Modular headgear

Abstract

A patient interface to deliver air at positive pressure to a patient's airways, the patient interface comprising: a nasal and mouth cushion; a positioning and stabilising structure to provide a force to hold a nasal seal forming structure or a nasal and oral seal forming structure in position on a patient's head, the positioning and stabilising structure comprising a nasal and oral headgear configuration and comprising left and right headgear portions, a pair of nasal headgear clips connecting a nasal headgear at a first angle and / or position to the left and right headgear portions to apply a nasal headgear force to the nasal seal forming structure; and a pair of oral-nasal headgear clips connecting an oral-nasal headgear at a second angle and / or position to the left and right headgear portions to apply an oral-nasal force to the mouth seal forming structure in the oral-nasal configuration. The first angle and / or position is different to the second angle and / or position.

Description

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

[0002] 1 CROSS-REFERENCE TO RELATED APPLICATIONS

[0003] This application claims priority to AU Provisional Application No. 2019902737 filed July 31, 2019, the entire contents of which are incorporated herein by reference. 2 BACKGROUND 2.1 TECHNICAL FIELD

[0006] The present technology relates to one or more of screening, diagnosis, monitoring, treatment, prevention and amelioration of a respiratory-related disorder. The present technology also relates to medical devices or apparatus, and their use.

[0007] 2.2 DESCRIPTION OF RELATED ART

[0008] 2.2.1 The Human Respiratory System and Its Disorders

[0009] The respiratory system facilitates gas exchange. The nose and mouth form the entrance to an airway, which branches into the bronchial tree and eventually to individual respiratory units, the alveoli. The lungs are surrounded by the chest wall, which serves as a resonator and protects the lungs.

[0010] The airways include a series of branching tubes that become narrower, shorter, and more numerous as they penetrate more deeply into the lung. The primary function of the lung is gas exchange, allowing oxygen to move from inhaled air into venous blood and carbon dioxide from venous blood into exhaled air. The trachea divides into the left and right main bronchus, which ultimately subdivide into end- bronchi. The bronchi constitute the conducting airways and do not participate in gas exchange. Further branching of the airways leads to the respiratory bronchioles, and ultimately the pulmonary alveolar regions. The pulmonary blood vessels run in the interstitium of the lung in parallel to the airways. The pulmonary capillary region, where pulmonary capillaries run parallel to the alveolar ducts, constitutes the area of the lung where gas exchange occurs. See West, John B. Respiratory Physiology, 9thedition, Lippincott Williams & Wilkins, 2012.

[0011] There is a range of respiratory disorders. Certain disorders can be characterised by particular events, such as apnoeas, hypopnoeas, and hyperpnoeas.

[0012] Examples of respiratory disorders include obstructive sleep apnoea (OSA), Cheyne-Stokes Respiration (CSR), respiratory insufficiency, Obesity Hypoventilation Syndrome (OHS), Chronic Obstructive Pulmonary Disease (COPD), Neuromuscular Disease (NMD), and Chest Wall Disorders.

[0013] Obstructive Sleep Apnea (OSA) is a form of Sleep Disordered Breathing (SDB) which involves partial or complete obstruction of the upper airway. It is characterized by events including occlusion or obstruction of the upper airway during sleep. It results from a combination of an abnormally small upper airway and muscular tone that is normally reduced during sleep. The condition causes the affected patient to stop breathing for periods of time, typically between 30 seconds and 120 seconds, sometimes 200 to 300 times per night. This often results in excessive daytime sleepiness, and can cause cardiovascular disorders and brain damage. The condition is a common disorder, particularly in middle aged overweight males, although a person affected can have no awareness of the problem. See US Patent No. 4,944,310 (Sullivan).

[0014] Cheyne-Stokes Respiratory (CSR) is another form of Sleep Disordered Breathing. CSR is a disorder of central origin in which there is a rhythmic alternating period of increasing and decreasing ventilation called a CSR cycle. CSR is characterised by repetitive hypovenilation and hyperpnoea of arterial blood. CSR can be harmful due to the repetitive hypercapia. In some patients CSR is associated with repetitive arousal from sleep, which results in severe sleep disruption, increased sympathetic activity, and increased afterload. See US Patent No. 6,532,959 (Berthon-Jones).

[0015] Respiratory failure is a term used for disorders of the respiratory system in which there is an inability of the lungs to intake sufficient oxygen or to exhale sufficient CO2 to meet the needs of the patient. Respiratory failure can encompass some or all of the following disorders.

[0016] A patient with respiratory insufficiency, a form of respiratory failure, can experience abnormally shortness of breath on exercise.

[0017] Obesity hypoventilation syndrome (OHS) is defined as the combination of severe obesity and chronic hypercapnia while awake, in the absence of other known causes of hypoventilation. Symptoms include breathlessness, morning headaches, and excessive daytime sleepiness.

[0018] 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, an extended expiratory phase, and loss of the normal elasticity of the lung. Examples of COPD are emphysema and chronic bronchitis. COPD is caused by chronic tobacco smoking (the primary risk factor), occupational exposures, air pollution, and genetic factors. Symptoms include laboured breathing, chronic cough, and sputum production.

[0019] Neuromuscular Disease (NMD) is a broad term that encompasses many diseases and ailments that impair muscle function either directly by intrinsic muscle pathology or indirectly by nerve pathology. Some NMD patients are characterised by progressive muscular impairment leading to loss of ambulation, being wheelchair-bound, dysphagia, 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 leads to 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 shortens life expectancy (e.g. Limb girdle, Facioscapulohumeral, and Myotonic muscular dystrophy). Symptoms of respiratory failure in NMD include: increasing generalised weakness, dysphagia, breathlessness during exercise and at rest, fatigue, sleepiness, morning headache, and difficulty concentrating and mood changes.

[0020] Chest wall disorders are a group of thoracic deformities that result in inefficient coupling of the respiratory muscles to the thoracic cage. The disorders are usually characterised by a restrictive defect and share the potential for long-term hypoxiaemic respiratory failure. Scoliosis and / or kyphoscoliosis can cause severe respiratory failure. Symptoms of respiratory failure include: breathlessness, peripheral oedema, orthopnoea, repeated chest infections, morning headaches, fatigue, poor sleep quality, and loss of appetite.

[0021] A range of therapies have been used to treat or ameliorate such conditions. Furthermore, otherwise healthy individuals can utilise such therapies to prevent the development of respiratory disorders. However, these therapies have a number of drawbacks.

[0022] 2.2.2 Treatment

[0023] Various therapies, such as continuous positive airway pressure (CPAP) therapy, non-invasive ventilation (NIV) and invasive ventilation (IV) have been used to treat one or more of the above respiratory disorders.

[0024] Continuous positive airway pressure (CPAP) therapy has been used to treat obstructive sleep apnoea (OSA). The mechanism of action is that continuous positive airway pressure acts as a pneumatic splint and can 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 can be voluntary and as such, patients can elect not to comply with treatment if they find the apparatus used to provide such therapy to be any one or more of: uncomfortable, difficult to use, expensive, and aesthetically unappealing.

[0025] Non-invasive ventilation (NIV) provides ventilatory support to a patient through the upper airways to assist the patient's breathing and / or to maintain an appropriate oxygen level in the body by doing some or all of the work of breathing. The ventilatory support is provided via a non-invasive patient interface. NIV has been used to treat CSR and respiratory failure, which takes forms such as OHS, COPD, NMD, and Chest Wall Disorder. In some forms, the comfort and effectiveness of these therapies can be improved.

[0026] Non-invasive ventilation (IV) provides ventilatory support to a patient who is unable to breathe effectively on their own, and can be provided using a tracheostomy tube. In some forms, the comfort and effectiveness of these therapies can be improved.

[0027] 2.2.3 Treatment Systems

[0028] These therapies can be provided by a treatment system or device. Such systems and devices can also be used to screen for, diagnose, or monitor a disorder without treating it.

[0029] A treatment system can include a respiratory pressure therapy device (RPT device), an air circuit, a humidifier, a patient interface, and data management.

[0030] Another form of treatment system is a mandibular repositioning device.

[0031] 2.2.3.1 Patient Interface

[0032] A patient interface can be used to interface a respiratory device to its wearer, for example, by providing a flow of air to the entrance of the airways. The flow of air can be provided via a mask to the nose and / or mouth of a patient, a tube to the mouth of a patient, or a tracheal tube to the tracheal of a patient. The patient interface can form a seal, e.g., with areas of the patient's face, to facilitate delivery of gas at a pressure sufficient to effect therapy, e.g., positive pressure of about 10 cm H20 relative to ambient pressure. For other forms of therapy, such as the delivery of oxygen, the patient interface can not include a seal sufficient to facilitate delivery to the airways of a supply of gas at a pressure of about 10 cm H20 relative to ambient pressure.

[0033] Certain other mask systems can not be functionally suitable for use in the art. For example, purely decorative masks can not be able to maintain an appropriate pressure. Mask systems used for underwater swimming or diving can be configured to prevent water from the higher pressure outside from entering, but do not maintain the air inside at a higher pressure than ambient.

[0034] Certain masks can be clinically disadvantageous for the present technology, for example, where they obstruct airflow through the nose and only allow it through the mouth.

[0035] If some masks require the patient to insert a portion of the mask structure into their mouth to create and maintain a seal through their lips, this can be uncomfortable or impractical for the present technology.

[0036] Some masks can not be achievable for use while sleeping, for example while sleeping on one's side in bed with one's head on a pillow.

[0037] The design of patient interfaces presents several challenges. The surface has a complex three-dimensional shape. The size and shape of the nose and head varies greatly between individuals. As the head comprises bone, cartilage, and soft tissue, different regions of the face respond differently to mechanical forces. The lower jaw or mandible can move relative to other bones of the skull. The entire head can move over the course of a respiratory therapy session.

[0038] Due to these challenges, some masks face one or more of the following issues: obtrusive, unaesthetic, expensive, disproportionate, difficult to use, and uncomfortable, particularly when worn for a long period of time or when the patient is not familiar with the system. A mask that is the wrong size can result in reduced compliance, reduced comfort, and poorer patient outcomes. Masks designed only for pilots, masks designed to be part of personal protection equipment, such as filtering masks, SCUBA masks, or masks designed to administer anaesthetics can be acceptable for their original application, but are not as ideally comfortable for long periods of wear, such as several hours. This discomfort can result in reduced patient compliance with therapy. This is even more so if the mask is to be worn during sleep.

[0039] CPAP therapy is very effective at treating certain respiratory disorders, assuming the patient complies with therapy. If the mask is uncomfortable or difficult to use, the patient can not comply with therapy. As it is generally recommended that patients clean their mask on a regular basis, if the mask is difficult to clean, for example difficult to assemble or disassemble, the patient can not clean their mask, which can impact patient compliance.

[0040] While masks for other applications, such as pilots, can not be suitable for treating sleep disordered breathing, masks designed for treating sleep disordered breathing can be suitable for other applications.

[0041] For these reasons, patient interfaces for the delivery of CPAP during sleep form a distinct field.

[0042] 2.2.3.1.1 Seal-forming structure

[0043] A patient interface can include a seal-forming structure. As it is in direct contact with the patient's face, the shape and construction of the seal-forming structure can directly impact the effectiveness and comfort of the patient interface.

[0044] A patient interface can be characterized in part by the design intent of the seal-forming structure to interface with the face in use. In one form of patient interface, the seal-forming structure can include a first sub-portion that forms a seal around the left naris and a second sub-portion that forms a seal around the right naris. In one form of patient interface, the seal-forming structure can include a single element that surrounds both naris in use. Such a single element can be designed to cover, for example, the upper lip region and the bridge of the nose region of the face. In one form of patient interface, the seal-forming structure can include an element that surrounds the mouth region in use, for example, by forming a seal over the lower lip region of the face. In one form of patient interface, the seal-forming structure can include a single element that surrounds both naris and the mouth region in use. These different types of patient interfaces can be variously named by their manufacturers, including nasal masks, full-face masks, nasal pillows, nasal puffs, and mouth-nose masks.

[0045] A seal-forming structure that can be effective in one region of a patient's face can not be suitable in another region, for example, because of the different shape, structure, variability, and sensitive areas of a patient's face. For example, a seal on a swimming goggle that covers a patient's forehead can not be suitable for use on a patient's nose.

[0046] Certain seal-forming structures can be designed for mass production, such that one design is suitable, comfortable, and effective for a wide range of different face shapes and sizes. To the extent there is a mismatch between the shape of a patient's face and the seal-forming structure of a mass-produced patient interface, one or both must accommodate to form a seal.

[0047] One type of seal-forming structure extends around the periphery of a patient interface and is intended to seal against a patient's face when a force is applied to the patient interface while the seal-forming portion is in confronting engagement with the patient's face. The seal-forming structure can include an air or fluid-filled cushion, or a molded or shaped surface of a resilient sealing element made of an elastomer such as rubber. With this type of seal-forming structure, if the fit is not adequate, there will be a gap between the seal-forming structure and the face, and additional force will be required to force the patient interface against the face to achieve a seal.

[0048] Another type of seal-forming structure incorporates a sheet-like seal of thin material around the periphery of the mask to provide a self-sealing action against a patient's face when positive pressure is applied within the mask. Similar to the previous type of seal-forming portion, if the fit between the face and the mask is not good, additional force can be required to achieve a seal, or the mask can leak. Furthermore, if the shape of the seal-forming structure does not match the shape of the patient, it can wrinkle or buckle in use, causing a leak.

[0049] Another type of seal-forming structure can include a friction fit element, for example for insertion into a nare, however some patients find these uncomfortable.

[0050] Another form of seal-forming structure can use an adhesive to achieve a seal. Some patients can find it inconvenient to apply and remove adhesive from their face on a regular basis.

[0051] 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.

[0052] One form of nasal pillow is found in the Adam Circuit manufactured by Puritan Bennett. Another nasal pillow or nasal prong is the subject of US Patent 4,782,832 (Trimble et al) assigned to Puritan-Bennett Corporation.

[0053] ResMed Limited has manufactured the following products incorporating nasal pillows: TM Nasal pillow mask, SWIFT TM II Nasal pillow mask, SWIFT TM LT Nasal pillow mask, SWIFT TM FX Nasal pillow mask and MIRAGE LIBERTY TM Full face mask. The following patent applications assigned to ResMed Limited describe examples of nasal pillow masks: International Patent Application WO 2004 / 073,778 (which describes aspects of the ResMed Limited SWIFT TM Nasal pillow), US Patent Application 2009 / 0044808 (which describes aspects of the ResMed Limited SWIFT TM LT nasal pillow); International Patent Application WO 2005 / 063,328 and WO 2006 / 130,903 (which describe aspects of the ResMed Limited MIRAGE LIBERTY TM Full face mask); International Patent Application WO 2009 / 052,560 (which describes aspects of the ResMed Limited SWIFT TM FX nasal pillow).

[0054] 2.2.3.1.2 Positioning and stabilisation

[0055] Seal-forming structures of patient interfaces for positive air pressure therapy are subject to respective forces of the air pressure that are to break the seal. Accordingly, various techniques have been used to position the seal-forming structure and maintain it in sealing relationship with the appropriate portion of the face.

[0056] One technique is the use of adhesives. See, for example, US Patent Application Publication US 2010 / 0000534. However, the use of adhesives can be uncomfortable for some people.

[0057] Another technique is the use of one or more straps and / or stabilizing ligatures. Many such ligatures suffer from one or more of being unsuitable, bulky, uncomfortable and inconvenient to use.

[0058] 2.2.3.2 Respiratory pressure therapy (RPT) device

[0059] A respiratory pressure therapy (RPT) device can be used alone or as part of a system to deliver one or more of a number of therapies described above, for example, by operating the device to generate a flow of air for delivery to an interface to the airways. The flow of air can be pressurised. Examples of RPT devices include CPAP devices and ventilators.

[0060] Air pressure generators are known in the range of applications such as industrial scale ventilation systems. However, air pressure generators for medical applications have specific requirements that are not met by more general air pressure generators, such as reliability, size and weight requirements of medical devices. Furthermore, even devices designed for medical use can suffer from drawbacks relating to one or more of comfort, noise, ease of use, efficacy, size, weight, manufacturability, cost and reliability.

[0061] One example of a particular requirement of certain RPT devices is noise.

[0062] Table of noise output levels of existing RPT devices (only one sample, measured at 10 cmH20 in CPAP mode using the test method specified in ISO 3744).

[0063]

[0064]

[0065] One known RPT device for treating sleep disordered breathing is the S9 Sleep Therapy System, manufactured by ResMed Limited. Another example of an RPT device is a ventilator. Ventilators, such as the ResMed Stellar™ Series of Adult and Paediatric Ventilators, can provide a range of invasive and non-invasive non- dependent ventilation support to a range of patients to treat a number of conditions such as, but not limited to, NMD, OHS and COPD. TM The ResMed Stellar™ Series of Adult and Paediatric Ventilators can provide a range of invasive and non-invasive non-dependent ventilation support to a range of patients to treat a number of conditions such as, but not limited to, NMD, OHS and COPD.

[0066] ResMed Elisée TM 150 ventilators and ResMed VS III TM Ventilators provide support for invasive and non-invasive dependent ventilation for adult or pediatric patients, treating a variety of conditions. These ventilators offer volume-based and pressure-based ventilation modes with single-limb or dual-limb circuits. RPT devices typically include a pressure generator, such as a motor-driven blower or compressed gas reservoir, and are configured to supply airflow to the patient's airway. In some cases, the airflow can be supplied to the patient's airway at positive pressure. The RPT device's outlet is connected via an air circuit to a patient interface such as those described above.

[0067] This provides designers with countless options. Design standards often conflict, meaning that some design choices deviate from the norm or are unavoidable. Furthermore, certain aspects of comfort and efficiency may be highly sensitive to minute variations in one or more parameters.

[0068] 2.2.3.3 Humidifier

[0069] Delivering an unhumidified airflow can lead to airway dryness. Using a humidifier with an RPT device and patient interface to generate humidified gas minimizes dryness of the nasal mucosa and increases patient airway comfort. Furthermore, in colder climates, warm air applied to the patient interface and the facial area around the patient interface is generally more comfortable than cold air.

[0070] Many artificial humidification devices and systems are known, however, they do not meet the specific requirements of medical humidifiers.

[0071] Medical humidifiers are used to increase the humidity, temperature (or both) of an airflow relative to ambient air, typically when the patient is asleep or resting (e.g., in a hospital). Bedside medical humidifiers can be small. Medical humidifiers can be configured to humidify and / or heat only the airflow delivered to the patient, without humidifying and / or heating the patient's surrounding environment. Room-based systems (e.g., saunas, air conditioners, evaporative coolers, etc.) can also humidify the air inhaled by the patient; however, these systems also humidify and / or heat the entire room, which can make the occupant uncomfortable. Furthermore, medical humidifiers can have more stringent safety constraints than industrial humidifiers.

[0072] While many medical humidifiers are known, they may have one or more drawbacks. Some medical humidifiers may provide insufficient humidification, and some may be difficult or inconvenient for patients to use.

[0073] 2.2.3.4 Data Management

[0074] There are many clinical reasons to obtain data to determine whether a patient is “adhering” to a prescription treatment for respiratory therapy, such as if the patient has used their RPT device according to one or more “adherence rules.” One example of an adherence rule for CPAP therapy is to require the patient to use their RPT device for at least four hours each night for at least 21 or 30 consecutive days to be considered adherent. To determine patient adherence, RPT device providers, such as healthcare providers, can manually obtain data describing the patient’s treatment with the RPT device, calculate usage over the predetermined time period, and compare it to the adherence rules. Once the healthcare provider has determined that the patient has used their RPT device according to the adherence rules, the healthcare provider can inform the patient of the third part of adherence.

[0075] Patient treatment can benefit from other aspects of communication between treatment data and third-party or external systems.

[0076] Existing methods for communicating and managing such data may be one or more of the following: expensive, time-consuming, and error-prone.

[0077] 2.2.3.5 Mandibular repositioning

[0078] A mandibular repositioning device (MRD) or mandibular advancement device (MAD) is one of the treatment options for sleep apnea and snoring. It is an adjustable oral appliance, available from a dentist or other vendor, that holds the lower jaw (mandible) in an forward position during sleep. An MRD is a removable device that the patient inserts into their mouth before falling asleep and removes it after falling asleep. Therefore, an MRD is not designed to be worn all the time. MRDs can be custom-made or manufactured in standard form and include occlusal impression portions designed to allow fitting to the patient's teeth. This mechanical protrusion of the jaw expands the space behind the tongue, applies tension to the pharyngeal walls to reduce airway collapse and palatal vibration.

[0079] In some instances, a mandibular advancement device may include an upper splint designed to engage or engage with teeth in the maxilla or mandible, and a lower splint designed to engage or engage with teeth in the maxilla or mandible. The upper and lower splints are laterally connected together by a pair of links. The pair of links are symmetrically fixed to the upper and lower splints.

[0080] In this design, the length of the connecting rod is chosen so that the mandible remains in an anteriorly protruded position when the MRD is placed in the patient's mouth. The length of the connecting rod can be adjusted to change the degree of mandibular protrusion. The dentist can determine the level of mandibular protrusion, which will determine the length of the connecting rod.

[0081] Some MRDs are constructed to push the mandible forward relative to the maxilla, while others (such as ResMed Narval CC)TM The MRD is designed to hold the mandible in an anterior position. The device also reduces or minimizes the side effects of dentistry and the temporomandibular joint (TMJ). It is therefore configured to minimize or prevent any movement of one or more teeth.

[0082] 2.2.3.6 Ventilation Port Technology

[0083] Some forms of therapy systems can include a ventilation port to allow flushing of exhaled carbon dioxide. The ventilation port can allow gas to flow from an interior space of the patient interface, such as a plenum chamber, to an exterior space of the patient interface, such as to ambient.

[0084] The ventilation port can include an orifice and in use of the mask gas can flow through the orifice. Many such ventilation ports are noisy. Others can become occluded in use, thereby providing inadequate flushing. Some ventilation ports can disturb the sleep of a bed partner 1100 of the patient 1000, for example, by noise or by disturbance of the flow of gas.

[0085] Resmed Limited has developed a number of improved mask ventilation technologies. See International Patent Application Publication No. WO 1998 / 034,665; and International Patent Application Publication No. WO 2000 / 078,381; U.S. Patent No. 6,581,594; U.S. Patent Application Publication No. US 2009 / 0050156; U.S. Patent Application Publication No. 2009 / 0044808.

[0086] Noise table for existing masks (ISO 17510-2:2007, 10 cm H20 pressure at 1 m)

[0087]

[0088] (* only one sample, measured at 10 cm H20 in CPAP mode using test method specified in ISO 3744)

[0089] The sound pressure values for various objects are listed below

[0090]

[0091] 2.2.4 Screening, Diagnosis and Monitoring Systems

[0092] Polysomnography (PSG) is a conventional system for diagnosing and monitoring cardiopulmonary disorders, and typically involves a clinical specialist to apply the system. PSG typically involves placing 15 to 20 contact sensors on a patient to record various body signals, such as electroencephalography (EEG), electrocardiography (ECG), electrooculography (EOG), electromyography (EMG), etc. PSG for sleep disordered breathing involves observing a patient for two nights in a clinic, one night purely for diagnosis and a second night for the clinician to titrate treatment parameters. PSG is therefore expensive and inconvenient. In particular, it is not suitable for home screening / diagnosis / monitoring of sleep disordered breathing.

[0093] Screening and diagnosis generally describe identifying a disorder from signs and symptoms of the disorder. Screening typically gives a true / false result indicating whether the patient's SDB is severe enough to warrant further investigation, whereas diagnosis can produce clinically actionable information. Screening and diagnosis tend to be one-off processes, whereas monitoring the progression of the condition can continue indefinitely. Some screening / diagnosis systems are suitable only for screening / diagnosis, whereas some can also be used for monitoring.

[0094] A clinical specialist can be able to adequately screen, diagnose or monitor a patient from visual observation of PSG signals. However, there are situations where a clinical specialist can not be available or can not be affordable. Different clinical specialists can disagree on a patient's condition. Furthermore, a given clinical specialist can apply different criteria at different times. 3SUMMARY

[0096] The present technology is directed towards providing a medical device for screening, diagnosing, monitoring, ameliorating, treating or preventing a respiratory disorder, with one or more of improved comfort, cost, efficacy, ease of use and manufacturability.

[0097] A first aspect of the present technology concerns apparatus for screening, diagnosing, monitoring, ameliorating, treating or preventing a respiratory disorder.

[0098] A further aspect of the present technology concerns methods for screening, diagnosing, monitoring, ameliorating, treating or preventing a respiratory disorder.

[0099] One aspect of certain forms of the present technology is to provide methods and / or apparatus to improve patient compliance with respiratory therapy.

[0100] One aspect of the present technology concerns a patient interface comprising: a cushion assembly comprising: a seal-forming structure constructed and arranged to form a seal with the patient's nasal and / or oral airways; and a positioning and stabilising structure to hold the cushion in position on the patient's head during therapy.

[0101] One aspect of the present technology relates to a patient interface for delivering a flow of air at a positive pressure with respect to ambient air pressure to an entrance of a patient’s airways including at least entrance of a patient’s nares, to improve sleep disordered breathing, while the patient is sleeping, the patient interface comprising:

[0102] a nasal cushion forming at least a portion of a plenum chamber pressurisable to a therapeutic pressure, wherein the nasal cushion comprises a nasal seal-forming structure configured and arranged to form a seal with a region of the patient’s face surrounding the entrance to the patient’s nares;

[0103] a mouth cushion pressurisable to the therapeutic pressure, wherein the mouth cushion comprises a mouth seal-forming structure configured and arranged to form a seal with a region of the patient’s face surrounding the entrance to the patient’s mouth;

[0104] a positioning and stabilising structure to provide a force to hold the nasal seal-forming structure or the nasal seal and the mouth seal-forming structure in a therapeutically effective position on the patient’s head, the positioning and stabilising structure comprising a nasal headgear configuration and an orinasal headgear configuration, the positioning and stabilising structure comprising a left headgear portion and a right headgear portion, the left and right headgear portions each being adapted to pass down a patient’s cheek, below the patient’s eye, and between the patient’s eye and ear;

[0105] a pair of nasal headgear clips connecting nasal headgear to the left and right headgear portions at a first angle and / or position to ensure that appropriate nasal headgear forces are applied to the nasal seal-forming structure when the patient wears the nasal cushion alone; and

[0106] a pair of nasal headgear clips connecting nasal headgear to the left and right headgear portions at a first angle and / or position to ensure that appropriate nasal headgear forces are applied to the nasal seal-forming structure when the patient wears the nasal cushion alone; and wherein the first angle and / or position is different to the second angle and / or position.

[0107] Another aspect of the present technology is to provide a modular headgear in which a patient interface is convertible between a nasal mask and an orinasal mask, and different headgear configurations are provided that are suitable for each. The nasal mask component can be the same for the nasal mask and the orinasal mask, and different headgear configurations can be connected to the nasal mask component (e.g. via headgear tubes) using first and second sets of clips having predetermined orientations that position and / or angle the one or more straps of the nasal headgear configuration differently to the one or more straps of the orinasal headgear configuration. The set of clips for the orinasal headgear configuration can be permanently attached to the straps of the orinasal headgear configuration, and the set of clips for the nasal headgear configuration can be permanently attached to the straps of the nasal headgear configuration.

[0108] In examples, the patient interface can include one or more of the following features: (a) the mouth-nose head strap clip is permanently connected to the mouth-nose head strap and / or the nasal head strap clip is permanently connected to the nasal head strap; (b) the mouth-nose clip includes indicia indicating use with the nasal / mouth cushion and / or mouth-nose head strap, and the nasal clip includes indicia indicating use with the nasal cushion and / or nasal head strap; (c) the nasal head strap clip has a shape that is different than the shape of the mouth-nose head strap clip; (d) each of the nasal head strap clip and the mouth-nose head strap clip is generally wedge-shaped, having one major side along the left and right head strap portions, an opposite side for connection to the mouth-nose head strap, an upper side, and a lower side, the upper side being wider than the lower side; (e) the major sides of the nasal clip and mouth-nose clip are the same, and the upper side of the nasal head strap clip is longer than the upper side of the mouth-nose head strap clip; (f) the mouth-nose head strap clip includes a slot configured to exclusively receive a mouth-nose head strap tie of the mouth-nose head strap, and the nasal head strap clip is configured to exclusively receive a nasal head strap tie of the nasal head strap; (g) the slot of the mouth-nose head strap clip has a different size / width than the slot of the nasal head strap clip; (h) the head strap clip includes a slot, and the slot in the nasal head strap clip is formed in a lower portion of the nasal head strap clip, and the mouth-nose head strap clip is formed in an upper portion of the mouth-nose head strap clip; (i) each of the left and right head strap portions includes a common connection element that is releasably connectable with the pair of nasal head strap clips, and optionally with the pair of mouth-nose head strap clips; (j) the common connection element includes a groove or a slider; (k) the groove and / or the slider includes a stop to ensure proper depth and / or direction of connection; (l) the common connection element includes a groove, and each clip includes a slider; (m) each of the nasal head strap clips includes a substantially straight nasal head strap clip slot, and each of the mouth-nose head strap clips includes a substantially straight mouth-nose head strap clip slot, the nasal head strap clip slot being formed at a nasal clip slot angle relative to the common connection element, and the mouth-nose clip slot being formed at a mouth-nose clip slot angle that is different than the nasal clip slot angle relative to the common connection element; (n) each of the pair of nasal head strap clips and the pair of mouth-nose head strap clips includes a slot for receiving a top tie of the nasal head strap or the mouth-nose head strap; (o) each of the pair of nasal head strap clips includes a nasal head strap slot, and each of the pair of mouth-nose head strap clips includes a mouth-nose head strap slot, each of the nasal head strap slots being positioned at a different slot angle and / or position relative to the left and right head strap portions than the mouth-nose head strap slots relative to the left and right head strap portions.(p) the orinasal headgear strap includes a pair of upper orinasal straps connectable to the orinasal headgear clips, and the nasal headgear strap includes a pair of upper nasal straps connectable to the nasal headgear clips; (q) the orinasal headgear clips are configured to hold upper ends of the upper orinasal straps in orinasal strap positions, and the nasal headgear clips are configured to hold upper ends of the upper nasal straps in nasal strap positions, the orinasal strap positions being different relative to the left and right headgear portions from the nasal strap positions; (r) the orinasal strap positions are higher than the nasal strap positions; (s) the orinasal headgear clips are configured to hold upper ends of the upper orinasal straps at orinasal strap angles, and the nasal headgear clips are configured to hold upper ends of the upper nasal straps at nasal strap angles, the orinasal strap angles being different relative to the left and right headgear portions from the nasal strap angles; (t) the orinasal strap positions are higher than the nasal strap positions; (u) the orinasal strap angles are less than the nasal strap angles relative to a Frankfort horizontal of the patient; (v) the angles are measured from lower portions of the left and right headgear portions; (w) wherein the mouth cushion comprises a second nasal cushion, or the mouth cushion does not comprise the nasal cushion; (x) the mouth cushion and the nasal cushion are releasably connected to one another; (y) each of the left and right headgear portions comprises a textile strap; (z) each of the left and right headgear portions comprises a hollow tube configured to deliver pressurized gas at the therapy pressure from a rear or crown of the patient's head to the nasal cushion and / or the mouth cushion for breathing by the patient; (aa) each of the hollow tubes supports the nasal cushion and / or the mouth cushion in place on the patient's face; (ab) the patient interface is devoid of a forehead support; (ac) the nasal headgear comprises a first strap and a second strap connected to the nasal headgear clips; (ad) the first and second straps are permanently connected to the nasal headgear clips; (ae) the nasal headgear comprises a central portion having a split, the central portion forming an upper strap portion and a lower strap portion, the upper and lower strap portions having a space therebetween and being adapted to cup the patient's head; (af) the orinasal headgear comprises the nasal headgear and a bottom strap portion releasably connected to the nasal headgear, the bottom strap portion comprising end portions connectable to the mouth cushion; (ag) the orinasal headgear comprises a pair of upper straps, each upper strap having an end portion connected to one of the orinasal headgear clips; (ah) the upper straps are permanently connected to the orinasal headgear clips; (ai) the orinasal headgear comprises a bottom strap portion adapted to pass under the patient's ears, the bottom strap portion comprising a pair of end portions attachable to the mouth cushion; (aj) the orinasal headgear comprises a pair of upper straps connected to the bottom strap portion at an angle forming a generally "V" shape;(al) the nasal headgear and the oral-nasal headgear are length adjustable; (am) each of the left and right headgear portions are releasably connected to the nasal cushion; (an) includes a crown piece connecting the left and right headgear portions, the crown piece including an opening receiving a rotatable elbow; (ao) the nasal seal-forming structure includes a nasal cradle cushion, a nasal cushion, or a pillow adapted to form a seal against an entrance of a patient's nose; and / or (ap) the oral cushion includes a chin support, or does not include a chin support.

[0109] One aspect of the present technology relates to a CPAP system for providing positive pressure gas for respiratory therapy to a patient, the CPAP system comprising an RPT device configured to supply a flow of air at a treatment pressure, a patient interface, and an air delivery conduit configured to deliver the flow of air from the RPT device to the patient interface at the treatment pressure.

[0110] Another aspect of one form of the present technology is a patient interface that is molded or otherwise constructed to have a peripheral shape that is complementary to the peripheral shape of an intended wearer.

[0111] One aspect of one form of the present technology is a method of manufacturing a device.

[0112] One aspect of certain forms of the present technology is a medical device that is easy to use, for example by a person who is not medically trained, by a person with limited dexterity, vision, or by a person with limited experience in using this type of medical device.

[0113] One aspect of one form of the present technology is a patient interface that can be washed in a patient's home, for example, in soapy water, without the need for specialized cleaning equipment.

[0114] The systems and methods described herein provide a technical solution that uses a patient interface to deliver a flow of air to a patient's airways, thereby improving the patient's seal and consistency. To improve the patient's seal and compliance using a patient interface, examples of the present technology provide positioning and stabilising structures that are configurable and adjustable in order to provide a therapeutically effective position and seal for different types of pads, such as (1) a nasal pad including a nasal seal-forming structure configured and arranged to form a seal with a region of the patient's face surrounding an entrance to the patient's nares, and (2) an oral pad including an oral seal-forming structure configured and arranged to form a seal with a region of the patient's face surrounding an entrance to the patient's mouth. The therapeutically effective position and seal are equipped with: a pair of nasal headgear clips connecting nasal headgear at a first angle and / or position to a headgear section to ensure that an appropriate nasal headgear force is applied to the nasal seal-forming structure when the patient is wearing only the nasal pad; and a pair of oral-nasal headgear clips connecting oral-nasal headgear at a second angle and / or position to a headgear section to ensure that an appropriate oral-nasal force is applied to the oral seal-forming structure when the patient is wearing the nasal pad and the oral pad.

[0115] Of course, some of these aspects can form sub-aspects of the present technology. The sub-aspects and / or individual aspects of the aspects can be combined in various ways, and also form further aspects or sub-aspects of the present technology.

[0116] Other features of the present technology will become apparent from consideration of the following detailed description, abstract, drawings and claims as well as the information contained in this summary. 4BRIEF DESCRIPTION OF DRAWINGS

[0118] The present technology is illustrated in the accompanying drawings, throughout which like reference characters refer to similar elements comprising:

[0119] 4.1 THERAPY SYSTEM

[0120] Figure 1A A system is shown including a patient 1000 wearing a patient interface 3000 in the form of a nasal pillow 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.

[0121] Figure 1B A system is shown 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.

[0122] Figure 1C A system is shown including a patient 1000 wearing a patient interface 3000 in the manner 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-lying sleep position.

[0123] 4.2 Respiratory system and facial anatomy

[0124] Figure 2A A diagrammatic view of the human respiratory system is shown, including nasal cavities and oral cavities, larynx, vocal folds, oesophagus, trachea, bronchi, lungs, alveolar sacs, heart and diaphragm.

[0125] Figure 2B A view of the upper airways of a human is shown, including nasal cavities, nasal bones, nasal cartilages, alar cartilages, nostrils, upper lip, lower lip, larynx, hard palate, soft palate, oropharynx, tongue, epiglottis, vocal folds, oesophagus and trachea.

[0126] Figure 2C is a front view of a face with several surface anatomical features identified, including the upper lip, upper vermilion, lower vermilion, lower lip, mouth width, endocanthion, alar base, nasolabial sulcus and labial commissure. Also identified are the superior, inferior, radial-in and radial-out directions.

[0127] Figure 2D is a side view of a head with several surface anatomical features identified, including the glabella, sellion, pronasale, subnasale, upper lip, lower lip, supramenton, nasal ridge, alar crest, otobasion superior and otobasion inferior. Also identified are the superior-inferior and anterior-posterior directions.

[0128] Figure 2E is another side view of a head. The approximate locations of the Frankfort horizontal and nasolabial angle are identified. Also identified is the coronal plane.

[0129] Figure 2F is a bottom view of a nose with several features identified, including the nasolabial sulcus, lower lip, upper vermilion, nostril, subnasale, columella, pronasale, long axis of the nostril and central sagittal plane.

[0130] Figure 2G is a side view of the surface features of a nose.

[0131] Figure 2H is a subdermal structure of a nose, including lateral cartilages, septal cartilage, alar cartilages, alar minor cartilages, ciliary cartilages, nasal bones, epidermis, adipose tissue, frontal process of the maxilla and fibrofatty tissue.

[0132] Figure 2IThe medial anatomy of the nose is shown, a few millimeters medial of the central sagittal plane, showing, among other things, the septal cartilage and the medial crura of the alar cartilages.

[0133] Figure 2J The frontal view of the skull is shown, including the frontal bone, the nasal bone, and the zygomatic bone. The concha is also indicated, as are the maxilla and the mandible.

[0134] Figure 2K The lateral view of the skull is shown, with the surface contours of the head, and several muscles. The following bones are shown: frontal, sphenoid, nasal, zygomatic, maxilla, mandible, parietal, temporal, and occipital. The mental protuberance is also indicated. The following muscles are shown: digastric, masseter, sternocleidomastoid, and trapezius.

[0135] Figure 2L The anterolateral view of the nose is shown.

[0136] 4.3 Patient interface

[0137] Figure 3A A patient interface in the form of a nasal mask according to an form of the present technology is shown.

[0138] Figure 3B A schematic diagram of a cross-section through a structure at a point is shown. The 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 curvature magnitude shown. Figure 3C

[0139] A schematic diagram of a cross-section through a structure at a point is shown. The 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 curvature magnitude shown. Figure 3C Figure 3B A schematic diagram of a cross-section through a structure at a point is shown. The outward normal at the point is indicated. The curvature at the point has a zero value.

[0140] Figure 3D A schematic diagram of a cross-section through a structure at a point is shown. The 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 curvature magnitude shown.

[0141] Figure 3E Figure 3F A schematic diagram of a cross-section through a structure at a point is shown. The 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 curvature magnitude shown.

[0142] Figure 3F A schematic diagram of a cross-section through a structure at a point is shown. The 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 curvature magnitude shown. Figure 3E

[0143] ​​​Figure 3G A cushion for a mask comprising two pillows is shown. The outer surface of the cushion is indicated. The edge of the surface is shown. The dome and saddle regions are shown.

[0144] Figure 3H A cushion for a mask is shown. The outer surface of the cushion is indicated. The edge of the surface is shown. A path on the surface between points A and B is indicated. The straight-line distance between A and B is indicated. Two saddle regions and a dome region are indicated.

[0145] Figure 3I A surface of a structure with a one-dimensional hole on the surface is shown. The planar curve shown forms the boundary of the one-dimensional hole.

[0146] Figure 3J A cross-section through Figure 3I of the structure is shown. The surface shown defines a two-dimensional hole in Figure 3I of the structure.

[0147] Figure 3K A perspective view of Figure 3I of the structure is shown, including a two-dimensional hole and a one-dimensional hole. The surface that bounds the two-dimensional hole in Figure 3I of the structure is also shown.

[0148] Figure 3L A mask with an inflatable bladder as a cushion is shown.

[0149] Figure 3M A cross-section through Figure 3L of the mask is shown, and the inner surface of the bladder is shown. The inner surface bounds a two-dimensional hole in the mask.

[0150] Figure 3N Another cross-section through Figure 3L of the mask is shown. The inner surface is also indicated.

[0151] Figure 3O A left-hand rule is shown.

[0152] Figure 3P A right-hand rule is shown.

[0153] Figure 3Q A left ear, including a left-ear spiral, is shown.

[0154] Figure 3R A right ear, including a right-ear spiral, is shown.

[0155] Figure 3S A right-hand spiral is shown.

[0156] Figure 3T A view of a mask is shown, including the notation of the twist of a space curve defined by the edge of a sealing membrane in different regions of the mask.

[0157] Figure 3U A view of the inflation chamber 3200 is shown, illustrating the sagittal plane and the intermediate contact plane.

[0158] Figure 3V It shows Figure 3U This is a view of the rear of the inflation chamber. The direction of this view is perpendicular to the central contact plane. Figure 3V The sagittal plane in the middle divides the air chamber into two equal parts, left and right.

[0159] Figure 3W It shows crossing Figure 3V The cross-section of the inflation chamber, said cross-section is in Figure 3V The image shows a section taken at the sagittal plane. An "intermediate contact" plane is shown. This intermediate contact plane is perpendicular to the sagittal plane. The orientation of this intermediate contact plane corresponds to the orientation of chord 3210, which lies on the sagittal plane and contacts the liner of the inflation chamber at exactly two points on the sagittal plane (upper point 3220 and lower point 3230). Depending on the geometry of the liner in this region, the intermediate contact plane can be a tangent at the upper and lower points.

[0160] Figure 3X It shows Figure 3U The position of the inflation chamber 3200 on the face. When the inflation chamber is in the use position, the sagittal plane of the inflation chamber 3200 approximately coincides with the central sagittal plane of the face. When the inflation chamber is in the use position, this intermediate contact plane generally corresponds to the 'plane of the face'. Figure 3X In the middle, the inflation chamber 3200 is the inflation chamber of the nose mask, and the upper point 3220 is roughly located on the root of the nose, while the lower point 3230 is located on the upper lip.

[0161] 4.4 Patient Interface According to This Technology

[0162] Figure 4A An example of a configurable patient interface according to this technology is shown.

[0163] Figure 4B A configurable patient interface in an example of a nasal "under" sealed mask configuration according to the present technology is shown.

[0164] Figure 4C A configurable patient interface in a convertible oronasal mask configuration, according to another example of the present technology, is shown.

[0165] Figure 5A A perspective view of a patient interface configured in a nasal configuration according to an example of this technology is shown.

[0166] Figure 5B A side view of a patient interface configured in a nasal configuration according to an example of this technology is shown.

[0167] Figure 5C A rear view of a patient interface configured in a nasal configuration according to an example of the present technology is shown.

[0168] Figure 5D An exploded view of a patient interface in a nasal configuration according to an example of the present technology is shown.

[0169] Figure 6A A perspective view of a patient interface configured in a mouth-nose configuration according to an example of the present technology is shown.

[0170] Figure 6B A side view of a patient interface configured in a mouth-nose configuration according to an example of the present technology is shown.

[0171] Figure 6C A rear view of a patient interface configured in a mouth-nose configuration according to an example of the present technology is shown.

[0172] Figure 6D An exploded view of a patient interface in a mouth-nose configuration according to an example of the present technology is shown.

[0173] Figure 7A A first view of a common connection element disposed on a headgear portion according to an example of the present technology is shown.

[0174] Figure 7B A second view of a common connection element disposed on a headgear portion according to an example of the present technology is shown.

[0175] Figure 7C A third view of a common connection element disposed on a headgear portion according to an example of the present technology is shown.

[0176] Figure 7D A fourth view of a common connection element disposed on a headgear portion according to an example of the present technology is shown.

[0177] Figure 7E Two common connection elements disposed on respective headgear portions according to an example of the present technology are shown.

[0178] Figure 8 A nasal headgear clip according to an example of the present technology is shown.

[0179] Figure 9 A mouth-nose headgear clip according to an example of the present technology is shown. 5DETAILED DESCRIPTION

[0181] Before describing the present technology in further detail, it is to be understood that the technology is not limited to the particular examples, which can vary. It is also to be understood that the terminology used herein is for the purpose of describing particular examples only and is not intended to be limiting.

[0182] The following description provides various examples of things that can share one or more common characteristics and / or features. It should be understood that one or more features of any one example can be combined with one or more features of another example or other instance. Furthermore, in any example, any single feature or combination of features can form another instance.

[0183] 5.1 Treatment

[0184] In one form, the technology includes a method for treating respiratory disorders, the method comprising the step of applying positive pressure to the airway inlet of a patient 1000.

[0185] In some instances of this technique, positive pressure air is supplied to the patient’s nasal passages through one or both nostrils.

[0186] In some examples of this technology, mouth breathing is restricted, constrained, or prevented.

[0187] 5.2 Treatment System

[0188] In one form, the technology includes a device or apparatus for treating respiratory disorders. The device or apparatus may include an RPT device 4000 for supplying pressurized air to a patient 1000 via an air circuit 4170 to a patient interface 3000, for example, see [link to relevant documentation]. Figures 1A to 1C .

[0189] 5.3 Patient Interface

[0190] Reference Appendix Figures 4A to 9 According to one aspect of the present technology, a non-invasive patient interface 3000 delivers a positive pressure airflow relative to the ambient air pressure to the inlet of the patient's airway. The patient interface 3000 includes a positioning and stabilizing structure 3300 comprising a first headband portion 3010 (e.g., a left headband portion) and a second headband portion 3020 (e.g., a right headband portion), each adapted to run along the patient's cheek below the patient's eyes and between the patient's eyes and ears. The positioning and stabilizing structure 3300 may include a nasal headband 3800 or a mouth-nose headband 3900.

[0191] Depending on whether the nasal pad 3050 and / or the mouth pad 3060 are connected to the first and second headband portions, the patient interface 3000 can be switched between a nasal "under-nasal" sealing mask and an oronasal mask. The first headband portion 3010 may include a left common pad interface 3012, and the second headband portion 3020 may include a right common pad interface 3022 for coupling to the nasal pad 3050 and / or the mouth pad 3060. The nasal pad 3050 includes a nasal seal forming structure 3052 configured and arranged to form a seal with a patient facial region surrounding the patient's nasal inlet. The mouth pad 3060 includes a mouth seal forming structure 3062 configured and arranged to form a seal with a patient facial region surrounding the patient's mouth inlet.

[0192] In some forms, the functional aspects may be provided by one or more physical components. In some forms, a single physical component may provide one or more functional aspects. In use, the nasal seal forming structure 3052 and / or the mouth seal forming structure 3062 are arranged around the inlet of the patient's airway to facilitate the supply of positive pressure air to the airway.

[0193] In the illustrated example, the patient interface 3000 includes a connection port or opening 3600 for connection to the air circuit 4170. The patient interface 3000 may include a crown connecting the left and right headband portions, the crown including an opening for receiving a rotatable bend 3650. The connection port rotatable bend 3650 is adapted for connection to the air circuit 4170. Figure 4B As shown, the first headband portion 3010 and the second headband portion 3020 can be connected via the connection port 3600.

[0194] The nasal pad 3050 and / or the mouth pad 3060 form at least a portion of an inflatable chamber 3200 pressurizable to a therapeutic pressure. The inflatable chamber 3200 can receive a pressurized gas flow from an air circuit 4170, which can pass through the nasal seal forming structure 3052 and / or the mouth seal forming structure 3062 and enter the patient's airway for inhalation.

[0195] If the patient interface cannot comfortably deliver a minimum level of positive pressure to the airway, the patient interface may not be suitable for respiratory pressure therapy.

[0196] According to one form of the present technology, a patient interface 3000 is constructed and arranged to supply air at a positive pressure of at least 6 cm H2O relative to the environment.

[0197] According to one form of the present technology, a patient interface 3000 is constructed and arranged to supply air at a positive pressure of at least 10 cm H2O relative to the environment.

[0198] The patient interface 3000 according to one form of the present technology is structured and arranged to be capable of supplying air at positive pressure of at least 20 cm H20 relative to ambient.

[0199] 5.3.1 Seal-forming structure

[0200] In one form of the present technology, the seal-forming structure can be a nasal seal-forming structure 3052 or an oral seal-forming structure 3062 which provides a target seal-forming region and can additionally provide a cushioning function. The target seal-forming region is the region on the nasal seal-forming structure 3052 or oral seal-forming structure 3062 where a seal is likely to occur. The region where a seal actually occurs - the actual sealing surface - can depend on whether a nasal cushion 3050 or an oral cushion 3060 is being used, and can vary from day to day and from patient to patient within a given treatment regime, depending on a range of factors including, for example, the position in which the patient interface is placed on the face, the tension in the positioning and stabilising structure, and the shape of the patient's face.

[0201] In one form, the target seal-forming region is located on an outer surface of the nasal seal-forming structure 3052 and / or the oral seal-forming structure 3062.

[0202] In certain forms of the present technology, the nasal seal-forming structure 3052 and / or the oral seal-forming structure 3062 is constructed from a biocompatible material, for example silicone rubber.

[0203] The nasal seal-forming structure 3052 and / or the oral seal-forming structure 3062 according to the present technology can be constructed from a soft, flexible, resilient material such as silicone.

[0204] In certain forms of the present technology, a system is provided which includes more than one nasal seal-forming structure 3052 and / or oral seal-forming structure 3062, each configured to correspond to a different size and / or shape range. For example, the system can include one form of seal-forming structure which is suitable for a large size head but not a small size head, and another which is suitable for a small size head but not a large size head.

[0205] 5.3.1.1 Seal mechanism

[0206] In one form, the nasal seal-forming structure 3052 and / or the oral seal-forming structure 3062 includes a seal flange which utilises a pressure-assisted seal mechanism. In use, the seal flange is able to readily respond to the system positive pressure acting on its underside from within the plenum chamber 3200, thereby causing it to form a tight sealing engagement with the face. This pressure-assisted mechanism can act in conjunction with the elastic tension in the positioning and stabilising structure.

[0207] In one form, the nasal seal-forming structure 3052 and / or the oral seal-forming structure 3062 includes a sealing flange and a support flange. The sealing flange includes a relatively thin member having a thickness of less than about 1 mm, for example about 0.25 mm to about 0.45 mm, which extends around the periphery of the plenum chamber 3200. The support flange can be relatively thicker than the sealing flange. The support flange is disposed between the sealing flange and the edge of the plenum chamber 3200 and extends around at least a portion of the path of the perimeter. The support flange is or includes a spring-like element and acts to support the sealing flange in use to prevent it from buckling.

[0208] In one form, the nasal seal-forming structure 3052 and / or the oral seal-forming structure 3062 can include a compression seal portion or a gasket seal portion. In use, the compression seal portion or the gasket seal portion is configured and disposed to be in compression, for example as a result of the elastic tension in the positioning and stabilising structure.

[0209] In one form, the nasal seal-forming structure 3052 and / or the oral seal-forming structure 3062 includes a tensioned portion. In use, the tensioned portion is held under tension, for example by adjacent regions of the sealing flange.

[0210] In one form, the nasal seal-forming structure 3052 and / or the oral seal-forming structure 3062 includes a region having a tacky or adhesive surface.

[0211] In certain forms of the present technology, the nasal seal-forming structure 3052 and / or the oral seal-forming structure 3062 can include one or more of a pressure- assisted sealing flange, a compression seal portion, a gasket seal portion, a tensioned portion, and a portion having a tacky or adhesive surface.

[0212] 5.3.1.2 Nasal bridge or nasal ridge region

[0213] In one form, the non-invasive patient interface 3000 includes a seal-forming structure that forms a seal on the nasal bridge or nasal ridge region of the patient’s face in use.

[0214] In one form, the seal-forming structure includes a saddle region configured to form a seal on the nasal bridge region or the nasal ridge region of the patient’s face.

[0215] 5.3.1.3 Upper lip region

[0216] In one form, the non-invasive patient interface 3000 includes a seal-forming structure that forms a seal on the upper lip region (i.e. the upper lip) of the patient’s face in use.

[0217] In one form the seal-forming structure includes a chin region configured to form a seal on the chin region of the face of a patient in use.

[0218] 5.3.1.4 Chin region

[0219] In one form the non-invasive patient interface 3000 includes a seal-forming structure which forms a seal on the chin region of the face of a patient in use.

[0220] In one form the seal-forming structure includes a chin region configured to form a seal on the chin region of the face of a patient in use.

[0221] 5.3.1.5 Forehead region

[0222] In one form the seal-forming structure forms a seal on the forehead region of the face of a patient in use. In this form the plenum chamber can cover the eyes in use.

[0223] 5.3.1.6 Nasal pillows

[0224] In one form the seal-forming structure of the non-invasive patient interface 3000 includes a pair of nasal puffs or pillows, each nasal puff or pillow being constructed and arranged to form a seal with a respective naris of the patient's nose.

[0225] A nasal pillow according to one aspect of the present technology includes a frusto-conical body which forms a seal on an underside of a patient's nose, a stem, and a flexible region on the underside of the frusto-conical body and connecting the frusto-conical body to the stem. Further, the nasal pillow of the present technology includes a flexible region proximate the underside of the stem. The flexible regions can act in concert to facilitate a universal joint structure which is able to accommodate relative movement of both displacement and angular between the frusto-conical body and the stem proximate structure. For example, the position of the frusto-conical body can be moved axially towards the stem proximate structure.

[0226] 5.3.1.7 Nasal and / or oral cushion

[0227] Figures 4A to 6DA seal-forming structure 3052 of a nasal cushion 3050 according to an example of the present technology is shown. In the illustrated example, the example seal-forming structure 3052 can be considered a nasal cradle cushion, and is intended to provide a flow of pressurized gas to the patient's nares by sealing at least to the underside of the patient's nose. The example seal-forming structure 3052 will engage the patient's face below the nasal bridge, and depending on the size and shape of the patient's nose, some examples can engage the patient's nose below the nasal tip. The example seal-forming structure 3052 can also engage the patient's face at least above the upper lip line. Thus, the example seal-forming structure 3052 can seal against the patient's upper lip in use. Furthermore, the patient's mouth can remain uncovered by the seal-forming structure 3052 of the depicted example, such that the patient can breathe freely, i.e. directly to atmosphere, without interference from the seal-forming structure 3052. In some examples, the nasal seal-forming structure 3052 comprises a nasal cradle cushion, nasal cushion, or pillow cushion adapted to form a seal against the entrance of the patient's nose.

[0228] Figures 4A to 6D Seal-forming structures 3052 and 3062 of nasal and mouth cushions 3050 and 3060, respectively, according to examples of the present technology are shown. In some examples, a combined nasal and mouth cushion 3050 and 3060 can be referred to as a full-face cushion or oronasal cushion. In the illustrated example, the seal-forming structure 3062 can provide a flow of pressurized gas to the patient's mouth by sealing over at least a portion of the patient's mouth. The example seal-forming structure 3062 will engage the patient's face around the mouth. In some examples, the seal-forming structure can also engage the underside of the patient's nose and / or the patient's face below the nasal bridge. The example seal-forming structure 3062 can engage the patient's face above the upper lip line and / or below the lower lip line. Thus, the example seal-forming structure 3062 can seal the patient's face around the mouth in use. In some forms of the present technology, the mouth cushion 3060 can comprise a second nasal cushion, or the mouth cushion can not comprise a nasal cushion. In some forms of the present technology, the mouth cushion 3062 and the nasal cushion 3050 are releasably connected to one another.

[0229] An example nasal cradle cushion can comprise an upper saddle or concave region having positive curvature on the cushion. Also, a nasal cradle cushion can be understood to have a single target seal-forming region or surface, as opposed to a nasal pillow cushion which can have two target seal-forming regions (one for each naris). The cradle cushion can also have a back wall that contacts the upper portion of the patient's lip and an upper central surface that contacts the underside of the patient's nose. These two surfaces of the patient's face can form a nasolabial angle therebetween (see Figure 2E ) between 90 degrees and 120 degrees.

[0230] Further, the shape and size of the example seal-forming structure 3052 can also be designed so that no part of the seal-forming structure 3052 enters the patient's nares during use.

[0231] In an example, the example seal-forming structure 3052 and / or 3062 can include at least two regions of different thickness. In an example, the different thicknesses can be created by extending regions of different thicknesses different distances into the interior of the seal-forming structure 3052 and / or 3062, such that the outer surface of the seal-forming structure 3052 and / or 3062 remains smooth. At the transition region between the regions of different thickness, the outer surface can not be uniform. Thus, the exterior of the example seal-forming structure 3052 and / or 3062 is continuous and smooth.

[0232] In an example, the nare openings can be formed to generally align with the respective nares of the patient to provide a flow of pressurized gas to the patient's nares for inhalation.

[0233] In an example, the seal-forming structure 3052 and / or 3062 in different examples can have different sizes and shapes, and thus each variant can provide an optimal fit for patients with noses and mouths of different shapes and sizes.

[0234] In an example, the seal-forming structure 3052 and / or 3062 can include two or more different sizes / shapes. For example, the size and / or profile of the seal-forming structure can vary to provide a selectable seal-forming surface for different patients.

[0235] In an example, one or more thickened portions (e.g., of silicone) can be provided to one or more regions of the seal-forming structure 3052 and / or 3062 to increase support and stability to the one or more regions, for example, to ensure cushion stability and sealing performance. In an example, the one or more thickened portions can be created by increasing the thickness of the seal-forming structure 3052 and / or 3062 in the one or more regions that enter the interior of the seal-forming structure 3052 and / or 3062, such that the outer surface of the seal-forming structure 3052 and / or 3062 remains continuous and smooth. The one or more thickened portions can include thicknesses that are similar to or different from one another. In an example, the thickness of the one or more thickened portions and / or the specific location of the one or more thickened portions along the seal-forming structure 3052 and / or 3062 can depend at least in part on the size of the seal-forming structure 3052 and / or 3062.

[0236] 5.3.2 Frame

[0237] In an example, the nasal seal-forming structure 3052 and / or the oral seal-forming structure 3062 can be connected to a frame.

[0238] The frame can be permanently (e.g., overmolded) or removably (e.g., interference fit assembly) connected to the seal-forming structure. For example, the nasal seal-forming structure 3052 and / or the oral seal-forming structure 3062 can be connected to the frame, together comprising an overmolded structure to form a single-piece integrated component.

[0239] 5.3.3 Plenum chamber

[0240] In use, the plenum chamber 3200 has a perimeter that is shaped to complement the surface contours of an average human face. In use, the bounding edges of the plenum chamber 3200 are positioned in close proximity to the adjacent surfaces of the face. Actual contact with the face is provided by the seal-forming structure 3052 and / or 3062. The seal-forming structure 3052 and / or 3062 can extend, in use, along the entire perimeter of the plenum chamber 3200. In some forms, the plenum chamber 3200 and the seal-forming structure 3052 and / or 3062 are formed from a single sheet of homogenous material.

[0241] In certain forms of the present technology, the plenum chamber 3200 does not cover the eyes of the patient in use. In other words, these eyes are outside the pressurized volume defined by the plenum chamber. Such forms tend to be less obtrusive and / or more comfortable for the wearer, which can improve compliance with therapy.

[0242] In certain forms of the present technology, the plenum chamber 3200 is constructed from a transparent material, for example, 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 help the clinician observe how the patient interface is positioned and functioning.

[0243] 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.

[0244] 5.3.4 Positioning and stabilising structure

[0245] The nasal seal-forming structure 3052 and / or the oral seal-forming structure 3062 of the patient interface 3000 of the present technology can be held in a sealing position in use by the positioning and stabilising structure 3300. The positioning and stabilising structure 3300 can ensure that the seal-forming structure mounted on the patient interface 3000 is properly positioned and stabilised. Because the shape and size of the seal-forming structure can differ depending on the type of cushion (e.g. nasal cushion and / or oral cushion) attached to the patient interface 3000, the location and / or surface area of the person’s face that presses on the cushion can differ for each cushion type. To improve the seal and fit of the patient interface on a person using it, examples of the present technology provide a positioning and stabilising structure 3300 that is configurable and adjustable in order to provide a therapeutically effective position and seal for different cushion types.

[0246] Figure 4A and 9 A patient interface 3000 is shown that provides a configurable or modular positioning and stabilising structure 3300 for different cushion types. When a nasal cushion 3050 is attached to the headgear portions 3010 and 3020, a first type of headgear 3800 and clips 3810 can be used, and when an oral cushion 3060 is attached to the headgear portions 3010 and 3020, a second type of headgear 3900 and clips 3910 can be used.

[0247] The positioning and stabilising structure 3300 is configured to provide a force that holds (1) the nasal seal-forming structure 3052 or (2) the nasal seal-forming structure 3052 and the oral seal-forming structure 3062 in a therapeutically effective position on the patient’s head. The positioning and stabilising structure 3300 is configurable in a nasal headgear configuration when the nasal cushion 3050 with the nasal seal-forming structure 3052 is coupled to the headgear portions 3010 and 3020, and is configurable in an oral-nasal headgear configuration when the oral cushion 3060 with the oral seal-forming structure 3062 is coupled to the headgear portions 3010 and 3020 (e.g. via one or more straps). In some examples, the oral-nasal headgear configuration can be used when both the nasal cushion 3050 and the oral cushion 3060 are attached to the headgear portions 3010 and 3020. In some examples, the oral cushion 3060 includes a chin support, or does not include a chin support.

[0248] In the nasal headgear configuration, a pair of nasal headgear clips 3810 connect the nasal headgear 3800 to the first and second headgear portions 3010 and 3020 at a first angle and / or position to ensure proper nasal headgear force application to the nasal seal-forming structure 3052.

[0249] In the mouth and nose headband configuration, a pair of mouth and nose headband clips 3910 connect the mouth and nose headband 3900 to the first and second headband portions 3010 and 3020 at a second angle and / or position to ensure that appropriate mouth and nose force is applied to the mouth and nose sealing formation. The first angle and / or position may differ from the second angle and / or position. In one example, the first and second angles may indicate the direction in which the main headband strap extends from the clamping slot relative to the headband portions 3010, 3020, the common connecting element 3980, or the Frankfurt horizontal plane.

[0250] like Figure 4A , 4B As shown in 4C, although the nose headband clip 3810 and the mouth-nose headband clip 3910 have different shapes providing different headband positioning, they have connectors configured to connect to a pair of common connecting elements 3980 (e.g., a common back strap interface), one connecting element disposed on the first headband portion 3010 and the other connecting element disposed on the second headband portion 3020. In the example, the clips may be made of a relatively rigid material (e.g., molded), such as polypropylene or polycarbonate. In another example, the clips may be made of a fabric material (e.g., a laminate of a fabric patient contact layer, a foam inner layer, and a fabric outer layer).

[0251] The nasal headband 3800 and the oronasal headband 3900 may include different banding configurations to provide effective positioning and sealing for treatment. See also Figure 4A , 4B In conjunction with 4C, the nasal headband 3800 may include a single strap connected between nasal headband clips 3810. The oronasal headband 3900 may include a first strap 3920 connected between the oronasal headband clips 3910, a second strap 3930 detachably coupled to an end of a mouth pad 3060 via a headband pad interface 3950, and a third strap 3940 connecting the first strap to the second strap 3930. The length of one or more straps in the nasal headband 3800 and / or oronasal headband 3900 may be adjustable to provide therapeutically effective positioning and sealing.

[0252] In one configuration, the positioning and stabilizing structure 3300 provides a holding force that is at least sufficient to overcome the positive pressure in the inflation chamber 3200 to lift the face away.

[0253] In one configuration, the positioning and stabilizing structure 3300 provides holding forces to overcome the gravitational effects on the patient interface 3000.

[0254] In one configuration, the positioning and stabilizing structure 3300 provides a holding force as a safety margin to overcome the potential effects of destructive forces on the patient interface 3000, such as from tube drag or accidental interference with the patient interface.

[0255] In one form of the technology, a positioning and stabilising structure 3300 is provided that is configured in a manner that is consistent with being worn by a patient while sleeping. In one example, the positioning and stabilising structure 3300 has a small side 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 that is rectangular in cross-section. In one example, the positioning and stabilising structure 3300 comprises at least one flat strap.

[0256] In one form of the technology, a positioning and stabilising structure 3300 is provided that is configured to not be too large and bulky to prevent a patient from lying in a supine sleeping position with the dorsal region of the patient's head on a pillow.

[0257] In one form of the technology, a positioning and stabilising structure 3300 is provided that is configured to not be too large and bulky to prevent a patient from lying in a side sleeping position with the lateral region of the patient's head on a pillow.

[0258] In one form of the technology, a positioning and stabilising structure 3300 is provided with a decoupling portion between the front of the positioning and stabilising structure 3300 and the back of the positioning and stabilising structure 3300. This decoupling portion does not resist compression and can be, for example, a flexible or soft strap. This decoupling portion is constructed and arranged so that when a patient lies with their head on a pillow, the presence of the decoupling portion prevents forces acting on the back from being transmitted along the positioning and stabilising structure 3300 and disrupting the seal.

[0259] In one form of the technology, a positioning and stabilising structure 3300 comprises one or more straps constructed from a laminate of a fabric patient contact layer, a foam inner layer and a fabric outer layer. In one form, the foam is porous to enable moisture (e.g. sweat) to pass through the strap. In one form, the fabric outer layer comprises loop material for partial engagement with hook material.

[0260] In certain forms of the technology, a positioning and stabilising structure 3300 comprises one or more straps that are extendable, for example elastically extendable. For example, the straps can be constructed to be in tension when in use and to direct forces to cause the seal-forming structure to be in sealing contact with a portion of the patient's face. In one example, the straps can be constructed as ties.

[0261] In one form of the technology, the positioning and stabilising structure comprises a first tie constructed and arranged so that, in use, at least a portion of a lower edge of the first tie passes over an upper ear base of the patient's head and covers a portion of the parietal bone without covering the occipital bone.

[0262] In one form of the present technology suitable for use with a nasal only mask or with a full face mask, the positioning and stabilising structure includes a second tie configured and arranged so that, in use, at least a portion of an upper edge of the second tie passes under the lower ear base of the patient's head and covers or lies under the occipital bone of the patient's head.

[0263] In one form of the present technology suitable for use with a nasal only mask or with a full face mask, the positioning and stabilising structure includes a third tie configured and arranged to interconnect the first and second ties to reduce the tendency of the first and second ties to separate from each other.

[0264] In certain forms of the present technology, the positioning and stabilising structure 3300 includes a strap that is flexible and, for example, non-rigid. An advantage of this aspect is that the strap is more comfortable for the patient to lie on while sleeping.

[0265] In certain forms of the present technology, the positioning and stabilising structure 3300 includes one or more straps configured to be breathable to allow moisture transport through the strap,

[0266] In certain forms of the present technology, a system is provided that includes more than one positioning and stabilising structure 3300, each configured to provide a holding force to correspond to a different size and / or shape range. For example, the system can include one form of positioning and stabilising structure 3300 suitable for large sized heads but not small sized heads, while another form of positioning and stabilising structure is suitable for small sized heads but not large sized heads.

[0267] In certain forms of the present technology, a system is provided that includes more than one positioning and stabilising structure 3300, each configured to provide a holding force to correspond to use of a nasal cushion 3050 or a nasal cushion 3050 with a mouth cushion 3060. The first and / or second headgear portions can include common modular conduits usable for both configurations, as well as interchangeable portions of the headgear (e.g. straps and cushions).

[0268] 5.3.4.1 Nasal headgear configuration

[0269] In Figures 5A-5DA patient interface 3000 according to an example of the present technology is shown, which includes a positioning and stabilising structure 3300 configured in a nasal headgear configuration when using a nasal cushion 3050. In the example shown, the positioning and stabilising structure 3300 is configured to provide a force to hold the nasal seal-forming structure 3052 in a therapeutically effective position on the patient’s head in use. As shown, each of the first and second headgear portions 3010, 3020 is adapted to extend from a posterior portion of the patient’s head, for example an upper portion of the back of the patient’s head, for example at or along the crown or parietal bone, towards the nasal cushion 3050.

[0270] The first and second headgear portions 3010, 3020 together with the nasal cushion 3050 form a loop. Each of the first and second headgear portions 3010, 3020 is adapted to pass along the patient’s cheeks below the patient’s eyes and between the patient’s eyes and ears towards an upper position behind the patient’s head.

[0271] The first headgear portion 3010 and / or the second headgear portion 3020 can include a hollow tube configured to convey pressurised gas at a therapeutic pressure from another portion of the headgear (for example, proximate to the back or crown of the patient’s head) to the nasal cushion 3050 for breathing by the patient. In examples, the first headgear portion 3010 and / or the second headgear portion 3020 is configured to convey pressurised gas at a therapeutic pressure from the back or crown of the patient’s head to the nasal and / or oral cushion for breathing by the patient. An end of the hollow tube can be configured to support the nasal and / or oral cushion in place on the patient’s face.

[0272] In one form of the present technology, the first headgear portion 3010 and / or the second headgear portion 3020 can include a fabric strap.

[0273] In examples, the first headgear portion 3010 can include a left common cushion interface 3012 and the second headgear portion 3020 can include a right common cushion interface 3022 for removably or releasably coupling to the nasal cushion 3050 and / or the oral cushion 3060. The left common cushion interface 3012 and / or the right common cushion interface 3022 can receive a smaller protruding coupling portion of the nasal cushion 3050 and secure the nasal cushion 3050 between the first and second headgear portions.

[0274] In examples, at least one feature is provided to maintain the openness of the hollow tube. For example, the at least one feature can include a rib or ring that resists the hollow tube from closing.

[0275] In some examples, one or both of the first headgear portion 3010 and the second headgear portion 3020 can include a strap (e.g., an adjustable strap) rather than providing a hollow tube. In this example, pressurized air can be provided to the nasal cushion 3050 via the headgear portion including a hollow tube or directly.

[0276] In examples, the first headgear portion 3010 and / or the second headgear portion 3020 can include a textile material and / or an elastomeric material (e.g., silicone).

[0277] In examples, the positioning and stabilizing structure can include first and second rigid pieces associated with the first headgear portion 3010 and / or the second headgear portion 3020.

[0278] As shown, each of the first headgear portion 3010 and the second headgear portion 3020 includes a pair of common connection elements 3980. The common connection elements 3980 can include rigid elongated portions that extend along a portion of the headgear portion and are permanently connected to the headgear portion. These elongated portions can include a generally U-shaped portion that is configured to receive a corresponding circular portion of the nasal headgear clip 3810, or vice versa. Figures 5A-5D

[0279] The nasal headgear 3800 includes a strap 3820 connected between a pair of nasal headgear clips 3810. The strap 3820 can be adapted to engage a back portion of the patient’s head. In the illustrated example, the strap 3820 bifurcates into two dorsal strap portions.

[0280] Each nasal headgear clip 3810 can include a slot 3812 to three-dimensionally receive an end of the strap 3820 in a length-adjustable manner (e.g., hook and loop fasteners).

[0281] In some examples, the nasal headgear 3800 includes a first strap 3802 and a second strap 3804 connected to the nasal headgear clip. The first and second straps can be detachably or permanently connected to the nasal headgear clip 3810. The nasal headgear 3800 can include a center portion having a split that forms an upper strap portion and a lower strap portion with a space therebetween and adapted to cup the patient’s head.

[0282] The nasal headgear clip 3810 is configured to connect the nasal headgear 3800 to the left headgear portion and the right headgear portion at a first angle and / or position to ensure that proper nasal headgear force is applied to the nasal seal-forming structure when the patient wears the nasal cushion alone. The nasal headgear clip 3810 can be detachably or permanently connected to the strap 3820. The nasal headgear clip 3810 can be configured to exclusively receive the nasal headgear strap of the nasal headgear 3800.

[0283] ​5.3.4.2 Oral-nasal headgear configuration

[0284] Figures 6A-6D A patient interface 3000 according to an example of the present technology is shown, which includes a positioning and stabilising structure 3300 configured in an oral-nasal headgear configuration when using a nasal cushion 3050 and an oral cushion 3060. The positioning and stabilising structure 3300 is configured to provide a force to hold the nasal seal-forming structure 3052 and the oral seal-forming structure 3062 in a therapeutically effective position on the patient’s head in use. As shown, each of the first and second headgear portions 3010, 3020 is adapted to extend from a posterior portion of the patient’s head, for example an upper portion of the back of the patient’s head, for example at or along the crown or parietal bone, towards the nasal cushion 3050.

[0285] The first and second headgear portions 3010, 3020, together with the nasal cushion 3050 and the oral cushion 3060, form a loop. Each of the first and second headgear portions 3010, 3020 is adapted to pass along the patient’s cheek below the patient’s eye and between the patient’s eye and ear towards an upper position behind the patient’s head.

[0286] The same first and second headgear portions 3010, 3020 and connecting elements 3980 in the nasal headgear configuration can be used in the oral-nasal headgear configuration. Accordingly, features of the first headgear portion 3010 and / or the second headgear portion 3020 and connecting elements 3980, as discussed above with reference to the nasal headgear configuration, can apply to the oral-nasal headgear configuration.

[0287] The oral-nasal headgear 3900 includes a strap system connected between a pair of oral-nasal headgear clips 3910. The strap system of the oral-nasal headgear 3900 can also be removably coupled to the oral cushion 3060. The strap system can be adapted to engage a posterior portion of the patient’s head and provide sufficient retention force to the oral-nasal seal-forming structure formed by the nasal cushion 3050 and the oral cushion 3060.

[0288] In the illustrated example, the strap system of the oral-nasal headgear 3900 includes a base strap portion 3955, a first upper strap 3957 and a second upper strap 3959, each end of the base strap portion including a connector 3956 adapted to couple to the oral cushion 3060, the first upper strap connecting the first strap to one of the oral-nasal headgear clips 3910, and the second upper strap connecting the second upper strap 3959 to the other of the oral-nasal headgear clips 3910. The upper straps 3957 and / or 3959 can be detachably or permanently connected to the oral-nasal headgear clips 3910. The length of one or more of the straps can be adjustable. In one example, the base strap portion 3955 can include a buckle 3360 near the end of the strap, through which the end of the strap is passed to allow length adjustment.

[0289] In some examples, the orinasal headgear 3900 includes the nasal headgear 3800 and a bottom strap portion 3955 releasably connected to the nasal headgear 3800.

[0290] The bottom strap portion 3955 can be adapted to pass under the patient's ears and / or include a pair of ends 3956 that can be attached to the mouth cushion 3060. Each end of the bottom strap portion 3955 can be detachably attached to a cushion clip or magnetic cushion clip that is attached to a cushion clip or magnetic cushion clip of the mouth cushion 3060. In one example, the ends of the bottom strap portion 3955 can pass through the buckle 3360 to allow for length adjustment.

[0291] In one example, the upper straps 3957 and 3959 are connected to the bottom strap portion 3955 at an angle to form a generally "V" shape.

[0292] The configuration of the straps and the number of straps is not limited as such and can include other configurations (see, for example, Figure 4A , 4B and 4C).

[0293] The orinasal headgear clip 3910 is configured to connect the orinasal headgear 3900 to the left and right headgear portions at a second angle and / or position to ensure that the appropriate orinasal force is applied to the orinasal seal forming structure when the patient is wearing the nasal cushion 3050 and the mouth cushion 3060. The orinasal headgear clip 3910 can be detachably or permanently connected to the upper straps 3957 and / or 3959. Each orinasal headgear clip 3910 can include a slot 3912 to receive an end of the upper straps 3957 and / or 3959. The nasal headgear clip 3810 can be configured to exclusively receive the orinasal headgear 3900.

[0294] In one form of the technology, a patient interface 3000 is provided that does not include a forehead support. The nasal headgear configuration or the orinasal headgear configuration can be sufficient to provide the required support and sealing without the inclusion of a forehead support.

[0295] 5.3.4.3 Nasal headgear clip and orinasal headgear clip connected to common connection element

[0296] As shown in Figures 4A-6D , the first headgear portion 3010 and the second headgear portion 3020 include a common connection element 3980 that releasably connects the nasal headgear clip 3810 to the first and second headgear portions and releasably connects the orinasal headgear clip 3910 to the first and second headgear portions. The different shapes and / or connection positions of the straps in the nasal headgear clip 3810 and the orinasal headgear clip 3910 provide angles and / or positions for the straps connected to the clips to ensure that the appropriate force is applied to provide a nasal seal or an orinasal seal.

[0297] Figures 7A-7E A common connection element 3980 that can be used to couple the nasal headgear 3800 and the oral-nasal headgear 3900 onto portions of the patient interface 3000 is shown in accordance with an example of the present technology. The common connection element 3980 protrudes from the outer surface of the respective first and second headgear portions 3010, 3020. The common connection element 3980 provides an elongate recess or slider 3982 that corresponds in shape and size to an elongate recess or slider 3990 provided on the nasal headgear clip 3810 and / or the oral-nasal headgear clip 3910. The elongate slider can be slid into the recess to detachably secure the nasal headgear clip 3810 or the oral-nasal headgear clip 3910 to the first and second headgear portions.

[0298] In one form of the present technology, the common connection element 3980 includes a receiving end 3984 provided on one distal end and a stop 3986 at the opposite distal end. The receiving end 3984 is configured to receive one end of the connector of the nasal headgear clip 3810 or the oral-nasal headgear clip 3910. The stop 3986 can include a tap that extends at least partially outwardly from the inner surface of the recess or the outer surface of the slider to prevent the connector of the nasal headgear clip 3810 or the oral-nasal headgear clip 3910 (corresponding recess or slider) from sliding out of the recess or beyond one end of the slider. In one form, the stop 3986 can extend from the recess interior and to the outer surface of the common connection element 3980. The stop 3986 can also provide an indication of when the nasal headgear clip 3810 or the oral-nasal headgear clip 3910 has been inserted far enough into the recess 3982. In one form, the stop 3986 can be provided in the recess and / or on the slider to ensure proper depth and / or direction of connection. In one form, the common connection element 3980 is provided with a recess and the clip is provided with a slider configured to removably engage the recess.

[0299] In one form of the present technology, both ends of the common connection element 3980 can have a receiving end and the connector of the clip can be inserted into either end of the common connection element 3980. In this example, the clip can include a stop to prevent the clip from popping out of the recess 3982.

[0300] In one form of the present technology, the recess 3982 can include an irregular shape that corresponds to the irregular shape of the connection provided on the nasal headgear clip 3810 and the oral-nasal headgear clip 3910 so that the clip can only be inserted in one direction. In this example, a person will be able to insert the clip in a single orientation to ensure that the nasal headgear 3800 and the oral-nasal headgear 3900 are correctly positioned and oriented.

[0301] The shape and size of the common connection element 3980 is not limited to the example shown and discussed, but can include other shapes and sizes (e.g., different grooves) to removably couple the connectors of the nasal headgear clips 3810 and the orinasal headgear clips 3910 to the first headgear section 3010 and the second headgear section 3020.

[0302] Figure 8 A nasal headgear clip 3810 according to an example of the present technology is shown. Figure 9 An orinasal headgear clip 3910 according to an example of the present technology is shown. As Figure 8 and 9 shown, while the nasal headgear clip 3810 and the orinasal headgear clip 3910 have some similar features, the nasal headgear clip 3810 has a shape that is different from the shape of the orinasal headgear clip 3910. In the nasal headgear configuration, two nasal headgear clips 3810 can be used to connect the nasal headgear 3800 to the first and second headgear sections. In the orinasal headgear configuration, two orinasal headgear clips 3910 can be used to connect the orinasal headgear 3900 to the first and second headgear sections.

[0303] Both the nasal headgear clip 3810 and the orinasal headgear clip 3910 can be generally wedge-shaped.

[0304] The nasal headgear clip 3810 includes a main side 3814 along the left and right headgear sections, an opposite side 3816 for connection to the nasal headgear 3900, an upper side 3818, and a lower side 3819 disposed opposite the upper side 3818. As Figure 8 shown, the upper side 3818 can be longer than the lower side 3819. From the main side, the upper side 3818 is wider than the lower side 3819.

[0305] The orinasal headgear clip 3910 includes a main side 3914 along the left and right headgear sections, an opposite side 3916 for connection to the orinasal headgear 3900, an upper side 3918, and a lower side 3919 opposite the upper side 3918. As Figure 9 shown, the upper side 3918 can be longer than the lower side 3919. From the main side, the upper side 3918 is wider than the lower side 3919.

[0306] Referring to Figure 8 and 9 , there are similarities and differences between the nasal headgear clip 3810 and the orinasal headgear clip 3910. The main sides 3814 and 3914 of the nasal and orinasal clips are the same (e.g., in size and / or shape). The upper side 3818 of the nasal headgear clip 3810 is longer than the upper side 3918 of the orinasal headgear clip 3910. The opposite side 3816 of the nasal headgear clip 3810 is shorter than the opposite side 3916 of the orinasal headgear clip 3910. The lower side 3819 of the nasal headgear clip 3810 can have about the same length as the lower side 3919 of the orinasal headgear clip 3910.

[0307] Nasal headgear clips 3810 and oral-nasal headgear clips 3910 can include holes 3988 for removably securing the clips when they are inserted into the grooves 3982 of the common element 3980. A locking pin can be placed through the holes 3988 and the common element 3980 to secure the clips in use. In some examples, the grooves can include a protruding pin to engage and secure the clips via the holes 3988 in use.

[0308] Nasal headgear clips 3810 and / or oral-nasal headgear clips 3910 can include indicia indicating which type of headgear and / or cushion should be used. As shown, nasal headgear clips 3810 can include an "N" indicating that the nasal headgear clips 3810 should be used with nasal cushions 3050 and / or nasal headgear 3800. As shown, oral-nasal headgear clips 3910 can include an "F" (full face) indicating that the oral-nasal headgear clips 3910 should be used with nasal / mouth cushions and / or oral-nasal headgear 3900. Nasal headgear clips 3810 and / or oral-nasal headgear clips 3910 can include indicia such as symbols or holes 3988 to indicate which end of the clip should be inserted into the common connection element 3980 and / or the top or bottom of the clip. Figure 8 Figure 9 Nasal headgear clips 3810 and / or oral-nasal headgear clips 3910 can include indicia indicating which type of headgear and / or cushion should be used. As shown, nasal headgear clips 3810 can include an "N" indicating that the nasal headgear clips 3810 should be used with nasal cushions 3050 and / or nasal headgear 3800. As shown, oral-nasal headgear clips 3910 can include an "F" (full face) indicating that the oral-nasal headgear clips 3910 should be used with nasal / mouth cushions and / or oral-nasal headgear 3900. Nasal headgear clips 3810 and / or oral-nasal headgear clips 3910 can include indicia such as symbols or holes 3988 to indicate which end of the clip should be inserted into the common connection element 3980 and / or the top or bottom of the clip.

[0309] Nasal headgear clips 3810 can include a slot 3812 configured to exclusively receive nasal headgear straps of nasal headgear 3800. Slot 3812 can be formed in a lower portion of nasal headgear clip 3810. Slot 3812 can be substantially straight and / or formed adjacent to and / or parallel to opposing sides 3816.

[0310] Oral-nasal headgear clips 3910 can include a slot 3912 configured to exclusively receive oral-nasal headgear straps of oral-nasal headgear 3900. Slot 3912 can be formed in an upper portion of oral-nasal headgear clip 3910. Slot 3912 can be substantially straight and / or formed adjacent to and / or parallel to opposing sides 3916.

[0311] In one form of the technology, slots 3812 and 3912 can have the same shape and size. In another form of the technology, slot 3912 of oral-nasal headgear clip 3910 can have a different size and / or width than slot 3812 of nasal headgear clip 3810.

[0312] ​In one embodiment of this technology, slots 3812 and 3912 may be positioned at different locations and / or angles relative to a common connecting element 3980 and / or to each other. For example, the nose headband clip slot 3812 may be formed relative to the common connecting element 3980 at a nose clip slot angle (α1), and the mouth and nose headband clip slot 3912 may be formed relative to the common connecting element 3980 at a mouth and nose headband clip slot angle (α2) different from the nose clip slot angle. In some examples, the mouth and nose headband clip slot angle (α1) may be greater than the mouth and nose clip slot angle (α2) (see [link]). Figure 5B and 6B ).

[0313] In one form of this technology, each of the nasal headband slots 3812 is positioned relative to the left and right headband portions at a different slot angle and / or position than the mouth-nose headband slot 3912 relative to the left and right headband portions. In one example, the slot angles of the nasal headband slot 3812 and the mouth-nose headband slot 3912 may be the same, but their positions relative to the main sides 3814 and 3914 may differ. For example, the nasal headband slot 3812 may be positioned closer to the main side 3814 and / or the lower side 3819 than the mouth-nose headband slot 3912 is positioned relative to the main side 3914 and / or the lower side 3919, and / or the headband slot 3812 may be positioned lower relative to the main side 3814 and / or the opposite side 3916 than the mouth-nose headband slot 3912 is relative to the main side 3914 and / or the opposite side 3916.

[0314] In one embodiment of the present technology, each of the pair of nose headband clips 3810 and the pair of mouth-nose headband clips 3910 includes a slot to receive the upper nose strap 3820 of the nose headband 3800 or the upper straps 3957, 3959 of the mouth-nose headband 3900. The mouth-nose headband clip 3910 is configured to hold the upper ends of the upper straps 3957, 3959 in the mouth-nose strap position, while the nose headband clip 3810 is configured to hold the upper end of the upper nose strap 3820 in the nose strap position, which differs from the nose strap positions relative to the left and right headband portions and / or the main sides 3814, 3914.

[0315] The mouth and nose headband 3900 may include a pair of upper mouth and nose straps 3957, 3959 that can be connected to the mouth and nose headband clip 3910, and the nose headband includes a pair of upper nose straps 3820 that can be connected to the nose headband clip 3810. In use, the upper mouth and nose straps may be positioned higher than the upper nose straps relative to the common connecting element 3980.

[0316] The orinasal head strap clip 3910 is configured to hold the upper end of the superior orinasal strap 3957, 3959 at an orinasal strap angle (β2), and the nasal head strap clip 3810 is configured to hold the upper end of the superior nasal strap 3820 at a nasal strap angle (β1) that is different from the orinasal strap angle relative to the Frankfort horizontal of the left head strap portion and right head strap portion or the patient. In some examples, the orinasal strap angle (β2) can be less than the nasal strap angle (β1). In some examples, the orinasal strap angle (β2) is less than the nasal strap angle (β1) relative to the Frankfort horizontal of the patient (see Figure 5A and 5B ). In some examples, the orinasal strap angle (β

[0317] 2) is greater than the nasal strap angle (β1) relative to the Frankfort horizontal of the patient, depending on various features including the intended treatment location on the patient’s nose and / or mouth and / or the configuration of the headgear straps. The orinasal strap angle and the nasal strap angle can be measured from the lower portion of the left head strap portion and right head strap portion. In some examples, the orinasal strap angle and the nasal strap angle can be measured between a line corresponding to a slot in the respective clip and the Frankfort horizontal.

[0318] 5.3.5 Vent

[0319] In one form, the patient interface 3000 includes a vent 3400 constructed and arranged to allow washout of exhaled gases, such as carbon dioxide.

[0320] In certain forms, the vent 3400 is configured to allow a continuous vent flow from an interior of the plenum chamber 3200 to ambient, while the pressure within the plenum chamber is positive relative to ambient. The vent 3400 is configured such that the vent flow has a magnitude sufficient to reduce rebreathing of exhaled C02 by the patient, while maintaining the therapeutic pressure in the plenum chamber in use.

[0321] The vent 3400 according to one form of the present technology includes a plurality of holes, for example, about 2 or more holes, about 5 to about 50 holes, about 10 to about 40 holes, about 10 to about 20 holes, about 20 to about 80 holes, or about 40 to about 60 holes, or about 45 to about 55 holes.

[0322] The vent 3400 can be located in the plenum chamber 3200. Alternatively, the vent 3400 is located in a decoupling structure, such as a swivel.

[0323] In certain forms, the nasal cushion 3050 and the oral cushion 3060 can include a common vent 3400 that can be positioned on the nasal cushion or the oral cushion (see, for example, Figure 4A). The opening left in the nasal cushion 3050 can serve as a way of connecting the nasal cushion 3050 to the mouth cushion 3060. In one example, the vent 3400 can be inserted into the mouth cushion 3060 and the mouth cushion 3060 can be coupled to the nasal cushion 3050 via the opening in the nasal cushion 3050 for the vent 3400.

[0324] 5.3.6 decoupling structure

[0325] In one form, the patient interface 3000 includes at least one decoupling structure, such as a swivel or a ball and socket.

[0326] 5.3.7 connection port

[0327] The connection port 3600 allows connection to the air circuit 4170.

[0328] 5.3.8 forehead support

[0329] In one form, the patient interface 3000 includes a forehead support 3700. For example, Figure 3A A patient interface 3000 according to an aspect of the present technology is shown to include a seal-forming structure 3100, a plenum chamber 3200, a positioning and stabilising structure 3300, a vent 3400, a connection port 3600 in one form for connection to an air circuit 4170, and a forehead support 3700.

[0330] In Figures 4A to 8 In an example of the patient interface 3000 without a forehead support is provided.

[0331] 5.3.9 anti-asphyxia valve

[0332] In one form, the patient interface 3000 includes an anti-asphyxia valve.

[0333] 5.3.10 port

[0334] In one form of the present technology, the 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 supplemental oxygen. In one form, this enables direct measurement of a property of the gas within the plenum chamber 3200, such as pressure.

[0335] 5.4 air circuit

[0336] An air circuit 4170 according to an aspect of the present technology is a conduit or tube that, in use, is constructed and arranged to allow a flow of air to travel between two components, such as the RPT device 4000 and the patient interface 3000.

[0337] In particular, the air circuit 4170 can be in fluid connection with the outlet of the pneumatic block of the RPT device 4000 and the patient interface. The air circuit can be referred to as an air delivery tube. In some cases, there can be separate limbs for inhalation and exhalation circuits. In other cases, a single limb is used.

[0338] In some forms, the air circuit 4170 can include one or more heating elements configured to heat air in the air circuit, for example to maintain or raise the temperature of the air. The heating elements can be in the form of a heating wire circuit, and can include one or more transducers, such as temperature sensors. In one form, the heating wire circuit can be helically wound around the axis of the air circuit 4170. The heating elements can be in communication with a controller, such as a central controller. One example of an air circuit 4170 including a heating wire circuit is described in US Patent 8,733,349, which is incorporated herein in its entirety by reference.

[0339] 5.4.1 Oxygen delivery

[0340] In one form of the technology, supplemental oxygen can be delivered to one or more points in the pneumatic path, such as upstream of the pneumatic block, the air circuit 4170 and / or the patient interface 3000.

[0341] 5.5 Glossary

[0342] For the purposes of the present technology disclosure, in certain forms of the technology one or more of the following definitions can apply. In other forms of the technology, alternative definitions can apply.

[0343] 5.5.1 General

[0344] Air: In certain forms of the technology, air can be taken to mean atmospheric air, and in other forms of the technology air can be taken to mean some other combination of breathable gas, such as atmospheric air enriched with oxygen.

[0345] Ambience: In certain forms of the technology, the term ambience can have the following meanings (i) the exterior of the therapy system or patient, and (ii) the immediate surroundings of the therapy system or patient.

[0346] For example, the ambience humidity relative to a humidifier can be the humidity of the air immediately surrounding the humidifier, such as the humidity in the room in which the patient is sleeping. This ambience humidity can be different to the humidity outside the room in which the patient is sleeping.

[0347] In another example, the ambience pressure can be the pressure immediately surrounding the body or outside the body.

[0348] In certain forms, ambient (e.g. acoustic) noise can be considered to be the background noise level in the room in which the patient is located, other than for example noise generated by the RPT device or from the mask or patient interface. Ambient noise can be generated by sound sources outside the room.

[0349] Auto-Positive Airway Pressure (APAP) therapy: a form of CPAP therapy in which the therapy pressure is automatically adjustable between a minimum and a maximum, for example differing with each breath, depending on whether or not there are indications of SBD events.

[0350] Continuous Positive Airway Pressure (CPAP) therapy: a form of respiratory pressure therapy in which the therapy pressure can be approximately constant throughout the patient’s respiratory cycle. 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 increasing in response to detecting indications of partial airway obstruction, and decreasing in the absence of indications of partial airway obstruction.

[0351] Flow: volume (or mass) of air delivered per unit of time. Flow can refer to instantaneous quantities. In some contexts, a reference to flow will be a reference to a scalar quantity, i.e. a quantity with only a magnitude. In other contexts, a reference to flow will be a reference to a vector quantity, i.e. a quantity with both a magnitude and a direction. Flow can be given the symbol Q. ‘Flow’ is sometimes simply abbreviated to ‘flow’ or ‘air flow’.

[0352] In the example of a patient breathing, the flow can be nominally positive for the inhalation portion of the patient’s respiratory cycle, and thus negative for the exhalation portion of the patient’s respiratory cycle. The total flow Qt is the flow of air leaving the RPT device. The ventilation flow Qv is the flow of air leaving the vent to allow flushing of exhaled gases. The leak flow Ql is the flow of leaks from the patient interface system or elsewhere. The respiratory flow Qr is the flow of air received into the patient’s respiratory system.

[0353] Humidifier: the term humidifier will be taken to mean a humidification apparatus constructed and arranged or configured with physical structures capable of providing a therapeutically beneficial amount of water (H2O) vapour to an air flow to improve a patient’s medical respiratory condition.

[0354] Leak: the word leak will be taken to mean an unwanted flow of air. In one example, a leak can occur due to an imperfect seal between the mask and the patient’s face. In another example, a leak can occur in a swivel elbow to the ambient environment.

[0355] Noise, conducted (acoustic): Conducted noise in this document refers to noise imparted to the patient through the pneumatic path, such as the air circuit and patient interface and the air therein. In one form, conducted noise can be quantified by measuring the sound pressure level at the end of the air circuit.

[0356] Noise, radiated (acoustic): Radiated noise in this document refers to noise imparted to the patient through the surrounding air. In one form, radiated noise can be quantified by measuring the sound power / pressure level of the object in question according to ISO 3744.

[0357] Noise, vented (acoustic): Vented noise in this document refers to noise generated by the flow of air through any vent, such as a vent of a patient interface.

[0358] Patient: A human, whether or not they suffer from a respiratory disorder.

[0359] Pressure: Force per unit area. Pressure can be expressed in units ranging from cmH20, g-f / cm 2 , to hundred Pascals. 1 cmH20 is equivalent to 1 g-f / cm 2 and is approximately 0.98 hundred Pascals. In this specification, pressure is given in units of cmH20 unless otherwise stated.

[0360] Pressure in the patient interface is given the symbol Pmand the therapy pressure is given the symbol Pt, which represents the target value obtained by the mask pressure Pmat the current instant.

[0361] Respiratory Pressure Therapy (RPT): The application of a supply of air at a therapy pressure typically positive with respect to atmosphere to the entrance of the airways.

[0362] Ventilator: A mechanical device that provides pressure support to a patient to perform some or all of the work of breathing.

[0363] 5.5.1.1 Materials

[0364] Silicone or silicone elastomer: A synthetic rubber. In this specification, reference to silicone refers to liquid silicone rubber (LSR) or compression molded silicone rubber (CMSR). One form of LSR that is commercially available is SILASTIC (including 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.

[0365] Polycarbonate: A transparent thermoplastic polymer of bisphenol A carbonate.

[0366] 5.5.1.2 Mechanical properties

[0367] Resilience: the ability of a material to absorb energy when deformed elastically and release the energy upon unloading.

[0368] Elastic: will release substantially all of the energy upon unloading. Includes for example certain silicones and thermoplastic elastomers.

[0369] Hardness: the ability of a material itself to resist deformation (described for example by Young’s modulus or the indentation hardness scale measured on a standardized sample size).

[0370] A “soft” material can include silicone or a thermoplastic elastomer (TPE) and can deform easily for example under finger pressure.

[0371] A “hard” material can include polycarbonate, polypropylene, steel or aluminum and can not deform easily for example under finger pressure.

[0372] Stiffness (or rigidity) of a structure or component: the ability of a structure or component to resist deformation in response to an applied load. The load can be a force or a moment, for example compression, tension, bending or torsion. A structure or component can provide different resistance in different directions.

[0373] Soft structure or component: a structure or component that will change shape (for example bend) when left to support its own weight for a relatively short time, for example 1 second.

[0374] Rigid structure or component: a structure or component that will not substantially change shape when subjected to loads typically encountered in use. An example of such use can be the setting and maintaining of a patient interface in a sealing relation with an entrance to a patient’s airways under pressures of around 20 to 30 cmH20.

[0375] As an example, an I-beam can include different bending stiffness (resistance to bending loads) in a first direction compared to a second, orthogonal direction. In another example, a structure or component can be soft in a first direction and rigid in a second direction.

[0376] 5.5.2 Breathing cycle

[0377] Apnea: According to some definitions, an apnea is considered to occur when the flow drops below a predetermined threshold for a duration of time (e.g., 10 seconds). An obstructive apnea is considered to occur when some obstruction of the airway does not allow air flow, even when the patient is trying. A central apnea is considered to occur when a reduction or absence of respiratory effort is detected, even though the airway is patent. A mixed apnea is considered to occur when a reduction or absence of respiratory effort occurs simultaneously with an obstructed airway.

[0378] Respiration rate: The rate of spontaneous respiration of a patient, usually measured in breaths per minute.

[0379] Duty cycle: The ratio of inspiration time, Ti, to total respiration time, Ttot.

[0380] Effort (breathing): The work done by a spontaneous breather in trying to breathe.

[0381] Exhalation portion of a breath cycle: The period of time from the start of exhalation flow to the start of inhalation flow.

[0382] Flow limitation: A flow limitation will be considered to be a state in a patient's breathing in which an increase in effort by the patient does not result in a corresponding increase in flow. A flow limitation that occurs during the inhalation portion of a breath cycle can be described as an inspiratory flow limitation. A flow limitation that occurs during the exhalation portion of a breath cycle can be described as an expiratory flow limitation.

[0383] Types of inspiratory waveforms of flow limitation:

[0384] (i) flattened: with one rise, followed by a relatively flat portion, then a fall.

[0385] (ii) M-shaped: with two local peaks, one at the leading edge and one at the trailing edge, with a relatively flat portion between the two peaks.

[0386] (iii) chair-shaped: with a single local peak, the peak at the leading edge, followed by a relatively flat portion.

[0387] (iv) reverse chair-shaped: with a relatively flat portion, followed by a single local peak, the peak at the trailing edge.

[0388] Hypopnea: According to some definitions, a hypopnea will be considered to be a reduction in flow, rather than a cessation of flow. In one form, a hypopnea can be considered to occur when the flow drops below a threshold for an existing duration of time. A central hypopnea is considered to occur when a hypopnea is detected due to a reduction in respiratory effort. In one form for adults, either of the following can be considered to be a hypopnea:

[0389] (i) a 30% reduction in patient breathing for at least 10 seconds plus an associated 4% desaturation; or

[0390] (ii) a reduction in patient breathing (but less than 50%) for at least 10 seconds with an associated at least 3% desaturation or arousal.

[0391] Hyperpnoea: an increase in flow to a level above normal.

[0392] Inspiratory portion of the respiratory cycle: the period of time from the start of inspiratory flow to the start of expiratory flow is considered the inspiratory portion of the respiratory cycle.

[0393] Open (airway): the degree to which the airway is open or the degree to which the airway is open. An open airway is open. Airway openness can be quantified, for example, with a value (1) for open, and a value of zero (0) for closed (obstructed).

[0394] Positive end-expiratory pressure (PEEP): a pressure above atmospheric pressure present in the lungs at the end of expiration.

[0395] Peak flow (Qpeak): the maximum value of flow during the inspiratory portion of the respiratory flow waveform.

[0396] Respiratory flow, patient air flow, respiratory air flow (Qr): these synonymous terms can be understood to refer to the RPT device's estimate of respiratory flow, as opposed to "true respiratory flow" or "true respiratory flow", which is the actual respiratory flow experienced by the patient, typically expressed in litres per minute.

[0397] Tidal volume (Vt): the volume of air inhaled or exhaled during normal breathing when no extra effort is applied. In principle, the inspiratory volume Vi (volume of air inhaled) is equal to the expiratory volume Ve (volume of air exhaled), so a single tidal volume Vt can be defined as equal to either quantity. In practice, the tidal volume Vt is estimated as some combination of the inspiratory volume Vi and the expiratory volume Ve, for example the average.

[0398] (Inspiratory) time (Ti): the duration of the inspiratory portion of the respiratory flow waveform.

[0399] (Expiratory) time (Te): the duration of the expiratory portion of the respiratory flow waveform.

[0400] (Overall) time (Ttot): the total duration between the start of one inspiratory portion of a respiratory flow waveform and the start of the subsequent inspiratory portion of a respiratory flow waveform.

[0401] Typical recent ventilation amount: a measure of the central tendency of ventilation values around which ventilation Vent recent values tend to cluster over some predetermined time horizon.

[0402] Upper airway obstruction (UAO): This includes partial and complete upper airway obstruction. This may be associated with a state of flow restriction, where the flow rate increases only slightly or even decreases as the pressure differential in the upper airway increases (Starling resistance behavior).

[0403] Ventilation: A measurement of the rate at which gases are exchanged by a patient's respiratory system. A measurement of ventilation can include one or both of inspiratory and expiratory flow rates (per unit of time). When expressed as volume per minute, this quantity is often referred to as "minute ventilation." Minute ventilation is sometimes simply given as volume and understood as volume per minute.

[0404] 5.5.3 Ventilation

[0405] Adaptive Servo Ventilator (ASV): A servo ventilator with a variable rather than a fixed target ventilation. The variable target ventilation can be determined from some characteristics of the patient, such as the patient's breathing characteristics.

[0406] Standby rate: A parameter of the ventilator that determines the minimum respiratory rate (usually measured in breaths per minute) that the ventilator will deliver to the patient if not triggered by spontaneous breathing effort.

[0407] Cyclic: Termination of the inspiratory phase of a ventilator. When a ventilator delivers breaths to a spontaneously breathing patient, the ventilator cycle is considered to end at the end of the inspiratory portion of the respiratory cycle.

[0408] Positive expiratory airway pressure (EPAP): The base pressure to which the ventilator will attempt to achieve the desired mask pressure at a given time, by adding pressure changes within the respiratory tract.

[0409] End-expiratory pressure (EEP): The desired mask pressure that the ventilator attempts to achieve at the end of the expiration phase. If the pressure waveform template □(□) is zero at the end of expiration, i.e., □(□) = 0, then EEP equals EPAP when □ = 1.

[0410] Positive inspiratory airway pressure (IPAP): The maximum desired mask pressure that the ventilator attempts to achieve during the inspiratory phase of breathing.

[0411] Pressure support: A number indicating the increase in pressure during inspiration that exceeds the pressure during expiration, and generally refers to the pressure difference between the maximum pressure during inspiration and the baseline pressure (e.g., PS = IPAP - EPAP). In some cases, pressure support refers to the difference the ventilator is designed to achieve, rather than the difference it actually achieves.

[0412] Servo ventilator: A ventilator that measures the patient's ventilation and has a target ventilation and adjusts the level of pressure support to bring the patient's ventilation to the target ventilation.

[0413] Spontaneous / timed (S / T): A mode of a ventilator or other device that attempts to detect the onset of a breath of a spontaneously breathing patient. However, if the device cannot detect a breath within a predetermined period of time, the device will automatically initiate the delivery of a breath.

[0414] Swing: A term synonymous with pressure support.

[0415] Triggered: When a ventilator delivers a breath of air to a spontaneously breathing patient, it is considered to be triggered by the patient's effort at the beginning of the inspiratory portion of the respiratory cycle.

[0416] 5.5.4 Anatomy

[0417] 5.5.4.1 Anatomy of the face

[0418] Ala: The outer lateral wall or "wing" of each nostril (plural: alae)

[0419] Alar angle:

[0420] Alar rim: The most lateral point on the ala.

[0421] Alar crease (or alar crest) point: The point of the curved base of each ala that is most lateral, found in the fold created by the junction of the ala with the cheek.

[0422] Auricle: The entire externally visible portion of the ear.

[0423] (Nasal) skeletal framework: The nasal skeletal framework includes the nasal bones, frontal process of the maxilla, and the nasal part of the frontal bone.

[0424] (Nasal) cartilaginous framework: The nasal cartilaginous framework includes the septum, lateral, greater, and lesser cartilages.

[0425] Columella: The skin strip that separates the nostrils and extends from the tip of the nose to the upper lip.

[0426] Columellar angle: The angle between a line drawn through the midpoint of the nostril and a line drawn perpendicular to the Frankfort horizontal (both lines intersect at the subnasal point).

[0427] Frankfort horizontal: A line extending from the lowest point of the orbital margin to the left ear canal. The canal is the deepest point in the notch superior to the tragus of the auricle.

[0428] Glabella: The most prominent point in the soft tissue, in the midline sagittal plane of the forehead.

[0429] Lateral nasal cartilage: A cartilaginous plate that is essentially triangular in shape. Its superior margin is attached to the nasal and frontal processes of the maxilla, and its inferior margin is connected to the alar cartilages.

[0430] Lip, lower (subnasale): The midpoint of the lower lip.

[0431] Lip, upper (pronasale): The midpoint of the upper lip.

[0432] Alar cartilages: Cartilaginous plates located below the lateral nasal cartilages. They curve around the front of the nostril. Their posterior ends are connected to the frontal process of the maxilla by tough fibrous membranes containing three or four small cartilages that comprise the alar base.

[0433] Nares (nares): The approximately elliptical openings that form the entrance to the nasal cavity. The singular form of nare is naris (nare). The nare is separated by the nasal septum.

[0434] Nasolabial sulcus or fold: The skin fold or groove that extends from each side of the nose to the corner of the mouth, separating the cheeks from the upper lip.

[0435] Nasolabial angle: The angle between the columella and the upper lip (while intersecting at the subnasale).

[0436] Infralobular point: The lowest point of attachment of the helix to the facial skin.

[0437] Supralobular point: The highest point of attachment of the helix to the facial skin.

[0438] Nasal tip point: The most projecting point or tip of the nose, which can be identified in a lateral view of the rest of the head.

[0439] Philtrum: The midline groove extending from the inferior border of the nasal septum to the lip superior in the region of the upper lip.

[0440] Prementale: The midpoint of the most anterior part of the chin, located on the soft tissue.

[0441] Ridge (nose): The nasal ridge is the midline protrusion of the nose that extends from the sellion to the tip of the nose.

[0442] Sagittal plane: A vertical plane that goes from front (anterior) to back (posterior). The midsagittal plane is the sagittal plane that divides the body into right and left halves.

[0443] Sellion: The most concave point, located on the soft tissue, overlying the region of the frontonasal suture.

[0444] Septal cartilage (nose): The nasal septal cartilage forms part of the septum and separates the anterior part of the nasal cavity.

[0445] Superior lateral crura: The points at the inferior border of the alar base where the alar base meets the skin of the superior (upper) lip.

[0446] Subnasale: Point on the soft tissue at the junction of the nasal septum and the upper lip in the median sagittal plane.

[0447] Submentale: Point on the midline of the lower lip at the maximum concavity between the lower lip midpoint and the soft tissue menton

[0448] 5.5.4.2 Anatomy of the Skull

[0449] Frontal bone: The frontal bone includes a large vertical portion (frontal squama) that corresponds to the area known as the forehead.

[0450] Mandible: The mandible forms the lower jaw. The mental protuberance is the bony protuberance of the lower jaw that forms the chin.

[0451] Maxilla: The maxilla forms the upper jaw and is located above the mandible and below the eye sockets. The frontal process of the maxilla protrudes upward from the sides of the nose and forms part of the lateral boundary.

[0452] Nasal bone: The nasal bone is a small, oval-shaped bone that varies in size and form from one individual to another; it is located side by side in the middle and upper part of the face and forms, with its point of junction, the “beam” of the nose.

[0453] Nasion: The intersection of the frontal bone and the two nasal bones, located directly between the eyes and in the depressed area of the upper part of the bridge of the nose.

[0454] Occipital bone: The occipital bone is located at the back and lower part of the skull. It includes an oval-shaped hole (foramen magnum) through which the cranial cavity communicates with the spinal canal. The curved plate behind the foramen magnum is the squama occipitalis.

[0455] Orbit: Bony cavity in the skull that houses the eyeball.

[0456] Parietal bone: The parietal bone is the bone that, when joined together, forms the roof of the skull and the two sides.

[0457] Temporal bone: The temporal bone is located at the bottom and on the sides of the skull and supports the part of the face known as the temple.

[0458] Zygomatic bone: The face includes two zygomatic bones, which are located in the upper and lateral parts of the face and form the prominence of the cheeks.

[0459] 5.5.4.3 Anatomy of the Respiratory System

[0460] Diaphragm: Muscle sheet that extends across the bottom of the rib cage. The diaphragm separates the thoracic cavity, which contains 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.

[0461] Larynx: The larynx or voice box houses the vocal cords and connects the lower part of the pharynx (hypopharynx) to the trachea.

[0462] Lungs: The human respiratory organs. The conduction area of ​​the lungs includes the trachea, bronchi, bronchioles, and terminal bronchioles. The respiratory area includes the respiratory bronchioles, alveolar ducts, and alveoli.

[0463] Nasal chambers: The nasal chambers (or nasal fossae) are large, air-filled spaces located in the middle of the face above and behind the nose. The nasal chambers are divided into two parts by vertical wings called the nasal septum. On the sides of the nasal chambers are three horizontal branches called nasal conchae (singular "concha"). The front of the nasal chambers is the nose, while the back connects to the nasopharynx via the internal nasal openings.

[0464] Pharynx: The part of the throat located below the nasal cavity and above the esophagus and larynx. The pharynx is conventionally divided into three segments: the nasopharynx (hyperpharynx) (the nasal part of the pharynx), the oropharynx (middle pharynx) (the oral part of the pharynx), and the laryngopharynx (hypopharynx).

[0465] 5.5.5 Patient Interface

[0466] Anti-asphyxiation valve (AAV): A component or sub-component of a mask system that reduces the risk of excessive CO2 rebreathing by opening to the atmosphere in a fail-safe manner.

[0467] Elbow: An elbow is an example of a structure that guides the axis of an airflow traveling through it to change direction by an angle. In one form, the angle can be approximately 90 degrees. In another form, the angle can be greater than or less than 90 degrees. An elbow can have an approximately circular cross-section. In another form, an elbow can have an elliptical or rectangular cross-section. In some forms, the elbow can rotate relative to the mating component, for example, about 360 degrees. In some forms, the elbow can be removable from the mating component, for example, via a snap-fit ​​connection. In some forms, the elbow can be assembled to the mating component during manufacturing via a single snap-fit, but cannot be removed by the patient.

[0468] Frame: The frame is generally considered to refer to the mask structure that bears the tensile load between two or more points of connection with the head strap. The mask frame can be a non-airtight load-bearing structure within the mask. However, some forms of mask frames can also be airtight.

[0469] Functional dead space: (Description to be inserted here)

[0470] Headband: A headband is considered to refer to a form of positioning and stabilization structure designed for use on the head. For example, a headband may include an assembly of one or more support bars, straps, and reinforcements configured to position and hold the patient interface on the patient's face for delivery of respiratory therapy. Some straps are formed from soft, flexible, resilient materials, such as laminated composites of foam and fabric.

[0471] Membrane: A membrane will be taken to mean a typically thin element which is preferably substantially non-bending resistant but is tensile resistant.

[0472] Plenum: A mask plenum will be taken to mean the portion of the patient interface which has walls which at least partially enclose a volume which in use has air pressurised within it to above atmospheric pressure. A shell can form part of the walls of the mask plenum.

[0473] Seal: Can be a noun form of structure (a seal) or a verb form of the effect (to seal). Two elements can be structured and / or arranged to'seal' or achieve'sealing' therebetween without the need for a separate'sealing' element per se.

[0474] Shell: A shell will be taken to mean a curved and relatively thin structure which has a bendable, stretchable and compressible stiffness. For example, a curved structural wall of a mask can be a shell. In some forms, a shell can be polyhedral. In some forms, a shell can be air-tight. In some forms, a shell can not be air-tight.

[0475] 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.

[0476] Support: A support will be taken to be a structural component designed to increase the compressive resistance of another component in at least one direction.

[0477] Swivel: (Noun) A subcomponent of a component configured to rotate about a common axis, preferably independently, preferably at low torque. In one form, a swivel can be configured to rotate through an angle of at least 360 degrees. In another form, a swivel can be configured to rotate through an angle of less than 360 degrees. When used in the context of an air delivery conduit, the subassembly of components preferably comprises a pair of mating cylindrical conduits. There can be little or no air leakage from the swivel in use.

[0478] Tie (Noun: A structure for resisting tension.

[0479] Vent: (Noun): A structure which allows air flow from inside a mask or conduit to ambient air, for example for effective flushing of exhaled gases. For example, clinically effective flushing can involve a flow of about 10 litres per minute to about 100 litres per minute, depending on mask design and therapy pressure.

[0480] 5.5.6 Shape of structure

[0481] Products according to the present technology can include one or more three-dimensional mechanical structures, such as a mask cushion or a propeller. Three-dimensional structures can be joined by two-dimensional surfaces. These surfaces can be distinguished using indicia to describe the relevant surface orientation, location, function, or some other characteristic. For example, a structure can include one or more of an anterior surface, a posterior surface, an inner surface, and an outer surface. In another example, a seal-forming structure can include a (e.g., external) surface that contacts a face and a separate (e.g., underside or internal) surface that does not contact a face. In another example, a structure can include a first surface and a second surface.

[0482] To aid in describing the shape of three-dimensional structures and surfaces, first consider a cross-section through a point p of a surface, see Figures 3B to Figure 3F , which show a cross-section at point p on a surface and resulting examples of planar curves. Figures 3B to 3F An outward normal vector at p is also shown. The outward normal vector at p points in a direction away from the surface. In some examples, the surface is described from the perspective of an imaginary person standing upright on the surface.

[0483] 5.5.6.1 One-dimensional curvature

[0484] The curvature of a planar curve at p can be described as having a sign (e.g., positive, negative) and a magnitude (e.g., the inverse of the radius of a circle that just touches the curve at p).

[0485] Positive curvature: If the curve at p turns away from the outward normal, the curvature at that point will take on a positive value (if the imaginary person leaves point p, they must walk uphill). See Figure 3B (Compare to Figure 3C relatively large positive curvature) and Figure 3C (Compare to Figure 3B relatively small positive curvature). Such curves are often referred to as concave.

[0486] Zero curvature: If the curve at p is a straight line, the curvature will take on a value of zero (if the imaginary person leaves point p, they can walk horizontally, neither uphill nor downhill). See Figure 3D .

[0487] Negative curvature: If the curve at p turns away from the outward normal, the curvature at that point in that direction will take on a negative value (if the imaginary person leaves point p, they must walk downhill). See Figure 3E (Compare to Figure 3F relatively small negative curvature) and Figure 3F (Compare to Figure 3E relatively large negative curvature). Such curves are often referred to as convex.

[0488] 5.5.6.2 Two-dimensional surface curvature

[0489] The description of the shape at a given point on a two-dimensional surface according to the present technology can include a plurality of normal cross-sections. The plurality of cross-sections can cut the surface in planes that include the outward normal (“normal planes”), and each cross-section can be taken in a different direction. Each cross-section yields a planar curve with a corresponding curvature. The different curvatures at a point can have the same sign or different signs. Each curvature at a point has a magnitude, for example a relatively small magnitude. Figures 3B to 3F The planar curves in are examples of such a plurality of sections at a particular point.

[0490] Principal curvatures and directions: The directions of the normal planes in which the curve curvature takes its maximum and minimum values are called principal directions. In Figures 3B to Figure 3F In the example of, the maximum curvature occurs in Figure 3B In, the minimum curvature occurs in Figure 3F Thus Figure 3B and Figure 3F are cross-sections in the principal directions. The principal curvatures at p are the curvatures in the principal directions.

[0491] Region of a surface: A connected set of points on a surface. The set of points in a region can have similar characteristics, for example curvatures or signs.

[0492] Saddle region: A region in which the principal curvatures have opposite signs at each point, i.e. one sign is positive and the other sign is negative (according to the direction in which an imaginary person turns, they can walk up or down).

[0493] Dome region: A region in which the principal curvatures have the same sign at each point, for example both positive (“concave dome”) or both negative (“convex dome”).

[0494] Cylindrical region: A region in which one principal curvature is zero (or, for example, within manufacturing tolerances, zero) and the other principal curvature is non-zero.

[0495] Planar region: A region of a surface in which both principal curvatures are zero (or, for example, within manufacturing tolerances, zero).

[0496] Edge of a surface: The boundary or limit of a surface or region.

[0497] Path: In certain forms of the present technology, a ‘path’ will be taken to mean a path in the mathematical-topological sense, for example a continuous space curve on a surface from f(0) to f(1). In certain forms of the present technology, a ‘path’ can be described as a route or a way, including for example a set of points on a surface. (An imaginary person’s path is where they walk on a surface, and is analogous to a garden path).

[0498] Path length: In some forms of this technique, 'path length' will be considered as the distance along the surface from f(0) to f(1), i.e., the distance along the path on the surface. There can be more than one path between two points on the surface, and such paths can have different path lengths. (The path length for an imaginary person would be the distance they must walk along the path on the surface.)

[0499] Straight-line distance: Straight-line distance is the distance between two points on a surface, but without considering the surface itself. On a planar region, there will exist paths on the surface with the same path length as the straight-line distance between the two points. On a non-planar surface, there may not be paths with the same path length as the straight-line distance between the two points. (For an imaginary individual, straight-line distance will correspond to the distance as a 'straight line'.)

[0500] 5.5.6.3 Space Curves

[0501] Space curves: Unlike planar curves, space curves do not necessarily lie in any particular plane. Space curves can be closed, that is, without endpoints. A space curve can be thought of as a one-dimensional segment of three-dimensional space. An imaginary human walking along one strand of a DNA helix travels along a space curve. The typical human left ear contains the helix, which is a left-handed helix; see [link to relevant documentation]. Figure 3Q The typical human right ear includes a spiral, which is a right-handed spiral; see [link / reference]. Figure 3R . Figure 3S A right-handed helix is ​​shown. The edges of a structure, such as the edges of a membrane or impeller, can follow a space curve. Typically, a space curve can be described by the curvature and torsion at each point on the space curve. Torque is a measure of how the curve deviates from the plane. Torque has a sign and magnitude. The torsion at a point on a space curve can be characterized by the tangent vector, normal vector, and double normal vector at that point.

[0502] Tangent unit vector (or unit tangent vector): For each point on a curve, the vector at that point specifies the direction and magnitude from that point. The tangent unit vector is a unit vector pointing in the same direction as the curve at that point. If a hypothetical person were flying along the curve and falling from their aircraft at a specific point, the direction of the tangent vector would be the direction they would have traveled.

[0503] Unit normal vector: This is the vector that changes as an imaginary person moves along the curve. The unit vector pointing in the direction of the change of the tangent vector is called the principal normal vector. It is perpendicular to the tangent vector.

[0504] A double-normal unit vector is a vector that is perpendicular to both the tangent vector and the principal normal vector. Its direction can be determined by the right-hand rule (see, for example, [link to relevant documentation]). Figure 3P ) or optionally by left-hand rule ( Figure 3O To determine.

[0505] Osculating plane: A plane containing the unit tangent vector and the unit principal normal vector. See Figure 3O and 3P .

[0506] Twist of a space curve: The twist of a space curve at a point 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 that lies in the plane has zero twist. A space curve that deviates from the osculating plane by a relatively small amount will have a relatively small amount of twist (e.g., a gently inclined helical path). A space curve that deviates from the osculating plane by a relatively large amount will have a relatively large amount of twist (e.g., a sharply inclined helical path). See Figure 3S Since T2 > T1, the amount of twist near the top coil of the helix of Figure 3S is greater than the amount of twist of the bottom coil of the helix of Figure 3S .

[0507] Referring to the right-hand rule of Figure 3P , a space curve that points in the right-hand binormal direction can be considered to have right-hand positive twist (e.g., a right-hand helix as shown in Figure 3S ). A space curve that turns away from the right-hand binormal direction can be considered to have right-hand negative twist (e.g., a left-hand helix).

[0508] Likewise, referring to the left-hand rule (see Figure 3O ), a space curve that points in the left-hand binormal direction can be considered to have left-hand positive twist (e.g., a left-hand helix). Left-hand positive is thus equivalent to right-hand negative. See Figure 3T .

[0509] 5.5.6.4 Holes

[0510] A surface can have one-dimensional holes, e.g., holes bounded by planar curves or by space curves. Thin structures (e.g., membranes) having holes can be described as having one-dimensional holes. See, e.g., the one-dimensional holes in the surfaces of the structures shown in Figure 3I .

[0511] A structure can have two-dimensional holes, e.g., holes bounded by surfaces. For example, a pneumatic tire has a two-dimensional hole bounded by the inner surface of the tire. In another example, a bladder having a cavity for air or gel can have a two-dimensional hole. See, e.g., the bladder of Figure 3L and the exemplary cross-sections in Figure 3M and Figure 3N , which show the inner surfaces bounding the two-dimensional holes. In yet another example, a catheter can include one-dimensional holes (e.g., at its inlet or at its outlet) and two-dimensional holes bounded by the inner surface of the catheter. See also Figure 3KA two-dimensional hole in the structure shown, bounded by the surfaces shown.

[0512] 5.6 Additional Notes

[0513] Unless the context clearly indicates otherwise, and in providing a range of values, it is to be understood that every 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 can independently be included in the intervening ranges, and are also encompassed within the technology, subject to any explicitly 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.

[0514] Further, where one or more values are stated in the art as being implemented as part of the technology, it is to be understood that such values can be approximate, and such values can be used to any suitable number of significant figures to the extent that practical implementation of the technology can permit or require.

[0515] 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 be used in the practice or testing of the present technology, a limited number of the exemplary methods and materials are described herein.

[0516] When a particular material is identified as being used to construct a component, obvious alternatives of similar properties can be used as substitutes. Moreover, any and all components described herein are to be understood to be capable of being manufactured, and thus can be manufactured, together or separately.

[0517] It must be noted that, as used herein and in the appended claims, singular articles such as "a", "an" and "the" include their plural adjectival equivalents unless the context clearly indicates otherwise.

[0518] All publications mentioned herein are incorporated herein by reference in their entirety to disclose and describe the methods and / or materials in connection with which the publications are cited. 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 publications by virtue of prior application. Further, the dates of publication provided can be different from the actual publication dates, which can require independent confirmation.

[0519] The terms "comprises", "comprising", "comprised", and "comprising" should be interpreted as a non- exhaustive listing of elements, components, or steps that the referenced element, component, or step can include or be used with or in combination with, but not to exclusion of other elements, components, or steps that are not expressly listed.

[0520] The subject matter headings used herein are for organizational purposes only and are not intended to be used in interpretation of the claims or scope of the disclosure.

[0521] Although the technology herein has been described with reference to particular embodiments, it is to be understood that these embodiments are illustrative of the principles and application of the technology. In some instances, terminology and symbols can imply specific details that are not required to practice the described technology. For example, although the terms "first" and "second" can be used, unless otherwise specified, they are not intended to denote any order but can be used to distinguish different elements. Also, although process steps in a method can be described or illustrated in sequence, such sequencing is not required. Those skilled in the art will recognize that such sequencing can be modified and / or such sequencing can be performed concurrently or even simultaneously.

[0522] It will thus be appreciated that many modifications can be made to the illustrative embodiments, and that other arrangements can be devised without departing from the spirit and scope of the technology.

[0523] 5.7 List of Reference Symbols

[0524]

[0525]

[0526]

Claims

1. A patient interface for delivering an airflow at a positive pressure relative to ambient air pressure to an inlet of a patient's airway during sleep to improve sleep-disordered breathing, said patient airway including at least an inlet in the patient's nostrils, said patient interface comprising: A nose mask, the nose mask including a nose pad; A mouth and nose mask, the mouth and nose mask including the nose pad and the mouth pad; The nasal pad forms at least a portion of an inflatable chamber pressurizable to a therapeutic pressure, wherein the nasal pad includes a nasal seal-forming structure configured to form a seal with a patient facial region surrounding an entrance to the patient's nostrils. The mouth liner forms at least a portion of the inflatable chamber pressurizable to the treatment pressure, wherein the mouth liner includes a mouth sealing formation configured to form a seal with a patient facial region surrounding an inlet to the patient's mouth. A positioning and stabilizing structure is configured to provide force to hold one of the nasal mask and the oronasal mask in a therapeutically effective position on the patient's head. The positioning and stabilizing structure is configured to operate in either a nasal headband configuration or an oronasal headband configuration, based on a selection of the nasal mask and the oronasal mask coupled to the positioning and stabilizing structure. Each of the nose headband configuration and the mouth-nose headband configuration of the positioning and stabilizing structure includes a left headband portion and a right headband portion, each of which is configured to run along the patient's cheek below the patient's eyes and between the patient's eyes and ears, and extend to the back or top of the patient's head. Wherein, when the nose mask is coupled to the positioning and stabilizing structure and the positioning and stabilizing structure is in the nose headband configuration, the ends of the left headband portion and the right headband portion are configured to connect to the nose mask, and Wherein, when the mouth and nose mask is coupled to the positioning and stabilizing structure and the positioning and stabilizing structure is in the mouth and nose headband configuration, the end of the left headband portion and the end of the right headband portion are configured to connect to the mouth and nose mask. The nasal headband configuration of the positioning and stabilizing structure includes a pair of nasal headband clips and a nasal headband. The pair of nasal headband clips connect the nasal headband to the sides of the left and right headband portions at a first angle and / or position to ensure that appropriate nasal headband force is applied to the nasal mask when the patient wears the nasal pad. The positioning and stabilizing structure includes a pair of headband clips and a headband. The clips connect the headband to the sides of the left and right headband portions at a second angle and / or position to ensure that appropriate oral and nasal force is applied to the headband when the patient wears it. The first angle and / or position provided by the nose headband configuration is different from the second angle and / or position provided by the mouth-nose headband configuration.

2. The patient interface of claim 1, wherein each of the pair of mouth and nose headband clips is permanently connected to the mouth and nose headband and / or each of the pair of nose headband clips is permanently connected to the nose headband.

3. The patient interface according to any one of claims 1 to 2, wherein each of the pair of mouth and nose headband clips includes a mark indicating use with the mouth and nose mask and / or mouth and nose headband, and each of the pair of nose headband clips includes a mark indicating use with the nose mask and / or nose headband.

4. The patient interface according to any one of claims 1 to 2, wherein each of the pair of nose headband clips has a shape different from the shape of each of the pair of mouth and nose headband clips.

5. The patient interface according to any one of claims 1 to 2, wherein each of the pair of nose headband clips and each of the pair of mouth-nose headband clips is generally wedge-shaped, having a main side along the left headband portion and the right headband portion, an upper side and a lower side for connecting to the respective opposite sides of the nose headband and the mouth-nose headband, the upper side being wider than the lower side.

6. The patient interface of claim 5, wherein the main sides of each of the pair of nose headband clips and each of the pair of mouth-nose headband clips are the same, and the upper side of each of the pair of nose headband clips is longer than the upper side of each of the pair of mouth-nose headband clips.

7. The patient interface according to any one of claims 1 to 2, wherein each of the pair of mouth and nose headband clips includes a slot configured to exclusively receive a respective mouth and nose headband strap of the mouth and nose headband, and each of the pair of nose headband clips includes a slot configured to exclusively receive a respective nose headband strap of the nose headband.

8. The patient interface of claim 7, wherein the slot of each of the pair of mouth and nose headband clips has a different size / width than the slot of each of the pair of nose headband clips.

9. The patient interface according to any one of claims 1 to 2, wherein each of the pair of nose headband clips includes a slot formed in the lower portion of the respective nose headband clip, and each of the pair of mouth-nose headband clips includes a slot formed in the upper portion of the respective mouth-nose headband clip.

10. The patient interface according to any one of claims 1 to 2, wherein each of the left headband portion and the right headband portion includes a common connecting element releasably connected to each of the pair of nose headband clips and releasably connected to each of the pair of mouth-nose headband clips.

11. The patient interface of claim 10, wherein the common connection element comprises a groove or a slider.

12. The patient interface of claim 11, wherein each of the groove and the slider includes a stop configured to ensure proper depth and / or orientation of the connection.

13. The patient interface of claim 11, wherein the common connection element includes the recess, and each of the pair of nose headband clips and each of the pair of mouth-nose headband clips includes a slider.

14. The patient interface of claim 10, wherein each of the pair of nasal headband clips includes a substantially straight nasal headband clip slot, and each of the pair of oral-nose headband clips includes a substantially straight oral-nose clip slot, the nasal headband clip slot being formed at a nasal clip slot angle relative to the common connecting element, and the oral-nose clip slot being formed at an oral-nose clip slot angle relative to the common connecting element, the oral-nose clip slot angle being different from the nasal clip slot angle.

15. The patient interface according to any one of claims 1 to 2, wherein each of the pair of nose headband clips includes a slot for receiving a top strap of the nose headband, and each of the pair of mouth-nose headband clips includes a slot for receiving a top strap of the mouth-nose headband.

16. The patient interface of claim 10, wherein each of the pair of nasal headband clips includes a nasal headband slot, and each of the pair of oral-nasal headband clips includes an oral-nasal headband slot, each of the nasal headband slots being positioned relative to its respective left headband portion and right headband portion at a slot angle and / or position different from the slot angle and / or position of each of the oral-nasal headband slots relative to its respective left headband portion and right headband portion.

17. The patient interface according to any one of claims 1 to 2, wherein the mouth and nose headband includes a pair of upper mouth and nose straps connectable to the respective mouth and nose headband clips of the pair of mouth and nose headband clips, and the nose headband includes a pair of upper nose straps connectable to the respective nose headband clips of the pair of nose headband clips.

18. The patient interface of claim 17, wherein the pair of mouth and nose headband clips are configured to hold the upper ends of the pair of upper mouth and nose bands in the mouth and nose band position, and the pair of nose headband clips are configured to hold the upper ends of the pair of upper nose bands in the nose band position, the mouth and nose band position being different from the nose band position relative to the left headband portion and the right headband portion.

19. The patient interface of claim 18, wherein the mouth-nose bandage is positioned higher than the nose bandage.

20. The patient interface of claim 17, wherein the pair of mouth and nose headband clips are configured to hold the upper ends of the pair of upper mouth and nose bands at a mouth and nose band angle, and the pair of nose headband clips are configured to hold the upper ends of the pair of upper nose bands at a nose band angle, the mouth and nose band angle being different from the nose band angle relative to the left headband portion and the right headband portion.

21. The patient interface of claim 20, wherein the angle of the oral-nasal strap is smaller than the angle of the nasal strap.

22. The patient interface of claim 20, wherein the angle of the oral-nasal strap is less than the angle of the nasal strap relative to the Frankfurt plane of the patient.

23. The patient interface of claim 20, wherein each of the mouth-nose bandage angle and the nose bandage angle is measured from the lower portion of the left headband portion and the right headband portion.

24. The patient interface according to any one of claims 1 to 2, wherein the mouth pad includes a second nasal pad, or the mouth pad does not include the nasal pad.

25. The patient interface according to any one of claims 1 to 2, wherein the mouth pad and the nose pad are releasably connected to each other.

26. The patient interface according to any one of claims 1 to 2, wherein each of the left headband portion and the right headband portion comprises a fabric strap.

27. The patient interface according to any one of claims 1 to 2, wherein each of the left headband portion and the right headband portion includes a hollow tube configured to deliver pressurized gas under the treatment pressure from the back or crown of the patient's head to the nasal pad and / or the mouth pad for the patient to breathe.

28. The patient interface of claim 27, wherein each of the hollow tubes supports the nasal pad and / or the mouth pad in an appropriate position on the patient's face.

29. The patient interface according to any one of claims 1 to 2, wherein the patient interface does not have a forehead support.

30. The patient interface according to any one of claims 1 to 2, wherein the nasal headband includes a first strap and a second strap connected to the respective nasal headband clips of the pair of nasal headband clips.

31. The patient interface of claim 30, wherein the first strap and the second strap are permanently connected to the respective nose headband clips of the pair of nose headband clips.

32. The patient interface according to any one of claims 1 to 2, wherein the nasal headband includes a central portion having a slit, the central portion forming an upper strap portion and a lower strap portion having a space between the upper strap portion and the lower strap portion and being configured to cover the patient's head.

33. The patient interface according to any one of claims 1 to 2, wherein the mouth-nose headband includes the nose headband and a bottom strap portion releasably connected to the nose headband, the bottom strap portion including an end that can be connected to the mouth pad.

34. The patient interface according to any one of claims 1 to 2, wherein the mouth and nose headband comprises a pair of upper straps, each upper strap having an end connected to a respective mouth and nose headband clip in the pair of mouth and nose headband clips.

35. The patient interface of claim 34, wherein each of the pair of upper straps is permanently connected to the respective mouth and nose head strap clip of the pair of mouth and nose head strap clips.

36. The patient interface according to any one of claims 1 to 2, wherein the mouth and nose headband includes a bottom strap portion configured to pass below the patient's ears, the bottom strap portion including a pair of ends that can be attached to the mouth pad.

37. The patient interface of claim 36, wherein the mouth and nose headband includes a pair of upper straps connected to the bottom strap portion at an angle forming a generally "V" shape.

38. The patient interface of claim 36, wherein each end of the bottom strap portion is attached to a pad clip or a magnetic pad clip, the pad clip or magnetic pad clip being attached to the mouth pad.

39. The patient interface according to any one of claims 1 to 2, wherein the nasal headband and the oral-nasal headband are length-adjustable.

40. The patient interface according to any one of claims 1 to 2, wherein each of the left headband portion and the right headband portion is releasably connected to the nasal pad.

41. The patient interface according to any one of claims 1 to 2, further comprising a crown connecting the left headband portion and the right headband portion, the crown including an opening for receiving a rotatable bend.

42. The patient interface according to any one of claims 1 to 2, wherein the nasal seal forming structure comprises a nasal support pad, nasal pad, or pillow pad configured to form a seal relative to the inlet of the patient's nose.

43. The patient interface according to any one of claims 1 to 2, wherein the mouth pad includes a chin support or does not include a chin support.

44. A CPAP system for providing a patient with positive pressure gas for respiratory therapy, the CPAP system comprising: RPT device, which is configured to supply a gas flow under therapeutic pressure; The patient interface according to any one of claims 1 to 43; and An air delivery conduit is configured to deliver airflow at the treatment pressure from the RPT device to the patient interface.

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