Patient interface cushion

Abstract

Cushion modules and cushion module components are provided for use in patient interfaces of respiratory therapy systems. In examples, the seal-forming structure of the cushion module is provided with thinned regions, which may provide improved patient comfort and / or improved manufacturing techniques, particularly when used in conjunction with patient interfaces that combine two or more different materials. In some examples, the cushion includes a lap seam between two different materials.

Description

[Technical Field]

[0001] [CROSS-REFERENCE TO RELATED APPLICATIONS] This application claims the benefit of and priority to Australian Provisional Patent Application No. 2023903550, filed November 6, 2023, Australian Provisional Patent Application No. 2022903613, filed November 29, 2022, and Australian Provisional Patent Application No. 2022903915, filed December 20, 2022, each of which is incorporated by reference herein in its entirety.

[0002] 2.1 Technical Fields The present technology relates to one or more of screening, diagnosing, monitoring, treating, preventing, and ameliorating respiratory-related disorders. The present technology also relates to medical devices or apparatuses and uses thereof. The present technology also relates to patient interfaces and cushion modules. [Background technology]

[0003] 2.2 Description of Related Art 2.2.1 The human respiratory system and its diseases The body's respiratory system facilitates gas exchange. The nose and mouth form the entrance to a patient's airways.

[0004] These airways contain a series of branches that become narrower, shorter, and more numerous the deeper they travel into the lungs. The primary function of the lungs is gas exchange, allowing oxygen to move from inhaled air to venous blood and carbon dioxide to move in the opposite direction. The trachea divides into right and left main bronchi, which further divide into terminal bronchioles. The bronchi constitute conducting airways and do not participate in gas exchange. The airways further divide into respiratory bronchioles and ultimately into alveoli. Gas exchange occurs in the alveolar region of the lung, which is called the respiratory region. Reference: Respiratory Physiology, 9th Edition, by John B. West, Lippincott Williams & Wilkins, 2012.

[0005] There are a variety of respiratory diseases. Particular disorders can be characterized by particular episodes (e.g., apnea, hypopnea, and hyperpnea).

[0006] Examples of respiratory diseases include obstructive sleep apnea (OSA), Cheyne-Stokes respiration (CSR), respiratory insufficiency, obesity hypoventilation syndrome (OHS), chronic obstructive pulmonary disease (COPD), neuromuscular diseases (NMD), and chest wall diseases.

[0007] Obstructive sleep apnea (OSA), a form of sleep-disordered breathing (SDB), is characterized by episodes of upper airway closure or obstruction during sleep. This is the result of an abnormally small upper airway combined with the normal loss of muscle tone in the tongue region, soft palate, and posterior oropharyngeal wall during sleep. This condition causes affected individuals to experience breathing pauses typically lasting 30 to 120 seconds, sometimes as many as 200 to 300 times per night. This can result in excessive daytime sleepiness, which can lead to cardiovascular disease and brain damage. This syndrome is common, particularly among middle-aged, overweight men, but patients often experience no symptoms. See U.S. Patent No. 4,944,310 (Sullivan).

[0008] Cheyne-Stokes respiration (CSR) is another form of sleep-disordered breathing. CSR is a disturbance in a patient's respiratory control system, resulting in alternating periods of waxing and waning ventilation, known as the CSR cycle. CSR is characterized by repeated deoxygenation and reaeration of arterial blood. CSR can be harmful due to repeated hypoxia. In some patients, CSR is associated with repeated awakenings from sleep, causing severe insomnia, increased sympathetic activity, and increased afterload. See U.S. Patent No. 6,532,959 (Berthon-Jones).

[0009] Respiratory failure is a general term for breathing problems that occur when the lungs are unable to take in enough oxygen or expel enough CO2 to meet the patient's needs. Respiratory failure can include some or all of the following conditions:

[0010] Patients with respiratory failure (a type of respiratory insufficiency) may experience abnormal shortness of breath when exercising.

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

[0012] Chronic obstructive pulmonary disease (COPD) encompasses any of a group of lower respiratory tract diseases that share certain common characteristics, including increased resistance to air movement, prolonged expiratory phase of breathing, and a decrease in normal lung elasticity. Examples of COPD include emphysema and chronic bronchitis. Causes of COPD include chronic smoking (the primary risk factor), occupational exposure, air pollution, and genetic factors. Symptoms include dyspnea on exertion, chronic cough, and sputum production.

[0013] Neuromuscular disease (NMD) is a broad term encompassing numerous diseases and illnesses that impair muscle function directly through intrinsic muscle pathology or indirectly through neuropathology. Some NMD patients are characterized by progressive muscle damage that leads to loss of walking ability, wheelchair use, difficulty swallowing, respiratory muscle weakness, and ultimately death from respiratory failure. Neuromuscular disorders can be divided into the following: (i) rapidly progressive disorders: characterized by muscle damage 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: characterized by muscle damage that worsens over years and only modestly reduces life expectancy (e.g., limb-girdle, facioscapulohumeral, and myotonic muscular dystrophies). Symptoms of NMD respiratory failure include increasing generalized weakness, difficulty swallowing, dyspnea on exertion and at rest, fatigue, drowsiness, morning headaches, and difficulty with attention and mood changes.

[0014] Chest wall disorders are a group of thoracic deformities that result in inefficient coupling between the respiratory muscles and the rib cage. These disorders are primarily characterized by restrictive obstruction and share the potential for long-term hypercapnic respiratory failure. Scoliosis and / or kyphoscoliosis can lead to severe respiratory failure. Symptoms of respiratory failure include exertional dyspnea, peripheral edema, orthopnea, recurrent chest infections, morning headache, fatigue, poor sleep quality, and loss of appetite.

[0015] A range of therapies are available to treat or ameliorate these conditions, and preventative therapies for respiratory disease are also available to otherwise healthy individuals. However, these have several deficiencies.

[0016] 2.2.2 Therapy A variety of respiratory therapies (e.g., continuous positive airway pressure (CPAP) therapy, non-invasive ventilation (NIV), invasive ventilation (IV), and high-flow therapy (HFT)) are used to treat one or more of the above-mentioned respiratory disorders.

[0017] 2.2.2.1 Respiratory pressure therapy Respiratory pressure therapy is the application of air to the entrance of the airways at a controlled target pressure that is nominally positive relative to the atmosphere throughout the patient's respiratory cycle (as opposed to negative pressure therapy, e.g., tank ventilators or positive-negative pressure extracorporeal ventilators (cuirass)).

[0018] Continuous positive airway pressure (CPAP) therapy is used to treat obstructive sleep apnea (OSA). Its mechanism of action is that CPAP therapy acts as a pneumatic splint, for example, by pushing the soft palate and tongue forward or backward against the posterior oropharyngeal wall, thereby preventing upper airway closure. Because CPAP therapy for OSA can be voluntary, patients may choose not to comply if they find one or more devices used to deliver the therapy uncomfortable, difficult to use, expensive, or unattractive.

[0019] Noninvasive ventilation (NIV) provides ventilatory support to patients via the upper airways to assist breathing and / or maintain adequate oxygen levels in the body by completing some or all of the work of breathing. Ventilatory support is provided via a noninvasive patient interface. NIV is used to treat CSR and respiratory failure in forms such as OHS, COPD, NMD, and chest wall disorders. Some forms may improve the comfort and effectiveness of these therapies.

[0020] Invasive ventilation (IV) provides ventilatory support to patients who can no longer breathe effectively on their own and may be provided using a tracheostomy or endotracheal tube. Some forms may improve the comfort and effectiveness of these therapies.

[0021] 2.2.2.2 Flow therapy Not all respiratory therapies are intended to deliver a prescribed therapeutic pressure. Some respiratory therapies are intended to deliver a prescribed respiratory volume by delivering an inspiratory flow profile (perhaps superimposed on a positive baseline pressure) for a targeted duration. In other cases, the interface to the patient's airway is "open" (unsealed), and respiratory therapy with a conditioned or concentrated gas flow may be used only to support the patient's spontaneous breathing. In one example, high-flow therapy (HFT) involves providing a continuous, heated, humidified airflow to the airway entrance through an unsealed or open patient interface at a "therapeutic flow" that can be maintained nearly constant throughout the respiratory cycle. The therapeutic flow is nominally set to exceed the patient's peak inspiratory flow. HFT is used to treat OSA, CSR, respiratory failure, COPD, and other respiratory disorders. One mechanism of action is that the high flow of air at the airway entrance improves venting efficiency by flushing or sweeping exhaled CO2 from the patient's anatomical dead space. Therefore, HFT is sometimes referred to as dead space therapy (DST). Other benefits may include improved warmth and humidification (possibly through the benefit of secretory control) and a gradual increase in airway pressure. As an alternative to a constant flow rate, the therapeutic flow rate may follow a profile that varies over the respiratory cycle.

[0022] Another form of flow therapy is long-term oxygen therapy (LTOT), or supplemental oxygen therapy. A physician may prescribe a continuous flow of oxygen-enriched air at a specific oxygen concentration (the fraction of oxygen in ambient air, from 21% to 100%) delivered to a patient's airways at a specific flow rate (e.g., 1 liter per minute (LPM), 2 LPM, 3 LPM, etc.).

[0023] 2.2.3 Respiratory Therapy Systems These respiratory therapies may be provided by respiratory therapy systems or devices. Such systems and devices may be used to screen, diagnose, or monitor disease without treating it.

[0024] The respiratory therapy system may include a respiratory pressure therapy device (RPT device), an air circuit, a humidifier, a patient interface, an oxygen source, and data management.

[0025] 2.2.3.1 Patient Interface A patient interface may be used to interface with a respiratory appliance, for example, by providing airflow to the entrance of the airway. Airflow may be provided via a mask to the nose and / or mouth, a tube to the mouth, or a tracheostomy tube to the patient's trachea. Depending on the therapy being applied, the patient interface may facilitate gas delivery at a pressure sufficiently different from ambient pressure, e.g., approximately 10 cmH2O positive pressure relative to ambient pressure, by forming a seal with, for example, a portion of the patient's face, to effectively implement the therapy. For other forms of therapy, such as oxygen delivery, the patient interface may not include sufficient sealing properties to facilitate gas delivery to the airway at a positive pressure of approximately 10 cmH2O. For flow therapies, such as nasal HFT, the patient interface is configured to insufflate the nares (and specifically avoid a complete seal). One example of such a patient interface is a nasal cannula.

[0026] Certain other mask systems may be functionally inadequate in this field. For example, a purely decorative mask may not be able to maintain adequate pressure. Mask systems used for underwater swimming or diving may be configured to protect against water intrusion from higher external pressures, but not to maintain internal air at pressures higher than ambient.

[0027] Certain masks may have clinical disadvantages to current technology, for example, if they block airflow through the nose and only allow airflow through the mouth, if they require the patient to insert part of the mask structure into the mouth to create and maintain a lip seal, and / or if they are impractical for use while sleeping, for example, when lying in bed with the head resting on a pillow.

[0028] Some masks can cause patients to feel claustrophobic, anxious, and / or overly conspicuous.

[0029] Designing a patient interface presented many challenges. The face has a complex three-dimensional shape. The size and shape of the nose and head vary greatly among individuals. Because the head contains bone, cartilage, and soft tissue, different regions of the face respond differently to mechanical forces. That is, the chin or mandible can move relative to the other bones of the skull. The entire head can move throughout the respiratory therapy session.

[0030] As a result, some masks can be one or more of the following: intrusive, aesthetically undesirable, costly, poor fit, difficult to use, and uncomfortable, especially if worn for extended periods or if the patient is unfamiliar with the system. Incorrectly sized masks can lead to reduced compliance, reduced comfort, and poor patient outcomes. While masks designed specifically for aviators, masks designed as part of personal protective equipment (e.g., filter masks), scuba masks, or masks designed for administering anesthetics may be tolerable for their intended use, such masks can still become uncomfortable when worn for extended periods of time, such as several hours. Such discomfort can reduce patient compliance with therapy.

[0031] CPAP therapy can be highly effective in treating certain respiratory conditions, as long as patients comply with the therapy. Patients may not comply if the mask is uncomfortable or difficult to use. Patients are often encouraged to clean their masks regularly, but if the mask is difficult to clean (e.g., difficult to assemble or disassemble), patients may not be able to clean the mask, which may affect patient compliance.

[0032] Masks for other uses (e.g., aviators) may be unsuitable for use in treating sleep-disordered breathing, and masks designed for use in treating sleep-disordered breathing may be suitable for other uses.

[0033] For these reasons, patient interfaces that deliver CPAP during sleep form a unique area.

[0034] 2.2.3.1.1 Seal formation structure The patient interface may include a seal-forming structure. Because the patient interface is in direct contact with the patient's face, the shape and configuration of the seal-forming structure can have a direct impact on the effectiveness and comfort of the patient interface.

[0035] Patient interfaces may be characterized in part according to the design intent of where the seal-forming structure engages with the face during use. In one form of patient interface, the seal-forming structure may include a first sub-portion for forming a seal around the left nostril and a second sub-portion for forming a seal around the right nostril. In one form of patient interface, the seal-forming structure may include a single element that surrounds both nostrils during use. Such a single element may be designed to rest, for example, on the upper lip region and nose bridge region of the face. In one form of patient interface, the seal-forming structure may include an element that surrounds the mouth region during 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 may include a single element that surrounds both the nostril and mouth regions during use. These different types of patient interfaces may be known by various names depending on their manufacturers, such as nasal masks, full face masks, nasal pillows, nasal puffs, and oronasal masks.

[0036] A seal-forming structure that may be effective in one area of ​​a patient's face may be inappropriate in another area, for example, due to different shapes, structures, variability, and sensitive areas of the patient's face. For example, a seal on swimming goggles that fits over the patient's forehead may not be appropriate for use on the patient's nose.

[0037] A particular seal-forming structure can be designed for mass production so that one design can fit a wide range of different facial shapes and sizes, and be comfortable and effective. If 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 will need to adapt to form a seal.

[0038] One type of seal-forming structure extends around the periphery of the patient interface and is intended to seal against the patient's face when force is applied to the patient interface while the seal-forming structure is engaged against the patient's face. This seal-forming structure may include an air or fluid-filled cushion, or may include a molded or formed surface of a resilient sealing element constructed of an elastomer such as rubber. With this type of seal-forming structure, if the fit is improper, a gap will form between the seal-forming structure and the face, requiring additional force to press the patient interface against the face to achieve a seal.

[0039] Another type of seal-forming structure uses a thin flap seal positioned around the periphery of the mask to provide a self-sealing seal against the patient's face when positive pressure is applied within the mask. As with the previous type of seal-forming portion, poor fit between the face and mask can require additional force to achieve a seal or the mask may leak. Furthermore, if the shape of the seal-forming structure does not match the shape of the patient, it may wrinkle or buckle during use, resulting in leakage.

[0040] Another type of seal-forming structure may include a friction fit element, for example, a friction fit element, although this may be uncomfortable for some patients.

[0041] Another form of seal-forming structure may use adhesives to achieve the seal, as some patients find it inconvenient to constantly apply and remove adhesives from their face.

[0042] A range of patient interface seal forming structural technologies are disclosed in the following patent applications assigned to ResMed: WO 1998 / 004310, WO 2006 / 074513, WO 2010 / 135785.

[0043] One form of nasal pillow is found in the Adam line manufactured by Puritan Bennett. Another nasal pillow, or nasal puff, is the subject of U.S. Patent No. 4,782,832 (Trimble et al.), assigned to Puritan-Bennett Corporation.

[0044] ResMed manufactures the following products that incorporate nasal pillows: SWIFT™ Nasal Pillows Mask, SWIFT™ II Nasal Pillows Mask, SWIFT™ LT Nasal Pillows Mask, SWIFT™ FX Nasal Pillows Mask, and the MIRAGE LIBERTY™ Full Face Mask. Examples of nasal pillow masks are described in the following patent applications assigned to ResMed Limited: International Patent Application No. WO 2004 / 073,778 (which describes, among other things, aspects of ResMed Limited's SWIFT™ nasal pillows); U.S. Patent Application No. 2009 / 0044808 (which describes, among other things, aspects of ResMed Limited's SWIFT™ LT nasal pillows); International Patent Applications Nos. WO 2005 / 063,328 and WO 2006 / 130,903 (which describe, among other things, aspects of ResMed Limited's MIRAGE LIBERTY™ full face mask); and International Patent Application No. WO 2009 / 052,560 (which describes, among other things, aspects of ResMed Limited's SWIFT™ FX nasal pillows).

[0045] 2.2.3.1.2 Positioning and stabilizing structures The seal-forming structures of patient interfaces used in positive air therapy are subject to a corresponding force of air pressure that disrupts the seal. Therefore, various techniques have been used to position and maintain the seal-forming structures in sealing relationship with the appropriate portion of the face. Several factors are considered when comparing different positioning and stabilization techniques. These include the effectiveness of the technique in maintaining the seal-forming structures in the desired position and engaging the facial seal during use of the patient interface; the comfort of the interface to the patient; whether the patient feels intrusive and / or claustrophobic when wearing the patient interface; and aesthetics.

[0046] One technique involves the use of adhesives. See, for example, U.S. Patent Application Publication No. 2010 / 0000534. However, adhesives can be uncomfortable.

[0047] Another technique uses one or more straps and / or stabilizing harnesses, the bulk of which suffer from one or more of poor fit, bulk, discomfort, and cumbersomeness.

[0048] 2.2.3.1.3 Pressurized air conduit In one type of treatment system, a flow of pressurized air is supplied to the patient interface via a conduit in the air circuit that is fluidly connected to the patient interface at a position in front of the patient's face when the patient interface is placed on the patient's face in use. The conduit may extend from the patient interface in a direction forward from the patient's face.

[0049] 2.2.3.1.4 Pressurized air conduit for positioning and stabilizing the seal-forming structure Another type of treatment system includes a patient interface, and a tube delivering pressurized air to the patient's airway is also used as part of the headgear to position and stabilize the seal-forming portion of the patient interface on the patient's face. This type of patient interface may be referred to as having "conduit-type headgear" or "headgear tubing." This patient interface allows a conduit in an air circuit providing pressurized air flow from a respiratory pressure therapy (RPT) device to be connected to the patient interface at a location other than in front of the patient's face. One example of such a treatment system is disclosed in U.S. Patent Publication No. 2007 / 0246043, the contents of which are incorporated herein by reference, in which the conduit is connected to a tube internal to the patient interface through a port positioned on the patient's head during use.

[0050] It is desirable for a patient interface incorporating headgear tubes to be comfortable for the patient to wear for extended periods of time while sleeping, to form an airtight and stable seal with the patient's face, and at the same time accommodate a variety of patient head shapes and sizes.

[0051] 2.2.3.2 Respiratory Pressure Therapy (RPT) Devices Respiratory pressure therapy (RPT) devices can be used alone or as part of a system to provide one or more of the above therapies; for example, the device can be actuated to generate and deliver a flow of air to an interface with the airway. The airflow can be pressure-controlled (for respiratory pressure therapy) or flow-controlled (for flow therapy, such as HFT). As such, RPT devices can also function as flow therapy devices. Examples of RPT devices include CPAP devices and mechanical ventilators.

[0052] 2.2.3.3 Air circuit An air circuit is a conduit or tube constructed and arranged so that, in use, airflow travels between two components of a respiratory therapy system (e.g., an RPT device and a patient interface). In some cases, there may be separate limbs of the air circuit for inhalation and exhalation. In other cases, a single-limb air circuit is used for both inhalation and exhalation.

[0053] 2.2.3.4 Humidifier Delivery of airflow without humidification can lead to drying of the airway. When a humidifier is used with an RPT device and patient interface, humidified gas is produced, minimizing drying of the nasal mucosa and increasing comfort of the patient's airway. Additionally, in cool climates, warm air, which is typically directed at the facial area in and around the patient interface, is more comfortable than cool air.

[0054] 2.2.3.5 Venting Technology Some forms of treatment systems may include a vent to expel exhaled carbon dioxide, which may allow gas flow from an interior space (e.g., a plenum chamber) of the patient interface to an exterior (e.g., ambient) of the patient interface. Summary of the Invention

[0055] The present technology relates to providing medical devices for use in screening, diagnosing, monitoring, ameliorating, treating or preventing respiratory disorders, which medical devices have one or more of improved comfort, cost, effectiveness, ease of use and manufacturability.

[0056] A first aspect of the present technology relates to devices used in screening, diagnosing, monitoring, ameliorating, treating or preventing respiratory disease.

[0057] Another aspect of the present technology relates to methods used in the screening, diagnosis, monitoring, amelioration, treatment or prevention of respiratory disorders.

[0058] An aspect of some forms of the present technology is to provide methods and / or devices for improving patient compliance with respiratory therapy.

[0059] One form of the present technology includes a positioning and stabilizing structure that provides a force to hold the seal-forming structure in a therapeutically effective position on the patient's head. In one example, the positioning and stabilizing structure includes at least one flat strap.

[0060] Another aspect of one form of the present technology relates to a patient interface that may include a plenum chamber, a seal-forming structure, and a positioning and stabilizing structure.

[0061] A patient interface according to some examples of the present technology includes a plenum chamber pressurizable to a therapeutic pressure of at least 6 cmH2O above ambient air pressure. The plenum chamber includes a plenum chamber inlet port configured to receive a flow of breathable gas at the therapeutic pressure for breathing by the patient. The patient interface includes a seal-forming structure constructed and arranged to form a seal with an area of ​​the patient's face surrounding an entrance to the patient's airway. The seal-forming structure has an opening therein such that the flow of breathable gas is delivered to an entrance to at least one of the patient's nostrils. The seal-forming structure is configured, in use, to maintain the therapeutic pressure within the plenum chamber throughout the patient's respiratory cycle. The patient interface includes a positioning and stabilizing structure for holding the seal-forming structure in a therapeutically effective position on the patient's head.

[0062] Another aspect of one form of the present technology could be a series of modular elements that can be interconnected to form different styles of patient interfaces.

[0063] In one form, there are at least two versions or styles of each modular element that can be used interchangeably to form different modular assemblies.

[0064] One form of the present technology involves a cushion module for a patient interface.

[0065] Another form of the present technology involves a cushion module for a patient interface that includes a thinned region within a seal-forming structure of the patient interface.

[0066] Another form of the present technology is a patient interface for delivering a flow of breathable gas to a patient's airway, comprising: a connection port configured to receive the flow of breathable gas; a cushion module including a plenum chamber configured to receive the flow of breathable gas; and a seal-forming structure configured to form a seal around the patient's airway or airway, the seal-forming structure comprising: a patient-contacting portion configured to engage the patient's face to provide the seal; and a support portion attached to a non-patient-contacting side of the patient-contacting portion, the support portion configured to support the patient-contacting portion, the support portion including a thinned region extending substantially parallel to at least a portion of a periphery of the patient-contacting portion.

[0067] Another form of the present technology is a patient interface for delivering a flow of breathable gas to a patient's airways, the patient interface comprising: a plenum chamber pressurizable to a therapeutic pressure of at least 6 cmH2O above ambient pressure; at least one plenum chamber inlet port sized and configured to receive the flow of breathable gas at the therapeutic pressure for breathing by the patient; and a seal-forming structure constructed and arranged to form a seal with an area of ​​the patient's face surrounding the entrance to the patient's airways, the seal-forming structure constructed and arranged to maintain said therapeutic pressure in the plenum chamber throughout the patient's respiratory cycle, in use,

[0068] Another form of the invention includes a cushion module for a patient interface, the cushion module including: a plenum chamber pressurizable to a therapeutic pressure of at least 6 cmH2O above ambient pressure; at least one plenum chamber inlet port sized and configured to receive a flow of breathable gas at the therapeutic pressure for breathing by the patient; and a seal-forming structure at least partially defining the plenum chamber and constructed and arranged to form a seal with an area of ​​the patient's face surrounding an entrance to the patient's airways, the seal-forming structure constructed and arranged to maintain the therapeutic pressure within the plenum chamber throughout the patient's respiratory cycle in use. In various examples, the seal-forming structure includes a first portion made from a first material, at least one opening in the first portion through which the flow of breathable gas is delivered to one or more airways of the patient in use, and a second portion comprising a second material, the second portion bonded to the first portion, the second portion having at least one groove or channel therein, the groove or channel located along a path generally parallel to at least a portion of the opening.

[0069] Another form of the present technology includes a cushion module for a patient interface, the cushion module including: a plenum chamber pressurizable to a therapeutic pressure of at least 6 cmH2O above ambient air pressure; at least one plenum chamber inlet port sized and configured to receive a flow of breathable gas at the therapeutic pressure for breathing by the patient; and a seal-forming structure at least partially defining the plenum chamber and constructed and arranged to form a seal with an area of ​​the patient's face surrounding an entrance to the patient's airway, the seal-forming structure constructed and arranged to maintain the therapeutic pressure within the plenum chamber throughout the patient's respiratory cycle in use. In some examples, the seal-forming structure may include a patient-contacting portion including a first material, the patient-contacting portion including a first side configured to engage and form a seal with the patient's face, a second side opposite the first side, and an opening through which the flow of breathable gas is delivered to the patient's airway in use. In some examples, the seal-forming structure further includes a support portion attached to the second side of the patient-contacting portion, the support portion including a second material different from the first material. In some examples, the support portion is configured to support at least a portion of the patient-contacting portion, and the support portion includes at least one thinned region having a thickness less than a thickness of an adjacent region of the support portion, the adjacent region being closer to the opening than the thinned region, and the thinned region being located on a path extending in a direction generally parallel to the opening.

[0070] In certain configurations, the thinned region may be substantially narrow (e.g., less than about 5 mm wide, e.g., about 1 mm to about 2 mm wide) and elongated (e.g., at least 20 mm long). In various examples, the length to width ratio of the thinned region may be at least 4:1. The thinned region may extend across one or more of the nasal side region, nasal bridge region, upper lip region, cheek region, lower lip region, chin region, and / or forehead region of the patient interface. For example, in one configuration, the thinned region may be provided in the nasal side and nasal bridge regions of the patient interface.

[0071] In certain configurations, the patient interface may include multiple thinned regions, while in other configurations, the patient interface may include a thinned region that forms a closed curve or continuous loop around the opening in the cushion module.

[0072] Another aspect of one form of the present technology is a plenum chamber pressurizable to a therapeutic pressure of at least 6 cmH2O above ambient pressure, the plenum chamber including at least one plenum chamber inlet port sized and configured to receive a flow of air at the therapeutic pressure for breathing by the patient; a seal-forming structure constructed and arranged to form a seal with an area of ​​the patient's face surrounding an entrance to the patient's airway, the seal-forming structure having at least one opening to allow a flow of air at a therapeutic pressure to be delivered to at least the entrances of the patient's nares, the seal-forming structure constructed and arranged to maintain said therapeutic pressure within the plenum chamber throughout the patient's respiratory cycle, in use; a vent for allowing gases exhaled by the patient to flow from the interior of the plenum chamber to the surroundings, the vent being sized and shaped to maintain a therapeutic pressure within the plenum chamber in use; The seal forming structure is a first layer behind the seal-forming structure, the first layer configured, in use, to seal around an entrance to the patient's airway, including at least a partially downwardly directed portion of the patient's nasal tip, the ala of the nose, and the upper lip of the patient's face; and a second layer connected to and supporting the first layer, the second layer including an overlapping portion that overlaps the first layer to form a lap joint with the first layer around the periphery of the first layer, the overlapping portion extending inwardly from the non-overlapping portion of the second layer relative to the periphery of the first layer; The overlapping portion includes a width that varies along the periphery of the overlapping portion of the first layer, the width being defined by an amount of inward extension of the overlapping portion from the non-overlapping portion of the second layer to provide a patient interface.

[0073] More examples: The overlapping portion includes a pair of outer nose portions, and the width of the overlapping portion is greater in the outer nose portions than in one or more other portions of the overlapping portion. • The width of the overlapping area is greater at the outer nose area than at the top of the overlapping area. • The overlap is at least twice as wide at the lateral nose as it is at the top. • The width of the overlap is greater at the lateral nose than at the bottom of the overlap. • The overlap is at least five times wider at the lateral nasal portion than at the lower portion. • The overlap is at least 10 times wider in the lateral nasal area than in the lower area. • The width of the overlapping area is greater at the top than at the bottom. The overlapping portion includes a pair of medial-lateral lower portions that are positioned outside the respective lower portions of the overlapping portion and inside the lateral nasal portions of the overlapping portion, and the width of the overlapping portion is greater in the lateral nasal portions than in the medial-lateral lower portions. • The overlap is at least 1.5 times wider in the lateral nasal portion than in the mediolateral inferior portion. • The width of the overlapping area is greater at the lower middle and outer parts than at the bottom of the overlapping area. ●The seal-forming structure includes a nasal portion configured to provide air flow to the entrances of the patient's nostrils when in use, and further includes an oral portion configured to provide air flow to the patient's mouth when in use. The overlapping portion includes a pair of outer upper lip portions that, in use, are provided on each outer side of the patient's upper lip. • The width of the overlapping area is greater in the outer upper lip area than in the outer nose area. • The width of the overlap is at least 1.5 times greater in the lateral upper lip area than in the lateral nasal area. • The outer upper lip portion extends from the non-overlapping portion of the second layer inward relative to the periphery of the first layer. Each outer upper lip portion includes an inner end that is positioned adjacent and inferior to a respective one of the alar crest points on the patient's face. • The width of the overlapping area is narrow between the outer upper lip area and the outer nose area. The overlapping portion includes a pair of nasolabial portions each positioned outside the outer upper lip portion, and the width of the overlapping portion is greater in the outer upper lip portion than in the nasolabial portion. ●The width of the overlapping area is larger in the outer part of the nose than in the nasolabial area. The overlapping portion includes a pair of cheek portions, and the width of the overlapping portion is greater at the outer upper lip portion than at the cheek portion. • The overlapping area includes the lower lip area, and the width of the overlapping area is greater at the outer upper lip area than at the lower lip area. • The width of the outer nose part tapers towards the top of the overlapping part. The overlapping portion of the second layer includes an outer surface to which the first layer is connected, the outer surface being offset from and narrower than the outer surface of the non-overlapping portion. • The patient-contacting surface of the first layer is flush with the outer surface of the non-overlapping portion of the second layer. • The overlapping portion of the second layer of the seal-forming structure has a thickness at one or more locations that is less than the non-overlapping portion of the second layer of the seal-forming structure. The first layer is made of a woven material. The second layer is made of an elastomeric material. - The patient interface includes a cushion module, the cushion module including a chassis portion, the seal-forming structure attached to the chassis portion, the chassis portion and the seal-forming structure together defining a plenum chamber. the chassis portion includes a pair of outwardly protruding connection portions, each defining a plenum chamber inlet port and each configured to connect to a respective one of a pair of gas delivery tubes; and / or ●The patient interface includes gas delivery tubes, which form part of a positioning and stabilising structure configured to provide a force to hold the seal-forming structure in a therapeutically effective position on the patient's head, and each gas delivery tube is configured to transport a flow of air from a position above the patient's head to the plenum chamber in use.

[0074] Another aspect of one aspect of the technology of the present invention is a plenum chamber pressurizable to a therapeutic pressure of at least 6 cmH2O above ambient pressure, the plenum chamber including at least one plenum chamber inlet port sized and configured to receive a flow of air at the therapeutic pressure for breathing by the patient; a seal-forming structure constructed and arranged to form a seal with an area of ​​the patient's face surrounding an entrance to the patient's airway, the seal-forming structure having at least one opening to allow a flow of air at a therapeutic pressure to be delivered to at least the entrances of the patient's nares, the seal-forming structure constructed and arranged to maintain said therapeutic pressure within the plenum chamber throughout the patient's respiratory cycle, in use; a vent for allowing gases exhaled by the patient to flow from the interior of the plenum chamber to the surroundings, the vent being sized and shaped to maintain a therapeutic pressure within the plenum chamber in use; The seal forming structure is a central portion configured to seal against at least a partially downwardly directed portion of the patient's nasal tip, the ala of the nose, and the upper lip of the patient's face in use; a central anterior portion of a forward-facing wall of the seal-forming structure, the central anterior portion being positioned inferiorly and proximate to the patient's nasal tip in use; A pair of medial-lateral anterior sections of the anterior-facing wall positioned on each side of the central anterior section, each medial-lateral anterior section including an upper and lower section, the lower section having a lower stiffness than the upper section, provide a patient interface.

[0075] Examples: • The inferior portion of each mediolateral anterior portion has a thickness less than the superior portion of the mediolateral anterior portion. • The lower part of each mediolateral anterior segment is stiffer than the central anterior segment. • The inferior part of each mediolateral anterior part has a greater thickness than the central anterior part. - The central portion is formed from a woven material. ●The patient interface is provided on the rear side of the seal-forming structure and includes a first layer that forms a central portion of the seal-forming structure, and a second layer that is connected to the periphery of the first layer and supports the first layer, the second layer forming a forward-facing wall of the seal-forming structure. The first layer is made of a woven material. The second layer is made of an elastomeric material. ●The second layer of the seal-forming structure includes an overlapping portion that overlaps with the first layer to form a lap joint with the first layer at the outer periphery of the first layer, and the overlapping portion extends inward from the non-overlapping portion of the second layer relative to the outer periphery of the first layer. • The overlapping portion of the second layer includes a thinned region extending along at least a portion of the overlapping portion. • A thinned region extends along the overlapping portion of the second layer at least in the outer nose portion and upper portion of the overlapping portion. - The patient interface includes a cushion module, the cushion module including a chassis portion, the seal-forming structure attached to the chassis portion, the chassis portion and the seal-forming structure together defining a plenum chamber. ●The seal-forming structure includes a pair of outer rear regions provided on each outer rear side of the seal-forming structure, each outer rear region extending rearward from the chassis portion and curved inward to contact the patient's face during use. Each outer posterior region curves inward to form a respective one of a pair of posterior corners of the seal-forming structure, each posterior corner configured to engage the patient's face proximate a respective one of the patient's nasolabial folds in use. ●The seal-forming structure includes an upper lip portion including a rear portion configured to seal against the patient's upper lip in use and a front portion adjacent to the chassis portion that is stiffer than the stiffness of the rear portion of the upper lip portion. the chassis portion includes a pair of outwardly protruding connection portions, each defining a plenum chamber inlet port and each configured to connect to a respective one of a pair of gas delivery tubes; and / or ●The patient interface includes gas delivery tubes, which form part of a positioning and stabilising structure configured to provide a force to hold the seal-forming structure in a therapeutically effective position on the patient's head, and each gas delivery tube is configured to transport a flow of air from a position above the patient's head to the plenum chamber in use.

[0076] Another aspect of one form of the present technology is a patient interface for delivering a flow of breathable gas to a patient's airway, the patient interface comprising: a plenum chamber pressurizable to a therapeutic pressure of at least 6 cmH2O above ambient pressure, the plenum chamber including at least one plenum chamber inlet port sized and configured to receive a flow of air at the therapeutic pressure for breathing by the patient; a seal-forming structure constructed and arranged to form a seal with an area of ​​the patient's face surrounding an entrance to the patient's airway, the seal-forming structure having at least one opening to allow a flow of air at a therapeutic pressure to be delivered to at least the entrances of the patient's nares, the seal-forming structure constructed and arranged to maintain said therapeutic pressure within the plenum chamber throughout the patient's respiratory cycle, in use; the seal-forming structure includes a first layer configured to engage and seal against the patient's face in use, and a second layer configured to provide support to at least a portion of the first layer in use; the first layer includes a first region bonded to the second layer and a second region not bonded to the second layer; the second layer includes a first thickness and a second thickness, the first thickness being adjacent to the second region of the first layer, and the second thickness being adjacent to the first thickness and farther from the second region than the first thickness; The first thickness is greater than the second thickness.

[0077] In some examples, the first region may be joined to the second layer by a lap seam.

[0078] In some examples, the second layer can include a third thickness adjacent to the second thickness and further from the second region than the second thickness, and in some examples, the first thickness can be greater than the third thickness.

[0079] In some examples, the first thickness and / or the second thickness can be provided as a channel having an elongated structure that extends circumferentially around at least a portion of the seal-forming structure, e.g., the elongated structure can form a continuous loop around at least one opening in the seal-forming structure.

[0080] In some examples, the first thickness and second thickness may be provided in one or more of the nasal side region, nasal bridge region, upper lip region, cheek region, lower lip region, chin region, ala region, and / or nasal tip region of the seal-forming structure.

[0081] In some examples, the first layer may include a woven fabric and the second layer may include an elastomeric material.

[0082] In some examples, the second layer may include a material having a Young's modulus of 0.4 GPa or less. For example, the material may be foam, silicone, or rubber.

[0083] Another aspect of one form of the present technology is a patient interface for delivering a flow of breathable gas to an airway of a patient, the patient interface comprising: a plenum chamber pressurizable to a therapeutic pressure of at least 6 cmH2O above ambient pressure, the plenum chamber including at least one plenum chamber inlet port sized and configured to receive a flow of air at the therapeutic pressure for breathing by the patient; a seal-forming structure constructed and arranged to form a seal with an area of ​​the patient's face surrounding an entrance to the patient's airway, the seal-forming structure constructed and arranged to maintain said therapeutic pressure within the plenum chamber throughout the patient's respiratory cycle, in use. the seal-forming structure includes an edge defining an opening such that a flow of air at a therapeutic pressure is delivered from the plenum chamber through the opening to the patient's airway; The seal-forming structure includes a patient-contacting portion configured to engage the patient's face to provide a seal, and a support portion attached to a non-patient-contacting side of the patient-contacting portion, the support portion configured to support the patient-contacting portion. The support portion includes a first region and a second region, the first region being thinner than the second region, and the second region being closer to the edge of the seal-forming structure than the first region.

[0084] In some examples, the first region has a width and a length, the length measured circumferentially around the seal-forming structure and the width measured in a direction substantially perpendicular to the circumferential direction across a surface of the seal-forming structure, and the length is substantially greater than the width.

[0085] In some examples, the patient interface further includes a third region, the third region being thicker than the first region and positioned farther from the edge of the seal-forming structure than the first region, and the third region may extend circumferentially around the seal-forming structure.

[0086] In some examples, the first region is provided on one or more of the side of the nose region, the bridge of the nose region, the upper lip region, the cheek region, the lower lip region, the chin region, and / or the tip of the nose region of the seal-forming structure. For example, the first region may be provided on the side of the nose and the bridge of the nose region of the patient interface.

[0087] In some examples, the support portion includes a plurality of first regions including the first region and a plurality of second regions including the second region, wherein each first region has a thickness less than a thickness of a corresponding second region, and the plurality of first regions are disposed in a substantially symmetrical arrangement on opposite sides of the seal-forming structure.

[0088] In some examples, the first region forms a continuous loop around the opening in the seal-forming structure.

[0089] In some examples, the transition region from the first region to the second region has a substantially curved profile when viewed in a cross-sectional plane extending substantially perpendicular to the longitudinal direction of the first region.

[0090] In some examples, the first region is provided as a channel on the non-patient contacting side of the patient contacting portion.

[0091] In some examples, the thickness of the first region varies around the perimeter of the opening in the seal-forming structure.

[0092] In some examples, the patient contacting portion comprises a fabric.

[0093] Another aspect of one form of the present technology is a patient interface for delivering a flow of breathable gas to the oral and nasal airways of a patient, the patient interface comprising: a plenum chamber pressurizable to a therapeutic pressure of at least 6 cmH2O above ambient pressure, the plenum chamber including at least one plenum chamber inlet port sized and configured to receive a flow of air at the therapeutic pressure for breathing by the patient; a seal-forming structure constructed and arranged to form a seal with an area of ​​the patient's face surrounding an entrance to the patient's airway, the seal-forming structure constructed and arranged to maintain said therapeutic pressure within the plenum chamber throughout the patient's respiratory cycle, in use; The seal-forming structure includes a patient-contacting fabric layer, the patient-contacting fabric layer comprising: a nasal region surrounding one or more nasal openings configured, in use, to deliver a flow of breathable gas to the patient's nares; an oral cavity region surrounding one or more oral openings configured, in use, to deliver a flow of breathable gas to the patient's mouth; the woven patient-contacting layer in the nasal region has a first width measured radially outward from the nasal opening(s) to an outer edge of the woven patient-contacting layer, and the woven patient-contacting layer in the oral region has a second width measured radially outward from the oral opening(s) to an outer edge of the woven patient-contacting layer in the chin region or a region on the side of the mouth; the fabric patient-contacting layer has a third width measured from the oral opening to an outer edge of the fabric patient-contacting layer in the region where the upper lip meets the oral region of the first layer; Here, the third width is smaller than the first width and the second width, and the third width is configured to allow the fabric patient-contacting layer to curve from the oral region to the nasal region and assume a concave shape in the nasal region.

[0094] In some examples, the third width may be 50% or less of the second width.

[0095] In some examples, the first, second, and third widths may be measured with the textile patient-contacting layer in a planar configuration.

[0096] In some examples, the seal-forming structure may include a second layer configured to support at least a portion of the fabric patient-contacting layer.

[0097] Another aspect of one form of the present technology is a patient interface that is molded or otherwise constructed with a peripheral shape that is complimentary to the shape of the intended wearer.

[0098] One aspect of the present technology is a method for manufacturing a device.

[0099] Another aspect of one form of the present technology is a method of assembling a modular system that includes selecting a positioning and stabilizing structure and connecting the positioning and stabilizing structure to either a first cushion module or a second cushion module.

[0100] One aspect of certain forms of the present technology is a medical device that is easy to use, for example, by individuals without medical training, individuals with limited dexterity, lack of insight, or individuals with limited experience using such medical devices.

[0101] One form of the present technology is a portable RPT device that can be carried by a user, for example, in the user's home.

[0102] One aspect of one form of the present technology is a patient interface that can be cleaned at the patient's home, for example, with soapy water, without the need for special cleaning equipment.One aspect of one form of the present technology is a humidifier tank that can be cleaned at the patient's home, for example, with soapy water, without the need for special cleaning equipment.

[0103] The above-described methods, systems, devices, and apparatus may be implemented to improve the functionality of processors of special purpose computers, respiratory monitors, and / or respiratory therapy devices, etc. Additionally, the above-described methods, systems, devices, and apparatus may provide improvements in the art of automated management, monitoring, and / or treatment of respiratory conditions, including, for example, sleep-disordered breathing.

[0104] Of course, some of the aspects may form sub-aspects of the technology, and various of the sub-aspects and / or aspects may be combined in various ways to form additional aspects or sub-aspects of the technology.

[0105] Other features of the technology will become apparent upon consideration of the information contained in the following detailed description, summary, drawings, and claims. [Brief explanation of the drawings]

[0106] BRIEF DESCRIPTION OF THE DRAWINGS The present technology is illustrated by way of example and not limitation in the accompanying drawings, in which like reference numerals include like elements as follows: 4.1 Respiratory Therapy Systems [Figure 1A] A system is shown including a patient 1000 wearing a patient interface 3000, which takes the form of nasal pillows and receives positively pressurized air supplied by an RPT device 4000. The air from the RPT device 4000 is humidified in a humidifier 5000 and delivered to the patient 1000 through an air circuit 4170. A bed companion 1100 is also shown. The patient is sleeping in a supine sleeping position. [Figure 1B] The system is shown to include a patient 1000 wearing a patient interface 3000 in the form of a nasal mask that receives air at positive pressure supplied from an RPT device 4000. The air from the RPT device is humidified in a humidifier 5000 and delivered to the patient 1000 along an air circuit 4170. [Figure 1C]The system is shown to include a patient 1000 wearing a patient interface 3000 in the form of a full face mask that receives air at positive pressure supplied by an RPT device 4000. The air from the RPT device is humidified in a humidifier 5000 and delivered to the patient 1000 along an air circuit 4170. The patient is sleeping in a lateral sleeping position. 4.2 Respiratory System and Facial Anatomy [Figure 2A] Outline of the human respiratory system including the nasal and oral cavities, larynx, vocal cords, esophagus, trachea, bronchi, lungs, alveolar sacs, heart and diaphragm. [Figure 2B] Diagram of the human upper respiratory tract including the nasal cavity, nasal bones, lateral nasal cartilages, greater alar cartilages, nostrils, upper lip, lower lip, larynx, hard palate, soft palate, oropharynx, tongue, epiglottis, vocal folds, esophagus, and trachea. [Figure 2C] A front view of the face including several features of the surface anatomy including upper lip, vermilion, lower lip, mouth width, medial canthus, ala of the nose, nasolabial folds, and cheilion. The superior, inferior, radially inward, and radially outward directions are also indicated. [Figure 2D] A lateral view of the head including several features of the surface anatomy, including the glabella, serrion, nasal tip, subnasal point, upper lip, lower lip, supramenton, nasal ridge, alar crest, superior and inferior ear base points. The directions of superior and inferior, and anterior and posterior are also indicated. [Figure 2E] Further lateral views of the head. The approximate locations of the Frankfort horizontal and nasolabial angle are noted. The coronal plane is also shown. 4.3 Patient Interface [Figure 3A] 1 shows a patient interface in the form of a nasal mask in accordance with one form of the present technology. [Figure 3B] 1 shows a mask cushion including two pillows, the outer surface of the cushion is shown, the edge of the surface is shown, and the dome and saddle regions are illustrated. [Figure 3C] 1 shows a mask cushion. The outer surface of the cushion is shown. The edge of the surface is shown. The path on the surface between points A and B is shown. The linear distance between A and B is shown. Two saddle regions and one dome region are shown. [Figure 3D] A diagram of the plenum chamber 3200 showing the sagittal and medial contact planes. [Figure 3E]

[0033] Figure 3E is a posterior view of the plenum chamber of Figure 3D. Directions in the figure are perpendicular to the central contact plane. In Figure 3E, a sagittal plane bisects the plenum chamber into a left-hand side and a right-hand side. [Figure 3F] FIG. 3D is a cross-sectional view through the plenum chamber of FIG. 3E, where the cross-section is taken in the sagittal plane shown in FIG. 3E. The "mid-contact" plane is illustrated. The mid-contact plane is perpendicular to the sagittal plane. The orientation of the mid-contact plane corresponds to the orientation of the tendon 3211, which lies on the sagittal plane and just contacts the cushion at two points on the sagittal plane: superior point 3220 and inferior point 3230. Depending on the geometry of the cushion in this region, the mid-contact plane may contact both the superior and inferior points. [Figure 3G] The plenum chamber 3200 of Figure 3D is shown in a use position on the face. The sagittal plane of the plenum chamber 3200 generally coincides with the mid-sagittal plane of the face when the plenum chamber is in the use position. The central contact plane generally corresponds to the "face plane" when the plenum chamber is in the use position. In Figure 3G, the plenum chamber 3200 is that of a nasal mask, with the upper point 3220 located approximately on the selion and the lower point 3230 located on the upper lip. 4.4RPT Device [Figure 4] 4.5 Cushion Module [Figure 5A]

[0023] Fig. 1 shows a cross-sectional view of a humidifier in accordance with one form of the present technology. [Figure 5B]

[0023] Fig. 1 shows a cross-sectional view of a humidifier in accordance with one form of the present technology. [Figure 5C] FIG. 13 shows a rear view of a cushion module having a pair of thinned regions in accordance with one form of the present technology. [Figure 5D] 10 illustrates another rear view of a cushion module having a thinned region according to one aspect of the present invention. [Figure 5E] 10 illustrates another rear view of a cushion module having a thinned region according to one aspect of the present invention. [Figure 5F]FIG. 13 shows an alternative rear view of a cushion module having a thinned region on a patient-contacting surface of a seal-forming structure in accordance with one form of the present technology. [Figure 6A]

[0033] Fig. 11 shows a cross-sectional view of a seal-forming structure in accordance with one form of the present technology. [Figure 6B]

[0023] Fig. 10 shows a cross-sectional view of a seal-forming structure having a substantially curved thinned region in accordance with one form of the present technology. [Figure 6C]

[0023] Fig. 10 shows a cross-sectional view of a seal-forming structure having a substantially triangular thinned region in accordance with one form of the present technology. [Figure 6D] FIG. 10 shows a cross-sectional view of a seal-forming structure having a substantially trapezoidal thinned region in accordance with one form of the present technology. [Figure 6E]

[0023] Fig. 10 shows a cross-sectional view of a seal-forming structure having a substantially rectangular thinned region in accordance with one form of the present technology. [Figure 7A]

[0033] Fig. 10 shows a cross-sectional view of a seal-forming structure including a patient-contacting layer and a support layer in accordance with one form of the present technology. [Figure 7B] FIG. 10 shows a cross-sectional view of a seal-forming structure including a patient-contacting layer and a support layer in accordance with another form of the present technology. [Figure 8A]

[0033] Fig. 13 shows a rear view of a cushion module including a fabric patient-contacting layer and a silicone support layer in accordance with one form of the present technology. [Figure 8B] 8B is a cross-sectional view of the cushion module of FIG. 8A, showing the area where the thickness of the silicon support layer is reduced. 4.6 Cushion Fabrication [Figure 9A] 1 shows a perspective view of a cushion module including exemplary thinned areas and sprue locations in accordance with one form of the present technology; [Figure 9B] FIG. 10 shows a perspective view of an alternative cushion module including exemplary thinned areas and sprue locations in accordance with one form of the present technology; [Figure 9C] 4.7 Composite Cushion Module Structure [Figure 10A]

[0033] Fig. 14 shows a perspective view of a cushion module according to another example of the present technology. [Figure 10B]10B shows a front view of the cushion module shown in FIG. 10A. [Figure 10C] 10B shows a top view of the cushion module shown in FIG. 10A. [Figure 10D] 10B shows a bottom view of the cushion module shown in FIG. 10A. [Figure 10E] 10B shows a side view of the cushion module shown in FIG. 10A. [Figure 10F] FIG. 10B is a rear view of the cushion module shown in FIG. 10A. [Figure 11A] 10B is a perspective view of the cushion module shown in FIG. 10A with a first layer of the seal-forming structure of the cushion module removed. [Figure 11B] 10B is a rear view of the cushion module shown in FIG. 10A with the first layer of the seal-forming structure of the cushion module removed. [Figure 12A] 10B is a rear view of the cushion module shown in FIG. 10A with the first layer of the seal-forming structure of the cushion module removed and the lower portion of the medial-lateral anterior portion of the seal-forming structure shaded. [Figure 12B] 10B is a cross-sectional view of the cushion module shown in FIG. 10A with the first layer of the seal-forming structure of the cushion module removed, with the lower portion of the medial-lateral anterior portion of the seal-forming structure being shaded. [Figure 12C] 10B shows a cross-sectional cutaway view of the seal-forming structure of the cushion module shown in FIG. 10A with a first layer removed. [Figure 12D] 10B shows another cross-sectional cutaway view of the cushion module shown in FIG. 10A with the first layer of the seal-forming structure removed. [Figure 12E] FIG. 10B is a perspective view of the cushion module shown in FIG. 10A, with the lower portion of the mediolateral anterior portion shaded. [Figure 13A] 13A is a cross-sectional view of the cushion module shown in FIG. 10A through the section line 13A-13A marked in FIG. 10B. [Figure 13B] FIG. 13B is a detailed view of region 13B shown in FIG. 13A. [Figure 13C]13C is a cross-sectional view of the cushion module shown in FIG. 10A taken through the section line 13C-13C marked in FIG. 10B. [Figure 13D] FIG. 13D is a detailed view of area 13D shown in FIG. 13C. [Figure 14A] FIG. 10 is a perspective view of a cushion module according to another example of the present technology. [Figure 14B] FIG. 14B is a top view of the cushion module shown in FIG. 14A with the first layer of the seal-forming structure removed. [Figure 14C] 14C is a cross-sectional view of the cushion module shown in FIG. 14A taken through section line 14C-14C shown in FIG. 14B. [Figure 14D] 14D is a cross-sectional view of the cushion module shown in FIG. 14A taken through section line 14D-14D shown in FIG. 14B. [Figure 14E] 14E is a cross-sectional view of the cushion module shown in FIG. 14A taken through section line 14E-14E shown in FIG. 14B. [Figure 14F] FIG. 14B is a rear-underside view of the cushion module shown in FIG. 14A with certain portions of the forward-facing wall of the seal-forming structure shaded. [Figure 14G] 14B is an exterior rear underside view of the cushion module shown in FIG. 14A with certain portions of the forward-facing wall of the seal-forming structure shaded. FIG. [Figure 15] FIG. 14B is a perspective view of a vent module configured for use with the cushion module shown in FIG. 10A or 14A. [Figure 16A] FIG. 1 is a perspective view of an exemplary gas delivery tube that can be used with the cushion module. [Figure 16B] FIG. 16B is a perspective view of a patient interface including the cushion module shown in FIG. 10A and the gas delivery tube shown in FIG. 16A. [Figure 16C] FIG. 16B is a perspective view of a patient interface including a nose-mouth cushion module including the gas delivery tube shown in FIG. 16A. [Figure 16D] 1 is a schematic diagram showing possible combinations of patient interfaces. [Figure 17A]

[0043] Fig. 134 is a front view of a nose-mouth cushion module in accordance with another example of the present technology. [Figure 17B] FIG. 17B is a rear and superior view of the nose-mouth cushion module of FIG. 17A. [Figure 17C] FIG. 17B is a rear view of the nose-mouth cushion module of FIG. 17A. [Figure 17D] FIG. 17B is a rear view of the nose-mouth cushion module of FIG. 17A with the first layer of the seal-forming structure removed. [Figure 17E] FIG. 17D is a partial cross-sectional view taken along section line FF of FIG. 17C. [Figure 18] FIG. 10 is a front view of a first layer of a seal-forming structure according to another example of the present technology. DETAILED DESCRIPTION OF THE INVENTION

[0107] Before describing the present technology in further detail, it is to be understood that the present technology is not limited to particular examples described herein, as such may vary, and it is also to be understood that the terminology used in this disclosure is for the purpose of describing only the particular examples described herein, and is not intended to be limiting.

[0108] The following description is provided in connection with various examples that may share one or more common characteristics and / or features. It should be understood that one or more features of any one example may be combined with one or more features of another example or the other examples. In addition, any single feature or combination of features in any of these examples may constitute a further example.

[0109] 5.1 Therapy In one form, the present technology includes a method of treating a respiratory disorder comprising applying positive pressure to the entrance of the airways of a patient 1000.

[0110] In a particular example of the present technology, a supply of air at positive pressure is provided to the patient's nasal passages via one or both nostrils.

[0111] In certain instances of the present technology, mouth breathing is restricted, limited, or prevented.

[0112] 5.2 Respiratory Therapy Systems In one form, the present technology includes a respiratory therapy system for treating respiratory disorders. The respiratory therapy system may include an RPT device 4000 for supplying airflow to a patient 1000 via an air circuit 4170 and a patient interface 3000.

[0113] 5.3 Patient Interface 3A, a non-invasive patient interface 3000 in accordance with one aspect of the present technology includes as functional aspects a seal-forming structure 3100, a plenum chamber 3200, a positioning and stabilizing structure 3300, a vent 3400, a form of connection port 3600 for connecting to an air circuit 4170, and a forehead support 3700. In some forms, the functional aspects may be provided by one or more physical components. In some forms, a single physical component may provide one or more functional aspects. In use, the seal-forming structure 3100 is positioned to surround an entrance to the patient's 1000 airway to maintain positive pressure at the entrance(s) of the patient's 1000 airway. The sealed patient interface 3000 is therefore suitable for delivery of positive pressure therapy.

[0114] If the patient interface cannot comfortably deliver a minimum level of positive pressure to the airway, the patient interface may not be suitable for respiratory pressure therapy.

[0115] A patient interface 3000 in accordance with one form of the present technology is constructed and arranged to be able to deliver air at a positive pressure, greater than ambient pressure.

[0116] A patient interface 3000 in accordance with one form of the present technology is constructed and arranged to be able to deliver air at a positive pressure of at least 2 cmH2O relative to ambient.

[0117] A patient interface 3000 in accordance with one form of the present technology is constructed and arranged to provide an air supply at a positive pressure of at least 20 cmH2O relative to ambient.

[0118] A patient interface 3000 in accordance with one form of the present technology is constructed and arranged to provide an air supply at a positive pressure of at least 20 cmH2O relative to ambient.

[0119] A patient interface 3000 in accordance with one form of the present technology is constructed and arranged to provide an air supply at a positive pressure of at least 20 cmH2O relative to ambient.

[0120] A patient interface 3000 in accordance with one form of the present technology is constructed and arranged to provide an air supply at a positive pressure of at least 10 cmH2O relative to ambient.

[0121] 5.3.1 Cushion In one form of the present technology, the patient interface includes a cushion which may be a resiliently deformable structure configured to conform to the contours of the patient's face to provide a seal-forming structure 3100 in use.

[0122] For example, the cushion may be constructed from a pliable material (e.g., constructed from a soft, flexible, resilient material such as silicone, fabric, foam, etc.). In some examples, the cushion may include a combination of materials, such as silicone and fabric, or silicone and foam. In some forms of the present technology, the cushion may be formed from a material having a Young's modulus of 0.4 GPa or less, such as foam. In some forms of the present technology, the cushion may be formed from a material having a Young's modulus of 0.1 GPa or less, such as rubber. In other forms of the present technology, the cushion may be formed from a material having a Young's modulus of 0.7 MPa or less, for example, between 0.7 MPa and 0.3 MPa. One example of such a material is silicone.

[0123] In one form of this technology, the cushion is attached to or molded to a rigid structure, such as a chassis or other support structure, to define a cushion module 3150 that at least partially includes a plenum chamber 3200. For example, the chassis may comprise a substantially rigid thermoplastic such as polycarbonate. In some examples, the cushion is configured to at least partially define the plenum chamber. For example, the cushion may be formed without a chassis and substantially define the plenum chamber 3200.

[0124] The cushion may include openings 5004 (see, e.g., FIG. 5A ) configured to deliver a flow of breathable gas to the patient's airway during use. For example, in a nasal-only patient interface, the openings 5004 may be configured to receive the patient's 1000 nose or to seal around the nasal airway. In a nasal pillows patient interface, the cushion may include one or more openings 5004 configured to provide a flow of breathable gas to the patient's airway. For example, a first opening 5004 may be configured to provide a flow of breathable gas to a first nostril of the patient, and a second opening 5004 may be configured to provide a flow of breathable gas to a second nostril of the patient.

[0125] The opening 5004 may include a perimeter that defines an edge 5006 of the seal-forming structure 3100 .

[0126] 5.3.2 Cushion module The cushion may form part of a cushion module 3150, which may be a replaceable or non-replaceable component of the patient interface 3000. The cushion module 3150 is provided in different sizes, each usable as part of the patient interface 3000, so that the patient 1000 or their clinician may select the size that best suits the patient's face. The cushion module 3150 may include a cushion and other components or portions, such as a chassis or other support structure for the cushion, a connector, and / or a vent module.

[0127] In some forms of the present technology, the cushion module 3150 is part of the patient interface 3000 that forms the plenum chamber 3200 and the seal-forming structure 3100. The cushion module 3150 may be separable from other components or portions of the patient interface 3000, such as the positioning and stabilizing structure 3300, the frame, and / or the connection port 3600, although in some examples the cushion module 3150 may be inseparable from one or more other components of the patient interface 3000.

[0128] In one form of the present technology shown in FIG. 5A, a cushion module 3150 includes a sidewall 5002 that extends substantially outwardly against a patient's face in use, and a membrane or seal-forming structure 3100 that curves generally radially inward from the sidewall 5002 to form a seal with the patient's face in use.

[0129] In some examples, such as the examples shown in FIGS. 10A-10F, the cushion module 3150 includes a chassis portion 3210 and a seal-forming structure 3100. The seal-forming structure 3100 may be attached to the chassis portion 3210 or integrally formed with the chassis portion 3210 (e.g., molded in a single molding step / shot). The cushion module 3150 may also include other components, such as connectors and a vent module, in some examples. For example, the cushion module 3150 shown in FIGS. 10A-10F includes a pair of connectors 3214 for connecting to gas delivery tubes. The connectors 3214 are connected to the chassis portion 3210 of the cushion module 3150. The cushion module 3150 also includes a vent module 3410 (shown separately in FIG. 15) configured to fit securely into a front hole 3215 in the chassis portion 3210.

[0013] The vent module 3410 includes a plurality of vent holes 3412 that provide a vent 3400 for the patient interface 3000 to exhaust gases in the plenum chamber 3200 during use. The vent module may include a diffuser and be removable for replacement or cleaning. In other examples of the present technology, the vent 3400 or vent module 3410 may take different forms. The chassis portion 3210 of the cushion module 3150 and the seal-forming structure 3100 may each partially form the plenum chamber 3200 of the patient interface 3000. The chassis portion 3210 may be more rigid than the seal-forming structure 3100 and may function as a chassis for the cushion module 3150. The chassis portion 3210 may support the overall structure of the cushion module 3150 and the seal-forming structure 3100. The chassis portion 3210 maintains the shape and position of the front or non-patient contacting side 5010 of the seal-forming structure 3100 while the rear or patient contacting side 5013 of the seal-forming structure 3100 deforms to fit snugly against the patient's face. The chassis portion 3210 and the seal-forming structure 3100 may at least partially define the plenum chamber 3200 of the patient interface 3000.

[0130] Any feature of the cushion disclosed herein may be applied to the cushion module 3150 of the patient interface 3000. The cushion module 3150 described herein may be provided with a chassis portion 3210 for supporting the seal-forming structure 3100.

[0131] In some examples, the cushion or cushion module 3150 may be attached to a frame during use. The cushion module 3150 shown in FIGS. 5A-5F is of this type. The frame may form part of the positioning and stabilizing structure 3300 and may provide connection to headgear straps. In some examples, the cushion or cushion module 3150 may be connected directly to the positioning and stabilizing structure 3300 without a frame, for example, to the headgear straps of the positioning and stabilizing structure 3300 or to a gas delivery tube of the positioning and stabilizing structure 3300, which holds the cushion module 3150 in place and also provides a flow of pressurized air or breathable gas to the interior of the cushion module 3150 (e.g., the plenum chamber 3200). For example, the cushion module 3150 shown in FIGS. 10A-10F and 17A-17D is of this type.

[0132] Any cushion, cushion module 3150, or seal-forming structure 3100, or features thereof, described herein may be incorporated into a patient interface 3000, such as the patient interface 3000 of the form shown in Figure 16B or 16C.

[0133] 5.3.3 Seal formation structure In one form of the present technology, the seal-forming structure 3100 provides a target seal-forming area and may also provide a cushioning function. The target seal-forming area is the area where a seal may occur on the seal-forming structure 3100. The area where the seal actually occurs, i.e., the actual sealing surface, may vary within a particular treatment session, from day to day, and from patient to patient depending on a variety of factors, such as where the patient interface is placed on the face, the tension of the positioning and stabilizing structure, the shape of the patient's face, etc.

[0134] In one form, the target seal-forming region is located on an outer surface of the seal-forming structure 3100.

[0135] In certain forms of the present technology, the seal-forming structure 3100 is constructed from a biocompatible material, such as, for example, silicone rubber.

[0136] A seal-forming structure 3100 according to the present technology may be constructed from a soft, flexible, resilient material, such as silicone.

[0137] In certain forms of the present technology, a system is provided that includes a plurality of seal-forming structures 3100, each configured to accommodate a range of different sizes and / or shapes. For example, the system may include one form of seal-forming structure 3100 that is suitable for large heads but not for small heads, and another form that is suitable for small heads but not for large heads.

[0138] 5.3.3.1 Sealing mechanism In one form, the seal-forming structure includes a sealing flange or patient-contacting layer 3100A that utilizes a pressure-assisted sealing mechanism. During use, the sealing flange 3100A readily responds to positive system pressure within the plenum chamber 3200, acting on its underside to urge it into tight, sealing engagement with the surface. The pressure-assisted mechanism may work in conjunction with the elastic tension of the positioning and stabilizing structure.

[0139] In one form, the seal-forming structure 3100 includes a sealing flange or patient-contacting layer 3100A and a support flange / layer 3100B (see FIGS. 5A-5C). The patient-contacting layer 3100A comprises a relatively thin member having a thickness of less than about 1 mm, for example, about 0.25 mm to about 0.45 mm, and extends around the periphery of the plenum chamber 3200. The support layer 3100B may be relatively thicker than the patient-contacting layer 3100A. The support layer 3100B is disposed between the patient-contacting layer 3100A and the edge of the plenum chamber 3200 and extends around at least a portion of the periphery. The support layer 3100B is or includes a spring-like element and functions to support the patient-contacting layer 3100A to prevent buckling during use.

[0140] In one form, the seal-forming structure may include a compressive sealing portion or a gasket sealing portion that is constructed and arranged to be compressed in use, for example as a result of the elastic tension of the positioning and stabilizing structure.

[0141] In one form, the seal-forming structure includes a tension portion that, during use, is held in tension by, for example, an adjacent region of the patient-contacting layer.

[0142] In one form, the seal-forming structure includes an area having a tacky or adhesive surface.

[0143] In certain forms of the present technology, the seal-forming structure may include one or more of a pressure-assisted patient-contacting layer, a compression sealing portion, a gasket sealing portion, a tension portion, and a portion having a sticky or adhesive surface.

[0144] 5.3.3.2 Nasal bridge or nasal ridge area In one form, the non-invasive patient interface 3000 includes a seal-forming structure that, in use, forms a seal with the nasal bridge or ridge region of the patient's face.

[0145] In one form, the seal-forming structure includes a saddle-shaped region constructed to form a seal with the nasal bridge or nasal ridge region of the patient's face in use.

[0146] For example, the seal-forming structure may include a sealing flange on the bridge or ridge of the nose of the patient's face.

[0147] 5.3.3.3 Upper lip area In one form, the non-invasive patient interface 3000 includes a seal-forming structure that, in use, forms a seal with the upper lip region (ie, upper lip) of the patient's face.

[0148] In one form, the seal-forming structure includes a saddle-shaped region constructed to form a seal against the upper lip region of the patient's face in use.

[0149] For example, the seal-forming structure may include a sealing flange in the upper lip region of the patient's face.

[0150] 5.3.3.4 Jaw area In one form, the non-invasive patient interface 3000 includes a seal-forming structure that, in use, forms a seal with the chin region of the patient's face.

[0151] In one form, the seal-forming structure includes a saddle-shaped region constructed to form a seal against the chin region of the patient's face in use.

[0152] For example, the seal-forming structure may include a sealing flange in the chin region of the patient's face.

[0153] 5.3.3.5 Frontal Area In one form, the seal-forming structure forms a seal against the forehead region of the patient's face in use, and in such a form, the plenum chamber may cover the eyes in use.

[0154] For example, the seal-forming structure may include a sealing flange in the forehead region of the patient's face.

[0155] 5.3.3.6 Nasal pillow In one form, the seal-forming structure of the non-invasive patient interface 3000 includes a pair of nasal puffs or nasal pillows, each constructed and arranged to form a seal with a respective nostril of the patient's 1000 nose.

[0156] Nasal pillows according to one aspect of the present technology include a frustum cone, at least a portion of which forms a seal under the patient's nose, a handle, and a flexible region below the frustum cone that connects the frustum to the handle. Additionally, the structure to which the nasal pillows of the present technology are connected includes a flexible region adjacent the base of the handle. The flexible regions can work together to facilitate a universal joint structure that accommodates relative movement (both displacement and angle) between the frustum cone and the structure to which the nasal pillows are connected. For example, the frustum cone can be displaced axially toward the structure to which the handle is connected.

[0157] 5.3.3.7 Nasal mask In one form, the patient interface 3000 includes a seal-forming structure 3100 configured to seal around the entrance to the patient's nasal airway but not around the patient's mouth. The seal-forming structure 3100 may be configured to seal against the patient's upper lip. The patient interface 3000 may leave the patient's mouth uncovered. The patient interface 3000 may deliver air or breathable gas to the two nostrils of the patient 1000 but not to the oral cavity. This type of patient interface may be identified as a nasal mask only.

[0158] A nasal mask-only form of the present technology is what is traditionally thought of as a "nasal mask" and has a seal-forming structure 3100 configured to seal around the nose and above the bridge of the nose on a patient's face. Nasal masks may typically be triangular in shape. In one form, the non-invasive patient interface 3000 includes a seal-forming structure 3100 that, in use, forms a seal with the upper lip area (e.g., upper lip), at least a portion of the patient's nasal bridge or nasal ridge above the anterior nostrils, and the patient's face on each side of the patient's nose (e.g., the patient's nearby nasolabial folds). The patient interface 3000 shown in FIG. 1B has this type of seal-forming structure 3100. The patient interface 3000 may deliver air or breathable gas to both nares of the patient 1000 via a single orifice.

[0159] Another form of nasal-only mask may seal around the bottom of the patient's nose without engaging the user's nasal bridge. For example, this type of patient interface 3000 may be identified as a "nasal cradle" mask, and the seal-forming structure 3100 may be identified as a "nasal cradle closure." In one form, the seal-forming structure 3100 is configured to form a seal with the underside of the nose around the nostrils during use. The seal-forming structure 3100 may be configured to seal around the patient's nostrils at the lower periphery of the patient's nose, including the underside and / or anterior surface of the patient's nose tip region and the patient's nostril ala. The seal-forming structure 3100 may seal against the patient's upper lip. The shape of the seal-forming structure 3100 may be configured to conform to or fit snugly against the underside of the patient's nose, but not contact the bridge region of the patient's nose or any portion above the tip of the patient's nose. In one form of the nasal cradle cushion, the seal-forming structure 3100 includes a bridge portion that divides the opening 5004 into two holes, each opening providing air or breathable gas to a corresponding one of the patient's nostrils in use. The bridge portion may be configured to contact or seal with the patient's trabeculae in use. Alternatively, the seal-forming structure 3100 may include a single opening 5004 that provides airflow or air or breathable gas to both of the patient's nostrils.

[0160] In some configurations, the nasal mask may only include nasal pillows, as described above.

[0161] 5.3.3.8 Oral-nasal mask In one form, the patient interface 3000 includes a seal-forming structure 3100 configured to seal around the entrance to the patient's nasal airways and around the patient's oral cavity. The seal-forming structure 3100 may be configured to seal against the patient's face near the chin region. The patient interface 3000 may deliver air or breathable gas to the patient's nares and oral cavity. This type of patient interface may be identified as a nasal-oral mask.

[0162] One form of oronasal mask according to the present technology is what is traditionally thought of as a "full face mask," having a seal-forming structure 3100 configured to seal around the patient's nose, under the mouth, and over the bridge of the nose. Typically, full face masks may be triangular in shape. In one form, the patient interface 3000 includes the seal-forming structure 3100 that, in use, forms a seal with the patient's chin region (which may include the patient's lower lip and / or the area directly below the lower lip), at least a portion of the patient's nasal bridge or nasal ridge above the anterior nostrils, and the cheek region of the patient's face. The patient interface 3000 shown in FIG. 1C is of this type. The patient interface 3000 may deliver air or breathable gas to the patient's nares and oral cavity through a single orifice. This type of seal-forming structure 3100 may be referred to as a "full face mask."

[0163] In another form, the patient interface 3000 includes a seal-forming structure 3100 that forms a seal in use with the patient's chin area (which may include the patient's lower lip and / or the area directly below the lower lip), the underside and / or front of the tip of the patient's nose, the nostrils of the patient's nose, and the patient's face on each side of the patient's nose (e.g., near the nasolabial folds). The seal-forming structure 3100 may also form a seal against the patient's upper lip. A patient interface 3000 having this type of seal-forming structure may have a single opening 5004 configured to deliver a flow of air or breathable gas to both the patient's 1000 nostrils and mouth, may have an oral opening 5004A configured to deliver air or breathable gas to the mouth and a nasal opening 5004B configured to deliver air or breathable gas to the nostrils, or may have an oral opening 5004A to deliver air to the patient's mouth and two nasal openings 5004B to deliver air to each nostril. This type of patient interface 3000 may have nasal and oral portions that are sealed to the patient's face in a position similar to a nasal cradle mask.

[0164] In another form of a nasal-oral mask, the patient interface 3000 may include a seal-forming structure 3100 having a nasal portion including nasal pillows and an oral portion configured to form a seal against the patient's face around the patient's mouth.

[0165] In some forms, the seal-forming structure 3100 may have a distinct nasal portion that is separate from the oral portion, hi other forms, the seal-forming structure 3100 may form a continuous seal around the patient's nose and mouth.

[0166] It should be understood that the above examples of different forms of the patient interface 3000 do not constitute an exhaustive list of possible configurations. In some forms, the patient interface 3000 may include different combinations of features of the nasal-only and oronasal mask-only examples described above.

[0167] 5.3.4 Plenum chamber The plenum chamber 3200 has a periphery shaped to be complementary to the surface contours of an average human face in the area where a seal is formed in use. In use, the periphery of the plenum chamber 3200 is positioned in close proximity to the adjacent surface of the face. Actual contact with the face is provided by the seal-forming structure 3100. The seal-forming structure 3100 may extend around substantially the entire circumference of the plenum chamber 3200 in use. In some forms, the plenum chamber 3200 and the seal-forming structure 3100 are formed from a single, homogenous sheet of material.

[0168] In certain forms of the present technology, the plenum chamber 3200 does not cover the eyes of the patient 1000 when in use. In other words, the eyes are outside the pressurized volume defined by the plenum chamber. Such a form may improve compliance with therapy, often resulting in less intrusiveness and / or greater wearer comfort.

[0169] In certain forms of the present technology, the plenum chamber 3200 is constructed from a transparent material (e.g., clear polycarbonate). For example, the plenum chamber may include, at least in part, a transparent chassis, shell, or support structure. The use of a transparent material may reduce the intrusiveness of the patient interface and may help improve compliance with therapy. The use of a transparent material may help the clinician see the placement and function of the patient interface.

[0170] In certain forms of the present technology, the plenum chamber 3200 comprises a translucent material. For example, the plenum chamber may comprise, at least in part, a translucent chassis, shell, or support structure. Use of a translucent material can reduce the intrusiveness of the patient interface and can help improve compliance with therapy.

[0171] In some forms, the plenum chamber 3200 comprises a rigid material, such as polycarbonate. For example, the plenum chamber comprises, at least in part, a rigid chassis, shell, or support structure. The rigid material may provide support to the seal-forming structure 3100.

[0172] In some forms, the plenum chamber 3200 comprises a flexible material (e.g., constructed from a soft, flexible, resilient material such as silicone, fabric, foam, etc.). For example, in various examples, the plenum chamber 3200 may be formed from a material having a Young's modulus of 0.4 GPa or less, such as foam. In some forms of the technology, the plenum chamber 3200 may be formed from a material having a Young's modulus of 0.1 GPa or less, such as rubber. In other forms of the technology, the plenum chamber 3200 may be formed from a material having a Young's modulus of 0.7 Mpa or less, such as between 0.7 Mpa and 0.3 Mpa. An example of such a material is silicone.

[0173] 5.3.5 Positioning and stabilizing structures The seal-forming structure 3100 of the patient interface 3000 of the present technology may be held in a sealing position in use by a positioning and stabilizing structure 3300. The positioning and stabilizing structure 3300 may be configured and function as "headgear" as it engages the patient's head to hold the patient interface 3000 in a sealing position. An example of a positioning and stabilizing structure is shown in Figure 3A.

[0174] In one form, the positioning and stabilizing structure 3300 provides sufficient holding force to at least overcome the effects of the positive pressure in the plenum chamber 3200 and lift it off the face.

[0175] In one form, the positioning and stabilizing structure 3300 provides a holding force to overcome the effects of gravity on the patient interface 3000.

[0176] In one form, the positioning and stabilizing structure 3300 provides a holding force as a safety margin to overcome the potentially destructive effects of forces on the patient interface 3000, such as resistance in the tubes or accidental interference with the patient interface.

[0177] In one form of the present technology, a positioning and stabilizing structure 3300 is provided that is configured in a manner suitable for being worn by a patient 1000 while sleeping. In one example, the positioning and stabilizing structure 3300 has a reduced profile or cross-sectional thickness to reduce the apparent or actual bulk of the device. In one example, the positioning and stabilizing structure 3300 includes at least one strap with a rectangular cross-section. In one example, the positioning and stabilizing structure 3300 includes at least one flat strap.

[0178] 5.3.5.1 Headgear straps In some forms, the positioning and stabilizing structure 3300 may include headgear 3302 including at least one strap that can be worn by the patient 1000 to help properly orient the seal-forming structure 3100 against the patient's face (e.g., to limit or prevent leakage).

[0179] As noted above, some forms of headgear 3302 may be constructed from a woven material that is comfortable against the patient's skin. The woven material may be flexible to conform to various facial contours. However, the woven material may include rigidizers along selected lengths that may limit the bending, flexing, and / or extension of the headgear 3302.

[0180] In certain forms, the headgear 3302 may be at least partially stretchable. For example, the headgear 3302 may comprise an elastic or similar stretchable material. For example, the entire headgear 3302 may be stretchable, or selected portions may be stretchable (or more stretchable than surrounding portions). This may allow the headgear 3302 to stretch under tension and help provide a sealing force to the seal-forming structure 3100.

[0181] 5.3.6 Venting In one form, the patient interface 3000 includes a vent 3400 constructed and arranged to allow the expulsion of exhaled gases, for example carbon dioxide.

[0182] In certain forms, the vent 3400 is configured to allow continuous vent port flow from the interior of the plenum chamber 3200 to the environment while the pressure within the plenum chamber is positive relative to ambient. The vent 3400 is configured to have a vent flow rate large enough to reduce rebreathing of CO2 inhaled by the patient 1000 while maintaining a therapeutic pressure within the plenum chamber during use.

[0183] One form of vent 3400 in accordance with the present technology includes a plurality of holes (eg, about 20 to about 80 holes, or about 40 to about 60 holes, or about 45 to about 55 holes).

[0184] The vent 3400 may be located on the plenum chamber 3200. Alternatively, the vent 3400 is located in a separate structure, such as a swivel.

[0185] 5.3.7 Decoupling structure(s) In one form, the patient interface 3000 includes at least one decoupling structure (eg, a swivel or a bulb).

[0186] 5.3.8 Connection Port The connection port 3600 allows connection to the air circuit 4170 .

[0187] 5.3.9 Forehead support In one form, the patient interface 3000 includes a forehead support 3700 .

[0188] 5.3.10 Anti-asphyxiation valve In one form, the patient interface 3000 includes an anti-asphyxiation valve.

[0189] 5.3.11 Port 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 provide supplemental oxygen. In one form, this allows a property of the gas (e.g., pressure) within the plenum chamber 3200 to be measured directly.

[0190] 5.3.12 Modularity The cushions, cushion modules 3150, headgear, and sleeves may be provided in a variety of styles and may accommodate a variety of uses (mouth breathing, nose breathing, etc.) The patient 1000 or clinician may select a particular combination of cushions, headgear, and sleeves to optimize the effectiveness of the therapy and / or comfort for the individual patient.

[0191] In some forms, as shown in FIG. 16D, different styles of cushions, cushion modules 3150, headgear, and sleeves may be used interchangeably to form various combinations of patient interfaces. This may be beneficial from a manufacturing standpoint, as a greater variety of patient interfaces may be created using fewer parts. Additionally or alternatively, the various combinations may allow the patient 1000 to change the style of the patient interface without having to change all of the components.

[0192] As mentioned above, the cushion may form part of the cushion module 3150 and multiple cushion modules 3150 of different sizes may be used with a particular positioning and stabilising structure 3300 to allow the patient interface 3000 to suit a wide range of patients 1000.

[0193] 5.3.13 Cushion design Figure 5A shows an example of a cushion module 3150 according to the present technology including a seal-forming structure 3100. In the example of Figure 5A, the seal-forming structure 3100 includes a support layer 3100B and a patient-contacting layer 3100A, although this is not considered a limitation of the technology.

[0194] In some forms, the seal-forming structure 3100 of the cushion module 3150 may include a first region, also referred to as a thin or thin-walled region 5008, as shown in FIG. 5B. In the illustrated example, the thin-walled region 5008 is provided in the seal-forming structure 3100 between the edge 5006 and the sidewall 5002 of the seal-forming structure 3100. In the illustrated example, the thin-walled region 5008 is provided on the non-patient-contacting side 5010 or front of the seal-forming structure 3100. Locating the thin-walled region 5008 on the non-patient-contacting side 5010 of the seal-forming structure or on the support layer 3100B of the seal-forming structure may be advantageous in improving comfort for the patient 1000. However, this should not be considered limiting of the technology, and in other examples, the thin-walled region 5008 may be located on the patient-contacting side 5013 of the seal-forming structure 3100.

[0195] 3C and 5C, the thinned region 5008 may follow a path on the surface of the seal-forming structure 3100 indicated by a curved line between points X and Y, or may follow a closed loop as shown in Figures 5D-5F. The path may extend circumferentially around at least a portion of the seal-forming structure 3100 in a direction substantially parallel to the edge 5006 of the seal-forming structure 3100.

[0196] Circumferential references herein should be understood to be defined relative to a longitudinal axis passing through the center of the front opening 5004 and the rear opening 5004 of the cushion module 3150 .

[0197] The thinned regions 5008 in the examples described herein are spaced a fixed radial distance from the longitudinal axis. In examples, the thinned regions 5008 extend circumferentially around a portion of the seal-forming structure 3100 of the patient interface 3000, i.e., between a first point X and a second point Y, where the magnitude of the angle between points X and Y as measured relative to the longitudinal axis is greater than 0, or more preferably greater than 30 degrees or greater than 0.52 radians. In some examples of the technology, such as the examples in Figures 5D-5F, the thinned regions 5008 form a closed loop around the seal-forming structure 3100 or otherwise extend 360 degrees or 2π radians relative to the longitudinal axis. While the terms circumferential and radial are used to help describe the directions, it should be understood that the thinned regions 5008 and / or other components of the seal-forming structure 3100 or cushion module 3150 may not actually be circular.

[0198] Because the thinned region 5008 extends circumferentially around the surface of the seal-forming structure 3100, the radial distance from the longitudinal axis may vary, for example, to define a non-circular path, to follow the contour of the seal-forming structure 3100, or to maintain a substantially constant distance from the edge 5006 of the seal-forming structure 3100 in one or more regions of the seal-forming structure 3100, such as the nasal bridge region, the side of the nose region, the upper lip region, or the chin region.

[0199] Throughout this specification, references to a thin or thin-walled region 5008 on a seal-forming structure 3100 or cushion module 3150 should be understood to include a region that includes a thickness that is less than one or more adjacent regions. For example, the seal-forming structure 3100 may transition from a first region having a first thickness to a second region having a second thickness, the second thickness being less than the first thickness. In some forms of this technology, the transition from the first region to the second region may occur in a direction between the edge 5006 and the sidewall 5002 of the forming structure 3100, although in other examples, the transition may be provided in any direction, including, for example, around the perimeter of the seal-forming structure 3100.

[0200] In some examples of the present technology, the seal-forming structure 3100 can include multiple first and second regions, as shown in, for example, Figure 5C. In some examples, the multiple first and second regions are separated from one another, but this should not be considered limiting. For example, two second regions (thinned regions 5008A and 5008B) can be provided that are separated from one another but contiguous with a single first region (e.g., a region surrounding thinned regions 5008A and 5008B) that is thicker than the second region.

[0201] In some forms, the thinned region 5008 substantially follows the contour of the seal-forming structure 3100, for example, the thinned region 5008 has an elongated profile that substantially follows the contour of the seal-forming structure 3100, or follows the contour of the seal-forming structure 3100 in a circumferential direction or in a direction substantially parallel to at least a portion of the inner circumference of the patient-contacting portion, such as the edge 5006.

[0202] In some forms of the technology, the thinned region 5008 has a thickness less than at least a portion of the seal-forming structure 3100 between the edge 5006 and the thinned region 5008. In other words, the thinned region 5008 may be positioned between an inner section 5012 of the seal-forming structure 3100 substantially adjacent the opening 5004 and an outer section 5014 of the seal-forming structure 3100 substantially adjacent the sidewall 5002.

[0203] The seal-forming structure 3100 includes a first region 5012 having a first thickness and a second thinned region 5008 adjacent at least a portion of the first region, the second thinned region 5008 having a thickness less than the first thickness. It should be noted that the thickness of the first region and / or the thinned region 5008 may vary around the periphery of the seal-forming structure 3100, for example around the periphery of the opening 5004 of the seal-forming structure 3100. However, according to one example of the present technology, the thickness of the thinned region 5008 may be less than the thickness of the first region, at least in the region of the first region adjacent to the thinned region 5008.

[0204] In some forms of this technology, the thickness of the thinned region 5008 will be less than the thickness of the portion of the seal-forming structure 3100 between the sidewall 5002 and the thinned region 5008 (i.e., the outer section 5014). For example, the thickness of the thinned region 5008 can be less than the thickness of at least the portion of the seal-forming structure 3100 between the edge 5006 and the thinned region 5008 and at least the portion of the seal-forming structure between the sidewall 5002 and the thinned region 5008.

[0205] In some examples of this technology, the thinned regions 5008 may be provided in the form of channels extending along one or more regions of the seal-forming structure 3100 of the cushion module 3150. For example, FIG. 5C shows an example of a patient interface including a first thinned region 5008A and a second thinned region 5008B. In the example shown, the first thinned region 5008A is provided in a first nasal region of the seal-forming structure 3100, and the second thinned region 5008B is provided in a second nasal region of the seal-forming structure 3100. This example should not be considered limiting, as these thinned regions 5008 may be provided in any region of the cushion module 3150, preferably within the seal-forming structure 3100 of the cushion module 3150 between the opening 5004 and the side wall 5002. For example, the thinned regions 5008 may be provided in one or more of the side of the nose region, the bridge of the nose region, the upper lip region, the cheek region, the lower lip region, the chin region, the tip of the nose region, and / or the forehead region of the patient interface 3000. For example, it may be advantageous to provide the thinned regions 5008 in the cheek and chin regions of the full face mask while avoiding the bridge of the nose region of the seal-forming structure 3100.

[0206] 5C, the first thinned region 5008A is substantially symmetrical (e.g., a mirror image) to the second thinned region 5008B. The use of symmetrically positioned thinned regions 5008 can be advantageous to match the substantially symmetrical facial features of the patient 1000 in use.

[0207] The thinned region 5008 may be positioned anywhere on the cushion module 3150, but is desirably positioned within the seal-forming structure 3100, or if not, on the surface of the cushion module 3150 between the edge 5006 and the side wall 5002. In some examples, it may be advantageous to position the thinned region(s) 5008 adjacent to the edge 5006 of the seal-forming structure 3100, for example, between 1 mm and 15 mm from the edge 5006, for example, between 2 mm and 5 mm from the edge 5006.

[0208] In some examples of the technique, such as the example of Figure 5D, the thinned region 5008 may be provided as a continuous channel that extends circumferentially around the seal-forming structure 3100 and forms a closed loop on the seal-forming structure 3100. For example, the thinned region 5008 may follow the contour of the seal-forming surface of the cushion module 3150 circumferentially around the entire periphery of the seal-forming structure 3100.

[0209] The use of one or more thinned regions 5008 in the seal-forming structure 3100 can create fold points that can further reduce the amount of pressure transferred to the soft tissue of the patient's face. For example, the thinned region 5008 can act as a pivot point, allowing the section of the seal-forming surface between the opening 5004 and the thinned region 5008 to rotate around the thinned region 5008 more easily than would be possible without the thinned region.

[0210] The thinned region 5008 may have any suitable shape and may be located in any suitable region of the seal-forming structure 3100. For example, Figure 5E shows yet another example of a patient interface 3000 in which the thinned region 5008 is provided as a continuous channel or closed loop that is located more inward or closer to the edge 5006 of the seal-forming structure 3100 than the example of Figure 5D. For example, the thinned region 5008 in the example of Figure 5E is located within about 1 mm to about 5 mm of the edge 5006, while in the example of Figure 5D the thinned region 5008 is located within about 1 mm to about 15 mm of the edge 5006.

[0211] The thinned regions 5008 can be located on any suitable surface of the seal-forming structure 3100. In previous examples, the thinned regions 5008 were provided on the underside (e.g., non-patient contacting side 5010) of the patient-contacting surface 3100A or on the support layer 3100B. In contrast, Figure 5F shows an example of a technique in which the thinned regions 5008 are provided on the patient-contacting surface of the seal-forming structure 3100.

[0212] 5.3.13.1 Thin-walled profiles Figure 6A shows a cross-sectional profile of a seal-forming structure 3100 of a patient interface. Figures 6B-6E show various cross-sectional profiles of the seal-forming structure 3100 including a thinned region 5008 in accordance with the present technology. For example, the cross-sections of Figures 6B-6E may substantially correspond to the region marked with "A" in Figure 5B.

[0213] 6B, the thinned region 5008 is provided in the form of a channel or groove having a curved, arcuate, or substantially semicircular cross-sectional shape. In some examples of this technology, the semicircular cross-sectional shape may have a radius of curvature of about 1 mm to about 0.25 mm, e.g., about 0.65 mm to 0.45 mm, or about 0.55 mm.

[0214] Figure 6C shows a thinned region 5008 having a substantially triangular cross-sectional shape. The triangular cross-sectional shape need not be symmetrical and could include, for example, a sawtooth profile. Figure 6D shows a thinned region 5008 having a substantially trapezoidal cross-sectional shape, and Figure 6E shows a thinned region 5008 having a substantially rectangular cross-sectional shape.

[0215] In each example, the thickness T1 of the thinned region 5008 is less than the thickness of the adjacent sections T2 and T3, i.e., the thickness of the section of the seal-forming structure between the edge 5006 and the thinned region 5008 (T2), and the thickness between the side wall 5002 and the thinned region 5008 (T3).

[0216] It should be understood that thicknesses T1, T2, and T3 may vary around the periphery of the seal-forming structure 3100. For example, in the cheek or lateral nose regions, thickness T2 may be approximately 1 mm, while thickness T1 may be 0.5 mm. In contrast, in the bridge of the nose, upper lip, and / or chin regions of the seal-forming structure, thickness T2 may be approximately 0.5 mm, and thickness T1 may be substantially 0.25 mm. In examples of this technology, thickness T3 increases as it approaches and transitions to the side wall 5002. In some examples of this technology, thickness T3 is substantially equal to or slightly greater than thickness T2 when measured adjacent the thinned region 5008.

[0217] In some examples of this technology, the depth (T1) of the thinned region 5008 may vary up to 1 mm, for example, the thinned region 5008 may be thinner in areas such as the bridge of the nose region of the seal-forming structure 3100 and thicker in the side of the nose regions of the seal-forming structure 3100. For example, the thinned region 5008 may be between about 0.5 mm and about 0.2 mm in the bridge of the nose region of the seal-forming structure 3100 and between about 1 mm and about 0.5 mm in the side of the nose regions.

[0218] In some examples of this technology, the depth or thickness T1 of the thinned region 5008 in the chin or lower lip region may be greater than the depth or thickness of the thinned region 5008 in any one or more of the cheek region, upper lip region, alar region, side of the nose region, bridge of the nose or tip of the nose region of the seal-forming structure 3100. Providing a greater depth in the chin region of the seal-forming structure 3100 may advantageously facilitate material flow in this region during manufacturing and / or reduce flexibility of the seal-forming structure 3100 in this region.

[0219] In some examples of this technology, the depth or thickness T1 of the thinned regions 5008 in the alar regions of the seal-forming structure 3100 may be greater than the depth or thickness of the thinned regions 5008 in any one or more of the cheek regions, upper lip regions, chin or lower lip regions, side of the nose regions, bridge or tip of the nose regions of the seal-forming structure 3100. Providing a greater depth in the alar regions of the seal-forming structure 3100 may advantageously facilitate material flow in this region during manufacturing and / or reduce flexibility of the seal-forming structure 3100 in this region.

[0220] In each of the above examples, the thinned region 5008 of the seal-forming structure 3100 is located on the inner surface of the seal-forming structure, i.e., the non-patient-contacting side 5010 or plenum chamber side, making the change in thickness less noticeable to the patient 1000 than if the thinned region 5008 were located on the patient-contacting side 5013 of the seal-forming structure 3100.

[0221] In examples, the width of thinned region 5008 can have a thickness of about 1 mm or less, e.g., about 0.5 mm or less, e.g., about 0.1 mm. In some examples, the length of thinned region 5008 is at least 20 mm, more preferably at least 40 mm. In examples, the ratio of the length of thinned region 5008 to the width of thinned region 5008 is at least 20:1, e.g., at least 50:1, e.g., at least 100:1.

[0222] The ratio of the thickness of the thinned region 5008 to the thickness of its immediate neighbors may be 2:3 or less, such as 1:2 or less.

[0223] 5.3.13.2 Composite seal-forming structure In some forms of this technology, the seal-forming structure 3100 includes multiple layers, for example, a first layer of patient-contacting material and a second, support layer that does not contact the patient. For example, in Figure 5B, the support layer 3100B and the patient-contacting layer 3100A are both formed of a resilient material such as silicone.

[0224] In another form of technology, as shown in FIG. 7A , the seal-forming structure 3100 includes a first layer 3100A configured to engage and seal with the face of the patient 1000 during use, and a second layer 3100B configured to support at least a portion of the first layer 3100A during use, the first layer 3100A being attached to the second layer 3100B. In the example of FIG. 7A , the first layer 3100A is attached to the second layer 3100B along a portion of its length, i.e., along a radial direction extending radially outward from the opening 5004. For example, the first layer 3100A may be connected to the second layer such that at least 10% of the first layer is connected to the second layer 3100B; for example, in some forms, approximately 50% of the first layer may be connected to the second layer. In various examples, the first layer 3100A and the second layer 3100B may form a laminate.

[0225] In certain forms of technology, it may be advantageous to combine the composite multi-layer seal-forming structure 3100 with the thinned regions 5008 described herein. For example, the first layer 3100A may be attached to the second layer 3100B in an area proximate the thinned region 5008.

[0226] 7A, the seal-forming structure 3100 may include a first portion / layer 3100A made from a first material (e.g., a woven fabric), the first layer including at least one opening 5004 through which, in use, a flow of breathable gas is supplied to one or more airways of a patient. The seal-forming structure 3100 may further include a second portion / layer 3100B including a second material (e.g., silicone), the second portion 3100B being joined to the first portion 3100A, the second portion including at least one groove or channel 5008, the groove or channel 5008 being disposed generally parallel to (i.e., along a path extending in a generally parallel direction with) at least a portion of the periphery of the first material.

[0227] In another example, the seal-forming structure 3100 includes a first layer 3100A (sometimes referred to as a patient-contacting portion) comprising a first material (e.g., a fabric), the first material including a first side / patient-contacting side 5013 configured to engage the patient's face to provide a seal, and a second side / non-patient-contacting side 5010 opposite the first side / patient-contacting side 5013, or facing inward toward the plenum chamber. In some examples, the seal-forming structure 3100 further includes a second layer 3100B (sometimes referred to as a support portion) attached to the non-patient-contacting side 5010 of the patient-contacting portion 3100A, the support portion comprising a second material (e.g., silicone) different from the first material. In this example, the support portion is configured to support at least a portion of the patient contacting portion 3100A and includes at least one thin region 5008 having a thickness T1 that is thinner than the thickness of adjacent regions (T2 and / or T3) of the support portion 3100B, and the thin region 5008 is located along a path that is approximately parallel to the periphery of the first material.

[0228] In other words, the second layer 3100B (support portion) includes a first region (thin region 5008) and a second region (adjacent region T2), the first region being thinner than the second region, and the second region being closer to the edge 5006 of the seal-forming structure than the first region.

[0229] In certain forms, the first layer 3100A may be at least partially attached to the second layer 3100B by a molding process (e.g., insert molding or overmolding), adhesive, ultrasonic welding, stitching, or other suitable attachment mechanism such as hook and loop fasteners.

[0230] In one form of this technology, the first layer 3100A comprises a woven material and the second layer comprises a flexible material (eg, constructed from a soft, flexible, resilient material such as silicone or foam).

[0231] In some forms of this technology, the first layer 3100A may include a first region joined to the second layer 7002B and a second unsupported region 7002 that is substantially unsupported or not joined to the second layer 3100B. The use of the unsupported region 7002 may help prevent the second layer 3100B from contacting the patient's face during use. For example, some patients may find a woven material more comfortable or less of an allergy concern than a silicone material.

[0232] In some examples of the technique as shown in FIG. 7B, the thinned region 5008 may be provided with an arcuate profile having a radius of curvature of about 1 mm to about 0.25 mm, e.g., about 0.65 mm to 0.45 mm, or about 0.55 mm, and the arc extends at an angle of about 45 degrees to about 75 degrees, e.g., substantially 55 degrees.

[0233] In some examples, the thickness (T2) of the second layer 3100B adjacent the unsupported first layer 3100A can be greater than the thickness (T3) of the second layer 3100B on the opposite side of the thinned region 5008. In other words, the second layer of material can have a first thickness (T2) adjacent the opening 5004, e.g., within 5 mm of the opening 5004, a second thickness (T1) positioned a greater distance from the opening 5004 than the first thickness, e.g., within 10 mm of the opening 5004, and a third thickness (T3) positioned a greater distance from the opening 5004 than the second thickness, e.g., within 15 mm of the opening 5004.

[0234] In other words, the second layer may include a first thickness and a second thickness, where the first thickness is adjacent to the second region (unsupported region) of the first layer, the second thickness is adjacent to the first thickness and farther from the second region than the first thickness, and the first thickness is greater than the second thickness.

[0235] In some examples, increasing the thickness of the second layer 3100B adjacent the opening 5004 can be advantageous in reducing resistance to the flow of material within the injection molding tool; for example, as shown in FIG. 9A, if the injection point is located near the opening 5004, this region allows the material to flow around the opening 5004 and then through the region of reduced thickness 5008.

[0236] 5.3.13.3 Manufacturing of composite seal-forming structures 8A and 8B show an example of a composite patient interface 3000 having a first layer 3100A comprising a textile attached to a second layer 3100B comprising silicone. In this example, the seal-forming structure 3100 has an elongated profile and includes thinned regions 5008 that extend circumferentially around the seal-forming structure in the side and bridge regions of the nose. In this example, the top edge region of the seal-forming structure 3100 does not include thinned regions 5008.

[0237] 8A and 8B, the first layer 3100A is attached to the second layer 3100B by an injection molding process. For example, the first layer (a fabric) may be positioned within a cavity in a molding tool, and the second layer may be injection molded around the fabric layer. This process is well known to those skilled in the art and is known as insert molding or overmolding.

[0238] One of the challenges of using insert molding or overmolding processes to mold dissimilar materials is that the layer being insert molded or overmolded may shift within the tool. This can be particularly problematic when the material being insert molded is flexible, such as when using fabric or woven materials. For example, when fabric or woven materials are used, the forces imparted to the fabric or fabric by the flow of the thermoset / thermoplastic material (e.g., silicone) within the molding tool can cause the fabric to shift or become dislodged from its intended position.

[0239] In accordance with one form of the technology, a cushion module 3150 is provided that includes a first layer 3100A, such as a first textile layer, and a second layer 3100B, such as a silicone layer, where the textile layer is attached to the silicone layer during a molding process. In examples, the silicone layer is attached to the textile layer on a first side 5013 and has a thinned region 5008 on an opposite second / non-patient-contacting side 5010 of the textile layer.

[0240] The thinned regions 5008 can have the advantage of restricting flow within the injection molding tool, thereby directing the flow of the thermoset / thermoplastic material and minimizing the forces acting on the fabric to move it within the tool.

[0241] 9A-9C illustrate various forms of techniques by which the cushion module 3150 can be molded to include a thinned region 5008. For clarity, the first layer 3100A is not shown in these figures. In each of these examples, the sprue 9002 is shown by way of example only. It should be understood that the sprue 9002 is removed after fabrication and serves as a channel for providing material to be molded within the injection molding tool.

[0242] In the illustrated example, the sprue 9002 is located on the patient-contacting surface 3100A between the opening 5004 and the thinned region 5008. In this manner, the injection-molded material is configured to flow radially outward of the opening 5004 through the patient-contacting portion of the seal-forming structure 3100. Because the sprue 9002 is located on either side of the seal-forming structure 3100, the forces exerted by the flowing injection-molded material are substantially equal and opposite, thereby preventing distortion or displacement of the fabric layer 3100A (not shown for clarity, but which in use will be at least partially attached to the second layer 3100B).

[0243] The thinned region 5008 may be formed by any suitable shape within the tool and can act as a flow restrictor or dam that encourages the injected material to move around the periphery of the seal-forming structure rather than continuing to flow radially outward. This allows for a continuous connection between the first layer 3100A and the second layer 3100B before other areas of the seal-forming structure 3100 are molded. One potential advantage of this approach is that it encourages the injection-molded material to first fill the thin, patient-contacting areas of the seal-forming structure 3100, securing the first layer 3100A to the second layer 3100B. This prevents a situation in which the injection-molded material first fills the thicker parts of the seal-forming structure 3100 and then backfills the thinner areas of the seal-forming structure, potentially causing displacement of the first layer 3100A.

[0244] Another potential benefit of the thinned regions 5008 is that they increase the pressure and therefore the force holding the fabric against the cavity of the inserted tool.

[0245] The amount of flow restriction provided by the thinned region 5008 is a function of the width and depth of the thinned region 5008. For example, in the example of FIG. 9A, the width of the channel is fairly constant, approximately 0.1 mm to 0.2 mm. In FIG. 9B, the thinned region 5008 is larger, e.g., 0.2 mm to 0.5 mm, in the nasal region (for a nasal patient interface) or buccal region (for a full-face patient interface). Adjusting the depth and thickness of the thinned region 5008 can control the flow of material within the tool to reduce potential clumping or displacement of the first layer 3100A material. Similarly, the depth of the thinned region 5008 can be adjusted to achieve desired flow characteristics. For example, the depth of the thinned region 5008 is 0.1 to 0.3 mm.

[0246] Thinned regions 5008 can also be used to influence the end of fill location within the molded part, control the location of weld lines, and improve features such as overflow location.

[0247] Those skilled in the art should be familiar with simulation software capable of performing flow simulations, such as Autodesk® Moldflow®.

[0248] 5.3.14 Composite cushion module structure 10A-10F show a cushion module 3150 according to an example of the present technology. In this example, the cushion module 3150 includes a chassis portion 3210 and a seal-forming structure 3100. The chassis portion 3210 and the seal-forming structure 3100 form a cushion module 3150 having certain features according to the present technology described herein. It is understood that such features may be applied to the cushion of the patient interface 3000 regardless of whether the cushion is attached to the chassis portion 3210. In some examples, the seal-forming structure 3100 may form the entire cushion, for example, when the seal-forming structure 3100 is attached to and supported by a shell. Thus, it is understood that features described herein as features of the cushion may also apply to the seal-forming structure 3100 (and vice versa). Similarly, while features may be described as features of the cushion module 3150, they shall be understood to be applicable to the cushion regardless of whether the cushion is part of a removable / separable cushion module 3150. In some examples, the cushion module 3150 may be inseparable from other components of the patient interface 3000.

[0249] The cushion module 3150 shown in Figures 10A-10F forms part of the patient interface 3000 (shown in Figure 16B). The patient interface 3000 includes a plenum chamber 3200 pressurizable to a therapeutic pressure of at least 6 cmH2O above ambient air pressure, the plenum chamber 3200 including at least one plenum chamber inlet port sized and configured to receive a flow of air at the therapeutic pressure for breathing by the patient 1000. In this example, the cushion module 3150 is hollow, defining the plenum chamber 3200 within its hollow interior. The patient interface 3000 further includes a seal-forming structure 3100 constructed and arranged to form a seal with an area of ​​the patient's face surrounding an entrance to the patient's airway, the seal-forming structure having at least one opening 5004 so that the flow of air at the therapeutic pressure can be delivered to at least the entrance of the patient's nares. The seal-forming structure 3100 may be constructed and arranged to maintain said therapeutic pressure within the plenum chamber throughout the patient's respiratory cycle in use. The patient interface 3000 further includes a vent 3400 for allowing gases exhaled by the patient 1000 to flow from the interior of the plenum chamber to the ambient, the vent being sized and shaped to maintain therapeutic pressure within the plenum chamber in use. In the example shown in Figures 10A-10F, the chassis portion 3210 and the seal-forming structure 3100 of the cushion module 3150 together form the plenum chamber 3200, the seal-forming structure 3100 being part of the cushion module 3150 and described in more detail below, and the vent 3400 being provided by a vent module 3410 (shown in Figure 15) that can be attached to the chassis portion 3210 within the front hole 3215.

[0250] The chassis portion 3210 in this example includes a pair of outer protruding connection portions 3212, each defining a plenum chamber inlet port and each configured to connect to a respective one of a pair of gas delivery tubes 3350. The plenum chamber inlet ports are openings at the ends of the outer protruding connection portions 3212. Furthermore, in this example, the cushion module 3150 includes a connector 3214 for releasably fluidly connecting to the gas delivery tubes 3350. In the example shown in FIG. 16B , the patient interface 3000 includes a pair of gas delivery tubes 3350 forming part of a positioning and stabilizing structure 3300 configured to provide a force that holds the seal-forming structure 3100 in a therapeutically effective position on the patient's head, and each gas delivery tube 3350 is configured to transmit air flow from a position above the patient's head to the plenum chamber 3200 in use. As shown in FIG. 16B , the patient interface 3000 includes a connection port 3600 at the top of the patient's head for connection to an air circuit 4170 connected to the RPT device 4000.

[0251] In other examples, the patient interface 3000 does not include a gas delivery tube 3350, but instead includes a positioning and stabilizing structure 3300 that includes headgear straps that hold the seal-forming structure 3100 in a sealing position on the patient's face. In such a configuration, the outer protruding connection portion 3212 may receive a flow of air or breathable gas from a tube extending downward from the patient interface 3000 or from a tube extending upward and attached to the headgear strap of the positioning and stabilizing structure 3300. Alternatively, the cushion module 3150 does not have an outer protruding connection portion 3212, and instead the patient interface 3000 may include a connection port 3600 in a forward location, such as the location of the vent module 3410. In such a configuration, the connection port 3600 and vent 3400 can be provided by the same component. FIG. 16D illustrates various possible configurations of a patient interface 3000 to which aspects of the present technology can be applied.

[0252] By way of example, the patient interface 3000, in particular the cushion module 3150, the chassis portion 3210, the outer protruding connection portion 3212, the connector 3214, the vent module 3410, the positioning and stabilizing structure 3300, may include one or more features described in WO2021 / 012005 (the entire contents of which are incorporated herein by reference).

[0253] In the examples shown in FIGS. 10A-10F and 17A-17E, the seal-forming structure 3100 includes a first layer 3100A on the rear side of the seal-forming structure 3100, which is configured to seal around the entrance to the patient's airway, including at least a partially downward-facing portion of the patient's nasal tip, the ala of the nose, and the upper lip of the patient's face during use. In the example shown in FIGS. 10A-10F, the first layer 3100A seals against the upper lip from one lateral side to the other lateral side across the midsagittal plane. FIGS. 17A-17E show a similar example. In other examples, the first layer 3100A may seal against the upper lip by sealing only the lateral portion of the upper lip. The seal-forming structure 3100 in the examples shown in FIGS. 10A-10F and 17A-17E further includes a second layer 3100B connected to the first layer 3100A. In these examples, the first layer 3100A is formed of a woven material. In these examples, the second layer 3100B is formed of an elastomeric material. In examples, the elastomeric material may be silicone or a thermoplastic elastomer (TPE). The seal-forming structure 3100 may take any form disclosed herein and may be formed of any material or combination of materials disclosed herein.

[0254] 5.3.14.1 Lap joints The second layer 3100B of the seal-forming structure 3100 may include an overlapping portion 3102 that overlaps the first layer 3100A of the seal-forming structure and form a lap joint with the first layer 3100A around the periphery of the first layer 3100A, such as around the entire periphery of the first layer 3100A, around a majority of the periphery of the first layer 3100A, or around at least a portion of the periphery of the first layer 3100A.

[0255] The lap seam may be in the form of an overlap between the first layer 3100A and the second layer 3100B, as shown in FIG. 7 or 8B, for example. FIGS. 11A and 11B show the cushion module 3150 with the first layer 3100A removed to show the features of the second layer 3100B, particularly the overlapping portion 3102 of the second layer 3100B. As shown in FIGS. 11A and 11B, the overlapping portion 3102 of the second layer 3100B of the seal-forming structure extends inwardly relative to the perimeter of the first layer 3100A from the non-overlapping portion 3104 of the second layer 3100B. In FIGS. 11A and 11B, the overlapping portion 3102 is shown with lighter hatching, and the non-overlapping portion 3104 is shown with darker hatching, for clarity. The overlapping portion 3102 of the second layer 3100B can also be described as extending inward relative to the outer periphery of the seal-forming structure 3100, or extending inward toward the center of the cushion module 3150, or extending inward toward one or more holes provided in the first layer 3100A to provide air flow to the patient's airway.

[0256] 5.3.14.1.1 Lap joint width 11A-11B and 13A-13D, the overlapping portion 3102 can include a width W that varies along the periphery of the overlapping portion 3102 of the first layer 3100A. The width W can be defined by the amount of inward extension of the overlapping portion 3102 from the non-overlapping portion 3104 of the second layer 3100B. Thus, the width W is also the lateral dimension of the overlapping portion 3102 relative to the length of the overlapping portion 3102 along the path around the periphery of the first layer 3100A or along the inner periphery of the non-overlapping portion 3104. The width W of the overlapping portion 3102 at a location on the overlapping portion 3102 can also be described as the distance between the inner edge of the overlapping portion 3102 and the outer edge of the overlapping portion 3102 that coincides with the inner edge of the non-overlapping portion 3104. The width W is displayed in FIGS. 13B and 13D.

[0257] As shown in particular in FIGS. 11A-11B, 13A-13D, and 17D, the overlapping portion 3102 may include a pair of outer nasal portions 3106. The width W of the overlapping portion 3102 may be greater in the outer nasal portion 3106 than in one or more other portions of the overlapping portion 3102. A greater width W of the outer nasal portion 3106 may be advantageous in providing a stronger connection between the first layer 3100A and the second layer 3100B. The width W of the overlapping portion 3102 may be greater in the outer nasal portion 3106 than in an upper portion 3107 of the overlapping portion 3102. For example, as can be seen by comparing FIGS. 13B and 13D, the width W of the outer nasal portion 3106 shown in FIG. 13B is greater than the width W of the upper portion 3107 shown in FIG. 13D. The increased width W of the outer nasal portion 3106 also increases the stiffness of the seal-forming structure 3100 compared to the stiffness of the first layer 3100A alone, which may advantageously prevent wrinkles from forming and spreading laterally along the seal-forming structure 3100 beyond the patient's ala during use.

[0258] A smaller width W of the upper portion 3107 of the overlapping portion 3102 may advantageously reduce the overall stiffness of the seal-forming structure 3100 in the area that seals below and / or partially in front of the patient's nasal tip. This area of ​​the patient's face may be somewhat sensitive, and a smaller width of the overlapping portion 3102 may reduce pressure on this area of ​​the patient's face and increase patient comfort during use. In some examples, the overlapping portion 3102 is at least twice as wide at the outer nasal portion 3106 as the upper portion 3107. In some examples, the overlapping portion 3102 is 1 1 / 4, 1 1 / 2, 1 3 / 4, 2, 2 1 / 4, 2 1 / 2, 2 3 / 4, or 3 or more times wider at the outer nasal portion 3106 than the upper portion 3107.

[0259] The width W of the overlapping portion 3102 may be greater at the outer nasal portion 3106 than at the lower portion 3108 of the overlapping portion 3102. A smaller width W of the lower portion 3108 of the overlapping portion 3102 may advantageously reduce the overall stiffness of the seal-forming structure 3100 in the area that fits against the patient's upper lip (upper lip portion 3116). This area of ​​the patient's face may be somewhat sensitive, and a smaller width W of the overlapping portion 3102 may reduce pressure on this area of ​​the patient's face, increasing patient comfort during use. In some examples, the overlapping portion 3102 may be at least 5 times, or at least 10 times, wider at the outer nasal portion 3106 than at the lower portion 3108. In some examples, the overlapping portion 3102 may be 4, 6, 8, 10, 12, 14, 16, 18, or 20 times wider at the outer nasal portion 3106 than at the lower portion 3108. 10A-10F and 11A-11B, the lower portion 3108 of the overlap portion 3102 is so small compared to the outer nose portion 3106 that it is not discernible in the views shown in FIGS. 11A-11B. The small overlap between the first layer 3100A and the second layer 3100B provides strength for the lap joint while maintaining a low overall stiffness for the seal-forming structure 3100. Additionally, as shown in FIGS. 11A and 11B, the width W of the overlap portion 3102 is greater at the upper portion 3107 than at the lower portion 3108 of the overlap portion 3102.

[0260] In some examples of the present technology, there may be no overlap portion 3102 on the upper lip of the seal-forming structure 3100, and the connection between the first layer 3100A and the second layer 3100B may be a butt joint between the two layers, which may have the advantage of further reducing pressure on the patient's upper lip during use.

[0261] In some examples of the present technology, the overlapping portion 3102 also includes a pair of medial-lateral lower portions 3109 disposed outside each of the lower portions 3108 of the overlapping portion 3102 and disposed inside the lateral nasal portion 3106 of the overlapping portion 3102. The width W of the overlapping portion 3102 may be greater in the lateral nasal portion 3106 than in the medial-lateral lower portion 3109. This is shown, for example, in FIGS. 11A-11B. In some examples, the overlapping portion 3102 is at least 1.5 times wider in the lateral nasal portion 3106 than the medial-lateral lower portion 3109. In some examples, the overlapping portion 3102 is at least 1 3 / 42, 2 1 / 4, 2 1 / 2, 2 3 / 4, or 3 times wider in the lateral nasal portion 3106 than the medial-lateral lower portion 3109. For example, as shown in FIGS. 11A and 11B, the width W of overlapping portion 3102 is greater in medial-lateral lower portion 3109 than in lower portion 3108 of overlapping portion 3102.

[0262] In other examples, the medial-lateral lower portion 3109 may not be present and the lateral nasal portion 3106 may be directly adjacent to the lower portion 3108 across the upper lip 3116 of the seal-forming structure 3100, or the medial-lateral lower portion 3109 or the lower portion 3108 may not be present.

[0263] In the example shown in FIGS. 17A-17E, the seal-forming structure 3100 includes a nasal portion configured to provide airflow to the entrances of the patient's nostrils during use. In this example, the overlapping portion 3102 includes a pair of outer upper lip portions 3124 that are disposed on the outside of each of the patient's upper lips during use. As shown in particular in FIG. 17D, the width of the overlapping portion 3102 is greater at the outer upper lip portion 3124 than at the outer nasal portion 3106. The width of the overlapping portion 3102 may be sufficiently wide at the outer upper lip portion 3124 to provide good support and / or a robust seal near the inferior corners / apex of the patient's nose, an area prone to leaks. For example, the overlapping portion 3102 may be at least 1.5 times wider at the outer upper lip portion 3124 than at the outer nasal portion 3106. As shown in FIG. 17D, the outer upper lip portion 3124 extends inward from the non-overlapping portion 3104 of the second layer 3100B relative to the periphery of the first layer 3100A. Each outer upper lip portion 3124 includes an inner edge that is positioned proximate to and below a respective alar crest point on the patient's face. This may be advantageous in that the portion of the first layer 3100A that seals against the inner portion of the patient's upper lip is more flexible, which may provide a good level of comfort during use, as the inner portion of the patient's upper lip may be a sensitive area. For example, as shown in FIG. 17D , the width of the overlapping portion 3102 tapers between the outer upper lip portion 3124 and the outer nose portion 3106.

[0264] 17D , in some examples, the overlapping portion 3102 includes a pair of nasolabial portions 3120, each positioned outside a respective one of the outer upper lip portions 3124, and the width of the overlapping portion 3102 is greater at the outer upper lip portion 3124 than at the nasolabial portions 3120. Additionally or alternatively, the width of the overlapping portion 3102 may be greater at the outer nasolabial portion 3106 than at the nasolabial portions 3120.

[0265] 17D , the overlapping portion 3102 includes a pair of cheek portions 3130, and the width of the overlapping portion 3102 is greater at the outer upper lip portion 3124 than at the cheek portions 3130. The overlapping portion 3102 in this example also includes a lower lip portion 3122, and the width of the overlapping portion 3102 is greater at the outer upper lip portion 3124 than at the lower lip portion 3122. In some examples, the width of the overlapping portion 3102 may be greatest at the outer upper lip portion 3124.

[0266] 11B and 17D , the overlapping portion 3102 may narrow (e.g., the width W may decrease) at the lateral nasal portion 3106 toward the upper portion 3107. The width of the lateral nasal portion 3106 may taper toward the upper portion 3107 of the overlapping portion 3102. In some forms of the present technology, the width W varies gradually rather than discretely between different portions of the overlapping portion 3102. The overlapping portion 3102 may have an inner edge that generally follows the shape of the boundary between the overlapping portion 3102 and the non-overlapping portion 3104, but may deviate in some locations to accommodate changes in the width W of the overlapping portion 3102. The overlapping portion 3102 may include rounded corners between the lateral nasal portion 3106 and the upper portion 3107 and / or between the lateral nasal portion 3106 and the mediolateral lower portion 3109. In some examples, the overlapping portion 3102 can have rounded corners between the inferior portion 3108 and the lateral nasal portion 3106, or, if present, between the mediolateral inferior portion 3109 and the inferior portion 3108.

[0267] 5.3.14.1.2 Overlapping and Non-Overlapping Profiles Figures 13A-13D show cross sections of overlapping portion 3102 and non-overlapping portion 3104 of second layer 3100B. First layer 3100A is not shown in Figures 13A-13D. Figure 13B shows second layer 3100B at outer nose portion 3106 of overlapping portion 3102, and Figure 13D shows second layer 3100B at upper portion 3107 of overlapping portion 3102.

[0268] 13B and 13D , respectively, the overlapping portion 3102 of the second layer 3100B includes an outer surface 3103 to which the first layer 3100A is connected, and the outer surface 3103 of the overlapping portion 3102 is offset from and farther away than the outer surface 3105 of the non-overlapping portion 3104. In other words, the outer surface 3105 of the non-overlapping portion 3104 is offset from and protrudes from the outer surface 3103 of the overlapping portion 3102. When the first layer 3100A is attached to the second layer 3100B, the patient-facing surface of the first layer 3100A can be flush with the outer surface 3105 of the non-overlapping portion 3104 of the second layer 3100B. The offset between the outer surfaces 3103 and 3105 allows the first layer 3100A, when attached, to be flush with the outer surface 3105 of the non-overlapping portion 3104. This allows the patient-facing surface of the seal-forming structure 3100 to be substantially continuous in shape, advantageously avoiding facial marks and uncomfortable contact points during use that may occur if there is a step between the surfaces. The offset between the outer surfaces 3103 and 3105 may be substantially equal to the thickness of the first layer 3100A, so that when the first layer 3100A is attached to the second layer 3100B, the patient-facing surface 3101 of the first layer 3100A may be flush with the outer surface 3105 of the non-overlapping portion 3104 of the second layer 3100B. In some examples, the offset between outer surfaces 3103 and 3105 is less than the thickness of the first layer 3100A, and the first layer 3100A is compressed at the lap seam, so that the outer surfaces 3103 and 3105 are substantially flush after attachment. The first layer 3100A and the second layer 3100B may be attached by adhesive or by a molding operation in which the second layer 3100B is overmolded onto the first layer 3100A, but these are just examples. In either case, compression of the first layer 3100A may occur during the attachment step.

[0269] The overlapping portion 3102 of the second layer 3100B of the seal-forming structure 3100 may be thinner than the non-overlapping portion 3104 of the second layer 3100B in one or more locations, for example, at the outer nose portion 3106 of the overlapping portion 3102. This can facilitate an offset between the outer surfaces 3103 and 3105, as shown, for example, in FIG. 13B. As shown in FIG. 13B, the inner surface of the second layer 3100B is continuous, but the outer surface includes a step that forms the outer surface 3103 of the overlapping portion 3102 and the outer surface 3105 of the non-overlapping portion 3104 and the offset therebetween.

[0270] The upper portion 3107 of the overlapping portion 3102 is stepped outward from the second layer 3100B, with the outer surfaces 3103 and 3105 offset similarly to the outer nose portion 3106. However, the upper portion 3107 of the overlapping portion 3102 is adjacent the central front portion 3115 of the seal-forming structure 3100 and is thinner than the outer nose portion 3106 of the seal-forming structure 3100. The upper portion 3107 has a portion that is thinner than the non-overlapping portion 3104, i.e., the thinned region 5008, and also has a portion that is thicker than the non-overlapping portion 3104, i.e., the portions on either side of the cross section of the thinned region 5008, which can advantageously help to form a strong bond between the first layer 3100A and the second layer 3100B.

[0271] 5.3.14.2 Parts of the seal-forming structure 10A-10F, 12A-12E, and 14A-14G, the seal-forming structure 3100 may include a variety of different portions, certain portions of which are described below, and other portions of which are as described in WO2021 / 012005.

[0272] The seal-forming structure 3100 may include a central portion 3111. The central portion 3111 may be configured to contact most or all of the patient's face and seal against at least a partially downward-facing portion of the patient's nasal tip, the ala of the nose, and the upper lip of the patient's face during use. In the examples shown in FIGS. 10A-10F, 12A-12E, and 14A-14G, most or all of the central portion 3111 may be formed by the first layer 3100A of the seal-forming structure 3100. The central portion 3111 is formed of a woven material in these examples, but may be formed of an elastomer or other suitable material in other examples. The central portion 3111 may be on a patient-facing wall of the seal-forming structure 3100. The patient interface 3000 may further include a second layer 3100B connected around the periphery of the first layer 3100A and supporting the first layer 3100A. The second layer 3100B may form a forward-facing wall of the seal-forming structure 3100. The second layer 3100B may be formed of an elastomeric material such as silicone or TPE. The second layer 3100B may include an overlapping portion 3102 that forms a lap seam with the first layer 3100A, as described above. The second layer 3100B may additionally or alternatively include a thinned region 5008, substantially as described above.

[0273] The seal-forming structure 3100 further includes a central front portion 3115 that is positioned inferiorly and proximate to the patient's nasal tip in use and may be within a forward-facing wall of the seal-forming structure 3100. FIGS. 10A, 12B, 12E, and 14C illustrate the central front portion 3115, which may be positioned in the center of the front wall of the seal-forming structure 3100 and intersect the sagittal plane of the patient's head in use. The central front portion 3115 may be positioned at least partially within a wall that faces away from the patient, e.g., a forward-facing wall generally away from the patient's face. The central front portion 3115 may have a lower boundary that coincides with the upper boundary of the chassis portion 3210. The central front portion 3115 may be adjacent to the upper portion of the chassis portion. The thickness of the central front portion 3115 may be 0.2 to 0.5 mm, e.g., 0.25 to 0.4 mm, e.g., 0.25 mm or 0.3 mm. The thin thickness of the central front portion 3115 may avoid placing excessive pressure on the user's nose tip area (which may be a sensitive area) during use, and may therefore advantageously provide a good level of comfort during use.

[0274] The seal-forming structure 3100 may further include a pair of medial-lateral anterior portions 3125 of forward-facing walls positioned on respective outer sides of the central anterior portion 3115. Each of the medial-lateral anterior portions 3125 may have a higher stiffness overall than the central anterior portion 3115. The central anterior portion 3115 may be formed with a thinner wall thickness than the other portions to keep pressure on the nasal tip low, but the medial-lateral anterior portion 3125 may be stiffer than the central anterior portion 3115 to provide more support to the central portion 3111, e.g., the first layer 3100A in the illustrated example.

[0275] Each of the mediolateral anterior portions 3125 may include an upper portion 3126 and a lower portion 3127. The lower portion 3127 may be less rigid than the upper portion 3126. The lower portion 3127 of the mediolateral anterior portion 3125 may be less rigid than the upper portion 3126, allowing for greater deformation of the anterior wall of the lower portion 3127 and reducing pressure on the side of the patient's nose during use. A thinner material may provide lower rigidity. FIGS. 12C and 12D show cross-sectional views of the mediolateral anterior portions 3125, illustrating in this example that the thickness of the lower portion 3127 of each mediolateral anterior portion 3125 is thinner than the thickness of the upper portion 3126 of the mediolateral anterior portion 3125. In FIGS. 12A, 12B, and 12E, the lower portion 3127 of the mediolateral anterior portion 3125 is highlighted, showing its location, shape, and dimensions. The location of the upper portion 3126 is also shown. In some examples, the thickness of the upper portion 3126 of the mediolateral anterior portion 3125 can be, for example, 0.7 to 1.3 mm, 0.8 to 1.2 mm, or 0.85 to 1.1 mm. In some examples, the thickness of the lower portion 3127 of the mediolateral anterior portion 3125 can be, for example, 0.3 to 0.7 mm, 0.4 to 0.6 mm, or 0.5 mm.

[0276] The lower portion 3127 of each medial lateral anterior portion 3125 may be stiffer than the central anterior portion 3115. This stiffness can be achieved by increasing the thickness of the material, such that the lower portion 3127 of each medial lateral anterior portion 3215 can be thicker than the central anterior portion 3115. Accordingly, the upper portion 3126 of each medial lateral anterior portion 3125 will also be thicker than the central anterior portion 3115 because the upper portion 3126 is thicker than the lower portion 3127.

[0277] The seal-forming structure 3100 may further include a pair of outer rear regions 3141. The outer rear regions 3141 may be provided on respective outer rear sides of the seal-forming structure 3100. Each outer rear region 3141 may extend rearward from the chassis portion 3210 and curve inward to contact the patient's face in use. In particular, as shown in FIGS. 10C, 10D, etc., each outer rear region 3141 may curve inward to form a respective one of a pair of rear corners 3131 of the seal-forming structure 3100. The rear corners 3131 may be configured to engage the patient's face proximate each of the patient's nasolabial folds in use. The outer rear regions 3141 may be the same thickness as or thicker than the medial-lateral anterior portion 3215, for example, the same thickness as or thicker than the upper portion 3126 of the medial-lateral anterior portion 3215.

[0278] The seal-forming structure 3100 may also include an upper lip 3116, as shown, for example, in FIGS. 10D, 10F, and 12B. The upper lip 3116 may include a rear portion 3133 configured to seal against the patient's upper lip during use. The upper lip 3116 may further include a front portion 3134 adjacent the chassis portion and having greater stiffness than the rear portion. The greater stiffness may be provided by a greater thickness. For example, as shown in FIGS. 12B and 12C, the front portion 3134 of the upper lip 3116 is thicker than the rear portion 3133. This arrangement may have the advantage that the thinner rear portion 3133 may be free to deform and form a good seal with the patient's upper lip, while the thicker front portion 3134 may provide good support to maintain the shape of the seal-forming structure 3100. The rear corners 3131 and / or outer rear region 3141 may be thicker than the rear portion 3133 of the upper lip 3116, or may be the same thickness as, for example, the front portion 3134 of the upper lip 3116. The rear corners 3131 and / or outer rear region 3141 may be relatively stiff and / or thick to help support the cushion module 3150 on the patient's face.

[0279] 14A-14G show a cushion module 3150 in accordance with another example of the present technology, which may be particularly suitable for patients with wide noses.

[0280] In this example, as shown in FIG. 14C, the central front portion includes a lower portion 3114 and an upper portion 3113. The lower portion 3114 may be stiffer than the upper portion 3113. As shown in FIG. 14C, greater stiffness may be achieved by increasing the thickness of the material. In some examples, the thickness of the upper portion 3113 may be 0.2-0.4 mm or 0.2-0.3 mm, e.g., 0.25 mm. In some examples, the thickness of the lower portion 3114 may be 0.3-0.8 mm, 0.4-0.7 mm, 0.45-0.6 mm, e.g., 0.5 mm. In this arrangement, the lower portion 3114 may be thick to provide good support for the central front portion 3115, while the upper portion 3113 may be thin to conform to the user's nasal tip (or at least the underside and / or partial underside thereof). Another feature of this example of the present technology is that the height of the lower portion 3114 of the central front portion 3115 is greater on the lateral side of the central front portion 3115 than on the medial side of the central front portion 3115. FIG. 14F shows the medial side of the forward-facing wall of the seal-forming structure 3100, with various portions highlighted including the lower portion 3114 and upper portion 3113 of the central front portion 3115. As shown, the boundary between the lower portion 3114 and upper portion 3113 curves upward toward the lateral side of the central front portion 3115. The lower portion 3114 may occupy a greater portion of the central front portion 3115 on the lateral side than on the medial side of the central front portion 3115.

[0281] 14A-14G, the seal-forming structure 3100 may further include a pair of medial medial lateral anterior portions 3128 disposed on each outer side of the central anterior portion 3115. In FIG. 14F, these portions are highlighted with a darker shade than the lower portion 3114 of the central anterior portion and the upper portion 3113 of the central anterior portion 3115. The medial medial lateral portions 3128 may be stiffer and / or thicker than the central anterior portion 3115. For example, the medial medial lateral portion 3128 may be thicker than the lower portion 3114 and / or upper portion 3113 of the central anterior portion. In some examples, the thickness of the medial medial lateral portion 3128 may be greater than 0.5 mm, such as between 0.5 mm and 0.8 mm, between 0.5 mm and 0.7 mm, or between 0.5 mm and 0.65 mm. The inner medial-lateral portion 3128 is thicker than the central anterior portion 3115 and may provide structural rigidity to the seal-forming structure 3100, while the central anterior portion 3115 is thinner and may easily fit under the front of the patient's nose and prevent excessive pressure being placed under the front of the nose.

[0282] The seal-forming structure 3100 may further include a pair of outer medial-lateral anterior portions 3129 disposed on respective outer sides of the medial-medial portion 3128. FIG. 14G illustrates the location of the outer medial-lateral anterior portion 3129 on one side of the cushion module 3150, which in this example is highlighted with a darker shade than the medial-medial anterior portion 3128 adjacent to the inner side of the outer medial-lateral anterior portion 3129. The outer medial-lateral anterior portion 3129 may be stiffer and / or thicker than the medial-medial anterior portion 3128. In some examples, the outer medial-lateral anterior portion 3129 may have a thickness of 0.8 to 1.5 mm, e.g., 0.9 to 1.4 mm or 1 to 1.3 mm. The lateral medial-lateral anterior portion 3129 being thicker than the medial medial-lateral anterior portion 3128 and / or the central anterior portion 3115 may provide additional structural rigidity to the seal-forming structure 3100, while the more medial portions may be thinner, reducing pressure on the nose near the tip, which may be more sensitive than other parts of the nose.

[0283] 14C, 14D, and 14E show thickness profiles of the central anterior portion 3115, the medial medial lateral anterior portion 3128, and the lateral medial lateral anterior portion 3129, respectively. As shown, the medial medial lateral anterior portion 3128 is thicker than the central anterior portion 3115 but thinner than the chassis portion 3210. The lateral medial lateral anterior portion 3129 is thicker than the medial medial lateral anterior portion 3128 and is about the same thickness as the chassis portion 3210. In some examples, the lateral medial lateral anterior portion 3129 has substantially the same thickness as an outer posterior region 3141, which may be adjacent to the lateral posterior of the lateral medial lateral anterior portion 3129. In other examples, the outer posterior region 3141 may be even thicker than the lateral medial lateral anterior portion 3129.

[0284] 5.3.14.3 Nose and mouth cushion 17A-17E, the cushion module 3150 is a nasal-oral cushion module, i.e., configured to deliver a flow of breathable gas to the mouth and nares of the patient 1000. In the illustrated example, the cushion module 3150 includes a seal-forming structure 3100 configured to form a seal around the mouth and nares of the patient 1000.

[0285] In the illustrated example, the forming structure 3100 includes a first layer 3100A made from a woven material and a second layer 3100B made from an elastomeric material. In examples, the elastomeric material may be silicone or a thermoplastic elastomer (TPE). The seal-forming structure 3100 may take any form disclosed herein and may be formed from any material or combination of materials disclosed herein.

[0286] The first layer 3100A includes an oral opening 5004A configured, in use, to communicate a flow of breathable gas to the oral airways of the patient 1000, and one or more nasal opening(s) 5004B configured, in use, to communicate a flow of breathable gas to the nasal airways of the patient 1000. In the example of Figures 17A-17D, two nostrils 5004B are provided, although in other examples this may be a single nostril 3100B, or multiple smaller nostrils.

[0287] In examples including two or more nostrils 5004B, it may be advantageous for the nostrils 5004B to be connected by a bridge 17002 between each nostril 5004B. For example, the bridge may be formed of the first layer 3100A of textile material and configured to provide additional support to the first layer 3100A below the nose region.

[0288] The first layer 3100A is comprised of a continuous portion of material that surrounds the oral opening 5004A and is configured, in use, to seal around the mouth of the patient 1000. In the illustrated example, the first layer 3100A includes an upper lip region configured, in use, to seal above or above the patient's 1000's upper lip and below the patient's 1000's nose, a lower lip region configured, in use, to seal above or below the patient's 1000's lower lip, and corresponding side regions of the mouth connecting the upper and lower lip regions (e.g., the side regions of the mouth may be configured to engage the patient's 1000's lips and / or cheeks in use).

[0289] The first layer 3100A is further configured to provide a continuous portion of material that surrounds one or more nostrils 5004B. For example, the first layer 3100A may be configured to engage and seal with any one or more of the upper lip area, alar, nostril entrances, columella, maxilla, and / or nasal tip. In some examples (not shown), the first layer 3100A may also include one or more nasal prongs configured to enter the patient's 1000 nostrils in use and engage the inner walls of the nostrils as needed.

[0290] In the illustrated example, the first layer 3100A is provided as a single continuous section of material that surrounds both the nasal opening 5004B and the oral opening 5004A. In other examples of this technology (not shown), a single opening 5004 may be provided that, in use, provides an air passageway to both the oral cavity and nose of the patient 1000. In other words, in some examples of this technology, the first layer 3100A may be configured so as not to seal against the upper lip area of ​​the patient 1000 in use.

[0291] The use of a continuous section of material herein should be understood to refer to material extracted from a single sheet of material and not requiring or including joints to connect the sections of material. The use of one or more continuous sections of material may, in some cases, improve the comfort of the patient 1000 and also help maintain an airtight seal against the patient's face, for example, by reducing pressure points and / or air leaks caused by material joints.

[0292] 17D shows an example of a nose-mouth cushion module 3150 with the first layer 3100A removed. In this example, it can be seen that the second layer 3100B of the seal-forming structure 3100 includes an overlapping portion 3102 that overlaps the first layer 3100A of the seal-forming structure, forming a lap seam with the first layer 3100A. In the example shown, this lap seam is located around the periphery of the first layer 3100A, e.g., the entire periphery of the first layer 3100A, although it should be understood that in other examples (not shown), the lap seam may be located around a majority of the periphery of the first layer 3100A excluding the lower lip or chin area, or around at least a portion of the periphery of the first layer 3100A, such as only the nose area of ​​the seal-forming structure 3100.

[0293] The overlapping portion 3102 of the second layer 3100B of the seal-forming structure extends inwardly from the non-overlapping portion 3104 of the second layer 3100B to the periphery of the first layer 3100A. The overlapping portion 3102 of the second layer 3100B may also be described as extending inwardly to the periphery of the seal-forming structure 3100, or extending inwardly toward the center of the cushion module 3150, or extending inwardly toward one or more openings 5004 in the first layer 3100A to provide airflow to the patient's nasal airways.

[0294] As previously mentioned, it may be advantageous for the width of the second layer 3100B providing the overlapping portion 3102 to vary along the periphery of the seal-forming structure 3100. For example, as shown in FIG. 17D , reducing the width of the upper portion 3107 of the seal-forming structure 3100 may advantageously reduce the overall stiffness of the seal-forming structure 3100 in the area that seals below and / or partially in front of the patient's nasal tip. This area of ​​the patient's face may be somewhat sensitive, and a reduced width of the overlapping portion 3102 may reduce pressure on this area of ​​the patient's face, improving patient comfort during use. In other words, the width of the overlapping region may be greater in the outer nasal portion 3106 of the nasal sealing region than in the upper portion 3107 of the nasal sealing region.

[0295] In some examples, the width of the second layer 3100B providing the overlap 3102 may gradually decrease from the alar region of the seal-forming structure 3100 to the region that seals beneath and / or partially in front of the patient's nasal tip. In some examples, gradually decreasing the width of the overlap may improve patient comfort and improve the seal of the treatment.

[0296] Additionally, as described herein, a narrow overlap portion 3102 may be provided in the nasolabial portion 3120 measured from the oral opening 5004A to the outer edge of the first layer in the area where the upper lip region of the first layer meets the side of the mouth region of the first layer, advantageously providing additional support and rigidity to the upper lip region.

[0297] In some examples, the width of the overlap region that supports the upper lip region of the seal-forming structure 3100 may be greater than the width of the seal-forming structure 3100 in other regions, such as the top region, the side regions of the mouth, or the chin region.

[0298] As with the previous example, the thinned regions 5008 may be used in one or more areas of the seal-forming structure 3100 to control the flexibility of the seal-forming structure 3100 or to control how the second layer 3100B is formed as part of the molding process. In the example shown, the thinned regions 5008 are provided around most of the periphery of the overlapping portion 3102 of the second layer 3100B, with the exception of the chin or lower lip areas of the seal-forming structure 3100. In other words, in the example shown, the seal-forming structure 3100 has thinned regions 5008 in the overlapping portion 3102 of the second layer 3100B to support the first layer 3100A, which contacts the mouth, alar, and nasal tip areas of the patient's face in use.

[0299] In one example of this technique, the second layer 3100B of the seal-forming structure 3100 may be provided with thinned regions 5008 in areas that contact and support the first layer 3100A (e.g., a fabric layer). In another example, the second layer 3100B of the seal-forming structure 3100 may be provided with thinned regions 5008 in areas that do not contact the first layer 3100A, for example to add flexibility or to control material flow within a forming tool rather than to facilitate connection between the first layer 3100A and the second layer 3100B. For example, the thinned regions 5008 may be provided in the jaw regions of the seal-forming structure 3100 in locations that are not adhered to the first layer 3100A.

[0300] 17E shows a partial cross-section of the wall thickness along section line FF of FIG. 17C. In this example, the thickness of the second layer 3100B gradually decreases from the non-patient-contacting portion of the seal-forming structure 3100 to the patient-contacting portion of the seal-forming structure 3100. The second layer 3100B may gradually decrease in thickness through the overlapping portion 3102. For example, the second layer 3100B may gradually decrease in thickness continuously through the non-overlapping portion 3104 to the overlapping portion 3102. In some examples, the second layer 3100B includes a gradual taper that decreases in thickness from the non-overlapping portion 3104 of the seal-forming structure 3100, through the overlapping portion 3104, to or near the inner edge of the second layer 3100B. The overlapping portion 3102 of the second layer 3100B supports and is joined to the first layer 3100A and may include a thinned region 5008 as described herein.

[0301] 5.3.14.4 Textile structure In some examples of this technology, the first layer 3100A may be formed of or include a woven fabric, for example, the first layer may include a woven fabric that includes an elastomeric coating or lining to provide the first layer 3100A with a substantially air impermeable property.

[0302] In some examples of this technology, the first layer 3100A may include a textile as part of a composite structure. For example, the first layer may include a textile and a substantially impermeable material, such as an elastomeric layer, such as silicone. The use of an impermeable layer may be advantageous in that the first layer 3100A is substantially air-impermeable, thereby allowing the first layer to seal with the patient's face during use. Bonding of the first layer 3100A to the second support layer 3100B may be achieved, for example, by bonding the impermeable material of the first layer 3100A to a corresponding impermeable material of the second layer 3100B. For example, the impermeable material of the first layer may be an elastomer, such as silicone, and the second layer may also include silicone. Thus, these two elastomeric layers may be bonded during manufacturing, such as by an injection molding process.

[0303] In an example of this technology, it may be advantageous for the thickness of the impermeable material to be less than 1 mm, for example 0.3 mm or less. Providing a thin impermeable material may have the advantage of maximizing the resiliency of the fabric and providing a fabric that feels more natural to the user.

[0304] Thus, in one example of this technology, the first layer 3100A is provided in a pre-configured shape designed to be received in a corresponding opening in a molding tool, such as an injection molding tool.

[0305] It should be noted that when the first layer 3100A is bonded to the second layer 3100B in the molding process, compression of the first layer 3100A may occur in the area where the first layer 3100A contacts the second layer 3100B, as shown in FIG. 7B.

[0306] An exemplary first layer 3100A of a nose-mouth cushion module 3150 is shown in Figure 18. In this example, the first layer 3100A may be formed of a substantially planar sheet material, such as cut from a roll or sheet. For example, the first layer may be cut using a rotary cutter, a die-cut machine, a laser, a CNC, a knife, or scissors.

[0307] The shape of the seal-forming structure 3100 used in the cushion module 3150 typically requires a complex three-dimensional shape that includes a combination of concave and convex curves through one or more axes, referred to herein as a saddle region. In elastomeric seal-forming structures 3100 made from materials such as silicone, the complex shape is formed as part of the molding process. However, when one or more layers are formed from a sheet of planar material, it may be desirable to provide a first layer 3100A that can conform to the desired shape of the seal-forming structure 3100 while minimizing distortions such as wrinkling or buckling that could affect the effectiveness of the seal or reduce comfort for the patient 1000.

[0308] 17A-17E, a seal-forming surface 3100 configured to engage at or around the nasal region of the patient 1000 is positioned on an upper surface of the cushion module 3150, and a seal-forming structure 3100 configured to engage at or around the mouth of the patient 1000 is provided in a posterior region of the cushion module 3150. Thus, if a first layer of fabric 3100A is used, this region of the seal-forming structure 3100 may be prone to buckling in the area where the transition occurs.

[0309] Thus, in one example of this technology, the first layer 3100A is configured to have a first width "W1" in the nasal region 18002 of the seal-forming structure 3100, a second width "W2" in the oral region 18004 of the seal-forming structure 3100, and a third width "W3" in the nasal-labial portion 3120 where the first layer 3100A transitions from the nasal region to the oral region. In the third region, the width of the first layer 3100A is less than the widths of the nasal region 18002 and the oral region 18004. It should be understood that at the nose-to-mouth interface, the transition between the nasal region 18002 of the seal-forming structure 3100 and the oral region 18004 of the seal-forming structure 3100 occurs in the upper lip region adjacent the ala of the patient's nose in use.

[0310] It should be noted that width in the foregoing context is measured in a direction radially outward of the respective oral opening 5004A or nasal opening 5004B.

[0311] In other words, the first layer 3100A of the seal-forming structure 3100 includes a first width W1 measured radially outward from the nasal opening 5004B to the outer edge of the first layer 3100A, a second width W2 measured radially outward from the oral opening 5004A to the outer edge of the first layer, and a third width W3 measured from the oral opening 5004A to the outer edge of the first layer in the region where the upper lip region of the first layer meets the mouth region of the first layer.

[0312] In another example, the third width may be measured from the outer edge of the first layer in an area adjacent the wings of the patient 1000 in use.

[0313] In yet another example, the third width may be measured from the outer edge above the oral opening 5004A of the patient 1000 and to the side of the nose when in use.

[0314] In examples, the third width may be measured at the nasolabial portion 3120, which is posterior and lateral to the alar region of the seal-forming structure 3100 and adjacent the patient's nasolabial fold in use.

[0315] In various examples, the first width W1 can be about 7 mm to about 20 mm, for example, about 10 mm to about 15 mm. The second width W2 can be about 5 mm to about 15 mm, for example, about 8 mm to about 12 mm. The third width W3 can be about 4 mm to about 10 mm, for example, about 5 mm to about 8 mm, for example, substantially 6 mm.

[0316] Reducing width W3 may allow the tension on the outer edge of the nasal portion of first layer 3100A to be decoupled from the outer edge of the oral section of first layer 3100A, thereby allowing complex seal geometries to be achieved with a single, continuous first layer 3100A without joining sections of material.

[0317] In some instances, width W1 is substantially constant, i.e., has a total variation of less than 50% around the nostril 5004B. Similarly, width W2 is substantially constant at the sides of the chin and mouth regions, i.e., has a total variation of less than 50%, while width W3 may represent a reduction of 50% or more of width W1 or W2.

[0318] Given the complex three-dimensional shape of the seal-forming structure 3100, it may be appropriate to measure the first layer 3100A in a substantially planar configuration, for example, by removing the first layer 3100A from the cushion module 3150 and placing it on a substantially flat surface.

[0319] The aforementioned reduced width region allows the first layer 3100A to curve from the oral region to the nasal region with minimal buckling or wrinkling. Additionally, the reduced width region allows the first layer 3100A to assume a concave shape in the nasal region while maintaining the first layer 3100A substantially wrinkle-free.

[0320] Furthermore, in order to provide a substantially smooth outer surface for the seal-forming structure, in areas where the width of the first layer 3100A is narrowed (e.g., W3), it may be advantageous to widen the second layer 3100B to provide a substantially smooth outer surface.

[0321] In another example of this technique (not shown), the first layer 3100A may be cut from a sheet of planar material, as shown in Figure 18, and then formed into the desired three-dimensional shape before being attached to the second layer 3100B of the seal-forming structure 3100. For example, the first layer may be subjected to a forming technique, such as thermoforming, before being positioned within the cavity of a forming tool.

[0322] 5.4RPT Device An RPT device 4000 according to one aspect of the present technology includes mechanical, pneumatic, and / or electrical components and is configured to execute, in whole or in part, one or more algorithms, such as any of the methods described herein. The RPT device 4000 may be configured to generate a flow of air for delivery to a patient's airway, such as for the treatment of one or more respiratory disorders described elsewhere herein.

[0323] In one form, the RPT device 4000 is constructed and arranged to deliver airflow in the range of -20 L / min to +150 L / min while maintaining a positive pressure of at least 4 cmH2O, or at least 10 cmH2O, or at least 20 cmH2O.

[0324] 5.5 Air circuit The air circuit 4170 according to one aspect of the present technology is a conduit or tube constructed and arranged to allow airflow to travel between two elements of a respiratory therapy system (e.g., the RPT device 4000 and the patient interface 3000 or 3800) in use.

[0325] 5.6 Glossary For purposes of this disclosure, in certain aspects of the technology, one or more of the following definitions may apply. In other aspects of the technology, alternative definitions may apply.

[0326] 5.6.1 Overview Air: In certain forms of the present technology, air may be considered to mean atmospheric air, and in other forms of the present technology, air may be considered to mean some other combination of breathable gases, such as, for example, oxygen-enriched air.

[0327] Peripheral: In certain forms of the present technology, the term periphery is considered to mean (i) external to the treatment system or patient, and (ii) immediately surrounding the treatment system or patient.

[0328] For example, the ambient humidity for a humidifier may be the humidity of the air immediately surrounding the humidifier, such as the humidity of the room the patient is sleeping in. Such ambient humidity may differ from the humidity outside the room where the patient is sleeping.

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

[0330] In certain embodiments, ambient (e.g., acoustic) noise is considered to be the background noise level in the room the patient is in, as opposed to, for example, noise generated by the RPT device or noise emanating from the mask or patient interface. Ambient noise may originate from outdoor sources.

[0331] Automatic Positive Airway Pressure (APAP) Therapy: A CPAP therapy in which the therapeutic pressure is automatically adjustable, for example, breath-to-breath, between minimum and maximum limits, depending on the presence or absence of signs of an SDB episode.

[0332] Continuous Positive Airway Pressure (CPAP) Therapy: A respiratory pressure therapy in which the therapeutic pressure remains nearly constant throughout the patient's respiratory cycle. In some forms, the pressure at the airway entrance is slightly higher during exhalation and slightly lower during inhalation. In some forms, the pressure varies during different patient respiratory cycles (e.g., increasing upon detection of signs of partial upper airway obstruction and decreasing if signs of partial upper airway obstruction are not present).

[0333] Flow rate: The amount (or mass) of air expelled per unit time. Flow rate can refer to an instantaneous quantity. In some cases, a reference to flow rate is a scalar, i.e., a quantity with only dimension. In other cases, a reference to flow rate is a vector quantity, i.e., a quantity with both magnitude and direction. Flow rate may be given the symbol Q. "Flow rate" is sometimes written simply as "flow" or "airflow."

[0334] In the example of patient breathing, flow may be nominally positive for the inspiratory portion of the patient's breathing cycle and therefore negative for the expiratory portion of the patient's breathing cycle. The device flow, Qd, is the flow rate of air leaving the RPT device. The total flow, Qt, is the flow rate of air reaching the patient interface via the air circuit, plus any supplemental gas. The vent flow, Qv, is the rate at which air leaves the exhaust port to expel expiratory gases. The leak flow, Ql, is the flow rate leaking from the patient interface system or other locations. The respiratory flow, Qr, is the flow rate of air receiving into the patient's respiratory system.

[0335] Flow Therapy: A respiratory therapy that involves delivering a flow of air to the entrance of the airways at a controlled flow rate, called the therapeutic flow rate, that is typically positive throughout the patient's respiratory cycle.

[0336] Humidifier: A humidifier is understood as a humidification device configured, constructed or arranged to have a physical structure capable of supplying a therapeutically beneficial amount of water (H2O) vapor to an airflow to improve the medical respiratory condition of a patient.

[0337] Leak: The word leak refers to unintended airflow. In one example, a leak can occur as a result of an imperfect seal between the mask and the patient's face. In another example, a leak can occur in a swivel elbow around the circumference.

[0338] Conducted (acoustic) noise: Conducted noise, as used herein, refers to noise carried to the patient by pneumatic pathways, such as the air circuit and patient interface, and the air therein. In one form, conducted noise can be quantified by measuring the sound pressure level at the end of the air circuit.

[0339] Radiated (acoustic) noise: Radiated noise herein refers to noise carried to the patient by the surrounding air. In one form, radiated noise can be quantified by measuring the volume / pressure level of the object in question according to ISO 3744.

[0340] (Acoustic) Noise, Vent: Vent noise herein refers to noise generated by airflow through any vent, such as a vent hole in a patient interface.

[0341] Oxygen-enriched air: Air with a higher oxygen concentration than atmospheric air (21%), such as at least about 50% oxygen, at least about 60% oxygen, at least about 70% oxygen, at least about 80% oxygen, at least about 90% oxygen, at least about 95% oxygen, at least about 98% oxygen, or at least about 99% oxygen. "Oxygen-enriched air" is sometimes referred to as "oxygen" for short.

[0342] Medical oxygen: Medical oxygen refers to oxygen-enriched air with an oxygen concentration of 80% or more.

[0343] Patient: A person, whether or not suffering from a respiratory disease.

[0344] Pressure: Force per unit area. Pressure is measured in cmH2O or gf / cm 2 1 cmH2O can be expressed in a variety of units, including 1 g-f / cm 2 is equal to approximately 0.98 hectopascals (1 hectopascal = 100 Pa = 100 N / m 2 = 1 mbar to 0.001 atm). Unless otherwise stated, pressures are given herein in units of cmH2O.

[0345] The pressure at the patient interface is labeled Pm, and the therapeutic pressure, which indicates the target value that the mask pressure Pm should currently achieve, is labeled Pt.

[0346] Respiratory pressure therapy: The application of air at a treatment pressure, typically positive relative to the atmosphere, to the entrance of the airways.

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

[0348] 5.6.1.1 Materials and their properties Hardness: refers to the material property durometer hardness (indentation hardness) measured by indentation with an indenter (measured in accordance with ASTM D2240). ● "Soft" materials may include silicone or thermoplastic elastomers (TPEs) and may easily deform under finger pressure, for example. • "Hard" materials may include polycarbonate, polypropylene, steel or aluminum and may not easily deform under finger pressure, for example.

[0349] Silicone or silicone elastomer: Synthetic rubber. In this specification, silicone refers to liquid silicone rubber (LSR) or compression molded silicone rubber (CMSR). One commercially available form of LSR is SILASTIC (included in the range of products sold under this trademark) manufactured by Dow Corning. Another manufacturer of LSR is Wacker. Unless otherwise specified, representative forms of LSR have a Shore A (or Type A) indentation hardness in the range of about 35 to about 45, as measured using ASTM D2240.

[0350] Polycarbonate: A thermoplastic polymer of bisphenol A carbonate.

[0351] 5.6.1.2 Mechanics shaft: • Neutral axis: The axis of a cross section of a beam or plate along which there are no longitudinal stresses or strains. Vertical axis: The axis that runs along the length of the shape. The axis usually passes through the center of the shape. Circumferential axis: An axis oriented perpendicular to the longitudinal axis. The axis may be present especially in pipes, tubes, cylinders, or similar shapes with circular and / or elliptical cross sections.

[0352] Deformation: The process by which a member changes its original shape when subjected to a force, such as a force directed against an axis. This process may include stretching or compression, bending, or twisting.

[0353] Elasticity: The ability of a material to return to its original shape after deformation.

[0354] Floppy structure or component: A structure or component that, when made to support its own weight, changes shape (e.g., bends) within a relatively short period of time (e.g., 1 second).

[0355] Elasticity: The ability of a material to absorb energy during elastic deformation and release energy when unloaded.

[0356] Resilience: Virtually all of the energy is released when unloaded. Examples include certain silicone and thermoplastic elastomers.

[0357] Rigid Structure or Component: A structure or component that does not change shape substantially when subjected to loads typically encountered in use. An example of such an application is establishing and maintaining a patient interface in a sealing relationship with the entrance to a patient's airway, e.g., under a pressure load of approximately 20-30 cmH2O.

[0358] As one example, an I-beam may have a different bending stiffness (resistance to bending load) in a first direction compared to a second orthogonal direction. As another example, a structure or component may be floppy in a first direction and rigid in a second direction.

[0359] Stiffness 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 (e.g., compression, tension, bending, or torsion). The structure or component may offer different resistance in different directions. The opposite of stiffness is flexibility.

[0360] Viscosity: The ability of a material to resist flow.

[0361] Viscoelasticity: The ability of a material to exhibit both elastic and viscous behavior upon deformation.

[0362] Yield: The inability of a material to return to its original shape after deformation.

[0363] 5.6.1.3 Structural Elements Compression member: A structural element subjected to compressive forces.

[0364] Elbow: An elbow is an example of a structure that guides the airflow axis to change direction through an angle. In one form, the angle may be approximately 90 degrees. In another form, the angle may be greater than or less than 90 degrees. The elbow may have a generally circular cross-section. In another form, the elbow may have an oval or rectangular cross-section. In certain forms, the elbow may be rotatable relative to the mating component, for example, approximately 360 degrees. In certain forms, the elbow may be removable from the mating component, for example, via a snap connection. In certain forms, the elbow may be assembled to the mating component via a one-time snap during manufacturing, but cannot be removed by the patient.

[0365] Frame: A frame is a mask structure that is tension-loaded between two or more connection points with the headgear. A mask frame can be a non-airtight support structure within the mask. However, some forms of mask frames can be airtight.

[0366] Membrane: Membrane is taken to mean a typically thin element that preferably has virtually no resistance to bending but does have resistance to stretching.

[0367] Tie (noun): A structure designed to withstand tension.

[0368] Thin structure: a.Beam: i. The beam may be relatively long in one dimension compared to the other two dimensions, in which case the smaller dimension will be relatively thin compared to the longer dimension. b. Membrane: i. Relatively long in two dimensions and thin in one dimension. Easily deforms in response to bending forces. Resists elongation (and may also resist compression). c. Plates and shells i. They may be relatively long in two directions and thin in one direction. They may be stiff in bending, tension, and / or compression.

[0369] Thick structure: solid

[0370] Seal: When used as a noun ("seal"), it can refer to a structure, and when used as a verb ("to seal"), it can refer to an effect. Two elements can be constructed and / or arranged to achieve a "seal" or "seal" between them, but not require a separate "seal" element itself.

[0371] Shell: A shell is taken to mean a curved, relatively thin structure that has bending, tensile, and compressive stiffness. For example, the curved structural wall of a mask may be a shell. In some forms, the shell may be faceted. In some forms, the shell may be airtight. In some forms, the shell may not be airtight.

[0372] Stiffener: A stiffener is taken to mean a structural component designed to increase the bending resistance of another component in at least one direction.

[0373] Strut::Strut is taken to mean a structural component designed to increase the compressive resistance of another component in at least one direction.

[0374] Swivel (noun): A subassembly of components configured to rotate, preferably independently, about a common axis, preferably under low torque. In one form, the swivel may be constructed to rotate through an angle of at least 360 degrees. In another form, the swivel may be constructed to rotate through an angle less than 360 degrees. When used in connection with an air delivery conduit, the subassembly of components preferably includes a mating cylindrical conduit. In use, there may be little or no leakage of air flow from the swivel.

[0375] 5.6.2 Respiratory cycle Apnea: According to some definitions, apnea is said to occur when the flow rate falls below a predetermined threshold for a period of time, e.g., 10 seconds. Obstructive apnea is said to occur when some airway obstruction does not allow airflow despite the patient's efforts. Central apnea is said to refer to a condition in which apnea is detected due to reduced or absent respiratory effort despite a patent airway. Mixed apnea is said to refer to a condition in which reduced or absent respiratory effort occurs simultaneously with airway obstruction.

[0376] 5.6.3 Anatomy 5.6.3.1 Facial Anatomy Alar: outer wall or "wing" of each nostril (complex number: alar)

[0377] Alar angle: the angle formed between the wings of each nostril.

[0378] Outermost point of the ala: The outermost point of the ala of the nose.

[0379] Alar bend (or alar apex point): The last point on the base line of the bend of each alar, located within the crease formed by the junction of the alar and cheek.

[0380] Pinna: the entire externally visible part of the ear.

[0381] (Nasal) bony framework: The bony framework of the nose consists of the nasal bones, the frontal process of the maxilla, and the nasal portion of the frontal bone.

[0382] (Nasal) Cartilaginous Framework: The nasal cartilaginous framework consists of the septal, lateral, greater, and lesser cartilages.

[0383] Columella: The strip of skin that separates the nostrils and runs from the tip of the nose to the upper lip.

[0384] Columella angle: The angle between a line drawn through the midpoint of the nostril opening and a line drawn perpendicular to the Frankfort horizontal while intersecting the subnasal passage.

[0385] Frankfort horizontal plane: A line extending from the lowest point of the orbital rim to the left tryon. The tragus is the deepest point of the recess of the auricle above the tragus.

[0386] Glabella: Located on the soft tissue, it is the most prominent point on the midsagittal plane of the forehead.

[0387] Lateral nasal cartilage: A usually triangular cartilage plate whose upper edge is connected to the nasal bone and the frontal process of the maxilla, and whose lower edge is connected to the large cartilage of the alar.

[0388] Lower lip (lower lip point): The lip that extends between the bottom of the nose and the mouth.

[0389] Upper lip (supralabial point): The lip that extends between the mouth and the alar cartilage of the nose.

[0390] Greater alar cartilage: a cartilaginous plate located below the lateral nasal cartilage, curved around the anterior part of the nostril. Its posterior end is connected to the frontal process of the maxilla through a layer of tough fibrous membrane containing three or four small anterior alar cartilages.

[0391] Nostrils: Near-oval openings that form the entrance to the nasal cavity. The singular form of nostril is nostril. The nostrils are separated by the nasal septum.

[0392] Nasolabial folds or nasolabial folds: creases or grooves of skin extending from either side of the nose to the corners of the mouth, separating the cheeks from the upper lip.

[0393] Nasolabial angle: the angle between the bridge of the nose and the upper lip where it intersects with the bottom of the nose.

[0394] Lower ear base point: The lowest point where the pinna attaches to the facial skin.

[0395] Superior ear base point: The highest point of the auricle and facial skin.

[0396] Apex: The most prominent point or tip of the nose, visible when the rest of the head is viewed from the side.

[0397] Philtrum: a midline groove extending from the lower edge of the nasal septum in the upper lip area to the top of the lip.

[0398] Mental point: the point located in the soft tissue at the center of the most anterior part of the jaw.

[0399] (Nasal) ridge: The nasal ridge is a protrusion along the midline of the nose, extending from the ala to the tip of the nose.

[0400] Sagittal plane: A vertical plane from anterior (front) to posterior (back). The midsagittal plane is the sagittal plane that divides the body into left and right halves.

[0401] Therion: The most concave point that lies on the soft tissue and covers the naso-forehead suture area.

[0402] Nasal Septal Cartilage (Nose): The nasal septal cartilage forms part of the nasal septum, separating the front of the nasal cavity.

[0403] Lowest point of the nasal ala: The point on the lower edge of the nasal ala, where the base of the ala meets the skin of the upper lip.

[0404] Subnasal point: Located on the soft tissue, the point where the columella joins the upper lip in the midsagittal plane.

[0405] Supramenton: The largest depression in the midline of the lower lip between the lower lip and the soft tissue protrusion

[0406] Skull Anatomy

[0407] Frontal bone: The frontal bone contains a large vertical portion called the scales, which correspond to the area called the forehead.

[0408] Mandible: The mandible forms the lower jaw. The mental protuberance is the bony protuberance of the jaw that forms the jaw.

[0409] Maxilla: The maxilla forms the upper jaw and is located above the mandible and below the orbit. The frontal process of the maxilla projects upwards next to the nose and forms part of its lateral border.

[0410] Nasal bones: The nasal bones are two small, oval bones that vary in size and shape in different individuals. They are positioned side by side in the midsection and part of the face and their junction forms the "bridge" of the nose.

[0411] Nasal base: the area where the frontal bone and the two nasal bones meet, the depression between the eyes and just above the bridge of the nose.

[0412] Occipital bone: The occipital bone is located at the back and bottom of the skull. It contains an oval opening, the foramen magnum, which connects the cranial cavity to the spinal canal. The curved plate behind the foramen magnum is the occipital squama.

[0413] Orbit: the bony cavity within the skull that houses the eyeball.

[0414] Parietal bone: The parietal bone is the bone that forms the top and lateral aspect of the skull.

[0415] Temporal bone: The temporal bone is at the base and side of the skull and supports the area of ​​the face called the temples.

[0416] Cheekbones: The face contains two cheekbones, located at the top and sides of the face and forming the cheek protrusions.

[0417] 5.6.4 Patient Interface Anti-asphyxiation valve (AAV): A component or subassembly of a mask system that reduces the risk of the patient rebreathing carbon monoxide (CO2) by venting to the atmosphere in a fail-safe manner.

[0418] Headgear: Headgear refers to any form of positioning and stabilizing structure designed to hold a device, such as a mask, on the head.

[0419] Plenum chamber: A mask plenum chamber is understood to be a part of the patient interface having a wall that at least partially encloses a spatial volume of air that is pressurized at a pressure higher than atmospheric pressure in use. The shell may form part of the wall of the mask plenum chamber.

[0420] Seal: When used as a noun ("seal"), it can refer to a structure, and when used as a verb ("to seal"), it can refer to an effect. Two elements can be constructed and / or arranged to achieve a "seal" or "seal" between them, but not require a separate "seal" element itself.

[0421] Vent (noun): A structure that allows airflow from the interior of the mask or conduit to the ambient air, providing a clinically effective flush of exhaled gases. For example, for clinically effective flushing, flow rates of about 10 liters / minute to about 100 liters / minute may be used, depending on the mask design and the therapeutic pressure.

[0422] 5.6.5 Shape of structure Products of the present technology may include one or more three-dimensional mechanical structures, such as a mask cushion or impeller. The three-dimensional structures may be bounded by two-dimensional surfaces. These surfaces may be distinguished using labels to describe the orientation, location, function, or some other characteristic of the associated surfaces. For example, the structure may include one or more of a front surface, a back surface, an interior surface, and an exterior surface. In another example, the seal-forming structure may include a face-contacting (e.g., exterior) surface and a separate non-face-contacting (e.g., bottom or interior) surface. In another example, the structure may include a first surface and a second surface.

[0423] To facilitate describing the shape of three-dimensional structures and surfaces, first consider a cross section across the surface of the structure at point p. Referring to Figures 3B-3F, examples of cross sections at point p on a surface and the resulting planar curves are shown. Figures 3B-3F also show the outward normal vector at p. The outward normal vector of p points away from the surface. In some examples, we describe the surface from the perspective of a fictitious small person standing upright on the surface.

[0424] 5.6.5.1 Curvature in one dimension The curvature of a plane curve at p can be described as having a sign (eg, positive, negative) and a magnitude (eg, the radius of a circle that touches the curve at 1 / p).

[0425] Positive curvature: If the curve at p bends outward toward the normal, the curvature at that point is considered positive (as if the hypothetical little person were to leave point p and walk uphill). See Figure 3B (relatively large positive curvature compared to Figure 3C) and Figure 3C (relatively small positive curvature compared to Figure 3B). Such curves are commonly called concave curves.

[0426] Zero curvature: If the curve at p is a straight line, the curvature is taken to be zero (a hypothetical small person could walk on level ground without going up or down when leaving point p).

[0427] Negative curvature: If the curve at p points away from the outer normal, the curvature in that direction at that point is considered negative (if a hypothetical little person leaves point p, they would have to walk downhill). Such curves are commonly called convex curves.

[0428] 5.6.5.2 Curvature of two-dimensional surfaces A description of a shape at a given point on a two-dimensional surface according to the present technology may include multiple normal cross sections. The multiple cross sections may cut the surface in a plane containing the outward normal (the "normal plane"), and each cross section may be taken in a different direction. Each cross section yields a plane curve with a corresponding curvature. Different curvatures at the point may have the same sign or different signs. Each curvature at the point may have, for example, a relatively small magnitude. The plane curves in Figures 3B-3F may be examples of such multiple cross sections at a particular point.

[0429] Principal curvatures and directions: The directions in the normal plane along which the curvature of a curve has its maximum and minimum values ​​are called principal directions.

[0430] Surface region: a set of connected points on a surface. A set of points within a region may have similar properties, such as curvature or sign.

[0431] Saddle region: A region where the principal curvatures at each point have opposite signs (i.e., one is positive and the other is negative) (a hypothetical person might walk uphill or downhill depending on which way they are facing).

[0432] Dome region: A region in which the principal curvatures at each point have the same sign (e.g., both positive (a "concave dome"), or both negative (a "convex dome")).

[0433] Cylindrical region: A region in which one principal curvature is zero (or, for example, zero within manufacturing tolerances) and the other principal curvature is non-zero.

[0434] Planar Region: The region of a surface where both principal curvatures are zero (or, for example, zero within manufacturing tolerances).

[0435] Surface Edge: The boundary or limit of a surface or area.

[0436] Path: In certain forms of the present technology, a "path" is taken to mean a path in the mathematical-topological sense (e.g., a continuous space curve on a surface from f(0) to f(1)). In certain forms of the present technology, a "path" may be described as a route or course that includes, for example, a set of points on a surface. (To a hypothetical person, a path is where that person walks on a surface, similar to a garden path.)

[0437] Path Length: In certain forms of the present technology, "path length" is taken to mean the distance along the surface from f(0) to f(1) (i.e., the distance along a path on the surface). There may be more than one path between two points on the surface, and such paths may have different path lengths (for a hypothetical person, the path length is the distance that person would have to walk along the path on the surface).

[0438] Straight-line distance: Straight-line distance is the distance between two points on a surface, but is independent of the surface. On a planar area, there is a distance 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 cannot be a path that has the same path length as the straight-line distance between two points (to a hypothetical person, the straight-line distance corresponds to the "as the crow flies" distance).

[0439] 5.7 Other Remarks A portion of the disclosure of this patent document contains material that is entitled to copyright protection. The copyright owner has no objection to the reproduction by anyone of this patent document or this patent disclosure by facsimile, for purposes of reproduction in any form, as set forth in the Patent and Trademark Office patent file or records, but reserves all copyright rights therefor for all other purposes.

[0440] Unless the context clearly dictates otherwise, when a range of values ​​is provided, it is understood that each intervening value, to the tenth of the unit of the lower limit, between the upper and lower limits of that range, and any other stated or intervening value within that range, is encompassed within the technology. If the upper and lower limits of these intervening ranges, independently included in the intervening range, are specifically exceeded, they are also encompassed within the technology. If the stated range includes one or both of these limits, then ranges exceeding either or both of these stated limits are also encompassed within the technology.

[0441] Furthermore, when one or more values ​​are described herein as being implemented as part of the present technology, unless otherwise noted, it is understood that such values ​​may be approximate and may be utilized to any suitable significant figure to the extent that practical technical implementation may permit or require it.

[0442] Additionally, "near," "substantially," "about," or any similar term used herein refers to + / - 5 to 10% of a value.

[0443] Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by those skilled in the art. Although any methods and materials similar or equivalent to those described herein can be used in the practice or testing of this technology, a limited number of exemplary methods and materials are described herein.

[0444] Although particular materials are described as being suitable for use in the construction of components, obvious alternative materials having similar properties may be substituted. Furthermore, unless stated to the contrary, any and all components described herein are understood to be manufacturable and therefore may be manufactured collectively or separately.

[0445] It should be noted that as used herein and in the appended claims, the singular forms "a," "an," and "the" include their plural equivalents unless the context clearly dictates otherwise.

[0446] All publications mentioned herein are incorporated by reference to disclose and describe the methods and / or materials that are the subject of such publications. The publications mentioned herein are provided solely for their disclosure prior to the filing date of the present application. Nothing herein should be construed as an admission that the present technology does not antedate such publications by virtue of prior patents. Furthermore, the dates of publications mentioned may differ from the actual publication dates, which may require independent confirmation.

[0447] The terms "comprises" and "comprising" should be construed as referring to elements, components, or steps in a non-exclusive sense, indicating that a described element, component, or step can be present in, utilized with, or combined with other elements, components, or steps not specifically stated.

[0448] The headings used in the detailed description are for the convenience of the reader and should not be used to limit the content found in the disclosure or claims as a whole. These headings should not be used in interpreting the scope of the claims or the claim limitations.

[0449] Although the technology herein has been described with reference to particular examples, it should be understood that these examples are merely illustrative of the principles and applications of the technology. In some cases, terms and symbols may indicate specific details that are not necessary for the practice of the technology. For example, although the terms "first" and "second" (etc.) are used, unless otherwise specified, these terms are not intended to indicate any order but are used to distinguish between separate elements. Furthermore, although the process steps in the method may be described or illustrated in an ordered manner, such an order is not required. Those skilled in the art will recognize that such an order can be changed and / or aspects can be performed simultaneously or even synchronously.

[0450] It is therefore to be understood that numerous modifications may be made in the illustrative examples and that other arrangements may be devised without departing from the spirit and scope of the present technology. [Explanation of symbols]

[0451] 1000 patients 1100 Bedmate 3000 Patient Interface 3100 Seal forming structure 3101 Patient-facing surface 3102 overlapping part 3103 Exterior 3104 Non-overlapping portion 3105 Exterior 3106 Outside nose part 3107 Upper 3108 Lower 3109 Lower mediolateral part 3111 Central part 3113 Upper 3114 Lower 3115 Center front 3116 Upper lip (upper lip part) 3120 Nasolabial region (nasolabial region) 3122 Lower lip part 3124 Lateral upper lip part 3125 Mediolateral anterior 3126 Upper 3127 Lower 3128 Medial mediolateral anterior 3129 Lateral mediolateral anterior 3130 Cheek 3131 rear corner 3133 rear 3134 Front 3141 Lateral Posterior Region 3150 Cushion Module 3200 Plenum Chamber 3210 Chassis part 3211 Tendon 3212 Outer protruding connection part 3214 Connector 3220 Upper point 3230 Down 3300 stabilizing structure 3302 Headgear 3350 Gas Delivery Tube 3400 Vent 3410 Vent Module 3412 Vent hole 3600 connection port 3700 Forehead support 3800 Patient Interface 4000 RPT devices 4170 Air Circuit 5000 humidifier 5002 Side wall 5004 Opening 5004A Oral opening 5004B Nasal opening 5004B Nostril 5006 Edge 5010 Non-patient contact side 5013 Patient contact 5014 Outer Section 7002 2nd non-support area 7002B 2nd layer 9002 sprue 17002 Bridge 18002 Nasal Domain 18004 Dental Field

Claims

1. 1. A patient interface for delivering a flow of breathable gas to an airway of a patient, said patient interface comprising: At least 6 cmH above ambient pressure ２ a plenum chamber pressurizable to an elevated therapeutic pressure, the plenum chamber including at least one plenum chamber inlet port sized and configured to receive a flow of air at the therapeutic pressure for breathing by a patient; a seal-forming structure constructed and arranged to form a seal with an area of ​​the patient's face surrounding an entrance to the patient's airway, the seal-forming structure having an aperture therein so that a flow of air at said therapeutic pressure is delivered to an entrance to at least one of the patient's nostrils, the seal-forming structure constructed and arranged to maintain said therapeutic pressure within said plenum chamber, in use, throughout the patient's respiratory cycle; the seal-forming structure includes a first layer configured to engage and seal against the patient's face in use, and a second layer configured to provide support to at least a portion of the first layer in use; the first layer includes a first region bonded to the second layer and a second region not bonded to the second layer; the second layer has a first thickness and a second thickness, the first thickness being adjacent to the second region of the first layer, and the second thickness being adjacent to the first thickness and farther from the second region than the first thickness; The first thickness is greater than the second thickness.

2. The patient interface of claim 1 , wherein the first region is joined to the second layer by a lap seam.

3. 3. The patient interface of claim 1 or 2, wherein the second layer further comprises a third thickness adjacent the second thickness and further from the second region than the second thickness.

4. The patient interface of claim 3 , wherein the first thickness is greater than the third thickness.

5. A patient interface according to any preceding claim, wherein the second thickness is provided as a channel having an elongated structure extending circumferentially around at least a portion of the seal-forming structure.

6. The patient interface of claim 5 , wherein the elongate structure forms a continuous loop around at least one opening in the seal-forming structure.

7. 7. A patient interface according to any one of claims 1 to 6, wherein the first thickness and the second thickness are in one or more of a nasal side region, a nasal bridge region, an upper lip region, a cheek region, a lower lip region, a chin region, an alar region, and / or a nasal tip region of a seal-forming structure.

8. A patient interface according to any preceding claim, wherein the first layer comprises a woven fabric and the second layer comprises an elastomeric material.

9. 1. A patient interface for delivering a flow of breathable gas to an airway of a patient, said patient interface comprising: At least 6 cmH above ambient pressure ２ a plenum chamber pressurizable to an elevated therapeutic pressure, the plenum chamber including at least one plenum chamber inlet port sized and configured to receive a flow of air at the therapeutic pressure for breathing by a patient; a seal-forming structure constructed and arranged to form a seal with an area of ​​the patient's face surrounding an entrance to the patient's airway, the seal-forming structure constructed and arranged to maintain the therapeutic pressure within the plenum chamber throughout the patient's respiratory cycle, in use; the seal-forming structure includes an edge defining an opening such that a flow of air at a therapeutic pressure is delivered from the plenum chamber through the opening to the patient's airway; the seal-forming structure includes a patient-contacting portion configured to engage a patient's face to provide a seal, and a support portion attached to a non-patient-contacting side of the patient-contacting portion, the support portion configured to support the patient-contacting portion; A patient interface wherein the support portion includes a first region and a second region, the first region being thinner than the second region, and the second region being closer to an edge of the seal-forming structure than the first region.

10. 10. A patient interface according to claim 9, wherein the first region has a width and a length, the length measured circumferentially around the seal-forming structure and the width measured in a direction substantially perpendicular to the circumferential direction across a surface of the seal-forming structure, and the length being substantially greater than the width.

11. 11. A patient interface according to claim 9 or 10, further comprising a third region, said third region being thicker than said first region and positioned further from the edge of the seal-forming structure than said first region.

12. The patient interface of claim 11 , wherein the third region extends circumferentially around the seal-forming structure.

13. 13. A patient interface according to any one of claims 9 to 12, wherein the first region is provided on one or more of the side of the nose region, bridge of the nose region, upper lip region, cheek region, lower lip region, chin region and / or nasal tip region of the seal-forming structure.

14. 14. The patient interface of claim 13, wherein the first region is provided on the sides of the nose and in a bridge of the nose region of the patient interface.

15. 15. A patient interface according to any one of claims 9 to 14, wherein the support portion includes a plurality of first regions including the first region and a plurality of second regions including the second region, each of the first regions having a thickness less than a corresponding one of the second regions.

16. 16. A patient interface according to claim 15, wherein the plurality of first regions are provided in a substantially symmetrical arrangement on opposite sides of the seal-forming structure.

17. A patient interface according to any one of claims 9 to 16, wherein the first region forms a continuous loop around the opening in the seal-forming structure.

18. 18. A patient interface according to any one of claims 9 to 17, wherein the transition region from the first region to the second region has a substantially curved profile when viewed in a cross-sectional plane extending substantially perpendicular to a longitudinal extent of the first region.

19. A patient interface according to any one of claims 9 to 18, wherein the first region is provided as a channel on a non-patient contacting side of the patient contacting portion.

20. 20. A patient interface according to claim 18 or 19, wherein the thickness of the first region varies around the periphery of the opening in the seal-forming structure.

21. A patient interface according to any one of claims 9 to 20, wherein the patient contacting portion comprises a textile.

22. 1. A patient interface for delivering a flow of breathable gas to an airway of a patient, said patient interface comprising: At least 6 cmH above ambient pressure ２ a plenum chamber pressurizable to an elevated therapeutic pressure, the plenum chamber including at least one plenum chamber inlet port sized and configured to receive a flow of breathable gas at the therapeutic pressure for breathing by a patient; a seal-forming structure constructed and arranged to form a seal with an area of ​​the patient's face surrounding an entrance to the patient's airway, the seal-forming structure constructed and arranged to maintain the therapeutic pressure within the plenum chamber throughout the patient's respiratory cycle, in use; the seal-forming structure includes a first region having a first thickness, the first region defining at least one opening through which, in use, a flow of breathable gas is delivered to one or more airways of a patient; A patient interface wherein the seal-forming structure includes a second region contiguous with at least a portion of the first region, the second region having a thickness less than the first thickness.

23. 1. A cushion module for a patient interface, said cushion module comprising: At least 6 cmH above ambient pressure ２ a plenum chamber pressurizable to an elevated therapeutic pressure, the plenum chamber including at least one plenum chamber inlet port sized and configured to receive a flow of breathable gas at the therapeutic pressure for breathing by a patient; a seal-forming structure at least partially defining the plenum chamber and constructed and arranged to form a seal with an area of ​​the patient's face surrounding an entrance to the patient's airway, the seal-forming structure constructed and arranged to maintain the therapeutic pressure within the plenum chamber throughout the patient's respiratory cycle in use; the seal-forming structure includes a first portion made from a first material and at least one opening in the first portion through which a flow of breathable gas is supplied to one or more airways of a patient in use; 10. A cushion module for a patient interface, wherein the seal-forming structure further includes a second portion including a second material, the second portion joined to the first portion, the second portion having at least one groove or channel located along a path generally parallel to at least a portion of the opening.

24. 1. A cushion module for a patient interface, said cushion module comprising: At least 6 cmH above ambient pressure ２ a plenum chamber pressurizable to an elevated therapeutic pressure, the plenum chamber including at least one plenum chamber inlet port sized and configured to receive a flow of breathable gas at the therapeutic pressure for breathing by a patient; a seal-forming structure at least partially defining the plenum chamber and constructed and arranged to form a seal with an area of ​​the patient's face surrounding an entrance to the patient's airway, the seal-forming structure constructed and arranged to maintain the therapeutic pressure within the plenum chamber throughout the patient's respiratory cycle in use; the seal-forming structure includes a patient-contacting portion including a first material, the patient-contacting portion including a first aspect configured to engage a patient's face to form a seal, a second aspect opposite the first aspect, and an opening through which a flow of breathable gas is provided to the patient's airway in use; the seal-forming structure further includes a support portion attached to a second side of the patient-contacting portion, the support portion including a second material different from the first material; 1. A cushion module for a patient interface, wherein the support portion is configured to support at least a portion of a patient-contacting portion, the support portion including at least one thinned region having a thickness less than a thickness of an adjacent region, the adjacent region being closer to an opening than the thinned region, and the thinned region being located on a path extending in a direction generally parallel to the opening.

25. 1. A patient interface comprising: At least 6 cmH above ambient pressure ２ a plenum chamber pressurizable to an elevated therapeutic pressure, the plenum chamber including at least one plenum chamber inlet port sized and configured to receive a flow of air at the therapeutic pressure for breathing by the patient; a seal-forming structure constructed and arranged to form a seal with an area of ​​the patient's face surrounding an entrance to the patient's airway, the seal-forming structure having at least one opening to allow a flow of air at a therapeutic pressure to be delivered to at least the entrances of the patient's nares, the seal-forming structure constructed and arranged to maintain said therapeutic pressure within a plenum chamber throughout the patient's respiratory cycle, in use; a vent for allowing gases exhaled by the patient to flow from the interior of the plenum chamber to the environment, the vent being sized and shaped to maintain a therapeutic pressure within the plenum chamber in use; The seal-forming structure includes: a first layer behind the seal-forming structure, the first layer configured, in use, to seal around an entrance to the patient's airways including at least a partially downwardly directed portion of the patient's nasal tip, the ala of the nose, and the upper lip of the patient's face; and a second layer connected to and supporting the first layer, the second layer including an overlapping portion that overlaps the first layer to form a lap joint with the first layer around the periphery of the first layer, the overlapping portion extending inwardly from the non-overlapping portion of the second layer relative to the periphery of the first layer; the overlapping portion includes a width that varies along the periphery of the overlapping portion of the first layer, the width being defined by an amount of inward extension of the overlapping portion from a non-overlapping portion of the second layer.

26. 26. A patient interface according to claim 25, wherein the overlapping portion includes a pair of outer nasal portions, the width of the overlapping portion being greater at the outer nasal portions than at one or more other portions of the overlapping portion.

27. 27. A patient interface according to claim 26, wherein the width of the overlapping portion is greater at an outer nasal portion than at an upper portion of the overlapping portion.

28. 28. A patient interface according to claim 27, wherein the overlapping portion is at least twice as wide at the outer nasal portion as it is at the top.

29. 27. A patient interface according to claim 26, wherein the width of the overlapping portion is greater at the outer nasal portion than at the lower portion of the overlapping portion.

30. 30. A patient interface according to claim 29, wherein the overlapping portion is at least five times wider at the lateral nasal portion than at the lower portion.

31. 31. A patient interface according to claim 29 or 30, wherein the overlapping portion is at least 10 times wider in the lateral nasal portion than in the lower portion.

32. A patient interface according to any one of claims 29 to 31, wherein the width of the overlapping portion is greater at an upper portion than at a lower portion of the overlapping portion.

33. 33. A patient interface according to any one of claims 29 to 32, wherein the overlapping portion includes a pair of medial-lateral lower portions positioned on respective outer sides of a lower portion of the overlapping portion and positioned medial to an outer nasal portion of the overlapping portion, the width of the overlapping portion being greater at the lateral nasal portions than at the medial-lateral lower portions.

34. 34. A patient interface according to claim 33, wherein the overlapping portion is at least 1.5 times wider in the lateral nasal portion than in the mediolateral inferior portion.

35. 35. A patient interface according to claim 33 or 34, wherein the width of the overlapping portion is greater at the lower mediolateral portion than at the lower portion of the overlapping portion.

36. 29. A patient interface according to any one of claims 25 to 28, wherein the seal-forming structure includes a nasal portion configured to, in use, provide a flow of air to the entrances of the patient's nares, and further includes an oral portion configured to, in use, provide a flow of air to the patient's mouth.

37. 37. A patient interface according to claim 36, wherein the overlapping portion includes a pair of outer upper lip portions that, in use, are provided on the outside of respective upper lips of the patient.

38. 38. A patient interface according to claim 37, wherein the width of the overlapping portion is greater at the outer upper lip portion than at the outer nose portion.

39. 39. A patient interface according to claim 38, wherein the overlapping portion is at least 1.5 times wider at the outer upper lip portion than at the outer nose portion.

40. A patient interface according to any one of claims 37 to 39, wherein the outer upper lip portion extends inwardly from the non-overlapping portion of the second layer relative to the periphery of the first layer.

41. 41. A patient interface according to any one of claims 37 to 40, wherein each outer upper lip portion includes an inner edge positioned proximate to and inferior to a respective one of the alar crest points of the patient's face.

42. A patient interface according to any one of claims 37 to 41, wherein the width of the overlapping portion tapers between the outer upper lip portion and the outer nose portion.

43. 43. A patient interface according to any one of claims 37 to 42, wherein the overlapping portion includes a pair of nasolabial portions each positioned outside the outer upper lip portion, the width of the overlapping portion being greater in the outer upper lip portions than in the nasolabial portions.

44. 44. A patient interface according to claim 43, wherein the width of the overlapping portion is greater in the outer nasal portion than in the nasolabial portion.

45. A patient interface according to any one of claims 37 to 44, wherein the overlapping portion includes a pair of cheek portions, the width of the overlapping portion being greater at the outer upper lip portion than at the cheek portions.

46. A patient interface according to any one of claims 37 to 45, wherein the overlapping portion includes a lower lip portion, the width of the overlapping portion being greater at the outer upper lip portion than at the lower lip portion.

47. A patient interface according to any one of claims 26 to 46, wherein the width of the outer nose portion tapers towards the top of the overlapping portion.

48. 48. A patient interface according to any one of claims 25 to 47, wherein the overlapping portion of the second layer includes an outer surface to which the first layer is connected, the outer surface being offset from and spaced apart from an outer surface of the non-overlapping portion.

49. 49. A patient interface according to claim 48, wherein the patient contacting surface of the first layer is flush with an outer surface of the non-overlapping portion of the second layer.

50. 50. A patient interface according to any one of claims 25 to 49, wherein the overlapping portion of the second layer of the seal-forming structure has a thickness at one or more locations that is less than a non-overlapping portion of the second layer of the seal-forming structure.

51. A patient interface according to any one of claims 25 to 50, wherein the first layer is formed from a woven material.

52. A patient interface according to any one of claims 25 to 51, wherein the second layer is formed from an elastomeric material.

53. 48. A patient interface according to any one of claims 31 to 47, wherein the patient interface includes a cushion module, the cushion module including a chassis portion, the seal-forming structure attached to the chassis portion, the chassis portion and the seal-forming structure together defining the plenum chamber.

54. 54. A patient interface according to claim 53, wherein the chassis portion includes a pair of outwardly protruding connection portions each defining a respective one of the plenum chamber inlet ports and each configured to connect to a respective one of a pair of gas delivery tubes.

55. 55. A patient interface according to claim 54, wherein the patient interface includes the gas delivery tubes forming part of a positioning and stabilising structure configured to provide a force to hold the seal-forming structure in a therapeutically effective position on the patient's head, and wherein each gas delivery tube is configured to transport a flow of air from a position above the patient's head to the plenum chamber in use.

56. 1. A patient interface comprising: At least 6 cmH above ambient pressure ２ a plenum chamber pressurizable to an elevated therapeutic pressure, the plenum chamber including at least one plenum chamber inlet port sized and configured to receive a flow of air at the therapeutic pressure for breathing by a patient; a seal-forming structure constructed and arranged to form a seal with an area of ​​the patient's face surrounding an entrance to the patient's airway, the seal-forming structure having at least one opening to allow a flow of air at a therapeutic pressure to be delivered to at least the entrances of the patient's nares, the seal-forming structure constructed and arranged to maintain said therapeutic pressure within a plenum chamber throughout the patient's respiratory cycle, in use; a vent for allowing gases exhaled by a patient to flow from the interior of the plenum chamber to the environment, the vent being sized and shaped to maintain a therapeutic pressure within the plenum chamber in use; The seal-forming structure includes: a central portion configured to seal against at least a partially downwardly directed portion of the patient's nasal tip, the ala of the nose, and the upper lip of the patient's face in use; a central front portion of a forward-facing wall of the seal-forming structure, the central front portion being positioned downwardly adjacent the patient's nasal tip in use; a pair of mediolateral anterior sections of anterior facing walls disposed outwardly of each of the central anterior sections, each mediolateral anterior section including an upper section and a lower section, the lower section having a lower stiffness than the upper section.

57. 57. A patient interface according to claim 56, wherein a lower portion of each mediolateral anterior portion has a lesser thickness than an upper portion of the mediolateral anterior portion.

58. 58. A patient interface according to claim 56 or 57, wherein a lower portion of each mediolateral anterior portion has greater stiffness than the central anterior portion.

59. 59. A patient interface according to claim 58, wherein a lower portion of each mediolateral anterior portion has a greater thickness than the central anterior portion.

60. A patient interface according to any one of claims 56 to 59, wherein the central portion is formed from a woven material.

61. 61. A patient interface according to any one of claims 56 to 60, wherein the patient interface includes a first layer provided rearward of the seal-forming structure and forming the central portion of the seal-forming structure, and a second layer connected to the first layer around its periphery and providing support to the first layer, the second layer forming a forward-facing wall of the seal-forming structure.

62. 62. A patient interface according to claim 61, wherein the first layer is formed from a woven material.

63. 63. A patient interface according to claim 61 or 62, wherein the second layer is formed from an elastomeric material.

64. 64. A patient interface according to any one of claims 56 to 63, wherein a second layer of the seal-forming structure includes an overlapping portion that overlaps the first layer to form a lap joint with the first layer along the periphery of the first layer, the overlapping portion extending from a non-overlapping portion of the second layer inward relative to the periphery of the first layer.

65. 65. A patient interface according to claim 64, wherein the overlapping portion of the second layer has a thinned region extending along at least a portion of the overlapping portion.

66. 66. A patient interface according to claim 65, wherein the thinned region extends along the overlapping portion of the second layer at least in an outer nasal portion and an upper portion of the overlapping portion.

67. 67. A patient interface according to any one of claims 56 to 66, wherein the patient interface includes the cushion module, the cushion module including a chassis portion, the seal-forming structure attached to the chassis portion, the chassis portion and the seal-forming structure together defining the plenum chamber.

68. 68. A patient interface according to claim 67, wherein the seal-forming structure includes a pair of outer rear regions on respective outer rear sides of the seal-forming structures, each outer rear region extending rearwardly from the chassis portion and curving inwardly for contacting the patient's face in use.

69. 69. A patient interface according to claim 68, wherein each said outer posterior region curves inwardly to form a respective one of a pair of posterior corners of a seal-forming structure, each said posterior corner configured to engage the patient's face adjacent a respective one of the patient's nasolabial folds in use.

70. 70. A patient interface according to any one of claims 67 to 69, wherein the seal-forming structure includes an upper lip portion including a posterior portion configured to seal against the patient's upper lip in use, and a front portion adjacent a chassis portion having a stiffness that is greater than the stiffness of the posterior portion of the upper lip portion.

71. 71. A patient interface according to claim 70, wherein the chassis portion includes a pair of outwardly protruding connection portions each defining a respective plenum chamber inlet port and each configured to connect to a respective one of a pair of gas delivery tubes.

72. 72. A patient interface according to claim 71, wherein the patient interface includes the gas delivery tubes forming part of a positioning and stabilising structure configured to provide a force to hold the seal-forming structure in a therapeutically effective position on the patient's head, each gas delivery tube configured to transport a flow of air from a position above the patient's head to the plenum chamber in use.

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