Patient interface

Abstract

To provide a medical device for use in screening, diagnosis, monitoring, amelioration, treatment or prevention of respiratory diseases, the medical device having one or more of improved comfort, cost, efficacy, ease of use, and manufacturability.SOLUTION: A patient interface may include a plenum chamber and a positioning and stabilizing structure. The plenum chamber may include a seal-forming structure and a fascia portion. At least a medial portion of the fascia portion is flexible. In embodiments, the patient interface may include a rigidizer to control flexion of the fascia portion.SELECTED DRAWING: Figure 13-3

Description

[Technical Field]

[0001] A portion of the disclosure of this patent document contains material that is entitled to copyright protection. The copyright owner has no objection to the facsimile reproduction by anyone of this patent document or this patent disclosure, as it appears in the Patent and Trademark Office patent file or records, but reserves all copyright rights therefor for all other purposes.

[0002] 1 Cross-reference to related applications This application claims convention priority to Patent Cooperation Treaty Application No. PCT / AU2019 / 050278, dated March 28, 2019, Australian Patent Application No. 2019901516, dated May 3, 2019, Australian Patent Application No. 2019903360, dated September 10, 2019, and Australian Patent Application No. 2019903948, dated October 21, 2019, the contents of which are incorporated by reference in their entirety.

[0003] 2. Technical Background 2.1 Technology field

[0004] 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]

[0005] 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.

[0006] These airways contain a series of branching tubes that become narrower, shorter, and more numerous the deeper they travel into the lungs. The primary function of the lungs is gas exchange, allowing oxygen from the air to enter the venous blood and carbon dioxide to leave. The trachea divides into right and left main bronchi, which further divide into terminal bronchioles. The bronchi constitute conducting airways and do not participate in gas exchange. The airways further divide into respiratory bronchioles and ultimately into alveoli. Gas exchange occurs in the alveolar region of the lung, which is called the respiratory region. See: "Respiratory Physiology," by John B. West, Lippincott Williams & Wilkins, 9th edition published 2012.

[0007] There is a range of respiratory diseases. Particular diseases can be characterized by particular manifestations such as apnea, hypopnea and hyperpnea.

[0008] 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.

[0009] Obstructive sleep apnea (OSA) is a form of sleep-disordered breathing (SDB) characterized by episodes of upper airway closure or obstruction during sleep. This is the result of an abnormally small upper airway combined with the normal loss of muscle tone in the tongue region, soft palate, and posterior oropharyngeal wall during sleep. This condition causes affected individuals to experience breathing pauses typically lasting 30 to 120 seconds, sometimes as many as 200 to 300 times per night. This can result in excessive daytime sleepiness, which can contribute to cardiovascular disease and brain damage. This condition is common, particularly among middle-aged, overweight men, but patients often experience no symptoms. See U.S. Pat. No. 4,944,310 (Sullivan).

[0010] Cheyne-Stokes respiration (CSR) is another form of sleep-disordered breathing. CSR is a disorder of a patient's respiratory regulator, characterized by alternating periods of waxing and waning ventilation, known as the CSR cycle. CSR is characterized by repeated deoxygenation and reaeration of arterial blood. CSR can be harmful due to repeated hypoxia. In some patients, CSR is associated with recurrent sleep arousals, which can cause severe insomnia, increased sympathetic activity, and increased afterload. See U.S. Patent No. 6,532,959 (Berthon-Jones).

[0011] Respiratory failure is a general term for respiratory disorders that refers to the inability of the lungs to take in enough oxygen or exhale enough CO2 to meet the patient's needs. Respiratory failure can include some or all of the following conditions:

[0012] Patients with respiratory failure (a type of respiratory insufficiency) may experience unusual shortness of breath during exercise.

[0013] Obesity hyperventilation syndrome (OHS) is defined as the combination of severe obesity and chronic awake hypercapnia in the absence of any other clear cause of hypoventilation. Symptoms include dyspnea, morning headache, and excessive daytime sleepiness.

[0014] Chronic obstructive pulmonary disease (COPD) encompasses any of a group of lower respiratory tract diseases that share certain common characteristics, including increased resistance to air movement, prolonged expiratory phase of breathing, and a decrease in normal lung elasticity. Examples of COPD include emphysema and chronic bronchitis. Causes of COPD include chronic smoking (the primary risk factor), occupational exposure, air pollution, and genetic factors. Symptoms include dyspnea on exertion, chronic cough, and sputum production.

[0015] Neuromuscular disease (NMD) is a broad term encompassing numerous diseases and illnesses that impair muscle function directly through intrinsic muscle pathology or indirectly through neuropathology. Some NMD patients are characterized by progressive muscle impairment, resulting in the inability to walk, wheelchair confinement, difficulty swallowing, respiratory muscle weakness, and ultimately death from respiratory failure. Neuromuscular disorders can be categorized as rapidly progressive or slowly progressive: (i) rapidly progressive disorders, characterized by muscle impairment that worsens over months and leads to death within a few years (e.g., amyotrophic lateral sclerosis (ALS) and Duchenne muscular dystrophy (DMD) in teenagers); (ii) variable or slowly progressive disorders, characterized by muscle impairment that worsens over years and results in only a modest reduction in life expectancy (e.g., limb-girdle, facioscapulohumeral, and myotonic muscular dystrophy). Symptoms of respiratory failure in NMD include: increasing general weakness, difficulty swallowing, difficulty breathing on exertion and at rest, fatigue, drowsiness, morning headache, and difficulty concentrating and mood changes.

[0016] Chest wall disorders are a group of thoracic deformities that result in ineffective connections between the respiratory muscles and the rib cage. These disorders are primarily characterized by restrictive obstruction and share the potential for long-term hypercapnic respiratory failure. Scoliosis and / or kyphoscoliosis can lead to severe respiratory failure. Symptoms of respiratory failure include: dyspnea on exertion, peripheral edema, orthopnea, recurrent chest infections, morning headache, fatigue, poor sleep quality, and loss of appetite.

[0017] A range of treatments are available to treat or ameliorate these conditions, and preventative treatments for respiratory disease are also available to benefit otherwise healthy individuals. However, these suffer from several deficiencies.

[0018] 2.2.2 Treatment A variety of therapies are used to treat one or more of the above respiratory disorders, such as continuous positive airway pressure (CPAP) therapy, non-invasive ventilation (NIV), and invasive ventilation (IV).

[0019] Continuous positive airway pressure (CPAP) therapy is used in the treatment of obstructive sleep apnea (OSA). Its mechanism of action is that continuous positive airway pressure acts as a pneumatic splint, for example, by pushing the soft palate and tongue forward or backward against the posterior oropharyngeal wall, thereby preventing closure of the upper airway. Because treatment of OSA with CPAP therapy can be voluntary, patients may choose not to adhere to treatment if they perceive one or more of the following about the device used to deliver the treatment: uncomfortable, difficult to use, expensive, or aesthetically unappealing.

[0020] Noninvasive ventilation (NIV) provides ventilatory support to a patient through the upper airway to assist the patient in breathing and / or maintain adequate oxygen levels in the body by performing some or all of the respiratory functions. Ventilatory support is provided through a noninvasive patient interface. NIV is used to treat CSR and respiratory failure in forms such as OHS, COPD, NMD, and chest wall disorders. In some forms, it can improve the comfort and effectiveness of these treatments.

[0021] Invasive ventilation (IV) provides ventilatory support to patients who are no longer able to breathe effectively on their own and may be provided using a tracheostomy tube. In some forms, the comfort and effectiveness of these treatments may be improved.

[0022] 2.2.3 Treatment System These treatments may be provided by therapeutic systems or devices. Such systems and devices may also be used to screen, diagnose, or monitor a disease without treating it.

[0023] The treatment system may include a respiratory pressure treatment device (RPT device), an air circuit, a humidifier, a patient interface, and data management.

[0024] Another form of treatment system is a mandibular repositioning device.

[0025] 2.2.3.1 Patient Interface A patient interface may be used to provide a wearer with an interface to a respiratory appliance, for example, by providing airflow to the airway entrance. Airflow may be provided via a mask to the nose and / or mouth, a tube to the mouth, or a tracheostomy tube to the patient's trachea. Depending on the 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 sufficient to disperse with atmospheric pressure for therapy implementation (e.g., at a positive pressure of about 10 cmH2O above atmospheric 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 airways at a positive pressure of about 10 cmH2O above atmospheric pressure.

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

[0027] Certain masks may be clinically unsuitable for this technology (for example, if the mask blocks airflow through the nose and only allows airflow through the mouth).

[0028] In certain masks, the patient must insert part of the mask structure into their mouth and create and maintain a seal via their lips, which may be uncomfortable or impractical in this technology.

[0029] Certain masks may be impractical for use while sleeping (eg, when sleeping on your side in bed with your head resting on a pillow).

[0030] There are multiple challenges in designing a patient interface. The face has a complex three-dimensional shape. The size and shape of the nose and head vary greatly between individuals. Because the head contains bone, cartilage, and soft tissue, different regions of the face respond differently to mechanical forces. That is, the chin or mandible can move relative to the other bones of the skull. The entire head can move throughout the respiratory treatment period.

[0031] These challenges can lead to one or more of the following: some masks can be intrusive, aesthetically undesirable, costly, poor fit, difficult to use, and uncomfortable, especially if worn for extended periods or if the patient is unfamiliar with the system. If the wrong size mask is used, this can lead to reduced compliance, reduced comfort, and poor patient outcomes. While masks specifically designed for aviators, personal protective equipment (e.g., filter masks), SCUBA masks, or anesthesia administration masks may be durable for their intended use, such masks may be undesirably uncomfortable to wear for extended periods (e.g., several hours). Such discomfort can reduce patient compliance with treatment. This is especially true if the mask must be worn while sleeping.

[0032] CPAP therapy is highly effective in treating certain respiratory conditions when patients comply with the therapy. However, if the mask is uncomfortable or difficult to use, patients may not comply. Patients are often encouraged to clean their masks regularly, but if the mask is difficult to clean (e.g., difficult to assemble or disassemble), patients may not be able to clean the mask, which may affect patient compliance.

[0033] Masks for other uses (e.g., aviators) may be unsuitable for use in treating sleep-disordered breathing, and masks designed for use in treating sleep-disordered breathing may be suitable for other uses.

[0034] For these reasons, patient interfaces for CPAP delivery during sleep form a distinct field.

[0035] 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.

[0036] Patient interfaces can be characterized in part according to the design intent of where the seal-forming structure engages with the face during use. In one form of patient interface, the seal-forming structure can include a first sub-portion for forming a seal around the left nostril and a second sub-portion for forming a seal around the right nostril. In one form of patient interface, the seal-forming structure can include a single element that surrounds both nostrils during use. Such a single element can be designed, for example, to rest on the upper lip region and nose bridge region of the face. In one form of patient interface, the seal-forming structure can include an element that surrounds the oral cavity region during use, for example, by forming a seal on the lower lip region of the face. In one form of patient interface, the seal-forming structure can include a single element that surrounds both nostrils and the mouth region during use. These different types of patient interfaces can be known by various names depending on their manufacturers, such as nasal masks, full face masks, nasal pillows, nasal puffs, and oronasal masks.

[0037] 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.

[0038] A particular seal-forming structure may be designed for mass production so that one design is compatible, comfortable, and effective for a wide range of different face shapes and sizes. To the extent there is a mismatch between the shape of the patient's face and the seal-forming structure of the mass-manufactured patient interface, one or both may need to be adapted to form a seal.

[0039] 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. This seal-forming structure may include an air or fluid-filled cushion, or may include a molded or shaped surface of a resilient sealing element constructed of an elastomer such as rubber. With this type of seal-forming structure, if the fit is improper, a gap will form between the seal-forming structure and the face, requiring additional force to press the patient interface against the face to achieve a seal.

[0040] Another type of seal-forming structure uses a thin flap seal positioned around the periphery of the mask to provide a self-sealing seal against the patient's face when positive pressure is applied within the mask. As with the previous type of seal-forming portion, poor fit between the face and the mask can require additional force to achieve a seal or the mask can leak. Furthermore, if the shape of the seal-forming structure does not match the shape of the patient, the seal-forming portion can fold or buckle during use, causing leakage.

[0041] 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.

[0042] Another form of seal-forming structure may use adhesives to achieve a seal, as some patients find it inconvenient to constantly apply and remove adhesives from their face.

[0043] 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).

[0044] One form of nasal pillow is found in the Adam line manufactured by Puritan Bennett. Another nasal pillow or nasal puff is the subject of U.S. Pat. No. 4,782,832 (Trimble et al.), assigned to Puritan-Bennett Corporation.

[0045] 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 pillow 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).

[0046] 2.2.3.1.2 Positioning and stabilization The seal-forming structures of patient interfaces used in positive air pressure therapy are subjected to corresponding forces of air pressure that disrupt the seal, and therefore a variety of techniques are used to position the seal-forming structures and maintain a seal against the appropriate portion of the face.

[0047] One technique involves the use of adhesives, see, for example, U.S. Patent Application Publication No. US2010 / 0000534, but adhesives can be uncomfortable.

[0048] Another technique involves the use of one or more straps and / or stabilizing harnesses, many of which suffer from one or more of the following problems: poor fit, bulky, uncomfortable, and cumbersome.

[0049] 2.2.3.2 Respiratory Pressure Therapy (RPT) Devices Respiratory pressure therapy (RPT) devices can be used individually or as part of a system to deliver one or more of the above-mentioned therapies, for example, by actuating the device to generate a delivery flow of air to an interface with the airway. This air flow can be pressurized. Examples of RPT devices include CPAP devices and mechanical ventilators.

[0050] Air pressure generators are known for a wide range of applications (e.g., industrial-scale ventilation systems). However, air pressure generators for medical applications have specific requirements that cannot be met by more common air pressure generators (e.g., the reliability, size, and weight requirements of medical equipment). In addition, even devices designed for medical treatment may suffer from deficiencies related to one or more of the following: comfort, noise, ease of use, effectiveness, size, weight, manufacturability, cost, and reliability.

[0051] One example of a special requirement for a particular RPT device is acoustic noise.

[0052] Table of noise output levels of conventional RPT devices (measured on one sample only at 10cmH2O in CPAP mode using the test method specified in ISO3744). [Table 1]

[0053] One known RPT device used to treat sleep-disordered breathing is the S9 Sleep Therapy System (manufactured by ResMed Limited). Another example of an RPT device is a ventilator. Ventilators (e.g., the ResMed Stellar® series of adult and pediatric ventilators) can provide invasive and non-invasive independent respiratory support for patients for a range of conditions, including, but not limited to, NMD, OHS, and COPD.

[0054] The ResMed Elis Accent-Aiguée® 150 ventilator and ResMed VSIII® ventilators can provide invasive and non-invasive dependent respiratory support suitable for adult or pediatric patients for the treatment of multiple conditions. These ventilators offer volumetric and pressure ventilation modes using single or dual limb circuits. RPT devices typically include a pressure generator (e.g., an electric blower or compressed gas reservoir) and are configured to deliver airflow to the patient's airway. In some cases, the airflow can be delivered to the patient's airway at positive pressure. The outlet of the RPT device is connected via an air circuit to a patient interface, as described above.

[0055] A device designer may be presented with a myriad of choices. Often, conflicting design criteria may make certain design choices unconventional or unavoidable. Furthermore, the comfort and effectiveness of a particular implementation may be significantly affected by minor changes in one or more parameters.

[0056] 2.2.3.3 Humidifier Delivery of airflow without humidification can lead to dryness of the airway. When a humidifier is used with an RPT device and patient interface, humidified gas is produced, minimizing drying of the nasal mucosa and increasing comfort of the patient's airway. Additionally, in cooler climates, the application of warm air to the facial area surrounding the patient interface generally provides more comfort than cool air.

[0057] A range of artificial humidification devices and systems are known, but do not meet the special requirements of medical humidifiers.

[0058] Medical humidifiers are typically used when a patient is sleeping or resting (e.g., in a hospital) to increase the humidity and / or temperature of an air stream relative to the ambient air when needed. Bedside medical humidifiers may be compact. Medical humidifiers may be configured to only humidify and / or heat the air stream delivered to the patient, not the patient's surroundings. For example, while room-based systems (e.g., saunas, air conditioners, or evaporative coolers) may also humidify the air breathed into the patient's body, these systems also humidify and / or heat the entire room, which may be uncomfortable for occupants. Additionally, medical humidifiers may have more stringent safety constraints than industrial humidifiers.

[0059] Although many medical humidifiers are known, such medical humidifiers may suffer from one or more deficiencies, such that some provide inadequate humidification or are difficult or inconvenient for the patient to use.

[0060] 2.2.3.4 Data Management For clinical reasons, data may be obtained to determine whether a patient prescribed respiratory therapy is "compliant" (e.g., whether the patient adheres to one or more "compliance rules" with their RPT device). An example of a compliance rule for CPAP therapy may require a patient to use the RPT device for at least four hours per night for at least 21 days out of 30 consecutive days to be considered compliant. To determine patient compliance, a provider of the RPT device (e.g., a healthcare provider) may manually obtain data describing the patient's treatment with the RPT device, calculate usage rates over a given period, and compare this to the compliance rules. Once the healthcare provider determines that the patient has used their RPT device in accordance with the compliance rules, the healthcare provider may notify a third party that the patient is compliant.

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

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

[0063] 2.2.3.5 Mandibular repositioning A mandibular repositioning device (MRD) or mandibular advancement device (MAD) is one treatment option for sleep apnea and snoring. It is an adjustable oral appliance available from dentists or other suppliers that holds the mandible (lower jaw) in an anterior position during sleep. MRDs are removable devices that are inserted into the mouth before a patient goes to sleep and removed afterward. As such, MRDs are not designed for full-time wear. MRDs can be custom-made or manufactured in standard forms and include bite impression sections designed to fit the patient's teeth. This mechanical protrusion from the mandible expands the space behind the tongue and applies tension on the pharyngeal walls, reducing airway collapse and palatal vibration.

[0064] In certain embodiments, 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.

[0065] In such a design, the length of the connecting rod is selected so that the mandible is held in a forward position when the MRD is placed in the patient's mouth. The length of the connecting rod can be adjusted to change the level of mandibular protrusion. The dentist can determine the level of protrusion required for the mandible, and the length of the connecting rod is then determined.

[0066] 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 a forward position. The devices also reduce or minimize dental and temporomandibular joint (TMJ) side effects. As such, the devices are configured to minimize or prevent any movement of one or more teeth.

[0067] 2.2.3.6 Ventilation technology Some forms of treatment systems may include a vent to push out exhaled carbon dioxide, which may allow gas flow from an interior space of the patient interface (e.g., a plenum chamber) to an exterior of the patient interface (e.g., ambient).

[0068] The vents may include orifices through which gas can flow when the mask is in use. Many such vents are noisy. Others may become blocked during use, resulting in insufficient pumping. Some vents may disrupt sleep for the patient 1000 and bed companion 1100, for example, due to noise or concentrated airflow.

[0069] ResMed Limited has developed several improved mask ventilation technologies, see International Patent Application Publication No. WO 1998 / 034,665; International Patent Application Publication No. WO 2000 / 078,381; U.S. Patent No. 6,581,594; U.S. Patent Application Publication No. US 2009 / 0050156; and U.S. Patent Application Publication No. 2009 / 0044808.

[0070] Conventional mask noise table (ISO17510-2:2007, 10cmH2O pressure at 1m) [Table 2]

[0071] (*Measured using only one sample at 10cmH2O in CPAP mode using the test method specified in ISO3744)

[0072] The sound pressure values ​​of various objects are listed below [Table 3]

[0073] 2.2.4 Screening, diagnostic, and surveillance systems Polysomnography (PSG) is a conventional system for diagnosing and monitoring cardiopulmonary diseases, but it typically requires specialized clinical staff for system application. PSG typically involves placing 15–20 contact sensors on the human body to record various body signals (e.g., electroencephalography (EEG), electrocardiography (ECG), electrooculography (EOG), and electromyography (EMG)). PSG for sleep-disordered breathing requires patients to be observed for two nights in a specialized hospital: the first night for pure diagnosis and the second night for clinician-assisted titration of treatment parameters. Therefore, PSG is expensive and inconvenient. Screening, diagnosing, and monitoring sleep-disordered breathing is particularly unsuitable for home use.

[0074] In general, screening and diagnosis involve identifying disease through signs and symptoms. Screening typically produces a true / false result indicating whether a patient's SDB warrants further investigation, while diagnosis often produces clinically actionable information. Screening and diagnosis tend to be one-time procedures, whereas monitoring the progression of disease can continue indefinitely. While some screening / diagnostic systems are adapted solely for screening / diagnosis, some can also be used for monitoring.

[0075] 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 for. Different clinical experts may have different opinions about a patient's condition. Furthermore, some clinical experts may apply different criteria at different times. Summary of the Invention [Means for solving the problem]

[0076] 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 diseases, which medical devices have one or more of improved comfort, cost, effectiveness, ease of use and manufacturability.

[0077] A first aspect of the present technology relates to devices used in the screening, diagnosis, monitoring, amelioration, treatment or prevention of respiratory disease.

[0078] Another aspect of the present technology relates to methods used in the screening, diagnosis, monitoring, amelioration, treatment or prevention of respiratory disorders.

[0079] An aspect of certain forms of the present technology is to provide methods and / or devices that improve patient compliance with respiratory therapy.

[0080] Aspects of the present technology relate to a patient interface including a plenum chamber, the plenum chamber including a seal-forming structure, a fascia portion, and a positioning and stabilizing structure, wherein at least an inner portion of the fascia portion is flexible.

[0081] Aspects of the present technology relate to a patient interface for use in the delivery of breathable gas to a patient during positive pressure therapy, the patient interface comprising: a plenum chamber having a seal-forming structure, the seal-forming structure having a nose region that, in use, engages with at least a lower portion of a wearer's nose, a mouth region that, in use, engages with a lower portion of the wearer's mouth below the lower lip region, and a fascia portion; and the fascia portion including positioning and stabilizing structure includes a flexible inner portion that is flexible and oriented to promote flexing of the plenum chamber about a substantially vertical axis when the patient interface is held in an upright position.

[0082] A patient interface used in the delivery of breathable gas to a patient during positive pressure therapy includes: a plenum chamber including at least two regions having different stiffnesses relative to one another, the plenum chamber having a first inlet port disposed on a first lateral side of the plenum chamber and a second inlet port disposed on a second lateral side of the plenum chamber; a seal-forming structure and a fascia portion, at least a portion of which is flexible; and a positioning and stabilizing structure, the positioning and stabilizing structure including a first conduit configured to connect to the first inlet port and a second conduit configured to connect to the second inlet port. A patient interface for use in the delivery of breathable gas to a patient during positive pressure therapy includes a plenum chamber and a positioning and stabilizing structure: the plenum chamber includes a seal-forming structure; and a flexible fascia portion in which a hollow protrusion extends downwardly and forwardly away from an inner region of the fascia portion, the hollow protrusion having an inlet port sized and configured to facilitate providing a flow of breathable gas into the plenum chamber.

[0083] A patient interface for use in the delivery of breathable gas to a patient during positive pressure therapy includes a plenum chamber and a positioning and stabilizing structure. The plenum chamber includes a seal-forming structure having a nasal portion configured to seal against at least the underside of the patient's nose; and a flexible fascia portion.

[0084] One aspect of the present technology relates to a patient interface comprising: a plenum chamber pressurizable in use to a therapeutic pressure of at least 6 cmH2O above ambient air pressure throughout the patient's respiratory cycle, said plenum chamber having a seal-forming structure constructed and arranged to form a seal with an area of ​​the patient's face surrounding an entrance to the patient's airways, said seal-forming structure having at least one aperture configured in use to deliver an airflow at said therapeutic pressure to an entrance to the patient's nares, said seal-forming structure constructed and arranged to maintain said therapeutic pressure in the plenum chamber throughout the patient's respiratory cycle; and a fascia portion having one or more plenum chamber inlet ports sized and configured to receive an airflow at the therapeutic pressure for breathing by the patient throughout the patient's respiratory cycle in use; and a positioning and stabilizing structure configured to generate a force to hold said seal-forming structure in a therapeutically effective position on the patient's head, said fascia portion including a flexible inner portion.

[0085] Aspects of the present technology relate to a patient interface that includes a plenum chamber and a positioning and stabilizing structure. The plenum chamber includes a seal-forming structure having a mouth region and a nose region; and a fascia portion, at least an inner portion of the fascia portion being flexible.

[0086] Aspects of the present technology relate to a patient interface including a plenum chamber and a positioning and stabilizing structure. The plenum chamber has a seal-forming structure with a mouth region and a nose region; and a fascia portion. At least an inner portion of the fascia portion is flexible. The patient interface includes a rigidizer that controls deflection of the fascia portion during use.

[0087] In embodiments, the rigidizer is constructed and / or arranged to allow deflection of the fascia portion toward the patient's face during use. In a preferred form, the rigidizer can limit or substantially prevent deflection of the fascia portion away from the patient's face during use by more than a predetermined amount. The rigidizer can have a relatively higher degree of flexibility when deflected in a first direction and a relatively lower degree of flexibility when deflected in a second direction.

[0088] In an embodiment, the rigidizer is structured to twist about an axis (eg, an axis oriented parallel to the plane of the patient's face).

[0089] One aspect of the present technology relates to a patient interface comprising a plenum chamber pressurizable, in use, to a therapeutic pressure of at least 6 cmH2O above ambient air pressure throughout a patient's respiratory cycle, said plenum chamber having a mouth portion and a nasal portion, said plenum chamber comprising a seal-forming structure constructed and arranged to form a seal against a region of a patient's face surrounding an entrance to the patient's airways, said nasal portion of said seal-forming structure having at least one nostril configured, in use, to deliver an airflow at said therapeutic pressure to an entrance to the patient's nares, and said mouth portion of said seal-forming structure configured, in use, to deliver an airflow at said therapeutic pressure to an entrance to the patient's mouth. a plenum chamber including a fascia portion having one or more plenum chamber inlet ports sized and configured to receive airflow at the therapeutic pressure for breathing by a patient throughout the patient's respiratory cycle in use, the fascia portion being joined to the mouth region and including at least an inner portion between a nose region and a lower portion of the mouth region, the inner portion being flexible.

[0090] In example embodiments: substantially the entire fascia portion may be flexible; only the inner portion of the fascia portion may be of a flexible material; the fascia portion may include at least one insert that is more rigid than the inner portion; the flexible inner portion may surround the rim of the at least one insert; the fascia portion may include a first lateral insert and a second lateral insert, and the flexible inner portion may be disposed between the first lateral insert and the second lateral insert.

[0091] In a further example, the plenum chamber includes a rigidizer that controls the extent of movement of the flexible portion during use. For example, the rigidizer may not prevent or affect inward deflection of the fascia portion of the interface. However, in examples, the rigidizer may limit or substantially prevent deflection of the flexible fascia portion during use from exceeding a predetermined amount in a direction away from the patient's face. The rigidizer may have a relatively higher degree of flexibility when deflected in a first direction and a relatively lower degree of flexibility when deflected in a second direction.

[0092] In example embodiments: at least the inner portion of the fascia is made of a flexible material; the flexible material can be one or more of the following: silicone, thermoplastic elastomer (TPE), foam, and the like.

[0093] Alternatively, an inner portion of the fascia portion may be provided with a rigidizer component that may control deflection of the fascia portion during use. In these embodiments, the rigidizer forms part of a plenum chamber of a patient interface according to the present technology. In these embodiments, the rigidizer allows deflection of the fascia portion toward the patient's face during use. In a preferred form, the rigidizer may limit or substantially prevent deflection of the fascia portion during use from exceeding a predetermined amount in a direction away from the patient's face. The rigidizer may have a relatively higher degree of flexibility when deflected in a first direction and a relatively lower degree of flexibility when deflected in a second direction.

[0094] In example embodiments: the seal-forming structure and the fascia portion may be integrally formed; the seal-forming structure may be overmolded onto the fascia portion; or the seal-forming structure may be formed separately from the fascia portion and configured to be permanently or removably connected to the fascia portion. In these embodiments, the rigidizer may be provided, for example, by being overmolded onto the fascia portion, or the fascia portion may be overmolded onto the rigidizer. Alternatively, the rigidizer may be permanently or releasably attached to the fascia portion, for example, by adhesive or other means.

[0095] In example embodiments: at least a portion of the fascia portion may have a higher stiffness than the seal-forming structure; the plenum chamber may include at least one reinforcement portion at the base of the nose portion, the at least one reinforcement portion having a higher stiffness than the nose portion; the nose portion of the seal-forming structure may include two side portions, the at least one reinforcement portion being provided below the side portion.

[0096] In example embodiments: the inner portion of the seal-forming structure may have a lower stiffness than the adjacent lateral portions of the seal-forming structure; the rearward-facing inner portion of the seal-forming structure may have a lower stiffness than the adjacent lateral portions of the seal-forming structure; the rearward-facing inner portion may include one or more of a lower lip portion that contacts the patient's chin area in use and an upper lip portion that contacts the patient's upper lip in use; the inner portion of the seal-forming structure has a lower stiffness than the adjacent lateral portions of the seal-forming structure and may include one or more of the following: an inner nose portion extending from a forward-facing portion of the nose portion to an upper lip portion that contacts the patient's upper lip in use, and an inner mouth portion extending from a forward-facing portion of the mouth portion to a lower lip portion that contacts the patient's chin area in use.

[0097] In example embodiments: a hollow protrusion that may be included in the plenum chamber extends from the fascia portion and has a plenum chamber inlet port; the hollow protrusion may extend from an inner and lower location on the fascia portion; the hollow protrusion may extend in a downward and forward direction; the hollow protrusion may extend substantially downward and partially forward; the hollow protrusion is integrally formed with the fascia portion; the hollow protrusion may have a lower rigidity than an upper portion of the fascia portion adjacent the hollow protrusion; the thickness of the upper portion of the fascia portion may taper downwardly into the hollow protrusion; and the inner portion of the seal-forming structure in the jaw region below the hollow protrusion may have a lower rigidity than the upper portion of the fascia portion.

[0098] In example embodiments, the difference in stiffness may be achieved by one or more of the following: wall thickness; stiffer material (e.g., the same material or another material with a different durometer), and reinforcing structure (e.g., ties or ribs, undercushion, section or chassis). In examples, one or more reinforcing structures may be selectively provided to the plenum chamber.

[0099] In example embodiments: the plenum chamber may include at least a first headgear connection point and a second headgear connection point, each of which is disposed laterally from the medial side of the fascia; the plenum chamber may include a first headgear connection support and a second headgear connection support, each of which includes at least one headgear connection point; the first headgear connection support and the second headgear connection support, each of which includes an upper headgear connection point and a lower headgear connection point. The fascia portion may include a gear connection point; the fascia portion may include a first lateral headgear support recess and a second lateral headgear support recess; the first lateral headgear support recess and the second lateral headgear support recess may be provided on the front side of the fascia portion; the first lateral headgear support recess and the second lateral headgear support recess may be configured to receive the first headgear connection support portion and the second headgear connection support portion, respectively; and the first headgear connection support portion and the second headgear connection support portion may each have a higher rigidity than the fascia portion.

[0100] In example embodiments: the plenum chamber may include a single plenum chamber inlet port; the plenum chamber may include at least a first plenum chamber inlet port and a second plenum chamber inlet port; the first plenum chamber inlet port may be provided on a first lateral side of the inner portion of the fascia portion, and the second plenum chamber inlet port may be provided on a second lateral side of the inner portion of the fascia portion; each plenum chamber port may be provided in an insert provided in the fascia portion; and each plenum chamber port may be provided in a flexible material of the fascia portion.

[0101] In example embodiments: the patient interface may include at least one conduit connector configured to connect to the plenum chamber inlet port; the patient interface may include a first conduit connector and a second conduit connector, the first conduit connector configured to pneumatically connect the first conduit to the plenum chamber to provide airflow at a therapeutic pressure to the plenum chamber for patient breathing, and the second conduit connector configured to pneumatically connect the second conduit to the plenum chamber to provide airflow at a therapeutic pressure to the patient interface chamber for patient breathing; and the first conduit connector and the second conduit connector may be configured to pneumatically connect a corresponding one of the first conduit and the second conduit to a corresponding one of the first plenum inlet port and the second plenum chamber aperture, respectively.

[0102] In examples, the plenum chamber may include a disconnect portion between the mouth region and the nose region. In examples, the plenum chamber may include a disconnect portion between the nose region and the fascia region. In examples, the plenum chamber may include a disconnect portion between the mouth region and the fascia region. In examples, the plenum chamber may include a disconnect portion between at least a portion of the seal-forming structure and one or more plenum chamber inlet ports. In examples, the disconnect portion may be provided by one or more of the following: one or more gusset portions, one or more pleats, one or more concertina portions.

[0103] In examples, at least a portion of the seal-forming structure may have a first surface finish, and other portions of the plenum chamber may have a second surface finish that is different from the first surface finish. In examples: the first surface finish may be provided on portions of the seal-forming structure that contact the patient's face during use, and the first surface finish may provide a higher coefficient of friction than the second surface finish; the first surface finish may be a polished finish; the second surface finish may be smoother to the touch than the first surface finish; the second surface finish may be a textured surface finish; the second surface finish may be flocked; the textured surface finish may be created by textured features in a material used to form the plenum chamber; the textured surface finish may be created by etching (e.g., laser etching).

[0104] In an example, the seal-forming structure may have a first surface finish in a first region and a second surface finish in a second region, the second surface finish being different from the first surface finish. In an example: the first surface finish may provide a higher coefficient of friction than the second surface finish; the first surface finish and the second surface finish may be provided on the mouth region and the nose region, respectively.

[0105] In example embodiments: the nasal portion of the seal-forming structure may include two lateral portions; each lateral portion has a lateral support portion, each lateral support portion having a higher resistance to deformation than an adjacent portion of the seal-forming structure; each lateral support portion may be thicker than an adjacent portion of the seal-forming structure; each lateral support portion may have a curved upper boundary; each lateral support portion may be substantially fin-shaped; the nasal portion of the seal-forming structure may include an inner portion configured to seal against an inferior periphery of the patient's nose surrounding the patient's nares and the patient's upper lip in use; the inner portion may have a lower stiffness than the lateral support portions; the nasal portion of the seal-forming structure may include an inner portion disposed between the inner portion and the lateral support portions; the inner portion may be configured to contact the ala of the patient's nose in use; the inner portion may be thicker than the inner portion; the inner portion may have a lower stiffness than the lateral support portions, and / or the seal-forming structure may be configured not to engage the patient's face below the chin in use.

[0106] In example embodiments, the seal-forming structure includes lateral perimeter supports disposed on opposite lateral sides of the oral cavity, the lateral perimeter supports being adjacent to the perioral portion and being stiffer than the perioral portion; the lateral perimeter supports may be thicker than the perioral portion. In examples, the seal-forming structure may include rearward-facing lateral portions that surround most of the perioral portion; the rearward-facing lateral portions may be stiffer than the perioral portion; the rearward-facing lateral portions may extend inwardly to the lateral-most edges of the oral cavity to form the lateral perimeter supports.

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

[0108] In examples, the vent structure may be provided in one or more of the following: the fascia; the fascia insert; and / or the conduit connector.

[0109] Another aspect of one form of the present technology is an oral-nasal patient interface that is configured to, in use, deliver a flow of air at a therapeutic pressure to the nasal and oral airways of a patient, where the oral-nasal patient interface seals against at least the underside of the patient's nose. Such an arrangement may be referred to as an "under-nose full-face" or "minimal contact full-face" type patient interface, and provides an ultra-compact form factor.

[0110] In examples, the oral-nasal patient interface may include a plenum chamber as described in any one of the aspects or examples thereof. In examples, the oral-nasal patient interface may include a seal-forming structure as described in any one of the aspects or examples thereof.

[0111] In examples, the seal-forming structure may not extend beyond the nasal bone of the patient's nose; the seal-forming structure may not extend beyond the nasal ridge of the patient's nose; the seal-forming structure may not extend beyond the upper surface of the tip of the patient's nose; and the seal-forming structure may not extend beyond the front surface of the tip of the patient's nose.

[0112] In examples, the seal-forming portion may include a first seal-forming portion constructed and arranged to form a seal with a patient's facial area surrounding an entrance to the patient's mouth, the seal-forming structure configured to deliver airflow at the therapeutic pressure to the mouth, the seal-forming structure constructed and arranged to maintain the therapeutic pressure in a plenum chamber throughout the patient's respiratory cycle in use. In examples, the seal-forming portion may include a second seal-forming portion constructed and arranged to form a seal with a patient's facial area surrounding an entrance to the patient's nose, the seal-forming structure configured to deliver airflow at the therapeutic pressure to the nose, the seal-forming structure constructed and arranged to maintain the therapeutic pressure in a plenum chamber throughout the patient's respiratory cycle in use. In examples, the first seal-forming portion may include a first hole configured to provide an air supply to the patient's mouth, and the second seal-forming portion may include at least one additional hole configured to provide an air supply to at least one of the patient's nostrils.

[0113] One form of the present technology includes a patient interface, the patient interface comprising: 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 the 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 a flow of air 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 airflow 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; and a venting structure that allows a continuous flow of gases exhaled by the patient to escape from within the plenum chamber to the ambient environment, the venting structure being sized and shaped to maintain the therapeutic pressure within the plenum chamber in use; The patient interface further includes: a pair of supports on opposite sides of an interface between the second seal-forming structure and the front wall of the plenum chamber, the supports configured to resist compression in the fore-and-aft direction;

[0114] In embodiments:

[0115] a) the support portion is connected to a portion of the second seal-forming structure that seals against the patient's upper lip in use;

[0116] 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 the lower corner of the patient's nose;

[0117] c) the support is curvilinear when viewed in a cross section parallel to the sagittal plane;

[0118] d) the support is curved when viewed in a cross section parallel to the frontal plane;

[0119] e) the plenum chamber includes a mouth region and a nose region;

[0120] f) each support is connected to a mouth region of the plenum chamber adjacent a boundary of the lateral sidewall of the mouth region and the lateral sidewall of the nose region;

[0121] g) each support is connected to a mouth region of the shell adjacent a boundary of the front wall of the mouth region and the front wall of the nose region;

[0122] h) the lateral sidewalls of the plenum chamber are curved inwardly adjacent their interface with the nasal region, and each support portion is substantially adjacent an adjacent lateral sidewall portion;

[0123] 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, wherein, in use, no part of any support or respective nasal aperture is directly under the support;

[0124] j) the interface further includes a positioning and stabilizing structure configured to generate a force to hold the seal-forming structure in a therapeutically effective position on the patient's head; and / or

[0125] k) The plenum chamber is at least partially defined by a shell, and a vent structure is provided in the shell.

[0126] 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 the 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 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; and a venting structure that allows a continuous flow of gases exhaled by the patient to escape from within the plenum chamber to the ambient environment, the venting structure being sized and shaped to maintain the therapeutic pressure within the plenum chamber in use; where: A first anterior wall portion of the nasal portion of the plenum chamber adjacent the boundary with the mouth portion of the plenum chamber is more flexible than the immediately adjacent area of ​​the mouth portion of the plenum chamber, and a second anterior wall portion of the nasal portion of the plenum chamber is immediately adjacent to the first anterior wall portion and is on the opposite side of the first anterior wall portion from the boundary with the mouth portion of the plenum chamber and is less flexible than the immediately adjacent area of ​​the anterior wall portion.

[0127] In the examples,

[0128] a) the first front wall portion is thinner than the immediately adjacent portion of the plenum chamber wall;

[0129] b) the second front wall is thicker than the immediately adjacent plenum chamber wall;

[0130] c) the first front wall portion and the second front wall portion are made of the same material;

[0131] d) the first front wall portion extends substantially across the entire width of the nose portion of the plenum chamber;

[0132] e) the second front wall portion extends across at least a majority of the width of the nasal portion of the plenum chamber;

[0133] f) the first front wall portion extends in an upward direction around at least one lateral edge of the second front wall portion;

[0134] g) the second front wall portion extends substantially across the entire width of the nose portion of the plenum chamber;

[0135] h) a central portion of the first front wall extends further upward than the lateral portions of the first front wall;

[0136] I) the upper boundary of the first anterior wall portion is curved;

[0137] j) the lower boundary of the first anterior wall is curved; and / or

[0138] k) The plenum chamber is at least partially defined by a shell, and a vent structure is provided in the shell.

[0139] 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 the 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 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; and a venting structure that allows a continuous flow of gases exhaled by the patient to escape from within the plenum chamber to the ambient environment, the venting 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 upward and forward from the boundary of the first seal-forming structure and the second seal-forming structure.

[0140] In the examples,

[0141] a) The inclination of each side section forms an angle of 20 to 90 degrees with the central contact surface of the mask;

[0142] b) when in use, no part of the patient interface comes into contact with the patient's nasal alar apex;

[0143] c) the interface is configured to avoid or at least reduce obstruction of the patient's nares relative to interfaces of the related art; and / or

[0144] d) The plenum chamber is at least partially defined by the shell, and the ventilation structure is provided in the shell.

[0145] 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 the 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 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; and a venting structure that allows a continuous flow of gases exhaled by the patient to escape from within the plenum chamber to the ambient environment, the venting 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.

[0146] In the examples,

[0147] a) the radius of curvature of the ridge is less than 2 mm;

[0148] b) the ridge extends substantially across the entire interface between the first seal-forming structure and the second seal-forming structure;

[0149] 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);

[0150] d) the raised portion resists wrinkling of the first seal-forming structure and / or the second seal-forming structure adjacent to the raised portion; and / or

[0151] e) In use, the plenum chamber is at least partially defined by the shell, and the vent structure is provided in the shell.

[0152] 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 the 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 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; and a venting structure that allows a continuous flow of gases exhaled by the patient to escape from within the plenum chamber to the ambient environment, the venting structure being sized and shaped to maintain the therapeutic pressure within the plenum chamber in use; where: At least a portion of the mouth region 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.

[0153] In the examples,

[0154] 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).

[0155] 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 to the component;

[0156] c) at least one component includes 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;

[0157] d) at least one component is releasably connectable to the flexible shell;

[0158] e) at least one component is permanently connected to the flexible shell;

[0159] f) at least one component is overmolded into the flexible shell;

[0160] g) the flexible shell includes a stiffened portion that is thicker than an immediately adjacent portion of the flexible shell;

[0161] h) at least one component is configured as a stiffening rib or band;

[0162] i) the central portion of the mouth of the plenum chamber has a higher stiffness than the remainder of the plenum chamber; and / or

[0163] j) The plenum chamber is at least partially defined by the shell, and the ventilation structure is provided in the shell.

[0164] An aspect of one form of the present technology is a patient interface that is capable of fitting a wide range of patient face shapes and sizes.

[0165] An aspect of one form of the present technology is a patient interface that is capable of fitting a wide variety of facial shapes and / or features.

[0166] An aspect of one form of the present technology is a patient interface that has a higher comfort level (e.g., due to lower headgear tension required to achieve a seal), which may result in reduced forces being applied to the patient's face and / or head.

[0167] An aspect of one form of the present technology is a patient interface that improves seal stability by reducing the transmission of destructive forces to the seal-forming structure (e.g., from lateral forces caused by a patient sleeping on their side with the side of their face against a pillow).

[0168] 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.

[0169] One aspect of the present technology is a method for manufacturing a device.

[0170] One aspect of certain forms of the present technology is a medical device that is easy to use, for example, by individuals without medical training, individuals with limited dexterity or acumen, or individuals with limited experience using such medical devices.

[0171] One aspect of one form of the present technology is a portable RPT device that can be carried by a person (e.g., around the home).

[0172] An aspect of one form of the present technology is a patient interface that can be cleaned at the patient's home, for example with soapy water, without the need for special cleaning equipment.An aspect of one form of the present technology is a patient interface that can be cleaned at the patient's home, for example with soapy water, without the need for special cleaning equipment.

[0173] The described methods, systems, devices, and apparatus may be implemented to enable improved functionality in a processor (e.g., a processor in a special purpose computer, a respiratory monitor, and / or a respiratory treatment device). Further, the described methods, systems, devices, and apparatus enable advancements in the art of automated management, monitoring, and / or treatment of respiratory conditions (e.g., sleep disordered breathing).

[0174] Of course, some of the above aspects may form sub-aspects of the present technology, and various sub-aspects and / or aspects may be combined in various ways to form further aspects or sub-aspects of the present technology.

[0175] Other features of the present technology will become apparent in light of the information contained in the following detailed description, abstract, drawings, and claims.

[0176] 4 Brief description of the drawings The present technology is illustrated by way of example and not limitation in the accompanying drawings, in which like reference numerals include like elements: [Brief explanation of the drawings]

[0177] [Figure 1A]4.1 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. The air from the RPT device 4000 is humidified by a humidifier 5000 and travels along an air circuit 4170 to the patient 1000. A bed companion 1100 is also shown. The patient is sleeping in a supine sleeping position. [Figure 1B] A system is shown including a patient 1000 wearing a patient interface 3000, which takes the form of a nasal mask and receives air at positive pressure supplied by an RPT device 4000. The air from the RPT device is humidified by a humidifier 5000 and travels along an air circuit 4170 to the patient 1000. [Figure 1C] The system includes a patient 1000 wearing a patient interface 3000. The patient interface 3000 takes the form of a full face mask and receives a positive pressure air supply from an RPT device 4000. Air from the RPT device is humidified by a humidifier 5000 and travels along an air circuit 4170 to the patient 1000. The patient is sleeping in a lateral sleep position. 4.2 Respiratory System and Facial Anatomy [Figure 2A] An outline of the human respiratory system including the nasal and oral cavities, larynx, vocal folds, esophagus, trachea, bronchi, lungs, alveolar sacs, heart and diaphragm. [Figure 2B] Diagram of the human upper respiratory tract including the nasal cavity, nasal bones, lateral nasal cartilages, greater alar cartilages, nostrils, upper lip, lower lip, larynx, hard palate, soft palate, oropharynx, tongue, epiglottis, vocal folds, esophagus, and trachea. [Figure 2C] A front view of the face including several features of the surface anatomy including upper lip, vermilion, lower lip, mouth width, medial canthus, alae of the nose, nasolabial folds, and corners of the mouth. The superior, inferior, radially inward, and radially outward directions are also indicated. [Figure 2D]A lateral view of the head including several features of the surface anatomy, including the glabella, serrion, nasal tip, subnasal point, upper lip, lower lip, supramenton, nasal ridge, alar crest, superior and inferior ear base points. The directions of superior and inferior, and anterior and posterior are also indicated. [Figure 2E]

[0023] Figure 1 is a further lateral view of the head, showing the approximate locations of the Frankfort horizontal and nasolabial angle. The coronal view is also shown. [Figure 2F] A bottom view of the nose including several features including the nasolabial fold, lower lip, upper lip vermilion, nostrils, subnasal point, columella, nasal tip, major axis of the nostrils and midsagittal plane. [Figure 2G] FIG. 1 is a side view of the surface features of the nose. [Figure 2H] Shown are the subcutaneous structures of the nose, including the lateral nasal cartilages, nasal septum cartilage, greater alar cartilage, lesser alar cartilage, nasal sesamoid cartilage, nasal bones, epidermis, adipose tissue, frontal process of the maxilla, and fibro-adipose tissue. [Figure 2I] The mid-nasal incision is shown approximately a few millimeters from the midsagittal plane, with particular attention paid to the 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] This is a side view of the skull, showing the outline of the head surface and some muscles. The following bones are shown: frontal, sphenoid, nasal, zygomatic, maxilla, mandible, parietal, temporal, and occipital. The mental protuberance is shown. The following muscles are shown: digastric, masseter, sternocleidomastoid, and trapezius. [Figure 2L] Shows the anterolateral side of the nose. 4.3 Patient Interface [Figure 3A] 1 shows a patient interface in the form of a nasal mask in accordance with one form of the present technology. [Figure 3B] 3C is a schematic cross-sectional view of the structure cut at a point, with the outward normal at this point shown, and the curvature at this point has a positive sign and a relatively large magnitude compared to the magnitude of the curvature shown in 3C. [Figure 3C]3B is a schematic cross-sectional view of the structure cut at a point, showing the outward normal at this point, where the curvature at this point has a positive sign and a relatively small magnitude compared to the magnitude of the curvature shown in FIG. [Figure 3D] Schematic cross-section of a structure cut at a point, where the outward normal at this point is shown and the curvature value at this point is zero. [Figure 3E] 3B is a schematic cross-sectional view of the structure cut at a point, showing the outward normal at this point. The curvature at this point has a negative sign and a relatively small magnitude compared to the magnitude of the curvature shown in FIG. 3F. [Figure 3F] 3B is a schematic cross-sectional view of the structure cut at a point, showing the outward normal at this point, where the curvature at this point has a negative sign and a relatively large magnitude compared to the magnitude of the curvature shown in FIG. [Figure 3G] 1 shows a mask cushion including two pillows, the outer surface of the cushion is shown, the edge of the surface is shown, and the dome region and saddle region are shown. [Figure 3H] 1 shows a cushion for a mask. The outer surface of the cushion is shown. The edge of the surface is shown. The path on the surface between points A and B is shown. The linear distance between A and B is shown. Two saddle regions and a dome region are shown. [Figure 3I] The surface of a structure is shown, with a one-dimensional hole drilled into the surface. The planar curves shown form the boundary of the one-dimensional hole. [Figure 3J] 3B is a cross-sectional view through the structure of Figure 3I. The surfaces shown bound a two-dimensional hole in the structure of Figure 3I. [Figure 3K] 3I includes a two-dimensional hole and a one-dimensional hole, and the surfaces bounding the two-dimensional hole in the structure of FIG. 3I are also shown. [Figure 3L] 1 shows a mask with an inflatable bladder as a cushion. [Figure 3M] 3L is a cross-sectional view of the mask of FIG. 3L showing the inner surface of the bladder, which bounds the two-dimensional hole in the mask. [Figure 3N] 3D shows a further cross section through the mask of FIG. 3L, with the interior surface also shown. [Figure 3O] Demonstrates the left-hand rule. [Figure 3P] Demonstrates the right-hand rule. [Figure 3Q] 1 shows the left ear including the left ear helix. [Figure 3R] The right ear is shown, including the right ear helix. [Figure 3S] Shows a right-handed spiral. [Figure 3T] 1 is a diagram of a mask including the signature of the twist of the space curve defined by the edges of the sealing membrane in different regions of the mask. [Figure 3U] A view 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] 3V is a cross-sectional view through the plenum chamber of FIG. 3V, the cross-section being taken in the midsagittal plane shown in FIG. 3V. The "central contact" plane is shown. The central contact plane is perpendicular to the midsagittal plane. The orientation of the central contact plane corresponds to the orientation of the tendon 3209. This tendon rests on the midsagittal plane and contacts the plenum chamber cushion only at two points on the midsagittal plane (i.e., superior point 3220 and inferior point 3229). Depending on the geometry of the cushion in this region, the central contact plane may contact both the superior and inferior points. [Figure 3X] The plenum chamber 3200 of Figure 3U is shown in a use position on the face. The midsagittal plane of the plenum chamber 3200 generally coincides with the midsagittal plane of the face when the plenum chamber is in the use position. The central contact plane generally corresponds to the "face plane" when the plenum chamber is in the use position. In Figure 3X, the plenum chamber 3200 is that of a nasal mask, with the upper point 3220 resting approximately on the selion and the lower point 3229 resting on the upper lip. 4.4 RPT Device [Figure 4A]1 shows an RPT device in accordance with one form of the present technology. [Figure 4B] 4.5 Humidifiers [Figure 5A]

[0023] Fig. 10 shows an isometric view of a humidifier in accordance with one form of the present technology. [Figure 5B] FIG. 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. [Figure 5C] The configuration of the humidifier controller 5250 is shown. 4.6 Respiration waveform [Figure 6] 4.7 First Embodiment of a Patient Interface of the Present Technology [Figure 7-1] FIG. 32 is a front view of a plenum chamber 3200 in accordance with one form of the present technology. [Figure 7-2] FIG. 7-2 is a rear view of the plenum chamber 3200 of FIG. 7-1. [Figure 7-3] FIG. 7-2 is a side view of the plenum chamber 3200 of FIG. 7-1. [Figure 7-4] FIG. 7-2 is a top view of the plenum chamber 3200 of FIG. 7-1. [Figure 7-5] FIG. 7-2 is a bottom view of the plenum chamber 3200 of FIG. 7-1. [Figure 7-6] FIG. 7-2 is a cross-sectional side view of the plenum chamber 3200 of FIG. 7-1. [Figure 8-1] FIG. 7-2 is a front view of a wall thickness heat map of the plenum chamber 3200 of FIG. 7-1. [Figure 8-2] FIG. 7-2 is a rear view of a wall thickness heat map of the plenum chamber 3200 of FIG. 7-1. [Figure 8-3]FIG. 7-2 is a side view of a wall thickness heat map of the plenum chamber 3200 of FIG. 7-1. [Figure 8-4] FIG. 7-2 is a top view of a wall thickness heat map of the plenum chamber 3200 of FIG. 7-1. [Figure 8-5] FIG. 7-2 is a bottom view of a wall thickness heat map of the plenum chamber 3200 of FIG. 7-1. [Figure 9] FIG. 36 shows a side view of a connection port 3600 3200 in accordance with one form of the present technology. [Figure 10-1] FIG. 10 is a first side view of a patient interface 3000 in accordance with another example of the present technology. [Figure 10-2] FIG. 10-2 is a second side view of the patient interface 3000 of FIG. 10-1. [Figure 11-1] FIG. 32 is a front view of a plenum chamber 3200 in accordance with another form of the present technology. [Figure 11-2] FIG. 11-2 is a rear view of the plenum chamber 3200 of FIG. 11-1. [Figure 11-3] FIG. 11-2 is a side view of the plenum chamber 3200 of FIG. [Figure 11-4] FIG. 11-2 is a top view of the plenum chamber 3200 of FIG. [Figure 11-5] FIG. 11-2 is a front view of the plenum chamber 3200 of FIG. 11-1 with the side inserts 3214 removed. [Figure 12-1] FIG. 11-2 is a front perspective view of the side insert 3214 of FIG. 11-1. [Figure 12-2] FIG. 11-2 is a rear perspective view of the lateral insert 3214 of FIG. [Figure 13-1] FIG. 30 is a front view of a patient interface 3000 in accordance with another embodiment of the present technology. [Figure 13-2] FIG. 13-2 is a side view of the patient interface 3000 of FIG. 13-1. [Figure 13-3] FIG. 13-2 is a perspective view of the patient interface 3000 of FIG. 13-1. [Figure 14-1] FIG. 10 is a front perspective view of a patient interface 3000 in accordance with another form of the present technology. [Figure 14-2]FIG. 14-2 is an exploded view of the patient interface 3000 of FIG. 14-1. [Figure 14-3] FIG. 14-1 is a front view of the plenum chamber 3200 in the patient interface 3000 of FIGS. 14-1 and 14-2. [Figure 14-4] FIG. 14-2 is a front perspective view of the plenum chamber 3200 of FIG. [Figure 14-5] FIG. 14-3 and FIG. 14-4 are front views of the rigidizer 3500 in the plenum chamber 3200. [Figure 14-6] Underside view of the rigidizer in Figure 14.5. [Figure 14-7] 14.5 and 14-6. FIG. 14.6 is a top view of the rigidizer 3500. [Figure 14-8] FIG. 14 is a front view of a chassis 3502 in the rigidizer 3500 of FIGS. 14-5 to 14-7. [Figure 14-9] FIG. 14-8 is a bottom view of the chassis 3502. [Figure 14-10] FIG. 14-8 is a top view of the chassis 3502 of FIGS. 14-9. [Figure 14-11] FIG. 14 is a front view of an insert 3504 in the rigidizer 3500 of FIGS. 14-5 to 14-7. [Figure 15-1] FIG. 32 is a front view of a plenum chamber 3200 in accordance with another form of the present technology. [Figure 15-2] FIG. 15-2 is a top view of the plenum chamber 3200 of FIG. 15-1. [Figure 15-3] FIG. 15-1 is a front view of the rigidizer 3500 in the plenum chamber of FIGS. 15-1 and 15-2. [Figure 15-4] FIG. 15-4 is a front view of the chassis 3502 of the rigidizer 3500 of FIG. 15-3. [Figure 15-5] 15.4 is a bottom view of the chassis 3502 of FIG. [Figure 15-6] FIG. 15-4 and FIG. 15-5 are top views of the chassis 3502. [Figure 15-7] FIG. 15-4 is a front view of the insert 3504 in the rigidizer 3500 of FIG. 15-3. [Figure 15-8]FIG. 15-8 is a bottom view of the insert 3504 of FIG. 15-7. [Figure 15-9] 15-8. 4.8 Second Embodiment of Patient Interface of the Present Technology [Figure 16] FIG. 10 is a rear perspective view of a plenum chamber, inlet ports not shown, in accordance with one form of the present technology. [Figure 17] FIG. 17 is a rear view of the plenum chamber of FIG. 16. [Figure 18] FIG. 17 is a front view of the plenum chamber of FIG. 16. [Figure 19] FIG. 17 is a side view of the plenum chamber of FIG. [Figure 20] FIG. 17 is a top view of the plenum chamber of FIG. 16. [Figure 21] 12 is a cross section of the plenum chamber through the plane 12-12. [Figure 22] FIG. 17 is a bottom view of the plenum chamber of FIG. [Figure 23] 14 is a cross section of the plenum chamber through the plane 14-14. [Figure 24] 15 is a cross section of the plenum chamber through plane 15-15. [Figure 25] 16 is a cross section of the plenum chamber through plane 16-16. [Figure 26] 17 is a cross section of the plenum chamber through plane 17-17. [Figure 27] 18 is a cross section of the plenum chamber through plane 18-18. [Figure 28] FIG. 1 is a side view of the plenum chamber in its in-use position on a patient's face, with the contours of the plenum chamber shown for clarity. [Figure 29] 10 illustrates specific areas of engagement with the patient's face by the seal-forming structures described. [Figure 30] FIG. 10 is a front perspective view of another form of a patient interface in accordance with the present technology. [Figure 31]

[0037] FIG. 10 is a front perspective view of a patient interface with the vent removed in accordance with yet another form of the present technology. DETAILED DESCRIPTION OF THE INVENTION

[0178] 5 Detailed Description of the Embodiments of the Present Technology Before describing the present technology in further detail, it is to be understood that the present technology is not limited to the specific embodiments described herein, which may vary. It is also to 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.

[0179] The following description is provided in connection 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.

[0180] While anatomical directional terms are used in describing aspects and examples of the present technology (e.g., "anterior," "posterior," "superior," "inferior," "lateral," "medial"), these directions apply in the context of the present technology during use by a patient. For example, the anterior side of a patient interface refers to the side of the patient interface that is anterior to the patient when the patient interface is worn in its intended manner.

[0181] When describing a surface or area as facing in a certain direction (e.g., "upward facing," "forward facing"), unless the context clearly indicates otherwise, the surface or area is to be understood as facing 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.

[0182] 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.

[0183] In certain embodiments of the present technology, a supply of air at positive pressure is provided to the patient's nasal passages via one or both nostrils.

[0184] In certain embodiments of the present technology, mouth breathing is restricted, limited or prevented.

[0185] 5.2 Treatment System In one form, the present technology includes an apparatus or device for the treatment of disordered breathing. The apparatus or device may include an RPT device 4000 that supplies pressurized air to the patient 1000 via an air circuit 4170 to a patient interface 3000.

[0186] 5.3 First Embodiment of Patient Interface A non-invasive patient interface 3000 in accordance with one aspect of the present technology includes the following functional features: a plenum chamber 3200 including a seal-forming structure 3100, a positioning and stabilizing structure 3300, a vent 3400, a form of connection port 3600 for connection to an air circuit 4170, and a forehead support 3700. In some forms, the functional features may be provided by one or more physical components. In some forms, a single physical component may provide one or more functional features. In use, the seal-forming structure 3100 is positioned to surround the entrance to the patient's airways to facilitate the delivery of air at positive pressure to the airways.

[0187] In some examples of the present technology, a plenum chamber 3200 is at least partially formed by a fascia portion 3210 (also referred to as a shell in some examples) and a seal-forming structure 3100. The plenum chamber 3200 may include, for example, a cushion module or cushion assembly. The fascia portion 3210 may function as a chassis for the seal-forming structure 3100.

[0188] In some examples of the present technology, the patient interface 3000 is an oral-nasal patient interface. That is, the patient interface 3000 is configured to seal against both the patient's nasal and oral airways. In some examples, the patient interface 3000 includes separate seals around the nasal and oral airways. For example, as shown in FIGS. 7-1 through 8-5, 10 through 11-5, and 13-1 through 13-3, the patient interface 3000 may include a plenum chamber 3200 having a nasal region 3230 and a mouth region 3260. The seal-forming structure may be configured to surround the nasal airways at the nasal region 3230 and to seal around the patient's mouth at the mouth region 3260. Thus, the seal-forming structure 3100 may also be considered to have a nasal region and a mouth region, where the nasal region and the mouth region of the seal-forming structure include portions that seal against the patient's nasal airways and around the oral cavity, respectively.

[0189] In the examples shown in FIGS. 7-1-8-5, 10-11-5, and 13-1-13-3, the seal-forming structure 3100 in the nasal region 3230 seals against the underside of the patient's nose rather than being positioned over the bridge or ridge regions of the patient's face. The nasal region 3230 may seal against the upper lip, the anterior surface of the ala and tip of the nose, and / or the underside of the tip of the nose. The actual seal location may vary from patient to patient. The nasal region 3230 may also be configured to contact and / or seal with the area of ​​the patient's face between the ala and nasolabial fold and the lateral portion of the upper lip adjacent to the nasolabial fold.

[0190] The seal-forming structure 3100 of the mouth region 3260 may be configured to form a seal against the periphery of a patient's mouth in use. The mouth region 3260 may be configured to form a seal against the patient's face, for example, at the upper lip, nasolabial folds, cheeks, lower lip, and chin.

[0191] One or more holes may be provided within the seal-forming structure 3100 to deliver airflow at therapeutic pressure to the patient's nostrils and the patient's mouth through the one or more holes. The seal-forming structure may define an oral hole and one or more nasal holes for delivery of airflow to the patient. In the example shown in FIGS. 7-1-8-5, 10-11-5, and 13-1-13-3, the plenum chamber 3200 includes the seal-forming structure 3100, which includes an oral cavity 3271 and two nostril portions 3272. Each of the nostril portions 3272 may be positioned on the plenum chamber 3200 to be substantially aligned with the patient's nostrils so as to deliver airflow to the patient's nasal passages in use. In another example, only a single hole may be provided in the nasal portion 3230 of the seal-forming structure 3100 to provide airflow to the patient's nasal passages.

[0192] 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.

[0193] 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 above ambient.

[0194] 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.

[0195] 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.

[0196] 5.3.1 Plenum chamber The plenum chamber 3200 has a perimeter shaped to be complementary to the surface contours of an average human face in the area where a seal is formed in use. In the examples shown in Figures 7-1-8-5, 10-11-5, and 13-1-13-3, the plenum chamber includes a fascia portion 3210 and a seal-forming structure 3100. In these examples, the peripheral edge of the plenum chamber 3200 is positioned in close proximity to the adjacent surface of the face. Actual contact with the face is provided by the seal-forming structure 3100. The seal-forming structure 3100 may extend around the entire edge of the plenum chamber 3200 in use.

[0197] In some forms of the present technology, the plenum chamber 3200 does not cover the patient's eye when in use. In other words, the eye is outside the pressurized space defined by the plenum chamber. Such forms may improve treatment compliance, often resulting in less intrusiveness and / or greater wearer comfort.

[0198] In certain forms of the present technology, at least a portion of the plenum chamber 3200 is constructed from a transparent material. The use of a transparent material may reduce the intrusiveness of the patient interface and may help improve compliance with treatment. The use of a transparent material may help the clinician see the placement and function of the patient interface.

[0199] 7-1-8-5, 10-11-5, and 13-1-13-3, according to examples of the present technology, a plenum chamber 3200 is formed in part by a fascia portion 3210. Furthermore, the plenum chamber 3100 is formed in part by a seal-forming structure 3200. In the examples shown in FIGS. 7-1-8-5, 10-11-5, and 13-1-13-3, at least a portion of the seal-forming structure 3100 and the fascia portion 3210 are integrally formed. In some forms, the plenum chamber 3200 (more specifically, the fascia portion 3210) and the seal-forming structure 3100 are formed from a single, homogenous piece of material.

[0200] In another example, the seal-forming structure 3100 is overmolded onto the fascia portion 3210. Alternatively, the seal-forming structure 3100 may be formed separately from the fascia portion 3210 and configured to be permanently or removably connected to the fascia portion 3210.

[0201] In examples, one or more reinforcing structures may be selectively provided in the plenum chamber 3200 to modify the fit and / or behavior of the patient interface 3000. A patient or clinician may be able to choose from multiple reinforcing structures (e.g., having different stiffness, shapes, or sizes). The reinforcing structures may be provided directly on the seal-forming structure 3100 and / or fascia portion 3200, or on components to which they are connected (e.g., the headgear connection support 3302, the lateral inserts 3214, or the headgear connector 3246 in various examples of the present technology).

[0202] 5.3.1.1 Plenum chamber fascia In the examples shown in Figures 7-1 to 8-5, 10-1 to 11-5, 13-1 to 13-3, 14-1 to 14-11, and 15-1 to 15-9, the seal-forming structure 3100 and the fascia portion 3210 are formed from a flexible material. In one example, the flexible material is silicone. In another example, the flexible material may be a thermoplastic elastomer (TPE), a suitable foam, or the like.

[0203] Generally, the fascia portion 3210 is configured to have sufficient stiffness to resiliently maintain the shape of the seal-forming structure 3100 while providing a degree of flexibility. In the examples shown in Figures 7-1-8-5, 10-1-11-5, 13-1-13-3, 14-1-14-11, and 15-1-15-9, at least a substantial portion of the fascia portion 3210 is stiffer than the seal-forming structure 3100.

[0204] In some examples, some portions of the fascia portion 3210 are more rigid than other portions. In the examples shown in FIGS. 7-1-8-5 and 10-1-10-2, the fascia portion 3210 includes first and second lateral headgear support recesses 3212 on a forward-facing side of the fascia portion 3210. The first and second lateral headgear support recesses 3212 are located adjacent the lateral portions 3145 of the mouth region 3260 of the seal-forming structure 3100 (discussed further below). The lateral headgear support recesses 3212 are configured to receive headgear connection supports 3302, as shown in FIG. 10-1. The headgear connection supports 3302 are constructed of a more rigid material (e.g., polycarbonate) to provide structural support for the headgear connection points. The wall thickness of the lateral headgear support recesses 3212 may be thinner than adjacent portions of the fascia portion 3210, with the required rigidity being provided in combination with the headgear connection support portions 3302. The headgear connection support portions 3302 may be secured in place by one or more of the following: overmolding, adhesive bonding, welding, etc. The provision of the headgear support recesses 3212 allows for avoidance of excess rigidity, bulk, and / or weight of the plenum chamber 3200.

[0205] In the exemplary plenum chamber 3200 shown in FIGS. 11-1 through 13-3, the fascia portion 3210 has first and second side inserts 3214. The side inserts 3214 are constructed of a stiffer material, such as polycarbonate, or a flexible material having a higher durometer than the rest of the fascia portion 3210. As shown in FIGS. 12-1 and 12-2, the side inserts 3214 have inner rims 3215 that define the plenum chamber inlet ports 3240. In the illustrated example, the outer rims 3216 of the side inserts 3214 are formed as flanges with a plurality of positioning features 3217 (e.g., in the form of windows, recesses, or protrusions). Referring to FIG. 11-5, the fascia portion 3210 has insert openings 3218 at upper and lateral positions. The insert openings 3218 receive the side inserts 3214. During manufacture, the side inserts 3214 may be inserted into a tool holding the plenum chamber 3200 and bonded to the fascia portion 3210 using an overmold on the outer rim 3216. In embodiments where a non-adhesive material is used (e.g., non-adhesive silicone), the locating features 3217 may help provide a mechanical bond. In another example, an adhesive material may be used that may obviate the need for locating features 3217 to achieve a sufficient bond.

[0206] Other examples are contemplated in which a substantial portion of the fascia portion 3210 is stiffer than the flexible inner portion 3219 (e.g., as shown in FIG. 11-1) that is maintained in the vertical direction. For example, the fascia insert of the exemplary plenum chamber 3200 shown in FIGS. 11-1 through 13-3 may be sized and shaped to occupy a substantial portion of the fascia portion 3210. In another embodiment, a portion of the fascia portion 3210 may be constructed of a flexible material, but may have a higher stiffness than the inner portion. Such a difference in stiffness may be enabled by one or more of the following: wall thickness; stiffer materials (e.g., the same material with a different durometer) and reinforcing structures (e.g., ties or ribs, undercushion, section or chassis) in various examples of the present technology.

[0207] Plenum chamber with rigidizer 14-1 through 14-11, an embodiment of a patient interface 3000 having another plenum chamber 3200 is illustrated in accordance with an embodiment of the present technology. In the embodiment of FIGS. 14-1 through 14-11, the medial portion 3219 is configured to allow for some control of the deflection allowed by the inner region of the fascia portion 3210. For example, a rigidizer 3500 is provided within the fascia portion 3210.

[0208] As shown in FIG. 14-2, the plenum chamber 3200 is formed as a two-part structure including a fascia portion 3210 and a seal-forming structure 3100. In this embodiment, the fascia portion 3210 and the seal-forming structure 3100 are constructed as separate components from flexible materials. However, the fascia portion 3210 and the seal-forming structure 3100 may also be constructed as a single component. Additionally, the fascia portion and the seal-forming structure 3100 may be constructed from more than one material, with at least one of them being relatively rigid to provide additional support and structure to the plenum chamber 3200.

[0209] The rigidizer component 3500 is constructed and / or arranged to promote or allow inward flexing of the medial portion 3219 about at least one axis (e.g., an axis in the inferior-superior direction (vertical axis) and an oblique front-to-rear axis). In a neutral position as shown in FIGS. 14-1 and 14-3-14-5, the rigidizer 3500 is shaped (e.g., curved) to generally correspond to the curve of the medial region 3210 of the plenum chamber 3200. However, the rigidizer 3500 can reduce or substantially limit outward flexing of the medial region 3210 beyond the neutral position.

[0210] Reducing or substantially limiting outward bending can improve the sealing performance of the plenum chamber 3200, particularly in the nose region 3230. For example, the rigidizer 3500 can prevent deformation of the nose region 3230 that can occur when internal pressure in the plenum chamber 3200 increases.

[0211] 14-6-14-11, further aspects of the rigidizer 3500 are shown. In the embodiment of FIGS. 14-6-14-11, the rigidizer 3500 is a two-part structure having a chassis 3502 and an insert 3504. However, the rigidizer 3500 may be formed as a single component (e.g., by 3D printing techniques or molding). The rigidizer 3500 is constructed and / or arranged to provide a single layer beam during deflection in a first direction and a composite beam during deflection in a second direction. The provision of a single layer beam and a composite beam allows the rigidizer to have a relatively higher flexibility in a first direction and a relatively lower flexibility in a second direction.

[0212] The chassis 3502 includes a bridge 3506. The bridge 3506 spans from a first lateral side 3508 to a second lateral side 3510 of the plenum chamber 3200. The rigidizer 3500 is generally symmetrical around the inner surface of the plenum chamber 3200.

[0213] A port structure 3512 is provided at each end of the bridge 3506. For example, each port structure 3512 may be molded as a one-piece, integral component with the bridge 3506. Alternatively, the port structure(s) 3512 may be molded separately from the bridge 3506 and then attached to the bridge 3506, for example, using adhesive. In a further embodiment, the rigidizer 3500 is not attached to the port structure(s) 3512, but instead may be provided as a separate component disposed between separate components (e.g., the lateral inserts 3214 described with reference to FIGS. 11-1-11-6 and 12-1-12-2).

[0214] Each port structure 3512 thus substantially corresponds to a lateral insert 3214. However, the port structure(s) 3512 may have other shapes and features.

[0215] As perhaps best shown in FIG. 14-8, the bridge 3506 has a plurality of teeth 3514. The teeth 3514 are tapered along their length such that adjacent teeth define tapered channels 3516. The ends of each tooth 3514 are cantilevered from the bridge 3506.

[0216] The insert 3504 includes a body portion 3518 and a plurality of teeth 3520. The shape of the teeth 3520 is substantially similar to, and preferably identical to, the shape of the teeth 3514. As can be seen in FIG. 14-11, the teeth 3520 are tapered such that tapered channels 3522 are defined with adjacent teeth.

[0217] The teeth 3520 on the insert 3504 and the teeth 3514 on the chassis 3506 interdigitate with each other so that the channels 3522 receive the teeth 3514 and the channels 3516 receive the teeth 3520 .

[0218] The angle of the tooth 3520 relative to the body is indicated by θ2 in FIG. 14-11 and is substantially the same as the angle θ1 shown in FIG. 14-8. This promotes intermeshing of the teeth 3514 and 3520 and minimizes or completely eliminates gaps between adjacent teeth on the lateral sides. For example, in the neutral position as shown in FIGS. 14-1 and 14-3-14-5, the adjacent and intermeshing teeth are in contact or slightly separated from each other.

[0219] This arrangement allows the rigidizer 3500 to flex slightly about an inferior-superior axis outward, away from the patient's face. However, because adjacent teeth contact each other during outward flexing of the plenum chamber 3200, a composite beam having at least two layers is created. This composite beam substantially limits or prevents further outward flexing about the axis. As a result, flexing of the fascia away from the patient's face can be reduced or substantially prevented. This composite beam is shown in FIG. 14-6, where a first layer thickness x is provided by the bridge 3506 and body portion 3518, and a second layer thickness y is provided by the teeth 3514 and 3520. The thicknesses x and y of the first and second layers can be adjusted to control the amount of flexing in one or more of the first and second directions. For example, increasing the thickness of the teeth 3514 and 3520 can provide a relative increase in stiffness and resistance to flexing in the second direction. Alternatively, increasing the thickness of the bridge 3506 and body portion 3518 may provide a relative increase in stiffness and therefore resistance to deflection in the first direction.

[0220] Additionally, the effective widths of each of the teeth 3514 and 3520 are shown as W1 and W2 in FIGS. 14-8 and 14-11, respectively. The effective widths W1 and W2 are identical to one another. This promotes the teeth 3514 and 3520 having the same stiffness as one another, so that the chassis 3502 and the insert 3504 have substantially the same bending stiffness. This may be advantageous in providing a rigidizer 3500 with predictable or consistent control of deflection in the second direction. However, it is contemplated that one or more of the teeth 3514 and 3520 may be a different size or shape or constructed of a different material than one or more of the other teeth, thereby allowing the rigidizer 3500 to achieve a desired amount of deflection in the second direction (e.g., away from the patient's face).

[0221] The bridge 3506 and body portion 3518 are structured to allow the rigidizer to flex toward the patient's face. However, as the bridge 3506 and body portion 3518 flex toward the patient's face, the adjacent teeth 3514 and 3520 are separated from one another, allowing the bridge 3506 and body portion 3518 to flex (according to the material properties and structure of the bridge 3506 and body portion 3518). Thus, the rigidizer 3500 allows the plenum chamber 3200 to flex inward toward the patient's face, providing a desired amount of resistance to flexing toward the patient's face.

[0222] 14-1-11, at least one of the bridge 3506 and the body portion 3518 has a curved shape. This curved shape may allow the rigidizer 3500 to better conform to the shape of the patient's face. Additionally, this curved shape may allow for a useful range of flexure within the fascia while still providing a lower profile mask.

[0223] 5.3.1.2 Separate plenum chamber with rigidizer 15-1 through 15-9, another embodiment of a plenum chamber 3200 is shown having a rigidizer 3500. The plenum chamber 3200 is similar to the plenum chamber 3200 of FIGS. 7-1 through 7-6 and 8-1 through 8-5. However, the rigidizer 3500 is provided at the front of the plenum chamber 3200 and is generally symmetrically disposed around the inner surface of the plenum chamber 3200.

[0224] The rigidizer 3500 is substantially identical to the rigidizer 3500 described with reference to Figures 14-1 to 14-11. Therefore, like reference numerals refer to like components. However, the rigidizer 3500 of Figures 15-1 to 15-9 does not include the port structure(s) 3512.

[0225] 5.3.1.3 Plenum chamber inlet port The fascia portion 3210 may include one or more plenum chamber inlet ports 3240. The one or more plenum chamber inlet ports 3240 may allow connection to other components (e.g., decoupling structures, venting arrangements, heat moisture exchangers (HMX), constant flow vents (CFV), anti-asphyxiation valves (AAV), and / or connections to conduits in various examples).

[0226] In the examples shown in FIGS. 7-1-8-5 and 10-1 and 10-2, the plenum chamber 3200 includes a single inlet port 3240. The fascia portion 3210 includes an integrally formed hollow protrusion 3250 extending from an inward and lower location on the fascia portion 3210. The hollow protrusion 3250 extends downward and forward and is positioned downward rather than forward. The free end of the hollow protrusion 3250 terminates in a rim 3252 that surrounds the inlet port 3240. A connection port ridge 3608 is provided on the interior of the rim 3252 to facilitate connection of the air circuit 4170 and / or the connection port 3600.

[0227] In this configuration, the hollow protrusion 3250 is adjacent to the patient's face and receives the air circuit (from a generally downward and partially forward position and angle). One advantage of this embodiment is that it aids in a low-profile appearance of the patient interface 3000. When a patient turns their head toward a pillow while sleeping on their side, there is less chance of disrupting the seal with the seal-forming structure 3100 through disruptive forces from the patient's pillow opposing the forward-projecting components of the patient interface 300. Furthermore, the closed connection and downward angle of the air circuit 4170 positions the air circuit 4170 closer to the patient's face. Forces applied from the air circuit 4170 to the plenum chamber 3200 (e.g., from tubing drag from the weight of the air circuit 4170 or forces acting on the air circuit 4170) are applied from a shorter distance away from the seal formed by the seal-forming structure 3100, thereby reducing the moment applied to the seal.

[0228] The stiffness of hollow protrusion 3250 between adjacent portions of fascia portion 3210 and rim 3252 is less than that of at least upper portion 32RR of fascia portion 3210. As can be seen in FIGS. 8-1 through 8-5, this lower stiffness can be achieved by providing a relatively thinner wall in this region of hollow protrusion 3250. In this example, the thickness of upper portion 3254 and other adjacent portions of fascia portion 3210 tapers downwardly into hollow protrusion 3250. Lower portion 3256 of hollow protrusion 3250 is provided below hollow protrusion 3250, where the lower portion 3256 is less stiff than upper portion 3254.

[0229] As a result of this arrangement, the hollow protrusion 3250 may be able to deform significantly while still providing function. More particularly, the hollow protrusion 3250 may deform without obstructing the connection between the plenum chamber 3200 and the air circuit 4170. Furthermore, because the hollow protrusion 3250 is flexible, a degree of disconnection may be achieved between the air circuit 4170 and the seal-forming structure 3100, thereby reducing the likelihood of the seal with the patient's face being broken due to forces experienced by the air circuit 4170.

[0230] This reduced spacing of the supply conduit connection from the seal-forming structure also provides benefits when the patient is sleeping in a face-up supine position. Positioning the hollow protrusion 3250 generally downwardly adjacent the patient's face and orifice holds the air circuit 4170 in close proximity to the patient, and the weight of the air circuit 4170 assists in creating a seal between the seal-forming structure 3100 and the patient's chin area. The fascia 3210 is also flexible adjacent the hollow protrusion 3250, allowing it to deform and absorb some of the forces imparted by the air circuit 4170. Without this flexibility, the positioning and stabilizing structure 3300 may need to be tightened to counteract these forces, which may result in patient discomfort.

[0231] In the examples shown in FIGS. 11-1 through 13-3, the plenum chamber 3200 includes two inlet ports 3240. The inlet ports 3240 are located on the lateral sides of the fascia portion 3210. In these examples, the inlet ports 3240 are configured to connect to conduits that connect to decoupling components located above the patient's head, where the conduits are connected to the air circuit. These conduits may form part of the positioning and stabilizing structure 3300 (i.e., may be "headgear conduits"). In the examples shown, the inlet ports 3240 may receive a combination headgear and conduit connection assembly to provide multiple functions (e.g., ventilation, airflow supply, and headgear attachment point). The combination headgear and conduit connection assembly may also include an AAV. In these examples, the inlet ports 3240 are non-circular in shape.

[0232] While the example shown in FIGS. 11-1 through 13-3 has the inlet port 3240 located in the side insert 3214, other examples are contemplated in which the inlet port 3240 is formed directly in the fascia portion 3210.

[0233] 5.3.1.4 Seal-forming structure In one form of the present technology, the seal-forming structure 3100 provides a target seal-forming area and may further provide a cushioning function. The target seal-forming area is the area where a seal may occur in the seal-forming structure 3100. The area where a seal actually occurs (i.e., the actual sealing surface) may vary from patient to patient in a given treatment session and from day to day, depending on a range of factors (e.g., placement of the patient interface on the face, tension in the positioning and stabilizing structure, and the shape of the patient's face).

[0234] In one form, the target seal-forming area is located on an exterior surface of the seal-forming structure 3100 .

[0235] In certain forms of the present technology, the seal-forming structure 3100 is constructed from a biocompatible material (eg, liquid silicone rubber (LSR), or a biocompatible TPE).

[0236] A seal-forming structure 3100 according to the present technology may be constructed from a soft, flexible and resilient material (eg, LSR or TPE).

[0237] In certain forms of the present technology, a system is provided that includes more than one seal-forming structure 3100. Each seal-forming structure 3100 is configured to accommodate a different size and / or shape range. For example, the system may include one form of seal-forming structure 3100 that is suitable for large head sizes but not small head sizes, and another that is suitable for small head sizes but not large head sizes.

[0238] In certain forms of the present technology, regions of the seal-forming structure 3100 may have a different stiffness than other regions of the seal-forming structure 3100. In various examples of the present technology, such differences in stiffness may be achieved by one or more of the following: wall thickness; stiffer materials (e.g., the same material or different materials with different durometer hardness) and reinforcing structures (e.g., ties or ribs, undercushions, sections or chassis).

[0239] In examples, the seal-forming structure 3100 may be substantially as described in International Application No. PCT / AU2019 / 050278, the entirety of which is incorporated herein by reference.

[0240] 5.3.1.4.1 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.

[0241] In one form, the seal-forming structure 3100 includes a sealing flange and a support flange. The sealing flange includes a relatively thin member having a thickness of less than about 1 mm (e.g., about 0.25 mm to about 0.45 mm) that extends around the peripheral length of the plenum chamber 3200. The support flange may be relatively thicker than the sealing flange. The support flange is disposed between the sealing flange and the peripheral edge of the plenum chamber 3200 and extends around at least a portion of the peripheral length. The support flange is or includes a spring-like element that functions to support the sealing flange against buckling during use.

[0242] In one form, the seal-forming structure may include a compression seal or gasket seal that is constructed and arranged to be in compression in use due to, for example, elastic tension in the positioning and stabilizing structure.

[0243] In one form, the seal-forming structure includes a tensioning portion that, in use, is held taut by, for example, an adjacent region of the sealing flange.

[0244] In certain forms of the present technology, the seal-forming structure may include one or more of a pressure-assisted sealing flange, a compression seal, a gasket seal, a tension section, and a section having a sticky or adhesive surface.

[0245] 5.3.1.4.2 First embodiment of the nose area In certain forms of the present technology, the seal-forming structure 3100 includes an inner portion configured to form a seal against the underside of the patient's nose. The inner portion may seal against the lower periphery of the patient's nose (e.g., around the patient's nostrils and the patient's upper lip). In examples, the seal-forming structure 3100 may be configured to contact the patient's face under the bridge of the nose or under the tip of the nose.

[0246] As shown in FIGS. 7-1 to 8-5, 10 to 11-5, and 13-1 to 13-3, seal-forming structure 3100 includes an inner portion configured to seal around the lower periphery of a patient's nose during use, and an inner portion configured to be positioned at or near the patient's ala during use. More specifically, inner portion includes upwardly facing inner portion 3111 and forwardly facing inner portion 3115. Further, middle portion includes upwardly facing middle portion 3121 and forwardly facing middle portion 3125. Most or all of the contact between the middle portion and the patient's nose is made by upwardly facing middle portion 3121.

[0247] The upper lip portion 3116 may significantly contact the underside of the patient's nose as well as the patient's upper lip. In some examples, the seal formed by the seal-forming surface 3100 and the lower periphery of the patient's nose may be largely comprised of the upwardly facing interior portion 3111 and the upper lip portion 3116. The upwardly facing interior portion 3111 and the upper lip portion 3116 may each be less stiff than other portions of the seal-forming structure 3100, which in some examples of the present technology is provided by a thinner wall thickness than other portions of the seal-forming structure 3100. The underside of the patient's nose and upper lip may have complex geometries and may be sensitive to pressure. Therefore, it is advantageous to make the areas of the plenum chamber 3200 that contact or seal against these locations flexible and compliant to avoid excessive pressure on the face in these areas. In these examples, the low stiffness made possible by the thin wall thickness in the inner portion of the nasal portion 3230 of the seal-forming structure 3100 near the nostrils 3272 allows the cushion to easily deform to seal against the lower surface of the patient's nose (e.g., the anterior tip, the lateral sides, and either ala of the upper lip).

[0248] The thin wall thickness of the upwardly facing medial portion 3111 and upper lip portion 3116 allows the seal-forming structure to expand in these areas to conform to the geometry of the underside and the surrounding area of ​​the patient's nose. The thin walls are able to deform and expand under pressure, conforming to the surface of the patient's face to create an effective and comfortable seal.

[0249] The upwardly facing inner region 3111 above and in front of the nostrils 3272 of the seal-forming structure is intended to seal below and partially in front of the patient's tip of the nose. Because the tip of the nose can be a relatively sensitive area on many patients, the wall thickness of this region of the seal-forming structure 3100 may be reduced. The inner portion may extend from the rear upwardly facing inner portion 3111 (i.e., facing the patient) side of the cushion through the inner saddle region 3112 and peripheral edge into the forward-facing inner portion 3115 on the anterior (i.e., away from the patient) side of the seal-forming structure. Reducing the wall thickness in this region avoids excessive pressure on the sensitive tip of the nose area.

[0250] The upper lip portion 3116 of the seal-forming structure 3100 is intended to seal against the upper lip. The upper lip portion 3116 is provided on the inside and below and behind the nostrils 3272. The upper lip portion 3116 may include low wall stiffness. In some instances, low wall stiffness is achieved by a thin wall thickness. Because the upper lip may be a sensitive area, as may the area of ​​the seal-forming structure 3100 intended to seal against the nasal tip, a thin wall thickness extends across the inside lower / back region of the nasal region 3230 of the seal-forming structure 3100. The thin wall thickness allows for less force to be applied to the upper lip than would be applied by a relatively thick wall thickness.

[0251] In these examples, as shown in FIGS. 7-1 through 8-5, 10 through 11-5, and 13-1 through 13-3, the nasal region 3230 of the seal-forming structure 3100 includes two lateral portions 3231. Each lateral portion 3231 of the nasal region 3230 may include a patient-facing side and a non-patient-facing side. The patient-facing side may face in a medial and posterior direction, and the non-patient-facing side may face in a lateral and anterior direction. Both the patient-facing side and the non-patient-facing side may face partially upward.

[0252] An additional benefit of the flexible inner region of the nasal portion 3230 is that it allows the sides of the nasal portion 3230 to be pulled inward (e.g., medially) when the patient interface 3000 is donned and a downward force is applied from the patient's nose onto the upwardly facing inner portion 3111 of the seal-forming structure. Pulling the sides of the nasal portion 3230 inward toward the sides of the patient's nose pulls the seal-forming structure 3100 into and around the lower periphery of the patient's nose, allowing for an improved seal.

[0253] In embodiments of the patient interface 3000 that include a rigidizer 3500 in the plenum chamber 3200, the flexible inner region allows the sides of the nasal regions 3230 to be pulled inward during use. However, the rigidizer 3500 may limit or substantially prevent the flexible inner region from flexing outward beyond a desired limit. This may help prevent or eliminate flaring of the nasal sealing region, which can affect the sealing performance of the mask. Thus, embodiments of the patient interface 3000 with a rigidizer achieve the benefits of providing a flexible interface that allows for improved comfort and seal performance, while also addressing factors that can adversely affect seal performance in more flexible patient interfaces. While the lateral sides of the nasal regions 3230 are pulled inward, the anterior region retains sufficient structural rigidity to maintain the overall shape of the seal-forming structure 3100 and avoid leak paths due to folds.

[0254] While it is advantageous to reduce the wall thickness of the seal-forming structure 3100 in the areas of the seal-forming structure 3100 described above to enable it to comfortably conform to complex geometries, relatively larger wall thicknesses in some areas of the seal-forming structure 3100 are advantageous in other forms of the present technology.

[0255] In examples, the seal-forming structure 3100 may generally be thicker toward its front side, which is closer to the fascia portion 3210. As noted above, the seal-forming structure 3100 includes lateral support portions 3151 in the form of thickened regions on the partially forward-facing lateral sides of the nose portion 3230 of the seal-forming structure 3100. The thicker regions of the seal-forming structure 3100 adjacent the shell fascia portion provide good support and structural rigidity for the seal-forming structure 3100.

[0256] While a thicker region adjacent the fascia portion 3210 may be advantageous for structural rigidity, the nose portion 3230 of the seal-forming structure 3100 also retains a level of flexibility to allow the sides of the seal-forming structure 3100 to be pushed outward or pulled inward to accommodate noses of different widths.

[0257] For example, the side or region of the nasal portion 3230 of the seal-forming structure 3100 that does not face the patient (e.g., the front side, the side that faces at least partially forward) (particularly the area on either side of the nasal portion 3230 of the seal-forming structure 3100 that does not contact the patient) is thick enough to provide sufficient structural rigidity to the seal-forming structure 3100, and is thin enough so that when a patient with a long, narrow nose wears the seal-forming structure 3100, a downward force acting on the inner region 3111 facing upward from the patient's nose can pull the side of the nasal portion 3230 slightly inward to enable the patient-contacting surface of the seal-forming structure 3100 on either side of the patient's nose to make good contact with the patient's nose. Similarly, the structure of the nose portion 3230 of the seal-forming structure 3100 is sufficiently flexible so that when a patient with a wider nose wears the seal-forming structure 3100, there is no excessive inward force on the sides of the patient's nose (which may occur if the seal-forming structure is too stiff to withstand the wider nose). It is also possible to provide a number of different sizes of the seal-forming structure 3100 to accommodate a range of nose widths.

[0258] In some examples of the present technology, the plenum chamber 3200 includes lateral support regions 3151 on the anterior sides of the nose region 3230 of the plenum chamber 3200. The lateral support regions 3151 may have a higher resistance to deformation than one or more adjacent portions 3100 of the seal-forming structure. The lateral support regions 3151 may be stiffer than regions of the plenum chamber 3200 above the lateral support regions 3151. Additionally or alternatively, the lateral support regions 3151 may be stiffer than inner regions of the plenum chamber 3200. The relatively stiffer regions may take on a fin shape configured to provide a relatively stiffer region than surrounding regions of the plenum chamber. The lateral support regions 3151 may be substantially fin-like shaped (e.g., having a curved upper boundary and a flatter lower boundary). The use of a fin-like shape (particularly providing a curved upper boundary or edge) is advantageous because the upper edge or boundary of the lateral support portion 3151 follows the curvature of the upper periphery of the nose portion 3230. This can be advantageous in that it provides a consistent height of the nose portion 3230 above the fascia 3210 and consistent or controlled stiffness of the nose portion 3230 structure.

[0259] In some examples of the present technology, the plenum chamber is helped to avoid buckling by reinforcement at the base of the nose section 3230. In examples, as shown in FIGS. 8-1 through 8-5, a thicker fascia portion 3210 extends along the base of the forward-facing portion of the nose section 3230 and at least partially around the lateral sides of the nose section 3230. As can be seen in at least FIGS. 8-1, 8-3, and 8-5, in examples, a portion of the fascia portion 3210 extends at least partially underneath the lateral support portion 3151 to provide reinforcement.

[0260] 7-1 and 7-2, an oral-nasal transition 3275 is provided at the periphery of the plenum chamber 3200 where the nasal region 3230 and the mouth region 3260 connect. Because the periphery of the seal-forming structure 3100 is preferably stiff enough to support the overall shape of the seal-forming structure 3100 and avoid significant folding and buckling, the shape of the periphery may be more varied than the regions that contact the patient's face and neighboring regions (i.e., thinner and thicker zones to avoid creating leak paths through the patient's face due to folding). In either case, the oral-nasal transition 3275 between the nasal and mouth regions of the seal-forming structure 3100 is relatively stiff (e.g., relatively thick) compared to less stiff portions of the seal-forming structure 3100 (e.g., the upwardly facing medial portion 3111) to avoid the development and creation of leaks between these regions due to folding or buckling. Alternatively, the oral-nasal transition 3275 may be reinforced by any suitable means (eg, an undercushion, ribs, a portion of the shell, or a frame).

[0261] 5.3.1.4.3 Oral area In one form, the non-invasive patient interface 3000 includes a seal-forming structure 3100 that, in use, forms a seal over the upper lip region (i.e., upper lip) of the patient's face. The seal-forming structure 3100 may include an upper lip portion 3116 configured to form a seal against the patient's upper lip.

[0262] In one form, the seal-forming structure 3100 includes a saddle-shaped region that is constructed to form a seal over the upper lip region of the patient's face in use.

[0263] In one form, the non-invasive patient interface 3000 includes a seal-forming structure 3100 that, in use, forms a seal around the patient's mouth at the mouth region 3260. The seal-forming structure 3100 may form a seal over the chin region of the patient's face.

[0264] In one form, the seal-forming structure 3100 includes a saddle-shaped region constructed to form a seal over the chin region of the patient's face in use.

[0265] In the examples of the plenum chamber 3200 shown in FIGS. 7-1-8-5, 10-11-5, and 13-1-13-3, the seal-forming structure 3100 includes a lower lip 3118 that forms a seal against the patient's chin area. In one example, the seal-forming structure 3100 including the lower lip 3118 does not extend below the patient's chin (i.e., below the mental prominence) in use or engage with the patient's face below the chin (i.e., below the mental prominence) in use. The lower lip 3118 of the seal-forming structure may seal against the patient's lower lip and chin. Further, in these examples, the seal-forming structure 3100 includes a mouth hole perimeter 3117. The lower lip 3118 may be connected to (e.g., adjacent to) the upper lip 3116 via the mouth hole perimeter 3117. The seal-forming structure 3100 includes a relatively small wall thickness (compared to other areas) at the mouth hole periphery 3117 and at the lower lip 3118 of the seal-forming structure 3100, which is positioned against the chin region. The reduced wall thickness in these locations helps achieve an effective and comfortable seal. The seal-forming structure 3100 in these areas can easily conform to any complex geometry (e.g., the mandibular fold).

[0266] In these examples, the mouth region 3260 includes rearward-facing side portions 3135 on the patient-contacting side of the seal-forming structure 3100. While the wall thickness of the mouth hole perimeter 3117 immediately surrounding the mouth hole 3271 is thinner compared to other areas of the seal-forming structure 3100, in these examples there are rearward-facing side portions 3135 on either lateral side of the mouth hole perimeter 3117 that are thicker than the mouth hole perimeter 3117. Because the areas that come into contact with these regions in use (i.e., the patient's cheeks) are often not as sensitive as other areas of the face, patients often can tolerate a seal-forming structure 3100 with greater wall thickness / stiffness in these areas. Additionally, the rearward-facing side portions 3135 of the mouth region 3260 are curved away from the contacting portions with the patient's face, thereby reducing the contact area on the patient's face in these areas. In another example, instead of being thicker, the rearward-facing side portions 3135 of the mouth area 3260 may be made stiffer by other means (e.g., reinforcing structures (e.g., ribs), stiffer material, undercushion)).

[0267] The lateral periphery of the mouth region 3260 includes lateral portions 3145 of the mouth region 3260 that are more distal from contact with the patient (e.g., closer to the fascia portion 3210) than the posterior-facing lateral portions 3135. In these examples, the lateral portions 3145 are thicker than the posterior-facing lateral portions 3135 of the mouth region. Because most or all of the lateral portions 3145 are unlikely to come into contact with the patient's face during use, patient comfort is less of a critical design consideration in these regions, and the wall thickness can be greater in these regions than in the patient-contacting regions. This increased wall thickness can provide structural rigidity to the overall shape of the mouth region 3260 of the seal-forming structure 3100. In some examples, the further distal from the patient's face a particular region of the seal-forming structure 3100 will be thicker unless there is a reason that that region needs to be flexible (e.g., to deform the sides of the nose portion of the seal-forming structure 3100). The lateral portions 3145 define the lateral periphery of the seal-forming structure 3100 within the mouth area 3260 .

[0268] 7-1 through 8-5, the inner portion of the lower mouth region 3260 of the hollow protrusion 3250, between the lower lip 3118 and the lower portion 3256 of the hollow protrusion 3250, is less rigid than the upper portion 3254 of the upper fascia portion 3210 of the hollow protrusion 3250. In this example, this inner portion of the mouth region 3260 has a thin wall thickness that is continuous around the lower periphery of the seal-forming structure 3100 and extends into the lower portion 3256 of the hollow protrusion 3250, thereby facilitating downward deformation of the hollow protrusion 3250, which directs the weight of the air circuit towards the chin area and improves the seal. This deformation of the hollow protrusion 3250 when the patient is in a supine position also advantageously allows the air circuit connections to move closer to the patient's face, thereby providing a more discreet appearance to the patient interface 3000.

[0269] 5.3.1.4.4 Frontal Area In one form, the seal-forming structure forms a seal on the forehead region of the patient's face when in use, and in such a form, the plenum chamber may cover the eyes when in use.

[0270] 5.3.1.5 Deformation behavior of the plenum chamber in the example of this technology A predicted benefit of the plenum chamber 3200 configuration illustrated in Figures 7-1-13-2 is that the flexibility thus enabled may allow the plenum chamber 3200 to fit a wider range of patient face shapes and sizes. That is, for example, only two sizes of plenum chamber 3200 may be needed to fit a particular target population (rather than three sizes that would be required with other, more conventional cushion modules). Alternatively, a set of three sizes of plenum chamber 3200 may be able to fit a wider range of populations than a set of three or more, more conventional cushion modules.

[0271] Another advantage is that each size of plenum chamber 3200 is expected to accommodate a wider variety of facial shapes and / or features. This high level of flexibility may allow the plenum chamber 3200 to better accommodate unusual or particularly complex facial geometries while forming a more effective and stable seal than a less flexible cushion. For example, the area where the ala meets the face in the recesses on either side of the lower nose is a difficult area to seal in because significant concavity often exists. A plenum chamber seal-forming structure 3100 according to aspects of the present technology may be able to more easily fit around a patient's nose and into these recesses.

[0272] Additionally, the plenum chamber 3200 may be able to accommodate a wide range of face shapes and sizes, as well as being more flexible, making the plenum chamber 3200 more comfortable for many patients. For example, the headgear tension that may be required to achieve a seal with the plenum chamber 3200 may be lower than with more conventional cushion modules, thereby reducing the force that may be exerted on the patient's face and / or head.

[0273] The most notable effect of the deformation permitted by the flexibility of the plenum chamber 3200 is its ability to bend about a vertical axis (i.e., an axis in a downward-upward direction). Because the fascia portion 3210 is flexible at least at the medial portion 3219, the lateral sides of the plenum chamber 3200 can be manipulated together. In examples, all headgear connections are located on the lateral sides of the plenum chamber 3200, allowing for bending of the medial portion of the fascia portion 3210. Furthermore, at the rear of the plenum chamber 3200, the medial portion of the seal-forming structure 3100 is relatively thin, which facilitates bending about the vertical axis. The lateral portions of the seal-forming structure 3100 are thicker than the medial portion and therefore do not bend as easily.

[0274] This may help achieve a good seal between the sides of the seal-forming structure 3100 and the face across a wider range of facial geometries and sizes. For example, the lateral sides of the seal-forming structure 3100 may bend inward to seal against narrower cheeks. Alternatively, the seal-forming structure 3100 may be flattened to provide a comfortable seal against wider cheeks. Additionally, being bendable about a vertical axis helps the nose region 3230 of the seal-forming structure 3100 wrap around the nose to fit within recesses on either side of the nose at the base of the nose (i.e., where the wings meet the face).

[0275] Flexibility about the vertical axis may also allow for increased influence of tension on seal behavior of the positioning and stabilizing structure 3300. While the positioning and stabilizing structure 3300 on more conventional patient interfaces pulls the seal-forming structure to the face, the positioning and stabilizing structure 3300 on the plenum chamber 3200 according to examples of the present technology may both pull the seal-forming structure 3100 into the face and help the seal-forming structure 3100 to conform and surround the facial geometry.

[0276] Additionally, in embodiments where the plenum chamber 3200 includes a rigidizer 3500, improved sealing characteristics of the patient interface may be possible, particularly at relatively higher internal pressures in the plenum chamber. For example, the rigidizer may limit or prevent sealing performance from being adversely affected in any way due to outward expansion of the plenum chamber sealing structure. In such embodiments, the benefits of increased flexibility for fit and sealing performance may be realized, while additional benefits for sealing performance may also be realized.

[0277] Flexion about the lateral axis (i.e., left-to-right axis) may be used to adjust the angle of the nose region 3230 relative to the angle of the mouth region 3260. This may be particularly useful where separate upper and lower headgear straps are provided in the plenum chamber 3200 (e.g., the upper straps 3310 and lower straps 3320 in the example of FIGS. 10-1 and 10-2). A degree of flexibility about the lateral axis may allow the upper straps 3310 and lower straps 3320 to have a separate and independently adjustable effect on the fit of the nose region 3230 and mouth region 3260.

[0278] For example, adjustment of the upper straps 3310 may allow adjustment of the fit of the nose region 3230 independently of the fit of the mouth region 3260, and vice versa. In contrast to conventional patient interfaces having rigid shells, the flexible fascia portion 3210 in examples of the present technology may deform due to headgear force vectors acting on the flexible portion of the plenum chamber 3200. Bendability about the lateral axis may help the seal-forming structure 3100 (when relative adjustments are made between the upper and lower straps 3310 and 3320) to surround and conform to facial geometry. That is, because the plenum chamber 3200 may deform in response to different upper and lower straps 3310 and 3320, different relative tensions in the upper and lower straps 3310 and 3320 may affect how the seal-forming structure 3100 seals with the patient's face.

[0279] The flexibility of the plenum chamber 3200 may also allow for more bending of the nose region 3230 about its oblique anterior-posterior axis, thereby allowing the effective width of the nose region 3230 to be varied relative to the mouth region 3260. This may allow for accommodating patients whose noses are particularly wide / large compared to their mouths. In other words, such flexibility may allow the plenum chamber 3200 to accommodate a wider range of nose widths.

[0280] This flexibility of the plenum chamber 3200 may also allow twisting to allow one lateral side to move in a posterior-anterior direction relative to the other lateral side. This twisting capability helps the plenum chamber 3200 accommodate torsional loads (while maintaining a seal) and also helps provide a decoupling effect, decoupling the left side of the plenum chamber 3200 from the right side of the plenum chamber 3200 (to a greater extent than in a conventional rigid shell configuration). This may advantageously prevent forces on one side of the plenum chamber 3200 from adversely affecting the other side of the plenum chamber 3200 (more specifically, the seal-forming structure 3100). A common situation in which lateral forces may occur is when a patient is sleeping on their side, face-down on a pillow. In this situation, the rigid shell of the cushion may transfer lateral forces from the pillow directly to the seal-forming structure, which may disrupt the seal. Allowing for such twisting may also assist in dynamic stability, for example, if a patient moves their head from one side to the other or moves their face (in a manner that may disrupt the seal), and allowing some disconnection on the left side from the right side may allow the seal-forming structure 3100 to have some resistance to such destructive forces.

[0281] 5.3.2 Disconnection section In an example of the present technology, the plenum chamber 3200 may include a disconnect between the mouth region 3260 and the nose region 3230. It is believed that this may help prevent tubing drag and other forces arising from the mouth region 3260 (e.g., from the patient's pillow when sleeping on their side) from being transferred to the nose region 3230 and affecting the seal at the nose region 3230.

[0282] In examples of the present technology, the plenum chamber 3200 may include a disconnect portion between the nose portion 3230 and the fascia portion 3210.

[0283] In examples of the present technology, the plenum chamber 3200 may include a disconnect portion between the mouth portion 3260 and the fascia portion 3210.

[0284] In an example of the present technology, the plenum chamber may include a disconnecting portion between at least a portion 3100 of the seal-forming structure and one or more plenum chamber inlet ports 3240. In the example shown in Figures 7-1 to 8-5, the disconnecting effect can be sufficiently obtained just by the hollow protrusion structure, but as shown, improvement by further disconnecting portions may be possible.

[0285] In examples, the disconnection portion may be provided by one or more of the following: one or more gusset portions, one or more pleats, one or more concertina portions.

[0286] 5.3.3 Surface Finish In an example, at least a portion of the seal-forming structure 3100 may have a first surface finish and another portion 3200 of the plenum chamber may have a second surface finish that is different from the first surface finish.

[0287] In examples, the first surface finish is provided on a portion of the seal-forming structure 3100 that will contact the patient's face during use, and the first surface finish has a higher coefficient of friction than the second surface finish. In examples, the first surface finish may be a polished finish. A polished surface finish may have a non-slip, sticky feel, thereby creating more friction when the seal-forming structure 3100 moves relative to the patient's face. This is generally desirable as it helps prevent movement of the plenum chamber 3200 when the patient is wearing it, thereby helping to maintain a seal.

[0288] In some examples, different regions of the seal-forming structure 3100 may have different surface finishes.

[0289] In an example, the second surface finish may have a smoother feel than the first surface finish, which may provide a more comfortable feel and give the patient the impression that the mask is comfortable, which may lead to improved patient compliance with treatment.

[0290] In an example, the second surface finish may be a textured surface finish. A textured surface may help provide a textile-like feel and / or appearance, which may help the patient interface feel more like bedding than a medical device, which may lead to improved patient compliance with treatment. For example, flocking the second surface finish may allow fibers (e.g., used in textile formation) to be contained within the plenum chamber 3200. In an example, other portions of the patient interface 3000 (e.g., headgear connections) may also be flocked, which provides the look and feel of a textile material.

[0291] In another example, the textured surface finish may be produced by textured features in the tooling used in forming the plenum chamber; the textured surface finish may be obtained by etching (e.g., laser etching).

[0292] 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.

[0293] In one form, the positioning and stabilizing structure 3300 provides at least enough holding force to overcome the effect of the positive pressure in the plenum chamber 3200 to lift off the face.

[0294] In one form, the positioning and stabilizing structure 3300 provides a holding force sufficient to overcome the attractive force on the patient interface 3000.

[0295] 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).

[0296] In one form of the present technology, there is provided a positioning and stabilizing structure 3300 configured to be worn by a patient while sleeping. In one example, the positioning and stabilizing structure 3300 has a low profile or cross-sectional thickness to reduce the perceived or actual bulk of the device. In one example, the positioning and stabilizing structure 3300 includes at least one strap having a rectangular cross-section. In one example, the positioning and stabilizing structure 3300 includes at least one flat strap.

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

[0298] In one form of the present technology, a positioning and stabilizing structure 3300 is provided that is configured so that it is not excessively large or bulky in size that would interfere with a patient sleeping in a lateral sleeping position with the side region of the patient's head resting on a pillow.

[0299] In one form of the present technology, the positioning and stabilizing structure 3300 comprises a decoupling located between the front of the positioning and stabilizing structure 3300 and a posterior portion of the positioning and stabilizing structure 3300. The decoupling does not resist compression and can be a flexible or flimsy strap, for example. The decoupling is constructed and positioned such that when a patient lies down with their head on a pillow, the presence of the decoupling prevents posterior forces from being transmitted along the positioning and stabilizing structure 3300 and disrupting the seal.

[0300] 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 loop material that engages with portions of hook material.

[0301] In certain forms of the present technology, the positioning and stabilizing structure 3300 includes stretchable (e.g., stretchable with elasticity) straps. For example, the straps can be configured to be tensioned in use to direct a force that seals the seal-forming structure against a portion of the patient's face. In one example, the straps can be configured as ties.

[0302] In one form of the present technology, the positioning and stabilizing structure includes a first tie constructed and arranged such that, in use, at least a portion of its lower edge passes over and moves to a superior-auricular point on the patient's head and covers a portion of the parietal bone without covering the occipital bone.

[0303] 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 below the inferior ear base point on the underside of the patient's head and covers or rests below the occipital bone of the patient's head.

[0304] 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.

[0305] 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.

[0306] 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.

[0307] 10-1 and 10-2 show a patient interface 3000 in accordance with an example of the present technology. The patient interface 3000 includes a positioning and stabilizing structure 3300 and a plenum chamber 3200 having a seal-forming structure 3100. In this example, the positioning and stabilizing structure 3300 includes a plurality of headgear straps connected to a headgear support portion 3302.

[0308] The plenum chamber 3200 of the exemplary patient interface 3000 shown in Figures 10-1 and 10-2 is the plenum chamber 3200 shown in Figures 7-1 to 8-5, although the positioning and stabilizing structure 3300 may be used with other plenum chambers 3200 in other examples of the present technology.

[0309] The positioning and stabilizing structure 3300 may include multiple straps or strap sections that connect to the headgear support portion 3302 and pass around the patient's head to support the plenum chamber 3200 in a sealing position against the patient's face. It will be appreciated that the single "strap" may be formed from multiple lengths of material that are cut or formed separately to create longer lengths and then joined at the ends, or the single "strap" may be a single length of material.

[0310] 10-1 and 10-2, the positioning and stabilizing structure 3300 includes a pair of upper straps 3310. Each upper strap 3310 is configured to pass between the patient's respective eye and ear. Additionally, the positioning and stabilizing structure 3300 includes a pair of lower straps 3320 configured to be positioned on the patient's cheeks below the patient's cheekbones. In this example, the plenum chamber 3200 is held in place via a four-point connection to the headgear straps via headgear supports 3302.

[0311] The headgear support portion 3302 includes a pair of opposing upper strap connection points 3315 to which the upper straps 3310 connect. In this example, each upper strap connection point 3315 includes an aperture. Each upper strap 3310 can connect to each upper strap connection point 3315 by passing through the aperture, looping back on itself, and then securing to itself. Each upper strap 3310 can be secured to itself via hook and loop material configured to releasably couple upon contact. In another example, each upper strap 3310 can be secured to itself by a band, clip, or the like after passing through a respective aperture and looping back on itself. In yet another example, the upper straps 3310 can connect to the headgear support portion 3302 via a side release buckle connection.

[0312] The headgear support portion 3302 also includes a pair of opposing lower strap connection points 3325 to which the lower straps 3320 connect. In this example, each lower strap connection point 3325 includes a magnet. Each lower strap 3320 includes a lower strap clip 3326 that includes a magnet or material. The magnet or material is attached to the magnet at the lower strap connection point 3325. In this example, each lower strap clip 3326 includes an aperture through which the end of each lower strap 3320 can be passed, then looped back and secured to itself (e.g., by hook and loop material, a webbing, a clip, etc.). In another example, the lower straps 3320 connect to the headgear support portion 3302 via a side release buckle connection, which may connect onto a hook or any other suitable connection.

[0313] In one example, the headgear support portion 3302 and upper strap connection points 3315 are constructed and arranged to direct the force / tension provided by the upper straps 3310 into a partially upward and partially backward force vector that is applied to the plenum chamber 3200. Specifically, this partially upward and partially backward force vector causes the nose portion 3230 of the seal-forming structure 3100 to make sealing contact with the lower periphery of the patient's nose and the patient's upper lip.

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

[0315] In one example, the headgear support portion 3302 and lower strap connection points 3325 are constructed and arranged to direct the force / tension provided from the lower straps 3320 into a partially posterior and partially downward force vector that is applied to the plenum chamber 3200. In particular, the partially posterior and partially downward force vector forces the mouth region 3260 into sealing contact with the patient's face around the periphery of the patient's mouth. The partially downward force applied by the lower straps 3320 may balance the partially upward force applied from the upper straps 3310 and any downwardly directed force that may be applied to the seal-forming structure 3100 from the patient's nose.

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

[0317] The positioning and stabilizing structure 3300 may also include one or more of a parietal coronal strap 3330, a pair of lateral parietal coronal straps 3332, and a neck strap 3334. In the example shown in FIG. 10-2 , the upper strap 3310 and the lower strap 3320 are connected to ends of the parietal coronal strap 3330. The parietal coronal strap 3330 is configured to pass around the patient's head and be positioned against surfaces facing upward and backward. The parietal coronal strap 3330 may be configured to be positioned on the parietal bone of the patient's skull. Each end of the parietal coronal strap 3330 is also connected to a respective upper strap 3310 and a respective pair of lateral parietal coronal straps 3332. Each lateral parietal coronal strap 3332 is connected between the upper strap 3310 and the lower strap 3320 on each side of the patient's head. The lower ends of the lateral parietal coronal straps 3332 are interconnected by the neck strap 3334. The neck strap 3334 may be configured to pass across the sagittal plane and be positioned against a downward and / or backward facing surface of the patient's head or behind the patient's neck. The neck strap 3334 may be positioned above or below the occipital bone of the patient's skull.

[0318] The length of the coronal strap 3330 can be selectably adjusted. In the example shown in FIG. 10-2, the coronal strap 3330 is formed by two strap sections connected by a link having a pair of apertures. Each of the two strap sections forming the coronal strap 3330 loops back after passing through its respective aperture and can be secured to itself via, for example, hook-and-loop material, additional clips, bands, and / or the like. The amount of each upper strap section that is routed through the link can be varied to adjust the length of the coronal strap 3330 and thus the fit of the positioning and stabilizing structure 3300.

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

[0320] In examples of the present technology, the ability to independently adjust the left and right straps and / or the upper and lower straps (e.g., the upper strap 3310) may assist in shaping and adjusting the seal-forming structure 3100 to achieve a desired fit.

[0321] In certain forms of the present technology, a system is provided that includes more than one positioning and stabilizing structure 3300. Each positioning and stabilizing structure 3300 is configured to provide a holding force to accommodate a range of different sizes and / or shapes. For example, the system may include one form of positioning and stabilizing structure 3300 that is suitable for large sized heads but not for small sized heads, and another form of positioning and stabilizing structure 3300 that is suitable for small sized heads but not for large sized heads.

[0322] FIGS. 13-1 to 13-3 (and more specifically FIG. 13-3) show a patient interface 3000 including the plenum chamber 3200 shown in FIGS. 11-1 to 11-5. In this example, the patient interface 3000 also includes a positioning and stabilizing structure 3300 for holding the plenum chamber 3200 in a sealing position on the patient's face during use. In this example, the positioning and stabilizing structure 3300 includes a pair of headgear tubes 3340. The pair of headgear tubes 3340 are interconnected at their upper ends and configured to be positioned on the upper and lateral surfaces of the patient's head during use, respectively. The headgear tubes 3340 are configured to be positioned between the patient's eyes and ears during use, respectively. The lower end of each headgear tube 3340 is configured to fluidly connect to the plenum chamber 3300. In this example, the lower end of each headgear tube 3340 connects to a headgear tube connector 3344. The headgear tube connector 3344 is permanently or releasably connected to the headgear connector 3246. The headgear connector 3246 is configured to connect to the inlet port 3240 of the lateral insert 3214 in the fascia portion 3210 of the plenum chamber 3200. The inner rim 3215 of the lateral insert 3214 includes locating features to secure the headgear connector 3246 in place. The positioning and stabilizing structure 3300 includes a conduit headgear inlet 3390 at the junction of the two headgear tubes 3340. The conduit headgear inlet 3390 is configured to receive a pressurized gas flow, for example, via an elbow including a connection port 3600, and to direct the gas flow into the hollow interior of the headgear tube 3340. These headgear tubes 3340 provide the pressurized gas flow to the plenum chamber 3200.

[0323] The positioning and stabilizing structure 3300 may include one or more straps in addition to the headgear tubes 3340. In this example, the positioning and stabilizing structure 3300 includes a pair of upper straps 3310 and a pair of lower straps 3320. The rear ends of the upper straps 3310 and lower straps 3320 are joined to one another. The joint between the upper straps 3310 and lower straps 3320 is configured to be positioned on the rear of the patient's head, thereby allowing the upper straps 3310 and lower straps 3320 to be anchored. The front end of the upper strap 3310 connects to a headgear tube 3340. In this example, each headgear tube 3340 includes a tab 3342 with an opening through which each upper strap 3310 can be routed and then looped back to secure the upper headgear strap 3310 to the headgear tube 3340. The positioning and stabilizing structure 3300 also includes a lower strap clip 3326 provided to the front end of each lower strap 3320. The lower strap clips 3326 are each configured to connect to a lower connection point 3325 on the plenum chamber 3200 (in the example of FIGS. 13-1 to 13-3), which is provided on the headgear connector 3246. In this example, the lower strap clips 3326 are magnetically secured to the lower connection points 3325. In some examples, a mechanical engagement is also provided between the lower strap clips 3326 and the lower connection points 3325.

[0324] The headgear tube connectors 3344 may be configured to allow the patient to breathe ambient air when there is no pressure in the plenum chamber 3200. Each headgear tube connector 3344 may include an anti-asphyxiation valve (AAV). The AAV in each headgear tube connector 3344 may be configured to open when there is no pressure in the plenum chamber 3200 to allow air flow between the interior of the plenum chamber 3200 and the ambient. Each AAV may be biased into a configuration that blocks air flow from the interior of the plenum chamber 3200 into the respective headgear tube 3340 and allows air exchange between the plenum chamber 3200 and the ambient. When the headgear tube 3340 is pressurized, the AAV in each headgear tube connector 3344 may prevent air exchange between the interior of the plenum chamber 3200 and the ambient and may allow air flow from each headgear tube 3340 into the plenum chamber 3204 for patient breathing.

[0325] 10 and 13-1 to 13-3, a common support base is provided for the upper and lower headgear connectors. That is, on each side of the plenum chamber 3200, both the upper headgear strap 3310 (or headgear tube 3340) and the lower headgear strap 3320 are connected to a common rigid connector. However, in some examples, separate upper and lower headgear connectors may be provided in the plenum chamber 3200. It is believed that the difference in tension between the upper and lower headgear straps may affect the deformation of the plenum chamber 3200 and the behavior of the seal-forming structure 3100. Separate upper and lower headgear connections (i.e., upper and lower headgear connections that can move relative to one another as the cushion flexes) may allow for some flexion about a horizontal axis, supporting proper fit with a wider range of patients, while also allowing this flexion to be adjustable, further improving the fit range and adjustability of the patient interface 3000 for a more comfortable and effective fit. As noted in relation to the headgear support portion 3302, separate headgear connectors may be used to help provide at least some of the necessary stiffness to the fascia portion 3210.

[0326] 5.3.5 Ventilation In one form, the patient interface 3000 includes a vent 3400 constructed and arranged to allow the expulsion of exhaled gases (eg, carbon dioxide).

[0327] In certain forms, the vent 3400 is configured to allow continuous vent flow from the interior of the plenum chamber 3200 to atmosphere when the pressure within the plenum chamber is positive relative 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 therapeutic pressure within the plenum chamber in use.

[0328] Ventilation section 3400 in one form according to the present technology includes a plurality of holes (eg, about 20 to about 80 holes, or about 40 to about 60 holes, or about 45 to about 55 holes).

[0329] The vent 3400 may be provided within the plenum chamber 3200 (more particularly, within the fascia 3210). Alternatively, the vent 3400 may be provided within a component provided within the plenum chamber 3200, such as a disconnect structure (e.g., a swivel). In an example, the patient interface may include a swivel elbow assembly having a vent substantially as described in International Publication No. WO 2017 / 049357 A1, the entirety of which is incorporated herein by reference.

[0330] 10-1 and 10-2, the patient interface 3000 includes a vent 3400. In this example, the vent 3400 includes holes that form part of the vent 3400 around the periphery of the inlet connection port 3600.

[0331] 5.3.6 Decoupling Structures (Singular or Plural) In one form, the patient interface 3000 includes at least one decoupling structure (eg, a swivel or a bulb).

[0332] 5.3.7 Connection Port The connection port 3600 allows connection to the air circuit 4170 .

[0333] 9, the inlet connection port 3600 is a rigid, generally tubular structure having a first end 3602 and a second end 3604. An annular groove 3606 is provided around its exterior periphery at the first end 3602 and is configured to receive a connection port ridge 3608 (as shown in FIGS. 7-6) to position the inlet connection port 3600 relative to the plenum chamber 3200.

[0334] The inlet connection port 3600 includes a conduit connection site 3610 at a second end 3604 to which the air circuit 4170 connects. The vent 3400 is provided in the form of a plurality of holes around the periphery of the inlet connection port 3600 between the annular groove 3606 and the conduit connection site 3610.

[0335] 5.3.8 Forehead support In one form, the patient interface 3000 includes a forehead support 3700, as shown in Figure 3A. In other examples, such as those shown in Figures 7-1 through 13-3, the patient interface 3000 may omit the forehead support portion. Additionally, the patient interface 3000 may be configured to not contact the patient's forehead at all.

[0336] 5.3.9 Anti-asphyxiation valve In one form, the patient interface 3000 includes an anti-asphyxiation valve.

[0337] As noted above, the patient interface 3000 may include one or more headgear tubes 3340 connected to the plenum chamber 3200 via headgear tube connectors 3344 that include an anti-asphyxiation valve. Alternatively or additionally, the patient interface 3000 may include a swivel elbow configured to connect to a supply conduit. The swivel elbow includes an anti-asphyxiation valve. In other examples, an anti-asphyxiation valve may be incorporated into the plenum chamber 3200, for example, by being provided in the fascia portion 3210 of the plenum chamber 3200.

[0338] 5.3.10 Ports In one form of the present technology, the patient interface 3000 includes one or more ports that allow access to the volume within the plenum chamber 3200. In one form, this allows a clinician to provide supplemental oxygen. In one form, this allows a property of the gas (e.g., pressure) within the plenum chamber 3200 to be directly measured.

[0339] 5.4 Second Patient Interface Embodiment 16-31 , there is illustrated an embodiment of a patient interface 6000 in accordance with aspects of the present technology. The patient interface 6000 primarily includes a seal-forming structure 6100 and a plenum chamber 6200 as described below.

[0340] 5.4.1 Sealing mechanism In one form, the seal-forming structure 6100 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 6200 by acting on its underside to form a tight sealing engagement with a surface. The pressure-assisted mechanism can work in conjunction with elastic tension in the positioning and stabilizing structure.

[0341] In one form, the seal-forming structure 6100 includes a sealing flange and a support flange. The sealing flange includes a relatively thin member having a thickness of less than about 1 mm (e.g., about 0.25 mm to about 0.45 mm) that extends around the peripheral length of the plenum chamber 6200. The support flange may be relatively thicker than the sealing flange. The support flange is disposed between the sealing flange and the peripheral edge of the plenum chamber 6200 and extends around at least a portion of the peripheral length. The support flange is or includes a spring-like element that functions to support the sealing flange against buckling during use.

[0342] In one form, the seal-forming structure may include a compression seal or gasket seal that is constructed and arranged to be in compression in use due to, for example, elastic tension in the positioning and stabilizing structure.

[0343] In one form, the seal-forming structure includes a tensioning portion that, in use, is held taut by, for example, an adjacent region of the sealing flange.

[0344] In one form, the seal-forming structure includes an area having a sticky or adhesive surface.

[0345] In certain forms of the present technology, the seal-forming structure may include one or more of a pressure-assisted sealing flange, a compression seal, a gasket seal, a tension section, and a section having a sticky or adhesive surface.

[0346] 5.4.1.1 Nasal area 16-27 , in some forms of the present technology, the second seal-forming structure 6102 includes a central portion 6110 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 6102 may further include lateral portions 6111 on the lateral sides of the central portion 6110. In examples, the seal-forming structure 6102 may be configured to contact the patient's face under the bridge of the nose or under the tip of the nose.

[0347] As can be seen from Figures 19 and 25 to 28, the rear surfaces 6112 of the side portions 6111 are angled forward in an upward and forward direction from the boundary 6103 between the first seal-forming structure 6101 and the second seal-forming structure 6102, causing the rear contour of the nose portion of the mask to be angled forward.

[0348] In embodiments using ridges 6120 (as described further below), the rear surfaces 6112 of the side portions 6111 may slope forward from the ridges 6120.

[0349] In some forms of the present technology, the rear surfaces 6112 of the side portions 6111 form an angle of between 20° and 90° with the central contact surface of the mask.

[0350] As shown in FIG. 26, in some embodiments, the lateral portions 6111 are configured so that no part of the patient interface 6000 contacts the patient's alar apex points 1020 during use.

[0351] Sloping the side portions 6111 in this manner allows a smaller section of the nose portion of the interface 6000 to extend over the sides of the wings (than in some similar interfaces of the related art). As a result, in some forms of the present technology, the section of the wings that contacts the interface 6100 is reduced relative to interfaces with sides that slope back towards the patient's face, resulting in a corresponding reduction in the amount of wings that can deform and occlude due to the interface 6100 (e.g., when the patient is sleeping on their side with the interface in contact with a pillow).

[0352] 5.4.1.2 Mouth and nose region boundaries 16, 18, 25 and 27, in one form of the present technology, the interface between the first seal-forming structure 6101 and the second seal-forming structure 6102 forms or includes a corner or ridge 6120. In use, the corner or ridge 6120 may engage the patient's face above the upper lip and just below the nose.

[0353] In embodiments, the corner or ridge 6120 forms a more acute angle than the corresponding portion or region of some oral-nasal masks of the related art (e.g., those described in PCT Application No. PCT / AU2019 / 050278).

[0354] Such sharper angles reduce the likelihood of wrinkles forming on or within the first seal-forming structure 6101 and / or second seal-forming structure 6102 adjacent to the corners or ridges 3120 when the mask is donned and treatment is applied. Some oral-nasal patient interfaces that do not use such structures may require a very thin, circular formation in this area (which may be less crease-resistant). In contrast, the corners or ridges 6120 may be more rigid and may hold their shape better than such interfaces, thereby better sealing against depressions and wrinkles present around the patient's nose. This effect may be enhanced in embodiments with supports (e.g., supports 6260 described herein) that withstand or prevent compression in this area.

[0355] In some forms of the present technology, the radius of the corners or ridges 6120 may be less than 2 mm (e.g., about 1.75 mm), hi 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.

[0356] The angle formed by the first sealing structure and the second sealing structure can be between 20 degrees and 90 degrees (eg, 36 degrees).

[0357] In some forms of the present technology, the corner or ridge 6120 may extend substantially across the entire boundary 6103 between the first seal-forming structure 6101 and the second seal-forming structure 6102. In embodiments, the corner or ridge 6120 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.

[0358] 5.4.1.3 Mouth area As such, in one form the non-invasive patient interface 6000 includes a first seal-forming structure 6101 which, in use, forms a seal around the patient's mouth. The first seal-forming structure 6101 may form a seal over the chin region of the patient's face.

[0359] In one form, the seal-forming structure includes a saddle-shaped region constructed to form a seal over the chin region of the patient's face in use.

[0360] The seal-forming structure 6100 includes a lower lip portion 6130. The lower lip portion 6130 forms a seal against the patient's jaw region and / or the patient's lower lip and / or chin. As shown in FIG. 25 , the lower lip portion 6130 may be connected to (e.g., adjacent to) the upper lip portion 6131 via a perioral portion 6132.

[0361] The seal-forming structure 6100 has a relatively small wall thickness (e.g., less than 0.7 mm) (compared to other areas of the interface) positioned relative to the perioral portion 6132, the lower lip portion 6130 of the seal-forming structure positioned relative to the jaw region, and at least the center of the lower lip portion 6130. The reduced wall thickness in these locations helps achieve an effective and comfortable seal. The seal-forming structure in these regions can easily conform to any complex geometry.

[0362] In some forms of the present technology, the oral cavity 6133 is substantially trapezoidal (as opposed to oval or elliptical). Such an oral cavity shape may allow the interface 6000 to be particularly compact.

[0363] 5.4.2 Plenum chamber In some forms, the plenum chamber 6200 (or at least a portion of the plenum chamber 6200) and the seal-forming structure 6100 are formed from a single homogenous piece of material.

[0364] 5.4.2.1 Adjustability of nose angle 17, 19 and 25-27, in one form of the present technology, a first anterior wall portion 6240 of the nasal region 6202 of the plenum chamber 6200 is more flexible than an immediately adjacent region of the mouth region 6201. The first anterior wall portion 6240 may be provided adjacent a boundary 6241 between the nasal and mouth regions of the plenum chamber 3200. In embodiments, the first anterior wall portion 6240 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 region 6202 of the plenum chamber. In some embodiments, the first anterior wall portion 6240 may extend across substantially the entire width of the nasal region 6202 of the plenum chamber.

[0365] In some forms of the present technology, the second anterior wall portion 6242 is less flexible than the immediately adjacent portions of the anterior wall portion. In some embodiments, the second anterior wall portion 6242 is immediately adjacent the first anterior wall portion 6240 opposite the boundary 6241 of the nasal and oral regions of the plenum chamber. In embodiments, the second anterior wall portion 6242 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 region 6202 of the plenum chamber. In some embodiments, the second anterior wall portion 6242 may extend across substantially the entire width of the nasal region 6202 of the plenum chamber.

[0366] The flexible first front wall 6240 may allow the patient-contacting portion 6110 of the second seal-forming structure 6102 to pivot or hinge about the posterior region of the interface 3000. This may help allow the interface to accommodate patients with a variety of angles between their lower nose and upper lip (i.e., nasolabial angles).

[0367] For example, in embodiments where a corner or ridge 6120 is provided between the first seal-forming structure 6101 and the second seal-forming structure 6102, as described above, the patient-contacting portion 6110 may pivot or move freely around the corner or ridge 6120 or an area nearby. In embodiments with one or more supports 6260 (discussed further below), a hinged area of ​​motion or pivot area may be provided directly above the supports 6260.

[0368] As shown in FIG. 18 , the first anterior wall portion 6240 can have an upper boundary 6243 and a lower boundary 6244. One or both of the upper boundary 6243 and the lower boundary 6244 can be curved, for example, with the center of the boundary below the lateral portions as shown. The first anterior wall portion 6240 can be of substantially the same height across its width (i.e., the upper and lower boundaries can be substantially parallel), or the height can vary across its width, for example, with the height of the center of the first anterior wall portion 6240 being greater than the height of the lateral portions, as shown in the embodiment in FIG. 18 . Varying the curvature of one or both of the boundaries 6243 and 6244 and / or height of the first anterior wall portion 6240 can also vary the stiffness (i.e., resistance to buckling or folding in response to a force on the patient-contacting portion 6110 of the second seal-forming means 6102) of the first anterior wall portion 6240.

[0369] Similarly, the second front wall 6242 may have an upper boundary 6247 and a lower boundary 6248. In some forms of the present technology, the lower boundary 6248 of the second front wall 6242 is the same as the upper boundary 6243 of the first front wall 6240. The upper boundary 6247 and the lower boundary 6248 of the second front wall 6242 may both be curved, so that, for example, the center of the boundary is located below the lateral portions. The second front wall 6242 may be of substantially the same height across its width (i.e., the upper and lower boundaries may be substantially parallel), or may have a height that varies across its width, so that, for example, the height of the center of the second front wall 6242 is less than the height of the lateral portions.

[0370] In some forms of the present technology, other construction methods for providing the necessary stiffness to the first front wall 6240 may be used in addition to or instead of a curved boundary. For example, the thickness of the first front wall 6240 may be selected to provide the necessary stiffness. In examples, the first front wall 6240 may be thinner than the immediately adjacent portions of the plenum chamber walls. Additionally and / or alternatively, the first front wall 6240 may extend upwardly around the lateral edges of the second front wall 6242, as shown in FIG. 29 , thereby reducing stiffness / resistance to compression or buckling compared to embodiments in which the first front wall 6240 is not so shaped.

[0371] The second anterior wall portion 6242 may help prevent buckling of the nasal region 6202 and may provide support for the patient-contacting portion 6110 of the second seal forming means 6102 (which is typically relatively thin). Insufficient support for the patient-contacting portion may lead to rupture of the sealing engagement with the patient's face. In one form, the second anterior wall portion 6242 is thicker than the immediately adjacent portions of the plenum chamber wall. In certain forms, the second anterior wall portion 6242 is provided as a band of thick material, as shown in FIGS. 25-27. The first anterior wall portion 6241 and the second anterior wall portion 6242 may be constructed from the same material (e.g., as part of an integrally formed shell 6250).

[0372] 5.4.2.2 Flexible shell In some forms of the present technology, the shell 6250 may be made of a rigid material such as polycarbonate. However, in other forms of the present technology, the shell 6250, or portions of the shell 6250, may have a degree of flexibility. For example, in examples, the shell 6250 may be formed from 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 6250 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 6250 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). An example of such a material is silicone.

[0373] In examples, the shell 6250 and one or both of the first seal-forming structure 6101 and the second seal-forming structure 6102 may be formed from the same material.

[0374] In some forms of the present technology, the shell 6250 may be sufficiently flexible so that one or more components are added to provide the necessary stiffness in one or more areas or regions of the shell 6250. For example, one or more of a ventilation module; a headgear connector; a headgear connector connected to a stiffening arm and a stiffening member may be connected to the shell 6250 to increase the stiffness of the plenum chamber 6200 in an area adjacent the component, for example, as described further below. In some forms of the present technology, such components may be releasably connectable to the flexible shell 6250. Additionally or alternatively, one or more components may be permanently connected to the shell 6250, for example, by gluing and / or overmolding.

[0375] In some forms of the present technology, the shell 6250 may be generally flexible, but may include stiffened portions that are thicker than immediately adjacent portions of the shell 6250. Such stiffened portions 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 portions, for example, made from polycarbonate, and portions that have some flexibility.

[0376] In some forms of the present technology, it may be preferable for the anterior central portion 6251 of the plenum chamber mouth region 6201 to be more rigid than the remainder of the plenum chamber 6200. In some forms of the present technology, the region of higher rigidity may be located directly below the nose region 6202, as shown in FIG. 29 and described further below, and / or directly above the mouth region 6201. In one form of the present technology, part or all of the first anterior wall portion 6240 may be a region of higher rigidity rather than a region of higher flexibility. Providing higher rigidity in one or more of these regions may provide shape stability and limit the extent to which the shell 6250 deforms due to headgear forces. Excessive deformation may lead to occlusion of the nares by the second seal-forming structure 6102. 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, which may result in a leak path.

[0377] 29 , in one form of the present technology, the shell 6250 may be provided with a rigid portion 6263, or at least a portion of the shell 6250 may be provided with (e.g., molded into) one or more connection ports 6600 to provide greater rigidity than the remainder of the shell. In one form of the present technology, the rigid portion 6263 may be made of polycarbonate. This may provide greater rigidity than a shell constructed solely of silicone. In one form of the present technology, holes forming the vent 6400 are molded into the rigid portion 6263. In some forms of the present technology, the connector 6310 for the positioning and stabilizing structure is mounted on an arm 6320 that provides a certain rigidity to the shell.

[0378] In one form of the present technology, the rigid portion 6263 extends laterally across the front of the plenum chamber adjacent the upper boundary of the first front wall portion 6240 (e.g., directly below the second front wall portion 6242). The rigid portion 6263 may extend continuously between the connection ports 6600.

[0379] In some forms of the present technology, the connection ports 6600 may have a substantially oval cross-section. The connection ports 6600 may be oriented such that the centerline of each port is substantially parallel to the outer surface of the plenum chamber adjacent the port.

[0380] In some forms of the present technology, the rigid section 6263 may project forward relative to an adjacent surface of the first anterior wall portion 6240 and may be shaped to increase bending resistance.

[0381] In some forms of the present technology, the connector 6310 and arm 6320 are provided to the lateral edge of the plenum chamber 6200 below the connection port 6600. The connector 6310 can be provided at the lateral end of the arm 6320.

[0382] 31 shows a plenum chamber 6200 including a vent mounting aperture 6410 into which a suitable vent or module may be inserted. To increase the rigidity of the plenum chamber, the vent may be constructed from a relatively rigid material. In some forms of the present technology, the vent mounting aperture 6410 may be substantially oval, with the minor axis of the oval being substantially parallel to the sagittal plane.

[0383] In the embodiment shown in FIG. 31, the vent attachment aperture is provided to the upper boundary of the mouth region of the upper chamber 6201 .

[0384] 31 , a connector 6310 is provided for the positioning and stabilizing structure. The connector 6310 may be mounted within a relatively thicker region of the shell 6250. In the illustrated embodiment, the connector 6310 is provided to the lateral side of the plenum chamber 6200 below the vent mounting aperture 6410. In some forms of the present technology, the connector 6310 is a substantially circular magnetic headgear connector.

[0385] While inlet ports are not shown in the drawings of the plenum chamber shown in Figures 16-28, one skilled in the art will appreciate that in practice one or more inlet ports will be provided (e.g., inlet port 6600 as shown in Figures 30 and 31). The inlet port 6600 allows connection from an interface, as further described below, to the air circuit 4170. In some forms of the present technology, one or more components of the air circuit 4170 may also function as components of the positioning and stabilizing structure.

[0386] In certain forms of the present technology, the plenum chamber 6200 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 may help improve compliance with treatment. The use of a transparent material may help the clinician see the placement and function of the patient interface.

[0387] In certain forms of the present technology, the plenum chamber 6200 is constructed from a translucent material, such as translucent silicone, which can make the patient interface less intrusive and help improve compliance with treatment.

[0388] 5.4.3 Support area 21 and 23-27, in one form of the present technology, supports 6260 are provided on opposite sides of the interface 6000 between the second seal-forming structure 6102 and the front wall of the plenum chamber 6200. As shown in FIG. 21 , in an example, each support 6260 extends to a lateral edge of the interface 6000.

[0389] The support portion 6260 is configured to withstand or impede compression in the anterior-posterior direction, thereby supporting or stiffening the portion of the second seal-forming structure 6102 that engages with the patient's upper lip (specifically, the portion of region 1010 adjacent the entrance to the nostril (where the wing meets the area above the upper lip) as shown in FIG. 29).

[0390] These supports 6260 help ensure that there are no wrinkles in the seal-forming structure 6100, particularly where the seal-forming structure seals to the patient's face area 1010. The supports 6260 can be particularly advantageous when the seal-forming structure is configured to create corners or ridges 6120 as described herein.

[0391] 23-25 ​​in particular, in one form of the present technology, the support portion 6260 is connected to the anterior side of the mouth region 6201 of the plenum chamber adjacent the boundary 6241 of the mouth region 6201 and the nose region 6202. In some embodiments, the support portion 6260 can be curved when viewed in a cross section parallel to the sagittal plane (as shown in FIGS. 25-27) and / or can be curved when viewed in a cross section parallel to the frontal plane (as shown in FIGS. 23 and 24). The curvature can be positive or negative. In some examples, the lateral sidewalls 6245 of the plenum chamber 6200 can be curved inwardly adjacent the boundary 6241 with the nose region 6202, and the support portion 6260 can be substantially contiguous with the adjacent lateral sidewalls 6245. As shown in FIG. 27, when viewed in a cross section parallel to the sagittal plane, at least a portion of the support portion 6260 may have a reduced thickness between a first end 6261 adjacent the front wall of the plenum chamber 6200 and a second end 6262 adjacent the seal-forming structure 6100.

[0392] 23 and 24, in one form of the present technology, the support portion 6260 is connected to the mouth region 6201 of the plenum chamber adjacent the boundary between the lateral sidewalls 6245 of the mouth region 6201 and the lateral sidewalls 6246 of the nose region 6202.

[0393] In some forms of the present technology, the supports 6260 are shaped to provide a substantially clear flow path from the mouth region 6201 of the plenum chamber to the nasal aperture(s) 6135. In some forms of the present technology, no portion of any of the supports 6260 is located directly below the nasal aperture(s) 6135.

[0394] 5.4.4 Other Components The patient interface of Figures 16-31 may include other components as with Figures 7-15 (e.g., at least a connection port 3600, a forehead support 3700, an anti-asphyxiation valve, a vent, a disconnect structure, a port, or a positioning and stabilizing structure).

[0395] Although no ventilation structure is shown in Figures 16-27, the embodiments of the present technology shown in Figures 16-25 may be provided with a suitable ventilation structure, for example, in plenum chamber 6200 (an example of which is shown in Figure 30).

[0396] 5.5 RPT Device An RPT device 4000 according to one aspect of the present technology includes mechanical, pneumatic, and / or electrical components and is configured to execute one or more algorithms (e.g., any of the methods described herein, in whole or in part). The RPT device 4000 can be configured to generate an airflow that is delivered to a patient's airway for treatment of, for example, one or more of the respiratory conditions described anywhere herein.

[0397] In one form, the RPT device 4000 is constructed and arranged to deliver airflow in the range of -20 L / min to +150 L / min while maintaining a positive pressure of at least 6 cmH2O, or at least 10 cmH2O, or at least 20 cmH2O. RPT Device Algorithm

[0398] The RPT device may have an outer housing 4010. The outer housing 4010 is formed by two portions: an upper portion 4012 and a lower portion 4014. Additionally, the outer housing 4010 may include one or more panel(s) 4015. The RPT device 4000 includes a chassis 4016 that supports one or more internal components of the RPT device 4000. The RPT device 4000 may include a handle 4018.

[0399] The air pressure path of the pneumatic RPT device 4000 may include one or more air circuit items (e.g., an inlet air filter 4112, an inlet muffler 4122, a pressure generator 4140 (e.g., a blower 4142) capable of supplying air at positive pressure, an outlet muffler 4124) and one or more transducers 4270 (e.g., a pressure sensor and a flow sensor).

[0400] As noted above, in some forms of the present technology, a central controller may be configured to implement one or more algorithms expressed as a computer program stored in a non-transitory computer-readable storage medium (e.g., memory), the algorithms typically being grouped into groups called modules.

[0401] The RPT device 4000 can have a power supply 4210, one or more input devices 4220, a central controller, a therapy device controller, a pressure generator 4140, one or more protection circuits, a memory, a transducer 4270, a data communication interface, and one or more output devices 4290. The electrical components 4200 can be mounted on a single printed circuit board assembly (PCBA) 4202. In an alternative, the RPT device 4000 can include more than one PCBA 4202.

[0402] An RPT device in accordance with one form of the present technology may include an air filter 4110 or multiple air filters 4110.

[0403] In one form, an outlet air filter 4114 (eg, an antibacterial agent) is located between the outlet of the pneumatic block 4020 and the patient interface 3000.

[0404] An RPT device in accordance with one form of the present technology may include a muffler 4120 or multiple mufflers 4120.

[0405] In one form of the present technology, an anti-spillback valve 4160 may be located between the humidifier 5000 and the pneumatic block 4020. The anti-spillback valve is constructed and positioned to reduce the risk of water flowing upstream from the humidifier 5000 (e.g., to the blower motor 4144).

[0406] 5.6 Air Circuit An air circuit 4170, according to one aspect of the present technology, is a conduit or tube constructed and arranged such that, in use, air flow travels between two components (e.g., the RPT device 4000 and the patient interface 3000).

[0407] 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.

[0408] In some forms, the air circuit 4170 may include one or more heating elements configured to heat the air in the air circuit (e.g., to maintain or increase the air temperature). The heating elements may take the form of a heated wire circuit and may include one or more transducers (e.g., temperature sensors). In one form, the heated wire circuit may be spirally wound around the axis of the air circuit 4170. The heating elements may be in communication with a controller (e.g., a central controller). One example of an air circuit 4170 including a heated wire circuit is described in U.S. Patent Application No. 8,733,349, which is incorporated herein by reference in its entirety.

[0409] 5.6.1 Oxygen delivery In one form of the present technology, supplemental oxygen 4180 can be delivered to one or more points in the pneumatic pathway (e.g., upstream of the pneumatic block 4020), the air circuit 4170 and / or the patient interface 3000.

[0410] 5.7 Humidifier 5.7.1 Humidifier Overview In one form of the present technology, a humidifier 5000 is provided (for example as shown in FIG. 5A) for changing the absolute humidity of air or gas to be delivered to a patient relative to ambient air. Typically, the humidifier 5000 is used to increase the absolute humidity (relative to ambient air) and increase the temperature of the air stream before delivery to the patient's airways.

[0411] 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.

[0412] As shown in FIG. 5C, the humidifier controller 5250 may include one or more controllers (e.g., a central humidifier controller 5251, a heated air circuit controller 5254 configured to control the temperature of the heated air circuit 4171, and / or a heating element controller 5252 configured to control the temperature of the heating element 5240).

[0413] 5.7.2 Humidifier Components 5.7.2.1 Water reservoir According to one arrangement, the humidifier 5000 may include a water reservoir 5110 configured to contain or hold a quantity of liquid (e.g., water) to be evaporated for humidifying the airflow. The water reservoir 5110 may be configured to contain a predetermined maximum quantity of water to provide adequate humidification for at least the duration of a respiratory therapy session (e.g., a night's sleep). Typically, the reservoir 5110 is configured to contain several hundred milliliters of water (e.g., 300 milliliters (ml), 325 ml, 350 ml, or 400 ml). In another form, the humidifier 5000 may be configured to receive a water supply from an external water source (e.g., a building's water supply system).

[0414] According to one embodiment, the water reservoir 5110 is configured to humidify the air flow from the RPT device 4000 as the air flow passes through the RPT device 4000. In one form, the water reservoir 5110 can be configured to encourage the air flow to travel a tortuous path through the reservoir 5110 while the air flow contacts a certain amount of water in the reservoir 5110.

[0415] According to one form, the reservoir 5110 may be removable from the humidifier 5000, for example, laterally as shown in Figures 5A and 5B.

[0416] The reservoir 5110 may also be configured to inhibit liquid release from the reservoir 5110, for example, when the reservoir 5110 is displaced and / or rotated from its normal operating orientation (e.g., through any aperture and / or between its subcomponents). Because the air stream to be humidified by the humidifier 5000 is often pressurized, the reservoir 5110 may also be configured to prevent loss of air pressure through leakage and / or flow impedance.

[0417] 5.7.2.2 Conductive parts According to one arrangement, the reservoir 5110 includes a conductive region 5120 configured to allow efficient heat transfer from the heating element 5240 to the volume of liquid in the reservoir 5110. In one form, the conductive region 5120 may be arranged as a plate, although other shapes may be suitable. All or part of the conductive region 5120 may be constructed of a thermally conductive material such as aluminum (e.g., approximately 2 mm thick (e.g., 1 mm, 1.5 mm, 2.5 mm, or 3 mm)), another thermally conductive metal, or some plastic. In some cases, adequate thermal conductivity may be achieved with a less conductive material of appropriate geometry.

[0418] 5.7.2.3 Humidifier Reservoir Dock In one form, the humidifier 5000 may include a humidifier reservoir dock 5130 (as shown in FIG. 5B) configured to receive the humidifier reservoir 5110. In some arrangements, the humidifier reservoir dock 5130 may include a locking feature (e.g., a locking lever 5135 configured to retain the reservoir 5110 within the humidifier reservoir dock 5130).

[0419] 5.7.2.4 Water Level Indicator The humidifier reservoir 5110 may include a water level indicator 5150 as shown in Figures 5A-5B. In some forms, the water level indicator 5150 may provide one or more indications to a user, such as the patient 1000 or a caregiver, about the amount of water in the humidifier reservoir 5110. These one or more indications provided by the water level indicator 5150 may include an indication of a maximum predetermined amount of water, any fraction thereof (e.g., 25%, 50%, or 75% or an amount (e.g., 200 ml, 300 ml, or 400 ml)).

[0420] 5.7.2.5 Humidifier Transducer(s) The humidifier 5000 may include one or more humidifier transducers (sensors) 5210 instead of or in addition to the transducer 4270 described above. The humidifier transducer 5210 may include one or more of an air pressure sensor 5212, an air flow transducer 5214, a temperature sensor 5216, or a humidity sensor 5218 as shown in FIG. 5C . The humidifier transducer 5210 may generate one or more output signals. These output signals may be communicated to a controller (e.g., a central controller and / or a humidifier controller 5250). In some forms, the humidifier transducer may be located external to the humidifier 5000 (e.g., within the air circuit 4170) while communicating the output signal to the controller.

[0421] 5.8 Respiratory waveform Figure 6A shows a typical respiratory waveform for a sleeping human model. The horizontal axis is time, and the vertical axis is respiratory flow. Because parameter values ​​can vary, a typical breath may have the following approximate values: tidal volume, Vt, 0.5 L; inspiratory time, Ti, 1.6 seconds; peak inspiratory flow, Qpeak, 0.4 L / sec; expiratory time, Te, 2.4 seconds; peak expiratory flow, Qpeak, -0.5 L / sec. The total duration of the breath, Ttot, is approximately 4 seconds. Humans typically breathe at approximately 15 breaths per minute (BPM), with a ventilation, Vent, of approximately 7.5 L / min. A typical duty cycle, the ratio of Ti to Ttot, is approximately 40%.

[0422] 5.9 Respiratory Pressure Therapy Mode Depending on the values ​​of the parameters A and P0 in the treatment pressure equation (Error! Reference source unknown) used by the treatment parameter determination algorithm in one form of the present technology, various respiratory pressure treatment modes can be performed by the RPT device 4000.

[0423] 5.10 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.

[0424] 5.10.1 General Air: In certain forms of the present technology, air may refer to atmospheric air, while in other forms of the present technology, air may refer to a combination of other breathable gases (e.g., oxygen-rich atmospheric air).

[0425] 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.

[0426] For example, the ambient humidity for a humidifier may be the humidity of the air immediately surrounding the humidifier (e.g., the humidity inside the room where the patient is sleeping). Such ambient humidity may differ from the humidity outside the room where the patient is sleeping.

[0427] In another example, the ambient pressure may be the pressure immediately surrounding or external to the body.

[0428] 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.

[0429] 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.

[0430] 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 airways increases slightly during exhalation and decreases slightly during inhalation. In some forms, the pressure varies during different respiratory cycles of the patient (e.g., increased in response to the detection of an indication of partial upper airway obstruction and decreased in the absence of notification of partial upper airway obstruction).

[0431] Flow Rate: The instantaneous amount (or mass) of air delivered per unit time. Flow rate can refer to an instantaneous quantity. In some cases, reference to flow rate refers to a scalar quantity (i.e., a quantity that has only magnitude). In other cases, reference to flow rate 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 simply called "flow."

[0432] Humidifier: The word "humidifier" is construed to mean a humidifying device constructed, arranged, or configured with a physical structure capable of providing a therapeutically beneficial amount of water (H2O) vapor to an air stream to improve the medical respiratory condition of a patient.

[0433] Leakage: The term "leakage" refers to unintended airflow. In one example, a leak can occur due to an imperfect seal between the mask and the patient's face. In another example, a leak can occur at the swivel elbow to the perimeter.

[0434] 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 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.

[0435] Noise Emission (Acoustic): In this document, radiated noise refers to noise carried by the ambient air to the patient. In one form, radiated noise can be quantified by measuring the sound power / pressure level of the target in accordance with ISO 3744.

[0436] Ventilation noise (acoustic): In this document, ventilation noise refers to the noise generated by airflow through any ventilation (eg, vents in the patient interface).

[0437] Patient: A person with or without a respiratory disease.

[0438] Pressure: Force per unit area. Pressure can be expressed in a variety of units (e.g., cmH2O, gf / cm 2 , and hectopascals). 1cmH2O is 1g-f / cm 2 which is approximately 0.98 hectopascals. In this specification, pressures are given in units of cmH2O unless otherwise specified.

[0439] The pressure in the patient interface is designated by the symbol Pm, and the therapeutic pressure, which represents the target value that the mask pressure Pm should achieve at this time, is designated by the symbol Pt.

[0440] Respiratory Pressure Therapy (RPT): The application to the airway entrance of an air supply at therapeutic pressure, typically positive pressure relative to atmosphere.

[0441] Ventilator: A mechanical device that provides pressure support to a patient while they perform some or all of the work of breathing.

[0442] 5.10.1.1 Materials Silicone or silicone elastomer: Synthetic rubber. References to silicone herein refer to liquid silicone rubber (LSR) or compression molded silicone rubber (CMSR). One commercially available form of LSR is SILASTIC (in a family of products sold under this registered trademark) manufactured by Dow Corning. Another LSR manufacturer is Wacker. Unless otherwise specified, exemplary forms of LSR have a Shore A (or Type A) indentation hardness of about 35 to about 45, as measured by ASTM D2240.

[0443] Polycarbonate: A thermoplastic polymer of bisphenol A carbonate.

[0444] 5.10.1.2 Mechanical properties Elasticity: The ability of a material to absorb energy during elastic deformation and to release the energy when unloaded.

[0445] Elastic: Releases substantially all of the energy upon unloading. Examples include certain silicone and thermoplastic elastomers.

[0446] Hardness: The ability of a material to resist deformation (e.g., as described by Young's modulus or the indentation hardness scale measured on 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.

[0447] 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.

[0448] 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.

[0449] 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 would 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.

[0450] As one example, an I-beam may have a different bending stiffness (resistance to bending load) in a first direction compared to a second, orthogonal direction. In another example, a structure or component may be floppy in a first direction and rigid in a second direction.

[0451] 5.10.2 Breathing Cycle Apnea: According to some definitions, apnea is said to occur when flow below a predetermined 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.

[0452] Respiratory rate: The patient's spontaneous breathing rate, usually measured in breaths per minute.

[0453] Duty cycle: The ratio of inspiration time Ti to total breathing time Ttot.

[0454] Exercise (Respiration): Respiratory effort is said to refer to the movement made by the spontaneous breathing of a person trying to breathe.

[0455] Expiratory portion of the respiratory cycle: the period from the start of expiratory flow to the start of inspiratory flow.

[0456] Flow limitation: Flow limitation is understood to be a condition in a patient's breathing where an increase in patient effort does not result in a corresponding increase in flow rate. If flow limitation occurs during the inspiratory portion of the respiratory cycle, the flow limitation can be referred to as inspiratory flow limitation. If flow limitation occurs during the expiratory portion of the respiratory cycle, the flow limitation can be referred to as expiratory flow limitation.

[0457] Flow-limited inspiration waveform types: (i) Flattening: An upswing followed by a relatively flat area, followed by a downswing. (ii) M-shaped: has two local peaks, one at the rise and one at the fall, with a relatively flat region between these two peaks. (iii) Chair-like: A single local peak occurs at the rising part, followed by a relatively flat region. (iv) Inverted chair: A relatively flat region is followed by a single local peak, which occurs on the trailing edge.

[0458] 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 flow is reduced below a threshold rate for a sustained period of time. When hypopnea is detected due to a decrease in respiratory effort, central hypopnea is said to occur. In one form, hypopnea may be considered when any of the following occur in adults: (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 at least 10 seconds and associated desaturation of at least 3% or arousal occurs.

[0459] Hyperventilation: An increase in flow to a level higher than normal.

[0460] Inspiratory 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 inspiratory portion of the respiratory cycle.

[0461] Patency (Airway): The degree to which the airway is open or the extent to which it is open. Airway patency is an opening. Airway patency can be quantified, for example, with a value of 1 indicating open and a value of 0 indicating closed (obstructed).

[0462] Positive end-expiratory pressure (PEEP): The pressure above atmosphere in the lungs that exists at the end of expiration.

[0463] Peak flow (Qpeak): The maximum value of flow during the inspiratory portion of the respiratory flow waveform.

[0464] 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.

[0465] Tidal volume (V t ): 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), a single tidal volume Vt can be defined as equal to either volume. In practice, the tidal volume Vt can be defined as equal to any combination (e.g., inspiratory volume V i and expiratory volume Ve).

[0466] (Inspiration) Time (Ti): The duration of the inspiratory portion of the respiratory flow waveform.

[0467] (Expiratory) Time (Te): The duration of the expiratory portion of the respiratory flow waveform.

[0468] (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.

[0469] Typical Recent Ventilation: The ventilation value around which recent values ​​of ventilationVent over a given time scale tend to cluster (i.e., the degree to which recent values ​​of ventilation tend to be central).

[0470] 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).

[0471] Vent: A measure of the rate of gas exchange performed by a patient's respiratory system. Measurements of ventilation may include either or both inspiratory and expiratory flow per unit of time. When expressed as volume per minute, this quantity is often referred to as "minute ventilation." Minute ventilation is sometimes given simply as volume and is understood as volume per minute.

[0472] 5.10.3 Ventilation Adaptive servo-ventilator (ASV): A servo-ventilator that does not have a fixed target ventilation but is variable. The variable target ventilation can be learned from some characteristic of the patient (e.g., the patient's breathing characteristics).

[0473] Backup Rate: A ventilator parameter that establishes the minimum respiratory rate (typically in breaths per minute) that will be delivered by the ventilator to the patient (when not triggered by spontaneous breathing efforts).

[0474] 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.

[0475] Expiratory Positive Airway Pressure (EPAP): The base pressure to which varying pressures are added during a breath to produce the desired mask pressure that the ventilator attempts to achieve at a given moment.

[0476] End Expiratory Pressure (EEP): The desired mask 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.

[0477] Inspiratory Positive Airway Pressure (IPAP): The maximum desired mask pressure that the ventilator attempts to achieve during the inspiratory portion of the breath.

[0478] Pressure Support: A number indicating the increase in pressure during ventilator inspiration compared to the corresponding ventilator expiration, and refers primarily to the pressure difference between the maximum inspiratory pressure and the base pressure (e.g., PS = IPAP - EPAP). In some contexts, pressure support refers to the difference the ventilator attempts to achieve (rather than the difference it actually achieves).

[0479] Servo-ventilator: A ventilator that has both patient ventilation and target ventilation, and adjusts the level of pressure support to bring the patient ventilation closer to the target ventilation.

[0480] 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.

[0481] Swing: A term equivalent to pressure assistance.

[0482] 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.

[0483] 5.10.4 Anatomy 5.10.4.1 Facial Anatomy Ala: The outer wall or "wing" of each nostril (plural: alar)

[0484] Alare: The outermost point on the ala of the nose.

[0485] Alar curvature (or alar crest) point: The most posterior point on the curved baseline of each alar, found in the crease formed by the union of the alar and cheek.

[0486] Pinna: the entire visible part of the ear.

[0487] (Nasal) skeleton: The nasal skeleton includes the nasal bones, the frontal process of the maxilla, and the nasal portion of the frontal bone.

[0488] (Nasal) cartilaginous rami: The cartilaginous rami of the nose include the septal cartilage, lateral cartilage, greater cartilage, and lesser cartilage.

[0489] Columella: The piece of skin that separates the nostrils and extends from the tip of the nose to the upper lip.

[0490] Columella angle: the angle between a line drawn through the midpoint of the nostril and a line drawn perpendicular to the Frankfurt horizontal and intersecting the subnasal point.

[0491] Frankfort horizontal plane: A line extending from the most inferior point of the orbital rim to the left auricular point, which is the deepest point of the auricle from the superior side of the notch to the tragus.

[0492] Glabellar: Located in the soft tissue, the most prominent point in the midsagittal direction of the forehead.

[0493] 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.

[0494] Lip, lower side (lower lip: labrale inferius):

[0495] Lip, upper side (upper lip: labrale superius):

[0496] Greater alar cartilage: a cartilaginous plate located beneath the lateral nasal cartilage. It curves around the anterior part of the nostril. Its posterior end is connected to the frontal process of the maxilla by a tough fibrous membrane containing three or four alar cartilages.

[0497] Nostrils (nares): Generally ellipsoidal alar openings that form the entrance to the nasal cavity. The singular form of nostrils is naris (nose hole). These nostrils are separated by the nasal septum.

[0498] 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, separating the cheek from the upper lip.

[0499] Nasolabial angle: the angle between the bridge of the nose and the upper lip, intersecting with the subnasal point.

[0500] Inferior ear point: lowest point of attachment of the pinna to the facial skin.

[0501] Superior auricular point: the highest point of attachment of the pinna to the facial skin.

[0502] 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.

[0503] Philtrum: midline groove extending from the lower border of the nasal septum to the top of the lip in the upper lip area.

[0504] Pogonion: The most anterior midpoint of the jaw, located on the soft tissue.

[0505] Nasal ridge: The nasal ridge is the midline prominence of the nose, extending from the serion to the apex.

[0506] Sagittal plane: A vertical plane running from anterior (front) to posterior (rear). The midsagittal plane is the sagittal plane that divides the body into right and left halves.

[0507] Cerion: Located on the soft tissue, it is the most concave point on the area of ​​the frontonasal suture.

[0508] Septal cartilage (nose): The nasal septum cartilage is part of the septum, which divides the anterior part of the nasal cavity.

[0509] Nasal alar nasal basin: the point on the lower periphery of the alar base where it joins with the skin of the upper (top) lip.

[0510] Subnasal point: Located on the soft tissue, the point where the columella joins the upper lip in the midsagittal plane.

[0511] Supramenton: The most concave point in the midline of the lower lip between the lower lip midpoint and the soft tissue pogonion.

[0512] 5.10.4.2 Skull anatomy Frontal bone: The frontal bone contains the squama frontalis, a large vertical portion that corresponds to the area known as the forehead.

[0513] Mandible: The mandible forms the lower jaw. The mental protuberance is a bony protuberance in the jaw, forming the chin.

[0514] Maxilla: The maxilla forms the upper jaw and is located below the mandible and below the orbit. The frontal process of the maxilla projects upward by the sides of the nose and forms part of its lateral border.

[0515] Nasal bones: The nasal bones are two small, rectangular bones that vary in size and shape between individuals. They lie side by side in the middle and upper parts of the face and together form the "bridge" of the nose.

[0516] 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.

[0517] Occipital bone: The occipital bone is located at the back and underside of the skull. It contains the foramen magnum, an oval hole through which the intracranial cavity connects with the vertebral canal. The curved plate posterior to the foramen magnum is the squama occipitalis.

[0518] Orbit: bony cavity in the skull that contains the eyeball.

[0519] Parietal bones: The parietal bones are bones that, when joined together, form the top and sides of the skull.

[0520] Temporal bone: The temporal bone is located on the base and sides of the skull and supports parts of the face known as the temples.

[0521] Cheekbones: The two cheekbones in the face are located in the upper and outer parts of the face and form the cheek ridges.

[0522] 5.10.4.3 Respiratory System Anatomy Diaphragm: A sheet of muscle that runs over the lower rib cage. The diaphragm 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.

[0523] Larynx: The larynx or voice box that houses the vocal cords and connects the lower part of the pharynx (hypopharynx) to the trachea.

[0524] Lung: respiratory organ in humans. The conductive zone of the lung includes the trachea, bronchi, bronchi, and terminal bronchioles. The respiratory zone includes the respiratory bronchi, alveolar ducts, and alveoli.

[0525] 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 nasal conchae (singular "concha") or turbinates. The nasal cavity is anteriorly connected to the nose, and posteriorly to the choanae, which open into the nasopharynx.

[0526] Pharynx: The part of the throat located immediately below (inferior to) the nasal cavity and above the esophagus and larynx. The pharynx is traditionally divided into three parts: the nasopharynx (upper pharynx) (nasal part of the pharynx), the oropharynx (mid pharynx) (oral part of the pharynx), and the hypopharynx (low pharynx).

[0527] 5.10.5 Patient Interface Anti-asphyxiation valve (AAV): A component or subassembly of a mask system that vents to atmosphere in a fail-safe manner to reduce the risk of excessive CO2 rebreathing by the patient.

[0528] 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 relative to the mating component, for example, approximately 360 degrees. In certain forms, the elbow may be detachable from the mating component, for example, via a snap connection. In certain forms, the elbow may be assembled to the mating component via a one-time snap during manufacturing, but cannot be removed by the patient.

[0529] Frame: Frame is taken to mean the mask structure that supports the tensile load between two or more points that connect the headgear. A mask frame can be a non-airtight load-bearing structure in the mask. However, some forms of mask frames may be airtight.

[0530] Headgear: Headgear is taken to mean a form of positioning and stabilizing structure designed for use 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).

[0531] Membrane: Membrane is taken to mean a typically thin-walled element, preferably substantially non-resistant to bending and resistant to stretching.

[0532] Plenum Chamber: Mask plenum chamber is taken to mean a part of a patient interface having walls that at least partially enclose 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.

[0533] Seal: When used as a noun ("seal"), it can refer to a structure, and when used as a verb ("to seal"), it can refer to an effect. Two elements can be constructed and / or arranged to "seal" or achieve a "sealing" effect between them without the need for a separate "sealing" element itself.

[0534] Shell: A shell is taken to mean a curved, relatively thin structure that has bending, tensile, and compressive stiffness. For example, the curved structural wall of a mask may be a shell. In some forms, the shell may be faceted. In some forms, the shell may be airtight. In some forms, the shell may not be airtight.

[0535] Stiffener: A stiffener is taken to mean a structural component designed to increase the bending resistance of another component in at least one direction.

[0536] Strut: A strut is taken to mean a structural component designed to increase the compressive resistance of another component in at least one direction.

[0537] 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 less than 360 degrees. When used in the context of an air delivery conduit, the subassembly of components preferably includes a mating cylindrical conduit. In use, there is little leakage of air flow from the swivel.

[0538] Tie (noun): A structure designed to resist tension.

[0539] Venting: (noun): A structure that allows airflow into the ambient atmosphere inside a mask or conduit, allowing clinically effective flushing of exhaled gases. For example, for clinically effective flushing, flow rates of about 10 liters / minute to about 100 liters / minute may be used depending on mask design and treatment pressure.

[0540] 5.10.6 Structural Shape Products 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 distinguished using labels to describe the orientation, location, function, or some other characteristic of the associated surfaces. For example, the structure may include one or more of a front surface, a back surface, an interior surface, and an exterior surface. In another example, the seal-forming structure may include a face-contacting (e.g., outer) surface and a separate non-face-contacting (e.g., lower or interior) surface. In another example, the structure may include a first surface and a second surface.

[0541] To facilitate the description of the shape and surface of a three-dimensional structure, we first consider a cross section at a point p through the surface of the structure. See Figures 3B-3F. Figures 3B-3F show an example cross section at 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 fictitious little person standing upright on the surface.

[0542] 5.10.6.1 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).

[0543] Positive curvature: If the curve at p bends toward the outward normal, the curvature at that point is taken to have a positive value (if our fictitious little person were to walk away from point p, they 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.

[0544] 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, they can walk on a horizontal plane that is neither pointing up nor pointing down). See Figure 3D.

[0545] 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 fictitious little person were to walk away from point p, they 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.

[0546] 5.10.6.2 Two-dimensional surface curvature A 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 containing 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 or different signs. Each curvature 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.

[0547] Principal curvature and direction: The directions of the normal plane in which the curvature of a curve reaches its maximum and minimum values ​​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.

[0548] Surface region: A set of connected points on a surface. This set of points within a region may have similar properties (e.g., curvature or sign).

[0549] Saddle region: A region where the principal curvatures at each point have opposite signs (i.e., one positive sign and the other negative sign) (depending on the direction a hypothetical person who may be walking uphill or downhill is facing).

[0550] Dome area: an area where the principal curvatures at each point have the same sign: either both positive ("concave dome") or both negative ("convex dome")

[0551] Cylindrical region: A region in which one principal curvature is zero (or, for example, zero within manufacturing tolerances) and the other principal curvature is non-zero.

[0552] Planar region: A region of a surface where both principal curvatures are zero (or are zero within a manufacturing tolerance, for example).

[0553] Surface Edge: The boundary or limit of a surface or area.

[0554] Path: In certain forms of the present technology, a "path" is taken to mean a path in the mathematical-topological sense (e.g., a continuous space curve from f(0) to f(1) on a surface). In certain forms of the present technology, a "path" may be described as a route or course that includes, for example, a set of points on a surface. (A hypothetical person's path is a place they walk on a surface, similar to a path in a garden.)

[0555] Path Length: In certain forms of the present technology, "path length" is taken to refer to the distance along the surface from f(0) to f(1) (i.e., the distance along a path on the surface). There may be more than one path between two points on the surface, and such paths may have different path lengths. (The path length of a fictional person is the distance walked along the path on the surface.)

[0556] 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.)

[0557] 5.10.6.3 Space curve Space Curve: Unlike a plane curve, a space curve does not necessarily exist within any particular plane. A space curve may be closed, i.e., it has no endpoint. 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 contains a left-handed helix (see Figure 3Q). A typical human right ear contains a right-handed helix (see Figure 3R). Figure 3S shows a right-handed helix. The edge of a structure (e.g., the edge of a membrane or impeller) may trace a space curve. In general, a space curve can be described by the curvature and twist at each point on the space curve. Torsion 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 can be characterized with respect to the tangent, normal, and binormal vectors at that point.

[0558] 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 were flying along the curve and fell off their vehicle at a particular point, the direction of the tangent vector would be the direction they would be traveling.

[0559] Unit normal vector: As the fictional character moves along the 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.

[0560] 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).

[0561] Oscillating plane: A plane containing a unit tangent vector and a unit principal normal vector. See Figures 3O and 3P.

[0562] Torsion of a Space Curve: The torsion at a point on 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. A space curve that lies within a plane has zero torsion. 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). Referring to Figure 3S, the magnitude of torsion near the top coil of the spiral in Figure 3S is greater than the magnitude of torsion of the bottom coil of the spiral in Figure 3S because T2 > T1.

[0563] Referring to the right-hand rule in Figure 3P, a space curve that bends toward the right-hand binormal can be considered to have a positive right-hand twist (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 right-hand twist (e.g., a left-hand spiral).

[0564] Similarly, with reference to the left-hand rule (see Figure 3O), a space curve oriented in a left-handed binormal direction can be considered as having a positive left-handed twist (e.g., a left-handed spiral). Thus, a positive left-handed direction corresponds to a negative right-handed direction. See Figure 3T.

[0565] 5.10.6.4 Holes A surface may have one-dimensional holes (e.g., holes bounded by a planar 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 planar curve.

[0566] A structure can 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's inner surface. In another example, a bladder with a cavity for air or gel can have a two-dimensional hole. See, for example, the cushion in FIG. 3L and the exemplary cross-section of FIG. 3L in FIGS. 3M and 3N, where the inner surface bounding the two-dimensional hole is shown. In yet another example, a conduit can include a one-dimensional hole (e.g., at its inlet or its outlet) and can 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.

[0567] 5.11 Other Notes Unless otherwise clearly indicated from the context and unless a range of values ​​is provided, it is understood that each intervening value, to the tenth of the unit of the lower limit, between the upper and lower limits of the range, and for any other stated or intervening value in the stated range, is encompassed by the technology. The upper and lower limits of these intervening ranges, 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.

[0568] Furthermore, when a value or values ​​are embodied herein as part of the present technology, unless otherwise specified, it is understood that such values ​​may be approximated and may be used to any appropriate significant figures to the extent practical technical practice permits or requires.

[0569] Unless otherwise defined, all technical and scientific terms used 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.

[0570] Although particular materials are described as being suitable for use in the construction of components, obvious alternative materials having similar properties may be substituted. Furthermore, unless stated to the contrary, any and all components described herein are understood to be manufacturable and therefore may be manufactured collectively or separately.

[0571] It should be noted that as used herein and in the appended claims, the singular forms "a," "an," and "the" include their plural equivalents unless the context clearly dictates otherwise.

[0572] All publications mentioned herein are incorporated by reference to disclose and describe the methods and / or materials that are the subject of these publications. The 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.

[0573] 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 not specifically described.

[0574] The headings used in the detailed description are for the convenience of the reader and should not be used to limit the content found in the disclosure or claims as a whole. These headings should not be used in interpreting the scope of the claims or the claim limitations.

[0575] 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 unnecessary for the practice of the technology. For example, although the terms "first" and "second" (etc.) are used, unless otherwise specified, these terms are not intended to indicate any order but are used to distinguish between separate elements. Furthermore, although the process steps in the method may be described or illustrated in an ordered manner, such an order is not required. Those skilled in the art will recognize that such an order can be changed and / or aspects thereof can be performed simultaneously or even synchronously.

[0576] It is therefore to be understood that numerous modifications may be made in the illustrative embodiments and that other arrangements may be devised without departing from the spirit and scope of the present technology. [Explanation of symbols]

[0577] patient 1000 Bedmate: 1100 Patient Interface 3000 Seal forming structure 3100 Inner part facing upwards 3111 Medial sella 3112 Forward-facing inner part 3115 Upper lip 3116 Mouth hole area 3117 Lower lip 3118 Middle part facing upwards 3121 Forward-facing middle section 3125 Rear-facing side 3135 Lateral part 3145 Lateral support part 3151 Plenum Chamber 3200 Tendon 3209 Fessia Department 3210 Lateral headgear support recesses 3212 Lateral Insert 3214 Internal Rim 3215 External rim 3216 Positioning Features 3217 Insert opening 3218 Inner part 3219 Top point 3220 Bottom point 3229 Nose part 3230 Lateral part 3231 Base 3232 Inlet port 3240 Hollow protrusion 3250 Rim 3252 Upper part 3254 Lower part 3256 Mouth part 3260 Mouth hole 3271 Nose hole 3272 Oronasal transition 3275 Positioning and stabilizing structure 3300 Headgear connection support 3302 Top Strap 3310 Upper strap connection point 3315 Lower Strap 3320 Lower connection point 3325 Lower Strap Clip 3326 Parietal Crown Strap 3330 Lateral crown strap 3332 Cervical strap 3334 Headgear tube 3340 Tab 3342 Headgear Tube Connector 3344 Headgear Connector 3246 Conduit headgear inlet 3390 Ventilation section 3400 Connection port 3600 First end 3602 Second end 3604 Annular groove 3606 bump 3608 Pipe connection part 3610 Forehead support part 3700 RPT Device 4000 Outer Housing 4010 Internal part 4012 Lower 4014 Panel 4015 Chassis 4016 Handle 4018 Pneumatic Block 4020 Air Filter 4110 Inlet Air Filter 4112 Outlet Air Filter 4114 Muffler 4120 Inlet muffler 4122 Outlet muffler 4124 Pressure Generator 4140 Blower 4142 Motor 4144 Anti-spillback valve 4160 Air Circuit 4170 Heated air circuit 4171 Supplemental oxygen 4180 Electrical parts 4200 Printed Circuit Board Assembly (PCBA) 4202 power supply 4210 Input Device 4220 Converter 4270 Output device 4290 Humidifier 5000 Humidifier inlet 5002 Humidifier outlet 5004 Humidifier Base 5006 Reservoir 5110 Conductive part 5120 Humidifier Reservoir Dock 5130 Lock lever 5135 Water Level Indicator 5150 Humidifier Converter 5210 Air pressure sensor 5212 Flow Converter 5214 Temperature Sensor 5216 heating element 5240 Humidifier Controller 5250 Central Humidifier Controller 5251 Heating Element Controller 5252 Air Circuit Controller 5254

Claims

1. A patient interface comprising: At least 6 cmH above ambient air pressure ２ a plenum chamber pressurizable to an elevated therapeutic pressure, said plenum chamber including a plenum chamber inlet port sized and configured to receive airflow at the therapeutic pressure for patient breathing; 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 a flow of air at the therapeutic pressure is delivered to the patient's mouth, the first seal-forming structure constructed and arranged to maintain the therapeutic pressure within the plenum chamber, in use, throughout the patient's respiratory cycle; 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 a flow of air at the therapeutic pressure is delivered to the patient's 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 venting structure that allows a continuous flow of gases exhaled by a patient to escape from the interior of the plenum chamber to the environment, the venting structure being sized and shaped to maintain the therapeutic pressure within the plenum chamber in use; Including, at least a portion of the mouth 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; at least one component releasably connected to the flexible shell, the at least one component being stiffer than a portion of the flexible shell adjacent to the at least one component; A patient interface wherein the plenum chamber is at least partially defined by a shell, and the vent structure is provided in the shell.

2. 10. The patient interface of claim 1, wherein the Young's modulus is less than 0.1 GPa.

3. 10. The patient interface of claim 1, wherein the Young's modulus is between 0.3 MPa and 0.7 MPa.

4. The at least one component is 4. A patient interface as described in any one of claims 1 to 3, comprising one or more of: a ventilation module; a headgear connector; a headgear connector connected to a stiffening arm; a stiffening member; a less flexible shell portion.

5. A patient interface according to any preceding claim, wherein the at least one component is permanently connected to the flexible shell.

6. The patient interface of claim 5 , wherein the at least one component is overmolded onto the flexible shell.

7. A patient interface according to any preceding claim, wherein the flexible shell includes a stiffened portion that is thicker than an immediately adjacent portion of the flexible shell.

8. A patient interface according to any preceding claim, wherein the at least one component is configured as a stiffening rib or band.

9. A patient interface according to any preceding claim, wherein a central portion of the mouth region of the plenum chamber is more rigid than the remainder of the plenum chamber.

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