WO2024243632A1

WO2024243632A1 - Eye cover for use with a respiratory therapy system

Info

Publication number: WO2024243632A1
Application number: PCT/AU2024/050560
Authority: WO
Inventors: Richard Charles Napper; Justin John Formica; Layale HARB; Andrew Chan; Mohankumar Krishnan Valiyambath
Original assignee: Resmed Pty Ltd
Current assignee: Resmed Pty Ltd
Priority date: 2023-05-31
Filing date: 2024-05-30
Publication date: 2024-12-05
Anticipated expiration: 2025-11-30

Abstract

An eye cover for use with a respiratory therapy system is disclosed. The eye cover includes an eye-covering structure arranged to engage the patient generally around a periphery of a patient's eyes in-use. The eye-covering structure is arranged to be held in opposing relation to the patient's face when a force is applied to the eye- covering structure by a positioning and stabilising structure. The eye cover is configured to interact with the respiratory therapy system to aid in respiratory therapy.

Description

EYE COVER FOR USE WITH A RESPIRATORY THERAPY SYSTEM

[0001] A portion of the disclosure of this patent document contains material which is subject to copyright protection. The copyright owner has no objection to the facsimile reproduction by anyone of the patent document or the patent disclosure, as it appears in Patent Office patent files or records, but otherwise reserves all copyright rights whatsoever.

1 CROSS-REFERENCE TO RELATED APPLICATION

[0002] This application claims the benefit of Australian Provisional Patent Application No. 2023901719, filed May 31, 2023, the entire contents of which are hereby incorporated herein by reference.

2 BACKGROUND OF THE TECHNOLOGY

2.1 FIELD OF THE TECHNOLOGY

[0003] 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.

2.2 DESCRIPTION OF THE RELATED ART

2.2.1 Human Respiratory System and its Disorders

[0004] The respiratory system of the body facilitates gas exchange. The nose and mouth form the entrance to the airways of a patient.

[0005] 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. [0006] A range of respiratory disorders exist. Certain disorders may be characterised by particular events, e.g. apneas, hypopneas, and hyperpneas.

[0007] Examples of 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.

[0008] Obstructive Sleep Apnea (OSA), a form of Sleep Disordered Breathing (SDB), is characterised by events including occlusion or obstruction of the upper air passage during sleep. It results from a combination of an abnormally small upper airway and the normal loss of muscle tone in the region of the tongue, soft palate and posterior oropharyngeal wall during sleep. The condition causes the affected 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, e.g. see US Patent No. 4,944,310 (Sullivan).

[0009] Cheyne-Stokes Respiration (CSR) is another form of sleep disordered breathing. CSR is a disorder of a patient's respiratory controller in which there are rhythmic alternating periods of waxing and waning ventilation known as CSR cycles. CSR is characterised by repetitive de-oxygenation and re-oxygenation of the arterial blood. It is possible that CSR is harmful because of the repetitive hypoxia. In some patients CSR is associated with repetitive arousal from sleep, which causes severe sleep disruption, increased sympathetic activity, and increased afterload, e.g. see US Patent No. 6,532,959 (Berthon-Jones).

[0010] 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.

[0011] A patient with respiratory insufficiency (a form of respiratory failure) may experience abnormal shortness of breath on exercise.

[0012] Obesity Hypoventilation Syndrome (OHS) is defined as the combination of severe obesity and awake chronic hypercapnia, in the absence of other known causes for hypoventilation. Symptoms include dyspnea, morning headache and excessive daytime sleepiness. [0013] 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. [0014] Neuromuscular Disease (NMD) is a broad term that encompasses many diseases and ailments that impair the functioning of the muscles either directly via intrinsic muscle pathology, or indirectly via nerve pathology. Some NMD patients are characterised by progressive muscular impairment leading to loss of ambulation, being wheelchair-bound, swallowing difficulties, respiratory muscle weakness and, eventually, death from respiratory failure. Neuromuscular disorders can be divided into rapidly progressive and slowly progressive: (i) Rapidly progressive disorders: Characterised by muscle impairment that worsens over months and results in death within a few years (e.g. Amyotrophic lateral sclerosis (ALS) and Duchenne muscular dystrophy (DMD) in teenagers); (ii) Variable or slowly progressive disorders: Characterised by muscle impairment that worsens over years and only mildly reduces life expectancy (e.g. Limb girdle, Facioscapulohumeral and Myotonic muscular dystrophy). Symptoms of respiratory failure in NMD include: increasing generalised weakness, dysphagia, dyspnea on exertion and at rest, fatigue, sleepiness, morning headache, and difficulties with concentration and mood changes.

[0015] 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.

[0016] 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. 2.2.2 Therapies

[0017] Various respiratory therapies, such as Continuous Positive Airway Pressure (CPAP) therapy, Non-invasive ventilation (NIV), Invasive ventilation (IV), and High Flow Therapy (HFT) have been used to treat one or more of the above respiratory disorders.

2.2.2.1 Respiratory pressure therapies

[0018] 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).

[0019] Continuous Positive Airway Pressure (CPAP) therapy has been used to treat Obstructive Sleep Apnea (OSA). The mechanism of action is that continuous positive airway pressure acts as a pneumatic splint and may prevent upper airway occlusion, such as by pushing the soft palate and tongue forward and away from the posterior oropharyngeal wall. Treatment of OSA by CPAP therapy may be voluntary, and hence patients may elect not to comply with therapy if they find devices used to provide such therapy one or more of: uncomfortable, difficult to use, expensive and aesthetically unappealing.

[0020] Non-invasive ventilation (NIV) 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.

[0021] Invasive ventilation (IV) provides ventilatory support to patients that are no longer able to effectively breathe themselves and may be provided using a tracheostomy tube or endotracheal tube. In some forms, the comfort and effectiveness of these therapies may be improved.

2.2.2.2 Flow therapies

[0022] Not all respiratory therapies aim to deliver a prescribed therapeutic pressure. Some respiratory therapies aim to deliver a prescribed respiratory volume, by delivering an inspiratory flow rate profile over a targeted duration, possibly superimposed on a positive baseline pressure. In other cases, the interface to the patient’s airways is ‘open’ (unsealed) and the respiratory therapy may only supplement the patient’s own spontaneous breathing with a flow of conditioned or enriched gas. In one example, High Flow therapy (HFT) is the provision of a continuous, heated, humidified flow of air to an entrance to the airway through an unsealed or open patient interface at a “treatment flow rate” that may be held approximately constant throughout the respiratory cycle. The treatment flow rate is nominally set to exceed the patient’s peak inspiratory flow rate. HFT has been used to treat OSA, CSR, respiratory failure, COPD, and other respiratory disorders. One mechanism of action is that the high flow rate of air at the airway entrance improves ventilation efficiency by flushing, or washing out, expired CO2 from the patient’s anatomical deadspace. Hence, HFT is thus sometimes referred to as a deadspace therapy (DST). Other benefits may include the elevated warmth and humidification (possibly of benefit in secretion management) and the potential for modest elevation of airway pressures. As an alternative to constant flow rate, the treatment flow rate may follow a profile that varies over the respiratory cycle.

[0023] Another form of flow therapy is long-term oxygen therapy (LTOT) or supplemental oxygen therapy. Doctors may prescribe a continuous flow of oxygen enriched air at a specified oxygen concentration (from 21%, the oxygen fraction in ambient air, to 100%) at a specified flow rate (e.g., 1 litre per minute (LPM), 2 LPM, 3 LPM, etc.) to be delivered to the patient’s airway.

2.2.3 Respiratory Therapy Systems

[0024] 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.

[0025] 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.

[0026] Another form of therapy system is a mandibular repositioning device.

2.2.3.1 Patient Interface

[0027] 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. Depending upon the therapy to be applied, 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 cmH20 relative to ambient pressure. For other forms of therapy, such as the delivery of oxygen, the patient interface may not include a seal sufficient to facilitate delivery to the airways of a supply of gas at a positive pressure of about 10 cmH20. For flow therapies such as nasal HFT, the patient interface is configured to insufflate the nares but specifically to avoid a complete seal. One example of such a patient interface is a nasal cannula.

2.2.3.2 Seal-forming structure

[0028] 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.

[0029] 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. In one form of patient interface, 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. In one form of patient interface, 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. In one form of patient interface 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. In one form of patient interface, a seal-forming structure may comprise a single element that surrounds both nares and a mouth region in use. These different types of patient interfaces may be known by a variety of names by their manufacturer including nasal masks, full-face masks, nasal pillows, nasal puffs and oro-nasal masks.

[0030] 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. [0031] 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. [0032] One type of 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. With this type of seal-forming structure, if the fit is not adequate, there will be gaps between the seal-forming structure and the face, and additional force will be required to force the patient interface against the face in order to achieve a seal.

[0033] 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. Like the previous style of seal-forming portion, if the match between the face and the mask is not good, additional force may be required to achieve a seal, or the mask may leak. Furthermore, if 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.

[0034] 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.

[0035] A range of patient interface seal-forming structure technologies are disclosed in the following patent applications: WO 1998/004310; WO 2006/074513; WO 2010/135785.

[0036] One form of nasal pillow is found in the Adam Circuit manufactured by Puritan Bennett. Another nasal pillow, or nasal puff is the subject of US Patent 4,782,832 (Trimble et al.), assigned to Puritan-Bennett Corporation.

[0037] ResMed Inc. 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. The following patent applications describe examples of nasal pillows masks: International Patent Application WO 2004/073778 (describing amongst other things aspects of the SWIFTTM nasal pillows mask), US Patent Application 2009/0044808 (describing amongst other things aspects of the SWIFTTM LT nasal pillows mask); International Patent Applications WO 2005/063328 and WO 2006/130903 (describing amongst other things aspects of the MIRAGE LIBERTYTM full-face mask); International Patent Application WO 2009/052560 (describing amongst other things aspects of the SWIFTTM FX nasal pillows mask).

2.2.3.3 Positioning and Stabilising Structure

[0038] 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. Thus a variety of techniques have been used to position the seal-forming structure, and to maintain it in sealing relation with the appropriate portion of the face. 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.

[0039] One technique is the use of adhesives, e.g. see US Patent Application Publication No. US 2010/0000534.

[0040] Another technique is the use of one or more straps and/or stabilising harnesses. Many such harnesses suffer from being one or more of ill-fitting, bulky, uncomfortable and awkward to use.

2.2.3.4 Pressurised Air Conduit

[0041] In one type of treatment system, 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.

2.2.3.4.1 Pressurised Air Conduit used for Positioning / Stabilising the Seal- Forming Structure

[0042] 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. 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. [0043] 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.

2.2.3.5 Respiratory Pressure Therapy (RPT) Device

[0044] A respiratory pressure therapy (RPT) device may be used individually or as part of a system to deliver one or more of a number of therapies described above, such as by operating the device to generate a flow of air for delivery to an interface to the airways. The flow of air may be pressure-controlled (for respiratory pressure therapies) or flow-controlled (for flow therapies such as HFT). Thus RPT devices may also act as flow therapy devices. Examples of RPT devices include a CPAP device and a ventilator.

2.2.3.6 Air circuit

[0045] An air circuit is a conduit or a tube constructed and arranged to allow, in use, a flow of air to travel between two components of a respiratory therapy system such as the RPT device and the patient interface. In some cases, there may be separate limbs of the air circuit for inhalation and exhalation. In other cases, a single limb air circuit is used for both inhalation and exhalation.

2.2.3.7 Humidifier

[0046] 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. In addition, in cooler climates, warm air applied generally to the face area in and about the patient interface is more comfortable than cold air. 2.2.3.8 Data Management

[0047] There may be clinical reasons to obtain data to determine whether the patient prescribed with respiratory therapy has been “compliant”, e.g. that the patient has used their RPT device according to one or more “compliance rules”. One example of a compliance rule for CPAP therapy is that a patient, in order to be deemed compliant, is required to use the RPT device for at least four hours a night for at least 21 of 30 consecutive days. In order to determine a patient's compliance, a provider of the RPT device, such as a health care provider, may manually obtain data describing the patient's therapy using the RPT device, calculate the usage over a predetermined time period, and compare with the compliance rule. Once the health care provider has determined that the patient has used their RPT device according to the compliance rule, the health care provider may notify a third party that the patient is compliant.

[0048] There may be other aspects of a patient’s therapy that would benefit from communication of therapy data to a third party or external system.

[0049] Existing processes to communicate and manage such data can be one or more of costly, time-consuming, and error-prone.

2.2.3.9 Vent technologies

[0050] 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.

2.2.4 Screening, Diagnosis, and Monitoring Systems

[0051] Polysomnography (PSG) is a conventional system for diagnosis and monitoring of cardio-pulmonary disorders, and typically involves expert clinical staff to apply the system. PSG typically involves the placement of 15 to 20 contact sensors on a patient in order to record various bodily signals such as electroencephalography (EEG), electrocardiography (ECG), electrooculograpy (EOG), electromyography (EMG), etc. PSG for sleep disordered breathing has involved two nights of observation of a patient in a clinic, one night of pure diagnosis and a second night of titration of treatment parameters by a clinician. PSG is therefore expensive and inconvenient. In particular, it is unsuitable for home screening / diagnosis / monitoring of sleep disordered breathing. [0052] Screening and diagnosis generally describe the identification of a condition from its signs and symptoms. Screening typically gives a true / false result indicating whether or not a patient’s SDB is severe enough to warrant further investigation, while diagnosis may result in clinically actionable information. Screening and diagnosis tend to be one-off processes, whereas monitoring the progress of a condition can continue indefinitely. Some screening / diagnosis systems are suitable only for screening / diagnosis, whereas some may also be used for monitoring.

[0053] Clinical experts may be able to screen, diagnose, or monitor patients adequately based on visual observation of PSG signals. However, there are circumstances where a clinical expert may not be available, or a clinical expert may not be affordable. Different clinical experts may disagree on a patient’s condition. In addition, a given clinical expert may apply a different standard at different times.

3 BRIEF SUMMARY OF THE TECHNOLOGY

[0054] 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.

[0055] A first aspect of the present technology relates to apparatus or systems used in the screening, diagnosis, monitoring, amelioration, treatment or prevention of a respiratory disorder.

[0056] Another aspect of the present technology relates to methods used in the screening, diagnosis, monitoring, amelioration, treatment or prevention of a respiratory disorder.

[0057] An aspect of certain forms of the present technology is to provide methods and/or apparatus and/or systems that improve the compliance of patients with respiratory therapy.

[0058] 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. [0059] One form of the present technology comprises a patient interface comprising a plenum chamber, a seal-forming structure, and a positioning and stabilising structure.

[0060] 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.

[0061] 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.

[0062] In one form, 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.

[0063] Another aspect of one form of the present technology is an eye cover for use with a respiratory therapy system to aid in respiratory therapy.

[0064] Another aspect of one form of the present technology is a treatment system that includes a respiratory therapy system and an eye cover.

[0065] In one form of the present technology, the eye cover includes an eyecovering structure extending generally around a periphery of a patient’s eyes in-use, the eye-covering structure being held in opposing relation to the patient’s face when a force is applied thereto by a positioning and stabilising structure. In one form, when the eye-covering structure is held in opposing relation to the patient’s face, the eyecover structure is configured to maintain a light-sealing position of the eye-covering on the patient’s head. [0066] In one form of the present technology, the eye cover includes at least one sensor to provide sensor data to a processor of the respiratory therapy system. In one form, the sensor data is provided to the processor to effect change to the respiratory therapy.

[0067] In one form of the present technology, the sensor data is provided to the processor to determine one or more characteristic of the patient. The one or more characteristic may be selected from the group comprising: sleep hygiene; sleep performance; a sleeping disorder; and a respiratory disorder.

[0068] In one form of the present technology the one or more sensor data includes one or more physiological characteristic of the patient. The one or more sensors may sense at least one of electroencephalography (EEG), electrocardiography (ECG), electrooculography (EOG), and electromyography (EMG) signals of the patient.

[0069] In one form of the present technology, the eye cover may further include one or more output devices. The one or more output devices of the eye cover may be configured to stimulate a response in the patient and/or to alter the environment around the patient.

[0070] In one form of the present technology, the one or more output devices may be controlled by a processor of the respiratory therapy system. The one or more output devices may be controlled by the processor based on the sensor data of the at least one sensor.

[0071] In one form of the present technology, the one or more output devices further comprises one or more LEDs configured to stimulate the patient’s eye for adjusting the patient’s sleep stage.

[0072] In one form of the present technology, the eye cover may be connected with respect to the patient interface of the respiratory therapy system.

[0073] In one form of the present technology, the eye cover further includes a positioning and stabilising structure structured and arranged to hold the eye-covering structure over the patient’s eyes.

[0074] In one form of the present technology, the positioning and stabilising structure of the eye cover may be releasably connectable to the eye-covering structure such that: the eye-covering structure can be connected to the positioning and stabilising structure of the eye cover to maintain the eye-covering structure in the light-sealing position on the patient’s head; or the eye-covering structure may be disconnected from the positioning and stabilising structure of the eye cover so as to be connected with respect to the positioning and stabilising structure of the respiratory system.

[0075] In one form of the present technology, the patient interface may be connected to the eye cover and held in sealing engagement with the patient by the positioning and stabilising structure of the eye cover.

[0076] In one form of the present technology, the eye cover may further include ear covers arranged to overlay the patient’s ears.

[0077] In one form, the treatment system may include a respiratory therapy system in any form described above and an eye cover constructed and arranged to overlay the patient’s eyes, the eye cover being in any form described above and being configured to interact with the respiratory therapy system to aid in respiratory therapy. [0078] In another aspect of the present technology, a sleep aid system for providing respiratory therapy comprises: 1) an eye cover including an eye-covering structure configured to engage a patient’ s face generally around a periphery of the patient’s eyes, in-use, to form a light seal to prevent ambient light from entering the patient’s eyes; 2) a positioning and stabilising structure configured to hold the eyecovering structure in opposing relation to the patient’s face when a force is applied to the eye-covering structure by the positioning and stabilising structure; and 3) a respiratory therapy system including a cushion assembly configured to deliver pressurised air to an airway of the patient for respiratory therapy, the cushion assembly including a seal-forming structure configured to form a seal with the patient’s face.

[0079] In examples: a) the eye cover is configured to interact with the respiratory therapy system to aid in respiratory therapy and includes at least one sensor adapted to provide sensor data for utilization by the respiratory therapy system; and/or b) the eye cover does not include an image display screen.

[0080] In further examples: c) the respiratory therapy system includes a processor, and the sensor data is provided to the processor to effect change to the respiratory therapy; b) the sensor is one of a group comprising a motion sensor, temperature sensor, oximeter, humidity sensor, light sensor, sonar sensor, tactile sensor, altitude sensor, gas sensor, accelerometer, gyroscope, GPS, or any combination thereof; c) the sensor data is provided to the processor to determine one or more characteristic of the patient; d) the one or more characteristic is selected from the group comprising: i) sleep hygiene; ii) sleep performance; iii) a sleeping disorder; and iv) a respiratory disorder; e) the one or more characteristic of the patient includes one or more physiological characteristic of the patient; f) the at least one sensor senses at least one of electroencephalography (EEG), electrocardiography (ECG), electrooculography (EOG), and electromyography (EMG) signals of the patient; g) the eye-covering structure has a fabric outer covering; and/or h) the seal-forming structure is configured to form a seal with an underside of the patient’s nose and the eye-covering structure includes a concave notch configured to, in use, align with the patient’s nose ridge, the seal-forming structure and the eye-covering structure thereby being configured to, in use, leave uncovered and thereby exposed to ambient a lower portion of the patient’s nose ridge.

[0081] In another aspect of the present technology, a sleep aid system for providing respiratory therapy comprises: 1) an eye cover including an eye-covering structure configured to engage a patient’ s face generally around a periphery of a patient’s eyes, in-use, to form a light seal to prevent ambient light from entering the patient’s eyes; 2) a positioning and stabilising structure configured to hold the eyecovering structure in opposing relation to the patient’s face when a force is applied to the eye-covering structure by the positioning and stabilising structure; and 3) a respiratory therapy system including a cushion assembly configured to deliver pressurised air to an airway of the patient for respiratory therapy, the cushion assembly including a seal-forming structure configured to form a seal with the patient’s face.

[0082] In examples: a) the seal-forming structure is configured to form a seal with an underside of the patient’s nose and the eye-covering structure includes a concave notch configured to, in use, align with the patient’s nose ridge, the sealforming structure and the eye-covering structure thereby being configured to, in use, leave uncovered and thereby exposed to ambient a lower portion of the patient’s nose ridge.

[0083] In further examples: b) the eye cover further comprises one or more output devices; c) the one or more output devices of the eye cover is configured to, in use, stimulate a response in the patient; d) the one or more output devices of the eye cover is configured to, in use, alter the environment around the patient; e) the one or more output devices is controlled by a processor of the respiratory therapy system; f) the one or more output devices is controlled by the processor based on the sensor data of the at least one sensor; g) the one or more output devices further comprises one or more LEDs configured to stimulate the patient’s eye, in use, for adjusting the patient’s sleep stage; and/or h) the cushion assembly is configured to be coupled to a flow generator for delivery of pressurised air to an airway of the patient for respiratory therapy.

[0084] In further examples i) the positioning and stabilising structure of the eye cover is releasably connectable to the eye-covering structure such that: 1) the eyecovering structure can be connected to the positioning and stabilising structure of the eye cover to maintain the eye-covering structure in the light-sealing position on the patient’s head in use; or 2) the eye-covering structure can be disconnected from the positioning and stabilising structure of the eye cover so as to be connected with respect to a positioning and stabilising structure of the respiratory therapy system arranged and configured to maintain the cushion assembly in sealing engagement with the patient’s face in use, the positioning and stabilising structure of the respiratory therapy system being configured to maintain the eye-covering structure in the lightsealing position on the patient’s head in use.

[0085] In further examples: j) the cushion assembly is connected to the eye cover and configured to, in use, be held in sealing engagement with the patient’s face by the positioning and stabilising structure of the eye cover; k) the sleep aid system further comprises ear covers arranged to overlay the patient’s ears in use; 1) the eye cover is configured to interact with the respiratory therapy system, in use, to aid in respiratory therapy and includes at least one sensor adapted to provide sensor data for utilization by the respiratory therapy system; m) the seal-forming structure and the eye-covering structure are configured to, in use, leave uncovered and thereby exposed to ambient at least half of the lower portion of the patient’s nose ridge; and/or n) the seal-forming structure and the eye-covering structure are configured to, in use, leave uncovered and thereby exposed to ambient substantially the patient’s entire nose ridge.

[0086] In another aspect of the present technology, a treatment system comprises: 1) the respiratory therapy system of any previous aspect; and 2) the eye cover according to any previous aspect. The respiratory therapy system may include: i) a flow generator configured to generate a flow of pressurized air; and ii) an air delivery tube coupled between the flow generator and cushion assembly to deliver the flow of pressurized air from the flow generator to the cushion assembly.

[0087] In examples: a) the respiratory therapy system further comprises a processor to interact with the eye cover; b) the processor is configured to control an operation of the respiratory therapy system based on the sensor data of the at least one sensor; c) the processor controls an operation of the flow generator; d) the sensor data is provided to the processor to determine one or more characteristic of the patient; e) the one or more output devices is configured to be controlled by the processor based on sensor data of the at least one sensor; and/or f) the respiratory therapy system further comprises a positioning and stabilising structure arranged and configured to, in use, maintain the cushion assembly in sealing engagement with the patient’s face.

[0088] Another aspect of the present technology relates to an eye cover for use with a respiratory therapy system. The eye cover comprises an eye-covering structure configured to engage the patient’s face generally around a periphery of a patient’s eyes in-use, to form a light seal to prevent ambient light from entering the patient’s eyes, the eye-covering structure being configured to be held in opposing relation to the patient’s face, in use, when a force is applied to the eye-covering structure by a positioning and stabilising structure.

[0089] In further examples: (a) the eye cover is adapted to interact with a respiratory therapy system to aid in respiratory therapy; (b) the positioning and stabilising structure comprises a first positioning and stabilising structure of the eye cover and a second positioning and stabilising structure of the respiratory therapy system, and the eye-covering structure comprises a connector configured to removably connect to the second positioning and stabilising structure of the respiratory therapy system; c) the connector is configured to interchangeably and removably connect to the first positioning and stabilising structure of the eye cover and to the second positioning and stabilising structure of the respiratory therapy system; d) the eye cover further comprises at least one sensor adapted to provide sensor data for utilization by the respiratory therapy system; e) the at least one sensor is provided in a sensor unit that is removably connected to the eye cover, and the eye cover further comprises a sensor retainer configured to removably retain the sensor unit on the eye cover; f) the at least one sensor comprises an orientation sensor configured to detect a sleeping position of the patient; g) the orientation sensor is configured to detect whether the patient is sleeping on their side; and/or h) based on an output from the orientation sensor, the eye cover is configured to determine whether the patient has positional obstructive sleep apnea.

[0090] In further examples: i) the eye-covering structure comprises a material having variable transparency, the eye-covering structure being configured to adjust a transparency of the material to control a magnitude of light entering the patient’s eyes in use; j) the eye cover further comprises one or more output devices; k) the one or more output devices of the eye cover is configured to, in use, stimulate a response in the patient; 1) the one or more output devices comprises one or more LEDs configured to stimulate the patient’s eye, in use, for adjusting the patient’s sleep stage; m) the eye cover comprises first and second arrangements of LEDs positioned to correspond to each of the patient’s eyes in use; n) each of the first and second arrangements of LEDs comprises two LEDs; o) each of the first and second arrangements of LEDs includes a first set and a second set of LEDs configured to be positioned around a perimeter of a respective one of the patient’s eyes in use, wherein each of the first and second arrangements of LEDs includes 5 or more LEDs; and/or p) each first set of LEDs is configured to be positioned along an upper perimeter of the patient’s eye in use, and each second set of LEDs is configured to be positioned along a lower perimeter of the patient’s eye in use.

[0091] 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.

[0092] An aspect of one form of the present technology is a method of manufacturing apparatus.

[0093] Another aspect of one form of the present technology is a method of structure, and connecting the positioning and stabilising structure to either a first cushion or a second cushion.

[0094] 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.

[0095] 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.

[0096] 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.

[0097] 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.

[0098] Of course, portions of the aspects may form sub-aspects of the present technology. Also, various ones of the sub-aspects and/or aspects may be combined in various manners and also constitute additional aspects or sub-aspects of the present technology.

[0099] Other features of the technology will be apparent from consideration of the information contained in the following detailed description, abstract, drawings and claims.

4 BRIEF DESCRIPTION OF THE DRAWINGS

[0100] The present technology is illustrated by way of example, and not by way of limitation, in the figures of the accompanying drawings, in which like reference numerals refer to similar elements including:

4.1 RESPIRATORY THERAPY SYSTEMS

[0101] Fig. 1A shows a system including a patient 1000 wearing a patient interface 2000, in the form of nasal pillows, receiving a supply of air at positive pressure from an RPT device 3000. Air from the RPT device 3000 is humidified in a humidifier 4000, and passes along an air circuit 3170 to the patient 1000. A bed partner 1100 is also shown. The patient is sleeping in a supine sleeping position. [0102] Fig. IB shows a system including a patient 1000 wearing a patient interface 2000, in the form of a nasal mask, receiving a supply of air at positive pressure from an RPT device 3000. Air from the RPT device is humidified in a humidifier 4000, and passes along an air circuit 3170 to the patient 1000.

[0103] Fig. 1C shows a system including a patient 1000 wearing a patient interface 2000, in the form of a full-face mask, receiving a supply of air at positive pressure from an RPT device 3000. Air from the RPT device is humidified in a humidifier 4000, and passes along an air circuit 3170 to the patient 1000. The patient is sleeping in a side sleeping position.

4.2 RESPIRATORY SYSTEM AND FACIAL ANATOMY

[0104] Fig. 2A 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.

[0105] Fig. 2B is a side view of a head with several features of surface anatomy identified including glabella, sellion, pronasale, subnasale, lip superior, lip inferior, supramenton, nasal ridge, alar crest point, otobasion superior and otobasion inferior. Also indicated are the directions superior & inferior, and anterior & posterior.

[0106] Fig. 2C 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.

4.3 PATIENT INTERFACE

[0107] Fig. 3A shows a patient interface in the form of a nasal mask in accordance with one form of the present technology.

[0108] Fig. 3B shows a patient interface having conduit headgear, in accordance with one form of the present technology.

4.4 RPT DEVICE

[0109] Fig. 4 shows an RPT device in accordance with one form of the present technology.

4.5 HUMIDIFIER

[0110] Fig. 5 shows an isometric view of a humidifier in accordance with one form of the present technology. 4.6 BREATHING WAVEFORMS

[0111] Fig. 6 shows a model typical breath waveform of a person while sleeping.

4.7 EYE COVER

[0112] Fig. 7A shows a perspective view of an in-use eye cover in accordance with one form of the present technology.

[0113] Fig. 7B-1 shows a perspective view of an in-use eye cover in accordance with one form of the present technology, the eye cover worn together with a full-face mask.

[0114] Fig. 7B-2 shows a perspective view of an in-use eye cover in accordance with one form of the present technology, the eye cover configured to attach to a patient interface comprising a full-face mask.

[0115] Fig. 7C shows a perspective view of an in-use eye cover in accordance with one form of the present technology, the eye cover configured to attach to a patient interface comprising a nasal pillows mask.

[0116] Fig. 7C-1 shows a perspective view of an in-use eye cover in accordance with one form of the present technology, the eye cover configured to attach to a patient interface comprising an ultra-compact full-face mask.

[0117] Fig. 7D shows a perspective view of an in-use eye cover in accordance with one form of the present technology, the eye cover configured to attach to a nasal pillows mask.

[0118] Fig. 8 shows a rear view of an embodiment of the eye cover.

5 DETAILED DESCRIPTION OF EXAMPLES OF THE

TECHNOLOGY

[0119] Before the present technology is described in further detail, it is to be understood that the technology is not limited to the particular examples described herein, which may vary. It is also to be understood that the terminology used in this disclosure is for the purpose of describing only the particular examples discussed herein, and is not intended to be limiting.

[0120] The following description is provided in relation to various examples which may share one or more common characteristics and/or features. It is to be understood that one or more features of any one example may be combinable with one or more features of another example or other examples. In addition, any single feature or combination of features in any of the examples may constitute a further example.

5.1 THERAPY

[0121] In one form, 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.

[0122] In certain examples of the present technology, a supply of air at positive pressure is provided to the nasal passages of the patient via one or both nares.

[0123] In certain examples of the present technology, mouth breathing is limited, restricted or prevented.

5.2 RESPIRATORY THERAPY SYSTEMS

[0124] In one form, the present technology comprises a respiratory therapy system for treating a respiratory disorder. The respiratory therapy system may comprise an RPT device 3000 for supplying a flow of air to the patient 1000 via an air circuit 3170 and a patient interface 2000 or 2800.

5.3 PATIENT INTERFACE

[0125] A non-invasive patient interface 2000, 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 2100, a plenum chamber 2200, a positioning and stabilising structure 2300, a vent 2400, one form of connection port 2600 for connection to air circuit 3170, and a forehead support 2700. The sealforming structure 2100 and plenum chamber 2000 may form a cushion module 2150 (also referred to as cushion assembly) In some forms a functional aspect may be provided by one or more physical components. In some forms, one physical component may provide one or more functional aspects. In use the seal-forming structure 2100 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 2000 is therefore suitable for delivery of positive pressure therapy.

[0126] The patient interface 2000 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. 1 5.3.1 Seal-forming structure

[0127] In one form of the present technology, a seal-forming structure 2100 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 2100 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.

[0128] In one form the target seal-forming region is located on an outside surface of the seal-forming structure 2100.

[0129] In certain forms of the present technology, the seal-forming structure 2100 is constructed from a biocompatible material, e.g. silicone rubber.

[0130] A seal-forming structure 2100 in accordance with the present technology may be constructed from a soft, flexible, resilient material such as silicone.

[0131] In certain forms of the present technology, a system is provided comprising more than one a seal-forming structure 2100, each being configured to correspond to a different size and/or shape range. For example the system may comprise one form of a seal-forming structure 2100 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.

5.3.1.1 Sealing mechanisms

[0132] In one form, the seal-forming structure includes a sealing flange utilizing a pressure assisted sealing mechanism. In use, the sealing flange can readily respond to a system positive pressure in the interior of the plenum chamber 2200 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.

[0133] In one form, the seal-forming structure 2100 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 2200. 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 2200, 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.

[0134] In one form, the seal-forming structure may comprise a compression sealing portion or a gasket sealing portion. In use 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.

[0135] In one form, the seal-forming structure comprises a tension portion. In use, the tension portion is held in tension, e.g. by adjacent regions of the sealing flange.

[0136] In one form, the seal-forming structure comprises a region having a tacky or adhesive surface.

[0137] In certain forms of the present technology, 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.

5.3.1.2 Nose bridge or nose ridge region

[0138] In one form, the non-invasive patient interface 2000 comprises a sealforming structure that forms a seal in use on a nose bridge region or on a nose-ridge region of the patient's face.

[0139] In one form, 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.

5.3.1.3 Upper lip region

[0140] In one form, the non-invasive patient interface 2000 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.

[0141] In one form, 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.

5.3.1.4 Chin-region

[0142] In one form the non-invasive patient interface 2000 comprises a sealforming structure that forms a seal in use on a chin-region of the patient's face.

[0143] In one form, 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. 5.3.1.5 Forehead region

[0144] In one form, the seal-forming structure that forms a seal in use on a forehead region of the patient's face. In such a form, the plenum chamber may cover the eyes in use.

5.3.1.6 Nasal pillows

[0145] In one form the seal-forming structure of the non-invasive patient interface 2000 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.

[0146] Nasal pillows in accordance with an aspect of the present technology include: a frusto-cone, at least a portion of which forms a seal on an underside of the patient's nose, a stalk, a flexible region on the underside of the frusto-cone and connecting the frusto-cone to the stalk. In addition, the structure to which the nasal pillow of the present technology is connected includes a flexible region adjacent the base of the stalk. The flexible regions can act in concert to facilitate a universal joint structure that is accommodating of relative movement both displacement and angular of the frusto-cone and the structure to which the nasal pillow is connected. For example, the frusto-cone may be axially displaced towards the structure to which the stalk is connected.

5.3.1.7 Nose-only Masks

[0147] In one form, the patient interface 2000 comprises a seal-forming structure 2100 configured to seal around an entrance to the patient’s nasal airways but not around the patient’s mouth. The seal-forming structure 2100 may be configured to seal to the patient’s lip superior. The patient interface 2000 may leave the patient’s mouth uncovered. This patient interface 2000 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.

[0148] One form of nose-only mask according to the present technology is what has traditionally been identified as a “nasal mask”, having a seal-forming structure 2100 configured to seal on the patient’s face around the nose and over the bridge of the nose. A nasal mask may be generally triangular in shape. In one form, the non- invasive patient interface 2000 comprises a seal-forming structure 2100 that forms a seal in use to an upper lip region (e.g. the lip superior), to the patient’s nose bridge or at least a portion of the nose ridge above the pronasale, and to the patient's face on each lateral side of the patient’s nose, for example proximate the patient’s nasolabial sulci. The patient interface 2000 shown in Fig. IB has this type of seal-forming structure 2100. This patient interface 2000 may deliver a supply of air or breathable gas to both nares of patient 1000 through a single orifice.

[0149] Another form of nose-only mask may seal around an inferior periphery of the patient’s nose without engaging the user’s nasal ridge. This type of patient interface 2000 may be identified as a “nasal cradle” mask and the seal-forming structure 2100 may be identified as a “nasal cradle cushion”, for example. In one form, for example as shown in Fig. 3B, the seal-forming structure 2100 is configured to form a seal in use with inferior surfaces of the nose around the nares. The sealforming structure 2100 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 2100 may seal to the patient’s lip superior. The shape of the sealforming structure 2100 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. In one form of nasal cradle cushion, the seal-forming structure 2100 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. Alternatively, the seal-forming structure 2100 may comprise a single opening to provide a flow or air or breathable gas to both of the patient’s nares.

[0150] In some forms, a nose-only mask may comprise nasal pillows, described above.

5.3.1.8 Nose and Mouth Masks

[0151] In one form, the patient interface 2000 comprises a seal-forming structure 2100 configured to seal around an entrance to the patient’s nasal airways and also around the patient’s mouth. The seal-forming structure 2100 may be configured to seal to the patient’s face proximate a chin region. This patient interface 2000 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. [0152] 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 2100 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. In one form the patient interface 2000 comprises a seal-forming structure 2100 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 2000 shown in Fig. 1C is of this type. This patient interface 2000 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 2100 may be referred to as a “nose-and-mouth cushion”.

[0153] In another form the patient interface 2000 comprises a seal-forming structure 2100 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 2100 may also form a seal against a patient’s lip superior. A patient interface 2000 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 2000 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.

[0154] In a further form of nose and mouth mask, the patient interface 2000 may comprise a seal-forming structure 2100 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.

[0155] In some forms, the seal-forming structure 2100 may have a nasal portion that is separate and distinct from an oral portion. In other forms, a seal-forming structure 2100 may form a contiguous seal around the patient’s nose and mouth.

[0156] It is to be understood that the above examples of different forms of patient interface 2000 do not constitute an exhaustive list of possible configurations. In some forms a patient interface 2000 may comprise a combination of different features of the above described examples of nose-only and nose and mouth masks.

5.3.2 Plenum chamber

[0157] The plenum chamber 2200 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 2200 is positioned in close proximity to an adjacent surface of the face. Actual contact with the face is provided by the seal-forming structure 2100. The seal-forming structure 2100 may extend in use about the entire perimeter of the plenum chamber 2200. In some forms, the plenum chamber 2200 and the seal-forming structure 2100 are formed from a single homogeneous piece of material.

[0158] In certain forms of the present technology, the plenum chamber 2200 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.

[0159] In certain forms of the present technology, the plenum chamber 2200 is constructed from a transparent material, e.g. a transparent polycarbonate. The use of 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.

[0160] In certain forms of the present technology, the plenum chamber 2200 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. [0161] In some forms, the plenum chamber 2200 is constructed from a rigid material such as polycarbonate. The rigid material may provide support to the sealforming structure.

[0162] In some forms, the plenum chamber 2200 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 2200 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 2200 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.

5.3.3 Positioning and stabilising structure

[0163] The seal-forming structure 2100 of the patient interface 2000 of the present technology may be held in sealing position in use by the positioning and stabilising structure 2300. The positioning and stabilising structure 2300 may comprise and function as “headgear” since it engages the patient’s head in order to hold the patient interface 2000 in a sealing position. Examples of a positioning and stabilising structure may be shown in Fig. 3A.

[0164] In one form the positioning and stabilising structure 2300 provides a retention force at least sufficient to overcome the effect of the positive pressure in the plenum chamber 2200 to lift off the face (i.e., Fpienum).

[0165] In one form the positioning and stabilising structure 2300 provides a retention force to overcome the effect of the gravitational force on the patient interface 2000.

[0166] In one form of the present technology, a positioning and stabilising structure 2300 comprises a strap constructed from a laminate of a fabric patientcontacting layer, a foam inner layer and a fabric outer layer. In one form, the foam is porous to allow moisture, (e.g., sweat), to pass through the strap. In one form, the fabric outer layer comprises loop material to engage with a hook material portion. [0167] In certain forms of the present technology, a positioning and stabilising structure 2300 comprises a strap that is extensible, e.g. resiliently extensible. For example 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. In an example the strap may be configured as a tie.

[0168] In one form of the present technology, 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.

[0169] In one form of the present technology suitable for a nasal-only mask or for a full-face mask, 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.

[0170] In one form of the present technology suitable for a nasal-only mask or for a full-face mask, 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.

[0171] In certain forms of the present technology, a positioning and stabilising structure 2300 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.

[0172] In certain forms of the present technology, a positioning and stabilising structure 2300 comprises a strap constructed to be breathable to allow moisture vapour to be transmitted through the strap,

[0173] In certain forms of the present technology, a system is provided comprising more than one positioning and stabilising structure 2300, each being configured to provide a retaining force to correspond to a different size and/or shape range. For example the system may comprise one form of positioning and stabilising structure 2300 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.

5.3.3.1 Conduit headgear

5.3.3.1.1 Conduit headgear tubes

[0174] In some forms of the present technology, the positioning and stabilising structure 2300 comprises one or more headgear tubes 2350 that deliver pressurised air received from a conduit forming part of the air circuit 3170 from the RPT device to the patient’s airways, for example through the plenum chamber 2200 and sealforming structure 2100. In the form of the present technology illustrated in Fig. 3B, the positioning and stabilising structure 2300 comprises two tubes 2350 that deliver air to the plenum chamber 2200 from the air circuit 3170. The tubes 2350 are configured to position and stabilise the seal-forming structure 2100 of the patient interface 2000 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 3170 providing the flow of pressurised air to connect to a connection port 2600 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. [0175] In the form of the present technology illustrated in Fig. 3B, the positioning and stabilising structure 2300 comprises two tubes 2350, each tube 2350 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 2610 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 2350 is compressed to block or partially block the flow of gas along the tube 2350, the other tube 2350 remains open to supply pressurised gas to the patient. In other examples of the technology, the patient interface 2000 may comprise a different number of tubes, for example one tube, or two or more tubes.

[0176] In one example in which the patient interface has one tube 2350, the single tube 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 2300 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 2000 on the patient’s head. For example, the tube 2350 and the strap may each be under tension in use in order to assist in maintaining the seal-forming structure 2100 in a sealing position.

[0177] In one form, the tube 2350 may be at least partially extensible so that the tube 2350 and the strap may adjust substantially equal lengths when worn by a patient. This may allow for substantially symmetrical adjustments between the tube 2350 and the strap so that the seal-forming structure remains substantially in the middle.

[0178] In the form of the technology shown in Fig. 3B, the two tubes 2350 are fluidly connected at superior ends to each other and to the connection port 2600. In some examples, the two tubes 2350 are integrally formed while in other examples the tubes 2350 are formed separately but are connected in use and may be disconnected, for example for cleaning or storage. Where separate tubes are used, 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 2350. Additionally, the T-shaped connector may have a third arm or opening providing the connection port 2600 for fluid connection to the air circuit 3170 in use. The opening may be an inlet 2332 (see e.g., 7C) for receiving the flow of pressurized air. [0179] In some forms, the third arm of the T-shaped connector may be substantially perpendicular to each of the first two arms.

[0180] In some forms, the third arm of the T-shaped connector may be obliquely formed with respect to each of the first two arms.

[0181] In some forms, 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.

[0182] In some forms, at least one of the arms of the T-shaped connector (or Y- 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 2300.

[0183] In some forms, at least one of the arms of the T-shaped connector (or Y- 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.

[0184] The tubes 2350 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 2350 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 2350 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.

[0185] In some examples, the one or more tubes 2350 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 2350. The tubes 2350 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.

[0186] Each tube 2350 may be configured to receive a flow of air from the connection port 2600 on top of the patient’s head and to deliver the flow of air to the seal-forming structure 2100 at the entrance of the patient’s airways. In the example shown in Fig. 3B, each tube 2350 lies in use on a path extending from the plenum chamber 2200 across the patient’s cheek region and superior to the patient’s ear to the elbow 2610. For example, a portion of each tube 2350 proximate the plenum chamber 2200 may overlie a maxilla region of the patient’s head in use. Another portion of each tube 2350 may overlie a region of the patient’s head superior to an otobasion superior of the patient’s head. Each of the tubes 2350 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 2610 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).

[0187] In certain forms of the present technology the patient interface 2000 is configured such that the connection port 2600 can be positioned in a range of positions across the top of the patient’s head so that the patient interface 2000 can be positioned as appropriate for the comfort or fit of an individual patient. In some examples, the headgear tubes 2350 are configured to allow movement of an upper portion of the patient interface 2000 (e.g. a connection port 2600) with respect to a lower portion of the patient interface 2000 (e.g. a plenum chamber 2200). That is, the connection port 2600 may be at least partially decoupled from the plenum chamber 2200. In this way, the seal-forming structure 2100 may form an effective seal with the patient’s face irrespective of the position of the connection port 2600 (at least within a predetermined range of positions) on the patient’s head.

[0188] As described above, in some examples of the present technology the patient interface 2000 comprises a seal-forming structure 2100 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 2300, including the tubes 2350 may be structured and arranged to pull the seal-forming structure 2100 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 posterosuperior direction may cause the seal-forming structure 2100 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.

5.3.3.1.2 Conduit headgear connection port

[0189] In certain forms of the present technology, the patient interface 2000 may comprise a connection port 2600 located proximal to a superior, lateral or posterior portion of a patient’s head. For example, in the form of the present technology illustrated in Fig 3B, the connection port 2600 is located on top of the patient’s head (e.g. at a superior location with respect to the patient’s head). In this example the patient interface 2000 comprises an elbow 2610 forming the connection port 2600. The elbow 2610 may be configured to fluidly connect with a conduit of an air circuit 3170. The elbow 2610 may be configured to swivel with respect to the positioning and stabilising structure 2300 to at least partially decouple the conduit from the positioning and stabilising structure 2300. In some examples the elbow 2610 may be configured to swivel by rotation about a substantially vertical axis and, in some particular examples, by rotation about two or more axes. In some examples the elbow may comprise or be connected to the tubes 2350 by a ball-and-socket joint. The connection port 2600 may be located in the sagittal plane of the patient’s head in use. [0190] 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. For example, 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. on their back, facing generally upwards) or in a prone position (e.g. on their front, facing generally downwards). Moreover, connecting a conduit to an anterior portion of a patient interface may exacerbate a problem known as tube drag in which the conduit exerts an undesired force upon the patient interface during movement of the patient’s head or the conduit, thereby causing dislodgement away from the face. 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).

5.3.3.1.3 Headgear Tube Fluid Connections

[0191] The two tubes 2350 are fluidly connected at their inferior ends to the plenum chamber 2200. In certain forms of the technology, the connection between the tubes 2350 and the plenum chamber 2200 is achieved by connection of two rigid connectors. The tubes 2350 and plenum chamber 2200 may be configured to enable the patient to easily connect the two components together in a reliable manner. The tubes 2350 and plenum chamber 2200 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 2350 has been correctly connected to the plenum chamber 2200. In one form, the tubes 2350 are formed from a silicone or textile material and the inferior end of each of the (silicone) tubes 2350 is overmolded to a rigid connector made, for example, from polypropylene, polycarbonate, nylon or the like. The rigid connector on each tube 2350 may comprise a female mating feature configured to connect with a male mating feature on the plenum chamber 2200. Alternatively, the rigid connector on each tube 2350 may comprise a male mating feature configured to connect to a female mating feature on the plenum chamber 2200. In other examples the tubes 2350 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 2350 are formed.

[0192] In other examples a compression seal is used to connect each tube 2350 to the plenum chamber 2200. For example, a resiliently flexible (e.g. silicone) tube 2350 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 2200 and the inherent resilience of the silicone pushes the tube 2350 outwards to seal the tube 2350 in the port in an air-tight manner. Alternatively, in a hard-to-hard type engagement between the tube 2350 and the plenum chamber 2200, each tube 2350 and/or plenum chamber 2200 may comprise a pressure activated seal, for example a peripheral sealing flange. When pressurised gas is supplied through the tubes 2350 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 2200 to form or enhance a seal between the tube 2350 and plenum chamber 2200.

5.3.3.2 Headgear straps

[0193] In some forms, the positioning and stabilising structure 2300 may include headgear 2302 with at least one strap which may be worn by the patient in order to assist in properly orienting the seal-forming structure 2100 against the patient’s face (e.g., in order to limit or prevent leaks).

[0194] As described above, some forms of the headgear 2302 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. Although the textile may include rigidisers along a selected length, which may limit bending, flexing, and/or stretching of the headgear 2302.

[0195] In certain forms, the headgear 2302 may be at least partially extensible. For example, the headgear 2302 may include elastic, or a similar extensible material. For example, the entire headgear 2302 may be extensible or selected portions may be extensible (or more extensible than surrounding portions). This may allow the headgear 2302 to stretch while under tension, which may assist in providing a sealing force for the seal-forming structure 2100.

[0196] Two forms of the headgear, four-point headgear 2302-1 (see Fig. 3A) and two-point headgear 2302-2 (see Fig. 3B).

5.3.4 Vent

[0197] In one form, the patient interface 2000 includes a vent 2400 constructed and arranged to allow for the washout of exhaled gases, e.g. carbon dioxide.

[0198] In certain forms the vent 2400 is configured to allow a continuous vent flow from an interior of the plenum chamber 2200 to ambient whilst the pressure within the plenum chamber is positive with respect to ambient. The vent 2400 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.

[0199] One form of vent 2400 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.

[0200] The vent 2400 may be located in the plenum chamber 2200. Alternatively, the vent 2400 is located in a decoupling structure, e.g., a swivel.

5.3.5 Decoupling structure(s)

[0201] In one form the patient interface 2000 includes at least one decoupling structure, for example, a swivel or a ball and socket.

5.3.6 Connection port

[0202] Connection port 2600 allows for connection to the air circuit 3170.

5.3.7 Forehead support

[0203] In one form, the patient interface 2000 includes a forehead support 2700.

5.3.8 Anti-asphyxia valve

[0204] In one form, the patient interface 2000 includes an anti-asphyxia valve. 5.3.9 Modularity

[0205] As described above, 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. An example of this sort of modular design is described in PCT/SG2022/050777 filed 28 October 2022, incorporated herein by reference in its entirety.

[0206] In some forms, 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.

[0207] Air may be delivered to the patient in one of two main ways. In one example, the patient may receive the flow of pressurized air through headgear tubes 2350 (see e.g., Fig. 3B). This may be referred to as a “tube up” configuration and may position a connection port at the top of the patient’s head. In other example, the patient may receive the flow of pressurized air through a conduit connected to the plenum chamber 2200, for example through the connection port 2600 (see e.g., Fig. 3A). 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.

[0208] 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.

5.4 RPT DEVICE

[0209] An RPT device 3000 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 3300, such as any of the methods, in whole or in part, described herein. The RPT device 3000 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.

5.5 AIR CIRCUIT

[0210] An air circuit 3170 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 3000 and the patient interface 2000 or 2800.

[0211] In particular, the air circuit 3170 may be in fluid connection with the outlet of the pneumatic block 3020 and the patient interface. The air circuit may be referred to as an air delivery tube. In some cases there may be separate limbs of the circuit for inhalation and exhalation. In other cases a single limb is used.

[0212] In some forms, the air circuit 3170 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. In one form, the heated wire circuit may be helically wound around the axis of the air circuit 3170. The heating element may be in communication with a controller such as a central controller 3230. One example of an air circuit 3170 comprising a heated wire circuit is described in United States Patent 8,733,349, which is incorporated herewithin in its entirety by reference.

5.6 HUMIDIFIER

5.6.1 Humidifier overview

[0213] In one form of the present technology there is provided a humidifier 4000 (e.g. as shown in Fig. 5) to change the absolute humidity of air or gas for delivery to a patient relative to ambient air. Typically, the humidifier 4000 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.

[0214] The humidifier 4000 may comprise a humidifier reservoir 4110, a humidifier inlet 4002 to receive a flow of air, and a humidifier outlet 4004 to deliver a humidified flow of air. In some forms, as shown in Fig. 5, an inlet and an outlet of the humidifier reservoir 4110 may be the humidifier inlet 4002 and the humidifier outlet 4004 respectively. The humidifier 4000 may further comprise a humidifier base 4006, which may be adapted to receive the humidifier reservoir 4110 and comprise a heating element 4240.

5.7 BREATHING WAVEFORMS

[0215] Fig. 6 shows a model typical breath waveform of a person while sleeping. The horizontal axis is time, and the vertical axis is respiratory flow rate. While the parameter values may vary, a typical breath may have the following approximate values: tidal volume Vt 0.5L, inhalation time T, 1.6s, peak inspiratory flow rate Q_peak 0.4 L/s, exhalation time T_e 2.4s, peak expiratory flow rate Q_peak -0.5 L/s. The total duration of the breath, T_M, is about 4s. The person typically breathes at a rate of about 15 breaths per minute (BPM), with Ventilation Vent about 7.5 L/min. A typical duty cycle, the ratio of Ti to T_tat, is about 40%.

5.8 RESPIRATORY THERAPY MODES

[0216] Various respiratory therapy modes may be implemented by the disclosed respiratory therapy system.

5.9 EYE COVER

[0217] Referring now to Figs. 7A to 7D, an eye cover 5000, 6000, 7000 is shown that may be configured for use with the respiratory therapy system as set forth previously. The eye cover and the respiratory therapy system may form a sleep aid system that provides respiratory therapy, e.g., treatment of sleep disordered breathing (e.g., sleep apnea). In the form shown in Fig. 7A, a first embodiment of an eye cover 5000 may be worn by a patient on its own, i.e. without a patient interface 2000. In this form, while the eye cover 5000 is not worn together with the patient interface 2000, the eye cover 5000 may be configured for use with, i.e., being in communication with, components of the respiratory therapy system, as set forth in more detail later.

[0218] In the form shown in Fig. 7B-1, the eye cover 5000 may also be used, i.e., worn together with the patient interface 2000, e.g., underneath the patient interface 2000. In alternative embodiments of the eye cover 5000, as shown in Figs. 7B-2, 7C and 7D, the eye cover 6000,7000 may also be worn together with the patient interface 2000, and, in some forms of the present technology, may be configured to releasably connect with (i.e., attach to) the patient interface 2000. The patient interface 2000 may include a seal-forming structure 2100 and a plenum chamber 2200, which together may also be referred to as a cushion module or cushion assembly 2150. As shown in Figs. 7B-1 and 7B-2, a pair of rigidiser arms 5020 extend from respective sides of the cushion assembly. Each rigidiser arm 5020 has a slot to receive an upper strap 5310 of the positioning and stabilising structure 5300,6300. The positioning and stabilising structure 5300,6300 may also include a pair of lower straps 5320 and a ring strap 5330 that connects to the upper straps 5310 and the lower straps 5320.

[0219] Referring to the eye cover 5000 as shown in-use in Fig. 7A, the eye cover may comprise an eye-covering structure 5002 and a positioning and stabilising structure 5004 configured to maintain or hold the eye-covering structure 5002 in a desired position over a patient’s face. That is, the positioning and stabilising structure 5004 may support the eye cover 5000 in opposing relation to the patient’s face.

[0220] In broad terms, the eye-covering structure 5002 is configured (in-use) to engage with the patient’s face generally around a periphery of a patients’ eyes e.g., along the patient’s nose, cheeks and forehead. More specifically, the eye-covering structure 5002,6002,7002 may be formed to engage with regions of the epicranius, the sphenoid, across the outer cheek region between the sphenoid to the left or right zygomatic arch, over the zygomatic arch, across the inner cheek region from the zygomatic arches towards the alar crests, and on the nasal ridge inferior to the sellion to enclose a portion of the patient’s face therebetween.

[0221] The eye-covering structure 5002, 6002, 7002 is thereby shaped such that the eye-covering structure may conform to the contours of the patient’s face. This enables the eye-covering structure 5002, 6002, 7002 to engage with the patient’s face to form a light seal to prevent ambient light from entering the patient’s eyes.

[0222] The eye cover 5000, 6000, 7000 (including the positioning and stabilising structure 5004,7004) may be formed from soft and flexible (e.g., elastic) materials. The flexible materials may be structured and arranged to allow more conformity to the patient’s head and cushioning for comfort. Such materials may be e.g., breathable materials, like textile-foam composites. Advantageously, textiles may provide a soft structure to stabilise the eye-covering structure 5002,6002,7002 on a patient’s head and allow the positioning and stabilising structure 5004,7004 to cushion against the patient’s head for optimised comfort. In examples, the eye-covering structure may have an outer (non-patient contacting) surface constructed of a textile material to provide the eye cover with a fabric appearance.

[0223] Although not shown, the positioning and stabilising structure 5004,7004 may comprise adjustment mechanisms to facilitate adjustment while on the patient’s head so as to allow for a wide fit range.

[0224] In the embodiment of Fig. 7A, the positioning and stabilising structure 5004 comprises a rear support structure 5006 (also referred to as a rear support hoop) adapted to contact regions of a patient’s head (e.g., positionable at a crown of the patient’s head). The positioning and stabilising structure 5004 may further comprise temporal portions 5008 extending between the rear support structure 5006 to the eyecovering structure 5002.

[0225] As set forth above, the positioning and stabilising structure 5004 may comprise adjustment mechanisms that, while not shown, may be structured and arranged at the temporal portions 5008, i.e., so as to interconnect the rear support structure 5006 to the eye-covering structure 5002.

[0226] The temporal portions 5008, in-use, may be configured to locate, i.e., contact a region of the patient’s head, proximal to the otobasion superior, i.e., above the patient’s ear. As shown in Fig. 7A, when referencing Figs. 2B and 2C, the temporal portions 5008 are arranged in-use to run generally along or parallel to the Frankfort Horizontal plane of the head and superior to the zygomatic bone, i.e., above the patient’s cheek bone.

[0227] In some forms, the positioning and stabilising structure 5004, 7004 may comprise one or more rigid portions (not shown) to, in use, stabilise the eye-covering structure 5002,6002,7002. For example, the temporal portions 5008, 6008, 7008 may include a rigidiser (not shown) that may be encapsulated within the textile of each temporal portion. In some alternative forms, the rigidiser may be stitched or otherwise attached (e.g., overmolded) to the textile. Such rigid portions may be of particular relevance in embodiments of the eye cover 7000, as shown in Fig. 7D and set forth in more detail later, whereby a patient interface 2000c may be connected to the temporal portions 7008 of the eye cover 7000. [0228] The use of rigid portions, e.g., rigidisers in the temporal portions 5008,7008 (also referred to as temporal arms) may allow the positioning and stabilising structure 5004,7004 to retain an in-use shape and configuration when not worn by a patient. Advantageously, maintaining the positioning and stabilising structure 5004,7004 in the in-use state prior to use may prevent or limit distortion whilst the patient is donning the eye cover 5000,7000 and thus, allow the patient to quickly fit or wear the eye cover 5000,7000.

[0229] In the forms shown in the Fig. 7A, 7B-1 and 7D the rear support structure 5006, 7006 is in the form of a hoop having a ring-like form and is arranged to have a three-dimensional contour curve to fit or conform to the shape of the rear of the patient’s head, e.g., a patient's crown. As shown, the rear support hoop 5006, 7006 comprises a parietal portion or parietal strap portion 5010, 7010 adapted to be in proximity to the parietal bone of the patient’s head in use, and an occipital portion or occipital strap portion 5012, 7012 adapted to be in proximity to the occipital bone of the patient’s head in use.

[0230] This hoop-like arrangement (e.g., circular, or ovular, or part circular/ovular) of the rear support hoop 5006, 7006 anchors the positioning and stabilising structure 5004, 7004 around the rear or rear bump of the patient’s head, which provides an effective support structure to hold the eye-covering structure 5002, 7002 at the front of the patient’s head. The rear support hoop 5006, 7006 may be formed from an elastic material, whereby elasticity may be used to stretch the hoop and securely hold the rear support hoop 5006, 7006 in position.

[0231] In other forms of the rear support structure (not shown), a single strap may be provided instead of the rear-support hoop 5006, 7006 for passing around the rear of the patient’s head. In this form the single strap may be continuous with the temporal portions 5008, 7008 configured to locate generally between the parietal bone and the occipital bone of the patient’s head in-use.

[0232] Referring now to the embodiments of the eye cover 6000 shown in Figs. 7B-2, 7C and 7C-1. In these embodiments of the eye cover 6000, like reference numerals are used for like features with the addition of the prefix ‘6’. The eye cover 6000 primarily differs from the eye cover 5000 in that the eye cover 6000 is configured to be connected with respect to the patient interface 2000.

[0233] Referring firstly to Fig. 7B-2, the eye cover 6000 may be used together with a full-face patient interface, i.e. ‘full-face mask’ 2000a. In the form shown in Fig. 7C, the eye cover 6000 may be used together with a nasal mask (e.g., a nasal pillows mask 2000b or a nasal cradle mask). In these forms, i.e., Figs. 7B-2 and 7C, the eye cover 6000 is not provided with a positioning and stabilising structure: the eye-covering structure 6002 being configured to connect to a positioning and stabilising structure 6300 of the patient interface.

[0234] It is noted that, while the eye-covering structure 6002 as shown in Fig. 7B-2, 7C and 7C-1 is not provided with a positioning and stabilising structure, the eye-covering structure 6002 may be configured to extend to temporal portions 6008 on opposing sides of the patient’s head. As set forth below, the temporal portions 6008 may be configured to connect the eye-covering structure 6002 to the patient interface, i.e., a full-face mask 2000a (see Fig. 7B-2), a nasal pillows mask 2000b (see Fig. 7C), or an ultra-compact full-face mask 2000d (see Fig. 7C-1).

[0235] The temporal portions 6008 may comprise a hook-and-loop fastening means for connecting to the positioning and stabilising structure 6300 (i.e., of the patient interface 2000). The hook-and-loop fastening means, e.g., Velcro, may allow fine adjustment of the position of the eye-covering structure 6002. For example, the patient may arrange the eye-covering structure 6002 in an optimal position, i.e., angled, located, etc., for comfort and fit (e.g., tightness), before connecting the hook- and-loop fastening means to secure the eye-covering structure 6002 in said optimal position.

[0236] In alternative forms, other attachment means may be provided to connect between the eye cover 6000 and the patient interface 2000. For example, a connector (not shown) may be configured at the temporal portion 6008 for connecting with respect to the positioning and stabilising structure 6300. The connector may be a type of releasable clip mounted towards an end of the temporal portion 6008 and configured to align with and mount to a corresponding clip of the positioning and stabilising structure 6300 (i.e., of the patient interface). In this way, the eye cover 6000 may utilise the positioning and stabilising structure 6300 of the patient interface

2000 to support the eye-covering structure 6002 in opposing relation to the patient’s face.

[0237] Advantageously, configuring the eye cover 6000 in this way, i.e., to ‘piggy-back’ the existing positioning and stabilising structure 6300 may minimise a ‘bulk’ of the eye cover 6000. That is, when a patient wears the eye cover 5000 of Fig. 7B-1 (i.e., together with a positioning and stabilising structure 5300) the two positioning and stabilising structures 5004,5300 are layered over one-another. In effect, the layered structures 5004,5300 protrude from the patient’s head such that, when the patient sleeps, the ‘bulk’, i.e., perceived thickness and weight of the two structures 5004,5300 may be considered uncomfortable. In addition, the additional weight and tension applied to the patient’s head from the layered structures 5004,5300 may be considered uncomfortable by the patient.

[0238] In some forms, the eye cover 6000 may be provided with a releasably connectable, i.e., separable, positioning and stabilising structure (not shown) for allowing a patient to interchange between wearing the eye cover 6000 alone, i.e., as shown in Fig. 7A or 7B-1 (not being connected to the patient interface 2000) or alternatively, together, connected to the patient interface 2000, i.e., as shown in Fig. 7B-2, 7C or 7C-1. In this form, the eye cover 6000 may be considered modular.

[0239] In the modular form, the eye-covering structure 6002 may comprise two separable components: a positioning and stabilising structure and an eye covering structure. In one form of the modular eye cover (not shown), the eye-covering structure 6002 may be releasably connected to a positioning and stabilising structure (not shown) of the eye cover 6000 (i.e., the two components of the eye cover 6000 may be connected/assembled together to form the eye cover as shown in Fig. 7 A). In a second form of the modular eye cover 6000 (shown in Figs. 7B-2, 7C and 7C-1) the eye-covering structure 6002 may be releasably connected to the positioning and stabilising structure 6300 of the patient interface 2000. The positioning and stabilising structure 6300 shown in Fig. 7C-1 may also include a lower strap 2320 that connects to a lower headgear connector of the cushion assembly 2150 and is configured to extend around a rear portion of the patient’ s neck. [0240] As set forth above, the eye-covering structure 6002 of the modular eye cover may comprise a connector (not shown), e.g., as hook-and-loop, clip, etc., for releasably connecting between the eye-covering structure 6002 and either form of the positioning and stabilising structures (i.e., the positioning and stabilising structure 6300 of the patient interface or the positioning and stabilising structure (not shown) of the eye cover 6000). Advantageously, the connector enables the patient to quickly and easily disconnect and connect the eye-covering structure 6002 so as to wear the eye cover 6000 by itself (to be in the form shown in Fig. 7 A) or attached to the patient interface (to be in the form of Figs. 7B-2, 7C or 7C-1).

[0241] Referring to Figs. 7C, 7C-1 and 7D, the seal-forming structure 2100 may be configured to seal with an underside of the patient’s nose. That is, in examples, the seal-forming structure may engage the patient’s nose along portions at or below the patient’s pronasale 1030. Additionally, the eye cover 6000 may include a notch 6010 (e.g., a concave notch) having a centre portion configured to be aligned with the patient’s nose ridge 1010. This arrangement may leave the patient’s entire nose ridge 1010 (or at least a lower half 1020 of the patient’s nose ridge) uncovered and thus exposed to the ambient environment in use. This arrangement may provide a low- profile, less cumbersome and less bulky assembly that may more comfortably facilitate different sleep positions. Additionally, this arrangement may allow more of the patient’s skin to engage the outside environment (e.g., the patient’s bed) thus providing a more natural feel conducive to sleeping.

[0242] Referring now to an embodiment of the eye cover 7000 shown in Fig. 7D. In this embodiment of the eye cover 7000, like reference numerals are used for like features with the addition of the prefix ‘7’. The eye cover 7000 primarily differs from the eye cover 5000 and 6000 in that the eye cover 7000 is provided with a positioning and stabilising structure 7004 (having components as set forth with respect to Fig. 7A), whereby the eye cover 7000 is configured to connect with a patient interface e.g., a full-face mask 2000a, nasal pillows mask 2000b, 2000c, and ultra-compact full-face mask 2000d. In the form shown, a nasal pillows mask 2000c is connected to the eye cover 7000.

[0243] In this embodiment of the eye cover 7000, the positioning and stabilising structure 7004 is configured to support the nasal pillows mask 2000c. In this regard, the patient interface 2000 does not comprise a positioning and stabilising structure. In other words, the eye cover 7000 is configured to replace the positioning and stabilising structure that would otherwise be provided with the patient interface 2000 to support, i.e., hold, stabilise, etc, the e.g., nasal pillows mask on the patient’s head.

[0244] The eye cover 7000 may comprise a connector 7014 arranged with respect to the temporal portion 7008 for releasably connecting with the patient interface 2000. The connector 7014 may comprise a type of releasable connection, such as a clip or hook-and-loop material. In the form shown, the connector 7008 is configured as a tab 7016 for connecting with respect to an end of a side-arm 2001 of the nasal pillows mask 2000c. The tab 7016 of the eye cover 7000 may comprise e.g., hook-and-loop material on one side, and be configured to pass through an aperture of the side-arm 2001 and loop back onto the temporal arm 7008 to connect with a corresponding hook-and-loop material arranged on the temporal arm 7008.

[0245] In alternative forms, the side-arm 2001 of the eye cover 7000 may comprise a connector in the form of a clip or hook-and-loop connector arranged at an inside surface of the side-arm 2001. The connector in this form may directly connect to a corresponding connector of the temporal portion 7008. For example, corresponding portions of hook-and-loop material may be arranged on opposing surfaces of the temporal arm 7008 and side-arm 2001, whereby a patient may simply press the side-arms 2001 onto the temporal portions 7008 in order to connect the components.

[0246] The side-arm 2001 of the nasal pillows mask 2000c may be configured to connect with the temporal arm 7008 so as to align with, and mount to, the positioning and stabilising structure 7004 (i.e., of the eye cover 7000). In this way, the patient interface 2000 may utilise the positioning and stabilising structure 7004 of the eye cover 7000 to support the eye-covering structure 7002 in opposing relation to the patient’s face.

[0247] Advantageously, the connector 7014 provided on the eye cover 7000 may allow a patient to readily attach their mask of choice, e.g., nasal pillows mask 2000c, nasal prongs, nasal cradle, etc., without requiring a positioning and stabilising structure, i.e., headgear to be attached to the mask. [0248] The eye cover 5000,6000,7000 may comprise a sensor system mounted to the eye-covering structure 5002,6002,7002 and in the embodiments shown in Figs. 7A, 7B-1 and 7D, additionally or alternatively in the positioning and stabilising structure 5004,7004. The sensor system of the eye cover 5000,6000,7000 may enable the eye cover to be used for: detecting and diagnosing a patient with a sleep related breathing disorder; allowing the affected patient to accustom themselves to the concept of wearing a patient interface, e.g., a full-face mask 2000a, prior to using a patient interface for the first time; optimising delivery of PAP therapy to the patient; and for improving general sleep health of the patient.

[0249] For each of these uses, the eye cover 5000,6000,7000 may be used with the respiratory therapy system as set forth previously. That is, the sensor system of the eye cover 5000,6000,7000 may be configured to communicate with a component of the respiratory therapy system, e.g., an RPT device, i.e., a flow generator, or a secondary device (as set forth in more detail later), the patient interface 2000, etc.

Each of the above-mentioned use-cases are set forth in more detail below.

[0250] In some forms, the sensor system may be powered by one or more power units provided on, i.e., mounted to, the eye cover 5000,6000,7000. In other forms, the sensor system may be powered by an electrical supply via the RPT device. In either form, the sensor system may be connected to a power source by wiring that is mounted on, or within, the material of the eye cover.

[0251] The sensor system may comprise at least one sensor (i.e., one or more sensors) that may be used to track patient data, e.g., during sleep, for enhancing the patient experience. For example, the sensors may include sleep state sensors (i.e., for measuring a physiology of the patient), environmental sensors (i.e., for measuring a property of the environment surrounding the patient), etc., that may be integrated with the eye cover 5000,6000,7000 to e.g., track when a patient has achieved a predetermined period of sleep.

[0252] The information detected and processed by the sensors may be provided in real-time to the patient as sensory feedback. The feedback may cross multiple modalities, including visual, auditory, haptic, somatosensory and olfactory. In an example, the RPT device of the respiratory therapy system may comprise a display for displaying the information detected and processed by the sensors. The information may be processed in such a way as to advise the patient about an aspect of their sleep, e.g., sleep performance, respiratory therapy performance, etc.

[0253] The one or more sensors may include motion sensors, heart rate sensor, moisture sensor, temperature sensor, flow sensor, light sensors, tactile sensors, oximeter, carbon dioxide sensor, electroencephalography sensor (EEG), electrooculograpy sensor (EOG), electromyography sensor (EMG), galvonic skin response sensor (GSR), sound sensor, CO2 sensor, a touch/ capacitive sensor, etc. As set forth in more detail below, the sensor system may be configured together with a processing unit (i.e., a processor) to control operation of one or more output devices based on a measured parameter of the at least one sensor.

[0254] In some examples, a polysomnography (PSG) sensor can be provided to detect sleep state and may be located with respect to the patient’ s forehead and/ or near their eyes. Further, a positional sensor may be provided at a location on the mask so as to detect if the patient is on their side, back or front. As set forth in more detail later, this may assist with the diagnosis of positional OSA.

[0255] In further examples, heart rate may be detected by locating a respective sensor on the forehead of a patient. In further examples, a thermistor and flow sensor may be located with respect to the patient’s nose. In some further examples, light sensors may be provided on an outwardly facing portion of the system, such that the light sensors are less likely to be obscured by e.g., a pillow.

[0256] The sensors may be configured for measuring parameters of the ambient environment or physiology of a patient. In the case of a patient’s physiology, the sensors may detect and measure e.g., heart rate, perspiration, temperature, breath rate, oxygen-saturation, brain activity, etc. In the case of the ambient environment surrounding the patient, the sensors may be configured to detect and measure e.g., ambient air temperature, humidity, pressure, etc.

[0257] The sensors may be arranged proximal to the patient’s skin so as to detect properties of the patient as set forth above. In some forms, the sensors may be arranged at a surface of the eye cover, e.g., at the temporal portions 5008,6008,7008, so as to be in skin contact with the patient. In other forms, the sensors may be arranged away from, i.e., spaced from, the patient’s skin.

[0258] In either form, i.e., in skin contact or spaced from skin contact, the one or more sensors may be integrated within the material of eye cover 5000, 6000, 7000. In this form, while the sensor may be integrated within the material, at least a portion of the sensor may protrude from the material, i.e., to be in skin contact. In this regard, the one or more sensors may not be removable from the eye cover 5000, 6000, 7000.

[0259] Such sensors, i.e., those integrated within the material and thereby, not removable, may be configured for reprocessing, i.e., repeated cleaning/ washing at high temperatures, mechanical cleaning, etc. These sensors may be waterproof, water resistant, thermally resistant, etc.

[0260] In alternative forms of the eye cover 5000,6000,7000, the sensors may be configured to be removable from the eye cover. In this regard, the one or more sensors may be provided as a removable sensor unit that may be removably connected, i.e., electrically and mechanically, to the eye cover 5000, 6000, 7000. The removable sensor unit may be removably contained in a portion of the eye cover.

[0261] For example, an eye cover 5000, 6000, 7000 may comprise sensor retainer, e.g., a pocket, pouch, closure, etc containing the removable sensor unit therewithin. A patient may open the pocket to access the sensor unit, whereby the sensor unit may be electrically disconnected so as to be removed from the pocket of the eye cover 5000, 6000, 7000. In a reverse process, the removable sensor unit may be electrically reconnected to the eye cover e.g., after reprocessing of the eye cover, and stowed in the pocket.

[0262] Providing the one or more sensors as the removable sensor unit may allow the eye cover 5000, 6000, 7000 to be cleaned, i.e., washed, reprocessed, etc., without requiring waterproof, water resistant, thermally resistant, etc., sensors.

Advantageously, this allows lower cost components, e.g., sensors, to be utilised in the sensor unit which are not required to be e.g., ‘waterproof/water resistant’, temperature resistant, etc. In effect, such lower cost sensors may require a simpler assembly and electrical configuration which, in effect, may reduce the cost and complexity of producing the sensor unit. [0263] Further, providing the one or more sensors as the removable unit may allow multiple sensor units to be provided for use with the eye cover 5000, 6000, 7000. In this case, each sensor unit may comprise a different combination of sensors for providing different properties to be measured of the patient. Advantageously, this may allow a patient to interchange which sensor units they utilise in their eye cover 5000, 6000, 7000 according to a desired function of the eye cover.

[0264] For example, a patient may have an option of a first sensor unit comprising one or more sensors configured for detecting physiological characteristics of the patient, and a second sensor unit comprising one or more sensors configured for detecting ambient environmental conditions surrounding the patient. The first and second sensor units may be interchanged by the patient according to e.g., whether the patient wants to measure their physiological and/ or surrounding environmental conditions.

[0265] Advantageously, providing the one or more sensors as a removable sensor unit may allow sensor units to be ‘loaned’ to patients for e.g., home sleep apnoea testing. For example, a patient may own an eye cover 5000, 6000, 7000 having a removable sensor unit for detecting and diagnosing a sleep related breathing disorder. In this case, if the removable sensor unit detects a sleep disordered breathing event, the patient may be able to loan, borrow, etc., a removable sensor unit having one or more sensors for detecting which type of sleep disordered breathing condition, e.g., positional OSA, insomnia, etc., the patient may suffer. The patient may then be able to install said removable sensor unit into their eye cover 5000, 6000, 7000.

[0266] Referring now to eye cover 5000 when utilised by itself, i.e., as shown in Fig. 7A without a patient interface, the sensor system may be utilised in this form to allow the eye cover to be used as a diagnostic/screening tool. The eye cover used in this form may allow a patient to determine whether they require respiratory therapy e.g., PAP therapy, positional therapy, insomnia treatment, etc. As set forth in the example above, the sensor system may be configured to register (i.e., detect) a sleep event that is indicative of a sleep related breathing disorder.

[0267] While the eye cover 5000 in this form may be worn without the patient interface 2000, the sensors of the eye cover may be configured to communicate measured information about a patient to e.g., the RPT device or the secondary device.

This communication may be through a wireless connection, e.g., a Bluetooth connection, or by a wired connection to the RPT device.

[0268] As set forth previously, in some forms of the respiratory therapy system a secondary computing device (i.e., the secondary device) may be provided in addition or alternative to, the RPT device. For example, the secondary device may be a mobile device, e.g., a smart phone, configured with software, i.e., a mobile application/app for communicating with the sensor system of the eye cover 5000, 6000, 7000. The mobile app may operate/ function in substantially the same manner as the RPT device as set forth later, i.e., for controlling and monitoring operation of the eye cover 5000, 6000, 7000.

[0269] In some forms, the eye cover 5000, 6000, 7000 may be configured to simply store the recorded data in order to transfer said data to the RPT device or the secondary device. For example, the eye cover 5000, 6000, 7000 may be configured to connect with the secondary device, i.e., as a mobile device, whereby the mobile device is able to process the measured parameter(s) of the sensor system. In another example, the sensors of the eye cover 5000, 6000, 7000 may be connected (wirelessly, or by wired connection) to the RPT device, that may be configured to process the recorded data of the patient.

[0270] In some forms whereby the patient is using an RPT device, the recorded data from the RPT device and the secondary device may be integrated together in the RPT device or at a server.

[0271] On the basis of the processed data obtained from the sensors, an assessment may be made as to whether, and if so to what degree, symptoms of e.g., OSA are present and whether a more in-depth investigation in a sleep laboratory should be recommended. In this regard, the sensors can be used to phenotype a patient. Advantageously, this can provide an understanding of alternative therapies for the patient, e.g. positional therapy, treatment for insomnia, etc.

[0272] For example, orientation sensors may be provided in the eye cover 5000, 6000, 7000 may be configured to detect a sleeping position of the patient’s body (e.g., whether a patient is sleeping on their side). In some forms, this may include detecting whether the patient’s head (being differently positioned to the patient’s body) is positioned on its side during sleep, or whether the patient’s body is orientated on its side during sleep. In either case, the eye cover 5000 may be utilised to understand whether that patient has positional OSA, or more generally, whether their sleeping position impacts their sleep.

[0273] In forms where the eye cover 5000, 6000, 7000 is utilised as the diagnostic/ screening tool, the eye cover may be configured together with the RPT and/or secondary device to advise a patient of e.g., treatment options when a sleep related breathing disorder is detected in said patient. Such advice may relate to types of therapy available, e.g., positional therapy, PAP therapy, insomnia treatment, etc., and further, how such therapies may be ideally administered. For example, in the case of PAP therapy, a patient may be recommended to use e.g., a nasal pillows mask 2000b, 2000c together with the eye cover 5000.

[0274] The eye cover 5000 configured in this manner is particularly suitable for use in a home, i.e., in the familiar surroundings of the affected patient.

Advantageously, the eye cover may thereby allow the affected patient to be evaluated in an adequately informative and standardised manner. In other words, placing the patient in a comfortable and familiar setting when analysing their sleep may be more effective than placing the patient in e.g., a sleep laboratory when analysing their sleep.

[0275] In addition to using the eye cover 5000 on its own (without a patient interface) as a diagnostic/ screen tool, the eye cover 5000 may be additionally or alternatively utilised on its own to allow a patient to accustom themselves to the act of wearing a patient interface. That is, by wearing the eye cover 5000 by itself, the patient may become familiar with having an object mounted to their head, i.e., applying pressure thereto, during sleep. Wearing the eye cover 5000 in this way provides a kind of exposure treatment for the patient to become comfortable wearing an object on their face prior to wearing a patient interface, e.g., a full-face mask 2000a or a nasal pillows mask 2000b, for PAP therapy.

[0276] The eye cover 5000, 6000, 7000 may also be configured together with the sensors (as set forth above) to optimise delivery of respiratory therapy, e.g., PAP therapy. Use of the eye cover in this way may be particularly useful in forms where the eye cover is used together with a patient interface 2000, i.e., Figs. 7B-1, 7B-2, 7C and 7D. However, the eye cover 5000 when used by itself, i.e., in the form shown in Fig. 7A, may also be used together with the sensors to collect data about a patient that may be used to optimise respiratory therapy. For example, a patient may wear the eye cover 5000 by itself, where data collected about the patient’s physiology may be later utilised when the patient is using a PAP device.

[0277] In an example, the eye cover 5000, 6000, 7000 may be configured with respect to the one or more sensors to detect a patient’s sleep state and/or conditions of the surrounding environment during respiratory therapy. The sensors may be configured together with the RPT device, i.e., having a processing unit therein, to effect change to the respiratory therapy system. For example, based on a measured parameter of the sensor system, the processor may be configured adjust the treatment pressure delivered by the RPT device. In this case, the treatment pressure may, for example, be adjusted depending on the presence or absence of indications of sleep disordered breathing events.

[0278] As set forth above, the eye cover 5000, 6000, 7000 may also be configured for detecting the position in which a patient is sleeping. The eye cover can thereby be utilised to detect positional OSA, i.e., when a patient wearing the eye cover is experiencing a OSA event based on the position in which they are sleeping.

[0279] In this form, the eye cover 5000, 6000, 7000 may be configured together with the sensors to effect change in the eye cover 5000, 6000, 7000 itself. That is, the eye cover 5000, 6000, 7000 in this form may comprise sensors (as set forth previously) configured such that, when the eye cover detects that the patient is e.g., sleeping on their back, the eye cover may be triggered to stimulate the patient to move to e.g., a side sleeping position.

[0280] Such stimulation, i.e., sensory feedback, may be initiated in real-time as the sensors detect and measure properties of the patient’s physiology and surrounding environment. The stimulation (or feedback) may cross multiple modalities, including visual, auditory, haptic, somatosensory and olfactory.

[0281] In the example where a patient is prompted to move from a sleeping position, the stimulation may be via haptic feedback, i.e., vibration, or alternatively, flashing lights or other form of stimulus. In some forms, the stimulation may occur pre-emptively, i.e., prior to the patient experiencing a positional OSA event.

[0282] In some forms, when the patient is detected as sleeping e.g., on their back, in addition to, or alternatively, the system may be configured to adjust a parameter of the respiratory therapy in response to the patient’s position. For example, pressure delivered to the patient’s airways may change, e.g., ramp. Such changes may be initiated based on the position of the patient and/ or detection of an impending OSA event.

[0283] The eye cover 5000 as shown in Fig. 7A, i.e., without a patient interface, may be configured with sensors for detecting the sleeping position of the patient. Based on the sleeping position detected, the eye cover may e.g., vibrate to stimulate the patient to move from their sleeping position.

[0284] The eye cover 5000 in this form, may be particularly useful for patients who do not wear a patient interface for treating sleep apnoea. In this regard, while the patient may not wear a patient interface, the eye cover 5000 may be connected with the respiratory therapy system so as to communicate with e.g., the RPT device or a secondary device, etc.

[0285] In variations, the eye cover 5000, 6000,7000 may be provided with sensors configured to detect a sleep apnea event, i.e., rather than detecting the position of a patient which may indicate a potential sleep apnoea event. Such sensors may be used in addition, or as an alternative, to sensors for detecting the sleeping position, i.e., orientation, of the patient.

[0286] The sensors provided for detecting a sleep apnoea event may include a microphone (i.e., sound sensor), sonar sensor, or any other appropriate sensor set forth below. For example, a microphone may be provided in the eye cover 5000, 6000, 7000 for detecting breathing (e.g., snoring sounds) sounds associated with a OSA event. Upon detecting such an event, the eye cover 5000 may be configured to prompt the user to move. As set forth above, this may be a vibration of the eye cover, or in other forms, the prompt may be a flash of light transmitted by one or more LEDs in the eye cover. [0287] In some forms, the eye cover 5000, 6000, 7000 as shown in Figs. 7B- l,7B-2, 7C, 7C-1 and 7D, i.e., used together with a patient interface 2000, may be configured together with the RPT device, i.e., a flow generator, for detecting a sleep apnoea event. In this form, the patient interface and/or flow generator may be configured with sensors, i.e., pressure sensors, flow sensors, etc., for detecting a sleep apnoea event. Based on the detected event, the eye cover may be configured to prompt the patient, e.g., by vibrating, in order to stimulate the patient to move from e.g., a back-sleeping position.

[0288] Utilising the eye cover 5000, 6000, 7000 to prompt a patient to move into a more ideal sleeping position, i.e., to a side-sleeping position, may be advantageous to improving the delivery of respiratory therapy via the patient interface 2000. For example, using the eye cover to move the patient into a side sleeping position may open their airways to allow for more effective and/or comfortable PAP therapy.

[0289] In some alternative forms, the sensors may not be provided with the eye cover, rather, the sensors may be provided separate to the eye cover, e.g., on the RPT device or patient interface. In this regard, the location/placement of the sensors may be optimised according to the types of parameters being detected by the sensors.

[0290] In some forms the eye cover 5000,6000,7000, may be configured together with the sensors to effect a change in the respiratory therapy system that may provide improvements to the general sleep health of a patient.

[0291] For example, the sensors may be configured to detect and measure environmental changes of e.g., a bedroom, such as ambient temperature, lighting, etc, that may be indicative of a sunrise. The sensors may be configured together with a processor to control operation of a component of the respiratory therapy system such as the eye cover 5000, 6000, 7000, the RPT device, etc. In this example, i.e., where a sunrise is detected by the sensors, the eye cover 5000, 6000, 7000 may be configured to stimulate, by e.g., vibration, to wake the user at an optimal time of the morning. In this example, the eye cover may be used to improve the circadian rhythm of the patient.

[0292] The sensors may also be configured to detect and measure physiological properties of the patient and thereby effect a change to the respiratory therapy system that may improve a patient’s general sleep health. For example, the eye cover may include one or more electroencephalography (EEG) sensors. The EEG sensors may be used for detecting a patient’s sleep state and be configured to stimulate the patient or optimise therapy parameters based on their sleep state. For example, the EEG may be used to determine when a patient is ready to wake from their sleep, and thereby effect a change in the respiratory therapy system that wakes the patient.

[0293] In some forms, the eye cover 5000, 6000, 7000 may comprise one or more LED’s for stimulating the patient based on physiological and/or environment properties detected and measured by the sensors.

[0294] For example, the eye cover may be provided with an array of LEDs configured to provide light-therapy to the patient. The light-therapy may help a patient change when they sleep and wake from sleep. In this example, at least one sensor, e.g., a light sensor, may be provided on the eye cover 5000, 6000, 7000, e.g., on the temporal portion 5008, 6008, 7008, to detect and measure light levels in the surrounding environment. The sensor may be configured together with a processor such that, based on a measured value, e.g., intensity of surrounding/external light, measured by the sensor, the processor may be configured to activate/deactivate the LEDs for administering the light- therapy.

[0295] Administration of light therapy may be coordinated according to a patient’s preferred wake-up time. For example, the eye cover 5000, 6000, 7000 may be configured so that a patient may input (e.g., via the RPT device or secondary device) their preferred wake-up time, so as to set the eye cover to e.g., activate the light-therapy in accordance with (i.e., taking into consideration) the preferred wakeup time. Alternatively, the eye cover 5000, 6000, 7000 may be configured to automatically activate the light-therapy based on detected light levels in the surrounding environment, e.g., changes in ambient light at sunrise.

[0296] Advantageously, utilising the eye cover 5000, 6000, 7000 to administer light therapy may assist the patient with adjustment to new time zones. For example, if a patient travels to a country having a different time zone to their native country, the light-therapy may be configured wake the patient according to the different time zone rather than waking according to their ‘body clock’, i.e., being based on the time zone of their native country.

[0297] In some forms, administration of light-therapy may be configured for use with one or more electroencephalography (EEG) sensors. The EEG sensors may be used for detecting a patient’s sleep state and be configured to activate the LED’s according to the patient’s sleep state. For example, the EEG may be used to determine when a patient is ready to wake from their sleep, and activate the LEDs to initiate the patient to wake.

[0298] In this form, i.e., incorporating the EEG sensors, the eye-covering structure 5002,6002,7002 may extend beyond the glabella and superciliary arch, i.e., towards the forehead, so as to arrange the EEG sensors in optimal locations for measuring electrical activity of the brain.

[0299] In another example, the eye cover 5000,6000,7000 (e.g., the eye-covering structure) may be configured with a material having a variable transparency. The transparency of the material may be regulated/adjusted to control a magnitude of light entering a patient’s eyes. As set forth above in regard to the configuration of LEDs, the transparency of the eye cover may be adjusted according to the light levels in the surrounding environment. Based on a measured value, e.g., intensity of surrounding/external light, measured by the sensor, the processor may be configured to adjust the transparency of the eye cover material to, e.g., allow a patient to wake as the sun rises.

[0300] In yet a further example, the eye cover 5000,6000,7000 may be connected with ear covers (not shown) for enclosing a patient’s ears. The ear covers may be configured to cover the ears of a patient to block, or at least attenuate, ambient sounds that may otherwise disturb a patient’s sleep. In some forms, the ear covers may be configured to incorporate ‘headphones’ for e.g., playing sounds that may assist a patient to fall sleep. In this form, the ear covers may be configured as e.g., pouches, being shaped to receive and hold the headphones therein.

[0301] The eye cover 5000,6000,7000 may be configured together with the headphones to detect environmental sounds to operate the headphones to e.g., play sounds for breath pacing, meditation, etc. In other variations, the headphones may be configured to play sounds, e.g., white noise, to actively block the environmental sounds that may otherwise disturb a patient’s sleep.

[0302] In further variations, the headphones may be configured to play sounds to wake a patient from sleep, i.e., as a type of alarm. In this form, the wake-up sounds may be coordinated with the EEG and the array of LEDs (as set forth above) for waking a patient at an optimal stage of their sleep.

[0303] The headphones may also be configured as noise-cancelling type headphones. This type of headphone may be particularly useful in damping sounds from a patient’s external environment, that would otherwise disturb the patient’s sleep. Alternatively, bone conduction speakers may be used.

[0304] Referring now to Fig. 8, a further embodiment of an eye cover 8000 is shown. The further embodiment of the eye cover 8000 primarily differs from the eye cover 5000, 6000, 7000 of Figs. 7A-7D in that the further embodiment of the eye cover 8000 comprises one or more light sources (e.g., LEDs 8003, 8005) configured to influence a patient’s sleep or waking.

[0305] In examples, suitable light sources may include organic light-emitting diodes (OLEDs), active-matrix organic light-emitting diodes (AMOLEDs), flexible light-emitting diodes (FLEDs), Mini LEDs, Micro LEDs, quantum dot light-emitting diodes (QLEDs), electroluminescence, and/or use of white light and movable colour filters. In further examples, the arrangements described below as including LED’s may instead include other light sources.

[0306] In examples, the light sources provided in the eye cover (i.e., any eye cover described herein) may be distinguished from an image (i.e., video) display screen (e.g., of an augmented reality (AR) or virtual reality (VR) headset). That is, in examples, the light sources are provided in an eye cover that does not include an image (video) display screen. This may allow the eye cover to be relatively lightweight and relatively less bulky, and facilitate provision of a low-profile eye cover more conducive to providing a comfortable sleeping arrangement. In further examples, any eye cover described herein may be provided without a video display screen (irrespective of whether the eye cover is also provided with light sources (e.g., LEDs)). [0307] As shown in Fig. 8, some forms of the eye cover 8000 may comprise an arrangement of LEDs 8003, 8005 aligned with each eye (i.e., left and right eyes). As set forth in more detail below, a first variation of the eye cover may comprise two LEDs 8003 arranged with respect to each eye of the patient, and in a second variation, the eye cover may comprise two sets of LEDs 8005 arranged with respect to each eye of the patient. In a further variation, both first and second variations may be combined together.

[0308] The arrangement of LEDs is configured to potentially induce lucid dreaming based on cues with light from LEDs configured to activate when REM sleep is detected.

[0309] In the first variation, i.e., whereby the eye cover comprises two LEDs per eye, the LEDs may be arranged centrally to the patient’s eye. The two LEDs may be differently coloured and arranged to alternate in colour and activation. For example, a first of the LEDs 8003a may be yellow, and a second of the two LEDs 8003b may be purple. The two differently coloured LEDs may be configured to alternatively activate so as to stimulate the patient’s eye, e.g., optical nerve. A frequency, brightness and pattern of the alternating lights may be adjusted according to the patient’s e.g., sensitivity to arousal.

[0310] The LEDs of the first variation may be spaced apart according to the patient’s eye anatomy. For example, the spacing of the two LEDs may be such that light emitted from the LEDs may be focussed with respect to the patient’s retina. In some forms, the light emitted may be configured to focus in front of the retina, or in other cases, behind the retina. In some forms, the LEDs are spaced at approximately 5 degrees apart with respect to a curvature of the patient’s eye.

[0311] In the second variation, i.e., whereby the eye cover comprises two sets of LEDs per eye, the LEDs may be arranged to generally follow a perimeter of the patient’s eye, i.e., to surround the patient’s eye. As shown in Fig. 8, the two sets of LEDs 8005 may include, for instance, five to fifteen (e.g., 5 or more, 5-10, 10-15, 10 or more) LEDs per eye, and may be distributed about an upper and lower region (e.g., upper and lower perimeters) of the patient’s eye. In in the form shown, the arrangement of LEDs may be asymmetrical about the patient’s eye. In other forms, not shown, the LEDs may be symmetrical about the patient’s eyes, e.g., having equal numbers of LEDs in the upper and lower regions.

[0312] In a similar manner to the first variation, the second variation of LEDs may be alternatively activated during use, and further, may be alternatively coloured. In the form shown in Fig. 8, the LEDs may alternate in a side-by-side arrangement of colours. For example, a red LED 8005a and a blue LED 8005b may be provided, and alternated across the upper and lower regions.

[0313] The LEDs of the second variation may configured for sleep onset latency reduction (i.e., as a paced breathing aid), circadian rhythm setting and/or slow wake up. In each case, the LEDs surrounding the patient’s eyes may be alternatively activated. For example, for sleep onset latency reduction, the red LED’s 8005a may be activated and the blue LEDs 8005b may be deactivated. In another example, for circadian rhythm setting, the blue LEDs 8005b may be activated and the red LEDs may be deactivated.

[0314] In other forms, the LEDs may be configured to gradually wake a patient from sleep at a predetermined time, i.e., as a kind of ‘alarm clock’. Alternatively, the gradual wake-up may be activated within a time range, depending on the completion of a detected sleep cycle, around the desired or set wake-up time.

[0315] The LEDs of the first and second variations may have variable LED colours. For example, one or more of the LEDs may be configured to alternate between a variety of colours. In some forms, the one or more LEDs in an arrangement may alternate through blue, red, green and yellow colours. The sequence, i.e., pattern of colours, and their frequency of alternation may vary, for instance, according to whether the patient is going to sleep or about to wake up, or is lucid dreaming.

[0316] The arrangement of LEDs as set forth above may be configured to activate at a predetermined period before a patient begins their sleep, e.g., before stage N1 (i.e., the first sleep stage). For example, the LEDs may activate for 10 minutes after the patient goes to bed or until the patient enters stage N 1. Following activation, the LEDs may be de-activated. The LEDs may also be configured to cycle through active periods. For example, if arousal in between sleep is detected, the LEDs may be re- activated, for instance to stimulate breath pacing, to help the patient fall back to sleep faster.

[0317] Advantageously, the LEDs may assist a patient to sleep again after an arousal. That is, in situations where one or more of a patient’s sleep stages are compromised, e.g., shortened due to an external stimulus/ interruption, the LEDs may be utilised to restore a ‘normal’ sleep for the patient, by stimulating paced breathing. In effect, this may assist with adherence to e.g., CPAP therapy.

[0318] In some forms of the eye cover 8000, at least a portion of the eye cover 8000 may be heated or cooled with respect to an ambient temperature of the room or of a patient wearing the eye cover 8000.

[0319] The eye cover 8000 may be configured to receive an input for controlling the temperature of the eye cover 8000. In some forms, the input may be a manual adjustment of the temperature by a patient, the temperature of the eye cover being changed according to a personal preference of the patient. In other forms, the temperature may be automatically adjusted based on measurements of a patient’s physiological state or surrounding environment. For example, if the ambient temperature surrounding the patient drops, the eye cover 8000 may be configured to automatically increase its temperature.

[0320] In some forms, the eye cover 8000 may be partitioned such that at least part of the eye cover 8000 may have its temperature changed while a remainder of the eye cover does not have its temperature changed. In this way, one or more parts of the eye cover 8000 may be heated or cooled.

[0321] For example, the eye cover 8000 may be partitioned such that an area around a patient’s eyes (i.e., periocular region) may be selectively heated or cooled separately to other areas of patient’s face in contact with the eye cover.

Advantageously, heating in this area, i.e., the periocular regions, may aid relaxation of the patient, i.e., to encourage their sleep. Additionally, heating of this area may advantageously ‘freshen up’ the patient upon waking.

[0322] The temperature of the eye cover 8000 may be changed by use of e.g., a Peltier element or a circulating fluid (air, water, etc.) in channels embedded in the eye cover 8000 configured to heat or cool a respective part of the eye cover 8000 as desired.

[0323] In some forms of the eye cover 8000, the temperature of the at least part of the eye cover 8000 may be controlled according to a patient’s sleep onset or waking phases. For example, the temperature may be adjusted to assist a patient to fall asleep, i.e., by relaxing the patient, or alternatively, the temperature may be adjusted once a patient has woken from sleep, in order to assist the patient to wake, i.e., to ‘freshen up’.

[0324] While temperature control of the eye cover 8000 is described in the context of the embodiment of Fig. 8, previous embodiments of the eye cover shown in Figs. 7A-7D may also have a controllable temperature as set forth above.

5.10 GLOSSARY

[0325] For the purposes of the present technology disclosure, in certain forms of the present technology, one or more of the following definitions may apply. In other forms of the present technology, alternative definitions may apply.

5.10.1 General

[0326] 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.

[0327] Ambient'. In certain forms of the present technology, the term ambient will be taken to mean (i) external of the treatment system or patient, and (ii) immediately surrounding the treatment system or patient.

[0328] For example, ambient humidity with respect to a humidifier may be the humidity of air immediately surrounding the humidifier, e.g. the humidity in the room where a patient is sleeping. Such ambient humidity may be different to the humidity outside the room where a patient is sleeping.

[0329] In another example, ambient pressure may be the pressure immediately surrounding or external to the body.

[0330] In certain forms, ambient (e.g., acoustic) noise may be considered to be the background noise level in the room where a patient is located, other than for example, noise generated by an RPT device or emanating from a mask or patient interface. Ambient noise may be generated by sources outside the room. [0331] Automatic Positive Airway Pressure (APAP) therapy. CPAP therapy in which the treatment pressure is automatically adjustable, e.g. from breath to breath, between minimum and maximum limits, depending on the presence or absence of indications of SDB events.

[0332] Continuous Positive Airway Pressure ( CPAP) therapy. Respiratory pressure therapy in which the treatment pressure is approximately constant through a respiratory cycle of a patient. In some forms, the pressure at the entrance to the airways will be slightly higher during exhalation, and slightly lower during inhalation. In some forms, the pressure will vary between different respiratory cycles of the patient, for example, being increased in response to detection of indications of partial upper airway obstruction, and decreased in the absence of indications of partial upper airway obstruction.

[0333] 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’.

[0334] In the example of patient respiration, a flow rate may be nominally positive for the inspiratory portion of a breathing cycle of a patient, and hence negative for the expiratory portion of the breathing cycle of a patient. 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.

[0335] Flow therapy. 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.

[0336] 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. [0337] 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. [0338] Noise, conducted (acoustic)'. Conducted noise in the present document refers to noise which is carried to the patient by the pneumatic path, such as the air circuit and the patient interface as well as the air therein. In one form, conducted noise may be quantified by measuring sound pressure levels at the end of an air circuit.

[0339] Noise, radiated (acoustic)'. Radiated noise in the present document refers to noise which is carried to the patient by the ambient air. In one form, radiated noise may be quantified by measuring sound power/pressure levels of the object in question according to ISO 3744.

[0340] Noise, vent (acoustic)'. Vent noise in the present document refers to noise which is generated by the flow of air through any vents such as vent holes of the patient interface.

[0341] 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”.

[0342] Medical Oxygen'. Medical oxygen is defined as oxygen enriched air with an oxygen concentration of 80% or greater.

[0343] Patient'. A person, whether or not they are suffering from a respiratory condition.

[0344] Pressure: Force per unit area. Pressure may be expressed in a range of units, including cmFhO, g-f/cm² and hectopascal. 1 cmFhO is equal to 1 g-f/cm² and is approximately 0.98 hectopascal (1 hectopascal = 100 Pa = 100 N/m² = 1 millibar ~ 0.001 atm). In this specification, unless otherwise stated, pressure is given in units of cmkhO.

[0345] 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.

[0346] 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. [0347] Ventilator. A mechanical device that provides pressure support to a patient to perform some or all of the work of breathing.

5.10.1.1 Materials & their properties

[0348] Silicone or Silicone Elastomer. A synthetic rubber. In this specification, a reference to silicone is a reference to liquid silicone rubber (LSR) or a compression moulded silicone rubber (CMSR). One form of commercially available LSR is SILASTIC (included in the range of products sold under this trademark), manufactured by Dow Coming. Another manufacturer of LSR is Wacker. Unless otherwise specified to the contrary, an exemplary form of LSR has a Shore A (or Type A) indentation hardness in the range of about 35 to about 45 as measured using ASTM D2240.

[0349] Polycarbonate-, a thermoplastic polymer of Bisphenol-A Carbonate.

5.10.1.2 Mechanics

[0350] Axes: a. 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.

[0351] Elasticity: The ability of a material to return to its original geometry after deformation.

[0352] Resilience: Ability of a material to absorb energy when deformed elastically and to release the energy upon unloading.

[0353] Resilient: Will release substantially all of the energy when unloaded. Includes e.g. certain silicones, and thermoplastic elastomers.

[0354] 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.

[0355] As an example, 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. In another example, a structure or component may be floppy in a first direction and rigid in a second direction. [0356] 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.

5.10.1.3 Structural Elements

[0357] Elbow. An elbow is an example of a structure that directs an axis of flow of air travelling therethrough to change direction through an angle. In one form, the angle may be approximately 90 degrees. In another form, the angle may be more, or less than 90 degrees. The elbow may have an approximately circular cross- section. In another form the elbow may have an oval or a rectangular cross-section. In certain forms an elbow may be rotatable with respect to a mating component, e.g. about 360 degrees. In certain forms an elbow may be removable from a mating component, e.g. via a snap connection. In certain forms, an elbow may be assembled to a mating component via a one-time snap during manufacture, but not removable by a patient. [0358] Frame-. Frame will be taken to mean a mask structure that bears the load of tension between two or more points of connection with a headgear. A mask frame may be a non-airtight load bearing structure in the mask. However, some forms of mask frame may also be air-tight.

[0359] Tie (noun): A structure designed to resist tension.

[0360] 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.

[0361] Swivel (noun): A subassembly of components configured to rotate about a common axis, preferably independently, preferably under low torque. In one form, the swivel may be constructed to rotate through an angle of at least 360 degrees. In another form, the swivel may be constructed to rotate through an angle less than 360 degrees. When used in the context of an air delivery conduit, the sub-assembly of components preferably comprises a matched pair of cylindrical conduits. There may be little or no leak flow of air from the swivel in use.

5.10.2 Respiratory cycle

[0362] Apnea-. According to some definitions, 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.

[0363] Breathing rate'. The rate of spontaneous respiration of a patient, usually measured in breaths per minute.

[0364] Duty cycle'. The ratio of inhalation time, Ti to total breath time, T_tot.

[0365] Effort (breathing): The work done by a spontaneously breathing person attempting to breathe.

[0366] Expiratory portion of a breathing cycle'. The period from the start of expiratory flow to the start of inspiratory flow.

[0367] Hypopnea'. According to some definitions, a hypopnea is taken to be a reduction in flow, but not a cessation of flow. In one form, 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. In one form in adults, either of the following may be regarded as being hypopneas:

(i) a 30% reduction in patient breathing for at least 10 seconds plus an associated 4% desaturation; or

(ii) a reduction in patient breathing (but less than 50%) for at least 10 seconds, with an associated desaturation of at least 3% or an arousal.

[0368] Hyperpnea'. An increase in flow to a level higher than normal.

[0369] 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.

[0370] Respiratory flow rate, patient airflow rate, respiratory airflow rate (Qr): These terms may be understood to refer to the RPT device’s estimate of respiratory flow rate, as opposed to “true respiratory flow rate” or “true respiratory flow rate”, which is the actual respiratory flow rate experienced by the patient, usually expressed in litres per minute.

[0371] Tidal volume (Vt): The volume of air inhaled or exhaled during normal breathing, when extra effort is not applied. In principle 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. In practice the tidal volume Vt is estimated as some combination, e.g. the mean, of the inspiratory volume Vi and the expiratory volume Ve.

[0372] Inhalation Time (Ti): The duration of the inspiratory portion of the respiratory flow rate waveform.

[0373] Exhalation Time (Te): The duration of the expiratory portion of the respiratory flow rate waveform.

[0374] Total Time (Ttot)'. 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.

[0375] Upper airway obstruction (UAO): 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).

[0376] Ventilation (Vent): 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.

5.10.3 Ventilation

[0377] Expiratory positive airway pressure (EPAP): 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.

[0378] Inspiratory positive airway pressure (IPAP): Maximum desired interface pressure which the ventilator will attempt to achieve during the inspiratory portion of the breath.

[0379] Pressure support'. A number that is indicative of the increase in pressure during ventilator inspiration over that during ventilator expiration, and generally means the difference in pressure between the maximum value during inspiration and the base pressure (e.g., PS = IPAP - EPAP). In some contexts, pressure support means the difference which the ventilator aims to achieve, rather than what it actually achieves. 5.10.4 Anatomy

5.10.4.1 Anatomy of the face

[0380] Ala-, the external outer wall or "wing" of each nostril (plural: alar)

[0381] Alar angle-. An angle formed between the ala of each nostril.

[0382] Alare'. The most lateral point on the nasal ala.

[0383] 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.

[0384] Auricle'. The whole external visible part of the ear.

[0385] (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. [0386] (nose) Cartilaginous framework. The cartilaginous framework of the nose comprises the septal, lateral, major and minor cartilages.

[0387] Columella-, the strip of skin that separates the nares and which runs from the pronasale to the upper lip.

[0388] 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.

[0389] Frankfort horizontal plane. A line extending from the most inferior point of the orbital margin to the left tragion. The tragion is the deepest point in the notch superior to the tragus of the auricle.

[0390] Glabella'. Located on the soft tissue, the most prominent point in the midsagittal plane of the forehead.

[0391] 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.

[0392] Lip, lower (labrale inferius)'. The lip extending between the subnasale and the mouth.

[0393] Lip, upper (labrale superius)'. The lip extending between the mouth and the supramenton.

[0394] 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. [0395] 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.

[0396] 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.

[0397] Naso-labial angle'. The angle between the columella and the upper lip, while intersecting subnasale.

[0398] Otobasion inferior. The lowest point of attachment of the auricle to the skin of the face.

[0399] Otobasion superior. The highest point of attachment of the auricle to the skin of the face.

[0400] Pronasalc. 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.

[0401] Philtrum'. the midline groove that runs from lower border of the nasal septum to the top of the lip in the upper lip region.

[0402] Pogonion: Located on the soft tissue, the most anterior midpoint of the chin.

[0403] Ridge (nasal): The nasal ridge is the midline prominence of the nose, extending from the Sellion to the Pronasale.

[0404] 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.

[0405] Sellion: Located on the soft tissue, the most concave point overlying the area of the frontonasal suture.

[0406] Septal cartilage (nasal): The nasal septal cartilage forms part of the septum and divides the front part of the nasal cavity.

[0407] Subalare: The point at the lower margin of the alar base, where the alar base joins with the skin of the superior (upper) lip.

[0408] Subnasal point: Located on the soft tissue, the point at which the columella merges with the upper lip in the midsagittal plane.

[0409] Supramenton: The point of greatest concavity in the midline of the lower lip between labrale inferius and soft tissue pogonion 5.10.4.2 Anatomy of the skull

[0410] Frontal bone-. The frontal bone includes a large vertical portion, the squama frontalis, corresponding to the region known as the forehead.

[0411] Mandible-. The mandible forms the lower jaw. The mental protuberance is the bony protuberance of the jaw that forms the chin.

[0412] 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.

[0413] 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.

[0414] 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.

[0415] 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.

[0416] Orbit'. The bony cavity in the skull to contain the eyeball.

[0417] Parietal bones'. The parietal bones are the bones that, when joined together, form the roof and sides of the cranium.

[0418] 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.

[0419] Zygomatic bones'. The face includes two zygomatic bones, located in the upper and lateral parts of the face and forming the prominence of the cheek.

5.10.4.3 Anatomy of the respiratory system

[0420] 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.

[0421] Larynx'. The larynx, or voice box houses the vocal folds and connects the inferior part of the pharynx (hypopharynx) with the trachea.

[0422] 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.

[0423] Nasal cavity: The nasal cavity (or nasal fossa) is a large air filled space above and behind the nose in the middle of the face. The nasal cavity is divided in two by a vertical fin called the nasal septum. On the sides of the nasal cavity are three horizontal outgrowths called nasal conchae (singular "concha") or turbinates. To the front of the nasal cavity is the nose, while the back blends, via the choanae, into the nasopharynx.

[0424] Pharynx: The part of the throat situated immediately inferior to (below) the nasal cavity, and superior to the oesophagus and larynx. The pharynx is conventionally divided into three sections: the nasopharynx (epipharynx) (the nasal part of the pharynx), the oropharynx (mesopharynx) (the oral part of the pharynx), and the laryngopharynx (hypopharynx).

5.10.5 Patient interface

[0425] Anti-asphyxia valve (AAV): The component or sub-assembly of a mask system that, by opening to atmosphere in a failsafe manner, reduces the risk of excessive CO2 rebreathing by a patient.

[0426] Headgear: 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.

[0427] 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.

[0428] 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.

[0429] 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. 5.10.6 Shape of structures

[0430] 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. For example a structure may comprise one or more of an anterior surface, a posterior surface, an interior surface and an exterior surface. In another example, 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. In another example, a structure may comprise a first surface and a second surface.

5.11 OTHER REMARKS

[0431] Unless the context clearly dictates otherwise and where a range of values is provided, it is understood that each intervening value, to the tenth of the unit of the lower limit, between the upper and lower limit of that range, and any other stated or intervening value in that stated range is encompassed within the technology. The upper and lower limits of these intervening ranges, which may be independently included in the intervening ranges, are also encompassed within the technology, subject to any specifically excluded limit in the stated range. Where the stated range includes one or both of the limits, ranges excluding either or both of those included limits are also included in the technology.

[0432] Furthermore, where a value or values are stated herein as being implemented as part of the technology, it is understood that such values may be approximated, unless otherwise stated, and such values may be utilized to any suitable significant digit to the extent that a practical technical implementation may permit or require it.

[0433] Furthermore, “approximately”, “substantially”, “about”, or any similar term used herein means +/- 5-10% of the recited value.

[0434] Unless defined otherwise, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this technology belongs. Although any methods and materials similar or equivalent to those described herein can also be used in the practice or testing of the present technology, a limited number of the exemplary methods and materials are described herein.

[0435] When a particular material is identified as being used to construct a component, obvious alternative materials with similar properties may be used as a substitute. Furthermore, unless specified to the contrary, any and all components herein described are understood to be capable of being manufactured and, as such, may be manufactured together or separately.

[0436] It must be noted that as used herein and in the appended claims, the singular forms "a", "an", and "the" include their plural equivalents, unless the context clearly dictates otherwise.

[0437] All publications mentioned herein are incorporated herein by reference in their entirety to disclose and describe the methods and/or materials which are the subject of those publications. The publications discussed herein are provided solely for their disclosure prior to the filing date of the present application. Nothing herein is to be construed as an admission that the present technology is not entitled to antedate such publication by virtue of prior invention. Further, the dates of publication provided may be different from the actual publication dates, which may need to be independently confirmed.

[0438] The terms "comprises" and "comprising" should be interpreted as referring to elements, components, or steps in a non-exclusive manner, indicating that the referenced elements, components, or steps may be present, or utilized, or combined with other elements, components, or steps that are not expressly referenced. [0439] The subject headings used in the detailed description are included only for the ease of reference of the reader and should not be used to limit the subject matter found throughout the disclosure or the claims. The subject headings should not be used in construing the scope of the claims or the claim limitations.

[0440] Although the technology herein has been described with reference to particular examples, it is to be understood that these examples are merely illustrative of the principles and applications of the technology. In some instances, the terminology and symbols may imply specific details that are not required to practice the technology. For example, although the terms "first" and "second" may be used, unless otherwise specified, they are not intended to indicate any order but may be utilised to distinguish between distinct elements. Furthermore, although process steps in the methodologies may be described or illustrated in an order, such an ordering is not required. Those skilled in the art will recognize that such ordering may be modified and/or aspects thereof may be conducted concurrently or even synchronously.

[0441] It is therefore to be understood that numerous modifications may be made to the illustrative examples and that other arrangements may be devised without departing from the spirit and scope of the technology.

5.12 REFERENCE SIGNS LIST

Claims

1. A sleep aid system for providing respiratory therapy, comprising: an eye cover including an eye-covering structure configured to engage a patient’s face generally around a periphery of the patient’s eyes, in-use, to form a light seal to prevent ambient light from entering the patient’s eyes; a positioning and stabilising structure configured to hold the eye-covering structure in opposing relation to the patient’s face when a force is applied to the eyecovering structure by the positioning and stabilising structure; a respiratory therapy system including a cushion assembly configured to deliver pressurised air to an airway of the patient for respiratory therapy, the cushion assembly including a seal-forming structure configured to form a seal with the patient’s face, wherein the eye cover is configured to interact with the respiratory therapy system to aid in respiratory therapy and includes at least one sensor adapted to provide sensor data for utilization by the respiratory therapy system, and wherein the eye cover does not include an image display screen.

2. The sleep aid system as defined in claim 1, wherein the respiratory therapy system includes a processor, and the sensor data is provided to the processor to effect change to the respiratory therapy.

3. The sleep aid system as defined in claims 1 or 2, wherein the sensor is one of a group comprising a motion sensor, temperature sensor, oximeter, humidity sensor, light sensor, sonar sensor, tactile sensor, altitude sensor, gas sensor, accelerometer, gyroscope, GPS, or any combination thereof.

4. The sleep aid system as defined in any one of claims 2 and 3, wherein the sensor data is provided to the processor to determine one or more characteristic of the patient.

5. The sleep aid system as defined in claim 4, wherein the one or more characteristic is selected from the group comprising: i) sleep hygiene; ii) sleep performance; iii) a sleeping disorder; and iv) a respiratory disorder.

6. The sleep aid system as defined in claim 4 or 5, wherein the one or more characteristic of the patient includes one or more physiological characteristic of the patient.

7. The sleep aid system as defined in claim 6, wherein the at least one sensor senses at least one of electroencephalography (EEG), electrocardiography (ECG), electrooculography (EOG), and electromyography (EMG) signals of the patient.

8. The sleep aid system as defined in any one of claims 1 to 7, wherein the eyecovering structure has a fabric outer covering.

9. The sleep aid system as defined in any one of claims 1 to 7, wherein the sealforming structure is configured to form a seal with an underside of the patient’s nose and the eye-covering structure includes a concave notch configured to, in use, align with the patient’s nose ridge, the seal-forming structure and the eye-covering structure thereby being configured to, in use, leave uncovered and thereby exposed to ambient a lower portion of the patient’s nose ridge.

10. A sleep aid system for providing respiratory therapy, comprising: an eye cover including an eye-covering structure configured to engage a patient’s face generally around a periphery of a patient’s eyes, in-use, to form a light seal to prevent ambient light from entering the patient’s eyes; a positioning and stabilising structure configured to hold the eye-covering structure in opposing relation to the patient’s face when a force is applied to the eyecovering structure by the positioning and stabilising structure; a respiratory therapy system including a cushion assembly configured to deliver pressurised air to an airway of the patient for respiratory therapy, the cushion assembly including a seal-forming structure configured to form a seal with the patient’s face, wherein the seal-forming structure is configured to form a seal with an underside of the patient’s nose and the eye-covering structure includes a concave notch configured to, in use, align with the patient’s nose ridge, the seal-forming structure and the eye-covering structure thereby being configured to, in use, leave uncovered and thereby exposed to ambient a lower portion of the patient’s nose ridge.

11. The sleep aid system as defined in any one of claims 1 to 10, wherein the eye cover further comprises one or more output devices.

12. The sleep aid system as defined in claim 11, wherein the one or more output devices of the eye cover is configured to, in use, stimulate a response in the patient.

13. The sleep aid system as defined in claim 11 or 12, wherein the one or more output devices of the eye cover is configured to, in use, alter the environment around the patient.

14. The sleep aid system as defined in any one of claims 11 to 13, wherein the one or more output devices is controlled by a processor of the respiratory therapy system.

15. The sleep aid system as defined in claim 14, when dependent on claim 2, wherein the one or more output devices is controlled by the processor based on the sensor data of the at least one sensor.

16. The sleep aid system as defined in any one of claims 11 to 15, wherein the one or more output devices further comprises one or more light-emitting diodes (LEDs) configured to stimulate the patient’s eye, in use, for adjusting the patient’s sleep stage.

17. The sleep aid system as defined in any one of claims 1 to 16, wherein the cushion assembly is configured to be coupled to a flow generator for delivery of pressurised air to an airway of the patient for respiratory therapy.

18. The sleep aid system as defined in any one of claims 1 to 17, when dependent on claim 15, wherein the positioning and stabilising structure of the eye cover is releasably connectable to the eye-covering structure such that: the eye-covering structure can be connected to the positioning and stabilising structure of the eye cover to maintain the eye-covering structure in the light- sealing position on the patient’s head in use; or the eye-covering structure can be disconnected from the positioning and stabilising structure of the eye cover so as to be connected with respect to a positioning and stabilising structure of the respiratory therapy system arranged and configured to maintain the cushion assembly in sealing engagement with the patient’s face in use, the positioning and stabilising structure of the respiratory therapy system being configured to maintain the eye-covering structure in the light-sealing position on the patient’s head in use.

19. The sleep aid system as defined in claim 18, wherein the cushion assembly is connected to the eye cover and configured to, in use, be held in sealing engagement with the patient’s face by the positioning and stabilising structure of the eye cover.

20. The sleep aid system as defined in any one of claims 1 to 19, further comprising ear covers arranged to overlay the patient’s ears in use.

21. The sleep aid system as defined in any one of claims 10 to 14, wherein the eye cover is configured to interact with the respiratory therapy system, in use, to aid in respiratory therapy and includes at least one sensor adapted to provide sensor data for utilization by the respiratory therapy system.

22. The sleep aid system as defined in any one of claims 10-14, wherein the sealforming structure and the eye-covering structure are configured to, in use, leave uncovered and thereby exposed to ambient at least half of the lower portion of the patient’s nose ridge.

23. The sleep aid system as defined in any one of claims 10-14, wherein the sealforming structure and the eye-covering structure are configured to, in use, leave uncovered and thereby exposed to ambient substantially the patient’s entire nose ridge.

24. A treatment system comprising: the respiratory therapy system of any one of claims 1 to 23, the respiratory therapy system including: a flow generator configured to generate a flow of pressurized air; and an air delivery tube coupled between the flow generator and cushion assembly to deliver the flow of pressurized air from the flow generator to the cushion assembly; and the eye cover according to any one of claims 1 to 23.

25. The treatment system as defined in claim 24, wherein the respiratory therapy system further comprises a processor to interact with the eye cover.

26. The treatment system as defined in claim 25, wherein the processor is configured to control an operation of the respiratory therapy system based on the sensor data of the at least one sensor.

27. The treatment system as defined in claim 26, wherein the processor controls an operation of the flow generator.

28. The treatment system as defined in any one of claims 25 to 27, wherein the sensor data is provided to the processor to determine one or more characteristic of the patient.

29. The treatment system as defined in claim 25, wherein the one or more output devices is configured to be controlled by the processor based on sensor data of the at least one sensor.

30. The treatment system as defined in any one of claims 24 to 29, wherein the respiratory therapy system further comprises a positioning and stabilising structure arranged and configured to, in use, maintain the cushion assembly in sealing engagement with the patient’s face.

31. An eye cover for use with a respiratory therapy system, the eye cover comprising: an eye-covering structure configured to engage the patient’s face generally around a periphery of a patient’s eyes in-use, to form a light seal to prevent ambient light from entering the patient’s eyes, the eye-covering structure being configured to be held in opposing relation to the patient’s face, in use, when a force is applied to the eye-covering structure by a positioning and stabilising structure, wherein the eye cover is adapted to interact with a respiratory therapy system to aid in respiratory therapy.

32. The eye cover as defined in claim 31, wherein the positioning and stabilising structure comprises a first positioning and stabilising structure of the eye cover and a second positioning and stabilising structure of the respiratory therapy system, wherein the eye-covering structure comprises a connector configured to removably connect to the second positioning and stabilising structure of the respiratory therapy system.

33. The eye cover as defined in claim 32, wherein the connector is configured to interchangeably and removably connect to the first positioning and stabilising structure of the eye cover and to the second positioning and stabilising structure of the respiratory therapy system.

34. The eye cover as defined in any one of claims 31 to 33, further comprising at least one sensor adapted to provide sensor data for utilization by the respiratory therapy system.

35. The eye cover as defined in claim 34, wherein the at least one sensor is provided in a sensor unit that is removably connected to the eye cover, and wherein the eye cover further comprises a sensor retainer configured to removably retain the sensor unit on the eye cover.

36. The eye cover as defined in any one of claims 34 and 35, wherein the at least one sensor comprises an orientation sensor configured to detect a sleeping position of the patient.

37. The eye cover as defined in claim 36, wherein the orientation sensor is configured to detect whether the patient is sleeping on their side.

38. The eye cover as defined in any one of claims 36 and 37, wherein, based on an output from the orientation sensor, the eye cover is configured to determine whether the patient has positional obstructive sleep apnea.

39. The eye cover as defined in any one of claims 31 to 38, wherein the eyecovering structure comprises a material having variable transparency, the eyecovering structure being configured to adjust a transparency of the material to control a magnitude of light entering the patient’s eyes in use.

40. The eye cover as defined in any one of claims 31 to 39, further comprising one or more output devices.

41. The eye cover as defined in claim 40, wherein the one or more output devices of the eye cover is configured to, in use, stimulate a response in the patient.

42. The eye cover as defined in any one of claims 40 and 41, wherein the one or more output devices comprises one or more LEDs configured to stimulate the patient’s eye, in use, for adjusting the patient’s sleep stage.

43. The eye cover as defined in any one of claims 31 to 42, wherein the eye cover comprises first and second arrangements of LEDs positioned to correspond to each of the patient’s eyes in use.

44. The eye cover as defined in claim 43, wherein each of the first and second arrangements of LEDs comprises two LEDs.

45. The eye cover as defined in claim 43, wherein each of the first and second arrangements of LEDs includes a first set and a second set of LEDs configured to be positioned around a perimeter of a respective one of the patient’s eyes in use, wherein each of the first and second arrangements of LEDs includes 5 or more LEDs.

46. The eye cover as defined in claim 45, wherein each first set of LEDs is configured to be positioned along an upper perimeter of the patient’s eye in use, and each second set of LEDs is configured to be positioned along a lower perimeter of the patient’s eye in use.