Oronasal Patient Interface

Abstract

A patient interface including a positioning and stabilizing structure configured to maintain a first seal-forming structure and a second seal-forming structure in a therapeutically effective position. The positioning and stabilizing structure includes a frame coupled to the plenum chamber. The frame includes a central portion coupled to the plenum chamber outside the cavity. The frame also includes a pair of arms extending rearwardly away from the central portion and through the second seal-forming structure. The pair of arms are more flexible than the central portion. The positioning and stabilizing structure also includes headgear straps coupled to the frame. The headgear straps are configured to apply tension through the frame to the first seal-forming structure and the second seal-forming structure within the patient's face.

Description

[Technical field]

[0001] 1 CROSS-REFERENCE TO RELATED APPLICATIONS This application claims the benefit of U.S. Provisional Application No. 63 / 058,001, filed July 29, 2020, and Australian Provisional Application No. 2019903360, filed September 10, 2019, the entire contents of which are incorporated herein by reference.

[0002] 2. Technology Background 2.1 Technology field The present technology relates to one or more of screening, diagnosing, monitoring, treating, preventing and ameliorating respiratory-related disorders. The present technology also relates to medical devices or apparatus and uses thereof. [Background technology]

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

[0004] 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 the right and left main bronchi, which further divide into the terminal bronchioles. The bronchi constitute the conducting airways and do not participate in gas exchange. The airways further divide into the respiratory bronchioles and finally into the alveoli. Gas exchange occurs in the alveolar region of the lungs, which is called the respiratory zone. See: "Respiratory Physiology", by John B. West, Lippincott Williams & Wilkins, 9th edition published 2011.

[0005] There is a range of respiratory diseases. Particular diseases can be characterized by particular manifestations such as apnea, hypopnea and hyperpnea.

[0006] 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.

[0007] Obstructive sleep apnea (OSA) is a form of sleep-disordered breathing (SDB) characterized by episodes such as closure or obstruction of the upper airway during sleep. It results from a combination of an abnormally small upper airway and normal loss of muscle tone in the tongue region, soft palate and posterior oropharyngeal wall during sleep. This condition causes affected patients to pause 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.

[0008] 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 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, which cause severe insomnia, increased sympathetic activity, and increased afterload. See U.S. Patent No. 6,532,959 (Berthon-Jones).

[0009] Respiratory failure is a general term for 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:

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

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

[0012] Chronic obstructive pulmonary disease (COPD) encompasses any of a group of lower airway diseases that share certain 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.

[0013] Neuromuscular diseases (NMD) is a broad term that encompasses numerous diseases and illnesses that impair muscle function directly through intrinsic muscle pathology or indirectly through neuropathology. Some NMD patients are characterized by progressive muscle 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.

[0014] 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 failure. Scoliosis and / or kyphoscoliosis can lead to severe respiratory failure. Symptoms of respiratory failure include: dyspnea on exertion, peripheral edema, orthopnea, recurrent chest infections, morning headache, fatigue, poor quality of sleep, and loss of appetite.

[0015] 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.

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

[0017] 2.2.2.1 Respiratory Pressure Therapy Respiratory pressure therapy is the application of a supply of air to the entrance of the airways at a controlled target pressure, usually a positive pressure relative to atmosphere, throughout the patient's respiratory cycle.

[0018] Continuous positive airway pressure (CPAP) therapy has been used in the treatment of obstructive sleep apnea (OSA). Its mechanism of action is that CPAP 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 treatment of OSA with CPAP therapy can be voluntary, patients may choose not to adhere to treatment if they perceive one or more of the following about the device used to deliver the treatment: uncomfortable, difficult to use, expensive, or aesthetically unappealing.

[0019] 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.

[0020] 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.

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

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

[0023] 2.2.2.3 Supplemental oxygen For certain patients, a combination of oxygen therapy and respiratory pressure therapy or HFT can be obtained by adding supplemental oxygen to the pressurized air stream. When oxygen is added to respiratory pressure therapy, this is referred to as RPT with supplemental oxygen. When oxygen is added to HFT, the resulting therapy is referred to as HFT with supplemental oxygen.

[0024] 2.2.3 Respiratory Treatment Systems These respiratory therapies may be provided by respiratory treatment systems or devices. Such systems and devices may also be used to screen, diagnose, or monitor disease without treating it.

[0025] The respiratory treatment system may include a respiratory pressure treatment device (RPT device), an air circuit, a humidifier, a patient interface, an oxygen breathing source, and data management.

[0026] Another form of therapy system is the mandibular repositioning device.

[0027] 2.2.3.1 Patient Interface 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 with, for example, an area of ​​the patient's face, thereby facilitating gas delivery at a pressure of sufficient dispersion with ambient pressure for therapy to take place (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. For flow therapy, such as nasal HFT, the patient interface is configured to insufflate the nares (and specifically avoid a complete seal). One example of such a patient interface is a nasal cannula.

[0028] 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.

[0029] 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).

[0030] 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.

[0031] Certain masks may be impractical for use while sleeping (eg, when sleeping on one's side in bed with head on a pillow).

[0032] 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.

[0033] 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 anesthesia administration masks may be tolerable for their intended use, such masks may be undesirably uncomfortable to wear for extended periods of time (e.g., hours). Such discomfort may result in poor patient compliance with treatment. This is especially true if the mask must be worn while sleeping.

[0034] CPAP therapy is highly effective in treating certain respiratory disorders 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.

[0035] 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.

[0036] For these reasons, patient interfaces for CPAP delivery during sleep form a distinct field.

[0037] 2.2.3.1.1 Seal formation structure The patient interface may include a seal-forming structure. Because the patient interface is in direct contact with the patient's face, the shape and configuration of the seal-forming structure may have a direct impact on the effectiveness and comfort of the patient interface.

[0038] 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 nasal bridge region of the face. In one form of the patient interface, the seal-forming structure may include an element that encloses the mouth region in use, for example by forming a seal on the lower lip region of the face. In one form of the patient interface, the seal-forming structure may include a single element that encloses both nostrils and the mouth region in use. These different types of patient interfaces may be known by various names by their manufacturers, such as nasal masks, full face masks, nasal pillows, nasal puffs, and oronasal masks.

[0039] 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.

[0040] 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.

[0041] 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.

[0042] 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 there is poor conformity between the face and the mask, additional force may be required to achieve a seal or the mask may leak. Additionally, if the shape of the seal-forming structure does not match the shape of the patient, the seal-forming portion may fold or buckle during use, causing leakage.

[0043] 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.

[0044] 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.

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

[0046] One form of nasal pillow is found in the Adam line manufactured by Puritan Bennett. Another nasal pillow or nasal puff is the subject of U.S. Patent No. 4,782,832 (Trimble et al.), assigned to the Puritan-Bennett Corporation.

[0047] ResMed Limited manufactures the following products that use nasal pillows: SWIFT® Nasal Pillows Mask, SWIFT® II Nasal Pillows Mask, SWIFT® LT Nasal Pillows Mask, SWIFT® FX Nasal Pillows Mask and MIRAGELIBERTY® Full Face Mask. 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).

[0048] 2.2.3.1.2 Positioning and stabilization 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.

[0049] In one technique, adhesives are used, see, for example, US Patent Application Publication US2010 / 0000534, but adhesives can be uncomfortable.

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

[0051] 2.2.3.2 Respiratory Pressure Therapy (RPT) Devices Respiratory pressure therapy (RPT) devices can be used individually or as part of a system to deliver one or more of the therapies described above, for example by activating the device to generate an air delivery flow to an interface to the airway. The air flow can be pressure controlled (for respiratory pressure therapy) or flow controlled (for flow therapy such as HFT). Thus, RPT devices can also function as flow therapy devices. Examples of RPT devices include CPAP devices and mechanical ventilators.

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

[0053] 2.2.3.4 Humidifier Delivery of the airflow without humidification can lead to drying of the airway. When a humidifier is used with an RPT device and patient interface, humidified gas is produced, minimizing drying of the nasal mucosa and increasing comfort of the patient airway. Additionally, in cooler climates, the addition of warm air to the facial area surrounding the patient interface generally provides more comfort than cool air. Thus, humidifiers often have the ability to humidify the airflow as well as heat it.

[0054] 2.2.3.5 Oxygen source Experts in the field have recognized that exercise for patients with respiratory failure can have long-term benefits that slow disease progression, improve quality of life, and extend the lifespan of patients. However, stationary forms of exercise, such as treadmills and stationary bicycles, can be too strenuous for these patients; therefore, the need for mobility has long been recognized. Until recently, this mobility has been facilitated through the use of small compressed oxygen tanks or cylinders mounted on trolleys. The drawbacks of these tanks are that they can only hold a limited amount of oxygen and are heavy, weighing approximately 50 pounds when loaded.

[0055] Oxygen concentrators have been used for approximately 50 years to provide oxygen for respiratory therapy. The bulk and weight of conventional oxygen concentrators make it difficult and impractical to perform normal ambulatory activities while wearing an oxygen concentrator. Recently, manufacturers of large stationary oxygen concentrators have begun to develop portable oxygen concentrators (POCs). The advantage of POCs is that they can theoretically provide an endless supply of oxygen. To make these devices small for mobility, the various systems required for oxygen-enriched gas generation have been densified. To minimize weight, size, and power consumption, POCs must use the oxygen generated as efficiently as possible. This can be accomplished by delivering oxygen as a series of pulses or "boluses," with each bolus timed to coincide with the start of inspiration. This mode of therapy is known as pulsed or demand delivery (POD) and is more suitable for stationary oxygen concentrators than traditional continuous flow delivery.

[0056] 2.2.3.6 Data Management 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.

[0057] There may be other aspects of a patient's care that would benefit from communication of treatment data to third parties or external systems.

[0058] Existing processes for communicating and managing such data can be one or more of: costly, time consuming, and error prone.

[0059] 2.2.3.7 Mandibular repositioning 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.

[0060] 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.

[0061] 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.

[0062] 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 prevent any movement of one or more of the teeth.

[0063] 2.2.3.8 Ventilation technology Some forms of treatment systems may include a vent to push out exhaled carbon dioxide, which may allow gas flow from an interior space of the patient interface (e.g., a plenum chamber) to an exterior of the patient interface (e.g., the surroundings).

[0064] 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.

[0065] 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.

[0066] Conventional mask noise table (ISO17510-2:2007, 10cmH2O pressure at 1m) [Table 1]

[0067] (*Measured one sample at 10cmH2O in CPAP mode using the test method specified in ISO3744)

[0068] The sound pressure values ​​of various objects are listed below. [Table 2]

[0069] 2.2.4 Screening, diagnostic and monitoring systems 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.

[0070] 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.

[0071] 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. [Prior art documents] [Patent documents]

[0072] [Patent Document 1] U.S. Pat. No. 4,944,310 [Patent Document 2] U.S. Patent No. 6,532,959 Summary of the Invention [Means for solving the problem]

[0073] 3. Brief description of the technology The present technology relates to the provision of medical devices for use in screening, diagnosing, monitoring, ameliorating, treating or preventing respiratory disease, which medical devices have one or more of improved comfort, cost, effectiveness, ease of use and manufacturability.

[0074] A first aspect of the present technology relates to devices for use in screening, diagnosing, monitoring, ameliorating, treating or preventing respiratory disease.

[0075] Another aspect of the present technology relates to methods for use in the screening, diagnosis, monitoring, amelioration, treatment or prevention of respiratory disorders.

[0076] One aspect of certain forms of the present technology is to provide methods and / or devices that improve patient compliance with respiratory treatment.

[0077] One form of the present technology includes a patient interface. The patient interface includes: a plenum chamber pressurizable to a therapeutic pressure of at least 6 cmH2O above ambient air pressure, said plenum chamber including a plenum chamber inlet port sized and configured to receive a flow of air at the therapeutic pressure for breathing by a patient; a first 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 mouth whereby an air flow at said therapeutic pressure is delivered to the mouth, the first seal-forming structure constructed and arranged to maintain said therapeutic pressure in the plenum chamber throughout the patient's respiratory cycle, in use; a second 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 nose whereby an air flow at said therapeutic pressure is delivered to the nose, the second seal-forming structure constructed and arranged to maintain said therapeutic pressure in the plenum chamber throughout the patient's respiratory cycle, in use; a vent structure that allows a continuous flow of gases exhaled by the patient to escape from within the plenum chamber to the environment, the vent structure being sized and shaped to maintain the therapeutic pressure within the plenum chamber in use; The patient interface further includes: The patient interface further includes a pair of supports provided on opposite sides of the interface between the second seal-forming structure and the front wall of the plenum chamber, the supports configured to resist compression in the anterior-posterior direction.

[0078] In embodiments:

[0079] a) the support portion is connected to a portion of the second seal-forming structure that, in use, seals against the patient's upper lip;

[0080] b) the support portion is connected to a portion of the second seal-forming structure that, in use, seals with the patient's upper lip directly below a lower corner of the patient's nose;

[0081] c) the support is curved when viewed in a cross section parallel to the sagittal plane;

[0082] d) the support is curved when viewed from a cross section parallel to the frontal plane;

[0083] e) the plenum chamber includes an oral section and a nasal section;

[0084] f) each support is connected to an oral portion of the plenum chamber adjacent a boundary between a lateral sidewall of the oral portion and a lateral sidewall of the nasal portion;

[0085] g) each support is connected to the oral portion of the shell adjacent a boundary between the anterior wall of the oral portion and the anterior wall of the nasal portion;

[0086] h) the lateral sidewalls of the plenum chamber are curved inwardly adjacent their interface with the nose portion, each support portion being substantially adjacent an adjacent lateral sidewall;

[0087] i) the second seal-forming structure includes at least one nasal aperture configured to deliver airflow at said therapeutic pressure to an entrance to the patient's nares, and in use no part of any support is directly under or on the respective nasal aperture;

[0088] j) the interface further includes 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;

[0089] k) the plenum chamber is at least partially defined by a shell, and the ventilation structure is provided in the shell; and / or

[0090] l) the support is connected to the second seal-forming structure and to a front wall of the plenum chamber.

[0091] Another form of the present technology includes a patient interface. The patient interface includes: a plenum chamber pressurizable to a therapeutic pressure of at least 6 cmH2O above ambient air pressure, said plenum chamber including a plenum chamber inlet port sized and configured to receive a flow of air at the therapeutic pressure for breathing by a patient; a first seal-forming structure connected to a mouth region of the plenum chamber, the first 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 mouth whereby airflow at the therapeutic pressure is delivered to the mouth, the first seal-forming structure constructed and arranged to maintain the therapeutic pressure within the plenum chamber throughout the patient's respiratory cycle, in use; a second seal-forming structure connected to a nasal region of the plenum chamber, the second 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 nose whereby an airflow at the therapeutic pressure is delivered to the nose, the second seal-forming structure constructed and arranged to maintain the therapeutic pressure within the plenum chamber throughout the patient's respiratory cycle in use; a vent structure that allows a continuous flow of gases exhaled by the patient to escape from within the plenum chamber to the environment, the vent structure being sized and shaped to maintain the therapeutic pressure within the plenum chamber in use; where: A first front wall portion of the nasal portion of the plenum chamber adjacent the boundary with the oral portion of the plenum chamber is more flexible than the area immediately adjacent the oral portion of the plenum chamber, and a second front wall portion of the nasal portion of the plenum chamber is immediately adjacent the first front wall portion and is on the opposite side of the first front wall portion to the boundary with the oral portion of the plenum chamber and is less flexible than the area immediately adjacent the front wall portion.

[0092] In the examples,

[0093] a) the first front wall is thinner than an immediately adjacent portion of the plenum chamber wall;

[0094] b) the second front wall is thicker than an immediately adjacent portion of the plenum chamber wall;

[0095] c) the first front wall portion and the second front wall portion are made of the same material;

[0096] d) the first front wall portion extends across substantially the entire width of the nose of the plenum chamber;

[0097] e) the second front wall extends across at least a majority of the width of the nose of the plenum chamber;

[0098] f) the first front wall extends in an upward direction around at least one lateral edge of the second front wall;

[0099] g) the second front wall extends across substantially the entire width of the nose of the plenum chamber;

[0100] h) a central portion of the first front wall extends further upward than a lateral portion of the first front wall;

[0101] I) the upper boundary of the first front wall is curved;

[0102] j) the lower boundary of the first front wall is curved;

[0103] k) the plenum chamber is at least partially defined by a shell, and the vent structure is provided in the shell;

[0104] l) the second anterior wall includes a band extending through the first anterior wall and is configured to extend through the plenum chamber to the patient;

[0105] m) a transition between the first and second front walls in the plenum chamber is substantially a step surface;

[0106] n) the transition between the first and second front walls outside the plenum chamber is a substantially smooth surface; and / or

[0107] o) the first front wall portion extends above at least a portion of the band in use;

[0108] Another form of the present technology includes a patient interface. The patient interface includes: a plenum chamber pressurizable to a therapeutic pressure of at least 6 cmH2O above ambient air pressure, said plenum chamber including a plenum chamber inlet port sized and configured to receive a flow of air at the therapeutic pressure for breathing by a patient; a first seal-forming structure connected to a mouth region of the plenum chamber, the first 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 mouth whereby airflow at the therapeutic pressure is delivered to the mouth, the first seal-forming structure constructed and arranged to maintain the therapeutic pressure within the plenum chamber throughout the patient's respiratory cycle, in use; a second seal-forming structure connected to a nasal region of the plenum chamber, the second 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 nose whereby an airflow at the therapeutic pressure is delivered to the nose, the second seal-forming structure constructed and arranged to maintain the therapeutic pressure within the plenum chamber throughout the patient's respiratory cycle in use; a vent structure that allows a continuous flow of gases exhaled by the patient to escape from within the plenum chamber to the environment, the vent structure being sized and shaped to maintain the therapeutic pressure within the plenum chamber in use; where: The rear surface of the lateral portion of the second seal-forming structure slopes upwardly and forwardly from the boundary of the first seal-forming structure and the second seal-forming structure.

[0109] In the examples,

[0110] a) The inclination of each side portion forms an angle of 20 degrees to 90 degrees with the central contact surface of the mask;

[0111] b) when in use, no part of the patient interface contacts the patient's nasal alar apex;

[0112] c) the interface is configured to avoid or at least reduce blockage of the patient's nares to related art interfaces; and / or

[0113] d) the plenum chamber is at least partially defined by the shell, and the vent structure is provided in the shell.

[0114] Another form of the present technology includes a patient interface. The patient interface includes: a plenum chamber pressurizable to a therapeutic pressure of at least 6 cmH2O above ambient air pressure, said plenum chamber including a plenum chamber inlet port sized and configured to receive a flow of air at the therapeutic pressure for breathing by a patient; a first seal-forming structure connected to a mouth region of the plenum chamber, the first 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 mouth whereby airflow at the therapeutic pressure is delivered to the mouth, the first seal-forming structure constructed and arranged to maintain the therapeutic pressure within the plenum chamber throughout the patient's respiratory cycle, in use; a second seal-forming structure connected to a nasal region of the plenum chamber, the second 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 nose whereby an airflow at the therapeutic pressure is delivered to the nose, the second seal-forming structure constructed and arranged to maintain the therapeutic pressure within the plenum chamber throughout the patient's respiratory cycle in use; a vent structure that allows a continuous flow of gases exhaled by the patient to escape from within the plenum chamber to the environment, the vent structure being sized and shaped to maintain the therapeutic pressure within the plenum chamber in use; where: The interface between the first seal-forming structure and the second seal-forming structure includes a ridge.

[0115] In the examples,

[0116] a) the radius of curvature of the protuberance is less than 2 mm;

[0117] b) the ridge extends substantially across an interface between the first seal-forming structure and the second seal-forming structure;

[0118] c) in use, the ridges engage the patient's face adjacent the entrance to the nostrils (where the wings meet the face above the upper lip);

[0119] d) the ridge resists wrinkling of the first seal-forming structure and / or the second seal-forming structure adjacent the ridge; and / or

[0120] e) in use, the plenum chamber is at least partially defined by the shell, and the vent structure is provided in the shell.

[0121] Another form of the present technology includes a patient interface. The patient interface includes: a plenum chamber pressurizable to a therapeutic pressure of at least 6 cmH2O above ambient air pressure, said plenum chamber including a plenum chamber inlet port sized and configured to receive a flow of air at the therapeutic pressure for breathing by a patient; a first seal-forming structure connected to a mouth region of the plenum chamber, the first 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 mouth whereby airflow at the therapeutic pressure is delivered to the mouth, the first seal-forming structure constructed and arranged to maintain the therapeutic pressure within the plenum chamber throughout the patient's respiratory cycle, in use; a second seal-forming structure connected to a nasal region of the plenum chamber, the second 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 nose whereby an airflow at the therapeutic pressure is delivered to the nose, the second seal-forming structure constructed and arranged to maintain the therapeutic pressure within the plenum chamber throughout the patient's respiratory cycle in use; a vent structure that allows a continuous flow of gases exhaled by the patient to escape from within the plenum chamber to the environment, the vent structure being sized and shaped to maintain the therapeutic pressure within the plenum chamber in use; where: At least a portion of the oral portion of the plenum chamber includes a flexible shell, the flexible shell being formed from a material having a Young's modulus of less than 0.4 GPa.

[0122] In the examples,

[0123] a) The flexible shell is formed from a material having a Young's modulus of less than 0.1 GPa (preferably 0.3 to 0.7 MPa).

[0124] b) at least one component is connected to the flexible shell, the at least one component being stiffer than a portion of the flexible shell adjacent the component;

[0125] c) at least one component including one or more of the following: a ventilation module, a headgear connector, a headgear connector connected to a stiffening arm, a stiffening member, a less flexible shell portion;

[0126] d) at least one component is releasably connectable to the flexible shell;

[0127] e) at least one component is permanently connected to the flexible shell;

[0128] f) at least one component is overmolded into the flexible shell;

[0129] g) the flexible shell includes a stiffened portion that is thicker than an immediately adjacent portion of the flexible shell;

[0130] h) at least one component is configured as a stiffening rib or band;

[0131] i) the central portion of the mouth of the plenum chamber has a higher stiffness than the remainder of the plenum chamber; and / or

[0132] j) the plenum chamber is at least partially defined by a shell, and a vent structure is provided in the shell.

[0133] Another form of the present technology includes a patient interface. The patient interface includes: a plenum chamber including a cavity pressurizable to a therapeutic pressure of at least 6 cmH2O above ambient air pressure, said plenum chamber including a plenum chamber inlet port sized and configured to receive a flow of air at the therapeutic pressure for breathing by a patient; a first 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 mouth whereby an air flow at said therapeutic pressure is delivered to the mouth, the first seal-forming structure constructed and arranged to maintain said therapeutic pressure in the plenum chamber throughout the patient's respiratory cycle, in use; a second 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 nose whereby an air flow at said therapeutic pressure is delivered to the nose, the second seal-forming structure constructed and arranged to maintain said therapeutic pressure in the plenum chamber throughout the patient's respiratory cycle, in use; a venting structure that allows a continuous flow of gases exhaled by the patient to escape from within the plenum chamber to the environment, the venting structure being sized and shaped to maintain the therapeutic pressure within the plenum chamber in use; and a positioning and stabilizing structure configured to maintain the first seal-forming structure and the second seal-forming structure in a therapeutically effective position, the positioning and stabilizing structure comprising: A frame coupled to the plenum chamber, the frame comprising: a central portion coupled to the plenum chamber exterior to the cavity; and a frame including a pair of arms extending rearwardly away from the central portion and through the second seal-forming structure, the pair of arms being more flexible than the central portion; and and a headgear strap coupled to the frame, the headgear strap configured to apply tension through the frame to the first seal-forming structure and the second seal-forming structure into the patient's face.

[0134] In the examples,

[0135] a) each arm of the pair of arms is more flexible than the frame;

[0136] b) the central portion is thicker than each of the pair of arms;

[0137] c) said central portion and each arm of said pair of arms are constructed from said same material;

[0138] d) each arm of the pair of arms includes a first connection point, the headgear straps being coupled to the first connection points of each arm;

[0139] e) the first connection points are loops, and connecting the headgear straps to the loops causes the straps to be perpendicular to the edges of each loop and imparts a force vector perpendicular to the edges from the straps;

[0140] f) the first connection point is a loop and includes an area of ​​reduced thickness, and a headgear strap may contact the area of ​​reduced thickness;

[0141] g) a first magnet is overmolded onto a central portion of said frame, said headgear strap including a second magnet removably coupled to said first magnet;

[0142] h) the first magnet includes an outer casing at least partially enclosing a magnetic material, the outer casing including a planar surface and a lip extending from the planar surface;

[0143] i) an overhang spaced from the second magnet and configured to engage the lip when the second magnet is coupled to the magnetic material;

[0144] j) the plenum chamber includes a groove, the central portion being positioned within the groove;

[0145] k) said central portion is removably positionable within said groove;

[0146] l) the groove includes a protrusion and the central portion includes a complementary slot configured to receive the protrusion;

[0147] m) the slot is tapered and includes a wider opening and a narrower opening, the protrusion being configured to be received through the wider opening prior to the narrower opening;

[0148] n) the protrusion includes an overhang extending over the slot and configured to hold the frame against the plenum chamber;

[0149] o) the plenum chamber includes a protrusion disposed adjacent the groove, the protrusion configured to retain the central portion within the groove;

[0150] p) an outer surface of the central portion is flush with an outer surface of the plenum chamber, the outer surface of the central portion and the outer surface of the plenum chamber being configured to face away from the patient in use;

[0151] q) the central portion includes an annular shape, and the plenum chamber inlet port is radially disposed within the central portion, while the frame is coupled to the plenum chamber;

[0152] r) the plenum chamber inlet port is configured to receive an elbow, the elbow configured to be received within the plenum chamber inlet port and spaced apart from the central portion;

[0153] s) each arm is formed as a cantilever structure relative to the central portion;

[0154] t) the thickness of each arm decreases as it approaches the fixed end toward the free end;

[0155] u) the arm includes a scalloped region on an inner surface configured to face the patient's skin;

[0156] v) each arm is pivotable relative to the central portion about a pivot point; and / or

[0157] w) The pivot point is a living hinge.

[0158] Another form of the present technology includes a patient interface. The patient interface includes: a plenum chamber including a cavity pressurizable to a therapeutic pressure of at least 6 cmH2O above ambient air pressure, said plenum chamber including a plenum chamber inlet port sized and configured to receive a flow of air at the therapeutic pressure for breathing by a patient; a seal-forming structure constructed and arranged to form a seal against a facial region of a patient whereby a flow of air at said therapeutic pressure is delivered to an airway, the seal-forming structure constructed and arranged to maintain said therapeutic pressure in the plenum chamber throughout the patient's respiratory cycle, in use; and a positioning and stabilizing structure configured to hold the seal-forming structure in a therapeutically effective position.

[0159] Another aspect of one form of the present technology is an oral-nasal patient interface that is more compact and less obtrusive to the patient.

[0160] Another aspect of one form of the present technology is an oral-nasal patient interface having a nasal cushion portion that allows for an improved fit against the inferior corners of the nose.

[0161] Another aspect of one form of the present technology is an oral-nasal patient interface that reduces occlusion contact on the nose.

[0162] Another aspect of one form of the present technology is an oral-nasal patient interface that can self-adjust to accommodate patients with varying nasolabial angles.

[0163] Another aspect of one form of the present technology is an oral-nasal patient interface having a relatively flexible shell.

[0164] 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.

[0165] One aspect of the present disclosure is a method for manufacturing a device.

[0166] 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.

[0167] 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).

[0168] 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.

[0169] 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).

[0170] 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.

[0171] Other features of the present technology will become apparent in light of the information contained in the following detailed description, abstract, drawings, and claims.

[0172] The present technology is illustrated by way of one non-limiting example in the accompanying drawings, in which like reference symbols include like elements: [Brief description of the drawings]

[0173] [Figure 1A] 4.1 Respiratory Treatment System: A system is shown including a patient 1000 wearing a patient interface 3000. The system takes the form of nasal pillows and receives air at positive pressure supplied by an RPT device 4000. Air from the RPT device 4000 is conditioned by a humidifier 5000 and travels along an air circuit 4170 to the patient 1000. A co-sleeper 1100 is also shown. The patient is sleeping in a supine sleep position. [Figure 1B] A system is shown including a patient 1000 wearing a patient interface 3000. The system takes the form of a nasal mask and receives air at positive pressure supplied by 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. [Figure 1C] The system includes a patient 1000 wearing a patient interface 3000. The patient interface 3000 takes the form of a full face mask and receives a positive pressure air supply from an RPT device 4000. Air from the RPT device is humidified by a humidifier 5000 and travels along an air circuit 4170 to the patient 1000. The patient is sleeping in a lateral sleep position. 4.2 Respiratory System and Facial Anatomy [Figure 2A]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] FIG. 1 is a front view of a face including several features of the surface anatomy including upper lip, upper lip vermilion, lower lip vermilion, lower lip, mouth width, medial canthus, alae of the nose, nasolabial folds, and corners of the mouth. The directions of superior, inferior, radially inward, and radially outward are also given. [Figure 2D] FIG. 1 is 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. The directions of superior and inferior, and anterior and posterior are also given. [Figure 2E] FIG. 1 is a further lateral view of the head, with the approximate locations of the Frankfort horizontal and nasolabial angle noted. The frontal 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 septal 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 with the outline of the head surface and some muscles. The following bones are shown: frontal, sphenoid, nasal, zygomatic, maxilla, mandible, parietal, temporal and occipital. The mental protuberance is shown. The following muscles are shown: digastric, masseter, sternocleidomastoid and trapezius. [Figure 2L] Shown is the anterolateral aspect of the nose. 4.3 Patient Interface [Figure 3A] 1 shows a patient interface in the form of a nasal mask in accordance with one form of the present technology. [Figure 3B] 3C is a schematic cross-sectional view of the structure cut at a point, with the outward normal at this point shown, and the curvature at this point having a positive sign and a relatively large magnitude compared to the magnitude of curvature shown in 3C. [Figure 3C] 3B is a schematic cross-sectional view of the structure cut at a point, with the outward normal at this point shown, and the curvature at this point having a positive sign and a relatively small magnitude compared to the magnitude of the curvature shown in FIG. [Figure 3D] 1 is a schematic cross-sectional view of a structure cut at a point, where the outward normal is shown and the curvature value at this point is zero. [Figure 3E] 3C is a schematic cross-sectional view of the structure cut at a point, where the outward normal is shown, and the curvature at this point has a negative sign and a relatively small magnitude compared to the magnitude of curvature shown in FIG. [Figure 3F] 3C is a schematic cross-sectional view of the structure cut at a point, where the outward normal is shown, and the curvature at this point has a negative sign and a relatively large magnitude compared to the magnitude of curvature shown in FIG. [Figure 3G] 1 shows a mask cushion including two pillows, the outer surface of the cushion is shown, the edge of the surface is shown, and the dome region and 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 a structure is shown, with a one-dimensional hole drilled into it. The planar curves shown form the boundary of the one-dimensional hole. [Figure 3J] FIGURE 3D is a cross-sectional view through the structure of Figure 3I.The surfaces shown bound a two-dimensional hole in the structure of Figure 3I. [Figure 3K] 3I includes a two-dimensional hole and a one-dimensional hole, and the surfaces bounding the two-dimensional hole in the structure of FIG. [Figure 3L] 1 shows a mask with an inflatable bladder as a cushion. [Figure 3M] 3L is a cross-sectional view of the mask of FIG. 3L showing the inner surface of the bladder, which bounds the two-dimensional hole in the mask. [Figure 3N] 3D shows a further cross section through the mask of FIG. 3L, with the interior surface also shown. [Figure 3O] Demonstrates the left hand rule. [Figure 3P] Demonstrates the right-hand rule. [Figure 3Q] 1 shows the left ear including the left ear helix. [Figure 3R] 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 Figure 3U. Directions in the figure are perpendicular to the central contact plane. In Figure 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, the cross-section being taken in the mid-sagittal plane shown in FIG. 3V. The "central contact" plane is illustrated. The central contact plane is perpendicular to the mid-sagittal plane. The orientation of the central contact plane corresponds to the orientation of the tendon 3210. The tendon 3210 rests on the mid-sagittal plane and contacts the cushion of the plenum chamber only at two points on the mid-sagittal plane (i.e., upper point 3220 and lower point 3230). Depending on the geometry of the cushion in this region, the central contact plane may contact both the upper and lower points. In the case of an oral-nasal interface configured with a plenum chamber having separate oral and nasal portions, for example an ultra compact full face (UCFF) mask, the upper and lower points are provided on the seal-forming structure of the oral portion of the mask. [Figure 3X] The plenum chamber 3200 of FIG. 3U is shown in a use position on the face. The mid-sagittal plane of the plenum chamber 3200 generally coincides with the mid-sagittal plane of the face when the plenum chamber is in the use position. The central contact plane generally corresponds to the "face of the face" 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 cerion and the lower point 3230 resting on the upper lip. 4.4 RPT Device [Figure 4A] 1 shows an RPT device in accordance with one form of the present technology. [Figure 4B] FIG. 4 is a schematic diagram of an air circuit of an RPT device in accordance with one form of the present technology. Upstream and downstream directions are indicated 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 disposed in the pneumatic path between the blower and the patient interface are downstream of the blower and upstream of the patient interface. 4.5 Humidifier [Figure 5A] FIG. 1 shows an isometric view of a humidifier in accordance with one form of the present technology. [Figure 5B]5 shows 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. 4.6 Breath Waveforms [Figure 6] A model of a typical human respiratory waveform during sleep is shown. 4.7 Example of a patient interface for this technology [Figure 7] FIG. 13 is a rear perspective view of a plenum chamber, inlet ports not shown, in accordance with one form of the present technology. [Figure 8] FIG. 8 is a rear view of the plenum chamber of FIG. [Figure 9] FIG. 8 is a front view of the plenum chamber of FIG. [Figure 10] FIG. 8 is a side view of the plenum chamber of FIG. [Figure 11] FIG. 8 is a top view of the plenum chamber of FIG. [Figure 12] 12 is a cross-section of the plenum chamber through the plane 12-12. [Figure 13] FIG. 8 is a bottom view of the plenum chamber of FIG. [Figure 14] 14 is a cross-section of the plenum chamber through the plane 14-14. [Figure 15] 15 is a cross-section of the plenum chamber through the plane 15-15. [Figure 16] 16 is a cross-section of the plenum chamber through the plane 16-16. [Figure 16-1] 1 is a cross section of the plenum chamber through the plane 16-1-16-1. [Figure 16-2] FIG. 16-2 is a cross-sectional view of the plenum chamber of FIG. 16-1, illustrating the plenum chamber in a deformed position. [Figure 17] 17 is a cross-section of the plenum chamber through plane 17-17. [Figure 18] 18 is a cross-section of the plenum chamber through the plane 18-18. [Figure 18-1] A cross section of the plenum chamber through the plane 18-1-18-1. [Figure 18-2] A cross section of the plenum chamber through the plane 18-2-18-2. [Figure 19] FIG. 2 is a side view of the plenum chamber in an in-use position on a patient's face, with the contours of the plenum chamber shown for clarity. [Figure 20] 13 illustrates specific areas of engagement with the patient's face by the seal-forming structures described. [Figure 21] 13 is a front perspective view of another form of a patient interface in accordance with the present technology. [Figure 21-1] 13 is a front perspective view of another form of a patient interface in accordance with the present technology. [Figure 22] FIG. 13 is a front perspective view of a patient interface in accordance with yet another form of the present technology, with the vent removed. [Diagram 23] FIG. 13 is a front perspective view of a patient interface having a frame connecting headgear straps to a plenum chamber. [Figure 24] FIG. 24 is an exploded view of the patient interface of FIG. [Diagram 25] FIG. 13 is a front view of a frame and plenum chamber in accordance with one form of the present technology. [Figure 26] FIG. 13 is a front view of a frame and plenum chamber in accordance with another form of the present technology. [Figure 26-1] FIG. 27 is a side perspective view of the frame and plenum chamber of FIG. [Figure 26-2] A cross-sectional view of the frame and plenum chamber of Figure 26-1 taken along section 26-26. [Figure 26-3] FIG. 27 is a top view of the frame and plenum chamber of FIG. [Figure 26-4] FIG. 27 is a perspective view of the frame and plenum chamber of FIG. 26 showing the arms of the frame movable between a first position and a second position. [Figure 26-5] FIG. 26-5 is a rear perspective view of the frame and plenum chamber of FIG. 26-4, showing bending of the plenum chamber in a second position. [Figure 27] FIG. 27 is a rear view of the frame of FIG. 26, showing the tapered opening. [Figure 27-1]FIG. 27 is a top perspective view of the frame of FIG. 26, illustrating a reduction in the thickness of the arms of the frame. [Figure 27-2] FIG. 27 is a perspective view of the frame of FIG. 26, showing the loops on the free ends of the frame. [Figure 28] FIG. 13 is a front view of a frame and plenum chamber in accordance with another form of the present technology. [Figure 28-1] FIG. 13 is a perspective view of a secondary connection point with a frame in accordance with one form of the present technology. [Figure 28-2] FIG. 28-1 is a cross-sectional view of the frame and plenum chamber of FIG. 28-1 showing the connection between the magnet and the secondary connection point of FIG. 28-1. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0174] 5 Detailed Description of Technical Examples 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.

[0175] 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.

[0176] Although anatomical directional terms are used in describing aspects and examples of the technology (e.g., "anterior," "posterior," "superior," etc.), these directions are to be read in the context of the technology as it is used 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.

[0177] 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.

[0178] 5.1 Treatment In one form, the present technology includes a method of treating a respiratory disorder, the method including applying positive pressure to the entrance of the airways of a patient 1000.

[0179] In a particular embodiment of the present technology, a supply of air at positive pressure is provided to the patient's nasal passages via one or both nostrils.

[0180] In certain embodiments of the present technology, mouth breathing is restricted, limited or prevented.

[0181] 5.2 Respiratory Treatment Systems In one form, the present technology includes a respiratory treatment system for the treatment of respiratory disorders. The respiratory treatment system may include an RPT device 4000 that provides an air flow to a patient 1000 via an air circuit 4170 and a patient interface 3000.

[0182] 5.3 Patient Interface A non-invasive patient interface 3000 according to one aspect of the present technology includes the following functionalities: a seal-forming structure 3100, a plenum chamber 3200, a positioning and stabilizing structure 3300, a vent 3400, a form of connection port 3600 for connection to an air circuit 4170, and a forehead support 3700. In some forms, the 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 1000 airway to maintain positive pressure at the entrance(s) to the airway. Thus, the sealed patient interface 3000 is suitable for delivery of positive pressure therapy.

[0183] In some examples of the present technology, the plenum chamber is at least partially formed by the shell 3250. In examples, the shell 3250 or a portion of the shell 3250 can have a degree of flexibility, as described further below.

[0184] In some examples of the present technology, the patient interface is an oral-nasal patient interface that is configured to seal around both the patient's nasal and oral airways, hi some examples, the patient interface includes separate seals around each of the nasal and oral airways.

[0185] In the examples shown in Figures 7-22, the seal-forming structure in the nasal region seals against the underside of the patient's nose, rather than being positioned over the nasal bridge or ridge area of ​​the patient's face.

[0186] 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.

[0187] 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.

[0188] A patient interface 3000 in accordance with one form of the present technology is constructed and arranged to provide an air supply at a positive pressure of at least 10 cmH2O relative to ambient.

[0189] A patient interface 3000 in accordance with one form of the present technology is constructed and arranged to provide an air supply at a positive pressure of at least 20 cmH2O relative to ambient.

[0190] 5.3.1 Seal formation structure In one form of the present technology, the seal-forming structure 3100 provides a target seal-forming area and may further provide a cushioning function. The target seal-forming area is the area where a seal may occur in the seal-forming structure 3100. The area where a seal actually occurs (i.e., the actual sealing surface) may vary from patient to patient in a given treatment session 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).

[0191] As described in more detail below, in certain forms of the invention, the seal-forming structure 3100 includes a first seal-forming structure 3101 and a second seal-forming structure 3102. The first seal-forming structure 3101 is connected to an oral portion 3201 of the plenum chamber and is constructed and arranged to form a seal with an area of ​​the patient's face surrounding an entrance to the patient's mouth. The second seal-forming structure 3102 is connected to a nasal portion 3202 of the plenum chamber 3200 that is constructed and arranged to form a seal with an area of ​​the patient's face surrounding an entrance to the patient's nose. As used herein, the term "connected" refers to portions or components formed as a single piece as well as portions or components that are formed separately and then joined together. In some cases, the components may be connected by an intermediate component.

[0192] In certain configurations, the first seal-forming structure 3101 independently seals to the patient's face rather than the second seal-forming structure 3102 .

[0193] In certain configurations, the first seal-forming structure 3101 and the second seal-forming structure 3102 cooperate to form a single common seal against the patient's face.

[0194] In one form, the target seal-forming area is located on an exterior surface of the seal-forming structure 3100 .

[0195] In certain forms of the present technology, the seal-forming structure 3100 is constructed from a biocompatible material (eg, silicone rubber).

[0196] A seal-forming structure 3100 in accordance with the present technology may be constructed from a material that is soft, flexible and resilient (eg, silicone).

[0197] 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.

[0198] 5.3.1.1 Sealing mechanism In one form, the seal-forming structure 3100 includes a sealing flange that employs a pressure-assisted sealing mechanism. In use, the sealing flange can readily respond to positive system pressure within the plenum chamber 3200 to act 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.

[0199] 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). The member 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. Limiting the onset of buckling may limit wrinkling in the seal-forming structure 3100, which may lead to leakage and loss of therapeutic pressure.

[0200] In one form, the seal-forming structure 3100 may include a compression sealing portion or a gasket sealing portion 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.

[0201] In one form, the seal-forming structure 3100 includes a tension section. In use, the tension section is held taut, for example, by an adjacent region of a sealing flange.

[0202] In one form, the seal-forming structure 3100 includes an area having a sticky or adhesive surface.

[0203] In certain forms of the present technology, the seal-forming structure 3100 may include one or more of a pressure assisted sealing flange, a compression sealing portion, a gasket sealing portion, a tension portion, and a portion having an adhesive or bonding surface.

[0204] 5.3.1.2 Nasal area 7-18, in some forms of the present technology, the second seal-forming structure 3102 includes a central portion 3110 configured to seal against a surface of the patient's nose in use. 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, a portion of the seal-forming structure may engage with the patient's septum. The second seal-forming structure 3102 may further include lateral portions 3111 on lateral sides of the central portion 3110. In examples, the seal-forming structure 3102 may be configured to contact the patient's face under the bridge of the nose or under the tip of the nose.

[0205] As can be seen from Figures 10 and 16 to 19, the rear surface 3112 of the side portion 3111 slopes forward in an upward-forward direction from the boundary 3103 between the first seal-forming structure 3101 and the second seal-forming structure 3102, causing the rear contour of the nose portion of the mask to slope forward.

[0206] In embodiments using ridges 3120 (as described further below), the rear faces 3112 of the side portions 3111 may slope forwardly from the ridges 3120.

[0207] In some forms of the present technology, the rear surfaces 3112 of the lateral portions 3111 form an angle of 20° to 90° with the central contact plane of the mask. The central contact plane may be perpendicular to the sagittal plane and may extend substantially along the length of the ridges 3120 and the chords 3210.

[0208] As shown in FIG. 19, in some embodiments, the lateral portions 3111 are configured such that no part of the patient interface 3000 contacts the patient's alar apex point 1020 during use.

[0209] Sloping the side portions 3111 in this manner allows a smaller portion of the nose portion of the interface 3000 to extend over the sides of the wings (than some similar interfaces of the related art). As a result, in some forms of the present technology, the portion of the wings that contacts the seal-forming structure 3100 is reduced relative to interfaces with sides that slope back towards the patient's face, and there is a corresponding reduction in the amount of wings that can deform and occlude due to the seal-forming structure 3100 (e.g., when the patient is sleeping on their side with the interface in contact with a pillow).

[0210] 5.3.1.3 Mouth and nose region boundaries 7, 8, and 16-18, in one form of the present technology, the interface between the first seal-forming structure 3101 and the second seal-forming structure 3102 forms or includes a corner or ridge 3120. In use, the corner or ridge 3120 may engage the patient's face above the upper lip and just below the nose.

[0211] In embodiments, the corner or ridge 3120 forms a sharper angle than comparable portions or regions of some oral-nasal masks of the related art (e.g., those described in PCT Application No. PCT / AU2019 / 050278).

[0212] Such sharper angles reduce the likelihood of wrinkles forming on or in the first seal-forming structure 3101 and / or second seal-forming structure 3102 adjacent to the corners or ridges 3120 when the mask is worn and treatment is applied. Some oral-nasal patient interfaces that do not use such structures may require the formation of very thin circular shapes in this area (which may be less crease-resistant). In contrast, the corners or ridges 3120 may be stiffer and may hold their shape better than such interfaces, and therefore may better seal against recesses and wrinkles present around the patient's nose. This effect may be enhanced in embodiments with supports (e.g., supports 3260 described herein) that resist or resist compression in this area.

[0213] In some forms of the present technology, the radius of the corners or ridges 3120 may be less than 2 mm (e.g., about 1.75 mm). In one form of the present technology, the radius may vary from approximately 1.75 mm at the center of the ridge to approximately 0.75 mm at the sides.

[0214] The angle formed by the first sealing structure and the second sealing structure can be between 20 degrees and 90 degrees (eg, 36 degrees).

[0215] In some forms of the present technology, the corner or ridge 3120 may extend substantially across the entire boundary 3103 between the first seal-forming structure 3101 and the second seal-forming structure 3102. In embodiments, the corner or ridge 3120 may engage the patient's face at least near the entrance to the nostril (e.g., where the ala meets the face above the upper lip) as shown by region 1010 in FIG.

[0216] 5.3.1.4 Mouth area As such, in one form the non-invasive patient interface 3000 includes a first seal-forming structure 3101. The first seal-forming structure 6101 forms a seal around the patient's mouth in use. The first seal-forming structure 3101 may form a seal over the chin area of ​​the patient's face.

[0217] In one form, the seal-forming structure includes a saddle region constructed to form a seal over the chin region of the patient's face in use.

[0218] The seal-forming structure 3100 includes a lower lip portion 3130. The lower lip portion 3130 forms a seal against the patient's jaw area and / or the patient's lower lip and / or chin. As shown in FIG. 16 , the lower lip portion 3130 may be connected to (e.g., adjacent to) an upper lip portion 3131 via a perioral portion 3132.

[0219] The seal-forming structure 3100 has a relatively small wall thickness (e.g., less than 0.7 mm) (compared to other areas of the interface) disposed relative to the perioral portion 3132, the lower lip portion 3130 of the seal-forming structure disposed relative to the chin area, and at least the center of the lower lip portion 3130. The reduced wall thickness in these locations assists in achieving an effective and comfortable seal. The seal-forming structure in these regions can easily conform to any complex geometry.

[0220] In some forms of the present technology, the oral cavity 3133 is substantially trapezoidal, rather than oval or elliptical, to more closely correspond to the shape of the patient's nose. Having the oral cavity in such a shape may allow the interface 3000 to be particularly compact and not substantially wider than the patient's nostril width.

[0221] 5.3.1.5 Nasal pillow In one form, the seal-forming structure of the non-invasive patient interface 3000 includes a pair of nasal puffs or nasal pillows, each constructed and arranged to form a seal with a respective nostril of the patient's nose.

[0222] 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.

[0223] 5.3.2 Plenum chamber In some forms, the plenum chamber 3200 (or at least a portion of the plenum chamber 3200) and the seal-forming structure 3100 are formed from a single homogenous piece of material (e.g., molded silicone). The combination of the seal-forming structure 3100 and the plenum chamber 3200 may be considered a cushion.

[0224] 5.3.2.1 Nose angle adjustability 9, 10 and 16-18-2, in one form of the present technology, the first anterior wall 3240 of the nasal portion 3202 of the plenum chamber 3200 is more flexible than the immediately adjacent region of the oral portion 3201. The first anterior wall 3240 may be provided adjacent the boundary 3241 of the nasal and oral portions of the plenum chamber 3200. In embodiments, the first anterior wall 3240 may be symmetrical about a midsagittal plane and may extend across at least 50% (e.g., at least 80%) of the width of the nasal portion 3202 of the plenum chamber. In some embodiments, the first anterior wall 3240 may extend across substantially the entire width of the nasal portion 3202 of the plenum chamber.

[0225] In some forms of the present technology, the second anterior wall 3242 is less flexible than the immediately adjacent anterior wall. In some embodiments, the second anterior wall 3242 is immediately adjacent the first anterior wall 3240 opposite the boundary 3241 of the nasal and oral portions of the plenum chamber. In embodiments, the second anterior wall 3242 may be symmetrical about the midsagittal plane and may extend across at least 50% (e.g., at least 80%) of the width of the nasal portion 3202 of the plenum chamber. In some embodiments, the second anterior wall 3242 may extend across substantially the entire width of the nasal portion 3202 of the plenum chamber.

[0226] The flexible first anterior wall 3240 may allow the patient contacting portion 3110 of the second seal-forming structure 3102 to pivot or hinge about the posterior region of the interface 3000. This may help allow the interface to accommodate patients having a variety of angles between the lower nose and upper lip (i.e., nasolabial angles).

[0227] In embodiments where a corner or ridge 3120 is provided between the first seal-forming structure 3101 and the second seal-forming structure 3102, such as those described above, the patient contacting portion 3110 may pivot or move squarely around the corner or ridge 3120 or an area nearby.

[0228] As shown in FIG. 9, the first anterior wall 3240 may have an upper boundary 3243 and a lower boundary 3244. One or both of the upper boundary 3243 and the lower boundary 3244 may be curved, for example, with a center of the boundary below the lateral portions as shown. The first anterior wall 3240 may be of substantially the same height across its width (i.e., the upper and lower boundaries may be substantially parallel), or the height may vary across its width, for example, with the height of the center of the first anterior wall 3240 being greater than the height of the lateral portions as shown in the embodiment in FIG. 9. As the curvature of one or both of the boundaries 3243 and 3244 and / or height of the first anterior wall 3240 changes, the stiffness of the first anterior wall 3240 (i.e., resistance to buckling or folding in response to a force on the patient contacting portion 3110 of the second seal-forming structure 3102) may also change.

[0229] Similarly, the second front wall 3242 may have an upper boundary 3247 and a lower boundary 3248. In some forms of the present technology, the lower boundary 3248 of the second front wall 3242 is the same as the upper boundary 3243 of the first front wall 3240. The upper boundary 3247 and the lower boundary 3248 of the second front wall 3242 may both be curved, such that, for example, the center of the boundary is located below the lateral portions. The second front wall 3242 may be of substantially the same height across its width (i.e., the upper and lower boundaries may be substantially parallel) or may vary in height across its width, such that, for example, the height of the center of the second front wall 3242 is less than the height of the lateral portions.

[0230] In some forms of the present technology, other construction methods for providing the first front wall 3240 with the required stiffness may be used in addition to or instead of a curved boundary. For example, the thickness of the first front wall 3240 may be selected to provide the required stiffness. In an example, the first front wall 3240 may be thinner than the immediately adjacent portions of the plenum chamber wall. Additionally and / or alternatively, the first front wall 3240 may extend upwardly around the lateral edges of the second front wall 3242 as shown in FIG. 21, thereby reducing stiffness / resistance to compression or buckling compared to embodiments in which the first front wall 3240 is not so shaped.

[0231] The second anterior wall 3242 (e.g., band 3270) may help prevent buckling of the nose portion 3202 and may provide support for the patient-contacting portion 3110 of the second seal-forming structure 3102 (which is typically relatively thin). Insufficient support of the patient-contacting portion may lead to rupture of the sealing engagement with the patient's face. In one form, the second anterior wall 3242 is thicker than the immediately adjacent portions of the plenum chamber wall. In certain forms, the second anterior wall 3242 is provided as a band of thick material 3270 as shown in FIGS. 16-19. The first anterior wall 3240 and the second anterior wall 3242 may be constructed from the same material (e.g., as part of an integrally formed shell 3250).

[0232] In some forms, the first anterior wall 3240 and the second anterior wall 3242 may include different thicknesses. For example, the thickness of the second anterior wall 3242 may be greater than the thickness of the first anterior wall 3240, which may lead to increased stiffness of the second anterior wall 3242 (e.g., as compared to the first anterior wall 3240). In particular, the second anterior wall 3242 may be a band 3270 and may extend into a cavity 3272 of the plenum chamber 3200. For example, the band 3270 may extend through the first anterior wall 3240 and toward a patient wearing the patient interface 3000. The exterior surface of the nose portion 3202 may be substantially smooth, and the interior surface of the nose portion (e.g., within the cavity 3272) may be stepped (or may include discontinuities).

[0233] As shown in FIGS. 16-1 and 16-2, the first anterior wall 3240 may act as a hinge and allow bending of the nasal portion 3202. The first anterior wall 3240 may be the thinnest area of ​​the nasal portion 3202 and therefore may be most susceptible to bending moments. This increased thickness of the band 3270 directs bending moments away from the second anterior wall 3242 and toward the thinner first anterior wall 3240. The increased height of the band 3270 (i.e., increasing the distance between the upper boundary 3247 and the lower boundary 3248) may also stiffen the nasal portion 3202 and allow for restrained bending around the first anterior wall 3240. The first anterior wall 3240 and the second anterior wall 3242 may move in an anterior direction (e.g., away from the patient) as bending occurs.

[0234] As shown in FIGS. 18-1 and 18-2, the upper boundary 3243 of the first anterior wall 3240 is not the same as the lower boundary 3248 of the second anterior wall 3242. Instead, the upper boundary 3243 may be at least partially higher than the lower boundary 3248 and at least partially aligned with the upper boundary 3247 of the second anterior wall 3242. This allows the first anterior wall 3240 to be at least partially disposed along the band 3270 (e.g., to surround the band 3270 on two or more sides). In other words, the first anterior wall 3240 may be disposed on at least one of the ends of the band 3270. This may lead to increased flexibility of the first anterior wall 3240, allowing further bending of the nose portion 3202 (e.g., in the forward direction).

[0235] 21-1, the nasal portion 3202 may be formed without a hinge. In other words, a band may not be formed on the second anterior wall portion 3242, which results in a substantially uniform thickness of the first anterior wall portion 3240 and the second anterior wall portion 3242. Because the nasal portion 3202 may be made of silicone, it may be bendable without a band, which provides some compliance in the nasal portion 3202 to accommodate different nasolabial angles.

[0236] 5.3.2.2 Flexible shell In some forms of the present technology, the shell 3250 may be made of a rigid material such as polycarbonate. However, in other forms of the present technology, the shell 3250 or portions of the shell 3250 may have a degree of flexibility. For example, in examples, the shell 3250 may be formed of a material having a Young's modulus of 0.4 GPa or less (e.g., foam or other form). In some forms of the present technology, the shell 3250 may be made of a material having a Young's modulus of 0.1 GPa or less (e.g., rubber). In other forms of the present technology, the shell 3250 may be made of a material having a Young's modulus of 0.7 MPa or less (e.g., 0.7 MPa to 0.3 MPa). One example of such a material is silicone.

[0237] In examples, the shell 3250 and one or both of the first seal-forming structure 3101 and the second seal-forming structure 3102 may be formed from the same material (eg, silicone, fabric, etc.).

[0238] In some forms of the present technology (see, e.g., Figs. 23-28-2), the shell 3250 may be constructed substantially entirely from a flexible material, which may maximize the freedom of movement of the shell 3250 (i.e., substantially no stiffness that restricts bending and / or substantially no thickened sections). The shell 3250 may be sufficiently flexible that one or more components are added to provide the necessary stiffness in one or more areas or regions of the shell 3250 (e.g., in the area in contact with region 1010). For example, one or more of a ventilation module, a connection port, a headgear connector, a stiffening arm, and a headgear connector connected to a stiffening member may be connected to the shell 3250 to increase the stiffness of the plenum chamber 3200 in the area adjacent the component, e.g., as further described below. In some forms of the present technology, such components may be releasably connectable to the flexible shell 3250. Additionally or alternatively, one or more components may be permanently connected to the shell 3250, for example by gluing and / or overmolding. The stiffening members may also perform the function of increasing stiffness and / or shape support for the seal-forming structure 3100.

[0239] In some forms of the present technology, the shell 3250 may be generally flexible, but may include stiffening sections that are thicker than immediately adjacent portions of the shell 3250. Such stiffening sections may be configured as ribs or bands, for example extending laterally and / or vertically across the shell, although numerous other configurations are possible. In some forms, the shell may include substantially rigid sections, for example made from polycarbonate, and sections that have some flexibility.

[0240] In some forms of the present technology, it may be advantageous to have a front central portion 3251 of the oral portion 3201 of the plenum chamber be more rigid than the remainder of the plenum chamber 3200. In some forms of the present technology, the region of higher rigidity may be located just below the nasal portion 3202 as shown in FIG. 21 and described further below, and / or just above the oral portion 3201. In one form of the present technology, part or all of the first front wall portion 3240 may be a region of higher rigidity rather than a region of higher flexibility. By providing higher rigidity in one or more of these regions, shape stability may be achieved and the extent to which the shell 3250 may deform due to headgear forces may be limited. If excessive deformation occurs, it may lead to the second seal-forming structure 3102 occluding the nares. Avoiding such deformation may be particularly advantageous for patients with relatively wide noses, and may be less important or even undesirable for patients with narrow noses. Additionally, the described regions of higher stiffness may help reduce twisting of the interface, which may result in loss of contact between one side of the second seal-forming structure 3102 and the patient's nose, resulting in a leak path.

[0241] As shown in FIG. 21 and FIG. 21-1, in one form of the present technology, the shell 3250 may be provided with a rigid portion 3263, or at least a portion of the shell 3250 may be provided with one or more connection ports 3600 (e.g., molded) to provide greater rigidity than the remainder of the shell. In one form of the present technology, the rigid portion 3263 may be made of polycarbonate. This may provide greater rigidity than a shell constructed solely of silicone. In one form of the present technology, the holes forming the vent 3400 are molded into the rigid portion 3263. In some forms of the present technology, the connector 3310 for the positioning and stabilizing structure is mounted on an arm 3320 that provides a certain rigidity to the shell.

[0242] In one form of the present technology, the rigid section 3263 extends laterally across the front of the plenum chamber adjacent the upper boundary of the first front wall portion 3240 (e.g., just below the second front wall portion 3242). The rigid section 3263 may extend continuously between the connection ports 3600 and may provide an air flow path to allow a flow of pressurized air to enter the plenum chamber 3200 through the connection ports 3600.

[0243] In some forms of the present technology, the connection ports 3600 may have a substantially oval cross-section. The connection ports 3600 may be oriented such that the centerline of each port is substantially parallel to the outer surface of the plenum chamber adjacent the port.

[0244] In some forms of the present technology, the rigid portion 3263 may project forwardly relative to an adjacent surface of the first front wall portion 3240 and may be shaped to enhance bending resistance.

[0245] In some forms of the present technology (see, for example, FIG. 21 ), the connector 3310 and arm 3320 are provided to a lateral edge of the plenum chamber 3200 below the connection port 3600. The connector 3310 may be provided at a lateral end of the arm 3320. The connector 3310 may provide additional rigidity to the plenum chamber 3200 and / or the seal-forming structure 3100.

[0246] In some forms of the present technology (see, for example, FIG. 21-1), the connector 3310 does not include the arm 3320 and is connected directly to the plenum chamber 3200. This can make the plenum chamber 3200 more flexible than the plenum chamber 3200 of FIG.

[0247] 22 shows a plenum chamber 3200 including a vent mounting aperture 3410 into which a suitable vent or module may be inserted. To increase the stiffness of the plenum chamber, the vent may be constructed from a relatively stiff material. In some forms of the present technology, the vent mounting aperture 3410 may be substantially oval in shape, with the minor axis of the oval being substantially parallel to the sagittal plane.

[0248] In the embodiment shown in FIG. 22, the vent mounting aperture is provided into the upper boundary of the mouth area 3201 of the plenum chamber 3200.

[0249] 22, a connector 3310 for positioning and stabilizing structure is provided. The connector 3310 may be mounted within a relatively thicker region of the shell 3250. In the embodiment shown, the connector 3310 is provided to the lateral side of the plenum chamber 3200 below the vent mounting aperture 3410. In some forms of the present technology, the connector 3310 is a substantially circular magnetic head gear connector.

[0250] Although no inlet or connection ports are shown in the drawings of the plenum chamber shown in Figures 7-19, one skilled in the art would understand that in practice one or more inlet ports would be provided (e.g., inlet port 3600 as shown in Figures 21 and 22). The inlet port 3600 allows connection of the interface to an air circuit 4170, as described further herein. In some forms of the present technology, one or more components of the air circuit 4170 may also function as components of a positioning and stabilizing structure.

[0251] In certain forms of the present technology, the plenum chamber 3200 is constructed from a transparent material (e.g., clear polycarbonate). The use of a transparent material may reduce the intrusiveness of the patient interface and aid in improved compliance with treatment. The use of a transparent material may aid the clinician in seeing the placement and function of the patient interface.

[0252] In certain forms of the present technology, the plenum chamber 3200 is constructed from a translucent material, such as translucent silicone. The use of a translucent material can make the patient interface less intrusive and can help improve compliance with treatment.

[0253] In certain forms of the present technology, dedicated stiffening or rigidifying members (e.g., without any other function) may be provided on the plenum chamber 3200. These members may be made of a material that is stiffer than the plenum chamber 3200 (e.g., stiffer than silicone). By overmolding the dedicated stiffening members onto the plenum chamber 3200, they provide stiffness greater than the rigid portion 3263 of the shell 3250 or the arm 3320.

[0254] 5.3.3 Support area 12 and 14-18, in one form of the present technology supports 3260 are provided on opposite sides of the interface 3000 between the second seal-forming structure 3102 and the front wall of the plenum chamber 3200. As shown in FIG 12, in an example, each support 3260 extends to a lateral edge of the interface.

[0255] The support portion 3260 is configured to resist or resist compression in the anterior-posterior direction rather than functioning as an undercushion. In this way, the support portion 3260 supports and / or stiffens the second seal-forming structure 3102 at a portion that engages the patient's upper lip. In particular, the support portion 3260 may support and / or stiffen an area of ​​the second seal-forming structure 3102 that may contact an area 1010 of the patient's face near the entrance to the nostrils (where the ala meets the area above the upper lip), as shown in FIG. 20. In other words, the area 1010 may be located directly below each of the lower corners of the patient's nose.

[0256] These supports 3260 help ensure that the seal-forming structure 3100 does not wrinkle. Wrinkles in the seal-forming structure may occur due to the seal-forming structure being very flexible and having a large radius of curvature to conform to the patient's face. If the seal-forming structure is too flexible, it may fold over itself or wrinkle, resulting in leakage in the seal-forming structure. Wrinkles may be of particular concern when the seal-forming structure is sealed against the area 1010 of the patient's face. The supports 3260 may be particularly advantageous when the seal-forming structure is configured to create corners and / or ridges 3120 as described herein. The corners and / or ridges 3120 may have sharper curves (e.g., smaller radii of curvature) compared to a seal-forming structure without the supports 3260. The added support and / or stiffness provided by the support 3260 reduces the ability of the second seal-forming structure 3102 to conform to the patient's face. To maintain patient comfort, the corners and / or ridges 3120 are selected and / or sized to substantially match the geometry (e.g., contour) of the patient's face. For example, the seal-forming structure 3100 for a particular patient may be selected from a variety of sizes to substantially fit the alar region (i.e., adjacent region 1010). Such sharper curvatures allow the second seal-forming structure 3102 to seal against a variety of gaps around the patient's nose, reducing the likelihood of wrinkle formation.

[0257] As can be seen particularly in Figs. 14-16, in one form of the present technology, the support 3260 is connected to the anterior side of the oral portion 3201 of the plenum chamber adjacent the interface 3241 of the oral and nasal portions 3201 and 3202. In some embodiments, the support 3260 may be curved when viewed in a cross section parallel to the sagittal plane (as shown in Figs. 16-18) and / or may be curved when viewed in a cross section parallel to the frontal plane (as shown in Figs. 14 and 15). The curvature may be positive or negative. In the illustrated example, the curvature may be negative (e.g., relative to the patient's nose). In some examples, the lateral sidewalls 3245 of the plenum chamber 3200 may be curved inwardly adjacent the interface 3241 with the nasal portion 3202, and the support 3260 may be substantially adjacent the adjacent lateral sidewalls 3245. As shown in FIG. 18, when viewed in a cross section parallel to the sagittal plane, at least a portion of the support 3260 may be thinned in thickness between a first end 3261 adjacent the front wall of the plenum chamber 3200 and a second end 3262 adjacent the seal-forming structure 3100. For example, the support 3260 may be thicker near the first end 3261 to help provide increased support and / or stiffness to the second seal-forming structure 3102. In some examples, the support 3260 may vary between a thickness of 0.1 mm (e.g., near the second end 3262) and a thickness of 3.5 mm (e.g., near the first end 3261). In some examples, the support 3260 may vary between a thickness of 0.3 mm (e.g., near the second end 3262) and a thickness of 3 mm (e.g., near the first end 3261). In some examples, the support portion 3260 can vary between a thickness of 1.3 mm (eg, near the second end 3262) and a thickness of 2.5 mm (eg, near the 1.3 end 3261).

[0258] Different geometry support portions 3260 may be used for different patients. For example, if a patient requires increased support and / or stiffness in the second seal-forming structure 3102, the seal-forming structure 3100 may be used with a thicker and / or more curvaceous (e.g., smaller radius of curvature) support portion 3260 (e.g., near the first end 3261 and / or anywhere along the length). For example, if a patient requires a more flexible second seal-forming structure 3102, the seal-forming structure 3100 may be used with a thinner and / or less curvaceous (e.g., larger radius of curvature) support portion 3260 (e.g., near the first end 3261 and / or anywhere along the length).

[0259] As can be seen particularly in Figures 14 and 15, in one form of the present technology, the support portion 3260 is connected to the oral portion 3201 of the plenum chamber adjacent the boundary between the lateral sidewalls 3245 of the oral portion 3201 and the lateral sidewalls 3246 of the nasal portion 3202.

[0260] In some forms of the present technology, the supports 3260 are shaped to provide a substantially clean flow path from the oral portion 3201 of the plenum chamber to the nasal aperture(s) 3135. In some forms of the present technology, no portion of any of the supports 3260 is located directly under the nasal aperture(s) 3135.

[0261] 5.3.4 Positioning and stabilizing structures The seal-forming structure 3100 of the patient interface 3000 of the present technology may be held in a sealed position by the positioning and stabilising structure 3300 in use.

[0262] 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.

[0263] In one form, the positioning and stabilising structure 3300 provides a retaining force sufficient to overcome the attractive force on the patient interface 3000.

[0264] In one form, the positioning and stabilizing structure 3300 provides a holding force as a safety margin to eliminate the possibility of destructive action on the patient interface 3000 (e.g., due to tube drag or inadvertent interference with the patient interface).

[0265] 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.

[0266] 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.

[0267] 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.

[0268] In one form of the present technology, the positioning and stabilizing structure 3300 comprises a decoupling site located between an anterior portion of the positioning and stabilizing structure 3300 and a posterior portion of the positioning and stabilizing structure 3300. The decoupling site does not resist compression and can be, for example, a flexible or flimsy strap. The decoupling site is constructed and positioned such that when a patient lies down with their head on a pillow, the presence of the decoupling site avoids a posterior force being transferred along the positioning and stabilizing structure 3300 that would disrupt the seal.

[0269] 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.

[0270] 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.

[0271] 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-basal point of the patient's head and covers a portion of the parietal bone without covering the occipital bone.

[0272] 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.

[0273] 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.

[0274] 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.

[0275] 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.

[0276] 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.

[0277] In the embodiment shown in Figures 21 and 22, a connector 3310 (eg, a magnet connector) is provided for connection to a positioning and stabilizing structure.

[0278] 5.3.4.1 Frames As shown in Figures 23-28-2, the frame 3350 is coupled to the plenum chamber 3200 and assists in maintaining a therapeutically effective position of the seal-forming structure 3100. Although the plenum chamber 3200 shown in Figures 23-28-2 specifically shows an elbow 3500 connected in front of the patient's face, the frame may be used with other types of plenum chambers 3200 (e.g., the plenum chamber 3200 of Figures 21-22 used with conduit headgear).

[0279] In some forms, the frame 3350 is constructed from a rigid or semi-rigid material and provides support to the seal-forming structure 3100 and / or the plenum chamber 3200. For example, the frame 3350 may help maintain the shape of the seal-forming structure 3100 and / or the plenum chamber 3200 to reduce leakage of pressurized air due to folding and / or wrinkling when the seal-forming structure 3100 engages the patient's face.

[0280] In some forms, at least one connection point 3352 provided by the frame 3350 may assist in indirect connection of the headgear strap 3354 to the plenum chamber 3200 and / or the seal-forming structure 3100. The connection point 3352 may be a loop (e.g., fully circumferential) that receives a portion of the headgear strap 3354. For example, a length of the left upper headgear strap 3356 may extend through the first loop 3352a and be pulled away from the plenum chamber 3200 to apply tension through the left upper headgear strap 3356. The left upper headgear strap 3356 may be folded back on itself and held at a selected length (e.g., by Velcro, magnets, adhesive, etc.) to maintain the applied tension. Similar steps may be taken in adjusting the tension of the right upper headgear strap 3358 in the second loop 3352b.

[0281] In some forms, each loop 3352a and 3352b can be oriented such that the force vector applied from each upper headgear strap 3356 and 3358 is substantially perpendicular to the loop inner surface 3351 in contact with the upper headgear straps 3356 and 3358. As shown in FIG. 23 , the top right headgear strap 3358 engages loop 3352b at substantially the center of the loop inner surface 3351. When the top right headgear strap 3358 is fastened, the force vector is applied in a substantially linear direction and not diagonal to the loop inner surface 3351. This may improve sealing of the seal-forming structure 3100 because the force directed along the arm 3362 is not diagonal to the arm 3362, which would require the upper headgear straps 3356 and 3358 to be tightened further to achieve the same sealing effect (e.g., at the expense of patient comfort) and / or would prevent proper engagement of the seal-forming structure 3100 with the patient's face (e.g., leading to leakage).

[0282] As shown in FIG. 27-2, certain configurations of the loops 3352a and 3352b may include eyelet cuts 3353. The eyelet cuts 3353 may be formed on the patient side of each loop 3352a and 3352b (e.g., adjacent the patient's skin in use). The eyelet cuts 3353 may form an area of ​​reduced thickness along the circumference of each loop 3352a and 3352b. The eyelet cuts 3353 may extend around a portion of the circumference of the loops 3352a and 3352b (e.g., less than 360°). In the illustrated example, each headgear strap 3354 may contact the eyelet cuts 3353 when received through the loops 3352a and 3352b. The reduced thickness of the eyelet cuts 3353 may result in reduced material used in the manufacture of the loops 3352a and 3352b, which may result in reduced manufacturing times and / or manufacturing costs. The eyelet cuts 3353 may additionally or alternatively result in reduced skin marking and increased patient comfort.

[0283] In one form, at least one of the loops 3352a and 3352b may not be completely formed around the outer periphery. In other words, the loops 3352a and 3352b may be C-shaped and / or U-shaped. The top left headgear strap 3356 and / or the top right headgear strap 3358 may be individually folded on itself and then inserted through the loops 3352a and 3352b. This allows the patient to maintain the same length adjustment in each upper headgear strap 3356 and 3358 (when the seal-forming structure 3100 is removed from the therapeutically effective position).

[0284] In some forms, the frame 3350 includes a central portion 3360 that is coupled to the plenum chamber 3200. The central portion 3360 may have an annular shape and may have a contour that corresponds to the shape of the plenum chamber 3200 (e.g., approximating a positive dome-like curvature).

[0285] In one form, a single size central portion 3360 may be used with various sizes of plenum chambers 3200 and / or seal-forming structures 3100. For example, the seal-forming structures 3100 may be made in multiple sizes (e.g., small, medium, large) and / or shapes (e.g., narrow, wide) for better sealing for patients with various face shapes. The engagement area of ​​the central portion 3360 may remain substantially the same regardless of the size of the plenum chamber 3200 and / or seal-forming structure 3100. Thus, the central portion 3360 may be coupled to cushions of various shapes and / or sizes and provide substantially the same support.

[0286] In one form, the central portion 3360 may be removably coupled to the plenum chamber 3200. A patient may use the same frame 3350 with multiple plenum chambers 3200. This may be useful when a patient first begins treatment to try different sizes of plenum chambers 3200 to find the right fit. Removing the frame 3350 may also be useful when cleaning the patient interface 3000 as it may allow different elements of the patient interface 3000 to be cleaned separately, helping ensure a more thorough cleaning.

[0287] In some forms, the frame 3350 includes arms 3362 extending away from a central portion 3360. The loops 3352a and 3352b are formed at the ends of the arms 3362. In use, the arms 3362 may extend at least partially in a rearward direction such that the loops 3352a and 3352b may be positioned rearward of the plenum chamber 3200 and / or the seal-forming structure 3100. The arms 3362 may extend laterally (e.g., left or right, respectively) generally following the contour of the patient's face.

[0288] In some forms, the arms 3362 engage a portion of the patient's face while the patient interface 3000 is worn by the patient. For example, the arms 3362 may contact the patient's cheek. The arms 3362 may be shaped (e.g., extending posteriorly and laterally) to accommodate the curvature of the patient's face.

[0289] In some forms, the arms 3362 cannot substantially stretch due to tension applied from the respective headgear straps 3356 and 3358 via the loops 3352a and 3352b (e.g., the arms 3362 can be rigidizer and / or non-extensible). Tension can be transferred along the arms 3362 to the plenum chamber 3200 and / or the seal-forming structure 3100 to maintain a therapeutically effective pressure and prevent leaks from occurring.

[0290] In one form, the arms 3362 are constructed from a more flexible material than the material used to construct the central portion 3360. These materials are molded together to construct the frame 3350 as a unitary, one-piece structure. The arms 3362 may have a certain stiffness to help maintain their shape. However, because the arms 3362 are bendable, the patient may be able to adjust the shape of the arms 3362 to accommodate their facial structure. The ability of the patient to adjust the shape of the arms 3362 may lead to increased comfort experienced by the patient, which may lead to increased patient compliance with treatment. In this manner, the arms 3362 may be able to bend or flex relative to the central portion 3360 (e.g., due to a cantilevered configuration), but may not be able to extend in a posterior direction (e.g., due to inextensibility). Additionally, the relatively flexible material used in the construction of each of the arms 3362 may help reduce facial marks and increase patient comfort.

[0291] In one form, the arms 3362 and the central portion 3360 are constructed from the same material. This material provides sufficient flexibility to allow shape adjustment, while also providing sufficient rigidity to maintain the adjusted shape. The central portion 3360 may be stiffer than the arms 3362 due to its connection to the plenum chamber 3200. Additionally or alternatively, the central portion 3360 may be thicker than the arms 3362, which may also lead to increased stiffness of the central portion 3360. Each arm 3362 is formed as a cantilever type shape, such that the adjacent ends of the loops 3352a and 3352b are not supported. Additionally, the thickness of the frame 3350 may be reduced along the length of each arm 3362 in the direction of the loops 3352a and 3352b (see, e.g., FIG. 27-1). This may provide each arm 3362 with the necessary flexibility to bend and / or shape to substantially correspond to the shape of the patient's face (e.g., cheeks). The reduced width of each arm 3362 may also reduce cheek contact between each arm 3362 and the patient's cheek, which may lead to improved patient comfort. The reduced width along the length of each arm 3362 may also provide increased flexibility in the vicinity of each loop 3352a and 3352b.

[0292] In some forms, the thickness of the fixed end of each arm 3362 can be from about 2 mm to about 7 mm. In some forms, the thickness of the fixed end of each arm 3362 can be from about 2.5 mm to about 6 mm. In some forms, the thickness of the fixed end of each arm 3362 can be from about 3 mm to about 5 mm. In some forms, the thickness of the fixed end of each arm 3362 can be about 4 mm.

[0293] In some forms, the thickness of the free end of each arm 3362 can be from about 0 mm to about 4 mm. In some forms, the thickness of the fixed end of each arm 3362 can be from about 0.5 mm to about 3 mm. In some forms, the thickness of the fixed end of each arm 3362 can be from about 1 mm to about 2.5 mm. In some forms, the thickness of the fixed end of each arm 3362 can be about 2 mm.

[0294] As shown in FIG. 27-3, some configurations of the cross section of each arm 3362 may be substantially rectangular. Corners (e.g., one corner, two corners, four corners) of the substantially rectangular shape may be curved. This may help improve patient comfort by reducing sharp surfaces that come into contact with the patient's skin. Each arm 3362 may also have a height that is greater than its thickness. This height may be designed to comfortably distribute pressure (e.g., by increasing height) across the patient's skin (without obstructing the patient's peripheral vision or otherwise causing patient discomfort).

[0295] In some forms, the height of each arm 3362 can be between about 5 mm and about 15 mm. In some forms, the height of each arm 3362 can be between about 6.5 mm and about 13.5 mm. In some forms, the height of each arm 3362 can be between about 8 mm and about 12 mm. In some forms, the height of each arm 3362 can be between about 9.5 mm and about 10.5 mm. In some forms, the height of each arm 3362 can be about 10 mm.

[0296] As shown in Figures 26-4 and 26-5, certain configurations of the frame 3350 may provide for pivotable movement between each arm 3362 and the central portion 3360. This pivotable movement may differ from the bending movement described above in that each arm 3362 may be connected to the central portion 3360 by a pivot point 6012 and allows the entire arm 3362 to move substantially the same angular distance. As described above, each arm 3362 may be capable of bending in addition to pivoting.

[0297] In one form, the pivot point 6012 is located in the same location on either side of the frame 3350. In other words, each arm 3362 may be connected to the central portion 3360 and each arm 3362 may extend the same length past the pivot point 6012. This may allow the patient to make mirror type adjustments of the arms 3362. The patient may then be able to flex or bend each arm individually to make a particular lateral adjustment.

[0298] In one form, each pivot point 6012 is a living hinge. In other words, the frame 3350 may be constructed from a substantially uniform material (or the transition between each arm 3362 and the central portion 3360 may be constructed from a substantially uniform material). The thickness at each hinge 6012 may be significantly less than the thickness of the arms 3362 and the central portion 3360 immediately adjacent the hinge 6012. For example, the hinge 6012 may be formed as a groove in a face of the frame 3350, and face away from the patient in use. Uniformly and integrally constructing the hinge 6012 from substantially the same material as the arms 3362 and the central portion 3360 may help reduce manufacturing costs (e.g., compared to having hinges constructed from different materials).

[0299] Each arm 3362 can be pivotable about a respective hinge 6012 between a first position and a second position. The loops 3352a and 3352b can be closely spaced together in the second position but not in the first position.

[0300] In one form, the first position can be a relaxed position and the second position can be a biased position. The arm 3362 can move to the second position when an external force is applied and return to the first position when the external force is removed.

[0301] In one form, the arms 3362 may be positioned in the first position or the second position without the continued application of an external force. When the arms 3362 are moved to the second position, the arms 3362 may overlap each other (e.g., like eyeglasses). This may assist in reducing footprint for packaging and / or storage.

[0302] In other configurations (not shown), each arm 3362 may be separate from the central portion 3360 and connected to the central portion 3360 by a rotational hinge (e.g., a pin joint). In yet other configurations, each arm 3362 may be connected to the central portion 3360 by overmolding flexibility therebetween, which may allow for some pivotable movement.

[0303] In some forms, the frame 3350 further includes at least one secondary connection point 3364 spaced apart from the loops 3352a and 3352b. The secondary connection point(s) 3364 may provide an additional connection location, which may further assist in indirect connection of the headgear straps 3354 to the plenum chamber 3200 and / or the seal-forming structure 3100.

[0304] In a particular form, the frame 3350 includes two secondary connection points 3364 (e.g., a left secondary connection point 3364a and a right secondary connection point 3364b). The secondary connection points 3364a and 3364b may be located below the loops 3352a and 3352b when the patient interface 3000 is worn by the patient. The headgear straps 3354 may further include a left lower headgear strap 3366 and a right lower headgear strap 3368. The left lower headgear strap 3366 and the right lower headgear strap 3368 are configured to connect to each of the secondary connection points 3364a and 3364b, respectively. The entire headgear 3354 may then be capable of providing force to the upper and lower regions of the seal-forming structure 3100 and / or the plenum chamber 3200.

[0305] In certain configurations, the secondary connection points 3364a and 3364b are formed directly on the central portion 3360. When the patient interface 3000 is worn by a patient, the secondary connection points 3364a and 3364b may be located anterior to the loops 3352a and 3352b.

[0306] In certain forms, the secondary connection points 3364a and 3364b may be constructed from a single component, which may help reduce tooling and / or manufacturing costs.

[0307] In certain configurations, the left headgear strap 3366 and / or the lower right headgear strap 3368 are removably coupled to respective secondary connection points 3364a and 3364b. The secondary connection points 3364a and 3364b may be magnetic, and the left headgear strap 3366 and / or the lower right headgear strap 3368 may be provided through a magnet 3370 that is of opposite polarity to the secondary connection points 3364a and 3364b. The length of the left headgear strap 3366 and / or the lower right headgear strap 3368 may be adjusted by folding each strap 3366 and 3368 on itself (e.g., similar to the left headgear strap 3356 and / or the upper right headgear strap 3358). Removal of each magnet 3370 from each secondary connection point 3364a and 3364b may be performed without changing the length adjustment of the left headgear strap 3366 and / or the lower right headgear strap 3368. The patient may be able to put on and take off the patient interface 3000 simply by removing the magnets 3370 from their respective secondary connection points 3364a and 3364b (e.g., without having to remove the left headgear strap 3356 and / or the upper right headgear strap 3358 from their respective loops 3352a and 3352b).

[0308] 28-1 and 28-2, each secondary connection point 3364a and 3364b may be constructed to improve retention by each magnet 3370. The outer casing 3376 of each secondary connection point 3364a and 3364b may include a substantially planar (e.g., flat) surface 3378 and a lip 3380 extending from the planar surface 3378.

[0309] In the illustrated example, the outer casing 3376 may have a substantially elliptical shape and the lip 3380 may extend near an apex of the planar surface 3378. The lip 3380 may extend around only a portion of the planar surface 3378 (e.g., less than 360°). In some examples, the lip 3380 may extend less than 180° around the planar surface 3378 (e.g., the lip 3380 may not extend to any co-apex of the substantially elliptical planar surface 3378).

[0310] 28-2, each secondary connection point 3364a and 3364b may be coupled to the frame 3350 such that the lip 3380 is located near the center of the frame 3350. In other words, each secondary connection point 3364a and 3364b may be oriented such that the lip 3380 is located near the elbow 3500 (when the frame 3350 is coupled to the plenum chamber 3200).

[0311] The magnet 3370 includes a substantially planar surface that can engage with a substantially planar surface 3378 of the outer casing 3376. While engaged with the planar surface 3378, the magnet 3370 can be magnetically coupled to the magnetic elements 3382 of the secondary connection points 3364a and 3364b. The overhang 3384 can be spaced apart from the magnet 3370. As shown, the overhang 3384 can be positioned on one side (e.g., on the inside) of the lip 3380 and the magnet 3370 can be positioned on the other side (e.g., on the outside) of the lip 3380. In use, the patient can adjust the length of each lower headgear strap 3366 and 3368. When one of the lower headgear straps 3366 and 3368 is fastened, a force can be applied that is directed away from the center of the frame 3350 (e.g., laterally outward). This force can be higher than the magnetic force between the magnet 3370 and the magnetic element 3382 and can cause the magnet 3370 to move relative to the planar surface 3378 .

[0312] The overhang 3384 may prevent the magnet 3370 from disengaging from the magnetic material 3382 as a result of fastening the lower headgear straps 3366 and 3368. As the magnet 3370 begins to move, the overhang 3384 may contact the lip 3380, thereby limiting further movement away from the center of the frame 3350. Thus, the engagement between the lip 3380 and the overhang 3384 may help reduce accidental disconnection of the magnet 3370 from the secondary connection points 3364a and 3364b (when fastening the lower headgear straps 3366 and 3368), but does not limit the ability of the patient to move the magnet 3370 substantially vertically relative to the frame 3350 (e.g., to remove the positioning and stabilizing structure 3300).

[0313] 24, the engagement region of the plenum chamber 3200 may include a groove 3280. In the illustrated example, the groove 3280 may be provided on the oral portion 3201 of the plenum chamber 3200 and may be provided radially outward of the central portion 3251. The central portion 3360 of the frame 3350 may be positioned within the groove 3280. The shape of the central portion 3360 may substantially correspond to the shape of the groove 3280, thereby assisting the patient in properly orienting the frame 3350 relative to the plenum chamber 3200 (e.g., in examples where the frame 3350 is removably coupled to the plenum chamber 3200).

[0314] In some forms, the groove 3280 can have a fully formed perimeter with a substantially annular shape, which perimeter can have substantially the same length in any size cushion.

[0315] In some forms, the groove 3280 is recessed relative to the remainder of the exterior surface of the plenum chamber 3200. The recessed groove 3280 may not extend substantially into the plenum chamber 3200 and does not obstruct the patient's face. The groove 3280 may have substantially the same depth around its entire perimeter.

[0316] In some forms, the length of the groove 3280 may be less than the width of the central portion 3360 of the frame 3350. The compliant nature of the cushion may allow the wider central portion 3360 to be received within the groove 3280. This may allow the central portion 3360 to be coupled (via a press fit, friction fit, and / or snap fit) to the groove 3280. The engagement of the groove 3280 with the central portion 3360 may help provide stiffness to the plenum chamber 3200 and / or the seal-forming structure 3100, since the stiffness of the frame 3350 (e.g., compared to the plenum chamber 3200) may limit the flexibility of the plenum chamber 3200 alone to a certain extent.

[0317] In some forms, the cushion may be molded into the frame 3350 such that the groove 3280 may be created during the molding process. The material of the plenum chamber 3200 (e.g., silicone) may be at least partially molded around the center portion 3360 of the frame 3350 to limit removal of the center portion 3360 from the groove 3280.

[0318] As shown in FIG. 25, the frame 3350 may be constructed from multiple pieces (e.g., each constructed from a different material). For example, the center portion may be constructed from a first material (e.g., hard plastic). The arms 3362 may be coupled (e.g., adhesive, molding, etc.) to the center portion 3360 and constructed from a second material (e.g., flexible plastic, foam, etc.) that is more flexible than the first material. The third material may be a magnetic material and coupled (e.g., via adhesive) to the center portion 3360. Once coupled to each other, the arms 3362 may be able to move similarly to a unitary, one-piece structure as described above.

[0319] 26 and 27, the frame 3350 may be constructed from a single piece of material. For example, the frame 3350 may be constructed from a TPE material such as Hytrel. As noted above, the material used to construct the frame 3350 may provide both rigidity and flexibility to the frame 3350. The magnet 3370 may be overmolded (or otherwise coupled) to the central portion 3360.

[0320] In some forms, the central portion 3360 includes slots 3372. These slots 3372 may be formed on either side of the central portion 3360. The slots 3372 may have a generally elongated shape (e.g., rectangular, oval) and may be formed entirely within the boundary of the central portion 3360.

[0321] 27, some forms of the central portion 3360 may include a tapered slot 3372. In particular, the opening to the slot 3372 may be wider near the rear face of the central portion 3360 (e.g., the face that contacts the plenum chamber 3200). The opening to the slot 3372 may decrease evenly as it approaches the front face of the central portion 3360.

[0322] 27 also shows that some forms of the arm 3362a (or arm 3362b) may include an indentation or scallop 3373. The scallop 3373 may be formed on an inner surface of the arm 3362a and positioned to be adjacent to the patient's skin (when the patient is wearing the positioning and stabilizing structure 3300). The scallop 3373 may reduce thickness along portions of the arm 3362a and reduce the likelihood of sink marks occurring in the arm 3362a during the manufacturing process (e.g., (e.g., injection molding)). The scallop 3373 may also result in a reduction in material used to manufacture the arm 3362a, which may result in fewer manufacturing iterations and / or reduced manufacturing costs.

[0323] 26-2, the plenum chamber 3200 may include protrusions 3284 on the oral cavity 3201. These protrusions may be elongated and may have a similar shape to the slots 3372 (e.g., may be tapered). The protrusions 3284 may be positioned within the grooves 3280 to cooperate with the frame 3350 during assembly.

[0324] 26-2, some forms of protrusions 3284 can include an overhang 6000 that extends at least partially over the groove 3280. The overhang 6000 can be formed asymmetrically about the circumference of the protrusion 3284. In other words, the overhang 6000 can extend further over the groove 3280 on one side than the other.

[0325] In some forms, the groove 3280 may also be asymmetric. The groove 3280 may include an undercut 6004 on one side of the protrusion 3284 and a beveled surface 6008. The overhang 6000 may extend further over the undercut 6004 than over the beveled surface 6008. The length of the overhang 6000 that extends over the undercut 6004 may limit the ability of the frame 3350 to be removed vertically from the plenum chamber 3200. The angle of the beveled surface 6008 may be oriented toward the overhang 6000 to limit the ability of the frame 3350 to be removed at an angle.

[0326] When the frame 3350 is assembled to the plenum chamber 3200 (e.g., via a press fit, friction fit, snap fit, etc.), the patient may align the protrusions 3284 with the slots 3372 to receive the protrusions 3284 therein during use. The wider openings of the adjacent slots 3372 on the rear side may aid in alignment of the patient with each protrusion 3284 in each slot 3372. The protrusions 3284 may be slightly wider than the front openings of each slot 3372, but may be received within the slots 3372 due to the flexibility of the plenum chamber 3200 (e.g., being constructed of a resilient material such as silicone). The protrusions 3284 may deform slightly as they enter each slot 3372 (e.g., due to the slots 3372 narrowing).

[0327] After the protrusion 3284 passes through the slot 3372, the protrusion 3284 may substantially return to its original shape. For example, the overhang 6000 may deform (e.g., elastically deform) (as the slot 3372 receives the protrusion 3284) and return to its initial position after the central portion 3360 is received within the groove 3280. The patient may experience this deformation as a tactile response to more easily observe a proper connection between the frame 3350 and the plenum chamber 3200. The overhang 6000 of the protrusion 3284 may be wider than the forward opening of each slot 3372 in the relaxed or initial position.

[0328] Additionally, the width of the undercut 6004 may be substantially the same as the center portion 3360 so that the frame 3350 is snugly received within the groove 3280. The flexible material of the plenum chamber 3200 may allow the undercut 6004 to be slightly smaller than the center portion 3360 so that the undercut 6004 may flex to receive the frame 3350 (via a press fit, friction fit, snap fit, etc.).

[0329] Thus, the frame 3350 may not be easily removed from the plenum chamber 3200. The patient may need to apply force to the frame 3350 to remove it from the grooves 3280. This user applied force may allow the frame 3350 to move vertically or diagonally and overcome the support provided by the overhang 6000. For example, the patient may lift the frame 3350 from the area of ​​the central portion 3360 that contacts the angled surface 6008 to provide force to disengage the frame 3350 from the plenum chamber 3200.

[0330] This force may exceed the force generated due to normal movement of the plenum chamber 3200 and / or the seal-forming structure 3100. In other words, the seal-forming structure 3100 and / or the plenum chamber 3200 may move relative to the frame 3350 while the protrusions 3284 are received within the respective slots 3372. This may allow the seal-forming structure 3100 and / or the plenum chamber 3200 to flex and conform to the patient's face (without coming loose from the frame 3350 and without the slots 3372 inadvertently disengaging from the protrusions 3284).

[0331] In other forms, the plenum chamber 3200 may be molded into the frame 3350 and the protrusions 3284 may result from the molding process to permanently retain the position of the frame 3350 relative to the plenum chamber 3200.

[0332] As shown in FIG. 26-3, some forms of the frame 3350 may be oriented to reduce cheek contact while the connected frame 3350 and plenum chamber 3200 are worn by a patient. For example, the arms 3362a and 3362b may be oriented (e.g., curved) to be substantially compliant at least at a portion of the patient's face (e.g., cheek). However, in some instances, the entire length of each arm 3362 may not contact the patient's skin because the patient may find foreign objects in contact with their cheek uncomfortable. Instead, a portion of each arm 3362 may be spaced away from the patient's face, thereby reducing the surface of the arm 3362 that contacts the patient's face. Moving the contact point between each arm 3362 and the plenum chamber 3200 (e.g., via a manufacturing process) while maintaining substantially the same curvature for each arm 3362 may change the entire length of each arm 3362 that contacts the patient's face. For example, if the arms 3362 contact the plenum chamber 3200 closer to the elbow 3500, the maximum clearance between the arms 3362 and the patient's face is increased, i.e., a greater portion of the arms 3362 is spaced away from the patient's face (as opposed to the arms 3362 contacting the plenum chamber 3200 distal to the elbow 3500). The reduced contact between the arms 3362 and the patient's face may result in improved patient comfort.

[0333] Additionally, contact of each arm 3362 with the plenum chamber 3200 adjacent the elbow (and thus distal from the rear surface 3112) may provide less support at the side 3111 of the plenum chamber 3200 (e.g., due to reduced engagement of the rigid or semi-rigid arm with the side 3111). Thus, the side 3111 may have a greater level of flexibility and may be able to better conform to the shape of the patient's nose and create an effective seal.

[0334] As shown in FIGS. 26-4 and 26-5, some forms of the frame 3350 may include a hinge 6012 between each arm 3362 and the central portion 3360. The hinges 6012 may allow movement (e.g., pivotal movement) of the arms 3362 (without affecting the connection between the frame 3350 and the plenum chamber 3200). In other words, pivoting of either arm 3362 about its respective hinge 6012 does not disengage the protrusion 3284 from the slot 3372.

[0335] In some forms, the patient may move the arm 3362 to the second position to get a better fit. For example, the distance between the loops 3352a and 3352b in the first position may be larger than the average patient's head size. Thus, the patient may move the arm 3362 to the second position to get a proper fit (e.g., contact between the arm 3362 and the patient's head). The arm 3362 may be held in the second position by adjustment of the upper headgear straps 3356 and 3358 (i.e., external force may be obtained from the upper headgear straps 3356 and 3358).

[0336] Similar to the arms 3362, the plenum chamber 3200 and / or the seal-forming structure 3100 may be larger than the size of an average patient's face. For example, the seal-forming structure 3100 may not snugly engage with the patient's mouth and / or nose. The plenum chamber 3200 and / or the seal-forming structure 3100 may be moved to a more compact position for improved engagement with an individual patient's face.

[0337] 26-5, moving the arm 3362 to the second position may directly move the seal-forming structure 3100 and / or the plenum chamber 3200 to a more compact position. The arm 3362 may contact the plenum chamber 3200 along the second front wall 3242. The arm 3362 may also contact the second front wall 3242 near the center of the plenum chamber 3200 and distal to the side 3111.

[0338] By pivoting each arm 3362 about the hinge 6012, an inwardly directed force may be provided to the plenum chamber 3200. This may reduce the distance between the sides 3111 of the second seal-forming structure 3102 and may snuggly position the second seal-forming structure 3102 against the patient's nose. Compressing the seal-forming structure 3100 and / or the plenum chamber 3200 may improve the seal against the patient's face (e.g., by limiting leakage). Additionally, applying an inwardly directed force near the center of the plenum chamber 3200 (e.g., as described with respect to FIG. 26-3) may limit wrinkling in the seal-forming structure 3100 by limiting the total compression of the plenum chamber 3200.

[0339] As shown in Figure 28, the frame 3350 may be shaped similarly to the frames in Figures 26 and 27. In other words, the frame 3350 may be constructed from a single material (e.g., semi-rigid). The frame 3350 may be thicker near the center 3360 and thinned out as it approaches each loop 3352a and 3352b.

[0340] In some forms, the central portion 3360 of the frame 3350 may be substantially solid throughout and may not include a slot 3372, and the plenum chamber 3200 may not include a protrusion 3284 within the groove 3280. Instead, the plenum chamber 3200 may include a protrusion 3288 disposed radially inward of the groove 3280. The protrusion 3288 may be elevated from the remainder of the front surface of the plenum chamber 3200. The protrusion 3288 may also extend at least partially radially outward. In other words, the protrusion 3288 may extend at least partially over the groove 3280 (e.g., the protrusion 3388 is spaced apart from the groove 3280).

[0341] During assembly of the removable frame 3350 to the plenum chamber 3200, it may be necessary to position the frame 3350 so that it extends into the grooves 3280 and under the protrusions 3288. After positioning of the central portion 3260, the protrusions 3288 may help hold the central portion 3360 in place. To uncouple the frame 3350 from the plenum chamber 3200, the patient may press on at least one of the protrusions 3288 (e.g., laterally closer to the other protrusions 3288) so that it does not extend over the grooves 3280. In other forms, the plenum chamber 3200 may be molded into the frame 3350 and the protrusions 3288 may prevent removal of the central portion 3360.

[0342] In some forms, the frame 3350 of any of the above examples may be substantially flush with the exterior surface of the plenum chamber 3200 when positioned within the groove 3280. The depth of the groove 3280 may substantially correspond to the thickness of the central portion 3360. Similarly, the shape of the central portion may substantially approximate the shape of the cushion as described above. The resulting assembly may have a substantially uniform surface. This helps maintain a low profile appearance of the patient interface 3000 by preventing the frame 3350 from protruding in front of the cushion (where the frame 3350 may obstruct the patient's line of sight).

[0343] 5.3.5 Ventilation 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).

[0344] In certain configurations, the vent 3400 is configured to allow continuous vent flow from the interior of the plenum chamber 3200 to atmosphere when pressure in 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 in the plenum chamber in use.

[0345] 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).

[0346] 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).

[0347] Although no ventilation structure is shown in Figures 7-18, the embodiments of the present technology shown in Figures 7-18 may be provided with a suitable ventilation structure, for example in the plenum chamber (an example of which is shown in Figure 21).

[0348] 5.3.6 Decoupling structure(s) In one form, the patient interface 3000 includes at least one decoupling structure 3500 (e.g., a swivel or bulb). In some examples, the decoupling structure can be an elbow 3500 connected (e.g., removably connected, permanently connected) to the plenum chamber 3200 (e.g., a plenum chamber inlet port).

[0349] As shown in FIG. 23-28, the central portion 3360 of the frame 3350 has an annular shape such that the central region of the oral portion 3201 of the plenum chamber 3200 is not covered by the frame 3350. In some examples, the oral portion 3201 includes an opening that receives the elbow 3500. The opening may be significantly wider than the opening that receives the elbow 3500 such that the frame 3350 is completely spaced from the opening. In other words, there is a length between the inner edge of the central portion 3360 and the opening that receives the elbow 3500. The arms 3362a, 3362b and the secondary connections 3342a and 3342b are spaced from the opening and elbow 3500, respectively, such that the headgear straps 3358 do not interfere with the movement (e.g., rotation) of the elbow.

[0350] Although not explicitly shown in the plenum chamber view shown in Figures 7-19, those skilled in the art will appreciate that in practice an elbow 3500 may be provided (e.g., as shown in Figure 23) to allow connection of the interface to the air circuit 4170.

[0351] 5.3.7 Connection Ports The connection ports 3600 allow for connection to the air circuit 4170 (e.g., removable connection via a snap fit, permanent connection, etc.). The patient interface 3000 may include two connection ports 3600 on either side of the plenum chamber 3200. Conduits may connect to the connection ports 3600 to deliver pressurized breathable gas to the patient. In some forms, these conduits may be conduit headgear and may contact the patient's head. These conduits may extend to the top of the patient's head (where the decoupling structure 3500 is located).

[0352] 5.3.8 Forehead support In one form, the patient interface 3000 includes a forehead support 3700.

[0353] 5.3.9 Anti-asphyxiation valves In one form, the patient interface 3000 includes an anti-asphyxiation valve.

[0354] 5.3.10 Ports In one form of the present technology, the patient interface 3000 includes one or more ports that allow access to the volume within the plenum chamber 3200. In one form, this allows a clinician to provide supplemental oxygen. In one form, this allows a characteristic of the gas (e.g., pressure) within the plenum chamber 3200 to be directly measured.

[0355] 5.4 RPT Devices 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 4300 (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.

[0356] 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.

[0357] 5.4.1.1 RPT Device Algorithm As noted above, in some forms of the present technology, the central controller 4230 may be configured to implement one or more algorithms 4300 expressed as a computer program stored in a non-transitory computer-readable storage medium (e.g., memory 4260). The algorithms 4300 are typically grouped into groups called modules.

[0358] In other forms of the present technology, some or all of the algorithm 4300 may be embodied by a controller of an external device, such as a local external device 4288 or a remote external device 4286. In such forms, data representing input signals and / or intermediate algorithm outputs required for the portion of the algorithm 4300 executed on the external device may be communicated to the external device via a local external communications network 4284 or a remote external communications network 4282. In such forms, the portion of the algorithm 4300 executed on the external device may be represented as a computer program stored on a non-transitory computer-readable storage medium accessible to the controller of the external device. Such a program configures the controller of the external device to execute a portion of the algorithm 4300.

[0359] In such an embodiment, treatment parameters generated by the external device via the treatment engine module 4320 (in such an embodiment, some portions of the algorithm 4300 are executed by the external device) may be communicated to the central controller 4230 and passed to the treatment control module 4330.

[0360] 5.5 Air Circuit An air circuit 4170, according to one aspect of the present technology, is a conduit or tube constructed and arranged such that, in use, air flow travels between two components (eg, the RPT device 4000 and the patient interface 3000).

[0361] 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.

[0362] 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., central controller 4230). 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.

[0363] 5.5.1 Make-up Gas Delivery In one form of the present technology, a supplemental gas, for example 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.

[0364] 5.6 Humidifier 5.6.1 Humidifier Overview 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.

[0365] 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.

[0366] 5.7 Respiratory waveform FIG. 6 shows a model of a typical human respiratory waveform during sleep. 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%.

[0367] 5.8 Respiratory Therapy Mode A variety of respiratory therapy modes may be implemented by the disclosed respiratory therapy system, including CPAP therapy and bi-level therapy.

[0368] 5.9 Glossary For purposes of this disclosure, in certain aspects of the technology, one or more of the following definitions may apply. In other aspects of the technology, other definitions may apply.

[0369] 5.9.1 General Air: In certain forms of the present technology, air may refer to atmospheric air, while in other forms of the present technology, air may refer to combinations of other breathable gases (e.g., oxygen-rich atmospheric air).

[0370] 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.

[0371] For example, the ambient humidity for a humidifier may be the humidity of the air immediately surrounding the humidifier (e.g., the humidity inside the room in which the patient sleeps). Such ambient humidity may differ from the humidity outside the room in which the patient sleeps.

[0372] In another example, the atmospheric pressure may be the pressure immediately surrounding or external to the body.

[0373] 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.

[0374] 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 signs of an SDB episode.

[0375] 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).

[0376] 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.

[0377] In the example of a patient's breath, the flow rate may be nominally positive for the inhalation portion of the patient's breathing cycle, and therefore negative for the exhalation portion of the patient's breathing cycle. The device flow rate Qd is the flow rate of air exiting the RPT device. The total flow rate Qt is the flow rate of air and any supplemental gases that reach the patient interface via the air circuit. The vent flow rate Qv is the flow rate of air exiting the vent to allow the outflow of exhaled gases. The leakage flow rate Ql is the flow rate of leakage from the patient interface system or elsewhere. The respiratory flow rate Qr is the flow rate of air that is received into the patient's respiratory system.

[0378] Flow Therapy: Respiratory treatment that involves delivering airflow to the entrance to the airways at a controlled flow rate, called the therapeutic flow, that is usually positive pressure throughout the patient's respiratory cycle.

[0379] 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.

[0380] Leakage: The term "leakage" is taken as an unintended air flow. In one embodiment, a leak may occur due to an imperfect seal between the mask and the patient's face. In another embodiment, a leak may occur at the elbow to the perimeter.

[0381] Noise Conduction (Acoustic): In this document, conducted noise refers to noise that is carried to the patient by the pneumatic pathway (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.

[0382] 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.

[0383] Ventilation Noise (Acoustic): In this document, ventilation noise refers to the noise generated by airflow through any vents (eg, vents in a patient interface).

[0384] Patient: A person with or without respiratory disease.

[0385] 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 (1 hectopascal = 100 Pa = 100 N / m2 = 1 millibar ~ 0.001 atm). In this specification, pressure is given in units of cmH2O unless otherwise specified.

[0386] The pressure in the patient interface is given the symbol Pm and the therapeutic pressure is given the symbol Pt, which represents the target value that the interface pressure Pm should reach at this moment.

[0387] 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.

[0388] Ventilator: A mechanical device that provides pressure support to a patient during some or all of the work of breathing.

[0389] 5.9.1.1 Materials 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.

[0390] Polycarbonate: A thermoplastic polymer of bisphenol A carbonate.

[0391] 5.9.1.2 Mechanical properties Elasticity: The ability of a material to absorb energy during elastic deformation and to release the energy when unloaded.

[0392] Elastic: Releases substantially all of the energy upon unloading. Examples include certain silicone and thermoplastic elastomers.

[0393] 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). "Soft" materials may include silicone or thermoplastic elastomers (TPEs) and may easily deform under finger pressure, for example. "Hard" materials may include polycarbonate, polypropylene, steel or aluminum, and do not easily deform under finger pressure, for example.

[0394] 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. The antonym of rigidity is flexibility.

[0395] 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.

[0396] 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.

[0397] 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.

[0398] 5.9.2 Breathing cycle 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.

[0399] Respiratory Rate: The patient's spontaneous breathing rate, usually measured in breaths per minute.

[0400] Duty Cycle: The ratio of inspiration time Ti to total breathing time Ttot.

[0401] Effort (Respiration): Respiratory effort is said to refer to the movement made by a person's spontaneous breathing in an attempt to breathe.

[0402] Expiratory portion of the respiratory cycle: the period from the start of the expiratory flow to the start of the inspiratory flow.

[0403] 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, the flow limitation may be referred to as inspiratory flow limitation. If the flow limitation occurs during the expiratory portion of the respiratory cycle, the flow limitation may be referred to as expiratory flow limitation.

[0404] Flow-limited inspiration waveform types: (i) Flattening: An upswing followed by a relatively flat area and then a downswing. (ii) M-shaped: has two local peaks, one at the leading edge and one at the trailing edge, with a relatively flat region between the two peaks. (iii) Chair-like: Has a single local peak that occurs at the rising edge and is followed by a relatively flat region. (iv) Inverted chair shape: A relatively flat region is followed by a single local peak, which occurs on the trailing edge.

[0405] 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: (i) A 30% decrease in patient respiration for at least 10 seconds plus an associated 4% desaturation, or (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.

[0406] Hyperventilation: An increase in flow to a level higher than normal.

[0407] 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.

[0408] Patency (Airway): The degree to which the airway is open or the extent to which the airway is open. Airway patency is an opening. Quantification of airway patency may be done with values ​​indicating patency (1) and closure (obstruction) (0).

[0409] Positive end-expiratory pressure (PEEP): The pressure above atmosphere in the lungs that exists at the end of expiration.

[0410] Peak flow (Qpeak): The maximum value of flow during the inspiratory portion of the respiratory flow waveform.

[0411] 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.

[0412] 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 V i and expiratory volume V e It is estimated as the average of

[0413] (Inspiration) Time (Ti): The duration of the inspiratory portion of the respiratory flow waveform.

[0414] (Expiratory) Time (Te): The duration of the expiratory portion of the respiratory flow waveform.

[0415] (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.

[0416] 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).

[0417] 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).

[0418] 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.

[0419] 5.9.3 Ventilation Adaptive servo-ventilator (ASV): A servo-ventilator that does not have a fixed target ventilation, but rather is variable. The variable target ventilation can be learned from some characteristics of the patient (e.g., the patient's breathing characteristics).

[0420] Backup Rate: A ventilator parameter that establishes the minimum respiratory rate (typically in breaths per minute) that will be delivered from the ventilator to the patient (when not triggered by spontaneous breathing efforts).

[0421] Cycle: The end of the inspiratory phase of a ventilator. When a ventilator delivers breaths to a spontaneously breathing patient, at the end of the inspiratory portion of the breathing cycle, the ventilator is said to be cycled to stop breath delivery.

[0422] Expiratory Positive Airway Pressure (EPAP): The base pressure to which varying pressures are added within a breath to produce the desired interface pressure that the ventilator is attempting to achieve at a given time.

[0423] End Expiratory Pressure (EEP): The desired interface pressure that the ventilator attempts to achieve at the end of the expiratory portion of the breath. If the pressure waveform template Π(Φ) has a value of zero at the end of expiration (i.e., Π(Φ)=0 when Φ=1), then EEP is equal to EPAP.

[0424] Inspiratory Positive Airway Pressure (IPAP): The maximum desired interface pressure that the ventilator attempts to achieve during the inspiratory portion of the breath.

[0425] Pressure Support: A number indicating the increase in pressure during ventilator inhalation followed by exhalation of the same ventilator, and generally refers to the pressure difference between the maximum inhalation pressure and the base pressure (e.g. PS=IPAP-EPAP). In some contexts, pressure support refers to the difference the ventilator tries to achieve (rather than the difference it actually achieves).

[0426] Servo-ventilator: a ventilator that has patient ventilation and has target ventilation, and adjusts the level of pressure support to approximate the patient ventilation to the target ventilation.

[0427] Spontaneous / Timed (S / T): A mode of a ventilator or other device that attempts to detect the onset of a breath in a spontaneously breathing patient. However, if the device fails to detect a breath within a predetermined period of time, the device automatically begins breath delivery.

[0428] Swing: A term equivalent to pressure assistance.

[0429] Triggered: When a ventilator delivers a breath of air to a spontaneously breathing patient, the ventilator is said to be triggered to deliver a breath when the patient himself initiates the breathing portion of the breathing cycle.

[0430] 5.9.4 Anatomy 5.9.4.1 Facial Anatomy Ala: The outer wall or "wing" of each nostril (plural: alar)

[0431] Alare: The outermost point on the ala of the nose.

[0432] 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.

[0433] Pinna: the entire visible part of the ear.

[0434] (Nasal) Skeleton: The nasal skeleton includes the nasal bones, the frontal process of the maxilla, and the nasal part of the frontal bone.

[0435] (Nasal) Cartilaginous folds: The nasal cartilaginous folds include the septal cartilage, lateral cartilage, greater cartilage and lesser cartilage.

[0436] Columella: The piece of skin that separates the nostrils and extends from the tip of the nose to the upper lip.

[0437] 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.

[0438] 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.

[0439] Glabellar: Located in the soft tissue, the most prominent point on the midsagittal portion of the forehead.

[0440] 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.

[0441] Lower lip (labulare inferius): the point on the face between the mouth and the chin, lying in the midsagittal plane.

[0442] Upper lip (labulare superioris): the point on the face between the mouth and the nose, lying in the midsagittal plane.

[0443] 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.

[0444] Nostrils (alanopsia): roughly ellipsoidal alar openings that form the entrance to the nasal cavity. The singular form of nostril is nostril (alanopsia). The nostrils are separated by the nasal septum.

[0445] 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.

[0446] Nasolabial angle: the angle between the bridge of the nose and the upper lip, intersecting with the subnasal point.

[0447] Inferior ear point: lowest point of attachment of the pinna to the facial skin.

[0448] Superior auricular point: the highest point of attachment of the pinna to the facial skin.

[0449] 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.

[0450] Philtrum: midline groove extending from the lower border of the nasal septum to the top of the lip in the upper lip area.

[0451] Pogonion: The most anterior midpoint of the jaw, located on the soft tissue.

[0452] (Nasal) ridge: The nasal ridge is the midline prominence of the nose, extending from the serion to the apex.

[0453] 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.

[0454] Cerion: Located on the soft tissue, it is the most concave point on the area of ​​the frontonasal suture.

[0455] Septal cartilage (nose): The nasal septal cartilage is part of the septum, which divides the anterior part of the nasal cavity.

[0456] 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.

[0457] Subnasal point: located on the soft tissue where the columella joins the upper lip in the midsagittal direction.

[0458] Supramenton: The most concave point in the midline of the lower lip between the lower lip midpoint and the soft tissue pogonion.

[0459] 5.9.4.2 Skull anatomy Frontal bone: The frontal bone contains the large vertical portion, the scales frontalis, which correspond to the area known as the forehead.

[0460] Mandible: The mandible forms the lower jaw. The mental eminence is a bony protuberance in the jaw, forming the chin.

[0461] 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.

[0462] 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.

[0463] 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.

[0464] 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.

[0465] Orbit: bony cavity in the skull that contains the eyeball.

[0466] Parietal bones: The parietal bones are the bones that, when joined together, form the top and sides of the skull.

[0467] 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.

[0468] Cheekbones: The two cheekbones in the face are located in the upper and outer parts of the face and form the cheek ridges.

[0469] 5.9.4.3 Respiratory system anatomy 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.

[0470] Larynx: The larynx or voice box that contains the vocal folds and connects the lower part of the pharynx (hypopharynx) to the trachea.

[0471] 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.

[0472] 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 conchae. At the front of the nasal cavity is the nose, and at the back it opens into the nasopharynx via the choanae.

[0473] 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 (middle pharynx) (oral part of the pharynx), and the hypopharynx (lower pharynx).

[0474] 5.9.5 Patient Interface 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.

[0475] 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.

[0476] 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.

[0477] 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).

[0478] Membrane: Membrane is taken to mean a typically thin-walled element, preferably offering substantially no resistance to bending and resistance to stretching.

[0479] 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.

[0480] 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.

[0481] Shell: A shell is taken to mean a curved, relatively thin structure that has some bending, tensile and compressive stiffness. For example, the curved structural wall of a mask may be a shell. In some forms, the shell or a portion of the shell may be non-rigid. 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.

[0482] Stiffener: A stiffener is taken to mean a structural component designed to increase the bending stiffness of another component in at least one direction.

[0483] Strut: A strut is taken to mean a structural component designed to increase the compressive resistance of another component in at least one direction.

[0484] 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 or no air leakage from the swivel.

[0485] Tie (noun): A structure designed to resist tension.

[0486] 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.

[0487] 5.9.6 Shape of structure 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.

[0488] 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.

[0489] 5.9.6.1 Curvature in one dimension The curvature of a plane curve at p can be described as having a sign (eg, positive, negative) and a magnitude (eg, 1 / radius of the circle tangent to the curve at p).

[0490] 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.

[0491] 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.

[0492] 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.

[0493] 5.9.6.2 Two-dimensional surface curvature 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.

[0494] 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.

[0495] 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).

[0496] Saddle region: a region where the principal curvatures at each point have opposite signs (i.e., one side has a positive sign and the other a negative sign) (depending on the direction a hypothetical person who may be walking uphill or downhill is facing).

[0497] Dome Area: A region where the principal curvatures at every point have the same sign: both positive ("concave dome") or both negative ("convex dome").

[0498] Cylindrical region: A region in which one principal curvature is zero (or zero, for example, within a manufacturing tolerance) and the other principal curvature is non-zero.

[0499] Planar Region: Region of a surface where both principal curvatures are zero (or are zero within a manufacturing tolerance, for example).

[0500] Surface Edge: the boundary or limit of a surface or area.

[0501] 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 fictional person's path is a place to walk on a surface, similar to a path in a garden.)

[0502] 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.)

[0503] 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.")

[0504] 5.9.6.3 Space curve 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.

[0505] 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.

[0506] 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.

[0507] 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).

[0508] Tangent plane: the plane containing the unit tangent vector and the unit principal normal vector, see Figures 3O and 3P.

[0509] 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.

[0510] 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).

[0511] 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.

[0512] 5.9.6.4 Holes 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.

[0513] 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.

[0514] 5.10 Other Notes 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.

[0515] 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.

[0516] Furthermore, where a value or values ​​are provided herein and implemented 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 figure to the extent practical technical implementation permits or requires.

[0517] 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.

[0518] 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.

[0519] Please note that as used in this specification and the appended claims, the singular forms "a," "an," and "the" include their plural equivalents unless the context clearly dictates otherwise.

[0520] 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 does not antedate such publications by virtue of prior patents. Furthermore, the dates of publications mentioned may differ from the actual publication dates, which may require independent confirmation.

[0521] 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.

[0522] 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.

[0523] 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 the 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 can be performed simultaneously or even synchronously.

[0524] It is therefore to be understood that numerous modifications may be made in the illustrative embodiments and other arrangements may be devised without departing from the spirit and scope of the present technology. [Explanation of symbols]

[0525] 1000 patients 1010 Area adjacent to the nasal ala 1020 Wing crest 1100 Bedmate 3100 Seal forming structure 3101 First seal forming structure 3102 Second seal forming structure 3103 Boundary 3110 Central part 3111 Lateral part 3112 Rear of side section 3120 Elevation 3130 Lower lip 3131 Upper lip 3132 Periphery 3133 Mouth hole 3135 Nostril(s) 3200 Plenum Chamber 3201 Plenum chamber mouth 3202 Plenum chamber nose 3210 Tendon 3220 Top point 3230 Down 3240 First front wall 3241 Mouth and nose area boundaries 3242 Second front wall 3243 First front wall upper boundary 3244 First front wall lower boundary 3245 Lateral side wall section 3246 Lateral side wall section 3247 Second front wall upper boundary 3248 Second front wall lower boundary 3250 shell 3251 Central part 3260 Support part 3261 First end of support 3262 Second end of support 3263 Rigid part 3270 Band 3272 Cavity 3280 Groove 3284 Protrusion 3288 Protrusion 3300 Positioning and stabilizing structure 3310 Connector 3320 Arm 3350 Frames 3351 Loop inner surface 3352 Connection Point 3352a First Loop 3352b Second Loop 3353 Eyelet Cut 3354 Headgear Straps 3356 Top left headgear strap 3358 Top right headgear strap 3360 central part 3362 Arm 3364 Second Connection Point 3364a Left secondary connection point 3364b Right secondary connection point 3366 Lower left strap 3368 Lower right strap 3370 Magnet 3372 Slots 3373 Scallop 3376 Outer casing 3378 plane 3380 Lip 3382 Magnetic materials 3384 Overhang 3400 Ventilation 3410 Vent mounting aperture 3600 Connection Port 3700 Forehead support 4000 RPT Devices 4010 Outer Housing 4012 Upper 4014 Lower 4015 Panel 4016 Chassis 4018 Handle 4020 Pneumatic Block 4110 Air Filter 4112 Inlet Air Filter 4120 Muffler 4124 Exit muffler 4140 Pressure Generator 4142 Blower 4144 Motor 4160 Anti-spillback valve 4170 Air Circuit 4180 Refill Gas 4200 Electrical Components 4202 PCBA 4210 Power supply 4220 Input Device 4270 Converter 5000 humidifier 5002 Humidifier inlet 5004 Humidifier outlet 5006 Humidifier Base 5110 Humidifier Reservoir 5120 Conductive parts 5130 Reservoir Dock 5135 Lock lever 5150 Water Level Indicator 5240 heating element 6000 Overhang 6004 Undercut 6008 Slope 6012 Pivot point

Claims

1. A patient interface comprising: a pressure sensor for detecting a pressure difference between the air pressure and the cavity; ２ a plenum chamber pressurizable to a therapeutic pressure of O, said plenum chamber including a plenum chamber inlet port sized and configured to receive a flow of air at said therapeutic pressure for breathing by a patient, said plenum chamber including an oral portion and a nasal portion; a first seal-forming structure constructed and arranged to, in use, form a seal against an area of ​​a patient's face surrounding an entrance to the patient's mouth whereby an air flow at said therapeutic pressure is delivered to said patient's mouth, the first seal-forming structure constructed and arranged to, in use, maintain said therapeutic pressure within said cavity throughout the patient's respiratory cycle; a second seal-forming structure constructed and arranged to, in use, form a seal against an area of ​​the patient's face surrounding an entrance to the patient's nose whereby an air flow at said therapeutic pressure is delivered to said patient's nose, the second seal-forming structure constructed and arranged to, in use, maintain said therapeutic pressure within said cavity throughout the patient's respiratory cycle; a vent structure that allows a continuous flow of gases exhaled by the patient to escape from the cavity to the environment, the vent structure being sized and shaped to maintain the therapeutic pressure within the cavity in use; Including, the oral portion of the plenum chamber and the first seal-forming structure together form an oral section of the cavity, and the nose portion of the plenum chamber and the second seal-forming structure together form a nose section of the cavity; the plenum chamber has a front wall formed from the silicone, the plenum chamber inlet port being an opening formed in the silicone of the front wall, the opening configured to directly receive a fluid connector; the plenum chamber, the first seal-forming structure, and the second seal-forming structure are integrally formed as a one-piece silicone structure; The patient interface includes: a pair of supports disposed within the cavity and on opposite sides of the plenum chamber, the pair of supports contacting the second seal-forming structure, extending from the second seal-forming structure through the cavity, and contacting the front wall of the plenum chamber; Each of the pair of supports includes an upper surface and a lower surface opposite the upper surface, the upper surface is disposed within the cavity and faces the nasal section of the cavity, and the lower surface is disposed within the cavity and faces the oral section of the cavity; The patient interface further comprising a pair of supports configured to resist compression in a front-to-back direction.

2. The patient interface of claim 1 , wherein the support portion is connected to a portion of the second seal-forming structure that, in use, seals against the patient's upper lip.

3. 2. A patient interface according to claim 1, wherein the support portion is connected to a portion of the second seal-forming structure that, in use, seals against the patient's upper lip just beneath the lower corner of the patient's nose.

4. A patient interface according to claim 1 , wherein the support portion is curved when viewed in a cross section parallel to a sagittal plane.

5. A patient interface according to claim 1 , wherein the support portion is curved when viewed in a cross section parallel to the frontal plane.

6. The patient interface of claim 1 , wherein each support is connected to an oral portion of the plenum chamber adjacent a boundary of a lateral sidewall of the oral portion and a lateral sidewall of the nasal portion.

7. 10. The patient interface of claim 1, wherein each support is connected to an oral portion of the plenum chamber adjacent a boundary of an anterior wall of the oral portion and an anterior wall of the nasal portion.

8. 7. A patient interface according to claim 6, wherein the plenum chamber lateral sidewalls are curved inwardly adjacent their interface with the nose portion, and each of the supports substantially abuts an adjacent lateral sidewall.

9. 9. A patient interface according to any one of claims 1 to 8, wherein the second seal-forming structure includes at least one nasal aperture configured to deliver air flow at the therapeutic pressure to an entrance to the patient's nares, and wherein, in use, no part of any support is directly under a respective nasal aperture.

10. 10. A patient interface according to any one of claims 1 to 9, further comprising 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.

11. 11. A patient interface according to any preceding claim, wherein the plenum chamber is at least partially defined by a shell, and the vent structure is provided in the shell.

12. 12. A patient interface according to any one of claims 1 to 11, wherein the support is connected to the second seal-forming structure and to a front wall of the plenum chamber.

13. 13. A patient interface according to any one of claims 1 to 12, wherein the supports extend radially inwardly within the cavity, towards each other from opposite sides of the patient interface.

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