original preformed shape in the absence of said force.
  • the tubes 3350 may be generally arcuate or curved in a shape approximating the contours of a patient’s head between the top of the head and the nasal or oral region.
  • the one or more tubes 3350 are crush resistant to resist being blocked if crushed during use, for example if squashed between a patient’s head and pillow, especially if there is only one tube 3350.
  • the tubes 3350 may be formed with a sufficient structural stiffness to resist crushing or may be as described in US Patent No. 6,044,844, the contents of which are incorporated herein by reference.
  • Each tube 3350 may be configured to receive a flow of air from the connection port 3600 on top of the patient’s head and to deliver the flow of air to the seal-forming structure 3100 at the entrance of the patient’s airways. In the example shown in Fig.
  • each tube 3350 lies in use on a path extending from the plenum chamber 3200 across the patient’s cheek region and superior to the patient’s ear to the elbow 3610.
  • a portion of each tube 3350 proximate the plenum chamber 3200 may overlie a maxilla region of the patient’s head in use.
  • Another portion of each tube 3350 may overlie a region of the patient’s head superior to an otobasion superior of the patient’s head.
  • Each of the tubes 3350 may also lie over the patient’s sphenoid bone and/or temporal bone and either or both of the patient’s frontal bone and parietal bone.
  • the elbow 3610 may be located in use over the patient’s parietal bone, over the frontal bone and/or over the junction therebetween (e.g. the coronal suture).
  • the patient interface 3000 is configured such that the connection port 3600 can be positioned in a range of positions across the top of the patient’s head so that the patient interface 3000 can be positioned as appropriate for the comfort or fit of an individual patient.
  • the headgear tubes 3350 are configured to allow movement of an upper portion of the patient interface 3000 (e.g. a connection port 3600) with respect to a lower portion of the patient interface 3000 (e.g. a plenum chamber 3200). That is, the connection port 3600 may be at least partially decoupled from the plenum chamber 3200. In this way, the seal-forming structure 3100 may form an effective seal with the patient’s face irrespective of the position of the connection port 3600 (at least within a predetermined range of positions) on the patient’s head.
  • the patient interface 3000 comprises a seal-forming structure 3100 in the form of a cradle cushion which lies generally under the nose and seals to an inferior periphery of the nose (e.g. an under-the-nose cushion).
  • the positioning and stabilising structure 3300, including the tubes 3350 may be structured and arranged to pull the seal-forming structure 3100 into the patient’s face under the nose with a sealing force in a posterior and superior direction (e.g. a postero superior direction).
  • a sealing force with a postero superior direction may cause the seal-forming structure 3100 to form a good seal to both the inferior periphery of the patient’s nose and anterior-facing surfaces of the patient’s face, for example on either side of the patient’s nose and the patient’s lip superior.
  • Conduits forming part of the positioning and stabilising structure 3300 may provide a force that contributes to the positioning and stabilising force Fpss.
  • the positioning and stabilising force Fpss may be the resultant force from the various forces of the different elements of the positioning and stabilising structure 3300.
  • each conduit may provide a force Fconduit directed in the posterior and respective lateral direction in order to hold the seal-forming structure 3100 against the patient’s face (into the upper lip and sealing under the nose) and oppose the effect of the positive pressure in the plenum chamber 3200 to lift off the face (i.e., Fpienum).
  • the force Fconduit directed may also be directed at least partially in the superior direction in order to overcome the gravitational force F g .
  • the conduits may provide a force directed into the patient’s head when the conduits are filled with pressurized air.
  • the force may assist in gripping the patient’s head.
  • the force may be caused by the inflation of the conduits during normal use.
  • the force may provide a cushioning effect to the patient’s head.
  • the conduits may be designed in order to limit expansion in order to prevent over-gripping the patient’s head.
  • the position of the patient’s head may also change the gripping force of the conduits. For example, if the patient is sleeping on his side, the weight of the patient’s head may compress one conduit, and the other conduit (e.g., the lateral portion not between the patient’s head and a sleeping surface, like a pillow) may additionally expand in order to keep substantially the same flow rate of pressurized air.
  • the other conduit e.g., the lateral portion not between the patient’s head and a sleeping surface, like a pillow
  • the gravitational force F g may be opposed by a frictional force Ff, which may act in a direction directly opposite of the gravitational force F g .
  • the frictional force Ff would act in the superior direction (e.g., against a patient’s face).
  • the patient may experience the frictional force Ff against his lip superior (and/or other surfaces of the patient’ s face in contact with the seal-forming structure 3100) in order to oppose the motion in the inferior direction (which may help to stabilising the cushion in place).
  • the frictional force Ff is shown specifically opposing the gravitational force F g of the seal-forming structure 3100 and the plenum chamber 3200, components of an overall frictional force (not shown) would also oppose the gravitational force F g associated with the positioning and stabilising structure 3300 and any other portions of the patient interface 3000.
  • a force of friction can act along any place where the patient interface 3000 contacts the patient’s skin (or hair).
  • the frictional force Ff extends in the opposite direction of the gravitational force F g and along the patient’s skin (or hair).
  • the sum of the various forces may equal zero so that the patient interface 3000 is at equilibrium (e.g., not moving along the patient’s face while in use).
  • the gravitational force F g and the blowout force Fpienum tend to move the seal-forming structure 3100 away from the desired sealing position.
  • the positioning and stabilising force Fpss is applied in order to counteract the gravitational force F g and the blowout force Fpienum (as well as any frictional forces Ff) and keep the seal-forming structure 3100 properly situated.
  • the positioning and stabilising force Fpss may exceed the sum of the gravitational force F g and the blowout force Fpienum (with any additional positioning and stabilising force Fpss being balanced by reaction force from the patient’s head acting on the portions of patient interface 3000) and still maintain the seal-forming structure 3100 in an appropriate sealing position, patient comfort may be sacrificed.
  • the positioning and stabilising structure 3300 may be adjustable such that when fitted the positioning and stabilising force Fpss is greater than required to exactly balance the gravitational force F g and the blowout force Fpienum to hold the patient interface 3000 against the patient’s head tightly enough that disruptive forces which may be experienced in use (such as tube drag or lateral shunting of the plenum chamber 3200 during side sleeping) do not disrupt the seal.
  • various positions of the patient’s head while using the patient interface 3000 may determine the positioning and stabilising force Fpss necessary to achieve equilibrium
  • the tubes 3350 are not extendable in length.
  • the tubes 3350 may comprise one or more extendable tube sections, for example formed by an extendable concertina structure.
  • the patient interface 3000 may comprise a positioning and stabilising structure 3300 including at least one gas delivery tube comprising a tube wall having an extendable concertina structure.
  • the patient interface 3000 shown in Fig. 3Y comprises tubes 3350, the superior portions of which comprise extendable tube sections each in the form of an extendable concertina structure 3362.
  • the extendable concertina structure 3328 may be formed as a series of ridges and grooves on the surface of the tubes 3350.
  • the concertina structure 3328 may be biased toward a retracted position, and may move to an expanded position when the patient dons the positioning and stabilising structure 3300.
  • portions of the tubes 3350 may be substantially inextensible (e.g., non- extendable tube sections 3363)
  • the concertina structures 3328 permit the positioning and stabilising structure 3300 to stretch in order to fit different sized heads. This may allow a single sized tube 3350 to be used with multiple sized heads.
  • the positioning and stabilising structure 3300 may be “one-size-fits-all” as a result of the concertina structure 3328.
  • the tubes 3350 may be manufactured in multiple sizes (e.g., small, medium, large). The patient may select a length that most closely conforms to their head, and the concertina structures 3328 may make small adjustments in order to tailor the fit to the individual patient.
  • the inlet 3332 may be disposed in the middle of the conduit 6320.
  • the tubes 3350 may be symmetric about the inlet 3332 through at least one axis.
  • the cross-sectional shape of the non-extendable tube sections 3363 of the tubes 3350 may be circular, elliptical, oval, D-shaped or a rounded rectangle, for example as described in US Patent No. 6,044,844.
  • a cross-sectional shape that presents a flattened surface of tube on the side that faces and contacts the patient’ s face or other part of the head may be more comfortable to wear than, for example a tube with a circular cross- section.
  • the non-extendable tube sections 3363 connects to the plenum chamber 3200 from a low angle.
  • the headgear tubes 3350 may extend inferiorly down the sides of the patient’s head and then curve anteriorly and medially to connect to the plenum chamber 3200 in front of the patient’s face.
  • the tubes 3350, before connecting to the plenum chamber 3200 may extend to a location at the same vertical position as (or, in some examples, inferior to) the connection with the plenum chamber 3200. That is, the tubes 3350 may project in an at least partially superior direction before connecting with the plenum chamber 3200.
  • a portion of the tubes 3350 may be located inferior to the plenum chamber 3200 and/or the seal forming structure 3100.
  • the tubes 3350 may contact the patient’s face below the patient’s cheekbones, which may be more comfortable than contact on the patient’s cheekbones and may avoid excessively obscuring the patient’s peripheral vision.
  • the patient interface 3000 may comprise a connection port 3600 located proximal to a superior, lateral or posterior portion of a patient’s head.
  • the connection port 3600 is located on top of the patient’s head (e.g. at a superior location with respect to the patient’s head).
  • the patient interface 3000 comprises an elbow 3610 forming the connection port 3600.
  • the elbow 3610 may be configured to fluidly connect with a conduit of an air circuit 4170.
  • the elbow 3610 may be configured to swivel with respect to the positioning and stabilising structure 3300 to at least partially decouple the conduit from the positioning and stabilising structure 3300.
  • the elbow 3610 may be configured to swivel by rotation about a substantially vertical axis and, in some particular examples, by rotation about two or more axes.
  • the elbow may comprise or be connected to the tubes 3350 by a ball-and-socket joint.
  • the connection portion 3600 may be located in the sagittal plane of the patient’s head in use.
  • Patient interfaces having a connection port that is not positioned anterior to the patient’s face may be advantageous as some patients may find a conduit that connects to a patient interface anterior to their face to be unsightly and/or obtrusive.
  • a conduit connecting to a patient interface anterior to the patient’s face may be prone to interference with bedclothes or bed linen, particularly if the conduit extends inferiorly from the patient interface in use.
  • Forms of the present technology comprising a patient interface having a connection port positioned superiorly to the patient’s head in use may make it easier or more comfortable for a patient to lie or sleep in one or more of the following positions: a side-sleeping position, a supine position (e.g.
  • Tube drag may be less of a problem when force is received at a superior location of the patient’ s head than anterior to the patient’ s face proximate to the seal-forming structure (where tube drag forces may be more likely to disrupt the seal).
  • the two tubes 3350 are fluidly connected at their inferior ends to the plenum chamber 3200.
  • the connection between the tubes 3350 and the plenum chamber 3200 is achieved by connection of two rigid connectors.
  • the tubes 3350 and plenum chamber 3200 may be configured to enable the patient to easily connect the two components together in a reliable manner.
  • the tubes 3350 and plenum chamber 3200 may be configured to provide tactile and/or audible feedback in the form of a ‘re-assuring click’ or a similar sound, so that the patient may easily know that each tube 3350 has been correctly connected to the plenum chamber 3200.
  • the tubes 3350 are formed from a silicone or textile material and the inferior end of each of the silicone tubes 3350 is overmolded to a rigid connector made, for example, from polypropylene, polycarbonate, nylon or the like.
  • the rigid connector on each tube 3350 may comprise a female mating feature configured to connect with a male mating feature on the plenum chamber 3200.
  • the rigid connector on each tube 3350 may comprise a male mating feature configured to connect to a female mating feature on the plenum chamber 3200.
  • the tubes 3350 may each comprise a male or female connector formed from a flexible material, such as silicone or TPE, for example the same material from which the tubes 3350 are formed.
  • a compression seal is used to connect each tube 3350 to the plenum chamber 3200.
  • a resiliently flexible (e.g. silicone) tube 3350 without a rigid connector may be configured to be squeezed to reduce its diameter so that it can be compressed into a port in the plenum chamber 3200 and the inherent resilience of the silicone pushes the tube 3350 outwards to seal the tube 3350 in the port in an air-tight manner.
  • each tube 3350 and/or plenum chamber 3200 may comprise a pressure activated seal, for example a peripheral sealing flange.
  • the sealing flange When pressurised gas is supplied through the tubes 3350 the sealing flange may be urged against the join between the tubes and a circumferential surface around a port or connector of the plenum chamber 3200 to form or enhance a seal between the tube 3350 and plenum chamber 3200.
  • the positioning and stabilising structure 3300 may include headgear 3302 with at least one strap which may be worn by the patient in order to assist in properly orienting the seal-forming structure 3100 against the patient’s face (e.g., in order to limit or prevent leaks).
  • some forms of the headgear 3302 may be constructed from a textile material, which may be comfortable against the patient’s skin.
  • the textile may be flexible in order to conform to a variety of facial contours.
  • the textile may include rigidisers along a selected length, which may limit bending, flexing, and/or stretching of the headgear 3302.
  • the headgear 3302 may be at least partially extensible.
  • the headgear 3302 may include elastic, or a similar extensible material.
  • the entire headgear 3302 may be extensible or selected portions may be extensible (or more extensible than surrounding portions). This may allow the headgear 3302 to stretch while under tension, which may assist in providing a sealing force for the seal-forming structure 3100.
  • the headgear 3302-1 may be a four- point connection headgear. This means that the headgear 3302-1 may connect to four separate places on the plenum chamber 3200, on a frame connected to the plenum chamber 3200, and/or on arms connected to the plenum chamber 3200.
  • the headgear 3302-1 may include four different straps providing a tensile force to help maintain the seal-forming structure 3100 in a sealing position.
  • the positioning and stabilising structure 3300 of Fig. 3A may also be considered a four-point connection headgear.
  • the headgear 3302-1 may include inferior straps 3304-1, which may connect to an inferior portion of the cushion 3050-1.
  • the inferior straps may connect to an inferior portion of the cushion 3050-1. The inferior straps
  • the inferior straps 3304-1 may extend along the patient’s cheek toward a posterior region of the patient’s head.
  • the inferior straps 3304-1 may overlay the masseter muscle on either side of the patient’s face.
  • the inferior straps 3304-1 may therefore contact the patient’s head below the patient’s ears.
  • the inferior straps 3304-1 may meet at the posterior of the patient’s head, and may overlay the occipital bone and/or the trapezius muscle.
  • the headgear 3302-1 may also include superior straps 3305-1, which may overlay the temporal bones, parietal bone, and/or occipital bone.
  • the superior straps 3305-1 may overlay the temporal bones, parietal bone, and/or occipital bone.
  • a rear strap 3307-1 may extend between the superior straps 3305-1 and between the inferior straps 3304-1.
  • the inferior and superior straps 3304-1, 3305-1 on a given side may also be connected to the rear strap 3307-1 adjacent to one another.
  • the height of the rear strap 3307-1 may therefore be approximately the combined height of the inferior and superior strap 3304-1, 3305-1.
  • the rear strap 3307-1 may overlay the occipital bone and/or the pariental bone in use. This may allow the rear strap 3307-1 to assist in anchoring the headgear 3302-1 to the patient’s head.
  • the headgear 3302-1 may be formed with a substantially X-shape.
  • the inferior and superior straps 3304-1, 3305-1 may be connected to a rear strap 3307-1 using stitching, ultrasonic welding, or any similar process.
  • the inferior straps 3304-1 are connected to a magnetic member 3306-1.
  • each inferior straps 3304-1 may be threaded through a magnetic member 3306-1, so that a length of each inferior strap 3304-1 may be adjusted.
  • the magnetic members 3306-1 may removably connect to the magnets 3370-1 (described below), so that the inferior straps 3304-1 may be disconnected from the plenum chamber 3200, but the length of the inferior straps 3304-1 may not be affected.
  • the superior straps 3305-1 may be connected directly to the tabs 3320 of the tubes 3350. The superior straps 3305 may be threaded through the tabs 3320 in order to adjust the length and control the tensile force of each superior strap 3305.
  • the headgear 3302-1 may be used only with the nose and mouth cushion 3050-1 (e.g., because the nose-only cushion 3050-1 does not have four connection points). However, the headgear 3302-1 may be used interchangeably with the tubes 3350 and the rigidiser arms 3340.
  • some forms of the headgear 3302-2 may be a two- point connection headgear. This means that the headgear 3302-2 may connect to two separate places.
  • the headgear 3302-2 may be formed from a continuous piece of material. In other words, the headgear 3302-2 may not be formed from multiple straps connected (e.g., stitched) together. This may be comfortable for a patient as they will not be in contact with any seams or joints connecting different straps. In other forms, the headgear 3302-2 may be formed from multiple straps (e.g., two superior straps, a rear strap, etc.) that are connected together (e.g., with stitching, ultra-sonic welding, etc.).
  • the positioning and stabilising structure 3300 comprises at least one headgear strap acting in addition to the tubes 3350 to position and stabilise the seal-forming structure 3100 at the entrance to the patient’s airways.
  • the patient interface 3000 comprises a strap 3307-2 forming part of the positioning and stabilising structure 3300.
  • the strap 3307- 2 may be known as a back strap or a rear headgear strap, for example.
  • the rear strap 3307-2 may overlay the temporal bones, parietal bone, and/or occipital bone. In other examples of the present technology, one or more further straps may be provided.
  • patient interfaces 3000 according to examples of the present technology having a nose-and-mouth cushion may have a second, lower, strap configured to lie against the patient’s head proximate the patient’s neck and/or against posterior surfaces of the patient’s neck.
  • strap 3310 of the positioning and stabilising structure 3300 is connected between the two tubes 3350 positioned on each side of the patient’s head and passing around the back of the patient’s head, for example overlying or lying inferior to the occipital bone of the patient’s head in use.
  • the strap 3310 connects to each tube above the patient’s ears.
  • the positioning and stabilising structure 3300 comprises a pair of tabs 3320. In use a strap 3310 may be connected between the tabs 3320.
  • the strap 3310 may be sufficiently flexible to pass around the back of the patient’s head and lie comfortably against the patient’s head, even when under tension in use.
  • some forms of the headgear 3302-2 may be at least partially bifurcated.
  • a rear strap 3307-2 of the headgear 3302-2 (e.g., configured to contact the posterior portion of the patient’s head) may be wider than the surrounding portions of the headgear 3302-2.
  • An intermediate section 3308-2 of the rear strap 3307-2 may include a slit 3309-2.
  • a superior section of the rear strap 3307-2 may therefore be movable relative to the inferior section as a result of the slit 3309-2. This may allow the patient to have a larger strap coverage on the posterior region of their head, which may assist in better anchoring the headgear 3302-2 to the patient’s head since there is no inferior strap (e.g., 3304-1).
  • the headgear 3302-2 may be used only with the nasal cushion 3050-2 (e.g., because the nose and mouth cushion 3050-1 does not have four connection points). However, the headgear 3302-2 may be used interchangeably with the tubes 3350 and the rigidiser arms 3340.
  • a rigidiser arm 3340 may be an elongated, rigid member that assists in maintaining the cushion (e.g., the nose and mouth cushion 3050-1 or the nasal cushion 3050-2) in an operating position.
  • the rigidiser arm 3340 may contact a side of the patient’s head and provide a force to limit slipping of the seal-forming structure 3100 from the patient’s nose and/or mouth.
  • the rigidiser arm 3340 is constructed from a rigid material (e.g., plastic).
  • the rigid material may not permit the rigidiser arm 3340 to stretch.
  • the rigidiser arm 3340 may be substantially inflexible and may be unable to bend.
  • the rigidiser arm 3340 may be pre-molded into a desired shape in order to fit a patient’s head.
  • the rigidiser arms 3340 may be molded with a curved shape to substantially correspond to the shape of the side of the patient’s head (e.g., overlaying the masseter muscle and/or the temporal bone).
  • the rigidiser arm 3340 may be molded in order to conform to a specific patient’s head (e.g., the rigidiser arm 3340 is customized).
  • the rigidiser arm 3340 may be flexible along at least one direction.
  • the rigidiser arm 3340 may be flexible about its width and may be inflexible along its length.
  • the rigidiser arm 3340 may be bendable about an axis along the width of the rigidiser arm 3340, but may be unable to bend about an axis perpendicular to the rigidiser arm 3340. This may allow an individual patient to adjust the rigidiser arm 3340 in order to better fit their individual head.
  • the rigidiser arm 3340 may remain in the new position after being bent. This may allow a patient adjust the shape of the rigidiser arm 3340 for their specific head and then the rigidiser arm 3340 will keep the desired shape while in use in order to promote patient comfort.
  • a first end 3342 of the rigidiser arm 3340 may be a free end and a second end 3344 (e.g., opposite of the first end 3342) of the rigidiser arm 3340 may be fixed.
  • the first end 3342 may be curved in order to minimize sharp edges that could cause patient discomfort.
  • the first end 3342 may also overlay the patient’s head proximate to the temporal bone, in use.
  • the second end 3344 may be fixed to an arm connection structure 3504.
  • the arm connection structure 3504 may be similar to the conduit connection structure 3500.
  • the arm connection structure 3504 and the conduit connection structure 3500 may have substantially the same shape. This may allow either the conduit connection structure 3500 or the arm connection structure 3504 to fit into the groove (e.g., 3266-1 or 3266-2) and connect to the plenum chamber inlet port 6254.
  • the arm connection structure 3504 may connect to the nose and mouth cushion 3050-1 or the nose-only cushion 3050-2 in substantially the same way as the conduit connection structure 3500 (e.g., via a snap fit, press fit, friction fit, etc.).
  • the arm connection structure 3504 may act as a plug for the plenum chamber inlet port 3254. Unlike the tubes 3350, the rigidiser arm 3340 does not convey pressurized air to the plenum chamber 3200.
  • the rigidised arm 3340 may be used with a “tube down” configuration, where a hose is connected to the vent opening 3402, and conveys air into the plenum chamber 3200 through the vent opening 3402. In this example, air does not need to travel into or out of the plenum chamber inlet openings 3254.
  • the arm connection structure 3504 may form a seal with the plenum chamber inlet opening 3254 in order to limit airflow into or out of the plenum chamber 3200.
  • the patient interface 3000 includes a vent 3400 constructed and arranged to allow for the washout of exhaled gases, e.g. carbon dioxide.
  • exhaled gases e.g. carbon dioxide.
  • the vent 3400 is configured to allow a continuous vent flow from an interior of the plenum chamber 3200 to ambient whilst the pressure within the plenum chamber is positive with respect to ambient.
  • the vent 3400 is configured such that the vent flow rate has a magnitude sufficient to reduce rebreathing of exhaled CO2 by the patient while maintaining the therapeutic pressure in the plenum chamber in use.
  • vent 3400 in accordance with the present technology comprises a plurality of holes, for example, about 20 to about 80 holes, or about 40 to about 60 holes, or about 45 to about 55 holes.
  • the vent 3400 may be located in the plenum chamber 3200.
  • the vent 3400 is located in a decoupling structure, e.g., a swivel.
  • a vent 3450 may be used with the patient interface 3000.
  • the vent 3450 may have a substantially similar shape to the vent opening 3402- 1 (e.g., a substantially circular shape).
  • the vent 3450 may be used with either the mouth and nose plenum chamber 3200-1 (e.g., illustrated in Fig. 6A) or the nose-only plenum chamber 3200-2 (e.g., illustrated in Fig.6B).
  • the vent 3450 may include a vent housing 3404, which may be configured to engage with the vent opening 3402.
  • the vent housing 3404 may be constructed from a rigid material or a semi-rigid material.
  • the vent housing 3404 may be constructed from plastic, metal, or any similar material.
  • the vent housing 3404 may add rigidity to the patient interface 3000 (e.g., to limit unwanted bending that may affect the position of the seal-forming structure 3100 on the patient’s face).
  • the vent housing 3404 may include an anterior surface 3408, a posterior surface 3412, and a groove (or channel) 3416.
  • the anterior surface 3408 faces away from the patient’s face in use, and may be positioned outside the pressurized volume of the plenum chamber 3200.
  • the posterior surface 3412 is disposed opposite to the anterior surface 3408. In use, the posterior surface 3412 may face the patient and may be disposed within the pressurized volume of the plenum chamber 3200.
  • the groove 3416 may be formed between the anterior and posterior surfaces 3408, 3412. A portion of the plenum chamber 3200 may be received within the groove 3416 in order to retain the vent 3400 in position.
  • a diffuser 3448 may be used with the vent housing 3404.
  • the diffuser 3448 may assist with limiting the decibel output from any of the patient interface 3000 (or any other patient interface). Specifically, the diffuser 3448 may assist in limiting the decibel level associated with air output from the patient interface 3000 (e.g., exhaled air), although the diffuser 3448 may limit the decibel level of at any point in the patient interface.
  • the diffuser 3448 may diffuse, and therefore slow, the exhaust gas exiting the plenum chamber 3200 and passing through the vent housing 3404.
  • the diffuser 3348 may assist in avoiding jetting and associated discomfort to the patient and/or bed partner (e.g., noise caused by jetting against a pillow, sheets, bedclothes, etc.).
  • the diffuser may include an anterior surface 3456 that faces away from the patient in use.
  • An outer diameter of the anterior surface 3456 may be less than an inner diameter of the vent housing 3404 proximate to the anterior surface 3408. This may form a gap 3464 through which air may travel.
  • vent 3400 may be in the form of a flow regulating vent and/or may comprise a flow regulating valve.
  • the flow regulating vent may be configured to regulate a flow rate of the gas being vented from a respiratory treatment system.
  • a respiratory treatment system may be able to control (e.g. regulate to a range) a flow rate of gas being vented therefrom.
  • the flow regulating vent in one form maintains a gas flow rate in a predetermined range across a range of pressures (e.g. differential pressures between the inlet and outlet of the flow regulating vent).
  • a flow regulating vent may be configured such that for a pressure range of between 5 and 30 cm H2O at the vent inlet, the flow rate through the vent 3400 may be approximately between 20 and 25 L/min.
  • a flow regulating vent may be configured such that for pressure range of between 10 and 20 cm H2O at the vent inlet, the flow rate through the vent may be approximately between 17 and 20 L/min.
  • the preferred range of flow rate(s) through the vent 3400 and their relationships to pressures may depend on a number of factors, such as the type of therapy and the patient.
  • Figs. 7 A through 7D show schematic representations of an exemplary flow regulating vent 7010 that illustrate the principles governing the operation of a flow regulating vent.
  • the flow regulating vent 7010 may comprise an inlet 7012, an outlet 7014, and a variable conduit 7016 through which the vented gas flows from the vent inlet 7012 to the vent outlet 7014.
  • variable conduit 7016 may be formed in part by a movable member (or puck) 7018.
  • the movable member 7018 may be configured to move toward and away from an opposite side of the variable conduit 7016 to widen or narrow the variable conduit 7016.
  • the impedance (i.e., resistance to gas flow) of the variable conduit 7016 depends at least in part on the width (Wconduit) of the variable conduit 7016.
  • the movement of the movable member 7018 affects the impedance of the variable conduit 7016.
  • the impedance of the variable conduit 7016 may be increased by moving the movable member 7018 toward the opposite side of the variable conduit 7016 because such movement narrows (or decreases the size of the cross-section of) the variable conduit 7016.
  • the impedance of the variable conduit 7016 may be decreased by moving the movable member 7018 away from the opposite side of the variable conduit 7016 because such movement widens (or increases the size of the cross-section of) the variable conduit 7016. It should be understood that a change in a shape of a cross-section of the variable conduit 7016 may also increase or decrease the impedance of the variable conduit 7016.
  • variable conduit 7016 It should also be understood that, typically, discussions in regards to cross-sections of the variable conduit 7016 relate to cross-sections with a normal coincident with a direction of the flow of air exiting the variable conduit 7016.
  • the movable member 7018 may comprise a first side 7020 facing the outside of the variable conduit 7016 and a second side 7022 facing the inside of the variable conduit 7016.
  • the pressure inside the variable conduit 7016 begins to decrease.
  • the pressure on the outside of the variable conduit e.g., the reference pressure, ambient pressure, or atmospheric pressure
  • the pressure differential between the outside of the variable conduit 7016 and the inside of the variable conduit 7016 increases as the flow rate of the vented gas increases.
  • the flow regulating characteristics of the flow regulating vent 7010 can be “tuned” to achieve the desired flow rate at various pressures. For example, the diameters and/or shapes of the inlet 7012 and outlet 7014 may be adjusted.
  • the type of material forming the housing of flow regulating vent 7010 e.g. polycarbonates, thermoplastic polymers, acrylonitrile butadiene styrene (ABS), thermoplastic resin and silicone
  • ABS acrylonitrile butadiene styrene
  • silicone thermoplastic resin and silicone
  • the dimensions of the movable member 7018, the length and width of the variable conduit 7016, and the material of the movable member 7018 may also be adjusted to “tune” for noise dampening performance.
  • the movable member 7018 may be formed of, e.g., polycarbonates, thermoplastic polymers, acrylonitrile butadiene styrene (ABS), thermoplastic resin, thermoplastic elastomers and silicone.
  • Fig. 7E shows an experimentally derived flow curve for an exemplary flow regulating vent.
  • Fig. 7E shows the air flow rate increasing at a steep gradient as a function of flow rate to approximately 18.5L/min, at a pressure of approximately 1.3 cm H2O (see measure 7024).
  • the flow rate is approximately 20 L/min at an increased pressure of approximately 5 cm H2O.
  • the flow rate has increased to approximately 24 L/min, indicating a decreased rate of increase of flow rate as a function of pressure.
  • a vent arrangement with a flow characteristic shown in Fig. 7E may reach a minimum flow rate for sufficient washout at a low pressure, while preventing an excessive washout of air through the vent arrangement at a high pressure.
  • Fig. 7F shows an experimentally derived flow curve for another exemplary flow regulating vent. It can be seen here that a low-pressure behaviour (e.g. between 0 and 6 cm H2O) can be varied substantially without greatly modifying the high-pressure behaviour (e.g. between 10 and 20 cm H2O).
  • a low-pressure behaviour e.g. between 0 and 6 cm H2O
  • a high-pressure behaviour e.g. between 10 and 20 cm H2O
  • Fig. 7G shows the flow curves of various flow regulating vents.
  • seven different flow regulating vents (1-7) were tested using a mask flow test bench.
  • Each flow regulating vent was connected to a 2m long tube with a diameter of 19mm, a flow computer (for recording test results), and a computer- controlled flow generator.
  • the flow generator was driven to produce a pressure of 43cmH2O.
  • Each flow regulating vent underwent four test runs under the above conditions, and the flow curves of Fig. 7G show the average of the four test runs for each flow regulating vent.
  • the design parameters for each flow regulating vent were modified and show that the flow curve for the flow regulating vent can be modified to suit different applications. These parameters included the diameter d of the inlet 7012, the starting width w of the variable conduit 7016, and the thickness t of the movable member 7018 (see Fig. 7H).
  • the starting width w of the variable conduit 7016 is the width of the variable conduit 7016 when the flow regulating vent 7010 is in a neutral state (e.g., prior to pressurized gas (either from the flow generator or patient interface) flowing through the flow regulating vent).
  • the thickness t of the movable member 7018 was 1.25 mm
  • the starting width w of the variable conduit was 1.25 mm
  • the thickness t of the movable member 7018 was 4 mm.
  • the thickness t of the movable member 7018 was 1.25 mm
  • the starting width w of the variable conduit was 1.25 mm
  • the thickness t of the movable member 7018 was 3 mm.
  • the thickness t of the movable member 7018 was 0.75 mm
  • the starting width w of the variable conduit was 1.50 mm
  • the thickness t of the movable member 7018 was 4 mm.
  • the thickness t of the movable member 7018 was 0.75 mm, the starting width w of the variable conduit was 1.75 mm, and the thickness t of the movable member 7018 was 4 mm.
  • the thickness t of the movable member 7018 was 0.75 mm, the starting width w of the variable conduit was 2.0 mm, and the thickness t of the movable member 7018 was 4 mm.
  • the thickness t of the movable member 7018 was 1.25 mm
  • the starting width w of the variable conduit was 1.5 mm
  • the thickness t of the movable member 7018 was 4 mm.
  • the thickness t of the movable member 7018 was 1.25 mm
  • the starting width w of the variable conduit was 1.75 mm
  • the thickness t of the movable member 7018 was 4 mm.
  • the flow regulating vent 8000 may be used with the nasal sealforming structure 3100 that comprises the vent opening 3402-2. Similar to the configuration with the oronasal seal-forming structure 3100, the flow regulating vent 8000 may be positioned between the plenum chamber inlet ports 3254-2. Also, the flow regulation vent 8000 can be located in other positions on the seal-forming structure 3100. For example, in configurations utilizing only one inlet port, the flow regulating vent 8000 may be located above, below or lateral to the inlet port. In addition, the flow regulating vent 8000 may be permanently or removably secured within the vent opening 3402-2.
  • the flow regulating vent 8000 may include a base portion 8010, a housing (or cap portion) 8020, a movable member (or puck or movable part) 8030 and a biasing mechanism 8040.
  • the base portion 8010 may secure the vent 8000 to the seal forming structure 3100, while the housing 8020 may enclose the movable member 8030 and the biasing mechanism 8040.
  • the base portion 8010 may be linked to the housing 8020 by way of one or more bridging portions 8050.
  • the one or more bridging portions (or spacers) 8050 may maintain a gap (or variable conduit) 8060 between the base portion 8010 and the housing 8020. It is contemplated that the one or more bridging portions (or spacers) 8050 may be incompressible.
  • a shape of the perimeter of the base portion 8010 may be made to match the shape of the vent opening 3402-1 (or 3402-2) in the seal-forming structure 3100.
  • the perimeter of the base portion 8010 may also be circular.
  • the perimeter of the base portion 8010 may be rectangular, square, triangular, ovoid, hexagonal, or any other shape that may secure the vent 8000 to the seal-forming structure 3100.
  • the base portion 8010 may include a pair of flanges 8070 and 8080 that together form a channel 8090.
  • the flanges 8070 and 8080 may extend radially outward from a circumferential wall 8095 of the base portion 8010 so that the channel 8090 is open in a radially outward direction.
  • the channel 8090 may receive a rim of the vent opening 3402-1 (or 3402-2) of the seal-forming structure 3100.
  • the diameter of the flanges 8070 and 8080 may be larger than the diameter of the vent opening 3402-1 (or 3402-2).
  • the base may be an integral part of a plenum wall of the seal-forming structure 3100.
  • the flanges 8070 and 8080 and the channel 8090 may be replaced with the rim of the vent opening 3402-1 or 3402-2.
  • the base portion 8010 may have an inlet side and an outlet side.
  • the inlet side of the base portion 8010 may include an inlet opening 8100 that receives gas washout from the vent opening 3402-1 (or 3402-2) of the seal-forming structure 3100.
  • the inlet opening 8100 may be bound by the circumferential wall 8095 so that the diameter of the inlet opening 8100 is the same size as the diameter of the base portion 8010 at the circumferential wall 8095.
  • the diameter of the inlet opening 8100 may be less than the diameter of the base portion 8010 at the circumferential wall 8095.
  • the outlet side of the base portion 8010 may include an intermediate wall 8110 with an intermediate opening 8120.
  • the intermediate wall 8110 may span radially outward from a central portion of the base to the circumferential wall 8095.
  • the intermediate wall 8110 may form one of the walls of the gap 8060.
  • the intermediate wall 8110 may be stationary.
  • the intermediate opening 8120 may be located at a central region of the intermediate wall 8110 (and/or a central region of the gap 8060) and may be positioned to allow the gas washout to exit the base portion 8010 into the gap 8060.
  • the intermediate opening 8120 may be smaller than or the same size as the inlet opening 8100. It is contemplated that the size of the intermediate opening 8120 and/or the inlet opening 8100 (e.g., the diameter) may be fixed or adjustable.
  • Gas washout from the plenum chamber 3200 may enter the base portion 8010 in a direction that is parallel to the central axis a of the vent 8000. Upon exiting the base portion 8010 through the intermediate opening 8120, the gas washout may enter the gap 8060. Upon entering the gap 8060, the gas washout may be deflected by the movable member 8030 to change direction so that the gas washout flows through the gap 8060 in a radially outward direction.
  • the gas washout changes direction while flowing through the vent 8000 from an axial direction (i.e., the direction parallel to the central axis a of the vent 8000) to a radially outward direction (i.e., a direction that is radially outward from the central axis a of the vent 8000).
  • the gap 8060 provides an outlet conduit for the gas washout so that the gas washout exits the vent 8000 through the gap 8060 and out a circumferential side (or perimeter) of the vent 8000.
  • the movable member 8030 may form the other wall of the gap 8060 and may oppose the intermediate wall 8110.
  • the movable member 8030 may be movable in the axial direction (i.e., the direction parallel to a central axis a of the vent 8000) so that movement of the movable member 8030 may decrease or increase a width of the gap 8060, which narrows or widens the flow path for the gas washout as the gas washout exits the vent 8000.
  • the gap 8060 functions as a variable conduit.
  • the movable member 8030 may be in the form of a disc or any other shape that is substantially wider (in the radial direction) than it is thin (in the axial direction).
  • the movable member 8030 may be larger than the intermediate opening 8120 and may extend to the perimeter of the housing 8020 and/or the perimeter of the vent 8000.
  • the movable member 8030 may be biased by the biasing mechanism 8040 toward a position that provides a maximum width of the gap 8060.
  • the biasing mechanism 8040 may be biased away from the intermediate wall 8110.
  • the gas pressure in the gap 8060 may decrease thereby overcoming the biasing force of the biasing mechanism 8040 and drawing the movable member 8030 closer to the intermediate wall 8110 of the base portion 8010.
  • the smaller width of the gap 8060 may increase the impedance (resistance to flow) of the gap 8060, thereby slowing or stopping the increase in gas flow rate through the gap 8060.
  • the configuration of the vent 8000 causes a feedback loop that regulates the flow of gas washout through the vent 8000 to achieve a target flow rate.
  • the movable member 8030 may be attached to the biasing mechanism 8040 at a central location on the movable member 8030 and at a central location on the biasing mechanism 8040 (e.g., at the central axis a of the vent 8000). The remaining portions of the movable member 8030 may be separated from the biasing mechanism 8040.
  • the biasing mechanism 8040 may be in the form of a spring.
  • the biasing mechanism 8040 may have a spiral shape that spirals radially inwardly from a perimeter of the vent 8000.
  • the biasing mechanism 8040 may be cantilevered (e.g., a cantilevered spiral lever).
  • the cantilevered structure of the biasing mechanism 8040 may have a stationary anchored end 8130 and a movable free end 8132.
  • the biasing mechanism 8040 be anchored to the housing 8020 at the anchored end 8130.
  • the anchored end 8130 may be located at an outer perimeter (or circumferential) portion of the biasing mechanism 8040.
  • the biasing mechanism 8040 may be secured to the movable member 8030 by way of a shaft 8134 located at the free end 8132 of the biasing mechanism 8040.
  • the free end 8132 may be positioned at a central location.
  • the shaft 8134 may be positioned at any location that is radially inward from the anchored end 8130.
  • the free end of the cantilever structure may also be positioned at any location that is radially inward from the anchored end 8130.
  • the biasing mechanism 8040 when the biasing mechanism 8040 is in a neutral state (i.e., the absence of any force acting on the biasing mechanism 8040), the anchored end 8130 and the free end 8132 may be coplanar.
  • the biasing mechanism 8040 may move in the axial direction.
  • the movement of the biasing mechanism 8040 may be greater in the central region than at the perimeter. This is because the central region is furthest along the spiral form from the anchored end 8130.
  • the movable member 8030 may be attached to the part of the biasing mechanism 8040 with the greatest movement.
  • the biasing mechanism 8040 may be most flexible at the free end 8132 and may be most rigid at the anchored end 8130.
  • the flow regulating characteristics of the flow regulating vent 8000 can be “tuned” to achieve the desired flow rate at various pressures.
  • the cross-sectional shape and dimensions of the biasing mechanism 8040, the material from which the biasing mechanism 8040 is made, and the spring constant of the biasing mechanism 8040 may affect the biasing force, which in turn affects the equilibrium of the system and the flow curve of the vent 8000.
  • the cross-sectional shape of the biasing mechanism 8040 may be square with each side of the square being 1.5 mm.
  • the length of the biasing mechanism 8040 may be 165.39 mm.
  • the biasing mechanism 8040 may be made of nylon (with or without additives such as glass beads or binders), polypropylene, a thermoplastic elastomer, a thermoplastic polyurethane, poly aryletherketones, jet fusion material, or any combination of the materials discussed above. It should be understood that the biasing mechanism 8040 is not limited to the dimensions, shapes, and materials discussed above, which may be different depending on the target flow curve or flow rate.
  • the movable member 8030 may be made of the same material as the biasing mechanism 8040 or may be made of different materials. Also, the locations of the connection between the housing 8020 and the biasing mechanism 8040 and the connection between the biasing mechanism and the movable member 8030 may be moved radially from those locations shown in Fig. 8D and 8J to adjust the flow curve of the vent 8000.
  • Other parameters of the vent 8000 may be adjusted to “tune” the characteristics of the vent 8000.
  • the diameter of the intermediate opening 8120 or the diameter of the base portion 8010 may be adjusted.
  • the axial length of the bridging portions 8050 may be adjusted to “tune” the starting vent flow (L/min) and correct pressure activation.
  • the diameter or largest length of the movable member 8030 may be adjusted. For example, by reducing the diameter or largest length of the movable member 8030, the initial low pressure flow rate can be changed to start at a higher flow rate.
  • connection between the biasing mechanism 8040 and the movable member 8030 may be rigid so that the entire movable member 8030 moves the same distance and the cross-sectional width of the gap 8060 is consistent throughout the gap 8060.
  • the connection between the biasing mechanism 8040 and the movable member 8030 may not be rigid.
  • the connection may be a ball-and-socket connection with the movable member 8030 comprising a ball portion 8160 and the biasing mechanism 8040 comprising the socket portion 8170 (or vice versa).
  • the ball and socket connection may allow the movable member 8030 to pivot relative to the biasing mechanism 8040.
  • the pivoting of the movable member 8030 may cause the cross- sectional width of the gap 8060 to be inconsistent (e.g., one portion of the gap 8060 being narrower than another portion of the gap 8060), which may allow the movable member 8030 to compensate for discrepancies in the pressure distribution in the gap 8060 that may arise during operation. Accounting for such discrepancies may lead to less turbulent and more laminar flow through the vent 8000, which in turn, may lead to less noise.
  • connection between the biasing mechanism 8040 and the movable member 8030 may be a hinged arrangement (e.g., a living hinge) or may simply be formed by a flexible material. These configurations may also allow the movable member 8030 to pivot relative to the biasing mechanism 8040 and compensate for discrepancies in the pressure distribution in the gap 8060 that may arise during operation.
  • the housing 8020 may include one or more openings.
  • the housing 8020 may include a central opening 8140 surrounded by one or more additional openings 8150.
  • the openings 8140, 8150 may facilitate the manufacture of the flow regulating vent 8000 (i.e., may provide a path for removal of excess material during manufacturing).
  • the central opening 8140 is shown as being circular, the central opening 8140 may have any shape such triangular, elliptical, quadrilateral, pentagonal, hexagonal, etc.
  • the additional openings 8150 are shown as being curved slits, the additional openings 8150 may have any shape.
  • the openings 8140 and 8150 may be created to allow a pathway to remove excess material left over from the manufacturing process.
  • the openings 8140 and 8150 may be located outside of the flow path of the gas washout so that the gas washout does not flow through the openings 8140 and 8150.
  • the biasing mechanism may be attached to the housing 8020 at the anchored end 8130.
  • the anchored end 8130 may be in the form of a shaft.
  • the attachment structure may be in any form.
  • Figs. 8D and 8 J show the majority of the biasing mechanism 8040 being spaced apart from the housing 8020 so that a gap is present between the housing 8020 and the biasing mechanism 8040
  • the biasing mechanism 8040 may be attached to the housing 8020 in a manner so that the entirety of the biasing mechanism 8040 is pressed against the housing 8020 when the biasing mechanism 8040 is in its fully biased state (or when the gap 8060 is in its widest state).
  • the connection between the biasing mechanism 8040 and the housing 8020 at the anchored end 8130 may be rigid, semi-rigid, or flexible.
  • vent 8000 may be integrally formed.
  • the base portion 8010, the movable member 8030 and the biasing mechanism 8040 may be formed unitarily.
  • the vent 8000 may be formed by way of a 3D printing process (for example, selected laser sintering (SLS)).
  • SLS selected laser sintering
  • all of the parts described above may be one continuous (and/or seamless) structure.
  • the movable member 8030 may be attached to the biasing mechanism 8040 at a central point.
  • the movable member 8030 is attached to the housing 8020 by way of the biasing mechanism 8040.
  • the movable member 8030 is attached to the base portion 8010 by way of the biasing mechanism 8040, the housing 8020 and the bridging portions 8050.
  • the vent 8000 may be made by way of injection molding.
  • the vent 8000 may optionally include one or more sensors 8180.
  • the sensors 8180 may be positioned inside the base portion 8010 (e.g., on an inner surface of the intermediate wall 8110 and/or in the gap 8060 (e.g., on an outer surface of the intermediate wall 8110 or on the movable member 8030).
  • the one or more sensors 8180 may be flow sensors, pressure sensors, displacement sensors, or any combination thereof.
  • the one or more sensors 8180 may transmit signals along a wire 8190 (or wirelessly) to a controller 8200 (Fig. 8K).
  • the signals may be indicative of a condition of the gas washout such as, for example, gas pressure, gas flow rate, and/or displacement of the movable member 8030.
  • the controller 8200 may be a stand-alone controller, a controller for a flow generator, or a controller for a humidifier.
  • the controller 8200 may analyse the signals generated by the one or more sensors 8180 and determine whether the vent 8000 has failed. Vent failure may be determined when the pressure exiting the vent 8000 is above and/or below a threshold pressure. Failure may also be determined when a pressure differential between gas pressure in the base portion 8010 and gas pressure in the gap 8060 is above a threshold pressure and/or below another threshold pressure. Failure may also be determined when the flow rate of gas flowing through the gap 8060 is above a target flow rate and/or below another target flow rate. In addition, failure may be determined when a distance travelled by the movable member 8030 is less than a threshold distance and/or greater than another threshold distance for a particular pressure in the plenum. Upon determining that the vent 8000 has failed, the controller 8200 may send a signal to a user (by way of a user interface 8210 or other method) that the vent 8000 has failed and needs to be replaced.
  • Figs. 8L-8N illustrate another flow regulating vent 9000. Similar to the flow regulating vent 8000, the flow regulating vent 9000 may comprise a movable member 9010 and a biasing mechanism 9020. The movable member 9010 and the biasing mechanism 9020 may be connected to each other by way of a shaft 9030. Thus the central portions of the movable member 9010 and the biasing mechanism 9020 may be connected to each other by way of the shaft 9030. It is contemplated that the movable member 9010 and the biasing mechanism 9020 may have the same structure, same material, and same dimensions as the movable member 8030 and the biasing mechanism 8040 of the vent 8000.
  • the vent 9000 may be attached to the vent opening 3402-1 in the oronasal seal-forming structure 3100 or the vent opening 3402- 2 in the nasal seal-forming structure 3100.
  • the vent 9000 may also be attached to other components such as an elbow, air delivery tube, etc. In other words, the vent 9000 may be connected to any component forming a plenum or gas flow path.
  • the movable member 9010 and the biasing mechanism 9020 may be on opposite sides of a wall (or base) 9040 bounding a plenum (or airflow path) 9050.
  • the biasing mechanism 9020 may be positioned in the interior of the plenum or air flow path 9050, while the movable member 9010 may be positioned outside of the plenum or air flow path 9050.
  • the movable member 9010 may be movable between a closed position and a venting position. When in the closed position, the movable member 9010 may be pulled against the wall 9040 so that the opening 9060 is covered by the movable member 9010. In other words, the movable member 9010 may block or prevent gas washout from exiting the plenum or airflow path 9050 through the opening 9060 in the wall 9040. When in the venting position, the movable member 9010 may be spaced away from the wall 9040 to form a gap (or variable conduit) 9070 between the wall 9040 and the movable member 9010.
  • the gap 9070 may be a variable conduit outside of the plenum or airflow path 9050 with the movable member 9010 forming one side of the gap 9070 (variable conduit) and the wall 9040 of the plenum or airflow path 9050 forming another side of the variable conduit that opposes the movable member 9010.
  • the movable member 9010 may be movable in a direction that is perpendicular to the wall 9040 so that movement of the movable member 9010 may decrease or increase a width of the gap 9070, which narrows or widens the flow path for the gas washout as the gas washout exits the vent 9000.
  • the movable member 9010 may be in the form of a disc or any other shape that is able to cover the opening 9060 in the wall 9040.
  • the perimeter of the movable member 9010 may be larger than the perimeter of the opening 9060 so that the movable member 9010 forms the gap 9070 when in the venting position. The longer the flow path of gas washout through the gap (variable conduit) 9070, the less turbulence in the gas washout flow and less noise at the outlet of the vent 9000.
  • the movable member 9010 may be biased by atmospheric or ambient pressure and the biasing mechanism 9020 toward the closed position (i.e., the position in which the movable member is pulled against the wall 9040).
  • the closed position i.e., the position in which the movable member is pulled against the wall 9040.
  • the combined biasing force of the biasing mechanism 9020 and the ambient or atmospheric pressure may be overcome, and the movable member 9010 may be pushed away from the wall 9040 to create the gap 9070.
  • the width of the gap 9070 may increase and the impedance (resistance to flow) of the gap 9070 may decrease, thereby allowing the gas flow rate through the gap 9070 to increase.
  • the configuration of the vent 9000 causes a feedback loop that regulates the flow of gas washout through the vent 9000 to achieve a target flow rate.
  • the biasing mechanism 9020 may be in the form of a spring.
  • the biasing mechanism 9020 may have a spiral shape that spirals radially inwardly from a perimeter of the vent 9000.
  • the biasing mechanism 9020 may be cantilevered (e.g., a cantilevered spiral lever).
  • the cantilevered structure of the biasing mechanism 9020 may have a stationary anchored end 9080 and a movable free end 9090.
  • the biasing mechanism 9020 may be anchored to an inner side of the wall 9040 at the anchored end 9080 at an outer perimeter (or circumferential) portion of the biasing mechanism 9020.
  • the biasing mechanism 9020 may be secured to the movable member 9010 by way of the shaft 9030, which is located at the free end 9090.
  • the free end 9090 may be positioned at a central location. It is contemplated that the shaft 9030 may be positioned at any location that is radially inward from the anchored end 9080.
  • the free end 9090 of the cantilever structure may also be positioned at any location that is radially inward from the anchored end 9080.
  • the biasing mechanism 9020 when the biasing mechanism 9020 is in a neutral state (i.e., the absence of any force acting on the biasing mechanism 9020), the anchored end 9080 and the free end 9090 may be coplanar.
  • the biasing mechanism 9020 may move toward the wall 9040.
  • the movement of the biasing mechanism 9020 may be greater at the central end 9090 than at the perimeter. This is because the central end 9090 is furthest along the spiral from the anchored end 9080.
  • the movable member 9010 may be attached to the part of the biasing mechanism 9020 with the greatest movement. It is also contemplated that the biasing mechanism 9020 may be spaced away from the inner side of the wall 9040 except at the anchored end 9080.
  • the majority of the biasing mechanism 9020 may be positioned against the inner side of the wall 9040 except for the portion in the vicinity of the central end 9090. The greater the portion of the biasing mechanism 9020 that is separated from the wall 9040, the greater the range of movement for the movable member 9010.
  • the flow regulating characteristics of the flow regulating vent 9000 can be “tuned” to achieve the desired flow rate at various pressures.
  • the cross-sectional shape and dimensions of the biasing mechanism 9020, the material from which the biasing mechanism 9020 is made, and the spring constant of the biasing mechanism 9020 may affect the biasing force, which in turn affects the equilibrium of the system and the flow curve of the vent 9000.
  • the cross-sectional shape of the biasing mechanism 9020 may be square with each side of the square being 1.5 mm.
  • the length of the biasing mechanism 9020 may be 165.39 mm.
  • the biasing mechanism 9020 may be made of nylon (with or without additives such as glass beads or binders), polypropylene, a thermoplastic elastomer, a thermoplastic polyurethane, poly aryletherketones, jet fusion material, or any combination of the materials discussed above.
  • the biasing mechanism 9020 is not limited to the dimensions, shapes, and materials discussed above, which may be different depending on the target flow curve or flow rate.
  • the movable member 9010 may be made of the same material as the biasing mechanism 9020 or may be made of different materials.
  • connection between the biasing mechanism 9020 and the movable member 9010 may be rigid so that the entire movable member 9010 moves the same distance and the cross-sectional width of the gap 9070 is consistent throughout the gap 9070.
  • connection between the biasing mechanism 9020 and the movable member 9010 may not be rigid.
  • the shaft 9030 may be made of a flexible material that allows the shaft 9030 to bend.
  • the shaft 9030 may be attached to the biasing mechanism 9020 and/or the movable member 9010 by a hinged arrangement (e.g., a living hinge) so that the movable member 9010 and/or the biasing mechanism 9020 is pivotable relative to the shaft 9030 and/or each other. It is contemplated that the shaft 9030 may be connected to the movable member 9010 and/or the biasing mechanism 9020 by way of a ball-and-socket configuration similar to the ball-and-socket configuration illustrated in Fig. 8J.
  • a hinged arrangement e.g., a living hinge
  • any of the movable member 9010, the biasing mechanism 9020, and the shaft 9030 may have the “ball” portion of the ball-and- socket connection and the other component comprising the “socket” portion of the ball-and-socket connection or vice versa.
  • vent 9000 may be integrally formed.
  • the base 9040, the movable member 9010 and the biasing mechanism 9020 may be formed unitarily.
  • the vent 9000 may be formed by way of a 3D printing process (for example, selected laser sintering (SLS)).
  • SLS selected laser sintering
  • all of the parts described above may be one continuous (and/or seamless) structure.
  • the vent 9000 may be made by way of injection molding.
  • the vent 9000 may optionally include one or more sensors 9100.
  • the sensors 9100 may be positioned on or imbedded in the movable member 9010 or on or imbedded in an outside surface of the wall 9040.
  • the one or more sensors 9100 may be flow sensors, pressure sensors, displacement sensors, or any combination thereof.
  • the one or more sensors 9100 may transmit signals along a wire 9110 (or wirelessly) to a controller 9120 (Fig. 8R).
  • the signals may be indicative of a condition of the gas washout such as, for example, gas pressure, gas flow rate, and/or displacement of the movable member 9010.
  • the controller 9120 may be a stand-alone controller, a controller for a flow generator, or a controller for a humidifier.
  • the controller 9120 may analyse the signals generated by the one or more sensors 9100 and determine whether the vent 9000 has failed. Vent failure may be determined when the pressure exiting the vent 9000 is above and/or below a threshold pressure. Failure may also be determined when a pressure differential between gas pressure in the plenum or airflow path 9050 and gas pressure in the gap 9070 is above a threshold pressure and/or below another threshold pressure. Failure may also be determined when the flow rate of gas flowing through the gap 9070 is above a target flow rate and/or below another target flow rate. In addition, failure may be determined when a distance travelled by the movable member 9010 is less than a threshold distance and/or greater than another threshold distance for a particular pressure in the plenum or airflow path 9050. Upon determining that the vent 9000 has failed, the controller 9120 may send a signal to a user (by way of a user interface 9130 or other method) that the vent 9000 has failed and needs to be replaced.
  • vents 7010, 8000, 9000, and 9050 discussed above regulate the flow of gas washout through the vent by way of a self-regulating feedback loop that relies on the flow of gas through the patient interface to actuate the vent.
  • the above flow regulating vent designs may be supplemented or augmented with external mechanisms that can actuate the flow-regulating vent in conjunction with the flow of gas through the patient interface or instead of the gas flowing through the patient interface. It is contemplated that such an actuation mechanism may be positioned outside the gas flow path.
  • the actuation mechanism may be electrical.
  • a flow regulating vent e.g, vents 7010, 8000, 9000, 9050
  • electrically actuating a flow regulating vent can account for additional factors present in the patient interface such as leakage. If a flow-regulating vent does not account for leakage in the patient interface, the vent may be susceptible to excessive vent flow because some of the venting of the patient interface may be occurring through the leakage. By reducing excess flow, less moisture may be carried away from the patient which will contribute to humidity retention in the mask.
  • An increase in flow can lead to increased noise at the mask which, in addition to vent noise, can be irritating and can interfere with the patient’s sleep.
  • An increase in flow may also be correlated to further drying of the mouth, eyes and nasal passages as more moisture is removed from the airpath. Moreover, this can lead to excess CO2 washout which can induce hypocapnia.
  • FIG. 9A illustrates an exemplary control system 9500 for an electrically actuated flow-regulating vent 9510.
  • the control system 9500 may include a controller 9512 that receives feedback signals from one or more sensors in the patient interface 3000 indicative of the pressure, the flow rate, and/or the CO2 level of the respiratory gas in the patient interface 3000.
  • the controller 9512 may also receive feedback signals from a sensor or sensing system 9514 located at or adjacent to an outlet of the RPT device 4000.
  • the sensor 9514 may be a pressure or flow rate sensor. It is contemplated that the controller 9512 may be similar in structure and function as the controller discussed above for the vent 9000.
  • the controller 9512 may rely on feedback from the sensor or sensing system 9514 at or in the RPT device 4000.
  • the controller 9512 may include a leak detection algorithm. When a leak is detected at the RPT device 4000, the vent 9510 may be actuated to reduce the vent flow.
  • Fig. 9B shows an exemplary response to the detection of leakage.
  • a sensor may be provided in or at the patient interface 3000 to measure flow and/or pressure and can be utilised to detect changes in flow due to leakage at the patient interface. This information may be applied to the leak detection algorithm.
  • One advantage of introducing a flow or pressure sensor at the patient interface is that it allows for leakage at the RPT device to be distinguished from leakage at the patient interface. This may be a desirable feature because a leak at the RPT device (perhaps due to a humidifier tub that is not aligned properly or a tube that is not fully sealed) could lead to incorrect leak detection which may mistake a leak at the RPT device for a leak at the patient interface.
  • the controller 9512 may receive feedback from the sensor in or at the patient interface 3000 instead of the sensor or sensing system 9514.
  • the venting of the gas washout flow and mask leakage may also perform the function of flushing out CO2 from the patient interface and even the overall system. Accordingly, the vent 9510 may also be actuated in response to the level of CO2 in the patient interface.
  • the patient interface may include a CO2 sensor configured to detect CO2 levels in the patient interface. The CO2 sensor may be part of a feedback loop to actuate the vent 9510 when CO2 in the patient interface is too high or too low. In the event that CO2 levels in the patient interface are too high, the vent 9510 may be actuated to increase venting and wash out excess CO2. This would reduce feelings of mask “stuffiness” and improve patient breathing comfort. CO2 levels in the patient interface that are below a predetermined threshold may indicate that excessive venting is occurring. Accordingly, in response to the CO2 levels being below the threshold, the vent 9510 may be actuated to decrease venting and retain CO2.
  • a simple vent control strategy might aim to control a low passed, or averaged flow generator flow signal by varying the resistance of the vent 9510.
  • a target averaged flow generator flow may be set as a function of the volume inside the patient interface plenum. For example, a smaller plenum would typically result in a smaller volume of CO2 being retained in the system and as such require less flow to flush CO2 out of the system. In contrast, a larger plenum may require more flow to achieve the equivalent level of CO2 rebreathing.
  • vent control For a smaller nasal or pillows mask the vent control might target an average flow generator flow of 15 to 20 LPM, whereas for a larger full face mask the vent control might target 20 to 25 LPM.
  • the vent resistance may be increased as the leak flow increases to maintain a constant flow generator flow within the target range.
  • Figs. 9C-9F illustrate various configurations of an exemplary flowregulating vent 9510 that includes an electrical actuation mechanism. Similar to the non-electrically actuated configurations of the flow-regulating vent, the flow regulating vent 9510 may include a base portion 9516, a housing (or cap portion) 9518, a movable member (or puck or movable part) 9520, a biasing mechanism 9522, a permanent magnet 9526 attached to the movable member 9520, and coil windings 9528.
  • the base portion 9516 may secure the vent 9510 to the seal forming structure 3100, while the housing 9518 may enclose the movable member 9520 and the biasing mechanism 9522.
  • the base portion 9516 may be linked to the housing 9518 by way of one or more bridging portions.
  • the one or more bridging portions may maintain a gap (or variable conduit) 9524 between the base portion 9516 and the housing 9518. It is contemplated that the one or more bridging portions (or spacers) may be incompressible.
  • a shape of the perimeter of the base portion 9516 may be made to match the shape of the vent opening 3402-1 (or 3402-2) in the seal-forming structure 3100.
  • the vent opening is circular
  • the perimeter of the base portion 9516 may also be circular.
  • the perimeter of the base portion 9516 may be rectangular, square, triangular, ovoid, hexagonal, or any other shape that may secure the vent 9510 to the seal-forming structure 3100.
  • the base may be an integral part of a plenum wall of the seal-forming structure 3100.
  • the flanges and the channel may be replaced with the rim of the vent opening 3402-1 or 3402-2.
  • the base portion 9516 may have an inlet side and an outlet side.
  • the inlet side of the base portion 9516 may include an inlet opening that receives gas washout from the vent opening 3402-1 (or 3402-2) of the seal-forming structure 3100.
  • the inlet opening may be bound by the circumferential wall so that the diameter of the inlet opening is the same size as the diameter of the base portion at the circumferential wall. Alternatively, the diameter of the inlet opening may be less than the diameter of the base portion at the circumferential wall.
  • the outlet side of the base portion 9516 may include an intermediate wall with an intermediate opening.
  • the intermediate wall may span radially outward from a central portion of the base to the circumferential wall.
  • the intermediate wall may form one of the walls of the gap 9524.
  • the intermediate wall may be stationary.
  • the intermediate opening may be located at a central region of the intermediate wall (and/or a central region of the gap 9524) and may be positioned to allow the gas washout to exit the base portion 9516 into the gap 9524.
  • the intermediate opening may be smaller than or the same size as the inlet opening. It is contemplated that the size of the intermediate opening and/or the inlet opening (e.g., the diameter) may be fixed or adjustable.
  • Gas washout from the plenum chamber 3200 may enter the base portion 9516 in a direction that is parallel to the central axis of the vent 9510. Upon exiting the base portion 9516 through the intermediate opening, the gas washout may enter the gap 9524. Upon entering the gap 9524, the gas washout may be deflected by the movable member 9520 to change direction so that the gas washout flows through the gap 9524 in a radially outward direction.
  • the gas washout changes direction while flowing through the vent 9510 from an axial direction (i.e., the direction parallel to the central axis a of the vent 9510) to a radially outward direction (i.e., a direction that is radially outward from the central axis a of the vent 9510).
  • the gap 9524 provides an outlet conduit for the gas washout so that the gas washout exits the vent 9510 through the gap 9524 and out a circumferential side (or perimeter) of the vent 9510.
  • the movable member 9520 may form the other wall of the gap 9524 and may oppose the intermediate wall.
  • the movable member 9520 may be movable in the axial direction (i.e., the direction parallel to a central axis of the vent 9510) so that movement of the movable member 9520 may decrease or increase a width of the gap 9524, which narrows or widens the flow path for the gas washout as the gas washout exits the vent 9510.
  • the gap 9524 functions as a variable conduit.
  • the movable member 9520 may be in the form of a disc or any other shape that is substantially wider (in the radial direction) than it is thin (in the axial direction).
  • the movable member 9520 may be larger than the intermediate opening and may extend to the perimeter of the housing 9518 and/or the perimeter of the vent 9510.
  • the movable member 9520 may be biased by the biasing mechanism 9522 toward a position that provides a minimum width of the gap 9524.
  • the biasing mechanism 9522 may be biased toward the intermediate wall.
  • the movable member 9520 may be attached to the biasing mechanism 9522 at a central location on the movable member 9520 or at any other location on the movable member 9520.
  • the biasing mechanism 9522 may be in the form of a spring.
  • the biasing mechanism 9522 may have a spiral or helical shape.
  • a magnet 9526 may be attached to the movable member 9520.
  • the magnet 9526 may be permanently affixed to the movable member 9520 or may be removable from the movable member 9520. It is contemplated that the magnet 9526 may be integrally formed with the movable member 9520. For example, the entire movable member 9520 may form the magnet 9526.
  • the biasing mechanism 9522 may be connected to the movable member 9520 by way of the magnet 9526.
  • the coil windings 9528 may be attached to the housing 9518 so that the magnet 9526 and the movable member 9520 are movable relative to the coil windings 9528.
  • the magnet 9526 and the coil windings 9528 may together form an electrical actuator 9530 that moves the movable member 9520 in response to an electrical current being applied to the coil windings 9528.
  • a magnetic field may be generated around the coil windings 9528, which in turn may interact with the magnetic field of the magnet 9526 to cause the magnet 9526 to move the movable member 9520 toward the base portion 9516 and narrow the gap 9524.
  • the force acting on the magnet 9526 to move the movable member 9520 may be proportional to the magnetic field generated by the electrical current.
  • the movement of the movable member 9520 may be controlled by varying the magnitude of the electrical current applied to the winding coils 9528. Increasing the electrical current will move the movable member 9520 toward the base portion 9516 and narrow the gap 9524. In addition, decreasing the electrical current will allow the biasing mechanism 9522 and the pressure of the washout gas flowing through the gap 9524 to push the movable member 9520 away from the base portion 9516, thereby increasing the gap 9524.
  • the controller 9512 may regulate the movement of the movable member 9520 by supplying electrical current to the coil windings 9528 in response to CO2 levels, flow rate, pressure, leakage, and/or other factors relating to a condition of the respiratory gas in the patient interface 3000.
  • the size of the gap 9524 may be variable (e.g., infinite number of potential widths) and is not limited to fully open or fully closed.
  • vent 9510 may be allowed to operate in a similar manner as the vents 7010, 8000, and 9000. That is, the movable member may be allowed to move in response to the flow rate of gas washout flowing through the gap 9524 so that the vent 9510 self-regulates the flow rate of the gas washout being vented through the vent 9510.
  • the controller 9512 may be configured to override the self-regulation of the vent 9510 by applying the electrical current to the coil windings 9528 to counter the pressure of the gas washout flowing through the gap 9524.
  • the vent 9510 may be allowed to regulate the flow rate of gas washout flowing through the vent 9510 without the intervention of the controller 9512 until the controller 9512 determines that the pressure, flow rate or CO2 level in the patient interface 3000 is at an undesired level.
  • the controller 9512 may then supply an electrical current (or adjust the magnitude of the electrical current) to the coil windings 9528 to actuate the movable member 9520 toward the base portion 9516 to narrow the gap 9524 and increase the flow rate of the gas washout vent (or move the movable member 9520 away from the base portion 9516 to decrease the flow rate of the gas washout vent).
  • the controller 9512 may cooperate with the gas washout flowing through the vent 9510 to create a hybrid control of the flow rate of gas washout flowing through the vent 9510.
  • the controller 9512 may always supply electrical current to the coil windings 9528 and may vary the magnitude of the electrical current in response to the conditions inside the patient interface 3000.
  • the controller 9512 may control the movable member 9520 so that the pressure of the gas washout flowing through the gap 9524 does not affect the position of the movable member 9520. Only the magnitude of the electrical current being supplied to the coil windings 9528 will affect the position of the movable member 9520.
  • Fig. 9D illustrates a configuration similar to the configuration of 9C.
  • positions of the coil windings 9528 and the magnet 9526 are swapped.
  • the coil windings 9528 are positioned on the movable member 9520, and the magnet 9526 is attached to the housing 9518.
  • the biasing mechanism 9522 may be in the form of a diaphragm attached to a perimeter of the movable member 9520.
  • the magnet 9526 may include a channel or recess configured to receive the coil windings 9528. This configuration may operate in a similar manner as the configuration illustrated in Fig. 9C.
  • Fig. 9E illustrates a configuration in which the magnet 9526 is located on an inside surface of the housing 9518, and the coil winding 9528 is in the form of a flat coil on the surface of the movable member 9520.
  • the biasing mechanism 9522 is in the form of a diaphragm attached to the perimeter of the movable member 9520.
  • this configuration may operate in a similar manner as the configuration illustrated in Fig. 9C.
  • Fig. 9F shows a similar configuration as the one illustrated in Fig. 9E.
  • the magnet 9526 and the coil windings 9528 are swapped so that the magnet 9526 is located on the movable member 9520 and the coil windings 9528 are located on the housing 9518.
  • the magnet 9526 is in the form of a flat magnet, while the coil windings 9528 are in the form of a flat coil.
  • this configuration may operate in a similar manner as the configuration illustrated in Fig. 9C.
  • Figs. 9G-9I illustrate another flow regulating vent 9600 with a “voice coil” type configuration. Similar to the passively actuated configurations and the previous electrically actuated configurations of the flow-regulating vent, the flow regulating vent 9600 may include a base portion 9610, a housing (or cap portion) 9612, a movable member (or puck or movable part) 9614, and a suspension mechanism 9616.
  • the base portion 9610 may secure the vent 9600 to the seal forming structure 3100, while the housing 9612 may enclose the movable member 9614 and the suspension mechanism 9616.
  • a shape of the perimeter of the base portion 9610 may be made to match the shape of the vent opening 3402-1 (or 3402-2) in the seal-forming structure 3100.
  • the perimeter of the base portion 9610 may also be circular.
  • the perimeter of the base portion 9610 may be rectangular, square, triangular, ovoid, hexagonal, or any other shape that may secure the vent 9600 to the seal-forming structure 3100.
  • the base portion 9610 may include a pair of flanges 9618 and 9620 that together form a channel 9622.
  • the flanges 9618 and 9620 may extend radially outward from a circumferential wall 9624 of the base portion 9610 so that the channel 9622 is open in a radially outward direction.
  • the channel 9622 may receive a rim of the vent opening 3402-1 (or 3402-2) of the seal-forming structure 3100.
  • the diameter of the flanges 9618 and 9620 may be larger than the diameter of the vent opening 3402-1 (or 3402-2).
  • the base may be an integral part of a plenum wall of the seal-forming structure 3100.
  • the flanges 9618 and 9620 and the channel 9622 may be replaced with the rim of the vent opening 3402-1 or 3402-2.
  • the base portion 9610 may have an inlet side and an outlet side.
  • the inlet side of the base portion 9610 may include an inlet opening 9626 that receives gas washout from the vent opening 3402-1 (or 3402-2) of the seal-forming structure 3100.
  • the inlet opening 9626 may be bound by the circumferential wall 9624 so that the diameter of the inlet opening 9626 is the same size as the diameter of the base portion 9610 at the circumferential wall 9624. Alternatively, the diameter of the inlet opening 9626 may be less than the diameter of the base portion 9610 at the circumferential wall 9624.
  • the outlet side of the base portion 9610 may include an intermediate wall 9628 with an intermediate opening 9630.
  • the intermediate wall 9628 may span radially outward from a central portion of the base to the circumferential wall 9624.
  • the intermediate wall 9628 may form one of the walls of a gap 9632 between the movable member 9614 and the base portion 9610. Unlike the movable member 9614, the intermediate wall 9628 may be stationary.
  • the intermediate opening 9630 may be located at a central region of the intermediate wall 9628 (and/or a central region of the gap 9632) and may be positioned to allow the gas washout to exit the base portion 9610 into the gap 9632.
  • the intermediate opening 9630 may be smaller than or the same size as the inlet opening 9626. It is contemplated that the size of the intermediate opening 9630 and/or the inlet opening 9626 (e.g., the diameter) may be fixed or adjustable.
  • Gas washout from the plenum chamber 3200 may enter the base portion 9610 in a direction that is parallel to the central axis P of the vent 9600. Upon exiting the base portion 9610 through the intermediate opening 9630, the gas washout may enter the gap 9632. Upon entering the gap 9632, the gas washout may be deflected by the movable member 9614 to change direction so that the gas washout flows through the gap 9632 in a radially outward direction.
  • the gas washout changes direction while flowing through the vent 9600 from an axial direction (i.e., the direction parallel to the central axis P of the vent 9600) to a radially outward direction (i.e., a direction that is radially outward from the central axis P of the vent 9600).
  • the gap 9632 provides an outlet conduit for the gas washout so that the gas washout exits the vent 9600 through the gap 9632 and out a circumferential side (or perimeter) of the vent 9600.
  • the movable member 9614 may form the other wall of the gap 9632 and may oppose the intermediate wall 9628.
  • the movable member 9614 may be movable in the axial direction (i.e., the direction parallel to a central axis P of the vent 9600) so that movement of the movable member 9614 may decrease or increase a width of the gap 9632, which narrows or widens the flow path for the gas washout as the gas washout exits the vent 9600.
  • the gap 9632 functions as a variable conduit.
  • the movable member 9614 may be in the form of a disc or any other shape that is substantially wider (in the radial direction) than it is thin (in the axial direction).
  • the movable member 9614 may be larger than the intermediate opening 9630 and may extend to the perimeter of the housing 9612 and/or the perimeter of the vent 9600.
  • the suspension mechanism 9616 may simply suspend the movable member 9614 from the housing 9612. However, it is contemplated that the movable member 9614 may be biased by the suspension mechanism 9616 toward a position that provides a maximum width of the gap 9632. In other words, the suspension mechanism 9616 may be biased away from the intermediate wall 9628. Alternatively, the suspension mechanism 9616 may be biased toward a position that provides a minimum width of the gap 9632 or closes the gap 9632. In other words, the suspension mechanism 9616 may be biased toward the intermediate wall 9628. The suspension mechanism 9616 may be configured to oppose a force caused by an electrical signal from an electrical actuator that causes the movable member 9614 to move.
  • the suspension mechanism 9616 may be in the form of a spring or suspension membrane.
  • the suspension mechanism 9616 may be formed from a memory foam or silicone foam material. It is contemplated that the suspension mechanism 9616 may alternatively be formed from an elastomeric silicone or rubber material. It is further contemplated that the suspension mechanism 9616 may be hollowed so that it forms a bladder that may be filled with a fluid (i.e., gas, liquid, or gel). The shape of the suspension mechanism 9616 may be circular with a central opening in the middle (see Figs. 9J and 9K).
  • the outer diameter DI of the suspension mechanism 9616 may be 20-30 mm (e.g., 28.8 mm), and the inner diameter D2 of the suspension mechanism 9616 may be 15-25 mm (e.g., 18 mm).
  • the suspension mechanism 9616 may have an outer flat portion 9634 at the perimeter of the suspension mechanism 9616 and an inner flat portion 9636 forming the rim of the central opening. Both sides of the suspension mechanism 9616 (i.e., the sides facing toward and away from the base portion 9610) may be substantially flat at the outer and inner flat portions 9634, 9636. A curved portion 9638 may connect the outer flat portion 9634 to the inner flat portion 9636 and may be positioned to decouple the movement of the outer flat portion 9634 from the inner flat portion 9636.
  • the side of the suspension mechanism 9616 facing the base portion 9610 may be concave at the curved portion 9638, while the side of the suspension mechanism 9616 facing away from the base portion 9610 may be convex at the curved portion 9638.
  • a thickness t of the material may be consistent throughout the suspension mechanism 9616 (e.g., about 1 mm).
  • the suspension mechanism 9616 may connect the movable member 9614 to the housing 9612 in a manner that suspends the movable member 9614 from the housing 9612.
  • the outer flat portion 9634 may be attached to the movable member 9614, while the inner flat portion 9636 may be attached to the housing 9612. This way, the curved portion 9638 may decouple movement of the movable member 9614 from the housing 9612.
  • the housing 9612 may be designed to enclose at least a portion of the movable member 9614 and the suspension mechanism 9616 and may have a wall thickness of, for example, 1-2 mm.
  • the base portion 9610 may be connected to the housing 9612 by way of one or more bridging portions 9640.
  • the one or more bridging portions (or spacers) may maintain the gap (or variable conduit) 9632. It is contemplated that the one or more bridging portions 9640 may be incompressible.
  • the bridging portions 9640 may be part of a snap fit connection.
  • the bridging portions 9640 may be projections extending from the housing 9612. The ends of the bridging portions 9640 may include an undercut.
  • the bridging portions 9640 When the housing 9612 is pressed against the base portion 9610, the bridging portions 9640 may resiliently flex outwardly until a lip of the base portion 9610 enters the undercuts of the bridging portions 9640. The bridging portions 9640 may then spring back to its unflexed configuration, thereby securing the housing 9612 to the base portion 9610. The housing 9612 may be released from the base portion 9610 by outwardly flexing the bridging portions 9640 so that the lip of the base portion 9610 can be removed from the undercut on the bridging portion 9640.
  • the housing 9612 may include a recessed portion 9642 in a central region. It is contemplated that the central axis P of the vent 9600 may extend through a center of the recessed portion 9642.
  • An opening 9644 may be located at a bottom of the recessed portion 9642.
  • the opening 9644 may have a diameter or may be wide enough so that a magnet 9646 may pass through the opening 9644 without contacting the housing 9612.
  • the magnet 9646 may be positioned on a central surface of the movable member 9614 in a manner that allows the magnet 9646 to move back and forth through the opening 9644 as the movable member 9614 moves toward and away from the base portion 9610.
  • Coil windings 9648 may be positioned on a side wall of the recessed portion 9642 so that the coil windings 9648 surround the magnet 9646 without coming into contact with the magnet 9646.
  • Fig. 9H shows the coil windings 9648 inside the recessed portion 9642
  • the coil windings 9648 may be positioned on the side wall outside of the recessed portion 9642.
  • the coil windings 9648 may be positioned so that the magnet 9646 may move relative to the coil windings 9648.
  • the movable member 9614 may be attached to the suspension mechanism 9616 at a central location on the movable member 9614 and at a central location on the suspension mechanism 9616 (e.g., at the central axis P of the vent 9600). The remaining portions of the movable member 9614 may be separated from the suspension mechanism 9616.
  • electrical current may be supplied to the coil windings 9648, which may generate a magnetic field that may cause the magnet 9646 to move relative to the coil windings in a direction parallel to the central axis P of the vent 9600.
  • the magnitude of the electrical signal may depend on signals received by a controller from a sensor located on the RPT device 4000, the air circuit 4170, or the patient interface 3100.
  • the electrical current supplied to the coil windings 9648 may be enough to move the movable member 9614 from a maximum width of the gap 9632 to a position that completely closes the gap 9632 or anywhere in between.
  • the polarity of the electrical signal may be used to move the magnet 9646 and the movable member 9614 back and forth.
  • a first polarity may cause the magnet 9646 and the movable member 9614 toward the base portion 9610, while an opposite polarity may cause the magnet 9646 and the movable member 9614 away from the base portion 9610.
  • the suspension mechanism 9616 may provide a biasing force that may move the magnet 9646 and the movable member 9614 back to a neutral position in the absence of an electrical signal from the controller or power source.
  • the suspension mechanism 9616 may be replaced with a simple membrane or bladder that does not provide any biasing force.
  • suspension mechanism 9616 may be used in any of the previously disclosed gas flow regulating vents.
  • Fig. 9 L illustrates an exemplary circuit 9650 for supplying power to the coil windings 9648.
  • a power supply 9652 may provide 7V to the circuit 9650.
  • a 4 Ohm resistor 9654 may be provided to achieve a voltage drop of about 3.5 V.
  • a diode 9656 may be positioned in parallel with the coil windings 9648 to mitigate interference from electric and magnetic fields (EMF). This configuration may provide a maximum current of 0.866 A to the coil windings 9648.
  • EMF electric and magnetic fields
  • Fig. 9M illustrates an exemplary algorithm or method 9800 for operating the vent 9600.
  • the method 9800 begins with step 9810 in which a target pressure level in the patient interface 3000 is determined.
  • the target pressure level may be a therapy pressure level such as, for example, 10 cmHiC) relative to ambient pressure.
  • the target pressure level may be the EPAP level (target pressure during exhalation) (e.g., 4 cmHiO relative to ambient pressure).
  • a controller may receive signals from a sensor located on or within the patient interface 3000 indicative of a pressure inside the patient interface 3000 (step 9812).
  • the sensor may be any type of sensor capable of detecting conditions within the patient interface 3000 indicative of the pressure inside the patient interface 3000 (e.g., gas flow or pressure).
  • the controller may then determine whether the pressure inside the patient interface 3000 is above the target level (step 9814). A pressure greater than the target pressure may be an indication that not enough gas is being vented through the vent 9600. Accordingly, if the controller determines that the pressure in the patient interface 3000 is greater than the target pressure, the controller may actuate the coil windings 9648 in the vent 9600 to move the magnet 9646 and the movable member 9614 in a direction away from the base portion 9610 (step 9816). This may be achieved by increasing or decreasing the voltage across the coil windings 9648 and/or changing the polarity of the voltage across the coil windings 9648. After adjusting the voltage across the coil windings 9648, step 9812 may be repeated (i.e., the pressure in the patient interface 3000 may be determined).
  • the controller may determine whether the pressure inside the patient interface is below the target pressure (step 9818). A pressure below the target pressure may be an indication that too much gas is being vented and/or the patient interface is experiencing a leak. If the controller determines that the pressure is below the target pressure, the coil windings 9648 may be actuated to decrease the flow of gas through the vent 9600 (step 9820). This way, the venting through the vent 9600 may compensate for any unintended gas leakage from the patient interface 3000.
  • the coil windings may be actuated to decrease the flow of gas through the vent 9600 by increasing or decreasing the voltage across the coil windings 9648 and/or changing the polarity of the voltage across the coil windings 9648.
  • step 9812 may be repeated (i.e., the pressure in the patient interface 3000 may be determined).
  • the controller determines that the pressure in the patient interface 3000 is not below the target pressure, the gas washout flow through the vent 9600 may be maintained at the current level (i.e., the voltage across the coil windings 9648 may remain unchanged), and step 9812 may be repeated (i.e., the pressure in the patient interface 3000 may be determined).
  • Fig. 9N illustrates another exemplary algorithm or method 9850 for operating the vent 9600. Similar to the method 9800, the method 9850 begins with step 9852 in which a target pressure level in the patient interface 3000 is determined. A threshold level of CO2 in the patient interface 3000 may also determined. The target pressure level may be a therapy pressure level such as, for example, 10 cmHiO relative to ambient pressure. For bi-level therapy, the target pressure level may be the EPAP level (target pressure during exhalation) (e.g., 4 cmHiO relative to ambient pressure). In addition, the threshold level of CO2 may be a level determined to be dangerous to the patient.
  • the target pressure level may be a therapy pressure level such as, for example, 10 cmHiO relative to ambient pressure.
  • the target pressure level may be the EPAP level (target pressure during exhalation) (e.g., 4 cmHiO relative to ambient pressure).
  • the threshold level of CO2 may be a level determined to be dangerous to the patient.
  • the controller may receive signals from a sensor located on or within the patient interface 3000 indicative of a pressure and level of CO2 inside the patient interface 3000 (step 9854).
  • the sensor may be any type of sensor capable of detecting conditions within the patient interface 3000 indicative of the pressure and CO2 level inside the patient interface 3000 (e.g., gas flow or pressure). It is contemplated that more than one sensor may be used to determine both conditions.
  • the controller may then determine whether the pressure inside the patient interface 3000 is above the target level (step 9856). A pressure greater than the target pressure may be an indication that not enough gas is being vented through the vent 9600. Accordingly, if the controller determines that the pressure in the patient interface 3000 is greater than the target pressure, the controller may actuate the coil windings 9648 in the vent 9600 to move the magnet 9646 and the movable member 9614 in a direction away from the base portion 9610 (step 9858). This may be achieved by increasing or decreasing the voltage across the coil windings 9648 and/or changing the polarity of the voltage across the coil windings 9648. After adjusting the voltage across the coil windings 9648, step 9854 may be repeated (i.e., the pressure in the patient interface 3000 may be determined).
  • the controller may determine whether the pressure inside the patient interface is below the target pressure (step 9859).
  • a pressure below the target pressure may be an indication that too much gas is being vented and/or the patient interface is experiencing a leak. If the controller determines that the pressure is below the target pressure, the controller may then determine whether the level of CO2 in the patient interface 3000 is above the threshold level (step 9860).
  • CO2 level in the patient interface 3000 may take precedent over the pressure level in the patient interface 3000. Accordingly, even if the pressure is below the threshold pressure, the coil windings 9648 may still be actuated to increase the flow of gas through the vent 9600 in order to reduce the level of CO2 in the mask (step 9858).
  • Fig. 9N shows that determination of whether the pressure is below the target level being performed prior to determining whether the level of CO2 is below the threshold level
  • the steps can be reversed so that the CO2 determination (step 9860) is performed before the pressure level determination (step 9859). In that circumstance, step 9859 would be performed upon the CO2 level being determined to be above the threshold level and step 9859 (determining whether the pressure is below the threshold) would be performed upon the CO2 level being determined to not be above the threshold level.
  • the coil windings 9648 may be actuated to decrease the flow of gas through the vent 9600 (step 9862). This way, the venting through the vent 9600 may compensate for any unintended gas leakage from the patient interface 3000.
  • the coil windings may be actuated to decrease the flow of gas through the vent 9600 by increasing or decreasing the voltage across the coil windings 9648 and/or changing the polarity of the voltage across the coil windings 9648.
  • step 9854 may be repeated (i.e., the pressure in the patient interface 3000 may be determined).
  • the controller may determine whether the CO2 level is above the threshold (step 9864). If the CO2 level is above the threshold level, the flow of gas through the vent 9600 may be increased (step 9866) even though the pressure is below the target value.
  • step 9868 i.e., the voltage across the coil windings 9648 may remain unchanged
  • step 9854 may be repeated (i.e., the pressure in the patient interface 3000 may be determined).
  • Fig. 90 replaces the “magnet and coils” electric actuator with an electric motor 9532.
  • the vent 9510 may include a base portion 9516, a housing (or cap portion) 9518, and a movable member (or puck or movable part) 9520.
  • the base portion 9516 may secure the vent 9510 to the seal forming structure 3100, while the housing 9518 may enclose the movable member 9520.
  • the base portion 9516 may be linked to the housing 9518 by way of one or more bridging portions.
  • the one or more bridging portions (or spacers) may maintain a gap (or variable conduit) 9524 between the base portion 9516 and the housing 9518. It is contemplated that the one or more bridging portions (or spacers) may be incompressible.
  • this configuration may also include a biasing mechanism similar to the configurations illustrated in Figs. 9C-9K.
  • the motor 9532 may be attached to a center of the movable member 9520 on a side opposite the gap 9524. Alternatively, the motor 9532 may be attached to the movable member 9520 at a location that is radially offset from the center of the movable member 9520.
  • the linear actuator 9536 may rotate, which may in turn cause the shaft 9534 to rotate.
  • the outer surface of the shaft 9534 may be threaded so that the rotational movement of the shaft 9534 may cause the shaft 9534 to move linearly into and out of the housing 9518.
  • Such linear movement may cause the movable member 9520 to move toward and away from the base portion 9516, thereby causing the gap 9524 to narrow and widen, accordingly.
  • the movement of the shaft 9534 may be performed in discrete steps or may be continuous.
  • the motor 9532 may be connected to the controller 9512.
  • the vent 9510 may operate in two modes.
  • the movable member In a passive mode, the movable member may be allowed to move in response to the flow rate of gas washout flowing through the gap 9524 so that the vent self-regulates the flow rate of the gas washout being vented through the vent 9510.
  • the controller 9512 may override the self-regulation of the vent 9510 by applying electrical current to the motor 9532 to position the movable member 9520 at a particular position.
  • the vent 9510 may mitigate CO2 washout as a secondary objective to flow control.
  • a CO2 sensor may be used to create a feedback loop with the vent actuation and effectively actuate the vent 9510 when CO2 in the patient interface is too high or too low.
  • Figs. 10A-10D illustrate various configurations of an exemplary flowregulating vent 9700 that includes pneumatic actuation mechanism. Similar to the passively actuated and electrically actuated configurations of the flow-regulating vent, the flow regulating vent 9700 may include a base portion 9710, a housing (or cap portion) 9712, a movable member (or puck or movable part) 9714, and a sealing member9716.
  • a shape of the perimeter of the base portion 9710 may be made to match the shape of the vent opening 3402-1 (or 3402-2) in the seal-forming structure 3100.
  • the perimeter of the base portion 9710 may also be circular.
  • the perimeter of the base portion 9710 may be rectangular, square, triangular, ovoid, hexagonal, or any other shape that may secure the vent 9700 to the seal-forming structure 3100.
  • the base portion 9710 may include a pair of flanges that together form a channel.
  • the flanges may extend radially outward from a circumferential wall of the base portion 9710 so that the channel is open in a radially outward direction.
  • the channel may receive a rim of the vent opening 3402-1 (or 3402-2) of the seal-forming structure 3100.
  • the diameter of the flanges may be larger than the diameter of the vent opening 3402-1 (or 3402-2).
  • the base may be an integral part of a plenum wall of the seal-forming structure 3100.
  • the flanges and the channel may be replaced with the rim of the vent opening 3402-1 or 3402-2.
  • the base portion 9710 may have an inlet side and an outlet side.
  • the inlet side of the base portion 9710 may include an inlet opening that receives gas washout from the vent opening 3402-1 (or 3402-2) of the seal-forming structure 3100.
  • the inlet opening may be bound by the circumferential wall so that the diameter of the inlet opening is the same size as the diameter of the base portion at the circumferential wall. Alternatively, the diameter of the inlet opening may be less than the diameter of the base portion at the circumferential wall.
  • the outlet side of the base portion 9710 may include an intermediate wall with an intermediate opening.
  • the intermediate wall may span radially outward from a central portion of the base to the circumferential wall.
  • the intermediate wall may form one of the walls of the gap 9718.
  • the intermediate wall may be stationary.
  • the intermediate opening may be located at a central region of the intermediate wall (and/or a central region of the gap 9718) and may be positioned to allow the gas washout to exit the base portion 9710 into the gap 9718.
  • the intermediate opening may be smaller than or the same size as the inlet opening. It is contemplated that the size of the intermediate opening and/or the inlet opening (e.g., the diameter) may be fixed or adjustable.
  • Gas washout from the plenum chamber 3200 may enter the base portion 9710 in a direction that is parallel to the central axis of the vent 9700. Upon exiting the base portion 9710 through the intermediate opening, the gas washout may enter the gap 9718. Upon entering the gap 9718, the gas washout may be deflected by the movable member 9714 to change direction so that the gas washout flows through the gap 9718 in a radially outward direction.
  • the gas washout changes direction while flowing through the vent 9700 from an axial direction (i.e., the direction parallel to the central axis a of the vent 9700) to a radially outward direction (i.e., a direction that is radially outward from the central axis a of the vent 9700).
  • the gap 9718 provides an outlet conduit for the gas washout so that the gas washout exits the vent 9700 through the gap 9718 and out a circumferential side (or perimeter) of the vent 9800.
  • the movable member 9714 may form the other wall of the gap 9718 and may oppose the intermediate wall.
  • the movable member 9714 may be movable in the axial direction (i.e., the direction parallel to a central axis of the vent 9700) so that movement of the movable member 9714 may decrease or increase a width of the gap 9718, which narrows or widens the flow path for the gas washout as the gas washout exits the vent 9700.
  • the gap 9718 functions as a variable conduit.
  • the movable member 9714 may be in the form of a disc or any other shape that is substantially wider (in the radial direction) than it is thin (in the axial direction).
  • the movable member 9714 may be larger than the intermediate opening and may extend to the perimeter of the housing 9714 and/or the perimeter of the vent 9700.
  • the movable member 9700 may be biased by the sealing member 9716 toward a position that provides a minimum width of the gap 9718.
  • the sealing member 9716 may generate a biasing force against the movable member 9714 toward the intermediate wall.
  • the movable member 9714 may be attached to the sealing member 9716 at a central location on the movable member 9714 or at any other location on the movable member 9714.
  • the sealing member 9716 may be in the form of a spring or any type of dampening device. It is also contemplated that the sealing member 9716 may provide no biasing force to the movable member 9716.
  • the vent 9700 may comprise a biasing member that is distinct from the sealing member 9716.
  • the sealing member 9716 may be in the form of a flexible bladder and may be secured to an inner rim of the housing 9712.
  • the joint between the sealing member 9716 and the housing 9712 may form a seal that is impermeable to the flow of gas.
  • the inner side of the housing 9712 may have a projection or ridge 9720 to which the outer perimeter of the sealing member 9716 may be attached.
  • the surface of the housing 9712 may be continuous within only one opening or pressure port 9722. Because the sealing member 9716 is sealingly attached to the housing 9712, the housing 9712 and the sealing member 9716 form a pneumatically sealed chamber 9724 on one side of the sealing member 9716 that is pneumatically isolated from the movable member 9714. Gas can enter and exit the chamber9724 only through the pressure port 9722.
  • a hose 9726 may be attached to the pressure port 9722. The hose may deliver pressurized gas to the chamber 9724 through the pressure port 9722 to increase or decrease the gas pressure in the chamber 9724. It is contemplated that the chamber 9724 may have a separate outlet port with a valve or other mechanism to maintain the pressure in the chamber 9724.
  • the gas pressure in the chamber 9724 may be used to control the movement of the movable member 9714, which in turn controls the width of the gap 9718 to control the flow rate of the gas washout flowing through the vent 9700.
  • increased gas pressure in the chamber 9724 may overcome the biasing force of the sealing member 9716 to move the sealing member 9716 toward the base portion 9710 and narrow the gap 9718.
  • decreased gas pressure in the chamber 9724 may allow the sealing member 9716 to move away from the base portion 9710 and widen the gap 9718.
  • the diameter of the movable member 9714 may be within a range of 15- 30 mm (e.g., 17, 20, or 27 mm). In addition, the movement of the movable member 9714 may be limited so that a width of the gap 9718 varies within a range of 0.5 to 1.5 mm (e.g., the gap may be 0.5, 1, 1.2, or 1.5 mm).
  • the inner diameter of the pressure port 9722 may be within a range of 3.5-6.5 mm (e.g., 3.5, 5, 5.5, or 6 mm). Accordingly, the inner diameter of the hose 9726 may be slightly larger or slightly smaller to allow the hose 9726 to be attached to the pressure port 9722.
  • the stiffness of the sealing member 9716 may be 40-50 durometer (e.g., 40 or 50 durometer).
  • the inlet opening of the gap 9718 may have a diameter between 3.5 and 6.5 mm.
  • a pressure port greater than 6.5 mm may create larger flow variations. It has also been found that a laminar flow at 20 L/min at 20 cm H2O can be achieved with the following combination: a movable member 9714 with a diameter of 20 mm, a sealing member 9716 with a stiffness of 40 durometer, a pressure port 9722 with a diameter of 5 mm, and a gap width of 1 mm.
  • the hose 9726 may be attached to the air circuit 4170 at a location downstream of an outlet of the RPT device 4000. Alternatively, the hose 9726may be connected to a port in the patient interface 3000. In both these configurations, the pressure in the chamber 9724 may be regulated based on the pressure in the air circuit 4170 or the patient interface 3000.
  • the hose 9726 may include a valve to further control the pressure in the chamber 9724. It is further contemplated that the hose 9726 may be connected to a pump (e.g., a piezoelectric pump).
  • the piezoelectric pump may be attached to the RPT device 4000, to the air circuit 4170 downstream of the RPT device 4000, or to the patient interface 3000.
  • the valve and/or the pump may be connected to the controller 9512, which may in turn regulate the operation of the pump and/or the valve to control the pressure in the chamber 9724.
  • the vent 9700 may be allowed to operate in a similar manner as the vents 7010, 8000, 9000, and 9510. That is, the movable member 9714 may be allowed to move in response to the flow rate of gas washout flowing through the gap 9718 so that the vent 9700 self-regulates the flow rate of the gas washout being vented through the vent 9700.
  • the controller 9512 may be configured to override the self-regulation of the vent 9700 by controlling the pump and/or valve to adjust the pressure in the chamber 9724 to counter the pressure of the gas washout flowing through the gap 9718.
  • the vent 9700 may be allowed to regulate the flow rate of gas washout flowing through the vent 9700 without the intervention of the controller 9512 until the controller 9512 determines that the pressure, flow rate or CO2 level in the patient interface 3000 is at an undesired level.
  • the controller 9512 may then actuate the pump and/or valve to adjust the pressure in the chamber 9724 and actuate the movable member 9714 toward the base portion 9710 to narrow the gap 9718 and increase the flow rate of the gas washout vent (or move the movable member 9714 away from the base portion 9710 to decrease the flow rate of the gas washout vent).
  • the controller 9512 may cooperate with the gas washout flowing through the vent 9700 to create a hybrid control of the flow rate of gas washout flowing through the vent 9700.
  • the controller 9700 may always operate the pump and/or valve and may vary the magnitude of the pressure in the chamber 9724 in response to the conditions inside the patient interface 3000.
  • the controller 9512 may control the movable member 9714 so that the pressure of the gas washout flowing through the gap 9718 does not affect the position of the movable member 9714. Only the magnitude of the pressure generated by the pump and/or valve will affect the position of the movable member 9714.
  • the patient interface 3000 includes at least one decoupling structure, for example, a swivel or a ball and socket.
  • Connection port 3600 allows for connection to the air circuit 4170.
  • the patient interface 3000 includes a forehead support 3700.
  • the patient interface 3000 includes an anti-asphyxia valve.
  • a patient interface 3000 includes one or more ports that allow access to the volume within the plenum chamber 3200. In one form this allows a clinician to supply supplementary oxygen. In one form, this allows for the direct measurement of a property of gases within the plenum chamber 3200, such as the pressure.
  • the cushion, headgear, and sleeves may come in different styles, which may correspond to different uses (e.g., mouth breathing, nasal breathing, etc.).
  • a patient or clinician may select certain combinations of cushions, headgear, and sleeves in order to optimize the effectiveness of the therapy and/or the individual patient’ s comfort.
  • the different styles of cushions, headgear, and sleeves may be used interchangeably with one another in order to form different combinations of patient interfaces. This may be beneficial from a manufacturing prospective because wider variety of patient interfaces may be created using fewer parts. Additionally or alternatively, the various combinations may allow a patient to change styles of patient interface without changing the every component.
  • Air may be delivered to the patient in one of two main ways.
  • the patient may receive the flow of pressurized air through headgear tubes 3350 (see e.g., Fig. 3Y). This may be referred to as a “tube up” configuration and may position a connection port at the top of the patient’s head.
  • the patient may receive the flow of pressurized air through a conduit connected to the plenum chamber 3200, for example through the connection port 3600 (see e.g., Fig.
  • This may be referred to a “tube down” configuration where the airflow conduit is positioned in front of the patient’s face.
  • Different patients may be more comfortable with one style of air delivery over the other (e.g., because of the patient’s sleep style). Therefore, it may be beneficial to allow a single style of patient interface to be used in either the “tube up” or “tube down” configuration.
  • the patient interface may be part of a modular assembly with a variety of interchangeable components that may be swapped out by a patient and/or clinician for one or more components for a different style.
  • the following description describes the various combinations that may be created by assembling the different components together.
  • a sleeve may be used with the tubes 3350 and/or the rigidisier arms 3340.
  • the sleeve may at least partially surround the tubes 3350 and/or the rigidiser arms 3340.
  • different shapes of sleeves may be used, which may correspond to different types of positioning and stabilising structures 3300.
  • the configuration of the sleeve may be customized to fit a particular user’s face. For instance, the sleeves may be configured in a relatively more posterior region of the patient’s head.
  • the sleeve may be constructed from a comfortable material.
  • the sleeve may be constructed from a textile material, a foam material, or a combination of the two.
  • the comfortable material may contact the patient in use, and may feel soft against the patient’s skin in order to improve patient compliance.
  • the material may also be flexible in order to assist in donning or doffing the sleeve from the tube 3350 or the rigidiser arms 3340.
  • the material may allow the sleeve to bend in order to conform to the shape of the conduit headgear 6319 or the rigidiser arms 3340, which may change depending on the shape of an individual patient’s head.
  • the sleeve may also be at least partially elastic (e.g., the material may allow the sleeve to stretch).
  • the elastic material may help the sleeve stretch in order to fit around the tubes 3350 or the rigidiser arms 3340.
  • the elastic material may then return to an initial position that is snug against the tubes 3350 or the rigidiser arms 3340 in order to limit the sleeve from sliding while in use.
  • some forms of the sleeves may be specific to a rigidising element (e.g., tubes 3350 and/or rigidiser arms 3340).
  • a rigidising element e.g., tubes 3350 and/or rigidiser arms 3340.
  • the sleeves may assist the rigidising elements in connecting interchangeably with the version or styles of cushions (e.g., the mouth and nose cushion 3050-1, the nose-only cushion 3050-2, etc.).
  • a sleeve is a conduit sleeve 3351, which may be usable with the tubes 3350 described above.
  • the conduit sleeve 3351 may include a curved shape that may be similar to the shape of the tubes 3350 shown in Fig. 6C.
  • the flexible material used to construct the conduit sleeve 3351 may allow the conduit sleeve 3351 to further curve in order to correspond to the shape of the tubes 3350 (e.g., when worn by the patient).
  • the conduit sleeve 3351 may include a first or superior opening 3352.
  • the superior opening 3352 may be disposed at one end of the conduit sleeve 3351.
  • the superior opening 3352 may be an opening to a passage that extends along at least a portion of the conduit sleeve 3351.
  • some forms of the conduit sleeve 3351 may also include an inferior extension 3354.
  • the inferior extension 3354 may be positioned on an opposite end of the conduit sleeve 3351 from the superior opening 3352.
  • the conduit sleeve 3351 may be customized to fit a particular user’s face.
  • the inferior extension 6354 of the conduit sleeve 6350 may be configured in a relatively more posterior region or anterior region of the patient’s head.
  • the inferior extension 3354 may include a rigid or semirigid piece (e.g., within the sleeve 3351).
  • the rigid or semi-rigid piece may be constructed from a plastic material, or a similar material.
  • the inferior extension 3354 may be stiffened using a manufacturing process (e.g., stitching rigidised thread, flat knitting, using thicker material).
  • the inferior extension 3354 may include a connection member 3356.
  • the connection member 3356 may be a magnet, although in other examples, the connection member 3356 may be a different type of connector (e.g., a mechanical fastener, an adhesive, hook and loop material, etc.).
  • the connection member 3356 may also be positioned at an end of the inferior extension 3354, although the connection member 3356 could alternatively be positioned anywhere along the inferior extension 3354.
  • connection member 3356 e.g., a magnet
  • the connection member 3356 may be removably connected to the magnets 3370-1 of the headgear 3302-1.
  • the magnets 3370-1 connected to the inferior straps 3304-1 may be removably connected to the connection member 3356 in order to provide the tensile force.
  • a sleeve is a four-point arm sleeve 3380, which may be usable with the rigidiser arms 3340 described above.
  • the four-point arm sleeve 3380 may include a curved shape that may be similar to the shape of the rigidiser arm 3340 shown in Fig. 6D.
  • the flexible material used to construct the four-point arm sleeve 3380 may allow the four-point arm sleeve 3380 to further curve in order to correspond to the shape of the rigidiser arm 3340 (e.g., when worn by the patient and/or went bent by the patient).
  • some forms of the four-point arm sleeve 3380 may include an inferior extension 3384.
  • the inferior extension 3384 may be positioned at an end of the four-point arm sleeve 3380.
  • the shape and/or structure of the inferior extension 3384 is substantially the same as the shape of the inferior extension 3354.
  • the inferior extension 3384 may be more rigid as compared to the rest of the four-point arm sleeve 3380 (e.g., as a result of rigidising thread or rigid material).
  • connection member 3386 may be a magnet, although in other examples, the connection member 3386 may be a different type of connector (e.g., a mechanical fastener, an adhesive, hook and loop material, etc.).
  • the connection member 3386 may also be positioned at an end of the inferior extension 3384, although the connection member 3386 could alternatively be positioned anywhere along the inferior extension 3384.
  • connection member 3386 e.g., a magnet
  • the connection member 3386 may be removably connected to the magnets 3370 of the headgear 3302-1.
  • the connection member 3386 may be removably connected to the magnets 3370 of the headgear 3302-1.
  • the magnets 3370 connected to the inferior straps 3304-1 may be removably connected to the connection member 3386 in order to provide the tensile force.
  • the four-point arm sleeve 3380 may include a pair of tabs 3394, which may be similar to the tab 3320 on the tubes 3350.
  • the tabs 3394 may be positioned in substantially the same place on the patient’s head as where the tabs 3320 are positioned when the patient wears the tubes 3350.
  • a sleeve is a two-point arm sleeve 3380-1, which may be usable with the rigidiser arms 3340 described above.
  • the two-point arm sleeve 3380-1 may be similar to the four-point arm sleeve 3380 described above. Only some similarities and differences may be described below.
  • the two-point arm sleeve 3380-1 may include an inferior opening 3388-1 that is positioned at an end of the two-point arm sleeve 3380- 1.
  • the inferior opening 3388-1 may form an opening to a passageway through the two-point arm sleeve 3380-1.
  • the inferior opening 3388-1 may open into a surface of the conduit sleeve 3380-1.
  • the two-point arm sleeve 3380-1 may include a pair of tabs 3394-1, which may be similar to the tab 3320 on the conduit headgear 6319.
  • the tabs 3394-1 may be positioned in substantially the same place on the patient’s head as where the tabs 3320 are positioned when the patient wears the tubes 3350.
  • the various elements described above may be combined into four different patient interfaces.
  • the different patient interfaces may allow patients to use different styles based on their individual comfort.
  • the modularity of the different elements e.g., the ability to be used in multiple styles of patient interfaces
  • the patient may wear the cushion 3050-1 in a tube-up configuration with the tubes 3350 and the four-point headgear 3302-1.
  • This assembly may form a tube up nose and mouth patient interface 3000-1.
  • a conduit sleeve may be used with the tubes 3350 in order to enable a patient to experience the “tube up” air delivery style with the mouth and nose cushion 3050-1.
  • the conduit sleeve provides additional connection locations for connecting the four-point headgear 3302-1.
  • other forms of connectors aside from or in addition to the conduit sleeve may be used.
  • the conduit sleeves may be connected to the tubes 3350 of the positioning and stabilising structure 3300.
  • the tubes 3350 via the conduit connection structure 3500, may be used to connect the tubes 3350 to the cushion 3050-1.
  • the conduit sleeves provide the magnets in order to connect to the magnets 3370-1 (see e.g., Fig. 6E) of the four-point headgear 3302-1.
  • a different connection form may be used.
  • the four-point headgear 3302-1 may connect in four separate locations in order to provide a tensile force that maintains the cushion 3050-1 in a sealing position on the patient’s head.
  • the inferior straps 3304-1 may removably connect to the magnets of the conduit sleeves.
  • each inferior strap 3304-1 may contact the patient’s cheek (e.g., overlaying the masseter muscle).
  • the inferior straps 3304-1 may also extend below the patient’s ears.
  • the patient may wear the cushion 3050-1 in a tube-down configuration with the rigidiser arms 3340 and the four-point headgear 3302-1.
  • This assembly may form a tube down nose and mouth patient interface 3000- 2.
  • a conduit sleeve may be used with the rigidiser arms 3340 in order to enable a patient to experience the “tube down” air delivery style with the mouth and nose cushion 3050-1.
  • the conduit sleeve provides additional connection locations for connecting the four-point headgear 3302-1.
  • other forms of connectors aside from or in addition to the conduit sleeve may be used.
  • the conduit sleeves may be connected to the rigidiser arms 3340 of the positioning and stabilising structure 3300.
  • the rigidiser arms 3340 (via the conduit connection structure 3504), may be used to connect the rigidiser arms 3340 to the cushion 3050-1.
  • the conduit sleeves provide the magnets in order to connect to the magnets 3370-1 (see e.g., Fig. 6E) of the four-point headgear 3302-1.
  • a different connection form may be used.
  • the four-point headgear 3302-1 may connect in four separate locations in order to provide a tensile force that maintains the cushion 3050-1 in a sealing position on the patient’s head.
  • the inferior straps 3304-1 may removably connect to the magnets of the conduit sleeves.
  • each inferior strap 3304-1 may contact the patient’s cheek (e.g., overlaying the masseter muscle).
  • the inferior straps 3304-1 may also extend below the patient’s ears.
  • the patient may wear the cushion 3050-2 in a tube-up configuration with the tubes 3350 and the two-point headgear 3302-2.
  • This assembly may form a tube up nose only patient interface 3000-3.
  • a conduit sleeve may be used with the tubes 3350, and may provide additional comfort to the patient.
  • the sleeve may not add additional connection points to connect the positioning and stabilising structure 3300 on the cushion 3050-2.
  • the tubes 3350 of the positioning and stabilising structure 3300 may be connected directly to the cushion 3050-2.
  • the two-point headgear 3302-2 may connect to the tabs 3320 on the tubes 3350 in order to provide a tensile force that maintains the cushion 3050-2 in a sealing position on the patient’s head.
  • the patient may wear the cushion 3050-2 in a tube-up configuration with the rigidiser arms 3340 and the two-point headgear 3302- 2.
  • This assembly may form a tube down nose only patient interface 3000-4.
  • a conduit sleeve may be used with the rigidiser arms 3340, and may provide additional comfort to the patient.
  • the sleeve may not add additional connection points to connect the positioning and stabilising structure 3300 on the cushion 3050-2.
  • the rigidiser arms 3340 of the positioning and stabilising structure 3300 may be connected directly to the cushion 3050-2.
  • the two-point headgear 3302-2 may connect to the tabs 3320 on the sleeve in order to provide a tensile force that maintains the cushion 3050-2 in a sealing position on the patient’s head.
  • Fig. 6P illustrates how the different elements can be combined in order to form the four different patient interfaces described above.
  • the different components may be reused for different styles of patient interfaces. This may allow for easier manufacturing and assembly, because a large number of the same components may be produced and used in a variety of styles.
  • the only components not used in multiple styles may be the sleeves. However, the sleeves may be easier to manufacture.
  • An RPT device 4000 in accordance with one aspect of the present technology comprises mechanical, pneumatic, and/or electrical components and is configured to execute one or more algorithms 4300, such as any of the methods, in whole or in part, described herein.
  • 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 elsewhere in the present document.
  • the RPT device 4000 is constructed 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 4 cmH20, or at least 10cmH2O, or at least 20 cmH20.
  • the RPT device may have an external housing 4010, formed in two parts, an upper portion 4012 and a lower portion 4014. Furthermore, the external housing 4010 may include one or more panel(s) 4015.
  • the RPT device 4000 comprises a chassis 4016 that supports one or more internal components of the RPT device 4000.
  • the RPT device 4000 may include a handle 4018.
  • the pneumatic path of the RPT device 4000 may comprise one or more air path items, e.g., an inlet air filter 4112, an inlet muffler 4122, a pressure generator 4140 capable of supplying air at positive pressure (e.g., a blower 4142), an outlet muffler 4124 and one or more transducers 4270, such as pressure sensors 4272 and flow rate sensors 4274.
  • One or more of the air path items may be located within a removable unitary structure which will be referred to as a pneumatic block 4020.
  • the pneumatic block 4020 may be located within the external housing 4010. In one form a pneumatic block 4020 is supported by, or formed as part of the chassis 4016.
  • the RPT device 4000 may have an electrical power supply 4210, one or more input devices 4220, a central controller 4230, a pressure generator 4140, 0 and one or more output devices 4290.
  • An RPT device may comprise one or more of the following components in an integral unit. In an alternative form, one or more of the following components may be located as respective separate units.
  • An RPT device in accordance with one form of the present technology may include an air filter 4110, or a plurality of air filters 4110.
  • an inlet air filter 4112 is located at the beginning of the pneumatic path upstream of a pressure generator 4140.
  • an outlet air filter 4114 for example an antibacterial filter, is located between an outlet of the pneumatic block 4020 and a patient interface 3000 or 3800.
  • An RPT device in accordance with one form of the present technology may include a muffler 4120, or a plurality of mufflers 4120.
  • an inlet muffler 4122 is located in the pneumatic path upstream of a pressure generator 4140.
  • an outlet muffler 4124 is located in the pneumatic path between the pressure generator 4140 and a patient interface 3000 or 3800.
  • a pressure generator 4140 for producing a flow, or a supply, of air at positive pressure is a controllable blower 4142.
  • the blower 4142 may include a brushless DC motor 4144 with one or more impellers.
  • the impellers may be located in a volute.
  • the blower may be capable of delivering a supply of air, for example at a rate of up to about 120 litres/minute, at a positive pressure in a range from about 4 cmH20 to about 20 cmH20, or in other forms up to about 30 cmH20 when delivering respiratory pressure therapy.
  • the blower may be as described in any one of the following patents or patent applications the contents of which are incorporated herein by reference in their entirety: U.S.
  • Patent No. 7,866,944 U.S. Patent No. 8,638,014; U.S. Patent No. 8,636,479; and PCT Patent Application Publication No. WO 2013/020167.
  • the pressure generator 4140 may be under the control of the therapy device controller 4240.
  • a pressure generator 4140 may be a piston-driven pump, a pressure regulator connected to a high pressure source (e.g. compressed air reservoir), or a bellows.
  • Transducers may be internal of the RPT device, or external of the RPT device. External transducers may be located for example on or form part of the air circuit, e.g., the patient interface. External transducers may be in the form of noncontact sensors such as a Doppler radar movement sensor that transmit or transfer data to the RPT device.
  • one or more transducers 4270 are located upstream and/or downstream of the pressure generator 4140.
  • the one or more transducers 4270 may be constructed and arranged to generate signals representing properties of the flow of air such as a flow rate, a pressure or a temperature at that point in the pneumatic path.
  • a signal from a transducer 4270 may be filtered, such as by low-pass, high-pass or band-pass filtering.
  • an anti-spill back valve 4160 is located between the humidifier 5000 and the pneumatic block 4020.
  • the anti-spill back valve is constructed and arranged to reduce the risk that water will flow upstream from the humidifier 5000, for example to the motor 4144. 4.4.2 RPT device electrical components
  • a power supply 4210 may be located internal or external of the external housing 4010 of the RPT device 4000.
  • power supply 4210 provides electrical power to the RPT device 4000 only. In another form of the present technology, power supply 4210 provides electrical power to both RPT device 4000 and humidifier 5000.
  • the power supply 4210 may provide electrical power to the input device 4220, the central controller 4230, the output device 4290, and the pressure generator 4140.
  • the power supply 4210 may also provide electric energy to other components of the RPT device 4000 (or the humidifier 5000, as described above).
  • an RPT device 4000 includes one or more input devices 4220 in the form of buttons, switches or dials to allow a person to interact with the device.
  • the buttons, switches or dials may be physical devices, or software devices accessible via a touch screen.
  • the buttons, switches or dials may, in one form, be physically connected to the external housing 4010, or may, in another form, be in wireless communication with a receiver that is in electrical connection to the central controller 4230.
  • the input device 4220 may be constructed and arranged to allow a person to select a value and/or a menu option.
  • the central controller 4230 is one or a plurality of processors suitable to control an RPT device 4000.
  • the central controller 4230 is show in Fig. C.
  • 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.
  • 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.
  • the central controller 4230 is a dedicated electronic circuit.
  • the central controller 4230 is an application-specific integrated circuit. In another form, the central controller 4230 comprises discrete electronic components.
  • the central controller 4230 may be configured to receive input signal(s) from one or more transducers 4270, one or more input devices 4220, and/or the humidifier 5000.
  • the central controller 4230 may be configured to provide output signal(s) to one or more of an output device 4290, a pressure generator 4140, a therapy device controller, a data communication interface, and/or the humidifier 5000.
  • the central controller 4230 is configured to implement the one or more methodologies described herein, such as the one or more algorithms 4300 which may be implemented with processor-control instructions, expressed as computer programs stored in a non-transitory computer readable storage medium.
  • the central controller 4230 may be integrated with an RPT device 4000.
  • some methodologies may be performed by a remotely located device.
  • the remotely located device may determine control settings for a ventilator or detect respiratory related events by analysis of stored data such as from any of the sensors described herein.
  • the central controller 4230 may be configured to implement one or more algorithms expressed as computer programs stored in a non-transitory computer readable storage medium.
  • the algorithms are generally grouped into groups referred to as modules.
  • some portion or all of the algorithms may be implemented by a controller of an external device such as a local external device or a remote external device.
  • data representing the input signals and / or intermediate algorithm outputs necessary for the portion of the algorithms to be executed at the external device may be communicated to the external device via a local external communication network or a remote external communication network.
  • the portion of the algorithms to be executed at the external device may be expressed as computer programs, such as with processor control instructions to be executed by one or more processor(s), stored in a non- transitory computer readable storage medium accessible to the controller of the external device. Such programs configure the controller of the external device to execute the portion of the algorithms.
  • a vent flow rate estimation algorithm receives as an input an estimated pressure, Pm, in the patient interface 3000 or 3800 from the interface pressure estimation algorithm and estimates a vent flow rate of air, Qv, from a vent 3400 in a patient interface 3000 or 3800.
  • the dependence of the vent flow rate Qv on the interface pressure Pm for the particular vent 3400 in use may be modelled by a vent characteristic Qv(Pm).
  • a ventilation determination algorithm 4323 receives an input a respiratory flow rate Qr, and determines a measure indicative of current patient ventilation, Vent.
  • the ventilation determination algorithm 4323 determines a measure of ventilation Vent that is an estimate of actual patient ventilation.
  • One such implementation is to take half the absolute value of respiratory flow rate, Qr, optionally filtered by low-pass filter such as a second order Bessel low- pass filter with a comer frequency of 0.11 Hz.
  • the ventilation determination algorithm 4323 determines a measure of ventilation Vent that is broadly proportional to actual patient ventilation.
  • One such implementation estimates peak respiratory flow rate Qpeak over the inspiratory portion of the cycle. This and many other procedures involving sampling the respiratory flow rate Qr produce measures which are broadly proportional to ventilation, provided the flow rate waveform shape does not vary very much (here, the shape of two breaths is taken to be similar when the flow rate waveforms of the breaths normalised in time and amplitude are similar).
  • Some simple examples include the median positive respiratory flow rate, the median of the absolute value of respiratory flow rate, and the standard deviation of flow rate.
  • Another example is the mean of the respiratory flow rate in the middle K proportion (by time) of the inspiratory portion, where 0 ⁇ K ⁇ 1.
  • the central controller 4230 takes as input the measure of current ventilation, Vent, and executes one or more target ventilation determination algorithms for the determination of a target value Vtgt for the measure of ventilation.
  • the target value Vtgt is predetermined, for example by hard-coding during configuration of the RPT device 4000 or by manual entry through the input device 4220.
  • the target ventilation determination algorithm computes a target value Vtgt from a value Vtyp indicative of the typical recent ventilation of the patient.
  • the target ventilation Vtgt is computed as a high proportion of, but less than, the typical recent ventilation Vtyp. The high proportion in such forms may be in the range (80%, 100%), or (85%, 95%), or (87%, 92%).
  • the target ventilation Vtgt is computed as a slightly greater than unity multiple of the typical recent ventilation Vtyp.
  • the typical recent ventilation Vtyp is the value around which the distribution of the measure of current ventilation Vent over multiple time instants over some predetermined timescale tends to cluster, that is, a measure of the central tendency of the measure of current ventilation over recent history.
  • the recent history is of the order of several minutes, but in any case should be longer than the timescale of Cheyne-Stokes waxing and waning cycles.
  • Ill algorithm may use any of the variety of well-known measures of central tendency to determine the typical recent ventilation Vtyp from the measure of current ventilation, Vent.
  • One such measure is the output of a low-pass filter on the measure of current ventilation Vent, with time constant equal to one hundred seconds.
  • An air circuit 4170 in accordance 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 between two components such as RPT device 4000 and the patient interface 3000 or 3800.
  • the air circuit 4170 may be in fluid connection with the outlet of the pneumatic block 4020 and the patient interface.
  • the air circuit may be referred to as an air delivery tube.
  • 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 temperature 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.
  • 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 4230.
  • a controller such as a central controller 4230.
  • a humidifier 5000 (e.g. as shown in Fig. 5A) to change the absolute humidity of air or gas for delivery to a patient relative to ambient air.
  • the humidifier 5000 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.
  • the humidifier 5000 may comprise a humidifier reservoir 5110, a humidifier inlet 5002 to receive a flow of air, and a humidifier outlet 5004 to deliver a humidified flow of air.
  • a humidifier reservoir 5110 may be the humidifier inlet 5002 and the humidifier outlet 5004 respectively.
  • the humidifier 5000 may further comprise a humidifier base 5006, which may be adapted to receive the humidifier reservoir 5110 and comprise a heating element 5240.
  • Air In certain forms of the present technology, air may be taken to mean atmospheric air, and in other forms of the present technology air may be taken to mean some other combination of breathable gases, e.g. oxygen enriched air.
  • ambient will be taken to mean (i) external of the treatment system or patient, and (ii) immediately surrounding the treatment system or patient.
  • 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 humidity outside the room where a patient is sleeping.
  • ambient pressure may be the pressure immediately surrounding or external to the body.
  • ambient 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.
  • APAP therapy in which the treatment pressure is automatically adjustable, e.g. from breath to breath, between minimum and maximum limits, depending on the presence or absence of indications of SDB events.
  • CPAP Continuous Positive Airway Pressure
  • Respiratory pressure therapy in which the treatment pressure is approximately constant through a respiratory cycle of a patient.
  • the pressure at the entrance to the airways will be slightly higher during exhalation, and slightly lower during inhalation.
  • the pressure will vary between different respiratory cycles of the patient, for example, being increased in response to detection of indications of partial upper airway obstruction, and decreased in the absence of indications of partial upper airway obstruction.
  • Flow rate The volume (or mass) of air delivered per unit time. Flow rate may refer to an instantaneous quantity. In some cases, a reference 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 quantity having both magnitude and direction. Flow rate may be given the symbol Q. ‘Flow rate’ is sometimes shortened to simply ‘flow’ or ‘airflow’.
  • 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.
  • Device flow rate, Qd is the flow rate of air leaving the RPT device.
  • Total flow rate, Qt is the flow rate of air and any supplementary gas reaching the patient interface via the air circuit.
  • Vent flow rate, Qv is the flow rate of air leaving a vent to allow washout of exhaled gases.
  • Leak flow rate, QI is the flow rate of leak from a patient interface system or elsewhere.
  • Respiratory flow rate, Qr is the flow rate of air that is received into the patient's respiratory system.
  • Respiratory therapy comprising the delivery of a flow of air to an entrance to the airways at a controlled flow rate referred to as the treatment flow rate that is typically positive throughout the patient’s breathing cycle.
  • Humidifier- The word humidifier will be taken to mean a humidifying apparatus constructed and arranged, or configured with a physical structure to be capable of providing a therapeutically beneficial amount of water (H2O) vapour to a flow of air to ameliorate a medical respiratory condition of a patient.
  • H2O water
  • leak The word leak will be taken to be an unintended 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.
  • Radiated noise in the present document refers to noise which is carried to the patient by the ambient air.
  • radiated noise may be quantified by measuring sound power/pressure levels of the object in question according to ISO 3744.
  • 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.
  • Oxygen enriched air Air with a concentration of oxygen greater than that of atmospheric air (21%), for example at least about 50% oxygen, at least about 60% oxygen, at least about 70% oxygen, at least about 80% oxygen, at least about 90% oxygen, at least about 95% oxygen, at least about 98% oxygen, or at least about 99% oxygen. “Oxygen enriched air” is sometimes shortened to “oxygen”.
  • Medical Oxygen is defined as oxygen enriched air with an oxygen concentration of 80% or greater.
  • the pressure in the patient interface is given the symbol Pm, while the treatment pressure, which represents a target value to be achieved by the interface pressure Pm at the current instant of time, is given the symbol Pt.
  • Respiratory Pressure Therapy The application of a supply of air to an entrance to the airways at a treatment pressure that is typically positive with respect to atmosphere.
  • Ventilator A mechanical device that provides pressure support to a patient to perform some or all of the work of breathing.
  • 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). May refer to durometer or indentation hardness, which is a material property measured by indentation of an indentor (e.g., as measured in accordance with ASTM D2240).
  • ‘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.
  • Silicone or Silicone Elastomer A synthetic rubber.
  • a reference to silicone is a reference to liquid silicone rubber (LSR) or a compression moulded silicone rubber (CMSR).
  • LSR liquid silicone rubber
  • CMSR compression moulded silicone rubber
  • SILASTIC included in the range of products sold under this trademark
  • Another manufacturer of LSR is Wacker.
  • 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.
  • Axes a. Neutral axis'. An axis in the cross-section of a beam or plate along which there are no longitudinal stresses or strains. b. Longitudinal axis'. An axis extending along the length of a shape. The axis generally passes through a center of the shape. c. Circumferential axis'. An axis oriented perpendicularly with respect to the longitudinal axis. The axis may be specifically present in pipes, tubes, cylinders, or similar shapes with a circular and/or elliptical cross-section. d. Radial axis
  • Deformation- The process where the original geometry of a member changes when subjected to forces, e.g. a force in a direction with respect to an axis.
  • the process may include stretching or compressing, bending and, twisting.
  • Elasticity The ability of a material to return to its original geometry after deformation.
  • 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.
  • Resilience- Ability of a material to absorb energy when deformed elastically and to release the energy upon unloading.
  • Resilient- Will release substantially all of the energy when unloaded. Includes e.g. certain silicones, and thermoplastic elastomers.
  • Rigid structure or component 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 cmH20 pressure.
  • an I-beam may comprise a different bending stiffness (resistance to a bending load) in a first direction in comparison to a second, orthogonal direction.
  • a structure or component may be floppy in a first direction and rigid in a second direction.
  • 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. The inverse of stiffness is flexibility.
  • Viscous The ability of a material to resist flow.
  • Visco-elasticity The ability of a material to display both elastic and viscous behaviour in deformation.
  • Yield The situation when a material can no longer return back to its original geometry after deformation.
  • Compression member A structural element that resists compression forces.
  • an elbow is an example of a structure that directs an axis of flow of air travelling therethrough to change direction through an angle.
  • the angle may be approximately 90 degrees.
  • the angle may be more, or less than 90 degrees.
  • the elbow may have an approximately circular cross- section.
  • the elbow may have an oval or a rectangular cross-section.
  • an elbow may be rotatable with respect to a mating component, e.g. about 360 degrees.
  • an elbow may be removable from a mating component, e.g. via a snap connection.
  • an elbow may be assembled to a mating component via a one-time snap during manufacture, but not removable by a patient.
  • a mask 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.
  • Membrane- Membrane will be taken to mean a typically thin element that has, preferably, substantially no resistance to bending, but has resistance to being stretched.
  • Tie (noun): A structure designed to resist tension.
  • Thin structures a. Beams, i. A beam may be relatively long in one dimension compared to the other two dimensions such that the smaller dimensions are comparatively thin compared to the long dimension.
  • Seal May be a noun form ("a seal”) which refers to a structure, or a verb form (“to seal”) which refers to the effect.
  • a seal noun form
  • to seal verb form
  • Two elements may be constructed and/or arranged to ‘seal’ or to effect ‘sealing’ therebetween without requiring a separate ‘seal’ element per se.
  • a shell will be taken to mean a curved, relatively thin structure having bending, tensile and compressive stiffness.
  • a curved structural wall of a mask may be a shell.
  • a shell may be faceted.
  • a shell may be airtight.
  • a shell may not be airtight.
  • Stiffener A stiffener will be taken to mean a structural component designed to increase the bending resistance of another component in at least one direction.
  • Strut A strut will be taken to be a structural component designed to increase the compression resistance of another component in at least one direction.
  • Swivel (noun): A subassembly of components configured to rotate about a common axis, preferably independently, preferably under low torque. In one form, the swivel may be constructed to rotate through an angle of at least 360 degrees. In another form, the swivel may be constructed to rotate through an angle less than 360 degrees.
  • 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.
  • an apnea is said to have occurred when flow falls below a predetermined threshold for a duration, e.g. 10 seconds.
  • An obstructive apnea will be said to have occurred when, despite patient effort, some obstruction of the airway does not allow air to flow.
  • a central apnea will be said to have occurred when an apnea is detected that is due to a reduction in breathing effort, or the absence of breathing effort, despite the airway being patent.
  • a mixed apnea occurs when a reduction or absence of breathing effort coincides with an obstructed airway.
  • Breathing rate The rate of spontaneous respiration of a patient, usually measured in breaths per minute.
  • Duty cycle The ratio of inhalation time, Ti to total breath time, Ttot.
  • Effort The work done by a spontaneously breathing person attempting to breathe.
  • Expiratory portion of a breathing cycle The period from the start of expiratory flow to the start of inspiratory flow.
  • Flow limitation will be taken to be the state of affairs in a patient's respiration where an increase in effort by the patient does not give rise to a corresponding increase in flow. Where flow limitation occurs during an inspiratory portion of the breathing cycle it may be described as inspiratory flow limitation. Where flow limitation occurs during an expiratory portion of the breathing cycle it may be described as expiratory flow limitation.
  • hypopnea is taken to be a reduction in flow, but not a cessation of flow.
  • a hypopnea may be said to have occurred when there is a reduction in flow below a threshold rate for a duration.
  • a central hypopnea will be said to have occurred when a hypopnea is detected that is due to a reduction in breathing effort.
  • either of the following may be regarded as being hypopneas:
  • Hyperpnea' An increase in flow to a level higher than normal.
  • Inspiratory portion of a breathing cycle The period from the start of inspiratory flow to the start of expiratory flow will be taken to be the inspiratory portion of a breathing cycle.
  • Patency airway: The degree of the airway being open, or the extent to which the airway is open. A patent airway is open. Airway patency may be quantified, for example with a value of one (1) being patent, and a value of zero (0), being closed (obstructed).
  • Peak flow rate (Qpeak): The maximum value of flow rate during the inspiratory portion of the respiratory flow waveform.
  • Tidal volume (Vt) The volume of air inhaled or exhaled during normal breathing, when extra effort is not applied.
  • the inspiratory volume Vi (the volume of air inhaled) is equal to the expiratory volume Ve (the volume of air exhaled), and therefore a single tidal volume Vt may be defined as equal to either quantity.
  • the tidal volume Vt is estimated as some combination, e.g. the mean, of the inspiratory volume Vi and the expiratory volume Ve.
  • Inhalation Time (Ti) The duration of the inspiratory portion of the respiratory flow rate waveform.
  • Exhalation Time The duration of the expiratory portion of the respiratory flow rate waveform.
  • Total Time The total duration between the start of one inspiratory portion of a respiratory flow rate waveform and the start of the following inspiratory portion of the respiratory flow rate waveform.
  • Typical recent ventilation- The value of ventilation around which recent values of ventilation Vent over some predetermined timescale tend to cluster, that is, a measure of the central tendency of the recent values of ventilation.
  • Upper airway obstruction includes both partial and total upper airway obstruction. This may be associated with a state of flow limitation, in which the flow rate increases only slightly or may even decrease as the pressure difference across the upper airway increases (Starling resistor behaviour).
  • Ventilation A measure of a rate of gas being exchanged by the patient’s respiratory system. Measures of ventilation may include one or both of inspiratory and expiratory flow, per unit time. When expressed as a volume per minute, this quantity is often referred to as “minute ventilation”. Minute ventilation is sometimes given simply as a volume, understood to be the volume per minute.
  • Adaptive Servo- Ventilator A servo-ventilator that has a changeable, rather than fixed target ventilation.
  • the changeable target ventilation may be learned from some characteristic of the patient, for example, a respiratory characteristic of the patient.
  • Backup rate A parameter of a ventilator that establishes the minimum breathing rate (typically in number of breaths per minute) that the ventilator will deliver to the patient, if not triggered by spontaneous respiratory effort.
  • Cycled The termination of a ventilator's inspiratory phase.
  • a ventilator delivers a breath to a spontaneously breathing patient, at the end of the inspiratory portion of the breathing cycle, the ventilator is said to be cycled to stop delivering the breath.
  • Expiratory positive airway pressure a base pressure, to which a pressure varying within the breath is added to produce the desired interface pressure which the ventilator will attempt to achieve at a given time.
  • Inspiratory positive airway pressure (IPAP): Maximum desired interface pressure which the ventilator will attempt to achieve during the inspiratory portion of the breath.
  • Servo-ventilator A ventilator that measures patient ventilation, has a target ventilation, and which adjusts the level of pressure support to bring the patient ventilation towards the target ventilation.
  • Spontaneous/Timed A mode of a ventilator or other device that attempts to detect the initiation of a breath of a spontaneously breathing patient. If however, the device is unable to detect a breath within a predetermined period of time, the device will automatically initiate delivery of the breath.
  • Swing Equivalent term to pressure support.
  • Triggered When a ventilator, or other respiratory therapy device such as an RPT device or portable oxygen concentrator, delivers a volume of breathable gas to a spontaneously breathing patient, it is said to be triggered to do so. Triggering usually takes place at or near the initiation of the respiratory portion of the breathing cycle by the patient's efforts.
  • Ala the external outer wall or "wing" of each nostril (plural: alar).
  • Alar angle An angle formed between the ala of each nostril.
  • Alare The most lateral point on the nasal ala.
  • Alar curvature (or alar crest) point The most posterior point in the curved base line of each ala, found in the crease formed by the union of the ala with the cheek.
  • Auricle The whole external visible part of the ear.
  • (nose) Bony framework The bony framework of the nose comprises the nasal bones, the frontal process of the maxillae and the nasal part of the frontal bone.
  • (nose) Cartilaginous framework The cartilaginous framework of the nose comprises the septal, lateral, major and minor cartilages.
  • Columella the strip of skin that separates the nares and which runs from the pronasale to the upper lip.
  • Columella angle The angle between the line drawn through the midpoint of the nostril aperture and a line drawn perpendicular to the Frankfort horizontal while intersecting subnasale.
  • Glabella Located on the soft tissue, the most prominent point in the midsagittal plane of the forehead.
  • Lateral nasal cartilage A generally triangular plate of cartilage. Its superior margin is attached to the nasal bone and frontal process of the maxilla, and its inferior margin is connected to the greater alar cartilage.
  • Greater alar cartilage A plate of cartilage lying below the lateral nasal cartilage. It is curved around the anterior part of the naris. Its posterior end is connected to the frontal process of the maxilla by a tough fibrous membrane containing three or four minor cartilages of the ala.
  • Nares Nostrils: Approximately ellipsoidal apertures forming the entrance to the nasal cavity. The singular form of nares is naris (nostril). The nares are separated by the nasal septum.
  • Naso-labial sulcus or Naso-labial fold The skin fold or groove that runs from each side of the nose to the corners of the mouth, separating the cheeks from the upper lip.
  • Naso-labial angle The angle between the columella and the upper lip, while intersecting subnasale.
  • Otobasion inferior The lowest point of attachment of the auricle to the skin of the face.
  • Otobasion superior The highest point of attachment of the auricle to the skin of the face.
  • Pronasale the most protruded point or tip of the nose, which can be identified in lateral view of the rest of the portion of the head.
  • Philtrum the midline groove that runs from lower border of the nasal septum to the top of the lip in the upper lip region.
  • Pogonion Located on the soft tissue, the most anterior midpoint of the chin.
  • Ridge (nasal): The nasal ridge is the midline prominence of the nose, extending from the Sellion to the Pronasale.
  • Sagittal plane A vertical plane that passes from anterior (front) to posterior (rear).
  • the midsagittal plane is a sagittal plane that divides the body into right and left halves.
  • Septal cartilage (nasal): The nasal septal cartilage forms part of the septum and divides the front part of the nasal cavity.
  • Subalare The point at the lower margin of the alar base, where the alar base joins with the skin of the superior (upper) lip.
  • Subnasal point Located on the soft tissue, the point at which the columella merges with the upper lip in the midsagittal plane.
  • Supramenton The point of greatest concavity in the midline of the lower lip between labrale inferius and soft tissue pogonion.
  • Frontal bone The frontal bone includes a large vertical portion, the squama frontalis, corresponding to the region known as the forehead.
  • Mandible The mandible forms the lower jaw.
  • the mental protuberance is the bony protuberance of the jaw that forms the chin.
  • Maxilla The maxilla forms the upper jaw and is located above the mandible and below the orbits. The frontal process of the maxilla projects upwards by the side of the nose, and forms part of its lateral boundary.
  • Nasal bones The nasal bones are two small oblong bones, varying in size and form in different individuals; they are placed side by side at the middle and upper part of the face, and form, by their junction, the "bridge" of the nose.
  • Nasion The intersection of the frontal bone and the two nasal bones, a depressed area directly between the eyes and superior to the bridge of the nose.
  • Occipital bone The occipital bone is situated at the back and lower part of the cranium. It includes an oval aperture, the foramen magnum, through which the cranial cavity communicates with the vertebral canal.
  • the curved plate behind the foramen magnum is the squama occipitalis.
  • Orbit The bony cavity in the skull to contain the eyeball.
  • Parietal bones The parietal bones are the bones that, when joined together, form the roof and sides of the cranium.
  • Temporal bones The temporal bones are situated on the bases and sides of the skull, and support that part of the face known as the temple.
  • Zygomatic bones The face includes two zygomatic bones, located in the upper and lateral parts of the face and forming the prominence of the cheek.
  • Diaphragm A sheet of muscle that extends across the bottom of the rib cage. The diaphragm separates the thoracic cavity, containing the heart, lungs and ribs, from the abdominal cavity. As the diaphragm contracts the volume of the thoracic cavity increases and air is drawn into the lungs.
  • Larynx The larynx, or voice box houses the vocal folds and connects the inferior part of the pharynx (hypopharynx) with the trachea.
  • Lungs The organs of respiration in humans.
  • the conducting zone of the lungs contains the trachea, the bronchi, the bronchioles, and the terminal bronchioles.
  • the respiratory zone contains the respiratory bronchioles, the alveolar ducts, and the alveoli.
  • Nasal cavity The nasal cavity (or nasal fossa) is a large air filled space above and behind the nose in the middle of the face.
  • the nasal cavity is divided in two by a vertical fin called the nasal septum.
  • On the sides of the nasal cavity are three horizontal outgrowths called nasal conchae (singular "concha") or turbinates.
  • nasal conchae singular "concha”
  • turbinates To the front of the nasal cavity is the nose, while the back blends, via the choanae, into the nasopharynx.
  • Pharynx The part of the throat situated immediately inferior to (below) the nasal cavity, and superior to the oesophagus and larynx.
  • the pharynx is conventionally divided into three sections: the nasopharynx (epipharynx) (the nasal part of the pharynx), the oropharynx (mesopharynx) (the oral part of the pharynx), and the laryngopharynx (hypopharynx).
  • Anti-asphyxia valve 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.
  • Headgear will be taken to mean a form of positioning and stabilising structure designed to hold a device, e.g., a mask, on a head.
  • Plenum chamber a mask plenum chamber 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’ element per se.
  • 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.
  • 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 surfaces. These surfaces may be distinguished using a label to describe an associated surface orientation, location, function, or some other characteristic.
  • a structure may comprise one or more of an anterior surface, a posterior surface, an interior surface and an exterior surface.
  • a seal-forming structure may comprise a face-contacting (e.g. outer) surface, and a separate non-face- contacting (e.g. underside or inner) surface.
  • a structure may comprise a first surface and a second surface.
  • the curvature of a plane curve at p may be described as having a sign (e.g. positive, negative) and a magnitude (e.g. 1/radius of a circle that just touches the curve at p).
  • Negative 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 convex.
  • a description of the shape at a given point on a two-dimensional surface in accordance with the present technology may include 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 curvatures 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 particular point.
  • Region of a surface A connected set of points on a surface.
  • the set of points in a region may have similar characteristics, e.g. curvatures or signs.
  • Saddle region A region where at each point, the principal curvatures have opposite signs, that is, one is positive, and the other is negative (depending on the direction to which the imaginary 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 “convex dome”).
  • Cylindrical region A region where one principal curvature is zero (or, for example, zero within manufacturing tolerances) and the other principal curvature is non-zero.
  • 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 will be taken to mean a path in the mathematical - topological sense, e.g. a continuous space curve from f(0) to f(l) on a surface.
  • 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 surface 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 is the distance between two points on a surface, but without regard to the surface. On planar regions, there would be a path on the surface having the same path length as the straight-line distance between two points on the surface. On non-planar surfaces, there may be no paths having the same path length as the straight-line distance between two points. (For the imaginary person, the straight-line distance would correspond to the distance ‘as the crow flies’.)
  • Space curves Unlike a plane curve, a space curve does not necessarily lie in any particular plane.
  • a space curve may be closed, that is, having no endpoints.
  • a space curve may be considered to be a one-dimensional piece of three-dimensional space.
  • An imaginary 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.
  • 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 tangent 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 direction she would be travelling.
  • Unit normal vector 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 right-hand rule (see e.g. Fig. 3P), or alternatively by a left-hand rule (Fig. 30).
  • Osculating plane The plane containing the unit tangent vector and the unit principal normal vector. See Figures 30 and 3P.
  • 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).
  • 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.
  • a space curve turning towards the direction of the right-hand binormal may be considered as having a righthand positive torsion (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 considered as having a right-hand negative torsion (e.g. a left-hand helix).
  • 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).
  • left-hand positive is equivalent to right-hand negative. See Fig. 3T.
  • 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
  • Thin structures with a hole, may be described as having a one-dimensional hole. See for example the one dimensional hole in the surface of structure shown in Fig. 31, bounded by a plane curve.
  • a structure may have a two-dimensional hole, e.g. a hole bounded by a surface.
  • a hole bounded by a surface For example, an inflatable tyre has a two dimensional hole bounded by the interior surface of the tyre.
  • a bladder with a cavity for air or gel could have a two-dimensional hole. See for example the cushion of Fig. 3E and the example cross-sections therethrough in Fig. 3M and Fig. 3N, with the interior surface bounding a two dimensional hole indicated.
  • a conduit may comprise a one-dimension hole (e.g. at its entrance or at its exit), and a two-dimension 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.

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  • Health & Medical Sciences (AREA)
  • Emergency Medicine (AREA)
  • Pulmonology (AREA)
  • Engineering & Computer Science (AREA)
  • Anesthesiology (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Hematology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Measurement Of The Respiration, Hearing Ability, Form, And Blood Characteristics Of Living Organisms (AREA)
  • Respiratory Apparatuses And Protective Means (AREA)

Abstract

Selon l'invention, un évent de purge de gaz pour la régulation de débit est conçu pour évacuer un gaz respiratoire à partir d'une interface patient. L'évent de purge de gaz comprend une base conçue pour ancrer l'évent de purge de gaz à l'interface patient. L'évent de purge de gaz comprend également un élément mobile qui est en regard de la base et qui forme un conduit variable avec la base. L'élément mobile est conçu pour se déplacer vers la base pour rétrécir le conduit variable et s'éloigner de la base pour élargir le conduit variable. Un mécanisme de sollicitation en porte-à-faux est fixé à l'élément mobile et est conçu pour pousser l'élément mobile pour l'éloigner de la base. Le mécanisme de sollicitation en porte-à-faux comprend une extrémité ancrée fixe et une extrémité libre mobile.
EP24736936.6A 2022-12-28 2024-01-02 Appareil de régulation de débit de gaz pour traitement respiratoire Pending EP4642502A1 (fr)

Applications Claiming Priority (4)

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US202263477519P 2022-12-28 2022-12-28
US202363465994P 2023-05-12 2023-05-12
US202363515675P 2023-07-26 2023-07-26
PCT/AU2024/050001 WO2024138245A1 (fr) 2022-12-28 2024-01-02 Appareil de régulation de débit de gaz pour traitement respiratoire

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WO2026000026A1 (fr) * 2024-06-26 2026-01-02 ResMed Pty Ltd Évents et ensembles évent pour systèmes de thérapie par pression respiratoire

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US20080142013A1 (en) * 2006-09-11 2008-06-19 Michael David Hallett Exhaust Apparatus For Use in Administering Positive Pressure Therapy Through the Nose or Mouth
WO2013040198A2 (fr) * 2011-09-13 2013-03-21 Resmed Limited Agencement d'évent de masque respiratoire
US10076619B2 (en) * 2012-09-11 2018-09-18 Resmed Limited Vent arrangement for respiratory mask
WO2014186584A2 (fr) * 2013-05-15 2014-11-20 Fresca Medical Inc. Valve d'auto-rétroaction pour dispositif contre l'apnée du sommeil
US11318275B2 (en) * 2013-10-30 2022-05-03 ResMed Pty Ltd Control for pressure of a patient interface
WO2022178381A1 (fr) * 2021-02-22 2022-08-25 The Trustees Of The University Of Pennsylvania Systèmes et procédés d'évaluation de réactivité cérébrovasculaire

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