Fabric conduit with window

Abstract

A patient interface positioning and stabilising structure includes a gas delivery tube having a tube wall with an internal passageway for a flow of pressurised air. A portion of the tube wall includes a patient contacting portion and a non-patient contacting portion. The patient contacting portion includes a layer of textile material or a layer of foam material configured to lie against a patient's head. At least a section of the non-patient contacting portion includes a transparent and / or translucent material. The layer of textile material or foam material is bonded to the transparent and / or translucent material such that the tube wall is formed as a single piece construction. A plane extending generally transverse to a longitudinal axis encompasses both (1) the layer of textile material or foam material and (2) the transparent and / or translucent material such that a patient can view the internal passageway along a transverse axis extending through the plane.

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] Cross Reference to Related Applications

[0003] This application claims the benefit of Australian Provisional Patent Application No. 2019902272, filed October 31, 2019, the entire contents of which are incorporated herein by reference. BACKGROUND 2.1 TECHNICAL FIELD

[0005] The present technology relates to one or more of the detection, diagnosis, treatment, prevention and amelioration of respiratory-related disorders. The present technology also relates to medical devices or apparatuses, and their use.

[0006] 2.2 DESCRIPTION OF RELATED ART

[0007] 2.2.1 The Human Respiratory System and Its Disorders

[0008] The respiratory system of the body facilitates gas exchange. The nose and mouth form entry points to the airways of a patient. It is through these entry points that air enters the respiratory system for gas exchange.

[0009] The airways include a sequence of branching tubes when the branching airways penetrate deeper into the lung, they become progressively narrower, shorter and more numerous. The principal function of the lung is gas exchange, allowing oxygen to enter the venous blood and carbon dioxide to leave the blood in the opposite direction. The trachea divides into the left and right bronchus, which ultimately subdivide into end- bronchioles. The bronchi constitute the conducting airways and do not take part in gas exchange. Further branching of the airways leads to the respiratory bronchioles, and ultimately the pulmonary alveolar regions. The pulmonary alveolar regions of the lung are the sites of gas exchange, and are referred to as the respiratory zone. See, West, John B. Respiratory Physiology, 9thEdition, Lippincott Williams & Wilkins, 2012.

[0010] There is a range of respiratory disorders. Certain disorders can be characterised by particular events, such as apnoeas, hypopnoeas, and hyperpnoeas.

[0011] 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.

[0012] 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 disease 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).

[0013] Cheyne-Stokes Respiratory (CSR) is another form of Sleep Disordered Breathing. CSR is a disorder of the patient's respiratory controller where the otherwise regular respiratory drive is disturbed. This results in rhythmic alternating periods of hypopneas and apneas which are characteristic of CSR. CSR is characterised by repetitive, rhythmic, and symmetrical swings in thoraco-abdominal effort and breath flow. These are usually seen in the form of repetitive and rhythmic hypopneas and apneas. The patient's blood oxygen saturation level can return to its normal level between apneas and hypopneas. However, the repeated hypoxia and hypercapnia can cause damage to the brain and heart. 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).

[0014] Respiratory failure is a term used to describe diseases of the respiratory system where the lungs are not able to take in sufficient oxygen or remove sufficient CO2 to meet the needs of the patient. Respiratory failure can encompass some or all of the following disorders.

[0015] A patient with respiratory insufficiency, a form of respiratory failure, can experience abnormally short breath.

[0016] 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.

[0017] 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 of respiration, and loss of the normal elasticity of the lung. Examples of COPD are emphysema and chronic bronchitis. COPD is caused by chronic tobacco smoking (the primary risk factor), occupational exposures, air pollution, and genetic factors. Symptoms include: labored breathing, cough, and mucus production.

[0018] 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.

[0019] 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.

[0020] 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.

[0021] 2.2.2 Treatment

[0022] 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.

[0023] 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.

[0024] 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.

[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] 2.2.3 Therapy Systems

[0027] These therapies can be provided by a therapy system or device. Such systems and devices can also be used to diagnose a disorder without treating the disorder.

[0028] A therapy system can include a respiratory pressure therapy device (RPT device), an air circuit, a humidifier, a patient interface, and data management.

[0029] 2.2.3.1 Patient Interface

[0030] A patient interface can be used to interface a respiratory treatment device to its wearer, such as 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 cmH20 relative to ambient pressure. For other forms of therapy, e.g., oxygen

[0031] Certain other mask systems can not be functionally suitable for the art. For example, purely decorative masks can not be able to maintain an appropriate pressure. Mask systems for use in 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 the environment.

[0032] Certain masks can be clinically disadvantageous for the art, e.g., where they block airflow through the nose and only allow it through the mouth.

[0033] If certain 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 art.

[0034] Certain 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.

[0035] The design of patient interfaces presents a number of challenges. The face has a complex three-dimensional shape. The size and shape of the nose and head varies greatly among different individuals. As the head includes bone, cartilage, and soft tissue, different regions of the face react 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.

[0036] Due to these challenges, some masks face one or more of the following problems: obtrusive, unaesthetic, expensive, unproportioned, 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 not the right size can cause reduced compliance, reduced comfort, and adverse patient outcomes. A mask designed only for pilots, designed to be part of a personal protection device (such as a filtering mask), a SCUBA mask, or a mask designed to administer anesthetic can be acceptable for its original purpose, but not as comfortable for long term (e.g. several hours) wear. This discomfort can lead to reduced patient compliance with therapy. This is even more true if the mask is worn during sleep.

[0037] CPAP therapy is very effective at treating certain respiratory disorders, assuming the patient complies with the therapy. If the mask is uncomfortable or difficult to use, the patient can not comply with the therapy. As patients are typically advised to clean their masks on a regular basis, if the mask is difficult to clean (e.g. difficult to assemble or disassemble), the patient can not clean their mask, which can affect patient compliance.

[0038] While masks for other applications (e.g. pilots) can not be suitable for treating sleep disordered breathing, masks designed for treating sleep disordered breathing can be suitable for other applications.

[0039] For these reasons, patient interfaces for delivering CPAP during sleep form a distinct field.

[0040] 2.2.3.1.1 Seal-forming structure

[0041] A patient interface can include a seal-forming structure. As it is in direct contact with the patient's face, the shape and configuration of the seal-forming structure can directly affect the effectiveness and comfort of the patient interface.

[0042] 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 to form a seal around the left nare and a second sub-portion to form a seal around the right nare. In one form of patient interface, the seal-forming structure can include a single element that surrounds both nare 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 nare 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.

[0043] 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 regions 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.

[0044] 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.

[0045] 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 an elastomeric (e.g., rubber) sealing element. 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.

[0046] 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.

[0047] 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.

[0048] 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.

[0049] 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; and WO 2010 / 135,785.

[0050] One form of nasal pillow was 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.

[0051] ResMed Limited has manufactured the following products incorporating nasal pillows: TM Nasal pillow masks, SWIFT TM II Nasal pillow masks, SWIFT TM LT Nasal pillow masks, SWIFT TM FX Nasal pillow masks and MIRAGE LIBERTY TM Full face masks. 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 further 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 further aspects of the ResMed Limited SWIFT TM FX Nasal pillow).

[0052] 2.2.3.1.2 Positioning and stabilisation

[0053] Seal-forming structures for patient interfaces for positive air pressure therapy are subject to corresponding forces of the air pressure that seeks 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.

[0054] One technique is the use of adhesive. See, for example, US Patent Application Publication US 2010 / 0000534. However, the use of adhesive can be uncomfortable for some people.

[0055] Another technique is the use of one or more straps and / or stabilizing ligatures. Many such ligatures suffer from one or more of being inappropriate, bulky, uncomfortable and inconvenient to use.

[0056] 2.2.3.1.3 Pressurized air conduit

[0057] In one type of therapy system, pressurized air flow is provided to the patient interface through a conduit in an air circuit that is fluidly connected to the patient interface such that the conduit extends forward from the patient interface out of the patient interface when the patient interface is positioned on the patient’s face during use. This can sometimes be referred to as an ‘elephant trunk’ type of interface.

[0058] Some patients find such interfaces aesthetically unpleasing and therefore unwilling to wear, thereby reducing patient compliance. Furthermore, the conduit connected to the interface forward of the patient’s face is sometimes easily entangled by bed linens.

[0059] 2.2.3.1.4 Pressurized air conduit for positioning / stabilizing seal-forming structure

[0060] Alternative types of therapy systems that seek to address these issues include patient interfaces in which the tube that delivers pressurized air to the patient’s airways also serves as part of the structure to position and stabilize the seal-forming portion of the patient interface to the appropriate portion of the patient’s face, also known as a ‘headgear tube’ or ‘conduit headgear’. This type of patient interface can be referred to as a ‘headgear tube’ or ‘conduit headgear’. Such patient interfaces allow the conduit in the air circuit that provides the flow of pressurized air from the respiratory pressure therapy device to be connected to the patient interface at a location other than forward of the patient’s face. One example of such a therapy system is disclosed in US Patent Publication No. 2007 / 0246043, the contents of which are incorporated herein by reference, in which the conduit is connected to the tube in the patient interface through a port that is positioned on top of the patient’s head in use.

[0061] Philips DreamWear TM The mask includes such a headgear tube. The length of the headgear tube cannot be adjusted. Therefore, three different sizes of the DreamWear TM headgear tube are provided. The DreamWear TMHeadgear is tailored to fit the faces of patients of different sizes. Providing a larger number of different sizes can increase the complexity and cost of manufacturing the headgear and can result in larger packaging. Additionally, the supply of discrete sizes of masks can limit the extent to which patient heads of different sizes can be accommodated. Some patients can have a greater chance of not achieving what they consider a "perfect" fit if forced to choose between discrete sizes of adjustable length.

[0062] Patient interfaces incorporating headgear tubes can provide some advantages, such as avoiding conduits connecting to the patient interface in front of the patient's face, which can be unsightly and protruding. However, for patient interfaces incorporating headgear tubes, it can be challenging to enable long-term wear by a patient while sleeping, while forming an effective seal with the patient's face, so that the patient is comfortable.

[0063] 2.2.3.2 Respiratory pressure therapy (RPT) devices

[0064] Respiratory pressure therapy (RPT) devices can be used to deliver one or more of a number of therapies described above, such as by generating a flow of air for delivery to an entrance to the airways. The flow of air can be pressurised. Examples of RPT devices include CPAP units and ventilators.

[0065] 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.

[0066] There can be an infinite number of choices available to the designer of a device. Design criteria often conflict, meaning that certain design choices are far from conventional or inevitable. Furthermore, comfort and efficacy in certain respects can be highly sensitive to small, subtle changes in one or more parameters.

[0067] 2.2.3.3 Humidifier

[0068] Delivery of a flow of air without humidification can cause drying of the airways. Use of a humidifier with an RPT device and patient interface generates humidified gas that minimises drying of the nasal mucosa and increases patient airway comfort. Furthermore, in cooler climates, warm air is generally more comfortable to apply into and around the facial area of the patient interface than cold air.

[0069] A number of artificial humidification devices and systems are known, however they do not meet the specific requirements of medical humidifiers.

[0070] Medical humidifiers are used when needed to increase the humidity, temperature (or both) of an air flow relative to ambient air, typically with the patient asleep or resting (e.g. in a hospital). Medical humidifiers placed at the bedside can be small. Medical humidifiers can be configured to humidify and / or heat only the air flow delivered to the patient, without humidifying and / or heating the patient’s surroundings. Room-based systems (e.g. a sauna, an air conditioner, an evaporative cooler, 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 occupants uncomfortable. In addition, medical humidifiers can have more stringent safety constraints than industrial humidifiers.

[0071] While many medical humidifiers are known, they can have one or more shortcomings. Some medical humidifiers can provide insufficient humidification, some are difficult or inconvenient for patients to use.

[0072] 2.2.3.4 Ventilation port technology

[0073] 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 (e.g. a plenum chamber) to an exterior space of the patient interface, e.g. to ambient.

[0074] The ventilation port can include an orifice and gas can flow through the orifice in use of the mask. Many such ventilation ports are noisy. Others can become occluded in use, providing insufficient flushing. Some ventilation ports can disturb a bed partner 1100 of the patient 1000’s sleep, e.g. through noise or focussed gas flow. SUMMARY

[0075] The technology relates to providing a medical device for diagnosing, ameliorating, treating or preventing a respiratory disorder, with one or more of improved comfort, cost, efficacy, ease of use, and manufacturability.

[0076] A first aspect of the technology relates to apparatus for diagnosing, ameliorating, treating or preventing a respiratory disorder.

[0077] A further aspect of the technology relates to methods for diagnosing, ameliorating, treating or preventing a respiratory disorder.

[0078] One aspect of certain forms of the technology is to provide methods and / or apparatuses to improve patient compliance with respiratory therapy.

[0079] One aspect of the technology includes a patient interface for delivering a supply of pressurized breathable gas to an entrance of a patient’s airways.

[0080] Another aspect of the present technology relates to a patient interface comprising a seal-forming structure constructed and arranged to form a seal with a region of the patient’s face surrounding an entrance to the patient’s airways for sealed delivery of a flow of pressurized air at a therapeutic pressure of at least 6 cmH20 above ambient air pressure throughout the patient’s respiratory cycle in use; a plenum chamber pressurisable to a therapeutic pressure of at least 6 cmH20 above ambient air pressure; and a positioning and stabilising structure to provide a force to hold the seal-forming structure in a therapeutically effective position on the patient’s head.

[0081] Another aspect of the present technology relates to a patient interface comprising: a gas delivery chamber; a seal-forming structure; a vent structure; and a positioning and stabilising structure to provide a force to hold the seal-forming structure in a therapeutically effective position on the patient’s head, the positioning and stabilising structure comprising at least one gas delivery tube to receive a flow of air from a connection port and to deliver the flow of air to an entrance to the patient’s airways via the seal-forming structure, the gas delivery tube being constructed and arranged to contact, in use, at least a region of the patient’s head superior to an otobasion superior of the patient’s head.

[0082] An aspect of the present technology relates to a positioning and stabilising structure to provide a force to hold a seal-forming structure in a therapeutically effective position on a patient’s head, the seal-forming structure being constructed and arranged to form a seal with a region of the patient’s face surrounding an entrance to the patient’s airways for sealed delivery of a flow of air at a therapeutic pressure of at least 6 cmH20 above ambient air pressure throughout the patient’s respiratory cycle in use, the positioning and stabilising structure comprising:

[0083] at least one gas delivery tube to receive the flow of air from a connection port on top of the patient’s head and to deliver the flow of air to the entrance to the patient’s airways via the seal-forming structure, the gas delivery tube being constructed and arranged to contact, in use, at least a region of the patient’s head superior to an otobasion superior of the patient’s head, the gas delivery tube comprising a tube wall defining a hollow interior through which air can flow to the seal-forming structure, the tube wall comprising:

[0084] a patient-contacting portion comprising a first outer layer comprising a textile material or a foam material configured to lie against the patient’s head in use; and

[0085] a non-patient-contacting portion comprising a second outer layer comprising a textile material or a foam material on a side of the gas delivery tube opposite the first outer layer.

[0086] According to an aspect of the present technology relates to a positioning and stabilising structure providing a force to hold a seal-forming structure in a therapeutically effective position on the head of a patient, the seal-forming structure being constructed and arranged to form a seal to an area of the patient's face surrounding an entrance to the patient's airways for sealed delivery of a flow of air at a therapeutic pressure of at least 6 cmH20 above ambient air pressure throughout the patient's respiratory cycle in use, the positioning and stabilising structure comprising:

[0087] at least one gas delivery tube to receive the flow of air from a connection port at the top of the patient's head and deliver the flow of air to the entrance to the patient's airways via the seal-forming structure, the gas delivery tube being constructed and arranged to contact, in use, at least an area of the patient's head superior to an otobasion superior of the patient's head, the gas delivery tube comprising a tube wall defining a hollow interior through which air can flow to the seal-forming structure, wherein at least a portion of the tube wall comprises:

[0088] a patient contacting portion comprising a layer of textile material or a layer of foam material configured to be placed against the patient's head in use; and

[0089] a non-patient contacting portion, wherein at least a section of the non-patient contacting portion is constructed from a transparent material.

[0090] According to an aspect of the present technology, a patient interface comprises:

[0091] a seal-forming structure constructed and arranged to form a seal to an area of the patient's face surrounding an entrance to the patient's airways for sealed delivery of a flow of pressurised air at a therapeutic pressure of at least 6 cmH20 above ambient air pressure throughout the patient's respiratory cycle in use;

[0092] a plenum chamber pressurisable to a therapeutic pressure of at least 6 cmH20 above ambient air pressure. and

[0093] a positioning and stabilising structure providing a force to hold a seal-forming structure in a therapeutically effective position on the head of a patient, the seal-forming structure being constructed and arranged to form a seal to an area of the patient's face surrounding an entrance to the patient's airways for sealed delivery of a flow of air at a therapeutic pressure of at least 6 cmH20 above ambient air pressure throughout the patient's respiratory cycle in use, the positioning and stabilising structure comprising:

[0094] at least one gas delivery tube coupled to the plenum and configured to receive a flow of pressurized air from a connection port on the patient's head and deliver the flow of pressurized air through the plenum to an entrance of the patient's airway, the at least one gas delivery tube constructed and arranged to contact at least one region of the patient's head superior to an otobasion superior of the patient's head in use, the at least one gas delivery tube comprising a tube wall having an internal passageway for the flow of pressurized air along a longitudinal axis of the tube to the seal-forming structure, wherein at least a portion of the tube wall comprises:

[0095] a patient-contacting portion comprising a first outer layer comprising a fabric or foam material configured to rest against the patient's head in use; and

[0096] a non-patient-contacting portion, wherein at least a segment of the non-patient-contacting portion is composed of a transparent and / or translucent material to allow the passage to be viewed from the exterior;

[0097] wherein the layer of fabric material is bonded to the transparent and / or translucent material such that the tube wall is formed as a single piece construction; and

[0098] wherein a plane extending generally transverse to the longitudinal axis contains (1) the fabric material or foam material and (2) the transparent and / or translucent material such that a patient can view the passage along a transverse axis extending through this plane.

[0099] In examples, the patient-contacting portion can comprise more than one layer. In these examples, the patient-contacting portion can comprise an outer layer of fabric material or foam material configured to rest against the patient's head in use; and at least a first inner layer of thermoplastic material forming at least a portion of an air path within the at least one gas delivery tube. The first inner layer is bonded to the outer layer.

[0100] In examples, the patient-contacting portion comprises a single layer of fabric material or foam material. In these examples, (a) the material properties of the fabric material or foam material are impermeable; and / or (b) the fabric material or foam material is coated with an impermeable substance along at least one surface, the at least one surface forming an interior surface of the at least one gas delivery tube configured to be in contact with the flow of pressurized gas.

[0101] In examples, the fabric material or foam material can comprise: (a) a blend of polyamides, such as nylon, polyester and / or spandex; (b) a laminate coating of a blend of polyamides, such as nylon, polyester and / or spandex and one or more silicone. In this example, each silicone laminate coating can be between 5 and 75 microns thick. In another example, each silicone laminate coating can be 20 to 30 microns thick, preferably 25 microns thick.

[0102] In examples, the patient-contacting portion can include a segment of transparent and / or translucent material, where a portion of the segment of transparent and / or translucent material is configured to receive a fabric material or a foam material. In these examples, the segment of transparent and / or translucent material of the non-patient-contacting portion can include an adhesive layer configured to bond to the fabric material or the foam material.

[0103] In examples, the non-patient-contacting portion can include a segment configured to receive the segment of transparent and / or translucent material. In examples of the technology, the fabric material or the foam material of the non-patient-contacting portion can include: (a) an adhesive layer configured to bond to the segment of transparent and / or translucent material; or (b) a hook-and-loop material layer configured to cooperatively engage with a complementary layer of hook-and-loop material bonded to the segment of transparent and / or translucent material.

[0104] In examples, one of the patient-contacting portion or the non-patient-contacting portion is configured to receive: (a) an adhesive layer to which the other of the patient-contacting portion or the non-patient-contacting portion can bond; or (b) a hook-and-loop material layer configured to cooperatively engage with a complementary layer of hook-and-loop material bonded to the other of the patient-contacting portion or the non-patient-contacting portion.

[0105] In examples, the non-patient-contacting portion can include two or more layers. In these examples, the non-patient-contacting portion can include an outer layer of transparent and / or translucent material and at least a first inner layer of thermoplastic material, the first inner layer defining at least a portion of an air path within the at least one gas delivery tube.

[0106] In examples, at least a portion of the segment of transparent and / or translucent material: (a) is configured as a rigid element; and / or (b) includes an accordion segment; and / or (c) includes a series of corrugations. In this example, (a) the fabric material or the foam material is overmolded onto the accordion segment; (b) the fabric material or the foam material is on the patient-contacting portion and is configured to contact the patient; and / or (c) the fabric material or the foam material is on the non-patient-contacting portion.

[0107] In one example of the technology, the segment of transparent and / or translucent material can extend substantially the length of the at least one gas delivery tube. In another example of the technology, the segment of transparent and / or translucent material can extend a portion of the length of the at least one gas delivery tube. In yet another example of the technology, the transparent and / or translucent material can be arranged in discrete segments along the length of the at least one gas delivery tube, each segment separated by a segment of opaque and / or translucent material, such as a fabric material or a foam material.

[0108] In one example, the patient-contacting portion and the non-patient-contacting portion can each be elongate and each include a side facing forward (in use, forward of the at least one gas delivery tube) and a side facing rearward (in use, rearward of the at least one gas delivery tube), respectively. The forward side and the rearward side of each of the patient-contacting portion and the non-patient-contacting portion are connected along a length of the at least one gas delivery tube. In this example, at least one or both of the forward side and the rearward side of the non-patient-contacting side are constructed of a transparent and / or translucent material.

[0109] In this example, the forward side of the non-patient-contacting portion can have a different rigidity than the rearward side; (a) the forward side of the non-patient-contacting portion can include a greater rigidity than the rearward side of the non-patient-contacting portion; (b) the forward side of the non-patient-contacting portion and / or the rearward side of the non-patient-contacting portion can have a rigidity that varies along a length of the at least one gas delivery tube; (c) the rigidity of the forward side of the non-patient-contacting portion and / or the rearward side of the non-patient-contacting portion at a lower portion of the at least one gas delivery tube can be greater than the rigidity at an upper portion of the at least one gas delivery tube.

[0110] In examples, the segment of transparent and / or translucent material of the second outer layer can be formed of an elastomer, wherein the elastomer is one or more of: a) a silicone; b) a thermoplastic elastomer; or c) a thermoplastic polyurethane (TPU).

[0111] In further examples: (a) the patient-contacting portion and / or the non-patient-contacting portion can be thermoformed; (b) the at least one gas delivery tube can include a substantially D-shaped cross-section; (b) the at least one gas delivery tube can include a generally rectangular cross-section having two or more rounded corners; (d) a width of the at least one gas delivery tube can vary between 34 mm to 18 mm along a length of the at least one gas delivery tube; (e) a height of the at least one gas delivery tube can vary between 8 mm to 6 mm along a length of the at least one gas delivery tube; and / or (f) the non-patient-contacting portion includes only a transparent material. In these examples, (i) the D-shaped cross-section includes a generally flat surface forming the patient-contacting portion and an arcuate surface forming the non-patient-contacting portion; (ii) the arcuate surface includes a first segment constructed of a transparent and / or translucent material and a second segment constructed of a fabric material or a foam material; and / or (iii) the first segment is directly coupled to the flat surface and the second segment is disposed opposite the flat surface.

[0112] In examples, the manufacturing method includes positioning a fabric material or a foam material in a mold; introducing the transparent and / or translucent material into the mold; bonding the transparent and / or translucent material to the fabric material and / or foam material to form the at least one gas delivery tube; and connecting the at least one gas delivery tube to the plenum and / or the seal-forming structure. In these examples, (a) the mold includes a semicircular protrusion, and the transparent and / or translucent material flows around the semicircular protrusion and forms a semicircular recess along a hollow interior; and / or (b) the semicircular protrusion directs the transparent and / or translucent material toward the fabric material or the foam material to allow bonding between the transparent and / or translucent material and the fabric material or the foam material prior to forming the non-patient contacting portion.

[0113] An aspect according to the present technology relates to a positioning and stabilising structure providing a force to hold a seal-forming structure in a therapeutically effective position on a patient’s head, the seal-forming structure being constructed and arranged to form a seal around a region of the patient’s face that encompasses an entrance to the patient’s airways for sealed delivery of a flow of air at a therapeutic pressure of at least 6 cmH20 above ambient air pressure throughout the patient’s respiratory cycle in use, the positioning and stabilising structure comprising:

[0114] at least one gas delivery tube to receive the flow of air from a connection port at the top of the patient’s head and deliver the flow of air to the entrance to the patient’s airways via the seal-forming structure, the at least one gas delivery tube being constructed and arranged to contact, in use, at least a region of the patient’s head superior to an otobasion superior of the patient’s head, the at least one gas delivery tube comprising a tube wall defining a hollow interior through which air can flow to the seal-forming structure, and wherein at least a portion of the tube wall comprises:

[0115] a patient contacting portion comprising a layer of fabric material or an outer layer of foam material configured to lie against the patient’s head in use; and

[0116] a non-patient contacting portion comprising a segment of at least a transparent material;

[0117] a rigid element, wherein the rigid element is a segment of the transparent material. In one example, the transparent material of the non-patient contacting portion can be an elastomer, wherein the elastomer is one or more of: a) a silicone; sb) a thermoplastic elastomer; or c) a thermoplastic polyurethane (TPU).

[0118] In one example of the technology, the transparent segment can extend substantially the length of the at least one gas delivery tube. In another example of the technology, the transparent segment extends a portion of the length of the at least one gas delivery tube. In yet another example of the technology, the transparent segment is arranged at regular intervals along the length of the at least one gas delivery tube.

[0119] In one example, the patient-contacting portion and the non-patient-contacting portion can each be elongate and each include a side that, in use, faces forward (forward of the at least one gas delivery tube in use) and rearward (rearward of the at least one gas delivery tube in use), respectively. The forward and rearward sides of each of the patient-contacting portion and the non-patient-contacting portion are connected along the length of the at least one gas delivery tube. In this example, at least one or both of the forward and rearward sides of the non-patient-contacting side are comprised of a transparent material.

[0120] In one example, a rigid element can be provided to one of the front edge and the rear side of the at least one gas delivery tube.

[0121] In this example, the front side of the at least one gas delivery tube can have a different rigidity than the rear side of the at least one gas delivery tube; (a) the front side of the at least one gas delivery tube can include a greater rigidity than the rear side of the at least one gas delivery tube; (b) the front side of the at least one gas delivery tube and / or the rear side of the at least one gas delivery tube can have a rigidity that varies along the length of the at least one gas delivery tube; (c) the front side of the at least one gas delivery tube and / or the rear side of the at least one gas delivery tube can have a greater rigidity at a lower portion of the at least one gas delivery tube than at an upper portion of the at least one gas delivery tube.

[0122] In examples, the rigid element is formed by: a) a thickness of the transparent material segment being greater at a first portion of the at least one gas delivery tube relative to a second portion of the at least one gas delivery tube; b) a width of the transparent material segment being greater at a first portion of the at least one gas delivery tube than at a second portion of the at least one gas delivery tube. In these examples, the first portion is a lower portion of the at least one gas delivery tube and the second portion is an upper portion of the at least one gas delivery tube. In other examples, the first portion is an upper portion of the at least one gas delivery tube and the second portion is a lower portion of the at least one gas delivery tube. In further examples, the first portion is a front side of the at least one gas delivery tube and the second portion is a rear side of the at least one gas delivery tube, or the first portion is a rear portion of the at least one gas delivery tube and the second portion is a front portion of the at least one gas delivery tube.

[0123] In examples, the non-patient-contacting side comprises a front side and a rear side, the front side and the rear side being configured to face forward and rearward, respectively, in use. In these examples, (a) both the front side and the rear side are composed of a transparent and / or translucent material; and / or (b) the transverse axis extends generally from the front to the rear, comprising only the transparent and / or translucent material.

[0124] In examples, the at least one gas delivery tube is selectively coupled to the plenum, and is configured to be removed so as to allow the patient to clean inside the tube.

[0125] Another aspect in accordance with the present technology relates to a positioning and stabilising structure providing a force to hold a seal-forming structure in a therapeutically effective position on a patient’s head, the seal-forming structure being constructed and arranged to form a seal around a region of the patient’s face that encompasses an entrance to the patient’s airways, for sealed delivery of a flow of air at a therapeutic pressure of at least 6 cmH20 above ambient air pressure throughout the patient’s respiratory cycle in use, the positioning and stabilising structure comprising:

[0126] at least one gas delivery tube to receive the flow of air from a connection port at the top of the patient’s head and deliver the flow of air to the entrance to the patient’s airways via the seal-forming structure, the at least one gas delivery tube being constructed and arranged to contact, in use, at least a region of the patient’s head superior to an otobasion superior of the patient’s head, the at least one gas delivery tube comprising a tube wall defining a hollow interior through which air can flow to the seal-forming structure, the at least one gas delivery tube comprising, in use:

[0127] an upper tube portion and a lower tube portion,

[0128] wherein the tube wall of the upper tube portion comprises a patient-contacting portion comprising an elastomer and a non-patient-contacting portion comprising an elastomer,

[0129] and wherein the tube wall of the lower tube portion comprises a patient-contacting portion and a non-patient-contacting portion, the patient-contacting portion comprising a first layer of a fabric material or a foam material configured to rest against the patient’s head in use, the non-patient-contacting portion comprising a second outer layer, wherein at least a portion of the second outer layer is composed of a transparent material.

[0130] In examples, the first layer of fabric material is a fabric material that is one or more of: a) nylon; b) polyester; c) spandex.

[0131] In examples, the first layer of fabric material is a) bonded to the second outer layer by an adhesive; b) bonded to the second outer layer by a hook-and-loop material.

[0132] In one example, the first layer of fabric material is also provided to the upper tube portion.

[0133] In one example, the transparent material of the second outer layer can be an elastomer, where the elastomer is one or more of: a) a silicone; b) a thermoplastic elastomer; or c) a thermoplastic polyurethane (TPU).

[0134] According to an aspect of the present technology there is provided a patient interface comprising.

[0135] a plenum chamber pressurisable to a therapeutic pressure of at least 6 cmH20 above ambient air pressure, said plenum chamber including a plenum chamber inlet port sized and structured to receive a flow of air at the therapeutic pressure for breathing by a patient,

[0136] a seal-forming structure constructed and arranged to form a seal with a region of the patient’s face surrounding the entrance to the patient’s airways, said seal-forming structure having a hole therein such that the flow of air at said therapeutic pressure is delivered to at least the entrance to the patient’s nares, said seal-forming structure constructed and arranged to maintain said therapeutic pressure in the plenum chamber throughout the patient’s respiratory cycle in use,

[0137] a positioning and stabilising structure according to any one of the above aspects; and

[0138] a vent structure configured to allow a continuous flow of gases exhaled by the patient from an interior of the plenum chamber to ambient, said vent structure being sized and shaped to maintain the therapeutic pressure in the plenum chamber in use;

[0139] wherein the patient interface is configured to allow the patient to breath from ambient through their mouth without a flow of pressurised air through the plenum chamber inlet port, or the patient interface is configured to not cover the patient’s mouth,

[0140] Another aspect of certain forms of the present technology is a system for treatment of a respiratory disorder, the system including a patient interface according to any one or more of the other aspects of the present technology, an air circuit, and a source of positive air pressure.

[0141] According to an aspect of the present technology relates to a method of manufacturing a positioning and stabilising structure providing a force to hold a seal-forming structure in a therapeutically effective position on a patient’s head, the seal-forming structure constructed and arranged to form a seal with a region of the patient’s face surrounding the entrance to the patient’s airways for sealed delivery of a flow of air at a therapeutic pressure of at least 6 cmH20 above ambient air pressure throughout the patient’s respiratory cycle in use, the positioning and stabilising structure comprising:

[0142] at least one gas delivery tube to receive the flow of air from a connection port on top of the patient's head and deliver the flow of air to the entrance of the patient's airways via the seal-forming structure, the gas delivery tube being constructed and arranged to contact, in use, at least a region of the patient's head above the otobasion superior of the patient's head, the gas delivery tube comprising a tube wall defining a hollow interior through which air can flow to the seal-forming structure, wherein at least a portion of the tube wall comprises:

[0143] a patient-contacting portion comprising a layer of textile material or an outer layer of foam material configured to be placed against the patient's head in use; and

[0144] a non-patient-contacting portion, wherein at least a section of the non-patient- contacting portion is constructed from a transparent material.

[0145] Another aspect of one form of the 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.

[0146] One aspect of one form of the technology is a method of manufacturing a device.

[0147] One aspect of certain forms of the technology is a medical device that is easy to use, for example by a person who does not have medical training, by a person who is dexterous, by a person who has limited vision, or by a person who has limited experience in using this type of medical device.

[0148] One aspect of one form of the technology is a portable RPT device that can be carried by a person, for example by a person in the person's home.

[0149] One aspect of one form of the technology is a patient interface that can be cleaned in a patient's home, for example in soapy water, without the need for specialized cleaning equipment.

[0150] According to an aspect of the technology, the patient interface comprises:

[0151] a seal-forming structure constructed and arranged to form a seal with a region of the patient's face surrounding an entrance to the patient's airways to deliver a flow of pressurized air at a therapeutic pressure of at least 6 cmH20 above ambient air pressure in use throughout the patient's respiratory cycle;

[0152] a plenum chamber pressurizable to a therapeutic pressure of at least 6 cmH20 above ambient air pressure. and

[0153] and a positioning and stabilising structure to provide a force to hold the seal-forming structure in a therapeutically effective position on the patient's head.

[0154] According to one aspect of the present technology, at least one gas delivery tube, which is coupled to the plenum chamber and configured to receive a flow of pressurised air from a connection port on the patient's head and deliver the flow of pressurised air through the plenum chamber to an entrance of the patient's airways, the at least one gas delivery tube constructed and arranged to contact at least one region of the patient's head above an otobasion superior of the patient's head in use, the at least one gas delivery tube comprising a tube wall having an internal passageway for the flow of pressurised air along a longitudinal axis of the tube to the seal-forming structure, wherein at least a portion of the tube wall comprises:

[0155] a patient-contacting portion comprising a layer of textile material or a layer of foam material, the layer of textile material or the layer of foam material configured to be placed against the patient's head in use; and

[0156] a non-patient-contacting portion, wherein at least a section of the non-patient- contacting portion is constructed from a transparent and / or translucent material to allow the passage to be viewed from the exterior;

[0157] wherein the layer of textile material is bonded to the transparent and / or translucent material such that the tube wall is formed as a single piece construction; and

[0158] wherein a plane extending generally transverse to the longitudinal axis contains (1) the textile material or the foam material and (2) the transparent and / or translucent material, such that a patient can view the passage along a transverse axis extending through this plane

[0159] Of course, some of these aspects can form sub-aspects of the present technology. The sub-aspects and / or various aspects of the aspects can be combined in various ways, and also form other aspects or sub-aspects of the present technology.

[0160] Other features of the present technology will be apparent from consideration of the following detailed description, from the abstract, from the drawings, and from the claims. BRIEF DESCRIPTION OF DRAWINGS

[0161] The present technology is illustrated in the drawings in which like reference numbers refer to like elements throughout the several figures, which illustrate by way of example, not limitation, aspects of the present technology comprising:

[0162] 4.1 Treatment system

[0163] 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.

[0164] Figure 1BA system is shown comprising a patient 1000 wearing a patient interface 3000 in the form of a nasal mask receives 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.

[0165] Figure 1C A system is shown comprising a patient 1000 wearing a patient interface 3000 in the form of a full face mask receives 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 sleeps in a side sleeping position.

[0166] 4.2 Respiratory system and facial anatomy

[0167] Figure 2A A diagram showing the human respiratory system including the nasal cavity and oral cavity, larynx, vocal folds, oesophagus, trachea, bronchi, lungs, alveolar sacs, heart and diaphragm is shown.

[0168] Figure 2B 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, nasal wing, nasolabial sulcus and labial commissure. Also indicated are superior, inferior, radially inward and radially outward directions.

[0169] Figure 2C is a side view of a head with several surface anatomical features identified including glabella, sellion, pronasale, subnasale, upper lip, lower lip, supramenton, nasal ridge, alar crest, otobasion superior and otobasion inferior. Also indicated are superior-inferior and anterior-posterior directions.

[0170] Figure 2D is another side view of a head. The approximate locations of the Frankfort horizontal and nasolabial angle are indicated. Also indicated is the coronal plane.

[0171] 3.3 Patient interface

[0172] Figure 3 A patient interface according to one form of the present technology in the form of a nasal mask and tube headgear is shown.

[0173] Figure 4 A form of tube headgear according to another form of the present technology is shown.

[0174] Figure 5 A cross-sectional view of one example of a gas delivery tube according to one form of the present technology is shown.

[0175] Figure 6 A perspective view of a gas delivery tube of Figure 5 is shown.

[0176] Figure 7 An end view of another example of a gas delivery pipe according to this technology is shown.

[0177] Figure 8 A side view of another example of a gas delivery pipe according to this technology is shown.

[0178] Figure 9 A perspective view of the lower part of another form of gas delivery pipe according to the present technology is shown.

[0179] Figure 10 A front view of one form of a catheter headband according to this technology is shown.

[0180] Figure 11 A perspective view of the upper part of another form of gas delivery pipe according to the present technology is shown.

[0181] Figure 12 It shows Figure 11 A perspective view of the lower part of the gas delivery pipe. Detailed Implementation

[0182] Before describing this technology in further detail, it should be understood that this technology is not limited to the specific examples described herein, and the specific examples described herein may be modified. It should also be understood that the terminology used in this disclosure is for the purpose of describing the specific examples described herein only and is not intended to be limiting.

[0183] The following description is provided in relation to various examples that may share one or more common features and / or characteristics. It should be understood that one or more features of any example may be combined with one or more features of another example or other examples. In addition, in any example, any single feature or combination of features may constitute another example.

[0184] 5.1 Treatment

[0185] 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.

[0186] In some examples of this technique, positive pressure air is supplied to the patient's nasal passages through one or both nostrils.

[0187] In some examples of this technique, mouth breathing is limited, restricted, or prevented.

[0188] 5.2 Treatment System

[0189] In one form, the technology comprises an apparatus or device for treating a respiratory disorder. The device or apparatus can comprise an RPT device 4000 for supplying pressurized air to a patient 1000 via an air circuit 4170 to a patient interface 3000.

[0190] 5.3 Patient interface

[0191] With reference to Figure 3 A patient interface 3000 according to an aspect of the technology comprises the following functional aspects: 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 (such as an air circuit 4170 as shown in Figures 1A-1C In the example, the seal-forming structure 3100 and the plenum chamber 3200 are provided by a cushion module 3150. The cushion module 3150 in this example is a cradle cushion module. In other examples, it can be a nasal pillow cushion assembly or other type of cushion assembly.

[0192] A patient interface can not be suitable for respiratory pressure therapy if it is not able to comfortably deliver a minimum level of positive pressure to the airways.

[0193] A patient interface 3000 according to one form of the technology is constructed and arranged to be able to supply air at a positive pressure of at least 6 cm H20 relative to ambient.

[0194] A patient interface 3000 according to one form of the technology is constructed and arranged to be able to supply air at a positive pressure of at least 10 cm H20 relative to ambient.

[0195] A patient interface 3000 according to one form of the technology is constructed and arranged to be able to supply air at a positive pressure of at least 20 cm H20 relative to ambient.

[0196] 5.3.1 Seal-forming structure

[0197] In one form of the technology, the seal-forming structure 3100 provides a target seal-forming region and can additionally provide a cushioning function. The target seal-forming region is the region of the seal-forming structure 3100 where a seal is intended to occur. The region where a seal actually occurs - the actual sealing surface - can vary from day to day and from patient to patient, depending on a range of factors including, for example, the position of the patient interface on the face, tension in the positioning and stabilising structure, and the shape of the patient's face.

[0198] In one form, the target seal-forming region is located on an outer surface of the seal-forming structure 3100.

[0199] In certain forms of the technology, the seal-forming structure 3100 is constructed from a biocompatible material, for example silicone rubber.

[0200] The seal-forming structure 3100 according to the technology can be constructed from a soft, flexible and resilient material such as silicone.

[0201] In certain forms of the technology, a system is provided that includes more than one seal-forming structure 3100, each configured to correspond to a different size and / or shape range. For example, the system can include one form of seal-forming structure 3100 that is suitable for a large size head but not a small size head, and another that is suitable for a small size head but not a large size head.

[0202] 5.3.1.1 Sealing mechanism

[0203] In one form, the seal-forming structure includes a pressure-activated auxiliary sealing flange that utilises a pressure-assisted sealing mechanism. In use, the pressure-activated auxiliary sealing 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.

[0204] In one form, the seal-forming structure 3100 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 perimeter 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 at least part of the way around the perimeter path. The support flange is or includes a spring-like element and acts to support the sealing flange against buckling in use.

[0205] In one form, the seal-forming structure can include a compression sealing portion or a gasket sealing portion. In use, the compression sealing portion or the gasket sealing portion is configured and disposed to be in compression, for example as a result of the elastic tension in the positioning and stabilising structure.

[0206] In one form, the seal-forming structure includes a tensioned portion. In use, the tensioned portion is held in tension, for example by adjacent regions of the sealing flange.

[0207] In one form, the seal-forming structure includes a region having a tacky or adhesive surface.

[0208] In certain forms of the present technology, the seal-forming structure can comprise one or more of a pressure-aided sealing flange, a compression sealing portion, a gasket sealing portion, a tensioning portion, and a portion having a tacky or adhesive surface.

[0209] In one form, the non-invasive patient interface 3000 comprises a seal-forming structure that forms a seal in use in the region of the patient's nasal bridge or nasal ridge region of the face and the upper lip region of the patient's face. In these forms, the seal-forming structure can be referred to as a nasal mask. This is the case, for example Figure 1B with the patient interface 3000 shown. The seal-forming portion delivers a supply of air or breathable gas to both nares of the patient 1000 through a single orifice. This type of seal-forming structure can be referred to as a "nosepad" or "nosemask". In some examples of the present technology, Figure 3 The positioning and stabilising structure 3300 shown in Figs. 3 and 4 can be used to hold a nosepad in sealing position on the patient's face.

[0210] In one form, for example as shown in Figure 3 The seal-forming structure 3100 is configured to form a seal in use with the underside of the nose around the nares, and optionally with the upper lip of the patient 1000. This type of seal-forming structure can be referred to as a "cradle pad" or "subnasal mask". The shape of the seal-forming structure can be configured to match or closely follow the underside of the patient's nose, i.e. the profile and angle of the seal-forming structure can be substantially parallel to the nasolabial angle of the patient. In one form of the nasal cradle cushion, the seal-forming structure comprises a nose portion that defines two orifices, each of which supplies air or breathable gas to a different one of the patient's nares in use. The nose portion can be configured to contact or seal with the patient's columella nasi in use. In some forms of the technology, the seal-forming structure 3100 is configured to form a seal on the underside of the patient's nose without contacting the nasal bridge region of the patient's nose. In some examples, the patient interface can comprise a seal-forming structure 3100 in the form of a cradle cushion as described in PCT Application No. PCT / AU2018 / 050289 filed 29 March 2018, the entire contents of which are incorporated herein by reference.

[0211] In one form, the patient interface 3000 comprises a seal-forming portion that forms a seal in use on the chin region, the nasal bridge region and the cheek region of the patient's face. This is the case, for example Figure 1C with the patient interface 3000 shown. The seal-forming portion delivers a supply of air or breathable gas to both nares and the mouth of the patient 1000 through a single orifice. This type of seal-forming structure can be referred to as a "full face mask". In some examples of the present technology, Figure 3Alternatively, the positioning and stabilizing structure 3300 shown in diagram 4 can be used to hold the full-face pad in a sealed position on the patient's face. Alternatively, Figure 3 and 4 The positioning and stabilizing structure 3300 can be used with the patient interface 3000, which includes a nasal seal-forming structure and an oral seal-forming structure in the form of a nasal pad or nasal support pad, the oral seal-forming structure being configured to form a seal around the patient's mouth (which may be referred to as a "mouth pad" or "mask") during use. In such a mask, air or breathable gas is supplied to the patient's nostrils and mouth during use through orifices. This type of seal-forming structure 3100 may be referred to as a "naso-oral pad" where separate seals exist around the mouth and nose, or as an "ultra-compact full-face pad" where the nasal seal surrounds or is close to the patient's nostrils. In one form, the nasal seal-forming structure and the oral seal-forming structure are integrally formed as a single component. In some examples, the patient interface may include a seal-forming structure 3100 in the form of a support pad as described in U.S. Patent Application No. 62 / 649,376, the entire contents of which are incorporated herein by reference.

[0212] 5.3.2 Pressurization Chamber

[0213] In the area forming a seal during use, the pressurization chamber 3200 has a periphery shaped to complement the surface contours of a typical human face. During use, the boundary edges of the pressurization chamber 3200 are positioned very close to the adjacent surfaces of the face. Actual contact with the face is provided by the sealing structure 3100. The sealing structure 3100 may extend along the entire periphery of the pressurization chamber 3200 during use. In some forms, both the pressurization chamber 3200 and the sealing structure 3200 are formed from a single sheet of homogeneous material.

[0214] In some forms of this technology, for example in Figure 3 In the patient interface 3000, the pressurization chamber 3200 does not cover the patient's eyes during use. In other words, the eyes are outside the pressurized volume defined by the pressurization chamber. This form tends to be less conspicuous and / or more comfortable for the wearer, which can improve treatment compliance.

[0215] In some forms of this technology, the pressurization chamber 3200 is made of a transparent material, such as transparent polycarbonate. Using a transparent material reduces the prominence of the patient interface and helps improve treatment compliance. The use of a transparent material also helps clinicians observe how the patient interface is positioned and functions.

[0216] In some forms of this technology, the pressure chamber 3200 is made of a translucent material. The use of a translucent material can reduce the protrusion of the patient interface and help improve treatment compliance.

[0217] 5.3.3 Positioning and stabilising structure

[0218] The seal-forming structure 3100 of the patient interface 3000 of the present technology can be held in a sealed condition, in use, by a positioning and stabilising structure 3300. The positioning and stabilising structure 3300 can be referred to as a “headgear” as it engages the patient’s head in order to hold the patient interface 3000 in a sealing position.

[0219] In one form, the positioning and stabilising structure 3300 provides a holding force that is at least sufficient to overcome the effect of the positive pressure in the plenum chamber 3200 to lift off the face.

[0220] In one form, the positioning and stabilising structure 3300 provides a holding force to overcome the effect of gravity on the patient interface 3000.

[0221] In one form, the positioning and stabilising structure 3300 provides a holding force as a safety margin to overcome potential effects of disruptive forces on the patient interface 3000, for example from tube drag or accidental interference with the patient interface.

[0222] In one form of the present technology, there is provided a positioning and stabilising structure 3300 that is configured in a manner consistent with being worn by a patient while sleeping. In one example, the positioning and stabilising structure 3300 has a small lateral or cross-sectional thickness to reduce the perceived or actual bulk of the apparatus. In one example, the positioning and stabilising structure 3300 includes at least one strap that is rectangular in cross-section. In one example, the positioning and stabilising structure 3300 includes at least one flat strap.

[0223] In one form of the present technology, there is provided a positioning and stabilising structure 3300 that is configured to be not too large and bulky to prevent the patient from lying in a supine sleeping position with the back region of the patient’s head on a pillow.

[0224] In one form of the present technology, there is provided a positioning and stabilising structure 3300 that is configured to be not too large and bulky to prevent the patient from lying in a side sleeping position with the side region of the patient’s head on a pillow.

[0225] In one form of the present technology, the positioning and stabilising structure 3300 is provided with a decoupling portion located between an anterior portion of the positioning and stabilising structure 3300 and a posterior portion of the positioning and stabilising structure 3300. The decoupling portion does not resist compression and can be, for example, a flexible or soft strap. The decoupling portion is constructed and arranged so that when the patient lies with their head on a pillow, the presence of the decoupling portion prevents the force acting on the posterior portion from being transmitted along the positioning and stabilising structure 3300 and disrupting the seal.

[0226] In one form of the present technology, the positioning and stabilising structure 3300 comprises a strap 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.

[0227] In certain forms of the present technology, the positioning and stabilising structure 3300 comprises a strap that is extendable, e.g. elastically extendable. For example, the strap can be configured to be in tension in use, and to direct a force to bring the seal-forming structure into sealing contact with a portion of the patient’s face. In one example, the strap can be configured as a tie.

[0228] A tie will be understood to be a structure designed to resist tension. In use, a tie can be part of the positioning and stabilising structure 3300 that is under tension. As will be described, some ties will exert an elastic force due to tension. Ties can be used to hold the seal-forming structure 3100 in a therapeutically effective position on the patient’s head.

[0229] In one form of the present technology, the positioning and stabilising structure comprises a first tie configured and arranged so that, in use, at least a portion of a lower edge of the first tie passes over the superior auricular point of the patient’s head and covers a portion of the parietal bone without covering the occipital bone. The first tie can be provided as part of the patient interface, including a cradle cushion, a nasal pillow, a nasal cushion, a full-face cushion, or a oro-nasal cushion, for example. Figure 3 The positioning and stabilising structure 3300 of the ResMed® Hudson RCI® Full-Face Mask with Headgear, for example, comprises a first tie in the form of a gas delivery tube 3350 located above the top of the patient’s head. The gas delivery tubes 3350 can also be referred to as headgear tubes 3350 because they provide the function of a headgear.

[0230] In one form of the present technology suitable for a nasal mask or for a full-face mask, the positioning and stabilising structure comprises 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 inferior auricular point of the patient’s head and covers or is located below the occipital bone of the patient’s head. The second tie can be provided as part of the patient interface, including a cradle cushion, a nasal pillow, a full-face cushion, a nasal cushion, or an oro-nasal cushion, for example. Figure 3 The positioning and stabilising structure 3300 of the ResMed® Hudson RCI® Full-Face Mask with Headgear, for example, comprises a second tie in the form of a strap 3310 that rests on the back surface of the patient’s head.

[0231] 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 move apart from each other. Also, in some forms, the positioning and stabilising structure includes a fourth tie configured and arranged to interconnect the second and third ties to reduce the tendency of the second and third ties to move away from each other.

[0232] 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. Figure 3 The positioning and stabilising structure 3300 of Figs. 33A and 33B includes a flexible strap 3310. The strap 3310 can be considered a rear strap. The strap 3310 is sufficiently flexible to pass around the back of the patient’s head and to lie comfortably against the patient’s head, even when under tension in use.

[0233] 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 retention force to correspond to a different range of sizes and / or shapes. For example, the system can include one form of positioning and stabilising structure 3300 suitable for large sized heads but not small sized heads, and another form of positioning and stabilising structure suitable for small sized heads but not large sized heads.

[0234] 5.3.3.1 Headgear tubes

[0235] In some forms of the present technology, the positioning and stabilising structure 3300 includes one or more tubes 3350 that convey pressurised air received from a conduit forming part of the air circuit 4170 from the RPT device to the patient’s airways, for example through the plenum chamber 3200 and the seal-forming structure 3100. In Figure 3In the form of the technology shown, the positioning and stabilising structure 3300 comprises two separate gas delivery tubes 3350 which deliver air from the air circuit 4170 to the seal-forming structure 3100. The tubes 3350 are an integral part of the positioning and stabilising structure 3300 of the patient interface 3000 to position and stabilise the seal-forming structure 3100 of the patient interface to the appropriate portion of the patient's face (e.g. the nose and / or mouth). This allows the conduit of the air circuit 4170 which provides the flow of pressurised air to be connected to the connection port 3600 of the patient interface at a location other than in front of the patient's face, which can be aesthetically unpleasing to some people. While a pair of tubes 3350 has some advantages (described below), in some examples the positioning and stabilising structure 3300 comprises only a single tube 3350 configured to cover the patient's head on one side. A strap or other stabilising component can be provided on the other side of the patient's head between the top end of the single tube 3350 and the seal-forming structure 3100 to provide a balancing force on the seal-forming structure 3100.

[0236] The positioning and stabilising structure 3300 can be described as being inflatable because air can be included and passed through the headgear tube 3350 in order to deliver pressurised air from the air circuit 4170 to the patient's airways. It will be appreciated that the inflatable positioning and stabilising structure 3300 does not require that all components of the positioning and stabilising structure 3300 are inflatable. For example, in some examples the headgear tube 3350 is not inflatable. Figure 3 In the example shown, the positioning and stabilising structure 3300 comprises an inflatable headgear tube 3350 and a non-inflatable strap 3310.

[0237] In certain forms of the technology, the patient interface 3000 can comprise a connection port 3600 located near the top, side or back of the patient's head. For example, in the form of the technology shown in Figure 4 In the form of the technology shown in, the connection port 3600 is located on the top of the patient's head. In this example, the patient interface 3000 comprises an elbow 3610 to which the connection port 3600 is provided. The elbow 3610 can be rotated relative to the positioning and stabilising structure 3300 in order to decouple movement of the conduit connected to the connection port 3600 from the positioning and stabilising structure 3300. As shown in Figure 3 The connection port can be configured as a fluid connection opening 3390 in the headgear tube 3350, or as shown in Figure 4 connected to the component to which the headgear tube 3350 is connected. Additionally or alternatively, the conduit connected to the connection port 3600 can be rotated relative to the elbow 3610. In the example shown, the elbow 3610 comprises a swivel conduit connector comprising the connection port 3600 to which the conduit of the air circuit 4170 is connectable such that the conduit can be rotated about its longitudinal axis relative to the elbow 3610. In Figure 3In the example, air circuit 4170 can be connected to a fluid connection opening. Bend 3610 can be rotatably connected to the fluid connection opening or to a ring received in the fluid connection opening.

[0238] The connection port 3600 is not positioned in a way that would make the catheter connected to the patient interface 3000 in front of the face unsightly and / or protruding. For example, the catheter connected to the patient interface 3000 in front of the face may easily become tangled in bedding or sheets, especially if the catheter extends downward from the patient interface during use. The use of a patient interface with a connection port could make it easier or more comfortable for the patient to be in one or more of the following positions: lying on their side or supine; lying supine (i.e., face up); and lying prone (i.e., prone, face down). Furthermore, connecting the catheter to the front of the patient interface could exacerbate a problem known as tube drag, where the catheter may provide an undesirable dragging force on the patient interface, causing it to move away from the face.

[0239] exist Figure 2C and 4 In the form of the present technology shown, the positioning and stabilizing structure 3300 includes two tubes 3350, each tube 3350 being positioned on a different side of the patient's head during use and extending across the corresponding cheek area, above the corresponding ear (above the supraaural base point of the patient's head, such as...). Figure 4 (As shown) a curved tube 3610 extending to the top of the patient's head. This form of technology can be advantageous because if the patient sleeps with their head turned to the side, and one tube is compressed to block or partially block the flow of gas along that tube, the other tube remains open to supply pressurized gas to the patient. In other examples of the technology, the patient interface 3000 may include a different number of tubes, such as one tube, or three or more tubes. In one example, the patient interface has a tube 3350, which is positioned on one side of the patient's head during use (e.g., across a cheek area), and a strap forms part of the positioning and stabilization structure 3300 and is positioned on the other side of the patient's head during use (e.g., across another area) to help secure the patient interface 3000 to the patient's head.

[0240] like Figure 3 As shown, the positioning and stabilizing structure can alternatively be configured as a single gas delivery tube with a left arm and a right arm. In the example shown, the connection port 3600 is located on the upper side of the positioning and stabilizing structure, instead of as... Figure 2C The example shows a separate connection module.

[0241] In certain forms of the present technology, the patient interface 3000 is configured so that the connection port 3600 is positioned generally at the vertex of the patient’s head. The connection port 3600 can be positioned in a sagittal plane and aligned with the pre-auricular points in a plane parallel to the coronal plane. In Figure 2D the pre-auricular points are identified. In some forms of the technology, the positioning and stabilising structure 3300 is configured to be worn in different positions, with the effect that the connection port 3600 can be positioned in the sagittal plane near the vertex of the patient’s head, forward of the pre-auricular points by about 20 mm or rearward of the pre-auricular points by about 20 mm.

[0242] As above, in some examples of the present technology, the patient interface 3000 includes a seal-forming structure 3100 in the form of a cradle cushion, which sits generally under the nose and seals to the lower perimeter of the nose. The positioning and stabilising structure 3300 can be constructed and arranged to pull the seal-forming structure 3100 into the patient’s face under the nose with a sealing force vector having a posterior and superior direction (e.g. a posterior-superior direction). A sealing force vector having a posterior-superior direction can assist the seal-forming structure 3100 to form a good seal to the lower perimeter of the patient’s nose and to the patient’s face on either side of the patient’s nose and upper lip facing forward.

[0243] In some examples, the positioning and stabilising structure 3300 can apply, in use, a sealing force vector having a posterior-superior direction of about 35° relative to the Frankfurt horizontal plane of the patient (identified in Figure 3 ). The upper portion of the tube 3350 (e.g. the portion of the tube 3350 above the strap 3310) can be oriented vertically, and the posterior headgear strap 3310 can extend from the tube 3350 in a posterior direction at an angle of about 35° relative to the Frankfurt horizontal plane of the patient. In this particular arrangement, an angle Θ of about 125° is formed between the strap 3310 and the upper portion of the tube 3350 where the strap 3310 connects to the tube 3350. In other examples, Θ can be greater or less than 125°.

[0244] In Figure 3 and 4 forms of the technology, the two tubes 3350 are fluidly connected to each other at their upper ends and to the connection port 3600. In Figure 4 , the tubes 3350 are separate tubes that are connected to the crown connector 3360. The tubes 3350 are indirectly connected to each other via the crown connector 3360 and can be disconnected, e.g. for cleaning, storage or replacement. In Figure 3In this configuration, two tubes are integrally formed and a connection port 3600 is included as a fluid connection opening 3390, to which a swivel elbow is connected. In other examples using separate tubes, they may be indirectly connected together, for example, each may be connected to a T-shaped catheter with two catheter arms, each catheter arm being fluidly connected to tube 3350. The coronal connector 3360 may include a third catheter arm. The connection port 3600 may include a bend 3610 received in the fluid connection opening 3390 at the center of the coronal connector 3360. The bend 3610 may be received in a ring within the fluid connection opening 3390 and may be configured to rotate within the ring. The fluid connection opening 3390 itself may also be considered as the connection port 3600.

[0245] Figure 3 and 4 The tube 3350 in the illustrated technical form has a length between 15 and 30 cm, for example, between 20 and 27 cm. The tube length is chosen to suit the size of a typical patient's head, for example, the area near the top of the head where the upper end of the tube 3350 is located, and when it descends along a roughly arc-shaped path along both sides of the head and passes through the patient's cheek area (such as...). Figure 5 and 4 The distance between the areas near the patient's airway opening (the arcuate path taken by the tube 3350 shown) and the area where the lower end of the tube 3350 connects to the pressurization chamber 3200 at that opening. In some examples, the patient interface 3000 may be configured such that the length of the tube 3350 can be varied. It should be understood that the length of the tube 3350 will depend on the length of other components in the patient interface 3000, such as the length of the coronal connector 3360 to which the upper end of the tube 3350 is connected and / or the size of the pressurization chamber 3200.

[0246] The gas delivery tube 3350 may have a circular, elliptical, oval, D-shaped, trapezoidal, or rounded rectangular cross-sectional shape, such as that described in U.S. Patent No. 6,044,844, the contents of which are incorporated herein by reference. A cross-sectional shape that presents a flat surface of the tube on the side facing and in contact with other parts of the patient's face or head may be more comfortable to wear than, for example, a tube with a circular cross-section.

[0247] The cross-sectional width and / or height of the tube 3350 can be in the range 8-35mm. In some forms where the tube has a generally D-shaped cross-section, the tube can have a width in the range 15-25mm and a height in the range 6-15mm. The height can be considered to be the dimension of the tube extending away from the patient’s face in use, i.e. the distance between the patient-contacting portion 3348 and the outermost portion of the non-patient-contacting portion 3349, while the width can be considered to be the dimension across the surface of the patient’s head. The cross-sectional thickness of the material forming the tube 3350 can be in the range 0.8-1.6mm, for example 1.0-1.5mm.

[0248] 5.3.3.1.1 Gas delivery tube configuration

[0249] In examples of the present technology, Figure 3 A cross-section of a gas delivery tube 3350 having a generally D-shaped profile is shown. In use, the flat side of the profile contacts the patient’s face and head, and should be understood as the patient-contacting portion of the gas delivery tube. The convex or arcuate side of the profile should be understood as the non-patient-contacting portion of the gas delivery tube. In some examples, the gas delivery tube can have a more square or rectangular profile, configured with slightly rounded corners for patient comfort.

[0250] The gas delivery tube 3350 is at least substantially composed of a fabric material and / or a foam material, and a transparent material at least substantially composed of an elastomeric material. The transparency of the elastomeric material, i.e. its translucency, is passable. In some examples, the transparency can be high, with minimal or no deflection of transmitted light, such that the transparency of the elastomeric material is similar to glass or film. In other examples, the transparency can have some limited deflection of transmitted light, such that the transparency of the elastomeric material is somewhat hazy but sufficient for the patient to detect significant dirt and mildew.

[0251] In use, the gas delivery tube is configured such that the patient-contacting portion of the gas delivery tube, i.e. the portion that contacts the patient’s face and head, is substantially composed of the fabric material. The transparent material comprises at least a portion of the non-patient-contacting side of the gas delivery tube.

[0252] This configuration provides a gas delivery tube that is comfortable for the patient to wear as part of a positioning and stabilising structure, while also allowing for inspection of the interior of the gas delivery tube. This can mean that the build-up of dirt or mildew etc. inside the gas delivery tube can be visually detected. The patient can disconnect the gas delivery tube 3350 from the plenum chamber 3200 in order to remove any debris detected inside. The transparent material allows the patient to confirm that any dirt and mildew has been removed when the gas delivery tube is cleaned.

[0253] In certain forms of the present technology, the gas delivery tube 3350 is constructed from a translucent material. The use of a translucent material can function in substantially the same way as a transparent material, and can be used in any embodiment in addition to or instead of a transparent material.

[0254] Another advantage of this construction is that the fabric material and the elastomeric material can combine to achieve an overall look and feel that provides a possibly higher quality feel compared to a conventional gas delivery tube constructed entirely from fabric material or elastomeric material. Additionally, the integrated construction can provide a low cost and light weight product compared to conventional gas delivery tubes.

[0255] 5.3.3.1.2 Fabric / Foam Material

[0256] The flat side 3351 of the gas delivery tube 3350 forms the patient contact side of the gas delivery tube. It is composed of a fabric material. In this example, the fabric material can have at least two layers; an inner layer 3352 composed of a gas impermeable layer, for example formed from a film or laminate of silicone or another elastomeric plastic material such as TPE or TPE; and an outer fabric layer 3353 forming the exterior of the gas delivery tube 3350. The inner layer 3352 is bonded to the outer fabric layer 3353. In some other examples, an additional layer can be provided between the gas impermeable layer and the outer fabric layer, for example an intermediate bonding layer that bonds the gas impermeable layer to the outer fabric layer 3353. In yet further examples, the fabric material can comprise a single layer. In these examples, the fabric material can be inherently gas impermeable such that no additional film or laminate layer is required.

[0257] In some examples of the present technology, as shown in the example of Figure 5 and 4 The headgear tube 3350 includes at least a patient contact side formed at least partially from a fabric material as previously described. Additionally or alternatively, the patient contact side of the gas delivery tube 3350 can be formed from a foam material. In some examples, the tube 3350 includes a combination of fabric and foam material. The fabric and / or foam material that comprises the patient contact side of the gas delivery tube can: hold air under pressure, be biocompatible and suitable / approved for use in forming a medical air path, be lighter than silicone tubing, be soft and flexible, generally maintain a predetermined shape, be cleanable and durable for a predetermined life cycle, for example one month, three months, six months, one year or more.

[0258] As previously mentioned, the arcuate side 3354 of the D-shaped profile forms the non-patient contacting portion of the gas delivery tube. In one example, at least a section of the non-patient contacting portion comprises the same way as the patient contacting side, i.e. a fabric material with at least two layers; an inner layer, the inner layer comprising a gas impermeable layer, the gas impermeable layer being formed of an elastomeric plastic material, the elastomeric plastic material being bonded to an outer fabric layer. However, in other examples, the fabric material that can comprise a portion of the non-patient contacting portion can be sufficiently gas impermeable such that the inner layer is not required, and the non-patient contacting portion comprises a single layer of fabric material and a transparent material. The fabric material of the non-patient contacting side 3354 can be reinforced (e.g. by a gas impermeable layer, by additional reinforcement, etc.) in order to help maintain the sharp shape. Alternatively, no reinforcement can be included, and the arcuate D-shape can form only when pressurised air is flowing through the gas delivery tube 3350.

[0259] In one example, the fabric material that constitutes the gas delivery tube can be a mixture of polyamides, such as nylon, polyester and / or spandex, weighing between 50 g / m 2 and 250 g / m 2 . In another example, the fabric material can be a material weighing 120 g / m 2 . In some examples, the inner layer of the fabric material can comprise two or more layers of silicone laminate coating. In one example, each layer of silicone laminate coating can be 5 to 75 microns thick. In another example, each layer of silicone laminate coating can be 20 to 30 microns thick, preferably 25 microns thick.

[0260] It is advantageous to have fabric outside the patient contacting side and the non-patient contacting side of the gas delivery tube. On the patient contacting side, it is more comfortable when contacting the face, while on the non-patient contacting side, it is less abrasive when the gas delivery tube contacts other fabrics, such as a pillow or a bed sheet, when the patient interface is worn in bed. It also feels more aesthetically pleasing to the touch.

[0261] 5.3.3.1.3 Transparent material - window section

[0262] In examples of Figure 5 and 6 , the front and back sides 3355, 3356 of the D-shaped profile where the patient contacting side of the gas delivery tube 3350 and the non-patient contacting side of the gas delivery tube 3350 meet are formed of a transparent material. This transparent material forms a window section in the profile of the gas delivery tube 3350, which allows the user to visually inspect the interior of it. This allows for easier detection of mould and / or dirt build-up, and facilitates better cleaning of the interior, while still maintaining the comfort of a substantially fabric exterior.

[0263] In examples of Figure 5 and 6In the example shown, the patient-contacting side 3351 and the non-patient- contacting side 3354 of the gas delivery tube 3350 are both formed from a single band of fabric material. Further, Figure 5 and 6 The gas delivery tube of FIG. 33 is configured with two window sections, one along each of the front side 3355 and the back side 3356 of the gas delivery tube. In the example shown, a transverse axis TA can extend through both the front side 3355 and the back side 3356 in a direction transverse to a longitudinal axis LA that extends in the direction of the pressurized air flow along at least a portion of the gas delivery tube 3350 (e.g., along the interface between the plenum 3200 and the positioning and stabilizing structure 3300). The transverse axis can not pass through either band of fabric material. For example, the transverse axis can extend along the band of fabric material that forms the patient-contacting side 3351 in the front / back direction, but does not intersect the band of fabric material that forms the non-patient-contacting side 3354. A patient viewing along the transverse axis TA is able to see completely through the gas delivery tube 3350. In other words, the gas delivery tube 3350 does not include opaque material when viewed along the transverse axis TA. The patient is able to more clearly identify debris within the gas delivery tube 3350 that can obstruct the clear line of sight along the transverse axis TA. However, both the transparent material and the fabric material are included along the perimeter of the gas delivery tube 3350 such that a transverse plane with respect to the longitudinal axis LA (i.e., a plane that includes the transverse axis TA) (i.e., a cross-section viewed in Figure 5 FIG. 33) includes both transparent material and fabric material in the direction exposed to the patient (e.g., for visual inspection).

[0264] Each band of fabric material has opposite edges along its elongate dimension; the transparent material of the window sections is bonded to the respective edges of the patient-contacting side 3351 and the non-patient-contacting side 3354 using an adhesive or heat welding technique. In other examples, the window sections can be overmolded to the edges of the fabric material of the patient-contacting side 3351 and the non-patient-contacting side 3354.

[0265] In other examples, the non-patient contact side 3354 can be formed from two or more strips of fabric material interspersed with a strip of transparent material. For example, the non-patient contact side 3354 can be formed from two strips of fabric material separated by a single strip of transparent material, bonded or overmolded to respective edges of the fabric material. This places the window segments on the center of the arcuate sides of the D-shaped profile, in addition to the window segments 3355, 3356 on either side of the D-shaped profile. In yet another example, the patient contact side and the non-patient contact side of the gas delivery tube are formed from a single strip of fabric material, with the edges of the fabric material positioned substantially centrally on the non-patient contact side 3354 of the D-shaped profile or alternatively on one side. The window segments in the example are between the elongated edges of the fabric material. In other words, the transparent material is positioned (e.g., overmolded) between the elongated edges of the fabric material such that the edges are not fully connected. In this example, the patient will have only a single viewing window and will not be able to see through the gas delivery tube 3350 completely.

[0266] In these examples, the transparent material forming the window segments 3355, 3356 is an elastomeric material. In one such example, the transparent material is a medical grade silicone. In some examples, the silicone can be selected from silicones having a Shore A durometer measurement in the range between 35 and 45; i.e., from soft to moderately soft. In further examples, the silicone has a Shore A durometer measurement between 38 and 42. In one such example, the Shore A durometer measurement of the silicone is 40.

[0267] In some examples, a harder durometer measurement can be used to provide greater structural integrity to the gas delivery tube. However, this can also mean that there is a greater potential for increased pressure if the non-patient contact side inadvertently comes into contact with the patient’s face when the positioning and stabilizing structure is worn. This can result in patient discomfort.

[0268] In other examples, the transparent material can be a TPE or TPU with an appropriate softness. An advantage of TPE is its relatively low cost and lower temperature required for working. For example, TPE can be molded at temperatures below 50°C with shorter cycle times than elastomeric materials such as silicone.

[0269] In one example, the window segments 3355, 3356 are formed by overmolding silicone onto strips of fabric material, forming the patient contact side 3351 and the non-patient contact side 3354, respectively. In some examples, the fabric material can be laminated or coated to form a gas-impermeable layer before being cut into strips, but in other examples, the strips can be laminated after being manufactured, for example, by flat knitting.

[0270] In one manufacturing example, a strip of fabric material is inserted into a mold, and the window segments 3355, 3356 are molded onto the fabric material. This can create an integral structure between the fabric material and the transparent material. In Figure 7 and 6 In these examples, the window segments 3355, 3356 include a semicircular profile 3357 on the hollow interior of the gas delivery tube, which can have a shape that is complementary to the profile 3357. These can help to direct the flow of silicone when being molded, thereby facilitating adhesion to the fabric strip before the portion forming the window segment is filled. This causes the fabric strips on either side of the window segment to be drawn toward one another for a more secure bond. Conversely, forming the window segment first can cause the fabric strips to be drawn apart, thereby affecting the quality and appearance of the gas delivery tube.

[0271] In some examples, a portion of the length of the gas delivery tube can be configured with one or more window segments, while in other examples the entire length of the gas delivery tube 3350 can be configured with one or more window segments 3355, 3356. In further examples, the length of the gas delivery tube can be configured to have a series of window segments arranged at intervals and / or at key locations. For example, in certain forms, the lower portion of the gas delivery tube 3350 proximate to the plenum chamber 3200 is provided with one or more window segments, while the upper portion of the gas delivery tube proximate to the connection port for the air supply is not. In some of these examples, at least some of the individual window segments can be separated from adjacent window segments by a segment of fabric material or foam material.

[0272] 5.3.3.1.4 Transparent material - non-patient contact side

[0273] In another example, Figure 7 A gas delivery tube 3350 is shown having a generally D-shaped profile. The curved portion of the profile is the non-patient contact side 3354 of the gas delivery tube 3350, and can be formed entirely of transparent material, while the flat portion of the profile is the patient contact side 3351 of the gas delivery tube, and is composed entirely of fabric material or foam material. The patient contact portion 3351 and the non-patient contact portion 3354 are joined at their respective flanges, which in use form the front and back sides, respectively, of the gas delivery tube 3350.

[0274] In other examples, the gas delivery tube can have a substantially square or rectangular profile, rather than the D-shaped profile of Figure 7 which can include rounded corners for patient comfort. Rounded corners, as opposed to sharp corners, help to reduce potential failure locations (e.g., locations where the gas delivery tube 3350 can fail due to repeated pressurization and depressurization).

[0275] Figure 7The arrangement of the described examples can be advantageous in that it will provide a comfortable to wear conduit headgear, but will also allow the interior of at least a portion, if not the entire length, of the gas delivery tube to be visible to the patient. Inspection and cleaning of the gas delivery tube can be more easily performed. In other examples, only a portion of the length of the non-patient contacting side can be formed of a transparent material. For example, only the non-patient contacting side of the lower end of the gas delivery tube can be comprised of a transparent material. In another example, the non-patient contacting side of the upper end of the gas delivery tube can be comprised of a transparent material.

[0276] In these examples, the transparent material forming the non-patient contacting side 3354 is an elastomeric material. In one such example, the transparent material is a medical grade silicone. In some examples, the silicone can be selected from a silicone having a Shore A durometer measurement in the range between 35 and 45; i.e. from soft to moderately soft. In further examples, the silicone has a Shore A durometer measurement between 38 and 42. In one such example, the Shore A durometer measurement of the silicone is 40.

[0277] In other examples, the transparent material can be a TPE or TPU having an appropriate softness. The harder the durometer measurement, the greater the likelihood of increased pressure if the non-patient contacting side 3354 inadvertently comes into contact with the patient’s face while the patient interface is positioned and stabilized. This can result in patient discomfort.

[0278] In this example, for patient comfort, the patient contacting side 3351 of the gas delivery tube 3350 is comprised of an opaque fabric material as previously described. In Figure 8 In this example, the fabric layer comprises an inner layer in the form of a gas impermeable layer 3352 of a laminate of silicone or similar. In some examples, a further adhesive layer or further laminate layer can be provided. As already described for this example, between the inner gas impermeable layer 3352 and the non-patient contacting side 3354 which is comprised entirely of an elastomeric material and is therefore medically compatible with a flow of cleaning gas, a flow path is formed.

[0279] Additionally or alternatively, the patient contacting side 3351 can be formed of or can include a foam material. In some examples, the tube 3350 can include a combination of fabric and foam material. The fabric and / or foam material comprising the patient contacting side 3351 of the gas delivery tube can: hold air under pressure, be biocompatible and suitable / approved for forming a medical air path, be lighter than a silicone tube, be soft and flexible, generally maintain a predetermined shape, be cleanable and durable for a predetermined life cycle, e.g. one month, three months, six months, one year or more.

[0280] In some examples, the non-patient contact side 3354 of the gas delivery tube 3350 can at least partially comprise one or more accordion sections 3358, as shown. Each accordion section 3358 can comprise a portion of the gas delivery tube 3350 having one or more folded portions, pleats, corrugations, or elbow tubes as described in PCT Application No. PCT / AU2019 / 050874, the contents of which are incorporated herein by reference. Figure 8

[0281] In some examples, the accordion sections can extend a portion of the length of the non-patient contact side of the gas delivery tube, as shown in Figure 11 In other examples, however, the accordion sections can extend the entire length of the non-patient contact side of the gas delivery tube. In further examples, the accordion sections 3358 can be located at key points along the length of the gas delivery tube. For example, the accordion sections can be located at points corresponding to the curves of the patient’s head (such as the top of the head and around the jaw, below the line of the mouth), but not at substantially flat portions of the head (such as the sides of the head, between the otobasion superior and otobasion inferior), to help position and stabilize the structure to the shape of the patient’s head.

[0282] In other examples, the accordion sections can extend partially around the circumference of the non-patient contact side of the gas delivery tube. In examples, the accordion sections can extend to include the posterior side and the anterior side of the gas delivery tube. In further examples, the accordion sections can extend completely around the circumference of the gas delivery tube. In this example, the accordion sections can encompass both the patient contact side and the non-patient contact side of the gas delivery tube. This example can have a greater extension functionality relative to other examples in which the accordion sections extend around only a portion of the circumference or the circumference of the non-patient contact side, to increase the length of the gas delivery tube.

[0283] In examples of Figure 11 and 12 , the accordion sections 3358 of the gas delivery tube 3350 are at least partially constructed from a fabric material or a foam material, and at least partially constructed from a transparent material, such as silicone, TPE, or TPU as previously described in previous examples. In some examples, the fabric material or foam material can be provided only to the patient contact side of the gas delivery tube, with the non-patient contact side being partially or entirely constructed from the transparent material. The fabric material and the transparent material can have similar stretch properties, such that the patient side and the non-patient side are able to stretch together (e.g., the accordion does not bend when stretched). However, in Figure 10 and 12 ​In this example, the non-patient contact side comprises an elongated strip of fabric material in the form of a fabric pad 3308 extending along the length of the gas delivery tube. In this example, the gas delivery tube 3350 is entirely made of a transparent material, and the fabric pad 3308 has been bonded (e.g., by overmolding, adhesive, etc.) to the non-patient contact side of the gas delivery tube 3350. In other words, the fabric material in this example does not come into contact with the compressed air as it flows through the gas delivery tube 3350.

[0284] In some further examples, an accordion-style section is provided on both the non-patient contact side and the patient contact side. In this example, the accordion-style section on the patient contact side may also be made of fabric or foam material for patient comfort.

[0285] The use of a gas delivery tube 3350 with one or more accordion-style sections gives the gas delivery tube 3350 some elongation and bending capabilities, which is advantageous in providing a catheter headband that can better conform to the shape of the patient's head. For example, in Figure 8 In the positioning and stabilizing structure 3300, the upper part of the gas delivery tube 3350 is provided with an accordion-style section 3358. This is advantageous because it allows the gas delivery tube to have a certain degree of extension and / or flexibility to conform to the upper part of the patient's head.

[0286] like Figure 3 As shown, the accordion-style section 3358 may include a series of alternating external ridges 3359A and grooves 3359B formed along at least a portion of the non-patient contact side 3351 of the gas delivery tube 3350. In some examples, the corresponding ridges and grooves may be provided inside the gas delivery tube, but this would compromise the cost efficiency of manufacturing.

[0287] In some examples, the alternating ridges 3359A and grooves 3359B can act like pleats or bellows that can independently or in unison fold and unfold to shorten or lengthen the accordion section 3358 and thus the corresponding gas delivery tube 3350. A large groove depth (or ridge height) can provide a more extendable or more bendable tube 3350. When tension is applied to the tube 3350, the ridges 3359A and grooves 3359B of the extendable accordion section 3358 can pull away from each other, which straightens the tube wall, lengthening the tube 3350. In this example, the accordion section 3358 is biased to an original (e.g., unextended) length. Upon release of the headgear tension, the ridges 3359A and grooves 3359B are biased back to the initial configuration, where the accordion section 3358 and tube 3350 have the initial length. This can help the gas delivery tube conform to the shape of the patient’s head. The stretching or extension of the accordion section on the gas delivery tube 3350 can be substantially elastic, such that it provides similar forces to the plenum chamber 3200 each time the plenum chamber is used in succession.

[0288] In other examples, the alternating ridges 3359A and grooves 3359B of the accordion section can be formed as corrugations, enabling the gas delivery tube to deform and bend. In this example, the accordion section can have only limited or no functionality to shorten or lengthen. The ridges 3359A and grooves 3359B can help change the shape of the accordion section 3358 of the gas delivery tube 3350, which helps the gas delivery tube conform to the patient’s head.

[0289] 5.3.3.1.5 RIGIDITY

[0290] In some examples of the present technology, the gas delivery tube 3350 or portions of the gas delivery tube of the positioning and stabilising structure 3300 can be configured to be more resistant to bending in some directions or axes than in other directions or axes, or around some directions or axes. A tube 3350 that includes relatively rigid portions on both the anterior and posterior sides of the tube 3350 can advantageously have a higher ability to resist bending towards the anterior and posterior sides of the tube 3350 when in use. However, in some examples, the rigid portions are provided on only one of the anterior or posterior sides of the tube 3350, as depending on the rigidity, the rigid portion on only one side can provide sufficient ability to resist bending towards both directions. In other examples, the rigid portions can be provided along the entire length of the gas delivery tube 3350, while in other examples, the rigid portions are provided to only a portion of the length of the gas delivery tube 3350. For example, the rigid portions can be provided on one of the lower or upper portions of the tube. For example, the rigid portions can be provided on the lower portion of the tube, which can be more effective at resisting bending than the upper portion of the tube, as the lower portion of the tube is closer to the patient’s head and thus more likely to be bent towards the patient’s head. In other examples, the rigid portions are provided on the upper portion of the tube, which can be more effective at resisting bending than the lower portion of the tube, as the upper portion of the tube is further from the patient’s head and thus less likely to be bent towards the patient’s head. Figure 3 and 4The upper portion of each tube 3350 of the positioning and stabilizing structure 3300 shown can be more flexible in a particular direction. For example, making the upper portion of the gas delivery tube more flexible can help position and stabilize structures that conform to the shape of the patient's skull, particularly the curvature around the top of the head.

[0291] Each gas delivery tube 3350 of the positioning and stabilizing structure 3300 may include an upper tube portion 3304 in use, which extends, for example, from the top of the patient's head backwards around a base point above the ear and is configured to cover the upper region of the patient's head in use. Conversely, Figure 5 and 4 The lower portion 3306 of each tube 3350 of the positioning and stabilizing structure 3300 shown, which extends backward from the base point above the ear on the patient's head during use, can be more flexible in a particular direction compared to the orthogonal direction.

[0292] In some examples of this technology, the upper tube portion 3304 may also include one or more reinforcements relative to the lower tube portion 3306. The reinforcements may be configured to provide higher resistance in the forward and / or rearward directions than in the upward and / or downward directions. This may be advantageous when dealing with any resistance, such as that caused by the air circuit. In some examples, the reinforcement may be provided along the entire length of the tube 3350, and in some examples, different stiffness may be provided along the length of the tube 3350.

[0293] In the example, the reinforcement of the gas delivery pipe can be provided by a window section. Because the window section is formed of an elastic material, it inherently has greater rigidity than at least most of the fabric or foam material forming the rest of the gas delivery pipe.

[0294] In some examples, the relative stiffness of the gas delivery pipe can be determined by the construction of the window section. For example, in Figure 5 In one implementation, the stiffness of the gas delivery pipe 3350 can be increased by increasing the thickness of one or both of the window segments 3355 and 3356. In another example, the stiffness of the gas delivery pipe can be increased by decreasing the thickness of one of the window segments 3355 relative to the other window segment 3356. Depending on the desired stiffness, the thickness of the window segments can be increased or decreased along the length of the gas delivery pipe 3350. This can give different stiffness to the lower portion 3306 and the upper portion 3304 of the gas delivery pipe.

[0295] A similar increase in rigidity of the gas delivery tube can be achieved by increasing the relative width of one or both of the window segments 3355, 3356, i.e. reducing the amount of fabric material present and increasing the amount of silicone present in the window segment, i.e. increasing the ratio of the surface area of the window segment to the fabric material of the non-patient contacting side of the gas delivery tube. The ratio of the window segment to the fabric material can be 1 : 10 to 1 : 1. For example, in Figure 5 , the window segments 3355, 3356 are approximately one-eighth the width of the fabric band forming the non-patient contacting side 3354, i.e. a ratio of 1 : 8. Doubling the width of the window segments 3355, 3356, while correspondingly reducing the width of the fabric material forming the non-patient contacting side 3354, can increase the rigidity of the gas delivery tube. The width of the window segments can be increased or decreased along the length of the gas delivery tube 3350, thereby providing different rigidity to the lower portion 3306 and the upper portion 3304 of the gas delivery tube.

[0296] Rigidity can also be increased by adding (e.g. stitching) a rigidizing thread to the fabric material to increase the rigidity of the gas delivery tube 3350. The rigidizing thread can provide stiffness to the fabric material without substantially increasing the weight of the fabric material. The rigidizing thread can be used in place of window segments having increased width in order to reduce weight and improve patient compliance.

[0297] In embodiments where the window segments 3355, 3356 are positioned along the posterior and anterior sides of the gas delivery tube (e.g. in Figure 9 and 6 ), one or the other of the window segments can be configured to be more rigid than the other. For example, the window segment of the anterior side of the gas delivery tube can be configured to be more rigid than the window segment of the posterior side of the gas delivery tube. This can mean that the gas delivery tube 3350 is more resistant to forces applied from the rear (as can occur when the gas circuit is dragged or caught on a bed linen or similar). In another example, the window segment of the posterior side of the gas delivery tube can be configured to be more rigid than the window segment of the anterior side of the gas delivery tube. This can mean that the gas delivery tube 3350 is more resistant to forces applied from the front.

[0298] 5.3.3.1.6 Alternative gas delivery tube configurations

[0299] In another example of the present technology, Figures 10 to 12The lower portion 3306 of the gas delivery tube 3350 is shown when the gas delivery tube has been separated from the plenum 3200. In contrast to the previous embodiments, the patient contact side 3351 and the non-patient contact side 3354 of the gas delivery tube 3360 are primarily constructed from a transparent material in the form of an elastomer. This means that the flow path within the gas delivery tube 3350 (or a major portion thereof) is entirely defined by the elastomer. In examples, the elastomer is silicone, which is gas impermeable and medically suitable for defining a hygienic flow path. Other examples of the elastomer can be TPE or TPU.

[0300] The patient contact side 3351 is configured to permanently or temporarily receive a fabric pad 3308, which provides a comfortable, softer surface that contacts the patient's face in use. In other words, the fabric pad 3308 does not form part of the channel through which the pressurised air flows. In examples, the fabric pad 3308 can be added during manufacture, or alternatively provided separately to the gas delivery tube for the patient to secure to the gas delivery tube when required. This can allow for a catheter head strap to be provided in a non-fabric form, allowing the patient to place the fabric pad on certain areas of the patient contact side of the gas delivery tube depending on their preference. For example, the fabric pad can be applied to the upper portion of the gas delivery tube 3350, which contacts the top of the patient's head.

[0301] As the fabric pad 3308 does not need to be configured to have a surface that forms part of the flow path of the gas delivery tube 3350, this functionality is entirely achieved by the transparent material forming at least a major portion of the flow path within the gas delivery tube, the fabric can not need to incorporate a gas impermeable layer. The fabric pad 3308 can be constructed from one or more fabrics, such as nylon, polyester or spandex or a mixture of these. In some examples, the fabric pad 3308 can be constructed from a material that is sufficiently stretchable and elastic such that it does not inhibit the bendability of the catheter head strap 3300, for example to allow Figure 9 the ready movement of the accordion section 3358 of the catheter head strap.

[0302] In these examples, the fabric pad 3308 is bonded to the transparent material using an adhesive or similar bonding agent. In other examples, the fabric pad 3308 can be secured to the transparent material, for example by a hook and loop material such as VELCRO TM In further examples, the transparent material can be overmoulded onto the fabric pad 3308.

[0303] In some examples, to help position the fabric pad 3308, the patient contact side 3351 of the gas delivery tube 3350 can be molded or otherwise formed to include a partial recess or depression. This is advantageous in providing a highly integrated look and feel to the gas delivery tube 3350, which can make it more appealing to consumers. In some examples, the recess can be provided with one of a hook and loop material, and the reverse side of the fabric pad 3308 provided with the other of the hook and loop material. This allows the fabric pad to be removed for cleaning to remove skin oils and dirt that can result from contact with the patient's face.

[0304] In Figure 9 some examples, the fabric pad 3308 extends upward from the lower end of the gas delivery tube 3350 as far as the tab 3312 that extends rearward from the gas delivery tube. In some examples, the fabric pad 3308 can be configured to have a corresponding tab so that the tab covers the tab 3312 of the gas delivery tube 3350. This can improve comfort in the event that the protrusion 3312 of the gas delivery tube comes into contact with the patient's face and / or hair while wearing the positioning and stabilizing structure.

[0305] Figure 10 Only the lower portion 3306 of the gas delivery tube is shown provided with a fabric pad 3308, but in other examples, the upper portion 3304 of the gas delivery tube 3350 can also or instead be configured with a fabric pad 3308. This can be a separate fabric pad from the lower portion 3306 of the gas delivery tube, or as shown in Figure 11 some examples, a single fabric pad can cover both the upper 3304 and lower 3306 portions of the gas delivery tube 3350. A fabric material covering both the upper 3304 and lower 3306 portions can be particularly beneficial for patients who have little or no hair on the scalp or side of the head and who do not like the feel of elastomeric materials against their skin. There is also less risk of the elastomeric material pinching and pulling at the patient's hair if the positioning and stabilizing structure inadvertently moves on the patient's head.

[0306] In some examples, such as Humidity and 12 those in which the patient contact side of the gas delivery tube 3350 includes a fabric pad 3308, a fabric pad can also be applied to the non-patient contact side of the gas delivery tube 3350 without covering the window segments 3355, 3356. In this example, the transparent material forms at least a majority of the flow path within the gas delivery tube. The use of a fabric pad 3350 in conjunction with an adhesive, molding technique, or hook and loop material such as VELCRO TM can provide a smooth finish to the non-patient contact side of the gas delivery tube that is aesthetically pleasing and comfortable to the touch if the patient needs to do so (e.g., when donning and doffing the positioning and stabilizing structure).

[0307] 5.3.4 Vent

[0308] In one form, the patient interface 3000 includes a vent 3400 constructed and arranged to allow flushing of exhaled gases, such as carbon dioxide.

[0309] 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 so 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.

[0310] One form of vent 3400 according to the present technology comprises a plurality of holes, for example, about 20 to about 80 holes, or about 40 to about 60 holes, or about 45 to about 55 holes.

[0311] The vent 3400 can be located in the plenum chamber 3200. Alternatively, the vent 3400 is located in a decoupling structure, for example, an elbow swivel.

[0312] 5.3.5 Decoupling structure

[0313] In one form, the patient interface 3000 includes at least one decoupling structure, for example, a swivel or a ball and socket.

[0314] 5.3.6 Connection port

[0315] The connection port 3600 allows connection to the air circuit 4170.

[0316] 5.3.7 Anti-asphyxia valve

[0317] In one form, the patient interface 3000 includes an anti-asphyxia valve.

[0318] 5.3.8 Port

[0319] 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 allows direct measurement of a property of the gas within the plenum chamber 3200, such as pressure.

[0320] 5.4 RPT device

[0321] An RPT device 4000 according to an aspect of the present technology includes mechanical, pneumatic, and / or electrical components, and is configured to execute one or more algorithms 4300. The RPT device 4000 can be configured to generate a flow of air for delivery to an airway of a patient, for example, for treatment of one or more respiratory conditions described elsewhere in this document.

[0322] In one form, the RPT device 4000 is constructed and arranged to be capable of delivering an air flow in the range -20 L / min to +150 L / min while maintaining a positive pressure of at least 6 cmH20, or at least 10 cmH20, or at least 20 cmH20.

[0323] 5. Glossary

[0324] To achieve the objects of the present technology, one or more of the following definitions can be applied in certain forms of the present technology. In other forms of the present technology, alternative definitions can be applied.

[0325] 5.1 General

[0326] Air: In certain forms of the present technology, air can be taken to mean atmospheric air, and in other forms of the present technology, air can be taken to mean some other combination of breathable gases, such as atmospheric air enriched with oxygen.

[0327] Ambient: In certain forms of the present technology, the term ambient 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.

[0328] For example, the ambient relative humidity with respect to the humidifier Patient may be the humidity of the air immediately surrounding the humidifier, such as the humidity within the room in which the patient is sleeping. This ambient humidity can be different from the humidity outside the room in which the patient is sleeping.

[0329] In another example, the ambient pressure can be the pressure immediately surrounding the body or outside the body.

[0330] In certain forms, the ambient (e.g. acoustic) noise can be taken to be the background noise level in the room in which the patient is located, other than noise generated for example by the RPT device or from the mask or patient interface. Ambient noise can be generated by sound sources outside the room.

[0331] Automatic 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 is an indication of an SBD event.

[0332] 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 an indication of partial airway obstruction, and decreasing in the absence of an indication of partial airway obstruction.

[0333] Flow: The volume (or mass) of air delivered per unit of time. Flow can refer to the instantaneous quantity. In some cases, reference to flow will be reference to a scalar quantity, i.e. a quantity with only a magnitude. In other cases, reference to flow will be 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'.

[0334] In the example of a patient breathing, the flow can be nominally positive for the inspiration portion of the patient's breathing cycle, and thus negative for the expiration portion of the patient's breathing 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 exhaust port 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.

[0335] Humidifier: The term humidifier will be taken to mean a humidification device constructed and arranged or configured with a physical structure capable of providing a therapeutically beneficial amount of water (H2O) vapour to an air flow to improve a patient's medical respiratory condition.

[0336] 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 a mask and a patient's face. In another example, a leak can occur in a swivel elbow to ambient.

[0337] Patient: A human being, whether or not they suffer from a respiratory disorder.

[0338] Pressure: Force per unit area. Pressure can be expressed in units ranging from cmH2O, g-f / cm 2 , to hundreds of Pascals. 1 cmH2O is equivalent to 1 g-f / cm 2 and is approximately 0.98 hundred Pascals. In this specification, pressure is given in units of cmH2O unless otherwise stated.

[0339] Pressure in the patient interface is given the symbol Pm, while the treatment pressure is given the symbol Pt, which represents the target value achieved by the mask pressure Pm at the current time instant.

[0340] Respiratory Pressure Therapy (RPT): The application of a supply of air at a therapeutic pressure typically positive relative to atmosphere to the entrance of the airways.

[0341] Ventilator: A mechanical device that provides pressure support to a patient to perform some or all of the work of breathing.

[0342] 5.1.1 Materials

[0343] Silicone or silicone elastomer: A synthetic rubber. In this specification, reference to silicone means liquid silicone rubber (LSR) or compression molded silicone rubber (CMSR). One form of commercially available LSR is SILASTIC (including the range of products sold under this trademark) manufactured by Dow Corning. Another manufacturer of LSR is Wacker. Unless 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.

[0344] Polycarbonate: A transparent thermoplastic polymer of bisphenol A carbonate.

[0345] 5.1.1.1 Mechanical properties

[0346] Resilience: The ability of a material to absorb energy when elastically deformed and to release the energy when unloaded.

[0347] Elastic: Will release substantially all of the energy when unloaded. Includes, for example, certain siloxanes and thermoplastic elastomers.

[0348] Hardness: The ability of a material itself to resist deformation (e.g. described by Young’s modulus or an indentation hardness scale measured on a standardized sample size).

[0349] A “soft” material can include a silicone or a thermoplastic elastomer (TPE) and can deform easily, for example, under finger pressure.

[0350] A “hard” material can include polycarbonate, polypropylene, steel or aluminum and can not deform easily, for example, under finger pressure.

[0351] 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.

[0352] Soft structure or component: A structure or component that will change shape (e.g. bend) when left to support its own weight for a relatively short time, for example 1 second.

[0353] 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 relationship with an entrance of a patient’s airways under a pressure of about 20 to 30 cmH20.

[0354] As an example, an I-beam can include a different bending stiffness (resistance to bending loads) in the first direction than in the second orthogonal direction. In another example, a structure or component can be soft in the first direction and rigid in the second direction.

[0355] 5.1.2 Respiratory Cycle

[0356] 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 with the patient's efforts. A central apnea is considered to occur when a respiratory pause is detected despite the airway being patent, due to a reduction or absence of respiratory effort. A mixed apnea is considered to occur when a reduction or absence of respiratory effort occurs simultaneously with an obstructed airway.

[0357] Respiratory rate: The rate of the patient's spontaneous breathing, which is typically measured in breaths per minute.

[0358] Exhalation portion of a respiratory cycle: The period of time from the start of exhalation flow to the start of inhalation flow.

[0359] Inhalation portion of a respiratory cycle: The period of time from the start of inhalation flow to the start of exhalation flow is considered the inhalation portion of the respiratory cycle.

[0360] 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 of (1) for open, and a value of zero (0) for closed (obstructed).

[0361] Ventilation (Vent): A measure of the rate of gas exchange by the patient's respiratory system. Measures of ventilation can include one or both of the inhalation and exhalation flow rates (per unit time). When expressed as a volume per minute, this quantity is often referred to as "minute ventilation." Minute ventilation is sometimes simply given as a volume and understood to be volume per minute.

[0362] 5.1.3 Anatomy

[0363] 5.1.3.1 Anatomy of the Face

[0364] Auricle: The entire externally visible portion of the ear.

[0365] (Nasal) Skeletal Framework: The nasal skeletal framework includes the nasal bones, frontal process of the maxilla, and nasal part of the frontal bone.

[0366] (Nasal) Cartilaginous Framework: The nasal cartilaginous framework includes the septum, lateral, greater, and lesser cartilages.

[0367] Frankfort horizontal: a line extending from the lowest point of the margin of the orbit to the left ear canal. The ear canal is the deepest point in the notch on the upper part of the pinna.

[0368] Glabella: the most prominent point in the soft tissue in the median sagittal plane of the forehead.

[0369] Lip, lower (subnasale): a point on the face between the mouth and the supramental point, in the median sagittal plane.

[0370] Lip, upper (sublabiale): a point on the face between the mouth and the nose, in the median sagittal plane.

[0371] Nares (nares): the approximately oval apertures that form the entrance to the nasal cavity. The singular form of nare is naris (nares). The naris is separated by the nasal septum.

[0372] Infralobular point: the lowest point at which the pinna attaches to the skin of the face.

[0373] Supralobular point: the highest point at which the pinna attaches to the skin of the face.

[0374] 5.1.3.2 Anatomy of the skull

[0375] Frontal bone: The frontal bone includes a large vertical part (frontal squama) that corresponds to the region called the forehead.

[0376] Mandible: The mandible forms the lower jaw. The mental protuberance is the bony protuberance of the lower jaw that forms the chin.

[0377] 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 side of the nose and forms part of the lateral border.

[0378] Nasal bone: The nasal bone is two small oval bones that vary in size and form from one individual to another; they are located side by side in the middle and upper part of the face and form, by their point of junction, the "bridge" of the nose.

[0379] Nasion: The intersection of the frontal bone and the two nasal bones, directly between the eyes and in the upper part of the bridge of the nose.

[0380] Occipital bone: The occipital bone is located at the back and lower part of the skull. It includes an oval foramen (foramen magnum) through which the cranial cavity communicates with the spinal canal. The curved plate behind the foramen magnum is the squama occipitalis.

[0381] Orbital: The bony cavity in the skull that houses the eyeball.

[0382] Parietal bone: The parietal bone is the bone that, when joined together, forms the roof of the skull and the two sides.

[0383] Temporal bone: The temporal bones are located at the bottom and sides of the skull and support the part of the face known as the temple.

[0384] Zygomatic bone: The face includes two zygomatic bones, which are located on the upper and lateral parts of the face and form the prominence of the cheeks.

[0385] 5.1.3.3 Anatomy of the respiratory system

[0386] Diaphragm: A sheet of muscle that extends across the bottom of the rib cage. The diaphragm separates the chest cavity, which contains the heart, lungs, and ribs, from the abdominal cavity. As the diaphragm contracts, the volume of the chest cavity increases and air is drawn into the lungs.

[0387] Larynx: The larynx, or voice box, houses the vocal cords and connects the lower part of the pharynx (hypopharynx) to the trachea.

[0388] Lungs: The respiratory organs of a human. The conducting region of the lungs includes the trachea, bronchi, bronchus, and terminal bronchioles. The respiratory region includes the respiratory bronchioles, alveolar ducts, and alveoli.

[0389] Nasal cavity: The nasal cavity (or nasal fossa) is the large, air-filled space in the middle of the face above and behind the nose. The nasal cavity is divided into two parts by a vertical wing called the nasal septum. There are three horizontal branches on the sides of the nasal cavity, which are called the nasal conchae (singular "concha") or turbinates. The front of the nasal cavity is the nose, while the back joins into the nasopharynx via the internal nares.

[0390] Pharynx: The part of the throat located just below the nasal cavity and above the esophagus and larynx. The pharynx is conventionally divided into three sections: the nasopharynx (upper pharynx), the oropharynx (middle pharynx), and the laryngopharynx (lower pharynx).

[0391] 5.1.4 Patient interface

[0392] Anti-asphyxia valve (AAV): A component or subcomponent of a mask system that reduces the risk of excessive CO2 rebreathing by the patient by opening to atmosphere in a fail-safe manner.

[0393] Elbow: An elbow is an example of a structure that directs the axis of an air flow traveling therethrough to change direction by an angle. In one form, the angle can be approximately 90 degrees. In another form, the angle can be greater or less than 90 degrees. The elbow can have a cross-section that is approximately circular. In another form, the elbow can have an oval or rectangular cross-section. In certain forms, the elbow can be rotatable relative to a mating component, for example, about 360 degrees. In certain forms, the elbow can be removable from a mating component, for example, via a snap connection. In certain forms, the elbow can be assembled to a mating component via a one-time snap during manufacturing, but not removable by a patient.

[0394] Frame: Frame will be taken to mean a load bearing structure of a mask that carries the tensile load between two or more connection points to a headgear. The mask frame can be a non-air-tight load bearing structure in the mask. However, some forms of mask frame can also be air-tight.

[0395] Headgear: Headgear will be taken to mean a form of positioning and stabilising structure designed for use on the head. For example, headgear can comprise a set of one or more of stays, straps and reinforcements configured to position and hold a patient interface in place on the patient's face for delivery of a respiratory therapy. Some straps are formed from a soft, flexible, resilient material, such as a laminate composite of foam and fabric.

[0396] Membrane: Membrane will be taken to mean a typically thin element that is preferably substantially non-bending resistant, but is tensile resistant.

[0397] Plenum: Mask plenum will be taken to mean the portion of a patient interface that has walls that at least partially enclose a volume of space that in use has air pressurised within it to above atmospheric pressure. A shell can form part of the walls of a mask plenum.

[0398] Seal: Can refer to the noun form of the structure (seal), and also to the verb form of the effect (sealing). Two elements can be constructed and / or arranged to'seal' or achieve'sealing' therebetween, without the need for a separate'seal' element per se.

[0399] Shell: Shell will be taken to mean a curved and relatively thin structure that has a bendable, stretchable and compressible rigidity. For example, a curved structural wall of a mask can be a shell. In some forms, a shell can be faceted. In some forms, a shell can be air-tight. In some forms, a shell can not be air-tight.

[0400] Stiffener: Stiffener will be taken to mean a structural component designed to increase the bending resistance of another component in at least one direction.

[0401] Support: Support will be taken to be a structural component designed to increase the compressive resistance of another component in at least one direction.

[0402] Swivel axis: (Noun) A subcomponent of a component configured to rotate about a common axis, preferably independently, preferably at low torque. In one form, a swivel axis can be configured to rotate through an angle of at least 360 degrees. In another form, a swivel axis 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 includes a pair of mating cylindrical conduits. Air flow from the swivel axis can be little or no flow when in use.

[0403] Tie: (Noun) A structure used to resist tension.

[0404] Vent: (Noun): A structure that allows air flow from inside a mask or conduit to ambient air, for example, to effectively flush exhaled gases. For example, a clinically effective flush can involve a flow of about 10 liters per minute to about 100 liters per minute, depending on the mask design and treatment pressure.

[0405] 5.1.5 Shape of a structure

[0406] A product 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 labels 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 the face and a separate (e.g., underside or internal) surface that does not contact the face. In another example, a structure can include a first surface and a second surface.

[0407] To help describe the shape of a three-dimensional structure and surface, first consider a cross-section through a point p of a surface of the structure. The outward normal vector at point p is directed away from the surface. In some examples, a surface is described from the perspective of an imaginary little person standing upright on the surface.

[0408] 5.1.5.1 One-dimensional curvature

[0409] 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 reciprocal of the radius of a circle that just touches the curve at p).

[0410] 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 little person leaves point p, they must walk uphill). Such curves are often referred to as concave.

[0411] Zero curvature: If the curve at p is a straight line, the curvature will take on a value of zero (if the imaginary little person leaves point p, they can walk horizontally, neither uphill nor downhill).

[0412] Negative curvature: the curvature in the direction at a point p will be taken as negative if the curve at that point turns away from the outward normal (if an imaginary person were to leave point p, they would have to walk downhill). Such curves are often referred to as convex.

[0413] 5.1.5.2 Two-dimensional surface curvature

[0414] 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 sections. The plurality of sections can cut the surface in planes that include the outward normal (the "normal plane"), and each section can be taken in a different direction. Each cross-section yields a planar curve with a corresponding curvature. The different curvatures at that point can have the same sign or different signs. Each curvature at that point has a magnitude, for example a relatively small magnitude.

[0415] Principal curvatures and directions: the directions of the normal planes in which the curve curvature takes its maximum and minimum values are referred to as the principal directions.

[0416] 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 curvature or sign.

[0417] 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 uphill or downhill).

[0418] 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").

[0419] 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.

[0420] Planar region: a region of a surface in which both principal curvatures are zero (or, for example, within manufacturing tolerances, zero).

[0421] Surface edge: a boundary or limit of a surface or region.

[0422] 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(l). 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).

[0423] Path length: In certain forms of the technology, a ‘path length’ will be taken to mean the distance along the surface from f(0) to f(l), 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. (For an imaginary person, the path length would be the distance they would have to walk along the path on the surface.

[0424] Straight-line distance: The straight-line distance is the distance between two points on the surface, but without regard to the surface. On a planar region, there will be a path on the surface that has the same path length as the straight-line distance between two points on the surface. On a non-planar surface, there can not be a path that has the same path length as the straight-line distance between two points. (For an imaginary person, the straight-line distance would correspond to the distance as a ‘straight line’.

[0425] 5.1.5.3 Holes

[0426] A surface can have a one-dimensional hole, e.g. a hole bounded by a planar curve or by a spatial curve. A thin structure (e.g. a membrane) with a hole can be described as having a one-dimensional hole.

[0427] A structure can have a two-dimensional hole, e.g. a hole bounded by a surface. For example, a pneumatic tyre has a two-dimensional hole bounded by the inner surface of the tyre. In another example, a bladder with a cavity for air or gel can have a two-dimensional hole. In yet another example, a catheter can include a one-dimensional hole (e.g. at its inlet or at its outlet) and a two-dimensional hole bounded by the inner surface of the catheter.

[0428] 5.2 Other Notes

[0429] 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 file or records, but otherwise reserves all copyright rights whatsoever.

[0430] Unless otherwise indicated within the context, and where a numerical range is provided, it is to be understood that every integer within the range is broadly included herein. The upper and lower limits of these intervening ranges can independently be included in the smaller ranges, and are also encompassed, subject to any specifically excluded limit within the scope of the narrower ranges. Where the stated range includes one or both of the limits, ranges excluding either or both of the included limits are also included.

[0431] Further, where one or more values are described as being part of a range of values, it is understood that the values can be approximate, unless otherwise specified, and the values can be to the extent permitted by practical technology employed to implement the described functionality.

[0432] Further, as used herein, "about," "substantially," "approximately," or any like term means + / - 5 to + / - 10% of the stated value.

[0433] 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.

[0434] When a particular material is identified as being used to construct a component, obvious alternative materials of similar properties can be used as a substitute. Further, unless specified to the contrary, any and all components described herein are understood to be capable of being manufactured and thus can be manufactured together or separately.

[0435] It must be noted that, as used herein and in the appended claims, the singular form "a", "an", and "the" include plural references unless the context clearly dictates otherwise.

[0436] 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. Further, the dates of publication provided can be different from the actual publication dates, which can require independent confirmation.

[0437] The terms "comprises" and "comprising" should be interpreted as referring to elements, components, or steps in a non-exclusive manner, referring to the possibility that there are other elements, components, or steps in addition to the listed ones.

[0438] The subject matter headings used in the detailed description are for convenience only and are not to be construed as limiting the subject matter described in any way.

[0439] While the technology herein has been described with reference to particular examples, it is to be understood that the examples 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 technology. For example, although the terms "first" and "second" can be used, unless otherwise specified, they are not intended to convey any order other than that a distinction is made between differing elements. Furthermore, although process steps within methods can be described or illustrated in a particular order, this order is not essential. One skilled in the art will recognize that modifications can be made to such order and / or the aspects thereof can be performed at the same time or even simultaneously.

[0440] Thus, it is to be understood that numerous modifications can be made to the illustrative examples and that other arrangements can be devised without departing from the spirit and scope of the technology.

[0441] 5.3 List of Reference Symbols

[0442] 1000 Bed partner 1100 Patient interface 3000 Seal or seal-forming structure 3100 Cushion module 3150 Plenum chamber 3200 Positioning and stabilising structure / headgear 3300 Upper tube portion 3304 Lower tube portion 3306 Textile cushion 3308 Tie 3310 Tab (for tie) 3312 Headgear tube 3350 Patient contacting side (of headgear tube) 3351 Inner, air-impermeable layer 3352 Outer, textile layer 3353 Non-patient contacting side (of headgear tube) 3354 Window segment (front side) 3355 Window segment (back side) 3356 Semi-circular profile (of window segment) 3357 Accordion segment (of headgear tube) 3358 Ridges (of accordion segment) 3359A Grooves (of accordion segment) 3359B Crown connector 3360 Fluid connection opening 3390 Vent 3400 Connection port 3600 Elbow 3610 RPT device 4000 Air circuit 4170 LA Longitudinal axis TA Transverse axis Theta Angle ​

Claims

1. A patient interface comprising: a seal-forming structure structured and arranged to form a seal with a region of a patient's face surrounding an entrance to the patient's airways to deliver a sealed flow of pressurized air at a therapeutic pressure of at least 6 cmH20 above ambient air pressure throughout the patient's respiratory cycle in use; a plenum chamber pressurisable to a therapeutic pressure of at least 6 cmH20 above ambient air pressure; and a positioning and stabilising structure to provide a force to hold the seal-forming structure in a therapeutically effective position on the patient's head, the positioning and stabilising structure comprising: at least one gas delivery tube coupled to the plenum chamber and configured to receive a flow of pressurised air from a connection port on the patient's head and to deliver the flow of pressurised air to the entrance of the patient's airways through the plenum chamber, the at least one gas delivery tube structured and arranged to contact at least a region of the patient's head superior to an otobasion superior of the patient's head in use, the at least one gas delivery tube comprising a tube wall having an internal passageway for the flow of pressurised air along a longitudinal axis of the tube to the seal-forming structure, wherein at least a portion of the tube wall comprises: a patient-contacting portion comprising a layer of textile material or foam material configured to be placed against the patient's head in use; and a non-patient-contacting portion, wherein at least a section of the non-patient- contacting portion is composed of a transparent and / or translucent material to allow the internal passageway to be viewed from the outside; wherein the layer of textile material or foam material is bonded to the transparent and / or translucent material such that the tube wall is formed as a single piece construction; wherein a plane extending generally transverse to the longitudinal axis contains both (1) the layer of textile material or foam material and (2) the transparent and / or translucent material, such that a patient can view the internal passageway along a transverse axis extending through the plane; wherein a portion of the section of the non-patient-contacting portion containing the transparent and / or translucent material is configured as a rigid element; and wherein the at least one gas delivery tube further comprises an anterior side between the patient- contacting portion and the non-patient-contacting portion, a posterior side between the patient- contacting portion and the non-patient-contacting portion, and at least one of the anterior side and the posterior side comprises the transparent and / or translucent material.

2. The patient interface of claim 1, wherein the patient contact portion comprises: an outer layer of textile material or foam material configured to be placed against the patient's head in use; and at least a first inner layer of thermoplastic material forming at least a portion of an air path within the at least one gas delivery tube, the first inner layer being bonded to the outer layer.

3. The patient interface of claim 1, wherein the patient-contacting portion comprises a single layer of textile material or foam material.

4. The patient interface of claim 3, wherein the material properties of the single layer of textile material or foam material are impermeable.

5. The patient interface of claim 3, wherein the single layer of fabric material or foam material is coated with an impermeable substance along at least one surface that forms an inner surface of the at least one gas delivery tube, the inner surface being configured to contact the flow of pressurized gas.

6. The patient interface of claim 3, wherein the single layer of fabric material or foam material comprises a blend of polyamides.

7. The patient interface of claim 6, wherein the single layer of fabric material or foam material comprises nylon, polyester, and / or spandex.

8. The patient interface of claim 6, wherein the single layer of fabric material or foam material further comprises one or more laminated coatings of silicone.

9. The patient interface of claim 1, wherein the non-patient contacting portion can comprise a segment configured to receive a segment of transparent and / or translucent material.

10. The patient interface of claim 8, wherein the segment of transparent material comprises an adhesive layer configured to bond to the single layer of fabric material or foam material.

11. The patient interface of any one of claims 1 to 10, wherein one of the patient contacting portion or the non-patient contacting portion is configured to receive an adhesive layer, and the other of the patient contacting portion or the non-patient contacting portion can bond to the adhesive layer.

12. The patient interface of any one of claims 1 to 10, wherein the non-patient contacting portion comprises an outer layer of transparent material and at least a first inner layer of thermoplastic material, the at least a first inner layer of thermoplastic material defining at least a portion of an air path within the at least one gas delivery tube.

13. The patient interface of any one of claims 1 to 10, wherein the segment of the non-patient contacting portion comprising the transparent and / or translucent material comprises an accordion segment.

14. The patient interface of claim 13, wherein a fabric material or foam material is overmolded onto the accordion segment.

15. The patient interface of claim 14, wherein the fabric material or the foam material is on the patient contacting portion and is configured to contact the patient.

16. The patient interface of claim 13, wherein the fabric material or the foam material is on the non-patient contacting portion.

17. The patient interface of any one of claims 1 to 10, wherein a portion of the segment of the non-patient contacting portion comprising the transparent and / or translucent material comprises a series of corrugations.

18. The patient interface of any one of claims 1 to 10, wherein the segment of the non-patient contacting portion comprising the transparent and / or translucent material extends substantially along a length of the at least one gas delivery tube.

19. The patient interface of claim 18, wherein the segment of the non-patient contacting portion comprising the transparent and / or translucent material extends over an entire length of the at least one gas delivery tube.

20. The patient interface of any one of claims 1 to 10, wherein the section of the non-patient contacting portion comprising the transparent and / or translucent material is arranged in discrete sections, each section separated by a section of non-transparent and / or non-translucent material.

21. The patient interface of claim 20, wherein the section of non-transparent and / or translucent material is a textile material or a foam material.

22. The patient interface of claim 1, wherein an anterior side of the non-patient contacting portion has a different rigidity than a posterior side.

23. The patient interface of claim 22, wherein the anterior side of the non-patient contacting portion has a greater rigidity than the posterior side of the non-patient contacting portion.

24. The patient interface of claim 1, wherein the anterior side of the non-patient contacting portion and / or the posterior side of the non-patient contacting portion has a rigidity that varies along a length of the at least one gas delivery tube.

25. The patient interface of claim 1, wherein the anterior side of the non-patient contacting portion and / or the posterior side of the non-patient contacting portion has a greater rigidity at a lower portion of the at least one gas delivery tube than at an upper portion of the at least one gas delivery tube.

26. The patient interface of any one of claims 22 to 25, wherein a thickness of the section of transparent and / or translucent material is greater at a first portion of the at least one gas delivery tube than at a second portion of the at least one gas delivery tube.

27. The patient interface of any one of claims 22 to 25, wherein a width of the section of transparent and / or translucent material is greater at a first portion of the at least one gas delivery tube than at a second portion of the at least one gas delivery tube.

28. The patient interface of any one of claims 1 to 10, wherein the non-patient contacting side comprises an anterior side and a posterior side, the anterior side and the posterior side being configured to face anteriorly and posteriorly, respectively, in use.

29. The patient interface of claim 28, wherein the anterior side and the posterior side are both comprised of transparent and / or translucent material.

30. The patient interface of claim 28, wherein the transverse axis extends generally from the anterior to the posterior, comprising only the transparent and / or translucent material.

31. The patient interface of any one of claims 1 to 10, wherein the section of the non-patient contacting portion comprising the transparent and / or translucent material is formed from an elastomer.

32. The patient interface of claim 31, wherein the elastomer is one or more of: a) silicone; b) thermoplastic elastomer.

33. The patient interface of any one of claims 1 to 10, wherein the patient contacting portion and / or the non-patient contacting portion is thermoformed.

34. The patient interface of any one of claims 1 to 10, wherein the at least one gas delivery tube comprises a generally D-shaped cross-section.

35. The patient interface of claim 34, wherein the generally D-shaped cross-section comprises a generally flat surface forming the patient contact portion and an arcuate surface forming the non-patient contact portion.

36. The patient interface of claim 35, wherein the arcuate surface comprises a first section and a second section, the first section being comprised of a transparent and / or translucent material, the second section being comprised of a fabric material or a foam material.

37. The patient interface of claim 36, wherein the first section is directly connected to the generally flat surface and the second section is disposed opposite the generally flat surface.

38. The patient interface of any one of claims 1 to 10, wherein the at least one gas delivery tube can comprise a generally rectangular cross-section having two or more rounded corners.

39. The patient interface of any one of claims 1 to 10, wherein the at least one gas delivery tube has a width of 34 mm to 18 mm along a length of the at least one gas delivery tube.

40. The patient interface of any one of claims 1 to 10, wherein the at least one gas delivery tube has a height of 8 mm to 6 mm along a length of the at least one gas delivery tube.

41. The patient interface of any one of claims 1 to 10, wherein the non-patient contact portion comprises only a transparent material.

42. The patient interface of any one of claims 1 to 10, wherein the at least one gas delivery tube is selectively coupled to the plenum chamber and is configured to be removed to allow the patient to clean inside the tube.

43. The patient interface of any one of claims 1 to 10, wherein the rigidizing element is disposed along an entire length of the gas delivery tube and is configured to rigidize the entire tube.

44. The patient interface of any one of claims 1 to 10, wherein the rigidizing element comprises a higher resistance to bending in a first direction than in a second direction, the first direction being generally orthogonal to the second direction.

45. The patient interface of claim 44, wherein in use, the first direction is an anterior-posterior direction and the second direction is an orthogonal direction, the gas delivery tube being configured to bend in the orthogonal direction to conform to a shape of the patient's skull.

46. The patient interface of claim 24, wherein an upper portion of the tube proximate the connection port has a greater resistance than a lower portion of the tube proximate the plenum chamber, the greater resistance in the upper portion being configured to limit resistance from an air circuit configured to be connected to the connection port.

47. The patient interface of claim 26, wherein the first portion is an anterior side and the second portion is a posterior side.

48. The patient interface of claim 27, wherein the first portion is an anterior side and the second portion is a posterior side.

49. The patient interface of claim 26, wherein the first portion is taller than the second portion such that the first portion is proximate the connection port.

50. The patient interface of claim 27, wherein the first portion is higher than the second portion, such that the first portion is proximate the connection port.

51. A method of manufacturing the patient interface of claim 1, the method comprising: positioning the layer of textile or foam material in a mold; introducing the transparent and / or translucent material into the mold; bonding the transparent and / or translucent material to the layer of textile and / or foam material to form the at least one gas delivery tube; and connecting the at least one gas delivery tube to the plenum and / or the seal-forming structure.

52. The method of claim 51, wherein the mold includes a semi-circular protrusion, and the transparent and / or translucent material flows around the semi-circular protrusion and forms a semi-circular recess along a hollow interior.

53. The method of claim 52, wherein the semi-circular protrusion directs the transparent and / or translucent material toward the layer of textile or foam material to allow bonding between the transparent and / or translucent material and the layer of textile or foam material prior to forming the non-patient contacting portion. ​

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