Patient Interface

Abstract

1. A patient interface comprising: a chassis portion at least partially forming a plenum chamber; a seal-forming structure; and a vent portion for permitting continuous flow of gases exhaled by the patient from an interior of the plenum chamber to the surroundings, said vent portion being sized and shaped to maintain a therapeutic pressure within the plenum chamber in use, the chassis portion including a membrane portion formed at least in part from a textile material, the seal-forming structure being supported on the membrane portion, the membrane portion being constructed and arranged to be flexible to permit relative movement between the seal-forming structure and the chassis portion in use.

Description

[Technical field]

[0001] [1 CROSS-REFERENCE TO RELATED APPLICATIONS] This application claims priority to Australian Provisional Patent Application No. 2020904681 filed on December 16, 2020, Australian Provisional Patent Application No. 2021900782 filed on March 18, 2021, Australian Provisional Patent Application No. 2021901506 filed on May 20, 2021, Australian Provisional Patent Application No. 2021902571 filed on August 18, 2021, and Australian Provisional Patent Application No. 2021903730 filed on November 19, 2021, the entire contents of each of which are incorporated herein by reference. [Background technology]

[0002] [2 Technology Background] [2.1 Technology field] The present technology relates to one or more of screening, diagnosis, monitoring, treatment, prevention and amelioration of respiratory related disorders. The present technology also relates to medical devices or apparatus and uses thereof.

[0003] [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.

[0004] The airways contain a series of branching tubes that become narrower, shorter, and more numerous the deeper they go into the lungs. The primary function of the lungs is gas exchange, allowing oxygen to move from inhaled air into the venous blood and carbon dioxide to move in the opposite direction. The trachea divides into right and left main bronchi, which further divide and eventually become terminal bronchioles. The bronchi make up the conducting airways and do not participate in gas exchange. The airways further divide into respiratory bronchioles and ultimately into alveoli. The alveolar regions of the lungs, where gas exchange occurs, are called respiratory regions. See Respiratory Physiology by John B. West, Lippincott Williams & Wilkins (9th Edition, 2012).

[0005] There are a variety of respiratory disorders. Particular disorders may be characterized by specific events, such as apnea, hypopnea, and hyperpnea.

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

[0007] Obstructive sleep apnea (OSA) is a form of sleep-disordered breathing (SDB) and is characterized by events involving the obstruction or closure of the upper airway during sleep. It is the result of an abnormally small upper airway combined with the normal loss of muscle tone in the area of ​​the tongue, soft palate, and posterior oropharyngeal wall during sleep. When affected, the patient's breathing typically stops for periods of 30 to 120 seconds, sometimes 200 to 300 times per night. The result is often excessive daytime somnolence, which can lead to cardiovascular disease and brain damage. The syndrome is a common disorder, especially in middle-aged overweight men, but affected individuals may not be aware of the problem. See U.S. Patent No. 5,339,933.

[0008] Cheyne-Stokes respiration (CSR) is another form of sleep-disordered breathing. CSR is a disorder of the patient's respiratory regulator, which has rhythmically alternating periods of increasing and decreasing ventilation, known as CSR cycles. CSR is characterized by repeated deoxygenation and reaeration of arterial blood. CSR can be harmful because of repeated hypoxia. In some patients, CSR is associated with repeated awakenings from sleep, which causes severe insomnia, increased sympathetic activity, and increased afterload. See US Pat. No. 5,399,633.

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

[0010] Patients with respiratory insufficiency (a form of respiratory failure) may experience abnormal shortness of breath during exercise.

[0011] 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.

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

[0013] Neuromuscular diseases (NMD) is a broad term that encompasses 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 that leads to inability to walk, wheelchair use, difficulty swallowing, respiratory muscle weakness, and ultimately death from respiratory failure. Neuromuscular disorders can be divided into rapidly progressive and 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 teenage Duchenne muscular dystrophy (DMD)); (ii) variable or slowly progressive disorders: characterized by muscle impairment that worsens over years but only results in a mild reduction in life expectancy (e.g., limb-girdle, facioscapulohumeral, and myotonic muscular dystrophies). Symptoms of respiratory failure in NMD include increasing general weakness, difficulty swallowing, shortness of breath on exertion and at rest, fatigue, drowsiness, morning headaches, and difficulty concentrating and mood changes.

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

[0015] A variety of therapies have been used to treat or ameliorate such diseases, and in addition, otherwise healthy individuals may utilize such therapies to prevent the development of respiratory disorders, but these suffer from a number of deficiencies.

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

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

[0018] Continuous positive airway pressure (CPAP) therapy has been used to treat obstructive sleep apnea (OSA). The mechanism of action is that the continuous positive airway pressure acts as a pneumatic splint, such as by pushing the soft palate and tongue forward and backward against the posterior oropharyngeal wall, which may prevent closure of the upper airway. Because treatment of OSA with CPAP therapy can be voluntary, patients may choose not to comply with the therapy if they perceive one or more of the following from the devices used to deliver such therapy: uncomfortable, difficult to use, expensive, and poor aesthetics.

[0019] [2.2.3 Respiratory Therapy Systems] These respiratory therapies may be provided by respiratory therapy systems or devices. Such systems and devices may also be used to screen, diagnose, or monitor disease without treating it.

[0020] The respiratory therapy system may include a respiratory pressure therapy device (RPT device), an air circuit, a humidifier, a patient interface, an oxygen source, and data management.

[0021] Another form of therapy system is the mandibular repositioning device.

[0022] 2.2.3.1 Patient Interface A patient interface may be used to provide its wearer with an interface to a respiratory device, for example by providing an airflow at an entrance to the airway. The airflow may be provided via a mask to the nose and / or mouth, via a tube to the mouth, or via a tracheotomy tube to the patient's trachea. Depending on the therapy being applied, the patient interface may, for example, form a seal with an area of ​​the patient's face to facilitate delivery of gas at a pressure sufficiently different from ambient pressure to provide the therapeutic effect, for example, a positive pressure of about 10 cmH2O relative to ambient pressure. In other forms of therapy, such as delivery of oxygen, 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. For flow therapy, such as nasal HFT, the patient interface is configured to blow into the nares but specifically avoid a complete seal. One example of such a patient interface is a nasal cannula.

[0023] Certain other mask systems may be functionally inadequate in this field, for example masks that are purely decorative may not be able to maintain adequate pressure, and mask systems used for underwater swimming or diving may be configured to not maintain an internal air pressure higher than ambient while still preventing water ingress due to external higher pressures.

[0024] A particular mask may be clinically unsuitable for this technology if, for example, it blocks airflow through the nose and only allows airflow through the mouth.

[0025] In certain masks, it may be uncomfortable or impractical for the patient to insert part of the mask structure into their mouth and create and maintain a seal with their lips.

[0026] Certain masks may be impractical for use while sleeping, for example when sleeping on one's side in bed with the head resting on a pillow.

[0027] There are many challenges in designing a patient interface. The face has a complex three-dimensional shape. The size and shape of the nose and head vary considerably between individuals. Because the head contains bone, cartilage and soft tissue, different regions of the face respond differently to mechanical forces. The jaw or mandible can move relative to other bones of the skull. The entire head can move during respiratory therapy.

[0028] Due to these challenges, some masks suffer from one or more of the following problems, especially if worn for extended periods or if the patient is unfamiliar with the system: unsightly, undesirable aesthetics, expensive, poor fit, difficult to use, and uncomfortable. If the wrong size mask is used, this can lead to reduced compliance, reduced comfort, and poor patient outcomes. While masks designed specifically for aviators, as part of personal protective equipment (e.g., filter masks), SCUBA masks, or masks for anesthesia administration may be tolerable upon initial use, such masks may be undesirably uncomfortable to wear for extended periods (e.g., several hours). Such discomfort can reduce patient compliance with the therapy. This is especially true if the mask must be worn during sleep.

[0029] CPAP therapy can be highly effective in treating certain breathing disorders if 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 wash their masks, which may affect patient compliance.

[0030] Masks for other applications (e.g., for aviators) may be inappropriate for use in treating sleep-disordered breathing, but masks designed for use in treating sleep-disordered breathing may be suitable for other applications.

[0031] For these reasons, patient interfaces for CPAP delivery during sleep form a separate field.

[0032] [2.2.3.1.1 Seal formation structure] The patient interface may include a seal-forming structure, which is in direct contact with the patient's face, and therefore the shape and configuration of the seal-forming structure may have a direct impact on the effectiveness and comfort of the patient interface.

[0033] The patient interface may be characterized in part according to the design intent of the location where the seal-forming structure engages the face in use. In one form of the patient interface, the seal-forming structure may include a first sub-portion for forming a seal around the left nostril and a second sub-portion for forming a seal around the right nostril. In one form of the patient interface, the seal-forming structure may include a single element that surrounds both nostrils in use. Such a single element may be designed to rest, for example, on the upper lip region and nasal bridge region of the face. In one form of the patient interface, the seal-forming structure may include an element that surrounds the mouth region in use, for example by forming a seal on the lower lip region of the face. In one form of the patient interface, the seal-forming structure may include a single element that surrounds both nostrils and the mouth region in use. These different types of patient interfaces may be known by a variety of names, including nasal masks, full face masks, nasal pillows, nasal puffs and oronasal masks, depending on their manufacturer.

[0034] 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, a seal on swimming goggles that rests on the patient's forehead may be inappropriate for use on the patient's nose.

[0035] A particular seal-forming structure may be designed for mass production so that one design will fit, be comfortable and effective for a wide range of different face shapes and sizes. If there is a mismatch between the shape of the patient's face and the seal-forming structure of the mass-produced patient interface, one or both will need to be adapted to form a seal.

[0036] One type of seal-forming structure extends around the periphery of the patient interface and is intended to seal against the patient's face when force is applied to the patient interface with the seal-forming structure engaging against the patient's face. The seal-forming structure may include an air or fluid filled cushion, or may include a molded or formed surface of a resilient sealing element made of an elastomer such as rubber. With this type of seal-forming structure, if the fit is insufficient, a gap will occur between the seal-forming structure and the face, requiring additional force to press the patient interface against the face and achieve a seal.

[0037] Another type of seal-forming structure incorporates 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 previous styles of seal-forming parts, if there is poor alignment between the face and the mask, additional force may be required to achieve a seal or the mask may leak. Additionally, if the shape of the seal-forming structure does not match the shape of the patient, it may wrinkle or buckle during use, causing leakage.

[0038] Other types of seal-forming structures may include friction-fit elements for insertion into the nostrils, for example, but some patients find this uncomfortable.

[0039] Another form of seal-forming structure may use an adhesive to achieve the seal, which some patients may find bothersome to have on their face all the time or to remove.

[0040] Various patient interface seal forming structures are disclosed in US Pat. Nos. 5,993,333, 5,993,425, and 5,143,636.

[0041] One form of nasal pillow is found in the Adam Circuit manufactured by Puritan Bennett. Another nasal pillow or nasal puff is the subject of U.S. Pat. No. 5,393,326 assigned to Puritan-Bennett Corporation.

[0042] ResMed Limited manufactures the following products incorporating nasal pillows: SWIFT nasal pillows mask, SWIFT II nasal pillows mask, SWIFT LT nasal pillows mask, SWIFT FX nasal pillows mask, and MIRAGE LIBERTY full face mask. Examples of nasal pillows masks are described in the following patent applications assigned to ResMed Limited: US Pat. No. 5,399,433 (which describes, among other things, aspects of ResMed Limited's SWIFT nasal pillows), US Pat. No. 5,399,433 (which describes, among other things, aspects of ResMed Limited's SWIFT LT nasal pillows), US Pat. No. 5,499,433 (which describes, among other things, aspects of ResMed Limited's MIRAGE LIBERTY full face mask), and US Pat. No. 5,499,433 (which describes, among other things, aspects of ResMed Limited's SWIFT FX nasal pillows).

[0043] [2.2.3.1.2 Positioning and stabilization] Because the seal-forming structures of patient interfaces used in positive air therapy are subject to the corresponding forces of air pressure that can disrupt the seal, a variety of techniques have been used to position and maintain the seal-forming structures in sealing relationship with the appropriate portion of the face.

[0044] In one technique, adhesives are used, see, for example, US Patent No. 5,399,633, however, the use of adhesives can be uncomfortable for some people.

[0045] Another technique uses one or more straps and / or stabilizing harnesses. Many such harnesses suffer from one or more of the following problems: poor fit, bulkiness, discomfort, and awkwardness when used.

[0046] [2.2.3.1.3 Pressurized air ducts] In one type of treatment system, the pressurized air flow is provided to the patient interface through a conduit in the air circuit that fluidly connects to the patient interface so that when the patient interface is positioned on the patient's face during use, the conduit extends forward out of the patient interface, away from the patient's face. This may sometimes be referred to as a "tube down" configuration.

[0047] Some patients find such interfaces unsightly or claustrophobic, resulting in them being discontinued and patient compliance reduced. Additionally, the conduits connecting to the interface in front of the patient's face can sometimes be prone to becoming entangled in bedding.

[0048] [2.2.3.1.4 Pressurized air conduits used to position / stabilize seal-forming structures] An alternative type of treatment system that seeks to solve such problems includes a patient interface in which a tube that delivers pressurized air to the patient's airway also functions as part of the headgear, positioning and stabilizing a seal-forming portion of the patient interface on an appropriate portion of the patient's face. This type of patient interface may be referred to as having "conduit headgear" or "headgear tubing." Such a patient interface allows a conduit in an air circuit that provides the pressurized air flow from a respiratory pressure therapy device to connect to the patient interface at a location other than in front of the patient's face. One example of such a treatment system is disclosed in U.S. Patent No. 5,399,993, the contents of which are incorporated herein by reference, where the conduit connects to a tube in the patient interface through a port that is positioned on the top of the patient's head in use.

[0049] Patient interfaces incorporating headgear tubing may offer several advantages, such as preventing conduits from connecting to the patient interface in front of the patient's face, which can be unsightly and unsightly, but it is desirable for a patient interface incorporating headgear tubing to be comfortable for the patient to wear for extended periods of time while the patient sleeps, and to be able to fit a range of patient head shapes and sizes while still forming an airtight and stable seal with the patient's face.

[0050] 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 numerous therapies discussed above, such as by operating the device to generate an airflow for delivery to an interface to the airway. The airflow can be pressure controlled (for respiratory pressure therapy) or flow controlled (for flow therapy such as HFT). Thus, RPT devices can also function as flow therapy devices. Examples of RPT devices include CPAP devices and ventilators.

[0051] A device designer may be presented with a myriad of choices. Design criteria are often in conflict, meaning that certain design choices are unconventional or unavoidable. Furthermore, the comfort and effectiveness of a particular embodiment may be highly sensitive to minor changes in one or more parameters.

[0052] [2.2.3.3 Air Circuit] An air circuit is a conduit or tube constructed and arranged to allow airflow to travel between two components of a respiratory therapy system (e.g., an RPT device and a patient interface) when in use. In some cases, an air circuit may have separate branches for inhalation and exhalation. In other cases, a single-limb air circuit is used for both inhalation and exhalation.

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

[0054] [2.2.3.5 Data Management] For clinical reasons, data may be obtained to determine whether a patient prescribed respiratory therapy has been "compliant" (e.g., that the patient has used his / her RPT device in accordance with one or more "compliance rules"). One example of a compliance rule for CPAP therapy is that a patient must use the RPT device for at least 4 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 therapy with the RPT device, calculate the rate of usage over a given period of time, and compare this to the compliance rules. Once the healthcare provider determines that the patient has used his / her RPT device in accordance with the compliance rules, the healthcare provider may notify a third party that the patient is compliant.

[0055] There may be other aspects of a patient's therapy that would benefit from the transmission of therapy data to third parties or external systems.

[0056] Existing processes for communicating and managing such data can be one or more of: expensive, time consuming, and error prone.

[0057] [2.2.3.6 Ventilation technology] Some forms of treatment systems may include a vent to flush out exhaled carbon dioxide. The vent 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., the surroundings).

[0058] [2.2.4 Screening, diagnostic, and surveillance systems] Polysomnography (PSG) is the traditional system for diagnosing and monitoring cardiopulmonary disorders, and typically requires specialized clinical staff to apply the system. PSG involves the placement of typically 15-20 contact sensors on the patient to record diverse body signals, such as electroencephalography (EEG), electrocardiography (ECG), electro-oculography (EOG), and electromyography (EMG). PSG for sleep-disordered breathing has involved observing the patient in a clinic for two nights (the first night is purely diagnostic, the second night is titration of treatment parameters by the clinician). As such, PSG is expensive and not convenient. In particular, it is inappropriate for screening / diagnosing / monitoring sleep-disordered breathing at home.

[0059] In general, during screening and diagnosis, the identification of a disease is described by its signs and symptoms. Screening usually produces a true / false result indicating whether a patient's SDB is severe enough to warrant further investigation, whereas diagnosis may produce clinically actionable information. Screening and diagnosis tend to be one-time processes, whereas monitoring the course of a disease can continue indefinitely. Some screening / diagnostic systems are suitable only for screening / diagnosis, while others can be used for monitoring as well. A clinical expert may be fully capable of screening, diagnosing, or monitoring a patient based on visual observation of the PSG signal. However, there are situations where a clinical expert is not available or cannot be paid for. Different clinical experts may have different opinions regarding a patient's illness. Furthermore, a particular clinical expert may apply different criteria at different times. [Prior art documents] [Patent documents]

[0060] [Patent Document 1] U.S. Pat. No. 4,944,310 [Patent Document 2] U.S. Patent No. 6,532,959 [Patent Document 3] International Publication No. 1998 / 004310 [Patent Document 4] International Publication No. 2006 / 074513 [Patent Document 5] International Publication No. 2010 / 135785 [Patent Document 6] U.S. Pat. No. 4,782,832 [Patent Document 7] International Application No. 2004 / 073778 [Patent Document 8] US Patent Application No. 2009 / 0044808 [Patent Document 9] International Application No. 2006 / 130903 [Patent Document 10] International Application No. 2005 / 063328 [Patent Document 11] International Application No. 2009 / 052560 [Patent Document 12] US Patent Application Publication No. 2010 / 0000534 [Patent Document 13] US Patent Application Publication No. 2007 / 0246043 [Patent Document 14] U.S. Patent No. 6,044,844 [Patent Document 15] International Application Publication No. 2019 / 183680 [Patent Document 16] U.S. Patent No. 7,866,944 [Patent Document 17] U.S. Patent No. 8,638,014 [Patent Document 18] U.S. Pat. No. 8,636,479 [Patent Document 19] International Publication No. 2013 / 020167 [Patent Document 20] International Publication No. 2012 / 171072 Summary of the Invention

[0061] [3 Brief explanation of the technology] The present technology relates to the provision of medical devices for use in screening, diagnosing, monitoring, ameliorating, treating or preventing respiratory disorders, having one or more of improved comfort, cost, effectiveness, ease of use and manufacturability.

[0062] A first aspect of the present technology relates to devices for use in screening, diagnosing, monitoring, ameliorating, treating or preventing respiratory disorders.

[0063] Another aspect of the present technology relates to methods used to screen for, diagnose, monitor, ameliorate, treat or prevent respiratory disorders.

[0064] One aspect of certain forms of the present technology is to provide methods and / or apparatus for improving patient compliance with respiratory therapy.

[0065] Another aspect of the present technology includes a patient interface, comprising: a chassis portion at least partially defining a plenum chamber pressurizable to a therapeutic pressure of at least 4 cmH2O above ambient air pressure, said plenum chamber including a plenum chamber inlet port sized and configured to receive an air flow at the therapeutic pressure for breathing by a patient; a seal-forming structure including a pair of nasal pillows, each nasal pillow constructed and arranged to form a seal with a respective nostril of the patient's nose, each nasal pillow having a hole therein such that airflow at said therapeutic pressure is delivered to at least the patient's nares, the seal-forming structure constructed and arranged, in use, to maintain said therapeutic pressure within the plenum chamber throughout the patient's respiratory cycle; a membrane portion at least partially forming a plenum chamber, the membrane portion connected to the chassis portion and formed at least partially from a textile material, the nasal pillows being supported on the membrane portion, the membrane portion constructed and arranged to be flexible to permit relative movement between the nasal pillows and the chassis portion in use; a vent for allowing a continuous flow of gases exhaled by the patient from the interior of the plenum chamber to the surroundings, said vent being sized and shaped to maintain a therapeutic pressure in the plenum chamber in use; The patient interface is configured to allow the patient to breathe from the environment through their mouth in the absence of pressurized air flow through the plenum chamber inlet port, or the patient interface is configured to leave the patient's mouth uncovered.

[0066] In the example: • the membrane portion is constructed and arranged to at least partially decouple movement of the nasal pillows from one another; • the membrane portion is constructed and arranged to allow each of the nasal pillows to move into alignment with each of the patient's nostrils when in use; • the membrane portion is constructed and arranged to expand when the plenum chamber is pressurized to a therapeutic pressure in use; ● The membrane portion is stretchable; • the membrane portion is constructed and arranged to expand and contract during inflation when the plenum chamber is pressurized to a therapeutic pressure in use; • the membrane portion is constructed and arranged to be taut in the absence of therapeutic pressure within the plenum chamber; • the membrane portion is constructed and arranged to expand in use to conform to one or more portions of the patient's nose; • the membrane portion is constructed and arranged to inflate, in use, to urge each of the nasal pillows towards each of the patient's nostrils; • the membrane portion is constructed and arranged to resist separation of the nasal pillows from the patient's nares when the chassis portion moves during use; ● the membrane portion is configured to engage the patient's uvacutibil in use; • the chassis portion is configured so as not to engage the patient's sitactibile during use; ● the membrane portion includes a textile layer and an air impermeable layer; • the textile layer provides the outer surface of the membrane portion; ● the plenum chamber includes a rearwardly-facing side configured to face rearwardly and upwardly in use, the membrane portion and the seal-forming structure forming a majority of the rearwardly-facing side; ● the membrane portion and seal-forming structure form substantially all of the rearwardly-facing side; ● the plenum chamber includes a front-upper-facing side configured to face forward and upward in use, the membrane portion forming a majority of the front-upper-facing side; ● the plenum chamber includes a rearwardly-facing side configured to face rearwardly and downwardly in use, the membrane portion forming a majority of the rearwardly-facing side; ● the chassis portion forms a majority of a forward and downward facing side of a plenum chamber configured to face forward and downward in use; ● the chassis portion is formed from an elastomeric material; ● The chassis part is made of silicone or TPE; • the chassis portion is configured not to engage the patient's periphery; ● Each nasal pillow is stalkless; • each of the nasal pillows includes a frusto-conical portion having a tip and a base that is wider than the tip, the base being attached directly to the membrane portion; • each nasal pillow is formed from a different material than the membrane portion; • each of the nasal pillows is formed from an elastomeric material; ● Each nasal pillow is made from silicone or TPE; • Each nasal pillow is formed from a single wall; ● The nasal pillow is a double-walled nasal pillow; ● the seal-forming structure further includes an oral portion configured to form a seal about the patient's mouth such that airflow at said therapeutic pressure is delivered to the patient's mouth; • The membrane portion forms the oral portion of the seal-forming structure; ● the patient interface includes a nasal cushion module and an oral cushion module, the chassis portion being a nasal chassis portion forming part of the nasal cushion module, the oral cushion module including an oral chassis portion supporting the oral portion of the seal-forming structure; ● the patient interface includes a positioning and stabilizing structure that provides a force to hold the seal-forming structure in a therapeutically effective position on the patient's head, the positioning and stabilizing structure including a tie, the tie constructed and arranged such that in use it overlies at least a portion of the patient's head above a superior auricular point of the patient's head; • the positioning and stabilizing structure includes one or more gas delivery tubes configured to provide an air flow at a therapeutic pressure to the plenum chamber; ● the positioning and stabilizing structure includes a pair of gas delivery tubes, and the chassis portion includes a pair of outwardly projecting connection portions configured to connect to the gas delivery tubes and sized and configured to receive an air flow at a therapeutic pressure for breathing by the patient; ● the patient interface further includes a vent module including a vent, the vent module being disposed on a front side of the chassis portion; ● the chassis portion includes a front hole for receiving the vent module; the vent module is configured to support a diffuser through which a continuous flow of gas exhaled by the patient can pass as it flows around; and / or - The vent module is configured to allow a continuous flow of gases exhaled by the patient from the interior of the plenum chamber to the surroundings, passing by the diffuser without flowing through the diffuser.

[0067] Another aspect of the present technology includes a patient interface, comprising: a chassis portion at least partially defining a plenum chamber pressurizable to a therapeutic pressure of at least 4 cmH2O above ambient air pressure, said plenum chamber including a plenum chamber inlet port sized and configured to receive an air flow at the therapeutic pressure for breathing by a patient; a seal-forming structure supported by the chassis portion and including a pair of nasal pillows, each nasal pillow constructed and arranged to form a seal with a respective nostril of the patient's nose, each nasal pillow having a hole therein such that airflow at said therapeutic pressure is delivered to at least the patient's nares, the seal-forming structure constructed and arranged to maintain said therapeutic pressure in the plenum chamber throughout the patient's respiratory cycle, in use; a membrane portion at least partially forming a plenum chamber, the membrane portion connected to the chassis portion and formed at least partially from a textile material, the nasal pillows being supported on the membrane portion, the membrane portion constructed and arranged to expand to conform to one or more portions of the patient's nose in use; a vent for allowing a continuous flow of gases exhaled by the patient from the interior of the plenum chamber to the surroundings, said vent being sized and shaped to maintain a therapeutic pressure in the plenum chamber in use; The patient interface is configured to allow the patient to breathe from the environment through their mouth in the absence of pressurized air flow through the plenum chamber inlet port, or the patient interface is configured to leave the patient's mouth uncovered.

[0068] In the example: • the membrane portion is constructed and arranged to be flexible to permit relative movement between the nasal pillows and the chassis portion in use; • the membrane portion is constructed and arranged to at least partially decouple movement of the nasal pillows from one another; • the membrane portion is constructed and arranged to allow each of the nasal pillows to move into alignment with each of the patient's nostrils when in use; • the membrane portion is constructed and arranged to stretch and / or flex to allow each of the nasal pillows to move and align with each of the patient's nostrils before pressure is applied; • the membrane portion is constructed and arranged to expand when the plenum chamber is pressurized to a therapeutic pressure in use; ● The membrane portion is stretchable; • the membrane portion is constructed and arranged to expand and contract during inflation when the plenum chamber is pressurized to a therapeutic pressure in use; • the membrane portion is constructed and arranged to be taut in the absence of therapeutic pressure within the plenum chamber; • the membrane portion is constructed and arranged to inflate, in use, to urge each of the nasal pillows towards each of the patient's nostrils; • the membrane portion is constructed and arranged to resist separation of the nasal pillows from the patient's nares when the chassis portion moves during use; ● the membrane portion is configured to engage the patient's uvacutibil in use; • the chassis portion is configured so as not to engage the patient's sitactibile during use; ● the membrane portion includes a textile layer and an air impermeable layer; • the textile layer provides the outer surface of the membrane portion; ● the plenum chamber includes a rearwardly-facing side configured to face rearwardly and upwardly in use, the membrane portion and the seal-forming structure forming a majority of the rearwardly-facing side; ● the membrane portion and seal-forming structure form substantially all of the rearwardly-facing side; ● the plenum chamber includes a front-upper-facing side configured to face forward and upward in use, the membrane portion forming a majority of the front-upper-facing side; ● the plenum chamber includes a rearwardly-facing side configured to face rearwardly and downwardly in use, the membrane portion forming a majority of the rearwardly-facing side; ● the chassis portion forms a majority of a forward and downward facing side of a plenum chamber configured to face forward and downward in use; ● the chassis portion is formed from an elastomeric material; ● The chassis part is made of silicone or TPE; • the chassis portion is configured not to engage the patient's periphery; ● Each nasal pillow is stalk-free; • each of the nasal pillows includes a frusto-conical portion having a tip and a base that is wider than the tip, the base being attached directly to the membrane portion; • each nasal pillow is formed from a different material than the membrane portion; • each of the nasal pillows is formed from an elastomeric material; ● Each nasal pillow is made from silicone or TPE; • Each nasal pillow is formed from a single wall; ● The nasal pillow is a double-walled nasal pillow; ● the seal-forming structure further includes an oral portion configured to form a seal about the patient's mouth such that airflow at said therapeutic pressure is delivered to the patient's mouth; • The membrane portion forms the oral portion of the seal-forming structure; ● the patient interface includes a nasal cushion module and an oral cushion module, the chassis portion being a nasal chassis portion forming part of the nasal cushion module, the oral cushion module including an oral chassis portion supporting the oral portion of the seal-forming structure; ● the patient interface includes a positioning and stabilizing structure that provides a force to hold the seal-forming structure in a therapeutically effective position on the patient's head, the positioning and stabilizing structure including a tie, the tie constructed and arranged such that in use it overlies at least a portion of the patient's head above a superior auricular point of the patient's head; • the positioning and stabilizing structure includes one or more gas delivery tubes configured to provide an air flow at a therapeutic pressure to the plenum chamber; ● the positioning and stabilizing structure includes a pair of gas delivery tubes, and the chassis portion includes a pair of outwardly projecting connection portions configured to connect to the gas delivery tubes and sized and configured to receive an air flow at a therapeutic pressure for breathing by the patient; ● the patient interface further includes a vent module including a vent, the vent module being disposed on a front side of the chassis portion; ● the chassis portion includes a front hole for receiving the vent module; the vent module is configured to support a diffuser through which a continuous flow of gas exhaled by the patient can pass as it flows around; and / or - The vent module is configured to allow a continuous flow of gases exhaled by the patient from the interior of the plenum chamber to the surroundings, passing by the diffuser without flowing through the diffuser.

[0069] Another aspect of the present technology includes a patient interface, comprising: a chassis portion at least partially defining a plenum chamber pressurizable to a therapeutic pressure of at least 4 cmH2O above ambient air pressure, said plenum chamber including a plenum chamber inlet port sized and configured to receive an air flow at the therapeutic pressure for breathing by a patient; a seal-forming structure constructed and arranged to form a seal with an area of ​​the patient's face surrounding an entrance to the patient's airway, said seal-forming structure having holes therein such that airflow at said therapeutic pressure is delivered to at least an entrance to the patient's nares, said seal-forming structure constructed and arranged to maintain said therapeutic pressure in a plenum chamber in use throughout the patient's respiratory cycle, the seal-forming structure including a nose portion formed from an elastomeric material; a membrane portion at least partially forming a plenum chamber, the membrane portion being connected to the chassis portion and at least partially formed from a textile material, a nose portion of the seal-forming structure being supported on the membrane portion; a vent for allowing a continuous flow of gases exhaled by the patient from the interior of the plenum chamber to the surroundings, said vent being sized and shaped to maintain a therapeutic pressure in the plenum chamber in use; The patient interface is configured to allow the patient to breathe from the environment through their mouth in the absence of pressurized air flow through the plenum chamber inlet port, or the patient interface is configured to leave the patient's mouth uncovered.

[0070] In the example: • the membrane portion is constructed and arranged to be flexible to allow relative movement between the seal-forming structure and the chassis portion in use; • the membrane portion is constructed and arranged to expand when the plenum chamber is pressurized to a therapeutic pressure in use; ● The membrane portion is stretchable; • the membrane portion is constructed and arranged to expand and contract during inflation when the plenum chamber is pressurized to a therapeutic pressure in use; • the membrane portion is constructed and arranged to be taut in the absence of therapeutic pressure within the plenum chamber; • the seal-forming structure includes a pair of nasal pillows, each constructed and arranged to form a seal with a respective nostril of the patient's nose, each nasal pillow having a hole therein for delivering airflow at said therapeutic pressure to the patient's nostril; • the membrane portion is constructed and arranged to be flexible to permit relative movement between the nasal pillows and the chassis portion in use; • the membrane portion is constructed and arranged to at least partially decouple movement of the nasal pillows from one another; • the membrane portion is constructed and arranged to allow each of the nasal pillows to move into alignment with each of the patient's nostrils when in use; ● Each nasal pillow is stalk-free; • each of the nasal pillows includes a frusto-conical portion having a tip and a base that is wider than the tip, the base being attached directly to the membrane portion; • each nasal pillow is formed from a different material than the membrane portion; • each of the nasal pillows is formed from an elastomeric material; ● Each nasal pillow is made from silicone or TPE; • Each nasal pillow is formed from a single wall; ● The nasal pillow is a double-walled nasal pillow; • the membrane portion is constructed and arranged to expand in use to conform to one or more portions of the patient's nose; • the membrane portion is constructed and arranged to inflate, in use, to urge each of the nasal pillows towards each of the patient's nostrils; • the membrane portion is constructed and arranged to resist separation of the nasal pillows from the patient's nares when the chassis portion moves during use; ● the membrane portion is configured to engage the patient's uvacutibil in use; • the chassis portion is configured so as not to engage the patient's sitactibile during use; ● the membrane portion includes a textile layer and an air impermeable layer; • the textile layer provides the outer surface of the membrane portion; ● the plenum chamber includes a rearwardly-facing side configured to face rearwardly and upwardly in use, the membrane portion and the seal-forming structure forming a majority of the rearwardly-facing side; ● the membrane portion and seal-forming structure form substantially all of the rearwardly-facing side; ● the plenum chamber includes a front-upper-facing side configured to face forward and upward in use, the membrane portion forming a majority of the front-upper-facing side; ● the plenum chamber includes a rearwardly-facing side configured to face rearwardly and downwardly in use, the membrane portion forming a majority of the rearwardly-facing side; ● the chassis portion forms a majority of a forward and downward facing side of a plenum chamber configured to face forward and downward in use; ● the chassis portion is formed from an elastomeric material; ● The chassis part is made of silicone or TPE; • the chassis portion is configured not to engage the patient's periphery; ● the seal-forming structure further includes an oral portion configured to form a seal about the patient's mouth such that airflow at said therapeutic pressure is delivered to the patient's mouth; • The membrane portion forms the oral portion of the seal-forming structure; ● the patient interface includes a nasal cushion module and an oral cushion module, the chassis portion being a nasal chassis portion forming part of the nasal cushion module, the oral cushion module including an oral chassis portion supporting the oral portion of the seal-forming structure; ● the patient interface includes a positioning and stabilizing structure that provides a force to hold the seal-forming structure in a therapeutically effective position on the patient's head, the positioning and stabilizing structure including a tie, the tie constructed and arranged such that in use it overlies at least a portion of the patient's head above a superior auricular point of the patient's head; • the positioning and stabilizing structure includes one or more gas delivery tubes configured to provide an air flow at a therapeutic pressure to the plenum chamber; ● the positioning and stabilizing structure includes a pair of gas delivery tubes, and the chassis portion includes a pair of outwardly projecting connection portions configured to connect to the gas delivery tubes and sized and configured to receive an air flow at a therapeutic pressure for breathing by the patient; ● the patient interface further includes a vent module including a vent, the vent module being disposed on a front side of the chassis portion; ● the chassis portion includes a front hole for receiving the vent module; the vent module is configured to support a diffuser through which a continuous flow of gas exhaled by the patient can pass as it flows around; and / or - The vent module is configured to allow a continuous flow of gases exhaled by the patient from the interior of the plenum chamber to the surroundings, passing by the diffuser without flowing through the diffuser.

[0071] Another aspect of the present technology includes a patient interface, comprising: a chassis portion at least partially defining a plenum chamber pressurizable to a therapeutic pressure of at least 4 cmH2O above ambient air pressure, said plenum chamber including a plenum chamber inlet port sized and configured to receive an air flow at the therapeutic pressure for breathing by a patient; a seal-forming structure supported by the chassis portion and including a pair of nasal pillows, each nasal pillow constructed and arranged to form a seal with a respective nostril of the patient's nose, each nasal pillow having a hole therein such that airflow at said therapeutic pressure is delivered to at least the patient's nares, the seal-forming structure constructed and arranged to maintain said therapeutic pressure in the plenum chamber throughout the patient's respiratory cycle, in use; a membrane portion at least partially forming a plenum chamber, the membrane portion being connected to the chassis portion, the nasal pillows being supported on the membrane portion, the membrane portion being formed from an elastic material that can stretch during inflation when the plenum chamber is pressurized to a therapeutic pressure in use; a vent for allowing a continuous flow of gases exhaled by the patient from the interior of the plenum chamber to the surroundings, said vent being sized and shaped to maintain a therapeutic pressure in the plenum chamber in use; The patient interface is configured to allow the patient to breathe from the environment through their mouth in the absence of pressurized air flow through the plenum chamber inlet port, or the patient interface is configured to leave the patient's mouth uncovered.

[0072] In the example: • the membrane portion is constructed and arranged to be flexible to allow movement of the nasal pillows relative to the chassis portion in use; • the membrane portion is constructed and arranged to at least partially decouple movement of the nasal pillows from one another; • the membrane portion is constructed and arranged to allow each of the nasal pillows to move into alignment with each of the patient's nostrils when in use; • the membrane portion is constructed and arranged to be taut in the absence of therapeutic pressure within the plenum chamber; • the membrane portion is constructed and arranged to, when inflated in use, bias each of the nasal pillows towards each of the patient's nostrils; • the membrane portion is constructed and arranged to resist separation of the nasal pillows from the patient's nares when the chassis portion moves during use; • the membrane portion is constructed and arranged to expand in use to conform to one or more portions of the patient's nose; ● the membrane portion is configured to engage the patient's uvacutibil in use; • the chassis portion is configured so as not to engage the patient's sitactibile during use; ● the membrane portion is at least partially formed from a textile material; ● the membrane portion includes a textile layer and an air impermeable layer; • the textile layer provides the outer surface of the membrane portion; ● the membrane portion is formed from silicone; ● The thickness of the membrane part is less than 0.25 mm; ● The thickness of the membrane part is less than 0.2 mm; ● The thickness of the membrane part is in the range of 0.1mm~0.19mm; The membrane portion is formed from silicone having a durometer hardness in the range of D20 to D40; ● the plenum chamber includes a rearwardly-facing side configured to face rearwardly and upwardly in use, the membrane portion and the seal-forming structure forming a majority of the rearwardly-facing side; ● the membrane portion and seal-forming structure form substantially all of the rearwardly-facing side; ● the plenum chamber includes a front-upper-facing side configured to face forward and upward in use, the membrane portion forming a majority of the front-upper-facing side; ● the plenum chamber includes a rearwardly-facing side configured to face rearwardly and downwardly in use, the membrane portion forming a majority of the rearwardly-facing side; ● the chassis portion forms a majority of a forward and downward facing side of a plenum chamber configured to face forward and downward in use; ● the chassis portion is formed from an elastomeric material; ● The chassis part is made of silicone or TPE; • the chassis portion is configured not to engage the patient's periphery; ● Each nasal pillow is stalk-free; • each of the nasal pillows includes a frusto-conical portion having a tip and a base that is wider than the tip, the base being attached directly to the membrane portion; • each nasal pillow is formed from a different material than the membrane portion; • each of the nasal pillows is formed from an elastomeric material; ● Each nasal pillow is made from silicone or TPE; • Each nasal pillow is formed from a single wall; ● The nasal pillow is a double-walled nasal pillow; ● the seal-forming structure further includes an oral portion configured to form a seal about the patient's mouth such that airflow at said therapeutic pressure is delivered to the patient's mouth; • The membrane portion forms the oral portion of the seal-forming structure; ● the patient interface includes a nasal cushion module and an oral cushion module, the chassis portion being a nasal chassis portion forming part of the nasal cushion module, the oral cushion module including an oral chassis portion supporting the oral portion of the seal-forming structure; ● the patient interface includes a positioning and stabilizing structure that provides a force to hold the seal-forming structure in a therapeutically effective position on the patient's head, the positioning and stabilizing structure including a tie, the tie constructed and arranged such that in use it overlies at least a portion of the patient's head above a superior auricular point of the patient's head; • the positioning and stabilizing structure includes one or more gas delivery tubes configured to provide an air flow at a therapeutic pressure to the plenum chamber; ● the positioning and stabilizing structure includes a pair of gas delivery tubes, and the chassis portion includes a pair of outwardly projecting connection portions configured to connect to the gas delivery tubes and sized and configured to receive an air flow at a therapeutic pressure for breathing by the patient; ● the patient interface further includes a vent module including a vent, the vent module being disposed on a front side of the chassis portion; ● the chassis portion includes a front hole for receiving the vent module; the vent module is configured to support a diffuser through which a continuous flow of gas exhaled by the patient can pass as it flows around; and / or - The vent module is configured to allow a continuous flow of gases exhaled by the patient from the interior of the plenum chamber to the surroundings, passing by the diffuser without flowing through the diffuser.

[0073] Another aspect of the present technology includes a patient interface, comprising: a chassis portion at least partially defining a plenum chamber pressurizable to a therapeutic pressure of at least 4 cmH2O above ambient air pressure, said plenum chamber including a plenum chamber inlet port sized and configured to receive an air flow at the therapeutic pressure for breathing by a patient; a seal-forming structure including a pair of nasal pillows, each nasal pillow constructed and arranged to form a seal with a respective nostril of the patient's nose, each nasal pillow having a hole therein such that airflow at said therapeutic pressure is delivered to the patient's nares, the seal-forming structure further including an oral portion configured to form a seal about the patient's mouth such that airflow at said therapeutic pressure is delivered to the patient's mouth, the seal-forming structure constructed and arranged to maintain said therapeutic pressure in the plenum chamber throughout the patient's respiratory cycle in use; a membrane portion at least partially defining a plenum chamber, the membrane portion being connected to the chassis portion and being more flexible than the chassis portion, nasal pillows of the seal-forming structure being supported on the membrane portion, the membrane portion forming an oral cavity portion of the seal-forming structure; a vent for allowing a continuous flow of gases exhaled by the patient from the interior of the plenum chamber to the surroundings, said vent being sized and shaped to maintain a therapeutic pressure in the plenum chamber in use; The patient interface is configured to allow the patient to breathe from the environment through his or her mouth in the absence of pressurized air flow through the plenum chamber inlet port.

[0074] Another aspect of the present technology includes a patient interface, comprising: a chassis portion at least partially defining a plenum chamber pressurizable to a therapeutic pressure of at least 4 cmH2O above ambient air pressure, said plenum chamber including a plenum chamber inlet port sized and configured to receive an air flow at the therapeutic pressure for breathing by a patient; a seal-forming structure constructed and arranged to form a seal with an area of ​​the patient's face surrounding an entrance to the patient's airway, said seal-forming structure having holes therein such that airflow at said therapeutic pressure is delivered to an entrance to at least the patient's nares, said seal-forming structure constructed and arranged to maintain said therapeutic pressure in a plenum chamber in use throughout the patient's respiratory cycle, the seal-forming structure including a nasal portion and an oral portion; a membrane portion at least partially defining a plenum chamber, the membrane portion connected to the chassis portion and being more flexible than the chassis portion, a nose portion of the seal-forming structure connected to the substantially sheet-like nose portion of the membrane portion, the nose portion of the membrane portion surrounding the nose portion of the seal-forming structure to space the nose portion of the seal-forming structure from the chassis portion, the membrane portion allowing the nose portion of the seal-forming structure to move relative to the chassis portion, and an oral portion of the membrane portion forming the oral portion of the seal-forming structure; a vent for allowing a continuous flow of gases exhaled by the patient from the interior of the plenum chamber to the surroundings, said vent being sized and shaped to maintain a therapeutic pressure in the plenum chamber in use; The patient interface is configured to allow the patient to breathe from the environment through his or her mouth in the absence of pressurized air flow through the plenum chamber inlet port. In the example: • the membrane portion is flexible to allow relative movement between the nose portion and the chassis portion of the seal-forming structure in use; • the nasal portion of the seal-forming structure includes a pair of nasal pillows supported on the membrane portion, each nasal pillow constructed and arranged to form a seal with a respective nostril of the patient's nose; • the membrane portion is constructed and arranged to at least partially decouple movement of the nasal pillows from one another; • the membrane portion is constructed and arranged to allow each of the nasal pillows to move into alignment with each of the patient's nostrils when in use; • the membrane portion is constructed and arranged to expand when the plenum chamber is pressurized to a therapeutic pressure in use; ● The membrane portion is stretchable; • the membrane portion is constructed and arranged to expand and contract during inflation when the plenum chamber is pressurized to a therapeutic pressure in use; • the membrane portion is constructed and arranged to be taut in the absence of therapeutic pressure within the plenum chamber; • the membrane portion is constructed and arranged to expand in use to conform to one or more portions of the patient's nose; • the membrane portion is constructed and arranged to inflate, in use, to urge each of the nasal pillows towards each of the patient's nostrils; • the membrane portion is constructed and arranged to resist separation of the nasal pillows from the patient's nares when the chassis portion moves during use; ● the membrane portion is formed at least in part from a textile material; ● the membrane portion includes a textile layer and an air impermeable layer; • the textile layer provides the outer surface of the membrane portion; ● the membrane portion is formed from an elastomeric material; ● the membrane portion is formed from silicone; ● The thickness of the membrane part is less than 0.25 mm; ● The thickness of the membrane part is less than 0.2 mm; • the chassis portion and the membrane portion form a nasal portion of the plenum chamber and an oral portion of the plenum chamber; ● the nasal portion of the plenum chamber includes a rear-superior-facing side configured to face rearward and upward in use, the membrane portion and the seal-forming structure forming a majority of the rear-superior-facing side, and the nasal pillows being positioned on the rear-superior-facing side; ● the membrane portion and seal-forming structure form substantially all of the rear-superior-facing side of the nose portion of the plenum chamber; ● the nose portion of the plenum chamber includes a front-upper-facing side configured to face forward and upward in use, the membrane portion forming the majority of the front-upper-facing side; • the chassis portion forms a majority of the forward-facing side of the oral portion of the plenum chamber; ● the chassis portion forms substantially all of the forward-facing side of the oral portion of the plenum chamber; ● the chassis portion and oral portion of the seal-forming structure form substantially all of the rearward-facing side of the oral portion of the plenum chamber; ● the chassis portion is flexible to at least partially decouple the membrane portion from disruptive forces applied to the chassis portion in use; ● the chassis portion is formed from an elastomeric material; ● The chassis part is made of silicone or TPE; ● the chassis portion is curved in use from one outer side of the patient's face to another outer side of the patient's face, the chassis portion being substantially flush with the patient's cheek on each outer side; • the chassis portion is substantially in the shape of a hyperbolic paraboloid or a parabolic cylinder; • the membrane portion is substantially in the shape of a hyperbolic paraboloid or a parabolic cylinder; • the chassis portion and the membrane portion are substantially in the shape of hyperbolic paraboloids rotated 90 degrees relative to one another; • the patient interface includes an undercushion attached to the chassis portion and configured to engage an inner surface of the membrane portion to support the membrane portion in use; • the undercushion is configured to engage a chin region of the membrane portion configured to contact the chin region of the patient's face in use; • the undercushion is configured to engage a cheek region of the membrane portion configured to contact the patient's cheek in use; • the undercushion is configured to engage a nasal region of the membrane portion configured to contact the patient's nose in use; • the undercushion is configured to engage the membrane portion around the entire periphery of the membrane portion; ● the undercushion includes a pair of wing portions extending inwardly relative to a periphery of the undercushion, each wing portion configured to bias the membrane portion to seal against the patient's face in an area adjacent a respective one of the patient's nasal ala; • each patient interface includes a pair of ribs extending between the chassis portion and each of the wing portions to provide support to each wing portion; ● the undercushion includes a rim disposed about a periphery of the undercushion, the membrane portion being attached to the rim, the rim being configured to space the membrane portion from the undercushion at least about a periphery of the undercushion; • the rim of the undercushion provides a connection surface along which the membrane portion is connected to the undercushion, the connection surface being raised relative to the remainder of the undercushion; ● Each nasal pillow is stalk-free; • each of the nasal pillows includes a frusto-conical portion having a tip and a base that is wider than the tip, the base being attached directly to the membrane portion; • each nasal pillow is formed from a different material than the membrane portion; ● the patient interface includes a positioning and stabilizing structure that provides a force to hold the seal-forming structure in a therapeutically effective position on the patient's head, the positioning and stabilizing structure including a tie, the tie constructed and arranged such that in use it overlies at least a portion of the patient's head above a superior auricular point of the patient's head; • the positioning and stabilizing structure includes one or more gas delivery tubes configured to provide an air flow at a therapeutic pressure to the plenum chamber; ● the positioning and stabilizing structure includes a pair of gas delivery tubes, and the chassis portion includes a pair of outwardly projecting connection portions configured to connect to the gas delivery tubes and sized and configured to receive an air flow at a therapeutic pressure for breathing by the patient; • the positioning and stabilizing structure includes a pair of lower straps, each configured to be positioned on a respective side of the patient's head below a respective inferior ear point of the patient's head; ● The lower strap is elastically extensible; • the lower strap is configured for releasable attachment to the chassis portion; ● the positioning and stabilizing structure includes a pair of gas delivery tubes, the chassis portion includes a pair of openings configured for connection of the gas delivery tubes to the chassis portion, the openings being sized and configured to receive airflow from the gas delivery tubes at a therapeutic pressure for breathing by the patient; • the positioning and stabilizing structure includes a pair of lower straps configured to be positioned on each side of the patient's head, respectively below each lower ear point of the patient's head; ● The lower strap is elastically extensible; • the patient interface includes a pair of lower arms extending from the chassis portion, each lower arm configured to attach to a respective lower strap of the positioning and stabilizing structure; • on each outer side of the chassis portion, each lower arm is connected to a chassis portion directly adjacent a respective gas delivery tube; • the positioning and stabilizing structure includes a pair of upper straps, each configured to be positioned on each side of the patient's head above a respective superior ear-base point of the patient's head; • the patient interface includes a pair of upper arms, each upper arm configured to attach to a respective upper strap; • each upper arm extends upwardly and rearwardly relative to a chassis portion; ● each upper arm extends from a chassis portion; ● the patient interface includes a pair of lower arms extending from the chassis portion, each lower arm configured to attach to a respective pair of lower straps of a positioning and stabilizing structure configured to be positioned on a respective side of the patient's head below a respective inferior ear point of the patient's head, and each upper arm extending from a respective lower arm; the patient interface further comprises a vent module including a vent, the vent module being disposed on a front side of the chassis portion; and / or - The chassis portion includes a front hole that receives the vent module.

[0075] Another aspect of the present technology includes a patient interface, comprising: a chassis portion at least partially defining a plenum chamber pressurizable to a therapeutic pressure of at least 4 cmH2O above ambient air pressure, said plenum chamber including a plenum chamber inlet port sized and configured to receive an air flow at the therapeutic pressure for breathing by a patient; a seal-forming structure including a pair of nasal pillows, each nasal pillow constructed and arranged to form a seal with a respective nostril of the patient's nose, each nasal pillow having a hole therein such that airflow at said therapeutic pressure is delivered to at least the patient's nares, the seal-forming structure constructed and arranged, in use, to maintain said therapeutic pressure within the plenum chamber throughout the patient's respiratory cycle; a membrane portion connected to the chassis portion and at least partially forming a plenum chamber, the nasal pillows being supported on the membrane portion, the membrane portion being constructed and arranged to be flexible in use to permit relative movement between the nasal pillows and the chassis portion, the membrane portion not having a predetermined three-dimensional shape in the absence of positive pressure relative to atmospheric pressure in the plenum chamber; a vent for allowing a continuous flow of gases exhaled by the patient from the interior of the plenum chamber to the surroundings, said vent being sized and shaped to maintain a therapeutic pressure in the plenum chamber in use; The patient interface is configured to allow the patient to breathe from the environment through their mouth in the absence of pressurized air flow through the plenum chamber inlet port, or the patient interface is configured to leave the patient's mouth uncovered.

[0076] In the example: • the membrane portion is constructed and arranged to at least partially decouple movement of the nasal pillows from one another; • the membrane portion is constructed and arranged to allow each of the nasal pillows to move into alignment with each of the patient's nostrils when in use; • the membrane portion is constructed and arranged to expand when the plenum chamber is pressurized to a therapeutic pressure in use; ● The membrane portion is stretchable; • the membrane portion is constructed and arranged to expand and contract during inflation when the plenum chamber is pressurized to a therapeutic pressure in use; • the membrane portion is constructed and arranged to be taut in the absence of therapeutic pressure within the plenum chamber; • the membrane portion is constructed and arranged to expand in use to conform to one or more portions of the patient's nose; • the membrane portion is constructed and arranged to inflate, in use, to urge each of the nasal pillows towards each of the patient's nostrils; • the membrane portion is constructed and arranged to resist separation of the nasal pillows from the patient's nares when the chassis portion moves during use; ● the membrane portion is configured to engage the patient's uvacutibil in use; ● the membrane portion is formed at least in part from a textile material; ● the membrane portion includes a textile layer and an air impermeable layer; • the textile layer provides the outer surface of the membrane portion; ● the membrane portion is formed from an elastomer; ● the membrane portion is formed from silicone; • the membrane portion is in the form of a sheet connected to the chassis portion at the edges of the membrane portion; ● the plenum chamber includes a rearwardly-facing side configured to face rearwardly and upwardly in use, the membrane portion and the seal-forming structure forming a majority of the rearwardly-facing side; ● the membrane portion and seal-forming structure form substantially all of the rearwardly-facing side; ● the plenum chamber includes a front-upper-facing side configured to face forward and upward in use, the membrane portion forming a majority of the front-upper-facing side; ● the plenum chamber includes a rearwardly-facing side configured to face rearwardly and downwardly in use, the membrane portion forming a majority of the rearwardly-facing side; ● the chassis portion forms a majority of a forward and downward facing side of a plenum chamber configured to face forward and downward in use; ● the chassis portion is formed from an elastomeric material; ● The chassis part is made of silicone or TPE; • the chassis portion is configured not to engage the patient's periphery; ● Each nasal pillow is stalk-free; • each of the nasal pillows includes a frusto-conical portion having a tip and a base that is wider than the tip, the base being attached directly to the membrane portion; • each nasal pillow is formed from a different material than the membrane portion; • each of the nasal pillows is formed from an elastomeric material; ● Each nasal pillow is made from silicone or TPE; ● the seal-forming structure further includes an oral portion configured to form a seal about the patient's mouth such that airflow at said therapeutic pressure is delivered to the patient's mouth; • The membrane portion forms the oral portion of the seal-forming structure; ● the patient interface includes a positioning and stabilizing structure that provides a force to hold the seal-forming structure in a therapeutically effective position on the patient's head, the positioning and stabilizing structure including a tie, the tie constructed and arranged such that in use it overlies at least a portion of the patient's head above a superior auricular point of the patient's head; the positioning and stabilizing structure includes one or more gas delivery tubes configured to provide an air flow at a therapeutic pressure to the plenum chamber; and / or ● The positioning and stabilizing structure includes a pair of gas delivery tubes, and the chassis portion includes a pair of outwardly protruding connection portions configured to connect to the gas delivery tubes and sized and configured to receive an air flow at therapeutic pressure for breathing by the patient.

[0077] One form of the present technology includes a patient interface for sealed delivery of an airflow at a continuous positive pressure relative to ambient air pressure to an entrance to the patient's airways, including the patient's nares and mouth, the patient interface being configured, in use, to maintain a therapy pressure in the range of about 4 cmH2O to about 30 cmH2O above ambient air pressure throughout the patient's respiratory cycle, and, when the patient is sleeping, to ameliorate sleep disordered breathing; The patient interface is a chassis portion formed from a textile material, the chassis portion having a predetermined three-dimensional shape that is maintained throughout the patient's respiratory cycle; and a seal-forming structure provided on the chassis portion, the seal-forming structure including a foam undercushion and a textile membrane portion connected to the foam undercushion and configured to inflate in use to form a seal around the entrances to the patient's nares and around the patient's mouth.

[0078] In the example:

[0079] a) the textile membrane portion forms a seal around the anterior and lateral portions of the periphery of the alar base of the patient's nose and from one side of the patient's nose to the other side of the patient's nose around the patient's mouth;

[0080] b) the textile membrane portion has an outer perimeter and an inner perimeter, the width of the textile membrane portion between the inner perimeter and the outer perimeter being greatest at an alar portion of the membrane portion configured to seal at the corner of the nose;

[0081] c) a connection is provided between opposing wings of the textile membrane to prevent rupture;

[0082] d) the textile membrane portion forms a first seal around the entrance to the patient's nares and a separate second seal around the patient's mouth;

[0083] e) the textile membrane portion includes a first hole for delivering pressurized air to the patient's nostrils and a second hole for delivering pressurized air to the patient's mouth;

[0084] f) the textile membrane portion has only two holes;

[0085] g) the entire textile membrane portion is integrally formed from a single sheet of material;

[0086] h) the foam undercushion includes a pair of inwardly projecting portions configured to engage the patient's face at the corners of the patient's nose;

[0087] i) the chassis portion comprises a plastically deformable element configured to allow the width of the frame to be adjusted;

[0088] j) the patient interface includes an inlet port connector extending through a lower wall portion of the chassis portion, the inlet port connector having a central axis that, in use, extends in a substantially downward direction;

[0089] k) the foam undercushion contacts the exterior surface of the inlet port connector;

[0090] l) a front wall of the chassis portion contacts an outer surface of the inlet port connector;

[0091] m) the inlet port connector protrudes through the front side wall of the chassis portion;

[0092] n) the chassis portion has a non-zero negative first principal curvature and a substantially zero second principal curvature, the second principal curvature being substantially parallel to the patient's midsagittal plane in use;

[0093] o) an exterior surface of the chassis portion immediately adjacent the inlet port connector has a radius substantially equal to the radius of the exterior immediately adjacent portion of the inlet port connector;

[0094] p) the patient interface includes a pair of upper headgear connectors and a pair of lower headgear connectors, at least one of the headgear connectors releasably connected to the chassis portion;

[0095] q) at least one headgear connector is connected to the chassis portion by a snap connector; and / or

[0096] r) The patient interface includes a vent module releasably connected to the chassis portion.

[0097] Another form of the present technology includes a patient interface for sealed delivery of an airflow at a continuous positive pressure relative to ambient air pressure to an entrance to the patient's airways including the patient's nares and mouth, the patient interface configured, in use, to maintain a therapy pressure in the range of about 4 cmH2O to about 30 cmH2O above ambient air pressure throughout the patient's respiratory cycle, and, when the patient is sleeping, to ameliorate sleep disordered breathing; The patient interface comprises: a chassis portion formed from a textile material, the chassis portion having a predetermined three-dimensional shape that is maintained throughout the patient's respiratory cycle; a seal-forming structure provided on the chassis portion, the seal-forming structure including a foam undercushion and a membrane portion connected to the foam undercushion and configured to inflate in use to form a seal around the entrances to the patient's nares and around the patient's mouth; The patient interface includes an inlet port connector extending through a lower wall portion of the chassis portion, the inlet port connector having a central axis that, in use, extends in a substantially downward direction.

[0098] In the example:

[0099] a) the foam undercushion contacts the exterior surface of the inlet port connector;

[0100] b) a front wall of the chassis portion contacts an outer surface of the inlet port connector;

[0101] c) the inlet port connector protrudes through a front side wall of the chassis portion;

[0102] d) the chassis portion has a non-zero negative first principal curvature and a substantially zero second principal curvature, the second principal curvature being substantially parallel to the patient's sagittal plane in use;

[0103] e) an exterior surface of the chassis portion immediately adjacent the inlet port connector has a radius substantially equal to the radius of the exterior immediately adjacent portion of the connection port;

[0104] f) the patient interface includes a pair of upper headgear connectors and a pair of lower headgear connectors, at least one of the headgear connectors releasably connected to the chassis portion;

[0105] g) at least one headgear connector is connected to the chassis portion by a snap connector;

[0106] h) the patient interface includes a vent module releasably connected to the chassis portion; and / or

[0107] i) The membrane portion is formed from a textile.

[0108] One form of the present technology includes a patient interface, comprising:

[0109] a chassis portion formed from a flexible material and partially defining a plenum chamber pressurizable to a therapeutic pressure of at least 6 cmH2O above ambient air pressure, the chassis portion having a non-zero negative first principal curvature and a substantially zero second principal curvature, the second principal curvature being substantially parallel to a sagittal plane of a patient in use;

[0110] an inlet port sized and configured to receive an air flow at a therapeutic pressure for breathing by a patient;

[0111] a pair of upper headgear connectors connected to the chassis portion, and a pair of lower headgear connectors connected to the chassis portion;

[0112] a seal-forming structure provided on the chassis portion and partially defining a plenum chamber, the seal-forming structure constructed and arranged to form a seal with an area of ​​the patient's face surrounding an entrance to the patient's airway, the seal-forming structure having at least one hole therein such that airflow at a therapeutic pressure is delivered to the entrance to the patient's nares and to the 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;

[0113] the seal-forming structure includes an undercushion formed from foam and a textile membrane portion connected to the undercushion and configured to inflate in use to form a seal around anterior and lateral portions of a periphery of the alar base of the patient's nose, the seal-forming structure being further configured to form a seal around the patient's mouth;

[0114] The chassis portion is configured to be flexible such that the magnitude of the first principal curvature can change when the patient interface is donned.

[0115] In the example:

[0116] a) the chassis portion is bent such that the magnitude of the first principal curvature is greater when worn by a patient with a narrow face than when worn by a patient with a relatively wide face;

[0117] b) the chassis portion is formed from a polymer;

[0118] c) the chassis portion is formed from biaxially oriented polyethylene terephthalate, such as Mylar®;

[0119] d) the thickness of the chassis portion is less than 0.5 mm, for example substantially 0.25 mm;

[0120] e) the chassis portion is formed from the sheet of material;

[0121] f) the chassis sections are stamped from the sheet of material;

[0122] g) the chassis portion is molded to shape;

[0123] h) a patient-facing side of the undercushion configured to maintain the textile membrane portion substantially taut when the patient interface is not in use;

[0124] i) the undercushion has a substantially "C" shaped cross-section;

[0125] j) a non-patient-facing side of the undercushion includes a connection formation configured to connect the undercushion to a chassis portion;

[0126] k) the connection formation includes a channel configured to receive an edge of the chassis portion;

[0127] l) the channel extends around the entire periphery of the non-patient-facing side of the undercushion;

[0128] m) the engagement between the channel and the chassis portion forms a seal;

[0129] n) the undercushion portion includes a first portion of a snap fastener and the chassis portion includes a second portion of a snap fastener;

[0130] o) the undercushion includes a rigid clip formation;

[0131] p) the undercushion is formed from a polyurethane, such as a thermoplastic polyurethane, or from a soft thermoplastic elastomer;

[0132] q) the textile membrane portion is attached to the undercushion around a periphery of the textile membrane portion;

[0133] r) the textile membrane portion is bonded to the undercushion;

[0134] s) the textile membrane portion includes a first hole through which air can flow to both nostrils of the patient in use;

[0135] t) the textile membrane portion includes a second hole through which air can flow to the patient's mouth in use, the textile membrane portion extending between the first hole and the second hole;

[0136] u) the textile membrane portion includes an air impermeable coating on its non-patient-facing side;

[0137] v) the air impermeable coating comprises a silicone layer;

[0138] w) the thickness of the silicone layer is substantially 0.05 mm;

[0139] x) the total thickness of the textile membrane portion is substantially 0.3 mm;

[0140] y) the textile membrane portion is formed from a single textile sheet;

[0141] z) each of the upper headgear connectors includes a curved arm;

[0142] aa) each of the lower headgear connectors includes a magnetic connector; and / or

[0143] ab) the chassis portion, the seal-forming structure, and the headgear connector have a combined weight of 45g or less;

[0144] Another form of the present technology includes a patient interface, comprising:

[0145] a chassis portion formed from a flexible material and partially defining a plenum chamber pressurizable to a therapeutic pressure of at least 6 cmH2O above ambient air pressure;

[0146] an inlet port sized and configured to receive an air flow at therapeutic pressure for breathing by the patient;

[0147] a pair of upper headgear connectors connected to the chassis portion, and a pair of lower headgear connectors connected to the chassis portion;

[0148] a seal-forming structure releasably connectable to the chassis portion and partially defining a plenum chamber, the 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 at least one hole therein such that airflow at a therapeutic pressure is delivered to the entrance to the patient's nares and to the patient's mouth, the seal-forming structure constructed and arranged to maintain said therapeutic pressure in the plenum chamber in use throughout the patient's respiratory cycle;

[0149] The seal-forming structure includes an undercushion formed from foam and a textile membrane portion connected to the undercushion and configured to expand in use to form a seal around anterior and lateral portions of the periphery of the alar base of the patient's nose, the seal-forming structure being further configured to form a seal around the patient's mouth.

[0150] In the example:

[0151] a) a non-patient-facing side of the undercushion including a connection formation configured to connect the undercushion to a chassis portion;

[0152] b) the connection formation includes a channel configured to receive an edge of the chassis portion;

[0153] c) the channel extends around the entire periphery of the non-patient-facing side of the undercushion;

[0154] d) the engagement between the channel and the chassis portion forms a seal;

[0155] e) the undercushion portion includes a first portion of a snap fastener and the chassis portion includes a second portion of a snap fastener;

[0156] f) the undercushion includes a rigid clip formation;

[0157] g) the undercushion is formed from a polyurethane, such as a thermoplastic polyurethane, or from a soft thermoplastic elastomer;

[0158] h) a patient-facing side of the undercushion configured to hold the textile membrane portion substantially taut when the interface is not in use;

[0159] i) the undercushion has a substantially "C" shaped cross-section;

[0160] j) the textile membrane portion is attached to the undercushion around a periphery of the textile membrane portion;

[0161] k) the textile membrane portion is bonded to the undercushion;

[0162] l) the textile membrane portion includes a first hole through which air can flow to both nostrils of the patient in use;

[0163] m) the textile membrane portion includes a second hole through which air can flow to the patient's mouth in use, the textile membrane portion extending between the first hole and the second hole;

[0164] n) the textile membrane portion includes an air impermeable coating on its non-patient-facing side;

[0165] o) the air impermeable coating comprises a silicone layer;

[0166] p) the thickness of the silicone layer is substantially 0.05 mm;

[0167] q) the total thickness of the textile membrane portion is substantially 0.3 mm;

[0168] r) the textile membrane portion is formed from a single textile sheet; and / or

[0169] s) the chassis portion has a non-zero negative first principal curvature and a substantially zero second principal curvature, the second principal curvature being substantially parallel to the patient's sagittal plane in use.

[0170] Another aspect of one form of the present technology is a patient interface that is molded or otherwise constructed with a perimeter shape that is complimentary to the shape of the intended wearer.

[0171] One aspect of one form of the present technology is a method of manufacturing a device.

[0172] 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 insight, or individuals with limited experience in using medical devices of this type.

[0173] One aspect of one form of the present technology is a portable RPT device that a person can carry around, for example, around the home.

[0174] One aspect of one form of the present technology is a patient interface that can be cleaned in the patient's home, for example with soapy water, without the need for special cleaning equipment.One aspect of one form of the present technology is a humidifier tank that can be cleaned in the patient's home, for example with soapy water, without the need for special cleaning equipment.

[0175] The described methods, systems, devices and apparatus may be implemented to improve the functionality of a processor (e.g., a processor of a special purpose computer, a respiratory monitor and / or a respiratory therapy device). Additionally, the described methods, systems, devices and apparatus enable advancements in the art of automated management, monitoring and / or treatment of respiratory disorders, including, for example, sleep disordered breathing.

[0176] Of course, some of the aspects may form sub-aspects of the technology, and various of the sub-aspects and / or aspects may be combined in various ways to form further aspects or sub-aspects of the technology.

[0177] 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 description of the drawings]

[0178] [4 Brief description of the drawings] The present technology is illustrated by way of non-limiting example in the diagrammatic drawings of the accompanying drawings in which like reference numbers refer to similar elements including: [4.1 Respiratory Therapy System] [Figure 1A] The system is shown including a patient 1000 wearing a patient interface 3000 in the form of nasal pillows that receive air at positive pressure supplied from an RPT device 4000. Air from the RPT device 4000 is humidified in a humidifier 5000 and delivered along an air circuit 4170 to the patient 1000. A bed companion 1100 is also shown. The patient is sleeping in a supine sleep position. [Figure 1B] The system is shown to include a patient 1000 wearing a patient interface 3000 in the form of a nasal mask that receives air at positive pressure supplied from an RPT device 4000. Air from the RPT device is humidified in a humidifier 5000 and delivered along an air circuit 4170 to the patient 1000. [Figure 1C]The system is shown to include a patient 1000 wearing a patient interface 3000 in the form of a full face mask that receives air at positive pressure supplied by an RPT device 4000. The air from the RPT device is humidified in a humidifier 5000 and delivered 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] 1 shows an 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] 1 shows a diagram of the human upper respiratory tract including the nasal cavity, nasal bones, lateral nasal cartilages, greater alar cartilage, nostrils, upper lip, lower lip, larynx, hard palate, soft palate, oropharynx, tongue, epiglottis, vocal cords, esophagus, and trachea. [Figure 2C] FIG. 1 is a front view of a face with several features of the surface anatomy identified, including upper lip, vermilion upper lip, lower lip, 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 shown. [Figure 2D] FIG. 1 is a lateral view of the head with several features of the surface anatomy identified, including the glabella, selion, nasal tip, subnasal point, ulnaris, umbilicus, supramenton, nasal ridge, lateral most point of the base of the nasal alar, superior and inferior ear base points. The orientation to the superior and inferior sides, as well as the anterior and posterior sides, is also shown. [Figure 2E] FIG. 1 is a further lateral view of the head, showing the approximate location of the Frankfort horizontal and the nasolabial angle. The coronal plane is also shown. [Figure 2F] A bottom view of the nose is shown with several features identified, including the nasolabial fold, lip, vermilion, nostrils, subnasal point, columella, nasal tip, long axis of the nostril and midsagittal plane. [Figure 2G] 1 shows a side view of the superficial features of the nose. [Figure 2H] The subcutaneous structures of the nose are shown, 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 nose is shown incised approximately a few millimeters medial to the midsagittal plane, with particular attention to the septal cartilage and the medial crus of the greater alar cartilage. [Figure 2J] Shows a frontal view of the skull, including the frontal, nasal and cheekbones. The nasal turbinates are shown along with the maxilla and mandible. [Figure 2K] A lateral view of the skull is shown, along with the outline of the head surface, as well as 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] The anterior lateral view of the nose is shown. [4.3 Patient Interface] [Figure 3A] 1 shows a patient interface in the form of a nasal mask in accordance with one form of the present technology. [Figure 3B] 3C shows a schematic diagram of a cross section through a structure at a point. The outward normal at the point is shown. The curvature at the point has a positive sign and a relatively large magnitude when compared to the magnitude of curvature shown in FIG. 3C. [Figure 3C] 3B shows a schematic diagram of a cross section through a structure at a point. The outward normal at the point is shown. The curvature at the point has a positive sign and a relatively small magnitude when compared to the magnitude of curvature shown in FIG. 3B. [Figure 3D] 1 shows a schematic diagram of a cross section through a structure at a point. The outward normal at the point is shown. The curvature at the point has a zero value. [Figure 3E] 3C shows a schematic diagram of a cross section through a structure at a point. The outward normal at the point is shown. The curvature at the point has a negative sign and a relatively small magnitude when compared to the magnitude of curvature shown in FIG. 3F. [Figure 3F] 3E shows a schematic diagram of a cross section through a structure at a point. The outward normal at the point is shown. The curvature at the point has a negative sign and a relatively large magnitude when compared to the magnitude of curvature shown in FIG. 3F. [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] Shown is a cushion for a mask. The exterior surface of the cushion is shown. The edge of the surface is shown. The path on the surface between points A and B is shown. The straight line distance between points A and B is shown. Two saddle regions and a dome region are shown. [Figure 3I] 1 illustrates the surface of a structure with a one-dimensional hole within the surface. The illustrated planar curve forms the boundary of the one-dimensional hole. [Figure 3J] A cross section is shown through the structure of Figure 3I. The illustrated surfaces bound a two-dimensional hole within the structure of Figure 3I. [Figure 3K] 3I includes a perspective view of the structure of FIG. 3I that includes a two-dimensional hole and a one-dimensional hole, and also shows a surface that bounds the two-dimensional hole in the structure of FIG. [Figure 3L] 1 shows a mask having an inflatable bladder as a cushion. [Figure 3M] 3D illustrates a cross section through the mask of FIG. 3L showing the interior surface of the bladder, which bounds a two-dimensional hole in the mask. [Figure 3N] 3D shows a further cross section through the mask of FIG. 3L, with the inner surface also shown. [Figure 3O] Illustrates the left-hand rule. [Figure 3P] Illustrates the right-hand rule. [Figure 3Q] 1 shows the left ear including the left ear helix. [Figure 3R] 1 shows the right ear including the right ear helix. [Figure 3S] Shows a right-handed spiral. [Figure 3T] 1 shows a diagram of a mask including the sign of twist of the space curve defined by the edges of the sealing membrane in different regions of the mask. [Figure 3U] A view of the plenum chamber 3200 showing the sagittal and medial contact surfaces is shown. [Figure 3V]FIG. 3U shows a rear view of the plenum chamber. The view is perpendicular to the mid-contact plane. FIG. 3V shows a sagittal plane that bisects the plenum chamber into a left and right side. [Figure 3W] A cross section through the plenum chamber of FIG. 3V is shown, with the cross section taken in the sagittal plane shown in FIG. 3V. The "mid-contact" plane is shown. The mid-contact plane is perpendicular to the sagittal plane. The orientation of the mid-contact plane corresponds to the orientation of the chord 3201, which is on the sagittal plane and touches the cushion of the plenum chamber at two points on the sagittal plane (upper point 3221 and lower point 3230). Depending on the geometry of the cushion in this region, the mid-contact plane may be tangent at both the upper and lower points. [Figure 3X] The plenum chamber 3200 of FIG. 3U is shown in position for use 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 position for use. The intermediate contact surface generally corresponds to the "face of the face" when the plenum chamber is in position for use. In FIG. 3X, the plenum chamber 3200 is the plenum chamber of a nasal mask, with the upper point 3221 being approximately on the cerion, while the lower point 3230 is on the uvaccibil. [Figure 3Y] 1 shows a patient interface in the form of a nasal cannula in accordance with one form of the present technology. [Figure 3Z]

[0036] Figure 1 illustrates a patient interface with conduit headgear in accordance with one form of the present technology. [4.4 RPT Device] [Figure 4A] 1 shows an RPT device in accordance with one form of the present technology. [Figure 4B] FIG. 4 is a schematic diagram of the air pressure path of an RPT device in accordance with one form of the present technology. Upstream and downstream directions are shown relative to the blower and patient interface. Regardless of the actual flow direction at any particular moment, the blower is defined as being upstream of the patient interface, and the patient interface is defined as being downstream of the blower. Items located in the air pressure path between the blower and the patient interface are downstream of the blower, and upstream of the patient interface. [4.5 Humidifier] [Figure 5A] FIG. 1 shows an isometric view of a humidifier in accordance with one form of the present technology. [Figure 5B] 4.6 Respiratory Waveforms [Figure 6A] A model of a typical breathing waveform for a sleeping person is shown. [4.7 Further drawings of patient interfaces according to examples of the present technology] [Figure 7] FIG. 13 is a perspective view of a patient interface according to an example of the present technology. [Figure 8] FIG. 8 is a front top view of the patient interface shown in FIG. [Figure 9] FIG. 8 is a rear top view of the patient interface shown in FIG. [Figure 10] FIG. 8 is a front view of the patient interface shown in FIG. [Figure 11] FIG. 8 is a rear view of the patient interface shown in FIG. [Figure 12] 8 illustrates the patient interface shown in FIG. 7 when worn by a patient prior to pressurizing the plenum chamber of the patient interface. [Figure 13] 8 illustrates the patient interface shown in FIG. 7 when worn by a patient and when the plenum chamber is pressurized. [Figure 14] FIG. 13 shows a top view of a patient interface according to another example of the present technology. [Figure 15] FIG. 15 illustrates a rear top view of the patient interface shown in FIG. [Figure 16] FIG. 15 illustrates a front top view of the patient interface shown in FIG. [Figure 17] 15 illustrates the patient interface shown in FIG. 14 when worn by a patient and when the plenum chamber is pressurized. [Figure 18] FIG. 13 shows a rear perspective view of a patient interface according to another example of the present technology. [Figure 19] FIG. 19 illustrates a front perspective view of the patient interface shown in FIG. [Figure 20]FIG. 19 illustrates a top, front perspective view of the patient interface shown in FIG. [Figure 21] FIG. 13 shows a front and top perspective view of a patient interface according to another example of the present technology. [Figure 22] FIG. 22 illustrates a rear top perspective view of the patient interface shown in FIG. [Figure 23] 22 illustrates an exploded view of the patient interface shown in FIG. 21. [Figure 24] 22 illustrates another exploded view of the patient interface shown in FIG. 21. [Diagram 25] FIG. 13 is a front and top perspective view of a patient interface according to another example of the present technology. [Figure 26] FIG. 26 is a rear perspective view of the patient interface shown in FIG. 25. [Figure 27] FIG. 26 is a front perspective view of the patient interface shown in FIG. 25 being used on a patient. [Figure 28] FIG. 26 is a front, top, perspective view of the patient interface shown in FIG. 25 being used on a patient. [Figure 29] FIG. 26 is a top perspective view of the patient interface shown in FIG. 25 being used on a patient. [Diagram 30] FIG. 26 is a rear, underside, perspective view of the patient interface shown in FIG. 25. [Diagram 31] FIG. 26 is a rear perspective view of the patient interface shown in FIG. 25 with a membrane portion removed. [Diagram 32] FIG. 26 is a rear side perspective view of the patient interface shown in FIG. 25 with a membrane portion removed. [Diagram 33] FIG. 13 is a front and top perspective view of a patient interface according to another example of the present technology. [Diagram 34] FIG. 34 is a rear perspective view of the patient interface shown in FIG. 33. [Diagram 35] FIG. 34 is a front perspective view of the patient interface shown in FIG. [Diagram 36] FIG. 34 is a front, top, perspective view of the patient interface shown in FIG. 33 being used on a patient. [Figure 37]FIG. 34 is a front side perspective view of the patient interface shown in FIG. 33 being used on a patient. [Figure 38] FIG. 13 is a side perspective view of a patient interface according to another example of the present technology being used on a patient. [Figure 39] FIG. 13 is a front-side perspective view of a patient interface according to another example of the present technology being used on a patient. [Diagram 40] FIG. 13 is a front-side perspective view of a patient interface according to another example of the present technology. [Diagram 41] FIG. 41 is a front side perspective view of the cushion module of the patient interface shown in FIG. 40. [Diagram 42] FIG. 41 is a top perspective view of the cushion module of the patient interface shown in FIG. [Diagram 43] FIG. 41 is a rear top perspective view of the cushion module of the patient interface shown in FIG. [Diagram 44] FIG. 41 is a front side perspective view of the cushion module of the patient interface shown in FIG. 40. [Diagram 45] FIG. 41 is a top perspective view of the cushion module of the patient interface shown in FIG. [Diagram 46] FIG. 41 is a side perspective view of the patient interface shown in FIG. 40 being used on a patient. [Figure 47]

[0033] FIG. 1 shows a front perspective view of a patient interface in accordance with one form of the present technology. [Figure 48]

[0033] Fig. 13 shows a front perspective view of a patient interface in accordance with another form of the present technology. [Figure 49] FIG. 9 shows a rear view of the patient interface of FIG. [Figure 50] 1 shows a blank for a frame of a patient interface in accordance with one form of the present technology. [Figure 51] 51 shows the blank of FIG. 50 folded and joined to form a frame. [Figure 52] 13 shows a foam undercushion of a patient interface prior to attachment to a frame in accordance with one form of the present technology. [Figure 53]FIG. 49 illustrates a rear perspective view of the patient interface of FIG. 48 with the textile membrane removed to reveal the undercushion. [Figure 54] 1 shows one form of textile membrane. [Figure 55] FIG. 49 illustrates a bottom view of the patient interface of FIG. [Figure 56]

[0033] FIG. 1 shows a perspective view of a patient interface in accordance with one form of the present technology. [Figure 57] FIG. 1 is a schematic perspective view of a frame in accordance with one form of the present technology; [Figure 58] FIG. 58 is a front view of the patient interface of FIG. [Figure 59] FIG. 58 is a rear view of the patient interface of FIG. [Figure 60] FIG. 58 is a rear view of the patient interface of FIG. 57 bent into a narrow configuration. [Figure 61] 1 is a schematic partial cross-section through plane BB. [Figure 62] FIG. 13 is a schematic perspective view of an engagement portion and frame of an undercushion in accordance with one form of the present technology. [Figure 63] FIG. 63 is an enlarged partial view of the engagement portion and frame of the undercushion of FIG. 62. [Figure 64] FIG. 13 is a close up view of a connection between an engagement portion of an undercushion and a frame in accordance with one form of the present technology. [Figure 65] FIG. 13 is a close up view of a connection between an engagement portion of an undercushion and a frame in accordance with one form of the present technology. [Figure 66] FIG. 2 is a schematic cross-sectional view through the plane AA. [Figure 67] FIG. 8 is a rear perspective view of the patient interface of FIG. [Figure 68] FIG. 13 is a front view of a foam undercushion in accordance with one form of the present technology. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0179] [5 Detailed description of examples of 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 only the specific examples discussed herein, and is not intended to be limiting.

[0180] The following description is provided in conjunction 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 the examples may constitute an additional example.

[0181] 5.1 Therapy In one form, the present technology includes a method of treating a respiratory disorder comprising applying positive pressure to an entrance to the airways of a patient 1000.

[0182] 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 of the nostrils.

[0183] In certain instances of the present technology, mouth breathing is restricted, limited or prevented.

[0184] [5.2 Respiratory Therapy Systems] In one form, the present technology includes a respiratory therapy system for the treatment of respiratory disorders. The respiratory therapy system may include an RPT device 4000 that delivers an air flow to a patient 1000 via an air circuit 4170 and a patient interface 3000 or 3800.

[0185] [5.3 Patient Interface] According to one embodiment of the present technology, the non-invasive patient interface 3000 as shown in FIG. 3A includes the following functional aspects: a seal-forming structure 3100, a plenum chamber 3200, a positioning and stabilizing structure 3300, a vent 3400, a form of connection port 3600 for connection to an air circuit 4170, and a forehead support 3700. In some forms, the functional aspects may be provided by one or more physical components. In some forms, one physical component may provide one or more functional aspects. In use, the seal-forming structure 3100 is positioned to surround an entrance to the patient's 1000 airway so as to maintain positive pressure at the entrance(s) to the patient's airway. Thus, the sealed patient interface 3000 is suitable for delivery of positive pressure therapy.

[0186] As shown in Fig. 3Z, a non-invasive patient interface 3000 according to another aspect of the present technology includes the following functional aspects: a seal-forming structure 3100, a plenum chamber 3200, a positioning and stabilizing structure 3300, a vent 3400, and a form of connection port 3600 for connection to an air circuit (e.g., air circuit 4170 shown in Figs. 1A-1C). The plenum chamber 3200 may be formed of one or more modular components in the sense that one or more modular components may be replaced with different components (e.g., different sized components).

[0187] 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.

[0188] 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.

[0189] 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.

[0190] 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.

[0191] [5.3.1 Seal formation structure] The patient interface 3000 may include a seal-forming structure 3100. The seal-forming structure 3100 may be constructed and arranged to form a seal with an area of ​​the patient's face surrounding an entrance to the patient's airways. Additionally, the seal-forming structure 3100 may have holes therein such that, in use, airflow at the therapeutic pressure is delivered to at least the entrance to the patient's nares. The seal-forming structure 3100 may be constructed and arranged to maintain a therapeutic pressure within the plenum chamber 3200 throughout the patient's respiratory cycle in use.

[0192] 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 on the seal-forming structure 3100 where a seal may occur. The area where a seal actually occurs (i.e., the actual sealing surface) may vary from patient to patient from day to day within a given treatment session depending on a variety of factors, including, for example, the placement location of the patient interface on the face, tension in the positioning and stabilizing structure, and the shape of the patient's face.

[0193] In one form, the target seal-forming area is located on an outer surface of the seal-forming structure 3100 .

[0194] In certain forms of the present technology, the seal-forming structure 3100 is constructed from a biocompatible material (e.g., silicone rubber.) In other forms, the seal-forming structure 3100 includes a foam undercushion 3110 and a textile membrane portion 3220, as described further below.

[0195] A seal-forming structure 3100 according to the present technology may be constructed from a soft, flexible and resilient material, such as silicone.

[0196] In certain forms of the present technology, systems are provided that include more than one seal-forming structure 3100, each configured to accommodate a range of different sizes and / or shapes. For example, a system may include one form of seal-forming structure 3100 suitable for large head sizes but not small head sizes, and another suitable for small head sizes but not large head sizes. However, examples of the present technology may be suitable for a wide range of heads and may therefore be used by patients with relatively large and relatively small heads.

[0197] [5.3.1.1 Sealing mechanism] In one form, the seal-forming structure includes a sealing flange that utilizes a pressure assisted sealing mechanism. In use, the sealing flange can readily respond to a system positive pressure inside the plenum chamber 3200 (acting on its bottom surface) to urge it into tight sealing engagement with the face. The pressure assisted mechanism can work in conjunction with elastic tension in the positioning and stabilizing structure.

[0198] 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 periphery 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 periphery of the plenum chamber 3200 and extends at least partially around the periphery. The support flange is or includes a spring-like element that functions to support the sealing flange against buckling in use.

[0199] In one form, the seal-forming structure may include a compressive sealing portion or a gasket sealing portion that is constructed and arranged to be in a compressed state in use, for example due to elastic tension in the positioning and stabilizing structure.

[0200] In one form the seal-forming structure includes a tension portion which, in use, is held in tension, for example by an adjacent region of the sealing flange.

[0201] In one form the seal-forming structure includes a region having a sticky or adhesive surface.

[0202] In certain forms of the present technology, the seal-forming structure may include one or more of a pressure assisted sealing flange, a compression sealing portion, a gasket sealing portion, a tension portion, and a portion having a sticky or adhesive surface.

[0203] [5.3.1.2 Nasal bridge or nasal ridge area] In one form, the non-invasive patient interface 3000 includes a seal-forming structure which, in use, forms a seal on the nasal bridge or nasal ridge region of the patient's face.

[0204] In one form, the seal-forming structure includes a saddle region constructed to form a seal over the nasal bridge or nasal ridge region of the patient's face in use.

[0205] [5.3.1.3 Upper lip area] In one form, the non-invasive patient interface 3000 includes a seal-forming structure which, in use, forms a seal over the upper lip area (ie, the upper lip) of the patient's face.

[0206] In one form, the seal-forming structure includes a saddle region constructed to form a seal over the upper lip region of the patient's face in use.

[0207] [5.3.1.4 Chin area] In one form, the non-invasive patient interface 3000 includes a seal-forming structure which, in use, forms a seal on the chin area of ​​the patient's face.

[0208] In one form, the seal-forming structure includes a saddle region constructed to form a seal over the chin region of the patient's face in use.

[0209] [5.3.1.5 Forehead area] In one form, the seal-forming structure forms a seal on the forehead area of ​​the patient's face in use, hi such a form, the plenum chamber may cover the eyes in use.

[0210] [5.3.1.6 Nasal pillow] In one form, the seal-forming structure of the non-invasive patient interface 3000 includes a pair of nasal puffs or nasal pillows, each constructed and arranged to form a seal with a respective nostril of the patient's nose.

[0211] A nasal pillow according to one aspect of the present technology includes a frustum (at least a portion of which forms a seal on the bottom surface of the patient's nose), a stalk, and a flexible region (which is on the bottom surface of the frustum and connects the frustum to the stalk). In addition, the structure to which the nasal pillow of the present technology is connected includes a flexible region adjacent the base of the stalk. The flexible regions may cooperate to facilitate a universal joint structure that accommodates relative movement (both translational and angular movement) between the frustum and the structure to which the nasal pillow is connected. For example, the frustum may be displaced axially toward the structure to which the stalk is connected.

[0212] In one example of nasal pillows, at least a portion of the frustum of each nasal pillow can be shaped and dimensioned to fit into a corresponding nostril of the patient. In another example of nasal pillows, the frustum of each nasal pillow can be shaped and dimensioned to not fit into a corresponding nostril of the patient. Each nasal pillow can be configured to seal against a portion of the patient's nose that defines each nostril, including the bridge of the patient's nose and each ala of the patient's nose.

[0213] In some examples of the nasal pillows, each nasal pillow may be devoid of a stalk. The frustum of each nasal pillow may be attached directly to the portion of the patient interface 3000 that defines the plenum chamber 3200.

[0214] [5.3.1.7 Nasal mask] In one form, the non-invasive patient interface 3000 includes a seal-forming structure 3100 that, in use, forms a seal up to the upper lip area (e.g., nasal tip), up to at least a portion of the patient's nasal bridge or nasal ridge above the nasal tip, and up to the patient's face on each side of the patient's nose, for example adjacent the patient's nasolabial folds. The patient interface 3000 shown in FIG. 1B has this type of seal-forming structure 3100. This patient interface 3000 may deliver a supply of air or breathable gas through a single orifice to both nares of the patient 1000. This type of seal-forming structure 3100 may be referred to as a "nasal cushion" and a patient interface 3000 having such a seal-forming structure 3100 may be identified as a "nasal mask."

[0215] [5.3.1.8 Full face mask] In one form, the patient interface 3000 includes a seal-forming structure 3100 that, in use, forms a seal over the patient's chin area (which may include the patient's lower lip and / or the area just below the lower lip), up to at least a portion of the patient's bridge of the nose, or nasal ridge above the nasal tip, and up to the cheek area of ​​the patient's face. The patient interface 3000 shown in FIG. 1C is of this type. This patient interface 3000 may deliver a supply of air or breathable gas through a single orifice to both nostrils and the mouth of the patient 1000. This type of seal-forming structure 3100 may be referred to as a "full face cushion" and the patient interface 3000 may be identified as a "full face mask."

[0216] [5.3.1.9 Ultra-compact full-face mask] In one form, the patient interface 3000 includes a seal-forming structure 3100 that, in use, forms a seal over the patient's chin area (which may include the patient's lower lip and / or the area immediately below the lower lip), down to the lower and / or anterior surface of the patient's nasal tip, and up to the patient's face on each side of the patient's nose, for example proximate the nasolabial folds. The seal-forming structure 3100 may also form a seal against the patient's upper lip. A patient interface 3000 with this type of seal-forming structure may have a single opening configured to deliver airflow or breathable gas to both nostrils and the mouth of the patient, may have an oral hole configured to provide air or breathable gas to the mouth and a nostril configured to provide air or breathable gas to the nostrils, or may have an oral hole for delivering air to the patient's mouth and two nostrils for delivering air to each nostril. This type of patient interface 3000 may be known as a miniature full face mask and may include a miniature full face cushion.

[0217] [5.3.1.10 Nasal cradle mask] In one form, as shown, for example, in FIG. 3Z, the seal-forming structure 3100 is configured to form a seal with the lower surface of the nose around the nostrils in use. The seal-forming structure 3100 may be configured to seal around the patient's nostrils at the lower periphery of the patient's nose, including up to the lower and / or anterior surface of the patient's nasal tip and up to the patient's ala. The seal-forming structure 3100 may seal against the patient's nasal cavity. This type of seal-forming structure 3100 may be referred to, for example, as a "cradle cushion," "nasal cradle cushion," or "under-nose cushion."

[0218] The shape of the seal-forming structure 3100 may be configured to conform or closely follow the bottom surface of the patient's nose and may not contact the bridge area of ​​the patient's nose or any portion of the patient's nose above the tip of the nose. In one form of a nasal cradle cushion, the seal-forming structure 3100 includes a bridge portion that divides the opening into two orifices (each providing air or breathable gas to each of the patient's nares in use). The bridge portion may be configured to contact or seal against the bridge of the patient's nose in use. Alternatively, the seal-forming structure 3100 may include a single opening to provide airflow or breathable gas to both of the patient's nares.

[0219] [5.3.2 Plenum chamber] The plenum chamber 3200 may be formed by a portion of the patient interface 3000 having a periphery shaped to be complementary to the surface contours of an average human face in the area where a seal is formed in use. In use, the periphery of the portion of the patient interface 3000 that forms 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 about the entire periphery of the portion of the patient interface 3000 that forms 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.

[0220] In some forms of the present technology, the plenum chamber 3200 does not cover the patient's eyes when in use. In other words, the eyes are outside of the pressurized volume defined by the plenum chamber. Such forms tend to be relatively unobtrusive and / or more comfortable for the wearer, which may improve compliance with the therapy.

[0221] In certain forms of the present technology, the plenum chamber 3200 is formed by one or more components constructed from a transparent material, such as clear polycarbonate. The use of a transparent material can help the patient interface to be unobtrusive and improve compliance with therapy. The use of a transparent material can help the clinician observe how the patient interface is positioned and functioning.

[0222] In certain forms of the present technology, the plenum chamber 3200 is formed by one or more components constructed from a translucent material. The use of a translucent material can help make the patient interface less obtrusive and improve compliance with therapy.

[0223] [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 in use by the positioning and stabilising structure 3300. The positioning and stabilising structure 3300 may function as or include "headgear" as it engages the patient's head to hold the patient interface 3000 in the sealed position.

[0224] In one form, the positioning and stabilizing structure 3300 provides at least sufficient retention to overcome the effects of the positive pressure in the plenum chamber 3200 and lift off the face.

[0225] In one form, the positioning and stabilising structure 3300 provides a holding force to overcome the effects of gravity on the patient interface 3000.

[0226] In one form, the positioning and stabilising structure 3300 provides a retaining force as a safety margin to overcome the potential effects of destructive forces on the patient interface 3000 (e.g. due to tube traction or inadvertent interference with the patient interface).

[0227] In one form of the present technology, a positioning and stabilizing structure 3300 is provided that is configured to blend in with what a patient wears 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 with a rectangular cross-section. In one example, the positioning and stabilizing structure 3300 includes at least one flat strap.

[0228] In one form of the present technology, a positioning and stabilizing structure 3300 is provided that is configured to be not too large or bulky to prevent the patient from lying in a supine sleep position with the posterior region of the patient's head resting on a pillow.

[0229] In one form of the present technology, a positioning and stabilizing structure 3300 is provided that is configured to be not too large or bulky to prevent the patient from lying in a lateral sleep position with the side region of the patient's head resting on a pillow.

[0230] In one form of the present technology, the positioning and stabilizing structure 3300 comprises a decoupling portion located between a front portion of the positioning and stabilizing structure 3300 and a rear portion of the positioning and stabilizing structure 3300. The decoupling portion does not resist compression and can be, for example, a flexible or flimsy strap. The decoupling portion is constructed and arranged such that when a patient lies with their head on a pillow, the presence of the decoupling portion prevents forces to the rear portion from being transmitted along the positioning and stabilizing structure 3300 and disrupting the seal.

[0231] In one form of the present technology, the positioning and stabilizing structure 3300 includes a strap constructed from 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 a loop material that engages with a hook material portion.

[0232] In certain forms of the present technology, the positioning and stabilizing structure 3300 includes a stretchable (e.g., elastically stretchable) strap. For example, the strap may be configured to be tensioned in use and direct a force that draws the seal-forming structure into a seal with a portion of the patient's face. In one example, the strap may be configured as a tie.

[0233] In one form of the present technology, the positioning and stabilizing structure includes a first tie that is constructed and arranged such that, in use, at least a portion of its lower edge passes above the superior auti-basal point of the patient's head and rests on a portion of the parietal bone without resting on the occipital bone.

[0234] In one form of the technology, suitable for a nasal only or full face mask, the positioning and stabilizing structure includes a second tie that is constructed and arranged such that, in use, at least a portion of its upper edge passes below the inferior ear point of the patient's head and rests below or on the occipital bone of the patient's head.

[0235] 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 to reduce the tendency of the first tie and the second tie to move away from each other.

[0236] In certain forms of the present technology, the positioning and stabilizing structure 3300 includes straps that are bendable (e.g., non-rigid). The advantage of this embodiment is that the patient feels more comfort from the straps when lying down to sleep.

[0237] In certain forms of the present technology, the positioning and stabilizing structure 3300 includes straps that are constructed to be breathable, allowing moisture vapor to pass through.

[0238] In certain forms of the present technology, a system is provided that includes more than one positioning and stabilizing structure 3300, each 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 suitable for large sized heads but not small sized heads, and another suitable for small sized heads but not large sized heads.

[0239] [5.3.3.1 Conduit Headgear] [5.3.3.1.1 Conduit Headgear Tubes] In some forms of the present technology, the positioning and stabilizing structure 3300 includes one or more headgear tubes 3350 that deliver pressurized air received from a conduit forming part of the air circuit 4170 from the RPT device, for example through the plenum chamber 3200 and the seal-forming structure 3100 to the patient's airway. In the form of the present technology illustrated in FIG. 3Z, the positioning and stabilizing structure 3300 includes two tubes 3350 that deliver air from the air circuit 4170 to the plenum chamber 3200. The tubes 3350 are configured to position and stabilize the seal-forming structure 3100 of the patient interface 3000 at an appropriate portion of the patient's face (e.g., nose and / or mouth). Thus, the conduit of the air circuit 4170 providing the pressurized air flow may connect to the connection port 3600 of the patient interface at a location other than the front of the patient's face, for example at the top of the patient's head. The patient interface 3000 shown in FIGS. 7-13 also includes a gas delivery tube 3350 that forms a conduit headgear.

[0240] The positioning and stabilizing structure 3300 may be described as inflatable because air may be contained in and passed through the headgear tubing to deliver pressurized air from the air circuit 4170 to the patient's airway. It is understood that an inflatable positioning and stabilizing structure 3300 does not require that all components of the positioning and stabilizing structure 3300 be inflatable. For example, in the example shown in FIG. 3Z, the positioning and stabilizing structure 3300 includes an inflatable tube 3350 and a non-inflatable strap portion 3310.

[0241] In the form of the technology illustrated in Figure 3Z, the positioning and stabilizing structure 3300 includes two tubes 3350, each positioned on a different side of the patient's head in use, extending across each cheek area and over each ear (above the upper ear base point on the patient's head) to an elbow 3612 at the top of the patient's 1000 head. This form of technology may be advantageous because if the patient sleeps with their head turned to the side and one of the tubes is compressed blocking or partially blocking gas flow along the tube, the other tube remains open to provide pressurized gas to the patient. In other examples of the technology, the patient interface 3000 may include a different number of tubes, for example one tube or three or more tubes. In one example where the patient interface has one tube 3350, the single tube 3350 is positioned on one side of the patient's head (e.g. across one cheek area) in use and a strap forms part of the positioning and stabilising structure 3300 and is positioned on the other side of the patient's head (e.g. across the other area) in use to assist in securing the patient interface 3000 to the patient's head.

[0242] In the form of the technology shown in Fig. 3Z, two tubes 3350 are fluidly connected to each other at their upper ends and to a connection port 3600. In some instances, the two tubes 3350 are integrally formed, while in other instances, the tubes 3350 are formed separately but may be connected during use and disconnected, for example for cleaning or storage. If separate tubes are used, they may be indirectly connected to each other, for example each may be connected to a T-shaped connector having two arms / branches each fluidly connectable to a respective tube 3350, and a third arm or opening which provides a connection port 3600 for fluid connection to the air circuit 4170 during use.

[0243] The tube 3350 may be formed from a flexible material such as an elastomer, e.g., silicone or TPE, or from one or more textile and / or foam materials. The tube 3350 may have a preformed shape and may be bent or reshaped into another shape upon application of force, but may return to its original preformed shape in the absence of said force. The tube 3350 may generally be an arcuate or curved shape that approximates the contour of the patient's head between the top of the head and the nasal or oral region.

[0244] As described in U.S. Patent No. 5,399,993, the contents of which are incorporated herein, the tubes 3350 may be crush resistant so that if any tube is crushed during use, for example between the patient's head and the pillow, the flow of breathable gas through the tubes is not blocked. Crush resistant tubes are not necessary in all cases, as the pressurized gas in the tubes may act as a splint to prevent or at least limit the collapse of the tubes 3350 during use. Crush resistant tubes may be advantageous when only a single tube 3350 is present, such as when a single tube is blocked during use, restricting gas flow and causing therapy to cease or reduce effectiveness. In some instances, the tubes 3350 may be sized such that each tube 3350 alone can provide sufficient gas flow to the plenum chamber 3200 if one of the tubes 3350 is blocked.

[0245] Each tube 3350 may be configured to receive airflow from a connection port 3600 at the top of the patient's head and deliver airflow to the seal-forming structure 3100 at the entrance to the patient's airway. In the example shown in FIG. 3Z, in use, each tube 3350 is on a path that extends from the plenum chamber 3200 across the patient's cheek region to an elbow 3612 above the patient's ear. For example, a portion of each tube 3350 proximate the plenum chamber 3200 may overlie the maxillary region of the patient's head in use. Another portion of each tube 3350 may overlie the region of the patient's head above the superior auricular point of the patient's head. Each tube 3350 may also overlie the patient's sphenoid and / or temporal bones, and one or both of the patient's frontal and parietal bones. The elbow 3612 may be located above the patient's parietal bone, above the frontal bone, and / or above the junction therebetween (e.g., the coronal suture) in use.

[0246] In certain forms of the present technology, the patient interface 3000 is configured such that the connection port 3600 may be positioned within a range of positions across the top of the patient's head, such that the patient interface 3000 may be positioned accordingly depending on the comfort or fit of an individual patient. In some examples, the headgear tubes 3350 are configured to allow movement of an upper portion of the patient interface 3000 (e.g., the connection port 3600) relative to a lower portion of the patient interface 3000 (e.g., the plenum chamber 3200). That is, the connection port 3600 may be at least partially decoupled from the plenum chamber 3200. In this manner, the seal-forming structure 3100 may form an effective seal with the patient's face regardless of the position of the connection port 3600 on the patient's head (at least within a range of positions).

[0247] As mentioned above, in some examples of the present technology, the patient interface 3000 includes a seal-forming structure 3100 in the form of a cradle cushion that is generally under the nose and seals against the lower periphery of the nose (e.g., an under-nose cushion). The positioning and stabilizing structure 3300 including the tube 3350 may be constructed and arranged to pull the seal-forming structure 3100 under the nose and into the patient's face with a sealing force vector in a posterior-lateral and superior direction (e.g., a posterior-superior direction). The posterior-superior sealing force vector may encourage the seal-forming structure 3100 to form a good seal against both the lower periphery of the patient's nose and the anterior-facing surface of the patient's face, on both sides of the patient's nose and the patient's labium.

[0248] 5.3.3.1.2 Expandable and non-expandable tube segments In some examples of the present technology, one or both of the tubes 3350 are not extensible in length. However, in some forms, the tube 3350 may include one or more extensible tube sections, for example formed by an extensible bellows structure. In some forms, the patient interface 3000 may include a positioning and stabilizing structure 3300 that includes at least one gas delivery tube that includes a tube wall having an extensible bellows structure. The patient interface 3000 shown in FIG. 3Z includes a tube 3350, the upper portion of which includes extensible tube sections each taking the form of an extensible bellows structure 3362.

[0249] The cross-sectional shape of the non-extensible tube section 3363 of the tube 3350 may be circular, oval, oval, D-shaped, or rectangular with rounded corners, for example as described in U.S. Patent No. 5,399,633. Cross-sectional shapes that present a flat surface of the tube on the side that faces and contacts other parts of the patient's face or head may be more comfortable to wear than a tube having, for example, a circular cross-section.

[0250] In some examples of the present technology, the non-extensible tube section 3363 connects to the plenum chamber 3200 at a low angle. The headgear tube 3350 may extend down the side of the patient's head, then curve forward and inward to connect to the plenum chamber 3200 in front of the patient's face. The tube 3350 may extend to the same vertical location as its connection to the plenum chamber 3200, or in some examples, to a lower location than its connection, before connecting to the plenum chamber 3200. That is, the tube 3350 may protrude at least partially upward before connecting to the plenum chamber 3200. A portion of the tube 3350 may be located below the cushion module 3150 and / or the seal-forming structure 3100. The low location of the tube 3350 in front of the patient's face promotes contact with the patient's face below the patient's cheekbone, which may be more comfortable than contact at the patient's cheekbone and may prevent excessive obstruction of the patient's peripheral vision.

[0251] [5.3.3.1.3 Conduit Headgear Connection Ports] In certain forms of the present technology, the patient interface 3000 may include a connection port 3600 located proximal to an upper, lateral, or posterior portion of the patient's head. For example, in the form of the present technology illustrated in FIG. 3Z, the connection port 3600 is located at the top of the patient's head (e.g., at an upper position relative to the patient's head). In this example, the patient interface 3000 includes an elbow 3612 that forms the connection port 3600. The elbow 3612 may be configured to fluidly connect with a conduit of the air circuit 4170. The elbow 3612 may be configured to pivot relative to the positioning and stabilizing structure 3300 to at least partially decouple the conduit from the positioning and stabilizing structure 3300. In some examples, the elbow 3612 may be configured to pivot by rotating about a substantially vertical axis, and in some particular examples by rotating about two or more axes. In some examples, the elbow may include a tube 3350 or be connected to it by a ball joint. The connection port 3600 may be located in the sagittal plane of the patient's head when in use.

[0252] A patient interface having a connection port that is not positioned in front of the patient's face may be advantageous because some patients may find a conduit that connects to a patient interface in front of their face unsightly and / or unsightly. For example, a conduit that connects to a patient interface in front of the patient's face may tend to interfere with bedding or bed linens, especially if the conduit extends downward from the patient interface when in use. Forms of the present technology that include a patient interface having a connection port that is positioned above the patient's head when in use may make it easier or more comfortable for a patient to lie or sleep in one or more of the following positions: lateral sleep position, supine position (e.g., facing up generally), or prone position (e.g., facing down generally). Furthermore, connecting the conduit to a front portion of the patient interface may exacerbate a problem known as tube traction, where the conduit applies an undesirable force to the patient interface during movement of the patient's head or the conduit, thereby causing it to detach from the face. Tube traction may be less of a problem if the force is received at a higher position on the patient's head than at the front of the patient's face, close to the seal-forming structures (where tube traction forces are more likely to disrupt the seal).

[0253] [5.3.3.1.4 Headgear Tube Fluid Connections] The two tubes 3350 are fluidly connected at their lower ends to the plenum chamber 3200. In a particular form of the present technology, the connection between the tubes 3350 and the plenum chamber 3200 is accomplished by the connection of two rigid connectors. The tubes 3350 and the plenum chamber 3200 may be configured to allow the patient to easily connect the two components to each other in a reliable manner. The tubes 3350 and the plenum chamber 3200 may be configured to provide tactile and / or audible feedback in the form of a "reassuring click" or a sound that the patient can easily use to ensure that the patient knows that each tube 3350 is properly connected to the plenum chamber 3200. In one form, the tubes 3350 are formed from a silicone or textile material and the lower end of each of the silicone tubes 3350 is overmolded to a rigid connector made from, for example, polypropylene, polycarbonate, nylon, etc. The rigid connectors on each tube 3350 may include a female mating feature configured to connect with a male mating feature on the plenum chamber 3200. Alternatively, the rigid connectors on each tube 3350 may include a male mating feature configured to connect to a female mating feature on the plenum chamber 3200. In other examples, the tubes 3350 may each include a male or female connector formed from a flexible material such as silicone or TPE, for example, the same material that forms the tube 3350.

[0254] In other examples, compression seals are used to connect each tube 3350 to the plenum chamber 3200. For example, a resiliently flexible (e.g., silicone) tube 3350 without a rigid connector may be configured to be squeezed to reduce its diameter so that it may be compressed into a port in the plenum chamber 3200, and the inherent resilience of the silicone will push the tube 3350 outward to seal the tube 3350 in the port in an airtight manner. Alternatively, in a rigid-to-rigid type of engagement between the tube 3350 and the plenum chamber 3200, each tube 3350 and / or the plenum chamber 3200 may include a pressure actuated seal, such as a peripheral sealing flange. When pressurized gas is supplied through the tube 3350, the sealing flange may be forced against a seam between the tube and a circumferential surface around a port or connector of the plenum chamber 3200 to form or reinforce a seal between the tube 3350 and the plenum chamber 3200.

[0255] [5.3.3.1.5 Conduit Headgear Straps] In certain forms of the present technology, the positioning and stabilizing structure 3300 includes at least one headgear strap that functions to position and stabilize the seal-forming structure 3100 at the entrance to the patient's airway in addition to the tube 3350. As shown in FIG. 3Z, the patient interface 3000 includes a strap portion 3310 that forms part of the positioning and stabilizing structure 3300. The strap portion 3310 may be known as, for example, a back strap or a rear headgear strap. In other examples of the present technology, one or more additional straps may be provided. For example, a patient interface 3000 according to an example of the present technology having a full face cushion may have a second lower strap configured to rest against the patient's head adjacent the patient's neck and / or against a rear surface of the patient's neck.

[0256] In the example shown in FIG. 3Z, a strap portion 3310 of the positioning and stabilizing structure 3300 is positioned on each side of the patient's head and connected between two tubes 3350 that pass around the back of the patient's head (e.g., overlying or below the occipital bone of the patient's head in use). The strap portion 3310 connects to each tube above the patient's ears. With reference to FIG. 3Z, the positioning and stabilizing structure 3300 includes a pair of tabs 3355. In use, the strap portion 3310 may be connected between the tabs 3355. The strap portion 3310 may be sufficiently flexible to pass around the back of the patient's head and rest comfortably against the patient's head even when under tension in use.

[0257] [5.3.4 Ventilation] In one form, the patient interface 3000 includes a vent 3400 constructed and arranged to allow for the washout of exhaled gases, for example carbon dioxide.

[0258] In certain forms, the vent 3400 is configured to allow continuous ventilation flow from the interior of the plenum chamber 3200 to the surroundings while the pressure in the plenum chamber is positive relative to the surroundings. The vent 3400 is configured such that the ventilation flow rate is large enough to reduce rebreathing of exhaled CO2 by the patient while maintaining a therapeutic pressure in the plenum chamber in use.

[0259] The ventilation portion 3400 in one embodiment according to the present technology includes a plurality of holes, for example, about 20 to about 80 holes, or about 40 to about 60 holes, or about 45 to about 55 holes.

[0260] The vent 3400 may be located within the plenum chamber 3200. Alternatively, the vent 3400 is located within a decoupling structure, such as a swivel.

[0261] 5.3.5 Cushion Module and Exemplary Patient Interface In the examples of the present technology shown in Figures 7-20 and 25-67, the patient interface 3000 includes a chassis portion 3210 that partially forms a plenum chamber 3200. The chassis portion 3210 and the membrane portion 3220 together (as shown below) may form the plenum chamber 3200 by enclosing a volume of space that may be filled with air at a therapeutic pressure, such as at least 4 cmH2O or at least 6 cmH2O above ambient air pressure. In some examples, the seal-forming structure 3100 may also partially form the plenum chamber 3200, depending on the type and / or shape of the seal-forming structure 3100.

[0262] The components forming the seal-forming structure 3100 and the plenum chamber 3200 form the cushion module 3150 of the patient interface 3000 in the examples shown in Figures 7-20 and 25-67. In the examples shown in Figures 7-13, Figures 7-11 show the cushion module 3150 alone and Figures 12-13 show it connected to a headgear tube 3350. In these examples, the cushion module 3150 is separable from other components of the patient interface 3000, such as the positioning and stabilizing structure 3300. The cushion module 3150 may be separable from the headgear tube 3350 of the positioning and stabilizing structure 3300. Thus, in some examples of the present technology, the patient interface 3000 includes a removable cushion module 3150.

[0263] In some examples, the cushion module 3150 may be replaced in the patient interface 3000 with another cushion module 3150, for example one of a different size (or at least one having a seal-forming structure 3100 with a different size or shape).

[0264] In other examples, the cushion module 3150 may not be separate from other components or portions of the patient interface 3000, such as the positioning and stabilizing structure 3300. In some examples, the cushion module 3150 may include a chassis portion 3210, at least a portion of which is integrally formed with one or both of the headgear tubes 3350 or is integrally formed with a portion of the positioning and stabilizing structure. It should be understood that the features of the patient interface 3000 disclosed herein are applicable regardless of whether the chassis portion 3210 is part of the removable cushion module 3150, unless the context clearly requires otherwise.

[0265] The plenum chamber 3200 may include one or more plenum chamber inlet ports that are sized and configured to receive an air flow at a therapeutic pressure for breathing by the patient.

[0266] In the example shown in Figures 7-13, the plenum chamber 3200 of the patient interface 3000 has two plenum chamber inlet ports. In particular, the chassis portion 3210 defines two openings, one on each side of the chassis portion 3210. In the example shown in Figures 14-17, the plenum chamber 3200 includes one plenum chamber inlet port. In particular, the chassis portion 3210 defines an opening at the connection to the stub tube 3610, which forms the plenum chamber inlet port.

[0267] In the example of the present technology shown in Figs. 18-20, the patient interface 3000 includes a chassis portion 3210 and a membrane portion 3220 that form a plenum chamber 3200. In this example, the patient interface 3000 is configured to provide a pressurized air flow to the patient's mouth as well as to the patient's nares. The plenum chamber 3200 is configured to be positioned in front of the patient's mouth in addition to under the patient's nose in use. The plenum chamber 3200 is therefore larger than the plenum chamber 3200 of the patient interface 3000 shown in Figs. 7-13. Therefore, in the example shown in Figs. 18-20, the plenum chamber 3200 is described as having a nasal portion configured to be positioned proximate the user's nose in use and an oral portion configured to be positioned proximate the user's mouth in use. In this example, the chassis portion 3210 forms a majority of the anterior-facing side of the oral portion of the plenum chamber 3200. In some examples, the chassis portion 3210 forms substantially all of the anterior-facing side of the oral portion of the plenum chamber 3200. In some examples, the chassis portion 3210 and the oral portion of the seal-forming structure 3100 form substantially all of the posterior-facing side of the oral portion of the plenum chamber 3200. The components forming the seal-forming structure 3100 and the plenum chamber 3200 form, in this example, the cushion module 3150 of the patient interface 3000. In this example, the cushion module 3150 is separable from other components of the patient interface, such as the positioning and stabilizing structure 3300.

[0268] [5.3.5.1 Nasal and Oral Cushion Modules] In the example of the present technology shown in Figs. 21-24, the patient interface 3000 includes a nasal cushion module 3160 and an oral cushion module 3170 (each forming a part of the plenum chamber 3200 of the patient interface 3000). In this example, the patient interface 3000 is configured to provide a pressurized airflow to the patient's mouth as well as the patient's nares. The nasal cushion module 3160 and the oral cushion module 3170 may be fluidly connected by an oral-nose connector 3165 which may also form part of the plenum chamber 3200. The nasal cushion module 3160 may be described as forming a nasal portion of the plenum chamber 3200 and the oral cushion module 3170 may be described as forming an oral portion of the plenum chamber 3200. The nasal cushion module 3160 may be configured to be positioned under the patient's nose in use and the oral cushion module 3170 may be configured to be positioned in front of the user's mouth in use.

[0269] In the example of Figures 21-24, the nasal cushion module 3160 of the seal-forming structure 3100 may be formed by a nasal chassis portion 3216, a membrane portion 3220, and a nasal portion 3101. In this example, the nasal portion 3101 of the seal-forming structure 3100 includes a nasal pillow, but in other examples, it may include another type of seal, such as, for example, a cradle cushion. The seal-forming structure 3100 in the form of a cradle cushion may be formed, for example, from silicone or TPE. The nasal chassis portion 3216 and the membrane portion 3220 may form the nasal portion of the plenum chamber 3200. The nasal portion 3101 of the seal-forming structure 3100 may be formed from an elastomeric material.

[0270] The oral cushion module 3170 may be formed by the oral chassis portion 3217 and the oral portion 3102 of the seal-forming structure 3100, which together may form the oral portion of the plenum chamber 3200. The oral portion 3102 of the seal-forming structure 3100 may include a sealing flange configured to form a seal around the patient's mouth and to seal against the patient's upper lip, lower lip, and cheeks. The sealing flange is formed from silicone in the example shown in Figures 21-24, but in other examples may be formed from another elastomeric material such as TPE, formed from a foam, or formed from a textile with an airtight membrane, such as a thin layer of silicone or another suitable material. The sealing flange forming the oral portion 3102 of the seal-forming structure 3100 may be integrally formed with the oral chassis portion 3217. The sealing flange may have a thickness, for example, in the range of 0.1 mm to 1 mm, or in the range of 0.2 mm to 0.8 mm, or in the range of 0.25 mm to 0.5 mm. The sealing flange may have a thickness of 0.25 mm in the supination area, which may provide a comfortable and effective seal at the supination of the patient and adaptability to different patient geometries. In some examples, the sealing flange may have a thickness of 0.2 mm.

[0271] The oral cushion module 3170 may include a cavity 3218 (e.g., a recessed portion) that can receive the nasal cushion module 3160. The cavity 3218 may be open toward an upward direction, such that the nasal cushion module 3160 can be positioned above the oral cushion module 3170 in use. The cavity 3218 may include a shape complementary to a portion of the nasal cushion module 3160 such that the nasal cushion module 3160 can fit within the cavity 3218. The cavity 3218 may be defined by the oral chassis portion 3217 and / or the oral portion 3102 of the seal-forming structure 3100. The cavity may be shaped such that when the nasal cushion module 3160 is received within the cavity 3218, the nasal cushion module 3160 and the oral cushion module 3170 are in the correct orientation relative to one another for use of the patient interface 3000.

[0272] The nasal cushion module 3160 of the patient interface 3000 shown in Figures 21-24 shares various features with the cushion module 3150 of the patient interface shown in Figures 7-13, 14-17, and 18-20, including the chassis portion 3210, the outwardly projecting connecting portion 3212, the membrane portion 3220, and the seal-forming structure 3100 or portions thereof. Unless the context requires otherwise, the features of the cushion module 3150 described with reference to the patient interface 3000 shown in Figures 7-13, 14-17, and 18-20 should be understood to be applicable to a nasal cushion module 3160 of the type shown in Figures 21-24. In some examples, the nasal cushion module 3160 of the modular patient interface 3000 (e.g., as shown in Figures 21-24) is substantially identical to the cushion module 3150 shown in Figures 7-13. In some examples, the nasal cushion module 3160 of the modular patient interface 3000 is separable from and may be used independently of the oral cushion module 3170 to leave the patient's mouth uncovered to form a nasal-only patient interface 3000. The vent module 3410 may be provided in place of the oral-nose connector 3165 (shown below).

[0273] Similarly, features of the chassis portion 3210 described with reference to the patient interface 3000 shown in Figures 7-13, 14-17, and 18-20 should be understood to be applicable to a nasal chassis portion 3216 of the type shown in Figures 21-24. Features of the membrane portion 3220 described herein should be understood to be features applicable to the membrane portion of the cushion module 3150 of the type shown in Figures 7-13, 14-17, and 18-20, and the nasal cushion module 3160 of the type shown in Figures 21-24, unless the context clearly requires otherwise.

[0274] [5.3.5.1.1 Oral-nasal connector] The oral-nasal connector 3165 of the patient interface 3000 shown in Figures 21-24 takes the form of a tubular section that fluidly connects the interior of the nasal cushion module 3160 to the interior of the oral cushion module 3170. The tubular section that forms the majority of the oral-nasal connector 3165 may be formed from silicone or TPE, with one or both ends formed from a harder plastic material (e.g., polycarbonate or nylon). In some examples, the tubular section that forms the majority of the oral-nasal connector 3165 may be of the same material as the oral chassis portion 3217 and / or the nasal chassis portion 3216. In the example shown in Figures 21-24, the oral-nasal connector 3165 includes a cross section that is rounded in shape. The cross section may be oval. In some examples, it may be rectangular and have rounded corners. In some examples, the entire oral-nasal connector 3165 may be formed from an elastomer, such as silicone or TPE.

[0275] The oral-nose connector 3165 may be removably attached to one or both of the nasal cushion module 3160 and the oral cushion module 3170, although in some examples it may be permanently connected to one or both of the nasal cushion module 3160 and the oral cushion module 3170. The nasal cushion module 3160 and the oral cushion module 3170 may each include an opening for fluid connection to the oral-nose connector 3165. The opening in the nasal cushion module 3160 may align with the oral-nose connector 3165 when the nasal cushion module 3160 is received in the cavity 3218 in the oral cushion module 3170.

[0276] The oral-nose connector 3165 may be configured to transfer a sealing force vector from the nasal cushion module 3160 to the oral cushion module 3170 (and vice versa) to assist in holding the oral cushion module 3170 in the correct orientation for use of the patient interface 3000. The oral-nose connector 3165 may be configured to correctly orient the nasal cushion module 3160 and the oral cushion module 3170 relative to one another.

[0277] [5.3.5.2 Connection to positioning and stabilising structures] The patient interface 3000 is illustrated in Figures 12-13 (whose cushion module 3150 is illustrated in Figures 7-11), 18-20, and 21-24, each including a positioning and stabilizing structure 3300 including one or more gas delivery tubes 3350 configured to provide airflow at therapeutic pressure to the plenum chamber 3200. In particular, the positioning and stabilizing structure 3300 includes a pair of gas delivery tubes 3350. The gas delivery tubes 3350 function as conduit headgear in these examples. Further description of the gas delivery tubes 3350, conduit headgear, the positioning and stabilizing structure 3300, and features thereof are included elsewhere herein.

[0278] The chassis portion 3210 (or the nasal chassis portion 3216, as the case may be) may include one or more outwardly projecting connecting portions 3212, which may be configured to connect to the gas delivery tube 3350 and sized and configured to receive air flow at therapeutic pressure for breathing by the patient. The outwardly projecting connecting portions 3212 may also partially form the plenum chamber 3200 with the chassis portion 3210 or the nasal chassis portion 3216 (as the case may be) and other portions of the membrane portion 3220. Each of the outwardly projecting connecting portions 3212 may be configured to connect to and receive gas flow from a respective gas delivery tube 3350 and may include an inlet to the interior of the chassis portion 3210. Each outwardly projecting connecting portion 3212 may define a plenum chamber inlet port. The chassis portion 3210 may include a pair of connectors 3214 configured to connect to the gas delivery tube 3350 of the positioning and stabilizing structure 3300.

[0279] As shown in Figures 7-11, connectors 3214 are provided on both exterior sides of the chassis portion 3210, and in particular, in this example, each connector 3214 is provided on a respective connecting portion 3212 that protrudes to the exterior of the chassis portion 3210. In this example, the connectors 3214 are provided at the inlets of the connecting portions 3212 that protrude to the exterior. Figures 12-13 show a gas delivery tube 3350 connected to the connecting portions 3212 that protrude to the exterior. The patient interface 3000 shown in Figures 18-20 also has a chassis portion 3210 that includes a connecting portion 3212 that protrudes to the exterior and that may be connected to a gas delivery tube 3350 via a connector 3214 (hidden within the tube 3350 in Figures 18-20). In the example shown in Figures 21-24, the nasal cushion module 3160 has a nasal chassis portion 3216 that includes a connection portion 3212 that protrudes outward and can be connected to a gas delivery tube 3350 via a connector 3214 (also hidden within the gas delivery tube 3350 in Figures 21-24).

[0280] The angle at which the outwardly protruding connecting portion 3212 advantageously protrudes orients the seal-forming structure 3100 (e.g., in the case of the patient interface 3000 shown in Figures 21-24, its nasal portion 3101 and oral portion 3102) at an angle that enables the seal-forming structure 3100 to form a stable seal with the patient's face without blocking the patient's nose.

[0281] In other examples, the chassis portion 3210 may not include an outwardly protruding connecting portion 3212. In some examples described in more detail below, such as the examples shown in Figures 14-17, the chassis portion 3210 includes a single opening, for example, on its front side (where the chassis portion 3210 may be in fluid communication with the air circuit 4170, for example, via a short tube, to receive air flow at therapeutic pressure into the plenum chamber 3200). In such examples, the chassis portion 3210 may be configured to connect to a headgear strap (e.g., via a rigidizer, which may be covered in a textile material or may take the form of a substantially rigid arm having at least a textile material on a patient-facing side for patient comfort) of the positioning and stabilizing structure 3300 of the patient interface 3000.

[0282] In the examples shown in Figures 18-20, the patient interface includes a cushion module 3150 that supplies air to both the patient's nose and mouth, and in the examples shown in Figures 21-24, the patient interface 3000 includes a nasal cushion module 3160 and an oral cushion module 3170. As previously mentioned, in these examples, the patient positioning and stabilizing structure 3300 includes a headgear tube 3350 that forms a conduit headgear. Additionally, in these examples, the positioning and stabilizing structure 3300 includes a pair of lower straps (not shown in the drawings, the lower straps may be those disclosed in U.S. Patent No. 5,331,633, the entire contents of which are incorporated herein by reference). Each lower strap may be configured to be positioned below a respective lower ear point of the patient's head and on each side of the patient's head. The lower straps may be configured to releasably attach to the chassis portion 3210 or the oral chassis portion 3217, as the case may be. In some examples, the connection between the lower straps and the chassis portion may be a magnetic connection and / or a mechanical connection. The lower strap may be elastically stretchable, which may have the advantage that the positioning and stabilising structure 3300 is tolerant to changes in the spacing between the patient's chin and neck as the patient moves their head.

[0283] [5.3.5.3 Ventilation] [5.3.5.3.1 Ventilation within chassis parts] In some forms, the patient interface 3000 may include a vent 3400 that allows for a continuous flow of gases exhaled by the patient from the interior of the plenum chamber 3200 to the surroundings, for example throughout the patient's breathing cycle, said vent 3400 being sized and shaped to maintain a therapeutic pressure in the plenum chamber in use. In the example illustrated in Figures 7-13, the patient interface 3000 includes a vent module 3410 that includes the vent 3400. The vent module 3410 may be a component or assembly formed from a substantially rigid material and including a plurality of holes that form the vent 3400. The vent module 3410 may be provided on the front side of the chassis portion 3210. In the example illustrated in Figures 7-13, the vent module 3410 is provided on the front lower side of the chassis portion 3210. The chassis portion 3210 includes a hole (which in the illustrated example is a front-lower hole, and in other examples can be a front- or lower-facing hole) that receives the vent module 3410. In some examples, the vent module 3410 is configured to support a diffuser through which a continuous flow of gas exhaled by the patient can pass as it flows to the surroundings. In some examples, the vent module 3410 is configured to allow a continuous flow of gas exhaled by the patient from the interior of the plenum chamber 3200 to the surroundings, passing by the diffuser without flowing through the diffuser.

[0284] In the example shown in Figures 18-20, the patient interface 3000 includes a vent 3400 and a vent module 3410, which may be substantially as described above in relation to Figures 7-13. However, in this example, the vent 3400 is provided in the chassis portion 3210 adjacent (e.g., in front of) the oral portion 3102 of the seal-forming structure 3100. The vent module 3410 may be provided on the front side of the chassis portion 3210. The chassis portion 3210 may include a front-facing hole that receives the vent module 3410.

[0285] It should be understood that patient interfaces according to other examples of the present technology (e.g., those described with reference to Figs. 25-67) have a gas flushing vent 3400 (e.g., a vent 3400 that allows for a continuous flow of gases exhaled by the patient from the interior of the plenum chamber 3200 to the surroundings (said vent 3400 being sized and shaped to maintain a therapeutic pressure in the plenum chamber in use)) even if the vent 3400 is not depicted or identified in the drawings. The vent 3400 may be provided in a vent module 3410.

[0286] [5.3.5.3.2 Vent in oral-nose connector] In the example shown in Figures 21-24, the oral-nasal connector includes a vent portion 3400 of the patient interface 3000. In this example, a vent module 3410 including the vent portion 3400 is provided on the oral-nasal connector 3165. The vent module 3410 is received within a hole on the oral-nasal connector 3165. The vent module 3410 may be provided on the oral-nasal connector 3165 and a front portion of the patient interface 3000 to direct gas flow away from the patient. The vent portion 3400 and vent module 3410 may be as described in relation to the vent portion 3400 and vent module 3410 in the example shown in Figures 7-13.

[0287] [5.3.5.4 Anti-asphyxiation valve (AAV)] Each of the patient interfaces 3000 shown in or described with reference to Figures 18-20 and 21-67 further includes an anti-asphyxiation valve (AAV), which is not visible in the drawings. The AAV may be provided in the oral portion of the patient interface 3000. In some examples, the AAV is integrated into the vent module 3410. The vent module 3410 may include a gas flush vent 3400 and an AAV. In some examples, the AAV is provided in the chassis portion 3210 (or the oral chassis portion 3217) of the patient interface 3000. In further examples, the AAV is provided in the connection port 3600 of the patient interface 3000 or in the connection between the plenum chamber and the stub tube 3610 (e.g., inlet port connector 3605).

[0288] [5.3.5.5 Seal formation structure] As previously mentioned, the patient interface 3000 includes a seal-forming structure 3100. The seal-forming structure 3100 may form part of the cushion module 3150. In examples where the patient interface 3000 includes a nasal cushion module 3160 and an oral cushion module 3170, the seal-forming structure 3100 may form part of the nasal cushion module 3160 and the oral cushion module 3170.

[0289] In the examples shown in Figures 7-13, 14-17, 18-20, 21-24, and 25-46, the seal-forming structure 3100 includes a pair of nasal pillows. Each nasal pillow may be constructed and arranged to form a seal with a respective nostril of the patient's nose. Each nasal pillow may have a hole therein so that airflow at therapeutic pressures may be delivered to at least one of the patient's nostrils.

[0290] 18-20, 21-24, and 25-46, the seal-forming structure 3100 includes a pair of nasal pillows that form a nasal portion 3101 of the seal-forming structure 3100, and further includes an oral portion 3102 of the seal-forming structure. The oral portion 3102 of the seal-forming structure 3100 shown in FIGS. 18-20 and 21-24 may be configured to form a seal about a patient's mouth such that airflow (e.g., at least a portion thereof) at a therapeutic pressure is delivered to the patient's mouth.

[0291] The nasal pillows of the patient interface 3000 according to one of the examples of the present technology, or more generally any seal-forming structure 3100, may be constructed and arranged to maintain the above-mentioned therapeutic pressure within the plenum chamber throughout the patient's respiratory cycle when in use.

[0292] In each of the examples shown in Figures 7-46, the nasal pillows forming the seal-forming structure 3100 are devoid of stalks. Each of the nasal pillows may include a conical portion (e.g., a truncated cone portion / frustum-shaped portion) having a tip and a base that is wider than the tip. The base may be directly attached to the membrane portion 3220 (described in detail below). That is, there may be no stalk or narrow connection between the truncated cone portion of each nasal pillow and the membrane portion 3220. The lack of a stalk may advantageously help to keep the force exerted by each pillow at the patient's nose low, which may provide a comfortable patient interface 3000. The absence of a stalk may also increase the stability of the nasal pillow, and therefore less force is required to hold it in place within the nares, which may provide a patient with a sense of comfort. In other examples, each of the nasal pillows includes a stalk connecting the truncated cone portion of the nasal pillow to the membrane portion 3220. However, the highly flexible membrane portion 3220 may allow sufficient movement of the nasal pillows such that a stalk for decoupling purposes may not be required.

[0293] The frusto-conical portion of each nasal pillow may seal against a respective nostril of the patient's nose. For example, the frusto-conical portion of each nasal pillow may be configured to seal against an inferior surface of the patient's nose that defines a respective nostril of the patient. For example, the frusto-conical portion of each nasal pillow may seal against the patient's nose at a respective nasal opening.

[0294] The nasal pillows forming part of the seal-forming structure 3100 may be formed separately from the membrane portion 3220 and attached to the membrane portion 3220 by any method that creates a seal between the nasal pillows and the membrane portion 3220 and secures the nasal pillows to the membrane portion 3220 throughout the desired life of the cushion module 3150. In some examples, the nasal pillows may be attached to the membrane portion 3220. In other examples, the nasal pillows may be molded to the membrane portion 3220, for example, by supporting the membrane portion 3220 or the cushion module in a mold and molding the nasal pillows in place on the membrane portion 3220.

[0295] In some examples, the nasal pillows are formed from a different material than the membrane portion 3220 (e.g., the nasal pillows may be formed from a first material and the membrane portion 3220 may be formed from a second material different from the first material). Each of the nasal pillows may be formed from an elastomeric material. The nasal pillows are formed from silicone in the examples shown in Figures 7-46. In other examples, the nasal pillows may be formed from, for example, a thermoplastic elastomer (TPE), foam, textile, or combinations thereof. The nasal pillows may be formed from a single wall or a dual wall construction. In some examples, each nasal pillow is formed from a single wall. In other examples, the nasal pillows may be dual wall nasal pillows (e.g., formed from two walls).

[0296] In other examples, the seal-forming structure 3100 may take the form of a nasal cradle cushion (e.g., a seal-forming structure 3100 configured to seal against the patient's nasal tip, nasal alar, and nasal cavity). The nasal cradle seal-forming structure 3100 may be formed from an elastomeric material such as silicone or TPE, or may be formed at least in part from a textile material, optionally with an undercushion that may be formed, for example, from foam.

[0297] [5.3.5.6 Chassis and membrane parts] The patient interface 3000 may include a membrane portion 3220 connected to the chassis portion 3210 (or possibly the nasal chassis portion 3216). The chassis portion 3210 and the membrane portion 3220 together may form a plenum chamber 3200 that together enclose a volume that may be filled with air, for example at a therapeutic pressure.

[0298] In some examples of the present technology, the membrane portion 3220 supports the seal-forming structure 3100 or at least a portion thereof (e.g., the nasal portion 3101 of the seal-forming structure 3100). For example, the seal-forming structure 3100 may be supported on the membrane portion 3220. In the examples shown in Figs. 7-13 and 14-17, the nasal pillows forming the seal-forming structure 3100 are supported on the membrane portion 3220. In the examples shown in Figs. 18-20 and 21-24, the nasal pillows supported on the membrane portion 3220 form the nasal portion 3101 of the seal-forming structure 3100.

[0299] The chassis portion 3210 (or possibly the nasal chassis portion 3216 or the oral chassis portion 3217) may be configured to support the membrane portion 3220, for example, by being stiffer than the membrane portion 3220. The chassis portion 3210 may be formed from a material that is stiffer than the material forming the membrane portion 3220. Additionally or alternatively, the chassis portion 3210 may be thicker than the membrane portion (e.g., at least 5 times, at least 7 times, at least 10 times or more thicker).

[0300] The chassis portion 3210 may be a portion of the cushion module 3150 (or nasal cushion module 3160 or oral cushion module 3170, as the case may be) that has sufficient stiffness (e.g., as a result of material and / or shape / structure) to maintain the shape of the cushion module 3150 and support the membrane portion 3220. The chassis portion 3210 may hold the membrane portion 3220 substantially taut when the plenum chamber 3200 is not pressurized. For example, the chassis portion 3210 may hold the membrane portion 3220 substantially taut such that the nasal pillows are held substantially in an in-use position before the plenum chamber 3200 is pressurized. The membrane portion 3220 may be sufficiently taut to align the nasal pillows with the patient's nares when the patient wears the patient interface 3000 before the plenum chamber 3200 is pressurized. In particular, the chassis portion 3210 may hold the membrane portion 3220 taut but not stretch when at rest. Also, the nasal pillows, or more generally the seal-forming structure 3100, may provide some support to the rest shape of the membrane portion 3220. The membrane portion 3220 at rest may be taut so that it is held substantially in a predetermined shape. In some examples, the membrane portion 3220 at rest may be taut but without stress in the material forming the membrane portion 3220. The membrane portion 3220 at rest may be taut so that it is generally held in a predetermined shape and holds the seal-forming structure 3100 (e.g., nasal pillows) generally in place relative to the chassis portion 3210, but may be easily deformable by forces acting on the membrane portion 3220, such as finger pressure.

[0301] In some examples, the chassis portion 3210 may be formed from an elastomeric material. In the examples shown in FIGS. 7-13, the chassis portion 3210 is formed from silicone. In other examples, the chassis portion 3210 may be formed from a thermoplastic elastomer (TPE). In further examples, the chassis portion 3210 may be formed from a substantially rigid material, such as a thermoplastic material, e.g., polycarbonate, nylon, and the like. In the examples described with reference to FIGS. 47-67, the chassis portion 3210 may be formed from a textile material. In other examples, the chassis portion 3210 may be formed from a foam or a combination of materials, such as those disclosed herein.

[0302] The membrane portion 3220 may be constructed and arranged to be flexible, such that the seal-forming structure 3100 may move relative to one or more other portions of the patient interface 3000 in use. In particular, the seal-forming structure 3100 may move relative to the chassis portion 3210. For example, in the patient interface 3000 shown in Figures 7-24, the membrane portion 3220 is constructed and arranged to be flexible to allow relative movement between the nasal pillows and the chassis portion 3210 (e.g., the nasal chassis portion 3216 in the example shown in Figures 21-24). The membrane portion 3220 may allow relative movement between the nasal pillows and a portion of the cushion module 3150 (or 3160), such as the chassis portion 3210, in use. The membrane portion 3220 may provide a trampoline function that allows the chassis portion 3210 to move relative to the nasal pillows by deformation of the membrane portion 3220, while the seal-forming structure 3100, such as the nasal pillows, is held in place. Relative movement between the seal-forming structure 3100 and the chassis portion 3210 may involve the seal-forming structure 3100 being stationary so that it may be held fixed against the patient's face or within the patient's nares, and the chassis portion being able to move relative to the seal-forming structure 3100 and the user's face. Advantageously, this at least partially decouples the seal-forming structure 3100 from the chassis portion 3210, which may improve stability and sealing, particularly during head movement.

[0303] For example, the highly flexible nature of the membrane portion 3220 supporting the nasal pillows, created by the thin thickness and material of the membrane portion 3220, may create a cushion that is highly resistant to the transmission of destructive forces from the structural components / portions (such as the chassis portion 3210 and the positioning and stabilizing structure 3300) through the nasal pillows. Most or all of the destructive forces expected to be received by the chassis portion 3210 during use of the patient interface 3000 may be absorbed by the membrane portion 3220 and the transfer of such forces to the nasal pillows may be prevented.

[0304] In some examples, the membrane portion 3220 may be constructed and arranged to at least partially decouple the movement of the nasal pillows from one another. In particular, the membrane portion 3220 may be constructed and arranged to allow each of the nasal pillows to move and align with each of the patient's nares during use. The membrane portion 3220 may be constructed and arranged to stretch and / or flex to allow each of the nasal pillows to move and align with each of the patient's nares before pressure is applied. Thus, the nasal pillows can easily fit a wide range of patient noses and / or tolerate uneven mask setups. Additionally, disruptive forces, especially during movement or lateral sleep, can cause asymmetric loading on the nasal pillows. The membrane portion 3220 may be configured to withstand uneven loading by decoupling the nasal pillows from one another to keep each nasal pillow in a sealed position.

[0305] The membrane portion 3220 may be constructed and arranged to be flexible to provide the effects described herein, for example, by being thin and not held so tightly that it cannot move or deform. For example, the membrane portion 3220 may be formed from a thin layer(s) of material(s) and held so that it can be deformed to allow relative movement between the seal-forming structure 3100 and the chassis portion 3210. A chassis portion 3210 formed from a flexible material, for example an elastomer such as silicone or TPE, may also advantageously aid in the deformation of the membrane portion 3220, such that the chassis portion 3210 is movable relative to the nasal pillows. In some examples, the chassis portion 3210 may be capable of bending, which may allow further shape changes of the membrane portion 3220 beyond the ability of the membrane portion 3220 alone to bend, stretch, and expand, since the boundaries of the membrane portion 3220 may move when the chassis portion 3210 bends.

[0306] In some examples, the membrane portion 3220 may be constructed and arranged to expand when the plenum chamber 3200 is pressurized to a therapeutic pressure in use. The membrane portion 3220 may be stretchable and in some examples may be constructed and arranged to stretch during expansion when the plenum chamber 3200 is pressurized to a therapeutic pressure in use. In some examples, the membrane portion 3220 may be formed from a stretchable material (e.g., a material that can stretch during expansion when the plenum chamber 3200 is pressurized to a therapeutic pressure in use).

[0307] In some examples, the membrane portion 3220 may be constructed and arranged to be taut in the absence of therapeutic pressure within the plenum chamber 3200. In such examples, the membrane portion 3220 may stretch (e.g., balloon shaped) during inflation to provide more surface area than at rest in the absence of pressure within the plenum chamber 3200. In other examples, the membrane portion 3220 may not be taut (e.g., may be loose / flaky) and may assume a taut configuration during inflation and then stretch while further expanding.

[0308] As described in more detail below, the membrane portion 3220 may not be molded into a three-dimensional shape (e.g., may be formed as a sheet). Due to the lack of a predetermined three-dimensional shape, the membrane portion 3220 may allow for a large amount of movement of the nasal pillows or other seal-forming structure 3100 for setup and disconnection purposes, as the membrane portion 3220 may have little or no inherent bias to return to a predetermined shape.

[0309] In examples of the present technology where the membrane portion 3220 partially forms both a nasal portion of the plenum chamber 3200 and an oral portion of the plenum chamber 3200 (e.g., the examples shown in Figs. 18-20), at least a portion of the membrane portion 3220 that forms the nasal portion of the plenum chamber 3200 (which may be identified as the nasal portion of the membrane portion 3220) may be inflated in the manner described above. Alternatively or additionally, in examples where the seal-forming structure 3100 includes a nasal portion 3101 and an oral portion 3102, the portion of the membrane portion 3220 that supports the nasal portion 3101 of the seal-forming structure 3100 may be inflated in the manner described above.

[0310] 5.3.5.6.1 Plenum chamber pressurization 7-11 show the patient interface 3000 prior to donning by a patient. As shown, the membrane portion 3220 is taut to the extent that there are substantially no wrinkles, folds, etc. FIGS. 12 and 13 show the patient interface 3000 of FIGS. 7-11 as it is being donned by a patient. In FIG. 12, the plenum chamber 3200 is unpressurized, and in FIG. 13, the plenum chamber 3200 is pressurized. Certain aspects and behaviors of the patient interface 3000 shown in FIGS. 7-11 are described below with reference to FIGS. 12-13, however, it should be understood that the described aspects and behaviors are applicable to the patient interfaces 3000 shown in FIGS. 14-17, 18-20, and 21-24, and 25-46, unless the context requires otherwise.

[0311] Figure 12 shows the patient interface 3000 worn by a patient but prior to pressurization of the plenum chamber 3200. Prior to pressurization, the membrane portion 3220 may form against the bottom of the patient's nose and / or upper lip, for example, the bottom of the patient's nasal tip as shown in Figure 12. Because the plenum chamber 3200 is not pressurized, the patient's nose pressing against the membrane portion 3220 will cause wrinkles in the membrane portion 3220 on the side of the plenum chamber 3200 facing anteriorly and superiorly. At this point, the nasal pillows are held against the nose by a resilient force (e.g., a spring return force) from the membrane portion 3220.

[0312] 12, the membrane portion 3220 has a front edge (e.g., the frontmost boundary of the membrane portion 3220 where the membrane portion 3220 is attached to the chassis portion 3210) that is spaced from the patient's nose. This spacing from the patient's nose, or from the upper back side of the plenum chamber 3200, may be considered the "depth" of the front portion of the membrane portion 3220. The depth provides a space for the patient's nose to press into the membrane portion 3220, causing compression of the front portion of the membrane portion 3220 during set-up. The depth of the membrane portion 3220 in this region may be selected such that the patient can tighten the headgear such that their nose is pressed into this region, but not so much that their nose touches the chassis portion 3210.

[0313] FIG. 13 shows the patient interface 3000 being worn by a patient and with the plenum chamber 3200 pressurized. As shown, the wrinkles in the membrane portion 3220 that were visible before pressurization in FIG. 12 are no longer directly under / in front of the patient's nose because the membrane portion 3220 has expanded and stretched (e.g., inflated like a balloon). This causes the frusto-conical sealing portion of the nasal pillows (portion of the seal-forming structure) to embed / burst into the patient's nares. The pressure in the plenum chamber 3200 continues to push the pillows during use, providing a mask with a tight seal. The inflatable nature of the membrane portion 3220 may bias the nasal pillows towards each nostril for a good, stable seal during use, so that the patient interface 3000 is effectively "self-adjusting."

[0314] Expansion of the membrane portion 3220 may advantageously serve to bias the seal-forming structure 3100 toward the patient's face. With respect to the example shown in Figures 7-24, the membrane portion 3220 may be constructed and arranged to expand in use to bias each of the nasal pillows toward each of the patient's nostrils. This may advantageously promote a good seal between each nasal pillow and each nostril.

[0315] In some examples, the membrane portion 3220 may be constructed and arranged to expand in use to conform to one or more portions of the patient's nose. This can effectively customize the fit to encase the patient's nose (e.g., the bottom of the nose) and distribute sealing forces, resulting in patient comfort and a good seal. As previously described, the membrane portion 3220 may conform to the patient's nasal tip. The membrane portion 3220 may conform to an inferior-facing surface of the patient's nasal tip. In some examples, the membrane portion 3220 may be configured to leave an anterior-most portion of the patient's nasal tip uncovered. This can advantageously provide an unobtrusive patient interface 3000. In some examples, the membrane portion 3220 may be configured to conform to an inferior-facing surface of the patient's nasal ala. The balloon-like effect of the membrane portion 3220 to seal against the under-facing surface of the patient's nose and the patient's lips (described below) (along with the ability of the thin membrane portion 3220 to conform to the patient's facial morphology) may advantageously distribute forces on the patient's nose and face over a wide area, which may provide comfort during use as there is a low risk of areas of high contact pressure.

[0316] Expansion of the membrane portion 3220 may also help maintain a good seal during use, for example, during movement of the patient's head or when the patient interface 3000 is subjected to disruptive forces such as tube traction or forces due to contact between the patient interface 3000 and the patient pillow or bedsheet. With particular reference to the examples shown in Figures 7-24, the membrane portion 3220 is constructed and positioned to resist separation of the nasal pillows from the patient's nares as the chassis portion 3210 moves during use. In some examples, the geometric orientation of the conical seal relative to the pressurized membrane ensures that the conical seal is locked within the nares.

[0317] The membrane portion 3220 may be configured to engage the patient's lips in use. In some instances, this may provide additional support, stability, and / or sealing to complement the seal-forming structure 3100. In some instances, this may provide a comfortable, stable fit (e.g., by distributing the load over a larger area). The chassis portion 3210 may be configured to not engage the patient's lips in use, which may be uncomfortable. The chassis portion 3210 may have a sufficiently small and / or unobtrusive profile such that the membrane portion 3220 contacts the lips in use, but the chassis portion 3210 does not contact the lips. A small and / or unobtrusive chassis portion 3210 may provide an unobtrusive patient interface 3000. Additionally, the chassis portion 3210 may be configured to not engage the patient's lips in use. That is, in some instances, the membrane portion 3220 may contact the patient's cytoplasm, but the chassis portion 3210 may not.

[0318] In some examples, the membrane portion 3220 does not contact the patient's face other than the patient's nose and upper lip when in use. The membrane portion 3220 may not contact the patient's cheek when in use. In some examples, the membrane portion 3220 may not contact the patient's nasolabial fold when in use. In some examples, the membrane portion 3220 may not contact the outward facing side of the patient's nose when in use. The membrane portion 3220 may not contact the patient's nasal ridge when in use.

[0319] In some examples, the chassis portion 3210 does not contact the patient's face during use. In some examples, the chassis portion does not contact the patient's cheek during use. In some examples, the chassis portion does not contact the patient's nasolabial fold during use.

[0320] [5.3.5.6.2 Textile membrane] In some examples of the present technology, the membrane portion 3220 is at least partially formed from a textile material, such as a woven material. The textile material may advantageously provide the membrane portion 3220 with a comfortable surface when in contact with the patient's face. In the examples described with reference to Figs. 7-67, the membrane portion 3220 includes a textile layer and an air impermeable layer. The textile layer may include a woven material and the air impermeable layer may include, for example, a polymer film. In some examples, the air impermeable layer may be formed from silicone. In some examples, the membrane portion 3220 may be formed from an air impermeable film flocked with a textile material. Advantageously, the use of a textile material in forming the membrane portion 3220 may allow the membrane portion 3220 to be sufficiently stretchable yet sufficiently tear resistant (at least during its usable life) to stretch during inflation without tearing when the plenum chamber 3200 is pressurized. 7-13, the textile layer provides an exterior surface of the membrane portion 3220. That is, the textile layer may be exterior to the plenum chamber 3200, which in the example of FIGS. 7-13 may be exterior to the cushion module 3150. In some examples, if the textile material of the membrane portion 3220 is sufficiently air impermeable, an additional sealing layer may not be included.

[0321] In some examples, the knit stitch of the textile material of the membrane portion 3220 can be a single jersey weft knit. In other examples, the textile material can include an alternative knit stitch (in some examples, a tricot knit).

[0322] The textile material may include one or more synthetic fibers. In some examples, the textile material may include 80% polyamide, 20% elastane. Elastane may advantageously provide high stretch / elasticity. The elastane content may be in the range of 5%-20%, in the range of 10%-20%, or in the range of 5%-15%, in examples. In some examples, the elastane content of the textile material is 15% or 10%. In some examples, the textile material includes polyester instead of polyamide. Other suitable materials that provide the effects of the membrane portion 3220 described herein may also be used.

[0323] In some examples, the textile material is 0.27 mm thick. The membrane portion 3220 may include an airtight silicone lining having a thickness of about 0.03 mm, for a total thickness of 0.3 mm. In some examples, the weight of the textile material may be 105 gsm.

[0324] In some examples, the textile material is provided to the patient interface 3000 having wales that run generally in a top-to-bottom direction in use, and courses that run outwardly in use. The textile material may have a high degree of stretch in the course direction, and the membrane portion 3220 may need to stretch more outwardly across the patient's face than in the top-to-bottom direction.

[0325] More generally, one aspect of the present technology, as specifically illustrated in FIGS. 7-13, is a patient interface 3000 having a chassis portion 3210 including a membrane portion 3220 formed at least partially from a textile material, and a seal-forming structure 3100 of the patient interface 3000 formed from an elastomeric material and supported on the membrane portion 3220. In the example shown in FIGS. 7-13, the chassis portion 3210 includes a textile membrane portion 3220 supporting an elastomeric seal-forming structure 3100 in the form of a nasal pillow. The textile surface of the membrane portion 3220 may provide a comfortable contact with the face around the patient's airway, and the elastomeric material forming the seal-forming structure 3100 may provide a good seal. The textile membrane portion 3220 may also have an additional advantage with respect to its ability to expand and contract without tearing, as discussed above.

[0326] Another advantage that may be provided by a configuration in which the membrane portion 3220 is at least partially formed from a textile material and the seal-forming structure 3100 is formed from an elastomeric material and includes nasal pillows supported on the membrane portion 3220 is that the nasal pillows may be stiffer than the textile membrane portion 3220. Both nasal pillows may help hold the membrane portion 3220 in a predetermined shape prior to expansion upon pressurization of the plenum chamber 3200. The nasal pillows may also transfer forces to the more flexible membrane portion 3220 during use. The flexibility of the membrane portion 3220 may distribute loads over a larger area on the patient's face, particularly the nose and the bottom of the lips, which may result in a comfortable patient interface 3000.

[0327] The textile membrane portion 3220 may be affixed to the chassis portion 3210 by molding the chassis portion 3210 to the textile membrane portion 3220 while the textile membrane portion 3220 is supported in a mold. Alternatively, the chassis portion 3210 may be molded separately and then the textile membrane portion 3220 may be attached thereto (e.g., glued, welded, taped, or otherwise attached). Similarly, the nasal pillows (or other seal-forming structures) may be molded onto the textile membrane portion 3220 or molded separately and then attached (e.g., glued or welded).

[0328] [5.3.5.6.3 Elastomer membrane part] In other examples of the present technology, the membrane portion 3220 may be formed from an elastomer such as silicone or TPE. The elastomer forming the membrane portion 3220 may be sufficiently thin and may have material properties that allow the membrane portion 3220 to function like the textile membrane portion 3220 described herein. Thus, features of the membrane portion 3220 described with reference to features provided by the textile membrane portion 3220 described herein should be understood to be applicable to the elastomer / silicone membrane portion 3220, and vice versa, unless the context requires otherwise. In particular, the silicone membrane portion 3220 may be sufficiently thin and formed from a suitable silicone material to be able to stretch while expanding when the plenum chamber 3200 is pressurized in use, while biasing the nasal pillows into engagement with the patient's nares, and / or while providing relative movement between the nasal pillows and the chassis portion 3210 or between the nasal pillows, respectively. The silicone membrane portion 3220 may be less than 0.25 mm thick, such as 0.2 mm thick, or may be less than 0.2 mm thick, less than 0.15 mm thick, and in some examples may be in the range of 0.05 mm to 0.2 mm or 0.1 mm to 0.15 mm thick. The silicone membrane portion 3220 may be formed from a silicone having a durometer hardness in the range of D20 to D40. In some examples, other durometer values ​​are contemplated, such as durometer values ​​indicative of softer properties.

[0329] In examples where the membrane portion 3220 is formed from silicone, the membrane portion 3220 may be formed separately from the chassis portion 3210. For example, the membrane portion 3220 may be formed first and placed in a mold, and then the chassis portion 3210 may be injection molded and joined (e.g., glued) to the membrane portion 3220. Alternatively, the chassis portion 3210 may be molded separately and then the membrane portion 3220 may be attached (e.g., glued or welded) to the chassis portion 3210. In other examples, the membrane portion 3220 may be integrally formed with the chassis portion 3210, for example, by molding the membrane portion 3220 and the chassis portion 3210 together in the same molding step, if the membrane portion 3220 has a moldable thickness. In some examples, the membrane portion 3220 is formed from silicone and includes a thickness of 0.2 mm. Advantageously, the silicone membrane portion 3220 having a thickness of 0.2 mm may be highly elastic, may be molded with the chassis portion 3210, and may be sufficiently tear-resistant.

[0330] As described elsewhere herein, in some examples, the membrane portion 3220 is formed from an elastomer, but is not formed into a predetermined three-dimensional shape. The membrane portion 3220 may have no bias to a predetermined shape. This may provide a highly flexible membrane portion 3220, which may advantageously aid in set-up (allowing the nasal pillows or other seal-forming structure 3100 to move and create a good seal) and decoupling (allowing some disruptive movement of the chassis portion 3210 relative to the nasal pillows or other seal-forming structure 3100 instead of transmitting the disruptive movement to the nasal pillows).

[0331] 5.3.5.6.4 Plenum chamber geometry and other aspects As previously mentioned, the chassis portion 3210 and the membrane portion 3220 may form the plenum chamber 3200. The plenum chamber 3200 may include a rear-superior-facing side configured to face rearward and upward in use. In examples of the present technology where the patient interface 3000 includes an oral portion, the rear-superior-facing side described herein may be part of the nasal portion of the plenum chamber 3200. A seal-forming structure 3100 such as the nasal pillows of the patient interface 3000 shown in Figs. 7-24 (or possibly the nasal portion of the seal-forming structure 3100) may be provided on the rear-superior-facing side. The seal-forming structure 3100 may be provided on the rear-superior-facing side such that the seal-forming structure 3100 faces rearward and upward in use to enable engagement with anterior and inferior facing surfaces of the patient's nose in use. The membrane portion 3220 and the seal-forming structure 3100 may form a majority of the rear-superior-facing side of the plenum chamber 3200. As illustrated in Figures 7-24, the membrane portion 3220 and the seal-forming structure 3100 form substantially all of the rear upwardly facing side.

[0332] The plenum chamber 3200 may include a front-superior-facing side configured to face anteriorly and superiorly in use. In examples of the present technology where the patient interface 3000 includes an oral portion, the rear-superior-facing side described herein may be part of the nasal portion of the plenum chamber 3200. As illustrated in FIGS. 7-24, the membrane portion 3220 may form a majority of the front-superior-facing side of the plenum chamber 3200, or possibly the nasal portion thereof. The membrane portion 3220 may extend from the rear-superior-facing side to the front-superior-facing side. The plenum chamber 3200 may include a curved boundary where the membrane portion 3220 meets the chassis portion 3210 at the front-superior-facing side.

[0333] The plenum chamber 3200 may further include a rear-inferior-facing side configured to face rearward and downward in use. As illustrated in Figures 7-17 and 21-24, the membrane portion 3220 may form a majority of the rear-inferior-facing side of the plenum chamber 3200 (or, in some cases, a nose portion thereof). The membrane portion 3220 may extend from the rear-superior-facing side to the rear-inferior-facing side. The plenum chamber 3200 may include a curved boundary where the membrane portion 3220 meets the chassis portion 3210 on the rear-inferior-facing side.

[0334] 18-67, the plenum chamber 3200 may not include a rearwardly facing side within the nasal portion, as the rearwardly superior facing side of the plenum chamber 3200 supporting the nasal pillows may be adjacent to and above the oral portion of the seal-forming structure 3100 also formed by the membrane portion 3220. The portion of the membrane portion 3220 that forms the oral portion of the seal-forming structure 3100 may be identified as the oral portion of the membrane portion 3220. Because the oral portion of the seal-forming structure 3100 is configured to seal the patient's face around the patient's mouth, the oral portion of the membrane portion 3220 may be configured to face substantially rearwardly in use, the oral portion being an extension of the membrane portion 3220 that descends to the rear of the cushion module 3150 in this example.

[0335] In some examples of the present technology, such as the examples illustrated in Figures 7-13, the chassis portion 3210 forms a majority of a front-downward facing side of a plenum chamber 3200 configured to face a front and downward side in use. In this example, the chassis portion 3210 includes a hole configured to receive a vent module 3410 including a vent 3400. The chassis portion 3210 may stretch-fit around the vent module 3410, allowing the vent module 3410 to be inserted into the hole in the chassis portion 3210.

[0336] In some examples, the chassis portion 3210 and the membrane portion 3220 may each provide approximately half of the surface area of ​​the cushion module 3150.

[0337] In some examples, the front-upper facing side of the plenum chamber 3200, or at least a portion thereof, is substantially planar in the rest position. Similarly, the rear-lower facing side of the plenum chamber 3200, or at least a portion thereof, may be substantially planar in the rest position. The front-upper facing side of the plenum chamber 3200, or at least a portion thereof, may be substantially parallel to the rear-lower facing side of the plenum chamber 3200, or at least a portion thereof.

[0338] In some instances, the rearmost portion of the nasal pillows is spaced rearward from the rearmost portion of the membrane portion 3220 in use. Substantially all of the membrane portion 3220 may be located in front of and below the nasal pillows. The membrane portion 3220 may not extend rearward beyond the tips of the nasal pillows, and in some instances may not extend rearward beyond the base of the nasal pillows.

[0339] In some examples, the cushion module 3150 (or in some cases the nasal cushion module 3160) of the patient interface 3000 does not include a portion on the outside of the nasal pillows that contacts the face. The cushion module 3150 may contact the nose and labialis, but not the patient's cheeks or nasolabial folds, for example. The patient interface 3000 may be constructed and / or arranged such that the nasal pillows are positioned within the patient's nares without the support portion of the cushion module 3150 contacting the patient's cheeks. In the examples illustrated herein, the membrane portion 3220 flexes and / or stretches when providing a counter force that resists separation of the nasal pillows from the patient's nares after the nasal pillows enter the nares. Pressure within the plenum chamber 3200 also acts on the membrane portion 3220 to push the nasal pillows into the nares. Additionally, in examples where the patient interface 3000 includes conduit headgear, the gas delivery tube 3350 may be bent to hug the flexible cushion module 3150 towards the nose, which helps prevent separation of the nasal pillows from the nares.

[0340] In some forms of the present technology, the membrane portion 3220 may not have a predetermined three-dimensional shape in the absence of positive pressure relative to the air pressure in the plenum chamber 3220. In some examples of the present technology, the nasal pillows are supported on the membrane portion 3220 that is not formed to a predetermined shape. In some examples, the membrane portion 3220 may not be formed to a predetermined shape by injection molding. In some examples, the membrane portion 3220 may be formed by a process other than molding (e.g., calendar molding). The membrane portion 3220 may not include a three-dimensional predetermined shape. That is, the membrane portion 3220 may be formed such that it is not biased to a predetermined shape. For example, the membrane portion 3220 may be manufactured in sheet form and thus may take the form of a sheet. In particular, the membrane portion 3220 may take the form of a sheet connected to the chassis portion 3210 at the edges of the membrane portion 3220 (e.g., after the membrane portion 3220 is cut to a shape and size that fits the edges of the chassis portion). The lack of a predetermined three-dimensional shape may result in less restriction to movement, particularly of the nasal pillows. As discussed elsewhere herein, the membrane portion 3220 may also be sheet-like and loose, and / or may be constructed such that it is unable to support itself in a predetermined three-dimensional shape.

[0341] The membrane portion 3220 is a thin sheet with no other preformed geometry (e.g., a thin silicone membrane or textile membrane), which may allow the nasal pillows to freely conform to the geometry of the patient's nose. On the other hand, a membrane portion 3220 molded to a shape may resist deformation from that shape, which may limit the ability of the pillows to move to conform to the patient's nose. The nasal pillows may be able to move in a less inhibited manner when the membrane portion 3220 is not molded to a predefined shape than if the membrane portion 3220 were molded to a predefined shape. In particular, the nasal pillows may be able to dangle better around their base and move more up and down along their axis. Furthermore, the lack of a molded shape in the membrane portion 3220 means that the nasal pillows are not molded to a predefined orientation relative to the cushion module 3150. Furthermore, a membrane portion 3220 that is not molded to a predefined shape may allow the nasal pillows to have a greater range of motion. This may help the nasal pillows to withstand destructive forces during use, since the nasal pillows are very free to move relative to the chassis portion 3210.

[0342] In some examples, the nasal pillows are not molded together. Each nasal pillow may be molded separately. Even if the nasal pillows are molded together, they may be separated from one another (e.g., by cutting) when attached to the membrane portion 3220. This advantageously serves to decouple the nasal pillows from one another. In some examples, the nasal pillows are attached to the membrane portion 3220 such that they are not tilted toward one another in a rest state before the plenum chamber 3200 is pressurized.

[0343] In some examples, the membrane portion 3220 expands to a convex shape (e.g., a shape with a convex exterior surface) when the plenum chamber 3200 is pressurized. This can help urge the nasal pillows toward the patient's nares and maintain continuous sealing alignment. As the nasal pillows are restrained and / or conform to the patient's nose and upper lip, some or all of the membrane portion 3220 can become concave due to the presence of the patient's nose and face resisting this expansion.

[0344] In some examples, the cushion module 3150 (or possibly the nasal cushion module 3160) may not have a rigid frame. The lack of a rigid frame allows the sides of the cushion module 3150 to be at least partially decoupled from one another, allowing the cushion module 3150 to conform to a particular patient as needed and provide a good seal, and allowing the cushion module 3150 to withstand destructive forces.

[0345] [5.3.5.6.5 Membrane parts forming seal-forming structures] In some examples, the membrane portion 3220 may form one or more portions of the seal-forming structure 3100. For example, the membrane portion 3220 may form an oral portion of the seal-forming structure 3100.

[0346] In the examples shown in Figures 18-20, the seal-forming structure 3100 includes a nasal portion 3101 and an oral portion 3102. The nasal portion 3101 of the seal-forming structure 3100 includes nasal pillows supported on a membrane portion 3220, and the oral portion 3102 of the seal-forming structure 3100 is formed by the membrane portion 3220. The patient interface 3000 shown in Figures 25-46 also has this configuration. The patient interface 3000 shown in Figures 47-67 also has nasal and oral portions, but in these examples the patient interface 3000 does not include nasal pillows, instead the membrane portion 3220 provides both the nasal portion 3101 of the seal-forming structure 3100, and the oral portion 3102 of the seal-forming structure 3100.

[0347] 18-20, the membrane portion 3220 may include a nasal portion that forms the part of the membrane portion 3220 that supports the nasal pillows (or other portion of the seal-forming structure 3100 that forms a seal and provides airflow to the patient's nares, such as a cradle in some examples), and the membrane portion 3220 may further include an oral portion that forms the oral portion of the seal-forming structure 3100.

[0348] The membrane portion 3220 (e.g., one or both of the nasal and oral portions of the membrane portion 3220) may be sheet-like. It may be sheet-like by taking the form of a sheet of material. The sheet-like membrane portion 3220 may be substantially flat in some instances. In some instances, the membrane portion 3220 may be sheet-like in the sense that it is not necessarily perfectly planar, but is formed to resemble a sheet, e.g., generally flat, with a width and length that is much greater than its thickness. The membrane portion 3220 may have a uniform thickness. The sheet-like membrane portion 3220 may be formed by a sheet production process, such as calendar molding, or may be formed by molding.

[0349] In some examples, in the absence of positive pressure in the plenum chamber 3200, the membrane portion 3220 is loose. The membrane portion 3220 may be structured in some examples such that it cannot support itself in a predetermined three-dimensional shape. The membrane portion 3220 may be flimsy, but held in place by a connection to the chassis portion 3200. In some examples, the membrane portion 3220 may not have a predetermined three-dimensional shape. The membrane portion 3220 may be structured such that it is not biased into a predetermined three-dimensional shape. A membrane portion 3220 that does not have a predetermined shape and / or is flexible enough that it cannot support itself in a predetermined shape may advantageously be particularly effective in decoupling the nose portion 3101 of the seal-forming structure 3100 from the chassis portion 3210 and / or in fitting or conforming the nose portion 3101 of the seal-forming structure 3100 to the patient's face.

[0350] The membrane portion 3220 may include a sealing flange that forms the oral portion 3102 of the seal-forming structure 3100. An upper portion of the sealing flange is integrally formed with a nasal portion of the membrane portion 3220 in the examples shown in Figures 18-20 and 25-46. More generally, the portion of the membrane portion 3220 that supports the nasal pillows is integrally formed with the portion of the membrane portion 3220 that forms the oral portion 3102 of the seal-forming structure 3100. The nasal portion of the membrane portion 3220 is integrally formed with the oral portion of the membrane portion 3220. The nasal portion of the membrane portion 3220 may also seal with the patient's nose and / or face adjacent to the nose in addition to the nasal pillows to form a seal.

[0351] The oral portion 3102 of the seal-forming structure 3100 may include a sealing flange configured to form a seal around the patient's mouth and configured to seal against the patient's upper and lower lips and cheeks and define an oral opening to the plenum chamber 3200. The sealing flange is formed by a membrane portion 3220 in the examples shown in Figures 18-20 and 25-46. The membrane portion 3220 is connected to and supported by the chassis portion 3210. The periphery of the sealing flange formed by the membrane portion 3220 is supported by the chassis portion 3210 on the outer side and underside of the sealing flange. The inner periphery of the sealing flange formed by the membrane portion 3220 is unconstrained so as to better conform to the shape of the patient's face around the patient's mouth.

[0352] The sealing flange may include a curved cross-section at one or more locations around the oral opening, for example at the upper lip and / or chin, such that the convex surface contacts the patient's face before conforming to the patient's facial surface. In some instances, the cross-section of the sealing flange may be convex at the patient's cheek. In other instances, it may be substantially flat. The curved cross-section may provide a pressure-assisted seal against the patient's face, whereby therapeutic pressure within the plenum chamber 3200 helps to hold the sealing flange against the patient's facial surface. The sealing flange formed by the membrane portion 3220 may be joined to the chassis portion 3210 such that the chassis portion 3210 does not contact the patient's face in use. For example, the seam between the chassis portion 3210 and the membrane portion 3220 in the oral portion of the plenum chamber 3200 may be spaced apart from the patient's face in use.

[0353] In the examples shown in Figures 18-20, the membrane portion 3220 may be formed from a textile material (e.g., with an airtight silicone layer) as described elsewhere herein, or may be formed from a thin silicone (e.g., about 0.2 mm in some examples) or another elastomer such as TPE.

[0354] 25-46 show further examples of patient interfaces 3000 including a cushion module 3150 having a membrane portion 3220 that forms the oral portion 3102 of the seal-forming structure 3100. These examples are described in more detail below.

[0355] 25-46, the chassis portion 3210 may be flexible to at least partially decouple the membrane portion 3220 from disruptive forces applied to the chassis portion 3210 during use. A disruptive force may be a force that may adversely affect the seal formed between the seal-forming structure 3100 and the patient's face, such as tube traction or forces applied to the patient interface 3000 by the patient's pillow / bed during lateral sleep. Despite some flexibility to provide this decoupling effect, the chassis portion 3210 has sufficient stiffness as a structure to support the membrane portion 3220.

[0356] In some examples, the chassis portion 3210 may be at least partially formed from a textile material, and may be a thick, somewhat rigid textile material, such as, for example, breathoprene, that can support its own shape. For example, the chassis portion 3210 may be formed from 2.5 mm thick breathoprene. In other examples, the chassis portion 3210 may be formed from a polymer material that is flexible due to its thinness and geometry. Such a polymer material may be substantially rigid in the thicker portions, but the chassis portion 3210 is thin enough in thickness that the material can at least partially absorb destructive forces by deformation. The chassis portion 3210 may be flexible to absorb destructive forces, but has sufficient stiffness to support its own shape and support the membrane portion 3220 in use.

[0357] In the example illustrated in FIGS. 25-46, the chassis portion 3210 is formed from Mylar. The Mylar material may have a thickness in the range of 0.2 mm to 0.5 mm, such as 0.25 mm. In another example, the chassis portion 3210 may be formed from polycarbonate having a thickness in the range of 0.4 to 1 mm, such as in the range of 0.5 to 0.75 mm. The chassis portion 3210 may include a molded shell, or a sheet that is vacuum formed (and cut to size as necessary). The chassis portion 3210 may be formed from an elastomeric material, such as silicone or TPE, in another example.

[0358] In the example shown in Figures 25-46, the chassis portion 3210 is curved from one side of the patient's face to the other side of the patient's face when in use. The chassis portion 3210 may be substantially flush with the patient's cheek on each side. For example, as shown in Figure 29, on both sides of the patient's face, the chassis portion 3210 is substantially flush with the patient's cheek, e.g., a line along the curvature of the chassis portion 3210 is substantially aligned with the surface of the patient's cheek. This flush relationship may help the patient interface 3000 maintain a low profile and / or provide better side sleeping than if the sides of the chassis portion 3210 were raised above the patient's cheek. The patient interface 3000 shown in Figures 40-46 (described in more detail below) also has this configuration and curvature of the cushion module 3150, which helps prevent destructive forces, especially during side sleeping.

[0359] The chassis portion 3210 may be substantially shaped as a hyperbolic paraboloid. The membrane portion 3220 may also be substantially shaped as a hyperbolic paraboloid. In the examples shown in FIGS. 25-46, the chassis portion 3210 and the membrane portion 3220 are each shaped as a hyperbolic paraboloid. It should be understood that the chassis portion 3210 and the membrane portion 3220 may each be shaped as a hyperbolic paraboloid, even though there are one or more portions or features that do not form part of the hyperbolic paraboloid shape. The chassis portion 3210 and the membrane portion 3220 may be substantially shaped as hyperbolic paraboloids rotated 90 degrees from one another and joined to one another around the edges. In some examples, one or both of the chassis portion 3210 and the membrane portion 3220 may be substantially shaped as a parabolic cylinder. That is, in some examples, the chassis portion 3210 and / or the membrane portion 3220 may be as described elsewhere herein, but may have a parabolic cylinder shape in an undeformed state prior to being worn by a patient. In further examples, the chassis portion 3210 and / or the membrane portion 3220 can have a shape other than a hyperbolic paraboloid or a parabolic cylinder.

[0360] For example, the membrane portion 3220 may have a curvature in the sagittal plane that, in an in-use orientation and prior to engaging the patient's face, curves upwardly from the chin area of ​​the patient's face toward the patient's nose and then forwards After the patient interface 3000 is donned and the membrane portion 3220 engages the patient's face, its shape has a more complex curvature to match the contours on the surface of the patient's face.

[0361] In a plane perpendicular to the sagittal plane (e.g., a horizontal plane, or a plane of posterior superior to anterior inferior orientation), in the in-use orientation, the membrane portion 3220 may have no curvature prior to engaging with the patient's face, since it is held sufficiently taut by the chassis portion 3210. After the patient dons the patient interface 3000 and the membrane portion 3220 engages with the patient's face, the membrane portion 3220 may conform to the geometry of the patient's face, curving forward from one outside of the patient's face along one of the patient's cheeks, then inward toward the sagittal plane of the user's head, then outward along the other of the patient's cheeks to the other outside of the patient's face, then back. In the same plane, the chassis portion 3210 may also curve forward from one outside of the patient's face along one of the user's cheeks, then inward toward the sagittal plane, then outward and back along the other of the user's cheeks to the other outside.

[0362] [5.3.5.6.6 Connection of cushioning modules to positioning and stabilizing structures] 25-46 show patient interfaces 3000 according to further examples of the present technology. In these examples, the patient interfaces 3000 have various forms of positioning and stabilizing structures 3300. All patient interfaces 3000 shown in Figs. 25-46 not only have a membrane portion 3220 forming the oral portion 3102 of the seal-forming structure 3100, but also include a cushion module 3150 supporting a nasal pillow forming the nasal portion 3101 of the seal-forming structure 3100. The membrane portion 3220 may be as previously described with reference to Figs. 18-20. It should be understood that the positioning and stabilizing structures 3300 described with reference to Figs. 25-46 and the manner in which the cushion module 3150 connects to the positioning and stabilizing structure 3300 are applicable to other examples of the present technology, such as patient interfaces 3000 having separate nasal cushion modules 3160 and oral cushion modules 3170, unless the context requires otherwise. Similarly, it should be understood that any of the features of the cushion module 3150 described with reference to FIGS. 25-46 are applicable to patient interfaces 3000 having alternative positioning and stabilizing structures 3300.

[0363] The patient interface 3000 shown in Figures 47-67 has several similarities and differences in the positioning and stabilising structure 3300 compared to the positioning and stabilising structure 3300 shown in Figures 25-46. It should be understood that the embodiments of the positioning and stabilising structure 3300 described with reference to Figures 25-46 may be applied to the embodiments shown in Figures 47-67 and vice versa, unless the context clearly requires otherwise.

[0364] Figures 25-30 show a patient interface 3000 in accordance with an example of the present technology. Figures 27-29 show the patient interface 3000, along with a positioning and stabilising structure 3300, in use on a patient.

[0365] In this example, the positioning and stabilizing structure 3300 includes a pair of upper straps 3316. Each upper strap 3316 is configured to be positioned on each side of the patient's head above a respective upper ear base point of the patient's head. In this example, the patient interface 3000 includes a pair of upper arms 3311 connected to the chassis portion 3210. Each upper arm 3311 is configured to attach to a respective upper strap 3316 as shown in FIGS. 27-29. In this example, each upper arm 3311 extends superiorly and posteriorly relative to the chassis portion 3210. The upper arms 3311 may also extend laterally relative to the chassis portion 3210. The upper arms 3311 may be flexible in one or more directions, but may be rigid in bending in one or more other directions. For example, the upper arms 3311 may be bent toward the medial and lateral directions to accommodate variations in patient head sizes. However, the upper arm 3311 may be structured to resist bending in the up and down direction, which may help translate the force vector from the upper strap 3316 to the seal-forming structure 3100. In some examples, the upper arm 3311 is overmolded onto the chassis portion 3210. In other examples, the upper arm 3311 may be formed separately and then mechanically connected (e.g., a snap fit connection) to the chassis portion 3210.

[0366] Each upper arm 3311 provides an upper headgear connection point at which a strap portion of the positioning and stabilizing structure 3300 can connect to each upper arm 3311. Each upper arm 3311 may include an upper headgear connection point in the form of an opening (e.g., eyelet or slot) at its end. In the example shown in Figures 25-30, each upper strap 3316 of the positioning and stabilizing structure 3300 passes through an opening in each upper arm 3311 and wraps back and is secured to itself, for example by a hook and loop connection.

[0367] 25-30, the chassis portion 3210 is flexible (but rigid enough to support the membrane portion 3220 and effectively transmit the sealing force vector). The chassis portion 3210 may be formed from Mylar in this example. More specifically, the chassis portion 3210 may be flexible enough to bend in the horizontal plane (e.g., the chassis portion 3210 may be deformed so that its outer sides can move closer together or farther apart), but may not bend in the vertical plane due to its geometry.

[0368] The chassis portion 3210 may include one or more wires that extend from one outside to the other outside of the chassis portion 3210, and adjusting the shape of the wires may selectively adjust the shape (such as curvature or width) of the chassis portion 3210. As shown in particular in FIG. 25, the chassis portion 3210 includes a pair of wires that extend from one outside to the other outside of the chassis portion 3210. In this example, the wires connect the locations where the upper arms 3311 connect to the chassis portion 3210. In other examples, the wires may be positioned such that their ends do not coincide with the ends of the upper arms 3311. The wires may more generally be plastically deformable elements 3266, for example as described with reference to FIG. 48.

[0369] In further examples, there may be no wire. The chassis portion 3210 may be flexible enough to adjust its shape in use without the user using the wire to selectively adjust its shape. In some examples, the upper arm 3311 and the wire may be built together as an assembly and then attached to the chassis portion 3210. The patient or their clinician may plastically deform the wire to selectively adjust the shape of the chassis portion 3210 to achieve a good fit of the patient interface 3000 to the patient's particular anatomy. The flexibility of the chassis portion 3210 may also allow for at least partial decoupling of lateral forces from the seal-forming structure 3100, such as disruptive forces that may occur during lateral sleep when the chassis portion 3210 is pressed against a pillow.

[0370] The upper arm 3311 of the patient interface 3000 shown in Figures 25-30 has a low-profile profile relative to the chassis portion 3210, for example being substantially flush with the exterior surface of the chassis portion 3210. As previously mentioned, in this example, the chassis portion 3210 is constructed to be flush with the surface of the user's cheek in use to maintain a low-profile profile. The upper arm 3311 is also substantially flush with the exterior surface of the chassis portion 3210, such that the cushion module 3150 generally maintains a low-profile profile relative to the patient's face. The upper arm 3311 and chassis portion 3210 are designed such that when worn, the patient interface 3000 sits flush against the cheek and then follows the triangular shape of the nose. The final shape creates a smooth rounded, compact mask volume below the nose and in front of the mouth. This shape may be advantageously conducive to lateral sleeping during use. Advantageously, the cushion module 3150 does not include shoulder features adjacent the sides of the nose that can normally cause the cushion module 3150 to deflect to the side during lateral sleep.

[0371] The positioning and stabilizing structure 3300 of the patient interface 3000 shown in Figures 25-30 also includes a pair of lower straps 3317, each configured to be positioned on each side of the patient's head below a respective lower ear point of the patient's head. The patient interface 3000 also includes a pair of lower arms 3313 extending from the chassis portion 3210, each configured to attach to a respective lower strap 3317. Each lower strap 3317 may be attached to a headgear clip 3315 configured to releasably attach to each lower arm 3313, for example, via a magnetic connection. As shown in Figure 25, each lower arm 3313 includes a lower headgear connection point 3314, which in this example includes a magnet. Each lower arm 3313 may include a magnet attached to the lower arm 3313, for example, by overmolding and attached to an end portion of the lower arm 3313 by being spot-wrapped. The headgear clip 3315 may also include a magnet or may include a magnetic material. In other examples, each lower headgear connection point 3314 may include a magnetic material and the headgear clips 3315 may include magnets. In some examples, the lower arms 3313 are overmolded onto the chassis portion 3210. In other examples, the lower arms 3313 may be formed separately and then mechanically connected (e.g., a snap-fit ​​connection) to the chassis portion 3210.

[0372] In the example shown in Figures 25-30, the patient interface 3000 includes a short tube 3610 fluidly connected at a proximal end to the chassis portion 3210. The short tube 3610 includes a connection port 3600 at a distal end that receives an air flow or other breathable gas from a conduit of the air circuit 4170 connected to the RPT device 4000 in use. The patient interface 3000 includes a vent 3400 provided at the connection of the short tube 3610 to the chassis portion 3210 in this example. The connection between the short tube 3610 and the chassis portion 3210 may be a swivel connection that allows the short tube 3610 to rotate relative to the chassis portion 3210 to help prevent tube traction and may take the form of an elbow. The short tube 3610 may extend forward and / or downward from the cushion module 3150. The patient interface 3000 includes an AAV (not shown) that may also be at the swivel connection.

[0373] 33-37 show a patient interface 3000 according to another example of the present technology. In this example, the patient interface 3000 includes a seal-forming structure 3100 of the type described with reference to Figs. 18-20 and 25-30, e.g. a nasal portion 3101 of the seal-forming structure 3100 taking the form of a nasal pillow, and a membrane portion 3220 forming an oral portion 3102 of the seal-forming structure 3100. The chassis portion 3210, the membrane portion 3220, and the seal-forming structure 3100 may be as described with reference to the patient interface 3000 shown in Figs. 18-20. The patient interface 3000 includes a positioning and stabilizing structure 3300 including a pair of upper straps 3316 and a pair of lower straps 3317. In this example, the patient interface 3000 includes a pair of upper arms 3311, each configured to attach to a respective one of the upper straps 3316. Each upper arm 3311 may extend upwardly and rearwardly relative to the chassis portion 3210 .

[0374] In the example shown in FIGS. 33-37, the patient interface 3000 also includes a pair of lower arms 3313 extending from the chassis portion 3210. Each lower arm 3313 is configured to attach to a respective lower strap 3317 of the positioning and stabilizing structure 3300. In this particular example, each upper arm 3311 extends from each of the lower arms 3313. The lower arms 3313 extend posteriorly from the chassis portion 3210 and the upper arms 3311 extend partially upwardly from the lower arms 3313. Thus, the upper arms 3311 are not directly attached to the chassis portion 3210. This provides a single connection point on each outer side of the patient interface 3000 between the positioning and stabilizing structure 3300 and the cushion module 3150. In other examples, each lower arm 3313 may extend from a respective upper arm 3311 and on each outer side of the patient interface 3000 there may be a single attachment point between the arms 3311 and 3313 and the chassis portion 3210 (created by the connection of the lower arm 3313 to the chassis portion 3210).

[0375] In the example shown in Figures 33-37, each of the upper and lower arms 3311, 3313 includes an eyelet at its end through which each of the upper and lower straps 3316, 3317 is looped and secured back to itself, for example using a hook and loop connection. This is the same manner of connection between the headgear straps and the arms as described above with reference to Figures 25-30. Each of the upper and lower straps 3316, 3317 is connected to and extends from a crown strap 3318 which in use overlies an upper surface of the patient's head and extends downwardly across at least a partially rear-facing surface of the patient's head on either lateral side of the patient's head to connect to the upper and lower straps 3316, 3317. The crown straps 3318 engage the upper and rear surfaces of the patient's head to provide anchors for the upper straps 3316 and lower straps 3317 such that the upper straps 3316 and lower straps 3317 are in tension between the cushion module 3150 and the crown straps 3318.

[0376] FIG. 38 illustrates a patient interface 3000 similar to that shown in FIGS. 33-37, but with a positioning and stabilizing structure 3300 that provides an alternative type of connection between the lower strap 3317 and the lower arm 3313. In this example, the lower arm 3313 extends from the chassis portion 3210 and the upper arm 3311 extends from the lower arm 3313 in the same manner as shown in FIGS. 33-37. However, in FIG. 38, the lower strap 3317 includes a headgear clip 3315 that is configured to releasably attach to a headgear connection point on the lower arm 3313. The headgear clip 3315 may be magnetically attached to the lower arm 3313 (e.g., in the same manner as the lower headgear connection point 3314 shown and described above with reference to FIG. 25). This may allow for quick connect and quick disconnect attachment between the lower straps 3317 and the lower arms 3313, so that the patient may quickly disconnect the lower straps 3317 from the lower arms 3313 when taking the patient interface 3000 off, and quickly connect when donning. In this example, the patient interface 3000 also includes a crown strap 3318 (from which extend the upper straps 3316 and lower straps 3317).

[0377] 39 shows a patient interface 3000 according to another example of the present technology, where the cushion module 3150 includes two headgear connections on each of its outer sides. In this example, the patient interface 3000 does not include an upper arm 3311. In this example, the cushion module 3150 includes an eyelet on each of its outer sides. The eyelets may be formed by portions of the chassis portion 3210, or may be formed by components attached to the chassis portion 3210, in examples. Each of the upper straps 3316 can be wrapped through a respective eyelet provided on the cushion module 3150 and secured back to itself, for example, using a hook and loop connection. The cushion module 3150 also includes a lower arm 3313 to which a lower strap 3317 of the positioning and stabilizing structure 3300 can be connected. In this example, the lower strap 3317 includes a headgear clip 3315 configured to releasably attach to a lower headgear connection point on the lower arm 3313 (which may take the same form as the lower headgear connection point 3314 shown and described with respect to FIG. 25 ). In this example, the patient interface 3000 also includes a crown strap 3318 from which extend the upper strap 3316 and the lower strap 3317.

[0378] 40-46 show a patient interface 3000 according to another example of the present technology. In this example, the patient interface 3000 includes a cushion module 3150 similar to that described with reference to Figs. 33-39. Many of the features and characteristics of the membrane portion 3220, chassis portion 3210, and undercushion 3225 (described below) are the same as those described with reference to Figs. 33-39. However, in this example, the patient interface 3000 includes a positioning and stabilizing structure 3300 including conduit headgear. As shown, the positioning and stabilizing structure 3300 includes a pair of gas delivery tubes 3350. The chassis portion 3210 includes a pair of openings configured for the gas delivery tubes 3350 to connect to the chassis portion, the openings being sized and configured to receive airflow from the gas delivery tubes 3350 at a therapeutic pressure for breathing by the patient. The gas delivery tube 3350 is configured to carry an air supply from a connection port 3600 on the top of the patient's head to a plenum chamber 3200 in the cushion module 3150 defined by the chassis portion 3210 and the membrane portion 3220. The gas delivery tube 3350 may be configured to be disconnected from the chassis portion 3210, for example for cleaning. Features of the positioning and stabilizing structure 3300 in the form of conduit headgear are described elsewhere herein, for example with reference to Figures 7-13 and 18-24.

[0379] In this particular example, the gas delivery tube 3350 includes a textile outer layer. The textile material may be very comfortable to the user and the appearance of the patient interface 3000 may resemble sleepwear rather than a medical device. The gas delivery tube 3350 may be thermoformed to a shape and may include a foam inner layer and may include a sealing layer in the form of a film applied to the inner surface of each gas delivery tube 3350. The patient facing outer surface of each gas delivery tube 3350 may be substantially flat and wide, which may distribute forces on the patient's head and face over a large area and provide a comfortable fit.

[0380] In the example shown in Figures 40-46, each of the gas delivery tubes 3350 connects to a respective outside of the cushion module 3150, and in particular to the chassis portion 3210. The chassis portion 3210 defines a pair of plenum chamber inlet ports through which the plenum chamber 3200 can receive a supply of air at therapeutic pressure for breathing by the patient. The attachment of the gas delivery tubes 3350 to the chassis portion 3210 aids in the stability of the patient interface 3000. The gas delivery tubes 3350 function as both a conduit for supplying air and as part of the positioning and stabilizing structure 3300, and aid in holding the cushion module 3150 in place with a good seal and good stability. In this example, the cushion module 3150 also includes a tight curvature in the chassis portion 3210, which allows the chassis portion 3210 to be highly flexible enough to bend about a vertical centerline and easily absorb potentially destructive forces that may be experienced during use, for example, lateral sleep.

[0381] As shown in FIG. 46, the positioning and stabilizing structure 3300 includes a pair of lower straps 3317 configured to be positioned on each side of the patient's head below the respective lower ear points of the patient's head; in this example, the lower straps 3317 each include a headgear clip 3315 configured to releasably attach to the cushion module 3150. The headgear clips 3315 may attach to the chassis portion 3210 with a magnetic connection. As shown in FIGS. 40, 41, 44, and 45, the cushion module includes a lower arm 3313 having a lower headgear connection point 3314 to which the headgear clips 3315 on the lower straps 3317 are releasably attached. The lower headgear connection point 3314 may be the same as that shown and described with reference to FIG. In this example, the lower strap 3317 is elastically stretchable to enable the positioning and stabilizing structure 3300 to withstand changes in the orientation of the patient's head and, in particular, changes in the distance between the patient's chin and the posterior surface of the patient's neck adjacent the base of the user's head.

[0382] In this example, the patient interface 3000 includes a pair of lower arms 3313 extending from the chassis portion 3210, each configured to attach to a respective lower strap 3317 of the positioning and stabilizing structure 3300. Each lower arm 3313 may include a lower headgear connection point where each lower strap 3317 can connect, for example, to a magnetic connection point (e.g., a magnet or magnetic material). In this example of the technology, on each lateral side of the chassis portion 3210, each lower arm 3313 is connected to the chassis portion 3210 directly adjacent a respective gas delivery tube 3350. This arrangement has the appearance of a single headgear connection on each lateral side of the cushion module 3150, which makes the patient interface 3000 appear smaller and easier to fit.

[0383] The positioning and stabilizing structure 3300 further includes back straps 3319 configured to connect the gas delivery tubes 3350 together and configured to overlie or underlie the occipital bone of the patient's head in use. The back straps 3319 may be connected to lower straps 3317 behind the patient's head and / or neck. As shown, the back straps 3319 are located on each side of the patient's head, with at least a portion of the back straps 3319 located above the superior ear base point. The back straps 3319 may connect to the gas delivery tubes 3350 above the superior ear base point.

[0384] [5.3.5.6.7 Undercushion] In some examples of the present technology, the patient interface 3000 includes an undercushion. The patient interface 3000 shown in Figs. 25-30 includes an undercushion 3225 behind the membrane portion 3220 visible in Fig. 26. The undercushion 3225 may be attached to the chassis portion 3210 and configured to engage an interior surface of the membrane portion 3220 to support the membrane portion 3220 in use. The undercushion 3225 may be configured to engage any one or more of a chin region of the membrane portion 3220 configured to contact a chin region of the patient's face in use, a cheek region of the membrane portion 3220 configured to contact a patient's cheek in use, and a nose region of the membrane portion 3220 configured to contact a patient's nose in use. In some examples, the undercushion 3225 may be located behind the cheek region of the membrane portion 3220 and behind the chin region of the membrane portion 3220. In some examples, the undercushion may be located behind only the chin region of the membrane portion 3220. It should be understood that in some examples of the present technology, the patient interface 3000 does not have an undercushion.

[0385] Figures 31 and 32 show views of the patient interface 3000 shown in Figures 25-30, but with portions removed including the membrane portion 3220 to expose the undercushion 3225. In this example, the undercushion 3225 engages the chin region of the membrane portion 3220, the cheek portions of the membrane portion, and the nose region of the membrane portion 3220. The undercushion 3225 is configured to engage the membrane portion 3220 around the entire periphery of the membrane portion 3220 in this example.

[0386] The undercushion 3225 may be formed from a flexible and resilient material, such as an elastomer (e.g., silicone or TPE). The undercushion 3225 may be molded onto the chassis portion 3210, for example, when the undercushion 3225 is formed from an elastomer and the chassis portion 3210 is formed from Mylar, polycarbonate, or the like, or a rigid textile material. The undercushion 3225 may take the form of a flange and may extend inwardly from the periphery of the chassis portion 3210. The undercushion 3225 is structured to act as a cantilever support to hold the membrane portion 3220 against the patient's face during use. In some examples, the undercushion 3225 may be formed from the same material as the chassis portion 3210 and may be integrally formed with the chassis portion 3210. In further examples, the undercushion 3225 may be attached to the chassis portion 3210.

[0387] The undercushion 3225 may deform together with the membrane portion 3220 to conform to the shape of the patient's face when engaged with the patient's face. The upper portion of the undercushion 3225 shown in Figures 31-32 is configured to flex and conform to the patient's nose and cheeks when the patient wears the patient interface 3000. The upper portion of the undercushion 3225 may have a thickness in the range of 0.5-1.5 mm, in the range of 0.75-1.25 mm, or may have a thickness of 1 mm, for example. The lower portion of the undercushion 3225 is configured to flex and conform to the chin area (e.g., adjacent to the patient's supramentum and subcutis and above the chin protuberance). The lower portion of the undercushion 3225 may vary in thickness. For example, an inner portion of the lower portion of the undercushion 3225 may be thinner than an outer portion of the lower portion of the undercushion 3225. This may provide comfort to the patient during use.

[0388] In the example shown in FIGS. 31-32, the undercushion 3225 includes a pair of wing portions 3227. The wing portions 3227 extend inward relative to the periphery of the undercushion 3225. Each wing portion 3227 is configured to bias the membrane portion 3220 to seal against the patient's face in an area proximate to each of the patient's alae, such as the area between the patient's nasolabial fold and the labial fold. The wing portions 3227 may bias the membrane portion 3220 against an area of ​​the patient's face below and / or outside the patient's alae (e.g., the corners of the nose). In examples where the undercushion 3225 takes the form of a flange, the wing portions 3227 may be extensions of the flange (e.g., a flange portion that extends inward to a greater extent than other flange portions). In some examples, the wing portions 3227 are integrally formed with other portions of the undercushion 3225. In other examples, the wing portions 3227 may be formed separately from the rest of the undercushion 3225. The undercushion 3225 may be formed from multiple separate pieces in some examples. In the example shown in FIGS. 31-32, the undercushion 3225 has a unitary construction. The wing portions 3227 may each extend inwardly in an in-use orientation of the patient interface 3000. As shown in FIGS. 31-32, the undercushion 3225 may define an opening through which air may flow from the plenum chamber 3200 to the patient's airway. The wing portions 3227 may divide the opening into a nasal portion of the opening and an oral portion of the opening.

[0389] In the example shown in FIGS. 25-32, the patient interface 3000 also includes a pair of ribs 3226 extending between the chassis portion 3210 and each of the wing portions 3227 to provide support to each wing portion 3227, respectively. The ribs 3226 may provide support to the wing portions 3227 by resisting compression and / or buckling. The ribs 3226 may act as struts and resist movement of the wing portions 3227 toward the interior surface of the chassis portion 3210. The ribs 3226 may be formed from the same material as the undercushion 3225, such as silicone, for example, and may be integrally formed with the undercushion 3225. In other examples, the ribs 3226 may be formed from the same material as the chassis portion 3210 and may be integrally formed with the chassis portion 3210. The ribs 3226 may be 1 mm thick in one example. In some examples, the patient interface 3000 does not include ribs 3226 and only the undercushion 3225 supports the membrane portion 3220.

[0390] The undercushion 3225 of the patient interface 3000 shown in Figures 25-32 also includes a rim 3228. The rim 3228 may space a portion of the membrane portion 3220 from the undercushion 3225. In this example, the membrane portion 3220 is attached to the rim 3228, which is structured to space the membrane portion 3220 from the undercushion 3225 at least around the periphery of the undercushion 3225. The rim 3228 of the undercushion 3225 may provide a connection surface where the membrane portion 3220 is connected to the undercushion 3225, the connection surface being raised above the remainder of the undercushion 3225 (which is a flange in the example shown in Figures 31-32). The connection surface may be 2 mm raised above the remainder of the undercushion 3225. The width of the connection surface may be, for example, 2 mm. The rim 3228 may have a square or rectangular cross-section. In some examples, the connecting surface may be more (or less) than 2 mm in width and may rise above the remainder of the undercushion by more (or less) than 2 mm. The membrane portion 3220 may be attached to the connecting surface.

[0391] The patient interface 3000 shown in Figures 33-37 also includes an undercushion 3225. Figure 35 shows the undercushion 3225 as hidden detail behind the chassis portion 3210. In this view, the nasal pillows forming the nasal portion 3101 of the seal-forming structure 3100 are also visible as hidden detail, along with the perimeter edge of the oral opening in the membrane portion 3220. In this example of the present technology, the undercushion 3225 does not extend around the entire periphery of the chassis portion 3210. The undercushion 3225 extends from a position adjacent one of the patient's cheeks in use, downwardly and medially to intersect the sagittal plane, and then laterally and upwardly to a position adjacent the other of the patient's cheek. The undercushion 3225 may be configured to engage a chin region of the membrane portion 3220 configured to contact the chin region of the patient, and may be configured to engage a cheek region of the membrane portion 3220 configured to contact the cheek of the patient in use. However, the undercushion 3225 does not extend to the nose portion of the cushion module 3150. That is, in this example, there is no undercushion 3225 behind the nose portion of the membrane portion 3220 that is configured to contact the patient's nose. The undercushion 3225 may include ends that are located behind the membrane portion 3220 at the patient's lips and / or the user's cheeks on either side of the nose. Without the undercushion 3225 behind the membrane portion 3220 at the patient's nose, a cushion module 3150 may be obtained that has an undercushion that at least supports the membrane portion 3220 against the patient's cheeks and chin while still being easier or more cost-effective to manufacture. The lack of an undercushion 3225 in the nasal region of the cushion module 3150 may also provide good comfort since the patient's nose is not pressed into the undercushion 3225, and may also provide a good seal since the thin membrane portion 3220 is free to deform so that the nasal pillows can hug the nose and move into the correct orientation to seal to the extent required for the patient's particular facial geometry. Additionally, tension in the membrane portion 3220 alone may be sufficient to hold the nasal pillows in place for setup and use.

[0392] The patient interface shown in Figures 40-46 also includes an undercushion 3225. The undercushion 3225 is shown as hidden detail in Figure 44. As shown, this is substantially identical to the undercushion 3225 of the patient interface 3000 shown in Figures 33-37.

[0393] 5.3.5.7 Plenum chamber connected to frame 14-17 show an example of a patient interface 3000 in which the seal-forming structure 3100 and the membrane portion 3220 are substantially the same as the examples shown in FIGS. 7-13, with differences. All disclosures made above regarding the plenum chamber 3200, the chassis portion 3210, the membrane portion 3220, and the seal-forming structure 3100 should be understood to be applicable to the example shown in FIGS. 14-17, unless otherwise stated or the context clearly requires otherwise. In this example, the patient interface 3000 does not have a conduit headgear. Instead, the patient interface 3000 includes a positioning and stabilizing structure 3300 including a pair of headgear strap portions 3310 (which in some examples may be rigidified). The positioning and stabilizing structure 3300 holds the plenum chamber 3200 and the seal-forming structure 3100 in place during use. The patient interface 3000 also includes a frame 3320 and a stub tube 3610. In this example, the plenum chamber 3200 and the seal-forming structure 3100 form a cushion module 3150.

[0394] [5.3.5.7.1 Strap Part] Each of the strap portions 3310 is located on each side of the patient's head in use. In some examples, the strap portions 3310 are connected to one another at the back of the patient's head, for example by a buckle. In other examples, the strap portions 3310 are integrally formed with one another. That is, they may be part of one length of headgear strap. Each strap portion 3310 may be located above a respective upper ear base point of the patient's head. The strap portions 3310 may be configured to lie on the parietal bone of the patient's head in use. In some examples, the strap portions 3310 may be connected to or formed with a bifurcated strap portion between the two strap portions 3310 configured to rest against the back and / or upper back surface of the patient's head.

[0395] The overall length of the strap portions 3310 may be selectively adjustable by a user, for example, with a buckle between the two strap portions 3310. In some examples, the strap portions 3310 may be elastically extensible such that, when worn by a patient, tension is generated within the strap portions 3310 to pull the seal-forming structure 3100 towards the patient's airway and resist forces that tend to separate the seal-forming structure 3100 from the patient's face.

[0396] 5.3.5.7.2 Frames The patient interface 3000 also includes a frame 3320 in the example shown in FIGS. 14-17. In this example, the plenum chamber 3200 of the patient interface 3000 is connected to the frame 3320. The chassis portion 3210 may be configured to connect to the frame 3320. Each of the strap portions 3310 is also connected to the frame 3320. The frame 3320 may be substantially rigid (e.g., not easily deformed by finger pressure alone) and may be formed from polycarbonate as an example. In other examples, the frame 3320 may be semi-rigid (e.g., bendable at least to some extent by finger pressure and / or when tension is present in the headgear strap portions 3310). The frame 3320 may curve in a left to right direction and may include a curvature that corresponds to the curvature of the front side of the chassis portion 3210. In some examples, the curvature of the frame 3320 may follow the curvature of the front boundary of the membrane portion 3220.

[0397] The plenum chamber 3200 may be larger than the frame 3320 such that the chassis portion 3210 extends beyond the frame 3320 by approximately 2-3 mm on each side of the frame.

[0398] [5.3.5.7.3 Short pipe] While the patient interface 3000 shown in Figures 7-13 includes conduit headgear where the plenum chamber 3200 receives airflow at therapeutic pressure via a gas delivery tube 3350, the patient interface 3000 shown in Figures 14-17 includes a short tube 3610 through which the plenum chamber 3200 receives airflow. The plenum chamber 3200 includes a central opening that receives airflow from the short tube 3610. The central opening of the plenum chamber 3200 may form a plenum chamber inlet port.

[0399] The short tube 3610 may be a short length of tubing having a connection port 3600 at its end distal to the patient. A longer conduit forming part of the air circuit 4170 between the RPT device 4000 and the patient interface 3000 may fluidly connect to the short tube 3610 at the connection port 3600. The short tube 3610 may include a swivel connector forming the connection port 3600. The short tube 3610 may advantageously function to at least partially decouple a conduit connected to the connection port 3600 from the seal-forming structure 3100. The short tube 3610 may be considered to form part of the patient interface 3000.

[0400] The frame 3320 may also include a central opening through which airflow enters the plenum chamber 3200. The central opening in the frame 3320 may be aligned with the central opening in the plenum chamber 3200 and may be aligned with the stub tube 3610. In this particular example, the plenum chamber 3200 connects to the frame 3320 around the periphery of the central opening in the frame 3320. In this example, the frame 3320 includes a flange around the periphery of the central opening through which the plenum chamber 3200 can connect.

[0401] The plenum chamber 3200 also includes a chassis portion 3210 and a membrane portion 3220, as shown in the example of Figures 7-13. A central opening in the plenum chamber 3200 may be formed in the chassis portion 3210. The chassis portion 3210 may be formed from silicone and may connect to the frame 3320 around the central opening of the frame 3320 using a stretch fit connection.

[0402] 5.3.5.7.4 Connections between frame parts and strap parts In the example shown in Figures 14-17, the plenum chamber 3200 includes two outer openings through which air may be exhausted from the plenum chamber 3200, for example, for gas flushing. Each outer opening in the plenum chamber 3200 may be on the outer side of the central opening and may be formed by a hole in the chassis portion 3210. Each outer opening may be aligned with a corresponding vent 3400 in the frame 3320 in use. Air from the plenum chamber 3200 may pass through the outer openings in the chassis portion 3210 and then through the corresponding vent 3400 in the frame 3320. Each vent 3400 may be formed by one or more openings in the frame 3320 through which air may pass.

[0403] The frame 3320 may include exterior openings that correspond to the exterior openings in the chassis portion 3210. The frame 3320 may include flanges around the exterior openings in the frame 3320, and the exterior openings in the chassis portion 3210 may stretch fit to the flanges around the exterior openings in the frame 3320. The chassis portion 3210 may be connected to the frame 3320 at each exterior opening and at a central opening of the frame 3320. In the example shown in FIGS. 14-17, each exterior opening in the frame 3320 includes a plurality of holes that form a vent 3400.

[0404] In this example, the headgear strap portions 3310 are configured to connect to the frame 3320 on an opposite side of the frame 3320 to the plenum chamber 3200. The headgear strap portions 3310 each include a connector 3312 configured to attach to a corresponding connection point on the frame 3320. Each connector 3312 can be attached to a respective connection point at a location corresponding to a respective vent 3400 in the frame. For example, the vent 3400 may be provided around or formed with the headgear strap connection point. Thus, in this example, the patient interface 3000 includes a split vent arrangement.

[0405] [5.3.5.8 Textile chassis parts] 47-55, in some examples, the patient interface 3000 may include a chassis portion 3210 constructed at least in part from a textile material. In some examples, the textile is coated with an air impermeable coating, such as a silicone coating. In some examples, the chassis portion 3210 is formed from bresoprene. In some examples, the chassis portion 3210 may be formed from foam. The chassis portion 3210 may form a portion of the cushion module 3150 of the patient interface 3000.

[0406] The chassis portion 3210 can be constructed to be sufficiently stiff to maintain a predetermined three-dimensional shape throughout the patient's respiratory cycle. The stiffness can result from the geometry of the chassis portion 3210 and / or the chassis portion 3210 can be thermoformed such that the material (e.g., a textile material) forming the chassis portion 3210 is inherently rigid. In some examples, the chassis portion 3210 can include folded portions that contribute to its stiffness. For example, portions of textile can be folded and joined to other portions, thereby creating a structure that can maintain a three-dimensional shape throughout the patient's respiratory cycle.

[0407] 50, an example of a blank 3250 for a textile chassis portion 3210 is shown. FIG. 51 shows the blank 3250 with two lower edges 3252 of the blank 3250 joined together such that the blank 3250 generally adopts the form of a cone or frustum of a cone, with a joint 3254 between the two edges 3252 located on the lower portion of the chassis portion 3210. In the example shown, the chassis portion 3210 does not have a seam or join above the opening 3256 through which the inlet port connector 3605 of the patient interface 3000 extends in use. In some examples, the chassis portion 3210 may appear substantially circular or oval when viewed from the front.

[0408] 51 , a lower portion of the blank 3250 is folded inwardly along an outwardly extending crease 3258, and an outer edge 3260 of a flap 3262 formed by this fold 3258 is connected to an inner surface 3264 of the chassis portion 3210. In this manner, the chassis portion 3210 is made to be sufficiently stiff or rigid to maintain its three-dimensional shape throughout the patient's respiratory cycle.

[0409] In instances where the textile chassis portion 3210 is thermoformed, it may not be necessary to include the flaps 3262 shown in FIG. 51, and the shape of the blank 3250 may be changed accordingly.

[0410] In an example, a plastically deformable element 3266, such as a thin steel wire or ribbon, may extend outwardly across the chassis portion 3210, as best shown in FIG 48. The plastically deformable element 3266 may be deformed by the patient to make the chassis portion 3210 wider or narrower as needed.

[0411] In particular, referring now to FIG. 47, in some examples, the chassis portion 3210 has a non-zero negative first principal curvature PC1 and a substantially zero second principal curvature PC2, where the second principal curvature PC2 is substantially parallel to the patient's sagittal plane in use.

[0412] In an example, the patient interface 3000 includes an inlet port connector 3605 extending through the lower wall 3268 of the chassis portion 3210, as best shown in FIG 55. In an example, the inlet port connector 3605 has a central axis AA that, in use, extends in a substantially inferior direction, as shown, for example, in FIG 48.

[0413] The inlet port connector 3605 may be configured to fluidly connect to a short tube 3610, for example as shown in Figures 47-49 or as described in any other example elsewhere herein. The short tube 3610 may connect to the inlet port connector 3605 at a proximal end of the short tube 3610 and may include a connection port 3600 for connecting to the RPT device 4000, for example, via a long conduit of the air circuit 4170. In other examples, the short tube 3610 is not provided and the inlet port connector 3605 provides a connection port 3600 of the patient interface 3000 that connects to the RPT device 4000 via a conduit of the air circuit 4170.

[0414] In some examples, the patient interface 3000 may be very compact such that the exterior of the inlet port connector 3605 contacts or is located very close to the foam undercushion 3225 and contacts the front wall of the chassis portion 3210. In some examples, the front wall 3270 of the chassis portion 3210 may have a cutout 3272 to allow the inlet port connector 3605 to protrude therethrough, as shown for example in FIG. 48. In examples, the depth of the bottom portion of the cushion module 3150 (e.g., the distance from the textile membrane portion 3220 to the front wall 3270 of the chassis portion 3210) may be substantially equal to the diameter of the inlet port connector 3605 plus the thickness of the foam undercushion 3225. The depth of the top portion of the cushion module 3150 may be substantially equal to the thickness of the foam undercushion 3225 plus the thickness of the textile chassis portion 3210.

[0415] In some examples, the exterior surface of the chassis portion 3210 at a location 3274 directly adjacent the inlet port connector 3605 has a radius substantially equal to the radius of the exterior, immediately adjacent portion of the inlet port connector 3605. In examples, a central front portion 3276 of the chassis portion 3210 (shown in FIG. 47 ), which extends from the top of the chassis portion 3210 to the bottom of the chassis portion 3210, can have a radius substantially the same as the radius of the inlet port connector 3605.

[0416] The patient interface 3000 shown in Figures 47 and 48 includes a vent 3400 which may be as described elsewhere herein. In one form, the patient interface 3000 may include a vent module 3410 including the vent 3400 which is releasably connectable to the chassis portion 3210 by the patient such that the vent 3400 may be disconnected and reconnected from the chassis portion 3210, for example for cleaning or replacement. The vent may take any form described herein.

[0417] [5.3.5.8.1 Headgear Connector] In an example, the patient interface 3000 includes a pair of upper headgear connectors 3301 and a pair of lower headgear connectors 3302. For example, in the example shown in Figures 47 and 48, the upper headgear connectors 3301 include upper arms 3311 that are elastically deformable but may be rigidified to resist bending in one or more directions. Each upper arm 3311 may include a strap connector portion 3340 at its distal end. The strap connector portions 3340 may include loops, slots, or the like.

[0418] The lower headgear connector 3302 of the example of Fig. 47 includes a lower arm 3313 that may be rigidified as described for the upper arm 3311. Any suitable type of headgear connector may be used for the lower headgear connector 3302, for example a magnetic connector provided at the end of the lower arm 3313.

[0419] In some examples, one or more of the headgear connectors 3301, 3302 may be releasably connected to the chassis portion 3210. That is, the connectors themselves may be repeatedly connected and disconnected from the chassis portion 3210 (rather than the connectors simply being repeatedly connectable and disconnectable from the headgear). In examples, the headgear connectors may be connected to the chassis portion 3210 by snap fasteners.

[0420] This method of connection between the headgear connectors and the chassis portion 3210 means that the chassis portion 3210 is replaceable and the headgear connectors 3301, 3302 can be removed and reused with a new chassis portion 3210. For example, the headgear connectors 3301 and 3302 can be removed so that the chassis portion 3210 and the seal-forming structure 3100 can be replaced together.

[0421] [5.3.5.8.2 Foam undercushion] 52, the seal-forming structure 3100 includes a foam undercushion 3225. In one form of the present technology, the foam undercushion 3225, when connected to the chassis portion 3210, is shaped to extend around the patient's mouth and under the anterior and lateral portions of the periphery of the alar base of the patient's nose. In use, the foam undercushion 3225 supports the textile membrane portion 3220. The undercushion 3225 has at least one opening 3112 that allows air to flow to the patient's airway.

[0422] In an example, the foam undercushion 3225 is made from a polyurethane, such as a thermoplastic polyurethane, or a soft thermoplastic elastomer. In an example, the undercushion material is soft enough that it does not cause substantial discomfort when engaged with the face.

[0423] In examples, the foam making up the undercushion 3225 is substantially air impermeable, for example the foam may be a skinned foam.

[0424] As shown in FIG. 53, the undercushion 3225 (e.g., prior to attachment to the chassis portion 3210) may have a substantially triangular shape, with one side 3114 of the triangle having a somewhat convex shape (e.g., corresponding to the portion under the mouth that fits into the seal-forming structure).

[0425] 53, in other examples, a foam undercushion 3225 having a substantially triangular shape may include a support portion 3116 that, in use, extends from outside inward to engage the corners of the patient's nose where the nose and mouth meet and / or ensures that the textile membrane portion 3220 is adequately supported (e.g., engages the patient's face at the corners of the patient's nose) in the area where the patient's nose meets the patient's face. In examples, the support portion 3116 may be compressed in use to abut the corners of the patient's nose or to abut the patient's face at or adjacent the corners of the nose, such as between the ala of the nose and the nasolabial fold.

[0426] [5.3.5.8.3 Textile membranes] As described elsewhere herein, the seal-forming structure 3100 may include a sealing flange that utilizes a pressure-assisted sealing mechanism. The sealing flange may include a textile membrane portion 3220, although in other examples alternative materials such as silicone may be used. In use, the sealing flange may readily respond to system positive pressure within the plenum chamber 3200 (acting on its bottom surface) to bias it into tight sealing engagement with the face. The pressure-assisted mechanism may work in conjunction with elastic tension in the positioning and stabilizing structure.

[0427] 55, for example, the patient interface 3000 includes a textile membrane portion 3220 connected around its perimeter 3140 (e.g., around the entire perimeter) to a patient-facing side of a foam undercushion 3225. In the example, the only connection between the textile membrane portion 3220 and the foam undercushion 3225 is at the perimeter 3140 of the textile membrane portion 3220. When subjected to therapeutic pressure inside the plenum chamber 3200, the textile membrane portion 3220 may "balloon up" under pressure and move away from the undercushion 3225 and towards the patient's face. This allows the textile membrane portion 3220 to conform to the shape of the patient's face.

[0428] In examples, the textile membrane portion 3220 is configured to form a seal around at least the anterior and lateral portions of the perimeter of the base of the alar of the patient's nose and / or the sides of the nose portion immediately adjacent to the lower perimeter. In some examples, the membrane portion 3220 may engage with the tip area, alar, and cuspids of the user's nose. In some examples, the membrane portion 3220 may engage with the area of ​​the patient's face between the alar and the nasolabial fold.

[0429] In examples, the entire textile membrane portion 3220 is integrally formed from a single textile sheet. For example, the textile membrane portion 3220 may not include a seam.

[0430] 54, in one form, the textile membrane portion 3220 can include an outer perimeter 3140 and an inner perimeter 3142 that defines the edges of the hole. In examples, the width W of the textile membrane portion 3220, measured between the outer perimeter 3140 and the inner perimeter 3142, can be greatest at the portion of the membrane that is intended to seal within the corner of the patient's nose where the patient's nose meets the face. In some examples, the membrane portion 3220 can form inwardly extending "wings" 3144 in this region.

[0431] In some instances, to prevent rupture of the textile membrane portion 3220 at these portions, a connecting portion or "bridge" may be provided between them.

[0432] 49, the textile membrane portion 3220 may include a first hole 3146 through which air may flow from the plenum chamber 3200 to the patient's nares and a second hole 3148 through which air may flow from the plenum chamber 3200 to the patient's mouth. The membrane portion 3220 may extend between the first and second holes 3146, 3148. In an example, only two holes 3146, 3148 are provided.

[0433] In examples having two holes, such as the example shown in FIG. 49, the textile membrane portion 3220 may form a seal around the entrance to the patient's nostrils and may form a separate seal around the patient's mouth.

[0434] The textile membrane portion 3220 may be coated with an air impermeable coating, such as a silicone coating. In one example, the silicone coating is substantially 0.05 mm thick and the textile membrane portion 3220 including the coating is substantially 0.3 mm thick. The coating may be on the non-patient contact side of the textile membrane portion 3220.

[0435] 49 and 55, the textile membrane portion may include a knitted fabric. The membrane portion 3220 may be highly flexible so as to easily conform to the shape of the patient's face.

[0436] The pressure activated highly compliant textile membrane portion 3220 allows for a tight seal. The compliant textile membrane portion 3220 can conform to a variety of facial shapes when subjected to treatment pressure.

[0437] In other examples of the present technology, the membrane portion 3220 can be as described elsewhere herein. In some examples, the membrane portion 3220 can be formed from silicone. In some examples, the membrane portion 3220 can be formed from a silicone sheet. In some examples, the membrane portion 3220 can be formed from unmolded silicone such that it does not have a predetermined three-dimensional shape. More generally, the membrane portion 3220 can be formed from a process other than molding and can be formed as a sheet.

[0438] Any feature of the textile membrane portion 3220 described with reference to Figures 47-55 may be applied to a patient interface 3000 according to another example of the present technology, such as any example disclosed herein. Similarly, any feature of the membrane portion 3220 of any other patient interface 3000 described herein may be applied to the patient interface 3000 of Figures 47-55.

[0439] 5.3.5.9 Frames made from resiliently flexible materials Exemplary patient interfaces 3000 of the present technology may be lightweight, particularly in comparison to some other patient interfaces of the prior art. For example, patient interfaces of the present technology may weigh less than 50 grams, and more preferably less than 45 grams. For example, the patient interface 3000 of Figures 56-58, including the chassis portion 3210, the foam undercushion 3225, the textile membrane portion 3220, the upper arm 3311, the lower headgear connection point 3314, and the integral short tube 3610, may weigh substantially 44.6 grams.

[0440] In one form of the present technology, the chassis portion 3210 is formed from a resiliently flexible material. In an example, the chassis portion 3210 is formed from a polymer, such as biaxially oriented polyethylene terephthalate, such as Mylar®. The material may be less than 0.5 mm thick, such as 0.25 mm thick. In another example, the chassis portion 3210 may be formed from silicone. Alternatively, the chassis portion 3210 may be as described elsewhere herein by another example of the present technology.

[0441] In the example, the chassis portion 3210 is curved to have a first non-zero principal curvature PC1 and a substantially zero second principal curvature PC2, as shown diagrammatically in FIG.

[0442] In an example, the patient interface 3000 is configured such that the second principal curvature PC2 is substantially parallel to the sagittal plane of the patient in use (eg, lies in the sagittal plane of the patient's head in use).

[0443] The chassis portion 3210 may be formed from a flat sheet of material that is held in a curved configuration by the seal-forming structure 3100, or the chassis portion 3210 may be inherently curved, for example, thermoformed, molded, or otherwise manufactured to have an inherent curve. In an example, the chassis portion 3210 may be stamped from a sheet of material, although other methods of forming the chassis portion 3210 are possible, such as any other method or manner described herein.

[0444] As shown in Fig. 58 and 59, in some forms of the present technology, the chassis portion 3210 comprises a pair of upper headgear connectors 3301 and a pair of lower headgear connectors 3302. In examples, the chassis portion 3210 also comprises an inlet port connector 3605 for connection to an air delivery tube in use (e.g., a releasable connection). In examples, the frame 3240 comprises at least one vent 3400 for gas flushing, which may be as described elsewhere herein. The patient interface 3000 may also include an AAV, for example integrated into the inlet port connector 3605.

[0445] In instances where the chassis portion 3210 is relatively thin and flexible and has a substantially zero principal curvature substantially aligned with the sagittal plane, the chassis portion 3210 may bend relatively easily, such that the magnitude of the first principal curvature PC1 may vary when the patient interface 3000 is worn. For example, the magnitude of the first principal curvature PC1 may be relatively large when the patient interface 3000 is worn by a patient with a relatively narrow face (e.g., the chassis portion 3210 may be curved more, as shown in exaggerated form in FIG. 60, which shows the patient interface 3000 squeezed into a narrow configuration by the patient), but may be smaller when the patient interface 3000 is worn by someone with a relatively wide face (e.g., the chassis portion 3210 may be relatively "flat," as shown, for example, in FIG. 59). In this manner, the patient interface 3000 may be adaptable to fit patients with a variety of different sized faces.

[0446] [5.3.5.9.1 Foam undercushion] 59 and 61, the seal-forming structure 3100 includes an undercushion 3225 formed from foam. The foam undercushion 3225 is shaped to extend around the patient's mouth and around the anterior and lateral portions of the periphery of the alar base of the patient's nose. An example of a patient interface 3000 made by the present technology may be referred to as a miniature full face mask.

[0447] The foam undercushion 3225 is preferably removably connected to the chassis portion 3210. In one example, the foam undercushion 3225 includes a channel 3130, shown in Figures 61, 62, and 63, configured to engage an outer edge of the chassis portion 3210. In an example, the channel 3130 is configured to engage the entire perimeter 3241 of the chassis portion 3210. If the patient wishes to separate the seal-forming structure 3100 from the chassis portion 3210 (e.g., to clean or replace the seal-forming structure 3100), the foam undercushion 3225 can be peeled away from the chassis portion 3210.

[0448] The connection between the foam undercushion 3225 and the chassis portion 3210 is substantially airtight. That is, a seal is formed between the foam undercushion 3225 and the chassis portion 3210. In one example, the channel 3130 is defined in part by a flexible lip 3131 at the edge of the undercushion 3225 that extends across and seals the chassis portion 3210. In an example, the lip 3131 is molded into the undercushion 3225 using the undercushion material (e.g., foam). This allows the connection between the chassis portion 3210 and the undercushion 3225 to remain flexible.

[0449] In examples, other connector mechanisms may be provided in addition to or as an alternative to the channel 3130 engagement portions described above. For example, in one embodiment, one or more snap fasteners 3132 are provided to connect the foam undercushion 3225 to the chassis portion 3210 as shown generally in FIG. 64. In another example, the foam undercushion 3225 may include one or more substantially rigid clipping portions 3133 that engage with the frame 3240 as shown generally in FIG.

[0450] In an example, the foam undercushion 3225 has a shape and configuration in at least some areas that reduces its resistance to compression by the patient's face (e.g., less resistance to compression than other areas). For example, as shown in FIG. 61, the foam undercushion 3225 may have a substantially "C" shaped cross-section that is relatively easily compressed, although other suitable cross-sectional shapes may also be used. In an example, the cross-sectional shape may vary around the periphery of the foam undercushion 3225 such that some portions of the foam undercushion 3225 (e.g., portions at the nose) are more easily compressed than other portions (e.g., portions around the mouth).

[0451] 66, in one example, the area of ​​the foam undercushion 3225 that receives the tip of the patient's nose has a depth d1 of 14 mm and a height h1 of 12 mm. In this particular example, the undercushion 3225 has a maximum depth d2 of 21 mm at the portion that engages the patient's cheek on the side of the patient's mouth. The width of this area may be 13 mm. The undercushion 3225 may have a depth d3 of 15 mm and a height h3 of 15 mm at the portion below the patient's mouth. In an example, the height, width, and / or depth of the undercushion 3225 may vary between the chassis portion 3210 and the textile membrane portion 3220. That is, the undercushion 3225 may not have a constant cross-section.

[0452] Referring to FIG. 68, which shows one example of the foam undercushion 3225 alone, the upper portion 3280 of the undercushion 3225, which is configured to engage the bottom surface of the patient's nose, includes a vertical portion 3281, a horizontal portion 3282, and a chamfered or angled portion 3283 between the vertical and horizontal portions, and is formed as a surface of revolution about a superior-subordinate axis A.

[0453] In examples, the foam undercushion 3225 is made from a polyurethane, such as a thermoplastic polyurethane, or from a soft thermoplastic elastomer. Foams having the following characteristics may be suitable: ● Deflection due to force: 95+ / -20N @40% (Test specification: AS 2282.8 Method A) ● Density: 54.5+ / -2.5kg / m3 (Test Specification: AS 2282.3) ● Air permeability: <1.5l / min @20cmH2O (R630-602 Permeability Test (Annular) Procedure).

[0454] Foam materials having different properties than those mentioned above may be used in other examples of the present technology, in one form of the present technology, polyethylene foam may be used.

[0455] In an example, the foam may be substantially water impermeable so that the mask, if washed earlier in the day, can be allowed to dry sufficiently before use in the evening.

[0456] In an example, the undercushion material is soft enough so as not to cause substantial discomfort when engaging the face, yet firm enough to maintain the frame and hold it in a sealing manner when the patient interface is worn.

[0457] In examples, the foam making up the undercushion is substantially air impermeable, for example the foam may be a skinned foam.

[0458] In use, the foam undercushion 3225 supports the textile membrane portion 3220.

[0459] [5.3.5.9.2 Textile membranes] 59 and 61, in one form the seal-forming structure 3100 includes a textile membrane portion 3220 that functions as a pressure assisted sealing mechanism. In use, the textile membrane portion 3220 can readily respond to system positive pressure inside the plenum chamber 3200 (acting on its bottom surface) to bias it into tight sealing engagement with the face. The pressure assisted mechanism can work in conjunction with elastic tension in the positioning and stabilizing structure 3300.

[0460] In an example, the textile membrane portion 3220 is connected at its perimeter 3140 to the patient-facing side of the foam undercushion 3225 so that the membrane is substantially taut when not in use. In an example, the only connection between the textile membrane portion 3220 and the foam undercushion 3225 is at the perimeter 3140 of the textile membrane portion 3220. When subjected to therapeutic pressure inside the plenum chamber 3200, the textile membrane portion 3220 may "balloon up" under pressure as shown at 3220a. This allows the textile membrane to conform to the shape of the patient's face.

[0461] In an example, the textile membrane portion 3220 is formed from a single textile sheet. The textile membrane portion 3220 may include a first hole 3146 through which air may flow from the plenum chamber 3200 to both nostrils of the patient, and a second hole 3148 through which air may flow from the plenum chamber 3200 to the patient's mouth. The membrane portion 3220 may extend between the first and second holes 3146, 3148. In another example (not shown), the membrane portion 3220 may have a single hole for both the patient's mouth and nostril. In an example, the membrane portion 3220 may effectively have only a single hole, but the opposing outer sides of the membrane portion 3220 at the edge of the hole may be connected by a bridge portion, e.g., a textile bridge portion. In another example, the membrane portion 3220 may include an oral hole and two nostrils, each configured to be in fluid communication with a respective nostril of the patient's nose in use.

[0462] The textile membrane portion 3220 may have a coating and thickness as described elsewhere herein, for example as described with reference to the examples shown in Figures 47-55, or as described with reference to any other example herein.

[0463] The textile membrane portion 3220 may include a knitted fabric. The membrane portion 3220 may be highly flexible so as to easily conform to the shape of the patient's face. In examples, the textile may include polyamide (e.g., nylon), polyester, and / or elastane (e.g., spandex).

[0464] In one example, a textile having the following characteristics may be used: ● Single jersey knit; ● Content: 80% polyamide, 20% elastane; ● Density: 136 courses per inch, 75 wales per inch; ● Weight: 105g / m2; and ● Elongation at 1.5kg: length 80-108%, width 93-126%.

[0465] In other examples, the textile material may have different properties than those mentioned above.

[0466] In an example, the chassis portion 3210 and the foam undercushion 3225 are shaped such that the patient-facing side 3121 of the textile membrane portion 3220 lies on a continuous convex curve 3235 when viewed in a cross section through a sagittal plane (e.g., the central sagittal plane) as shown in FIG.

[0467] For example, the textile membrane portion 3220 may be free of secondary geometric features that may create wrinkles, allowing the membrane to remain in a wrinkle-free configuration when the patient interface 3000 is not in use. When the patient interface 3000 is applied to the face, the membrane portion 3220 will flex and conform to the face around the periphery of the nose and mouth cavities as this may be the initial point of engagement.

[0468] A highly compliant textile membrane portion 3220 that is pressure activated may allow for a tight seal. The compliant textile membrane portion 3220 may conform to a variety of face shapes when subjected to treatment pressure. The compliant nature of the textile membrane and / or the large area of ​​the membrane in contact with the patient's face may help reduce pressure build-up areas between the seal-forming structure 3100 and the patient's face, as prior art seal-forming structures may be less compliant. In some examples, the textile may be a fine knit. The textile surface may be low friction so that the patient can easily position the cushion module 3150 when wearing the patient interface 3000, and so that the fabric does not leave wrinkles when in contact with the patient's skin.

[0469] [5.3.5.9.3 Connectors for positioning and stabilizing structures] As shown in Figures 58 and 59, in an example, connectors for connecting the positioning and stabilising structure 3300 to the patient interface 3000 are provided on the chassis portion. In an example, the chassis portion 3210 comprises a pair of upper headgear connectors 3301 and a pair of lower headgear connectors 3302. The upper headgear connectors 3301 and the lower headgear connectors 3302 may be as previously described with reference to the examples shown in Figures 47-55.

[0470] In the example shown in Figures 47-55 the patient interface 3000 includes a lower arm 3313 having a magnetic connection point at its end, while in the example shown in Figures 56-67 the chassis portion 3210 includes a lower headgear connection point 3314 in the form of a magnet attached directly to the chassis portion 3210. In this example the lower headgear connection point 3314 is configured to magnetically connect to a headgear connector provided on a lower strap of the positioning and stabilizing structure 3300. The patient interface 3000 shown in Figures 47-68 may include a positioning and stabilizing structure 3300 as shown in Figures 27 and 28 by way of example only.

[0471] The upper arm 3311 may include an outwardly extending portion 3332 and a rearwardly extending portion 3334. The rearwardly extending portion 3334 may also extend in an upward direction in use.

[0472] [5.3.6 Decoupling structures (singular or plural)] In one form, the patient interface 3000 includes at least one decoupling structure, such as a swivel or ball and socket.

[0473] [5.3.7 Connection Port] The connection port 3600 allows connection to the air circuit 4170 .

[0474] [5.3.8 Forehead support] In one form, the patient interface 3000 includes a forehead support 3700.

[0475] [5.3.9 Anti-asphyxiation valve] In one form, the patient interface 3000 includes an anti-asphyxiation valve.

[0476] 5.3.10 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 within the plenum chamber 3200, such as pressure, to be directly measured.

[0477] [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 may be configured to generate an airflow for delivery to a patient's airway to treat one or more of the respiratory conditions described elsewhere herein.

[0478] In one form, the RPT device 4000 is constructed and arranged to deliver air flow 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.

[0479] The RPT device may have an outer housing 4010 formed in 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 ...

Claims

1. 1. A patient interface, comprising: a chassis portion at least partially defining a plenum chamber pressurizable to a therapeutic pressure of at least 4 cmH2O above ambient air pressure, said plenum chamber including a plenum chamber inlet port sized and configured to receive an air flow at said therapeutic pressure for breathing by a patient; a seal-forming structure including a pair of nasal pillows, each nasal pillow constructed and arranged to form a seal with a respective nostril of the patient's nose, each nasal pillow having a hole therein such that the airflow at the therapeutic pressure is delivered to at least a nostril of the patient, 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 membrane portion connected to said chassis portion and at least partially forming said plenum chamber, said nasal pillows being supported on said membrane portion, said membrane portion being constructed and arranged to be flexible in use to permit relative movement between said nasal pillows and said chassis portion, said membrane portion having no predetermined three-dimensional shape in the absence of positive pressure relative to atmospheric pressure in said plenum chamber; a vent for allowing a continuous flow of gases exhaled by the patient from within the plenum chamber to the surroundings, the vent being sized and shaped to maintain the therapeutic pressure within the plenum chamber in use; The patient interface is configured such that, in the absence of pressurized air flow through the plenum chamber inlet port, the patient interface allows the patient to breathe from the environment through his or her mouth or the patient interface is configured to leave the patient's mouth uncovered.

2. The patient interface of claim 1 , wherein the membrane portion is stretchable.

3. The patient interface of claim 2 , wherein the membrane portion is constructed and arranged to expand and contract during inflation when the plenum chamber is pressurized to the therapeutic pressure in use.

4. A patient interface according to any one of claims 1 to 3, wherein the membrane portion is constructed and arranged to expand, in use, to conform to one or more portions of the patient's nose.

5. A patient interface according to any preceding claim, wherein the membrane portion is constructed and arranged to inflate, in use, to bias each of the nasal pillows towards each of the patient's nares.

6. A patient interface according to any one of claims 1 to 5, wherein the membrane portion is configured to engage, in use, the patient's vasculature.

7. A patient interface according to any preceding claim, wherein the membrane portion is formed at least in part from a textile material.

8. The patient interface of claim 7 , wherein the membrane portion includes a textile layer and an air impermeable layer.

9. The patient interface of claim 7, wherein each of the nasal pillows is formed from an elastomeric material.

10. The patient interface of any one of claims 1 to 7, wherein the membrane portion is formed from an elastomer.

11. The patient interface of claim 10 , wherein the membrane portion is formed from silicone.

12. A patient interface according to claim 10 or 11, wherein the membrane portion is in the form of a sheet connected to the chassis portion at edges of the membrane portion.

13. The patient interface of any one of claims 1 to 12, wherein the chassis portion is formed from an elastomeric material.

14. A patient interface according to any preceding claim, wherein the nasal pillows are formed separately from and attached to the membrane portion.

15. A patient interface according to any preceding claim, wherein each of the nasal pillows is devoid of a stalk.

16. 16. The patient interface of claim 1, wherein each of the nasal pillows includes a frusto-conical portion having a tip and a base that is wider than the tip, the base being directly attached to the membrane portion.

17. A patient interface according to any preceding claim, wherein each nasal pillow is formed from a different material than the membrane portion.

18. A patient interface of any one of claims 1 to 16, wherein each of the nasal pillows is formed from an elastomeric material.

19. The patient interface of claim 18, wherein each of the nasal pillows is formed from silicone.

20. A patient interface of any one of claims 1 to 16, wherein each of the nasal pillows is formed at least in part from a textile material.

21. A patient interface of any one of claims 1 to 20, wherein each of the nasal pillows is formed from a single wall.

22. A patient interface of any one of claims 1 to 20, wherein each of the nasal pillows is formed from a double wall structure.

23. 23. The patient interface of any one of claims 1 to 22, wherein the seal-forming structure further comprises an oral portion configured to form a seal around a mouth of the patient such that the air flow at the therapeutic pressure is delivered to the patient's mouth.

24. The patient interface of claim 23 , wherein the membrane portion forms an oral portion of the seal-forming structure.

25. 25. The patient interface of any one of claims 1 to 24, wherein the patient interface comprises a positioning and stabilising structure that provides a force to hold the seal-forming structure in a therapeutically effective position on the patient's head, the positioning and stabilising structure comprising a tie, the tie constructed and arranged to overlie at least a portion of the patient's head in use above a superior auricular point of the patient's head.

26. 26. The patient interface of claim 25, wherein the positioning and stabilizing structure includes a pair of gas delivery tubes, and the chassis portion includes a pair of outwardly projecting connection portions configured to connect to the gas delivery tubes and sized and configured to receive an air flow at the therapeutic pressure for breathing by the patient.

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