Patient Interface

Abstract

The disclosed patient interface includes: a plenum chamber pressurizable to a therapeutic pressure; a seal-forming structure joined to the plenum chamber, the seal-forming structure including a nasal portion, an oral portion, and at least one orifice configured, in use, to deliver an air flow at said therapeutic pressure to at least the patient's nares, the seal-forming structure constructed and arranged, in use, to maintain said therapeutic pressure in the plenum chamber throughout the patient's respiratory cycle; a vent portion including a plurality of orifices configured to allow continuous ventilatory air flow from the interior of the plenum chamber to the surroundings; a positioning and stabilizing structure including at least one tie, the positioning and stabilizing structure configured, in use, to hold the seal-forming structure in a therapeutically effective position on the patient's head; and a textile portion configured to contact the patient's face.

Description

[Technical Field]

[0001] 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 facsimile reproduction by anyone of this patent document or this patent disclosure, as it appears in the Patent and Trademark Office patent file or records, but reserves all copyright rights therefor for all other purposes.

[0002] 1 Cross-reference to related applications This application claims the benefit of Australian Provisional Application No. 2020901894, filed June 9, 2020, and Australian Provisional Application No. 2020903878, filed October 26, 2020, both of which are incorporated by reference in their entirety. [Background technology]

[0003] 2. Technical Background 2.1 Technology field 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 apparatus and uses thereof.

[0004] 2.2 Description of Related Art 2.2.1 The human respiratory system and its disorders The body's respiratory system facilitates gas exchange. The nose and mouth form the entrance to a patient's airways.

[0005] These airways contain a series of branching tubes that become narrower, shorter, and more numerous the deeper they travel into the lungs. The primary function of the lungs is gas exchange, transferring oxygen from inhaled air into the venous blood and carbon dioxide outflowing. The trachea divides into the right and left main bronchi, which further divide into the terminal bronchioles. The bronchi constitute the 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, known as the respiratory zone. See: "Respiratory Physiology," by John B. West, Lippincott Williams & Wilkins, 9th edition published 2012.

[0006] A range of respiratory disorders exists, and particular disorders may be characterized by particular manifestations such as apnea, hypopnea, and hyperpnea.

[0007] Examples of respiratory disorders include obstructive sleep apnea (OSA), Cheyne-Stokes respiration (CSR), respiratory failure, obesity hyperventilation syndrome (OHS), chronic obstructive pulmonary disease (COPD), neuromuscular diseases (NMD), and chest wall disorders.

[0008] Obstructive sleep apnea (OSA) is a form of sleep-disordered breathing (SDB) characterized by episodes of upper airway closure or obstruction during sleep. It results from 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. As a result of this disorder, affected individuals experience breathing cessation typically lasting 30 to 120 seconds, sometimes 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. Pat. No. 4,944,310 (Sullivan).

[0009] Cheyne-Stokes respiration (CSR) is another form of sleep-disordered breathing. CSR is a disorder of a patient's respiratory 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 recurrent sleep arousals, which can cause severe insomnia, increased sympathetic activity, and increased afterload. See U.S. Patent No. 6,532,959 (Berthon-Jones).

[0010] Respiratory failure is a general term for respiratory disorders that refers to the inability of the lungs to take in enough oxygen or exhale enough CO2 to meet the patient's needs. Respiratory failure can include some or all of the following disorders:

[0011] Patients with respiratory failure (a type of respiratory insufficiency) may experience unusual shortness of breath during exercise.

[0012] Obesity hyperventilation syndrome (OHS) is defined as the combination of severe obesity and chronic awake hypercapnia in the absence of any other clear cause of hypoventilation. Symptoms include dyspnea, morning headache, and excessive daytime sleepiness.

[0013] 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.

[0014] 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 impairment, resulting in inability to walk, wheelchair confinement, difficulty swallowing, respiratory muscle weakness, and ultimately death from respiratory failure. Neuromuscular disorders can be categorized as rapidly progressive or slowly progressive: (i) rapidly progressive disorders, characterized by muscle impairment that worsens over months and leads to death within a few years (e.g., amyotrophic lateral sclerosis (ALS) and Duchenne muscular dystrophy (DMD) in teenagers); (ii) variable or slowly progressive disorders, characterized by muscle impairment that worsens over years and only modestly reduces life expectancy (e.g., limb-girdle, facioscapulohumeral, and myotonic muscular dystrophies). Symptoms of respiratory failure in NMD include: increasing general weakness, difficulty swallowing, difficulty breathing on exertion and at rest, fatigue, drowsiness, morning headache, and difficulty concentrating and mood changes.

[0015] Chest wall disorders are a group of thoracic deformities that result in ineffective connections 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: dyspnea on exertion, peripheral edema, orthopnea, recurrent chest infections, morning headache, fatigue, poor sleep quality, and loss of appetite.

[0016] A range of treatments are available to treat or ameliorate such diseases, and otherwise healthy individuals can also benefit from preventative treatments for respiratory disorders. However, these suffer from several deficiencies.

[0017] 2.2.2 Treatment A variety of therapies are used to treat one or more of the above-mentioned respiratory disorders, such as continuous positive airway pressure (CPAP) therapy, non-invasive ventilation (NIV), and invasive ventilation (IV).

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

[0019] Noninvasive ventilation (NIV) provides ventilatory support to a patient through the upper airway to assist the patient in breathing and / or maintain adequate oxygen levels in the body by performing some or all of the respiratory functions. Ventilatory support is provided through a noninvasive patient interface. NIV is used to treat CSR and respiratory failure in forms such as OHS, COPD, NMD, and chest wall disorders. In some forms, it can improve the comfort and effectiveness of these treatments.

[0020] Invasive ventilation (IV) provides ventilatory support to patients who are no longer able to breathe effectively on their own and may be provided using a tracheostomy tube. In some forms, the comfort and effectiveness of these treatments may be improved.

[0021] 2.2.3 Treatment System These treatments may be provided by therapeutic systems or devices. Such systems and devices may also be used to screen, diagnose, or monitor a disease without treating it.

[0022] The treatment system may include a respiratory pressure treatment device (RPT device), an air circuit, a humidifier, a patient interface, and data management.

[0023] Another form of treatment system is the mandibular repositioning device.

[0024] 2.2.3.1 Patient Interface A patient interface may be used to provide a wearer with an interface to a respiratory appliance, for example, by providing airflow to the airway entrance. 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 treatment being applied, the patient interface may form a seal with, for example, an area of ​​the patient's face, thereby facilitating gas delivery at a pressure sufficient to disperse with ambient pressure for treatment to occur (e.g., at a positive pressure of about 10 cmH2O relative to ambient pressure). In other forms of treatment, such as oxygen delivery, the patient interface may not include a seal sufficient to facilitate delivery of a gas supply to the airway at a positive pressure of about 10 cmH2O.

[0025] Certain other mask systems may be functionally inadequate in this field. For example, masks intended for purely decorative purposes 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 and not maintain internal air at pressures higher than ambient.

[0026] Certain masks may be clinically unsuitable for this technology (for example, if the mask blocks airflow through the nose and only allows airflow through the mouth).

[0027] In certain masks, the patient must insert part of the mask structure into their mouth to create and maintain a seal via their lips, which may be uncomfortable or impractical in this technology.

[0028] Certain masks may be impractical for use while sleeping (eg, when sleeping on your side in bed with your head resting on a pillow).

[0029] There are multiple challenges in designing a patient interface. The face has a complex three-dimensional shape. The size and shape of the nose and head vary greatly between individuals. Because the head contains bone, cartilage, and soft tissue, different regions of the face respond differently to mechanical forces. That is, the jaw or mandible can move relative to the other bones of the skull. The entire head can move throughout the respiratory treatment period.

[0030] These challenges can lead to one or more of the following: some masks can be intrusive, aesthetically undesirable, costly, poor fit, difficult to use, and uncomfortable, especially when worn for extended periods or when the patient is unfamiliar with the system. Using the wrong size mask can lead to reduced compliance, reduced comfort, and poor patient outcomes. While masks specifically designed for aviators, personal protective equipment (e.g., filter masks), SCUBA masks, or anesthesia administration masks may be durable for their intended use, such masks can be undesirably uncomfortable to wear for extended periods (e.g., several hours). Such discomfort can reduce patient compliance with treatment. This is especially true when the mask must be worn during sleep.

[0031] CPAP therapy is highly effective in treating certain breathing disorders when patients comply with the therapy. If the mask is uncomfortable or difficult to use, patients may not comply with the therapy. Because patients are often encouraged to clean their masks regularly, 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 for CPAP delivery during sleep form a distinct field.

[0034] 2.2.3.1.1 Seal-forming 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 may have a direct impact on the effectiveness and comfort of the patient interface.

[0035] Patient interfaces can 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 can 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 can include a single element that surrounds both nostrils during use. Such a single element can be designed, for example, to rest on the upper lip region and nose bridge region of the face. In one form of patient interface, the seal-forming structure can include an element that surrounds the mouth region during use, for example, by forming a seal on the lower lip region of the face. In one form of patient interface, the seal-forming structure can include a single element that surrounds both nostrils and the mouth region during use. These different types of patient interfaces can be known by various names depending on their manufacturer, 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 due to, for example, different shapes, structures, variability, and sensitive areas of the patient's face. For example, the seal of swimming goggles that rests on the patient's forehead may be inappropriate for use on the patient's nose.

[0037] A particular seal-forming structure may be designed for mass production so that one design is compatible, comfortable, and effective for a wide range of different face shapes and sizes. To the extent there is a mismatch between the shape of the patient's face and the seal-forming structure of the mass-manufactured patient interface, one or both must be adapted 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 shaped 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 action against the patient's face when positive pressure is applied within the mask. As with the previous type of seal-forming structure, 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 fold or buckle during use, causing leakage.

[0040] Other types of seal-forming structures may include friction-fit elements that are inserted into the nostrils, for example, but some patients find this uncomfortable.

[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] In another form of seal-forming structure, textile materials may be used in the face-contacting portion to achieve a seal. Some patients find that textile materials can provide increased comfort and reduced friction against the patient's skin. However, fabricating textile seal-forming portions into complex three-dimensional shapes can be difficult. While it is often easy to form textile materials into curves around a single axis, when curved around two or more axes simultaneously, folds and wrinkles can begin to form in the textile. Folds and wrinkles on the textile surface are undesirable because they can create leak paths through which treatment air can escape, reducing the effectiveness of CPAP therapy. Another way folds and wrinkles can occur is when excess material is added to the textile seal-forming portion (to prevent the material from being supported under tension before use). This can make it difficult to form the textile seal-forming portion into a complex three-dimensional shape that will hold during use (without forming undesirable wrinkles or folds). Therefore, it may be desirable to reduce the need to manufacture complex three-dimensional shapes in textile seal-forming structures. A textile seal-forming part that allows for maximization of textile compliance and tactile benefits to comfort while minimizing the formation of folds and wrinkles may also be needed.

[0043] Seal-forming structures using textile materials may exhibit increased compliance and / or decreased elasticity. As a result, the resulting textile seal-forming structure may not be able to effectively maintain its shape. As a result, the material used to form the support structure may also need to be supported under tension to relieve excess slack across the textile seal-forming structure, which may lead to the formation of undesirable wrinkles or folds during use, thereby causing unwanted leakage.

[0044] In another form of seal-forming structure, the face-contacting portion of the textile material may be supported on an additional substrate layer, which may add sufficient stiffness to reduce compliance of the textile.

[0045] A range of patient interface seal forming structures are disclosed in the following patent applications (assigned to ResMed Limited: WO1998 / 004,310; WO2006 / 074,513; WO2010 / 135,785).

[0046] 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. Pat. No. 4,782,832 (Trimble et al.), assigned to Puritan-Bennett Corporation.

[0047] ResMed Limited manufactures the following products that use nasal pillows: SWIFT™ Nasal Pillows Mask, SWIFT™ II Nasal Pillows Mask, SWIFT™ LT Nasal Pillows Mask, SWIFT™ FX Nasal Pillows Mask, and MIRAGELIBERTY™ Full Face Mask. Examples of nasal pillow masks are described in the following patent applications assigned to ResMed Limited: International Patent Application No. WO2004 / 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. WO2005 / 063,328 and WO2006 / 130,903 (which describe, among other things, aspects of ResMed Limited's MIRAGE LIBERTY™ full face mask); and International Patent Application No. WO2009 / 052,560 (which describes, among other things, aspects of ResMed Limited's SWIFT™ FX nasal pillows).

[0048] 2.2.3.1.2 Positioning and stabilization The seal-forming structures of patient interfaces used in positive air pressure therapy are subjected to corresponding forces of air pressure that disrupt the seal, and therefore a variety of techniques are used to position the seal-forming structures and maintain a seal against the appropriate portion of the face.

[0049] One technique involves the use of adhesives, see, for example, U.S. Patent Application Publication No. US2010 / 0000534, but adhesives can be uncomfortable.

[0050] Another technique involves the use of one or more straps and / or stabilizing harnesses, many of which suffer from one or more of the following problems: poor fit, bulky, uncomfortable, and cumbersome.

[0051] 2.2.3.2 Respiratory Pressure Therapy (RPT) Devices Respiratory pressure therapy (RPT) devices can be used individually or as part of a system to deliver one or more of the above-mentioned therapies, for example, by actuating the device to generate a delivery flow of air to an interface with the airway. This air flow can be pressurized. Examples of RPT devices include CPAP devices and mechanical ventilators.

[0052] 2.2.3.3 Humidifier Delivery of airflow without humidification can lead to dryness 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 patient airway comfort. Additionally, in cooler climates, the application of warm air to the facial area surrounding the patient interface generally provides more comfort than cool air.

[0053] 2.2.3.4 Data Management For clinical reasons, data may be obtained to determine whether a patient prescribed respiratory therapy is "compliant" (e.g., whether the patient adheres to one or more "compliance rules" with their RPT device). An example of a compliance rule for CPAP therapy may require a patient to use the RPT device for at least four hours per night for at least 21 days out of 30 consecutive days to be considered compliant. To determine patient compliance, a provider of the RPT device (e.g., a healthcare provider) may manually obtain data describing the patient's treatment with the RPT device, calculate usage rates over a given period, and compare this to the compliance rules. Once the healthcare provider determines that the patient has used their RPT device in accordance with the compliance rules, the healthcare provider may notify a third party that the patient is compliant.

[0054] There may be other aspects of patient care that benefit from communication of treatment data to third parties or external systems.

[0055] Existing processes for communicating and managing such data can be costly, time consuming, and / or error prone.

[0056] 2.2.3.5 Mandibular repositioning A mandibular repositioning device (MRD) or mandibular advancement device (MAD) is one treatment option for sleep apnea and snoring. It is an adjustable oral appliance available from dentists or other suppliers that holds the lower jaw (mandible) in an anterior position during sleep. MRDs are removable devices that are inserted into the patient's mouth before sleep and removed after sleep. As such, MRDs are not designed for full-time wear. MRDs can be custom-made or manufactured in standard forms and include a bite impression portion designed to fit the patient's teeth. This mechanical protrusion from the mandible expands the space behind the tongue and applies tension on the pharyngeal walls, reducing airway collapse and palatal vibration.

[0057] In certain instances, the mandibular advancement device may include an upper splint intended to engage or mate with teeth on the upper jaw or maxilla, and a lower splint intended to engage or mate with teeth on the upper jaw or mandible. The upper and lower splints are laterally connected to each other via a pair of connecting rods that are fixed symmetrically on the upper and lower splints.

[0058] In such a design, the length of the connecting rod is selected so that the mandible is held in an anterior position when the MRD is placed in the patient's mouth. The length of the connecting rod can be adjusted to change the level of mandibular protrusion. The dentist can determine the level of protrusion required for the mandible, and the length of the connecting rod will be determined accordingly.

[0059] Some MRDs are configured to push the mandible forward relative to the maxilla, while others, such as the ResMed Narval CC™ MRD, are designed to hold the mandible in an anterior position. The device also reduces or minimizes dental and temporomandibular joint (TMJ) side effects. As such, it is configured to minimize or avoid any movement of one or more of the teeth.

[0060] 2.2.3.6 Ventilation technology Some forms of treatment systems may include a vent to push out exhaled carbon dioxide, which may allow gas flow from an interior space of the patient interface (e.g., a plenum chamber) to an exterior of the patient interface (e.g., ambient).

[0061] The vent may include an orifice through which gas may flow when the mask is in use. Many such vents are noisy. Others may block during use, resulting in insufficient pumping. Some vents may disrupt sleep for the patient 1000 and bed companion 1100, for example, due to noise or concentrated airflow.

[0062] ResMed Limited has developed several improved mask ventilation technologies, see International Patent Application Publication No. WO 1998 / 034,665; International Patent Application Publication No. WO 2000 / 078,381; U.S. Patent No. 6,581,594; U.S. Patent Application Publication No. US 2009 / 0050156; and U.S. Patent Application Publication No. 2009 / 0044808.

[0063] Conventional mask noise table (ISO17510-2:2007, 10cmH2O pressure at 1m) [Table 1]

[0064] (*Measured using only one sample at 10cmH2O in CPAP mode using the test method specified in ISO3744)

[0065] The sound pressure values ​​for various objects are listed below: [Table 2]

[0066] 2.2.4 Screening, diagnostic and surveillance systems Polysomnography (PSG) is a conventional system for diagnosing and monitoring cardiopulmonary disorders, but it typically requires specialized clinical staff for system application. PSG typically involves placing 15–20 contact sensors on the human body to record various body signals (e.g., electroencephalography (EEG), electrocardiography (ECG), electrooculography (EOG), and electromyography (EMG)). PSG for sleep-disordered breathing requires patients to be observed for two nights in a specialized hospital: the first night for pure diagnosis and the second night for clinician-assisted titration of treatment parameters. Therefore, PSG is expensive and inconvenient. Screening, diagnosing, and monitoring sleep-disordered breathing at home is particularly unsuitable.

[0067] In general, screening and diagnosis involve identifying disease through signs and symptoms. Screening typically produces a true / false result indicating whether a patient's SDB warrants further investigation, while diagnosis often produces clinically actionable information. Screening and diagnosis tend to be one-time procedures, whereas monitoring the progression of disease can continue indefinitely. Some screening / diagnostic systems are adapted solely for screening / diagnosis, while some can also be used for monitoring.

[0068] A clinical expert may adequately screen, diagnose, or monitor a patient based on visual observation of the PSG signal. However, there are situations where a clinical expert is unavailable or cannot be paid for. Different clinical experts may have different opinions about a patient's illness. Furthermore, some clinical experts may apply different criteria at different times. Summary of the Invention [Means for solving the problem]

[0069] The present technology relates to the provision of 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.

[0070] A first aspect of the present technology relates to devices used in screening, diagnosing, monitoring, ameliorating, treating or preventing respiratory disorders.

[0071] Another aspect of the present technology relates to methods used in the screening, diagnosis, monitoring, amelioration, treatment or prevention of respiratory disorders.

[0072] An aspect of certain forms of the present technology is to provide methods and / or devices that improve patient compliance with respiratory therapy.

[0073] Aspects of the present technology relate to a patient interface that includes: a plenum chamber pressurizable to a therapeutic pressure; a seal-forming structure joined to the plenum chamber, the seal-forming structure including a nasal portion and an oral portion; a vent including a plurality of holes; and a positioning and stabilizing structure including at least one tie. The nasal portion of the seal-forming structure includes a nasal textile portion that is positively curved around a nasal axis; and the oral portion of the seal-forming structure includes an oral textile portion that is separate from the nasal textile portion and positively curved around an oral axis that is oriented differently from the nasal axis.

[0074] Aspects of the present technology relate to a patient interface that includes: ambient air pressure throughout the patient's breathing cycle when in use; than At least 6cmH2O expensivea plenum chamber pressurizable to a therapeutic pressure; a seal-forming structure joined to the plenum chamber, the seal-forming structure including a nasal portion and an oral portion, the nasal portion having at least one nasal hole configured, in use, to deliver an airflow at said therapeutic pressure to a patient's nares and the oral portion having an oral hole configured, in use, to deliver an airflow at said therapeutic pressure to a patient's mouth, the seal-forming structure constructed and arranged, in use, to maintain said therapeutic pressure in the plenum chamber throughout the patient's respiratory cycle; a vent portion including a plurality of holes configured to direct a continuous vent flow of air from the interior of the plenum chamber to the surroundings throughout the patient's respiratory cycle when the therapeutic pressure in the plenum chamber is positive relative to the surroundings; and a positioning and stabilizing structure including at least one tie, the positioning and stabilizing structure configured, in use, to hold the seal-forming structure in a therapeutically effective position on the patient's head. The nasal textile portion included in the nasal portion of the seal-forming structure defines at least one nostril and is configured to contact the patient's nose in use, the nasal textile portion being positively curved around the nasal axis; the oral portion of the seal-forming structure includes an oral textile portion separate from the nasal textile portion and defines an oral opening and is configured to contact the patient's face adjacent the patient's mouth in use, the oral textile portion being positively curved around an oral axis that is oriented differently from the nasal axis; and the patient interface is configured to allow the patient to breathe from the environment in the absence of airflow at the treatment pressure.

[0075] In examples of the embodiment of the above two paragraphs: (a) the seal-forming structure may be established by silicone overmolded onto the nasal textile portion and the oral textile portion; (b) the silicone may be exposed between the nasal textile portion and the oral textile portion; (c) the silicone exposed between the nasal textile portion and the oral textile portion may be configured to be positioned adjacent to the patient's upper lip in use; (d) the nasal axis and the oral axis may be disposed in the patient's sagittal plane in use; (e) the nasal axis and the oral axis may be oriented relative to one another at an angle greater than 90°; (f) the radius of curvature of the nasal textile portion may be less than the radius of curvature of the oral textile portion; and (g) the nasal textile portion and the oral textile portion are air impermeable. (h) the nasal textile portion may be constructed of a first textile and the oral textile portion may be constructed of a second textile; (i) the first textile and the second textile may have the same property; (j) the first textile and the second textile may have at least one different property; (k) the nasal textile portion may comprise one nostril configured to direct airflow into both nostrils in use; (l) the nasal textile portion may comprise two nostrils configured to direct airflow into corresponding ones of the nostrils in use; and / or (m) the nasal textile portion may be configured to be positioned adjacent to the bridge of the patient's nose in use.

[0076] Aspects of the present technology relate to a patient interface including: a plenum chamber pressurizable to a therapeutic pressure; a seal-forming structure joined to the plenum chamber, the seal-forming structure including a nasal portion and an oral portion; a vent including a plurality of holes; a positioning and stabilizing structure including at least one tie; and an integral textile portion. The integral textile portion includes: a nasal textile portion positioned on the nasal portion to contact the patient's nose in use, the nasal textile portion positively curved around a nasal axis; an oral textile portion positioned on the oral portion to contact the patient's face adjacent the patient's mouth in use, the oral textile portion positively curved around an oral axis that is oriented differently from the nasal axis; and a bridge portion joining the nasal textile portion and the oral textile portion.

[0077] Aspects of the present technology relate to a patient interface that includes: ambient air pressure throughout the patient's breathing cycle when in use; than At least 6cmH2O expensivea plenum chamber pressurizable to a therapeutic pressure; a seal-forming structure joined to the plenum chamber, the seal-forming structure including a nasal portion and an oral portion, the nasal portion having at least one nasal hole configured, in use, to deliver an airflow at said therapeutic pressure to the patient's nares and the oral portion having an oral hole configured, in use, to deliver an airflow at said therapeutic pressure to the patient's mouth, the seal-forming structure constructed and arranged, in use, to maintain said therapeutic pressure in the plenum chamber throughout the patient's respiratory cycle; a vent portion including a plurality of holes configured to direct a continuous vent flow of air from the interior of the plenum chamber to the surroundings throughout the patient's respiratory cycle when the therapeutic pressure in the plenum chamber is positive relative to the surroundings; a positioning and stabilizing structure including at least one tie, the positioning and stabilizing structure configured, in use, to hold the seal-forming structure in a therapeutically effective position on the patient's head; and an integral textile portion. The one-piece textile portion includes: a nasal textile portion forming at least one nostril, the nasal textile portion being positioned on the nasal portion to contact the patient's nose in use, the nasal textile portion being positively curved around the nasal axis; an oral textile portion forming an oral orifice, the oral textile portion being positioned on the oral portion to contact the patient's face adjacent the patient's mouth in use, the oral textile portion being positively curved around an oral axis that is oriented differently from the nasal axis; and a bridge portion joining the nasal textile portion and the oral textile portion. The patient interface is configured to allow the patient to breathe from their surroundings in the absence of airflow at the treatment pressure.

[0078] In examples of the embodiment of the above two paragraphs: (a) the seal-forming structure may be constructed by silicone overmolded onto the unitary textile portion; (b) the nasal axis and the oral axis may be positioned in the patient's sagittal plane during use; (c) the nasal axis and the oral axis may be oriented relative to one another at an angle greater than 90°; (d) the radius of curvature of the nasal textile portion may be less than the radius of curvature of the oral textile portion; (e) the nasal textile portion may be constructed by a first textile, the oral textile portion may be constructed by a second textile, and the bridge portion may be constructed by a third textile; (f) the first textile, the second textile, and the third textile may have the same property; (g) the first textile, the second textile, and the third textile may have at least one property that is different; and (h) the first textile, the second textile, and the third textile may have at least one property that is different. The textile may be air impermeable; (i) joining of the nasal textile portion, oral textile portion, and bridge portion may be by stitching or welding; (j) the nasal textile portion, oral textile portion, and bridge portion may be constructed from a single continuous textile piece; (k) the one-piece textile portion may be curved or bent around the nasal-labial axis at the bridge portion; (l) the bridge portion may be narrower than the nasal textile portion and oral textile portion; (m) the bridge portion may be configured to be positioned adjacent the patient's upper lip in use; (n) the nasal textile portion may comprise one nostril configured to direct airflow into both nostrils in use; and / or (o) the nasal textile portion may comprise two nostrils configured to direct airflow into a corresponding one of the nostrils in use.

[0079] Aspects of the present technology relate to a patient interface including: a plenum chamber pressurizable to a therapeutic pressure; a seal-forming structure joined to the plenum chamber, the seal-forming structure including a nasal portion and an oral portion, the seal-forming structure having at least one hole configured to deliver airflow to the patient's nares and mouth at the therapeutic pressure in use; a vent including a plurality of holes; a positioning and stabilizing structure including at least one tie; a first textile portion bounding a first portion of the at least one hole; and a second textile portion joined to the first textile portion, the second textile portion bounding a second portion of the at least one hole.

[0080] Aspects of the present technology relate to a patient interface that includes: ambient air pressure throughout the patient's breathing cycle when in use; than At least 6cmH2O expensivea plenum chamber pressurizable to a therapeutic pressure; a seal-forming structure joined to the plenum chamber, the seal-forming structure including a nasal portion and an oral portion, the seal-forming structure having at least one hole configured, in use, to deliver an air flow at said therapeutic pressure to the patient's nares and mouth, the seal-forming structure constructed and arranged, in use, to maintain said therapeutic pressure in the plenum chamber throughout the patient's respiratory cycle; a vent portion including a plurality of holes configured to direct a continuous vent flow of air from the interior of the plenum chamber to the surroundings throughout the patient's respiratory cycle when the therapeutic pressure in the plenum chamber is positive relative to the surroundings; a positioning and stabilizing structure including at least one tie, the positioning and stabilizing structure configured, in use, to hold the seal-forming structure in a therapeutically effective position on the patient's head; a first textile portion bounding a first portion of the at least one hole; and a second textile portion joined to the first textile portion, the second textile portion bounding a second portion of the at least one hole. The patient interface is configured to allow the patient to breathe from the environment in the absence of airflow at therapeutic pressure.

[0081] In examples of the embodiment of the above two paragraphs: (a) the seal-forming structure may be constructed by silicone overmolded onto the first textile portion and the second textile portion; (b) the seal-forming structure may comprise a single oral-nose opening configured to receive the patient's nose and mouth in use; (c) the at least one opening may include at least one nasal opening formed in the nasal portion and an oral opening formed in the oral portion; (d) the at least one nasal opening may comprise two nasal openings configured to direct airflow into a corresponding one of the nasal openings in use; (e) the at least one nasal opening may comprise one nasal opening configured to direct airflow into both nasals in use; (f) the first textile portion may surround the at least one nasal opening; (g) the first textile portion may partially surround the oral opening; and (h) the first The textile portion and the second textile portion may be joined to surround an oral cavity, (i) the first textile portion and the second textile portion may be joined to surround at least one cavity, (j) the first textile portion may be constructed of a first textile and the second textile portion may be constructed of a second textile, (k) the first textile and the second textile may have the same property, (l) the first textile and the second textile may have at least one different property, (m) the first textile and the second textile may be air impermeable, (n) the joining of the first textile portion and the second textile portion may be by stitching or welding, and / or (o) the second textile portion may be configured to contact the patient's lower lip during use.

[0082] Aspects of the present technology relate to a patient interface that includes: a plenum chamber pressurizable to a therapeutic pressure; a seal-forming structure joined to the plenum chamber, the seal-forming structure including a nasal portion and an oral portion; a vent including a plurality of holes; a positioning and stabilizing structure including at least one tie; and a textile portion, the textile portion including: a nasal textile portion positioned on the nasal portion to contact the patient's nose in use; an oral textile portion positioned on the oral portion to contact the patient's face adjacent the patient's mouth in use; and a gap in the textile portion between at least one nasal hole and the oral hole.

[0083] Aspects of the present technology relate to a patient interface that includes: ambient air pressure throughout the patient's breathing cycle when in use; than At least 6cmH2O expensivea plenum chamber pressurizable to a therapeutic pressure; a seal-forming structure joined to the plenum chamber, the seal-forming structure including a nasal portion and an oral portion, the nasal portion having at least one nasal opening configured, in use, to deliver an airflow at said therapeutic pressure to a patient's nares and the oral portion having an oral opening configured, in use, to deliver an airflow at said therapeutic pressure to a patient's mouth, the seal-forming structure constructed and arranged, in use, to maintain said therapeutic pressure within the plenum chamber throughout the patient's respiratory cycle; and multiple seal-forming structures configured to direct a continuous flow of air from the interior of the plenum chamber to the ambient air throughout the patient's respiratory cycle when the therapeutic pressure within the plenum chamber is positive relative to the ambient air. a vent including a number of holes; a positioning and stabilizing structure including at least one tie, the positioning and stabilizing structure configured to hold the seal-forming structure in a therapeutically effective position on the patient's head in use; and a textile portion including a nasal textile portion and an oral textile portion, the nasal textile portion at least partially forming at least one nostril and positioned on the nasal portion to contact the patient's nose in use, and the oral textile portion at least partially forming the oral portion and positioned on the oral portion to contact the patient's face adjacent the patient's mouth in use; and a gap in the textile portion, the gap being located between the at least one nostril and the oral hole. The patient interface is configured to allow the patient to breathe from the environment in the absence of airflow at the therapeutic pressure.

[0084] In examples of the embodiments of the above two paragraphs: (a) the seal-forming structure may be constructed by silicone overmolded onto the textile portion; (b) the textile portion may be unitary; (c) the silicone of the seal-forming structure may be exposed at the gap; (d) the silicone of the seal-forming structure exposed at the gap may be configured to be positioned adjacent the patient's upper lip in use; (e) the nasal textile portion may be constructed by a first textile and the oral textile portion may be constructed by a second textile; and (f (a) the first textile and the second textile may have the same properties; (g) the first textile and the second textile may have at least one property that is different; (h) the first textile and the second textile may be air impermeable; (i) the nasal textile portion may comprise one nostril configured to direct airflow into both nostrils in use; and / or (j) the nasal textile portion may comprise two nostrils configured to direct airflow into a corresponding one of the nostrils in use.

[0085] Aspects of the present technology relate to a patient interface including a plenum chamber and a positioning and stabilizing structure, wherein the plenum chamber is adapted to maintain ambient air pressure throughout the patient's breathing cycle in use. than At least 6cmH2O expensiveThe device is pressurizable to a therapeutic pressure. The plenum chamber includes a seal-forming structure and a shell. The seal-forming structure is constructed and arranged to include a patient-contacting surface. The patient-contacting surface forms a seal with an area of ​​the patient's face surrounding an entrance to the patient's airway. The seal is configured to deliver an airflow at the therapeutic pressure to the entrance to the patient's airway in use. The seal-forming structure is constructed and arranged to maintain the therapeutic pressure in the plenum chamber throughout the patient's respiratory cycle in use. The shell has one or more plenum chamber inlet ports sized and configured to receive an airflow at the therapeutic pressure for breathing by the patient throughout the patient's respiratory cycle in use. The shell supports the seal-forming structure. The positioning and stabilizing structure is configured to generate forces to hold the seal-forming structure in a therapeutically effective position on the patient's head. The seal-forming structure has regions of varying geometric complexity (as defined by the principal curvature characteristics and torsion of each region). In the seal-forming structure, at least one region is a textile material and at least one region is a non-textile material. At least one region of the textile material exhibits less shape complexity than at least one region of the non-textile material.

[0086] In some embodiments, these characteristics may include one or more of the following: curvature and / or twist, the direction of curvature or twist, or one or more relationships between the specific principal curvatures and twists, respectively. In some embodiments, at least one region of the textile material may not include a direction of curvature in more than one direction. In some embodiments, the geometric complexity that at least one region of the textile material may exhibit does not promote wrinkling of the textile.

[0087] In some embodiments, the seal-forming structure may include a nose portion configured to seal around the lower part of the patient's nose. The nose portion of the seal-forming structure may have a pair of nostrils configured to deliver airflow to corresponding nostrils of the patient in use. The seal-forming structure may include a bridge portion between the pair of nostrils. The bridge portion may be provided between a central portion of the nose portion configured to be positioned below the tip of the patient's nose in use and an upper lip portion of the nose portion configured to seal against the patient's upper lip in use. The bridge portion includes one or more regions of textile material.

[0088] In some embodiments, the bridge portion may sag, allowing the central portion to move away from the upper lip in use. In some embodiments, the bridge portion may include a curved portion configured to straighten when the central portion is moved away from the upper lip. In some embodiments, in use, the curved portion may be configured to extend away from the patient's nose in an undeformed state, and to straighten when the central portion is moved away from the upper lip. In some embodiments, in use, the bridge portion allows the central portion to move anteriorly relative to the patient to receive the patient's nasal tip, thereby accommodating noses of different lengths (without disengaging the upper lip from the patient's upper lip when the patient is wearing the patient interface).

[0089] In some embodiments, the seal-forming structure may include an oral cavity perimeter that surrounds at least a majority of the oral cavity configured to surround the patient's mouth in use. The seal-forming structure may include lateral peripheral support portions disposed on opposite lateral sides of the oral cavity. The lateral peripheral support portions may be adjacent to the oral cavity perimeter. In some embodiments, the lateral peripheral support portions may be more rigid than the oral cavity perimeter. In some embodiments, the oral cavity perimeter may include one or more regions of textile material. In some embodiments, the lateral peripheral support portions may include one or more regions of non-textile material.

[0090] Aspects of the present technology relate to a patient interface including a plenum chamber and a positioning and stabilizing structure, wherein the plenum chamber is adapted to maintain ambient air pressure throughout the patient's breathing cycle in use. than At least 6cmH2O expensive The device is pressurizable to a therapeutic pressure. The plenum chamber includes a seal-forming structure and a shell. The seal-forming structure is constructed and arranged to include a patient-contacting surface. The patient-contacting surface forms a seal with an area of ​​the patient's face surrounding an entrance to the patient's airway. The seal is configured to deliver an airflow at the therapeutic pressure to the entrance to the patient's airway in use. The seal-forming structure is constructed and arranged to maintain the therapeutic pressure in the plenum chamber throughout the patient's respiratory cycle in use. The shell has one or more plenum chamber inlet ports sized and configured to receive an airflow at the therapeutic pressure for breathing by the patient throughout the patient's respiratory cycle in use. The shell supports the seal-forming structure. The positioning and stabilizing structure is configured to generate forces to hold the seal-forming structure in a therapeutically effective position on the patient's head. The seal-forming structure has regions of varying geometric complexity (as defined by the principal curvature characteristics and torsion of each region). In the seal-forming structure, at least one region is a textile material and at least one region is a non-textile material. At least one region of the textile material exhibits a shape complexity below a threshold value to reduce wrinkling of the textile.

[0091] In some embodiments, the plenum chamber may have an oral portion and a nasal portion. The nasal portion of the seal-forming structure may have at least one nasal hole configured to deliver an airflow at therapeutic pressure to an entrance to the patient's nares in use. The oral portion of the seal-forming structure may have an oral hole configured to deliver an airflow at therapeutic pressure to an entrance to the patient's mouth. In some embodiments, the shell may be joined to the oral portion of the plenum chamber. In some embodiments, the seal-forming structure may form substantially the entire nasal portion.

[0092] In some embodiments, at least a partially anterior wall of the nasal portion of the seal-forming structure may include two lateral support portions. The lateral support portions may be laterally spaced apart. Each lateral support portion may have a higher deformation resistance than an adjacent portion of the seal-forming structure. In some embodiments, each lateral support portion may be thicker than an adjacent portion of the seal-forming structure. In some embodiments, each lateral support portion may have a curved upper boundary. In some embodiments, each lateral support portion may have a substantially fin-shaped configuration. In some embodiments, the nasal portion of the seal-forming structure may include a central portion configured to seal between the lower periphery of the patient's nostril surrounding the patient's nose and the patient's upper lip in use. The central portion may include one or more regions of textile material. In some embodiments, the nasal portion of the seal-forming structure may include intermediate portions between the central portion and the lateral support portions. These intermediate portions may include one or more regions of non-textile material. In some embodiments, the intermediate portion may be configured to contact the ala of the patient's nose during use, and the intermediate portion may be stiffer than the central portion. In some embodiments, the intermediate portion may include a pair of outer walls of the seal-forming structure that face partially medially and partially upwardly. In some embodiments, these intermediate portions may be configured to resist wrinkling. In some embodiments, the intermediate portion may be configured to limit the formation of a leakage path beyond the lower periphery of the patient's nose due to wrinkling. In some embodiments, the intermediate portion may be thicker than the central portion. In some embodiments, the shell may include a rearward protruding portion configured to stiffen the seal-forming structure at the base of the nose portion during use. In some embodiments, the seal-forming structure may be configured not to engage the patient's face below the chin during use.

[0093] In some embodiments, the seal-forming structure may include an oral cavity perimeter that surrounds at least a majority of the oral cavity configured to surround the patient's mouth in use. The seal-forming structure may include lateral peripheral support portions disposed on opposite lateral sides of the oral cavity. The lateral peripheral support portions may be adjacent to the oral cavity perimeter. In some embodiments, the lateral peripheral support portions may be more rigid than the oral cavity perimeter. In some embodiments, the oral cavity perimeter may include one or more regions of textile material. In some embodiments, the lateral peripheral support portions may include one or more regions of non-textile material.

[0094] Aspects of the present technology relate to a patient interface that includes a plenum chamber that, in use, maintains ambient air pressure throughout the patient's breathing cycle. than At least 6cmH2O expensiveThe patient interface is pressurizable to a therapeutic pressure. The patient interface further includes a seal-forming structure defining at least a portion of the plenum chamber. The seal-forming structure is 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 includes a nasal portion and an oral portion. The nasal portion has at least one nasal hole configured to deliver an airflow at therapeutic pressure to an entrance to the patient's nares in use. The oral portion has an oral hole configured to deliver an airflow at therapeutic pressure to an entrance to the patient's mouth in use. The seal-forming structure is constructed and arranged to maintain a therapeutic pressure in the plenum chamber throughout the patient's respiratory cycle in use. The patient interface further includes a shell. The shell defines at least a portion of the plenum chamber and has one or more plenum chamber inlet ports. The plenum chamber inlet ports are sized and configured to receive an airflow at therapeutic pressure for breathing by the patient throughout the patient's respiratory cycle in use. The shell supports the seal-forming structure. The patient interface further includes a positioning and stabilizing structure configured to generate a force to hold the seal-forming structure in a therapeutically effective position on the patient's head. The nasal portion of the seal-forming structure has a textile patient-contacting surface that surrounds an entrance to the patient's nares. The oral portion of the seal-forming structure has a textile patient-contacting surface that surrounds an entrance to the patient's mouth. The textile patient-contacting surface of the nasal portion of the seal-forming structure and the textile patient-contacting surface of the oral portion of the seal-forming structure are separate.

[0095] In some examples, the textile patient-contacting surface of the nasal portion of the seal-forming structure and the textile patient-contacting surface of the oral portion of the seal-forming structure can be joined to one another by a textile connector. In some examples, the textile patient-contacting surface of the nasal portion of the seal-forming structure and the textile patient-contacting surface of the oral portion of the seal-forming structure can be configured such that conforming one textile patient-contacting surface to the patient's profile does not significantly affect the shape or contour of the other textile patient-contacting surface. In some examples, the textile patient-contacting surface of the nasal portion of the seal-forming structure and the textile patient-contacting surface of the oral portion of the seal-forming structure can be formed from a compliant textile material. In some examples, the textile patient-contacting surface can be attached to the seal-forming structure through an overmolding process.

[0096] Aspects of the present technology relate to a patient interface that includes a plenum chamber that, in use, maintains ambient air pressure throughout the patient's breathing cycle. than At least 6cmH2O expensiveThe patient interface is pressurizable to a therapeutic pressure. The seal-forming structure defines at least a portion of a plenum chamber. The seal-forming structure may be 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 includes a nasal portion and an oral portion. The nasal portion has at least one nasal hole configured to deliver an airflow at therapeutic pressure to an entrance to the patient's nares in use. The oral portion has an oral hole configured to deliver an airflow at therapeutic pressure to an entrance to the patient's mouth in use. The seal-forming structure is constructed and arranged to maintain a therapeutic pressure in the plenum chamber throughout the patient's respiratory cycle in use. The patient interface further includes a shell defining at least a portion of the plenum chamber and having one or more plenum chamber inlet ports. The plenum chamber inlet ports are sized and configured to receive an airflow at therapeutic pressure for breathing by the patient throughout the patient's respiratory cycle in use. The shell supports the seal-forming structure. The patient interface further includes a positioning and stabilizing structure configured to generate a force to hold the seal-forming structure in a therapeutically effective position on the patient's head. The nasal portion of the seal-forming structure has a textile patient-contacting surface that surrounds an entrance to the patient's nares. The oral portion of the seal-forming structure has a textile patient-contacting surface that surrounds an entrance to the patient's mouth. The interface is configured such that, in use, a major curvature of the textile patient-contacting surface of the nasal portion of the seal-forming structure occurs around a first surface and a major curvature of the textile patient-contacting surface of the oral portion of the seal-forming structure occurs around a second surface, the first surface and the second surface being non-parallel.

[0097] In some examples, the textile patient-contacting surface of the nasal portion of the seal-forming structure and the textile patient-contacting surface of the oral portion of the seal-forming structure can be joined to one another by a textile connector. In some examples, the textile patient-contacting surface of the nasal portion of the seal-forming structure and the textile patient-contacting surface of the oral portion of the seal-forming structure can be configured such that conforming one textile patient-contacting surface to the patient's profile does not significantly affect the shape or contour of the other textile patient-contacting surface. In some examples, the textile patient-contacting surface of the nasal portion of the seal-forming structure and the textile patient-contacting surface of the oral portion of the seal-forming structure can be formed from a compliant textile material.

[0098] Aspects of the present technology relate to a patient interface including a plenum chamber including a seal-forming structure, a shell, and a positioning and stabilizing structure. An at least partially anterior wall of a nasal portion of the seal-forming structure includes two lateral support portions, each laterally spaced apart, each having a higher resistance to deformation compared to an adjacent portion of the seal-forming structure.

[0099] Aspects of the present technology relate to a patient interface that includes: ambient air pressure throughout the patient's breathing cycle when in use; than At least 6cmH2O expensivea plenum chamber pressurizable to a therapeutic pressure, the plenum chamber having an oral portion and a nasal portion, the plenum chamber including: a seal-forming structure constructed and arranged to form a seal with an area of ​​a patient's face surrounding an entrance to the patient's airways, the nasal portion of the seal-forming structure having at least one nasal opening configured to deliver an airflow at the therapeutic pressure in use to an entrance to the patient's nares, and the oral portion of the seal-forming structure having an oral opening configured to deliver an airflow at the therapeutic pressure in use to an entrance to the patient's mouth, the seal-forming structure constructed and arranged to maintain the therapeutic pressure in the plenum chamber throughout the patient's respiratory cycle; and a shell having one or more plenum chamber inlet ports sized and configured to receive an airflow at the therapeutic pressure in use for breathing by the patient throughout the patient's respiratory cycle, the shell supporting the seal-forming structure; and a positioning and stabilizing structure configured to generate a force to hold the seal-forming structure in a therapeutically effective position on the patient's head. The shell is joined to the oral portion of the plenum chamber, and substantially the entire nasal portion is formed by the seal-forming structure, the nasal portion of the plenum chamber including posterior corners configured to engage the patient's face near the nasolabial fold, and an at least partially anterior wall of the nasal portion of the seal-forming structure includes two lateral support portions, each laterally spaced apart, and each lateral support portion having a higher resistance to deformation than an adjacent portion of the seal-forming structure.

[0100] In examples of the above two embodiments, (a) each of the lateral support portions may be thicker than adjacent portions of the seal-forming structure, (b) each of the lateral support portions may have a curved upper boundary, and each of the lateral support portions may be substantially fin-shaped, (c) the nasal portion of the seal-forming structure may include a central portion configured to seal against the lower periphery of the patient's nares surrounding the patient's nose and the patient's upper lip in use, the central portion being thinner than the lateral support portions, (d) the nasal portion of the seal-forming structure may have an intermediate portion provided between the central portion and the lateral support portions, the intermediate portion being thicker than the central portion, (e) the intermediate portion may be thinner than the lateral support portions, (f) the shell may include posterior protruding portions configured to stiffen the seal-forming structure at the base of the nasal portions in use, and / or (g) the seal-forming structure may be configured not to engage the patient's face below the chin in use.

[0101] Aspects of the present technology relate to a patient interface including a plenum chamber, the plenum chamber including a seal-forming structure, a shell, and a positioning and stabilizing structure, the shell including two lateral support portions that project upwardly into a wall at least partially anterior to a nose portion of the seal-forming structure, the lateral support portions being laterally spaced apart.

[0102] Aspects of the present technology relate to a patient interface that includes: ambient air pressure throughout the patient's breathing cycle when in use; than At least 6cmH2O expensivea plenum chamber pressurizable to a therapeutic pressure, the plenum chamber having an oral portion and a nasal portion, the plenum chamber including: a seal-forming structure constructed and arranged to form a seal with an area of ​​a patient's face surrounding an entrance to the patient's airways, the nasal portion of the seal-forming structure having at least one nasal opening configured to deliver an airflow at the therapeutic pressure in use to an entrance to the patient's nares, and the oral portion of the seal-forming structure having an oral opening configured to deliver an airflow at the therapeutic pressure in use to an entrance to the patient's mouth, the seal-forming structure constructed and arranged to maintain the therapeutic pressure in the plenum chamber throughout the patient's respiratory cycle; and a shell configured to support the seal-forming structure, the shell having one or more plenum chamber inlet ports sized and configured to receive an airflow at the therapeutic pressure in use for breathing by the patient throughout the patient's respiratory cycle; and a positioning and stabilizing structure configured to generate a force to hold the seal-forming structure in a therapeutically effective position on the patient's head. The shell includes two lateral support portions that project upwardly into a wall at least partially forward of the nose portion of the seal-forming structure, the lateral support portions being laterally spaced apart.

[0103] In examples of the above two embodiments, (a) each of the lateral support portions may have a curved upper boundary, (b) the curvature of the curved upper boundary may substantially match or substantially follow the curvature of the upper periphery of the seal-forming structure, (c) the shell may include two plenum chamber inlet ports, and / or (d) the upper boundary of each of the two plenum chamber inlet ports may be formed by a respective lateral support portion.

[0104] Aspects of the present technology relate to a patient interface including a plenum chamber. The plenum chamber includes: one or more walls; a seal-forming structure; one or more plenum chamber inlet ports; and a positioning and stabilizing structure. The seal-forming structure includes a central portion configured to seal around the lower part of the patient's nose in use. The seal-forming structure includes an intermediate portion configured to contact the ala of the patient's nose in use. The intermediate portion has a higher stiffness than the central portion.

[0105] Aspects of the present technology relate to a patient interface that includes: a plenum chamber for the patient interface, the plenum chamber being configured to maintain ambient air pressure throughout the patient's breathing cycle in use; than At least 6cmH2O expensive a plenum chamber pressurizable to a therapeutic pressure, the plenum chamber including one or more walls at least partially enclosing a volume of space; a seal-forming structure constructed and arranged to form a seal with an area of ​​a patient's face surrounding an entrance to the patient's airways, the seal-forming structure including a nasal portion having at least one nasal hole configured to deliver an airflow at the therapeutic pressure to an entrance to the patient's nares in use, and an oral portion having an oral hole configured to deliver an airflow at the therapeutic pressure to an entrance to the patient's mouth in use, the seal-forming structure constructed and arranged to maintain the therapeutic pressure in the plenum chamber throughout the patient's respiratory cycle; and one or more plenum chamber inlet ports sized and configured to receive the airflow at the therapeutic pressure for breathing by the patient throughout the patient's respiratory cycle in use, and a positioning and stabilizing structure configured to generate a force to hold the seal-forming structure in a therapeutically effective position on the patient's head. The seal-forming structure includes a central portion configured to seal around the lower part of the patient's nose in use. The seal-forming structure includes an intermediate portion configured to contact the ala of the patient's nose in use, the intermediate portion having a greater stiffness than the central portion.

[0106] In examples of the above two embodiments, (a) the intermediate portion may include a pair of opposing outer walls of the seal-forming structure partially in a medial direction and partially in an upward direction; (b) the intermediate portion may be configured to resist wrinkling; (c) the intermediate portion may be configured to limit the formation of leakage paths due to wrinkling beyond the area below the patient's nose; (d) the intermediate portion may be thicker than the central portion; and / or (e) the seal-forming structure may be configured to engage the patient's face below the chin in use.

[0107] Aspects of the present technology relate to a patient interface including a plenum chamber. The plenum chamber includes: one or more walls; a seal-forming structure; and one or more plenum chamber inlet ports sized and configured, in use, to receive airflow at a therapeutic pressure for breathing by the patient throughout the patient's respiratory cycle; and a positioning and stabilizing structure. The seal-forming structure includes lateral peripheral support portions on opposite sides of the oral cavity, the lateral peripheral support portions adjacent the oral cavity periphery and being stiffer than the oral cavity periphery.

[0108] Aspects of the present technology relate to a patient interface that includes: a plenum chamber for the patient interface, the plenum chamber configured to provide a pressure equal to or greater than ambient air pressure throughout the patient's breathing cycle in use; than At least 6cmH2O expensivea plenum chamber pressurizable to a therapeutic pressure, the plenum chamber including one or more walls at least partially enclosing a volume of space; a seal-forming structure constructed and arranged to form a seal with an area of ​​a patient's face surrounding an entrance to the patient's airways, the seal-forming structure including a nose portion having at least one nasal orifice configured to deliver an airflow at the therapeutic pressure to an entrance to the patient's nostrils in use, and an oral portion having an oral orifice configured to deliver an airflow at the therapeutic pressure to an entrance to the patient's mouth in use, the seal-forming structure constructed and arranged to maintain the therapeutic pressure in the plenum chamber throughout the patient's respiratory cycle; and one or more plenum chamber inlet ports sized and configured to receive the airflow at the therapeutic pressure for breathing by the patient throughout the patient's respiratory cycle in use; and a positioning and stabilizing structure configured to generate a force to hold the seal-forming structure in a therapeutically effective position on the patient's head. The seal-forming structure includes an oral orifice periphery surrounding at least a majority of the oral orifice configured to surround the patient's mouth in use. The seal-forming structure includes lateral peripheral support portions disposed on opposite lateral sides of the oral cavity, the lateral peripheral support portions being adjacent to the oral cavity periphery and being stiffer than the oral cavity periphery.

[0109] In examples of the above two embodiments, (a) the lateral peripheral support portions may be thicker than the oral cavity periphery, (b) the seal-forming structure may include rearward-facing lateral portions that surround most of the oral cavity periphery, the rearward-facing lateral portions being thicker than the oral cavity periphery, (c) the rearward-facing lateral portions may extend medially to the lateral-most edges of the oral cavity to form the lateral peripheral support portions, and / or (d) the seal-forming structure may be configured not to engage the patient's face below the chin in use.

[0110] Aspects of the present technology relate to a plenum chamber for a patient interface, the plenum chamber including: one or more walls; one or more plenum chamber inlet ports; a seal-forming structure; and a positioning and stabilizing structure. The seal-forming structure includes a nasal portion configured to seal around the underside of a patient's nose in use. The nasal portion has a central portion configured to be positioned below the patient's nasal tip in use and an intermediate portion configured to contact corresponding alar sections of the patient in use, the intermediate section being stiffer than the central portion.

[0111] Aspects of the present technology relate to a plenum chamber for a patient interface that, in use, maintains ambient air pressure throughout the patient's breathing cycle. than At least 6cmH2O expensive the plenum chamber being pressurizable to a therapeutic pressure and including: one or more walls at least partially enclosing a volume of space; one or more plenum chamber inlet ports sized and configured to, in use, receive an airflow at the therapeutic pressure for breathing by the patient throughout the patient's respiratory cycle; and 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 airways, the seal-forming structure including a nasal portion having at least one nasal hole configured to, in use, deliver the airflow at said therapeutic pressure to an entrance to the patient's nares, and the seal-forming structure including an oral portion having an oral hole configured to, in use, deliver the airflow at said therapeutic pressure to an entrance to the patient's mouth, the seal-forming structure constructed and arranged to, in use, maintain said therapeutic pressure in the plenum chamber throughout the patient's respiratory cycle; and a positioning and stabilizing structure configured to generate a force to hold the seal-forming structure in a therapeutically effective position on the patient's head. The seal-forming structure includes a nose portion configured to seal around the underside of the patient's nose in use, the nose portion having a central portion configured to be positioned below the patient's nasal tip in use and an intermediate portion configured to contact the patient's corresponding ala in use, the intermediate portion being stiffer than the central portion.

[0112] In examples of the above two embodiments, (a) the middle portion of the seal-forming structure may be thicker than the central portion, (b) the central portion of the seal-forming structure may include a forward-facing central portion and an upward-facing central portion, (c) the middle portions may each include an upward-facing central portion and a forward-facing central portion, and the forward-facing central portion may be thinner than the forward-facing central portion, (d) the side portions of the nose portion may be configured to retract inward toward the patient's ala when a force below the patient's ala is applied from the patient's nose to the central portion, and / or (e) the seal-forming structure may be configured not to engage the patient's face below the chin during use.

[0113] Aspects of the present technology relate to a patient interface including a plenum chamber. The plenum chamber includes: one or more walls; one or more plenum chamber inlet ports; a seal-forming structure; and a positioning and stabilizing structure. The seal-forming structure includes a nose portion configured to seal around the underside of a patient's nose, the nose portion of the seal-forming structure having a pair of nostrils configured to deliver airflow to corresponding nostrils in use, the seal-forming structure including a bridge portion between the pair of nostrils, the bridge portion being disposed between a central portion of the nose portion configured to be positioned below the patient's nasal tip in use and an upper lip portion of the nose portion configured to seal against the patient's upper lip in use, the bridge portion being flexible such that the central portion can move away from the upper lip in use.

[0114] Aspects of the present technology relate to a patient interface that includes: a plenum chamber for the patient interface, the plenum chamber configured to provide a pressure equal to or greater than ambient air pressure throughout the patient's breathing cycle in use; than At least 6cmH2O expensivethe plenum chamber being pressurizable to a therapeutic pressure and including: one or more walls at least partially enclosing a volume of space; one or more plenum chamber inlet ports sized and configured to, in use, receive an airflow at the therapeutic pressure for breathing by the patient throughout the patient's respiratory cycle; and 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 airways, the seal-forming structure including a nasal portion having at least one nasal hole configured to, in use, deliver the airflow at said therapeutic pressure to an entrance to the patient's nares, and an oral portion having an oral hole configured to, in use, deliver the airflow at said therapeutic pressure to an entrance to the patient's mouth, the seal-forming structure configured to, in use, deliver the airflow at said therapeutic pressure to an entrance to the patient's mouth, the seal-forming structure configured to, in use, deliver the airflow within the plenum chamber. a seal-forming structure constructed and arranged to maintain said therapeutic pressure throughout the patient's respiratory cycle; and a positioning and stabilising structure configured to generate a force to hold the seal-forming structure in a therapeutically effective position on the patient's head, wherein the seal-forming structure includes a nasal portion configured to seal around the underside of the patient's nose, the nasal portion of the seal-forming structure having a pair of nostrils configured to deliver airflow to corresponding nares of the patient in use, the seal-forming structure including a bridge portion between the pair of nostrils, the bridge portion being located between a central portion of the nasal portion configured to be positioned below the patient's nasal tip in use and an upper lip portion of the nasal portion configured to seal against the patient's upper lip in use, the bridge portion being flexible so as to allow the central portion to move away from the upper lip in use.

[0115] In examples of the above two embodiments, (a) the bridge portion includes a curved portion configured to straighten when the central portion is moved away from the upper lip; (b) in use, the curved portion may be configured to extend away from the patient's nose in an undeformed state and be configured to straighten when the central portion is moved away from the upper lip; and / or (c) in use, the bridge portion may allow the central portion to move anteriorly relative to the patient to accommodate the patient's nasal tip and thereby accommodate noses of different lengths (without disengaging the upper lip portion from the patient's upper lip when the patient interface is worn by the patient).

[0116] Aspects of the present technology relate to a plenum chamber for a patient interface that includes: one or more plenum chamber inlet ports; and a seal-forming structure, wherein a first surface finish is provided on a first surface of a nasal portion configured to engage a patient's face, and a second surface finish is provided on a second surface of an oral portion configured to engage a patient's face, the second surface finish being different from the first surface finish.

[0117] Aspects of the present technology relate to a plenum chamber for a patient interface that, in use, maintains ambient air pressure throughout the patient's breathing cycle. than At least 6cmH2O expensiveThe device is pressurizable to a therapeutic pressure, and the plenum chamber includes: one or more plenum chamber inlet ports sized and configured to receive an airflow 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 an entrance to the patient's airways. The seal-forming structure includes a nasal portion having at least one nasal hole configured to deliver the airflow at the therapeutic pressure to an entrance to the patient's nares in use, and the seal-forming structure includes an oral portion having an oral hole configured to deliver the airflow at the therapeutic pressure to an entrance to the patient's mouth in use, the seal-forming structure constructed and arranged to maintain the therapeutic pressure in the plenum chamber throughout the patient's respiratory cycle. A first surface of the nasal portion configured to engage the patient's face has a first surface finish, and a second surface of the oral portion has a second surface finish different from the first surface finish.

[0118] In examples of the above two embodiments, (a) the first surface finish and the second surface finish may differ such that the coefficient of friction between the seal-forming structure and the patient's face is higher in the oral portion than in the nasal portion; (b) the first surface finish may be configured so that the nasal portion feels smoother on the patient's face; (c) the second surface finish may be configured so that the oral portion feels grippier on the patient's face; (d) the first surface finish may be a matte surface finish; (e) the second surface finish may be a mirror surface finish; (f) the interface between the first surface finish and the second surface finish may be located on a portion of the seal-forming structure configured to contact the patient's cheek in use; and / or (e) the seal-forming structure is configured not to engage the patient's face below the chin in use.

[0119] Aspects of the present technology relate to a patient interface including: a plenum chamber according to any one of the above aspects or examples thereof; a positioning and stabilizing structure configured to generate a force to hold a seal-forming structure in a therapeutically effective position on a patient's head, the positioning and stabilizing structure including a tie, the tie constructed and arranged such that in use at least a portion of the tie rests on a region of the patient's head above an upper ear-base point of the patient's head; and a venting structure configured to allow a continuous flow of patient-exhaled gases from an interior of the plenum chamber to the ambient environment, the venting structure being sized and shaped to maintain a therapeutic pressure within the plenum chamber in use. The patient interface is configured to allow the patient to breathe from the ambient environment through their mouth (in the absence of a flow of pressurized air through one or more plenum chamber inlet ports).

[0120] In accordance with aspects of the present technology, there is provided a plenum chamber for a patient interface. The plenum chamber is configured to receive ambient air pressure. than At least 6cmH2O expensivea plenum chamber configured to be pressurizable to a therapeutic pressure, the plenum chamber having an oral portion and a nasal portion, the plenum chamber including: a seal-forming structure constructed and arranged to form a seal with an area of ​​a patient's face surrounding an entrance to the patient's airways, the seal-forming structure having one or more apertures therein such that an airflow at the therapeutic pressure is delivered through the one or more apertures to entrances to the patient's nares and to the patient's mouth, the seal-forming structure constructed and arranged, in use, to maintain the therapeutic pressure in the plenum chamber throughout the patient's respiratory cycle; and a shell having one or more plenum chamber inlet ports sized and configured to receive an airflow at the therapeutic pressure for breathing by the patient, the shell supporting the seal-forming structure, the shell disposed in the oral portion of the plenum chamber, and substantially the entire nasal portion being formed by the seal-forming structure. The lateral support portions included in the seal-forming structure are located on at least partially forward-facing sides spaced laterally from the nose portion, the lateral support portions having a higher resistance to deformation in use than one or more adjacent portions of the seal-forming structure.

[0121] In accordance with another aspect of the present technology, there is provided a plenum chamber for a patient interface, the plenum chamber being configured to receive ambient air pressure. than At least 6cmH2O expensivea plenum chamber configured to pressurize to a therapeutic pressure, the plenum chamber having an oral portion and a nasal portion, the plenum chamber including: a seal-forming structure constructed and arranged to form a seal with an area of ​​a patient's face surrounding an entrance to the patient's airways, the seal-forming structure having one or more apertures therein such that airflow at the therapeutic pressure is delivered to the entrances to the patient's nares and to the patient's mouth through the one or more apertures, the seal-forming structure constructed and arranged, in use, to maintain the therapeutic pressure within the plenum chamber throughout the patient's respiratory cycle; Substantially the entire nasal portion is formed by the seal-forming structure, and the seal-forming structure includes lateral support portions disposed on at least partially forward-facing sides spaced laterally from the nasal portion, the lateral support portions having a higher resistance to deformation in use than one or more adjacent portions of the seal-forming structure.

[0122] In examples: the lateral support portions are portions of the seal-forming structure that have a relatively higher stiffness compared to one or more adjacent portions of the seal-forming structure; the lateral support portions are portions of the seal-forming structure that are supported by the support structure; the support structure is part of a frame or clip-on support portion; the lateral support portions include portions of the seal-forming structure that have a relatively greater thickness compared to one or more adjacent portions of the seal-forming structure; the lateral support portions are disposed substantially directly above portions of the shell; the lateral support portions each have a substantially flat lower boundary; the flat lower boundary is disposed adjacent to the upper edge of the shell; the lateral support portions each have a curved upper boundary. The curvature of the upper boundary can substantially match or substantially follow the curvature of the upper periphery of the seal-forming structure; the lateral support portions are substantially fin-shaped.

[0123] In examples: the seal-forming structure includes a central portion configured, in use, to seal around the lower periphery of the patient's nostril surrounding the patient's nose and against the patient's upper lip, the central portion being thinner than the lateral support portions; the seal-forming structure has intermediate portions disposed between the central portion and the lateral support portions, the thickness of the seal-forming structure being greater at the intermediate portion than at the central portion; the thickness of the seal-forming structure being less at the intermediate portions than at the lateral support portions; the seal-forming structure has laterally facing posterior portions disposed between each intermediate portion and a lateral support portion on each side of the nose portion, the thickness of the seal-forming structure being less at the posteriorly facing portions than at the intermediate portions; at least a portion of each intermediate portion is disposed above and in front of a respective lateral support portion; and at least a portion of each laterally facing posterior portion is disposed above and behind a respective lateral support portion.

[0124] In an example: the seal-forming structure includes a joint between each lateral support portion, the middle portion and the laterally-facing posterior portion, on each lateral side of the nose portion, the joint being located near the uppermost point of the lateral support portion; the joint being located forward of the uppermost point of the lateral support portion.

[0125] In an example: the central portion of the seal-forming structure includes a forward-facing central portion and an upward-facing central portion; the upward-facing central portion and the forward-facing central portion are interconnected by a central saddle region of the nose portion of the seal-forming structure; the upward-facing central portion has a positive curvature in the lateral direction, and the lateral portions of the upward-facing central portion face partially in the medial direction.

[0126] In examples: each of the intermediate portions includes an upwardly facing central portion and a forwardly facing central portion; the upwardly facing central portion and the forwardly facing central portion are interconnected around the upper periphery of the seal-forming structure; the nose portion includes an upper lip portion configured to seal against the patient's upper lip in use; the stiffness of the upper lip portion is similar to the stiffness of the central portion; the wall thickness of the upper lip portion is substantially equal to the wall thickness of the central portion; and the wall thickness of the upper lip portion is less than the wall thickness of the intermediate portion.

[0127] In examples: the nose portion includes posterior corners configured to rest on the patient's face adjacent the nasolabial folds on the patient's face; the posterior corners configured to contact the patient's face on each lateral side of the upper lip; the posterior corners configured to contact the patient's face adjacent areas lateral and inferior to the ala of the nose; and the posterior corners configured to fit between the ala of the patient's nose and the patient's nasolabial folds.

[0128] In examples: the stiffness of the posterior corner is greater than the stiffness of the central nasal portion of the seal-forming structure; the wall thickness of the posterior corner is greater than the wall thickness of the middle portion of the nasal portion; the wall thickness of the posterior corner is less than the wall thickness of the posterior portion facing laterally of the nasal portion; the posterior corner is substantially dome-shaped; and the transition between the posterior corner and the upper lip portion is configured to be positioned below the patient's ala of the nose when in use.

[0129] In an example: the shell includes rearward protruding portions that reinforce the seal-forming structure at the base of the nose portion; the rearward protruding portions are located at the upper lateral corners of the shell; the rearward pointing portions are located inferiorly relative to the lateral support portions; the rearward pointing portions have flat upper edges; and a flat lower boundary of each lateral support portion is located adjacent each rearward pointing portion.

[0130] In examples: the oral cavity portion includes a lower lip portion configured to form a seal against the patient's lower lip, the lower lip portion having a wall thickness substantially equal to the wall thickness of the upper lip portion; the oral cavity portion includes an oral cavity periphery, the wall thickness of the oral cavity periphery being substantially equal to the wall thickness of the upper lip portion; the oral cavity periphery being adjacent to either or both of the upper and lower lip portions; the oral cavity portion has rearward-facing lateral portions on either lateral side of the oral cavity periphery configured to seal against the patient's cheek in use; the wall thickness of the rearward-facing lateral portions is greater than the wall thickness of the oral cavity periphery; the rearward-facing lateral portions are curved in a direction away from contact with the patient's face; the lower lip portion is approximately half the width of the oral opening; the transition between the lower lip portion and the rearward-facing lateral portions on either lateral side of the lower lip portion is configured to rest on or near the labial crease of the patient's face; the lower lip portion is wider around the oral cavity than around the seal-forming structure.

[0131] In examples: the oral portion includes lateral portions at the lateral periphery of the seal-forming structure; the wall thickness of the lateral portions is greater than the wall thickness of the rearward-facing lateral portions; the oral portion includes forward-facing lateral portions in front of the seal-forming structure; the wall thickness of the forward-facing lateral portions is greater than the wall thickness of the lateral portions; the oral portion includes a front support portion in front of the seal-forming structure; the wall thickness of the front support portion is greater than the wall thickness of the forward-facing lateral portions; the oral portion includes two front support portions near the upper lateral corners of the shell; the oral portion includes two front support portions near the lower lateral corners of the shell.

[0132] In examples: the plenum chamber includes a single plenum chamber inlet port; the single plenum chamber inlet port is centrally located within the shell; the plenum chamber inlet port is configured to connect to the frame; and the plenum chamber inlet port is substantially circular.

[0133] In accordance with another aspect of the present technology, there is provided a plenum chamber for a patient interface, the plenum chamber being configured to receive ambient air pressure. than At least 6cmH2O expensive a patient interface including a plenum chamber configured to support the seal-forming structure, the plenum chamber having an oral portion and a nasal portion, the plenum chamber being pressurizable to a therapeutic pressure, the plenum chamber having an oral portion and a nasal portion, the plenum chamber including: a seal-forming structure constructed and arranged to form a seal with an area of ​​a patient's face surrounding an entrance to the patient's airways, the seal-forming structure having one or more apertures therein such that an airflow at the therapeutic pressure is delivered through the apertures to the entrances to the patient's nares and to the patient's mouth, the seal-forming structure constructed and arranged, in use, to maintain the therapeutic pressure in the plenum chamber throughout the patient's respiratory cycle; and a shell configured to support the seal-forming structure, the shell having one or more plenum chamber inlet ports sized and configured to receive the airflow at the therapeutic pressure for breathing by the patient. The shell includes lateral support portions that project upwardly into the nasal portion of the patient interface on at least partially forward-facing sides spaced laterally from the nasal portion.

[0134] In examples: the lateral support portions each have a curved upper boundary; the curvature of the upper boundary substantially matches or substantially follows the curvature of the upper periphery of the seal-forming structure; and the lateral support portions are substantially fin-shaped.

[0135] In an example: the plenum chamber includes two plenum chamber inlet ports; the plenum chamber inlet ports are located on lateral sides of the shell; the plenum chamber inlet ports are configured to connect to a conduit; the plenum chamber inlet ports are approximately oval; and an upper periphery of the two plenum chamber inlet ports is formed by a respective one of the lateral support portions.

[0136] In accordance with another aspect of the present technology, there is provided a plenum chamber for a patient interface, the plenum chamber being configured to receive ambient air pressure. than At least 6cmH2O expensive and a plenum chamber configured to receive an airflow at the therapeutic pressure for breathing by the patient, the plenum chamber being pressurizable to a therapeutic pressure, the plenum chamber including: one or more walls at least partially enclosing a volume of space; 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 airways, the seal-forming structure having one or more holes therein such that an airflow at the therapeutic pressure is delivered to entrances to the patient's nares and to the patient's mouth through the one or more holes, the seal-forming structure constructed and arranged, in use, to maintain the therapeutic pressure in the plenum chamber throughout the patient's respiratory cycle; and one or more plenum chamber inlet ports sized and configured to receive an airflow at the therapeutic pressure for breathing by the patient, the seal-forming structure including a central portion configured to seal around the lower part of the patient's nose surrounding the patient's nares and the patient's upper lip in use, and an intermediate portion configured to be positioned at or adjacent the ala of the patient's nose in use, the intermediate portion being stiffer than the central portion.

[0137] In examples: one or more walls may comprise part or all of the seal-forming structure; one or more walls may be separate from the seal-forming structure; the middle portion comprises a pair of outer walls of the seal-forming structure that face partially medially and partially upwardly; the middle portion is configured to resist wrinkling; and the middle portion is configured to limit the formation of leak paths due to wrinkling beyond the area below the patient's nose.

[0138] In accordance with another aspect of the present technology, there is provided a plenum chamber for a patient interface, the plenum chamber being configured to receive ambient air pressure. than At least 6cmH2O expensive the plenum chamber is pressurizable to a therapeutic pressure and includes: one or more walls at least partially enclosing a volume of space; a seal-forming structure constructed and arranged to form a seal with an area of ​​a patient's face surrounding an entrance to the patient's airway, the seal-forming structure having at least one hole therein such that airflow at the therapeutic pressure is directed through the at least one hole to the entrance to the patient's nares and to the patient's mouth, respectively, the seal-forming structure constructed and arranged to maintain the therapeutic pressure in the plenum chamber throughout the patient's respiratory cycle in use; and one or more plenum chamber inlet ports sized and configured to receive the airflow at the therapeutic pressure for breathing by the patient. The seal-forming structure includes an oral cavity periphery surrounding at least a majority of the oral cavity configured to surround the patient's mouth in use, and lateral peripheral support portions on opposite lateral sides of the oral cavity, the lateral peripheral support portions having a greater rigidity than the oral cavity periphery.

[0139] In some embodiments, the wall thickness of the lateral peripheral support portions is greater than the wall thickness of the oral cavity periphery; the seal-forming structure includes rearward-facing lateral portions that surround most of the oral cavity periphery, the rearward-facing lateral portions having a greater thickness than the oral cavity periphery; the rearward-facing lateral portions form the lateral peripheral support portions. The rearward-facing lateral portions extend medially to the lateral-most edges of the oral cavity to form the lateral peripheral support portions; the lateral support portions provide resistance to buckling of the seal-forming structure.

[0140] In accordance with another aspect of the present technology, there is provided a plenum chamber for a patient interface, the plenum chamber being configured to receive ambient air pressure. than At least 6cmH2O expensive a plenum chamber pressurizable to a therapeutic pressure, the plenum chamber including: one or more walls at least partially enclosing a volume of space; one or more plenum chamber inlet ports sized and configured to receive an airflow at the therapeutic pressure for breathing by a patient; and 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 airways, the seal-forming structure having one or more holes therein such that an airflow at the therapeutic pressure is delivered through the one or more holes to entrances to the patient's nares and to the patient's mouth, 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 nasal portion configured to form a seal around the underside of the patient's nose in use, the nasal portion having a central portion configured to be positioned below the patient's nasal tip in use and an intermediate portion configured to be positioned adjacent the patient's ala in use, the seal-forming structure having a stiffness greater in the intermediate portion than in the central portion.

[0141] In examples: the wall thickness of the intermediate portions of the seal-forming structure is greater than the wall thickness of the central portion; the intermediate portions may each include a medially facing wall configured to rest on or near the ala of the patient's nose in use; the central portions of the seal-forming structure include a forward-facing central portion and an upward-facing central portion; the upward-facing central portion and the forward-facing central portion are interconnected by a central saddle region of the nose portion of the seal-forming structure; the upward-facing central portion includes a positive curvature in the lateral direction, and the sides of the upward-facing central portion face partially in the medial direction; the intermediate portions each include an upward-facing central portion and a forward-facing central portion; the upward-facing central portion and the forward-facing central portion the forward-facing central portion are interconnected around the entire upper periphery of the seal-forming structure; the central saddle portion includes a wall thickness equal to that of the central portion; the wall thickness of the forward-facing central portion is less than the wall thickness of the forward-facing middle portion; when a downward force is applied to the central portion from the patient's nose, the sides of the nose portion are drawn inwardly toward the patient's ala; the middle portion is drawn inward to rest on or near the patient's ala; the nose portion includes an upper lip portion configured to seal against the patient's upper lip in use; the stiffness of the upper lip portion is similar to the stiffness of the central portion; the wall thickness of the upper lip portion is substantially equal to the wall thickness of the central portion; and the wall thickness of the upper lip portion is less than the wall thickness of the middle portion.

[0142] In accordance with another aspect of the present technology, there is provided a plenum chamber for a patient interface, the plenum chamber being configured to receive ambient air pressure. than At least 6cmH2O expensiveThe plenum chamber is pressurizable to a therapeutic pressure and includes: one or more walls at least partially enclosing a volume of space; one or more plenum chamber inlet ports sized and configured to receive an airflow 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 an entrance to the patient's airways, the seal-forming structure having a plurality of holes therein such that an airflow at the therapeutic pressure is delivered through the plurality of holes to the entrances to the patient's nares and to the patient's mouth, the seal-forming structure constructed and arranged to maintain the therapeutic pressure in the plenum chamber throughout the patient's respiratory cycle, in use. The plenum chamber includes a nose portion, a seal-forming structure within the nose portion configured to seal around the lower part of the patient's nose, the seal-forming structure defining a pair of nostrils configured to deliver airflow to the patient's nasal air passages in use, the seal-forming structure including a bridge portion between the pair of nostrils, the bridge portion being centrally located between a central portion and an upper lip portion of the seal-forming structure within the nose portion, and relaxation of the bridge portion allowing the central portion to move away from the posterior region.

[0143] In examples: the bridge portion includes a curved portion configured to straighten when the central portion is moved away from the upper lip; the curved portion includes a single curve; the curved portion includes two curves; the curved portion is approximately S-shaped when viewed from the side; the curved portion includes a sawtooth shape; the curved portion includes one or more folds; the bridge portion is dependent downwardly relative to the central portion and can straighten when the central portion is moved away from the upper lip; the bridge portion allows the central portion to move to accommodate the patient's nose (when the patient interface is worn by the patient); the bridge portion allows the central portion to move in an anterior direction to accommodate the patient's nasal tip (when the patient interface is worn by the patient).

[0144] In accordance with another aspect of the present technology, there is provided a plenum chamber for a patient interface, the plenum chamber being configured to receive ambient air pressure. than At least 6cmH2O expensive the plenum chamber is pressurizable to a therapeutic pressure and includes: one or more plenum chamber inlet ports sized and configured to receive an airflow 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 airways, the seal-forming structure having one or more holes therein such that an airflow at the therapeutic pressure is delivered through the one or more holes to the entrances to the patient's nares and to the patient's mouth, the seal-forming structure constructed and arranged to maintain the therapeutic pressure in the plenum chamber throughout the patient's respiratory cycle in use; the seal-forming structure includes a nasal portion configured to form a seal against the patient's face at or near the patient's nose and an oral portion configured to form a seal against the patient's face around the patient's mouth, the seal-forming structure having a first surface finish on the nasal portion and a second surface finish on the oral portion that is different from the first surface finish.

[0145] In examples: the first surface finish and the second surface finish are different such that the coefficient of friction between the seal-forming structure and the patient's face is higher in the oral portion than in the nasal portion; the first surface finish is configured to provide a smooth feel on the patient's face in the nasal portion (e.g., for comfort); the second surface finish is configured to provide a grippy contact on the patient's face in the oral portion (e.g., for a more robust seal); the first surface finish may be a matte surface finish; the second surface finish may be a mirror surface finish; the interface between the first surface finish and the second surface finish may be located at a portion of the seal-forming structure that contacts the patient's cheek in use; the nasal portion may include an upper lip portion having the first surface finish; the non-patient-contacting surface of the nasal portion may include a surface finish other than the first surface finish; and the non-patient-contacting surface of the nasal portion may include the second surface finish.

[0146] In accordance with another aspect of the present technology, there is provided a patient interface including: a plenum chamber according to the aspect of the present technology described above; a positioning and stabilizing structure for providing a force to hold the seal-forming structure in a therapeutically effective position on a patient's head, the positioning and stabilizing structure including a tie, the tie constructed and arranged such that in use at least a portion of the tie rests on a region of the patient's head above an upper ear-base point of the patient's head; and a venting structure configured to allow a continuous flow of patient-exhaled gases from an interior of the plenum chamber to the ambient environment, the venting structure being sized and shaped to maintain a therapeutic pressure within the plenum chamber in use. The patient interface is configured to allow the patient to breathe from the ambient environment through their mouth in the absence of a flow of pressurized air through the plenum chamber inlet port.

[0147] 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.

[0148] One aspect of the present technology is a method for manufacturing a device.

[0149] 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 or acumen, or individuals with limited experience using such medical devices.

[0150] One aspect of one form of the present technology is a portable RPT device that can be carried by a person (e.g., around the home).

[0151] An 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.An 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.

[0152] The described methods, systems, devices, and apparatus may be implemented to enable improved functionality in a processor (e.g., a processor in a special purpose computer, a respiratory monitor, and / or a respiratory treatment device). Further, the described methods, systems, devices, and apparatus enable advancements in the art of automated management, monitoring, and / or treatment of respiratory disorders (e.g., sleep-disordered breathing).

[0153] Of course, some of the above aspects may form sub-aspects of the present technology, and various sub-aspects and / or aspects may be combined in various ways to form further aspects or sub-aspects of the present technology.

[0154] Other features of the present technology will become apparent in light of the information contained in the following detailed description, abstract, drawings, and claims. [Brief explanation of the drawings]

[0155] The present technology is illustrated by way of example and not limitation in the accompanying drawings, in which like reference numerals include like elements:

[0156] 4.1 Treatment System

[0157] [Figure 1A] A system is shown including a patient 1000 wearing a patient interface 3000, which takes the form of nasal pillows and receives air at positive pressure supplied by an RPT device 4000. The air from the RPT device 4000 is humidified by a humidifier 5000 and travels along an air circuit 4170 to the patient 1000. A bed companion 1100 is also shown. The patient is sleeping in a supine sleeping position. [Figure 1B]A system is shown including a patient 1000 wearing a patient interface 3000, which takes the form of a nasal mask and receives air at positive pressure supplied by an RPT device 4000. The air from the RPT device is humidified by a humidifier 5000 and travels along an air circuit 4170 to the patient 1000. [Figure 1C] The system includes a patient 1000 wearing a patient interface 3000. The patient interface 3000 takes the form of a full face mask and receives a positive pressure air supply from an RPT device 4000. Air from the RPT device is humidified by a humidifier 5000 and travels along an air circuit 4170 to the patient 1000. The patient is sleeping in a lateral sleep position. 4.2 Respiratory System and Facial Anatomy [Figure 2A] Outline of the human respiratory system including the nasal and oral cavities, larynx, vocal folds, 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, alae of the nose, nasolabial folds, and corners of the mouth. 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]

[0023] Figure 1 is a further lateral view of the head, showing the approximate locations of the Frankfort horizontal and nasolabial angle. The coronal view is also shown. [Figure 2F] A bottom view of the nose including several features including the nasolabial fold, lower lip, upper lip vermilion, nostrils, subnasal point, columella, nasal tip, major axis of the nostrils and midsagittal plane. [Figure 2G]FIG. 1 is a side view of the surface features of the nose. [Figure 2H] Shown are the subcutaneous structures of the nose, including the lateral nasal cartilages, nasal septum cartilage, greater alar cartilage, lesser alar cartilage, nasal sesamoid cartilage, nasal bones, epidermis, adipose tissue, frontal process of the maxilla, and fibro-adipose tissue. [Figure 2I] The mid-nasal incision is shown approximately a few millimeters from the midsagittal plane, with particular attention paid to the nasal septum cartilage and the medial crus of the greater alar cartilage. [Figure 2J] FIG. 1 is a frontal bony view of the skull, including the frontal, nasal, and cheekbones, with the nasal turbinates shown along with the maxilla and mandible. [Figure 2K] Lateral view of the skull, showing the outline of the head surface and some muscles. The following bones are shown: frontal, sphenoid, nasal, zygomatic, maxilla, mandible, parietal, temporal, and occipital. The mental protuberance is shown. The following muscles are shown: digastric, masseter, sternocleidomastoid, and trapezius. [Figure 2L] Shows the anterolateral side of the nose. 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] 3C is a schematic cross-sectional view of the structure cut at a point, showing the outward normal at this point, where the curvature at this point has a positive sign and a relatively large magnitude compared to the magnitude of the curvature shown in FIG. [Figure 3C] 3B is a schematic cross-sectional view of the structure cut at a point, showing the outward normal at this point, where the curvature at this point has a positive sign and a relatively small magnitude compared to the magnitude of the curvature shown in FIG. [Figure 3D] Schematic cross-section of a structure cut at a point, where the outward normal at this point is shown and the curvature value at this point is zero. [Figure 3E] 3B is a schematic cross-sectional view of the structure cut at a point, showing the outward normal at this point. The curvature at this point has a negative sign and a relatively small magnitude compared to the magnitude of the curvature shown in FIG. 3F. [Figure 3F] 3B is a schematic cross-sectional view of the structure cut at a point, showing the outward normal at this point, where the curvature at this point has a negative sign and a relatively large magnitude compared to the magnitude of the curvature shown in FIG. [Figure 3G] 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 shown. [Figure 3H] 1 shows a cushion for a mask. The outer surface of the cushion is illustrated. The edge of the surface is illustrated. The path on the surface between points A and B is illustrated. The linear distance between A and B is illustrated. Two saddle regions and a dome region are illustrated. [Figure 3I] The surface of a structure is shown, with a one-dimensional hole drilled into the surface. The planar curves shown form the boundary of the one-dimensional hole. [Figure 3J] 3B is a cross-sectional view through the structure of Figure 3I. The surfaces shown bound a two-dimensional hole in the structure of Figure 3I. [Figure 3K] 3I includes a two-dimensional hole and a one-dimensional hole, and the surfaces bounding the two-dimensional hole in the structure of FIG. 3I are also shown. [Figure 3L] 1 shows a mask with an inflatable bladder as a cushion. [Figure 3M] 3L is a cross-sectional view of the mask of FIG. 3L showing the inner surface of the bladder, which bounds the two-dimensional hole in the mask. [Figure 3N] 3D shows a further cross section through the mask of FIG. 3L, with the interior surface also shown. [Figure 3O] Demonstrates the left-hand rule. [Figure 3P] Demonstrates the right-hand rule. [Figure 3Q] 1 shows the left ear including the left ear helix. [Figure 3R] The right ear is shown, including the right ear helix. [Figure 3S] Shows a right-handed spiral. [Figure 3T] 1 is a diagram of a mask including the signature of the twist of the space curve defined by the edges of the sealing membrane in different regions of the mask. [Figure 3U] A diagram of the plenum chamber 3200 showing the sagittal and medial contact planes. [Figure 3V] A posterior view of the plenum chamber of Figure 3U. Directions in the figure are perpendicular to the central contact plane. In Figure 3V, a sagittal plane bisects the plenum chamber into a left-hand side and a right-hand side. [Figure 3W] 3V is a cross-sectional view through the plenum chamber of FIG. 3V, the cross-section being taken in the sagittal plane shown in FIG. 3V. The "central contact" plane is shown. The central contact plane is perpendicular to the sagittal plane. The orientation of the central contact plane corresponds to the orientation of the tendon 3209. This tendon rests on the sagittal plane and contacts only the cushion of the plenum chamber at two points on the sagittal plane (i.e., superior point 3220 and inferior point 3229). Depending on the geometry of the cushion in this region, the central contact plane may contact both the superior and inferior points. [Figure 3X] The plenum chamber 3200 of Figure 3U 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 3X, the plenum chamber 3200 is that of a nasal mask, with the upper point 3220 resting approximately on the selion and the lower point 3229 resting on the upper lip. 4.4 RPT Device [Figure 4A] 1 shows an RPT device in accordance with one form of the present technology. [Figure 4B] 4.5 Humidifiers [Figure 5A] FIG. 10 is an isometric view of a humidifier in accordance with one form of the present technology. [Figure 5B] FIG. 10 is an isometric view of a humidifier in accordance with one form of the present technology, showing the humidifier reservoir 5110 removed from the humidifier reservoir dock 5130. [Figure 5C] The humidifier controller 5250 is shown. 4.6 Respiration Waveform [Figure 6A] A model of a typical human breathing waveform during sleep is shown. 4.7 Example of a patient interface for this technology [Figure 7] FIG. 32 is a front view of a plenum chamber 3200 in accordance with one form of the present technology. [Figure 8] FIG. 8 is a rear view of the plenum chamber 3200 of FIG. [Figure 9] FIG. 8 is a side view of the plenum chamber 3200 of FIG. [Figure 10] FIG. 8 is a top view of the plenum chamber 3200 of FIG. [Figure 11] FIG. 8 is a bottom view of the plenum chamber 3200 of FIG. [Figure 12] FIG. 8 is a perspective view of the plenum chamber 3200 of FIG. [Figure 13] FIG. 8 is another perspective view of the plenum chamber 3200 of FIG. [Figure 14] FIG. 8 is another perspective view of the plenum chamber 3200 of FIG. [Figure 15] FIG. 8 is a front view of the plenum chamber 3200 of FIG. 7 labeled with section lines 16-16 through 19-19. [Figure 16] FIG. 16 is a cross-sectional view of the plenum chamber 3200 of FIG. 15 taken along line 16-16. [Figure 17] 17 is a cross-sectional view of the plenum chamber 3200 of FIG. 15 taken along line 17-17. [Figure 18] FIG. 18 is a cross-sectional view of the plenum chamber 3200 of FIG. 15 taken along line 18-18. [Figure 19] 19 is a cross-sectional view of the plenum chamber 3200 of FIG. 15 taken along line 19-19. [Figure 20] FIG. 8 is a rear view of the plenum chamber 3200 of FIG. 7 labeled with section lines 21-21 through 25-25. [Figure 21] 21 is a cross-sectional view of the plenum chamber 3200 of FIG. 20 taken along line 21-21. [Figure 22] 22 is a cross-sectional view of the plenum chamber 3200 of FIG. 20 taken along line 22-22. [Figure 23] 23 is a cross-sectional view of the plenum chamber 3200 of FIG. 20 taken along line 23-23. [Figure 24] 24 is a cross-sectional view of the plenum chamber 3200 of FIG. 20 taken along line 24-24. [Figure 25] 25 is a cross-sectional view of the plenum chamber 3200 of FIG. 20 taken along line 25-25. [Figure 26] FIG. 8 is a side view of the plenum chamber 3200 of FIG. 7 labeled with section lines 27-27 through 33-33. [Figure 27] 27 is a cross-sectional view of the plenum chamber 3200 of FIG. 26 taken along line 27-27. [Figure 28] 28 is a cross-sectional view of the plenum chamber 3200 of FIG. 26 taken along line 28-28. [Figure 29] 29 is a cross-sectional view of the plenum chamber 3200 of FIG. 26 taken along line 29-29. [Figure 30] FIG. 30 is a cross-sectional view of the plenum chamber 3200 of FIG. 26 taken along line 30-30. [Figure 31] FIG. 31 is a cross-sectional view of the plenum chamber 3200 of FIG. 26 taken along line 31-31. [Figure 32] FIG. 32 is a cross-sectional view of the plenum chamber 3200 of FIG. 26 taken along line 32-32. [Figure 33] FIG. 33 is a cross-sectional view of the plenum chamber 3200 of FIG. 26 taken along line 33-33. [Figure 34] FIG. 32 is a rear view of another plenum chamber 3200 with various parts identified. [Figure 35] FIG. 35 is a front view of the plenum chamber 3200 of FIG. 34 with various parts identified. [Figure 36] FIG. 35 is a top view of the plenum chamber 3200 of FIG. 34 with various parts identified. [Figure 37]FIG. 35 is a bottom view of the plenum chamber 3200 of FIG. 34 with various parts identified. [Figure 38] FIG. 35 is a side view of the plenum chamber 3200 of FIG. 34 with various parts identified. [Figure 39] FIG. 32 is another front view of a plenum chamber 3200 in accordance with one form of the present technology. [Figure 40] FIG. 40 is a cross-sectional view of the plenum chamber 3200 of FIG. [Figure 41] FIG. 8 is a front view of the shell 3210 of the plenum chamber 3200 of FIG. [Figure 42] FIG. 8 is a rear view of the shell 3210 of the plenum chamber 3200 of FIG. [Figure 43] FIG. 8 is a side view of the shell 3210 of the plenum chamber 3200 of FIG. [Figure 44] FIG. 8 is a front perspective view of the shell 3210 of the plenum chamber 3200 of FIG. [Figure 45] FIG. 8 is a rear perspective view of the shell 3210 of the plenum chamber 3200 of FIG. [Figure 46] FIG. 8 is a top view of the shell 3210 of the plenum chamber 3200 of FIG. [Figure 47] FIG. 32 is a rear view of another plenum chamber 3200 in accordance with one form of the present technology. [Figure 48] FIG. 32 is a rear view of another plenum chamber 3200 with various parts identified in accordance with an aspect of the present technology. [Figure 49] FIG. 32 is a front view of a plenum chamber 3200 in accordance with one form of the present technology. [Figure 50] FIG. 50 is a rear view of the plenum chamber 3200 of FIG. [Figure 51] FIG. 50 is a side view of the plenum chamber 3200 of FIG. [Figure 52] FIG. 50 is a top view of the plenum chamber 3200 of FIG. [Figure 53] FIG. 50 is a bottom view of the plenum chamber 3200 of FIG. [Figure 54] FIG. 50 is a perspective view of the plenum chamber 3200 of FIG. [Figure 55] FIG. 50 is another perspective view of the plenum chamber 3200 of FIG. 49. [Figure 56] FIG. 50 is another perspective view of the plenum chamber 3200 of FIG. 49. [Figure 57] FIG. 50 is a front view of the plenum chamber 3200 of FIG. 49 with section lines 58-58 through 61-61 labeled. [Figure 58] FIG. 58 is a cross-sectional view of the plenum chamber 3200 of FIG. 57 taken along line 58-58. [Figure 59] 59 is a cross-sectional view of the plenum chamber 3200 of FIG. 57 taken along line 59-59. [Figure 60] FIG. 60 is a cross-sectional view of the plenum chamber 3200 of FIG. 57 taken along line 60-60. [Figure 61] FIG. 61 is a cross-sectional view of the plenum chamber 3200 of FIG. 57 taken along line 61-61. [Figure 62] FIG. 50 is a rear view of the plenum chamber 3200 of FIG. 49 labeled with section lines 63-63 through 67-67. [Figure 63] 63 is a cross-sectional view of the plenum chamber 3200 of FIG. 62 taken along line 63-63. [Figure 64] FIG. 64 is a cross-sectional view of the plenum chamber 3200 of FIG. 62 taken along line 64-64. [Figure 65] FIG. 65 is a cross-sectional view of the plenum chamber 3200 of FIG. 62 taken along line 65-65. [Figure 66] FIG. 66 is a cross-sectional view of the plenum chamber 3200 of FIG. 62 taken along line 66-66. [Figure 67] FIG. 67 is a cross-sectional view of the plenum chamber 3200 of FIG. 62 taken along line 67-67. [Figure 68] FIG. 49 is a side view of the plenum chamber 3200 of FIG. 49 labeled with section lines 69-69 through 75-75. [Figure 69] FIG. 69 is a cross-sectional view of the plenum chamber 3200 of FIG. 68 taken along line 69-69. [Figure 70] FIG. 70 is a cross-sectional view of the plenum chamber 3200 of FIG. 68 taken along line 70-70. [Figure 71]FIG. 71 is a cross-sectional view of the plenum chamber 3200 of FIG. 68 taken along line 71-71. [Figure 72] FIG. 72 is a cross-sectional view of the plenum chamber 3200 of FIG. 68 taken along line 72-72. [Figure 73] FIG. 73 is a cross-sectional view of the plenum chamber 3200 of FIG. 68 taken along line 73-73. [Figure 74] FIG. 74 is a cross-sectional view of the plenum chamber 3200 of FIG. 68 taken along line 74-74. [Figure 75] FIG. 75 is a cross-sectional view of the plenum chamber 3200 of FIG. 68 taken along line 75-75. [Figure 76] FIG. 32 is a rear view of another plenum chamber 3200 with various parts identified in accordance with an aspect of the present technology. [Figure 77] FIG. 77 is a front view of the plenum chamber 3200 of FIG. 76 with various parts identified. [Figure 78] FIG. 77 is a top view of the plenum chamber 3200 of FIG. 76 with various parts identified. [Figure 79] FIG. 77 is a bottom view of the plenum chamber 3200 of FIG. 76 with various parts identified. [Figure 80] FIG. 77 is a side view of the plenum chamber 3200 of FIG. 76 with various parts identified. [Figure 81] FIG. 49 is a front view of the shell 3210 of the plenum chamber 3200. [Figure 82] FIG. 50 is a rear view of the shell 3210 of the plenum chamber 3200 of FIG. [Figure 83] FIG. 50 is a side view of the shell 3210 of the plenum chamber 3200 of FIG. [Figure 84] FIG. 50 is a front perspective view of the shell 3210 of the plenum chamber 3200 of FIG. [Figure 85] FIG. 50 is a rear perspective view of the shell 3210 of the plenum chamber 3200 of FIG. [Figure 86] FIG. 50 is a top view of the shell 3210 of the plenum chamber 3200 of FIG. [Figure 87]FIG. 324 is a cross section of a connection between a plenum chamber 3200 and a frame 3350 in accordance with one form of the present technology. [Figure 88] 33 is another cross-sectional view of the connection between the plenum chamber 3200 and the frame 3350. FIG. [Figure 89] FIG. 30 is a perspective view of a patient interface 3000 according to an example of the present technology. [Figure 90] FIG. 90 is a front view of the patient interface 3000 of FIG. [Figure 90A] 90A is a cross-sectional view of the patient interface 3000 shown in FIG. 90 taken through line 90A-90A. [Figure 91] FIG. 90 is a rear view of the patient interface 3000 of FIG. 89. [Figure 92] FIG. 90 is a top view of the patient interface 3000 of FIG. [Figure 93] FIG. 90 is a bottom view of the patient interface 3000 of FIG. 89. [Figure 94] FIG. 90 is a side view of the patient interface 3000 of FIG. 89. [Figure 95] FIG. 90 is another rear view of the patient interface 3000 of FIG. 89. [Figure 96] FIG. 90 is a perspective view of the patient interface 3000 of FIG. 89 as worn by a patient. [Figure 97] FIG. 90 is a front view of the patient interface 3000 of FIG. 89 as worn by a patient. [Figure 98] FIG. 90 is a rear view of the patient interface 3000 of FIG. 89 as worn by a patient. [Figure 99] FIG. 90 is a top view of the patient interface 3000 of FIG. 89 as worn by a patient. [Figure 100] FIG. 90 is a bottom view of the patient interface 3000 of FIG. 89 as worn by a patient. [Figure 101] FIG. 90 is a side view of the patient interface 3000 of FIG. 89 as worn by a patient. [Figure 102] FIG. 90 is another rear view of the patient interface 3000 of FIG. 89 as worn by a patient. [Figure 103] FIG. 33 is a perspective view of a frame 3350 according to an example of the present technology. [Figure 104] FIG. 104 is a front view of the frame 3350 of FIG. 103. [Figure 105] FIG. 104 is a rear view of the frame 3350 of FIG. [Figure 106] FIG. 104 is a top view of the frame 3350 of FIG. [Figure 107] FIG. 104 is a bottom view of the frame 3350 of FIG. [Figure 108] FIG. 104 is a side view of the frame 3350 of FIG. [Figure 109] 89. A strap of the positioning and stabilizing structure 3300 of the patient interface 3000 of FIG. 89 is shown. [Figure 110] FIG. 90 is a cross-sectional view of the plenum chamber 3200 of the patient interface 3000 of FIG. 89 in a sealed position on the patient. [Figure 111] FIG. 90 is a cutaway view of the plenum chamber 3200 of the patient interface 3000 of FIG. 89 in a sealed position on the patient. [Figure 112] FIG. 90 is a cross-sectional view of a portion of the plenum chamber 3200 of the patient interface 3000 of FIG. 89 prior to sealing against the patient's nose. [Figure 113] FIG. 113 is a cross-sectional view of a portion of the plenum chamber 3200 of FIG. 112 in a sealing position against the patient's nose. [Figure 114] FIG. 90 is a cross-sectional view of a portion of the plenum chamber 3200 of the patient interface 3000 of FIG. 89 in a sealing position against the patient's nose without side loading. [Figure 115] 114 is a cross-sectional view of a portion of the plenum chamber 3200 of FIG. 113 in a sealed position against the patient's nose when undergoing side loading. [Figure 116] FIG. 32 is a rear view of the plenum chamber 3200 having the various portions described and having folds in the nose portion 3230 of the plenum chamber 3200. [Figure 117] FIG. 10 is a side cross-sectional view of the plenum chamber 3200 of the patient interface 3000 in an isolated state when in a sealing position against the face of a short-nosed patient. [Figure 118] FIG. 118 is a side cross-sectional view of the plenum chamber 3200 of FIG. 117 in a sealed position against the face of a patient with a long nose. [Figure 119] FIG. 32 is a perspective view of a plenum chamber 3200 in accordance with another form of the present technology. [Figure 120] FIG. 120 is a front view of the plenum chamber 3200 shown in FIG. [Figure 121] FIG. 120 is a rear view of the plenum chamber 3200 shown in FIG. 119. [Figure 122] FIG. 120 is a top view of the plenum chamber 3200 shown in FIG. [Figure 123] FIG. 120 is a bottom view of the plenum chamber 3200 shown in FIG. [Figure 124] FIG. 120 is a left side view of the plenum chamber 3200 shown in FIG. 119. [Figure 125] FIG. 120 is a right side view of the plenum chamber 3200 shown in FIG. 119. [Figure 126] FIG. 32 is a front perspective view of a plenum chamber 3200 according to another example of the present technology having a small width size. [Figure 127] FIG. 127 is a rear perspective view of the plenum chamber 3200 shown in FIG. 126. [Figure 128] FIG. 127 is a front view of the plenum chamber 3200 shown in FIG. 126. [Figure 129] FIG. 127 is a rear view of the plenum chamber 3200 shown in FIG. 126. [Figure 130] FIG. 127 is a top view of the plenum chamber 3200 shown in FIG. [Figure 131] FIG. 127 is a bottom view of the plenum chamber 3200 shown in FIG. [Figure 132] FIG. 127 is a side view of the plenum chamber 3200 shown in FIG. 126. [Figure 133] 133 is a cross-sectional view of the plenum chamber 3200 shown in FIG. 130 through line 133-133. [Figure 134] FIG. 32 is a front perspective view of a plenum chamber 3200 according to another example of the present technology having a medium size. [Figure 135]FIG. 135 is a rear perspective view of the plenum chamber 3200 shown in FIG. [Figure 136] FIG. 135 is a top view of the plenum chamber 3200 shown in FIG. [Figure 137] FIG. 135 is a bottom view of the plenum chamber 3200 shown in FIG. [Figure 138] FIG. 135 is a front view of the plenum chamber 3200 shown in FIG. [Figure 139] FIG. 135 is a rear view of the plenum chamber 3200 shown in FIG. 134. [Figure 140] FIG. 135 is a side view of the plenum chamber 3200 shown in FIG. 134. [Figure 141] 141-141 is a cross-sectional view of the plenum chamber 3200 shown in FIG. 136 through line 141-141. [Figure 142] FIG. 32 is a front perspective view of a plenum chamber 3200 according to another example of the present technology having a small width size. [Figure 143] FIG. 143 is a rear perspective view of the plenum chamber 3200 shown in FIG. [Figure 144] FIG. 143 is a top view of the plenum chamber 3200 shown in FIG. [Figure 145] FIG. 143 is a bottom view of the plenum chamber 3200 shown in FIG. [Figure 146] FIG. 143 is a front view of the plenum chamber 3200 shown in FIG. [Figure 147] FIG. 143 is a rear view of the plenum chamber 3200 shown in FIG. 142. [Figure 148] FIG. 143 is a side view of the plenum chamber 3200 shown in FIG. 142. [Figure 149] 149 is a cross-sectional view of the plenum chamber 3200 shown in FIG. 144 through line 149-149. [Figure 150] FIG. 32 is a front perspective view of a plenum chamber 3200 according to another example of the present technology having a wide size. [Figure 151] FIG. 151 is a rear perspective view of the plenum chamber 3200 shown in FIG. [Figure 152] FIG. 151 is a top view of the plenum chamber 3200 shown in FIG. [Figure 153] FIG. 151 is a bottom view of the plenum chamber 3200 shown in FIG. [Fig. 154] FIG. 151 is a front view of the plenum chamber 3200 shown in FIG. [Figure 155] FIG. 151 is a rear view of the plenum chamber 3200 shown in FIG. [Figure 156] FIG. 151 is a side view of the plenum chamber 3200 shown in FIG. [Figure 157] 157 is a cross-sectional view of the plenum chamber 3200 shown in FIG. 152 through line 157-157. [Figure 158] FIG. 127 is a side view of the plenum chamber 3200 shown in FIG. 126 with various parts identified. [Figure 159] FIG. 127 is a bottom perspective view of the plenum chamber 3200 shown in FIG. 126 with various parts identified. [Figure 160] FIG. 127 is a top view of the plenum chamber 3200 shown in FIG. 126 with various parts identified. [Figure 161] FIG. 127 is a rear view of the plenum chamber 3200 shown in FIG. 126 with various parts identified. [Figure 162] FIG. 127 is a front view of the plenum chamber 3200 shown in FIG. 126 with various parts identified. [Figure 163] FIG. 127 is a front perspective view of the plenum chamber 3200 shown in FIG. 126 with various parts identified. [Fig. 164] FIG. 127 is a rear perspective view of the plenum chamber 3200 shown in FIG. 126 with various parts identified. [Figure 165] FIG. 135 is a side view of the plenum chamber 3200 shown in FIG. 134 with various parts identified. [Figure 166] FIG. 135 is a bottom view of the plenum chamber 3200 shown in FIG. 134 with various parts identified. [Figure 167] FIG. 135 is a top view of the plenum chamber 3200 shown in FIG. 134 with various parts identified. [Figure 168]FIG. 135 is a rear view of the plenum chamber 3200 shown in FIG. 134 with various parts identified. [Figure 169] FIG. 135 is a front perspective view of the plenum chamber 3200 shown in FIG. 134 with various parts identified. [Figure 170] FIG. 135 is a rear perspective view of the plenum chamber 3200 shown in FIG. 134 with various parts identified. [Figure 171] FIG. 135 is a front view of the plenum chamber 3200 shown in FIG. 134 with various parts identified. [Fig. 172] FIG. 143 is a side view of the plenum chamber 3200 shown in FIG. 142 with various parts identified. [Figure 173] FIG. 143 is a bottom perspective view of the plenum chamber 3200 shown in FIG. 142 with various parts identified. [Fig. 174] FIG. 143 is a top view of the plenum chamber 3200 shown in FIG. 142 with various parts identified. [Figure 175] FIG. 143 is a rear view of the plenum chamber 3200 shown in FIG. 142 with various parts identified. [Figure 176] FIG. 143 is a front view of the plenum chamber 3200 shown in FIG. 142 with various parts identified. [Figure 177] FIG. 151 is a side view of the plenum chamber 3200 shown in FIG. 150 with various parts identified. [Figure 178] FIG. 151 is a bottom view of the plenum chamber 3200 shown in FIG. 150 with various parts identified. [Figure 179] FIG. 151 is a top view of the plenum chamber 3200 shown in FIG. 150 with various parts identified. [Figure 180] FIG. 151 is a rear view of the plenum chamber 3200 shown in FIG. 150 with various parts identified. [Figure 181] FIG. 151 is a front view of the plenum chamber 3200 shown in FIG. 150 with various parts identified. [Figure 182] FIG. 151 is a front perspective view of the plenum chamber 3200 shown in FIG. 150 with various parts identified. [Figure 183] FIG. 151 is a rear perspective view of the plenum chamber 3200 shown in FIG. 150 with various parts identified. [Figure 184] FIG. 30 is a perspective view of a patient interface 3000 in accordance with another example of the present technology. [Figure 185] FIG. 30 is a perspective view of a patient interface 3000 in accordance with another example of the present technology. [Figure 186] FIG. 31 is a rear perspective view of a seal-forming structure 3100 in accordance with another example of the present technology. [Figure 187] FIG. 13 is a rear perspective view of a textile portion 3170 of a seal-forming structure 3100 according to a further example of the present technology. [Figure 188] 188 is a rear perspective view of the textile portion 3170 of FIG. 187 at an intermediate molding step with the seal-forming structure 3100. FIG. [Figure 189] 188 is a rear perspective view of the textile portion 3170 of FIG. 187 molded into the seal-forming structure 3100. FIG. [Figure 190] FIG. 31 is a rear perspective view of a seal-forming structure 3100 in accordance with another example of the present technology. [Figure 190A] 190A is a detailed cross-sectional view taken through line 190A-190A of FIG. 190. [Figure 191] FIG. 31 is a rear perspective view of a seal-forming structure 3100 in accordance with another example of the present technology. [Figure 192] FIG. 31 is a rear perspective view of a seal-forming structure 3100 in accordance with another example of the present technology. DETAILED DESCRIPTION OF THE INVENTION

[0158] 5 Detailed description of examples of this technology Before describing the present technology in further detail, it should be understood that the present technology is not limited to the specific examples described herein, which may vary. It should also be understood that the terminology used in this disclosure is for the purpose of describing the specific examples described herein, and is not intended to be limiting.

[0159] 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 other examples. In addition, any single feature or combination of features in any of these examples may constitute an additional example.

[0160] While anatomical directional terms are used in describing aspects and examples of the present technology (e.g., "anterior," "posterior," "superior," "inferior," "lateral," "medial"), these directions apply in the context of the present technology during use by a patient. For example, the anterior side of a patient interface refers to the side of the patient interface that is anterior to the patient when the patient interface is worn in its intended manner.

[0161] When describing a surface or portion as facing in a certain direction (e.g., "upward facing," "forward facing"), unless the context clearly indicates otherwise, the surface or portion is to be understood as facing at least partially in a particular direction. If a portion faces generally upward, the portion may be said to "face upward" even if it also faces partially in another direction.

[0162] 5.1 Treatment In one form, the present technology includes a method for treating disordered breathing, the method including applying positive pressure to the entrance of the airways of a patient 1000.

[0163] 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.

[0164] In certain instances of the present technology, mouth breathing is restricted, limited or prevented.

[0165] 5.2 Treatment System In one form, the present technology includes an apparatus or device for the treatment of disordered breathing. The apparatus or device may include an RPT device 4000 that supplies pressurized air to the patient 1000 via an air circuit 4170 to a patient interface 3000.

[0166] 5.3 Patient Interface A non-invasive patient interface 3000 in accordance with one aspect of the present technology includes the following functional features: a plenum chamber 3200 including a seal-forming structure 3100, a positioning and stabilizing structure 3300, a vent 3400, a form of connection port 3600 for connection to an air circuit 4170, and a forehead support 3700. In some forms, the functional features may be provided by one or more physical components. In some forms, a single physical component may provide one or more functional features. In use, the seal-forming structure 3100 is positioned to surround an entrance to the patient's airways to facilitate the delivery of air at positive pressure to the airways.

[0167] In some examples of the present technology, the plenum chamber 3200 is at least partially formed by the shell 3210 and the seal-forming structure 3100. The plenum chamber 3200 may include, for example, a cushion module or cushion assembly. The shell 3210 may act as a chassis for the seal-forming structure 3100.

[0168] 126-157 , for example, as shown in FIGS. 7-14 , 49-56 , 119-125 , and 126-157 , the patient interface 3000 may include a plenum chamber 3200 having a nasal portion 3230 and an oral portion 3260. The seal-forming structure may be configured to surround the nasal airway at the nasal portion 3230 and to seal around the patient's mouth at the oral portion 3260. Thus, the seal-forming structure 3100 may also be considered to have a nasal portion and an oral portion, where the nasal portion and oral portion of the seal-forming structure include portions that seal around the patient's nasal airway and around the mouth, respectively.

[0169] In the examples shown in Figures 7-14, 49-56, 119-125, and 126-157, the seal-forming structure 3100 in the nasal portion 3230 seals against the underside of the patient's nose rather than being positioned over the bridge or ridge regions of the patient's face. The nasal portion 3230 may seal against the upper lip, the anterior aspect of the ala and tip of the nose, and / or the underside of the tip of the nose. The actual seal location may vary from patient to patient. The nasal portion 3230 may also be configured to contact and / or seal with the area of ​​the patient's face between the ala and the nasolabial fold and the lateral portion of the upper lip adjacent to the nasolabial fold.

[0170] The seal-forming structure 3100 of the oral portion 3260 can be configured to form a seal against the periphery of a patient's mouth in use. The oral portion 3260 can be configured to form a seal against the patient's face, for example, at the upper lip, nasolabial folds, cheeks, lower lip, and supramentum.

[0171] One or more holes may be provided within the seal-forming structure 3100 to deliver an airflow at therapeutic pressure to the patient's nares and the patient's mouth through the one or more holes. The seal-forming structure may define an oral hole and one or more nasal holes for delivery of the airflow to the patient. In the examples shown in Figures 7-14, 49-56, 119-125, and 126-157, the plenum chamber 3200 includes the seal-forming structure 3100 including an oral hole 3271 and two nasal holes 3272. Each of the nasal holes 3272 may be positioned on the plenum chamber 3200 to be substantially aligned with the patient's nares so as to deliver an airflow to the patient's nares in use.

[0172] If the patient interface cannot comfortably deliver a minimum level of positive pressure to the airway, the patient interface may be unsuitable for respiratory pressure therapy.

[0173] 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 6 cmH2O relative to ambient.

[0174] 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.

[0175] 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.

[0176] 5.3.1 Plenum chamber The plenum chamber 3200 has a perimeter shaped to complement the surface contours of an average human face in the area where a seal is formed in use. In the examples shown in FIGS. 7-14, 49-56, 119-125, and 126-157, the plenum chamber includes a shell 3210 and a seal-forming structure 3100. In these examples, 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 the entire edge 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 piece of material.

[0177] In some forms of the present technology, the plenum chamber 3200 does not cover the patient's eye when in use. In other words, the eye is outside the pressurized space defined by the plenum chamber. Such forms may improve treatment compliance, often resulting in less intrusiveness and / or greater wearer comfort.

[0178] In certain forms of the present technology, a portion of the plenum chamber 3200 is constructed from a transparent material (e.g., clear polycarbonate). In the examples shown in Figures 7-14, 49-56, 119-125, and 126-157, the shell 3210 is made from clear polycarbonate. The use of a transparent material may reduce the intrusiveness of the patient interface and may help improve compliance with treatment. The use of a transparent material may help the clinician verify the placement and function of the patient interface. In some examples, the shell 3210 may be formed from silicone.

[0179] In certain forms of the present technology, the plenum chamber 3200 is constructed from a translucent material that can make the patient interface less intrusive and help improve compliance with treatment.

[0180] 7-47, 49-75 and 119-183 show a plenum chamber 3200 according to an example of the present technology that is formed in part by a shell 3210. Additionally, the plenum chamber 3100 is formed in part by the seal-forming structure 3200. In some examples, the seal-forming structure 3100 is overmolded onto the shell 3210. Alternatively, the seal-forming structure 3100 may be formed separately from the shell 3210 and configured to be permanently or removably connected to the shell 3210. The seal-forming structure 3100 and the shell 3210 may be integrally formed.

[0181] In the examples shown in FIGS. 7-47, 49-75, and 119-183, the shell 3210 is formed from polycarbonate and the seal-forming structure 3100 is formed from silicone. The silicone may have a Shore A hardness of 30 or 40 durometers. Silicone or similar materials with this hardness offer advantages in terms of comfort and flexibility in conforming and sealing to the patient's face. The use of polycarbonate (or other stiffer materials) with a higher hardness and stiffness than silicone is advantageous in that it provides a section that is more resistant to deformation (using less material than would be required to achieve the same resistance using silicone). The reduced material usage can be advantageous because it maintains a reduced overall bulk and weight, making it less intrusive to the user. In another example, the shell 3210 can be formed from nylon or polypropylene. Alternatively, the seal-forming structure 3100 can be formed from silicone, a suitable foam, a textile material, or any suitable thermoplastic elastomer.

[0182] As shown in FIGS. 40-46, the shell 3210 may have posterior projections 3215 at the upper lateral corners of the shell 3210. The posterior projections 3215 may strengthen the base of the nose portion and help stabilize the seal-forming structure 3100. The posterior projections 3215 may also help strengthen the location of the seal-forming structure proximal posterior corners 3131 (e.g., as shown in FIGS. 10 and 52), which also supports the nose portion of the plenum chamber on the patient's face and advantageously fits within the patient's nasolabial fold. The posterior projections 3215 may protrude from the shell 3210 toward the patient's cheeks at or along the patient's nasolabial fold. The posterior projections 3215 may be provided below the lateral support portions 3151 (described below).

[0183] 5.3.1.1 Lateral support parts In some examples of the present technology, as shown in, for example, FIGS. 18, 19, 32, 35, and 38, a plenum chamber 3200 includes lateral support portions 3151 on the front sides of the nose portion 3230 of the plenum chamber 3200. The lateral support portions 3151 may have a higher resistance to deformation than one or more adjacent portions 3100 of the seal-forming structure. The lateral support portions 3151 may be stiffer than regions of the plenum chamber 3200 above the lateral support portions 3151. Additionally or alternatively, the lateral support portions 3151 may be stiffer than a central region of the plenum chamber 3200. The relatively stiffer regions may take the form of fins configured to provide a relatively stiffer region than peripheral regions of the plenum chamber. The seal-forming structure 3100 shown in FIGS. 34-38 includes lateral support portions 3151 therein. Additionally, the plenum chamber 3200 shown in Figures 49-56 includes side support portions 3151 within the shell 3210. The shell 3210 of the plenum chamber 3200 of Figures 49-56 is shown in isolation in Figures 81-86. As shown, the side support portions 3151 are formed by the upper side portions of the shell 3210 itself.

[0184] The lateral support portions 3151 may assist in lateral stability of the nasal portion 3230 of the plenum chamber 3200. In the examples of FIGS. 7-38 , the lateral support portions 3151 are provided on laterally spaced, at least partially forward-facing sides of the plenum chamber 3200. Specifically, the lateral support portions 3151 are provided on the sides of the nasal portion 3230 that do not face the patient (e.g., the anterior side or the at least partially forward-facing side). In these examples, one lateral support portion 3151 is provided on the at least partially forward-facing wall on each lateral side of the plenum chamber 3200. The plenum chamber 3200 is configured such that, in use, the lateral support portions 3151 are positioned within the seal-forming structure 3100 approximately opposite the patient's ala.

[0185] The lateral support portions 3151 may include regions of the plenum chamber 3200 that have a greater material thickness than the surrounding or adjacent regions. Alternatively or additionally, the lateral support portions 3151 may be formed of a stiffer material than the material in the surrounding or adjacent regions.

[0186] The lateral support portions 3151 may be substantially fin-shaped (e.g., having a curved upper boundary and a flatter lower boundary). As shown in FIGS. 34-38, the lateral support portions 3151 of the seal-forming structure 3100 include a curved upper boundary 3153 and a flatter lower boundary 3152. Similarly, the lateral support portions 3151 of the shell 3210 as shown in FIGS. 49-56 have a curved upper boundary 3153 (but in this example, there is no distinct lower boundary of the lateral support portion 3151). The use of a fin-like shape (specifically, the provision of a curved upper boundary or edge) is advantageous because the upper edge or boundary of the lateral support portion 3151 follows the curvature of the upper periphery 3232 of the nose portion 3230. This can be advantageous in that it provides a consistent height for the nasal portion 3230 above the shell 3210, which, as described below, provides a consistent or controlled stiffness for the structure of the nasal portion 3230. Furthermore, the curved upper boundary 3153, rather than a flat boundary around the entire anterior portion of the nasal portion 3230, allows the central, forward-facing portion of the nasal portion to remain flexible, thereby avoiding excessive force on the patient's nasal tip.

[0187] The lateral support portions 3151 may control the collapsibility of the front portions of the plenum chamber 3200. The height of the lateral support portions 3151 (e.g., the amount of upper extension) may be selected to achieve a balance between collapsibility and structural rigidity. A certain amount of flexibility in the structure of the seal-forming structure 3100 is desirable because it allows the seal-forming structure 3100 to accommodate a wide range of nose shapes and sizes. However, if the lateral support portions 3151 extend upward too much, the seal-forming structure 3100 may be insufficiently accommodating or insufficiently comfortable. Alternatively, if the lateral support portions 3151 do not extend upward enough, the seal-forming structure 3100 may be prone to collapse, making it impossible to avoid rupturing the sealing engagement with the patient's face.

[0188] Additionally, providing some flexibility in the overall structure of the seal-forming structure 3100 can be advantageous in accommodating long and / or narrow noses. A certain amount of flexibility in the overall structure of the nasal portion 3230 is undesirable when the seal-forming structure 3100 is moved upward to contact the underside of a narrow nose because such flexibility could cause the lateral sides of the seal-forming structure 3100 to be pulled inward as a result of a downward force from the patient's nose being applied to the center of the seal-forming structure 3100. FIGS. 112 and 113 show the seal-forming structure 1000 before and after being moved into a sealing position with the patient's 3100 nose. As shown in FIG. 113, when the seal-forming structure 3100 in the nasal portion 3230 is brought into contact with the patient's nose, the outward-facing lateral sides of the seal-forming structure 3100 are pulled inward, helping the inward-facing lateral sides of the seal-forming structure 3100 conform to the periphery of the underside of the patient's nose. If the lateral sides of the seal-forming structure 3100 are not flexible enough, the seal-forming structure 3100 may not fit narrower noses well and / or may be less comfortable when the patient needs to tighten the headgear to compensate. If it is too flexible, the seal-forming structure 3100 may not be able to hold its shape and maintain an effective seal.

[0189] The height of the lateral support portions 3151 should be appropriate to provide sufficient structural rigidity to the nose portion 3230 while retaining sufficient flexibility to allow the seal-forming structure 3100 to comfortably seal over a wide range of noses. The lateral support portions 3151 may extend upward by approximately 35-65% of the height of the nose portion 3230 (e.g., in examples, 40-60% or 50% of the distance between the base of the nose portion 3230 on the anterior side of the plenum chamber 3200 and the uppermost point of the plenum chamber 3200).

[0190] In other examples, other stiffening / rigidifying structures or features may be used in place of the lateral support portions 3151. In some examples, ribs are provided on the interior or exterior of the nose portion 3230 of the seal-forming structure 3100, generally at the location of the lateral support portions 3151, to impart structural stiffness to the nose portion 3230. In other examples, the lateral support portions 3151 may be stiffened. The seal-forming structure 3100 may include support inserts (e.g., stiffener elements) provided on the lateral support portions 3151. In one example, the seal-forming structure 3100 may be overmolded with one or more stiffener elements to impart stiffness to the lateral support portions 3151.

[0191] In other examples, the plenum chamber 3200 may include an undercushion that provides necessary support to the structure of the nasal portion 3230. The undercushion may be thicker than the face-contacting portion of the seal-forming structure 3100, allowing the patient-contacting wall to be thin for comfort and conformance to the patient's nose and face.

[0192] Additionally, in some examples, separate components are provided for structural support of the nose portion 3230 of the seal-forming structure 3100. For example, the frame to which the plenum chamber 3200 is connected may have portions that strengthen the seal-forming structure 3100 in the area of ​​the lateral support portions 3151.

[0193] 5.3.1.1.1 Lateral support areas formed by seal-forming structures The plenum chamber 3200 shown in Figures 7-40 includes lateral support portions 3151 provided by the seal-forming structure 3100. The lateral support portions 3151 are provided to the front of the plenum chamber 3200 and on each lateral side of the nose portion 3230. In this example, the lateral support portions 3151 are provided in the lower region of each lateral side of the nose portion 3230.

[0194] In this example, at least a majority of the nose portion 3230 is formed by the seal-forming structure 3100. A majority of the nose portion 3230 of the plenum chamber 3200 is formed from a soft, flexible, resilient material. In this example, a majority of the nose portion 3230 is formed from silicone. In the examples of Figures 7-33, substantially the entire nose portion is formed by the seal-forming structure 3100. In the examples of Figures 49-75, portions of the nose portion are formed by the shell 3210. In the examples of Figures 186-192, the nose portion of the seal-forming structure 3100 is formed from one or more sections of textile material.

[0195] In these examples, the lateral support portions 3151 are regions of the seal-forming structure 3100 that are relatively stiffer than one or more adjacent regions of the seal-forming structure 3100. Specifically, the lateral support portions 3151 have a thicker material than regions of the seal-forming structure 3100 above the lateral support portions 3151. This thicker material thickness imparts a certain amount of stiffness or structural rigidity to the structure of the seal-forming structure 3100 and specifically to the nasal portion 3230. The posterior majority of the nasal portion 3230 does not contribute significant structural rigidity to the shape of the nasal portion 3230 because it can have a thinner wall thickness for comfort and be able to seal against the patient's face. The lateral support portions 3151 compensate for the lack of structural rigidity available from the patient-contacting walls and increase the overall structural rigidity to the nasal portion 3230.

[0196] 35 and 38 , the lateral support portions 3151 each include a substantially flat lower boundary 3152. The substantially flat lower boundary 3152 is generally flat, but may have a small amount of curvature, for example, due to a certain curvature required for the base of the nasal portion to transition into the oral portion 3260 of the plenum chamber 3200. Each flat lower boundary 3152 may be adjacent to a respective posterior protruding portion 3215 of the shell 3210. In this example, the lateral support portions 3151 each include a curved upper boundary 3153. Furthermore, the curvature of the curved upper boundary 3153 may substantially match or follow the curvature of the upper periphery 3232 of the seal-forming structure 3100 in the nasal portion 3230.

[0197] 5.3.1.1.2 Lateral support areas formed by the shell The plenum chamber 3200 shown in Figures 49-75 and 126-157 each includes a lateral support portion 3151 provided by the shell 3210 of the plenum chamber 3200. Figures 81-86 show the shell 3210 of the plenum chamber 3200 in isolation in Figures 49-75. In these examples, the lateral support portion 3151 includes an upper portion of the shell 3210. The lateral support portion 3151 extends upward into the nose portion 3230 of the plenum chamber 3200. In these examples, the lateral support portion 3151 includes a portion of the shell 3210 that is provided to the nose portion 3230. While the shell 3210 in the examples shown in FIGS. 7-33 has a generally flat upper edge, the shell 3210 in the examples shown in FIGS. 49-75 and 81-86 includes a curved upper edge 3211 that includes lateral support portions 3151. The lateral support portions 3151 extend upwardly over a greater area than the center of the upper edge 3211 to form two lateral support portions 3151. In these examples, the lateral support portions 3151 each include a curved upper edge or boundary. The curvature of each upper edge substantially matches or follows the curvature of the upper periphery 3232 of the seal-forming structure. The lateral support portions 3151 of the shell 3210 occupy the forward-facing and side-facing regions of the nasal portion 3230 and are generally opposite the ala of the patient's nose in use.

[0198] The lateral support portions 3151 in the examples shown in Figures 49-75 and 81-86 provide a similar function as the lateral support portions 3151 shown in the examples of Figures 7-33. The lateral support portions 3151 provide structural rigidity to the nasal portion 3230 of the seal-forming structure 3100. Because the patient-contacting (rear) side of the seal-forming structure 3100 includes a relatively thin, flexible wall, the flexible wall, the lateral support portions 3151, provide a level of structural rigidity to the nasal portion 3230.

[0199] 5.3.1.2 Plenum chamber inlet port The shell 3210 may include one or more plenum chamber inlet ports 3240. The one or more plenum chamber inlet ports 3240 may allow connection to other components (e.g., a frame, a decoupling structure, a venting arrangement, a heat moisture exchanger (HMX), a constant flow vent (CFV), an anti-asphyxiation valve (AAV), and / or connection ports to conduits in various examples).

[0200] 7-14, the plenum chamber 3200 includes a single inlet port 3240. The inlet port 3240 is located substantially centrally in the shell 3210. In this example, the inlet port 3240 may be configured to connect to a frame to which headgear or other positioning and stabilizing structural components may be connected. In this exemplary form of the present technology, the inlet port 3240 is substantially circular.

[0201] In the examples shown in FIGS. 49-56 and 126-183, the plenum chamber 3200 includes two inlet ports 3240. The inlet ports 3240 are provided on the lateral sides 3210 of the shell. In these examples, the inlet ports 3240 are configured to connect to conduits that connect to decoupling components located above the patient's head, where the conduits are connected to the air circuit. These conduits may form part of the positioning and stabilizing structure 3300 (i.e., may be "headgear conduits"). In some examples, the inlet ports 3240 may receive a combination headgear and conduit connection assembly to provide multiple functions (e.g., ventilation, air flow supply, and headgear attachment point). The combination headgear and conduit connection assembly may also include an AAV. In these examples, the inlet ports 3240 are approximately oval-shaped (e.g., elliptical).

[0202] In some examples, the plenum chamber 3200 shown in Figures 7-14 may include one or two inlet ports 3240 on the lateral sides 3210 of the shell for connection to conduit headgear. It will be understood that any of the features described herein of the seal-forming structure 3100 (e.g., those of the plenum chamber 3200 shown in Figures 7-48) may be employed in a patient interface that includes conduit headgear.

[0203] 49-56, the upper periphery of each inlet port 3240 is formed by the lateral support portions 3151 of the nose portion 3230. In examples where the inlet ports 3240 connect to headgear conduits, the connection from the plenum chamber 3200 to the headgear conduits can advantageously be made at an upper location on the plenum chamber 3200. This allows for a shorter conduit, a better force vector, and / or a smaller conduit footprint on the patient's face compared to inlet ports 3240 located at a lower location on the plenum chamber 3200.

[0204] In one example, the plenum chamber 3200 connects to a frame and is supported in front of the patient's face via a positioning and stabilizing structure 3300 (e.g., headgear). The connection to the frame can be a snap-fit ​​connection. Alternatively, the connection can be a press-fit, bayonet connection, or other suitable connection.

[0205] In one example, the frame 3350 includes a snap-fit ​​hook 3351 that snaps through a rim of the shell 3210. In some examples, two snap-fit ​​hooks 3351 are attached to the frame snap through a rim 3218 attached to the air inlet port 3240 of the plenum chamber 3200. FIG. 87 is a cross-sectional view of the connection between the frame 3350 and the plenum chamber 3200 in a horizontal plane, showing a horizontal snap-fit ​​hook 3351 snapped through the rim 3218 of the air inlet port 3240. In this example, the two snap-fit ​​hooks 3351 are horizontally opposed on the air inlet port 3240. In other examples, the arms are vertically opposed. Providing horizontally corresponding snap-fit ​​arms (e.g., at the 9 o'clock and 3 o'clock positions around the air inlet 3240) advantageously provides resistance to disengagement when a lateral force is applied on the plenum chamber 3200 or the frame 3350. 88 is a cross-sectional view of the connection in a vertical plane between the frame 3350 and the plenum chamber 3200, illustrating the lack of a snap-fit ​​connection on the vertically opposing sides of the connection. Because a patient may sleep with their head on their side, the plenum chamber 3200 is more likely to experience lateral forces than vertical forces during use. The horizontally opposing snap-fit ​​connection allows the patient to rotate the plenum chamber 3200 up or down relative to the frame 3350 for disassembly, but makes it less likely that the plenum chamber 3200 will disengage from the frame due to lateral forces on the plenum chamber 3200 during use.

[0206] 5.3.2 Seal formation structure In one form of the present technology, the seal-forming structure 3100 provides a target seal-forming area and may further provide a cushioning function. The target seal-forming area is the area where a seal may occur in the seal-forming structure 3100. The area where a seal actually occurs (i.e., the actual sealing surface) may vary from patient to patient in a given treatment session and from day to day, depending on a range of factors (e.g., placement of the patient interface on the face, tension in the positioning and stabilizing structure, and the shape of the patient's face).

[0207] In one form, the target seal-forming area is located on an exterior surface of the seal-forming structure 3100 .

[0208] In certain forms of the present technology, the seal-forming structure 3100 is constructed from a biocompatible material (eg, liquid silicone rubber (LSR)).

[0209] The seal-forming structure 3100 according to the present technology may be constructed from a soft, flexible and resilient material (eg, liquid silicone (LSR) or a textile material).

[0210] In one form of the present technology, the seal-forming structure 3100 may be constructed of a textile material. In some forms, the textile material may be formed of a textile having a constant cross-sectional thickness. In some forms, the textile material may be formed of multiple textile sections, each with a different cross-sectional thickness, or a textile section with a varying cross-sectional thickness over the length of the section.

[0211] In one form of the present technology, the seal-forming structure 3100 may be formed by a plurality of separate textile segments.In one form of the present technology, the seal-forming structure 3100 may be formed by a plurality of separate textile materials.

[0212] In one form of the present technology where a textile material is used, the textile seal-forming structure 3100 may be formed from multiple layers. In some further forms, at least one of the layers may be formed from a laminate. The cross-sectional thickness of the laminate may be varied as needed across the textile material, so that the compliance of the textile material may be varied accordingly. For example, in some forms of the present technology, the textile seal-forming structure 3100 may be formed with multiple different compliant regions by locally varying the laminate thickness in these regions.

[0213] In one form of the present technology, the seal-forming structure 3100 of the present technology can be constructed from a combination of soft, flexible, resilient materials (e.g., silicone and textile material). In some forms, the textile material can be placed over the silicone. Such a form can improve the comfort of the seal-forming surface in the area that comes into contact with the patient's face.

[0214] Textiles may have increased compliance or decreased elasticity compared to elastomeric materials. Therefore, to maintain the shape of the textile, the textile may include an additional substrate layer of elastomeric material (e.g., silicone) or may be layered to include a laminate. This additional layer may increase stiffness and decrease the compliance of the textile material. Because elastomeric materials (e.g., silicone or TPE) are more elastic than textile materials, their use in combination with textile materials may contribute stiffness to the resulting textile material. In some embodiments, the increased elasticity and stiffness may increase the sealing force of the textile seal, thereby improving the robustness of the seal. This increased robustness, combined with the compliant nature of the textile material, may balance overall patient comfort and improve the adaptability of the resulting seal-forming structure to various facial geometries. In some embodiments, the resulting seal-forming structure may improve the ability of the textile material to provide a pressurized seal against the patient's face during dynamic movement of the seal-forming structure relative to the patient's face during use.

[0215] In some forms, the seal-forming structure 3100 may be formed from a compliant textile material that can easily conform and adjust to the patient's profile during use. For example, the textile material used for the seal-forming structure 3100 may be able to stretch to accommodate the patient's more prominent facial features (e.g., the patient's nose). In some forms, the seal-forming structure 3100 may be at least partially formed from a thin single layer of textile material or a highly elastic composite of multiple textile layers. The resulting seal-forming structure 3100 may in some forms be sufficiently compliant so that it can at least partially expand and establish a pressurized seal around the patient's facial contours and creases. In some forms, when compliant textile materials are used in one or more segments of the seal-forming structure 3100, the combined effect of the various seal-forming structures 3100 may functionally improve and enhance the seal against the patient's face. In some forms, it may be beneficial to provide multiple physically distinct or at least functionally distinct textile segments, each of which may define a zone of the seal-forming structure 3100. Forming the seal-forming structure 3100 from multiple segments allows for overmolding of one or more textile materials into a shell 3210 having a complex three-dimensional shape. In some forms, molding of complex regions may be performed in a manner that is substantially capable of maintaining the desired complex shape.

[0216] The seal-forming structure 3100 can be formed to include regions of varying complexity, where the complexity of the shape is defined by the properties of the principal curvatures and torsion of each region. In the context of the present disclosure, a complex shape is defined as a shape that includes curvature in more than one direction (i.e., a three-dimensional (3D) shape), where the complex curvature is maintained at rest. For example, a silicone region can be molded to retain a preformed shape. In contrast, for regions formed using textile materials, it is often impossible to maintain a preformed shape at rest, making it more difficult to mold textiles with curvature in more than one direction into complex shapes.

[0217] The characteristics of the textile material used in the seal-forming structure 3100 are such that even a small change in the sign of the curvature can be difficult to form using the textile material, and therefore are considered complex shapes. For example, in some configurations, even a small change in curvature from negative to positive or from positive to negative can result in an overly complex shape (e.g., a saddle or valley shape). In another example, a simple dome or crater has only one curvature, and therefore would not result in an overly complex shape to form using the textile material.

[0218] In some forms, the seal-forming structure 3100 may be formed using at least one region of a textile material and at least one region of a non-textile material (e.g., silicone or TPE). The non-textile material may be used for formation of the region(s) requiring a complex shape, and the textile material may be used in the region(s) requiring a less complex curvature.

[0219] In some forms, a complex shape may be further defined as a shape having a magnitude of twist and curvature in two or more directions, where the combination of twist and curvature exceeds a threshold such that the material begins to form folds or wrinkles at rest (either before or during use). When regions of the seal-forming structure 3100 are formed from a textile material, this threshold is a lower magnitude of twist and / or curvature compared to certain non-textile materials (e.g., silicone, TPE, or other elastomeric materials).

[0220] In the context of this specification, a complex three-dimensional shape is defined as a plenum shell 3210 having a rear patient-engaging side that is curved about two or more axes.

[0221] In some forms, a moldable elastomeric material (e.g., silicone or TPE) may be used in conjunction with or in place of the textile material forming one or more of the seal-forming structures 3100. For example, a moldable elastomeric material may be used in place of a textile material in zones of the seal-forming structure 3100 that have a curvature that passes through a complex three-dimensional shape (e.g., adjacent the upper lip of a patient's face). The moldable elastomeric material may be more easily molded to hold complex shapes (without the overall efficiency of a typical textile material seal-forming structure 3100).

[0222] In certain forms of the present technology, a system is provided that includes more than one seal-forming structure 3100. Each seal-forming structure 3100 is configured to accommodate a different size and / or shape range. For example, the system may include one form of seal-forming structure 3100 that is suitable for large head sizes but not small head sizes, and another that is suitable for small head sizes but not large head sizes.

[0223] 5.3.2.1 Sealing mechanism In one form, the seal-forming structure 3100 includes a sealing flange that employs a pressure-assisted sealing mechanism. In use, the sealing flange can readily respond to positive system pressure within the plenum chamber 3200 by acting on its underside to form a tight sealing engagement with the surface. The pressure-assisted mechanism can work in conjunction with elastic tension in the positioning and stabilizing structure. If the seal-forming structure 3100 includes a textile material, the positive pressure from within the plenum chamber 3200 can cause at least a portion of the seal-forming structure 3100 to expand. As a result, the overall sealing engagement with the patient's face can be further improved.

[0224] In one form, the seal-forming structure 3100 includes a sealing flange and a support flange. The sealing flange includes a relatively thin member having a thickness of less than about 1 mm (e.g., about 0.25 mm to about 0.45 mm) that extends around the peripheral length of the plenum chamber 3200. The support flange may be relatively thicker than the sealing flange. The support flange is disposed between the sealing flange and the peripheral edge of the plenum chamber 3200 and extends around at least a portion of the peripheral length. The support flange is or includes a spring-like element that functions to support the sealing flange against buckling during use.

[0225] In one form, the seal-forming structure may include a compression seal or gasket seal that is constructed and arranged such that, in use, it is in a compressed state due to, for example, elastic tension in the positioning and stabilizing structure.

[0226] In one form, the seal-forming structure includes a tensioning portion that, in use, is held taut by, for example, an adjacent region of the sealing flange.

[0227] In one form, the seal-forming structure includes an area having a sticky or adhesive surface.

[0228] In certain forms of the present technology, the seal-forming structure may include one or more of a pressure-assisted sealing flange, a compression seal, a gasket seal, a tension section, and a section having a sticky or adhesive surface.

[0229] 5.3.2.2 Nasal area In certain forms of the present technology, the seal-forming structure 3100 includes a central portion configured to form a seal against the underside of the patient's nose. The central portion may seal against the lower periphery of the patient's nose (e.g., around the patient's nostrils and the patient's upper lip). In examples, the seal-forming structure 3100 may be configured to contact the patient's face under the bridge of the nose or under the tip of the nose.

[0230] As shown in Figures 34-80 and 158-183, seal-forming structure 3100 includes a central portion configured to seal around the lower periphery of a patient's nose in use, and an intermediate portion configured to be positioned at or near the ala of a patient's nose in use. More specifically, central portion includes upwardly facing central portion 3111 and forwardly facing central portion 3115. Most or all of the contact between the central portion and the patient's nose is made by upwardly facing central portion 3111. Further, intermediate portion includes upwardly facing intermediate portion 3121 and forwardly facing intermediate portion 3125. Most or all of the contact between the intermediate portion and the patient's nose is made by upwardly facing intermediate portion 3121.

[0231] It will be understood that the actual amount of contact that the seal-forming structure 3100 makes with the patient's face will depend on the particular implementation of the technology and the particular patient's anatomy. The seal-forming structure 3100 for the plenum chamber 3200 shown in Figures 158-164 (small plenum chamber 3200) and 165-171 (medium plenum chamber 3200) is configured for use with patients with long and narrow noses. In contrast, the seal-forming structure 3100 for the plenum chamber 3200 shown in Figures 172-176 (small wide plenum chamber 3200) and 177-183 (wide plenum chamber 3200) is configured for use with patients with relatively short and relatively wide noses. 158-171, the upwardly facing middle portion allows for a greater amount of contact with the underside lateral surface 3121 of the patient's nose (than with the small, wide and wide plenum chambers 3200 shown in FIGS. 172-183) because patients using the small and medium plenum chambers 3200 may generally have narrower noses and the small and medium plenum chambers 3200 may have a larger depression in the nose portion 3230 of the seal-forming structure 3100. In each of these specific examples of the present technology, the upwardly facing middle portion 3111 allows for a greater amount of contact with the underside of the patient's nose.

[0232] The upper lip portion 3116 may significantly contact the underside of the patient's nose as well as the patient's upper lip. In some examples, the majority of the seal formed from the seal-forming surface 3100 to the underside periphery of the patient's nose may be comprised of the upwardly facing central portion 3111 and the upper lip portion 3116. The upwardly facing central portion 3111 and the upper lip portion 3116 may each be less stiff than the other portions of the seal-forming structure 3100, which in some examples of the present technology is provided by a thinner wall thickness than the other portions of the seal-forming structure 3100. The underside of the patient's nose and upper lip may have complex geometries and may be sensitive to pressure. Therefore, it is advantageous to make the areas of the plenum chamber 3200 that contact or seal against these locations flexible and compliant to avoid excessive pressure on the face in these areas. In these examples, the lower stiffness made possible by the thinner wall thickness in the central portion of the nasal portion 3230 of the seal-forming structure 3100 near the nostrils 3272 allows the cushion to easily deform to seal against the lower surface of the patient's nose (e.g., the anterior tip, the lateral sides, and either ala of the upper lip). FIG. 110 is a cross-sectional view of the plenum chamber 3200 in sealing contact with the lower periphery of the patient's 1000 nose. The overall shape and structure of the outward-facing regions of the nasal portion 3230 (e.g., the posterior corners 3131, the forward-facing middle portion 3125, and the forward-facing central portion 3115) are generally maintained during use, while the more flexible upward-facing central portion 3111 can conform to the lower periphery of the patient's nose.

[0233] The thinner wall thickness of the upwardly facing central portion 3111 and the upper lip portion 3116 allows the seal-forming structure to expand in these areas to conform to the geometry of the underside and surrounding the patient's nose. As shown in FIG. 110, the thinner walls of the seal-forming structure 3100 in the upwardly facing central portion 3111 and the upper lip portion 3116 are advantageous in creating a good seal against the complex geometry under and around the nose. The thinner walls can deform and expand under pressure to conform to the surface of the patient's face and create an effective and comfortable seal.

[0234] The upwardly facing central region 3111 above and in front of the nostrils 3272 of the seal-forming structure is intended to seal below and partially in front of the patient's tip of the nose. Because the tip of the nose can be a relatively sensitive area on many patients, the wall thickness of this region of the seal-forming structure 3100 may be reduced. The central portion may extend from the rear upwardly facing central portion 3111 (i.e., facing the patient) side of the cushion through the central saddle portion 3112 and peripheral edge into the forward-facing central portion 3115 on the front (i.e., away from the patient) side of the seal-forming structure. Reducing the wall thickness in this region avoids applying excessive pressure on the sensitive tip of the nose area.

[0235] The upper lip portion 3116 of the seal-forming structure 3100 is intended to seal against the upper lip. The upper lip portion 3116 is provided in the center and below and behind the nostrils 3272. The upper lip portion 3116 may include a low wall stiffness. In some instances, the low wall stiffness is achieved by a thin wall thickness. Because the upper lip may be a sensitive area, as may the area of ​​the seal-forming structure 3100 intended to seal against the nasal tip, a thin wall thickness extends across the central lower / back region of the nasal portion 3230 of the seal-forming structure 3100. The thin wall thickness allows for less force to be applied to the upper lip than would be applied from a relatively thick wall thickness.

[0236] While maintaining a thin wall thickness in areas configured to contact the sensitive nasal tip and upper lip areas is advantageous for comfort, in examples of the present technology, the wall thickness in these areas is not reduced to an extent that the seal-forming structure 3100 cannot maintain a stable seal against the patient's face. If the wall thickness is too thin in these areas, the seal-forming structure may be prone to puckers, which may lead to seal failure and create leak paths, allowing air to flow between the patient's face and the cushion to the environment.

[0237] The upwardly facing intermediate portion 3121 may be positioned around some or all of the lower periphery of the patient's nose during use. For example, the upwardly facing intermediate portion 3121 may be configured to be positioned just outside the patient's nose at the base of the nose (e.g., near or against the ala of the nose). The upwardly facing intermediate portion 3121 of the seal-forming structure 3100 may include a pair of outer walls that face partially medially and partially upwardly (e.g., have medially and upwardly facing outer and outer surfaces) and, in some instances, partially posteriorly. As shown in FIG. 113 , the upwardly facing intermediate portion 3121 of the nasal portion 3230 is positioned proximate to the lower periphery of the patient's 1000 nose. The seal-forming structure 3100 has a higher rigidity at the upwardly facing intermediate portion 3121 than at the central portions 3111 and 3115. In these examples, the wall thickness of the seal-forming structure 3100 is thicker at the middle portions 3121 and 3125 than at the central portions 3111 and 3115 and the upper lip portion 3116 .

[0238] Generally, increasing the stiffness of an area of ​​the seal-forming structure 3100 compared to other areas of the seal-forming structure 3100 may be achieved by using increased wall thickness, multiple layers (e.g., a textile material including multiple layers), stiffer materials (e.g., higher durometer silicone or other materials (e.g., textiles)), reinforcing structures (e.g., ties or ribs), undercushions, portions or chassis, etc. across various examples of the present technology.

[0239] 34-38 and 76-80, the nasal portion has a central saddle portion 3112 that can seal against an area in front of or below the patient's nasal tip in addition to the upwardly facing central portion 3111. In these examples, these intermediate portions are provided to the lateral sides of the nasal portion 3230 of the seal-forming structure 3100 on either side of the upwardly facing central portion 3111, but not the central saddle portion 3112. The central saddle portion 3112 includes the same low stiffness as the upwardly facing central portion 3111 and the forward facing central portion 3115 in these examples of the present technology.

[0240] The seal-forming structure 3100 may have a wall thickness of 0.15 to 0.4 mm (e.g., 0.2 mm to 0.3 mm (e.g., 0.25 mm)) at the upwardly facing central portion 3111, the forwardly facing central portion 3115 and / or the upper lip portion 3116. The wall thickness of the upwardly facing intermediate portion 3121 and the forwardly facing intermediate portion 3125 may be 0.5 mm to 1 mm (e.g., 0.6 mm to 0.9 mm (e.g., 0.75 mm)).

[0241] In some examples, the upwardly facing middle portion 3121 of the seal-forming structure 3100 strengthens the upwardly facing central portion 3111 of the seal-forming structure 3100. In a further example, the upwardly facing middle portion 3121 provides a barrier to creases and prevents leak paths from forming within the seal-forming structure 3100. Additionally, the upwardly facing middle portion 3121 may provide flexibility and support for side loading onto the plenum chamber 3200, helping to prevent seal failure under side forces.

[0242] The upwardly facing central portion 3111 is extremely flexible due to its thinner wall thickness and therefore prone to puckers under certain conditions. The upwardly facing intermediate portion 3121 is stiffer and less prone to puckers due to its thicker wall thickness. In some instances, the nose portion 3230 of the seal-forming structure 3100 is particularly prone to puckers near the lateral sides of the patient's nose. If puckers begin to form in the seal-forming surface and continue outside of the seal-forming surface, the puckers can create a leak path through which gas can leak from the interior of the plenum chamber 3200 through the puckers to the environment and past the patient's face.

[0243] In some instances, the upwardly facing middle portion 3121 resists folding of the seal-forming structure 3100 due to its increased wall stiffness. If folding occurs within the upwardly facing central portion 3111 of the seal-forming structure 3100, the upwardly facing middle portion 3121 and / or the thicker posterior corner region 3131 may limit the size of the folding, preventing it from continuing up the patient-facing side of the nasal portion 3230 and past a seal-forming surface (e.g., a portion of the periphery of the patient's nose). Thus, the upwardly facing middle portion 3121, positioned at or near the edge of the patient's alar around the base of the nose, acts as a barrier to folding that closely follows the shape of the patient's nose. FIG. 116 illustrates the plenum chamber 3200 with various portions of various depicted seal-forming structures 3100. As shown, the pleats 3110 are formed in the upwardly facing central portion 3111, but the upwardly facing middle portion 3121 and the rear corners 3131 effectively provide a barrier to prevent the pleats 3110 from propagating outward and creating a leak path through the seal formed with the patient's face. The rear corners 3131 may provide a barrier to the pleats 3110 below and to the sides of the upwardly facing central portion 3111. The upwardly facing middle portion 3121 may provide a barrier to the pleats 3110 above and to the sides of the upwardly facing central portion 3111.

[0244] Additionally, the intermediate portion 3121 or 3125 may help resist or prevent the formation of creases in the thinner central portion 3111 or 3115. When the patient interface 3000 is worn by the patient, the intermediate portion may cause the thinner central portion to stretch over the base of the nose (e.g., towards the lower periphery). Due to the increased resistance to deformation provided by the intermediate portion near the patient's ala, stretching the central portion over the base of the nose may help resist or prevent the formation of creases in the central portion.

[0245] The seal-forming structure 3100 may also include laterally facing posterior portions 3141 on the lateral, non-patient-facing areas of the nasal portion 3230 of the seal-forming structure 3100. The laterally facing posterior portions 3141 of the nasal portion 3230 may be stiffer than the upwardly facing middle portion 3121 and the forwardly facing middle portion 3125. The laterally facing posterior portions 3141 may have a greater wall thickness than the middle portion, central portion, and / or upper lip portion 3116.

[0246] The upwardly facing middle portion 3121 is positioned to contact the sides of the patient's nose when the patient interface 3000 is worn by the patient, but is also flexible enough to deform laterally due to the patient's nose. In use, the seal-forming structure 3100 is biased at the upwardly facing middle portion 3121 to contact the patient's nasal ala. When the patient wears the patient interface 3000, an outward force is applied from the patient's nose onto the sides of the seal-forming structure 3100. As a result, the sides of the seal-forming structure 3100 in the nasal portion 3230 conform to the periphery of the patient's nose to form a stable and robust seal. FIGS. 112 and 113 show the nasal portion 3230 before and after the patient 1000 wears the patient interface 3000. As shown, the seal-forming structure 3100 is shaped within the nasal portion 3230 to conform to the lower periphery of the patient's nose when the patient 1000 wears the patient interface 3000. 113 shows how the seal-forming structure 3100 in the upwardly facing central portion 3111 adjacent to the upwardly facing middle portion 3121 conforms to the periphery of the nose of the patient 1000 to form a good seal. The stiffness of the seal-forming structure 3100 in the upwardly facing middle portion 3121 is advantageously large enough so that the nose portion 3230 can conform to and create a robust seal with narrow noses, but is not so stiff that it would be uncomfortable for wider noses.

[0247] 114 shows the seal-forming structure 3100 in sealing contact with the nose of the patient 1000 without any lateral displacement of the plenum chamber 3200. FIG. 115 shows the same view as FIG. 114, but after the seal-forming structure 3100 has been displaced laterally (e.g., due to tube drag). As shown in FIG. 115, by biasing the seal-forming structure 3100 into contact with the nose of the patient 1000, the seal-forming structure 3100 remains in sealing contact with both sides of the nose, even with relatively large displacements of the plenum chamber 3200.

[0248] In these examples, as shown in FIGS. 7-8 , 49-50 , 128-129 , 138-139 , 146-147 , and 154-155 , the nasal portion 3230 of the seal-forming structure 3100 includes two lateral portions 3231. Each lateral portion 3231 of the nasal portion 3230 can include a patient-facing side and a non-patient-facing side. The patient-facing side can face medially and posteriorly, and the non-patient-facing side can face laterally and anteriorly. Both the patient-facing side and the non-patient-facing side can partially face upward. The patient-facing side of the lateral portion 3231 of the nasal portion 3230 can include a portion of an upwardly facing central surface 3111 and an adjacent upwardly facing middle portion 3121. The non-patient-facing side of the lateral portion 3231 of the nasal portion 3230 may include a forward-facing middle portion 3125 and a laterally-facing posterior portion 3134 .

[0249] In some examples of the present technology, the lateral portions 3231 of the nasal portion 3230 of the seal-forming structure 3100 can be taller than in other examples of the present technology. That is, the lateral portions 3231 may protrude upwardly from the oral portion 3260 a greater distance during use. The plenum chambers 3200 shown in FIGS. 7-8 and 49-50 include tall lateral portions 3231 within the nasal portion 3230. These plenum chambers 3200 may better fit patients with relatively long noses, narrow noses, and / or noses with longer alar sections than the columella. The plenum chambers 3200 shown in FIGS. 128-129 and 138-139 include lateral portions 3231 within the nasal portion 3230. These lateral portions 3231 are not as tall as the examples shown in FIGS. 7-8 and 49-50, but are of medium height. These side sections 3231 may also fit well on patients with longer and narrower noses. The side sections 3231 shown in Figures 146-147 and 154-155 have shorter side sections 3231 in the nose portion 3230. These plenum chambers 3200 may fit well on patients with wider, shorter and / or flatter noses.

[0250] The front region of the nasal portion 3230 is configured to be comfortable while still being able to form a stable seal against the patient's nose.

[0251] In some examples, the thickness of the forward-facing central portion 3115 is approximately 0.15-0.4 mm (e.g., 0.2-0.3 mm), and in the illustrated example, the wall thickness is approximately 0.25 mm. The forward-facing intermediate portion 3125 may include a wall thickness greater than the wall thickness in the forward-facing central portion 3115, which may be 0.5 mm-1 mm (e.g., 0.65 mm-0.85 mm), or in the illustrated example, approximately 0.75 mm. In some examples, the thickness of the seal-forming structure 3100 tapers between regions having different thicknesses. In other examples, the thickness changes relatively abruptly (e.g., in a stepwise fashion). The anterior region of the nasal portion 3230 is configured to be somewhat compliant and is therefore not as thick and rigid as other regions of the nasal portion 3230 (e.g., the posterior corner 3131 of the nasal portion 3230 (which has a thickness in the range of 1-1.5 mm)). The front region of the nose portion 3230 may be thick enough so that it is rigid enough to retain its overall shape when worn by a patient.

[0252] Making the anterior portion of the nasal portion 3230 flexible allows the seal-forming structure 3100 to deform slightly when accommodating a patient's nose, particularly a long nose. FIG. 117 shows the plenum chamber 3200 in sealing contact with the face of a patient 1000 with a short nose. FIG. 118 shows the plenum chamber 3200 in sealing contact with the face of a patient 1000 with a long nose. In this example, the seal-forming structure 3100 can deform to a greater extent to accommodate a longer nose. This can be achieved without adversely affecting patient comfort. The patient's tip of the nose can be a particularly sensitive area, and flexibility in the anterior portion of the nasal portion 3230 can help reduce the force applied by the seal-forming structure 3100 to the patient's nose. This flexibility is particularly advantageous at the location of the tip of the nose, so the central portion is less stiff than the anterior-facing intermediate portion 3125. The upwardly facing central portion 3111 and the forwardly facing central portion 3115 may be approximately 0.25 mm thick, and the forwardly facing middle portion 3125 may have a wall thickness of approximately 0.75 mm. The thinner middle portion reduces pressure on the nasal tip, and the thicker middle portion 3125 provides some support to the overall structure of the nose portion 3230.

[0253] An additional benefit of the flexible central region of the nasal portion 3230 is that it allows the sides of the nasal portion 3230 to be pulled inward (e.g., medially) when the patient interface 3000 is donned and a downward force is applied from the patient's nose onto the upwardly facing central portion 3111 of the seal-forming structure. Pulling the sides of the nasal portion 3230 inward toward the sides of the patient's nose pulls the seal-forming structure 3100 into and around the lower periphery of the patient's nose, allowing for an improved seal. FIG. 113 shows the seal-forming structure 3100 conforming to the periphery of a patient's nose.

[0254] Although the lateral sides of the nose portion 3230 are pulled inward, the forward portion and particularly the forward facing middle portion 3125 on either side of the more flexible forward facing middle portion 3115 retain sufficient structural rigidity to maintain the overall shape of the seal-forming structure 3100 and avoid leak paths due to creases. In another example, the forward facing middle portion 3115 can be similar in thickness to the forward facing middle portion 3125, thereby providing additional crease resistance in the central saddle portion 3112 of the nose portion 3230.

[0255] The nasal portion 3230 of the seal-forming structure 3100, and particularly the region between the nostrils 3272 and the central saddle region 3112 of the nasal portion 3230, is advantageously relatively elongated in the anterior and posterior directions. This portion of the nasal portion 3230 of the seal-forming structure 3100 is less supported than other regions. The elongated region in this portion of the seal-forming structure 3100 provides sufficient space for deformation of the nasal portion 3230 of the seal-forming structure 3100, which is advantageous when the seal-forming structure 3100 receives the nose. If the seal-forming structure 3100 had a stiffer structure in this region, excessive force could be applied to the patient's nasal tip (especially for longer noses). Because the nasal tip can be a particularly sensitive area, avoiding such excessive force is advantageous in terms of comfort. However, there are also patients with noses that may be shorter and relatively wider. The plenum chambers 3200 shown in Figures 142-149 and 150-157 are suitable for patients with shorter noses. These plenum chambers 3200 include a nasal portion 3230 that is shorter in length between the upper lip 3116 and the central saddle region 3112. These plenum chambers 3200 also have a surface in the upwardly facing central portion 3111 between the aperture 3272 and the central saddle region 3112 that can accommodate the tip of the nose in a manner that is comfortable for the patient, but is not as long as the portion between the upper lip 3116 and the central saddle region 3112. This is because the plenum chambers 3200 shown in Figures 126-133 or 134-141 are more suitable for patients with longer noses. The plenum chamber 3200 shown in Figures 126-133 and 134-141 also includes a central saddle region 3200 that is positioned further forward relative to the chassis 3210 than the central saddle region 3112 of the plenum chamber 3112 shown in Figures 142-149 and 150-157.

[0256] The upwardly facing central portion 3111 of the nasal portion 3230 of the seal-forming structure 3100 has a bridge portion 3113 that connects the anterior region of the upwardly facing central portion 3111 with the upper lip portion 3116 of the nasal portion. The bridge portion 3113 is thus positioned below the bridge of the patient's nose in use and partially defines two nostrils 3272 (one on either side) through which air may be delivered to the patient.

[0257] The bridge portion 3113 is flexible and curved so that it is loose when the patient interface 3000 is not being worn by the patient. The looseness of the bridge portion 3113 allows the front portion of the central portion 3111 (the front of the bridge that contacts the patient's nasal tip in use) to move away from the upper lip portion 3116 when the patient is wearing the patient interface 3000.

[0258] Advantageously, this also allows noses of longer lengths to be comfortably accommodated by the seal-forming structure 3100. A longer and / or narrower nose can comfortably push the front portion of the upward-facing central portion 3111 forward. Deforming the nose portion 3230 in this manner can significantly reduce the force that the seal-forming structure 3100 can re-apply onto the patient's nasal tip (which is generally very sensitive). FIGS. 117 and 118 show the plenum chamber 3200 and seal-forming structure 3100 with a bridge portion 3113. The bridge portion 3113 is configured to be relaxed and is worn by patients 1000 with short and long noses, respectively. As shown in FIG. 117, the bridge portion 3113 is generally curved and relaxed because the front portion of the upward-facing central portion 3111 is not pushed forward to a significant extent by the nose of the patient 1000. However, as shown in Fig. 118, a longer nose will push the front portion of the upwardly facing central section 3111 forward to the extent that the bridge portion 3113 will stretch into a straighter configuration. The bridge portion 3113 therefore advantageously allows the seal-forming structure to accommodate a range of nose sizes while remaining comfortable and allowing a good seal to be achieved.

[0259] The bridge portion 3113 may be S-shaped so that it can straighten and resist movement of the upwardly facing central portion 3111 of the seal-forming structure 3100 away from the upper lip 3116. The bridge portion 3113 may be bowed, curved, or creased. The bridge portion 3113 may have a concertina or bellows. The bridge portion 3113 may include only one curve so that the bridge is C-shaped, or may include two bows so that it is S-shaped for greater relaxation. The bridge portion 3113 may be sling-shaped (e.g., a portion suspended between its ends). The bridge portion 3113 is longer and includes more material than would be necessary to fill the gap between the front and rear portions of the upwardly facing central portion 3111 of the nose portion 3230. This extra material allows the bridge portion 3113 to stretch from straight to taut. The more such excess material, the more the bridge portion 3113 can stretch before it becomes taut due to the force applied to the front of the upwardly facing central portion 3111. The bridge portion 3113 does not need to seal against the bridge of the patient's nose to completely seal against the patient's nose, allowing the bridge portion 3113 to still provide a good seal for small noses even when it is slightly relaxed.

[0260] The bridge portion 3113 may have a thickness of approximately 0.2 mm to 0.45 mm or 0.3 to 0.4 mm (e.g., 0.35 mm). The thickness of the material of the bridge portion 3113 is greater than the material thickness of the upwardly facing central portion 3111 around the periphery of the seal-forming structure 3100, thereby helping to resist or prevent the bridge portion 3113 from breaking. Alternatively, the bridge portion 3113 may be wider and thinner. In one example, a thicker and narrower bridge portion 3113 is provided to accommodate the relatively large nostrils 3272.

[0261] The bridge portion 3113 may also serve other purposes. For example, it may maintain the integrity of the thinned zone of the central portion 3111. If there were no bridge portion 3113 but instead a single nostril, the relatively thin wall thickness of the central portion could cause rupture in the upwardly facing central portion 3111 when the seal-forming structure is re-donned under pressure (e.g., via facial pulling and repositioning) or when the seal-forming structure is subjected to rapid dynamic loading. Fastening of the upwardly facing central portion 3111 to the upper lip portion 3116 by the bridge portion 3113 reduces the likelihood of rupture in the upwardly facing central portion 3111.

[0262] Additionally, the bridge portion 3113 may help prevent the patient from incorrectly setting up the patient interface 3000. If the bridge portion 3113 were not provided and instead there was a single nostril, the patient could accidentally insert their nose into the nostril. In some instances, because the seal-forming structure 3100 is configured to seal around the lower periphery of the patient's nose, if the patient inserts their nose into the nostril, the seal-forming structure will not be able to achieve a proper seal.

[0263] Despite the benefits of the bridge portion 3113 in some forms of the present technology, in some alternative examples, the bridge portion 3113 is not provided, and only a single hole is provided in the nose portion 3230 of the seal-forming structure 3100. This allows the upwardly facing central portion 3111 of the nose portion 3230 to move relative to the lower portion, and also makes the seal-forming structure 3100 easier to clean. However, if the upwardly facing central portion 3111 of the seal-forming structure 3100 is not fastened to the upper lip portion 3116, there may be an increased risk of rupture for some patients. Furthermore, there is the possibility that a patient may insert their nose into the single hole. Steps are taken to mitigate these risks (e.g., by providing the seal-forming structure with a thicker, smaller, or tighter membrane around the hole). A single hole (i.e., no bridge) may then be provided in some examples of the present technology. The seal-forming structure 3100 of a patient interface 3000 in accordance with examples of the present technology may include one or two apertures for providing airflow to the patient's nasal passages.

[0264] While it is advantageous to reduce the wall thickness of the seal-forming structure 3100 in the areas of the seal-forming structure 3100 described above to allow it to comfortably fit complex geometries, relatively larger wall thicknesses in some areas of the seal-forming structure 3100 are advantageous in other forms of the present technology.

[0265] For example, the nasal portion 3230 of the seal-forming structure 3100 includes posterior corners 3131 configured to seal against the patient's face adjacent the nasolabial folds. These posterior corners 3131 have greater wall thickness compared to the central portion of the nasal portion 3230 of the seal-forming structure 3100. This greater wall thickness can provide significant structural rigidity to the seal-forming structure 3100 in these regions, which can provide several benefits.

[0266] The posterior corner 3131 may help support the seal-forming structure on the patient's face and should therefore have sufficient structural rigidity not to collapse and compromise the seal achieved by the central portion of the seal-forming structure 3100 (e.g., the upwardly facing central portion 3111 and / or the upper lip portion 3116). In another example, the posterior corner 3131 includes a reinforcing undercushion. In the illustrated example with a single-wall seal-forming structure 3100, structural rigidity is provided by a sufficiently large wall thickness, which in one example may be approximately 0.8 to 1.6 mm (e.g., 1.1 mm to 1.45 mm or 1.25 mm). The posterior corner 3131 is configured to be positioned on the patient's face in the area below the patient's ala and below and laterally outward of the patient's nose (e.g., between the nasolabial fold and the area of ​​the upper lip located below the ala).

[0267] As shown in Figures 27, 34, 69, and 76, there is an abrupt transition (e.g., a sharp taper or step) between the greater wall thickness in the posterior corner 3131 and the thinner wall thickness in the upper lip portion 3116 of the seal-forming structure 3100 (i.e., in the region sealing against the upper lip). The thicker posterior corner 3131 provides support for the seal-forming structure when support is needed / advantageous with the upper lip portion 3116 positioned in a sealed manner against the patient's upper lip, and can be significantly more flexible to conform to the contours of the patient's face while minimizing force. Because facial geometry can vary greatly from patient to patient, the abrupt transition can be located almost directly from the underside to the ala of the nose on the upper lip.

[0268] In some examples of the present technology, the seal-forming structure 3100 includes lateral corner regions 3114 that form portions of the central portion. These lateral corner regions 3114 are configured to contact and seal against the alae of the nose. As shown in FIGS. 34, 76, 160, 161, 164, 168, and 170, above the location of the junction between the thicker wall of the posterior corners 3131 and the thinner wall thickness of the upper lip portion 3116 of the nasal portion 3230 of the seal-forming structure 3100, the lateral corner regions 3114 of the upwardly facing central portion 3111 extend laterally, posteriorly, and superiorly to either side of the target seal-forming region (e.g., extending upward on the medial-facing side of the seal-forming structure 3100). The alae of the nose can be significantly curved, and for many patients, the alae may join the face in a significantly recessed pocket or depression. These pockets may result from the alar, which curves back medially (e.g., toward the sagittal plane) between the widest part of the nose and the junction of the alar and face. Providing low stiffness in these lateral corner regions 3114, achieved in these instances by a thin wall thickness, allows the seal-forming structure 3100 to deform and conform to the curvature of the alar. Such flexibility and ability to conform may assist the seal-forming structure 3100 in filling recesses that may exist in the lower corners of a patient's nose.

[0269] The seal-forming structure 3100 can be configured such that the transitions between the thick rear corners 3131 and the thin upper lip portions 3116 are positioned adjacent to the ala on the patient's face on the sides of the ala. The areas of the seal-forming structure 3100 that contact the patient's face on either lower lateral side of the nose can be part of the thick rear corners 3131 to provide good support and stability to the seal-forming structure 3100. FIG. 111 shows a cutaway view of a plenum chamber 3200 according to an example of the present technology in a sealing position on a patient's face. The upward-facing central portion 3111 seals against the lower periphery of the patient's 1000 nose, and the upper lip portion 3116 seals against the patient's upper lip. The upward-facing middle portion 3121 is positioned adjacent to the sides of the patient's nose (e.g., adjacent the ala). Additionally, the lateral corner regions 3114 of the upward-facing central portion 3111 can deform to accommodate the ala of the patient's nose. For example, the lateral corner regions 3114 may cup the patient's ala. The lateral corner regions 3114 may create a shelf in the cushion that may provide support adjacent the patient's ala during use, allowing the seal-forming structure 3100 to better conform to the lower periphery of the patient's nose (particularly adjacent the upper lip) during use.

[0270] 111 , the boundary between the thickened wall forming the posterior corner 3131 and the intermediate adjacent portion of the seal-forming structure 3100 can be traced upward, outward, and then inward, thereby following the curvature of the patient's nose in an upward direction starting from the underside of the patient's ala. The intermediate boundary of the wall forming the thickened posterior corner 3131 can trace a path up the patient's face on either side of the nose following the curvature along either side of the nose. This can allow the thinner portions (e.g., the upward-facing central portion 3111 and upper lip portion 3116) to conform and seal against the ala and underside of the patient's nose, while still providing good support when needed (e.g., the patient's face just below the patient's nose and on either side of the patient's nose).

[0271] As shown in the side views shown in Figures 18, 19, 30, 31, 32, 38, 58 and 80, for example, the seal-forming structure 3100 is thicker towards the front side closer to the shell 3210 (the shell 3210 not shown in Figures 38 or 80 but shown in Figures 9 and 51). As noted above, the seal-forming structure 3100 includes lateral support portions 3151 in the form of thickened regions on the partially forward-facing lateral sides of the nose portion 3230 of the seal-forming structure 3100. The thicker regions of the seal-forming structure 3100 closer to the shell 3210 provide good support and structural rigidity for the seal-forming structure 3100.

[0272] While the thicker region adjacent the shell 3210 is advantageous for structural rigidity, the nose portion 3230 of the seal-forming structure 3100 also retains a level of flexibility to allow the sides of the seal-forming structure 3100 to be pushed outward or pulled inward to accommodate noses of different widths.

[0273] For example, the side or area of ​​the nasal portion 3230 of the seal-forming structure 3100 that does not face the patient (e.g., the front side, the side that faces at least partially forward) (particularly the area on either side of the nasal portion 3230 of the seal-forming structure 3100 that does not contact the patient) is thick enough to provide sufficient structural rigidity to the seal-forming structure 3100, and is thin enough so that when a patient with a long, narrow nose wears the seal-forming structure 3100, a downward force acting on the central region 3111 facing upward from the patient's nose can pull the sides of the nasal portion 3230 slightly inward to allow the patient-contacting surface of the seal-forming structure 3100 on either side of the patient's nose to make good contact with the patient's nose. Similarly, the construction of the nose portion 3230 of the seal-forming structure 3100 is sufficiently flexible to prevent excessive inward force on the sides of the patient's nose when the seal-forming structure 3100 is worn by a patient with a wider nose (which may occur if the seal-forming structure is too stiff to withstand the wider nose). It is also possible to provide a number of different sizes of the seal-forming structure 3100 to accommodate a range of nose widths.

[0274] As shown in Figures 7, 8 and 49, 55, 126, 129, 138-139, 146, 147, 154, and 155, for example, the oral-nasal transition 3275 at the periphery of the plenum chamber 3200 connects the nasal portion 3230 and the oral portion 3260. The periphery of the seal-forming structure 3100 varies at this location between examples of the present technology. As shown in Figure 7, the oral-nasal transition 3275 is relatively abrupt, with a relatively large positive curvature at the periphery of the seal-forming structure 3100 between the nasal portion 3230 and the oral portion 3260. In contrast, as shown in Figure 49, the oral-nasal transition 3275 is relatively gradual, with a relatively small positive curvature at the periphery of the seal-forming structure 3100 between the nasal portion 3230 and the oral portion 3260. In either case, the oral-nasal transition 3275 includes a saddle region. The plenum chamber 3200 shown in FIGS. 128, 138, 146 and 154 includes a clear and gradual oral-nasal transition 3275.

[0275] Because it is preferred that the periphery of the seal-forming structure 3100 be stiff enough to support the overall shape of the seal-forming structure 3100 and avoid significant folding and buckling, the shape of the periphery may vary more than the areas that contact the patient's face and neighboring regions (i.e., thinner and thicker zones to avoid creating leak paths through the patient's face due to folding). In either case, the oral-nasal transition 3275 between the nasal and oral portions of the seal-forming structure 3100 is relatively stiff (e.g., relatively thick) compared to less stiff portions of the seal-forming structure 3100 (e.g., the upwardly facing central portion 3111) to avoid the development and creation of leaks between these portions due to folding or buckling. Alternatively, the oral-nasal transition 3275 may be reinforced by any suitable means (e.g., an undercushion, ribs, a portion of a shell, or a frame).

[0276] In some instances, the oral portion 3260 of the seal-forming structure 3100 includes features to prevent folding, which are more likely to occur at the side periphery of the oral cavity 3271 than at the top and bottom of the oral cavity 3271 due to the downward force of the cushion on the nasal portion and the wide oval shape of the oral opening.

[0277] 34-80, the seal-forming structure 3100 includes an oral cavity perimeter 3117 around the oral cavity 3271 that is thinner than other portions of the seal-forming structure 3100. Additionally, the seal-forming structure in these examples includes rearward-facing side portions 3135. These rearward-facing side portions 3135 are thicker than the oral cavity perimeter 3117 to resist puckers and buckling in the cushion that can cause leak paths to form. In some examples of the present technology, the seal-forming structure 3100 shown in FIGS. 126-157 can also include an oral cavity perimeter that is less stiff than the rearward-facing side portions of the oral portion 3260.

[0278] 48, the seal-forming structure includes lateral peripheral support portions 3136 on opposite lateral sides of the oral cavity 3271. In this example, the posteriorly facing lateral portions 3135 form the lateral peripheral support portions 3136. The posteriorly facing lateral portions 3135 extend medially toward the lateral-most edges of the oral cavity 3271 to provide the lateral peripheral support portions 3136. The lateral peripheral support portions 3136 provide additional resistance to buckling. In some examples of the present technology, the seal-forming structure 3100 shown in FIGS. 126-157 can also include lateral peripheral support portions 3136.

[0279] 5.3.2.3 Oral area In one form, the non-invasive patient interface 3000 includes a seal-forming structure 3100 that, in use, forms a seal over the upper lip region of the patient's face (i.e., the upper lip). The seal-forming structure 3100 may include an upper lip portion 3116 configured to form a seal against the patient's upper lip.

[0280] In one form, the seal-forming structure 3100 includes a saddle-shaped region that is constructed to form a seal over the upper lip region of the patient's face in use.

[0281] In one form, the non-invasive patient interface 3000 includes a seal-forming structure 3100 that, in use, forms a seal around the patient's mouth in the oral cavity portion 3260. The seal-forming structure 3100 may form a seal over the chin region of the patient's face.

[0282] In one form, the seal-forming structure 3100 includes a saddle-shaped region that is constructed to form a seal over the chin region of the patient's face in use.

[0283] As shown in FIGS. 34-80 and 126-183, the seal-forming structure 3100 includes a lower lip 3118 that forms a seal against the patient's chin area. In one example, the seal-forming structure 3100 including the lower lip 3118 does not extend below the patient's chin (i.e., below the mental prominence) in use or engage the patient's face below the chin (i.e., below the mental prominence) in use. The lower lip 3118 of the seal-forming structure may seal against the patient's lower lip and supramentum. Further, in these examples, the seal-forming structure 3100 includes an oral cavity perimeter 3117. The lower lip 3118 may be connected to (e.g., adjacent to) the upper lip 3116 via the oral cavity perimeter 3117. The seal-forming structure 3100 includes a relatively small wall thickness (compared to other areas) at the oral cavity periphery 3117 and at the lower lip portion 3118 of the seal-forming structure 3100, which is positioned against the jaw region. The reduced wall thickness in these locations assists in achieving an effective and comfortable seal. The seal-forming structure 3100 in these areas can easily conform to any complex geometry (e.g., the mandibular fold).

[0284] In these examples, the oral portion 3260 includes rearward-facing lateral portions 3135 on the patient-contacting side of the seal-forming structure 3100. As noted above, the wall thickness of the oral orifice periphery 3117 immediately surrounding the oral orifice 3271 is thinner compared to other areas of the seal-forming structure 3100; however, in these examples, there are rearward-facing lateral portions 3135 on either lateral side of the oral orifice periphery 3117 that are thicker than the oral orifice periphery 3117. The wall thickness in these areas may be approximately 1 mm to 1.5 mm (e.g., 1.15 mm to 1.35 mm (e.g., approximately 1.25 mm thick)). Areas that come into contact with these areas during use (i.e., the patient's cheeks) are often less sensitive than other areas of the face, and therefore patients can often tolerate a seal-forming structure 3100 with greater wall thickness / stiffness in these areas. Additionally, the rearward facing sides 3135 of the oral portion 3260 are curved away from the contacting portions with the patient's face, thereby reducing the contact area on the patient's face in these areas. In another example, instead of making the rearward facing sides 3135 of the oral portion 3260 thicker, they may be made stiffer by other means (e.g., reinforcing structures (e.g., ribs), stiffer material, undercushions).

[0285] The rearward-facing lateral portions 3135 provide resistance to folds that may form near the oral orifice 3271, thereby avoiding the creation of a leak path. The rearward-facing lateral portions 3135 provide a barrier to folds that may form at the thinner oral orifice periphery 3117, thereby limiting the extent of folds away from the oral orifice 3271. This function of the rearward-facing lateral portions 3135 may be similar to the fold resistance function provided by the upward-facing middle portion 3121 of the nasal portion 3230 described above.

[0286] The lower lip 3118 of the oral portion 3260 is approximately half the width of the oral portion 3260 and is centered below the oral cavity 3271. As noted above, the lower lip 3118 may be relatively thin. The transition between the thinner lower lip 3118 on either side and the thicker posteriorly-facing lateral portions 3135 may be configured to be positioned at or near the patient's jaw crease. The lower lip 3118 is wider at the periphery of the oral cavity 3271 than at the lower periphery of the seal-forming structure 3100. Thus, the width of the lower lip 3118 tapers downwardly from the oral cavity 3271. In the example shown in FIGS. 49-80 , the lower lip 3118 extends from the posteriorly-facing side of the seal-forming structure 3100 to the downwardly-facing periphery. The actual amount of the lower lip 3118 that contacts the patient's face may depend on the shape of the patient's jaw. For patients with a more forward protruding jaw, there may be increased contact with the lower lip 3118. In the plenum chamber 3200 shown in Figures 158-183, the lower periphery of the shell 3210 is not as downward as the lower periphery of the shell 3210 of the plenum chamber 3200 shown in Figures 49-80 and the seal-forming structure 3100 and lower lip 3118 around the lower periphery of the seal-forming structure 3100, thereby forming a partially forward facing portion of the lower lip 3118.

[0287] The lateral periphery of the oral portion 3260 includes lateral portions 3145 of the oral portion 3260 that are more distal from patient contact (e.g., closer to the shell 3210) than the rearward-facing lateral portions 3135. In these examples, the lateral portions 3145 are thicker than the rearward-facing lateral portions 3135 of the oral portion. In some examples, the thickness of the lateral portions 3145 of the oral portion is in the range of 1.5 to 2.2 mm (e.g., 1.7 to 2 mm). Because most or all of the lateral portions 3145 are unlikely to come into contact with the patient's face during use, patient comfort is less of a critical design consideration in these regions, and the wall thickness can be greater in these regions than in the patient-contacting regions. This increased wall thickness can provide structural rigidity to the overall shape of the oral portion 3260 of the seal-forming structure 3100. In some instances, certain areas of the seal-forming structure 3100 will be thicker further distal from the patient's face, unless there is a reason that those areas need to be flexible (e.g., to accommodate deformation of the sides of the nose portion of the seal-forming structure 3100). The side portions 3145 define the lateral perimeter of the seal-forming structure 3100 within the oral cavity portion 3260.

[0288] On the anterior side of the seal-forming structure 3100, the wall thickness is generally greater than in these examples, except for the anterior side of the nasal portion and the central lower region of the oral portion of the seal-forming structure 3100. In these examples, the seal-forming structure 3100 includes forward-facing lateral portions 3155. In these examples, the wall thickness of the lateral forward-facing portions 3155 is greater than the lateral portions 3145 (and the rearward-facing lateral portions 3135). The wall thickness of the forward-facing lateral portions may be in the range of 1.7-2.7 mm (e.g., in the range of 2.0-2.5 mm). These thicker regions provide substantial support and structural organization to the overall shape of the seal-forming structure 3100. The lateral forward facing portions 3155 cooperate with other portions of the seal-forming structure (e.g., the lateral portions 3145) which have thicker walls to maintain the general shape of the seal-forming structure 3100 and resist folding and / or buckling, etc., while the thinner areas on the patient-facing side of the seal-forming structure 3100 are pressed against and deformed by the patient's face under the force applied from the positioning and stabilizing structure 3300 to the plenum chamber 3200.

[0289] Also provided on the front side of the seal-forming structure 3100 is a front support portion 3161 of the oral portion 3260. The front support portion 3161 is a thicker zone of the seal-forming structure 3100 at the base of the nasal portion on the front side (where the nasal portion joins with the adjacent oral portion of the frame) and at the lower lateral corners of the oral portion 3260. The wall thickness in these regions may be in the range of 2-3 mm (e.g., 2.5-3 mm). These regions may provide additional structural rigidity to the seal-forming structure. The front support portion 3165 may have a greater wall thickness than the forward-facing side portions 3155. Typically, the cushion has a greater wall thickness further distal from the seal-forming region, but immediately proximal to the shell 3210, the thickness may be similar to that of the forward-facing side portions 3155, even though the front support portion 3165 is thicker. In some instances, the seal-forming structure 3100 immediately adjacent the shell 3210 may be reinforced by the peripheral edge of the shell 3210, allowing for a smaller wall thickness.

[0290] 5.3.2.4 Frontal area In one form, the seal-forming structure forms a seal on the forehead region of the patient's face when in use, and in such a form, the plenum chamber may cover the eyes when in use.

[0291] 5.3.2.5 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 nose.

[0292] Nasal pillows according to one aspect of the present technology include a truncated cone. At least a portion of the truncated cone forms a seal over the underside of the patient's nose, the stem, and a flexible region on the underside of the truncated cone, connecting the truncated cone to the stem. Additionally, the structure to which the nasal pillows of the present technology are connected includes a flexible region adjacent to the base of the stem. The flexible region can function to facilitate a universal joint structure. The universal joint structure accommodates both the displacement and angle of the truncated cone and the relative movement of the structure to which the nasal pillows are connected. For example, the truncated cone can be displaced axially toward the structure to which the stem is connected.

[0293] 5.3.2.6 Surface Finish In some examples, different regions of the seal-forming structure 3100 include different surface finishes.

[0294] 47, the plenum chamber 3200 includes a seal-forming structure 3100 that includes a nasal portion 3230 and an oral portion 3260. The seal-forming structure includes a first surface finish in the nasal portion and a second surface finish in the oral portion that is different from the first surface finish. In the illustrated example, region 3101 has the first surface finish and region 3103 has the second surface finish. The boundary between the first and second surface finishes is identified by a line 3102 that may contact the patient's cheeks during use.

[0295] The coefficient of friction between the seal-forming structure 3100 and the patient's face is higher in the oral portion 3260 than in the nasal portion 3230. The first surface finish in region 3101 can be configured to provide the nasal portion with a smooth feel on the patient's face, which can be more comfortable. The second surface finish in region 3103 can be configured to provide the oral portion with a gripping contact on the patient's face, which can enable a more robust seal. In some examples, the first surface finish in region 3101 can be a matte surface finish. In some examples, the second surface finish in region 3103 can be a polished surface finish. In this example, the nasal portion 3230 includes an upper lip 3116 having the first surface finish.

[0296] A polished surface finish may have a non-slippery, sticky feel, creating more friction as the seal-forming structure 3100 moves relative to the patient's face. This is generally desirable because it helps prevent movement of the plenum chamber 3200 when the patient wears it, thereby helping to maintain a seal. However, patients may find the feel of a polished surface finish less pleasant on their face than a smoother, lower-friction surface finish. Because the nose is often a more sensitive area, patients may tolerate the feel of a polished finish on their cheeks and under their mouth, but not on and around their nose. Therefore, in this example, a polished finish is provided around the oral cavity portion 3260, while a matte finish is provided on the nose portion 3230 of the seal-forming structure 3100. Providing a matte finish on the nose portion 3230 may also assist in movement of the seal-forming structure 3100 relative to the nose as the matte finish conforms to the surface around the nose, which may also assist in forming a seal.

[0297] Additionally, the increased grip provided by the higher friction within the area of ​​the second surface in region 3103 helps the oral cavity portion 3260 maintain a seal when the patient's jaw is moving. The jaw may tend to move (and subsequently drop) relative to the head. The increased grip helps maintain a seal position around the patient's mouth when the jaw is moving.

[0298] The boundary 3102 between the polished finish at 3103 and the matte finish at 3101 is near the boundary between the nasal portion 3230 and oral portion 3260 of the seal-forming structure 3100 (slightly closer to the oral portion 3260 than to the nasal portion 3230). The boundary 3102 is positioned across the seal-forming structure 3100 approximately perpendicular to a path on the oral portion 3260 that surrounds the oral orifice 3271. At the periphery of the oral orifice 3271, the boundary 3102 may be positioned on the upper lip. At the periphery of the oral portion 3260 of the seal-forming structure 3100, the boundary may be positioned adjacent to the patient's cheekbones.

[0299] In some forms, when the seal-forming structure 3100 includes multiple physical or functional segments, each segment may be formed with the same finish so that together they form a common, continuous surface. Alternatively, in some forms, each segment may be formed with a distinct surface finish. For example, a segment adjacent the patient's chin may be formed with a higher friction for additional grip, while a segment adjacent the patient's nose may have a more matte finish compared to the other segments.

[0300] 5.3.2.7 Textile Portion of Seal-Forming Structure 3100 In the examples shown in FIGS. 186-192, the patient interface 3000 includes a seal-forming structure 3100 that may have one or more sections of textile. In these examples, the textile may be made air-impermeable, ensuring that pressurized air in the plenum chamber 3200 does not leak through the seal-forming structure 3100. In such examples, each section of textile may be curved about a single axis. This may avoid the need for complex manufacturing processes when forming the seal-forming structure 3100, allowing the seal-forming structure 3100 to be formed with complex three-dimensional curvatures while minimizing the occurrence of seal interruptions (e.g., wrinkles in the textile sections). In these examples, the textile portion 3170 may be overmolded with another material (e.g., silicone, thermoplastic elastomer (TPE), and / or thermoplastic polyurethane (TPU)) to form the seal-forming structure 3100. The textile portion 3170 may form the surface on the seal-forming structure 3100 that primarily contacts the patient's face, as textile may be more comfortable against the patient's skin. However, other materials for the seal-forming structure 3100 (e.g., silicone, thermoplastic elastomer (TPE) and / or thermoplastic polyurethane (TPU)) may be more easily formed to conform to complex facial shapes, and may depend on the overall structure of the seal-forming structure 3100.

[0301] 5.3.2.7.1 Separate textile parts For example, in some embodiments of FIG. 186, the seal-forming structure 3100 may include a textile portion 3170 formed by multiple distinct zones or segments. The underside of a patient's nose and upper lip may have complex geometries and be sensitive to pressure. While textile materials may be advantageous in providing greater comfort than some other materials (e.g., silicone), it may be difficult to fabricate a seal-forming structure 3100 that can engage with the patient's face around the entrances to both the nasal and oral air passages (without creating undesirable wrinkles in the seal-forming structure 3100 when the textile portion 3170 is applied). Additionally, such regions may be defined as shapes with a certain amount of twist and curvature in two or more directions, where the combination of twist and curvature exceeds a threshold such that the textile material does not form undesirable folds or wrinkles in its resting state.

[0302] In the example of FIG. 186 , the seal-forming structure 3100 has a textile portion 3170, which may include a nasal textile portion 3171 on the nasal portion 3120 of the seal-forming structure 3100. The nasal textile portion 3171 may seal against the underside(s) of the patient's nose in use. The textile portion 3170 of the seal-forming structure 3100 may also include an oral textile portion 3172 in the oral portion 3130. The oral textile portion 3172 seals around the patient's mouth (including the upper lip region of the patient's face and the chin region of the patient's face) in use. As will be appreciated, the nasal textile portion 3171 and the oral textile portion 3172 are separate from one another. The textile of the nasal textile portion 3171 may have the same properties as the textile of the oral textile portion 3172, or at least one property of these textiles may be different.

[0303] The nasal textile portion 3171 may include a single nostril 3272 to direct airflow into the patient's nostril or both nostrils 3272, directing the flow into a corresponding one of the patient's nostrils. In the latter example shown in FIG. 186 , the nasal textile portion 3171 between the nostrils 3272 may be positioned adjacent the bridge of the patient's nose in use. The oral textile portion 3172 may also include an oral opening 3271 to direct airflow into the patient's mouth.

[0304] The seal-forming structure 3100 may be constructed by overmolding silicone onto each of the nasal textile portion 3171 and the oral textile portion 3172. The area of ​​the seal-forming structure 3100 between the nasal textile portion 3171 and the oral textile portion 3172 may be exposed to and adjacent to the patient's upper lip in use.

[0305] Because the areas of the patient's face that engage the nasal textile portion 3171 and the oral textile portion 3172 each have different shapes and orientations, the nasal textile portion 3171 and the oral textile portion 3172 may be differently shaped and oriented for an optimal seal during use. The nasal textile portion 3171 may be positively curved around the nasal axis 6000. The oral textile portion 3172 may be positively curved around the oral axis 6001. FIG. 186 illustrates these axes and how they may be oriented differently from one another. The angle between the nasal axis 6000 and the oral axis 6001 may be greater than 90°. This orientation allows the nasal textile portion 3171 to be tilted upward and away from the patient's face during use, ensuring contact along the length of the base of the patient's nose during use. Additionally, the radius of curvature around the nasal axis 6000 of the nasal textile portion 3171 may be smaller than the radius of curvature around the oral axis 6001 of the oral textile portion 3172. The nasal axis 6000 and the oral axis 6001 may also lie in the same plane (e.g., in the sagittal plane of the patient) when in use. As such, the seal-forming structure 3100 may also be symmetrical across the plane in which these axes lie.

[0306] Each separate nasal textile portion 3171 and oral textile portion 3172 of the seal-forming structure 3100 can contact a respective one of the nasal or oral air passages while remaining flexible, compliant, and substantially wrinkle-free, so that a comfortable level of pressure can be provided on the patient's face in these areas by the seal-forming structure 3100. In this manner, non-textile materials can be used to form area(s) requiring complex shapes, while textile materials can be used in areas requiring less complex curvatures.

[0307] 5.3.2.7.2 Integral textile parts In some forms, the textile portion 3170 of the seal-forming structure 3100 may be formed from a single textile piece or may function as multiple separate zones or segments, as shown in Figures 187-189. As best shown in Figure 187, the nasal textile portion 3171 and the oral textile portion 3172 of the seal-forming structure 3100 may be joined by a bridge portion 3174 to form the unitary textile portion 3170 of the seal-forming structure 3100.

[0308] In such a configuration, the textile of the bridge portion 3174 may be relatively thin and narrow compared to the nasal textile portion 3171 and the oral textile portion 3172. The bridge portion 3174 may be positioned adjacent the patient's upper lip during use. Because the bridge portion 3174 is relatively narrow, it may not impart a significant amount of twist to the nasal textile portion 3171 and the oral textile portion 3172 after construction of the seal-forming structure 3100. As such, it may be less likely to cause undesirable wrinkling in the nasal textile portion 3171 and the oral textile portion 3172.

[0309] Because the nasal textile portion 3171 and the oral textile portion 3172 are each formed with a dome-like curvature around the nasal axis 6000 and the oral axis 6001, respectively, they may be substantially functionally independent of one another when overmolded onto their respective portions of the seal-forming structure 3100. Such functional independence also results in the shape of the textile portion 3170 being less complex, so that it does not cause significant distortion of one another when a force is applied to one of the nasal textile portion 3171 and the oral textile portion 3172. In other words, the nasal textile portion 3171 and the oral textile portion 3172 may be sufficiently separated from one another that they do not significantly distort each other's supporting shape before or during use. Additionally, such regions define a shape with a certain amount of twist and curvature in two or more directions, and the combination of twist and curvature is below a threshold so that undesirable folds or wrinkles do not occur in the resting state when the textile seal-forming structure 3100 is in use.

[0310] The textile of the nasal textile portion 3171 may have the same properties as the textile of the oral textile portion 3172, or at least one property of these textiles may be different. The bridge portion 3174 may also have the same properties as the nasal textile portion 3171 and the oral textile portion 3172, or at least one property of these textiles may be different. The textiles of the nasal textile portion 3171, the oral textile portion 3172, and the bridge portion 3174 may be a single, continuous textile piece. Alternatively, if the properties differ between the nasal textile portion 3171, the oral textile portion 3172, and the bridge portion 3174, these textiles may be different pieces joined by stitching or welding.

[0311] The nasal textile portion 3171 may include a single nostril 3272 to direct airflow into the patient's nostril or both nostrils 3272, directing the flow into a corresponding one of the patient's nostrils. In the latter example shown in FIGS. 187-189, the nasal textile portion 3171 between the nostrils 3272 may be positioned adjacent the bridge of the patient's nose in use. The oral textile portion 3172 may also include an oral opening 3271 to direct airflow into the patient's mouth.

[0312] Because the areas of the patient's face that engage the nasal textile portion 3171 and the oral textile portion 3172 each have different shapes and orientations, the nasal textile portion 3171 and the oral textile portion 3172 may be differently shaped and oriented for an optimal seal during use. The nasal textile portion 3171 may be positively curved around the nasal axis 6000. The oral textile portion 3172 may be positively curved around the oral axis 6001. FIG. 189 illustrates these axes and how they may be oriented differently from one another. The angle between the nasal axis 6000 and the oral axis 6001 may be greater than 90°. This orientation allows the nasal textile portion 3171 to be tilted upward and away from the patient's face during use, ensuring contact along the length of the base of the patient's nose during use. Additionally, the radius of curvature of the nasal textile portion 3171 about the nasal axis 6000 may be smaller than the radius of curvature of the oral-textile portion 3172 about the oral axis 6001. The nasal axis 6000 and the oral axis 6001 may also lie in the same plane (e.g., in the patient's sagittal plane) during use. As such, the seal-forming structure 3100 may also be symmetrical across the plane in which these axes lie. Additionally, the bridge portion 3174 may be bent or curved about the nasal-labial axis 6002 shown in FIG. 189 so that the nasal textile portion 3171 and the oral-textile portion 3172 occupy their intended orientations.

[0313] In some forms, the seal-forming structures 3100 may be attached to the support structure of the shell 3210 by an overmolding process so that the outer periphery of each textile seal-forming structure 3100 abuts the shell 3210 while the inner periphery of the textile seal-forming structure 3100 (i.e., that which forms the aperture adjacent each air passage) extends to a free end. This may advantageously increase the compliance of the textile material, thereby improving the seal.

[0314] FIGS. 187, 188, and 189 show the textile portion 3170 and the seal-forming structure 3100 in various states of manufacture. In FIG. 187, the one-piece textile portion 3170 is alone, but can be bent / curved into a shape that can approximate its position in a mold. FIG. 188 shows the one-piece textile portion 3170 further bent / curved into its finished shape, with fold lines 3190 also shown. The final form of the seal-forming structure 3100 in FIG. 189 does not include any sharp fold lines 3190, but the fold lines 3190 can enable the one-piece textile portion 3170 to be shaped to fit within a mold (when overmolding silicone, TPE, and / or TPU into the mold), for example, as this could create a leak path. FIG. 189 shows the seal-forming structure 3100 in its finished state.

[0315] 5.3.2.7.3 Multi-segment textile part(s) In some forms, two segments of textile that may be included in the seal-forming structure 3100 are arranged to cooperate to effectively function as a single textile portion 3170. In this manner, curvature complexity may also be distributed across multiple cooperating segments of textile. Figures 190-191 show examples of such arrangements.

[0316] In FIG. 190 , a single oral nostril 3273 is formed to direct airflow into the nasal and oral air passages, and the seal-forming structure 3100 includes a first textile segment 3180 adapted to engage and seal against the nose and around the patient's face on either side of the mouth, and a second textile segment 3181 formed adjacent the patient's chin or upper lip on the underside of the oral air passage. The oral nostril 3273 may be partially bounded by the first textile segment 3180 and partially bounded by the second textile segment 3181. The first textile segment 3180 may be positioned in the nasal portion 3120 and may extend to a lateral side of the oral portion 3130. The second textile segment may be positioned only in the oral portion 3130.

[0317] Forming the textile portion 3170 of the seal-forming structure 3100 from multiple individual textile strips may allow the textile to curve around complex three-dimensional geometries, reducing wrinkles that can cause leakage. This textile may also improve comfort without reducing the overall effectiveness of the seal between the seal-forming structure 3100 and the patient's face. In contrast, if a seal-forming structure 3100 with an integral textile portion 3170 were formed with the same complex curvature, it may need to be stretched during the molding process, which may lead to residual stresses and textile distortion in the final molded product.

[0318] The cross section in Figure 190A shows how the first textile segment 3180 is overmolded onto the remainder of the seal-forming structure 3100. The first textile segment 3180 may be cantilevered from the remainder of the seal-forming structure 3100, and although not shown, the second textile segment 3181 may similarly extend.

[0319] 191, separate apertures are formed for the nasal and oral air passages. A first textile segment 3180 can be positioned in the nasal portion 3120 and can extend to a lateral side of the oral portion 3130. A second textile segment can be positioned only in the oral portion 3130.

[0320] A single nostril 3272 may be formed through the first textile segment 3180 to direct airflow into both of the patient's nostrils, or two nostrils 3272 may be formed through the first textile segment 3180 to direct such flow into a corresponding one of the patient's nostrils. An example of the former is shown in FIG. 191. In the latter example (not shown), the nasal textile portion 3171 between the nostrils 3272 may be positioned adjacent the bridge of the patient's nose in use. An oral hole 3271 may be formed through the second textile segment 3181 to direct airflow into the patient's mouth.

[0321] Because the areas of the patient's face that engage the nasal textile portion 3171 and the oral textile portion 3172 each have different shapes and orientations, the nasal textile portion 3171 and the oral textile portion 3172 may be differently shaped and oriented for an optimal seal during use. The nasal textile portion 3171 may be positively curved around the nasal axis 6000. The oral textile portion 3172 may be positively curved around the oral axis 6001. FIG. 191 illustrates these axes and how they may be oriented differently from one another. The angle between the nasal axis 6000 and the oral axis 6001 may be greater than 90°. This orientation allows the nasal textile portion 3171 to be tilted upward and away from the patient's face during use, ensuring contact along the length of the base of the patient's nose during use. Additionally, the radius of curvature around the nasal axis 6000 of the nasal textile portion 3171 can be smaller than the radius of curvature around the oral axis 6001 of the oral textile portion 3172. The nasal axis 6000 and oral axis 6001 can also be disposed in the same plane (e.g., in the patient's sagittal plane) during use. As such, the seal-forming structure 3100 can also be symmetrical across the plane in which these axes lie. FIG. 191 also shows the nasolabial fold axis 6003. The nasal portion 3120 and oral portion 3130 can be oriented (e.g., curved or bent) relative to one another about the nasolabial fold axis 6003.

[0322] In these examples, the textile segments may be overmolded with silicone, TPE, and / or TPU to form the seal-forming structure 3100. As will be appreciated, the first textile segment 3180 and the second textile segment 3181 are separate from one another. The textile of the first textile segment 3180 may have the same properties as the textile of the second textile segment 3181, or at least one property of the textiles may be different. The first textile segment 3180 and the second textile segment 3181 may be joined by stitching or welding. While these examples illustrate one of the two textile segments 3180 and 3181 positioned on the upper lip of the contact patient and the other forming the remainder of the textile portion 3170, it is contemplated that any number of textile segments may be used to form the textile portion depending on the complexity of the intended shape of the textile portion 3170.

[0323] 5.3.2.7.1 Textile parts containing gaps In a further example shown in FIG. 192, separate apertures are formed for the nasal and oral air passages (nose openings 3272 and oral openings 3271), and a gap 3175 may be included in the textile portion 3170 between the nasal openings 3272 and the oral openings 3271. The gap 3175 in the textile portion 3170 may allow the seal-forming structure 3100 to flex in this area (without forming wrinkles that could cause leakage). The gap 3175 may expose the material of the seal-forming structure 3100 (e.g., silicone, TPE, and / or TPU) that is overmolded onto the textile portion 3170. The gap 3175 may be positioned adjacent the patient's upper lip in use.

[0324] In this example, the textile portion 3170 may be one piece or may be formed from multiple different textile pieces. The textile of the nasal textile portion 3171 may have the same properties as the textile of the oral textile portion 3172, or at least one property of these textiles may be different.

[0325] In some forms, the gaps 3175 in the textile portion 3170 may be occupied by a secondary material (e.g., another textile that may be more resistant to wrinkling or silicone). In some forms not shown, there is no material in the gaps 3175, so the nasal orifices 3272 and the oral orifices 3271 are continuous.

[0326] 5.3.3 Positioning and stabilizing structures The seal-forming structure 3100 of the patient interface 3000 of the present technology may be held in a sealed position by the positioning and stabilising structure 3300 in use.

[0327] In one form, the positioning and stabilizing structure 3300 provides at least enough holding force to overcome the effect of the positive pressure in the plenum chamber 3200 to lift off the face.

[0328] In one form, the positioning and stabilizing structure 3300 provides a holding force sufficient to overcome the attractive force on the patient interface 3000.

[0329] In one form, the positioning and stabilizing structure 3300 provides a holding force as a safety margin to eliminate the possibility of destructive action on the patient interface 3000 (e.g., due to tube drag or inadvertent interference with the patient interface).

[0330] In one form of the present technology, there is provided a positioning and stabilizing structure 3300 configured to be worn by a patient while sleeping. In one example, the positioning and stabilizing structure 3300 has a low profile or cross-sectional thickness to reduce the perceived or actual bulk of the device. In one example, the positioning and stabilizing structure 3300 includes at least one strap having a rectangular cross-section. In one example, the positioning and stabilizing structure 3300 includes at least one flat strap.

[0331] In one form of the present technology, a positioning and stabilizing structure 3300 is provided that is configured so that it is not excessively large or bulky in size that would interfere with a patient sleeping in a supine sleeping position with the posterior region of the patient's head resting on a pillow.

[0332] In one form of the present technology, a positioning and stabilizing structure 3300 is provided that is configured so that it is not excessively large or bulky in size that would interfere with a patient sleeping in a lateral sleeping position with the side region of the patient's head resting on a pillow.

[0333] In one form of the present technology, the positioning and stabilizing structure 3300 comprises a decoupling portion located between an anterior section of the positioning and stabilizing structure 3300 and a posterior section of the positioning and stabilizing structure 3300. The decoupling portion does not resist compression and can be a flexible or flimsy strap, for example. The decoupling portion is constructed and positioned such that when a patient lies down with their head on a pillow, the presence of the decoupling portion prevents posterior forces from being transmitted along the positioning and stabilizing structure 3300 and disrupting the seal.

[0334] In one form of the present technology, the positioning and stabilizing structure 3300 includes a strap constructed by a laminate of a fabric patient-contacting layer, a foam inner layer, and a fabric outer layer. In one form, the foam is porous to allow moisture (e.g., sweat) to pass through the strap. In one form, the fabric outer layer includes loop material that engages with portions of hook material.

[0335] In certain forms of the present technology, the positioning and stabilizing structure 3300 includes stretchable (e.g., stretchable with elasticity) straps. For example, the straps can be configured to be tensioned in use to direct a force that seals the seal-forming structure against a portion of the patient's face. In one example, the straps can be configured as ties.

[0336] In one form of the present technology, the positioning and stabilizing structure includes a first tie constructed and arranged such that, in use, at least a portion of its lower edge passes over and moves to a superior auricular point of the patient's head and covers a portion of the parietal bone without covering the occipital bone.

[0337] In one form of the present technology, suitable for a nasal-only or full-face mask, the positioning and stabilizing structure includes a second tie constructed and arranged such that, in use, at least a portion of its upper edge passes under the inferior ear base of the underside of the patient's head and covers or rests under the occipital bone of the patient's head.

[0338] In one form of the present technology suitable for a nasal-only or full-face mask, the positioning and stabilizing structure includes a third tie constructed and arranged to interconnect the first tie and the second tie in a manner that reduces the tendency of the first tie and the second tie to move apart.

[0339] In certain forms of the present technology, the positioning and stabilizing structure 3300 includes straps that are bendable, e.g., non-rigid. An advantage of this embodiment is that the straps are more comfortable when the patient lies down to sleep.

[0340] In a particular form of the present technology, the positioning and stabilizing structure 3300 includes straps configured to be breathable to allow water vapor to pass therethrough.

[0341] 89-95 show a patient interface 3000 in accordance with an example of the present technology. The patient interface 3000 has a positioning and stabilizing structure 3300 and a plenum chamber 3200 with a seal-forming structure 3100. In this example, the positioning and stabilizing structure 3300 includes a frame 3350 and a number of headgear straps connected to the frame 3350.

[0342] The plenum chamber 3200 of the patient interface 3000 is connected to the frame 3350. The plenum chamber 3200 of the exemplary patient interface 3000 shown in FIGS. 89-95 is the plenum chamber 3200 shown in FIGS. 7-14 , although the positioning and stabilizing structure 3300 may be used with other plenum chambers 3200 in other examples of the present technology. The plenum chamber 3200 may connect to the frame 3350 via a snap-fit ​​connection. In one example, the plenum chamber 3200 may connect to the frame 3350 in the manner described with reference to FIGS. 87-88 . In other examples, the plenum chamber 3200 may form a different type of removable connection to the frame 3350, a snap-fit, a removable press fit, or the like, or may be permanently connected to the frame 3350.

[0343] The positioning and stabilizing structure 3300 may include multiple straps or strap portions that connect to the frame 3350 and pass around the patient's head to support the plenum chamber 3200 in a sealed position against the patient's face. It will be appreciated that a single "strap" may be formed from multiple lengths of material that are cut or formed separately to create longer lengths and then joined at the ends, or the single "strap" may be a single length of material.

[0344] 89-95, the positioning and stabilizing structure 3300 includes a pair of upper straps 3310. Each upper strap 3310 is configured to pass between a patient's eyes and ears. Additionally, the positioning and stabilizing structure 3300 includes a pair of lower straps 3320 configured to be positioned on the patient's cheeks below the patient's cheekbones. In this example, the plenum chamber 3200 is held in place via a four-point connection to the headgear straps via the frame 3350.

[0345] The frame 3350 is shown in isolation in FIGS. 103-108. The frame 3350 includes a frame inlet connection port 3354. The frame inlet connection port 3354 may be configured to connect to a source of pressurized breathable gas (e.g., air). In one example, such as the patient interface shown in FIGS. 89-95, the frame inlet connection port 3354 may be configured to allow connection to a swivel elbow assembly 3610 that provides a connection port 3600 for connection to the air circuit 4170. In this example, the frame inlet connection port 3354 includes a connecting rim 3355. The connecting rim 3355 may include a radially outwardly extending flange. The swivel elbow assembly 3610 may form a releasable snap fit with the connecting rim 3355, thereby creating a fluid connection between the swivel elbow assembly and the frame 3350. 87-88 and 90A, the opposite side of the frame inlet connection port 3354 is configured to fluidly connect to the plenum chamber, such that the frame 3350 allows fluid communication between the swivel elbow assembly 3610 and the interior of the plenum chamber 3200.

[0346] The frame 3350 also includes a pair of opposing upper strap connection points 3315 to which the upper straps 3310 connect. In this example, each upper strap connection point 3315 includes an aperture formed in the frame 3350. Each upper strap 3310 can connect to each upper strap connection point 3315 by passing through the aperture, looping back on itself, and then securing to itself. Each upper strap 3310 can be secured to itself via hook-and-loop material configured to releasably couple upon contact. In another example, each upper strap 3310 can be secured to itself by a band, clip, or the like after passing through a respective aperture and looping back on itself. In yet another example, the upper straps 3310 can connect to the frame via a side-release buckle connection.

[0347] The frame 3350 also includes a pair of opposing lower strap connection points 3325 to which the lower straps 3320 connect. In this example, each lower strap connection point 3325 includes a magnet. Each lower strap 3320 includes a lower strap clip 3326 that includes a magnet or material that is attached to the magnet at the lower strap connection point 3325. In this example, each lower strap clip 3326 includes an aperture through which the end of each lower strap 3320 can be passed, then looped back and secured to itself (e.g., by hook-and-loop material, a webbing, a clip, etc.). In another example, the lower straps 3320 may connect to the frame 3350 via a side release buckle connection, onto a hook, or any other suitable connection.

[0348] In one example, the frame 3350 and upper strap connection points 3315 are constructed and arranged to direct the force / tension provided by the upper straps 3310 into a partially upward and partially backward force vector that is applied to the plenum chamber 3200. Specifically, this partially upward and partially backward force vector causes the nasal portion 3230 of the seal-forming structure 3100 to make sealing contact with the lower periphery of the patient's nose and the patient's upper lip.

[0349] Each upper strap 3310 may be selectively adjustable. For example, the effective length of each upper strap 3310 can be changed by changing the amount of the upper strap 3310 that loops back on itself after passing through the aperture at each upper strap connection point 3315. Increasing the amount of upper strap 3310 that passes through the aperture effectively reduces the length of the upper strap 3310, thereby allowing for alteration of the force vector and adjustment of the fit of the patient interface 3000.

[0350] In one example, the frame 3350 and lower strap connection points 3325 are constructed and arranged to direct the force / tension provided from the lower straps 3320 into a partially posterior and partially downward force vector that is applied to the plenum chamber 3200. Specifically, the partially posterior and partially downward force vector causes the oral portion 3260 to be in sealing contact with the patient's face around the periphery of the patient's mouth. The partially downward force applied from the lower straps 3320 to the frame 3350 may balance the partially upward force applied from the upper straps 3310 and any downwardly directed force that may be applied to the seal-forming structure 3100 from the patient's nose.

[0351] The lower straps 3320 may be selectively adjustable. For example, the effective length of each lower strap 3320 may be changed by changing the amount of each lower strap 3310 that loops back on itself after passing through an aperture in each lower strap clip 3326. Increasing the amount of each lower strap 3320 that passes through the aperture effectively reduces the length of the lower strap 3320, thereby allowing for alteration of the force vector and adjustment of the fit of the patient interface 3000.

[0352] The positioning and stabilizing structure 3300 may also include one or more of a top crown strap 3330, a pair of side crown straps 3332, and a neck strap 3334. In the example shown in FIGS. 89-95 , the upper strap 3310 and the lower strap 3320 are connected to ends of the top crown strap 3330. The top crown strap 3330 is configured to pass around the patient's head and be positioned against surfaces facing upward and backward. The top crown strap 3330 may be configured to be positioned on the parietal bone of the patient's skull. Each end of the top crown strap 3330 also connects to a respective upper strap 3310 and a respective pair of side crown straps 3332. Each side crown strap 3332 is connected between the upper strap 3310 and the lower strap 3320 on each side of the patient's head. The lower ends of the side crown straps 3332 are interconnected by the neck strap 3334. The neck strap 3334 may be configured to pass across the sagittal plane and be positioned against a downward and / or backward facing surface of the patient's head or behind the patient's neck. The neck strap 3334 may be positioned above or below the occipital bone of the patient's skull.

[0353] The length of the top crown strap 3330 can be selectably adjusted. In the example shown in FIGS. 89-95 , the top crown strap 3330 is formed by two strap portions connected by a link having a pair of apertures. Each of the two strap portions forming the top crown strap 3330 loops back after passing through its respective aperture and can be secured to itself via, for example, hook-and-loop material, additional clips, bands, and / or the like. The amount of each top strap portion threaded through the link can be varied to adjust the length of the top crown strap 3330 and thus the fit of the positioning and stabilizing structure 3300.

[0354] After all headgear straps have been adjusted and the desired fit of the patient interface 3000 has been achieved, the magnetic clip connections provided by the lower strap clips 3326 allow the lower straps 3320 to be quickly disengaged from the lower strap connection points 3325 on the frame 3350, thereby allowing the patient interface 3000 to be removed from the patient without any strap adjustments. Similarly, when the patient is ready to put the patient interface back on, the lower strap clips 3326 can be quickly disengaged at the lower strap connection points 3325 to allow the patient interface 3000 to fit without the need for strap adjustments. Further advantages and features of positioning and stabilizing structures including magnetic clips are described in WO2014 / 110622, which is incorporated herein by reference in its entirety.

[0355] In certain forms of the present technology, a system is provided that includes more than one positioning and stabilizing structure 3300. Each positioning and stabilizing structure 3300 is configured to provide a holding force to accommodate a range of different sizes and / or shapes. For example, the system may include one form of positioning and stabilizing structure 3300 that is suitable for large sized heads but not for small sized heads, and another form of positioning and stabilizing structure 3300 that is suitable for small sized heads but not for large sized heads.

[0356] 184 and 185 show a patient interface 3000 including the plenum chamber 3200 shown in FIGS. 134-141. In this example, the patient interface 3000 also includes a positioning and stabilizing structure 3300 for holding the plenum chamber 3200 in a sealing position on the patient's face during use. In this example, the positioning and stabilizing structure 3300 includes a pair of headgear tubes 3340. The pair of headgear tubes 3340 are interconnected at their upper ends and configured to be positioned on the upper and lateral surfaces of the patient's head during use, respectively. The headgear tubes 3340 are configured to be positioned between the patient's eyes and ears during use, respectively. The lower end of each headgear tube 3340 is configured to fluidly connect to the plenum chamber 3200. In this example, the lower end of each headgear tube 3340 connects to a headgear tube connector 3344 configured to connect to the shell 3210 of the plenum chamber 3200. The positioning and stabilizing structure 3300 includes a conduit headgear inlet 3390 at the junction of two headgear tubes 3340. The conduit headgear inlet 3390 is configured to receive a pressurized gas flow, for example, via an elbow including a connection port 3600, and direct the gas flow into the hollow interior of the headgear tubes 3340. The headgear tubes 3340 provide the pressurized gas flow to the plenum chamber 3200.

[0357] The positioning and stabilizing structure 3300 may include one or more straps in addition to the headgear tubes 3340. In this example, the positioning and stabilizing structure 3300 includes a pair of upper straps 3310 and a pair of lower straps 3320. The rear ends of the upper straps 3310 and lower straps 3320 are joined to one another. The joint between the upper straps 3310 and lower straps 3320 is configured to be positioned on the rear of the patient's head, thereby allowing the upper straps 3310 and lower straps 3320 to be anchored. The front end of the upper strap 3310 connects to a headgear tube 3340. In this example, each headgear tube 3340 includes a tab 3342 with an opening through which each upper strap 3310 can be routed and then looped back to secure the upper headgear straps 3310 to the headgear tube 3340. The positioning and stabilizing structure 3300 also includes a lower strap clip 3326 provided to the forward end of each lower strap 3320. The lower strap clips 3326 are each configured to connect to a lower connection point 3325 on the plenum chamber 3200. In this example, the lower strap clips 3326 are magnetically secured to the lower connection points 3325. In some examples, a mechanical engagement is also provided between the lower strap clips 3326 and the lower connection points 3325.

[0358] The headgear tube connectors 3344 may be configured to allow the patient to breathe ambient air when there is no pressure in the plenum chamber 3200. Each headgear tube connector 3344 may include an anti-asphyxiation valve (AAV). The AAV in each headgear tube connector 3344 may be configured to open when there is no pressure in the plenum chamber 3200 to allow air flow between the interior of the plenum chamber 3200 and the ambient air. Each AAV may be biased into a configuration that blocks air flow from the interior of the plenum chamber 3200 into each headgear tube 3340 and allows air exchange between the plenum chamber 3200 and the ambient air. When the headgear tube 3340 is pressurized, the AAV in each headgear tube connector 3344 may prevent air exchange between the interior of the plenum chamber 3200 and the ambient air and allow air flow from each headgear tube 3340 into the plenum chamber 3204 for patient breathing.

[0359] 5.3.4 Ventilation In one form, the patient interface 3000 includes a vent 3400 constructed and arranged to allow for the expulsion of exhaled gas (eg, carbon dioxide).

[0360] In certain forms, the vent 3400 is configured to allow continuous ventilation flow from the interior of the plenum chamber 3200 to the ambient when the pressure within the plenum chamber is positive relative to the ambient. The vent 3400 is configured such that the magnitude of the ventilation flow is sufficient to reduce rebreathing of exhaled CO2 by the patient while maintaining therapeutic pressure within the plenum chamber in use.

[0361] Ventilation section 3400 in one form according to 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).

[0362] The vent 3400 may be located within the plenum chamber 3200. Alternatively, the vent 3400 is located within a decoupling structure (e.g., a swivel).

[0363] In the example shown in FIGS. 89-95, the patient interface 3000 includes a vent 3400. In this example, the vent 3400 includes passages within the frame 3350 and the swivel elbow assembly 3610. These passages allow air to flow from the interior of the plenum chamber 3200 to the atmosphere. As shown in FIGS. 91, 95, and 103-105, the frame 3350 includes four holes that form part of the vent 3400 around the periphery of the frame inlet connection port 3354. In other examples, any number of vent holes (e.g., a single vent hole) may be provided in the frame 3350. As shown in FIG. 90, air may flow into the swivel elbow assembly 3610 and then to the atmosphere through an external hole in the swivel elbow assembly 3610 that forms part of the vent 3400. The swivel elbow assembly 3610 may be substantially similar to that described in International Publication No. WO 2017 / 049357 A1. The entire document is incorporated herein by reference.

[0364] 126-157 includes a vent 3400. In this example, the vent 3400 includes a plurality of holes. In these examples, the vent 3400 is provided in the shell 3210. In this example, the holes for the vent 3400 are formed in the shell 3210. In other examples of the present technology, the patient interface 3000 may include a vent module permanently or removably connected to the plenum chamber 3200. In some examples of the present technology, the patient interface 3000 includes a diffuser configured to diffuse air passing through the vent 3400. In the plenum chamber 3200 shown in FIGS. 126-157, the vent 3400 is centrally located. A vent 3400 that is centrally located relative to the plenum chamber 3200 is advantageous because it is less likely to be blocked when sleeping on one's side. Further, in these examples, the vent 3400 is located at a lower position on the shell 3210. The lower position on the shell 3210 aligns the vent 3400 approximately with the patient's mouth. Because the majority of gas exhaled from the patient comes from the patient's mouth, having the vent 3400 located opposite the patient's mouth may allow for better gas flushing. Furthermore, because the inlet port 3240 of the plenum chamber 3200 is located at an upper position of the plenum chamber 3200, the energized airflow received from the inlet port 3240 may flow through a larger volume (e.g., from an upper position to a lower position), allowing for efficient gas flushing and reducing the likelihood of the energized airflow bypassing stagnant air pockets.

[0365] 5.3.5 Decoupling Structures (Singular or Plural) In one form, the patient interface 3000 includes at least one decoupling structure (eg, a swivel or a bulb).

[0366] 5.3.6 Connection Port The connection port 3600 allows connection to the air circuit 4170 .

[0367] 5.3.7 Forehead support In one form, the patient interface 3000 includes a forehead support 3700 as shown in Figure 3A. In other examples, such as those shown in Figures 7-125, the patient interface 3000 may omit the forehead support. Additionally, the patient interface 3000 may be configured to not contact the patient's forehead at all.

[0368] 5.3.8 Anti-asphyxiation valve In one form, the patient interface 3000 includes an anti-asphyxiation valve.

[0369] As noted above, the patient interface 3000 may include one or more headgear tubes 3340 connected to the plenum chamber 3200 via headgear tube connectors 3344 that include an anti-asphyxia valve. Alternatively or additionally, the patient interface 3000 may include a swivel elbow configured to connect to a supply conduit. The swivel elbow includes an anti-asphyxia valve. In other examples, an anti-asphyxia valve may be incorporated into the plenum chamber 3200, for example, by being provided in the shell 3210 of the plenum chamber 3200.

[0370] 5.3.9 Ports 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 directly measured.

[0371] 5.4 RPT 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 one or more algorithms (e.g., any of the methods described herein, in whole or in part). The RPT device 4000 can be configured to generate an airflow that is delivered to a patient's airways for the treatment of, for example, one or more of the respiratory ailments described anywhere herein.

[0372] 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 6 cmH2O, or at least 10 cmH2O, or at least 20 cmH2O. RPT Device Algorithm

[0373] The RPT device may have an outer housing 4010. The outer housing 4010 is formed by two portions: an upper portion 4012 and a lower portion 4014. Additionally, the outer housing 4010 may include one or more panel(s) 4015. The RPT device 4000 includes a chassis 4016 that supports one or more internal components of the RPT device 4000. The RPT device 4000 may include a handle 4018.

[0374] The air pressure path of the pneumatic RPT device 4000 may include one or more air path items (e.g., an inlet air filter 4112, an inlet muffler 4122, a pressure generator 4140 (e.g., a blower 4142) capable of supplying air at positive pressure, an outlet muffler 4124) and one or more transducers 4270 (e.g., a pressure sensor and a flow sensor).

[0375] As noted above, in some forms of the present technology, a central controller may be configured to embody one or more algorithms expressed as a computer program recorded in a non-transitory computer-readable storage medium (e.g., memory), the algorithms typically being grouped into groups called modules.

[0376] The RPT device 4000 can have an electrical power source 4210, one or more input devices 4220, a central controller, a therapy device controller, a pressure generator 4140, one or more protection circuits, a memory, a transducer 4270, a data communication interface, and one or more output devices 4290. The electrical components 4200 can be mounted on a single printed circuit board assembly (PCBA) 4202. In an alternative, the RPT device 4000 can include more than one PCBA 4202.

[0377] An RPT device in accordance with one form of the present technology may include an air filter 4110 or multiple air filters 4110.

[0378] In one form, an outlet air filter 4114 (eg, an antibacterial agent) is located between the outlet of the pneumatic block 4020 and the patient interface 3000.

[0379] An RPT device in accordance with one form of the present technology may include a muffler 4120 or multiple mufflers 4120.

[0380] In one form of the present technology, an anti-spillback valve 4160 may be located between the humidifier 5000 and the pneumatic block 4020. The anti-spillback valve is constructed and positioned to reduce the risk of water flowing upstream from the humidifier 5000 (e.g., towards the motor 4144).

[0381] 5.5 Air Circuit An air circuit 4170, according to one aspect of the present technology, is a conduit or tube constructed and arranged such that, in use, air flow travels between two components (e.g., the RPT device 4000 and the patient interface 3000).

[0382] In particular, the air circuit 4170 may be fluidly connected to the outlet of the pneumatic block 4020 and the patient interface. The air circuit may be referred to as an air delivery tube. In some cases, there may be separate limbs of the circuit for inhalation and exhalation. In other cases, a single limb is used.

[0383] In some forms, the air circuit 4170 may include one or more heating elements configured to heat the air in the air circuit (e.g., to maintain or increase the air temperature). The heating elements may take the form of a heated wire circuit and may include one or more transducers (e.g., temperature sensors). In one form, the heated wire circuit may be spirally wound around the axis of the air circuit 4170. The heating elements may be in communication with a controller (e.g., a central controller). An example of an air circuit 4170 including a heated wire circuit is described in U.S. Patent Application No. 8,733,349, which is incorporated herein by reference in its entirety.

[0384] 5.5.1 Oxygen delivery In one form of the present technology, supplemental oxygen 4180 can be delivered to one or more points in the pneumatic pathway (e.g., upstream of the pneumatic block 4020), the air circuit 4170 and / or the patient interface 3000.

[0385] 5.6 Humidifier 5.6.1 Humidifier Overview In one form of the present technology, a humidifier 5000 is provided (for example as shown in FIG. 5A) for changing the absolute humidity of air or gas to be delivered to a patient relative to the ambient air. Typically, the humidifier 5000 is used to increase the absolute humidity (relative to ambient air) and increase the temperature of the air stream before delivery to the patient's airways.

[0386] The humidifier 5000 may include a humidifier reservoir 5110, a humidifier inlet 5002 that receives an airflow, and a humidifier outlet 5004 for delivering a humidified airflow. In some forms, such as shown in Figures 5A and 5B, the inlet and outlet of the humidifier reservoir 5110 may be the humidifier inlet 5002 and the humidifier outlet 5004, respectively. The humidifier 5000 may further include a humidifier base 5006. The humidifier base 5006 may be adapted to receive the humidifier reservoir 5110 and may include a heating element 5240.

[0387] As shown in FIG. 5C, the humidifier controller 5250 may include one or more controllers (e.g., a central humidifier controller 5251, a heated air circuit controller 5254 configured to control the temperature of the heated air circuit 4171, and / or a heating element controller 5252 configured to control the temperature of the heating element 5240).

[0388] 5.6.2 Humidifier components 5.6.2.1 Water reservoir According to one arrangement, the humidifier 5000 may include a water reservoir 5110 configured to contain or hold a quantity of liquid (e.g., water) to be evaporated for humidifying the airflow. The water reservoir 5110 may be configured to contain a predetermined maximum quantity of water to provide adequate humidification for at least the duration of a respiratory therapy session (e.g., a night's sleep). Typically, the reservoir 5110 is configured to contain several hundred milliliters of water (e.g., 300 milliliters (ml), 325 ml, 350 ml, or 400 ml). In another form, the humidifier 5000 may be configured to receive a water supply from an external water source (e.g., a building's water supply system).

[0389] According to one embodiment, the water reservoir 5110 is configured to humidify the air flow from the RPT device 4000 as the air flow passes through the RPT device 4000. In one form, the water reservoir 5110 can be configured to encourage the air flow to travel a tortuous path through the reservoir 5110 while the air flow contacts a certain amount of water in the reservoir 5110.

[0390] According to one form, the reservoir 5110 may be removable from the humidifier 5000 in a lateral direction, for example as shown in Figures 5A and 5B.

[0391] The reservoir 5110 may also be configured to inhibit liquid release from the reservoir 5110, for example, when the reservoir 5110 is displaced and / or rotated from its normal operating orientation (e.g., through any aperture and / or between its subcomponents). Because the air stream to be humidified by the humidifier 5000 is often pressurized, the reservoir 5110 may also be configured to prevent loss of air pressure through leakage and / or flow impedance.

[0392] 5.6.2.2 Conductive parts According to one arrangement, the reservoir 5110 includes a conductive portion 5120 configured to allow efficient heat transfer from the heating element 5240 to the volume of liquid in the reservoir 5110. In one form, the conductive portion 5120 may be arranged as a plate, although other shapes may be suitable. All or part of the conductive portion 5120 may be constructed of a thermally conductive material such as aluminum (e.g., approximately 2 mm thick (e.g., 1 mm, 1.5 mm, 2.5 mm, or 3 mm)), another thermally conductive metal, or some plastic. In some cases, adequate thermal conductivity may be achieved with a less conductive material of appropriate geometry.

[0393] 5.6.2.3 Humidifier Reservoir Dock In one form, the humidifier 5000 may include a humidifier reservoir dock 5130 (as shown in FIG. 5B) configured to receive the humidifier reservoir 5110. In some arrangements, the humidifier reservoir dock 5130 may include a locking feature (e.g., a locking lever 5135 configured to retain the reservoir 5110 within the humidifier reservoir dock 5130).

[0394] 5.6.2.4 Water Level Indicator The humidifier reservoir 5110 may include a water level indicator 5150 as shown in Figures 5A-5B. In some forms, the water level indicator 5150 may provide one or more indications to a user, such as the patient 1000 or a caregiver, about the amount of water in the humidifier reservoir 5110. These one or more indications provided by the water level indicator 5150 may include an indication of a maximum predetermined amount of water, any fraction thereof (e.g., 25%, 50%, or 75% or an amount (e.g., 200 ml, 300 ml, or 400 ml)).

[0395] 5.6.2.5 Humidifier Transducer(s) The humidifier 5000 may include one or more humidifier transducers (sensors) 5210 instead of or in addition to the transducer 4270 described above. The humidifier transducer 5210 may include one or more of an air pressure sensor 5212, an air flow transducer 5214, a temperature sensor 5216, or a humidity sensor 5218 as shown in FIG. 5C . The humidifier transducer 5210 may generate one or more output signals. These output signals may be communicated to a controller (e.g., a central controller and / or a humidifier controller 5250). In some forms, the humidifier transducer may be located external to the humidifier 5000 (e.g., within the air circuit 4170) while communicating the output signal to the controller.

[0396] 5.7 Respiratory waveform Figure 6A shows a model of a typical human respiratory waveform during sleep. The horizontal axis is time, and the vertical axis is respiratory flow. Because parameter values ​​can vary, a typical breath may have the following approximate values: tidal volume, Vt, 0.5 L; inspiratory time, Ti, 1.6 seconds; peak inspiratory flow, Qpeak, 0.4 L / sec; expiratory time, Te, 2.4 seconds; peak expiratory flow, Qpeak, -0.5 L / sec. The total duration of the breath, Ttot, is approximately 4 seconds. Humans typically breathe at approximately 15 breaths per minute (BPM), with a ventilation, Vent, of approximately 7.5 L / min. A typical duty cycle, the ratio of Ti to Ttot, is approximately 40%.

[0397] 5.8 Respiratory Pressure Therapy Mode Depending on the values ​​of the parameters A and P0 in the treatment pressure equation (1) used by the treatment parameter determination algorithm in one form of the present technology, various respiratory pressure treatment modes can be performed by the RPT device 4000.

[0398] 5.9 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, other definitions may apply.

[0399] 5.9.1 General Air: In certain forms of the present technology, air may refer to atmospheric air, while in other forms of the present technology, air may refer to a combination of other breathable gases (e.g., oxygen-rich atmospheric air).

[0400] Surroundings: In certain forms of the present technology, the term "surroundings" should be taken to mean (i) that which is external to the treatment system or patient, and (ii) that which immediately surrounds the treatment system or patient.

[0401] For example, the ambient humidity for a humidifier may be the humidity of the air immediately surrounding the humidifier (e.g., the humidity inside the room where the patient is sleeping). Such ambient humidity may differ from the humidity outside the room where the patient is sleeping.

[0402] In another example, the ambient pressure may be the pressure immediately surrounding or external to the body.

[0403] In certain embodiments, ambient (e.g., acoustic) noise can be considered the background noise level in the room the patient is in, other than noise emanating from, for example, the RPT device or from the mask or patient interface. Ambient noise can originate from sources outside the room.

[0404] Automatic Positive Airway Pressure (APAP) Therapy: CPAP therapy that is capable of automatically adjusting the therapy pressure between minimum and maximum limits, for example, between breaths, depending on the presence or absence of signs of an SDB episode.

[0405] Continuous Positive Airway Pressure (CPAP) Therapy: Respiratory...

Claims

1. 1. A patient interface comprising: When in use, the patient remains at least 6 cmH above ambient air pressure throughout the respiratory cycle ２ Plenum chamber pressurizable to high therapeutic pressures; a seal-forming structure joined to the plenum chamber, the seal-forming structure including a nasal portion and an oral portion, the nasal portion having at least one nasal hole configured, in use, to deliver an airflow at the therapeutic pressure to the patient's nares and the oral portion having an oral hole configured, in use, to deliver the airflow at the therapeutic pressure to the patient's mouth, the seal-forming structure constructed and arranged, in use, to maintain the therapeutic pressure in the plenum chamber throughout the patient's respiratory cycle; a vent including a plurality of holes configured to direct a continuous vent flow from the interior of the plenum chamber to the ambient air throughout the patient's breathing cycle when the therapeutic pressure in the plenum chamber is positive relative to the ambient air; and a positioning and stabilising structure including at least one tie, the positioning and stabilising structure being configured to hold the seal-forming structure in a therapeutically effective position on the patient's head in use; a nasal textile portion included in the nasal portion of the seal-forming structure defines the at least one nostril and is configured to contact the patient's nose in use, the nasal textile portion being positively curved around a nasal axis; an oral portion of the seal-forming structure including an oral-textile portion separate from the nasal-textile portion, forming the oral cavity, and configured to contact the patient's face adjacent the patient's mouth in use, the oral-textile portion being positively curved around an oral axis that is oriented differently from the nasal axis; The patient interface is configured to allow the patient to breathe from ambient air in the absence of the airflow at the treatment pressure.

2. The patient interface of claim 1 , wherein the seal-forming structure is established by silicone overmolded onto the nasal textile portion and the oral textile portion.

3. The patient interface of claim 2 , wherein the silicone is exposed between the nasal textile portion and the oral textile portion.

4. 4. The patient interface of claim 2 or 3, wherein the silicone exposed between the nasal textile portion and the oral textile portion is configured to be positioned adjacent the patient's upper lip in use.

5. A patient interface according to any preceding claim, wherein the nasal axis and the oral axis are positioned in the sagittal plane of the patient in use.

6. A patient interface according to any preceding claim, wherein the nasal axis and the oral axis are oriented at an angle of greater than 90° relative to one another.

7. The patient interface of any one of claims 1 to 6, wherein the radius of curvature of the nasal textile portion is less than the radius of curvature of the oral textile portion.

8. The patient interface of any one of claims 1 to 7, wherein the nasal textile portion and the oral textile portion are constructed of an air impermeable textile.

9. The patient interface of any one of claims 1 to 8, wherein the nasal textile portion is constructed from a first textile and the oral textile portion is constructed from a second textile.

10. The patient interface of claim 9 , wherein the first textile and the second textile have the same characteristics.

11. The patient interface of claim 9 , wherein the first textile and the second textile have at least one different characteristic.

12. 12. The patient interface of any one of claims 1 to 11, wherein the nasal textile portion comprises one nostril configured to direct the airflow into both nostrils in use.

13. 13. The patient interface of any one of claims 1 to 12, wherein the nasal textile portion comprises two nostrils configured to direct the air flow into a corresponding one of the nostrils, in use.

14. The patient interface of any one of claims 1 to 13, wherein the nasal textile portion is configured to be positioned adjacent the bridge of the patient's nose in use.

15. 1. A patient interface comprising: When in use, the patient remains at least 6 cmH above ambient air pressure throughout the respiratory cycle ２ Plenum chamber pressurizable to high therapeutic pressures; a seal-forming structure joined to the plenum chamber, the seal-forming structure including a nasal portion and an oral portion, the nasal portion having at least one nasal hole configured, in use, to deliver an airflow at the therapeutic pressure to the patient's nares and the oral portion having an oral hole configured, in use, to deliver the airflow at the therapeutic pressure to the patient's mouth, the seal-forming structure constructed and arranged, in use, to maintain the therapeutic pressure in the plenum chamber throughout the patient's respiratory cycle; a vent including a plurality of holes configured to direct a continuous vent flow from the interior of the plenum chamber to the ambient air throughout the patient's breathing cycle when the therapeutic pressure in the plenum chamber is positive relative to the ambient air; a positioning and stabilizing structure including at least one tie, the positioning and stabilizing structure being configured, in use, to hold the seal-forming structure in a therapeutically effective position on the patient's head; and a textile portion, a nasal textile portion at least partially defining the at least one nostril, the nasal textile portion being positioned in the nasal portion so as to contact the patient's nose in use; and an oral textile portion at least partially defining the oral cavity, the oral textile portion being positioned in the oral portion in use to contact the patient's face adjacent the patient's mouth; and a textile portion including a gap in the textile portion between the at least one nasal opening and the oral opening; The patient interface is configured to allow the patient to breathe from ambient air in the absence of the airflow at the treatment pressure.

16. The patient interface of claim 15 , wherein the seal-forming structure is established by silicone overmolded onto the textile portion.

17. 17. The patient interface of claim 15 or 16, wherein the textile portion is unitary.

18. A patient interface according to any one of claims 15 to 17, wherein the silicone of the seal-forming structure is exposed in the gap.

19. A patient interface according to any one of claims 15 to 18, wherein the silicone of the seal-forming structure exposed in the gap is configured to be positioned adjacent the patient's upper lip in use.

20. 20. The patient interface of any one of claims 15 to 19, wherein the nasal textile portion is constructed from a first textile and the oral textile portion is constructed from a second textile.

21. 21. The patient interface of claim 20, wherein the first textile and the second textile have the same characteristics.

22. 21. The patient interface of claim 20, wherein the first textile and the second textile have at least one characteristic that is different.

23. 23. The patient interface of any one of claims 20 to 22, wherein the first textile and the second textile are air impermeable.

24. 24. The patient interface of any one of claims 15 to 23, wherein the nasal textile portion comprises one nostril configured to direct the airflow into both nostrils in use.

25. 25. The patient interface of any one of claims 15 to 24, wherein the nasal textile portion comprises two nostrils configured to direct the air flow into a corresponding one of the nostrils, in use.

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