Patient Interface

Abstract

The patient interface may include a plenum chamber having a mouth region and a nose region, and a positioning and stabilizing structure configured to generate a force to hold the seal-forming structure on the patient's head. The plenum chamber may include a seal-forming structure constructed and arranged to form a seal with the patient's face, the nose region of the seal-forming structure having at least one nostril and the mouth region of the seal-forming structure having a mouth hole, and a shell supporting the seal-forming structure, the shell having one or more plenum chamber inlet ports sized and configured to receive airflow at a therapeutic pressure for breathing by the patient throughout the patient's respiratory cycle in use.

Description

[Technical field]

[0001] The present technology relates to one or more of screening, diagnosing, monitoring, treating, preventing and ameliorating respiratory-related disorders. The present technology also relates to medical devices or apparatus and uses thereof.

[0002] A portion of the disclosure of this patent document contains material which is subject to copyright protection. The copyright owner has no objection to the reproduction by any person of this patent document or the patent disclosure by facsimile, for purposes of disclosure in the Patent and Trademark Office patent file or records, but reserves all copyright rights thereto for all other purposes.

[0003] (CROSS REFERENCE TO RELATED APPLICATIONS)

[0004] This application claims the benefit of U.S. Provisional Patent Application No. 62 / 649,376, filed March 28, 2018, and U.S. Provisional Patent Application No. 62 / 731,456, filed September 14, 2018, both of which are incorporated by reference in their entireties. [Background technology]

[0005] 2.2.1 The human respiratory system and its diseases

[0006] The body's respiratory system facilitates gas exchange. The nose and oral cavity form the entrance to a patient's airways.

[0007] These 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 enter the venous blood from the air and carbon dioxide to leave. The trachea divides into right and left main bronchi, which further divide into terminal bronchioles. The bronchi constitute the conducting airways and do not participate in gas exchange. The airways further divide into respiratory bronchioles and finally into alveoli. Gas exchange occurs in the alveolar region of the lungs, which is called the respiratory region. See: "Respiratory Physiology", by John B. West, Lippincott Williams & Wilkins, 9th edition published 2012.

[0008] There is a range of respiratory diseases. Particular diseases can be characterized by particular manifestations such as apnea, hypopnea and hyperpnea.

[0009] Examples of respiratory diseases include obstructive sleep apnea (OSA), Cheyne-Stokes respiration (CSR), respiratory failure, obesity hyperventilation syndrome (OHS), chronic obstructive pulmonary disease (COPD), neuromuscular diseases (NMD) and chest wall diseases.

[0010] Obstructive sleep apnea (OSA) is a form of sleep-disordered breathing (SDB) characterized by episodes of closure or obstruction 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 region of the tongue, soft palate and posterior oropharyngeal wall during sleep. The condition causes affected patients to pause in breathing, typically for 30-120 seconds, sometimes as many as 200-300 times per night. This results in excessive daytime sleepiness, which can lead to cardiovascular disease and brain damage. The condition is common, especially in middle-aged, overweight men, but patients are asymptomatic. See U.S. Pat. No. 4,944,310 (Sullivan).

[0011] Cheyne-Stokes respiration (CSR) is another form of sleep-disordered breathing. CSR is a disease of the patient's respiratory regulator, followed by alternating periods of waxing and waning of ventilation, known as the CSR cycle. CSR is characterized by repeated deoxygenation and reaeration of arterial blood. Because of the repeated hypoxia, CSR can be harmful. In some patients, CCR is accompanied by recurrent sleep arousals that cause severe insomnia, increased sympathetic activity, and increased afterload. See U.S. Patent No. 6,532,959 (Berthon-Jones).

[0012] Respiratory failure is a general term for respiratory disorders that refers to the inability of the lungs to take in enough oxygen or breathe out enough CO2 to meet the patient's needs. Respiratory failure can include some or all of the following conditions:

[0013] Patients with respiratory failure (a type of respiratory insufficiency) may experience abnormal shortness of breath during exercise.

[0014] 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.

[0015] Chronic obstructive pulmonary disease (COPD) encompasses any of a group of lower airway diseases that share certain common characteristics. These include increased resistance to air movement, prolongation of the expiratory phase of breathing, and a decrease in the normal elasticity of the lungs. Examples of COPD include emphysema and chronic bronchitis. Causes of COPD include chronic smoking (the primary risk factor), occupational exposure, air pollution, and genetic factors. Symptoms include dyspnea on exertion, chronic cough, and sputum production.

[0016] 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 damage, resulting in inability to walk, wheelchair confinement, difficulty swallowing, respiratory muscle weakness, and ultimately death due to respiratory failure. Neuromuscular disorders can be classified as rapidly and slowly progressive: (i) rapidly progressive disorders, characterized by muscle damage that worsens over months and leads to death within a few years (e.g., amyotrophic lateral sclerosis (ALS) and Duchenne muscular dystrophy (DMD) in teenagers); (ii) variable or slowly progressive disorders, characterized by muscle damage that worsens over years and only slightly reduces life expectancy (e.g., limb-girdle, facioscapulohumeral, and myotonic muscular dystrophies). Symptoms of respiratory failure in NMD include: increasing generalized weakness, difficulty swallowing, dyspnea on exertion and at rest, fatigue, drowsiness, morning headache, and difficulty concentrating and mood changes.

[0017] Chest wall disorders are a group of thoracic deformities that result in ineffective connections between the respiratory muscles and the rib cage. These disorders are primarily characterized by restrictive defects and share the potential for long-term hypercapnic respiratory insufficiency. Scoliosis and / or kyphoscoliosis can lead to severe respiratory insufficiency. Symptoms of respiratory insufficiency include: dyspnea on exertion, peripheral edema, orthopnea, recurrent chest infections, morning headache, fatigue, poor quality of sleep, and loss of appetite.

[0018] A range of treatments are available to treat or ameliorate such conditions, and otherwise healthy individuals may also benefit from preventative treatments for respiratory disease, but these suffer from a number of deficiencies.

[0019] 2.2.2 Treatment

[0020] A variety of therapies are used to treat one or more of the above-mentioned respiratory disorders, including continuous positive airway pressure (CPAP) therapy, non-invasive ventilation (NIV) and invasive ventilation (IV).

[0021] Continuous positive airway pressure (CPAP) therapy has been used in the treatment of obstructive sleep apnea (OSA). Its mechanism of action is that CPAP therapy acts as a pneumatic splint, for example by pushing the soft palate and tongue forward or backward against the posterior oropharyngeal wall, which may prevent the upper airway from closing. Because the treatment of OSA with CPAP therapy may be voluntary, patients may choose not to comply with the treatment if they perceive one or more of the following from the device used to deliver the treatment: uncomfortable, difficult to use, expensive, or aesthetically unappealing.

[0022] Non-invasive ventilation (NIV) provides ventilatory support to a patient through the upper airway to assist in breathing by performing some or all of the respiratory functions and / or to maintain adequate oxygen levels in the body. Ventilatory support is provided through a non-invasive patient interface. NIV is used to treat forms of CSR and respiratory failure such as OHS, COPD, NMD, and chest wall disorders. In some forms, it may improve the comfort and effectiveness of these treatments.

[0023] Invasive ventilation (IV) provides ventilatory support to patients who can no longer breathe effectively on their own and may be provided using a tracheotomy tube. In some forms, the comfort and effectiveness of these treatments may be improved.

[0024] 2.2.3 Treatment system

[0025] These therapies may be provided by a therapeutic system or device. Such systems and devices may also be used to screen, diagnose, or monitor a disease without treating it.

[0026] The treatment system may include a respiratory pressure treatment device (RPT device), an air circuit, a humidifier, a patient interface, and data management.

[0027] Another form of treatment system is a mandibular repositioning device.

[0028] 2.2.3.1 Patient Interface

[0029] The patient interface may be used to provide the wearer with an interface to the respiratory appliance, for example by providing airflow to the airway entrance. Airflow may be provided via a mask to the nose and / or mouth, a tube to the mouth, or a tracheotomy tube to the patient's trachea. Depending on the therapy being applied, the patient interface may form a seal, for example, with an area of ​​the patient's face, thereby facilitating gas delivery at a pressure of sufficient dispersion with ambient pressure for therapy to be performed (e.g., at a positive pressure of about 10 cmH2O relative to ambient pressure). In other forms of therapy, such as oxygen delivery, the patient interface may not include a seal sufficient to facilitate delivery of a gas supply to the airway at a positive pressure of about 10 cmH2O.

[0030] Certain other mask systems may be functionally inadequate in the field, for example masks that are purely decorative may not be able to maintain adequate pressure, mask systems used for underwater swimming or diving may be configured to protect against water intrusion from higher external pressures and not maintain internal air at pressures higher than ambient.

[0031] Certain masks may be clinically unsuitable for use with this technology (eg, if the mask blocks airflow through the nose and only allows airflow through the mouth).

[0032] In certain masks, where the patient must insert part of the mask structure into their mouth and create and maintain a seal via the lips, this may be uncomfortable or impractical in the art.

[0033] Certain masks may be impractical for use while sleeping (eg, when sleeping on one's side in bed with head on a pillow).

[0034] There are several challenges in designing a patient interface: The face has a complex three-dimensional shape. The size and shape of the nose and head vary greatly between individuals. Because the head contains bone, cartilage and soft tissue, different regions of the face respond differently to mechanical forces; i.e., the chin or mandible may move relative to other bones of the skull. The entire head may move throughout the respiratory treatment period.

[0035] These challenges may result in one or more of the following: some masks may be intrusive, aesthetically undesirable, costly, poor fit, difficult to use, and uncomfortable, especially if the wear time is long or the patient is unfamiliar with the system. If the wrong size mask is used, this may lead to poor compliance, poor 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 for their intended use, such masks may be undesirably uncomfortable to wear for extended periods of time (e.g., several hours). Such discomfort may result in poor patient compliance with the treatment. This is especially true if the mask must be worn while sleeping.

[0036] CPAP therapy is highly effective in treating certain respiratory diseases if the patient complies with the therapy. If the mask is uncomfortable or difficult to use, the patient 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), the patient may not be able to clean the mask, which may affect patient compliance.

[0037] Masks for other uses (e.g., for aviators) may be unsuitable for use in treating sleep-disordered breathing, and masks designed for use in treating sleep-disordered breathing may be suitable for other uses.

[0038] For these reasons, patient interfaces for CPAP delivery during sleep form a distinct field.

[0039] 2.2.3.1.1 Seal formation structure

[0040] The patient interface may include a seal-forming structure. Because the patient interface is in direct contact with the patient's face, the shape and configuration of the seal-forming structure may have a direct impact on the effectiveness and comfort of the patient interface.

[0041] The patient interface may be characterized in part according to the design intent of 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 encloses both nostrils in use. Such a single element may be designed to rest, for example, on the upper lip region and nose bridge region of the face. In one form of the patient interface, the seal-forming structure may include an element that encloses the oral cavity 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 encloses both nostrils and the mouth region in use. These different types of patient interfaces may be known by various names such as nasal masks, full face masks, nasal pillows, nasal puffs, and oronasal masks by their manufacturers.

[0042] A seal-forming structure that may be effective in one area of ​​a patient's face may be inappropriate in another area due to, for example, different shapes, structures, variability, and sensitive areas of the patient's face. For example, the seal of swim goggles that rests on the patient's forehead may be inappropriate for use on the patient's nose.

[0043] 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. To the extent 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 may need to be adapted in order to form a seal.

[0044] 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 comprised of an elastomer such as rubber. With this type of seal-forming structure, if the fit is improper, a gap will develop between the seal-forming structure and the face, requiring additional force to press the patient interface against the face to achieve a seal.

[0045] Another type of seal-forming structure uses a thin flap seal located around the periphery of the mask to provide a self-sealing action against the patient's face when positive pressure is applied within the mask. As with the previous type of seal-forming portion, if the fit between the face and the mask is poor, 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, the seal-forming portion may fold or buckle during use, causing leakage.

[0046] Other types of seal-forming structures may include friction-fit elements that are inserted into the nostrils, for example, but some patients find these seal-forming parts uncomfortable.

[0047] Another form of seal-forming structure may use adhesives to achieve a seal. Some patients find it inconvenient to constantly apply and remove adhesives from their face.

[0048] A range of patient interface seal forming structures are disclosed in the following patent applications (assigned to ResMed Limited: WO1998 / 004,310; WO2006 / 074,513; WO2010 / 135,785).

[0049] One form of nasal pillow is found in the Adam line manufactured by Puritan Bennett. Another nasal pillow or nasal puff is the subject of U.S. Patent No. 4,782,832 (Trimble et al.), assigned to the Puritan-Bennett Corporation.

[0050] ResMed Limited manufactures the following products that use nasal pillows: SWIFT® Nasal Pillows Mask, SWIFT® II Nasal Pillows Mask, SWIFT® LT Nasal Pillows Mask, SWIFT® FX Nasal Pillows Mask and MIRAGELIBERTY® Full Face Mask. Embodiments of nasal pillows masks are described in the following patent applications assigned to ResMed Limited: International Patent Application WO 2004 / 073,778 (which describes, among other things, aspects of ResMed Limited's SWIFT® nasal pillows); U.S. Patent Application No. 2009 / 0044808 (which describes, among other things, aspects of ResMed Limited's SWIFT® LT nasal pillows); International Patent Applications WO 2005 / 063,328 and WO 2006 / 130,903 (which describe, among other things, aspects of ResMed Limited's MIRAGE LIBERTY® full face mask); and International Patent Application WO 2009 / 052,560 (which describes, among other things, aspects of ResMed Limited's SWIFT® FX nasal pillows).

[0051] 2.2.3.1.2 Positioning and stabilization

[0052] Seal-forming structures in patient interfaces used in positive air therapy experience corresponding forces from the air pressure that disrupt a seal, and therefore a variety of techniques are used to position the seal-forming structures and maintain a seal against the appropriate portion of the face.

[0053] In one technique, adhesives are used, see, for example, US Patent Application Publication US2010 / 0000534, but adhesives can be uncomfortable.

[0054] Another technique involves the use of one or more straps and / or stabilizing harnesses, many of which suffer from one or more of the following problems: poor fit, bulkiness, discomfort and awkwardness.

[0055] 2.2.3.2 Respiratory Pressure Therapy (RPT) Devices

[0056] Respiratory pressure therapy (RPT) devices may be used individually or as part of a system to deliver one or more of the therapies described above, for example by actuating the device to generate an air delivery flow to an interface to the airway. This air flow may be pressurized. Examples of RPT devices include CPAP devices and mechanical ventilators.

[0057] 2.2.3.3 Humidifier

[0058] 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, the application of warm air to the facial area surrounding the patient interface generally provides more comfort than cool air.

[0059] 2.2.3.4 Data Management

[0060] For clinical reasons, data may be obtained to determine whether a patient prescribed respiratory treatment is "compliant" (e.g., whether the patient complies with one or more "compliance rules" with their RPT device). One example of a compliance rule for CPAP treatment may require a patient to 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 treatment with the RPT device, calculate a usage rate over a period of time, and compare this to the compliance rules. Once the healthcare provider determines that the patient has used their RPT device in accordance with the compliance rules, the healthcare provider may notify a third party that the patient is compliant.

[0061] There may be other aspects of a patient's care that would benefit from communication of treatment data to third parties or external systems.

[0062] Existing processes for communicating and managing such data can be one or more of: costly, time consuming, and error prone.

[0063] 2.2.3.5 Mandibular repositioning

[0064] Mandibular repositioning devices (MRDs) or mandibular advancement devices (MADs) are a treatment option for sleep apnea and snoring. They are adjustable oral appliances available from dentists or other suppliers that hold the mandible (lower jaw) in an anterior position during sleep. MRDs are removable devices that are inserted into the oral cavity before the patient sleeps and removed afterwards. As such, MRDs are not designed for full-time wear. MRDs may be custom made or manufactured in standard forms and include bite impression sites designed to fit the patient's teeth. This mechanical protrusion from the mandible expands the space behind the tongue and applies tension on the pharyngeal walls to reduce airway collapse and reduce palate vibration.

[0065] In certain examples, the mandibular advancement device may include an upper splint intended to engage or mate with teeth on the upper jaw or maxilla, and a lower splint intended to engage or mate with teeth on the upper jaw or mandible. The upper and lower splints are laterally connected to each other via a pair of connecting rods that are fixed symmetrically on the upper and lower splints.

[0066] In such a design, the length of the connecting rod is selected so that the mandible is held in an anterior position when the MRD is placed in the patient's mouth. The length of the connecting rod can be adjusted to vary the level of protrusion of the mandible. The dentist can determine the level of protrusion required for the mandible, which in turn determines the length of the connecting rod.

[0067] Some MRDs are configured to push the mandible forward relative to the maxilla, while others, such as the ResMed Narval CC® MRD, are designed to hold the mandible in an anterior position. The device also reduces or minimizes dental and temporomandibular joint (TMJ) side effects. As such, the device is configured to minimize or avoid any movement of one or more of the teeth.

[0068] 2.2.3.6 Ventilation technology

[0069] Some forms of treatment systems may include a vent to push out exhaled carbon dioxide, which may allow gas flow from an interior space of the patient interface (e.g., a plenum chamber) to an exterior of the patient interface (e.g., the surroundings).

[0070] The vent may include an orifice through which gas may flow when the mask is in use. Many such vents are noisy. Others may become blocked when in use, resulting in insufficient pumping. Some vents may disrupt sleep for the patient 1000 and bed companion 1100, for example, due to noise or airflow concentration.

[0071] ResMed Limited has developed several improved mask ventilation technologies, see International Patent Application Publication No. WO1998 / 034,665; International Patent Application Publication No. WO2000 / 078,381; U.S. Patent No. 6,581,594; U.S. Patent Application Publication No. US2009 / 0050156; U.S. Patent Application Publication No. 2009 / 0044808.

[0072] Conventional mask noise table (ISO17510-2:2007, 10cmH2O pressure at 1m)

[0073] [Table 1]

[0074] ( * (Only one sample was measured at 10cmH2O in CPAP mode using the test method specified in ISO3744)

[0075] The sound pressure values ​​of various objects are listed below.

[0076] [Table 2]

[0077] 2.2.4 Screening, diagnostic and surveillance systems

[0078] Polysomnography (PSG) is a conventional system for diagnosing and monitoring cardiopulmonary diseases, which typically requires expert clinical staff for system application. In PSG, typically 15-20 contact sensors are placed on the human body to record various body signals (e.g., electroencephalography (EEG), electrocardiography (ECG), electrooculography (EOG), electromyography (EMG)). For PSG of sleep-disordered breathing, patients need to be observed for two nights in a specialized hospital; the first night is purely for diagnosis, and the second night is required for titration of treatment parameters by the clinician. Therefore, PSG is expensive and inconvenient. Screening / diagnosis / monitoring of sleep-disordered breathing is particularly unsuitable at home.

[0079] In general, screening and diagnosis are the identification of disease by signs and symptoms of the disease. Screening usually produces a true / false result indicating whether or not a patient's SDB warrants further investigation, whereas diagnosis often produces clinically actionable information. Screening and diagnosis tend to be one-time procedures, whereas monitoring the progression of the disease can continue indefinitely. Some screening / diagnostic systems are adapted for screening / diagnosis only, while some can be used for monitoring as well.

[0080] A clinical expert may adequately screen, diagnose, or monitor a patient based on visual observation of the PSG signal. However, there are situations where a clinical expert is not available or cannot be paid. Different clinical experts may have different opinions about a patient's condition. Furthermore, a given clinical expert may apply different criteria at different times. Summary of the Invention [Means for solving the problem]

[0081] 3. Brief description of the technology

[0082] The present technology relates to the provision of medical devices for use in screening, diagnosing, monitoring, ameliorating, treating or preventing respiratory diseases, which medical devices have one or more of improved comfort, cost, effectiveness, ease of use and manufacturability.

[0083] A first aspect of the present technology relates to devices for use in screening, diagnosing, monitoring, ameliorating, treating or preventing respiratory disease.

[0084] Another aspect of the present technology relates to methods for use in the screening, diagnosis, monitoring, amelioration, treatment or prevention of respiratory disorders.

[0085] One aspect of certain forms of the present technology is to provide methods and / or devices that improve patient compliance with respiratory treatment.

[0086] Aspects of the present technology relate to a patient interface including a plenum chamber including a seal-forming structure, a shell, and a positioning and stabilizing structure, wherein an at least partially anterior wall of a nasal portion of the seal-forming structure includes two lateral support portions that are laterally spaced apart, each of the lateral support portions having a higher resistance to deformation relative to an adjacent portion of the seal-forming structure.

[0087] One aspect of the present technology relates to a patient interface comprising a plenum chamber pressurizable in use to a therapeutic pressure of at least 6 cmH2O above ambient air pressure throughout a patient's respiratory cycle, said plenum chamber having a mouth portion and a nose portion, said plenum chamber comprising a seal-forming structure constructed and arranged to form a seal against an area of ​​the patient's face surrounding an entrance to the patient's airways, said nose portion of said seal-forming structure having at least one nasal hole configured in use to deliver an airflow at said therapeutic pressure to an entrance to the patient's nares, and said mouth portion of said seal-forming structure having a mouth hole configured in use to deliver an airflow at said therapeutic pressure to an entrance to the patient's mouth, said seal-forming structure constructed and arranged to maintain said therapeutic pressure in the plenum chamber throughout a patient's respiratory cycle, a plenum chamber including a seal-forming structure and a shell supporting said seal-forming structure having one or more plenum chamber inlet ports sized and configured to receive airflow at a therapeutic pressure for breathing by a patient throughout the patient's respiratory cycle in use; and a positioning and stabilizing structure configured to generate a force to hold the seal-forming structure in a therapeutically effective position on the patient's head, said shell being joined to the mouth region of said plenum chamber, said seal-forming structure forming substantially the entirety of said nasal region, said nasal region of said plenum chamber including a posterior corner configured to engage the patient's face adjacent said nasolabial fold, and at least a partially anterior wall of the nasal region of the seal-forming structure including two lateral support regions each laterally spaced apart, each lateral support region having a higher resistance to deformation relative to an adjacent portion of the seal-forming structure.

[0088] In examples of the two embodiments above, (a) each of the lateral support portions may be thicker than adjacent portions of the seal-forming structure; (b) each of the lateral support portions may have a curved upper boundary, and each of the lateral support portions may be substantially fin-like in shape; (c) the nasal portions of the seal-forming structure may include a central portion configured to seal against an inferior periphery of the patient's nose around the patient's nares and the patient's upper lip in use, and the central portion may be thinner than the lateral support portions; (d) the nasal portions of the seal-forming structure may include an intermediate portion disposed between the central portion and the lateral support portions, and the intermediate portion may be thicker than the central portion; (e) the intermediate portion may be thinner than the lateral support portions; (f) the shell may include a posterior protrusion configured to stiffen the seal-forming structure at the base of the nasal portions in use; and / or (g) the seal-forming structure may be configured not to engage the patient's face below the chin in use.

[0089] Aspects of the present technology relate to a patient interface including a plenum chamber including a seal-forming structure, a shell, and a positioning and stabilizing structure, the shell including two lateral support portions projecting upwardly into a wall at least partially anterior to the nasal portion of the seal-forming structure, the lateral support portions being each laterally spaced apart.

[0090] One aspect of the present technology relates to a patient interface comprising a plenum chamber pressurizable in use to a therapeutic pressure of at least 6 cmH2O above ambient air pressure throughout a patient's respiratory cycle, said plenum chamber having a mouth portion and a nose portion, said plenum chamber comprising a seal-forming structure constructed and arranged to form a seal against an area of ​​a patient's face surrounding an entrance to the patient's airways, said nose portion of said seal-forming structure having at least one nasal hole configured in use to deliver an airflow at said therapeutic pressure to an entrance to the patient's nares, said mouth portion of said seal-forming structure having a mouth hole configured in use to deliver an airflow at said therapeutic pressure to an entrance to the patient's mouth, said seal-forming structure comprising: a plenum chamber including a seal-forming structure constructed and arranged to maintain the therapeutic pressure in the plenum chamber throughout the patient's respiratory cycle; a shell configured to support the seal-forming structure, the shell having one or more plenum chamber inlet ports sized and configured to receive an air flow at the therapeutic pressure for breathing by the patient throughout the patient's respiratory cycle in use; and a positioning and stabilizing structure configured to generate a force to hold the seal-forming structure in a therapeutically effective position on the patient's head, the shell including two lateral support portions protruding upwardly into a wall at least partially anterior to the nasal portion of the seal-forming structure, each of the lateral support portions being laterally spaced apart.

[0091] In examples of the above two embodiments, (a) each of the lateral support portions may have a curved upper boundary, (b) the curvature of the curved upper boundary may substantially match or substantially follow the curvature of the upper periphery of the seal-forming structure, (c) the shell may include two plenum chamber inlet ports, and / or (d) the upper boundary of each of the two plenum chamber inlet ports may be formed by a respective lateral support portion.

[0092] Aspects of the present technology relate to a patient interface including a plenum chamber including one or more walls, a seal-forming structure, one or more plenum chamber inlet ports, and a positioning and stabilizing structure, the seal-forming structure including a central portion configured to seal against an inferior periphery of the patient's nose in use, the seal-forming structure including an intermediate portion configured to contact the patient's ala in use, the intermediate portion being stiffer than the central portion.

[0093] One aspect of the present technology relates to a patient interface, the patient interface comprising: a plenum chamber for a patient interface, said plenum chamber being pressurizable, in use, to a therapeutic pressure of at least 6 cmH2O above ambient air pressure throughout a patient's respiratory cycle, said plenum chamber comprising one or more walls at least partially enclosing a volume of space, and a seal-forming structure constructed and arranged to form a seal with an area of ​​the patient's face surrounding an entrance to the patient's airways, said seal-forming structure including a nasal region having at least one nostril configured to, in use, deliver an airflow at said therapeutic pressure to an entrance to the patient's nares, said seal-forming structure being configured to, in use, deliver an airflow at said therapeutic pressure to an entrance to the patient's mouth. a mouth area having a mouth hole configured to allow a patient to breathe through the plenum chamber, the seal-forming structure being constructed and arranged to maintain the therapeutic pressure in the plenum chamber throughout the patient's respiratory cycle in use; and one or more plenum chamber inlet ports sized and configured to receive an air flow at the therapeutic pressure for breathing by the patient throughout the patient's respiratory cycle in use; and a positioning and stabilizing structure configured to generate a force to hold the seal-forming structure in a therapeutically effective position on the patient's head, the seal-forming structure including a central portion configured to seal against an inferior periphery of the patient's nose in use, the seal-forming structure including an intermediate portion configured to contact the ala of the patient's nose in use, the intermediate portion being stiffer than the central portion.

[0094] In examples of the above two embodiments, (a) the intermediate portion may include a pair of outer walls of the seal-forming structure facing partially in a medial direction and partially in an upward direction; (b) the intermediate portion may be configured to resist folds; (c) the intermediate portion may be configured to limit the formation of a leakage path from the lower periphery of the patient's nose to the surroundings due to folds; (d) the intermediate portion may be thicker than the central portion; and / or (e) the seal-forming structure may be configured not to engage the patient's face under the chin in use.

[0095] Aspects of the present technology relate to a patient interface including a plenum chamber including one or more walls, a seal-forming structure, one or more plenum chamber inlet ports sized and configured to receive airflow at a therapeutic pressure for a patient's breath throughout the patient's breathing cycle in use, and a positioning and stabilizing structure. The seal-forming structure includes lateral peripheral support regions on opposing lateral sides of the oral cavity, the lateral peripheral support regions adjacent the mouth hole perimeter, the lateral peripheral support regions being stiffer than the mouth hole perimeter.

[0096] One aspect of the present technology relates to a patient interface, the patient interface comprising: a plenum chamber for a patient interface, said plenum chamber being pressurizable, in use, to a therapeutic pressure of at least 6 cmH2O above ambient air pressure throughout a patient's respiratory cycle, said plenum chamber comprising one or more walls at least partially enclosing a volume of space, and a seal-forming structure constructed and arranged to form a seal with an area of ​​the patient's face surrounding an entrance to the patient's airways, said seal-forming structure including a nose region having at least one nostril configured, in use, to deliver an airflow at said therapeutic pressure to an entrance to the patient's nares, said seal-forming structure including a mouth region having a mouth hole configured, in use, to deliver an airflow at said therapeutic pressure to an entrance to the patient's mouth, a plenum chamber including a seal-forming structure constructed and arranged to, in use, maintain said therapeutic pressure in the plenum chamber throughout the patient's respiratory cycle; and one or more plenum chamber inlet ports sized and configured to receive an air flow at the therapeutic pressure for breathing by a patient throughout the patient's respiratory cycle, in use; and a positioning and stabilizing structure configured to generate a force to hold said seal-forming structure in a therapeutically effective position on the patient's head, said seal-forming structure including a mouth hole perimeter surrounding at least a majority of a mouth hole configured to, in use, surround the patient's mouth, said seal-forming structure including lateral peripheral support regions on opposing lateral sides of said mouth hole, said lateral peripheral support regions adjacent said mouth hole perimeter, said lateral peripheral support regions being stiffer than said mouth hole perimeter.

[0097] In examples of the above two embodiments, (a) the lateral peripheral support region may be thicker than the mouth hole periphery; (b) the seal-forming structure may include a rearwardly facing lateral portion that surrounds a majority of the mouth hole periphery, the rearwardly facing lateral portion being thicker than the mouth hole periphery; (c) the rearwardly facing lateral portion may extend medially to the lateral-most edge of the oral cavity to form the lateral peripheral support region; and / or (d) the seal-forming structure may be configured not to engage the patient's face under the chin in use.

[0098] Aspects of the present technology relate to a plenum chamber for a patient interface, the plenum chamber including one or more walls, one or more plenum chamber inlet ports, a seal-forming structure, and a positioning and stabilizing structure. The seal-forming structure includes a nose portion configured to seal against an inferior periphery of a patient's nose in use. The nose portion has a central portion configured to be positioned inferiorly against the patient's nasal tip in use, and an intermediate portion configured to contact a corresponding ala of the patient's nose in use, the intermediate portion being stiffer than the central portion.

[0099] One aspect of the present technology relates to a plenum chamber for a patient interface, said plenum chamber being pressurizable in use to a therapeutic pressure of at least 6 cmH2O above ambient air pressure throughout a patient's respiratory cycle, said plenum chamber comprising one or more walls at least partially enclosing a volume of space, one or more plenum chamber inlet ports sized and configured in use to receive an airflow at the therapeutic pressure for breathing by the patient throughout the patient's respiratory cycle, and a seal-forming structure constructed and arranged to form a seal against an area of ​​the patient's face surrounding an entrance to the patient's airway, said seal-forming structure comprising a nasal cavity having at least one nostril configured in use to deliver the airflow at the therapeutic pressure to an entrance to the patient's nostril. a plenum chamber including a seal-forming structure, the seal-forming structure comprising a mouth region having a mouth hole configured in use to deliver an air flow at the therapeutic pressure to an entrance to the patient's mouth, the seal-forming structure constructed and arranged to maintain the therapeutic pressure in the plenum chamber throughout the patient's respiratory cycle in use, and a positioning and stabilising structure configured to generate a force to hold the seal-forming structure in a therapeutically effective position on the patient's head, the seal-forming structure comprising a nasal region configured to seal against an inferior periphery of the patient's nose in use, the nasal region having a central portion configured to be positioned below the patient's nasal tip in use and an intermediate portion configured to contact the patient's corresponding ala in use, the intermediate portion being stiffer than the central portion.

[0100] In examples of the above two embodiments, (a) the middle portion of the seal-forming structure may be thicker than the central portion; (b) the central portion of the seal-forming structure may include a forward facing central portion and an upward facing central portion; (c) the middle portions may each include an upward facing central portion and a forward facing central portion, the forward facing central portion may be thinner than the forward facing central portion; (d) the sides of the nose area may be configured to be pulled inwardly toward the patient's alae of the nose when a downward force is applied from the patient's nose to the central portion; and / or (e) the seal-forming structure may be configured not to engage the patient's face under the chin in use.

[0101] Aspects of the present technology relate to a patient interface including a plenum chamber including one or more walls, one or more plenum chamber inlet ports, a seal-forming structure, and a positioning and stabilizing structure, the seal-forming structure including a nose portion configured to seal against an inferior periphery of a patient's nose, the seal-forming structure nose portion having a pair of nostrils configured to deliver airflow to corresponding nares of the patient in use, the seal-forming structure including a bridge portion between the pair of nostrils, the bridge portion being disposed between a central portion of the nose portion configured to be positioned below the patient's nasal tip in use and an upper lip portion of the nose portion configured to seal against the patient's upper lip in use, the bridge portion being loose to allow the central portion to be moved away from the upper lip portion in use.

[0102] Aspects of the present technology relate to a patient interface, the patient interface comprising: a plenum chamber for a patient interface, the plenum chamber being pressurizable in use to a therapeutic pressure of at least 6 cmH2O above ambient air pressure throughout a patient's respiratory cycle, the plenum chamber comprising one or more walls at least partially enclosing a volume of space, one or more plenum chamber inlet ports sized and configured in use to receive an airflow at the therapeutic pressure for breathing by the patient throughout the patient's respiratory cycle, and a seal-forming structure constructed and arranged to form a seal with an area of ​​the patient's face surrounding an entrance to the patient's airway, the seal-forming structure including a nose region having at least one nostril configured in use to deliver the airflow at the therapeutic pressure to an entrance to the patient's nares, the seal-forming structure having a mouth hole configured in use to deliver the airflow at the therapeutic pressure to an entrance to the patient's mouth. and a positioning and stabilising structure configured to generate a force to hold the seal-forming structure in a therapeutically effective position on the patient's head, the seal-forming structure including a nasal portion configured to seal against an inferior periphery of the patient's nose, the nasal portion of the seal-forming structure having a pair of nostrils configured to deliver airflow to corresponding nasal cavities of the patient in use, the seal-forming structure including a bridge portion between the pair of nostrils, the bridge portion being between a central portion of the nasal portion configured to be positioned below the patient's nasal tip in use and an upper lip portion of the nasal portion configured to seal against the patient's upper lip in use, the bridge portion being loose to allow the central portion to move away from the upper lip portion in use.

[0103] In examples of the two above embodiments, (a) the bridge portion includes a curved portion configured to become straight when the central portion is moved away from the upper lip portion; (b) in use, the curved portion may be configured to extend away from the patient's nose in an undeformed state and the central portion is configured to become straight when moved away from the upper lip portion; and / or (c) in use, the bridge portion may allow the central portion to move in an anterior direction relative to the patient to receive the patient's nasal tip to accommodate different nose lengths when the patient wears the patient interface (without the upper lip portion disengaging from the patient's upper lip).

[0104] Aspects of the present technology relate to a plenum chamber for a patient interface including one or more plenum chamber inlet ports and a seal-forming structure, wherein a first surface of a nose region configured to engage a patient's face has a first surface finish and a second surface of a mouth region has a second surface finish different than the first surface finish.

[0105] One aspect of the present technology relates to a plenum chamber for a patient interface, said plenum chamber being pressurizable in use to a therapeutic pressure of at least 6 cmH2O above ambient air pressure throughout a patient's respiratory cycle, said plenum chamber comprising one or more plenum chamber inlet ports sized and configured to receive an airflow at the therapeutic pressure for breathing by the patient, and a seal-forming structure constructed and arranged to form a seal against an area of ​​the patient's face surrounding an entrance to the patient's airway, said seal-forming structure adapted to, in use, transmit the airflow at the therapeutic pressure to the patient's a nose portion having at least one nostril configured to deliver air to an entrance to a nostril, the seal-forming structure including a mouth portion having a mouth hole configured to, in use, deliver an air flow at the therapeutic pressure to an entrance to the patient's mouth, the seal-forming structure constructed and arranged to, in use, maintain the therapeutic pressure in a plenum chamber throughout the patient's respiratory cycle; and a seal-forming structure, wherein a first surface of the nose portion configured to engage a patient's face has a first surface finish and a second surface of the mouth portion has a second surface finish different from the first surface finish.

[0106] In examples of the above two embodiments, (a) the first surface finish and the second surface finish may differ such that a coefficient of friction between the seal-forming structure and the patient's face is higher in the mouth area than in the nose area; (b) the first surface finish may be configured to impart a smooth feel to the patient's face in the nose area; (c) the second surface finish may be configured to impart an enhanced grip on the patient's face in the mouth area; (d) the first surface finish may be a matte surface finish; (e) the second surface finish may be a polished surface finish; (f) the interface between the first surface finish and the second surface finish may be located on a portion of the seal-forming structure configured to contact the patient's cheeks in use; and / or (e) the seal-forming structure is configured not to engage the patient's face under the chin in use.

[0107] Aspects of the present technology relate to a patient interface, comprising: a plenum chamber as described in any of the previous aspects or examples thereof; a positioning and stabilizing structure configured to generate a force to hold the seal-forming structure in a therapeutically effective position on the patient's head, the positioning and stabilizing structure comprising a tie, the tie being constructed and arranged such that in use at least a portion of the tie is located on an area of ​​the patient's head above an upper ear base point of the patient's head; and a venting structure configured to transfer a continuous flow of gas exhaled by the patient from within the plenum chamber to atmosphere, the venting structure being sized and shaped such that in use a therapeutic pressure can be maintained within the plenum chamber, the patient interface configured to allow the patient to breathe from atmosphere through his or her oral cavity in the absence of pressurized air flow through one or more plenum chamber inlet ports.

[0108] In accordance with one aspect of the present technology there is provided a plenum chamber for a patient interface, said plenum chamber pressurizable to a therapeutic pressure of at least 6 cmH2O above ambient air pressure, said plenum chamber having a mouth portion and a nose portion, said plenum chamber comprising: a seal-forming structure constructed and arranged to form a seal against an area of ​​a patient's face surrounding an entrance to the patient's airways, said seal-forming structure having one or more holes therein such that airflow at said therapeutic pressure is delivered to entrances to the patient's nares and through the one or more holes to the patient's mouth, said seal-forming structure providing a seal against an area of ​​a patient's face surrounding an entrance to the patient's airways ... nares and through the one or more holes to the patient's mouth, a seal-forming structure constructed and arranged to maintain a therapeutic pressure within a plenum chamber; and a shell supporting said seal-forming structure having one or more plenum chamber inlet ports sized and configured to receive an air flow at the therapeutic pressure for breathing by a patient, said shell being provided at a mouth region of said plenum chamber, said nose region being substantially entirely formed by the seal-forming structure, said seal-forming structure including lateral support regions located on at least partially forward-facing laterally spaced apart sides of said nose region, said lateral support regions having a higher resistance to deformation than one or more adjacent portions of the seal-forming structure.

[0109] According to another aspect of the present technology there is provided a plenum chamber for a patient interface, said plenum chamber being pressurizable to a therapeutic pressure of at least 6 cmH2O above ambient air pressure, said plenum chamber having a mouth region and a nose region, said plenum chamber including: a seal-forming structure constructed and arranged to form a seal against an area of ​​a patient's face surrounding an entrance to the patient's airways, said seal-forming structure having one or more apertures therein such that airflow at said therapeutic pressure is delivered to entrances to the patient's nares and through the one or more apertures to the patient's mouth, said seal-forming structure constructed and arranged to maintain said therapeutic pressure within the plenum chamber throughout the patient's respiratory cycle in use, substantially the entirety of said nose region is formed by the seal-forming structure, said seal-forming structure including lateral support regions located on at least partially forward facing laterally spaced apart sides of the nose region, said lateral support regions having a higher resistance to deformation than one or more adjacent portions of the seal-forming structure.

[0110] In examples, the lateral support regions are regions of the seal-forming structure that are relatively stiffer than one or more adjacent portions of the seal-forming structure, the lateral support regions are regions of the seal-forming structure supported by a support structure, the support structure being part of a frame or a clip-on support region, the lateral support regions include regions of the seal-forming structure that are relatively thicker than one or more adjacent portions of the seal-forming structure, the lateral support regions are disposed substantially directly above the portions of the shell, the lateral support regions each have a substantially flat lower boundary, the flat lower boundary is disposed adjacent an upper edge of the shell, and the lateral support regions each have a curved upper boundary, the curvature of the upper boundary substantially matches or follows the curvature of the upper periphery of the seal-forming structure, and the lateral support regions are substantially fin-like in shape.

[0111] In examples, the seal-forming structure includes a central portion configured to, in use, form a seal against an inferior periphery of the patient's nose around the patient's nares and against the patient's upper lip, the central portion being thinner than the lateral support portions, the seal-forming structure includes intermediate portions disposed between the central portion and the lateral support portions, the seal-forming structure being thicker at the intermediate portion than at the central portion, the seal-forming structure being thinner at the intermediate portion than at the lateral support portions, the seal-forming structure includes laterally facing rear portions disposed between each intermediate portion and a lateral support portion on each side of the nose portion, the seal-forming structure having a greater thickness at the posterior laterally facing portions than at the intermediate portions, at least a portion of each intermediate portion is disposed above and in front of a respective lateral support portion, and at least a portion of each laterally facing rear portion is disposed above and behind a respective lateral support portion.

[0112] In an example, the seal-forming structure includes a junction between each lateral support section, a middle section and a laterally facing rear section on each lateral side of the nose section, the junction being located proximate to the uppermost point of the lateral support section, and the junction being located anterior to the uppermost point of the lateral support section.

[0113] In an example, the central portion of the seal-forming structure includes a forward facing central portion and an upward facing central portion, the upward facing central portion and the forward facing central portion are interconnected by a central saddle region of the nose portion of the seal-forming structure, the upward facing central portion has a positive curvature in the lateral direction, and the sides of the upward facing central portion face partially in a medial direction.

[0114] In examples, each of the intermediate portions includes an upwardly facing central portion and a forwardly facing central portion, the upwardly facing central portion and the forwardly facing central portion being interconnected around an upper periphery of the seal-forming structure, and the nasal region includes an upper lip portion configured to seal against the patient's upper lip in use, the upper lip portion having a stiffness similar to that of the central portion, the upper lip portion having a wall thickness substantially equal to the thickness of the central portion, and the upper lip portion including a wall thickness less than the wall thickness of the intermediate portion.

[0115] In an example, the nasal region includes a posterior corner configured to be positioned on the patient's face adjacent the nasolabial fold on the patient's face, the posterior corner configured to contact the patient's face on each lateral side of the upper lip, the posterior corner configured to contact the lateral and inferior areas of the patient's face adjacent the ala, and the posterior corner configured to fit between the ala of the patient's nose and the patient's nasolabial fold.

[0116] In examples, the posterior corner is stiffer than the central nasal portion of the seal-forming structure, the wall thickness of the posterior corner is greater than the middle portion of the nasal portion, the wall thickness of the posterior corner is less than the wall thickness of the laterally facing posterior portion of the nasal portion, the posterior corner is substantially dome-shaped, and the transition between the posterior corner and the upper lip portion is configured to be positioned below the patient's ala of the nose in use.

[0117] In an example, the shell includes rearward protrusions that reinforce the seal-forming structure at the base of the nose region, the rearward protrusions being located at the upper lateral corners of the shell, the rearward directional portions being located below the lateral support regions, the rearward directional portions having flat upper edges, and a flat lower boundary of each lateral support region being located adjacent each rearward directional portion.

[0118] In examples, the mouth region includes a lower lip portion configured to form a seal against a patient's lower lip, a wall thickness of the lower lip portion substantially equal to a wall thickness of the upper lip portion, the mouth region includes a mouth hole perimeter, a wall thickness of the mouth hole perimeter substantially equal to a wall thickness of the upper lip portion, the mouth hole perimeter adjacent one or both of the upper and lower lip portions, the mouth region includes a rearwardly facing lateral portion on either lateral side of the mouth hole perimeter configured to seal against the patient's cheeks in use, a wall thickness of the rearwardly facing lateral portion is greater than a wall thickness of the mouth hole perimeter, the rearwardly facing lateral portion is curved away from contact with the patient's face, the lower lip portion is approximately half the width of the oral opening, a transition between the lower lip portion and the rearwardly facing lateral portion on either lateral side of the lower lip portion is configured to be positioned at or adjacent the mandibular fold of the patient's face, and the lower lip portion is wider at the perimeter of the oral cavity than at a lower perimeter of the seal-forming structure.

[0119] In examples, the mouth area includes a lateral portion at a lateral periphery of the seal-forming structure, the wall thickness of the lateral portion being greater than the wall thickness of the rearwardly facing lateral portion, the mouth area includes a forwardly facing lateral portion on a front side of the seal-forming structure, the wall thickness of the forwardly facing lateral portion being greater than the wall thickness of the lateral portion, the mouth area includes a forward support portion on a front side of the seal-forming structure, the wall thickness of the forward support portion being greater than the wall thickness of the forwardly facing lateral portion, the mouth area includes two forward support portions proximate upper lateral corners of the shell, and the mouth area includes two forward support portions proximate lower lateral corners of the shell.

[0120] In an example, the plenum chamber includes a single plenum chamber inlet port, the single plenum chamber inlet port is centrally located in the shell, the plenum chamber inlet port is configured to connect to the frame, and the plenum chamber inlet port is substantially circular.

[0121] According to another aspect of the present technology there is provided a plenum chamber for a patient interface, said plenum chamber pressurizable to a therapeutic pressure of at least 6 cmH2O above ambient air pressure, said plenum chamber having a mouth region and a nose region, said plenum chamber including: a seal-forming structure constructed and arranged to form a seal against an area of ​​a patient's face surrounding an entrance to the patient's airways, said seal-forming structure having one or more apertures therein such that an air flow at said therapeutic pressure is delivered to entrances to the patient's nares and via the apertures to the patient's mouth, said seal-forming structure constructed and arranged to maintain said therapeutic pressure within the plenum chamber throughout the patient's respiratory cycle in use; and a shell configured to support said seal-forming structure, the shell having one or more plenum chamber inlet ports sized and structured to receive the air flow at the therapeutic pressure for breathing by the patient, said shell including lateral support regions projecting upwardly into the nose region of the patient interface on at least partially forward facing sides spaced laterally from the nose region.

[0122] In examples, the lateral support regions each have a curved upper boundary, the curvature of the upper boundary substantially matching or following the curvature of the upper periphery of the seal-forming structure, and the lateral support regions are substantially fin-like in shape.

[0123] In an example, the plenum chamber includes two plenum chamber inlet ports, the plenum chamber inlet ports are disposed on lateral sides of the shell, the plenum chamber inlet ports are configured to connect to the conduit, the plenum chamber inlet ports are approximately elliptical, and an upper periphery of each of the two plenum chamber inlet ports is formed by a respective one of the lateral support portions.

[0124] According to another aspect of the present technology there is provided a plenum chamber for a patient interface, said plenum chamber pressurizable to a therapeutic pressure of at least 6 cmH2O above ambient air pressure, said plenum chamber comprising: one or more walls at least partially enclosing a volume of space; a seal-forming structure constructed and arranged to form a seal against an area of ​​the patient's face surrounding an entrance to the patient's airways, said seal-forming structure having one or more holes therein such that an airflow at said therapeutic pressure is delivered to an entrance to the patient's nares and through the one or more holes to the patient's mouth, said seal-forming structure constructed and arranged to maintain said therapeutic pressure within the plenum chamber throughout the patient's respiratory cycle in use; and one or more plenum chamber inlet ports sized and configured to receive an airflow at the therapeutic pressure for breathing by the patient, said seal-forming structure comprising a central portion configured to form a seal against the patient's upper lip and a lower periphery of the patient's nose in use, and an intermediate portion configured to be positioned against or adjacent the ala of the patient's nose in use, the intermediate portion being stiffer than the central portion.

[0125] In examples, the one or more walls may include some or all of the seal-forming structure, the one or more walls may be separate from the seal-forming structure, the intermediate portion may include a pair of outer walls of the seal-forming structure facing partially in a medial direction and partially in an upward direction, the intermediate portion may be configured to resist folds, and the intermediate portion may be configured to limit the formation of a leakage path from the lower periphery of the patient's nose to the surroundings due to the folds.

[0126] In accordance with another aspect of the present technology, there is provided a plenum chamber for a patient interface, said plenum chamber pressurizable to a therapeutic pressure of at least 6 cmH2O above ambient air pressure, said plenum chamber comprising: one or more walls at least partially enclosing a volume of space; and a seal-forming structure constructed and arranged to form a seal against an area of ​​the patient's face surrounding an entrance to the patient's airways, said seal-forming structure having at least one hole therein such that airflow at said therapeutic pressure is delivered to an entrance to the patient's nares and through the at least one hole to the patient's mouth. and one or more plenum chamber inlet ports sized and configured to receive air flow at the therapeutic pressure for breathing by the patient, the seal-forming structure including a mouth hole periphery surrounding at least a majority of a mouth hole configured to surround the patient's mouth in use, the mouth hole periphery including a periphery that is configured to surround the patient's mouth in use, and lateral peripheral support regions on opposing lateral sides of the mouth hole, the lateral peripheral support regions being stiffer than the mouth hole periphery.

[0127] In an example, the wall thickness of the lateral peripheral support region is greater than the wall thickness of the mouth hole periphery, the seal-forming structure includes a rearwardly facing lateral portion that surrounds a majority of the mouth hole periphery, the rearwardly facing lateral portion being thicker than the mouth hole periphery, the rearwardly facing lateral portion forming the lateral peripheral support region, the rearwardly facing lateral portion extending medially toward a lateral-most edge of the oral cavity to form the lateral peripheral support region, the lateral support region providing resistance to buckling of the seal-forming structure.

[0128] In accordance with another aspect of the present technology, there is provided a plenum chamber for a patient interface, said plenum chamber pressurizable to a therapeutic pressure of at least 6 cmH2O above ambient air pressure, said plenum chamber comprising: one or more walls at least partially enclosing a volume of space; one or more plenum chamber inlet ports sized and configured to receive an airflow at the therapeutic pressure for breathing by the patient; and a seal-forming structure constructed and arranged to form a seal against an area of ​​the patient's face surrounding an entrance to the patient's airway, said seal-forming structure having one or more holes therein to accommodate the airflow at the therapeutic pressure. to an entrance to the patient's nares and then through one or more holes to the patient's mouth, the seal-forming structure being constructed and arranged to maintain said treatment pressure within a plenum chamber throughout the patient's respiratory cycle, said seal-forming structure including a nasal portion configured to form a seal against an inferior periphery of the patient's nose in use, the nasal portion having a central portion configured to be positioned inferior to the patient's nasal tip in use and an intermediate portion configured to be positioned adjacent the patient's ala in use, said seal-forming structure being stiffer in the intermediate portion than in the central portion.

[0129] In examples, a wall thickness of the intermediate portions of the seal-forming structure is greater than a wall thickness of the central portion, the intermediate portions may each include a medially facing wall configured to be positioned at or adjacent the ala of the patient's nose in use, the central portions of the seal-forming structure include a forward facing central portion and an upward facing central portion, the upward facing central portion and the forward facing central portion are interconnected by a central saddle region of the nasal portion of the seal-forming structure, the upward facing central portion includes a positive curvature in the lateral direction, the sides of the upward facing central portion face partially in the medial direction, the intermediate portions each include an upward facing central portion and a forward facing central portion, the upward facing central portion and the forward facing central portion face partially in the medial direction, the central portion facing forward is interconnected around the entire upper periphery of the seal-forming structure, the wall thickness of the central saddle portion is equal to the wall thickness of the central portion and the wall thickness of the forward facing central portion is less than the wall thickness of the forward facing middle portion, when a downward force is applied from the patient's nose to the central portion, the sides of the nose portion are pulled inwardly toward the patient's ala and the middle portion is pulled inwardly to or near the ala of the patient's nose, the nose portion includes an upper lip portion configured to seal against the patient's upper lip in use, the upper lip portion includes a stiffness similar to that of the central portion, the wall thickness of the upper lip portion is substantially equal to the wall thickness of the central portion and the upper lip portion includes a wall thickness less than the wall thickness of the middle portion.

[0130] In accordance with another aspect of the present technology, there is provided a plenum chamber for a patient interface, said plenum chamber pressurizable to a therapeutic pressure of at least 6 cmH2O above ambient air pressure, said plenum chamber comprising: one or more walls at least partially enclosing a volume of space; one or more plenum chamber inlet ports sized and configured to receive an airflow at the therapeutic pressure for breathing by the patient; and a seal-forming structure constructed and arranged to form a seal against an area of ​​the patient's face surrounding an entrance to the patient's airways, said seal-forming structure having a plurality of holes therein such that the airflow at the therapeutic pressure is delivered via the plurality of holes to entrances to the patient's nares and to the patient's mouth. and a seal-forming structure constructed and arranged to maintain said therapeutic pressure in the plenum chamber throughout the patient's respiratory cycle, said plenum chamber including a nasal region, and wherein the seal-forming structure in the nasal region is configured to seal against an inferior periphery of the patient's nose, said seal-forming structure defining a pair of nostrils configured to deliver airflow to the patient's nasal airways in use, said seal-forming structure including a bridge region between the pair of nostrils, said bridge region being provided centrally between an upper lip portion and a central portion of the seal-forming structure in the nasal region, said bridge region being loose to allow the central portion to move away from the posterior region.

[0131] In examples, the bridge portion includes a curved portion configured to straighten when the central portion is moved away from the upper lip, the curved portion includes a single curve, the curved portion includes two curves, the curved portion is approximately S-shaped when viewed from the side, the curved portion includes a sawtooth shape, the curved portion includes one or more folds, the bridge portion depends below the central portion and can straighten when the central portion is moved away from the upper lip, the bridge portion allows the central portion to move to receive the patient's nose when the patient interface is worn by a patient, and the bridge portion allows the central portion to move forward to receive the patient's nasal tip when the patient interface is worn by a patient.

[0132] According to another aspect of the present technology there is provided a plenum chamber for a patient interface, said plenum chamber pressurizable to a therapeutic pressure of at least 6 cmH2O above ambient air pressure, said plenum chamber comprising: one or more plenum chamber inlet ports sized and configured to receive an airflow at the therapeutic pressure for breathing by the patient; and a seal-forming structure constructed and arranged to form a seal against an area of ​​the patient's face surrounding an entrance to the patient's airways, said seal-forming structure having one or more holes therein such that the airflow at the therapeutic pressure is delivered to entrances to the patient's nares and via the one or more holes to the patient's mouth, said seal-forming structure constructed and arranged to maintain said therapeutic pressure within the plenum chamber throughout the patient's respiratory cycle in use, said seal-forming structure comprising a nose region configured to form a seal against the patient's face at or adjacent the patient's nose and a mouth region configured to form a seal against the patient's face around the patient's mouth, said seal-forming structure comprising a first surface finish in the nose region and a second surface finish in the mouth region different from the first surface finish.

[0133] In examples, the first surface finish and the second surface finish differ such that a coefficient of friction between the seal-forming structure and the patient's face is higher in the mouth area than in the nose area, the first surface finish is configured to impart a smooth feel on the patient's face to the nose area (e.g., for comfort) and the second surface finish is configured to impart a gripping contact with the patient's face to the mouth area (e.g., for a more robust seal), the first surface finish may be a matte surface finish and the second surface finish may be a polished surface finish, the interface between the first surface finish and the second surface finish is located on a portion of the seal-forming structure that contacts the patient's cheeks in use, the nose area may include an upper lip having the first surface finish, a non-patient contacting surface of the nose area may include a surface finish other than the first surface finish, and a non-patient contacting surface of the nose area may include the second surface finish.

[0134] According to another aspect of the present technology, there is provided a patient interface comprising: a plenum chamber according to the aspect of the present technology described above; a positioning and stabilizing structure providing a force to hold the seal-forming structure in a therapeutically effective position on the patient's head, the positioning and stabilizing structure comprising a tie, the tie constructed and arranged such that in use at least a portion of the tie is located on an area of ​​the patient's head above an upper ear base point of the patient's head; and a venting structure for transferring a continuous flow of gas exhaled by the patient from within the plenum chamber to atmosphere, said venting structure being sized and shaped such that in use a therapeutic pressure can be maintained within the plenum chamber, the patient interface configured to allow the patient to breathe from atmosphere through his or her oral cavity in the absence of pressurized air flow through the plenum chamber inlet port.

[0135] Another aspect of one form of the present technology is a patient interface that is molded or otherwise constructed with a peripheral shape that is complimentary to the shape of the intended wearer.

[0136] One aspect of the present disclosure is a method for manufacturing a device.

[0137] 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.

[0138] One aspect of one form of the present technology is a portable RPT device that a person can carry with them (eg, around the home).

[0139] One aspect of one form of the present technology is a patient interface that can be cleaned at the patient's home, for example with soapy water, without the need for special cleaning equipment.One aspect of one form of the present technology is a patient interface that can be cleaned at the patient's home, for example with soapy water, without the need for special cleaning equipment.

[0140] The described methods, systems, devices and apparatus may be implemented to enable improved functionality in a processor (e.g., a processor of a special purpose computer, a respiratory monitor and / or a respiratory treatment device). Additionally, the described methods, systems, devices and apparatus enable advances in the art of automated management, monitoring and / or treatment of respiratory conditions (e.g., sleep disordered breathing).

[0141] Of course, some of the above aspects may form sub-aspects of the present technology, and various one of the sub-aspects and / or aspects may be combined in various ways to form further aspects or sub-aspects of the present technology.

[0142] Other features of the present technology will become apparent in light of the information contained in the following detailed description, abstract, drawings, and claims.

[0143] The present technology is illustrated by way of one non-limiting example in the accompanying drawings, in which like reference numerals include similar elements: [Brief description of the drawings]

[0144] [Figure 1A] The system is shown including a patient 1000 wearing a patient interface 3000 (which takes the form of a nasal pillow and receives positive pressure air supplied from an RPT device 4000. The air from the RPT device 4000 is humidified by a humidifier 5000 and travels along an air circuit 4170 to the patient 1000. A bed companion 1100 is also shown. The patient is sleeping in a supine sleeping position). [Figure 1B]The system is shown including a patient 1000 wearing a patient interface 3000 (which takes the form of a nasal mask and receives positive pressure air supplied from an RPT device 4000. The air from the RPT device is humidified by a humidifier 5000 and travels along an air circuit 4170 to the patient 1000). [Figure 1C] The system includes a patient 1000 wearing a patient interface 3000 (which wears a full face mask and receives a positive pressure air supply from an RPT device 4000. Air from the RPT device is humidified by a humidifier 5000 and travels along an air circuit 4170 to the patient 1000. The patient is sleeping in a lateral sleeping position). [Figure 2A] An outline of the human respiratory system is shown, including the nasal and oral cavities, larynx, vocal folds, esophagus, trachea, bronchi, lungs, alveolar sacs, heart and diaphragm. [Figure 2B] FIG. 1 is 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] A frontal view of the face including several features of the surface anatomy including upper lip, upper lip vermilion, lower lip vermilion, lower lip, mouth width, medial canthus, nasolabial folds, and corners of the mouth (superior, inferior, radially inward, and radially outward directions are also given). [Figure 2D] A lateral view of the head including several features of the surface anatomy including the glabella, serion, nasal tip, subnasal point, upper lip, lower lip, supramenton, nasal ridge, alar crest, superior and inferior temporal points (also orientation of superior and inferior, anterior and posterior). [Figure 2E] Further lateral views of the head (approximate positions of Frankfort horizontal and nasolabial angle are noted; coronal plane is also noted). [Figure 2F] A bottom view of the nose including several features including nasolabial fold, lower lip, upper lip vermilion, nostrils, subnasal point, columella, nasal tip, nostril axis and midsagittal plane. [Figure 2G] FIG. 2 is a side view of the superficial features of the nose. [Figure 2H] Shown are the subcutaneous structures of the nose including the lateral nasal cartilages, nasal septum cartilage, greater alar cartilage, lesser alar cartilage, nasal sesamoid cartilage, nasal bones, epidermis, adipose tissue, frontal process of the maxilla and fibro-adipose tissue. [Figure 2I] The mid-nasal incision is shown approximately a few millimeters from the midsagittal plane, with particular attention to the nasal septum cartilage and the medial crus of the greater alar cartilage. [Figure 2J] FIG. 1 is a frontal bony view of the skull including the frontal, nasal and cheekbones, with the nasal turbinates shown along with the maxilla and mandible. [Figure 2K] Side view of the skull along with the outline of the head surface and some muscles (the following bones are shown: frontal, sphenoid, nasal, zygoma, maxilla, mandible, parietal, temporal and occipital. The mental eminence is shown. The following muscles are shown: digastric, masseter, sternocleidomastoid and trapezius). [Figure 2L] Shows the anterior lateral aspect of the nose. [Figure 3A] 1 shows a patient interface in the form of a nasal mask in accordance with one form of the present technology. [Figure 3B] 3C is a schematic cross-sectional view of the structure cut at a point (the outward normal at this point is shown; the curvature at this point has a positive sign and a relatively large magnitude compared to the magnitude of curvature shown in 3C). [Figure 3C] Schematic cross-sectional view of the structure cut at a point (the outward normal at this point is shown; the curvature at this point has a positive sign and a relatively small magnitude compared to the magnitude of curvature shown in FIG. 3B). [Figure 3D] Schematic cross-section of the structure cut at a point (the outward normal at this point is shown; the curvature value at this point is zero). [Figure 3E] Schematic cross-sectional view of the structure cut at a point (the outward normal at this point is shown; the curvature at this point has a negative sign and a relatively small magnitude compared to the magnitude of curvature shown in FIG. 3F). [Figure 3F]Schematic cross-sectional view of the structure cut at a point (the outward normal at this point is shown; the curvature at this point has a negative sign and a relatively large magnitude compared to the magnitude of curvature shown in FIG. 3E). [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; the dome region and the saddle region are shown). [Figure 3H] 1 shows a cushion for a mask (the outer surface of the cushion is illustrated; the edge of the surface is illustrated; the path on the surface between points A and B is illustrated; the straight line distance between A and B is illustrated; two saddle regions and a dome region are illustrated). [Figure 3I] The surface of the structure is shown, with a one-dimensional hole drilled into the surface (the planar curves shown form the boundary of the one-dimensional hole). [Figure 3J] 3I (the surface shown bounds a two-dimensional hole in the structure of FIG. 3I). [Figure 3K] 3I includes a two-dimensional hole and a one-dimensional hole, and the surfaces bounding the two-dimensional hole in the structure of FIG. [Figure 3L] 1 shows a mask with an inflatable bladder as a cushion. [Figure 3M] FIG. 3C is a cross-sectional view of the mask of FIG. 3L showing the inner surface of the bladder (which bounds the two-dimensional hole in the mask). [Figure 3N] 3D shows a further cross section through the mask of FIG. 3L, with the interior surface also shown. [Figure 3O] Demonstrates the left hand rule. [Figure 3P] Demonstrates the right-hand rule. [Figure 3Q] 1 shows the left ear including the left ear helix. [Figure 3R] 1 shows the right ear including the right ear helix. [Figure 3S] Shown is a right-handed spiral. [Figure 3T] FIG. 13 is a diagram of a mask including the signature of the twist of the space curve defined by the edges of the sealing membrane in different regions of the mask. [Figure 3U] A diagram of the plenum chamber 3200 showing the midsagittal plane and the central contact plane. [Figure 3V] A posterior view of the plenum chamber of FIG. 3U (directions in the view are perpendicular to the central contact plane. In FIG. 3V, the midsagittal plane bisects the plenum chamber into a left hand side and a right hand side). [Figure 3W] FIG. 3V is a cross-sectional view through the plenum chamber of FIG. 3V, with the cross-section taken in the midsagittal plane shown in FIG. 3V. (The "central contact" plane is shown. The central contact plane is perpendicular to the midsagittal plane. The orientation of the central contact plane corresponds to the orientation of the tendon 3209, which rests on the midsagittal plane and contacts only the cushion of the plenum chamber at two points on the midsagittal plane (i.e., upper point 3220 and lower point 3229). Depending on the geometry of the cushion in this region, the central contact plane may contact both the upper and lower points.) [Figure 3X] FIG. 3U shows the plenum chamber 3200 in a use position on the face (the midsagittal plane of the plenum chamber 3200 generally coincides with the midsagittal plane of the face when the plenum chamber is in the use position. The central contact plane generally corresponds to the "face plane" when the plenum chamber is in the use position. In FIG. 3X, the plenum chamber 3200 is of a nasal mask, with the upper point 3220 resting approximately on the selion and the lower point 3229 resting on the upper lip). [Figure 4A] 1 shows an RPT device in accordance with one form of the present technology. [Figure 4B] 1 is a schematic diagram of an 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). [Figure 5A] FIG. 1 shows an isometric view of a humidifier in accordance with one form of the present technology. [Figure 5B] Shown is an isometric view of a humidifier in accordance with one form of the present technology, showing the humidifier reservoir 5110 removed from the humidifier reservoir dock 5130. [Figure 6A] 1 shows a typical respiratory waveform of a model of a sleeping person. [Figure 7] FIG. 32 is a front view of a plenum chamber 3200 in accordance with one form of the present technology. [Figure 8] FIG. 8 is a rear view of the plenum chamber 3200 of FIG. [Figure 9] FIG. 8 is a side view of the plenum chamber 3200 of FIG. [Figure 10] FIG. 8 is a top view of the plenum chamber 3200 of FIG. [Figure 11] FIG. 8 is a bottom view of the plenum chamber 3200 of FIG. [Figure 12] FIG. 8 is a perspective view of the plenum chamber 3200 of FIG. [Figure 13] FIG. 8 is another perspective view of the plenum chamber 3200 of FIG. [Figure 14] FIG. 8 is another perspective view of the plenum chamber 3200 of FIG. [Figure 15] FIG. 8 is a front view of the plenum chamber 3200 of FIG. 7 labeled with section lines 16-16 through 19-19. [Figure 16] 16 is a cross-sectional view of the plenum chamber 3200 of FIG. 15 taken along line 16-16. [Figure 17] 17 is a cross-sectional view of the plenum chamber 3200 of FIG. 15 taken along line 17-17. [Figure 18] 18 is a cross-sectional view of the plenum chamber 3200 of FIG. 15 taken along line 18-18. [Figure 19] 19 is a cross-sectional view of the plenum chamber 3200 of FIG. 15 taken along line 19-19. [Figure 20] FIG. 8 is a rear view of the plenum chamber 3200 of FIG. 7 labeled with section lines 21-21 through 25-25. [Figure 21] 21 is a cross-sectional view of the plenum chamber 3200 of FIG. 20 taken along line 21-21. [Figure 22]22 is a cross-sectional view of the plenum chamber 3200 of FIG. 20 taken along line 22-22. [Figure 23] 23 is a cross-sectional view of the plenum chamber 3200 of FIG. 20 taken along line 23-23. [Figure 24] 24 is a cross-sectional view of the plenum chamber 3200 of FIG. 20 taken along line 24-24. [Diagram 25] 25 is a cross-sectional view of the plenum chamber 3200 of FIG. 20 taken along line 25-25. [Figure 26] FIG. 8 is a side view of the plenum chamber 3200 of FIG. 7 labeled with section lines 27-27 through 33-33. [Figure 27] 27 is a cross-sectional view of the plenum chamber 3200 of FIG. 26 taken along line 27-27. [Figure 28] 28 is a cross-sectional view of the plenum chamber 3200 of FIG. 26 taken along line 28-28. [Figure 29] 29 is a cross-sectional view of the plenum chamber 3200 of FIG. 26 taken along line 29-29. [Diagram 30] 30 is a cross-sectional view of the plenum chamber 3200 of FIG. 26 taken along line 30-30. [Diagram 31] 31 is a cross-sectional view of the plenum chamber 3200 of FIG. 26 taken along line 31-31. [Diagram 32] 32 is a cross-sectional view of the plenum chamber 3200 of FIG. 26 taken along line 32-32. [Diagram 33] 33 is a cross-sectional view of the plenum chamber 3200 of FIG. 26 taken along line 33-33. [Diagram 34] FIG. 32 is a rear view of another plenum chamber 3200 with various parts identified. [Diagram 35] FIG. 35 is a front view of the plenum chamber 3200 of FIG. 34 with various parts identified. [Diagram 36] FIG. 35 is a top view of the plenum chamber 3200 of FIG. 34 with various parts identified. [Figure 37] FIG. 35 is a bottom view of the plenum chamber 3200 of FIG. 34 with various parts identified. [Figure 38]FIG. 35 is a side view of the plenum chamber 3200 of FIG. 34 with various parts identified. [Figure 39] FIG. 32 is another front view of a plenum chamber 3200 in accordance with one form of the present technology. [Diagram 40] FIG. 40 is a cross-sectional view of the plenum chamber 3200 of FIG. [Diagram 41] FIG. 8 is a front view of the shell 3210 of the plenum chamber 3200 of FIG. [Diagram 42] FIG. 8 is a rear view of the shell 3210 of the plenum chamber 3200 of FIG. [Diagram 43] FIG. 8 is a side view of the shell 3210 of the plenum chamber 3200 of FIG. [Diagram 44] FIG. 8 is a front perspective view of the shell 3210 of the plenum chamber 3200 of FIG. [Diagram 45] FIG. 8 is a rear perspective view of the shell 3210 of the plenum chamber 3200 of FIG. [Diagram 46] FIG. 8 is a top view of the shell 3210 of the plenum chamber 3200 of FIG. [Figure 47] FIG. 32 is a rear view of another plenum chamber 3200 in accordance with one form of the present technology. [Figure 48] FIG. 32 is a rear view of another plenum chamber 3200 with various parts identified in accordance with one form of the present technology. [Figure 49] FIG. 32 is a front view of a plenum chamber 3200 in accordance with one form of the present technology. [Figure 50] FIG. 50 is a rear view of the plenum chamber 3200 of FIG. [Figure 51] FIG. 50 is a side view of the plenum chamber 3200 of FIG. [Figure 52] FIG. 50 is a top view of the plenum chamber 3200 of FIG. [Diagram 53] FIG. 50 is a bottom view of the plenum chamber 3200 of FIG. [Figure 54] FIG. 50 is a perspective view of the plenum chamber 3200 of FIG. [Figure 55] FIG. 50 is another perspective view of the plenum chamber 3200 of FIG. [Figure 56] FIG. 50 is another perspective view of the plenum chamber 3200 of FIG. [Figure 57] FIG. 49 is a front view of the plenum chamber 3200 of FIG. 49 labeled with section lines 58-58 through 61-61. [Figure 58] 58 is a cross-sectional view of the plenum chamber 3200 of FIG. 57 taken along line 58-58. [Figure 59] 59 is a cross-sectional view of the plenum chamber 3200 of FIG. 57 taken along line 59-59. [Figure 60] 58 is a cross-sectional view of the plenum chamber 3200 of FIG. 57 taken along line 60-60. [Figure 61] 61 is a cross-sectional view of the plenum chamber 3200 of FIG. 57 taken along line 61-61. [Figure 62] FIG. 50 is a rear view of the plenum chamber 3200 of FIG. 49 labeled with section lines 63-63 through 67-67. [Figure 63] A cross-sectional view of the plenum chamber 3200 of Figure 62 taken along line 63-63. [Figure 64] A cross-sectional view of the plenum chamber 3200 of Figure 62 taken along line 64-64. [Figure 65] A cross-sectional view of the plenum chamber 3200 of Figure 62 taken along line 65-65. [Figure 66] A cross-sectional view of the plenum chamber 3200 of Figure 62 taken along line 66-66. [Figure 67] A cross-sectional view of the plenum chamber 3200 of Figure 62 taken along line 67-67. [Figure 68] FIG. 49 is a side view of the plenum chamber 3200 of FIG. 49 labeled with section lines 69-69 through 75-75. [Figure 69] A cross-sectional view of the plenum chamber 3200 of Figure 68 taken along line 69-69. [Figure 70] 70 is a cross-sectional view of the plenum chamber 3200 of FIG. 68 taken along line 70-70. [Figure 71] A cross-sectional view of the plenum chamber 3200 of Figure 68 taken along line 71-71. [Figure 72]A cross-sectional view of the plenum chamber 3200 of Figure 68 taken along line 72-72. [Figure 73] A cross-sectional view of the plenum chamber 3200 of Figure 68 taken along line 73-73. [Figure 74] 74 is a cross-sectional view of the plenum chamber 3200 of FIG. 68 taken along line 74-74. [Figure 75] A cross-sectional view of the plenum chamber 3200 of Figure 68 taken along line 75-75. [Figure 76] FIG. 32 is a rear view of another plenum chamber 3200 with various parts identified in accordance with one form of the present technology. [Figure 77] FIG. 77 is a front view of the plenum chamber 3200 of FIG. 76 with various parts identified. [Figure 78] FIG. 77 is a top view of the plenum chamber 3200 of FIG. 76 with various parts identified. [Figure 79] FIG. 77 is a bottom view of the plenum chamber 3200 of FIG. 76 with various parts identified. [Figure 80] FIG. 77 is a side view of the plenum chamber 3200 of FIG. 76 with various parts identified. [Figure 81] FIG. 50 is a front view of the shell 3210 of the plenum chamber 3200 of FIG. [Figure 82] FIG. 50 is a rear view of the shell 3210 of the plenum chamber 3200 of FIG. [Figure 83] FIG. 50 is a side view of the shell 3210 of the plenum chamber 3200 of FIG. [Figure 84] FIG. 50 is a front perspective view of the shell 3210 of the plenum chamber 3200 of FIG. [Figure 85] FIG. 50 is a rear perspective view of the shell 3210 of the plenum chamber 3200 of FIG. [Figure 86] FIG. 50 is a top view of the shell 3210 of the plenum chamber 3200 of FIG. [Figure 87] 32 is a cross-sectional view of a connection between a plenum chamber 3200 and a frame 3350 in accordance with one form of the present technology. [Figure 88]3 is another cross-sectional view of the connection between the plenum chamber 3200 and the frame 3350. FIG. [Figure 89] FIG. 30 is a perspective view of a patient interface 3000 according to an embodiment of the present technology. [Figure 90] FIG. 91 is a front view of the patient interface 3000 of FIG. [Figure 90A] 90A is a cross-sectional view of the patient interface 3000 shown in FIG. 90 taken along line 90A-90A. [Figure 91] FIG. 90 is a rear view of the patient interface 3000 of FIG. [Figure 92] FIG. 90 is a top view of the patient interface 3000 of FIG. [Figure 93] FIG. 90 is a bottom view of the patient interface 3000 of FIG. [Figure 94] FIG. 91 is a side view of the patient interface 3000 of FIG. [Figure 95] FIG. 90 is another rear view of the patient interface 3000 of FIG. [Figure 96] FIG. 91 is a perspective view of the patient interface 3000 of FIG. 89 as worn by a patient. [Figure 97] FIG. 91 is a front view of the patient interface 3000 of FIG. 89 as worn by a patient. [Figure 98] FIG. 91 is a rear view of the patient interface 3000 of FIG. 89 as worn by a patient. [Figure 99] FIG. 90 is a top view of the patient interface 3000 of FIG. 89 as worn by a patient. [Figure 100] FIG. 91 is a bottom view of the patient interface 3000 of FIG. 89 as worn by a patient. [Figure 101] FIG. 91 is a side view of the patient interface 3000 of FIG. 89 as worn by a patient. [Figure 102] FIG. 91 is another rear view of the patient interface 3000 of FIG. 89 as worn by a patient. [Figure 103] FIG. 33 is a perspective view of a frame 3350 according to an embodiment of the present technology. [Figure 104]Front view of frame 3350 of FIG. 103. [Figure 105] Rear view of frame 3350 of FIG. 103. [Fig. 106] Top view of frame 3350 of FIG. 103. [Figure 107] Bottom view of frame 3350 of FIG. 103. [Figure 108] Side view of frame 3350 of FIG. 103. [Fig. 109] Shows the strap of the positioning and stabilization structure 3300 of the patient interface 3000 of FIG. 89. [Figure 110] Cross-sectional view of the plenum chamber 3200 of the patient interface 3000 of FIG. 89 in the sealed position on the patient. [Figure 111] Fragmentary view of the plenum chamber 3200 of the patient interface 3000 of FIG. 89 in the sealed position on the patient. [Figure 112] Partial cross-sectional view of the plenum chamber 3200 of the patient interface 3000 of FIG. 89 before sealing to the patient's nose. [Figure 113] Cross-sectional view of the portion of the plenum chamber 3200 of FIG. 112 in the sealed position with respect to the patient's nose. [Fig. 114] Partial cross-sectional view of the plenum chamber 3200 of the patient interface 3000 of FIG. 89 in the sealed position with respect to the patient's nose without lateral loading. [Fig. 115] Cross-sectional view of the portion of the plenum chamber 3200 of FIG. 113 in the sealed position with respect to the patient's nose when receiving lateral loading. [Fig. 116] Rear view of the plenum chamber 3200 having the various sites described and having a fold in the nasal site 3230 of the plenum chamber 3200. [Figure 117] Side cross-sectional view of the plenum chamber 3200 of the patient interface 3000 in an isolated state when in the sealed position with respect to the face of a patient with a short nose. [Figure 118]FIG. 117 is a side cross-sectional view of the plenum chamber 3200 of FIG. 117 in a sealed position against the face of a patient with a long nose. [Figure 119] FIG. 32 is a perspective view of a plenum chamber 3200 in accordance with another form of the present technology. [Figure 120] FIG. 120 is a front view of the plenum chamber 3200 shown in FIG. [Figure 121] FIG. 120 is a rear view of the plenum chamber 3200 shown in FIG. [Figure 122] FIG. 120 is a top view of the plenum chamber 3200 shown in FIG. [Figure 123] FIG. 120 is a bottom view of the plenum chamber 3200 shown in FIG. [Figure 124] FIG. 120 is a left side view of the plenum chamber 3200 shown in FIG. [Fig. 125] FIG. 120 is a right side view of the plenum chamber 3200 shown in FIG. [Fig. 126] FIG. 32 is a front perspective view of a plenum chamber 3200 according to another embodiment of the present technology having a small width size. [Figure 127] FIG. 127 is a rear perspective view of the plenum chamber 3200 shown in FIG. [Figure 128] FIG. 127 is a front view of the plenum chamber 3200 shown in FIG. [Figure 129] FIG. 127 is a rear view of the plenum chamber 3200 shown in FIG. [Fig. 130] FIG. 127 is a top view of the plenum chamber 3200 shown in FIG. [Fig. 131] FIG. 127 is a bottom view of the plenum chamber 3200 shown in FIG. [Fig. 132] FIG. 127 is a side view of the plenum chamber 3200 shown in FIG. [Fig. 133] 133 is a cross-sectional view of the plenum chamber 3200 shown in FIG. 130 through line 133-133. [Fig. 134] FIG. 32 is a front perspective view of a plenum chamber 3200 according to another embodiment of the present technology having a medium size. [Fig. 135]FIG. 135 is a rear perspective view of the plenum chamber 3200 shown in FIG. [Fig. 136] FIG. 135 is a top view of the plenum chamber 3200 shown in FIG. [Fig. 137] FIG. 135 is a bottom view of the plenum chamber 3200 shown in FIG. [Figure 138] FIG. 135 is a front view of the plenum chamber 3200 shown in FIG. [Figure 139] FIG. 135 is a rear view of the plenum chamber 3200 shown in FIG. [Fig. 140] FIG. 135 is a side view of the plenum chamber 3200 shown in FIG. [Fig. 141] A cross-sectional view of the plenum chamber 3200 shown in FIG. 136 through line 141-141. [Fig. 142] FIG. 32 is a front perspective view of a plenum chamber 3200 according to another embodiment of the present technology having a small width size. [Fig. 143] FIG. 143 is a rear perspective view of the plenum chamber 3200 shown in FIG. [Fig. 144] FIG. 143 is a top view of the plenum chamber 3200 shown in FIG. [Fig. 145] FIG. 143 is a bottom view of the plenum chamber 3200 shown in FIG. [Fig. 146] FIG. 143 is a front view of the plenum chamber 3200 shown in FIG. [Fig. 147] FIG. 143 is a rear view of the plenum chamber 3200 shown in FIG. [Fig. 148] FIG. 143 is a side view of the plenum chamber 3200 shown in FIG. [Figure 149] 149 is a cross-sectional view of the plenum chamber 3200 shown in FIG. 144 through line 149-149. [Fig. 150] FIG. 32 is a front perspective view of a plenum chamber 3200 according to another embodiment of the present technology having a wide size. [Fig. 151] FIG. 151 is a rear perspective view of the plenum chamber 3200 shown in FIG. [Fig. 152] FIG. 151 is a top view of the plenum chamber 3200 shown in FIG. [Fig. 153] FIG. 151 is a bottom view of the plenum chamber 3200 shown in FIG. [Fig. 154] FIG. 151 is a front view of the plenum chamber 3200 shown in FIG. [Fig. 155] FIG. 151 is a rear view of the plenum chamber 3200 shown in FIG. [Fig. 156] FIG. 151 is a side view of the plenum chamber 3200 shown in FIG. [Fig. 157] 157 is a cross-sectional view of the plenum chamber 3200 shown in FIG. 152 through line 157-157. [Fig. 158] FIG. 127 is a side view of the plenum chamber 3200 shown in FIG. 126 with various parts identified. [Fig. 159] FIG. 127 is a bottom perspective view of the plenum chamber 3200 shown in FIG. 126 with various parts identified. [Fig. 160] FIG. 127 is a top view of the plenum chamber 3200 shown in FIG. 126 with various parts identified. [Fig. 161] FIG. 127 is a rear view of the plenum chamber 3200 shown in FIG. 126 with various parts identified. [Fig. 162] FIG. 127 is a front view of the plenum chamber 3200 shown in FIG. 126 with various parts identified. [Fig. 163] FIG. 127 is a front perspective view of the plenum chamber 3200 shown in FIG. 126 with various parts identified. [Fig. 164] FIG. 127 is a rear perspective view of the plenum chamber 3200 shown in FIG. 126 with various parts identified. [Fig. 165] FIG. 135 is a side view of the plenum chamber 3200 shown in FIG. 134 with various parts identified. [Fig. 166] FIG. 135 is a bottom view of the plenum chamber 3200 shown in FIG. 134 with various parts identified. [Fig. 167] FIG. 135 is a top view of the plenum chamber 3200 shown in FIG. 134 with various parts identified. [Fig. 168]FIG. 135 is a rear view of the plenum chamber 3200 shown in FIG. 134 with various parts identified. [Fig. 169] FIG. 135 is a front perspective view of the plenum chamber 3200 shown in FIG. 134 with various parts identified. [Fig. 170] FIG. 135 is a rear perspective view of the plenum chamber 3200 shown in FIG. 134 with various parts identified. [Fig. 171] FIG. 135 is a front view of the plenum chamber 3200 shown in FIG. 134 with various parts identified. [Fig. 172] FIG. 143 is a side view of the plenum chamber 3200 shown in FIG. 142 with various parts identified. [Fig. 173] FIG. 143 is a bottom perspective view of the plenum chamber 3200 shown in FIG. 142 with various parts identified. [Fig. 174] FIG. 143 is a top view of the plenum chamber 3200 shown in FIG. 142 with various parts identified. [Fig. 175] FIG. 143 is a rear view of the plenum chamber 3200 shown in FIG. 142 with various parts identified. [Fig. 176] FIG. 143 is a front view of the plenum chamber 3200 shown in FIG. 142 with various parts identified. [Fig. 177] FIG. 151 is a side view of the plenum chamber 3200 shown in FIG. 150 with various parts identified. [Fig. 178] FIG. 151 is a bottom view of the plenum chamber 3200 shown in FIG. 150 with various parts identified. [Fig. 179] FIG. 151 is a top view of the plenum chamber 3200 shown in FIG. 150 with various parts identified. [Fig. 180] FIG. 151 is a rear view of the plenum chamber 3200 shown in FIG. 150 with various parts identified. [Fig. 181] FIG. 151 is a front view of the plenum chamber 3200 shown in FIG. 150 with various parts identified. [Fig. 182] FIG. 151 is a front perspective view of the plenum chamber 3200 shown in FIG. 150 with various parts identified. [Fig. 183] FIG. 151 is a rear perspective view of the plenum chamber 3200 shown in FIG. 150 with various parts identified. [Fig. 184] FIG. 30 is a perspective view of a patient interface 3000 according to another embodiment of the present technology. [Fig. 185] FIG. 30 is a perspective view of a patient interface 3000 according to another embodiment of the present technology. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0145] 5 Detailed Description of the Embodiments of the Present Technology

[0146] Before describing the present technology in further detail, it should be understood that the present technology is not limited to the specific embodiments described herein, which may vary. It should also be understood that the terminology used in the present disclosure is for the purpose of describing the specific embodiments described herein, and is not intended to be limiting.

[0147] The following description is provided in conjunction with various embodiments that may share one or more common characteristics and / or features. It should be understood that one or more features of any one embodiment may be combined with one or more features of another embodiment or other embodiments. In addition, any single feature or combination of features in any of these embodiments may constitute an additional embodiment.

[0148] Although anatomical directional terms are used in describing aspects and examples of the technology (e.g., "anterior," "posterior," "superior," "inferior," "lateral," "medial"), these directions apply in the context of the technology during use by a patient. For example, the anterior side of a patient interface refers to the side of the patient interface that is anterior to the patient when the patient interface is worn in its intended manner.

[0149] When describing a surface or portion as facing in a certain direction (e.g., "facing upward," "facing forward"), unless the context clearly indicates otherwise, it is to be understood that the surface or portion faces at least partially in a particular direction. If an area faces generally upward, the area may be said to "face upward" even if it also faces partially in another direction.

[0150] 5.1 Treatment

[0151] In one form, the present technology includes a method of treating a respiratory disorder, the method including the step of applying positive pressure to an entrance to the airways of a patient 1000.

[0152] In certain embodiments of the present technology, a supply of air at positive pressure is provided to the patient's nasal passages via one or both nostrils.

[0153] In certain embodiments of the present technology, mouth breathing is restricted, limited or prevented.

[0154] 5.2 Treatment system

[0155] In one form, the present technology includes an apparatus or device for the treatment of respiratory disorders. The apparatus or device may include an RPT device 4000 that supplies pressurized air to a patient 1000 via an air circuit 4170 to a patient interface 3000.

[0156] 5.3 Patient Interface

[0157] A non-invasive patient interface 3000 according to one aspect of the present technology includes the following functionalities: a plenum chamber 3200 including a seal-forming structure 3100, a positioning and stabilizing structure 3300, a vent 3400, a form of connection port 3600 for connection to an air circuit 4170, and a forehead support 3700. In some forms, the functionalities may be provided by one or more physical components. In some forms, one physical component may provide one or more functionalities. In use, the seal-forming structure 3100 is positioned to surround an entrance to the patient's airway to facilitate the supply of air at positive pressure to the airway.

[0158] In some examples of the present technology, the plenum chamber 3200 is at least partially formed by the shell 3210 and the seal-forming structure 3100. The plenum chamber 3200 may include, for example, a cushion module or cushion assembly. The shell 3210 may act as a chassis for the seal-forming structure 3100.

[0159] In some examples of the present technology, the patient interface 3000 is an oral-nasal patient interface. That is, the patient interface 3000 is configured to seal both the nasal and oral airways of the patient. In some examples, the patient interface 3000 includes separate seals around the nasal and oral airways, respectively. For example, as shown in Figs. 7-14, 49-56, 119-125, and 126-157, the patient interface 3000 may include a plenum chamber 3200 having a nasal region 3230 and a mouth region 3260. The seal-forming structure may be configured to enclose the nasal airway at the nasal region 3230 and to seal around the patient's mouth at the mouth region 3260. Thus, the seal-forming structure 3100 may also be considered as having a nasal region and a mouth region, where the nasal region and the mouth region of the seal-forming structure include portions that seal around the nasal airway and the oral cavity, respectively, of the patient.

[0160] In the examples shown in Figures 7-14, 49-56, 119-125 and 126-157, the seal-forming structure 3100 in the nose region 3230 does not place on the bridge or ridge region of the patient's face, but seals against the underside of the patient's nose. The nose region 3230 may seal against the upper lip, the anterior surface of the ala and tip of the nose, and / or the underside of the tip of the nose. The actual location of the seal may vary from patient to patient. The nose region 3230 may also be configured to contact and / or seal with the area of ​​the patient's face between the ala and the nasolabial fold and the lateral portion of the upper lip adjacent the nasolabial fold.

[0161] The seal-forming structure 3100 of the mouth region 3260 may be configured to form a seal against the periphery of a patient's mouth in use. The mouth region 3260 may be configured to form a seal against the patient's face, for example, at the upper lip, nasolabial folds, cheeks, lower lip, and chin.

[0162] One or more holes may be provided within the seal-forming structure 3100 to deliver an airflow at therapeutic pressure to the patient's nares and the patient's mouth through the one or more holes. The seal-forming structure may define an oral hole and one or more nasal holes for delivery of the airflow to the patient. In the example shown in Figures 7-14, 49-56, 119-125 and 126-157, the plenum chamber 3200 includes the seal-forming structure 3100 including an oral hole 3271 and two nasal holes 3272. Each of the nasal holes 3272 may be positioned on the plenum chamber 3200 to be substantially aligned with the patient's nares to deliver the airflow to the patient's nares in use.

[0163] 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.

[0164] 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.

[0165] 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.

[0166] 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.

[0167] 5.3.1 Plenum chamber

[0168] The plenum chamber 3200 has a perimeter with a shape that is complementary to the surface contours of an average human face in the area where a seal is formed in use. In the examples shown in Figures 7-14, 49-56, 119-125 and 126-157, the plenum chamber includes a shell 3210 and a seal-forming structure 3100. In these examples, the peripheral edge of the plenum chamber 3200 is positioned in close proximity to the adjacent surface of the face. Actual contact with the face is provided by the seal-forming structure 3100. The seal-forming structure 3100 may extend around the entire edge of the plenum chamber 3200 in use. In some forms, the plenum chamber 3200 and the seal-forming structure 3100 are formed from a single homogenous piece of material.

[0169] In some forms of the present technology, the plenum chamber 3200 does not cover the patient's eye when in use. In other words, the eye is outside the pressurized space defined by the plenum chamber. Such forms may improve treatment compliance because they are often less intrusive and / or more comfortable for the wearer.

[0170] In certain forms of the present technology, a portion of the plenum chamber 3200 is constructed from a transparent material (e.g., clear polycarbonate). In the examples shown in Figures 7-14, 49-56, 119-125, and 126-157, the shell 3210 is made of clear polycarbonate. The use of a transparent material may reduce the intrusiveness of the patient interface and may help improve compliance with treatment. The use of a transparent material may help the clinician see the placement and function of the patient interface. In some examples, the shell 3210 may be formed from silicone.

[0171] In certain forms of the present technology, the plenum chamber 3200 is constructed from a translucent material. The use of a translucent material can make the patient interface less intrusive and can help improve compliance with treatment.

[0172] 7-47, 49-75 and 119-183 show a plenum chamber 3200 according to examples of the present technology formed in part by a shell 3210. Additionally, the plenum chamber 3100 is formed in part by a seal-forming structure 3200. In some examples, the seal-forming structure 3100 is overmolded onto the shell 3210. Alternatively, the seal-forming structure 3100 may be formed separately from the shell 3210 and configured to be permanently or removably connected to the shell 3210. The seal-forming structure 3100 and the shell 3210 may be integrally formed.

[0173] In the examples shown in Figures 7-47, 49-75 and 119-183, the shell 3210 is formed from polycarbonate and the seal-forming structure 3100 is formed from silicone. The silicone may have a Shore A hardness of 30 or 40 durometer. Silicone or similar materials with this hardness are advantageous in terms of comfort and flexibility in conforming and sealing to the patient's face. The use of polycarbonate (or other stiffer material) with a higher hardness and stiffness than silicone is advantageous in that it provides areas that are more resistant to deformation (with less material than would be required to achieve the same resistance with silicone). The reduced material used may be advantageous as it maintains an overall reduced bulk and weight and may be less intrusive to the user. In another example, the shell 3210 may be formed from nylon or polypropylene. Alternatively, the seal-forming structure 3100 may be formed from silicone, a suitable foam or any suitable thermoplastic elastomer.

[0174] As shown in Figures 40-46, the shell 3210 may have rear projections 3215 at the upper lateral corners of the shell 3210. The rear projections 3215 may strengthen the base of the nose region and aid in stabilizing the seal-forming structure 3100. The rear projections 3215 may also help strengthen the location of the seal-forming structure proximate rear corners 3131 (e.g., as shown in Figures 10 and 52), which also supports the nose region of the plenum chamber on the patient's face and advantageously fits within the patient's nasolabial fold. The rear projections 3215 may project from the shell 3210 toward the patient's nasolabial fold or along the patient's cheeks. The rear projections 3215 may be provided below the lateral support portions 3151 (described below).

[0175] 5.3.1.1 Lateral support areas

[0176] In some examples of the present technology, as shown in, for example, Fig. 18, Fig. 19, Fig. 32, Fig. 35 and Fig. 38, the plenum chamber 3200 includes a lateral support region 3151 on the front side of the nose region 3230 of the plenum chamber 3200. The lateral support region 3151 may have a higher resistance to deformation than one or more adjacent portions 3100 of the seal-forming structure. The lateral support region 3151 may be stiffer than a region of the plenum chamber 3200 above the lateral support region 3151. Additionally or alternatively, the lateral support region 3151 may be stiffer than a central region of the plenum chamber 3200. The relatively stiffer region may take the form of a fin configured to provide a relatively stiffer region than a peripheral region of the plenum chamber. The seal-forming structure 3100 shown in Figs. 34-38 includes a lateral support region 3151 therein. Additionally, the plenum chamber 3200 shown in Figures 49-56 includes a lateral support feature 3151 within the shell 3210. The shell 3210 of the plenum chamber 3200 of Figures 49-56 is shown in isolation in Figures 81-86. As shown, the lateral support feature 3151 is formed by an upper lateral portion of the shell 3210 itself.

[0177] The lateral support regions 3151 may aid in lateral stability of the nasal region 3230 of the plenum chamber 3200. In the examples of Figures 7-38, the lateral support regions 3151 are provided on laterally spaced apart at least partially forward facing sides of the plenum chamber 3200. In particular, the lateral support regions 3151 are provided on the sides of the nasal region 3230 not facing the patient (e.g., the front side or the at least partially forward facing side). In these examples, one lateral support region 3151 is provided on the at least partially forward facing wall on each lateral side of the plenum chamber 3200. The plenum chamber 3200 is configured such that in use the lateral support region 3151 is located in the seal forming structure 3100 approximately opposite the ala of the patient's nose.

[0178] The lateral support region 3151 may include an area of ​​the plenum chamber 3200 that has a greater material thickness than the surrounding or adjacent regions. Alternatively or additionally, the lateral support region 3151 may be formed of a stiffer material than the material in the surrounding or adjacent regions.

[0179] The lateral support region 3151 may be substantially fin-like in shape (e.g., having a curved upper boundary and a flatter lower boundary). As shown in Figs. 34-38, the lateral support region 3151 of the seal-forming structure 3100 includes a curved upper boundary 3153 and a flatter lower boundary 3152. Similarly, the lateral support region 3151 of the shell 3210 as shown in Figs. 49-56 has a curved upper boundary 3153 (but in this example there is no separate lower boundary of the lateral support region 3151). Using a fin-like shape (specifically the provision of a curved upper boundary or edge) is advantageous because the upper edge or boundary of the lateral support region 3151 follows the curvature of the upper periphery 3232 of the nose region 3230. This may be advantageous in providing a consistent height for the nose portion 3230 above the shell 3210, which, as described below, provides a consistent or controlled stiffness for the structure of the nose portion 3230. Additionally, the curved upper boundary 3153, rather than a flat boundary around the entire anterior portion of the nose portion 3230, allows the central, forward facing portion of the nose portion to remain flexible, thus avoiding excessive force on the patient's nasal tip.

[0180] The lateral support portion 3151 may control the collapsibility of the front side of the plenum chamber 3200. The height of the lateral support portion 3151 (e.g., the amount of upper extension) may be selected to provide a balance between collapsibility and structural rigidity. A certain amount of flexibility in the structure of the seal-forming structure 3100 is desirable because it allows the seal-forming structure 3100 to accommodate a wide range of nose shapes and sizes. However, if the lateral support portion 3151 extends upward too much, the seal-forming structure 3100 may be insufficiently accommodating or insufficiently comfortable. Alternatively, if the lateral support portion 3151 does not extend upward enough, the seal-forming structure 3100 may be prone to collapse, making it impossible to avoid rupturing the sealing engagement with the patient's face.

[0181] Additionally, providing some flexibility in the overall structure of the seal-forming structure 3100 may be advantageous in accommodating long and / or narrow noses. A certain amount of flexibility in the overall structure of the nose region 3230 is undesirable when the seal-forming structure 3100 is moved upward to contact the underside of a narrow nose, as such flexibility may cause the lateral sides of the seal-forming structure 3100 to be pulled inward as a result of a downward force from the patient's nose being applied to the center of the seal-forming structure 3100. FIGS. 112 and 113 show the seal-forming structure 1000 before and after being moved into a sealing position with the nose of the patient 1000. As shown in FIG. 113, when the seal-forming structure 3100 in the nose region 3230 is brought into contact with the patient's nose, the outwardly facing lateral sides of the seal-forming structure 3100 are pulled inward to help the inwardly facing lateral sides of the seal-forming structure 3100 conform to the underside perimeter of the patient's nose. If the lateral sides of the seal-forming structure 3100 are not flexible enough, the seal-forming structure 3100 may accommodate narrower noses less well and / or be less comfortable as the patient must tighten the headgear to compensate. If it is too flexible, the seal-forming structure 3100 may not be able to retain its shape and maintain an effective seal.

[0182] The height of the lateral support region 3151 should be appropriate to provide sufficient structural rigidity to the nose region 3230 while retaining sufficient flexibility to allow the seal-forming structure 3100 to comfortably seal over a wide range of noses. The lateral support region 3151 may extend upwardly by approximately 35-65% of the height of the nose region 3230 (e.g., in examples, 40-60% or 50% of the distance between the base of the nose region 3230 on the anterior side of the plenum chamber 3200 and the uppermost point of the plenum chamber 3200).

[0183] In other examples, other stiffening / rigidifying structures or features may be used in place of the lateral support region 3151. In some examples, ribs are provided on the interior or exterior of the nasal region 3230 of the seal-forming structure 3100, generally at the location of the lateral support region 3151, to provide structural stiffness to the nasal region 3230. In other examples, the lateral support region 3151 may be stiffened. The seal-forming structure 3100 may include a support insert (e.g., stiffener element) provided in the lateral support region 3151. In one example, the seal-forming structure 3100 may be overmolded to one or more stiffener elements to provide stiffness to the lateral support region 3151.

[0184] In another example, the plenum chamber 3200 may include an undercushion that provides necessary support to the structure of the nose region 3230. The undercushion may be thicker than the face-contacting portion of the seal-forming structure 3100, allowing the patient-contacting wall to be thin for comfort and conformance to the patient's nose and face.

[0185] Further, in some examples, separate components are provided for structural support of the nasal portion 3230 of the seal-forming structure 3100. For example, the frame to which the plenum chamber 3200 is connected may have portions that strengthen the seal-forming structure 3100 in the area of ​​the lateral support portions 3151.

[0186] 5.3.1.1.1 Lateral support areas provided by seal-forming structures

[0187] The plenum chamber 3200 shown in Figures 7-40 includes lateral support regions 3151 provided by the seal-forming structure 3100. The lateral support regions 3151 are provided to the front of the plenum chamber 3200 and on each lateral side of the nasal region 3230. In this example, the lateral support regions 3151 are provided in the lower region of each lateral side of the nasal region 3230.

[0188] In this example, at least a majority of the nose region 3230 is formed by the seal-forming structure 3100. A majority of the nose region 3230 of the plenum chamber 3200 is formed from a soft flexible resilient material. In this example, a majority of the nose region 3230 is formed from silicone. In the examples of Figures 7-33, substantially the entire nose region is formed by the seal-forming structure 3100. In the examples of Figures 49-75, a portion of the nose region is formed by the shell 3210.

[0189] In these examples, the lateral support region 3151 is a region of the seal-forming structure 3100 that is relatively stiffer than one or more adjacent regions of the seal-forming structure 3100. Specifically, the lateral support region 3151 has a thicker material than the region of the seal-forming structure 3100 above the lateral support region 3151. This thicker material thickness provides an amount of stiffness or structural rigidity to the structure of the seal-forming structure 3100 and specifically the nasal region 3230. The majority of the posterior side of the nasal region 3230 does not contribute significant structural rigidity to the shape of the nasal region 3230 because it can have a thinner wall thickness for comfort and be able to seal against the patient's face. The lateral support region 3151 compensates for the lack of structural rigidity available from the patient-contacting wall and increases the overall structural rigidity to the nasal region 3230.

[0190] 35 and 38, each of the lateral support regions 3151 includes a substantially flat lower boundary 3152. The substantially flat lower boundary 3152 is generally flat, but may have a small amount of curvature, for example, due to a certain amount of curvature required for the base of the nose region to transition into the mouth region 3260 of the plenum chamber 3200. Each flat lower boundary 3152 may be adjacent to a respective posterior projection 3215 of the shell 3210. In this example, each of the lateral support regions 3151 includes a curved upper boundary 3153. Furthermore, the curvature of the curved upper boundary 3153 may substantially match or follow the curvature of the upper perimeter 3232 of the seal-forming structure 3100 at the nose region 3230.

[0191] 5.3.1.1.2 Lateral support areas formed by shells

[0192] The plenum chamber 3200 shown in Figures 49-75 and Figures 126-157 each include a lateral support region 3151 provided by the shell 3210 of the plenum chamber 3200. Figures 81-86 show the shell 3210 of the plenum chamber 3200 in isolation in Figures 49-75. In these examples, the lateral support region 3151 includes an upper portion of the shell 3210. The lateral support region 3151 extends upwardly into the nose region 3230 of the plenum chamber 3200. In these examples, the lateral support region 3151 includes a portion of the shell 3210 provided to the nose region 3230. In the examples shown in Figures 7-33, the shell 3210 has a generally flat upper edge, whereas the shell 3210 in the examples shown in Figures 49-75 and 81-86 includes a curved upper edge 3211 including lateral support regions 3151. The lateral support regions 3151 extend upwardly over a greater area than the center of the upper edge 3211 to form two lateral support regions 3151. In these examples, the lateral support regions 3151 each include a curved upper edge or boundary. The curvature of each upper edge substantially matches or follows the curvature of the upper periphery 3232 of the seal-forming structure. The lateral support regions 3151 of the shell 3210 occupy the forward facing and laterally facing side regions of the nasal region 3230 and are generally opposite the ala of the patient's nose in use.

[0193] The lateral support members 3151 in the examples shown in Figures 49-75 and 81-86 provide a similar function as the lateral support members 3151 shown in the examples of Figures 7-33. The lateral support members 3151 provide structural rigidity to the nasal portions 3230 of the seal-forming structure 3100. Because the patient-contacting (rear) side of the seal-forming structure 3100 includes a relatively thin flexible wall, the flexible wall, the lateral support members 3151, provide a level of structural rigidity to the nasal portions 3230.

[0194] 5.3.1.2 Plenum chamber inlet port

[0195] The shell 3210 may include one or more plenum chamber inlet ports 3240. The one or more plenum chamber inlet ports 3240 may allow connection to other components (e.g., a frame, a decoupling structure, a venting arrangement, a heat moisture exchanger (HMX), a constant flow vent (CFV), an anti-asphyxiation valve (AAV), and / or connection ports to conduits in various examples).

[0196] 7-14, the plenum chamber 3200 includes a single inlet port 3240. The inlet port 3240 is substantially centrally located in the shell 3210. In this example, the inlet port 3240 may be configured to connect to a frame to which headgear or other positioning and stabilizing structural components may be connected. In this exemplary form of the technology, the inlet port 3240 is substantially circular.

[0197] In the examples shown in Figures 49-56 and 126-183, the plenum chamber 3200 includes two inlet ports 3240. The inlet ports 3240 are provided on the lateral side 3210 of the shell. In these examples, the inlet ports 3240 are configured to connect to conduits that connect to decoupling components located above the patient's head where the conduits are connected to the air circuit. These conduits may form part of the positioning and stabilizing structure 3300 (i.e., may be "headgear conduits"). In some examples, the inlet ports 3240 may receive a combination headgear and conduit connection assembly to provide multiple functions (e.g., ventilation, air flow supply, and headgear attachment point). The combination headgear and conduit connection assembly may also include an AAV. In these examples, the inlet ports 3240 are approximately elliptical in shape (e.g., oval).

[0198] In some examples, the plenum chamber 3200 shown in Figures 7-14 may include one or two inlet ports 3240 on the lateral sides 3210 of the shell for connection to conduit headgear. It is understood that any of the features described herein of the seal-forming structure 3100 (e.g., those of the plenum chamber 3200 shown in Figures 7-48) may be employed in a patient interface that includes conduit headgear.

[0199] The upper periphery of each inlet port 3240 in the examples shown in Figures 49-56 is formed by the lateral support portion 3151 of the nose portion 3230. In examples where the inlet ports 3240 connect to headgear conduits, the connection from the plenum chamber 3200 to the headgear conduits may advantageously be made at an upper location of the plenum chamber 3200. This allows for shorter conduits, better force vectors and / or a smaller conduit footprint on the patient's face compared to inlet ports 3240 located at a lower location of the plenum chamber 3200.

[0200] In one example, the plenum chamber 3200 connects to a frame and is supported in front of the patient's face via a positioning and stabilizing structure 3300 (e.g., headgear). The connection to the frame can be a snap-fit ​​connection. Alternatively, the connection can be a press-fit, bayonet connection, or other suitable connection.

[0201] In one example, the frame 3350 includes a snap-fit ​​hook 3351 that snaps through a rim of the shell 3210. In some examples, two snap-fit ​​hooks 3351 are provided to the frame snap through a rim 3218 provided to the air inlet port 3240 of the plenum chamber 3200. FIG. 87 is a cross-sectional view of a connection in a horizontal plane between the frame 3350 and the plenum chamber 3200, showing a horizontal snap-fit ​​hook 3351 snapped through a rim 3218 of the air inlet port 3240. In this example, the two snap-fit ​​hooks 3351 are horizontally opposed on the air inlet port 3240. In other examples, the arms are vertically opposed. Providing horizontally corresponding snap-fit ​​arms (e.g., at the 9 o'clock and 3 o'clock positions around the air inlet 3240) advantageously provides resistance to disengagement when a lateral force is applied on the plenum chamber 3200 or the frame 3350. 88 is a cross-sectional view of the connection in a vertical plane between the frame 3350 and the plenum chamber 3200, showing the lack of a snap-fit ​​connection on the vertically opposing sides of the connection. Because a patient may sleep with their head on their side, the plenum chamber 3200 is more likely to experience lateral forces than vertical forces during use. A horizontally opposing snap-fit ​​connection allows the patient to disassemble the plenum chamber 3200 by rotating it up or down relative to the frame 3350, but is less likely to disengage the plenum chamber 3200 from the frame due to lateral forces on the plenum chamber 3200 during use.

[0202] 5.3.1.3 Seal formation structure

[0203] In one form of the present technology, the seal-forming structure 3100 provides a target seal-forming area and may further provide a cushioning function. The target seal-forming area is the area where a seal may occur in the seal-forming structure 3100. The area where a seal actually occurs (i.e., the actual sealing surface) may vary from patient to patient in a given treatment session from day to day depending on a range of factors (e.g., placement of the patient interface on the face, tension in the positioning and stabilizing structure, and the shape of the patient's face).

[0204] In one form, the target seal-forming area is located on an exterior surface of the seal-forming structure 3100 .

[0205] In certain forms of the present technology, the seal-forming structure 3100 is constructed from a biocompatible material (eg, liquid silicone rubber (LSR)).

[0206] A seal-forming structure 3100 according to the present technology may be constructed from a material that is soft, flexible and resilient (eg, liquid silicone (LSR)).

[0207] In certain forms of the present technology, a system is provided that includes more than one seal-forming structure 3100. Each seal-forming structure 3100 is configured to accommodate a different size and / or shape range. For example, the system may include one form of seal-forming structure 3100 suitable for large head sizes but not small head sizes, and another suitable for small head sizes but not large head sizes.

[0208] 5.3.1.3.1 Sealing mechanism

[0209] In one form, the seal-forming structure 3100 includes a sealing flange that employs a pressure-assisted sealing mechanism. In use, the sealing flange can readily respond to positive system pressure within the plenum chamber 3200 by acting on its underside to form a tight sealing engagement with a surface. The pressure-assisted mechanism can work in conjunction with elastic tension in the positioning and stabilizing structure.

[0210] 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 edge length of the plenum chamber 3200. The support flange may be relatively thicker than the sealing flange. The support flange is disposed between the sealing flange and the periphery of the plenum chamber 3200 and extends around at least a portion of the edge length. The support flange is or includes a spring-like element and functions to support the sealing flange against buckling in use.

[0211] In one form, the seal-forming structure may include a compression seal or gasket seal that is constructed and arranged such that, in use, it is in a compressed state due to, for example, elastic tension in the positioning and stabilizing structure.

[0212] In one form the seal-forming structure includes a tension part which, in use, is held taut, for example by an adjacent region of the sealing flange.

[0213] In one form the seal-forming structure includes an area having a sticky or adhesive surface.

[0214] In certain forms of the present technology, the seal-forming structure may include one or more of a pressure-assisted sealing flange, a compression seal, a gasket seal, a tension section, and a section having a sticky or adhesive surface.

[0215] 5.3.1.3.2 Nasal area

[0216] In certain forms of the present technology, the seal-forming structure 3100 includes a central portion configured to form a seal against the underside of the patient's nose. The central portion may seal against the lower periphery of the patient's nose (e.g., around the patient's nostrils and the patient's upper lip). In examples, the seal-forming structure 3100 may be configured to contact the patient's face under the bridge of the nose or under the tip of the nose.

[0217] As shown in Figures 34-80 and 158-183, the seal-forming structure 3100 includes a central portion configured to seal against the lower periphery of a patient's nose in use, and an intermediate portion configured to be positioned at or adjacent the patient's ala in use. More specifically, the central portion includes an upwardly facing central portion 3111 and a forwardly facing central portion 3115. Most or all of the contact between the central portion and the patient's nose is made by the upwardly facing central portion 3111. Further, the intermediate portion includes an upwardly facing intermediate portion 3121 and a forwardly facing intermediate portion 3125. Most or all of the contact between the intermediate portion and the patient's nose is made by the upwardly facing intermediate portion 3121.

[0218] It is understood that the actual amount of contact that the seal-forming structure 3100 has with the patient's face will depend on the particular implementation of the technology and the particular patient's anatomy. The seal-forming structure 3100 for the plenum chamber 3200 shown in Figures 158-164 (small plenum chamber 3200) and 165-171 (medium plenum chamber 3200) is configured for use with patients with long and narrow nose shapes. In contrast, the seal-forming structure 3100 for the plenum chamber 3200 shown in Figures 172-176 (small wide plenum chamber 3200) and 177-183 (wide plenum chamber 3200) is configured for use with patients with shorter and wider noses. In the small and medium sized plenum chambers 3200 shown in Figs. 158-171, the upwardly facing middle portion allows for a greater amount of contact with the lateral undersurface 3121 of the patient's nose (than in the small wide and wide plenum chambers 3200 shown in Figs. 172-183) because patients using the small and medium sized plenum chambers 3200 may generally have narrower noses and the small and medium sized plenum chambers 3200 may have a greater depression in the nasal region 3230 of the seal-forming structure 3100. In each of these particular examples of the present technology, the upwardly facing middle portion 3111 allows for contact between the majority and the undersurface of the patient's nose.

[0219] The upper lip 3116 may significantly contact the underside of the patient's nose as well as the patient's upper lip. In some examples, the majority of the seal formed by the seal-forming surface 3100 to the underside periphery of the patient's nose may be comprised of the upwardly facing central portion 3111 and the upper lip 3116. The upwardly facing central portion 3111 and the upper lip 3116 may each be less stiff than the other portions of the seal-forming structure 3100, which in some examples of the present technology is provided by a thinner wall thickness than the other portions of the seal-forming structure 3100. The underside of the patient's nose and upper lip may have complex geometries and may also be sensitive to pressure. Therefore, it is advantageous to make the areas of the plenum chamber 3200 that contact or are sealed to these locations flexible and compliant to avoid excessive pressure on the face in these areas. In these examples, the low stiffness allowed by the thin wall thickness in the central portion of the nasal region 3230 of the seal-forming structure 3100 adjacent the nasal orifice 3272 allows the cushion to easily deform to seal against the lower surface of the patient's nose (e.g., the anterior tip, lateral sides, and either ala of the upper lip). FIG. 110 is a cross-sectional view of the plenum chamber 3200 in sealing contact with the lower periphery of the patient's 1000 nose. The overall shape and structure of the outwardly facing regions of the nasal region 3230 (e.g., the posterior corners 3131, the forwardly facing intermediate portion 3125, and the forwardly facing central portion 3115) are generally maintained in use, while the more flexible upwardly facing central portion 3111 can conform to the lower periphery of the patient's nose.

[0220] The thin wall thickness of the upward facing central portion 3111 and the upper lip portion 3116 allows the seal-forming structure 3100 to expand in these areas to conform to the geometry of the underside and surrounding the patient's nose. As shown in FIG. 110, the thin walls of the seal-forming structure 3100 in the upward facing central portion 3111 and the upper lip portion 3116 are advantageous in creating a good seal against the complex geometry under and around the nose. The thin walls are able to deform and expand under pressure to conform to the surface of the patient's face to create an effective and comfortable seal.

[0221] The upwardly facing central region 3111 above and in front of the nasal orifice 3272 of the seal-forming structure is intended to seal under and partially in front of the patient's nasal tip. Because the nasal tip may be a relatively sensitive area in many patients, the wall thickness of this region of the seal-forming structure 3100 may be thinned. The central portion may extend from the rear upwardly facing central portion 3111 (i.e., facing the patient) side of the cushion through the central saddle area 3112 and peripheral edge into the forward facing central portion 3115 on the front (i.e., facing away from the patient) side of the seal-forming structure. By thinning the wall thickness in this region, excessive pressure on the sensitive nasal tip area is avoided.

[0222] The upper lip 3116 of the seal-forming structure 3100 is intended to seal against the upper lip. The upper lip 3116 is provided centrally as well as below and behind the nostril 3272. The upper lip 3116 may include a low wall stiffness. In some instances, the low wall stiffness is achieved by a thin wall thickness. The thin wall thickness extends across the central under / back region of the nose region 3230 of the seal-forming structure 3100, as the upper lip may be a sensitive region, as well as the region of the seal-forming structure 3100 intended to seal against the nasal tip. The thin wall thickness allows a lower force to be applied to the upper lip than would be applied from a relatively thick wall thickness.

[0223] While keeping the wall thickness thin in areas configured to contact the sensitive nasal tip and upper lip areas is advantageous for comfort, in examples of the present technology, the wall thickness in these areas is not reduced to an extent that the seal-forming structure 3100 cannot maintain a stable seal against the patient's face. If the wall thickness is too thin in these areas, the seal-forming structure will be prone to puckers, which can lead to seal failure and leak paths allowing air to flow between the patient's face and the cushion to the surroundings.

[0224] The upwardly facing intermediate portion 3121 may be disposed around some or all of the lower periphery of the patient's nose in use. For example, the upwardly facing intermediate portion 3121 may be configured to be disposed just outside the patient's nose at the base of the nose (e.g., adjacent to or against the ala of the nose). The upwardly facing intermediate portion 3121 of the seal-forming structure 3100 may include a pair of outer walls that face partially in a medial direction and partially in an upward direction (e.g., having an outer surface and an outer surface that face in a medial direction and an upward direction) and in some examples face partially in a posterior direction. As shown in FIG. 113, the upwardly facing intermediate portion 3121 of the nasal region 3230 is disposed proximate to the lower periphery of the patient's 1000 nose. The stiffness of the seal-forming structure 3100 is higher in the upwardly facing intermediate portion 3121 than in the central portions 3111 and 3115. In these examples, the wall thickness of the seal-forming structure 3100 is thicker at the middle portions 3121 and 3125 than at the central portions 3111 and 3115 and the upper lip portion 3116 .

[0225] In various examples of the present technology, generally, greater wall thickness, stiffer materials (e.g., higher durometer silicone or other materials), reinforcing structures (e.g., ties or ribs, undercushions, sections or chassis, etc.) may be used to make areas of the seal-forming structure 3100 stiffer than other areas of the seal-forming structure 3100.

[0226] 34-38 and 76-80, the nasal section has a central saddle section 3112 that may seal against an area in front of or below the patient's nasal tip in addition to the upwardly facing central section 3111. In these examples, these intermediate sections are provided to the lateral sides of the nasal section 3230 of the seal-forming structure 3100 on either side of the upwardly facing central section 3111, but not in the central saddle section 3112. The central saddle section 3112 includes the same low stiffness as the upwardly facing central section 3111 and the forward facing central section 3115 in these examples of the present technology.

[0227] The seal-forming structure 3100 may have a wall thickness at the upwardly facing central portion 3111, the forwardly facing central portion 3115 and / or the upper lip portion 3116 of 0.15-0.4 mm (e.g., 0.2 mm-0.3 mm (e.g., 0.25 mm)). The wall thickness at the upwardly facing intermediate portion 3121 and the forwardly facing intermediate portion 3125 may be 0.5 mm-1 mm (e.g., 0.6 mm-0.9 mm (e.g., 0.75 mm)).

[0228] In some examples, the upwardly facing middle portion 3121 of the seal-forming structure 3100 strengthens the upwardly facing central portion 3111 of the seal-forming structure 3100. In further examples, the upwardly facing middle portion 3121 provides a barrier against puckers and prevents leak paths from forming within the seal-forming structure 3100. Additionally, the upwardly facing middle portion 3121 can provide flexibility and support for side loading onto the plenum chamber 3200 to help prevent seal failure under lateral forces.

[0229] The upward facing central portion 3111 is extremely flexible due to its thinner wall thickness and therefore prone to folding under certain conditions. The upward facing intermediate portion 3121 is stiffer and less prone to folding due to its thicker wall thickness. In some instances, the nose portion 3230 of the seal-forming structure 3100 is particularly prone to folding near the lateral sides of the patient's nose. If folding begins in the seal-forming surface and continues outside of the seal-forming surface, the folding can create a leak path through which gas can leak from the interior of the plenum chamber 3200 through the folding to the environment and past the patient's face.

[0230] In some instances, the upwardly facing intermediate portion 3121 resists puckers of the seal-forming structure 3100 due to its increased wall stiffness. If puckers do occur within the upwardly facing central portion 3111 of the seal-forming structure 3100, the upwardly facing intermediate portion 3121 and / or the thicker rear corner region 3131 may limit the pucker size so that the puckers do not continue to move up the patient-facing side of the nasal region 3230 and past the seal-forming surface (e.g., a portion of the periphery of the patient's nose). Thus, the upwardly facing intermediate portion 3121 is positioned at or near the edge of the patient's alar around the base of the nose to act as a barrier against puckers closely following the shape of the patient's nose. FIG. 116 shows the plenum chamber 3200 with various portions of various depicted seal-forming structures 3100. As shown, the pleats 3110 are formed in the upwardly facing central portion 3111, but the upwardly facing middle portion 3121 and the rear corners 3131 effectively provide a barrier to prevent the pleats 3110 from propagating outwardly and creating a leak path through the seal formed with the patient's face. The rear corners 3131 may provide a barrier to the inferior and lateral pleats 3110 of the upwardly facing central portion 3111. The upwardly facing middle portion 3121 may provide a barrier to the superior and lateral pleats 3110 of the upwardly facing central portion 3111.

[0231] Additionally, the intermediate portion 3121 or 3125 may help resist or avoid the formation of creases in the thinner central portion 3111 or 3115. When the patient interface 3000 is worn by the patient, the intermediate portion may stretch the thinner central portion over the base of the nose (e.g., toward the lower periphery). Stretching the central portion over the base of the nose may resist or avoid the formation of creases in the central portion due to the increased resistance to deformation provided by the intermediate portion near the patient's ala.

[0232] The seal-forming structure 3100 may also include a laterally facing posterior portion 3141 on a lateral, non-patient facing area of ​​the nasal region 3230 of the seal-forming structure 3100. The laterally facing posterior portion 3141 of the nasal region 3230 may be stiffer than the upwardly facing middle portion 3121 and the forwardly facing middle portion 3125. The laterally facing posterior portion 3141 may have a greater wall thickness than the middle portion, central portion and / or upper lip portion 3116.

[0233] The upwardly facing intermediate portion 3121 is positioned to contact the side of the patient's nose when the patient interface 3000 is worn by the patient, but is also flexible to allow for lateral deformation due to the patient's nose. In use, the seal-forming structure 3100 is biased at the upwardly facing intermediate portion 3121 to contact the patient's nasal ala. When the patient wears the patient interface 3000, an outward force is applied from the patient's nose onto the side of the seal-forming structure 3100. As a result, the side of the seal-forming structure 3100 in the nasal region 3230 conforms to the periphery of the patient's nose to form a stable and robust seal. Figures 112 and 113 show the nasal region 3230 before and after the patient 1000 wears the patient interface 3000. As shown, the seal-forming structure 3100 is shaped within the nasal region 3230 to conform to the lower periphery of the patient's nose when the patient 1000 wears the patient interface 3000. 113 shows how the seal-forming structure 3100 in the upwardly facing central portion 3111 adjacent the upwardly facing intermediate portion 3121 conforms to the periphery of the nose of the patient 1000 to form a good seal. The stiffness of the seal-forming structure 3100 in the upwardly facing intermediate portion 3121 is advantageously large enough for the nose area 3230 to conform and create a robust seal with narrow noses, yet not so stiff that it would be uncomfortable for wider noses.

[0234] Additionally, the preload on the sides of the nose provided by the upwardly facing middle portion 3121 allows for decoupling between the patient's nose and the remainder of the plenum chamber 3200 and the patient interface 3000, allowing some lateral movement of some parts of the plenum chamber 3200 (e.g., the shell 3210) to be tolerated in use without disrupting the seal. FIG. 114 shows the seal-forming structure 3100 in sealing contact with the nose of the patient 1000 without any lateral displacement of the plenum chamber 3200. FIG. 115 shows the same view as FIG. 114, but after the seal-forming structure 3100 has been laterally displaced (e.g., by tube traction). As shown in FIG. 115, biasing the seal-forming structure 3100 into contact with the nose of the patient 1000 allows the seal-forming structure 3100 to remain in sealing contact with both sides of the nose, even when the plenum chamber 3200 is displaced relatively significantly.

[0235] In these examples, as shown in Figures 7-8, 49-50, 128-129, 138-139, 146-147, and 154-155, the nasal region 3230 of the seal-forming structure 3100 includes two lateral portions 3231. Each lateral portion 3231 of the nasal region 3230 may include a patient-facing side and a non-patient-facing side. The patient-facing side may face in a medial and posterior direction, and the non-patient-facing side may face in a lateral and anterior direction. Both the patient-facing side and the non-patient-facing side may face partially in an upward direction. The patient-facing side of the lateral portion 3231 of the nasal region 3230 may include a portion of an upwardly facing central surface 3111 and an adjacent upwardly facing intermediate portion 3121. The non-patient facing side of the lateral portion 3231 of the nasal region 3230 may include a forward facing middle portion 3125 and a laterally facing posterior portion 3134 .

[0236] In some examples of the present technology, the lateral portion 3231 of the nose region 3230 of the seal-forming structure 3100 can be taller than in other examples of the present technology. That is, the lateral portion 3231 can protrude upwardly from the mouth region 3260 a greater distance in use. The plenum chambers 3200 shown in Figs. 7-8 and 49-50 include tall lateral portions 3231 in the nose region 3230. These plenum chambers 3200 can be a good fit for patients with relatively long noses, narrow noses, and / or noses with longer alae than nasal bridge. The plenum chambers 3200 shown in Figs. 128-129 and 138-139 include lateral portions 3231 in the nose region 3230. These lateral portions 3231 are of medium height, though not as tall as the examples shown in Figs. 7-8 and 49-50. These lateral portions 3231 may also fit well with patients with longer and narrower noses. The lateral portions 3231 shown in Figures 146-147 and 154-155 have shorter lateral portions 3231 in the nasal region 3230. These plenum chambers 3200 may fit well with patients with wider, shorter and / or flatter noses.

[0237] The anterior region of the nasal section 3230 is configured to be comfortable while still being able to form a stable seal against the patient's nose.

[0238] In some examples, the thickness of the forward facing central portion 3115 is approximately 0.15-0.4 mm (e.g., 0.2-0.3 mm), and in the illustrated example, the wall thickness is approximately 0.25 mm. The forward facing intermediate portion 3125 may include a wall thickness greater than the wall thickness in the forward facing central portion 3115, which may be 0.5 mm-1 mm (e.g., 0.65 mm-0.85 mm), or in the illustrated example, approximately 0.75 mm. In some examples, the thickness of the seal-forming structure 3100 tapers between regions having different thicknesses. In other examples, the thickness changes relatively abruptly (e.g., in a stepwise fashion). The anterior region of the nasal region 3230 is configured to be somewhat compliant and is therefore not as thick and stiff as other regions of the nasal region 3230 (e.g., the rear corners 3131 of the nasal region 3230 (which may be in the range of 1-1.5 mm thick)). The front region of the nasal portion 3230 may be thick enough so that it is stiff enough to retain its overall shape when worn by a patient.

[0239] Making the front of the nose region 3230 flexible allows the seal-forming structure 3100 to deform slightly when accommodating a patient's nose, particularly a long nose. FIG. 117 shows the plenum chamber 3200 in sealing contact with the face of a patient 1000 with a short nose. FIG. 118 shows the plenum chamber 3200 in sealing contact with the face of a patient 1000 with a long nose. In this example, the seal-forming structure 3100 can deform to a greater extent to accommodate a longer nose. This can be accomplished without adversely affecting patient comfort. The patient's nose tip may be a particularly sensitive area, and flexibility in the front of the nose region 3230 may help reduce the force applied from the seal-forming structure 3100 to the patient's nose. This flexibility is particularly advantageous at the location of the nose tip, so that the central portion is less stiff than the forward facing intermediate portion 3125. The upward facing central portion 3111 and the forward facing central portion 3115 may be approximately 0.25 mm thick, and the forward facing intermediate portion 3125 may have a wall thickness of approximately 0.75 mm. The thinner central portion reduces pressure on the nasal tip, while the thicker intermediate portion 3125 provides some support to the overall structure of the nasal area 3230.

[0240] An additional benefit of the flexible central region of the nose portion 3230 is that it allows the sides of the nose portion 3230 to be pulled inwardly (e.g., medially) when the patient interface 3000 is donned and a downward force is applied from the patient's nose onto the upwardly pointing central portion 3111 of the seal-forming structure. Pulling the sides of the nose portion 3230 inwardly towards the sides of the patient's nose allows for an improved seal as the seal-forming structure 3100 is pulled into and around the lower perimeter of the patient's nose. FIG. 113 shows the seal-forming structure 3100 conforming to the perimeter of the patient's nose.

[0241] Although the lateral sides of the nose region 3230 are pulled inwardly, the front and particularly the forward facing intermediate portions 3125 on either side of the more flexible forward facing central portion 3115 retain sufficient structural rigidity to maintain the overall shape of the seal-forming structure 3100 and avoid leak paths due to creases. In another example, the forward facing central portion 3115 may be similar in thickness to the forward facing intermediate portion 3125, thus providing additional crease resistance in the central saddle region 3112 of the nose region 3230.

[0242] The nose region 3230 of the seal-forming structure 3100, and specifically the region between the nostrils 3272 and the central saddle region 3112 of the nose region 3230, is advantageously relatively elongated at the front and rear. This portion of the nose region 3230 of the seal-forming structure 3100 is less supported compared to other regions. The elongated region in this portion of the seal-forming structure 3100 provides sufficient space for deformation of the nose region 3230 of the seal-forming structure 3100, which is advantageous when the seal-forming structure 3100 receives the nose. If the seal-forming structure 3100 had a stiffer structure in this region, excessive force could be applied on the patient's nasal tip (especially longer noses). The nasal tip can be a particularly sensitive area, so avoiding such excessive force is advantageous in terms of comfort. However, there are also patients with noses that may be shorter and relatively wider. The plenum chambers 3200 shown in Figures 142-149 and 150-157 are suitable for patients with shorter noses. These plenum chambers 3200 include a nasal region 3230 that has a shorter length between the upper lip 3116 and the central saddle region 3112. These plenum chambers 3200 also have a surface in the upwardly facing central portion 3111 between the aperture 3272 and the central saddle region 3112 that can accommodate the nasal tip in a manner that is comfortable for the patient, but is not as long as between the upper lip 3116 and the central saddle region 3112. This is because the plenum chambers 3200 shown in Figures 126-133 or 134-141 are more suitable for patients with longer noses. The plenum chamber 3200 shown in Figures 126-133 and 134-141 also includes a central saddle region 3112 that is positioned further forward relative to the chassis 3210 than the central saddle region 3112 of the plenum chamber 3112 shown in Figures 142-149 and 150-157.

[0243] The upwardly facing central portion 3111 of the nasal section 3230 of the seal-forming structure 3100 has a bridge portion 3113 which connects a front region of the upwardly facing central portion 3111 with the upper lip portion 3116 of the nasal section. The bridge portion 3113 is thus positioned below the bridge of the patient's nose in use and partially defines two nostrils 3272 (one on either side) through which an air supply to the patient may be provided.

[0244] The bridge region 3113 is flexible and curved so that it is loose when the patient interface 3000 is not being worn by the patient. The looseness of the bridge region 3113 allows the front portion of the central portion 3111 (the front of the bridge that contacts the patient's nasal tip in use) to move away from the upper lip 3116 when the patient interface 3000 is being worn by the patient.

[0245] Advantageously, this also allows a longer nose length to be comfortably accommodated by the seal-forming structure 3100. A longer and / or narrower nose allows the front portion of the upwardly facing central portion 3111 to be comfortably pushed forward. This deformation of the nose portion 3230 allows a significant level of force to be retained by the seal-forming structure 3100 to be reapplied onto the patient's nasal tip (which is generally quite sensitive). FIG. 117 and FIG. 118 show the plenum chamber 3200 and the seal-forming structure 3100 with the bridge portion 3113. The bridge portion 3113 is configured to be relaxed and is worn by patients 1000 with short and long noses, respectively. As shown in FIG. 117, the bridge portion 3113 is generally curved and relaxed, as the front portion of the upwardly facing central portion 3111 is not pushed forward to any significant extent by the nose of the patient 1000. However, as shown in Fig. 118, a longer nose will push the front portion of the upwardly facing central portion 3111 forward to the extent that the bridge portion 3113 will stretch into a straighter configuration. Thus, the bridge portion 3113 advantageously allows the seal-forming structure to accommodate a range of nose sizes while remaining comfortable and allowing a good seal to be achieved.

[0246] The bridge region 3113 may be S-shaped so that it can straighten and resist movement of the upwardly facing central portion 3111 of the seal-forming structure 3100 away from the upper lip 3116. The bridge region 3113 may be bowed, curved, or creased. The bridge region 3113 may have bellows or bellows. The bridge region 3113 may include only one curve so that the bridge is C-shaped, or may include two bows so that the bridge is S-shaped for greater relaxation. The bridge region 3113 may be sling-shaped (e.g., a region suspended between ends). The bridge region 3113 is longer and includes more material than would be required to fill the gap between the front and back of the upwardly facing central portion 3111 of the nose region 3230. This extra material allows the bridge region 3113 to stretch from straight to taut. The more such excess material, the more the bridge region 3113 can stretch before it becomes taut due to the force applied to the front portion of the upward facing central portion 3111. The bridge region 3113 can provide a good seal for small noses even when the bridge region 3113 is slightly relaxed, since it does not need to seal against the bridge of the patient's nose to completely seal against the patient's nose.

[0247] The thickness of the bridge region 3113 can be about 0.2 mm to 0.45 mm or 0.3 to 0.4 mm (e.g., 0.35 mm). The thickness of material in the bridge region 3113 is greater than the thickness of material in the upwardly facing central portion 3111 around the periphery of the seal-forming structure 3100, thereby helping to resist or avoid fracturing the bridge region 3113. Alternatively, the bridge region 3113 may be wider and thinner. In one example, a thicker and narrower bridge region 3113 is provided so that the nasal holes 3272 are relatively large.

[0248] The bridge portion 3113 may be used for other purposes as well. For example, the bridge portion 3113 may maintain the integrity of the thinned zone of the central portion 3111. Without the bridge portion 3113 and instead with a single nostril, rupture may occur in the upwardly facing central portion 3111 when the seal-forming structure is reseat under pressure (e.g., via facial pulling and repositioning) or when the seal-forming structure is subject to rapid dynamic loading due to the relatively thin wall thickness of the central portion. Fastening of the upwardly facing central portion 3111 to the upper lip 3116 by the bridge portion 3113 reduces the likelihood of rupture in the upwardly facing central portion 3111.

[0249] Additionally, the bridge portion 3113 may help prevent the patient from incorrectly configuring the patient interface 3000. If the bridge portion 3113 were not provided and instead there was a single nostril, the patient may accidentally insert their nose into the nostril. In some instances, the seal-forming structure 3100 is configured to seal against the lower periphery of the patient's nose, such that if the patient inserts their nose into the nostril, the seal-forming structure may not achieve a proper seal.

[0250] Despite the benefits of the bridge portion 3113 in some forms of the present technology, in some alternative examples, the bridge portion 3113 is not provided and only a single hole is provided in the nose portion 3230 of the seal-forming structure 3100. This allows the upwardly facing central portion 3111 of the nose portion 3230 to move relative to the lower portion and also makes the seal-forming structure 3100 easier to clean. However, if the upwardly facing central portion 3111 of the seal-forming structure 3100 is not fastened to the upper lip 3116, there may be an increased risk of rupture for some patients. Furthermore, there is a possibility that the patient may insert their nose into the single hole. Steps are taken to mitigate these risks (e.g., by providing the seal-forming structure with a thicker, smaller, or tighter membrane around the hole). A single hole (i.e., no bridge) may then be provided in some examples of the present technology. The seal-forming structure 3100 of a patient interface 3000 according to examples of the present technology may include one or two apertures for providing airflow to the patient's nasal passages.

[0251] While it is advantageous to have a thin wall thickness of the seal-forming structure 3100 in the areas of the seal-forming structure 3100 described above to enable it to comfortably conform to complex geometries, a relatively larger wall thickness in some areas of the seal-forming structure 3100 is advantageous in other forms of the present technology.

[0252] For example, the nasal region 3230 of the seal-forming structure 3100 includes posterior corners 3131 configured to seal against the patient's face adjacent the nasolabial folds. These posterior corners 3131 have a greater wall thickness compared to the central portion of the nasal region 3230 of the seal-forming structure 3100. This greater wall thickness can provide significant structural rigidity to the seal-forming structure 3100 in these regions, which can provide several benefits.

[0253] The rear corner 3131 may aid in supporting the seal-forming structure on the patient's face and should have sufficient structural rigidity not to collapse and compromise the seal achieved by the central portion of the seal-forming structure 3100 (e.g., the upwardly facing central portion 3111 and / or the upper lip portion 3116). In another example, the rear corner 3131 includes an undercushion for reinforcement. In the illustrated example where a single wall seal-forming structure 3100 is provided, the structural rigidity is provided by a sufficiently large wall thickness, which in one example may be about 0.8-1.6 mm (e.g., 1.1 mm-1.45 mm or 1.25 mm). The rear corner 3131 is configured to be positioned below and laterally outward of the patient's face and nose in the area below the patient's ala (e.g., between the nasolabial fold and the area of ​​the upper lip located below the ala).

[0254] As shown in Figures 27, 34, 69 and 76, there is an abrupt transition (e.g., abrupt taper or step) between the greater wall thickness in the rear corner 3131 and the thinner wall thickness in the upper lip portion 3116 of the seal-forming structure 3100 (i.e., in the area that seals against the upper lip). The thicker rear corner 3131 provides support for the seal-forming structure when the upper lip portion 3116 is placed in a sealed manner against the patient's upper lip, where support is needed / advantageous, and can be significantly more flexible to conform to the contours of the patient's face while minimizing forces. Because facial geometry can vary greatly from patient to patient, the abrupt transition can be placed almost directly from the underside to the ala on the upper lip.

[0255] In some examples of the present technology, the seal-forming structure 3100 includes lateral corner regions 3114 that form a portion of the central portion. These lateral corner regions 3114 are configured to contact and seal against the alae of the nose. As shown in Fig. 34, Fig. 76, Fig. 160, Fig. 161, Fig. 164, Fig. 168 and Fig. 170, above the location of the junction between the thicker of the rear corners 3131 and the thinner wall thickness of the upper lip portion 3116 of the nasal region 3230 of the seal-forming structure 3100, there are lateral corner regions 3114 of the upwardly facing central portion 3111 that extend laterally, posteriorly and superiorly on either side of the target seal-forming region (e.g., extending upward on the medial facing side of the seal-forming structure 3100). The alae of the nose can be significantly curvilinear, and for many patients, the alae of the nose can join the face in a highly recessed pocket or recess. These pockets may result from the alar, which curves back in a medial direction (e.g., toward the sagittal plane) between the widest part of the nose and the junction of the alar and the face. Providing low stiffness in these lateral corner regions 3114, achieved in these instances by a thin wall thickness, allows the seal-forming structure 3100 to deform and conform to the curvature of the alar. Such flexibility and ability to conform may assist the seal-forming structure 3100 in filling recesses that may exist at the lower corners of the patient's nose.

[0256] The seal-forming structure 3100 may be configured such that the transitions between the thick rear corners 3131 and the thin upper lip 3116 are positioned adjacent to the ala on the patient's face lateral to the ala. The area of ​​the seal-forming structure 3100 that contacts the patient's face on either lower lateral side of the nose may be part of the thick rear corners 3131 to provide good support and stability to the seal-forming structure 3100. FIG. 111 shows a cutaway view of a plenum chamber 3200 according to one example of the present technology in a sealed position on the patient's face. The upwardly facing central portion 3111 seals against the lower periphery of the patient's 1000 nose, and the upper lip 3116 seals against the patient's upper lip. The upwardly facing intermediate portion 3121 is positioned adjacent to the side of the patient's nose (e.g., adjacent to the ala). Additionally, the lateral corner regions 3114 of the upwardly facing central portion 3111 may deform to accommodate the ala of the patient's nose. For example, the lateral corner regions 3114 may cup the patient's ala. The lateral corner regions 3114 may create a shelf in the cushion to provide support adjacent the patient's ala in use, allowing the seal-forming structure 3100 to better conform to the lower periphery of the patient's nose, particularly adjacent the upper lip, in use.

[0257] As shown in FIG. 111, the boundary between the thick wall forming the posterior corner 3131 and the intermediate adjacent portion of the seal-forming structure 3100 can be traced upward, outward and then inward, so as to follow the curvature of the patient's nose in an upward direction starting from the underside of the patient's ala. The intermediate boundary of the wall forming the thick posterior corner 3131 can follow a path up the patient's face on either side of the nose following the curvature along either side of the nose. This can allow for better support when needed (e.g., the patient's face just below the patient's nose and on either side of the patient's nose) while still allowing the thinner areas (e.g., the upward facing central portion 3111 and the upper lip portion 3116) to conform and seal to the ala and underside of the patient's nose.

[0258] As shown in the side views shown in Figures 18, 19, 30, 31, 32, 38, 58 and 80, for example, the seal-forming structure 3100 is thicker toward the front side closer to the shell 3210 (the shell 3210 not shown in Figures 38 or 80 but shown in Figures 9 and 51). As noted above, the seal-forming structure 3100 includes lateral support portions 3151 in the form of thickened regions on the partially forward facing lateral sides of the nose portion 3230 of the seal-forming structure 3100. The thicker regions of the seal-forming structure 3100 closer to the shell 3210 provide good support and structural rigidity for the seal-forming structure 3100.

[0259] While the thicker regions adjacent the shell 3210 are advantageous for structural rigidity, the nose portion 3230 of the seal-forming structure 3100 also retains a level of flexibility to allow the sides of the seal-forming structure 3100 to be pushed outward or pulled inward to accommodate noses of different widths.

[0260] For example, the sides or areas of the nasal portion 3230 of the seal-forming structure 3100 that do not face the patient (e.g., the front side, the side that faces at least partially forward) (particularly the areas on either side of the nasal portion 3230 of the seal-forming structure 3100 that do not contact the patient) are thick enough to provide sufficient structural rigidity to the seal-forming structure 3100, yet thin enough so that when a patient with a long, narrow nose wears the seal-forming structure 3100, a downward force acting on the central region 3111 facing upward from the patient's nose can pull the sides of the nasal portion 3230 slightly inward to enable the patient-contacting surfaces of the seal-forming structure 3100 on either side of the patient's nose to make good contact with the patient's nose. Similarly, the structure of the nose portion 3230 of the seal-forming structure 3100 is sufficiently flexible so that there is no excessive inward force on the sides of the patient's nose when a patient with a wider nose wears the seal-forming structure 3100 (which may occur if the seal-forming structure is too stiff to withstand the wider nose). It is also possible to provide a number of different sizes of the seal-forming structure 3100 to accommodate a range of nose widths.

[0261] As shown in Figures 7, 8 and 49, 55, 126, 129, 138-139, 146, 147, 154, 155, for example, the oral-nasal transition 3275 at the periphery of the plenum chamber 3200 connects the nasal region 3230 and the mouth region 3260. The periphery of the seal-forming structure 3100 varies at this location between examples of the present technology. As shown in Figure 7, the oral-nasal transition 3275 is relatively abrupt, with a relatively large positive curvature at the periphery of the seal-forming structure 3100 between the nasal region 3230 and the mouth region 3260. In contrast, as shown in Figure 49, the oral-nasal transition 3275 is relatively gradual, with a relatively small positive curvature at the periphery of the seal-forming structure 3100 between the nasal region 3230 and the mouth region 3260. In either case, the oral-nasal transition 3275 includes a saddle region. The plenum chamber 3200 shown in FIGS. 128, 138, 146 and 154 includes a clear and gradual oral-nasal transition 3275.

[0262] Since it is preferred that the periphery of the seal-forming structure 3100 be stiff enough to support the overall shape of the seal-forming structure 3100 and avoid significant folding and buckling, the shape of the periphery may vary more than the areas that contact the patient's face and neighboring areas (i.e., thinner and thicker zones to avoid leakage paths through the patient's face due to folding). In either case, the oral-nasal transition 3275 between the nose and mouth regions of the seal-forming structure 3100 is relatively stiff (e.g., relatively thick) compared to the less stiff regions of the seal-forming structure 3100 (e.g., the upwardly facing central portion 3111) to avoid the development and creation of leakage between these regions due to folding or buckling. Alternatively, the oral-nasal transition 3275 may be reinforced by any suitable means (e.g., an undercushion, ribs, a portion of a shell, or a frame).

[0263] In some instances, the seal-forming structure 3100 mouth area 3260 includes features to prevent folding. The lateral periphery of the mouth hole 3271 is more susceptible to folding or buckling than the top and bottom of the mouth hole 3271 due to the downward force of the cushion on the nose area and the wide oval shape of the oral opening.

[0264] In the examples shown in Figs. 34-80, the seal-forming structure 3100 includes a mouth hole perimeter 3117 around the mouth hole 3271 that is thinner than other portions of the seal-forming structure 3100. Additionally, the seal-forming structure in these examples includes rearward facing lateral portions 3135. These rearward facing lateral portions 3135 are thicker than the mouth hole perimeter 3117 to resist puckers and buckling in the cushion that can cause leak paths to form. In some examples of the present technology, the seal-forming structure 3100 shown in Figs. 126-157 can also include a mouth hole perimeter that is less stiff than the rearward facing lateral portions of the mouth region 3260.

[0265] In some examples, such as the plenum chamber 3200 shown in FIG. 48, the seal-forming structure includes lateral peripheral support regions 3136 at opposing lateral sides of the mouth hole 3271. In this example, the rearwardly facing lateral portion 3135 forms the lateral peripheral support region 3136. The rearwardly facing lateral portion 3135 extends medially toward the most lateral edge of the mouth hole 3271 to provide the lateral peripheral support region 3136. The lateral peripheral support region 3136 provides additional resistance to buckling. In some examples of the present technology, the seal-forming structure 3100 shown in FIGS. 126-157 may also include lateral peripheral support regions 3136.

[0266] 5.3.1.3.3 Oral area

[0267] In one form, the non-invasive patient interface 3000 includes a seal-forming structure 3100 that, in use, forms a seal over the upper lip region (i.e., upper lip) of the patient's face. The seal-forming structure 3100 may include an upper lip portion 3116 configured to form a seal against the patient's upper lip.

[0268] In one form, the seal-forming structure 3100 includes a saddle-shaped region constructed to form a seal over the upper lip region of the patient's face in use.

[0269] In one form, the non-invasive patient interface 3000 includes a seal-forming structure 3100 which, in use, forms a seal around the patient's mouth at the mouth site 3260. The seal-forming structure 3100 may form a seal over the chin area of ​​the patient's face.

[0270] In one form, the seal-forming structure 3100 includes a saddle-like region constructed to form a seal over the chin region of the patient's face in use.

[0271] As shown in Figures 34-80 and 126-183, the seal-forming structure 3100 includes a lower lip 3118 that forms a seal against the patient's chin area. In one example, the seal-forming structure 3100 including the lower lip 3118 does not extend under the patient's chin (i.e., under the chin protuberance) in use or does not engage the patient's face under the chin (i.e., under the chin protuberance) in use. The lower lip 3118 of the seal-forming structure may seal against the patient's lower lip and chin. Further, in these examples, the seal-forming structure 3100 includes an oral hole perimeter 3117. The lower lip 3118 may be connected to (e.g., adjacent to) the upper lip 3116 via the oral hole perimeter 3117. The seal-forming structure 3100 includes a relatively small wall thickness (compared to other areas) at the mouth orifice periphery 3117 and at the lower lip 3118 of the seal-forming structure 3100 disposed against the chin region. The reduced wall thickness in these locations assists in achieving an effective and comfortable seal. The seal-forming structure 3100 in these areas can easily conform to any complex geometry (e.g., the mandibular fold).

[0272] In these examples, the mouth region 3260 includes a rearwardly facing lateral portion 3135 on the patient-contacting side of the seal-forming structure 3100. As noted above, the wall thickness immediately surrounding the mouth hole 3271 at the mouth hole perimeter 3117 is thinner compared to other areas of the seal-forming structure 3100, but in these examples, there are rearwardly facing lateral portions 3135 on either lateral side of the mouth hole perimeter 3117 that are thicker than the mouth hole perimeter 3117. The wall thickness in these areas may be about 1 mm to 1.5 mm (e.g., 1.15 mm to 1.35 mm (e.g., about 1.25 mm thick)). Areas that come into contact with these areas in use (i.e., the patient's cheeks) are often not as sensitive as other areas of the face, so patients can often tolerate a seal-forming structure 3100 with greater wall thickness / stiffness in these areas. Additionally, the rearward facing lateral portions 3135 of the mouth area 3260 are curved away from the contact portions with the patient's face, thereby reducing the contact area on the patient's face in these areas. In another example, instead of making the rearward facing lateral portions 3135 of the mouth area 3260 thicker, they may be made stiffer by other means (e.g., reinforcing structures (e.g., ribs), stiffer material, undercushion).

[0273] The rearwardly facing lateral portions 3135 provide resistance to folds that may form adjacent the mouth orifice 3271, thereby avoiding the creation of a leak path. The rearwardly facing lateral portions 3135 provide a barrier to folds that may form at the thinner mouth orifice periphery 3117, thereby limiting the extent of folds away from the mouth orifice 3271. This function of the rearwardly facing lateral portions 3135 may be similar to the fold resistance function provided by the upwardly facing intermediate portions 3121 of the nose region 3230 described above.

[0274] The lower lip 3118 of the mouth region 3260 is approximately half the width of the mouth region 3260 and is centered below the mouth hole 3271. As noted above, the lower lip 3118 may be relatively thin. The transition between the thinner lower lip 3118 on either lateral side and the thicker rearwardly facing lateral portion 3135 may be configured to be positioned at or near the patient's jaw crease. The lower lip 3118 is wider at the periphery of the mouth hole 3271 than at the lower periphery of the seal-forming structure 3100. Thus, the width of the lower lip 3118 tapers downwardly from the mouth hole 3271. In the example shown in FIGS. 49-80, the lower lip 3118 extends from the rearwardly facing side to the downwardly facing periphery of the seal-forming structure 3100. The actual amount of the lower lip 3118 that contacts the patient's face may depend on the shape of the patient's jaw. For patients with a more forward protruding jaw, there may be increased contact with the lower lip 3118. In the plenum chamber 3200 shown in Figures 158-183, the lower periphery of the shell 3210 is not as downward as the lower periphery of the shell 3210 and the seal-forming structure 3100 and lower lip 3118 around the lower periphery of the seal-forming structure 3100 of the plenum chamber 3200 shown in Figures 49-80, thereby forming a partially forward facing portion of the lower lip 3118.

[0275] The lateral portions 3145 of the mouth region 3260 are located distal from patient contact (e.g., closer to the shell 3210) than the rearward facing lateral portions 3135 of the lateral periphery of the mouth region 3260. In these examples, the lateral portions 3145 are thicker than the rearward facing lateral portions 3135 of the mouth region. In some examples, the thickness of the lateral portions 3145 of the mouth region is in the range of 1.5-2.2 mm (e.g., 1.7-2 mm). Because most or all of the lateral portions 3145 are unlikely to come into contact with the patient's face during use, patient comfort is less of a design consideration for these regions, and the wall thickness can be greater in these regions than in the patient contacting regions. This increased wall thickness can provide structural rigidity in the overall shape of the mouth region 3260 of the seal-forming structure 3100. In some instances, a particular region of the seal-forming structure 3100 will be thicker than regions further distal from the patient's face unless there is a reason that region needs to be flexible (e.g., to deform the sides of the nose region of the seal-forming structure 3100). The lateral portions 3145 define the lateral perimeter of the seal-forming structure 3100 within the mouth region 3260.

[0276] On the front side of the seal-forming structure 3100, the wall thickness is generally greater than in these examples, except for the front side of the nose region and the central lower region of the mouth region of the seal-forming structure 3100. In these examples, the seal-forming structure 3100 includes a forward-facing lateral portion 3155. In these examples, the wall thickness of the lateral forward-facing portion 3155 is greater than the lateral portion 3145 (and the rearward-facing lateral portion 3135). The wall thickness of the forward-facing lateral portion may be in the range of 1.7-2.7 mm (e.g., in the range of 2.0-2.5 mm). These thicker regions provide substantial support and structural organization to the overall shape of the seal-forming structure 3100. The laterally forward facing portion 3155 cooperates with other portions of the seal-forming structure having a thicker wall thickness (e.g., the lateral portion 3145) to maintain the general shape of the seal-forming structure 3100 and resist folding and / or buckling, etc., while the thinner areas on the patient-facing side of the seal-forming structure 3100 are pressed against the patient's face and deformed under the force applied from the positioning and stabilizing structure 3300 to the plenum chamber 3200.

[0277] Also provided on the front side of the seal-forming structure 3100 is a forward support region 3161 of the mouth region 3260. The forward support region 3161 is a thicker zone of the seal-forming structure 3100 at the base of the nose region on the front side (where the nose region joins with the adjacent mouth region of the frame) and at the lower lateral corners of the mouth region 3260. The wall thickness in these regions may be in the range of 2-3 mm (e.g., 2.5-3 mm). These regions may provide additional structural rigidity to the seal-forming structure. The forward support region 3165 may have a greater wall thickness than the forward facing lateral portion 3155. Typically, the cushion will have a greater wall thickness further distal from the seal-forming region, but immediately proximal to the shell 3210 the thickness may be similar to that of the forward facing lateral portion 3155, even though the forward support region 3165 is thicker. In some instances, the silicone immediately adjacent the shell 3210 may be reinforced by the peripheral edge of the shell 3210 so that a smaller wall thickness may be required.

[0278] 5.3.1.3.4 Frontal area

[0279] In one form, the seal-forming structure forms a seal on the forehead region of the patient's face when in use, hi such a form, the plenum chamber may cover the eye when in use.

[0280] 5.3.1.3.5 Nasal pillow

[0281] 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.

[0282] A nasal pillow according to one aspect of the present technology includes a frustum of a cone. At least a portion of the frustum forms a seal over the underside of the patient's nose, the stalk, and a flexible region on the underside of the frustum, connecting the frustum to the stalk. Additionally, the structure to which the nasal pillows of the present technology are connected includes a flexible region adjacent the base of the stalk. The flexible region may function to facilitate a universal joint structure. The universal joint structure accommodates both the displacement and angle of the frustum of the cone and the relative movement of the structure to which the nasal pillows are connected. For example, the frustum of the cone may be displaced axially towards the structure to which the stalk is connected.

[0283] 5.3.1.3.6 Surface Finish

[0284] In some instances, different regions of the seal-forming structure 3100 include different surface finishes.

[0285] 47, the plenum chamber 3200 includes a seal-forming structure 3100 that includes a nose region 3230 and a mouth region 3260. The seal-forming structure includes a first surface finish in the nose region and a second surface finish in the mouth region that is different from the first surface finish. In the illustrated example, region 3101 has the first surface finish and region 3103 has the second surface finish. The boundary between the first surface finish and the second surface finish is identified by a line 3102 that may contact the cheeks of the patient in use.

[0286] The coefficient of friction between the seal-forming structure 3100 and the patient's face is higher in the mouth region 3260 than in the nose region 3230. The first surface finish in region 3101 can be configured to provide a smooth feel on the patient's face to the nose region, which may be more comfortable. The second surface finish in region 3103 can be configured to provide a gripping contact on the patient's face to the mouth region, which may allow for a more robust seal. In some examples, the first surface finish in region 3101 can be a matte surface finish. In some embodiments, the second surface finish in region 3103 can be a polished surface finish. In this example, the nose region 3230 includes an upper lip 3116 having a first surface finish.

[0287] A polished surface finish may have a non-slippery, sticky feel, which creates more friction as the seal-forming structure 3100 moves relative to the patient's face. This is generally desirable as it helps to prevent the plenum chamber 3200 from moving when the patient wears it, thereby helping to maintain a seal. However, patients may find the feel of a polished surface finish less pleasant on the face than a smoother-feeling, low-friction surface finish. Because the nose is often a more sensitive area, patients may tolerate a polished finish on their cheeks and under their mouth, but not on and around their nose. Therefore, in this example, a polished finish is provided around the mouth area 3260, while a matte finish is provided on the nose area 3230 of the seal-forming structure 3100. Providing a matte finish in the nose area 3230 may also assist in movement of the seal-forming structure 3100 relative to the nose as the matte finish conforms to the perinasal surfaces, which may also assist in seal formation.

[0288] Additionally, the increased grip provided by the higher friction within the area of ​​the second surface finish in region 3103 helps the mouth area 3260 maintain a seal as the patient's jaw moves. The jaw may tend to move (and subsequently drop) relative to the head. The increased grip helps maintain the seal in place around the patient's mouth as the jaw moves.

[0289] The boundary 3102 between the polished finish at 3103 and the matte finish at 3101 is close to the boundary between the nose region 3230 and the mouth region 3260 of the seal-forming structure 3100 (slightly closer to the mouth region 3260 than to the nose region 3230). The boundary 3102 is located across the seal-forming structure 3100 approximately perpendicular to a path on the mouth region 3260 surrounding the mouth hole 3271. At the periphery of the mouth hole 3271, the boundary 3102 may be located on the upper lip. At the periphery of the mouth region 3260 of the seal-forming structure 3100, the boundary may be located adjacent to the cheekbones of the patient.

[0290] 5.3.2 Positioning and stabilizing structures

[0291] The seal-forming structure 3100 of the patient interface 3000 of the present technology may be held in a sealed position by the positioning and stabilising structure 3300 in use.

[0292] In one form, the positioning and stabilizing structure 3300 provides at least enough retention force to overcome the effect of the positive pressure in the plenum chamber 3200 to lift off the face.

[0293] In one form, the positioning and stabilising structure 3300 provides a retaining force sufficient to overcome the attractive force on the patient interface 3000.

[0294] In one form, the positioning and stabilizing structure 3300 provides a retention force as a safety margin to eliminate the possibility of destructive action on the patient interface 3000 (e.g., due to tube drag or inadvertent interference with the patient interface).

[0295] In one form of the present technology, a positioning and stabilizing structure 3300 is provided that is configured to be worn by a patient while sleeping. In one embodiment, 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 embodiment, the positioning and stabilizing structure 3300 includes at least one strap having a rectangular cross-section. In one embodiment, the positioning and stabilizing structure 3300 includes at least one flat strap.

[0296] In one form of the present technology, a positioning and stabilizing structure 3300 is provided that is configured so as not to be excessively large or bulky in size that would interfere with a patient sleeping in a supine sleep position with the posterior region of the patient's head resting on a pillow.

[0297] In one form of the present technology, a positioning and stabilizing structure 3300 is provided that is configured so as not to be excessively large or bulky in size that would interfere with a patient sleeping in a lateral sleep position with the side region of the patient's head resting on a pillow.

[0298] In one form of the present technology, the positioning and stabilizing structure 3300 comprises a decoupling located between a front of the positioning and stabilizing structure 3300 and a rear portion of the positioning and stabilizing structure 3300. The decoupling does not resist compression and can be, for example, a flexible or flimsy strap. The decoupling is constructed and positioned such that when a patient lies down with their head on a pillow, the presence of the decoupling prevents rearward forces from being transmitted along the positioning and stabilizing structure 3300 and disrupting the seal.

[0299] 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 material inner layer, and a fabric outer layer. In one form, the foam material 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.

[0300] In certain forms of the present technology, the positioning and stabilizing structure 3300 includes a stretchable (e.g., stretchable with elasticity) strap. For example, the strap can be configured to be tensioned in use to direct a force that urges the seal-forming structure into contact with a portion of the patient's face. In one example, the strap can be configured as a tie.

[0301] In one form of the present technology, the positioning and stabilizing structure includes a first tie constructed and arranged such that, in use, at least a portion of its lower edge passes over and moves to a superior-temporal point on the patient's head to cover a portion of the parietal bone without covering the occipital bone.

[0302] In one form of the present technology, suitable for a nasal only or full face mask, the positioning and stabilizing structure includes a second tie constructed and arranged such that, in use, at least a portion of its upper edge passes under the lower ear base point on the underside of the patient's head and covers or rests under the occipital bone of the patient's head.

[0303] In one form of the present technology, suitable for a nasal only or full face mask, the positioning and stabilizing structure includes a third tie constructed and arranged to interconnect the first tie and the second tie in a manner that reduces the tendency of the first tie and the second tie to move apart relative to one another.

[0304] In certain forms of the present technology, the positioning and stabilizing structure 3300 includes straps that are bendable, e.g., non-rigid. An advantage of this embodiment is that the straps are more comfortable when the patient lies down to sleep.

[0305] In a particular form of the present technology, the positioning and stabilizing structure 3300 includes straps configured to be breathable to allow water vapor to pass therethrough.

[0306] 89-95 show a patient interface 3000 according to an example of the present technology. The patient interface 3000 includes a positioning and stabilizing structure 3300 and a plenum chamber 3200 having a seal-forming structure 3100. In this example, the positioning and stabilizing structure 3300 includes a frame 3350 and a number of headgear straps connected to the frame 3350.

[0307] The plenum chamber 3200 of the patient interface 3000 is connected to the frame 3350. The plenum chamber 3200 of the exemplary patient interface 3000 shown in Figs. 89-95 is the plenum chamber 3200 shown in Figs. 7-14, but the positioning and stabilizing structure 3300 may be used with other plenum chambers 3200 in other examples of the present technology. The plenum chamber 3200 may be connected to the frame 3350 via a snap-fit ​​connection. In one example, the plenum chamber 3200 may be connected to the frame 3350 in the manner described with reference to Figs. 87-88. In other examples, the plenum chamber 3200 may form a different type of removable connection to the frame 3350, a snap-fit, a removable press fit or otherwise, or may be permanently connected to the frame 3350.

[0308] The positioning and stabilizing structure 3300 may include multiple straps or strap sections that connect to the frame 3350 and pass around the patient's head to support the plenum chamber 3200 in a sealed position against the patient's face. It is understood that a single "strap" may be formed by multiple lengths of material that are cut or formed separately to create longer lengths and then joined at the ends, or the single "strap" may be a single length of material.

[0309] In the example shown in Figures 89-95, the positioning and stabilizing structure 3300 includes a pair of upper straps 3310. Each upper strap 3310 is configured to pass between a respective eye and ear of the patient. Additionally, the positioning and stabilizing structure 3300 includes a pair of lower straps 3320 configured to be positioned on the patient's cheeks and below the patient's cheekbones. In this example, the plenum chamber 3200 is held in place via a four-point connection to headgear straps via a frame 3350.

[0310] The frame 3350 is shown in isolation in FIGS. 103-108. The frame 3350 includes a frame inlet connection port 3354. The frame inlet connection port 3354 may be configured to connect to a source of pressurized breathable gas (e.g., air). In one example, such as the patient interface shown in FIGS. 89-95, the frame inlet connection port 3354 may be configured to allow connection to a swivel elbow assembly 3610 that provides a connection port 3600 for connection to the air circuit 4170. In this example, the frame inlet connection port 3354 includes a connecting rim 3355. The connecting rim 3355 may include a flange extending radially outward. The swivel elbow assembly 3610 may form a releasable snap fit with the connecting rim 3355, thereby creating a fluid connection between the swivel elbow assembly and the frame 3350. 87-88 and 90A, the opposite side of the frame inlet connection port 3354 is configured to fluidly connect to the plenum chamber. Thus, the frame 3350 allows for a fluid connection between the swivel elbow assembly 3610 and the interior of the plenum chamber 3200.

[0311] The frame 3350 also includes a pair of opposing upper strap connection points 3315 to which the upper straps 3310 connect. In this example, each upper strap connection point 3315 includes an aperture formed in the frame 3350. Each upper strap 3310 can connect to each upper strap connection point 3315 by passing through the aperture, looping back on itself, and then securing to itself. Each upper strap 3310 can be secured to itself via a hook and loop material configured to releasably join when they come into contact. In another example, each upper strap 3310 can be secured to itself by a band, clip, or the like after passing through a respective aperture and looping back on itself. In yet another example, the upper strap 3310 can connect to the frame via a side release buckle connection.

[0312] The frame 3350 also includes a pair of opposing lower strap connection points 3325 to which the lower straps 3320 connect. In this example, each lower strap connection point 3325 includes a magnet. Each lower strap 3320 includes a lower strap clip 3326 that includes a magnet or material that is attached to the magnet at the lower strap connection points 3325. In this example, each lower strap clip 3326 includes an aperture through which an end of each lower strap 3320 can be passed and then looped back and secured to itself (e.g., by hook and loop material, straps, clips, etc.). In another example, the lower straps 3320 can connect to the frame 3350 via a side release buckle connection, onto a hook or any other suitable connection.

[0313] In one example, the frame 3350 and upper strap connection points 3315 are constructed and arranged to direct the force / tension provided from the upper straps 3310 into a partially upward and partially backward force vector that is applied to the plenum chamber 3200. In particular, this partially upward and partially backward force vector causes the nasal portion 3230 of the seal-forming structure 3100 to make sealing contact with the lower periphery of the patient's nose and the patient's upper lip.

[0314] Each of the upper straps 3310 may be selectively adjustable. For example, the effective length of each of the upper straps 3310 may be changed by changing the amount of the upper strap 3310 that loops back on itself after passing through an aperture at each upper strap connection point 3315. Increasing the amount of the upper strap 3310 that passes through the aperture effectively reduces the length of the upper strap 3310, thereby allowing for alteration of the force vector and adjustment of the fit of the patient interface 3000.

[0315] In one example, the frame 3350 and the lower strap connection points 3325 are constructed and arranged to direct the force / tension provided from the lower straps 3320 into a partially posterior and partially downward force vector applied to the plenum chamber 3200. In particular, the partially posterior and partially downward force vector causes the mouth area 3260 to be in sealing contact with the patient's face around the periphery of the patient's mouth. The partially downward force applied from the lower straps 3320 to the frame 3350 may balance the partially upward force applied from the upper straps 3310 and any downwardly directed force that may be applied from the patient's nose to the seal-forming structure 3100.

[0316] The lower straps 3320 may be selectively adjustable. For example, the effective length of each of the lower straps 3320 may be altered by changing the amount of each lower strap 3310 that loops back on itself after passing through an aperture in each lower strap clip 3326. Increasing the amount of each lower strap 3320 that passes through the aperture effectively reduces the length of the lower strap 3320, thereby allowing the force vector to be altered and the fit of the patient interface 3000 to be adjusted.

[0317] The positioning and stabilizing structure 3300 may also include one or more of a top crown strap 3330, a pair of lateral crown straps 3332, and a neck strap 3334. In the example shown in FIGS. 89-95, the upper strap 3310 and the lower strap 3320 are connected to ends of the top crown strap 3330. The top crown strap 3330 is configured to pass around the patient's head and to be positioned against an upwardly and backwardly facing surface. The top crown strap 3330 may be configured to be positioned on the parietal bone of the patient's skull. Each end of the top crown strap 3330 also connects to a respective upper strap 3310 and a respective pair of lateral crown straps 3332. Each lateral crown strap 3332 is connected between the upper strap 3310 and the lower strap 3320 on each side of the patient's head. The lower ends of the lateral crown straps 3332 are interconnected by the neck strap 3334. The neck strap 3334 may be configured to pass across the sagittal plane and be placed against a downward and / or rearward facing surface of the patient's head or at the back of the patient's neck. The neck strap 3334 may be placed above or below the occipital bone of the patient's skull.

[0318] The length of the top crown strap 3330 can be selectably adjusted. In the example shown in FIGS. 89-95, the top crown strap 3330 is formed by two strap sections connected by a link having a pair of apertures. Each of the two strap sections forming the top crown strap 3330 loops back after passing through a respective aperture and can be secured to itself, for example, via hook-and-loop material, additional clips, bands, and / or the like. The amount of each top strap section that is routed through the link can be varied to adjust the length of the top crown strap 3330 and thus the fit of the positioning and stabilizing structure 3300.

[0319] After all headgear strap adjustments have been made and the desired fit of the patient interface 3000 has been achieved, the magnetic clip connection provided by the lower strap clips 3326 allows the lower straps 3320 to be quickly disengaged from the lower strap connection points 3325 on the frame 3350, thereby allowing the patient interface 3000 to be removed from the patient without strap adjustments. Similarly, when the patient is re-donning the patient interface, the lower strap clips 3326 can be quickly disengaged at the lower strap connection points 3325 to allow the patient interface 3000 to fit without the need for strap adjustments. Further advantages and features of positioning and stabilizing structures including magnetic clips are described in WO2014 / 110622, which is incorporated herein by reference in its entirety.

[0320] In certain forms of the present technology, a system is provided that includes more than one positioning and stabilizing structure 3300. Each positioning and stabilizing structure 3300 is configured to provide a holding force to accommodate a range of different sizes and / or shapes. For example, a system may include one form of positioning and stabilizing structure 3300 that is suitable for a large sized head but not a small sized head and another that is suitable for a small sized head but not a large sized head.

[0321] 184 and 185 show a patient interface 3000 including the plenum chamber 3200 shown in Figs. 134-141. In this example, the patient interface 3000 also includes a positioning and stabilizing structure 3300 for holding the plenum chamber 3200 in a sealed position on the patient's face in use. In this example, the positioning and stabilizing structure 3300 includes a pair of headgear tubes 3340 interconnected at their upper ends and configured to be positioned on the upper and lateral surfaces of the patient's head in use, respectively. Each headgear tube 3340 is configured to be positioned between the patient's eyes and ears in use. A lower end of each headgear tube 3340 is configured to fluidly connect to the plenum chamber 3300. In this example, the lower end of each headgear tube 3340 connects to a headgear tube connector 3344 configured to connect to the shell 3210 of the plenum chamber 3200. The positioning and stabilizing structure 3300 includes a conduit headgear inlet 3390 at the junction of two headgear tubes 3340. The conduit headgear inlet 3390 is configured to receive a pressurized gas flow, for example via an elbow including a connection port 3600, and direct the gas flow into the hollow interior of the headgear tubes 3340. The headgear tubes 3340 provide the pressurized gas flow to the plenum chamber 3200.

[0322] The positioning and stabilizing structure 3300 may include one or more straps in addition to these headgear tubes 3340. In this example, the positioning and stabilizing structure 3300 includes a pair of upper straps 3310 and a pair of lower straps 3320. The rear ends of the upper straps 3310 and lower straps 3320 are joined to each other. The joint between the upper straps 3310 and lower straps 3320 is configured to be placed on the rear of the patient's head, thereby allowing the upper straps 3310 and lower straps 3320 to be anchored. The front ends of the upper straps 3310 connect to headgear tubes 3340. In this example, each headgear tube 3340 includes a tab 3342 with an opening through which each upper strap 3310 can be routed and then looped back and secured to itself to secure the upper headgear straps 3310 to the headgear tubes 3340. The positioning and stabilizing structure 3300 also includes a lower strap clip 3326 provided to a front end of each of the lower straps 3320. The lower strap clips 3326 are each configured to connect to a lower connection point 3325 on the plenum chamber 3200. In this example, the lower strap clips 3326 are magnetically secured to the lower connection points 3325. In some examples, a mechanical engagement is also provided between the lower strap clips 3326 and the lower connection points 3325.

[0323] The headgear tube connectors 3344 may be configured to allow the patient to breathe ambient air when there is no pressure in the plenum chamber 3200. Each headgear tube connector 3344 may include an anti-asphyxiation valve (AAV). The AAV in each headgear tube connector 3344 may be configured to open when there is no pressure in the plenum chamber 3200 to allow air flow between the interior of the plenum chamber 3200 and the ambient. Each AAV may be biased into a configuration that blocks air flow from the interior of the plenum chamber 3200 into the respective headgear tube 3340 and allows air exchange between the plenum chamber 3200 and the ambient. When the headgear tube 3340 is pressurized, the AAV in each headgear tube connector 3344 may prevent air exchange between the interior of the plenum chamber 3200 and the ambient and allow air flow from each headgear tube 3340 into the plenum chamber 3204 for the patient to breathe.

[0324] 5.3.3 Ventilation

[0325] In one form, the patient interface 3000 includes a vent 3400 constructed and arranged to allow for the expulsion of exhaled gases (eg, carbon dioxide).

[0326] In certain forms, the vent 3400 is configured to allow continuous vent flow from the interior of the plenum chamber 3200 to atmosphere when pressure within the plenum chamber is positive with respect to atmosphere. The vent 3400 is configured such that the magnitude of the vent flow is sufficient to reduce rebreathing of exhaled CO2 by the patient while maintaining a therapeutic pressure within the plenum chamber in use.

[0327] The ventilation section 3400 in one embodiment according to the present technology includes a plurality of holes (eg, about 20 to about 80 holes, or about 40 to about 60 holes, or about 45 to about 55 holes).

[0328] The vent 3400 may be disposed within the plenum chamber 3200. Alternatively, the vent 3400 is disposed within a decoupling structure (e.g., a swivel).

[0329] In the example shown in Figures 89-95, the patient interface 3000 includes a vent 3400. In this example, the vent 3400 includes passages in the frame 3350 and the swivel elbow assembly 3610. These passages allow air to flow from the interior of the plenum chamber 3200 to the surroundings. As shown in Figures 91, 95 and 103-105, the frame 3350 includes four holes that form part of the vent 3400 around the periphery of the frame inlet connection port 3354. In other examples, any number of vent holes (e.g., a single vent hole) may be provided to the frame 3350. As shown in Figure 90, air may flow into the swivel elbow assembly 3610 and then to the surroundings through swivel elbow assembly 3610 exterior holes that form part of the vent 3400. The swivel elbow assembly 3610 may be substantially similar to that described in International Publication No. WO2017 / 049357A1. The entire document is incorporated herein by reference.

[0330] The plenum chamber 3200 shown in Figs. 126-157 includes a vent 3400. In this example, the vent 3400 includes a plurality of holes. In these examples, the vent 3400 is provided to the shell 3210. In this example, the holes of the vent 3400 are formed in the shell 3210. In other examples of the present technology, the patient interface 3000 may include a vent module permanently or removably connected to the plenum chamber 3200. In some examples of the present technology, the patient interface 3000 includes an air diffuser configured to diffuse air passing through the vent 3400. In the plenum chamber 3400 shown in Figs. 126-157, the vent 3400 is centrally located. A centrally located vent 3400 relative to the plenum chamber 3200 is advantageous because it is less likely to be blocked when sleeping on one's side. Further, in these examples, the vent 3400 is provided at a lower position on the shell 3210. The lower position on the shell 3210 aligns the vent 3400 approximately with the patient's mouth. Since the majority of the exhaled air from the patient comes from the patient's mouth, the vent 3400 located opposite the patient's mouth may allow for better gas flushing. Furthermore, since the inlet port 3240 of the plenum chamber 3200 is provided at an upper position of the plenum chamber 3200, the energized air flow received from the inlet port 3240 may flow through a larger volume (e.g., from an upper position to a lower position), allowing for efficient gas flushing and reducing the possibility of the energized air flow bypassing stagnant air pockets.

[0331] 5.3.4 Decoupling Structures (Singular or Plural)

[0332] In one form, the patient interface 3000 includes at least one decoupling structure (eg, a swivel or ball socket).

[0333] 5.3.5 Connection Ports

[0334] The connection port 3600 allows connection to the air circuit 4170 .

[0335] 5.3.6 Forehead support

[0336] In one form, the patient interface 3000 includes a forehead support 3700 as shown in Figure 3A. In other examples, such as those shown in Figures 7-125, the patient interface 3000 may exclude the forehead support portion. Additionally, the patient interface 3000 may be configured to not contact the patient's forehead at all.

[0337] 5.3.7 Anti-asphyxiation valves

[0338] In one form, the patient interface 3000 includes an anti-asphyxiation valve.

[0339] As noted above, the patient interface 3000 may include one or more headgear tubes 3340 connected to the plenum chamber 3200 via a headgear tube connector 3344 that includes an anti-asphyxia valve. Alternatively or additionally, the patient interface 3000 may include a swivel elbow configured to connect to a supply conduit. The swivel elbow includes an anti-asphyxia valve. In other examples, an anti-asphyxia valve may be incorporated into the plenum chamber 3200, for example, by being provided to the shell 3210 of the plenum chamber 3200.

[0340] 5.3.8 Ports

[0341] 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 characteristic of the gas (e.g., pressure) within the plenum chamber 3200 to be directly measured.

[0342] 5.4 RPT Devices

[0343] 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 that is delivered to a patient's airway for treatment of one or more of the respiratory conditions described anywhere herein, for example.

[0344] In one form, the RPT device 4000 is constructed and arranged to deliver airflow in the range of -20 L / min to +150 L / min while maintaining a positive pressure of at least 6 cmH2O, or at least 10 cmH2O, or at least 20 cmH2O. RPT Device Algorithm

[0345] The RPT device may have an outer housing 4010. The outer housing 4010 is formed by two portions, an upper portion 4012 and a lower portion 4014. Additionally, the outer housing 4010 may include one or more panel(s) 4015. The RPT device 4000 includes a chassis 4016 that supports one or more internal components of the RPT device 4000. The RPT device 4000 may include a handle 4018.

[0346] The air pressure path of the pneumatic RPT device 4000 may include one or more air circuit items (e.g., an inlet air filter 4112, an inlet muffler 4122, a pressure generator 4140 (e.g., a blower 4142) capable of supplying air at positive pressure, an outlet muffler 4124) as well as one or more transducers 4270 (e.g., pressure and flow sensors).

[0347] As noted above, in some forms of the technology, the central controller may be configured to implement one or more algorithms expressed as a computer program stored in a non-transitory computer-readable storage medium (e.g., memory), the algorithms typically being grouped into groups called modules.

[0348] The RPT device 4000 can have a power supply 4210, one or more input devices 4220, a central controller, a therapy device controller, a pressure generator 4140, one or more protection circuits, a memory, a transducer 4270, a data communication interface, and one or more output devices 4290. The electrical components 4200 can be mounted on a single printed circuit board assembly (PCBA) 4202. In an alternative, the RPT device 4000 can include more than one PCBA 4202.

[0349] An RPT device according to one form of the present technology may include an air filter 4110 or multiple air filters 4110.

[0350] In one form, an outlet air filter 4114 (eg, antibacterial factor) is located between the outlet of the pneumatic block 4020 and the patient interface 3000.

[0351] An RPT device according to one form of the present technology may include a muffler 4120 or multiple mufflers 4120.

[0352] In one form of the present technology, an anti-spillback valve 4160 may be disposed between the humidifier 5000 and the pneumatic block 4020. The anti-spillback valve is constructed and positioned to reduce the risk of water flowing upstream from the humidifier 5000 (e.g., to the blower motor 4144).

[0353] 5.5 Air Circuit

[0354] An air circuit 4170, according to one aspect of the present technology, is a conduit or tube constructed and arranged such that, in use, air flow travels between two components (eg, the RPT device 4000 and the patient interface 3000).

[0355] In particular, the air circuit 4170 may be fluidly connected to the outlet of the pneumatic block 4020 and the patient interface. The air circuit may be referred to as an air delivery tube. In some cases, there may be separate limbs of the circuit for inhalation and exhalation. In other cases, a single limb is used.

[0356] In some forms, the air circuit 4170 may include one or more heating elements configured to heat the air in the air circuit (e.g., to maintain or increase the air temperature). The heating elements may take the form of a heated wire circuit and may include one or more transducers (e.g., temperature sensors). In one form, the heated wire circuit may be spirally wound around the axis of the air circuit 4170. The heating elements may be in communication with a controller (e.g., a central controller). One example of an air circuit 4170 including a heated wire circuit is described in U.S. Patent Application No. 8,733,349, which is incorporated by reference in its entirety.

[0357] 5.5.1 Oxygen delivery

[0358] In one form of the present technology, supplemental oxygen 4180 can be delivered to one or more points in the pneumatic pathway (eg, upstream of the pneumatic block 4020), the pneumatic circuit 4170 and / or the patient interface 3000.

[0359] 5.6 Humidifier

[0360] 5.6.1 Humidifier Overview

[0361] In one form of the present technology, a humidifier 5000 is provided for changing the absolute humidity of air or gas to be delivered to a patient relative to the ambient air (e.g., as shown in FIG. 5A). Typically, the humidifier 5000 is used to increase the absolute humidity (relative to ambient air) and increase the temperature of the air stream before delivery to the patient's airway.

[0362] The humidifier 5000 may include a humidifier reservoir 5110, a humidifier inlet 5002 for receiving an airflow, and a humidifier outlet 5004 for delivering a humidified airflow. In some forms, such as shown in Figures 5A and 5B, the inlet and outlet of the humidifier reservoir 5110 may be the humidifier inlet 5002 and the humidifier outlet 5004, respectively. The humidifier 5000 may further include a humidifier base 5006. The humidifier base 5006 may be adapted to receive the humidifier reservoir 5110 and may include a heating element 5240.

[0363] As shown in FIG. 5C, the humidifier controller 5250 may include one or more controllers (e.g., a central humidifier controller 5251, a heated air circuit controller 5254 configured to control the temperature of the heated air circuit 4171, and / or a heating element controller 5252 configured to control the temperature of the heating element 5240).

[0364] 5.6.2 Humidifier Components

[0365] 5.6.2.1 Water reservoir

[0366] According to one arrangement, the humidifier 5000 may include a water reservoir 5110 configured to contain or hold a quantity of liquid (e.g., water) to be evaporated for humidification of the airflow. The water reservoir 5110 may be configured to contain a predetermined maximum quantity of water to provide adequate humidification for at least the duration of a respiratory therapy session (e.g., a night's sleep). Typically, the reservoir 5110 is configured to contain several hundred milliliters of water (e.g., 300 milliliters (ml), 325 ml, 350 ml, or 400 ml). In another form, the humidifier 5000 may be configured to receive a water supply from an external water source (e.g., a building's water supply system).

[0367] According to one embodiment, the water reservoir 5110 is configured to humidify the air flow from the RPT device 4000 as the air flow passes through the RPT device 4000. In one form, the water reservoir 5110 may be configured to promote the air flow traveling a tortuous path through the reservoir 5110 while the air flow contacts a volume of water in the reservoir 5110.

[0368] According to one form, the reservoir 5110 may be removable from the humidifier 5000 laterally, for example as shown in Figures 5A and 5B.

[0369] The reservoir 5110 may also be configured to inhibit liquid release from the reservoir 5110, for example, when the reservoir 5110 is displaced and / or rotated from its normal operating orientation (e.g., through any aperture and / or between its subcomponents). Because the air flow to be humidified by the humidifier 5000 is often pressurized, the reservoir 5110 may also be configured to prevent loss of air pressure through leakage and / or flow impedance.

[0370] 5.6.2.2 Conductive Sites

[0371] According to one arrangement, the reservoir 5110 includes a conductive region 5120 configured to allow efficient heat transfer from the heating element 5240 to the volume of liquid in the reservoir 5110. In one form, the conductive region 5120 may be arranged as a plate, although other shapes may be suitable. All or part of the conductive region 5120 may be constructed of a thermally conductive material such as aluminum (e.g., approximately 2 mm (e.g., 1 mm, 1.5 mm, 2.5 mm, or 3 mm) thick), another thermally conductive metal, or some plastic. In some cases, adequate thermal conductivity may be achieved with a less conductive material of appropriate geometry.

[0372] 5.6.2.3 Humidifier Reservoir Dock

[0373] In one form, the humidifier 5000 may include a humidifier reservoir dock 5130 (as shown in FIG. 5B) configured to receive the humidifier reservoir 5110. In some arrangements, the humidifier reservoir dock 5130 may include a locking feature (e.g., a locking lever 5135 configured to hold the reservoir 5110 within the humidifier reservoir dock 5130).

[0374] 5.6.2.4 Water Level Indicator

[0375] The humidifier reservoir 5110 may include a water level indicator 5150 as shown in Figures 5A-5B. In some forms, the water level indicator 5150 may provide one or more indications to a user, such as the patient 1000 or a caregiver, about the amount of water in the humidifier reservoir 5110. The one or more indications provided by the water level indicator 5150 may include an indication of a maximum predetermined amount of water, any portion thereof (e.g., 25%, 50% or 75% or an amount (e.g., 200ml, 300ml or 400ml)).

[0376] 5.6.2.5 Humidifier Transducer(s)

[0377] The humidifier 5000 may include one or more humidifier transducers (sensors) 5210 instead of or in addition to the transducer 4270 described above. The humidifier transducer 5210 may include one or more of an air pressure sensor 5212, an air flow transducer 5214, a temperature sensor 5216, or a humidity sensor 5218 as shown in FIG. 5C. The humidifier transducer 5210 may generate one or more output signals. These output signals may be communicated to a controller (e.g., a central controller and / or a humidifier controller 5250). In some forms, the humidifier transducer may be located outside the humidifier 5000 (e.g., within the air circuit 4170) while communicating the output signal to the controller.

[0378] 5.7 Respiratory waveform

[0379] FIG. 6A shows a typical breathing waveform of a model of a sleeping person. The horizontal axis is time and the vertical axis is respiratory flow. Since parameter values ​​can vary, a typical breath can have the following approximate values: tidal volume, Vt, 0.5L; inhalation time, Ti, 1.6 seconds; peak inhalation flow, Qpeak, 0.4L / sec; exhalation time, Te, 2.4s; peak expiratory flow, Qpeak, -0.5L / sec. The total duration of the breath, Ttot, is about 4 seconds. Humans typically breathe about 15 times per minute (BPM) and the ventilation, Vent, is about 7.5L / min. A typical duty cycle, the ratio of Ti to Ttot, is about 40%.

[0380] 5.8 Respiratory Pressure Therapy Mode

[0381] Depending on the values ​​of parameters A and P0 in the treatment pressure equation (Error! Reference source unknown) used by the treatment parameter determination algorithm in one form of the present technology, various respiratory pressure treatment modes may be performed by the RPT device 4000.

[0382] 5.9 Glossary

[0383] For purposes of this disclosure, in certain aspects of the present technology, one or more of the following definitions may apply. In other aspects of the present technology, other definitions may apply.

[0384] 5.9.1 General

[0385] Air: In certain forms of the present technology, air may refer to atmospheric air, while in other forms of the present technology, air may refer to combinations of other breathable gases (e.g., oxygen-rich atmospheric air).

[0386] Atmosphere: In certain forms of the present technology, the term "atmosphere" should be taken to mean: (i) that which is external to the treatment system or patient, and (ii) that which immediately surrounds the treatment system or patient.

[0387] For example, the atmosphere for a humidifier humidityThis may be the humidity of the air immediately surrounding the humidifier (e.g., the humidity inside the room where the patient is sleeping). Such ambient humidity may differ from the humidity outside the room where the patient is sleeping.

[0388] In another example, the atmospheric pressure may be the pressure immediately surrounding or external to the body.

[0389] In certain embodiments, ambient (e.g., acoustic) noise can be considered the background noise level in the room the patient is in, other than noise emanating from, for example, the RPT device or from the mask or patient interface. Ambient noise can originate from sources outside the room.

[0390] Automatic Positive Airway Pressure (APAP) Therapy: A CPAP therapy that is capable of automatically adjusting therapeutic pressure between minimum and maximum limits, for example, between breaths, depending on the presence or absence of notification of an SDB episode.

[0391] Continuous Positive Airway Pressure (CPAP) Therapy: Respiratory pressure therapy in which the therapeutic pressure is approximately constant throughout the patient's respiratory cycle. In some forms, the pressure at the entrance to the airway increases slightly during expiration and decreases slightly during inspiration. In some forms, the pressure varies during different respiratory cycles of the patient (e.g., increased in response to detection of an indication of partial upper airway obstruction and decreased in the absence of notification of partial upper airway obstruction).

[0392] Flow Rate: The instantaneous amount (or mass) of air delivered per unit time. Flow rate may refer to an instantaneous quantity. In some cases, when referring to flow rate, it refers to a scalar quantity (i.e., a quantity that has only magnitude). In other cases, when referring to flow rate, it refers to a vector quantity (i.e., a quantity that has both magnitude and direction). Flow rate may be given the symbol Q. "Flow rate" may also be called "flow" for short.

[0393] Humidifier: The word "humidifier" is to be construed as meaning a humidification device constructed, arranged or configured with a physical structure capable of providing a therapeutically beneficial quantity of water (H2O) vapor to an air stream to improve the medical respiratory condition of a patient.

[0394] Leakage: The term "leakage" is taken as an unintended air flow. In one example, leakage may occur due to an imperfect seal between the mask and the patient's face. In another example, leakage may occur at the swivel elbow to the perimeter.

[0395] Noise Conduction (Acoustic): In this document, conducted noise refers to noise that is carried to the patient by the pneumatic path (e.g., the air circuit and the patient interface and the air therein). In one form, conducted noise can be quantified by measuring the sound pressure level at the end of the air circuit.

[0396] Noise Emission (Acoustic): In this document, radiated noise refers to noise that is carried by the surrounding air to the patient. In one form, radiated noise can be quantified by measuring the sound power / pressure level of the target according to ISO 3744.

[0397] Ventilation Noise (Acoustic): In this document, ventilation noise refers to the noise generated by airflow through any vents (eg, vents in a patient interface).

[0398] Patient: A person with or without respiratory disease.

[0399] Pressure: force per unit area. Pressure can be expressed in a variety of units (e.g., cmH2O, gf / cm 2 , and hectopascals). 1cmH2O is 1g-f / cm 2 which is approximately 0.98 hectopascals. In this specification, pressure is given in units of cmH2O unless otherwise specified.

[0400] The pressure in the patient interface is given the symbol Pm, and the therapeutic pressure, which represents the target value that the mask pressure Pm should achieve at this moment, is given the symbol Pt.

[0401] Respiratory Pressure Therapy (RPT): The application to the airway inlet of an air supply at therapeutic pressure, typically a positive pressure relative to the atmosphere.

[0402] Ventilator: A mechanical device that provides pressure support to a patient during some or all of the work of breathing.

[0403] 5.9.1.1 Materials

[0404] Silicone or Silicone Elastomer: Synthetic rubber. In this specification, when silicone is mentioned, it refers to liquid silicone rubber (LSR) or compression molded silicone rubber (CMSR). One form of commercially available LSR is SILASTIC (in a family of products sold under this trademark) manufactured by Dow Corning. Another LSR manufacturer is Wacker. Unless otherwise specified to the contrary, exemplary forms of LSR have a Shore A (or Type A) indentation hardness of about 35 to about 45 as measured by ASTM D2240.

[0405] Polycarbonate: A thermoplastic polymer of bisphenol A carbonate.

[0406] 5.9.1.2 Mechanical properties

[0407] Elasticity: The ability of a material to absorb energy during elastic deformation and to release the energy when unloaded.

[0408] Elastic: Releases substantially all of the energy upon unloading. Examples include certain silicone and thermoplastic elastomers.

[0409] Hardness: The ability of a material to resist deformation within itself (as described, for example, by Young's Modulus or the indentation hardness scale measured over a standardized sample size).

[0410] "Soft" materials may include silicone or thermoplastic elastomers (TPEs) and may easily deform under finger pressure, for example.

[0411] "Hard" materials may include polycarbonate, polypropylene, steel or aluminum, and do not easily deform under finger pressure, for example.

[0412] Stiffness (or rigidity) of a structure or component: The ability of a structure or component to resist deformation when subjected to a load. The load can be a force or a moment (e.g., compression, extension, bending, or torsion). A structure or component may offer different resistance in different directions.

[0413] Floppy Structure or Component: A structure or component that changes shape (e.g., flexes) within a relatively short period of time (e.g., 1 second) when forced to support its own weight.

[0414] Rigid Structure or Component: A structure or component that does not substantially change shape when subjected to loads typically encountered in use. An example of such an application may be setting up and maintaining a patient interface in a sealed manner against a patient airway entrance under a pressure load of, for example, approximately 20-30 cmH2O.

[0415] As one example, an I-beam may include a different bending stiffness (resistance to bending load) in a first direction compared to a second, orthogonal direction, hi another example, a structure or component may be floppy in a first direction and stiff in a second direction.

[0416] 5.9.2 Breathing cycle

[0417] Apnea: According to some definitions, apnea is said to occur when flow below a certain threshold continues for a duration of, for example, 10 seconds. Obstructive apnea is said to occur when some airway obstruction does not allow airflow despite patient effort. Central apnea is said to refer to a condition in which apnea is detected due to reduced or absent respiratory effort despite a patent airway. Mixed apnea is said to refer to a condition in which reduced or absent respiratory effort occurs simultaneously with airway obstruction.

[0418] Respiratory Rate: The patient's spontaneous breathing rate, usually measured in breaths per minute.

[0419] Duty Cycle: The ratio of inspiration time Ti to total breathing time Ttot.

[0420] Effort (Respiration): Respiratory effort is said to refer to the movement made by a person's spontaneous breathing in an attempt to breathe.

[0421] Expiratory portion of the respiratory cycle: the period from the start of the expiratory flow to the start of the inspiratory flow.

[0422] Flow limitation: Flow limitation is understood to be a situation in a patient's breathing where an increase in effort by the patient does not cause a corresponding increase in flow rate. If the flow limitation occurs during the inspiratory portion of the respiratory cycle, it can be referred to as inspiratory flow limitation. If the flow limitation occurs during the expiratory portion of the respiratory cycle, it can be referred to as expiratory flow limitation.

[0423] Hypopnea: By some definitions, hypopnea refers to a reduction in flow, rather than an interruption of flow. In one form, hypopnea is said to occur when there is a sustained period of reduced flow below a threshold rate. When hypopnea is detected due to a reduction in respiratory effort, central hypopnea is said to occur. In one form in adults, hypopnea may be considered when any of the following occur:

[0424] (i) A 30% decrease in patient respiration for at least 10 seconds plus an associated 4% desaturation, or

[0425] (ii) A reduction in patient respiration (less than 50%) lasting for at least 10 seconds and associated with at least 3% desaturation or arousal occurs.

[0426] Hyperventilation: An increase in flow to a level higher than normal.

[0427] Inspiration portion of the respiratory cycle: The period from the start of the inspiratory flow to the start of the expiratory flow is taken as the inspiration portion of the respiratory cycle.

[0428] Patency (Airway): The degree to which the airway is open or the extent to which the airway is open. Airway patency is an opening. Airway patency may be quantified, for example, with a value of 1 indicating open and a value of 0 indicating closed (obstructed).

[0429] Positive end-expiratory pressure (PEEP): The pressure above atmosphere in the lungs that exists at the end of expiration.

[0430] Peak flow (Qpeak): The maximum value of flow during the inspiratory portion of the respiratory flow waveform.

[0431] Respiratory airflow, airflow, patient airflow, respiratory airflow (Qr): these terms may be understood to refer to the RPT device's estimate of respiratory airflow and are used in contrast to "true respiratory flow" or "true respiratory airflow", which is the patient's actual respiratory flow, usually expressed in liters / minute.

[0432] Tidal volume (Vt): The volume of air inhaled or exhaled during normal breathing without extra effort. In principle, the inhaled volume V i (volume of inhaled air) is the expiratory volume V e (volume of exhaled air), so a single tidal volume V t can be defined as being equal to either quantity. In practice, the tidal volume V t is some combination (e.g., intake volume Vi and expiratory volume V e It is estimated as the average of

[0433] (Inspiration) Time (Ti): The duration of the inspiratory portion of the respiratory flow waveform.

[0434] (Expiratory) Time (Te): The duration of the expiratory portion of the respiratory flow waveform.

[0435] (Total) Time (Ttot): The total duration between the start of one inspiratory portion of the respiratory flow waveform and the start of the next inspiratory portion of the respiratory flow waveform.

[0436] Typical Recent Ventilation: The ventilation value around which the most recent values ​​of ventilationVent tend to cluster over a given time scale (i.e., the degree to which the most recent values ​​of ventilation tend to be central).

[0437] Upper Airway Obstruction (UAO): Includes both partial and total upper airway obstruction. May be associated with a state of flow limitation in which flow may increase or decrease slightly with increasing pressure differential across the upper airway (Starling resistor behavior).

[0438] Vent: A measurement of the rate of gas exchange performed by a patient's respiratory system. Measurements of ventilation may include either or both inhaled and exhaled airflow per unit of time. When expressed as volume per minute, this amount is often referred to as "minute ventilation." Minute ventilation is sometimes simply given as volume and is understood as volume per minute.

[0439] 5.9.3 Anatomy

[0440] 5.9.3.1 Facial Anatomy

[0441] Ala: The outer wall or "wing" of each nostril (plural: alar)

[0442] Alare: The outermost point on the ala of the nose.

[0443] Alar curvature (or alar crest) point: The most posterior point on the curved baseline of each ala, found in the crease formed by the union of the ala and cheek.

[0444] Pinna: the entire visible part of the ear.

[0445] (Nasal) Skeleton: The nasal skeleton includes the nasal bones, the frontal process of the maxilla, and the nasal part of the frontal bone.

[0446] (Nasal) Cartilaginous folds: The nasal cartilaginous folds include the septal cartilage, lateral cartilage, greater cartilage and lesser cartilage.

[0447] Columella: The piece of skin that separates the nostrils and extends from the tip of the nose to the upper lip.

[0448] Columella angle: the angle between a line drawn through the midpoint of the nostrils and a line drawn perpendicular to the Frankfurt horizontal intersecting the subnasal point.

[0449] Frankfort horizontal plane: A line extending from the inferiormost point of the orbital rim to the left auricular point, which is the deepest point above the notch to the tragus of the pinna.

[0450] Glabellar: Located in the soft tissue, the most prominent point on the midsagittal portion of the forehead.

[0451] Lateral nasal cartilage: A generally triangular plate of cartilage whose upper margin is attached to the nasal bone and the frontal process of the maxilla and whose lower margin is connected to the greater alar cartilage.

[0452] Lip, lower side (lower lip: labrale inferius):

[0453] Lip, upper side (upper lip: labrale superius):

[0454] Greater alar cartilage: a plate of cartilage located beneath the lateral nasal cartilage. It curves around the anterior part of the nostril. Its posterior end is attached to the frontal process of the maxilla by a tough fibrous membrane containing three or four alar cartilages.

[0455] Nostrils (nose holes): roughly ellipsoidal alar openings that form the entrance to the nasal cavity. The singular form of nares is naris (nose hole). The nostrils are separated by the nasal septum.

[0456] Nasolabial fold or nasolabial crease: a fold or groove of skin that runs from each side of the nose to the corners of the mouth and separates the cheeks from the upper lip.

[0457] Nasolabial angle: the angle between the bridge of the nose and the upper lip, intersecting with the subnasal point.

[0458] Inferior ear point: lowest point of attachment of the pinna to the facial skin.

[0459] Superior auricular point: the highest point of attachment of the pinna to the facial skin.

[0460] Nasal tip: the most prominent point or tip of the nose, which can be seen in a lateral view of the rest of the head section.

[0461] Philtrum: midline groove extending from the lower border of the nasal septum to the top of the lip in the upper lip area.

[0462] Pogonion: The most anterior midpoint of the jaw, located on the soft tissue.

[0463] (Nasal) ridge: The nasal ridge is the midline prominence of the nose, extending from the serion to the apex.

[0464] Sagittal Plane: A vertical plane running from anterior (front) to posterior (back). The midsagittal plane is the sagittal plane that divides the body into right and left halves.

[0465] Cerion: Located on the soft tissue, it is the most concave point on the area of ​​the frontonasal suture.

[0466] Septal cartilage (nose): The nasal septal cartilage is part of the septum, which divides the anterior part of the nasal cavity.

[0467] Nasal Alar Lowest Point: The point on the lower margin of the alar base where it joins with the skin of the upper (top) lip.

[0468] Subnasal point: located on the soft tissue where the columella joins the upper lip in the midsagittal direction.

[0469] Supramenton: The most concave point in the midline of the lower lip between the lower lip midpoint and the soft tissue pogonion.

[0470] 5.9.3.2 Skull anatomy

[0471] Frontal bone: The frontal bone contains the large vertical portion, the scales frontalis, which correspond to the area known as the forehead.

[0472] Mandible: The mandible forms the lower jaw. The mental eminence is a bony protuberance in the jaw, forming the chin.

[0473] Maxilla: The maxilla forms the upper jaw and is located below the mandible and below the eye socket. The frontal process of the maxilla projects upwards by the side of the nose and forms part of its lateral border.

[0474] Nasal bones: The nasal bones are two small rectangular bones that vary in size and shape from one individual to another. They lie side by side in the middle and upper parts of the face and their junction forms the "bridge" of the nose.

[0475] Nasion: the intersection of the frontal bone and the two nasal bones, a concave area directly between the eyes and the upper side of the bridge of the nose.

[0476] Occipital bone: The occipital bone is located at the back and lower part of the skull. It contains an oval hole, the foramen magnum, through which the intracranial cavity communicates with the vertebral canal. The curved plate posterior to the foramen magnum is the squama occipitalis.

[0477] Orbit: bony cavity in the skull that contains the eyeball.

[0478] Parietal bones: The parietal bones are the bones that, when joined together, form the top and sides of the skull.

[0479] Temporal Bone: The temporal bone is located at the base and on the side of the skull and supports parts of the face known as the temples.

[0480] Cheekbones: The two cheekbones in the face are located in the upper and outer parts of the face and form the cheek ridges.

[0481] 5.9.3.3 Respiratory system anatomy

[0482] Diaphragm: A sheet of muscle that runs over the lower rib cage. It separates the thoracic cavity, which contains the heart, lungs, and ribs, from the abdominal cavity. When the diaphragm contracts, it increases the volume of the thoracic cavity and draws air into the lungs.

[0483] Larynx: The larynx or voice box that contains the vocal folds and connects the lower part of the pharynx (hypopharynx) to the trachea.

[0484] Lung: respiratory organ in humans. The conductive zone of the lung includes the trachea, bronchi, bronchiole, and terminal bronchioles. The respiratory zone includes the respiratory bronchi, alveolar ducts, and alveoli.

[0485] Nasal Cavity: The nasal cavity (or nasal fossa) is a large air-filled space in the center of the face above and behind the nose. The nasal cavity is divided into two by a vertical fin called the nasal septum. On the sides of the nasal cavity are three horizontal extensions called the turbinates or nasal bones. At the front of the nasal cavity is the nose, and at the back it opens into the nasopharynx via the choanae.

[0486] Pharynx: The part of the throat located immediately below (inferior to) the nasal cavity and above the esophagus and larynx. The pharynx is traditionally divided into three parts: the nasopharynx (upper pharynx) (nasal part of the pharynx), the oropharynx (mid pharynx) (oral part of the pharynx), and the hypopharynx (low pharynx).

[0487] 5.9.4 Patient Interface

[0488] Anti-asphyxiation valve (AAV): A component or subassembly of a mask system that reduces the risk of excessive rebreathing of CO2 by the patient by venting to atmosphere in a fail-safe manner.

[0489] Elbow: An elbow is an example of a structure that directs the axis of airflow moving therethrough to change direction through an angle. In one form, the angle may be approximately 90 degrees. In another form, the angle may be greater than or less than 90 degrees. The elbow may have a generally circular cross section. In another form, the elbow may have an oval or rectangular cross section. In certain forms, the elbow may be rotatable, for example, about 360 degrees, relative to the mating component. In certain forms, the elbow may be removable from the mating component, for example, via a snap connection. In certain forms, the elbow may be assembled to the mating component via a one-time snap at the time of manufacture, but cannot be removed by the patient.

[0490] Frame: Frame is taken to mean a mask structure that supports a tensile load between two or more points that connect the headgear. A mask frame may be a non-airtight load-bearing structure in the mask. However, some forms of mask frames may be airtight.

[0491] Headgear: Headgear is taken to mean a form of positioning and stabilizing structure designed to be used on the head. For example, the headgear may include a collection of one or more posts, ties and stiffeners configured to position and hold the patient interface in place on the patient's face for delivery of respiratory therapy. Some ties are formed from a soft, flexible, elastic material (e.g., a layered composite of foam and fabric).

[0492] Membrane: Membrane is taken to mean a typically thin-walled element, preferably offering substantially no resistance to bending and resistance to stretching.

[0493] Plenum Chamber: Mask plenum chamber is taken to mean a part of a patient interface having a wall that at least partially encloses a volume of space, the air in the volume being pressurized to exceed atmospheric pressure in use. The shell may form part of the wall of the mask plenum chamber.

[0494] Seal: When used as a noun ("seal") it can refer to a structure, and when used as a verb ("seal") it can refer to an effect. Two elements can be constructed and / or arranged to "seal" or achieve a "sealing" effect between them without the need for a separate "sealing" element itself.

[0495] Shell: A shell is taken to mean a curved, relatively thin structure that has bending, tensile and compressive stiffness. For example, the curved structural wall of a mask may be a shell. In some forms, the shell may be faceted. In some forms, the shell may be airtight. In some forms, the shell may not be airtight.

[0496] Stiffener: A stiffener is taken to mean a structural component designed to increase the bending stiffness of another component in at least one direction.

[0497] Strut: A strut is taken to mean a structural component designed to increase the compressive resistance of another component in at least one direction.

[0498] Swivel (noun): A subassembly of components configured to rotate, preferably independently, about a common axis, preferably under low torque. In one form, the swivel may be configured to rotate through an angle of at least 360 degrees. In another form, the swivel may be configured to rotate through an angle of less than 360 degrees. When used in the context of an air delivery conduit, the subassembly of components preferably includes a mating cylindrical conduit. In use, there is little leakage of air flow from the swivel.

[0499] Tie (noun): A structure designed to resist tension.

[0500] Venting: (noun): A structure that allows airflow to the ambient air inside a mask or conduit, allowing clinically effective flushing of exhaled gases. For example, flow rates of about 10 liters / minute to about 100 liters / minute may be used for clinically effective flushing, depending on mask design and treatment pressure.

[0501] 5.9.5 Shape of structure

[0502] A product of the present technology may include one or more three-dimensional mechanical structures (e.g., a mask cushion or impeller). The three-dimensional structures may be bounded by two-dimensional surfaces. These surfaces may be differentiated with labels to describe the orientation, location, function or some other characteristic of the associated surfaces. For example, the structure may include one or more of a front surface, a back surface, an inner surface, and an outer surface. In another example, the seal-forming structure may include a face-contacting (e.g., outer) surface and a separate non-face-contacting (e.g., lower or inner) surface. In another example, the structure may include a first surface and a second surface.

[0503] To facilitate the description of the shape and surface of a three-dimensional structure, a cross section at a point p through the surface of the structure is first considered. See Figures 3B-3F. Figures 3B-3F show an example cross section at a point p on the surface, and an example of the resulting planar curve. Figures 3B-3F also show the outward normal vector at p. The outward normal vector at p points away from the surface. In some examples, the surface is described from the perspective of a fictional little person standing upright on the surface.

[0504] 5.9.5.1 Curvature in one dimension

[0505] The curvature of a plane curve at p can be described as having a sign (eg, positive, negative) and a magnitude (eg, 1 / radius of the circle tangent to the curve at p).

[0506] Positive curvature: If the curve at p bends towards the outward normal, the curvature at that point is taken to have a positive value (if this imaginary little person walks away from point p, he or she would have to walk uphill). See Figure 3B (relatively large positive curvature compared to Figure 3C) and Figure 3C (relatively small positive curvature compared to Figure 3B). Such curves are often called concave.

[0507] Zero curvature: If the curve at p is a straight line, the curvature is taken as zero (if this imaginary little person walks away from point p, he can walk on a horizontal plane that is neither pointing up nor down). See Figure 3D.

[0508] Negative curvature: If the curve at p bends away from the outward normal, the curvature at that point and in that direction is taken to have a negative value (if this imaginary little person were to walk away from point p, he would have to walk downhill). See Figure 3E (relatively small negative curvature compared to Figure 3F) and Figure 3F (relatively large negative curvature compared to Figure 3E). Such curves are often called convex.

[0509] 5.9.5.2 Two-dimensional surface curvature

[0510] The description of a shape at a given point on a two-dimensional surface according to the present technology may include multiple perpendicular cross sections. The multiple cross sections may cut the surface in a plane that includes the outward normal (the "normal plane"), and each cross section may be taken in a different direction. Each cross section results in a plane curve with a corresponding curvature. The different curvatures at the point may have the same sign or different signs. Each of the curvatures at the point has a (e.g., relatively small) magnitude. The plane curves in Figures 3B-3F may be examples of such multiple cross sections at a particular point.

[0511] Principal curvature and direction: The directions of the normal plane in which the curvature of the curve has a maximum and a minimum value are called the principal directions. In the example of Figures 3B-3F, the maximum curvature occurs in Figure 3B and the minimum occurs in Figure 3F, so Figures 3B and 3F are cross sections in the principal directions. The principal curvature at p is the curvature in the principal direction.

[0512] Surface region: A collection of connected points on a surface. This set of points within a region may have similar properties (e.g., curvature or sign).

[0513] Saddle Region: A region where the principal curvatures at each point have opposite signs (i.e., one positive sign and the other negative sign) (depending on the direction a hypothetical person who may be walking uphill or downhill is facing).

[0514] Dome Area: A region where the principal curvatures at every point have the same sign: both positive ("concave dome") or both negative ("convex dome").

[0515] Cylindrical domain: A domain in which one principal curvature is zero (or, for example, zero within manufacturing tolerances) and the other principal curvature is non-zero.

[0516] Planar Region: Region of a surface where both principal curvatures are zero (or are zero within a manufacturing tolerance, for example).

[0517] Surface Edge: the boundary or limit of a surface or area.

[0518] Path: In certain forms of the technology, a "path" is taken to mean a path in the mathematical-topological sense (e.g., a continuous space curve from f(0) to f(1) on a surface). In certain forms of the technology, a "path" may be described as a route or course that includes, for example, a set of points on a surface. (A hypothetical person's path is a place to walk on a surface, similar to a path in a garden.)

[0519] Path Length: In certain forms of the present technology, "path length" is taken to refer to the distance along a surface from f(0) to f(1) (i.e., the distance along a path on the surface). There may be more than one path between two points on a surface, and such paths may have different path lengths. (The path length of a fictional person is the distance walked along a path on the surface.)

[0520] Straight-line distance: Straight-line distance is the distance between two points on a surface, but does not take the surface into account. On a planar area, there is a distance on the surface edge that has the same path length as the straight-line distance between two points on the surface. On a non-planar surface, there cannot be a path that has the same path length as the straight-line distance between two points. (For a fictional person, straight-line distance corresponds to the distance "as the crow flies.")

[0521] 5.9.5.3 Space curve

[0522] Space Curve: Unlike a plane curve, a space curve does not necessarily lie in any particular plane. A space curve may be closed, i.e., it has no end point. A space curve may be considered a one-dimensional piece of three-dimensional space. A fictional character walking on a strand of DNA helix walks along a space curve. A typical human left ear includes a left-handed helix (see FIG. 3Q). A typical human right ear includes a right-handed helix (see FIG. 3R). FIG. 3S shows a right-handed helix. The edge of a structure (e.g., the edge of a membrane or an impeller) may trace a space curve. In general, a space curve may be described by the curvature and twist at each point on the space curve. Twist is a measure of the way the curve emanates from the plane. Twist has a sign and a magnitude. The twist at a point on a space curve may be characterized with respect to the tangent, normal, and binormal vectors at that point.

[0523] Tangent unit vector (or unit tangent vector): For each point on a curve, the vector at that point specifies the direction and magnitude from that point. A tangent unit vector is a unit vector that points in the same direction as the curve at that point. If a fictional character was flying along a curve and fell off his vehicle at a particular point, the direction of the tangent vector is the direction he would be traveling.

[0524] Unit normal vector: If a fictional character is moving along a curve, this tangent vector itself changes. The unit vector that points in the same direction as the tangent vector is changing is called the unit principal normal vector. It is perpendicular to the tangent vector.

[0525] Binormal unit vector: The binormal unit vector is perpendicular to both the tangent vector and the principal normal vector. Its direction can be determined by the right-hand rule (see, for example, Figure 3P) or the left-hand rule (Figure 3O).

[0526] Tangent plane: the plane containing the unit tangent vector and the unit principal normal vector, see Figures 3O and 3P.

[0527] Torsion of a Space Curve: The torsion at a point of a space curve is the magnitude of the rate of change of the binormal unit vector at that point. It measures the degree of deviation of the curve from the tangential plane. The torsion of a space curve that lies within the plane is zero. If the space curve deviates from the tangential plane by a relatively small amount, the magnitude of torsion of the space curve is relatively small (e.g., a gently sloping spiral path). If the space curve deviates from the tangential plane by a relatively large amount, the magnitude of torsion of the space curve is relatively large (e.g., a steeply sloping spiral path). With reference to FIG. 3S, the magnitude of torsion of the neighbors of the top coil of the spiral in FIG. 3S is greater than the magnitude of torsion of the bottom coil of the spiral in FIG. 3S because T2>T1.

[0528] Referring to the right-hand rule in Figure 3P, a space curve that bends towards the right-hand binormal can be considered to have a positive twist in the right-hand direction (e.g., a right-hand spiral as shown in Figure 3S). A space curve that bends away from the right-hand binormal can be considered to have a negative twist in the right-hand direction (e.g., a left-hand spiral).

[0529] Similarly, with reference to the left-hand rule (see Figure 3O), a space curve with a left-handed binormal direction can be considered as having a left-handed positive twist (e.g., a left-handed spiral), where a left-handed positive direction thus corresponds to a right-handed negative direction, see Figure 3T.

[0530] 5.9.5.4 Holes

[0531] A surface may have one-dimensional holes (e.g., holes bounded by a plane or space curve). In the case of a thin structure (e.g., a membrane) that contains holes, the structure may be described as having one-dimensional holes. See, for example, how the one-dimensional holes in the surface of the structure shown in Figure 3I are bounded by a plane curve.

[0532] A structure may have a two-dimensional hole (e.g., a hole bounded by a surface). For example, an inflatable tire has a two-dimensional hole bounded by the tire inner surface. In another example, a bladder with a cavity for air or gel may have a two-dimensional hole. See, for example, the cushion in FIG. 3L and the exemplary cross-section of FIG. 3L in FIG. 3M and FIG. 3N, where the inner surface bounding the two-dimensional hole is shown. In yet another example, a conduit may include a one-dimensional hole (e.g., at its inlet or its outlet) and may include a two-dimensional hole bounded by the inner surface of the conduit. See also the two-dimensional hole through the structure shown in FIG. 3K and bounded by a surface as shown.

[0533] 5.10 Other Notes

[0534] Unless otherwise clearly indicated from the context and unless a range of values ​​is provided, it is understood that each intervening value between the upper and lower limits of the range, the unit of the lower limit, and any other stated or intervening value of the stated range is encompassed by the technology. The upper and lower limits of these intervening ranges, which are independently included in the intervening range, are also encompassed by the technology if they specifically exceed the limits in the stated range. If the stated range includes one or both of these limits, then ranges exceeding either or both of these stated limits are also encompassed by the technology.

[0535] Furthermore, when a value or values ​​are embodied herein as part of the present technology, unless otherwise indicated, it is understood that such values ​​may be approximated and may be used to any appropriate significant figures to the extent practical technical practice permits or requires.

[0536] Unless otherwise specified, all technical and scientific terms herein have the same meaning as commonly understood by one of ordinary skill in the art to which this technology belongs. Although any methods and materials similar or equivalent to those described herein can be used in the practice or testing of this technology, a limited number of exemplary methods and materials are described herein.

[0537] Although particular materials are described as being preferred for use in the construction of components, obvious alternative materials having similar properties may be substituted. Further, unless stated to the contrary, any and all components described herein are understood to be manufacturable and therefore may be manufactured collectively or separately.

[0538] Please note that as used herein and in the appended claims, the singular forms "a," "an," and "the" include their plural equivalents unless the context clearly dictates otherwise.

[0539] All publications mentioned herein are incorporated by reference to disclose and describe the methods and / or materials that are the subject of these publications. Publications mentioned herein are provided solely for their disclosure prior to the filing date of this application. Nothing herein should be construed as an admission that the present technology has not antedated such publications by virtue of prior patents. Furthermore, the dates of publications mentioned may differ from the actual publication dates, which may require independent confirmation.

[0540] The terms "comprises" and "comprising" should be construed as referring to elements, components, or steps in a non-exclusive sense, indicating that a described element, component, or step may be present in, utilized with, or combined with other elements, components, or steps that are not specifically described.

[0541] The headings used in the detailed description are for the convenience of the reader and should not be used to limit the content found in the disclosure or claims as a whole. These headings should not be used in interpreting the scope of the claims or the limitations of the claims.

[0542] Although the technology herein has been described with reference to specific embodiments, it should be understood that these embodiments are merely illustrative of the principles and applications of the technology. In some cases, terms and symbols may indicate specific details that are not necessary for the practice of the technology. For example, the terms "first" and "second" (and the like) are used, but unless otherwise specified, these terms are not intended to indicate any order, but are used to distinguish separate elements. Furthermore, although the description or illustration of process steps in the method may be described in an order, such order is not required. Those skilled in the art will recognize that such order can be changed and / or aspects thereof can be performed simultaneously or even synchronously.

[0543] It is therefore to be understood that numerous modifications may be made in the illustrative embodiments and that other arrangements may be devised without departing from the spirit and scope of the present technology. [Explanation of symbols]

[0544] 1000 patients 1100 Bedmate 3000 Patient Interface 3100 Seal forming structure 3101 area 3102 Boundary 3103 area 3111 Center part facing upwards 3112 Central saddle area 3113 Bridge part 3114 Horizontal corner area 3115 Center section facing forward 3116 Upper lip 3117 Mouth hole surrounding area 3118 Lower lip 3121 Middle part facing upwards 3125 Forward facing middle section 3131 Back corner 3135 Rear-facing transverse section 3136 Lateral peripheral support area 3141 Sideways facing rear 3145 Horizontal section 3151 Lateral support part 3152 Flat Lower Boundary 3153 Curved upper border 3155 Forward facing lateral section 3161 Anterior support part 3165 Anterior support part 3200 Plenum Chamber 3209 Tendon 3210 Shell 3211 Upper edge 3215 Protrusion 3218 Rim 3220 Top point 3229 Down 3230 Nose part 3231 Horizontal section 3232 Upper periphery 3240 Ingress Port 3260 Mouth part 3271 Mouth hole 3272 Nose hole 3275 Oral-nasal transition 3300 Positioning and stabilizing structure 3310 Top Strap 3315 Upper strap connection point 3320 Lower Strap 3325 Lower junction 3326 Lower Strap Clip 3330 Upper Crown Strap 3332 Side Crown Strap 3334 Neck strap 3340 Headgear Pipe 3342 Tabs 3344 Headgear Tube Connector 3350 Frames 3351 Snap-on hook 3354 Frame Inlet Connection Port 3355 Connecting Rim 3390 Conduit Headgear Inlet 3400 Ventilation section 3600 Connection Port 3610 Swivel Elbow Assembly 3700 Forehead support 4000 RPT Devices 4010 Outer Housing 4012 Internal part 4014 Lower 4015 Panel 4016 Chassis 4018 Handle 4020 Pneumatic Block 4110 Air Filter 4112 Inlet Air Filter 4114 Outlet Air Filter 4120 Muffler 4122 Inlet muffler 4124 Exit muffler 4140 Pressure Generator 4142 Blower 4144 Motor 4160 Anti-spillback valve 4170 Air Circuit 4171 Heated Air Circuit 4180 Supplemental Oxygen 4200 Electrical Components 4202 Printed Circuit Board Assembly (PCBA) 4210 Power supply 4220 Input Device 4270 Converter 4290 output device 5000 humidifier 5002 Humidifier inlet 5004 Humidifier outlet 5006 Humidifier Base 5110 Reservoir 5120 Conductive parts 5130 Humidifier Reservoir Dock 5135 Lock lever 5150 Water Level Indicator 5210 Humidifier Converter 5212 Air pressure sensor 5214 Flow Converter 5216 Temperature Sensor 5240 heating element 5250 Humidifier Controller 5251 Central Humidifier Controller 5252 Heating Element Controller 5254 Air Circuit Controller

Claims

1. A patient interface comprising: A plenum chamber for a patient interface, the plenum chamber having a pressure of at least 6 cmH above ambient air pressure throughout a patient's breathing cycle in use. ２ The plenum chamber is pressurizable up to a therapeutic pressure of O one or more walls at least partially enclosing a volume of space; a seal-forming structure constructed and arranged to form a seal against a region of a patient's face surrounding an entrance to the patient's airways, said seal-forming structure including a nose region having at least one nostril configured to, in use, deliver an air flow at said therapeutic pressure to an entrance to the patient's nares, said seal-forming structure including a mouth region having a mouth hole configured to, in use, deliver an air flow at said therapeutic pressure to an entrance to the patient's mouth, said seal-forming structure constructed and arranged to, in use, maintain said therapeutic pressure in a plenum chamber throughout the patient's respiratory cycle; a plenum chamber including one or more plenum chamber inlet ports sized and configured to, in use, receive a flow of air at a therapeutic pressure for breathing by a patient throughout the patient's breathing cycle; a positioning and stabilizing structure configured to generate a force to maintain the seal-forming structure in a therapeutically effective position on the patient's head; the nose portion of the seal-forming structure includes a central portion configured to seal against an inferior periphery of the patient's nose in use; the nose portion of the seal-forming structure includes a pair of intermediate portions configured to contact the patient's nasal ala in use, the pair of intermediate portions being stiffer than the central portion; a patient interface, wherein the nasal portion of the seal-forming structure includes a pair of posterior corners, each of the posterior corners being positioned on a patient-facing side of the nasal portion such that, in use, the posterior corners contact the patient's face in a lateral lower region relative to a respective one of the patient's alae, the posterior corners being thicker than the intermediate portion.

2. The pair of intermediate portions includes a portion of an outer wall of the seal-forming structure, 2. A patient interface according to claim 1, wherein a portion of the outer wall faces partially inwardly towards a sagittal plane of the patient and partially upwardly towards the patient in use.

3. 3. A patient interface according to claim 1 or 2, wherein the intermediate portion is configured to limit leakage paths caused by folds from the lower periphery of the patient's nose to the environment.

4. A patient interface according to any preceding claim, wherein the intermediate section is thicker than the central section.

5. A patient interface according to any preceding claim, wherein the seal-forming structure is configured, in use, not to engage on the underside of the patient's face under the chin.

6. the plenum chamber comprises a shell; A patient interface according to any preceding claim, wherein the seal-forming structure is coupled to the shell.

7. A patient interface according to any preceding claim, wherein the plenum chamber inlet port is a single inlet port.

8. A patient interface according to any preceding claim, wherein the plenum chamber comprises a pair of inlet ports for connection to conduit headgear of the patient interface.

9. A patient interface according to any preceding claim, wherein the seal-forming structure comprises a pair of nasal holes arranged, in use, to direct airflow to corresponding nares of the patient.

10. 10. A patient interface according to any one of the preceding claims, wherein the seal-forming structure includes an upper lip configured to seal against an upper lip of a patient in use, and wherein the posterior corner is thicker than the upper lip.

11. 11. The patient interface of claim 10, wherein the seal-forming structure is configured such that a transition region from each of the posterior corners to the upper lip is positioned adjacent to a laterally outer side of the patient's ala in use.

12. A patient interface as described in any one of claims 1 to 11, wherein the edge of the posterior corner region adjacent the central portion follows a path that faces upwardly relative to the patient's face during use on either side of the nose following the curvature along either side of the nose.

13. 13. A patient interface according to claim 12, wherein each of the paths that point upwardly relative to the patient's face follows a curvature along either side of the nose.

14. A patient interface according to any one of claims 1 to 13, wherein the thickness of the posterior corner is between 0.8mm and 1.6mm.

15. A patient interface according to any one of claims 1 to 14, wherein each of the posterior corners is configured such that, in use, no portion of the posterior corner other than an edge portion contacts a respective one of the patient's nasal alae.

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