Cushion module with spring clip portion

Abstract

A cushion module for a patient interface is disclosed. The cushion module comprises a seal-forming structure connected to a chassis portion, together defining at least part of a plenum chamber. An opening is provided on the anterior side of the cushion module. A spring clip portion, configured as an open curve, is arranged at least partially around the opening. The spring clip portion is configured to engage with at least outer lateral surfaces of a frame of the patient interface, thereby securing the cushion module to the frame.

Description

CUSHION MODULE WITH SPRING CLIP PORTION 1 CROSS-REFERENCE TO RELATED APPLICATIONS

[0001] This application claims priority from Australian Provisional Patent Application No. 2024903407, filed 22 October 2024, the contents of which is incorporated by reference.2 BACKGROUND OF THE TECHNOLOGY2.1 FIELD OF THE TECHNOLOGY

[0002] 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 ART2.2.1 Human Respiratory System and its Disorders

[0003] The respiratory system of the body facilitates gas exchange. The nose and mouth form the entrance to the airways of a patient.

[0004] 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.

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

[0006] Examples of respiratory disorders include Obstructive Sleep Apnea (OSA), Cheyne-Stokes Respiration (CSR), respiratory insufficiency, ObesityHyperventilation Syndrome (OHS), Chronic Obstructive Pulmonary Disease (COPD), Neuromuscular Disease (NMD) and Chest wall disorders.

[0007] 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. See US Patent No. 4,944,310 (Sullivan).

[0008] Cheyne-Stokes Respiration (CSR) is another form of sleep disordered breathing. CSR is a disorder of a patient's respiratory controller in which there are rhythmic alternating periods of waxing and waning ventilation known as CSR cycles. CSR is characterised by repetitive de-oxygenation and re-oxygenation of the arterial blood. It is possible that CSR is harmful because of the repetitive hypoxia. In some patients CSR is associated with repetitive arousal from sleep, which causes severe sleep disruption, increased sympathetic activity, and increased afterload. See US Patent No. 6,532,959 (Berthon-Jones).

[0009] 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.

[0010] A patient with respiratory insufficiency (a form of respiratory failure) may experience abnormal shortness of breath on exercise.

[0011] Obesity Hyperventilation Syndrome (OHS) is defined as the combination of severe obesity and awake chronic hypercapnia, in the absence of other known causes for hypoventilation. Symptoms include dyspnea, morning headache and excessive daytime sleepiness.

[0012] 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.

[0013] 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.

[0014] 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.

[0015] A range of therapies have been used to treat or ameliorate such conditions. Furthermore, otherwise healthy individuals may take advantage of such therapies toprevent respiratory disorders from arising. However, these have a number of shortcomings.2.2.2 Therapies

[0016] 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

[0017] 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).

[0018] 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.2.2.3 Respiratory Therapy Systems

[0019] 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.

[0020] 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.2.2.3.1 Patient Interface

[0021] 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 cmFFO 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 cmFFO. 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.

[0022] Certain other mask systems may be functionally unsuitable for the present field. For example, purely ornamental masks may be unable to maintain a suitable pressure. Mask systems used for underwater swimming or diving may be configured to guard against ingress of water from an external higher pressure, but not to maintain air internally at a higher pressure than ambient.

[0023] Certain masks may be clinically unfavourable for the present technology e.g. if they block airflow via the nose and only allow it via the mouth.

[0024] Certain masks may be uncomfortable or impractical for the present technology if they require a patient to insert a portion of a mask structure in their mouth to create and maintain a seal via their lips.

[0025] Certain masks may be impractical for use while sleeping, e.g. for sleeping while lying on one’s side in bed with a head on a pillow.

[0026] The design of a patient interface presents a number of challenges. The face has a complex three-dimensional shape. The size and shape of noses and heads varies considerably between individuals. Since the head includes bone, cartilage and soft tissue, different regions of the face respond differently to mechanical forces. Thejaw or mandible may move relative to other bones of the skull. The whole head may move during the course of a period of respiratory therapy.

[0027] As a consequence of these challenges, some masks suffer from being one or more of obtrusive, aesthetically undesirable, costly, poorly fitting, difficult to use, and uncomfortable especially when worn for long periods of time or when a patient is unfamiliar with a system. Wrongly sized masks can give rise to reduced compliance, reduced comfort and poorer patient outcomes. Masks designed solely for aviators, masks designed as part of personal protection equipment (e.g. filter masks), SCUBA masks, or for the administration of anaesthetics may be tolerable for their original application, but nevertheless such masks may be undesirably uncomfortable to be worn for extended periods of time, e.g., several hours. This discomfort may lead to a reduction in patient compliance with therapy. This is even more so if the mask is to be worn during sleep.

[0028] CPAP therapy is highly effective to treat certain respiratory disorders, provided patients comply with therapy. If a mask is uncomfortable, or difficult to use a patient may not comply with therapy. Since it is often recommended that a patient regularly wash their mask, if a mask is difficult to clean (e.g., difficult to assemble or disassemble), patients may not clean their mask and this may impact on patient compliance.

[0029] While a mask for other applications (e.g. aviators) may not be suitable for use in treating sleep disordered breathing, a mask designed for use in treating sleep disordered breathing may be suitable for other applications.

[0030] For these reasons, patient interfaces for delivery of CPAP during sleep form a distinct field.2.2.3.1.1 Seal-forming structure

[0031] 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.

[0032] 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.

[0033] 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.

[0034] Certain seal-forming structures may be designed for mass manufacture such that one design fit and be comfortable and effective for a wide range of different face shapes and sizes. To the extent to which there is a mismatch between the shape of the patient’s face, and the seal-forming structure of the mass-manufactured patient interface, one or both must adapt in order for a seal to form.

[0035] 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, andadditional force will be required to force the patient interface against the face in order to achieve a seal.

[0036] 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.

[0037] 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.

[0038] Another form of seal-forming structure may use adhesive to achieve a seal. Some patients may find it inconvenient to constantly apply and remove an adhesive to their face.

[0039] A range of patient interface seal-forming structure technologies are disclosed in the following patent applications, assigned to ResMed Limited: WO 1998 / 004,310; WO 2006 / 074,513; WO 2010 / 135,785.

[0040] 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.

[0041] ResMed Limited has manufactured the following products that incorporate nasal pillows: SWIFT™ nasal pillows mask, SWIFT™ II nasal pillows mask, SWIFT™ LT nasal pillows mask, SWIFT™ FX nasal pillows mask and MIRAGE LIBERTY™ full-face mask. The following patent applications, assigned to ResMed Limited, describe examples of nasal pillows masks: International Patent Application W02004 / 073,778 (describing amongst other things aspects of the ResMed Limited SWIFT™ nasal pillows), US Patent Application 2009 / 0044808 (describing amongst other things aspects of the ResMed Limited SWIFT™ LT nasal pillows); International Patent Applications WO 2005 / 063,328 and WO 2006 / 130,903(describing amongst other things aspects of the ResMed Limited MIRAGE LIBERTY™ full-face mask); International Patent Application WO 2009 / 052,560 (describing amongst other things aspects of the ResMed Limited SWIFT™ FX nasal pillows).2.2.3.1.2 Positioning and stabilising

[0042] 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.

[0043] One technique is the use of adhesives. See for example US Patent Application Publication No. US 2010 / 0000534. However, the use of adhesives may be uncomfortable for some.

[0044] 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.2.2.3.1.3 Pressurised Air Conduit

[0045] 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.2.2.3.1.4 Pressurised Air Conduit used for Positioning / Stabilising the Seal- Forming Structure

[0046] 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 otherthan 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.

[0047] 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.2.2.3.1 Respiratory Pressure Therapy (RPT) Device

[0048] 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. The designer of a device may be presented with an infinite number of choices to make. Design criteria often conflict, meaning that certain design choices are far from routine or inevitable. Furthermore, the comfort and efficacy of certain aspects may be highly sensitive to small, subtle changes in one or more parameters.2.2.3.3 Air circuit

[0049] 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.2.2.3.4 Humidifier

[0050] 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 increasespatient 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.2.1.3.5 Data Management

[0051] 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.

[0052] 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.

[0053] Existing processes to communicate and manage such data can be one or more of costly, time-consuming, and error-prone.2.1.3.6 Vent technologies

[0054] 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.

[0055] The vent may comprise an orifice and gas may flow through the orifice in use of the mask. Many such vents are noisy. Others may become blocked in use and thus provide insufficient washout. Some vents may be disruptive of the sleep of a bed partner 1100 of the patient 1000, e.g. through noise or focussed airflow.

[0056] ResMed Limited has developed a number of improved mask vent technologies. See International Patent Application Publication No. WO 1998 / 034,665; International Patent Application Publication No. WO 2000 / 078,381; US Patent No.6,581,594; US Patent Application Publication No. US 2009 / 0050156; US Patent Application Publication No. 2009 / 0044808.

[0057] Table of noise of prior masks (ISO 17510-2:2007, 10 cmH20 pressure at Im)Mask name Mask type A-weighted A-weighted Year (approx.) sound power sound pressurelevel dB(A) dB(A)(uncertainty) (uncertainty)Glue-on (*) nasal 50.9 42.9 1981 ResCare nasal 31.5 23.5 1993 standard (*)ResMed nasal 29.5 21.5 1998 MirageTM (*)ResMed nasal 36 (3) 28 (3) 2000 UltraMirageTMResMed nasal 32 (3) 24 (3) 2002 MirageActivaTMResMed nasal 30 (3) 22 (3) 2008 MirageMicroTMResMed nasal 29 (3) 22 (3) 2008 MirageTMSoftGelResMed nasal 26 (3) 18 (3) 2010 MirageTM FXResMed nasal pillows 37 29 2004 MirageSwiftTM (*)ResMed nasal pillows 28 (3) 20 (3) 2005 MirageSwiftTM IIResMed nasal pillows 25 (3) 17 (3) 2008 MirageSwiftTM LTResMed AirFit nasal pillows 21 (3) 13 (3) 2014P10

[0058] (* one specimen only, measured using test method specified in ISO 3744 in CPAP mode at 10 cmH20)

[0059] Sound pressure values of a variety of objects are listed belowObject A-weighted sound pressure dB(A) Notes Vacuum cleaner: Nilfisk 68 ISO 3744 at Im Walter Broadly Litter Hog: B+ distance GradeConversational speech 60 Im distance Average home 50Quiet library 40Quiet bedroom at night 30Background in TV studio 202.2.4 Screening, Diagnosis, and Monitoring Systems

[0060] 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.

[0061] 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.

[0062] 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

[0063] 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.

[0064] A first aspect of the present technology relates to apparatus used in the screening, diagnosis, monitoring, amelioration, treatment or prevention of a respiratory disorder.

[0065] Another aspect of the present technology relates to methods used in the screening, diagnosis, monitoring, amelioration, treatment or prevention of a respiratory disorder.

[0066] An aspect of certain forms of the present technology is to provide methods and / or apparatus that improve the compliance of patients with respiratory therapy.

[0067] One form of the present technology comprises a cushion module for a patient interface, the cushion module comprising a seal forming structure connected to a chassis portion, the seal forming structure and chassis portion together defining, at least in part, a plenum chamber,the cushion module comprising an opening on an anterior side of the cushion module,the cushion module further comprising a spring clip portion configured as an open curve, the spring clip arranged at least partially around the opening, wherein the spring clip portion is configured to connect the cushion module to a frame of the patient interface by engagement of the spring clip portion with at least outer lateral surfaces of the frame

[0068] In examples:a) the frame is configured to fit within the opening;b) the spring clip portion extends around a top of the opening and at least partially around each side of the opening;c) the spring clip portion extends around at least three quarters of the circumference of the opening;d) the spring clip portion has a substantially transversely extending superior portion and downwardly extending lateral portions extending from the superior portion;e) the lateral portions are convex;f) the spring clip portion is formed from a harder material than the chassis portion;g) the spring clip portion is made from stainless steel, a thermoplastic, or a high durometer silicone;h) the spring clip portion is made from a silicone with a Shore A durometer hardness of at least 60, more preferably at least 70;i) the chassis portion comprises a lip seal adjacent the opening, the lip seal configured to seal between the chassis portion and the frame, in use; and / orj) each lateral portion comprises an inwardly extending protrusion, the protrusions configured to engage corresponding recesses in the frame.

[0069] Another form of the technology comprises a patient interface comprising a cushion module connected to a frame,the cushion module comprising a seal forming structure connected to a chassis portion, the seal forming structure and chassis portion together defining, at least in part, a plenum chamber,the cushion module comprising an opening on an anterior side of the cushion module,the cushion module further comprising a spring clip portion configured as an open curve, the spring clip portion arranged at least partially around the opening, wherein the spring clip portion is configured to connect the cushion module to the frame by engagement of the spring clip portion with at least outer lateral surfaces of the frame.In examples:a) the frame is configured to fit within the opening;b) the frame comprises a plurality of headgear connectors;c) the frame comprises a connection port;d) the frame comprises or is connected to a pair of conduits configured to form part of a positioning and stabilising structure for the patient interface;e) the frame comprises a vent;f) the frame is configured to engage a heat and moisture exchanger; g) the spring clip portion has a substantially transversely extending superior portion and downwardly extending lateral portions extending from the superior portion;h) each lateral portion comprises an inwardly extending protrusion, the protrusions configured to engage corresponding recesses in the frame; and / ori) the protrusions comprise a ramp surface configured cause an outward deflection of the lateral portions when the frame is moved into engagement with the cushion module.

[0070] Another aspect of one form of the present technology is a method of manufacturing a cushion module comprising the steps of:i. moulding a chassis portion around a mould core such that the chassis portion comprises an opening in an anterior face thereof, wherein a spring clip portion is provided around the opening;ii. forming a seal forming structure around the mould core such that the seal forming structure is connected to the chassis portion; andiii. removing the mould core from the chassis portion through the opening in the anterior face.

[0071] Another form of the present technology comprises a cushion module for a patient interface, the cushion module comprising a seal forming structure connected to a chassis portion, the seal forming structure and chassis portion together defining, at least in part, a plenum chamber,the cushion module comprising an opening on an anterior side of the cushion module,the cushion module further comprising a spring clip portion arranged at least partially around the opening, wherein the spring clip portion is configured to connect the cushion module to a frame of the patient interface.

[0072]

[0073] 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.

[0074] An aspect of one form of the present technology is a method of manufacturing apparatus.

[0075] 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.

[0076] 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.

[0077] 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 ahumidifier tank that may be washed in a home of a patient, e.g., in soapy water, without requiring specialised cleaning equipment.

[0078] 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.

[0079] 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.

[0080] 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

[0081] 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

[0082] Fig. 1A shows a system including a patient 1000 wearing a patient interface 3000, in the form of nasal pillows, receiving a supply of air at positive pressure from an RPT device 4000. Air from the RPT device 4000 is humidified in a humidifier 5000, and passes along an air circuit 4170 to the patient 1000. A bed partner 1100 is also shown. The patient is sleeping in a supine sleeping position.

[0083] Fig. IB shows a system including a patient 1000 wearing a patient interface 3000, in the form of a nasal mask, receiving a supply of air at positive pressure from an RPT device 4000. Air from the RPT device is humidified in a humidifier 5000, and passes along an air circuit 4170 to the patient 1000.

[0084] Fig. 1C shows a system including a patient 1000 wearing a patient interface 3000, in the form of a full-face mask, receiving a supply of air at positive pressure from an RPT device 4000. Air from the RPT device is humidified in a humidifier 5000, and passes along an air circuit 4170 to the patient 1000. The patient is sleeping in a side sleeping position.4.2 RESPIRATORY SYSTEM AND FACIAL ANATOMY

[0085] Fig. 2A shows an overview of a human respiratory system including the nasal and oral cavities, the larynx, vocal folds, oesophagus, trachea, bronchus, lung, alveolar sacs, heart and diaphragm.

[0086] Fig. 2B shows a view of a human upper airway including the nasal cavity, nasal bone, lateral nasal cartilage, greater alar cartilage, nostril, lip superior, lip inferior, larynx, hard palate, soft palate, oropharynx, tongue, epiglottis, vocal folds, oesophagus and trachea.

[0087] Fig. 2C is a front view of a face with several features of surface anatomy identified including the lip superior, upper vermilion, lower vermilion, lip inferior, mouth width, endocanthion, a nasal ala, nasolabial sulcus and cheilion. Also indicated are the directions superior, inferior, radially inward and radially outward.

[0088] Fig. 2D is a side view of a head with several features of surface anatomy identified including glabella, sellion, pronasale, subnasale, lip superior, lip inferior, supramenton, nasal ridge, alar crest point, otobasion superior and otobasion inferior. Also indicated are the directions superior & inferior, and anterior & posterior.

[0089] Fig. 2E is a further side view of a head. The approximate locations of the Frankfort horizontal and nasolabial angle are indicated. The coronal plane is also indicated.

[0090] Fig. 2F shows a base view of a nose with several features identified including naso-labial sulcus, lip inferior, upper Vermilion, naris, subnasale, columella, pronasale, the major axis of a naris and the midsagittal plane.

[0091] Fig. 2G shows a side view of the superficial features of a nose.

[0092] Fig. 2H shows subcutaneal structures of the nose, including lateral cartilage, septum cartilage, greater alar cartilage, lesser alar cartilage, sesamoid cartilage, nasal bone, epidermis, adipose tissue, frontal process of the maxilla and fibrofatty tissue.

[0093] Fig. 21 shows a medial dissection of a nose, approximately several millimeters from the midsagittal plane, amongst other things showing the septum cartilage and medial crus of greater alar cartilage.

[0094] Fig. 2J shows a front view of the bones of a skull including the frontal, nasal and zygomatic bones. Nasal concha are indicated, as are the maxilla, and mandible.

[0095] Fig. 2K shows a lateral view of a skull with the outline of the surface of a head, as well as several muscles. The following bones are shown: frontal, sphenoid, nasal, zygomatic, maxilla, mandible, parietal, temporal and occipital. The mental protuberance is indicated. The following muscles are shown: digastricus, masseter, sternocleidomastoid and trapezius.

[0096] Fig. 2L shows an anterolateral view of a nose.4.3 PATIENT INTERFACE

[0097] Fig. 3 A shows a patient interface in the form of a nasal mask in accordance with one form of the present technology.

[0098] Fig. 3B shows a schematic of a cross-section through a structure at a point. An outward normal at the point is indicated. The curvature at the point has a positive sign, and a relatively large magnitude when compared to the magnitude of the curvature shown in Fig. 3C.

[0099] Fig. 3C shows a schematic of a cross-section through a structure at a point. An outward normal at the point is indicated. The curvature at the point has a positive sign, and a relatively small magnitude when compared to the magnitude of the curvature shown in Fig. 3B.

[0100] Fig. 3D shows a schematic of a cross-section through a structure at a point. An outward normal at the point is indicated. The curvature at the point has a value of zero.

[0101] Fig. 3E shows a schematic of a cross-section through a structure at a point. An outward normal at the point is indicated. The curvature at the point has a negative sign, and a relatively small magnitude when compared to the magnitude of the curvature shown in Fig. 3F.

[0102] Fig. 3F shows a schematic of a cross-section through a structure at a point. An outward normal at the point is indicated. The curvature at the point has a negative sign, and a relatively large magnitude when compared to the magnitude of the curvature shown in Fig. 3E.

[0103] Fig. 3G shows a cushion for a mask that includes two pillows. An exterior surface of the cushion is indicated. An edge of the surface is indicated. Dome and saddle regions are indicated.

[0104] Fig. 3H shows a cushion for a mask. An exterior surface of the cushion is indicated. An edge of the surface is indicated. A path on the surface between points A and B is indicated. A straight line distance between A and B is indicated. Two saddle regions and a dome region are indicated.

[0105] Fig. 31 shows the surface of a structure, with a one dimensional hole in the surface. The illustrated plane curve forms the boundary of a one dimensional hole.

[0106] Fig. 3J shows a cross-section through the structure of Fig.31. The illustrated surface bounds a two dimensional hole in the structure of Fig. 31.

[0107] Fig. 3K shows a perspective view of the structure of Fig. 31, including the two dimensional hole and the one dimensional hole. Also shown is the surface that bounds a two dimensional hole in the structure of Fig. 31.

[0108] Fig. 3L shows a mask having an inflatable bladder as a cushion.

[0109] Fig. 3M shows a cross-section through the mask of Fig. 3L, and shows the interior surface of the bladder. The interior surface bounds the two dimensional hole in the mask.

[0110] Fig. 3N shows a further cross-section through the mask of Fig. 3L. The interior surface is also indicated.

[0111] Fig. 30 illustrates a left-hand rule.

[0112] Fig. 3P illustrates a right-hand rule.

[0113] Fig. 3Q shows a left ear, including the left ear helix.

[0114] Fig. 3R shows a right ear, including the right ear helix.

[0115] Fig. 3S shows a right-hand helix.

[0116] Fig. 3T shows a view of a mask, including the sign of the torsion of the space curve defined by the edge of the sealing membrane in different regions of the mask.

[0117] Fig. 3U shows a view of a plenum chamber 3200 showing a sagittal plane and a mid-contact plane.

[0118] Fig. 3 V shows a view of a posterior of the plenum chamber of Fig. 3U. The direction of the view is normal to the mid-contact plane. The sagittal plane in Fig. 3 V bisects the plenum chamber into left-hand and right-hand sides.

[0119] Fig. 3W shows a cross-section through the plenum chamber of Fig. 3 V, the cross-section being taken at the sagittal plane shown in Fig. 3 V. A ‘mid-contact’ plane is shown. The mid-contact plane is perpendicular to the sagittal plane. The orientation of the mid-contact plane corresponds to the orientation of a chord 3210 which lies on the sagittal plane and just touches the cushion of the plenum chamber at two points on the sagittal plane: a superior point 3220 and an inferior point 3230. Depending on the geometry of the cushion in this region, the mid-contact plane may be a tangent at both the superior and inferior points.

[0120] Fig. 3X shows the plenum chamber 3200 of Fig. 3U in position for use on a face. The sagittal plane of the plenum chamber 3200 generally coincides with the midsagittal plane of the face when the plenum chamber is in position for use. The mid-contact plane corresponds generally to the ‘plane of the face’ when the plenum chamber is in position for use. In Fig. 3X the plenum chamber 3200 is that of a nasal mask, and the superior point 3220 sits approximately on the sellion, while the inferior point 3230 sits on the lip superior.4.4 HUMIDIFIER

[0121] Fig. 4A shows an isometric view of a humidifier in accordance with one form of the present technology.

[0122] Fig. 4B shows an isometric view of a humidifier in accordance with one form of the present technology, showing a humidifier reservoir 5110 removed from the humidifier reservoir dock 5130.4.5 BREATHING WAVEFORMS

[0123] Fig. 5 shows a model typical breath waveform of a person while sleeping.4.6 PATIENT INTERFACES OF THE PRESENT TECHNOLOGY

[0124] Fig. 6 shows a front perspective view of a patient interface according to one form of the technology.

[0125] Fig. 7 shows a front perspective view of a cushion module of the patient interface of Fig. 6.

[0126] Fig. 8 shows a front view of a patient interface according to one form of the technology.

[0127] Fig. 9 shows a rear perspective view of a frame of the patient interface of Fig. 6, including a heat and moisture exchanger engaged with the frame.

[0128] Fig. 10 shows a horizontal cross-section view of the patient interface of Fig. 6.

[0129] Fig. 10A is an enlarged horizontal cross-section view of the clip portion to frame engagement of the patient interface of Fig. 6.

[0130] Fig. 11 shows a front perspective view of a patient interface according to another form of the technology.

[0131] Fig. 12 shows a rear perspective view of the frame of the patient interface of Fig. 11, with no HME installed.

[0132] Fig. 13 shows a top view of a patient interface according to another form of the technology being removed from a mould core.5 DETAILED DESCRIPTION OF EXAMPLES OF THE TECHNOLOGY

[0133] 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.

[0134] 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

[0135] 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.

[0136] 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.

[0137] In certain examples of the present technology, mouth breathing is limited, restricted or prevented.5.2 RESPIRATORY THERAPY SYSTEMS

[0138] 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 4000 for supplying a flow of air to the patient 1000 via an air circuit 4170 and a patient interface 3000.5.3 PATIENT INTERFACE

[0139] A non-invasive patient interface 3000 in accordance with one aspect of the present technology comprises the following functional aspects: a seal-forming structure 3100, a plenum chamber 3200, a positioning and stabilising structure 3300, a vent 3400, one form of connection port 3600 for connection to air circuit 4170, and a forehead support 3700. 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 3100 is arranged to surround an entrance to the airways of the patient so as to maintain positive pressure at the entrance(s) to the airways of the patient 1000. The sealed patient interface 3000 is therefore suitable for delivery of positive pressure therapy.

[0140] An unsealed patient interface, in the form of a nasal cannula, includes nasal prongs which can deliver air to respective nares of the patient 1000 via respective orifices in their tips. Such nasal prongs do not generally form a seal with the inner or outer skin surface of the nares. This type of interface results in one or more gaps that are present in use by design (intentional) but they are typically not fixed in size such that they may vary unpredictably by movement during use. This can present a complex pneumatic variable for a respiratory therapy system when pneumatic control and / or assessment is implemented, unlike other types of maskbased respiratory therapy systems. The air to the nasal prongs may be delivered by one or more air supply lumens that are coupled with the nasal cannula-type unsealed patient interface. The lumens lead from the nasal cannula-type unsealed patient interface to a respiratory therapy device via an air circuit. The unsealed patient interface is particularly suitable for delivery of flow therapies, in which the RPT device generates the flow of air at controlled flow rates rather than controlled pressures. The “vent” or gap at the unsealed patient interface, through which excessairflow escapes to ambient, is the passage between the end of the prongs of the nasal cannula-type unsealed patient interface via the patient’s nares to atmosphere.

[0141] A patient interface according to one form of the technology is shown in Fig. 6. The patient interface comprises a cushion module 3250 which is connected to a frame 3260, as described further below.

[0142] If a patient interface is unable to comfortably deliver a minimum level of positive pressure to the airways, the patient interface may be unsuitable for respiratory pressure therapy.

[0143] The patient interface 3000 in accordance with one form of the present technology is constructed and arranged to be able to provide a supply of air at a positive pressure of at least 6 cmH20 with respect to ambient.

[0144] The patient interface 3000 in accordance with one form of the present technology is constructed and arranged to be able to provide a supply of air at a positive pressure of at least 10 cmH20 with respect to ambient.

[0145] The patient interface 3000 in accordance with one form of the present technology is constructed and arranged to be able to provide a supply of air at a positive pressure of at least 20 cmH20 with respect to ambient.5.3.1 Seal-forming structure

[0146] In one form of the present technology, a seal-forming structure 3100 provides a target seal-forming region, and may additionally provide a cushioning function. The target seal-forming region is a region on the seal-forming structure 3100 where sealing may occur. The region where sealing actually occurs- the actual sealing surface- may change within a given treatment session, from day to day, and from patient to patient, depending on a range of factors including for example, where the patient interface was placed on the face, tension in the positioning and stabilising structure and the shape of a patient’s face.

[0147] In one form the target seal-forming region is located on an outside surface of the seal-forming structure 3100.

[0148] In certain forms of the present technology, the seal-forming structure 3100 is constructed from a biocompatible material, e.g. silicone rubber.

[0149] A seal-forming structure 3100 in accordance with the present technology may be constructed from a soft, flexible, resilient material such as silicone.

[0150] In certain forms of the present technology, a system is provided comprising more than one a seal -forming structure 3100, 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 3100 suitable for a large sized head, but not a small sized head and another suitable for a small sized head, but not a large sized head.5.3.1.1 Sealing mechanisms

[0151] 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 3200 acting on its underside to urge it into tight sealing engagement with the face. The pressure assisted mechanism may act in conjunction with elastic tension in the positioning and stabilising structure.

[0152] In one form, the seal-forming structure 3100 comprises a sealing flange and a support flange. The sealing flange comprises a relatively thin member with a thickness of less than about 1mm, for example about 0.25mm to about 0.45mm, which extends around the perimeter of the plenum chamber 3200. Support flange may be relatively thicker than the sealing flange. The support flange is disposed between the sealing flange and the marginal edge of the plenum chamber 3200, and extends at least part of the way around the perimeter. The support flange is or includes a springlike element and functions to support the sealing flange from buckling in use.

[0153] 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.

[0154] 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.

[0155] In one form, the seal-forming structure comprises a region having a tacky or adhesive surface.

[0156] 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

[0157] In one form, the non-invasive patient interface 3000 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.

[0158] 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

[0159] In one form, the non-invasive patient interface 3000 comprises a sealforming structure that forms a seal in use on an upper lip region (that is, the lip superior) of the patient's face.

[0160] 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

[0161] In one form the non-invasive patient interface 3000 comprises a sealforming structure that forms a seal in use on a chin-region of the patient's face.

[0162] 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

[0163] 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

[0164] In one form the seal -forming structure of the non-invasive patient interface 3000 comprises a pair of nasal puffs, or nasal pillows, each nasal puff or nasal pillow being constructed and arranged to form a seal with a respective naris of the nose of a patient.

[0165] 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.5.3.2 Plenum chamber

[0166] The plenum chamber 3200 has a perimeter that is shaped to be complementary to the surface contour of the face of an average person in the region where a seal will form in use. In use, a marginal edge of the plenum chamber 3200 is positioned in close proximity to an adjacent surface of the face. Actual contact with the face is provided by the seal-forming structure 3100. The seal-forming structure 3100 may extend in use about the entire perimeter of the plenum chamber 3200. In some forms, the plenum chamber 3200 and the seal-forming structure 3100 are formed from a single homogeneous piece of material.

[0167] In certain forms of the present technology, the plenum chamber 3200 does not cover the eyes of the patient in use. In other words, the eyes are outside the pressurised volume defined by the plenum chamber. Such forms tend to be lessobtrusive and / or more comfortable for the wearer, which can improve compliance with therapy.

[0168] In certain forms of the present technology, the plenum chamber 3200 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.

[0169] In certain forms of the present technology, the plenum chamber 3200 is constructed from a translucent material. The use of a translucent material can reduce the obtrusiveness of the patient interface, and help improve compliance with therapy.5.3.3 Cushion module with spring clip portion

[0170] Referring next to Figs. 6 - 10, a patient interface according to one form of the technology comprises a cushion module 3250 which is connected to a frame 3260 in use. In examples, the frame 3260 is provided with a plurality of headgear connectors 3270, for example two headgear connectors or four headgear connectors.

[0171] The cushion module 3250 comprises a seal forming structure 3100 connected to a chassis portion 3280. The chassis portion 3280 may be formed from a somewhat flexible material, for example silicone. In examples, the seal forming structure 3100 and chassis portion 3280 are formed integrally, e.g. both moulded from silicone. In other examples, the seal forming structure 3100 may comprise a textile. Typically, the seal forming structure 3100 is more flexible than the chassis portion 3280.

[0172] The seal forming structure 3100 and chassis portion 3280 define, at least in part, a plenum chamber 3200. In examples, the seal forming structure 3100, chassis portion 3280 and frame 3260 together define the plenum chamber 3200.

[0173] The cushion module 3250 comprises an opening 3290 in an anterior side thereof. The cushion module 3250 further comprises a spring clip portion 3500 provided around the opening 3290. The frame 3260 may be configured to fit within the opening 3290, and may be secured to the cushion module 3250 by the spring clip portion 3500.

[0174] The spring clip portion 3500 defines an open curve. In examples, the spring clip portion 3500 extends around more than 50% of the perimeter of the opening 3290, for example substantially three quarters of the way around the opening 3290. In examples, the spring clip portion 3500 comprises an upper portion 3510 and two downwardly extending lateral portions 3520. In one form of the technology, the upper portion 3510 extends substantially transversely. In examples, the lateral portions 3520 are substantially convex.

[0175] The spring clip portion 3500 is formed from a resilient material which is harder than the material of the chassis portion 3280. In examples, the spring clip portion 3500 may be made from a ductile thermoplastic, for example polycarbonate, nylon or polybutylene terephthalate (PBT). In another example, the spring clip portion 3500 may be made from a high durometer silicone (e.g. Shore A hardness of 60 or more, for example 70 or more). In another example, the spring clip portion 3500 may be made from a biocompatible metal such as stainless steel. In examples where the spring clip portion 3500 is metallic, the spring clip portion may be embedded within the chassis portion 3280, for example by providing an overmoulded layer of silicone over the metal part.

[0176] The spring clip portion 3500 is configured to engage at least one outer lateral surface 3261 of the frame 3260, for example opposed lateral surfaces 3261, and one or more of an upper surface and a lower surface 3264. In examples, there is no connection between the spring clip portion 3500 and the anterior surface of the frame 3260.

[0177] In examples, the spring clip portion 3500 is configured to allow the lateral portions 3520 to be displaced outwardly and to resiliently return to their original position to engage the lateral surface 3261 of the frame. In some forms of the technology, at least the portion of the chassis surrounding the opening 3290 (e.g. portion 3282 adjacent an inferior edge of opening 3290) may be flexible and / or stretchable to allow the displacement of the lateral portions 3520 of the spring clip portion 3500. However, the spring clip portion 3500 itself preferably bends, but does not stretch, when engaging the frame 3260.

[0178] As best seen in Figs. 7, 9, 10 and 10A, in one example the lateral portions 3520 of the spring clip portion 3500 comprise inwardly protruding tabs 3530 which are configured to engage corresponding recesses 3540 provided to outer lateral sides 3261 of the frame 3260. In examples, an anterior face 3532 of each tab 3530 slopes inwardly and in a posterior direction to form a ramp surface. The ramp may cause an outward deflection of the lateral portions 3520 when the frame 3260 is moved in a posterior direction (relative to the cushion module 3250) to engage the frame 3260 with the cushion module 3250.

[0179] In other examples (not shown) no tabs are provided, and the lateral portions 3520 of the spring clip portion 3500 engage corresponding channels provided to the outer lateral sides of the frame 3260, e.g. in the manner of a circlip.

[0180] In examples, an advantage of forming the spring clip portion 3500 from a relatively hard material is that the clip 3500 tends to provide a more positive engagement than a system which relies on a “stretch” or “press” fit . In examples, the spring clip may provide haptic and audible feedback (e.g. a “click”) when clipped into position. In addition, all parts of the clip 3500 which engage the frame 3260 may do so substantially simultaneously, rather than engaging portion-by-portion, as might be the case if a stretch fit connection was used. The spring clip portion 3500 may also increase the stiffness of the chassis portion 3280, which may make the cushion module 3250 easier to handle and assemble. Furthermore, because a relatively large elastic deflection of the lateral portions 3520 is possible, at least in some forms of the technology, the engaging features (e.g. tabs 3530 and recesses 3540) and can be manufactured with larger dimensional tolerances than would otherwise be possible.

[0181] Referring next to Figs. 7, 8, 10 and 10A, in examples, the chassis portion 3280 is provided with a lip seal 3292. The lip seal 3292 may extend around a perimeter of the opening 3290, and may be configured to engage with, and seal against, a posterior surface 3262 of the frame 3260.

[0182] The patient interface shown in Figs. 6-10 is configured to connect to an air circuit 4170 which extends forwards or downward away from the patient’s face in use. However, as shown in Figs. 11 and 12, in other forms of the technology the frame 3260 may be configured for use with conduit headgear, as discussed further below.

[0183] In examples, the frame 3260 may be configured to receive and engage a heat and moisture exchanger (HME) 3900, as seen in Figs. 9, 10 and 10A.5.3.4 Method of manufacture of cushion module

[0184] Cushion modules 3250 such as that shown in Figs. 6 - 8 and 11 may be formed, at least in part, by moulding a chassis portion 3280 (and optionally an integral silicone seal forming structure 3100) around a suitable mould core 6000 (see Fig. 13). The chassis portion 3280 may be made from a relatively elastic or "stretchy” material, for example silicone.

[0185] In the cushion modules of the prior art, the mould core may be removed from the cushion module 3250 via the oral opening (i.e. the opening which the patient breaths into through their mouth). However, in some examples of the cushion module 3250 (for example those which comprise a textile seal forming structure 3100) the material surrounding the oral opening (including the seal forming structure) may not be sufficiently elastic to allow the core to pass through. In some examples the opening(s) (e.g. individual nasal openings of a nasal cradle mask) may not be large enough for the core to pass through.

[0186] In examples such as those shown in Figs 6-8 and 13, the opening 3290 in the anterior side of the cushion module 3250 may be sufficiently large, and the material surrounding at least portions of the opening 3290 sufficiently elastic, that the mould core 6000 can be removed from this opening 3290, as shown in Fig. 13. In such examples the spring clip portion 3500 is capable of elastically deforming / bending sufficiently to allow removal of the core 6000.

[0187] By removing the core 6000 from the anterior opening 3290 it may be possible to use materials and / or geometries for the seal forming structure 3100 which would not be possible if the mould 6000 was to be removed via the oral opening.5.3.5 Positioning and stabilising structure

[0188] The seal-forming structure 3100 of the patient interface 3000 of the present technology may be held in sealing position in use by the positioning and stabilising structure 3300.

[0189] In one form the positioning and stabilising structure 3300 provides a retention force at least sufficient to overcome the effect of the positive pressure in the plenum chamber 3200 to lift off the face.

[0190] In one form the positioning and stabilising structure 3300 provides a retention force to overcome the effect of the gravitational force on the patient interface 3000.

[0191] In one form the positioning and stabilising structure 3300 provides a retention force as a safety margin to overcome the potential effect of disrupting forces on the patient interface 3000, such as from tube drag, or accidental interference with the patient interface.

[0192] In one form of the present technology, a positioning and stabilising structure 3300 is provided that is configured in a manner consistent with being worn by a patient while sleeping. In one example the positioning and stabilising structure 3300 has a low profile, or cross-sectional thickness, to reduce the perceived or actual bulk of the apparatus. In one example, the positioning and stabilising structure 3300 comprises at least one strap having a rectangular cross-section. In one example the positioning and stabilising structure 3300 comprises at least one flat strap.

[0193] In one form of the present technology, a positioning and stabilising structure 3300 is provided that is configured so as not to be too large and bulky to prevent the patient from lying in a supine sleeping position with a back region of the patient’s head on a pillow.

[0194] In one form of the present technology, a positioning and stabilising structure 3300 is provided that is configured so as not to be too large and bulky to prevent the patient from lying in a side sleeping position with a side region of the patient’s head on a pillow.

[0195] In one form of the present technology, a positioning and stabilising structure 3300 is provided with a decoupling portion located between an anterior portion of the positioning and stabilising structure 3300, and a posterior portion of the positioning and stabilising structure 3300. The decoupling portion does not resist compression and may be, e.g. a flexible or floppy strap. The decoupling portion isconstructed and arranged so that when the patient lies with their head on a pillow, the presence of the decoupling portion prevents a force on the posterior portion from being transmitted along the positioning and stabilising structure 3300 and disrupting the seal.

[0196] In one form of the present technology, a positioning and stabilising structure 3300 comprises a strap constructed from a laminate of a fabric patientcontacting layer, a foam inner layer and a fabric outer layer. 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.

[0197] In certain forms of the present technology, a positioning and stabilising structure 3300 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.

[0198] 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.

[0199] 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.

[0200] 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.

[0201] In certain forms of the present technology, a positioning and stabilising structure 3300 comprises a strap that is bendable and e.g. non-rigid. An advantage ofthis aspect is that the strap is more comfortable for a patient to lie upon while the patient is sleeping.

[0202] In certain forms of the present technology, a positioning and stabilising structure 3300 comprises a strap constructed to be breathable to allow moisture vapour to be transmitted through the strap,

[0203] In certain forms of the present technology, a system is provided comprising more than one positioning and stabilizing structure 3300, 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 stabilizing structure 3300 suitable for a large sized head, but not a small sized head, and another, suitable for a small sized head, but not a large sized head.5.3.5.1 Conduit headgear

[0204] In some forms of the present technology, the positioning and stabilising structure 3300 comprises one or more headgear tubes 3350 that deliver pressurised air received from a conduit forming part of the air circuit 4170 from the RPT device to the patient’s airways, for example through the plenum chamber 3200 and sealforming structure 3100. In the form of the present technology illustrated in Figs. 11 and 12, the positioning and stabilising structure 3300 comprises two tubes 3350 that deliver air to the plenum chamber 3200 from the air circuit 4170. The tubes 3350 are configured to position and stabilise the seal -forming structure 3100 of the patient interface 3000 at the appropriate part of the patient’s face (for example, the nose and / or mouth) in use. This allows the conduit of air circuit 4170 providing the flow of pressurised air to connect to a connection port 3600 of the patient interface in a position other than in front of the patient’s face, for example on top of the patient’s head.

[0205] In the form of the present technology illustrated in Figs. 11 and 12, the positioning and stabilising structure 3300 comprises two tubes 3350, each tube 3350 being positioned in use on a different side of the patient’s head and extending across the respective cheek region, above the respective ear (superior to the otobasion superior on the patient’s head) to an elbow on top of the head of the patient 1000. This form of technology may be advantageous because, if a patient sleeps with their head on its side and one of the tubes 3350 is compressed to block or partially block theflow of gas along the tube 3350, the other tube 3350 remains open to supply pressurised gas to the patient. In other examples of the technology, the patient interface 3000 may comprise a different number of tubes, for example one tube, or two or more tubes.5.3.6 Vent

[0206] In one form, the patient interface 3000 includes a vent 3400 constructed and arranged to allow for the washout of exhaled gases, e.g. carbon dioxide.

[0207] In certain forms the vent 3400 is configured to allow a continuous vent flow from an interior of the plenum chamber 3200 to ambient whilst the pressure within the plenum chamber is positive with respect to ambient. The vent 3400 is configured such that the vent flow rate has a magnitude sufficient to reduce rebreathing of exhaled CO2 by the patient while maintaining the therapeutic pressure in the plenum chamber in use.

[0208] One form of vent 3400 in accordance with the present technology comprises a plurality of holes, for example, about 20 to about 80 holes, or about 40 to about 60 holes, or about 45 to about 55 holes.

[0209] The vent 3400 may be located in the plenum chamber 3200. Alternatively, the vent 3400 is located in a decoupling structure, e.g., a swivel.5.3.7 Decoupling structure(s)

[0210] In one form the patient interface 3000 includes at least one decoupling structure, for example, a swivel or a ball and socket.5.3.8 Connection port

[0211] Connection port 3600 allows for connection to the air circuit 4170.5.3.9 Forehead support

[0212] In one form, the patient interface 3000 includes a forehead support 3700.5.3.10 Anti-asphyxia valve

[0213] In one form, the patient interface 3000 includes an anti-asphyxia valve.5.3.11 Ports

[0214] In one form of the present technology, a patient interface 3000 includes one or more ports that allow access to the volume within the plenum chamber 3200. In one form this allows a clinician to supply supplementary oxygen. In one form, this allows for the direct measurement of a property of gases within the plenum chamber 3200, such as the pressure.5.4 RPT DEVICE

[0215] An RPT device 4000 in accordance with one aspect of the present technology comprises mechanical, pneumatic, and / or electrical components and is configured to execute one or more algorithms, such as any of the methods, in whole or in part, described herein. The RPT device 4000 may be configured to generate a flow of air for delivery to a patient’s airways, such as to treat one or more of the respiratory conditions described elsewhere in the present document.5.5 HUMIDIFIER5.5.1 Humidifier overview

[0216] In one form of the present technology there is provided a humidifier 5000 (e.g. as shown in Fig. 4A) to change the absolute humidity of air or gas for delivery to a patient relative to ambient air. Typically, the humidifier 5000 is used to increase the absolute humidity and increase the temperature of the flow of air (relative to ambient air) before delivery to the patient’s airways.

[0217] The humidifier 5000 may comprise a humidifier reservoir 5110, a humidifier inlet 5002 to receive a flow of air, and a humidifier outlet 5004 to deliver a humidified flow of air. In some forms, as shown in Fig. 4A and Fig. 4B, an inlet and an outlet of the humidifier reservoir 5110 may be the humidifier inlet 5002 and the humidifier outlet 5004 respectively. The humidifier reservoir may comprise a conductive base portion 5120 and a water level indicator 5150. The humidifier 5000 may further comprise a humidifier base 5006, which may be adapted to receive the humidifier reservoir 5110 and comprise a heating element 5240.

[0218] In some arrangements the dock 5130 may comprise a locking lever 5135.5.6 BREATHING WAVEFORMS

[0219] Fig. 5 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 Ti 1.6s, peak inspiratory flow rate Qpeak 0.4 L / s, exhalation time Te 2.4s, peak expiratory flow rate Qpeak -0.5 L / s. The total duration of the breath, Tlol. 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 Ttot, is about 40%.5.7 GLOSSARY

[0220] 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.5.7.1 General

[0221] 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.

[0222] 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.

[0223] 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.

[0224] In another example, ambient pressure may be the pressure immediately surrounding or external to the body.

[0225] 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.

[0226] Automatic Positive Airway Pressure (APAP) therapy. CP AP 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.

[0227] 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.

[0228] 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’.

[0229] 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.

[0230] 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.

[0231] 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.

[0232] 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.

[0233] 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.

[0234] 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.

[0235] 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.

[0236] 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”.

[0237] Medical Oxygen'. Medical oxygen is defined as oxygen enriched air with an oxygen concentration of 80% or greater .Patient'. A person, whether or not they are suffering from a respiratory condition.

[0238] Pressure: Force per unit area. Pressure may be expressed in a range of units, including cmFFO, g-f / cm2and hectopascal. 1 cmFFO is equal to 1 g-f / cm2and 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 crnLLO.

[0239] 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.

[0240] 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.

[0241] Ventilator'. A mechanical device that provides pressure support to a patient to perform some or all of the work of breathing.5.7.1.1 Materials

[0242] Silicone or Silicone Elastomer'. A synthetic rubber. In this specification, a reference to silicone is a reference to liquid silicone rubber (LSR) or a compression moulded silicone rubber (CMSR). One form of commercially available LSR is SILASTIC (included in the range of products sold under this trademark), manufactured by Dow Corning. Another manufacturer of LSR is Wacker. Unless otherwise specified to the contrary, 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.

[0243] Polycarbonate', a thermoplastic polymer of Bisphenol-A Carbonate.5.7.1.2 Mechanical properties

[0244] Resilience'. Ability of a material to absorb energy when deformed elastically and to release the energy upon unloading.

[0245] Resilient'. Will release substantially all of the energy when unloaded. Includes e.g. certain silicones, and thermoplastic elastomers.

[0246] Hardness'. The ability of a material per se to resist deformation (e.g. described by a Young’s Modulus, or an indentation hardness scale measured on a standardised sample size).• ‘Soft’ materials may include silicone or thermo-plastic elastomer (TPE), and may, e.g. readily deform under finger pressure.• ‘Hard’ materials may include polycarbonate, polypropylene, steel or aluminium, and may not e.g. readily deform under finger pressure.

[0247] 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.

[0248] Floppy structure or component: A structure or component that will change shape, e.g. bend, when caused to support its own weight, within a relatively short period of time such as 1 second.

[0249] 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.

[0250] 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.5.7.2 Respiratory cycle

[0251] 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.

[0252] Breathing rate'. The rate of spontaneous respiration of a patient, usually measured in breaths per minute.

[0253] Duty cycle'. The ratio of inhalation time, Ti to total breath time, Ttot.

[0254] Effort (breathing): The work done by a spontaneously breathing person attempting to breathe.

[0255] Expiratory portion of a breathing cycle: The period from the start of expiratory flow to the start of inspiratory flow.

[0256] Flow limitation'. Flow limitation will be taken to be the state of affairs in a patient's respiration where an increase in effort by the patient does not give rise to a corresponding increase in flow. Where flow limitation occurs during an inspiratory portion of the breathing cycle it may be described as inspiratory flow limitation. Where flow limitation occurs during an expiratory portion of the breathing cycle it may be described as expiratory flow limitation.

[0257] Types of flow limited inspiratory waveforms:(i) Flattened: Having a rise followed by a relatively flat portion, followed by a fall.(ii) M-shaped: Having two local peaks, one at the leading edge, and one at the trailing edge, and a relatively flat portion between the two peaks.(iii) Chair-shaped: Having a single local peak, the peak being at the leading edge, followed by a relatively flat portion.(iv) Reverse-chair shaped: Having a relatively flat portion followed by single local peak, the peak being at the trailing edge.

[0258] Efypopnea'. 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.

[0259] Hyperpnec. An increase in flow to a level higher than normal.

[0260] 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.

[0261] Patency (airway): The degree of the airway being open, or the extent to which the airway is open. A patent airway is open. Airway patency may be quantified, for example with a value of one (1) being patent, and a value of zero (0), being closed (obstructed).

[0262] Positive End-Expiratory Pressure (PEEP) '. The pressure above atmosphere in the lungs that exists at the end of expiration.

[0263] Peak flow rate (Qpeakf. The maximum value of flow rate during the inspiratory portion of the respiratory flow waveform.

[0264] 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.

[0265] 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.

[0266] Inhalation Tim (Ti) The duration of the inspiratory portion of the respiratory flow rate waveform.

[0267] Exhalation Time (Te) The duration of the expiratory portion of the respiratory flow rate waveform.

[0268] 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.

[0269] Typical recent ventilation'. The value of ventilation around which recent values of ventilation Vent over some predetermined timescale tend to cluster, that is, a measure of the central tendency of the recent values of ventilation.

[0270] 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).

[0271] 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.5.7.3 Ventilation

[0272] Adaptive Servo-Ventilator (ASV): A servo-ventilator that has a changeable, rather than fixed target ventilation. The changeable target ventilation may be learned from some characteristic of the patient, for example, a respiratory characteristic of the patient.

[0273] Backup rate: A parameter of a ventilator that establishes the minimum breathing rate (typically in number of breaths per minute) that the ventilator will deliver to the patient, if not triggered by spontaneous respiratory effort.

[0274] Cycled: The termination of a ventilator's inspiratory phase. When a ventilator delivers a breath to a spontaneously breathing patient, at the end of theinspiratory portion of the breathing cycle, the ventilator is said to be cycled to stop delivering the breath.

[0275] 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.

[0276] End expiratory pressure (EEP): Desired interface pressure which the ventilator will attempt to achieve at the end of the expiratory portion of the breath. If the pressure waveform template 11( ) is zero-valued at the end of expiration, i.e. n( ) = 0 when = 1, the EEP is equal to the EPAP.

[0277] Inspiratory positive airway pressure (IPAP): Maximum desired interface pressure which the ventilator will attempt to achieve during the inspiratory portion of the breath.

[0278] 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.

[0279] Servo-ventilator: A ventilator that measures patient ventilation, has a target ventilation, and which adjusts the level of pressure support to bring the patient ventilation towards the target ventilation.

[0280] Spontaneous / Timed (S / T): A mode of a ventilator or other device that attempts to detect the initiation of a breath of a spontaneously breathing patient. If however, the device is unable to detect a breath within a predetermined period of time, the device will automatically initiate delivery of the breath.

[0281] Swing: Equivalent term to pressure support.

[0282] Triggered: When a ventilator, or other respiratory therapy device such as an RPT device or portable oxygen concentrator, delivers a volume of breathable gas to a spontaneously breathing patient, it is said to be triggered to do so. Triggeringusually takes place at or near the initiation of the respiratory portion of the breathing cycle by the patient's efforts.5.7.4 Anatomy5.7.4.1 Anatomy of the face

[0283] Ala: the external outer wall or "wing" of each nostril (plural: alar)

[0284] Alare: The most lateral point on the nasal ala.

[0285] 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.

[0286] Auricle: The whole external visible part of the ear.

[0287] (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.

[0288] (nose) Cartilaginous framework: The cartilaginous framework of the nose comprises the septal, lateral, major and minor cartilages.

[0289] Columella: the strip of skin that separates the nares and which runs from the pronasale to the upper lip.

[0290] 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.

[0291] 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.

[0292] Glabella: Located on the soft tissue, the most prominent point in the midsagittal plane of the forehead.

[0293] 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.

[0294] Lip, lower (labrale inferius):

[0295] Lip, upper (labrale superius):

[0296] 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.

[0297] 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.

[0298] 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.

[0299] Naso-labial angle: The angle between the columella and the upper lip, while intersecting subnasale.

[0300] Otobasion inferior: The lowest point of attachment of the auricle to the skin of the face.

[0301] Otobasion superior: The highest point of attachment of the auricle to the skin of the face.

[0302] Pronasale: the most protruded point or tip of the nose, which can be identified in lateral view of the rest of the portion of the head.

[0303] Philtrum: the midline groove that runs from lower border of the nasal septum to the top of the lip in the upper lip region.

[0304] Pogonion: Located on the soft tissue, the most anterior midpoint of the chin.

[0305] Ridge (nasal): The nasal ridge is the midline prominence of the nose, extending from the Sellion to the Pronasale.

[0306] 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.

[0307] Sellion: Located on the soft tissue, the most concave point overlying the area of the frontonasal suture.

[0308] Septal cartilage (nasal): The nasal septal cartilage forms part of the septum and divides the front part of the nasal cavity.

[0309] Subalare: The point at the lower margin of the alar base, where the alar base joins with the skin of the superior (upper) lip.

[0310] Subnasal point: Located on the soft tissue, the point at which the columella merges with the upper lip in the midsagittal plane.

[0311] Supramenton: The point of greatest concavity in the midline of the lower lip between labrale inferius and soft tissue pogonion5.7.4.1 Anatomy of the skull

[0312] Frontal bone: The frontal bone includes a large vertical portion, the squama frontalis, corresponding to the region known as the forehead.

[0313] Mandible: The mandible forms the lower jaw. The mental protuberance is the bony protuberance of the jaw that forms the chin.

[0314] 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.

[0315] 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.

[0316] 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.

[0317] 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.

[0318] Orbit: The bony cavity in the skull to contain the eyeball.

[0319] Parietal bones: The parietal bones are the bones that, when joined together, form the roof and sides of the cranium.

[0320] 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.

[0321] 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.5.7.4.3 Anatomy of the respiratory system

[0322] 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.

[0323] Larynx: The larynx, or voice box houses the vocal folds and connects the inferior part of the pharynx (hypopharynx) with the trachea.

[0324] 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.

[0325] 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 thefront of the nasal cavity is the nose, while the back blends, via the choanae, into the nasopharynx.

[0326] 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).5.7.5 Patient interface

[0327] 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.

[0328] 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.

[0329] 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.

[0330] Headgear: Headgear will be taken to mean a form of positioning and stabilizing structure designed for use on a head. For example the headgear may comprise a collection of one or more struts, ties and stiffeners configured to locate and retain a patient interface in position on a patient’s face for delivery of respiratory therapy. Some ties are formed of a soft, flexible, elastic material such as a laminated composite of foam and fabric.

[0331] Membrane: Membrane will be taken to mean a typically thin element that has, preferably, substantially no resistance to bending, but has resistance to being stretched.

[0332] 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.

[0333] 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.

[0334] Shell: A shell will be taken to mean a curved, relatively thin structure having bending, tensile and compressive stiffness. For example, a curved structural wall of a mask may be a shell. In some forms, a shell may be faceted. In some forms a shell may be airtight. In some forms a shell may not be airtight.

[0335] Stiffener: A stiffener will be taken to mean a structural component designed to increase the bending resistance of another component in at least one direction.

[0336] Strut: A strut will be taken to be a structural component designed to increase the compression resistance of another component in at least one direction.

[0337] 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.

[0338] Tie (noun): A structure designed to resist tension.

[0339] 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.5.7.6 Shape of structures

[0340] 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-facecontacting (e.g. underside or inner) surface. In another example, a structure may comprise a first surface and a second surface.

[0341] To facilitate describing the shape of the three-dimensional structures and the surfaces, we first consider a cross-section through a surface of the structure at a point, / ?. See Fig. 3B to Fig. 3F, which illustrate examples of cross-sections at point p on a surface, and the resulting plane curves. Figs. 3B to 3F also illustrate an outward normal vector at p. The outward normal vector at p points away from the surface. In some examples we describe the surface from the point of view of an imaginary small person standing upright on the surface.5.7.6.1 Curvature in one dimension

[0342] The curvature of a plane curve at p may be described as having a sign (e.g. positive, negative) and a magnitude (e.g. 1 / radius of a circle that just touches the curve at p).

[0343] Positive curvature: If the curve at p turns towards the outward normal, the curvature at that point will be taken to be positive (if the imaginary small person leaves the point p they must walk uphill). See Fig. 3B (relatively large positivecurvature compared to Fig. 3C) and Fig. 3C (relatively small positive curvature compared to Fig. 3B). Such curves are often referred to as concave.

[0344] Zero curvature: If the curve at p is a straight line, the curvature will be taken to be zero (if the imaginary small person leaves the point p, they can walk on a level, neither up nor down). See Fig. 3D.

[0345] Negative curvature: If the curve at p turns away from the outward normal, the curvature in that direction at that point will be taken to be negative (if the imaginary small person leaves the point p they must walk downhill). See Fig. 3E (relatively small negative curvature compared to Fig. 3F) and Fig. 3F (relatively large negative curvature compared to Fig. 3E). Such curves are often referred to as convex.5.7.6.1 Curvature of two dimensional surfaces

[0346] A description of the shape at a given point on a two-dimensional surface in accordance with the present technology may include multiple normal crosssections. The multiple cross-sections may cut the surface in a plane that includes the outward normal (a “normal plane”), and each cross-section may be taken in a different direction. Each cross-section results in a plane curve with a corresponding curvature. The different curvatures at that point may have the same sign, or a different sign. Each of the curvatures at that point has a magnitude, e.g. relatively small. The plane curves in Figs. 3B to 3F could be examples of such multiple cross-sections at a particular point.

[0347] Principal curvatures and directions: The directions of the normal planes where the curvature of the curve takes its maximum and minimum values are called the principal directions. In the examples of Fig. 3B to Fig. 3F, the maximum curvature occurs in Fig. 3B, and the minimum occurs in Fig. 3F, hence Fig. 3B and Fig. 3F are cross sections in the principal directions. The principal curvatures at p are the curvatures in the principal directions.

[0348] Region of a surface: A connected set of points on a surface. The set of points in a region may have similar characteristics, e.g. curvatures or signs.

[0349] Saddle region: A region where at each point, the principal curvatures have opposite signs, that is, one is positive, and the other is negative (depending on the direction to which the imaginary person turns, they may walk uphill or downhill).

[0350] Dome region: A region where at each point the principal curvatures have the same sign, e.g. both positive (a “concave dome”) or both negative (a “convex dome”).

[0351] Cylindrical region: A region where one principal curvature is zero (or, for example, zero within manufacturing tolerances) and the other principal curvature is non-zero.

[0352] Planar region: A region of a surface where both of the principal curvatures are zero (or, for example, zero within manufacturing tolerances).

[0353] Edge of a surface: A boundary or limit of a surface or region.

[0354] Path: In certain forms of the present technology, ‘path’ will be taken to mean a path in the mathematical - topological sense, e.g. a continuous space curve from f(0) to f(l) on a surface. In certain forms of the present technology, a ‘path’ may be described as a route or course, including e.g. a set of points on a surface. (The path for the imaginary person is where they walk on the surface, and is analogous to a garden path).

[0355] Path length: In certain forms of the present technology, ‘path length’ will be taken to mean the distance along the surface from f(0) to f(l), that is, the distance along the path on the surface. There may be more than one path between two points on a surface and such paths may have different path lengths. (The path length for the imaginary person would be the distance they have to walk on the surface along the path).

[0356] Straight-line distance: The straight-line distance is the distance between two points on a surface, but without regard to the surface. On planar regions, there would be a path on the surface having the same path length as the straight-line distance between two points on the surface. On non-planar surfaces, there may be no paths having the same path length as the straight-line distance between two points.(For the imaginary person, the straight-line distance would correspond to the distance ‘as the crow flies’.)5.7.6.3 Space curves

[0357] Space curves: Unlike a plane curve, a space curve does not necessarily lie in any particular plane. A space curve may be closed, that is, having no endpoints. A space curve may be considered to be a one-dimensional piece of three-dimensional space. An imaginary person walking on a strand of the DNA helix walks along a space curve. A typical human left ear comprises a helix, which is a left-hand helix, see Fig. 3Q. A typical human right ear comprises a helix, which is a right-hand helix, see Fig. 3R. Fig. 3S shows a right-hand helix. The edge of a structure, e.g. the edge of a membrane or impeller, may follow a space curve. In general, a space curve may be described by a curvature and a torsion at each point on the space curve. Torsion is a measure of how the curve turns out of a plane. Torsion has a sign and a magnitude. The torsion at a point on a space curve may be characterised with reference to the tangent, normal and binormal vectors at that point.

[0358] Tangent unit vector (or unit tangent vector): For each point on a curve, a vector at the point specifies a direction from that point, as well as a magnitude. A tangent unit vector is a unit vector pointing in the same direction as the curve at that point. If an imaginary person were flying along the curve and fell off her vehicle at a particular point, the direction of the tangent vector is the direction she would be travelling.

[0359] Unit normal vector: As the imaginary person moves along the curve, this tangent vector itself changes. The unit vector pointing in the same direction that the tangent vector is changing is called the unit principal normal vector. It is perpendicular to the tangent vector.

[0360] Binormal unit vector: The binormal unit vector is perpendicular to both the tangent vector and the principal normal vector. Its direction may be determined by a right-hand rule (see e.g. Fig. 3P), or alternatively by a left-hand rule (Fig. 30).

[0361] Osculating plane: The plane containing the unit tangent vector and the unit principal normal vector. See Figures 30 and 3P.

[0362] Torsion of a space curve: The torsion at a point of a space curve is the magnitude of the rate of change of the binormal unit vector at that point. It measures how much the curve deviates from the osculating plane. A space curve which lies in a plane has zero torsion. A space curve which deviates a relatively small amount from the osculating plane will have a relatively small magnitude of torsion (e.g. a gently sloping helical path). A space curve which deviates a relatively large amount from the osculating plane will have a relatively large magnitude of torsion (e.g. a steeply sloping helical path). With reference to Fig. 3S, since T2>T1, the magnitude of the torsion near the top coils of the helix of Fig. 3S is greater than the magnitude of the torsion of the bottom coils of the helix of Fig. 3S

[0363] With reference to the right-hand rule of Fig. 3P, a space curve turning towards the direction of the right-hand binormal may be considered as having a righthand positive torsion (e.g. a right-hand helix as shown in Fig. 3S). A space curve turning away from the direction of the right-hand binormal may be considered as having a right-hand negative torsion (e.g. a left-hand helix).

[0364] Equivalently, and with reference to a left-hand rule (see Fig. 30), a space curve turning towards the direction of the left-hand binormal may be considered as having a left-hand positive torsion (e.g. a left-hand helix). Hence left-hand positive is equivalent to right-hand negative. See Fig. 3T.5.7.6.4 Holes

[0365] A surface may have a one-dimensional hole, e.g. a hole bounded by a plane curve or by a space curve. Thin structures (e.g. a membrane) with a hole, may be described as having a one-dimensional hole. See for example the one dimensional hole in the surface of structure shown in Fig. 31, bounded by a plane curve.

[0366] A structure may have a two-dimensional hole, e.g. a hole bounded by a surface. For example, an inflatable tyre has a two dimensional hole bounded by the interior surface of the tyre. In another example, a bladder with a cavity for air or gel could have a two-dimensional hole. See for example the cushion of Fig. 3L and the example cross-sections therethrough in Fig. 3M and Fig. 3N, with the interior surface bounding a two dimensional hole indicated. In a yet another example, a conduit may comprise a one-dimension hole (e.g. at its entrance or at its exit), and a two-dimensionhole bounded by the inside surface of the conduit. See also the two dimensional hole through the structure shown in Fig. 3K, bounded by a surface as shown.5.8 OTHER REMARKS

[0367] 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.

[0368] 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.

[0369] 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.

[0370] 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.

[0371] When a particular material is identified as being used to construct a component, obvious alternative materials with similar properties may be used as asubstitute. 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.

[0372] 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.

[0373] 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.

[0374] 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.

[0375] 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.

[0376] 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 bemodified and / or aspects thereof may be conducted concurrently or even synchronously.

[0377] 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.5.9 REFERENCE SIGNS LISTpatient 1000 bed partner 1100 patient interface 3000 seal forming structure 3100 plenum chamber 3200 chord 3210 superior point 3220 inferior point 3230 cushion module 3250 frame 3260 posterior surface 3262 headgear connectors 3270 chassis portion 3280 portion of chassis 3282 opening 3290 lip seal 3292 positioning and stabilising structure 3300 tube 3350 vent 3400 spring clip 3500 upper portion 3510 lateral portion 3520 tabs 3530 anterior face of tab 3532 recess 3540 connection port 3600 forehead support 3700 patient interface 3800 HME 3900 RPT device 4000 humidifier 5000 humidifier inlet 5002 humidifier outlet 5004 humidifier base 5006 humidifier reservoir 5110 conductive portion 5120 reservoir dock 5130 locking lever 5135 water level indicator 5150 heating element 5240mould core 6000

Claims

1. 6 CLAIMS1. A cushion module for a patient interface, the cushion module comprising a seal forming structure connected to a chassis portion, the seal forming structure and chassis portion together defining, at least in part, a plenum chamber,3.the cushion module comprising an opening on an anterior side of the cushion module,4.the cushion module further comprising a spring clip portion configured as an open curve, the spring clip arranged at least partially around the opening, wherein the spring clip portion is configured to connect the cushion module to a frame of the patient interface by engagement of the spring clip portion with at least outer lateral surfaces of the frame.

2. The cushion module of claim 1, wherein the frame is configured to fit within the opening.

3. The cushion module of claim 1 or 2, wherein the opening has a top portion and two lateral side portions, and the spring clip portion extends around the top of the opening and at least partially around each side of the opening.

4. The cushion module of claim any one of the preceding claims, wherein the spring clip portion extends around at least three quarters of the circumference of the opening.

5. The cushion module of any one of claims 1 to 4, wherein the spring clip portion has a substantially transversely extending superior portion and downwardly extending lateral portions extending from the superior portion.

6. The cushion module of claim 5, wherein each of the lateral portions is convex.

7. The cushion module of claims 5 or 6, wherein each lateral portion comprises an inwardly extending protrusion, the protrusions configured to engage corresponding recesses in the frame.

8. The cushion module of any one of claims 1 to 7, wherein the spring clip portion is formed from a harder material than the chassis portion.

9. The cushion module of claim 8, wherein the spring clip portion is made from stainless steel, a thermoplastic, or a high durometer silicone.

10. The cushion module of claim 9, wherein the spring clip portion is made from a silicone with a Shore A durometer hardness of at least 60, more preferably at least 70.

11. The cushion module of any one of the preceding claims, wherein the chassis portion comprises a lip seal adjacent the opening, the lip seal configured to seal between the chassis portion and the frame, in use.

12. A patient interface comprising a cushion module connected to a frame,15.the cushion module comprising a seal forming structure connected to a chassis portion, the seal forming structure and chassis portion together defining, at least in part, a plenum chamber,16.the cushion module comprising an opening on an anterior side of the cushion module,17.the cushion module further comprising a spring clip portion configured as an open curve, the spring clip portion arranged at least partially around the opening, wherein the spring clip portion is configured to connect the cushion module to the frame by engagement of the spring clip portion with at least outer lateral surfaces of the frame.

13. The patient interface of claim 12, wherein the frame is configured to fit within the opening.

14. The patient interface of claim 12 or 13, wherein the frame comprises a plurality of headgear connectors.

15. The patient interface of claim 12, 13 or 14, wherein the frame comprises a connection port.

16. The patient interface of any one of claims 12 to 15, wherein the frame comprises a vent.

17. The patient interface of any one of claims 12 to 16, wherein the frame is configured to engage a heat and moisture exchanger.

18. The patient interface of any one of claims 12 to 17, wherein the spring clip portion has a substantially transversely extending superior portion and downwardly extending lateral portions extending from the superior portion.

19. The patient interface of claim 18, wherein each lateral portion comprises an inwardly extending protrusion, the protrusions configured to engage corresponding recesses in the frame.

20. The patient interface of claim 19, wherein the protrusions comprise a ramp surface configured cause an outward deflection of the lateral portions when the frame is moved into engagement with the cushion module.

21. A method of manufacturing a cushion module comprising the steps of;26.a) moulding a chassis portion around a mould core such that the chassis portion comprises an opening in an anterior face thereof, wherein a spring clip portion is provided around the opening;27.b) forming a seal forming structure around the mould core such that the seal forming structure is connected to the chassis portion; and28.c) removing the mould core from the chassis portion through the opening in the anterior face.

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