Patient interface

Abstract

To provide: one or more of the diagnosis, treatment, prevention and amelioration of respiratory-related disorders; and medical devices or apparatuses, and their use.SOLUTION: A patient interface comprises a support structure and a seal-forming structure. The support structure is arranged to support a sealing portion and is configured to connect to a frame. The sealing portion comprises textile and is attached to the support structure along an outer perimeter of the sealing portion, so that the sealing portion is in tension during use because of reactive stress of the support structure and / or a resilient stretch characteristic of the textile and thus exerts a force on the patient's face.SELECTED DRAWING: Figure 33-1

Description

[Technical Field]

[0001] 1 Cross-reference to related applications This application claims the benefit of U.S. Provisional Application No. 62 / 805,147, filed February 13, 2019, and also claims the benefit of Australian Provisional Application No. AU2018904886, filed December 21, 2018, and Australian Provisional Application No. AU2018903752, filed October 16, 2018, each of which is incorporated by reference in its entirety. [Background technology]

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

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

[0004] These airways comprise a series of branching tubes that become narrower, shorter and more numerous the deeper they go into the lungs. The primary function of the lungs is gas exchange, allowing oxygen to enter the venous blood from the air and carbon dioxide to leave. The trachea divides into the right and left main bronchi, which further divide to eventually become the terminal bronchioles. The bronchi constitute the conducting airways and do not participate in gas exchange. The airways further divide into the respiratory bronchioles and ultimately the alveoli. Gas exchange occurs in the alveolar region of the lungs, and this region is called the respiratory region. See: Non-Patent Document 1.

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

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

[0007] Obstructive sleep apnea (OSA) is a form of sleep-disordered breathing (SDB) characterized by episodes 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 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. Patent No. 6,244,999 (Sullivan).

[0008] 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. 5,929,999 (Berthon-Jones).

[0009] Respiratory failure is a general term for respiratory disorders that refers to the inability of the lungs to take in enough oxygen or exhale enough CO2 to meet the patient's needs. Respiratory failure can include some or all of the following conditions:

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

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

[0012] Chronic obstructive pulmonary disease (COPD) encompasses any of a group of lower 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.

[0013] 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.

[0014] Chest wall disorders are a group of thoracic deformities that result in ineffective connections between the respiratory muscles and the rib cage. These disorders are primarily characterized by restrictive 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.

[0015] A range of treatments are available to treat or ameliorate these conditions. In addition, otherwise healthy individuals can benefit from preventative treatments for respiratory disease. However, these suffer from several deficiencies.

[0016] 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).

[0017] 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.

[0018] 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.

[0019] 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.

[0020] 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.

[0021] The treatment system may include a respiratory pressure treatment device (RPT device), an air circuit, a humidifier, a patient interface, and data management.

[0022] Another form of treatment system is a mandibular repositioning device.

[0023] 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 relative to 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.

[0024] 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.

[0025] 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).

[0026] 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.

[0027] Certain masks may be impractical for use while sleeping (eg, when sleeping on your side in bed with your head resting on a pillow).

[0028] 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.

[0029] 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.

[0030] 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.

[0031] Masks designed for use in treating sleep-disordered breathing may be suitable for other uses, such as for aviators, and masks designed for use in treating sleep-disordered breathing may be suitable for other uses.

[0032] For these reasons, patient interfaces for CPAP delivery during sleep form a distinct field.

[0033] 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.

[0034] 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.

[0035] 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 sealing portion of swim goggles that rests on the patient's forehead may be inappropriate for use on the patient's nose.

[0036] 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 that there is a mismatch between the shape of the patient's face and the seal-forming structure of the mass-manufactured patient interface, one or both must be adapted to form a seal, which can result in patient discomfort.

[0037] A seal-forming structure that fits one individual may not fit another. Furthermore, a design that fits a patient at one pressure or in one position may be inadequate at other pressures or in other positions. Some designs may leak when the patient moves (e.g., while falling asleep).

[0038] One type of seal-forming structure extends around the periphery of the patient interface and is intended to seal against the patient's face when force is applied to the patient interface 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.

[0039] 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.

[0040] Additionally, some manufacturing processes can result in undesirable folds, wrinkles or buckling of the seal-forming structure during use.

[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: US Pat. No. 5,623,999; US Pat. No. 5,623,999; and US Pat. No. 5,623,999).

[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 MIRAGE LIBERTY® full face mask. Examples of nasal pillows masks are described in the following patent applications assigned to ResMed Limited: U.S. Patent No. 6,223,999 (depicting, among other things, aspects of ResMed Limited's SWIFT® nasal pillows), U.S. Patent No. 6,223,999 (depicting, among other things, aspects of ResMed Limited's SWIFT® LT nasal pillows), U.S. Patent No. 6,223,999 and U.S. Patent No. 6,223,999 (depicting, among other things, aspects of ResMed Limited's MIRAGE LIBERTY® full face mask), and U.S. Patent No. 6,223,999 (depicting, 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 therapy are subjected to corresponding air pressure forces 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] In one technique, adhesives are used, see, for example, US Patent No. 5,929,999, however, 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 Elise Accessory 150 ventilator and ResMed VSIII ventilator 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 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).

[0064] 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.

[0065] ResMed Limited has developed several improved mask ventilation technologies, see: US Patent Nos. 5,629,999; ... and 5,629,999.

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

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

[0068] The sound pressure values ​​for various subjects are listed below. [Table 3]

[0069] 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.

[0070] A clinical expert may adequately 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. [Prior art documents] [Patent documents]

[0071] [Patent Document 1] U.S. Patent No. 4,944,310 [Patent Document 2] U.S. Patent No. 6,532,959 [Patent Document 3] International Publication No. 1998 / 004310 Pamphlet [Patent Document 4] International Publication No. 2006 / 074513 Pamphlet [Patent Document 5] International Publication No. 2010 / 135785 Brochure [Patent Document 6] International Publication No. 2004 / 07,778 Pamphlet [Patent Document 7] U.S. Patent Application No. 2009 / 0044808 Pamphlet [Patent Document 8] International Publication No. 2005 / 063328 Pamphlet [Patent Document 9] International Publication No. 2006 / 130903 Brochure [Patent Document 10] International Publication No. 2009 / 052560 Brochure [Patent Document 11] US Patent Application Publication US2010 / 0000534 [Patent Document 12] International Publication No. 1998 / 034665 Pamphlet [Patent Document 13] International Publication No. 2000 / 078381 Pamphlet [Patent Document 14] U.S. Patent No. 6,581,594 [Patent Document 15] U.S. Patent Application Publication No. US2009 / 0050156 [Patent Document 16] US Patent Application Publication No. 2009 / 0044808

[0072] [Non-Patent Document 1] “Respiratory Physiology”, by John B. West, Lippincott Williams & Wilkins, 9th edition published 2012 Summary of the Invention [Means for solving the problem]

[0073] 3. Brief description of the technology The present technology relates to the provision of medical devices for use in the diagnosis, amelioration, treatment or prevention of respiratory disorders, which medical devices have one or more of improved comfort, cost, effectiveness, ease of use and manufacturability.

[0074] A first aspect of the present technology relates to devices used in the diagnosis, amelioration, treatment or prevention of respiratory disorders.

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

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

[0077] Another aspect of the present technology relates to a seal-forming structure for a patient interface, the seal-forming structure including a woven membrane.

[0078] In one form, the woven membrane is air impermeable.

[0079] Another aspect of the present technology relates to a manufacturing process for a patient interface using a flat woven composite to create a contoured woven membrane.

[0080] Another aspect of the present technology relates to a seal-forming structure for a patient interface, the seal-forming structure including a woven membrane, the seal-forming structure being free of (or having reduced) buckling or wrinkling.

[0081] Another aspect of the present technology relates to a patient interface that includes a textile membrane that includes a knitted textile material.

[0082] One form of knitted textile material is warp knitting.

[0083] One form of knitted textile material is weft knitting.

[0084] In one form, the woven membrane is compliant (eg, equally compliant) in both the vertical and horizontal directions.

[0085] In one embodiment, the woven membrane is more extensible in the horizontal direction than in the vertical direction.

[0086] Another aspect of the present technology relates to a wide wear patient interface.

[0087] Another aspect of the present technology relates to a seal-forming structure for a patient interface, the seal-forming structure including a sealing portion (eg, comprising a woven material) that is held taut prior to use.

[0088] Another aspect of the present technology relates to a seal-forming structure for a patient interface, the seal-forming structure including a tension-free woven membrane that is free of wrinkles, folds, creases, or buckles on an outer surface of the woven membrane.

[0089] Another aspect of the present technology relates to a seal-forming structure for a patient interface. The seal-forming structure includes a woven membrane having bridge regions that relax and / or buckle with excess material.

[0090] Another aspect of the present technology relates to a patient interface for delivering a flow of air at a continuous positive pressure relative to ambient air pressure in a sealed manner to an entrance to a patient's airways, including at least the entrance to the patient's nostrils. The patient interface is configured to maintain a therapy pressure in a range of about 4 cmH2O to about 30 cmH2O above ambient air pressure throughout the patient's respiratory cycle while the patient is sleeping to ameliorate sleep-disordered breathing, the patient interface including: 1) a plenum chamber at least partially defining a cavity pressurizable to a therapy pressure of at least 6 cmH2O above ambient air pressure, the plenum chamber adapted to receive an airflow at the therapy pressure for breathing by the patient; and 2) a seal-forming structure having a textile membrane constructed and arranged to form a pressure-assisted seal with an area of ​​the patient's face surrounding an entrance to the patient's airways, the textile membrane having holes formed therein such that the airflow at the therapy pressure is delivered to at least entrances to the patient's nares, the seal-forming structure constructed and arranged to maintain the therapy pressure in the cavity throughout the patient's respiratory cycle in use.

[0091] In an embodiment, (a) the seal-forming structure includes a support structure for supporting the woven membrane, the support structure configured to connect to the plenum chamber; and (b) the woven membrane is attached to the support structure along its outer periphery in a manner such that the woven membrane is in a taut state prior to use.

[0092] Another aspect of the present technology relates to a patient interface for delivering a flow of air at a continuous positive pressure relative to ambient air pressure in a sealed manner to an entrance to a patient's airways, including at least the entrance to the patient's nostrils. The patient interface is configured to maintain a therapy pressure in a range of about 4 cmH2O to about 30 cmH2O above ambient air pressure in use throughout the patient's respiratory cycle while the patient is sleeping to ameliorate sleep-disordered breathing, the patient interface including: 1) a plenum chamber at least partially defining a cavity pressurizable to a therapy pressure of at least 6 cmH2O above ambient air pressure, the plenum chamber including a plenum chamber inlet port sized and configured to receive a flow of air at the therapy pressure for breathing by the patient; and 2) a seal-forming structure having a textile membrane constructed and arranged to form a pressure-assisted seal with an area of ​​the patient's face surrounding an entrance to the patient's airways, the textile membrane having holes formed therein such that the flow of air at the therapy pressure is delivered to at least entrances to the patient's nares, the seal-forming structure constructed and arranged to maintain the therapy pressure in the cavity throughout the patient's respiratory cycle in use. The seal-forming structure may include a flexible support structure for supporting the textile membrane, the support structure connected to the plenum chamber, the support structure being more rigid than the textile membrane. In use, the textile membrane may be configured to be pressed against the patient's face so that the patient's nose is not received in the cavity. The textile membrane may be attached to the support structure along an outer periphery of the textile membrane, thereby extending radially inward beyond the support structure.

[0093] In embodiments, (a) the plenum chamber and support structure comprise silicone and form a one-piece structure having first lateral support sections of a first thickness and a second, centrally located, nose base section of a second thickness less than the first thickness, the nose base section configured to fold or form a pivot point when the woven membrane engages with the patient's face, causing the right and left lateral sides of the support structure to deform inward to cradle the patient's nose; (b) the support structure comprises an underlying cushion; (c) the support structure comprises foam; (d) the support structure comprises silicone, and the woven membrane is molded to the inner edge of the support structure; (e) the woven membrane has a dome shape in corner regions of the woven membrane; and (f) the woven membrane has a saddle shape in a lower central region of the woven membrane configured to seal under the patient's nose in use.

[0094] In further embodiments, (a) the woven membrane comprises a woven material to which a membrane layer is added to render the woven material substantially air impermeable; (b) the thickness of the woven membrane is within the range of 0.3 mm to 0.5 mm; (c) the thickness of the membrane layer is within the range of 0.05 mm to 0.1 mm; (d) the woven material is weft knit; (e) the weight of the woven material is within the range of 105 gsm to 120 gsm; (f) the machine gauge of the woven material is within the range of 44 GG to 60 GG; (g) the woven material has a mélange aesthetic; (h) the woven material has a solid color aesthetic; (i) the membrane layer comprises silicone; (j) the woven material comprises nylon, spandex, or polyester; (k) in use, treatment pressure within the cavity directs the woven membrane toward the patient's face; and (l) the plenum chamber comprises silicone and is formed in one piece with the support structure.

[0095] In further embodiments, (a) the patient interface further comprises a positioning and stabilizing structure that provides force to hold the seal-forming structure in a therapeutically effective position on the patient's head, the positioning and stabilizing structure including a tie, the tie constructed and arranged to rest at least a portion of the tie against a region of the patient's head above the superior ear-base point in use; (b) the patient interface further comprises a venting structure that allows continuous flow of gases exhaled by the patient from within the cavity to the surroundings, the venting structure being sized and shaped to maintain a therapeutic pressure within the cavity in use; (c) the plenum chamber and the seal-forming structure form an oronasal cushion assembly; and (d) the plenum chamber and the seal-forming structure form a nasal cushion.

[0096] Another aspect of the present technology relates to a patient interface for delivering a flow of air at a continuous positive pressure relative to ambient air pressure in a sealed manner to an entrance to a patient's airways, including at least the entrance to the patient's nostrils. The patient interface is configured to maintain a therapy pressure in a range of about 4 cmH2O to about 30 cmH2O above ambient air pressure in use throughout the patient's respiratory cycle while the patient is sleeping to ameliorate sleep-disordered breathing, the patient interface including: 1) a plenum chamber at least partially defining a cavity pressurizable to a therapy pressure of at least 6 cmH2O above ambient air pressure, the plenum chamber including a plenum chamber inlet port sized and configured to receive a flow of air at the therapy pressure for breathing by the patient; and 2) a seal-forming structure having a woven membrane constructed and arranged to form a pressure-assisted seal with an area of ​​the patient's face surrounding an entrance to the patient's airways, the woven membrane having at least one hole formed therein such that the flow of air at the therapy pressure is delivered to at least an entrance to the patient's nares, the seal-forming structure constructed and arranged to maintain the therapy pressure in the cavity throughout the patient's respiratory cycle in use. The seal-forming structure may include a flexible support structure for supporting the woven membrane, the support structure being stiffer than the woven membrane, and the support structure connected to the plenum chamber. At the transition region, the woven membrane may extend radially inward beyond the support structure by being attached to the support structure along an outer edge of the woven membrane and an inner edge of the support structure. At the transition region, both the support structure and the woven membrane may extend along a curve in a direction from the anterior side of the seal-forming structure to the front, patient-facing side of the seal-forming structure.

[0097] In embodiments, (a) at the transition region, the support structure and the woven membrane have generally the same radius of curvature; (b) the woven membrane extends continuously along a curve from the transition region to the inner edge of the woven membrane; (c) in use, the woven membrane is configured to be pressed against the patient's face so that the patient's nose is not received in the cavity; (d) the at least one hole in the woven membrane includes two holes, and a bridge region is disposed between the two holes in the woven membrane; (e) the support structure includes silicone, and the woven membrane is molded to the inner edge of the support structure; and (f) the seal-forming structure has a seamless transition along its outer surface from the support structure to the woven membrane.

[0098] In further embodiments, (a) the woven membrane comprises a woven material to which a membrane layer is added to render the woven material substantially air impermeable; (b) the thickness of the woven membrane is in the range of 0.3 mm to 0.5 mm; (c) the woven material is weft knitted; (d) the membrane layer comprises silicone; (e) the woven material comprises nylon, spandex, or polyester; (f) in use, treatment pressure within the cavity directs the woven membrane toward the patient's face; (g) the plenum chamber and seal-forming structure form an oral-nasal cushion assembly; and (h) the plenum chamber and seal-forming structure form a nasal cushion.

[0099] Another aspect of the present technology relates to a patient interface for delivering a flow of air at a continuous positive pressure relative to ambient air pressure in a sealed manner to an entrance to a patient's airways, including at least the entrance to the patient's nostrils. The patient interface is configured to maintain a therapy pressure in a range of about 4 cmH2O to about 30 cmH2O above ambient air pressure in use throughout the patient's respiratory cycle while the patient is sleeping to ameliorate sleep-disordered breathing, the patient interface including: 1) a plenum chamber at least partially defining a cavity pressurizable to a therapy pressure of at least 6 cmH2O above ambient air pressure, the plenum chamber including a plenum chamber inlet port sized and configured to receive a flow of air at the therapy pressure for breathing by the patient; and 2) a seal-forming structure having a woven membrane constructed and arranged to form a pressure-assisted seal with an area of ​​the patient's face surrounding an entrance to the patient's airways, the woven membrane having at least one hole formed therein such that the flow of air at the therapy pressure is delivered to at least an entrance to the patient's nares, the seal-forming structure constructed and arranged to maintain the therapy pressure in the cavity throughout the patient's respiratory cycle in use. The textile membrane may include a textile material to which a membrane layer is added to render the textile material substantially air-impermeable, and the textile material may be a weft-knitted fabric. The seal-forming structure may include a flexible support structure for supporting the textile membrane, which may be connected to the plenum chamber and which may be more rigid than the textile membrane. The textile membrane may be attached to the support structure along the periphery of the textile membrane, thereby extending radially inward beyond the support structure. In use, the textile membrane may be configured to be pressed against the patient's face so that the patient's nose is not received in the cavity. The textile membrane may have a dome shape in corner regions of the textile membrane configured to seal against the patient's alar-lowest regions and a saddle shape in a lower central region of the textile membrane configured to seal below the patient's nose.

[0100] In embodiments, (a) during use, treatment pressure within the cavity directs the woven membrane toward the patient's face, assisting the woven membrane in forming a seal with the patient's face; (b) the at least one hole in the woven membrane includes two holes, and a bridge portion is disposed between the two holes in the woven membrane, and when the bridge portion buckles with excess material, the woven membrane can expand to accommodate different sized noses; (c) the support structure includes silicone, and the woven membrane is molded to the inner edge of the support structure; (d) the plenum chamber includes silicone and is formed in one piece with the support structure; (e) the woven membrane is attached to the support structure in a manner such that the woven membrane is in a taut state before use; (f) a first region of the woven membrane is in a taut state before use, and a second region of the woven membrane is in an untensioned state before use.

[0101] In further embodiments, (a) the woven membrane has four-way elasticity; (b) the woven membrane has a first elasticity in the left-right lateral direction and a second, different elasticity in the up-down direction, the elasticity in the first direction being higher than the elasticity in the second direction; (c) the membrane layer comprises silicone; (d) the woven material comprises nylon, spandex, or polyester; (e) the plenum chamber and seal-forming structure form an oral-nasal cushion assembly; and (f) the plenum chamber and seal-forming structure form a nasal cushion.

[0102] Another aspect of the present technology relates to a method of forming a cushion assembly for a patient interface configured to deliver a flow of air at a continuous positive pressure relative to ambient air pressure in a sealed manner to an entrance to a patient's airways, including at least the entrances to the patient's nares, and configured to maintain a therapeutic pressure in use in a range of about 4 cmH2O to about 30 cmH2O above ambient air pressure throughout the patient's respiratory cycle while the patient is sleeping, to ameliorate sleep-disordered breathing, the method comprising: 1) adding an air-impermeable material to a woven material to form an airtight woven composite having a flat shape, 2) cutting the woven composite to desired dimensions depending on the particular cushion assembly typology being used, and 3) overmolding a flexible support structure onto the cut woven composite to form a seal-forming structure with a woven membrane, such that the woven membrane is attached to the support structure along an outer edge of the woven membrane and an inner edge of the support structure. In the overmolding step, the woven composite has a non-flat shape when overmolded because it can be held in place by a vacuum, which imparts a curved, non-flat shape to the woven membrane, which is free of wrinkles, wrinkles, folds, and / or buckles.

[0103] In embodiments, (a) the seal-forming structure has a seamless transition along its outer surface from the support structure to the woven membrane; (b) at the transition region, the woven membrane is attached to the support structure along the outer edge of the woven membrane and the inner edge of the support structure, thereby extending radially inward beyond the support structure, and at the transition region, both the support structure and the woven membrane extend along a curve in a direction from the anterior side of the seal-forming structure to the anterior, patient-facing side of the seal-forming structure; (c) two holes are formed in the woven membrane, and a bridge region is disposed between the two holes in the woven membrane, such that when the bridge region buckles with excess material, the woven membrane can expand to accommodate different sized noses; (d) the support structure includes silicone.

[0104] Another aspect of the present technology relates to a seal-forming structure for a patient interface, the seal-forming structure including a support structure and a sealing portion, the support structure supporting the sealing portion, the sealing portion being attached to the support structure along an outer periphery of the sealing portion thereby extending radially inwardly beyond the support structure, and wherein, in use, the sealing portion is configured to be pressed against a patient's face such that the patient's nose is not received in the cavity, and the sealing portion is placed in tension due to the reaction stress of the support structure and / or the elastic elongation properties of the fabric, thereby causing the sealing portion to apply a force against the patient's face.

[0105] According to a further aspect of the present technology, the sealing portion comprises a fabric. In a further embodiment, the patient interface includes a plenum chamber, the support structure configured to connect to the plenum chamber, the plenum chamber at least partially forming a cavity pressurizable to a therapeutic pressure of at least 6 cmH2O above ambient air pressure, the plenum chamber including a plenum chamber inlet port sized and configured to receive an airflow at the therapeutic pressure for breathing of the patient. In a further embodiment, the sealing portion is constructed and arranged to form a seal with an area of ​​the patient's face surrounding an entrance to the patient's airways, the sealing portion having holes formed therein whereby an airflow at the therapeutic pressure is delivered to at least the entrance to the patient's nares, and the seal-forming structure is constructed and arranged to maintain the therapeutic pressure in the cavity throughout the patient's respiratory cycle in use. In a further embodiment, the support structure comprises silicone and / or a thermoplastic elastomer.

[0106] In accordance with a further aspect of the present technology, a wall structure of a support structure between a sealing portion and a plenum chamber includes a first member having a first thickness and a second member having a second thickness different from the first thickness.

[0107] Another aspect of the present technology relates to a seal-forming structure for a patient interface, the seal-forming structure including a support structure and a sealing portion, the support structure supporting the sealing portion and attached to the support structure along a periphery of the sealing portion in a manner such that the sealing portion is in a taut state prior to use.

[0108] According to a further aspect of the present technology, the sealing portion comprises a fabric material. In a further embodiment, the patient interface includes a plenum chamber, and the support structure is configured to connect to the plenum chamber, the plenum chamber at least partially forming a cavity pressurizable to a therapeutic pressure of at least 6 cmH2O above ambient air pressure, and the plenum chamber includes a plenum chamber inlet port sized and configured to receive an airflow at the therapeutic pressure for breathing of the patient. In a further embodiment, the sealing portion is constructed and arranged to form a seal with an area of ​​the patient's face surrounding an entrance to the patient's airways, the sealing portion having holes formed therein whereby an airflow at the therapeutic pressure is delivered to at least the entrance to the patient's nares, and the seal-forming structure is constructed and arranged to maintain the therapeutic pressure in the cavity throughout the patient's respiratory cycle in use. In a further embodiment, the support structure comprises silicone and / or a thermoplastic elastomer.

[0109] Another aspect of the present technology relates to a seal-forming structure for a patient interface, the seal-forming structure including a support structure and a sealing portion, the support structure supporting the sealing portion, the sealing portion including a fabric material and attached to the support structure along an outer periphery of the sealing portion, the support structure being more rigid than the sealing portion, and the support structure including a first member having a first thickness and a second member having a second thickness different from the first thickness.

[0110] According to further aspects of the present technology, the support structure comprises silicone and / or thermoplastic elastomer, the patient interface includes a plenum chamber, the support structure configured to connect to the plenum chamber, the plenum chamber at least partially defining a cavity pressurizable to a therapeutic pressure of at least 6 cmH2O above ambient air pressure, the plenum chamber including a plenum chamber inlet port sized and configured to receive an airflow at the therapeutic pressure for breathing of the patient. In further embodiments, the sealing portion is constructed and arranged to form a seal with an area of ​​the patient's face surrounding an entrance to the patient's airways, the sealing portion having holes formed therein whereby the airflow at the therapeutic pressure is delivered to at least the entrance to the patient's nares, and the seal-forming structure is constructed and arranged to maintain the therapeutic pressure in the cavity throughout the patient's respiratory cycle in use.

[0111] 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.

[0112] One aspect of the present technology is a method for manufacturing a device.

[0113] 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.

[0114] An aspect of one form of the present technology is a patient interface that can be cleaned in the patient's home, for example with soap and water, without the need for special cleaning equipment.

[0115] Another aspect of the present technology relates to a treatment system for use in treating sleep disordered breathing, the system including: 1) a patient interface according to any of the above aspects; 2) a respiratory pressure therapy (RPT) device for supplying breathable gas at positive pressure; and 3) an air delivery tube for passing breathable gas from the RPT device to the patient interface.

[0116] 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).

[0117] 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.

[0118] Other features of the present technology will become apparent in light of the information contained in the following detailed description (4 brief description of the drawings), abstract, drawings, and claims. [Additional note 1] 1. A patient interface for sealingly delivering a flow of air at a continuous positive pressure relative to ambient air pressure to an entrance to a patient's airways, including at least the entrance to the patient's nostrils, the patient interface being configured to maintain a therapy pressure in use in a range of about 4 cmH2O to about 30 cmH2O above ambient air pressure throughout the patient's respiratory cycle while the patient is sleeping to improve sleep disordered breathing, the patient interface comprising: a plenum chamber at least partially defining a cavity pressurizable to a therapeutic pressure of at least 6 cmH2O above ambient air pressure, said plenum chamber including a plenum chamber inlet port sized and configured to receive a flow of air at the therapeutic pressure for breathing by a patient; a seal-forming structure having a textile membrane constructed and arranged to form a pressure-assisted seal with an area of ​​the patient's face surrounding an entrance to the patient's airways below a nasal bridge region of the patient's face, the textile membrane having holes formed therein such that airflow at the therapeutic pressure is delivered to at least the entrance to the patient's nares, the seal-forming structure constructed and arranged to maintain the therapeutic pressure within the cavity in use throughout the patient's respiratory cycle; the seal-forming structure includes a flexible support structure for holding a woven fabric membrane in a predetermined curved shape, the woven fabric membrane including a mid-nasal tip region whose outer surface has a predetermined curved shape with a positive left-right curvature, and the woven fabric membrane including a mid-nasal subnasal region whose outer surface has a predetermined curved shape with a positive left-right curvature, the support structure being connected to the plenum chamber; In use, the textile membrane is configured to be pressed against the patient's face such that the patient's nose is not received in the cavity; A patient interface wherein the textile membrane is attached to the support structure along a periphery of the textile membrane such that it extends radially inward beyond the support structure. [Additional note 2] the plenum chamber and the support structure comprise silicone and form a one-piece structure having first lateral support portions of a first thickness and a second centrally disposed nose base section having a second thickness less than the first thickness; 10. The patient interface of claim 1, wherein the nose base section is configured to fold or form a pivot point when the textile membrane engages with the patient's face, thereby allowing the left and right lateral sides of the support structure to deform inward to cradle the patient's nose. [Additional note 3] 3. The patient interface of any one of clauses 1 to 2, wherein the support structure includes an underlying cushion. [Additional note 4] 4. The patient interface of any one of clauses 1 to 3, wherein the support structure comprises foam. [Additional note 5] 5. The patient interface of any one of clauses 1 to 4, wherein the support structure comprises silicone and the textile membrane is molded to an inner edge of the support structure. [Additional note 6] 6. The patient interface of any one of clauses 1 to 5, wherein the textile membrane has a dome shape in corner regions of the textile membrane. [Additional note 7] 7. A patient interface according to any one of clauses 1 to 6, wherein the textile membrane has a saddle-like shape in a lower central region thereof configured to seal under the patient's nose in use. [Additional note 8] 8. A patient interface according to any one of clauses 1 to 7, wherein the textile membrane comprises a membrane layer applied to the textile material to render the textile material substantially air impermeable. [Additional note 9] 9. The patient interface of any one of claims 1 to 8, wherein the thickness of the textile membrane is in the range of 0.3 mm to 0.5 mm. [Additional Note 10] 10. The patient interface of claim 8 or 9, wherein the thickness of the membrane layer of the textile membrane is in the range of 0.05 mm to 0.1 mm. [Additional Note 11] 11. The patient interface of any one of clauses 8 to 10, wherein the woven material is weft knitted. [Additional Note 12] 12. The patient interface of any one of clauses 8 to 11, wherein the weight of the woven material is in the range of 105 gsm to 120 gsm. [Additional Note 13] 13. The patient interface of any one of clauses 8 to 12, wherein the mechanical gauge of the woven material is in the range of 44GG to 60GG. [Additional Note 14] 14. The patient interface of any one of clauses 8 to 13, wherein the woven material has a mélange aesthetic. [Additional Note 15] 15. The patient interface of any one of clauses 8 to 14, wherein the textile material has a solid color aesthetic. [Additional Note 16] 16. The patient interface of any one of clauses 8 to 15, wherein the membrane layer comprises silicone. [Additional Note 17] 17. The patient interface of any one of clauses 8 to 16, wherein the textile material comprises nylon, spandex, or polyester. [Additional Note 18] 18. A patient interface according to any one of clauses 1 to 17, wherein in use, treatment pressure within the cavity causes the textile membrane to direct towards the patient's face. [Additional Note 19] 19. A patient interface according to any one of clauses 1 to 18, wherein the plenum chamber comprises silicone and is formed in one piece with the support structure. [Additional Note 20] 20. The patient interface of any one of clauses 1 to 19, further comprising a positioning and stabilising structure that provides a force to hold the seal-forming structure in a therapeutically effective position on the patient's head, the positioning and stabilising structure comprising a tie, the tie constructed and arranged such that, in use, at least a portion of the tie rests on a region of the patient's head above the superior auricular point of the patient's head. [Additional Note 21] 21. The patient interface of any one of clauses 1 to 20, further comprising a vent structure that allows a continuous flow of gases exhaled by the patient from within the cavity to the surroundings, the vent structure being sized and shaped to maintain a therapeutic pressure within the cavity in use. [Additional note 22] 22. A patient interface according to any one of clauses 1 to 21, wherein the plenum chamber and seal-forming structure form an oral-nasal cushion assembly. [Additional Note 23] 22. A patient interface according to any one of clauses 1 to 21, wherein the plenum chamber and seal-forming structure form a nasal cushion. [Additional note 24] 1. A treatment system for use in treating sleep disordered breathing, comprising: The patient interface according to any one of claims 1 to 23; Respiratory Pressure Therapy (RPT) devices that deliver breathable gas at positive pressure; and A treatment system including an air delivery tube for passing breathable gas from the RPT device to the patient interface. [Additional note 25] 1. A patient interface for sealingly delivering a flow of air at a continuous positive pressure relative to ambient air pressure to an entrance to a patient's airways, including at least the entrance to the patient's nostrils, the patient interface being configured to maintain a therapy pressure in use in a range of about 4 cmH2O to about 30 cmH2O above ambient air pressure throughout the patient's respiratory cycle while the patient is sleeping to improve sleep disordered breathing, the patient interface comprising: a plenum chamber at least partially defining a cavity pressurizable to a therapeutic pressure of at least 6 cmH2O above ambient air pressure, said plenum chamber including a plenum chamber inlet port sized and configured to receive a flow of air at the therapeutic pressure for breathing by a patient; a seal-forming structure having a textile membrane constructed and arranged to form a pressure-assisted seal with an area of ​​the patient's face surrounding an entrance to the patient's airway, the textile membrane having at least one hole formed therein to allow a flow of air at the therapeutic pressure to be delivered to at least an entrance to the patient's nares, the seal-forming structure constructed and arranged to, in use, maintain the therapeutic pressure within the cavity throughout the patient's respiratory cycle; the seal-forming structure includes a flexible support structure for supporting the textile membrane, the support structure being more rigid than the textile membrane, the support structure being connected to the plenum chamber; at a transition region, the woven membrane is attached to the support structure along an outer edge of the woven membrane and an inner edge of the support structure, thereby extending radially inwardly beyond the support structure along a posterior patient-contacting side of the seal-forming structure; A patient interface wherein, in a cross-sectional view, at a transition region, both the support structure and the textile membrane extend along a curve in a direction from the anterior side of the seal-forming structure to the front patient-facing side of the seal-forming structure. [Additional note 26] 26. The patient interface of clause 25, wherein at the transition region, the support structure and the textile membrane have generally the same radius of curvature. [Additional note 27] 27. The patient interface of claim 25 or 26, wherein the woven membrane extends continuously along a curve from the transition region to the inner edge of the woven membrane. [Additional note 28] 27. A patient interface according to claim 25 or 26, wherein in use the textile membrane is configured to be pressed against the patient's face so that the patient's nose is not received in the cavity. [Additional note 29] 29. The patient interface of any one of clauses 25-26 or 28, wherein the at least one hole in the woven membrane includes two holes, and a bridge portion is disposed between the two holes in the woven membrane. [Additional note 30] 30. The patient interface of any one of clauses 25 to 29, wherein the support structure comprises silicone and the textile membrane is molded to an inner edge of the support structure. [Additional note 31] 31. A patient interface according to any one of clauses 25 to 30, wherein the seal-forming structure has a seamless transition along its outer surface from the support structure to the textile membrane. [Additional note 32] 32. A patient interface according to any one of clauses 25 to 31, wherein the textile membrane comprises a textile material to which a membrane layer is added to render the textile material substantially air impermeable. [Additional note 33] 33. A patient interface as described in any one of appendix items 25 to 32, wherein the woven membrane is given a curvature so that a portion of the woven membrane that is not directly supported by the support structure extends along a curved portion. [Additional note 34] 34. The patient interface of claim 32 or 33, wherein the textile material is weft knitted. [Additional note 35] 35. The patient interface of any one of clauses 32 to 34, wherein the membrane layer comprises silicone. [Additional note 36] 36. The patient interface of any one of clauses 32 to 35, wherein the textile material comprises nylon, spandex, or polyester. [Additional note 37] 37. A patient interface according to any one of clauses 25 to 36, wherein in use, treatment pressure within the cavity causes the textile membrane to direct towards the patient's face. [Additional note 38] 38. A patient interface according to any one of clauses 25 to 37, wherein the plenum chamber and seal-forming structure form an oral-nasal cushion assembly. [Additional note 39] 39. A patient interface according to any one of clauses 25 to 38, wherein the plenum chamber and seal-forming structure form a nasal cushion. [Additional note 40] 1. A treatment system for use in treating sleep disordered breathing, comprising: The patient interface according to any one of claims 25 to 39; Respiratory Pressure Therapy (RPT) devices that deliver breathable gas at positive pressure; and A treatment system including an air delivery tube for passing breathable gas from the RPT device to the patient interface. [Additional note 41] 1. A patient interface for sealingly delivering a flow of air at a continuous positive pressure relative to ambient air pressure to an entrance to a patient's airways, including at least the entrance to the patient's nostrils, the patient interface being configured to maintain a therapy pressure in use in a range of about 4 cmH2O to about 30 cmH2O above ambient air pressure throughout the patient's respiratory cycle while the patient is sleeping to improve sleep disordered breathing, the patient interface comprising: a plenum chamber at least partially defining a cavity pressurizable to a therapeutic pressure of at least 6 cmH2O above ambient air pressure, said plenum chamber including a plenum chamber inlet port sized and configured to receive a flow of air at the therapeutic pressure for breathing by a patient; a seal-forming structure having a textile membrane constructed and arranged to form a pressure-assisted seal with an area of ​​the patient's face surrounding an entrance to the patient's airway, the textile membrane having at least one hole formed therein to allow a flow of air at the therapeutic pressure to be delivered to at least an entrance to the patient's nares, the seal-forming structure constructed and arranged to, in use, maintain the therapeutic pressure within the cavity throughout the patient's respiratory cycle; the textile membrane comprises a textile material to which a membrane layer is added to render the textile material substantially air impermeable, the textile material being a weft knitted fabric; the seal-forming structure includes a flexible support structure for supporting the textile membrane, the support structure being connected to the plenum chamber, the support structure being more rigid than the textile membrane; the textile membrane is attached to a support structure along a periphery of the textile membrane such that it extends radially inward beyond the support structure; In use, the textile membrane is configured to be pressed against the patient's face such that the patient's nose is not received in the cavity; a patient interface, wherein the textile membrane has a dome shape at corner regions of the textile membrane configured to seal against the patient's alar lowest regions, and a saddle shape at a lower central region of the textile membrane configured to seal under the patient's nose. [Additional note 42] 42. A patient interface as described in clause 41, wherein, in use, treatment pressure within the cavity directs the textile membrane towards the patient's face, assisting the textile membrane to form a seal with the patient's face. [Additional note 43] the at least one hole in the textile membrane includes two holes, and a bridge portion is disposed between the two holes in the textile membrane; 43. A patient interface as described in clause 41 or 42, wherein the bridge region buckles with excess material, allowing the textile membrane to expand to accommodate different sized noses. [Additional note 44] 44. A patient interface according to any one of clauses 41 to 43, wherein the support structure comprises silicone and the textile membrane is molded to an inner edge of the support structure. [Additional note 45] 45. A patient interface according to any one of clauses 41 to 44, wherein the plenum chamber comprises silicone and is formed in one piece with the support structure. [Additional note 46] 46. ​​A patient interface according to any one of clauses 41 to 45, wherein the textile membrane is attached to the support structure in a manner such that the textile membrane is in a taut state prior to use. [Additional note 47] 47. A patient interface according to any one of claims 41 to 46, wherein a first region of the woven membrane is in a taut state prior to use and a second region of the woven membrane is in an untensioned state prior to use. [Additional note 48] 48. The patient interface of any one of claims 41 to 47, wherein the textile membrane has elasticity in four directions. [Additional note 49] 48. A patient interface as described in any one of appended clauses 41 to 47, wherein the textile membrane has a first elasticity in the left-right lateral direction and a second, different elasticity in the up-down direction, the elasticity in the first direction being greater than the elasticity in the second direction. [Additional Note 50] 50. The patient interface of any one of clauses 41 to 49, wherein the membrane layer comprises silicone. [Additional Note 51] 51. The patient interface of any one of clauses 41 to 50, wherein the textile material comprises nylon, spandex, or polyester. [Additional note 52] 52. A patient interface according to any one of clauses 41 to 51, wherein the plenum chamber and seal-forming structure form an oral-nasal cushion assembly. [Additional note 53] 53. A patient interface according to any one of clauses 41 to 52, wherein the plenum chamber and seal-forming structure form a nasal cushion. [Additional note 54] 1. A treatment system for use in treating sleep disordered breathing, comprising: A patient interface according to any one of appendixes 41 to 50; Respiratory Pressure Therapy (RPT) devices that deliver breathable gas at positive pressure; and A treatment system including an air delivery tube for passing breathable gas from the RPT device to the patient interface. [Additional note 55] 1. A method of forming a cushion assembly for a patient interface, the cushion assembly configured to deliver a flow of air at a continuous positive pressure relative to ambient air pressure in a sealed manner to an entrance to a patient's airways, including at least the entrances to the patient's nostrils, the cushion assembly configured to maintain a therapeutic pressure in use in a range of about 4 cmH2O to about 30 cmH2O above ambient air pressure throughout the patient's respiratory cycle while the patient is sleeping to improve sleep-disordered breathing, the method comprising: forming an airtight woven composite having a flat shape by adding an air impermeable material to the woven material; cutting the fabric composite to the desired dimensions depending on the particular cushion assembly type to be used; overmolding a flexible support structure onto the cut woven composite to form a seal-forming structure having a woven membrane, whereby the woven membrane is attached to the support structure along an outer edge of the woven membrane and an inner edge of the support structure; in the overmolding step, the woven composite has a non-flat shape when overmolded because it is held in place by a vacuum, thereby imparting a curved, non-flat shape to the woven membrane; The method wherein the woven membrane is free of wrinkles, creases, or folds. [Additional note 56] 56. The method of claim 55, wherein the seal-forming structure has a seamless transition along its outer surface from the support structure to the textile membrane. [Additional note 57] at a transition region, the textile membrane is attached to the support structure along an outer edge of the textile membrane and an inner edge of the support structure, thereby extending radially inward beyond the support structure; 57. The method of claim 55 or 56, wherein at the transition region, both the support structure and the textile membrane extend along a curve in a direction from the anterior portion of the seal-forming structure to the front, patient-facing side of the seal-forming structure. [Additional note 58] Two holes are formed in the woven membrane, and a bridge portion is disposed between the two holes in the woven membrane; 58. A patient interface as described in any one of clauses 55 to 57, wherein the bridge portion buckles with excess material, allowing the textile membrane to expand to accommodate different sized noses. [Additional note 59] 59. The method of any one of clauses 55 to 58, wherein the support structure comprises silicone. [Brief explanation of the drawings]

[0119] The present technology is illustrated by way of example and not limitation in the accompanying drawings, in which like reference numerals include like elements: 4.1 Treatment System [Figure 1A] A system is shown including a patient 1000 wearing a patient interface 3000, which takes the form of nasal pillows and receives air at positive pressure supplied by an RPT device 4000. The air from the RPT device 4000 is humidified by a humidifier 5000 and travels along an air circuit 4170 to the patient 1000. A bed companion 1100 is also shown. The patient is sleeping in a supine sleeping position. [Figure 1B] A system is shown including a patient 1000 wearing a patient interface 3000, which takes the form of a nasal mask and receives air at positive pressure supplied by an RPT device 4000. The air from the RPT device is humidified by a humidifier 5000 and travels along an air circuit 4170 to the patient 1000. [Figure 1C] The system includes a patient 1000 wearing a patient interface 3000. The patient interface 3000 takes the form of a full face mask and receives a positive pressure air supply from an RPT device 4000. Air from the RPT device is humidified by a humidifier 5000 and travels along an air circuit 4170 to the patient 1000. The patient is sleeping in a lateral sleep position. 4.2 Respiratory System and Facial Anatomy [Figure 2A]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] An anterior lateral view of the nose is shown. 4.3 Patient Interface [Figure 3A] 1 shows a patient interface in the form of a nasal mask in accordance with one form of the present technology. [Figure 3B] 3C 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, where the cross-section is 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 3210. The tendon 3210 rests on the midsagittal plane and contacts the cushion of the plenum chamber only at two points on the midsagittal plane (i.e., superior point 3220 and inferior point 3230). 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 3230 resting on the upper lip. 4.4 RPT Device [Figure 4A] 4.5 Patient Interfaces According to the Present Technology [Figure 5] FIG. 10 is a perspective view of a patient interface according to an embodiment of the present technology as it is being worn by a patient; [Figure 6] FIG. 10 is a perspective view of a patient interface according to another embodiment of the present technology as it is being worn by a patient; [Figure 7] FIG. 7 is a cross-sectional view of the positioning and stabilizing structure taken along line 7-7 of FIG. 6. [Figure 8] FIG. 8 is an enlarged view of a portion of the positioning and stabilizing structure of FIG. [Figure 9] FIG. 8 is an enlarged view of a portion of the positioning and stabilizing structure of FIG. [Figure 10] FIG. 6 is a front view of the cushion assembly of FIG. 5 positioned on a patient's face. [Figure 11] FIG. 6 is a front view of the cushion assembly of FIG. 5. [Figure 12] FIG. 6 is a top perspective view of the cushion assembly of FIG. 5. [Figure 13] FIG. 6 is a top view of the cushion assembly of FIG. 5. [Figure 14] FIG. 6 is a side view of the cushion assembly of FIG. 5. [Figure 15] FIG. 6 is a front view of the cushion assembly of FIG. 5. [Figure 16] FIG. 6 is a side view of the cushion assembly of FIG. 5. [Figure 17] FIG. 6 is a top view of the cushion assembly of FIG. 5. [Figure 18] FIG. 10 is a front view of a cushion assembly positioned on a patient's face in accordance with another embodiment of the present technology. [Figure 19] FIG. 19 is a top view of the cushion assembly of FIG. 18. [Figure 20] FIG. 19 is a front view of the cushion assembly of FIG. 18. [Figure 21] FIG. 19 is a bottom view of the cushion assembly of FIG. 18. [Figure 22] FIG. 19 is a side perspective view of the cushion assembly of FIG. 18. [Figure 23] FIG. 13 is a front view of a cushion assembly according to another embodiment of the present technology. [Figure 24] FIG. 24 is a bottom perspective view of the cushion assembly of FIG. 23. [Figure 25] FIG. 24 is a side perspective view of the cushion assembly of FIG. 23. [Figure 26] FIG. 24 is a top perspective view of the cushion assembly of FIG. 23. [Figure 27] FIG. 24 is a rear perspective view of the cushion assembly of FIG. 23. [Figure 28] FIG. 10 is a top perspective view of a cushion assembly according to another embodiment of the present technology. [Figure 29] FIG. 29 is a front view of the cushion assembly of FIG. 28. [Figure 30] FIG. 29 is a side perspective view of the cushion assembly of FIG. 28. [Figure 31] FIG. 29 is a rear perspective view of the cushion assembly of FIG. 28. [Figure 32] FIG. 29 is a bottom view of the cushion assembly of FIG. 28. [Figure 33] FIG. 10 is a front perspective view of a cushion assembly according to another embodiment of the present technology. [Figure 33-1] FIG. 10 is a front perspective view of a cushion assembly according to another embodiment of the present technology. [Figure 33-2] This is a cross-sectional view taken along line 33-2-33-2 in Figure 33-1. [Figure 33-3] This is a cross-sectional view taken along line 33-3-33-3 in Figure 33-1. [Figure 33-4] Enlarged detail taken from Figure 33-2. [Figure 34] FIG. 34 is a cross-sectional view of the cushion assembly of FIG. 33. [Figure 35] FIG. 10 is a front perspective view of a cushion assembly with a grip pad disposed on a textile membrane according to an example of the present technology. [Figure 36] FIG. 10 is a front perspective view of a cushion assembly with a grip pad disposed on a textile membrane according to an example of the present technology. [Figure 37] FIG. 10 is a front perspective view of a cushion assembly with a grip pad disposed on a textile membrane according to an example of the present technology. [Figure 38] FIG. 10 is a perspective view of a patient interface according to another embodiment of the present technology as it is being worn by a patient; [Figure 39] FIG. 10 is a perspective view of a patient interface according to another embodiment of the present technology. [Figure 40] FIG. 40 is a perspective view of the patient interface of FIG. 39 as worn by a patient. [Figure 41] FIG. 41 is a side view of the patient interface of FIG. [Figure 42] FIG. 41 is a front perspective view of the patient interface of FIG. [Figure 43] FIG. 40 is a front view of the cushion assembly of the patient interface of FIG. 39. [Figure 44] FIG. 40 is a top view of the cushion assembly of FIG. 39. [Figure 45] FIG. 40 is a bottom view of the cushion assembly of FIG. 39. [Figure 46] FIG. 40 is a front perspective view of the cushion assembly of FIG. 39. [Figure 47] FIG. 40 is a rear perspective view of the cushion assembly of FIG. 39. [Figure 48] FIG. 40 is a side perspective view of the cushion assembly of FIG. 39. [Figure 49] FIG. 40 is a front perspective view of the cushion assembly of FIG. 39 showing an inner portion of the cushion assembly. [Figure 50] FIG. 40 is a front view of the cushion assembly of FIG. 39 showing an inner portion of the cushion assembly. [Figure 51] FIG. 10 is a rear view of a cushion assembly according to an embodiment of the present technology. [Figure 52] FIG. 52 is a front view of the cushion assembly of FIG. 51. [Figure 53] FIG. 52 is a cross-sectional view of the cushion assembly of FIG. 51. [Figure 54] FIG. 10 is a front perspective view of a cushion assembly with a grip pad disposed on a textile membrane according to an example of the present technology. [Figure 55] FIG. 10 is a front perspective view of a cushion assembly with a grip pad disposed on a textile membrane according to an example of the present technology. [Figure 56] FIG. 10 is a front perspective view of a cushion assembly with a grip pad disposed on a textile membrane according to an example of the present technology. [Figure 57] FIG. 10 is a perspective view of a patient interface 30000 according to an embodiment of the present technology. [Figure 58] FIG. 58 is a perspective view of the patient interface 30000 of FIG. 57 as worn by a patient. [Figure 59] FIG. 58 is a cross-sectional view of the patient interface 30000 shown in FIG. 57. [Figure 60] FIG. 58 is a side view of the patient interface 30000 of FIG. 57 as worn by a patient. [Figure 61] FIG. 58 is a front perspective view of the cushion assembly 30105 of FIG. 57. [Figure 62]FIG. 58 is a rear perspective view of the cushion assembly 30105 of FIG. 57. [Figure 63] FIG. 58 is a front view of the frame 30350 of FIG. 57. [Figure 64] FIG. 58 is a rear view of the frame 30350 of FIG. 57. [Figure 65] FIG. 58 is a rear view of the patient interface 30000 of FIG. 57 as worn by a patient. [Figure 66] 58 shows the straps of the positioning and stabilizing structure 30300 of the patient interface 30000 of FIG. 57. [Figure 67] FIG. 10 is a perspective view of a patient interface according to another embodiment of the present technology as it is being worn by a patient; [Figure 68] FIG. 68 is a side view of the patient interface of FIG. 67. [Figure 69] FIG. 68 is an exploded view of the patient interface shown in FIG. 67, showing the cushion assembly, frame assembly, arm cover, and elbow assembly. [Figure 70] FIG. 13 is a front exploded view of a cushion assembly according to an embodiment of the present technology. [Figure 71] FIG. 71 is a rear exploded view of the cushion assembly of FIG. 70. [Figure 72] FIG. 68 is a front view of the cushion assembly of the patient interface of FIG. 67; [Figure 73] FIG. 73 is a front perspective view of the cushion assembly of FIG. 72. [Figure 74] FIG. 73 is a rear perspective view of the cushion assembly of FIG. 72. [Figure 75] FIG. 73 is a top perspective view of the cushion assembly of FIG. 72. [Figure 76] FIG. 73 is a bottom perspective view of the cushion assembly of FIG. 72. [Figure 77] FIG. 73 is a side perspective view of the cushion assembly of FIG. 72. [Figure 78] 1 is a schematic diagram of a process for applying an air impermeable layer to a textile material, according to one embodiment of the present technology; [Figure 79]FIG. 1 is a schematic diagram of a patient's face being placed against a woven membrane with low tension before use. [Figure 80] FIG. 1 is a schematic diagram illustrating the force exerted by the textile membrane on the patient's face due to tensile stress in the textile membrane. [Figure 81] FIG. 10 is a schematic diagram of tension applied to a sealing portion of a cushion assembly in accordance with an embodiment of the present technology. [Figure 82] 1 is a schematic diagram illustrating the force exerted by the fabric membrane on the patient's face due to air pressure within the cavity formed by the cushion assembly. FIG. [Figure 83] 13 is a cutaway cross-sectional view of a cushion assembly according to an embodiment of the present technology. [Figure 84] 13 is a cutaway cross-sectional view of a cushion assembly according to an embodiment of the present technology. [Figure 85] 13 is a cutaway cross-sectional view of a cushion assembly according to an embodiment of the present technology. [Figure 86] 13 is a cutaway cross-sectional view of a cushion assembly according to an embodiment of the present technology. [Figure 87] FIG. 102 is a partial perspective view of a support structure and sealing portion of a cushion assembly having an external biasing portion according to an embodiment of the present technology. [Figure 88] 13 is a partial perspective view of a support structure and sealing portion of a cushion assembly having an internal biasing portion according to an embodiment of the present technology;

[0032] FIG. [Figure 89] FIG. 10 is a partial cross-sectional view of a cushion assembly according to an embodiment of the present technology. [Figure 90A] FIG. 10 is a partial cross-sectional view of a cushion assembly according to an embodiment of the present technology. [Figure 90A-1] FIG. 90B is an enlarged view of a section of the sealing portion of the cushion assembly of FIG. 90A. [Figure 90B] FIG. 10 is a partial cross-sectional view of a cushion assembly according to an embodiment of the present technology. [Figure 91] FIG. 10 is a partial cross-sectional view of a cushion assembly according to an embodiment of the present technology. [Figure 92] FIG. 10 is a partial cross-sectional view of a cushion assembly according to an embodiment of the present technology. [Figure 93] FIG. 10 is a partial cross-sectional view of a cushion assembly according to an embodiment of the present technology. [Figure 94] FIG. 10 is a partial cross-sectional view of a cushion assembly according to an embodiment of the present technology. [Figure 95] FIG. 10 is a partial cross-sectional view of a cushion assembly according to an embodiment of the present technology. [Figure 96] FIG. 10 is a partial cross-sectional view of a cushion assembly according to an embodiment of the present technology. [Figure 97] FIG. 10 is a partial cross-sectional view of a cushion assembly according to an embodiment of the present technology. [Figure 98] FIG. 10 is a partial cross-sectional view of a cushion assembly according to an embodiment of the present technology. [Figure 99] FIG. 10 is a partial cross-sectional view of a cushion assembly according to an embodiment of the present technology. [Figure 100] FIG. 10 is a partial cross-sectional view of a cushion assembly according to an embodiment of the present technology. [Figure 101] 14 is a cross-sectional view of a sealing portion modular assembly according to an embodiment of the present technology; [Figure 102] FIG. 102 is a partial cross-sectional view of a cushion assembly incorporating the sealing portion modular assembly of FIG. 101 according to an embodiment of the present technology. [Figure 103]

[0023] Figure 10 is a perspective view of a modular support structure according to an embodiment of the present technology; [Figure 104] 10 illustrates a process for molding a sealing portion onto a support structure according to an embodiment of the present technology. [Figure 105] 10 illustrates a process for molding a sealing portion onto a support structure according to an embodiment of the present technology. [Figure 106] FIG. 106 is a side view of a sealing modular assembly formed by the process shown in FIGS. 104 and 105. [Figure 107] 14 shows a "one size fits all" cushion assembly in accordance with an example of the present technology. [Figure 108] 14 shows a "one size fits all" cushion assembly in accordance with an example of the present technology. [Figure 109] 10 shows a custom cushion assembly created by utilizing a three-dimensional contour obtained by scanning a patient's face, in accordance with an example of the present technology. [Figure 110] 10 shows a custom cushion assembly created by utilizing a three-dimensional contour obtained by scanning a patient's face, in accordance with an example of the present technology. [Figure 111] FIG. 10 is a front perspective view of a cushion assembly according to another embodiment of the present technology. [Figure 112] FIG. 112 is a rear perspective view of the seal-forming structure of the cushion assembly of FIG. 111; [Figure 113] Shows the knitting process. [Figure 114] Shows the knitting process. [Figure 115] 1 shows a warp knitted fabric according to one embodiment of the present technology. [Figure 116] 1 shows a weft knit fabric according to one embodiment of the present technology. [Figure 117] 10 is a block diagram illustrating a process for overmolding a support structure onto a woven composite to form a seal-forming structure with a woven membrane, according to an example of the present technology; DETAILED DESCRIPTION OF THE INVENTION

[0120] 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.

[0121] 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.

[0122] 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.

[0123] 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.

[0124] In certain embodiments of the present technology, mouth breathing is restricted, limited or prevented.

[0125] 5.2 Treatment System In one form, the present technology includes an apparatus or device for the treatment of respiratory disorders. The apparatus or device may include an RPT device 4000 that supplies pressurized air to a patient 1000 via an air circuit 4170 to a patient interface 3000 (see, for example, FIGS. 1A-1C).

[0126] 5.3 Patient Interface A non-invasive patient interface 3000 in accordance with one aspect of the present technology includes the following functional features: a seal-forming structure 3100, a plenum chamber 3200, a positioning and stabilizing structure 3300, a vent 3400, a form of connection port 3600 for connection to an air circuit 4170, and a forehead support 3700. In some forms, the functional 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.

[0127] 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.

[0128] A patient interface 3000 in accordance with one form of the present technology is constructed and arranged to provide an air supply at a positive pressure of at least 6 cmH2O relative to ambient.

[0129] 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.

[0130] 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.

[0131] 5.3.1 Plenum chamber The plenum chamber has edges shaped to complement the surface contours of an average human face in the area where a seal is formed in use. In use, the peripheral edges of the plenum chamber are positioned proximate to the adjacent surface of the face. Actual contact with the face is provided by the seal-forming structure. The seal-forming structure may extend around the entire periphery of the plenum chamber in use. In some forms, the plenum chamber and the seal-forming structure are formed from a single, homogenous piece of material.

[0132] 5.3.2 Seal formation structure In one form of the present technology, the seal-forming structure 3100 provides a target seal-forming area and may further provide a cushioning function. The target seal-forming area is the area where a seal may occur in the seal-forming structure 3100. The area where a seal actually occurs (i.e., the actual sealing surface) may vary from patient to patient in a given treatment session and from day to day, depending on a range of factors (e.g., placement of the patient interface on the face, tension in the positioning and stabilizing structure, and the shape of the patient's face).

[0133] In one form, the target seal-forming area is located on an exterior surface of the seal-forming structure 3100 .

[0134] In certain forms of the present technology, the seal-forming structure 3100 is constructed from a biocompatible material (eg, liquid silicone rubber (LSR) (or "silicone")).

[0135] A seal-forming structure 3100 according to the present technology may be constructed from a soft, flexible and resilient material (eg, silicone).

[0136] In some embodiments, such as those shown in Figures 5-77, the seal-forming structure has a sealing portion that includes a woven material. The woven material can cover all or part of the seal-forming structure. In some embodiments, the woven material can include a material formed by a fiber network and adapted to be impermeable to air. For example, the woven material can have an air-impermeable film on at least one surface thereof, thereby forming a woven membrane or woven sealing portion.

[0137] In some embodiments, the woven membrane can be constructed to be elastically stretchable in at least one dimension. For example, if the woven membrane is constructed from a fiber network, the woven membrane can be stretchable in the longitudinal direction (warp) and / or the transverse direction (weft) across the woven membrane. In some embodiments, the woven membrane is constructed to be elastically stretchable to a range beyond that achievable with conventional silicone seal-forming structures.

[0138] In some embodiments, the woven membrane is constructed to be substantially inelastic in at least one dimension. For example, if the woven membrane is constructed from a woven material, the woven membrane may be capable of substantially withstanding elongation in one or both of the longitudinal warp direction or the transverse weft direction across the woven membrane.

[0139] The woven membrane may include a single layer or multiple layers. In configurations where multiple layers are used, the individual layers may be formed using the same material or a variety of different materials, each with unique material properties.

[0140] In some embodiments, the woven membrane may include at least one layer that exhibits substantially air-impermeable properties (while maintaining the material properties necessary to provide comfort and minimal pressure points to the patient). For example, as shown in FIG. 78, in some embodiments, the woven membrane may include an air-impermeable material 10131 formed on the inner surface of a woven material 10133. In some embodiments, the air-impermeable material may be laminated onto the woven material. In some embodiments, the air-impermeable material and the woven material may be selected so that the resulting woven membrane exhibits a predetermined overall elasticity or elastic resistance, as desired. For example, the addition of an air-impermeable material (or membrane layer) may impart elasticity (or extensibility) to the woven material, thereby increasing the extensibility of the resulting woven membrane.

[0141] In some configurations, the membrane may exhibit a low spring constant (i.e., high compliance) in both the warp and weft directions. In such configurations, in contrast to conventional designs that may result in distortion of the patient's face 1300 due to a fixed cushion (to form an effective seal), the woven material and / or resulting woven membrane may have a material spring constant and spring length that makes the woven membrane more compliant than the patient's skin that engages it. This may advantageously improve mask comfort and reduce the formation of localized pressure "hot spots."

[0142] In some embodiments, the surface of the woven material that contacts the patient's face 1300 can have low-friction characteristics. This can advantageously increase the surface texture comfort of the woven membrane and reduce friction against the patient's face 1300. The surface of the woven material (e.g., herringbone) can have a first coefficient of friction in a first direction. The first coefficient of friction is different (e.g., higher or lower) from the coefficient of friction in a second direction. In contrast, a higher-friction woven material can cause the woven membrane to snag or rub in the contact area with the patient's face during use. Such rubbing or snagging can cause the woven membrane to distort or deform, leading to reduced sealing effectiveness and the potential for undesirable air leakage from the device.

[0143] In some embodiments, the overall thickness of the woven material of the woven membrane is 0.275 mm or less.

[0144] 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.

[0145] It should be noted that although reference may be made herein (e.g., using reference numerals) to particular illustrated examples or features of particular illustrated examples (e.g., seal-forming structure 3100), such discussion may also apply to other examples and / or features (e.g., seal-forming structure 5100).

[0146] 5.3.2.1 Sealing mechanism In one form, the seal-forming structure includes a sealing flange that employs a pressure-assisted sealing mechanism. In use, the sealing flange can readily respond to positive system pressure within the plenum chamber 3200 by acting on its underside to form a tight sealing engagement with the surface. The pressure-assisted mechanism can work in conjunction with elastic tension in the positioning and stabilizing structure.

[0147] 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.

[0148] In one form, a woven membrane (e.g., comprising nylon, polyester, a blend of nylon and polyester, microfiber, or polyurethane) is used as the face-contacting portion of the seal-forming structure 3100 for a CPAP mask. The woven membrane may have properties that allow it to stretch in at least one dimension. The woven membrane may be held under tension across the support structure before and / or during use. Before use, the woven membrane may be permanently attached (e.g., molded) or may be attached to the support structure as a removable module (pre-tensioned and slightly stretched).

[0149] Alternatively, the woven fabric may be formed into a complex three-dimensional predetermined shape so that it is not under tension (e.g., loose, relaxed, and / or wrinkle-free) before and / or during use, but is substantially free of leakage that would cause wrinkles. Due to manufacturing, the woven polymer may shrink, resulting in a loss of inherent pre-tension in the woven fabric membrane, but the woven fabric membrane may remain substantially wrinkle-free.

[0150] FIG. 79 illustrates an example in which a light tension is applied to the woven membrane in both the X and Y directions through the woven surface. Before the patient's face 1300 (e.g., nose) approaches and presses against the woven membrane 3130, the woven membrane is adapted to form a consistent surface without any obstructions (e.g., wrinkles, folds, or fine wrinkles) in the woven material prior to contact between the patient's face 1300 and the seal-forming structure 3100. In some embodiments, this can be achieved by applying a light pre-tension or by shaping the woven membrane so that there are substantially no wrinkle-causing leaks in the woven membrane. This can be advantageous because it ensures that the woven membrane forms a smooth, continuous seal around and around the patient's face 1300. As a result, improved respiratory pressure therapy can be achieved by reducing the occurrence of folds or fine wrinkles in the components of the seal-forming structure 3100 that could be sources of therapeutic air leakage. This may also be advantageous in that it forces the fabric membrane against the patient's face 1300 (FIG. 80), thereby ensuring that the fabric membrane is under a minimum threshold tension.

[0151] In some configurations, regions of the woven membrane can be pre-tensioned to stretch slightly, while other regions of the woven membrane can remain relaxed. For example, in some configurations, the under-nose region can be pre-tensioned, while the outside of the nose and / or the region cupping the patient's mouth can be held untensioned (e.g., with excess material) to form a saddle-like or valley shape prior to use. This can advantageously allow for improved sealing efficiency while reducing pressure (i.e., "hot spots") on areas where facial anthropometric features protrude longer distances into or into the cavity. In another example, the sides of the nose region and / or nose bridge region can remain untensioned and / or relaxed prior to use, providing additional material to accommodate the facial contours of these sensitive facial areas. In another example, a bridge region (e.g., bridge region 3104) extending between two nostril openings may become untensioned (e.g., due to excess material prior to use, as shown in FIG. 33-1 ) and may relax and / or buckle. A bridge region (e.g., 3104) with excess material may allow the textile membrane to expand (e.g., in the superior / inferior (height) direction to accommodate different sized noses.

[0152] In some configurations, instead of providing pre-tensioned regions, the woven membrane may be configured to be substantially free of leaks that can cause wrinkles. This can be advantageous because it can be difficult to form complex three-dimensional shapes that are substantially leak-free from a relaxed woven membrane or from a woven membrane that includes material that is not overly tensioned. Using an untensioned woven membrane can also reduce pressure on the patient's face, which can be more comfortable in some configurations.

[0153] In some forms, the woven membrane can be substantially tension-free and can be formed onto a support structure or directly onto the plenum chamber (so that it remains untensioned and / or relaxed). In examples, such a woven membrane can still maintain a wrinkle-free state to avoid leaks in the seal with the patient's face. In some forms, an untensioned and / or wrinkle-free woven membrane can utilize cushion support (e.g., the underlying cushion, the seal support region (e.g., the support structure), and / or air pressure within the cavity) to form an effective seal against the patient's face.

[0154] In some forms, the tensioned and / or wrinkle-free state of the fabric membrane (see FIGS. 80 and 81 ) can be maintained to maintain sealing contact with the patient's face 1300 by one or a combination of the following: a) the pre-applied tensile stress and the additional applied tensile stress of the textile membrane upon engagement of the textile membrane with the patient's face 1300; b) a preformed state of the woven membrane that is untensioned and formed as a substantially uniform surface, without leaks that would cause obstructions in the woven membrane (e.g., wrinkles, folds, buckles, or creases); c) the stiffness of the support structure and / or plenum chamber, the ability of the support structure and / or plenum chamber to accommodate and react to added tensile stresses (upon engagement of the patient's face 1300 with the fabric membrane); and d) Additional air pressure applied from within the cavity to the inner surface of the woven membrane. The internal air pressure may apply additional tensile stress to the inner surface of the woven membrane, causing the woven membrane to stretch further against the patient's face 1300, and the woven membrane may be stressed against the patient's face 1300 (e.g., creating a pressure-assisted seal).

[0155] Continually maintaining the woven membrane under tensile stress and / or in a wrinkle-free state before and during use allows the woven membrane to conform to the profile of the patient's face while minimizing wrinkles and / or rupture of the seal-forming structure. This may also allow for improved sealing performance in some forms by maximizing the contact area of ​​the woven membrane on the patient's face 1300. This may also allow for improved performance of the CPAP device when impacted by external lateral or longitudinal forces (e.g., tubing drag).

[0156] In some forms, application of air pressure from within the plenum chamber can assist in maintaining an effective seal at the woven membrane when the plenum chamber is pulled a short distance away from the patient's face 1300. The application of air pressure can be sufficient to elastically stretch the woven membrane in at least one dimension, forming a "hovercraft"-like balloon effect over the anthropometric contours of the patient's face 1300, thereby maintaining an effective seal over the anthropometric contours of the patient's face 1300.

[0157] In some embodiments, the fabric membrane can be held under tension by a relatively rigid support structure. In various embodiments, the support structure can be formed from, for example, silicone, PU foam, PU solid material, or another suitable material. In some embodiments, the support structure can be relatively less rigid than the shell or frame of the plenum chamber.

[0158] In some configurations, the magnitude of the tensile stress may be varied across the seal-forming structure woven membrane as needed, for example, areas of stress concentration may exist near one or more holes in the woven membrane as a passageway for therapeutic application in the more stretched material.

[0159] In some configurations, the seal-forming structure may use multiple different cushion configurations (e.g., a single air-assisted woven membrane, a double air-assisted woven membrane, a woven membrane with compression supports, or a woven membrane with TPU / TPE / Si supports). In some configurations, the cushion configurations of the seal-forming structure may be configured to advantageously provide a "one size fits most" solution.

[0160] In examples, the seal-forming structures and plenum chambers may be applied to nasal cushions, nasal cradles, oral-nasal cushions, miniature full face masks, full face masks, and other suitable cushion arrangements.

[0161] In some forms, the woven membrane can be configured to create an effective seal over the patient's nasal tip, as shown, for example, in Figure 58. In some forms, the woven membrane can be configured to create an effective seal against the subnasal area of ​​the patient's nose, so that the woven membrane does not engage the nasal tip, as shown, for example, in Figure 40.

[0162] In some embodiments, stretching and / or maintaining the wrinkle-free state of the woven membrane (to conform to the patient's face 1300) during use can apply stress to the walls of the support structure. This stress can cause the walls of the support structure to be pulled inwardly toward each other during use. In some embodiments, the support structure can be adapted to withstand additional stress loads to avoid inward deformation. Thus, the stiffness of the support structure can apply additional stress to the woven membrane, resulting in elastic stretching of the woven membrane during use.

[0163] In some embodiments, such as those shown in FIGS. 87 and 88 , the support structure may include pleats, folds, or gussets (e.g., seal biasing portions 10140, 10140′) that use internal air pressure to dynamically support the textile membrane. This may advantageously provide additional support to the textile membrane under dynamic loads (e.g., tubing drag). In other embodiments, the pleats, folds, or gussets may use internal air pressure to decouple dynamic loads (e.g., tubing drag) from the seal-forming structure. In some embodiments, the air pressure within the cavity loads the textile membrane's inner surface, creating additional tensile stress, causing the textile membrane to substantially fill the compressed contours of the patient's face 1300 (e.g., around either side of the nose). In some embodiments, the elasticity of the textile membrane, combined with the load of the internal air pressure, elastically stretches the textile membrane to create a larger seal contact area on the patient's face. This may also be advantageous in some configurations in providing a continuous seal even when the mask is partially displaced from its optimal interface with the patient's face, since the fabric membrane may partially expand due to reaction forces from internal air pressure (i.e., the "hovercraft effect").

[0164] In some configurations, such as those shown in FIGS. 35-37 and 54-56, one or more grip pads 29150, 31150 may be disposed on the textile membrane. In one example, the grip pads 29150, 31150 may be configured to be substantially flat along the patient-facing surface of the textile membrane. In another example, the grip pads 29150, 31150 may be embossed to form a bead or rim that protrudes slightly above the surface of the textile membrane. In some configurations, the grip pads 29150, 31150 may have a high coefficient of friction. In some configurations, the grip pads may have a predetermined shape (e.g., oval (see FIGS. 35, 37, 54, and 56), circle, square, etc.). In some configurations, the grip pads may be elongated (see FIGS. 35 and 54). In some forms, the grip pads 29150, 31150 may be linear. In some forms, the grip pads may be arranged in a pattern across the surface of the seal-forming structure 3100. In some forms, the grip pads may be arranged interspersed across the surface of the seal-forming structure 3100 (see FIGS. 37 and 56). In some forms, the grip pads may be arranged to form a perimeter about the periphery of the textile membrane (see FIGS. 34, 35, 54, and 55). In some forms, the grip pads 29150, 31150 forming the perimeter may be in the form of dotted lines (see FIGS. 35 and 54). In some forms, the grip pads forming the perimeter may be in the form of solid lines (see FIGS. 36 and 55). In some forms, the grip pads forming the perimeter may be in the form of multiple lines (dotted or solid) or a combination thereof. In some forms, the grip pads may assist the textile membrane in gripping the patient's face. In one example, the grip pad may be formed as a relatively thin silicone layer applied to the surface of the fabric membrane.

[0165] In some configurations, the textile membrane may be integrated with the support structure by attaching (e.g., molding) the outer edge (e.g., periphery) of the textile membrane around the lip (e.g., inner edge) of the curved edge of the support structure. In one embodiment, the textile membrane may be angled slightly inward toward the interior of the mask. In one example, the textile membrane is attached to provide a front surface of the seal-forming structure. That is, the support structure forms a portion of the seal-forming structure that curves from the front side to the rear, face-contacting side of the seal-forming structure (see FIG. 11). In this manner, the textile membrane may be eliminated from the curved portion extending from the rear to the front. This arrangement may allow the textile membrane to be provided only along the front surface of the seal-forming structure, as shown, for example, in FIGS. 11-17. This arrangement may be advantageous because it eliminates the need to fold or cut the textile membrane to fit around the corners of the support structure. This may improve sealing performance as it helps reduce the occurrence of prominent folds or wrinkles in the woven membrane (which may cause leakage).

[0166] In some configurations, the textile membrane can be attached to the outer edge of the textile membrane such that the textile membrane forms a portion of the seal-forming structure that curves from the anterior side of the seal-forming structure to the posterior, face-contacting side (see, e.g., FIGS. 33-1 through 33-4, 73, and 74). This can provide a larger surface area of ​​the textile membrane (facing the support structure) for engagement with the patient's face, improving comfort. In one example, the textile membrane is attached to the support structure by a specific process (described below) that can create a curved region without creating folds, wrinkles, creases, or buckling in the textile membrane surface. As will be appreciated, in some examples, at transition region 36, both the support structure and the textile membrane can have a radius of curvature (e.g., the same or similar radii of curvature) along curve 35 in the direction from the anterior side of the seal-forming structure to the posterior side of the seal-forming structure (see, e.g., FIGS. 33-1 through 33-4). The woven membrane may be given a predetermined curvature, so that the portion of the woven membrane not directly supported by the support structure extends along the curved portion 35 (FIGS. 33-2-33-4). This may assist in creating a dome shape (e.g., a convex dome) in certain regions of the woven membrane (e.g., lateral side portions 3250 and / or corner regions 3252), which may assist in sealing the woven membrane against the contours of the patient's face (e.g., the lowest alar region of the patient's face (i.e., the corners of the nasal region (i.e., the region where the alar terminates on the upper lip adjacent to the nasolabial fold))), as shown, for example, in FIG. 33-1. The dome shape may assist in avoiding the formation of wrinkles, creases, folds, and buckling in the woven membrane, which may assist in the development of leak paths. The dome shape may also assist in reaching the woven membrane into difficult-to-seal regions of the patient's face (e.g., the corners of the nasal region). The woven membrane 29130 may have a saddle-like shape in the mid-subnasal point region 3260 configured to seal against the patient's subnasal point, thereby conforming to the saddle-like shape formed by the patient's nasolabial angle and upper lip, as shown in FIG. 33-1. Similarly, the tip of the nose region 3270 may have a saddle-like shape configured to seal against a conforming profile presented at or below the patient's tip of the nose.The curvature (e.g., the curvature and / or the magnitude of the radius of curvature) of the woven membrane in the direction of the curve 35 may be different in different regions of the cushion assembly along the circumference of the woven membrane. For example, as shown in FIG. 33-2 , the woven membrane 29130 in the mid-tip point region 3270 may have a different curvature in the direction of the curve 35 than the woven membrane in the mid-subnasal point region 3260. In the example of FIG. 33-2 , the woven membrane in the mid-tip point region 3270 may have a relatively larger (e.g., smaller radius) curvature (e.g., a negative curvature in the inferior / superior direction along the curve 35) than the curvature in the mid-subnasal point region 3260 (e.g., a negative curvature in the inferior / superior direction along the curve 35). In one example, the curvature (e.g., the curvature and / or the magnitude of the radius of curvature) at the lateral side portions 3250 of the woven membrane may be different from the curvature in the mid-tip point region 3270 and / or the mid-subnasal point region 3260. The nasal regions of the cushion assemblies 14105, 30105, 31105 may have similar dome and saddle features, for example, as shown in FIGS.

[0167] 73, the curvature of the woven membrane 16230 from its connection with the support structure 16220 (e.g., at the transition region) can continue to the inner edge of the woven membrane. For example, the woven membrane can have a dome or saddle shape at the inner edge of the woven membrane in certain areas of the cushion.

[0168] In some forms, the woven membrane may be angled or curved slightly inward (e.g., positive curvature in the left-right direction) as it approaches the mask interior, as shown, for example, in FIGS. 11-17, 23-26, and 3-37. In some forms, the woven membrane may form a dome shape on the support structure, as shown, for example, in FIGS. 19-22 and 43-50. Note that any of the cushion assemblies disclosed herein may have a woven membrane attached to the outer edge of the woven membrane, such that the woven membrane forms part of the seal-forming structure and extends from the front to the rear, face-contacting side of the seal-forming structure along curved portion 35 as described above with respect to FIG. 33-1, so that, for example, the woven membrane 6130 of cushion assembly 6105 may have more of a dome shape with additional convexity from one lateral side to the other.

[0169] In some configurations where the woven membrane is not under continuous tension or is inelastic (before and / or during use), the woven membrane may form an improved air-assisted seal on the patient's face that dynamically conforms to changes / movements (i.e., a "hovercraft" effect), for example, due to the woven membrane being thinner and having less structural stiffness than a silicone membrane.

[0170] In some embodiments, the woven fabric membrane can be supported by a secondary or tertiary support structure that can function as a cushion support. The cushion support can provide additional flexibility and be suitable for use with most patient faces (one size fits most). The second or third support layer can be formed using a woven fabric membrane, a woven fabric including a PU / Si membrane, laminated open-cell foam, laminated PU foam, molded PU, TPU / TPE, or silicone. In some embodiments, the additional support layer itself can be supported by a structural / rigid plastic (e.g., PP / PC / PA / PET or other suitable material).

[0171] In some forms, 3D printing the textile membrane and / or cushion support section as a "skeleton" can reduce thickness and, consequently, mask weight.

[0172] In some configurations, different layers of the mask layer can be printed with different stiffness, hardness, or thickness. For example, the "skeleton" member can be formed using Si, PU foam, PU solid material, or any suitable plastic material.

[0173] In some forms, pleats or folds may be formed along the cushion assembly (eg, in the textile membrane and / or support structure) to provide dynamic force / support or decoupling areas.

[0174] In one form, the seal-forming structure may include a compressive or gasket sealing portion that is constructed and arranged to be in compression in use due to, for example, elastic tension in the positioning and stabilizing structure.

[0175] 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.

[0176] In one form, the seal-forming structure includes an area having a sticky or adhesive surface.

[0177] In certain forms of the present technology, the seal-forming structure may include one or more of a pressure-assisted sealing flange, a compression sealing portion, a gasket sealing portion, a tension portion, and a portion having an adhesive or adhesive surface.

[0178] 5.3.2.2 Nasal bridge or nasal ridge area In one form, the non-invasive patient interface 3000 includes a seal-forming structure that, in use, forms a seal on the nasal bridge or nasal ridge region of the patient's face.

[0179] In one form, the seal-forming structure includes a saddle-shaped region constructed to form a seal over the nasal bridge or nasal ridge region of the patient's face in use.

[0180] 5.3.2.3 Upper lip area In one form, the non-invasive patient interface 3000 includes a seal-forming structure that, in use, forms a seal over the upper lip region (ie, upper lip) of the patient's face.

[0181] In one form, the seal-forming structure includes a saddle-shaped region constructed to form a seal over the upper lip region of the patient's face in use.

[0182] 5.3.2.4 Jaw area In one form, the non-invasive patient interface 3000 includes a seal-forming structure that, in use, forms a seal over the chin area of ​​the patient's face.

[0183] 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.

[0184] 5.3.2.5 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.

[0185] 5.3.2.6 Nasal pillow In one form, the seal-forming structure of the non-invasive patient interface 3000 includes a pair of nasal puffs or nasal pillows, each constructed and arranged to form a seal with a respective nostril of the patient's nose.

[0186] Nasal pillows according to one aspect of the present technology include a truncated cone. At least a portion of the truncated cone forms a seal over the underside of the patient's nose, the stem, and a flexible region on the underside of the truncated cone, connecting the truncated cone to the stem. Additionally, the structure to which the nasal pillows of the present technology are connected includes a flexible region adjacent to the base of the stem. The flexible region can function to facilitate a universal joint structure. The universal joint structure accommodates both the displacement and angle of the truncated cone and the relative movement of the structure to which the nasal pillows are connected. For example, the truncated cone can be displaced axially toward the structure to which the stem is connected.

[0187] 5.3.3 Nasal cushion 5-14, a patient interface 3000, 6000 having a cushion assembly 3105 including a seal-forming structure 3100 and a plenum chamber 3200 is shown in accordance with a first embodiment of the present technology. FIGS. 15-17 show a cushion assembly 5105 including a seal-forming structure 5100 and a plenum chamber 3200 in accordance with a second embodiment of the present technology. FIGS. 18-22 show a cushion assembly 6105 including a seal-forming structure 6100 and a plenum chamber 3200 in accordance with a third embodiment of the present technology. FIGS. 23-27 show a cushion assembly 7105 including a seal-forming structure 7100 and a plenum chamber 3200 in accordance with a fourth embodiment of the present technology. Referring to FIGS. 28-32, a cushion assembly 8105 including a seal-forming structure 8100 and a plenum chamber 3200 is shown in accordance with a fifth embodiment of the present technology. FIG. 3 shows a patient interface 9000 having a cushion assembly 9105 including seal-forming structures 9100 and 9200 according to a sixth embodiment of the present technology.

[0188] 11-14 include dashed lines defining boundaries of regions of different thickness, it should be understood that these are nominal boundaries only and not actual structures.

[0189] The examples of the seal-forming structures 3100, 5100, 6100, 7100, 8100, and 9100 described in the preceding paragraphs can be considered nasal cradle cushions and are intended to provide a flow of pressurized gas to a patient's nares by sealing at least below the patient's nose. The example seal-forming structures engage the patient's face below the bridge of the nose, and in some instances, depending on the size and shape of the patient's nose, below the nasal tip. The example seal-forming structures can also engage the patient's face at least above the upper vermilion lip. Thus, the example seal-forming structures can seal against the patient's upper lip during use. Furthermore, because the patient's mouth remains exposed by the example seal-forming structures shown, the patient can breathe freely (i.e., directly to the atmosphere) without interference from the seal-forming structure. The under-nose nasal cradle can be configured without an aperture sized to receive the patient's nose within its cavity. Furthermore, the height of the cushion from the lower edge of the woven membrane in the mid-subnasal point region to the upper edge of the woven membrane in the mid-tip point region may be less than the width of the cushion in the left-right direction from one lateral edge of the woven membrane to the other lateral edge of the woven membrane (see Figures 33 and 33-1).

[0190] An example nasal cradle cushion (e.g., an exemplary seal-forming structure disclosed herein) may include a superior sellar or concave region with a positive curvature across the cushion. Additionally, a nasal cradle cushion may be understood as having a single target seal-forming area or surface, while a pillow cushion may have two target seal-forming areas (one for each nostril). The cradle cushion may also have a posterior wall that contacts the patient's upper lip and an upper central surface that contacts the underside of the patient's nose. These two surfaces on the patient's face form a nasolabial angle between them (see FIG. 2E). The cradle cushion may be shaped to have a nasolabial angle ranging from 90 degrees to 120 degrees.

[0191] Additionally, the exemplary seal-forming structure may also be shaped and dimensioned such that, in use, no portion of the seal-forming structure enters the patient's nares.

[0192] Plenum Chamber 5-17, the plenum chamber 3200 has edges shaped to complement the surface contours of an average human face in the area where a seal is formed in use. In use, the peripheral edges of the plenum chamber 3200 are positioned in close proximity to the adjacent surfaces 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.

[0193] In certain forms of the present technology, the plenum chamber 3200 is constructed from a relatively rigid material (e.g., polycarbonate) compared to the seal-forming structure. Alternatively, the plenum chamber 3200 may be constructed from a flexible material (e.g., silicone) and formed as a one-piece structure with the support structure (e.g., from any of the materials described herein as suitable for the support structure and / or plenum chamber). In one example, the seal-forming structure may be an extension of the plenum chamber, or may be formed as part of the plenum chamber, such that the plenum chamber includes the seal-forming structure. In such an example, the support structure and the fabric membrane may be considered part of the plenum chamber. In another example, the plenum chamber 3200 may be constructed from a transparent material (e.g., transparent polycarbonate). The use of a transparent material may reduce the intrusiveness of the patient interface and help improve compliance with treatment. The use of a transparent material may help the clinician confirm the placement and function of the patient interface.

[0194] In certain forms of the present technology, the plenum chamber 3200 is constructed from a translucent material, which can make the patient interface less intrusive and help improve compliance with treatment.

[0195] 5 and 10-17 show an example of a seal-forming structure 3100 with a plenum chamber 3200. The seal-forming structure 3100 may include a plenum chamber connection opening where the seal-forming structure 3100 is sealingly joined to the plenum chamber 3200. The seal-forming structure 3100 and the plenum chamber 3200 may at least partially form a cavity 3101 that is pressurized by the air flow. In the illustrated embodiment, the seal-forming structure 3100 and the plenum chamber 3200 together form the cavity 3101.

[0196] The connection between the seal-forming structure 3100 and the plenum chamber 3200 at the plenum chamber connection opening 3106 may be a permanent connection. The connection between the seal-forming structure 3100 and the plenum chamber 3200 at the plenum chamber connection opening 3106 may be a chemical bond. The joining of the seal-forming structure 3100 and the plenum chamber 3200 at the plenum chamber connection opening may be made without a mechanical connection. Alternatively, the joining of the seal-forming structure 3100 and the plenum chamber 3200 at the plenum chamber connection opening may be made with a mechanically detachable connection.

[0197] At each lateral side of the plenum chamber 3200, a plenum chamber lateral end 3202 may be provided as a hollow passageway forming a plenum chamber inlet port sized and configured to receive airflow. A plenum chamber connector 3204 may also be provided on each lateral side of the plenum chamber 3200 outwardly of the plenum chamber lateral end 3202. The plenum chamber connector 3204 may connect to each end 3314 of the positioning and stabilizing structure 3300. The connection between the plenum chamber connector 3204 and each end 3314 of the positioning and stabilizing structure 3300 may be removable on both sides. In other examples, a permanent connection may be provided on one side and a releasable connection on the other side. In a further example, the connections between the plenum chamber connector 3204 and each end 3314 of the positioning and stabilizing structure 3300 may both be permanent.

[0198] The plenum chamber lateral ends 3202 may receive a flow of pressurized gas from the positioning and stabilizing structure 3300. The flow of pressurized gas may then pass through the plenum chamber 3200 and then through the seal-forming structure 3100 and into the patient's airway for exhalation.

[0199] 32. It shows how the end 3314 of the positioning and stabilizing structure 3300 may be connected to the plenum chamber lateral end 3202. In these embodiments, each plenum chamber connector 3204 may include a slot 3209, a chamfered edge 3208, and a notch 3206 that may be removably connected to a clip of the positioning and stabilizing structure with a snap fit.

[0200] The third, fourth, and fifth plenum chambers 3200 of the present technology substantially as shown in FIGS. 18-32 may be similar to or identical to the plenum chambers of FIGS. 10-17. It should also be noted that one or more aspects of the present technology may be combined with one or more aspects of U.S. Provisional Application No. 62 / 764,992 (filed August 20, 2018, entitled "Patent Interface") or PCT / AU2019 / 050873 (filed August 20, 2019), each of which is incorporated by reference in its entirety herein. For example, the plenum chamber of the present technology may be identical to the plenum chamber in either of the embodiments of the '992 application or the '837 application. Additionally, any of the seal-forming structures in any of the patient interfaces disclosed in the '992 or '873 applications may be used in place of the seal-forming structures disclosed herein, and the seal-forming structures of the present technology may include any of the features of the seal-forming structures in any of the embodiments of the '992 or '873 applications.

[0201] 28-32, the plenum chamber 13200 has the plenum chamber lateral side edge 3202, plenum chamber connector 3204, notch 3206, chamfered edge 3208, and slot 3209 similar to the plenum chamber 3200 described above. However, the vent 3400 may be provided by a vent insert 13400. The vent insert 13400 may be removably or permanently attached to the plenum chamber 13200 (e.g., by insertion into an opening in the plenum chamber). Note that in any of the other examples, a vent insert may be provided (e.g., the vent 3400 in the plenum chamber 3200 of FIGS. 10-27 may be provided by a vent insert 13400, such as shown in FIGS. 28-32).

[0202] 38, the frame 9200 may include a centrally located connection for the air circuit 4170. The frame may also include headgear attachment sites 9210 on the lateral sides thereof. The seal-forming structure 9100 may be connected to the frame 9200 by spaced apart connectors 9122. These connectors 9122 may include clips on the seal-forming structure and receiving connectors on the frame.

[0203] Seal formation structure of the present technology The seal-forming structure 3100, 5100, 6100, 7100, 8100, 9100, 29100 may include a support structure 3120, 6120, 7120, 8120, 9120, 29120 that provides support to the sealing portion 3130, 5130, 6130, 7130, 8130, 9130, 29130 (e.g., a fabric membrane). The sealing portion is configured to sealingly engage the patient's face. Depending on the size and contour of the patient's nose, in the examples of FIGS. 5-27, the support structure may also sealingly engage the patient's face.

[0204] The exemplary seal-forming structures 3100, 5100, 6100, 7100, 8100, 9100, 29100 differ in various aspects, described further below, but may each include a support structure having at least two regions (e.g., two, three, or four regions) of different thicknesses (e.g., seal-forming structure 3100 includes support structure 3120 (having a wall structure with lateral support regions 3122 of greater thickness relative to other portions of the wall structure). For example, as shown in FIG. 59, support structure portion (d1) may be thicker than support structure portion (d2). For example, portion (d1) may be adjacent to or connect to a plenum chamber, and portion (d2) may be adjacent to or connect to a sealing portion, thereby providing structural stability at the connection with the plenum chamber and flexibility at the interface with the patient. Alternatively, thicker lateral support regions 3122 may be positioned, for example, at the corners of the nasal region of the seal-forming structure (e.g., directly connected to the fabric membrane) to ensure proper sealing in the lowest alar region of the patient's face.

[0205] Additionally, in the illustrated embodiment, each sealing portion has two separate nostril openings 3102, each corresponding to one of the patient's nostrils, to provide airflow to both of the patient's nares. A bridge region 3104 may be provided between the nostril openings 3102. The bridge region 3104 may assist in providing a taut fabric membrane before and / or during use. In another example, a single opening may be used to provide pressurized flow to both of the patient's nares.

[0206] In some forms, as described above, the seal-forming structure 3100 can include a plenum chamber connection opening through which the seal-forming structure 3100 is sealingly joined to the plenum chamber 3200. In the embodiments of Figures 5-38, the support structures 3120, 5120, 6120, 7120, 8120, 9120, 29120 connect directly to the plenum chamber or frame. As such, the support structures can include openings through which the support structures are sealingly joined to the plenum chamber 3200.

[0207] The support structure may be less rigid than the plenum chamber 3200 and may be constructed from silicone, foam (e.g., polyurethane foam) (see FIGS. 28-32), polyurethane solid material, thermoplastic elastomer (e.g., thermoplastic polyurethane), suitable plastic, or other suitable material as described below. Additionally, the sealing portion may be less rigid than the support structure and may be constructed from a woven material (e.g., nylon, polyester, nylon and polyester blends, microfiber, or polyurethane, e.g., as described in more detail below). The sealing portion described in any of the examples of this disclosure may be referred to as a woven sealing portion or woven membrane and may include a woven material having an air impermeable material laminated, coated, or otherwise applied thereto.

[0208] The support structure may have an aperture formed therein, thereby providing an inner edge of the support structure. Along this inner edge, a sealing portion (e.g., the outer periphery of the sealing portion) is attached to the support structure, extending radially inward of the seal-forming structure (beyond or further than the support structure), as shown, for example, in FIGS. 11-27 and 33-38. For example, the sealing portion may be molded around the inner edge of the support structure, or may be connected to the support structure by other suitable methods, as described below. However, in the alternative example of FIGS. 28-32, the sealing portion 8130 may be laminated (e.g., foam) onto the support structure 8120.

[0209] 11-14, the wall structure of the seal-forming portion 3100 may include lateral support regions 3122. The lateral support regions 3122 are thicker than other portions of the wall structure of the support structure 3120. Each seal-forming structure 3100 may include a lateral support region 3122 at its lateral-most side. The seal-forming structure 3100 may include two lateral support regions 3122, each spaced apart distally from a plane that bisects the seal-forming structure 3100 in use, parallel to the sagittal plane of the patient. The lateral support regions 3122 may be the thickest portions of the seal-forming structure 3100, thereby providing resistance to lateral displacement (e.g., when a patient rests their head on their side and presses a pillow laterally against the seal-forming structure) and robust engagement with the patient's wings. The thickness of the lateral support regions 3122 may be from about 0.9 mm to about 1.5 mm, or from about 1.3 mm to about 1.4 mm, or from about 1.3 mm, or from about 1 mm to about 1.5 mm. Because the lateral support regions 3122 are the thickest regions in the seal-forming structure 3100 in the depicted figures, the lateral support regions 3122 may also provide the greatest resistance to deformation.

[0210] Additionally, the lateral support regions 3122 may provide sufficient rigidity to ensure adequate sealing (e.g., by the lateral support regions 3122) in the alar nadir region of the patient's face (i.e., the region where the alar terminates at the upper lip adjacent the nasolabial fold), a region of particularly complex geometry. The alar nadir region of the patient's face has particularly complex geometry because at least three facial surfaces (the alar, upper lip, and cheek) converge in this region. As such, sufficient rigidity in the lateral support regions 3122 may allow the pulling force from the positioning and stabilizing structure 3300 to urge the seal-forming structure 3100 into the alar nadir region (without buckling). The lateral support regions 3122 may be positioned below and laterally outward of the patient's face and nose in the region below the patient's alar (e.g., between the nasolabial fold and the region of the upper lip located below the alar).

[0211] The seal-forming structure 5100 in the embodiment of Figures 15-17 may have an enlarged sealing portion 5130 compared to the sealing portion 3130 of Figures 11-14. That is, the support structure 5120 within the seal-forming structure 5100 may be retracted, causing the sealing portion 5130 to expand, thereby allowing the sealing portion 5130 to engage the lowest alar region of the patient's face in use. As a result, the seal-forming structure 5100 may be more flexible and compliant so that it can more easily conform to the contours of the patient's face.

[0212] 18-22, the seal-forming structure in this example is positioned to provide a larger cavity 3101 such that, in use, the sealing portion 6130 protrudes further from the plenum chamber in the direction of the patient's face due to increased tension in the sealing portion, causing the sealing portion to balloon outward. In use, the patient's nose can be pressed against sealing portion 6130 in the direction of cavity 3101 and plenum chamber 3200, causing sealing portion 6130 to stretch and invert, as shown in FIG. 18, so that the space created by cavity 3101 receives the patient's nose and sealing portion 6130 seals above the patient's nasal tip. In contrast, sealing portions 3130 and 5130 seal below the patient's nasal tip, as shown in FIG. 10.

[0213] 23-27 is also configured to seal above the patient's nasal tip due to the height of the cushion. Compared to sealing portion 6130, sealing portion 7130 is configured to seal further in the direction of the septum along the bridge of the nose.

[0214] In the exemplary cushion assembly of Figures 28-32, the support structure 8120 may be provided by a foam material laminated onto the plenum chamber 3200. The sealing portion 8130 may be laminated directly onto the support structure. The support structure 8120 may extend across the plenum chamber connecting opening, except for a pair of holes formed therein corresponding to the nostril openings 3102 in the sealing portion 8130. Such an arrangement provides a compression-type seal against the patient's face, and as the cushion assembly 8105 is pulled towards the patient's face by the headgear, the seal-forming structure 8100 conforms to the contours of the patient's face through compression of the support structure 8120.

[0215] The cushion assembly 8105 is configured to seal against the underside of the patient's nose. The seal-forming structure 8100 includes an end 8122. The end 8122 curves around the posterior portion of the plenum chamber 3200 and is configured to engage the patient's upper lip in use.

[0216] 33-37, cushion assembly 29105 is similar to cushion assembly 3105, but may extend further laterally. Cushion assembly 29105 includes a seal-forming structure 29100, a support structure 29120, and a sealing portion 29130. Referring to FIG. 33-1, cushion assembly 29105-1 is similar to cushion assembly 29105, but may have a woven fabric membrane 29105 formed such that the woven fabric membrane forms a portion of the seal-forming structure that extends in a curved manner from the anterior side to the posterior, face-contacting side of the seal-forming structure, as described above.

[0217] As mentioned above, Figures 35-37 show grip pads 29150 on the surface of the textile membrane.

[0218] In the example of Figure 38, the sealing portion 9130 is positioned to seal over the patient's nasal tip.

[0219] 5.3.3.1 Positioning and stabilizing structures The cushion assembly 3105, 5105, 6105, 7105, 8105, 29105 of the patient interface 3000, 6000 of the present technology may be held in a sealed position in use by the positioning and stabilising structure 3300. The cushion assembly 9105 of the patient interface 9000 of the present technology may be held in a sealed position in use by the positioning and stabilising structure 9300.

[0220] In one form, the positioning and stabilizing structure 3300, 9300 provides at least enough holding force to overcome the effect of positive pressure in the cavity 3101 to lift off the face.

[0221] In one form, the positioning and stabilizing structure provides a holding force sufficient to overcome the attractive force on the patient interface.

[0222] In one form, the positioning and stabilizing structure provides a holding force as a safety margin to eliminate the possibility of destructive action on the patient interface (e.g., due to tube drag or inadvertent interference with the patient interface).

[0223] In one form of the present technology, there is provided a positioning and stabilizing structure 3300, 9300 configured to be worn by a patient while sleeping. In one example, the positioning and stabilizing structure 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 includes at least one strap having a rectangular cross-section. In one example, the positioning and stabilizing structure includes at least one flat strap.

[0224] In one form of the present technology, a positioning and stabilizing structure is provided that is configured so that it does not have an excessively large or bulky size that would interfere with a patient sleeping in a supine sleep position with the posterior region of the patient's head resting on a pillow.

[0225] In one form of the present technology, a positioning and stabilizing structure is provided that is configured so that it does not have an excessively large or bulky size that would interfere with a patient sleeping in a lateral sleeping position with the side regions of the patient's head resting on pillows.

[0226] In one form of the present technology, the positioning and stabilizing structure 3300, 9300 comprises a decoupling site located between the anterior portion of the positioning and stabilizing structure and the posterior portion of the positioning and stabilizing structure. The decoupling site does not resist compression and can be, for example, a flexible or flimsy strap. The decoupling site is constructed and positioned such that when a patient lies with their head on a pillow, the presence of the decoupling site prevents forces from being transmitted along the positioning and stabilizing structure to the posterior portion, disrupting the seal.

[0227] In one form of the present technology, a positioning and stabilizing structure includes a strap constructed from a laminate of a fabric patient-contacting layer, a foam material inner layer, and a fabric outer layer. In one form, the foam material is porous to allow moisture (e.g., sweat) to pass through the strap. In one form, the fabric outer layer includes a loop material that engages with a hook material portion.

[0228] In certain forms of the present technology, the positioning and stabilizing structure includes an extensible (e.g., elastically extensible) strap. For example, the strap can be configured to be tensioned in use to direct a force that urges the seal-forming structure into contact with a portion of the patient's face. In one example, the strap can be configured as a tie.

[0229] 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-aural-base point of the patient's head and covers a portion of the parietal bone without covering the occipital bone.

[0230] 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.

[0231] 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.

[0232] In certain forms of the present technology, the positioning and stabilizing structures include 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.

[0233] In certain forms of the present technology, the positioning and stabilizing structure includes straps configured to be breathable to allow water vapor to pass therethrough.

[0234] In certain forms of the present technology, systems are provided that include more than one positioning and stabilizing structure 3300, 9300. Each positioning and stabilizing structure is configured to provide a holding force to accommodate a different size and / or shape range. For example, a system may include one form of positioning and stabilizing structure that is suitable for large sized heads but not small sized heads, and another form that is suitable for small sized heads but not large sized heads.

[0235] 5.3.3.1.1 Positioning and stabilizing structures of the technology 5 shows an example of the present technology including a positioning and stabilizing structure 3300. In this example, the positioning and stabilizing structure 3300 includes a lateral portion 3302 and an upper portion 3304 in the form of a conduit that directs the flow of pressurized gas from the hub 3306 to the end 3314. The positioning and stabilizing structure 3300 may be positioned such that, in use, the hub 3306 and decoupling structure 3500 are positioned above the patient's head. As described below, the decoupling structure 3500 may be rotatable within the hub 3306 such that when the patient is wearing the patient interface 3000, for example during treatment, the hub 3306 and decoupling structure 3500 are positioned above the patient's head, allowing the patient greater freedom of movement (without entanglement with the air circuit 4170).

[0236] The positioning and stabilizing structure 3300 may be constructed from silicone. For example, the side portions 3302, upper portion 3304, hub 3306 and lateral side edges 3314 may be constructed or molded from a single piece of silicone.

[0237] The upper portion 3304 of the positioning and stabilizing structure 3300 has peaks and valleys (or bellows) that allow the upper portion 3304 to conform to the shape of corresponding portions of a patient's head during use. The peaks and valleys of the upper portion 3304 allow the upper portion 3304 to expand or contract along a longitudinal axis to accommodate larger or smaller heads. The peaks and valleys of the upper portion 3304 allow the upper portion 3304 to flex to different radii of curvature to accommodate patient heads of different shapes and sizes.

[0238] The side portions 3302 of the positioning and stabilizing structure 3300 may not be formed with the peaks and valleys of the upper portion 3304. As such, the side portions 3302 may be able to be less extensible and flexible than the upper portion 3304, which may be advantageous as it reduces the shape and size variability of the sides of the patient's head.

[0239] The ends 3314 may connect to each plenum chamber lateral end 3202. As described above, the plenum chamber lateral ends 3202 receive the flow of pressurized gas from the positioning and stabilizing structure 3300. This flow of pressurized gas passes through the plenum chamber 3200 and the seal-forming structure 3100 to the patient's airway. As described above, the ends 3314 may connect to the plenum chamber connectors 3204 of each plenum chamber lateral end 3202.

[0240] The positioning and stabilizing structure 3300 may be constructed and arranged to direct the force / tension provided by the lateral portions 3302 into a partially superior and partially posterior force vector that is applied to the plenum chamber 3200. Specifically, this partially superior and partially posterior force vector causes the fabric membrane of the seal-forming structure 3100 to make sealing contact underneath the patient's nose (e.g., at or below the nasal tip and at least above the vermilion of the upper lip).

[0241] Additionally, the side portions 3302 may each include a tab 3308 that receives a rear strap end 3311 of the rear strap 3310. The rear strap 3310 may be adjustable in length, for example, by a hook and loop material arrangement so that one of the rear strap ends 3311 and the remainder of the rear strap 3310 has the hook material on the exterior and the other has the loop material on the exterior. In this manner, the rear strap 3310 is adjustable in length so that tension on the side portions 3302 can be increased to draw the seal-forming structure 3100 into sealing engagement with the patient's face at a desired amount of pressure (i.e., tight enough to avoid leakage but not so tight as to cause discomfort).

[0242] The side portions 3302 may also be provided with sleeves 3312 to cushion and protect the patient's face from the side portions 3302. The sleeves 3312 may be constructed of a soft feeling, breathable fabric material.

[0243] 6 , the patient interface 6000 includes a positioning and stabilizing structure 6300. The positioning and stabilizing structure 6300 has at least one tube 6350. The at least one tube 6350 is formed from a woven material (e.g., one or more sheets or layers of woven material) and receives pressurized air from an air delivery tube 6348 via a connection port 6600. The tube 6350 includes a left arm 6305 and a right arm 6307.

[0244] In some forms, the woven tube 6350 can be formed with a first side configured to contact the patient, which can be referred to as the inner layer 6352. The woven conduit can also include a second side, which is attached to the inner layer but faces away from the patient, which can be referred to as the outer layer 6354. The inner and outer layers can be secured to each other along their edges, respectively, such that a flow path or passageway is formed between the seams of the inner and outer layers. That is, the space between the seams remains unattached, forming the air passageway 6372. The inner and outer layers can be joined using various techniques to impart specific attributes to the seam or joint. For example, in some forms, the seam is formed using ultrasonic welding, radio frequency welding, and cutting and welding techniques. The application of heat to specific areas activates thermosetting or thermoplastic materials used in the tube 6350. This heat can be used to thermally form layers, such as the outer layer 6354, as well as to bond the layers together. Additionally, in some embodiments, the layers can be joined together using adhesives such as stitching or glue. In some embodiments, stitching is not used. In further embodiments, no material beyond the material disposed within the layer is used to join the inner and outer layers of the tube. For example, in some embodiments, the inner and outer layers can be formed such that no additional material, such as glue or stitching, is required to join the inner and outer layers.

[0245] The inner and outer layers can each include an inner surface and an outer surface. The inner surface of the inner layer is the surface facing the outer layer. The inner surface of the outer layer is the surface facing the inner layer. Similarly, the outer surface of the outer layer faces away from the inner layer, and the outer surface of the inner layer faces away from the outer layer. Furthermore, in embodiments including a single sheet, the inner surface is the surface of the sheet that is disposed inward or facing toward itself.

[0246] In some embodiments, the sheet or tube sheet may include an air impermeable layer or membrane. In some embodiments, the inner surface of both layers includes a membrane configured to restrict or inhibit air from passing through the layer from the inner surface to the outer surface. The impermeable layer may be a thin layer less than the thickness of the fabric sheet of the inner or outer layer. In other embodiments, the impermeable layer may exceed the thickness of the fabric sheet of either layer. The impermeable layer or membrane or film may be completely impermeable to air movement, or may be configured to allow a predetermined velocity or air movement and a specific pressure.

[0247] The membrane may be formed from a thermoplastic or thermosetting material such that when exposed to a particular temperature, the membrane material can be molded or formed into a particular shape and then hardened or solidified by cooling. In some forms, the membrane may be formed from silicone or polyurethane. In some forms, the outer layer 6354 is pre-formed such that, in an unpressurized or supported state, the outer layer 6354 is pre-positioned and pre-formed to extend away from the inner layer 6352 between opposing joints 6312. That is, the outer layer 6354 can support its own weight, so that the outer layer 6354 remains spaced apart from the inner layer 6352 between the joints 6312 even when not supported by pressurized air or other support mechanism.

[0248] In contrast, the inner layer 6352 can be a flexible component. When the inner layer 6352 is attached and secured to the edge of the outer layer 6354, the inner layer 6352 becomes a substantially planar layer.

[0249] As shown in Figure 7, and particularly as shown in Figure 8, the inner layer 6352 includes a fabric sheet 6360 with a membrane 6362. The fabric sheet 6360 may be formed from a felt, a foam material, a woven, knitted, or nonwoven material or other fiber network.

[0250] The outer layer 6354 includes a tube sheet 6364 and an outer covering 6366. In some forms, both sides of the tube sheet 6364 can be covered with a membrane. As shown in FIG. 9 , the tube sheet 6364 includes a membrane 6368 exposed to the chamber of the tube 6350 and a membrane 6370 along the opposite side of the tube sheet 6364. The membrane 6368 can assist in providing a seal between the inner layer 6352 and the outer layer 6354 and forming an airtight tube. The membrane 6370 can assist in bonding the tube sheet 6364 to the outer covering 6366.

[0251] It should also be understood that one or more aspects of the present technology may be combined with one or more aspects of the following: U.S. Provisional Application No. 62 / 821,878, filed March 21, 2019, entitled "Textile Headgear Tubing for a Patient Interface," or PCT / AU2019 / 050655, filed June 25, 2019, each of which is incorporated by reference in its entirety herein. For example, the positioning and stabilizing structure of the present technology may be identical to the positioning and stabilizing structure in any of the embodiments of the '968 application or the '655 application. Furthermore, any of the cushion assemblies or seal-forming structures in any of the patient interfaces disclosed in the '968 application or the '655 application may be used in place of the cushion assemblies or seal-forming structures disclosed herein.

[0252] 38 , the patient interface 9000 includes a positioning and stabilizing structure 9300. The positioning and stabilizing structure 9300 has a pair of sides that extend between the patient's eyes and ears on each side of the patient's head. These sides may include holes or other connectors for connection to headgear attachment sites 9210 on the frame 9200. The positioning and stabilizing structure 9300 also includes a posterior strap 9310 that extends around the rear of the patient's head and a crown strap 9312 that extends across the top of the patient's head.

[0253] 5.3.3.2 Ventilation In one form, the patient interface 3000, 6000, 9000 includes a vent 3400 constructed and arranged to allow the expulsion of exhaled gas (eg, carbon dioxide), as shown, for example, in FIG.

[0254] In certain forms, the vent 3400 is configured to allow continuous vent flow from the interior of the cavity 3101 to atmosphere when the pressure in 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 in the plenum chamber in use.

[0255] 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).

[0256] The vent 3400 may be disposed within the plenum chamber 3200. The vent 3400 may include a plurality of holes as described above. The holes in the vent 3400 may be divided into two laterally spaced groups. The axes of the flow paths through each of the holes in the vent 3400 may be parallel, thereby avoiding cross-flow and further noise generation. The vent holes may be circular.

[0257] The radius of the holes in the vent 3400 may decrease from the inside to the outside of the plenum chamber 3200. Each vent hole has a draft angle. The diameter of each hole is smaller at the front end than at the rear end. The draft angle means that the cross section of the hole does not decrease across the entire thickness of the chassis, which helps provide carbon dioxide flushing at high humidification levels. Furthermore, a large draft angle may make the plenum chamber 3200 easier to manufacture (especially if the plenum chamber 3200 is formed from an injection-molded plastic material). The draft angle allows for the use of thicker vent pins in the mold and easier injection.

[0258] The holes in the vent 3400 may be provided in two sets towards the middle of the plenum chamber 3200, and the sets may be symmetrical across the centerline of the plenum chamber 3200. Providing multiple vent patterns may allow for noise reduction and may allow for dispersion of flow concentrations.

[0259] The holes in the vent 3400 may be positioned an optimal distance away from the centerline of the plenum chamber 3200. Positioning the holes in the vent 3400 toward the centerline may be advantageous because it may reduce the likelihood of the vent becoming blocked when the patient is lying down. However, positioning the vent too close to the middle of the plenum chamber 3200 may cause the plenum chamber 3200 to become too weak in the center, especially since the cross-section of the plenum chamber 3200 in the illustrated example is smallest in the center (due to the overall shape of the plenum chamber 3200). The location of the holes in the vent 3400 may avoid blockage of the holes during lying down while still allowing the middle member of the chassis to remain sufficiently rigid.

[0260] The size of each vent and the number of vents can be optimized to achieve a balance between noise reduction while achieving the necessary carbon dioxide washout, even at extreme humidification. In the example shown, the vents in the vent 3400 do not provide the entire airflow for the system. The decoupling structure 3500 can include a decoupling structure vent 3402. The decoupling structure vent 3402 can include one or more holes through the decoupling structure 3500. The decoupling structure vent 3402 can function to bleed off excess pressure generated by the RPT device 4000 (before it reaches the patient), while the vent 3400 can function to wash out carbon dioxide exhaled by the patient during treatment.

[0261] 31 and 32 show another example of a vent 3400. In this example, holes are provided in the vent insert 13400. The vent insert is removably or permanently attached to the plenum chamber 3200 at the vent insert opening. The vent insert 13400 may be constructed from a material that is more flexible than the material of the plenum chamber 3200.

[0262] 5.3.3.3 Decoupling Structures (Singular or Plural) In one form, the patient interface 3000, 6000, 9000 includes at least one decoupling structure (eg, a swivel or a bulb).

[0263] The hub 3306, as described above, is connected to a decoupling mechanism 3500, which is a rotatable elbow in these examples. The decoupling mechanism 3500 may be rotatable 360° within the hub 3306 when in use. To remove the decoupling mechanism 3500 from the hub 3306, a button 3504 is manually depressed to release a catch (not shown) from within the hub 3306.

[0264] The decoupling structure 3500 may also include a swivel 3502 that allows for a rotatable connection to the air circuit 4170 .

[0265] The fact that the decoupling structure 3500 is rotatable, that the decoupling structure 3500 is in the form of an elbow, and that the swivel 3502 is rotatable on the decoupling structure 3500 can lead to increased degrees of freedom, which in turn leads to reduced tubing drag and torque on the patient interface 3000 due to connection to the air circuit 4170.

[0266] 5.3.3.4 Connection Port The connection port 3600 allows connection to the air circuit 4170 .

[0267] 5.3.3.5 Forehead support In one form, the patient interface includes a forehead support 3700.

[0268] 5.3.3.6 Anti-asphyxiation valves In one form, the patient interface includes an anti-asphyxiation valve.

[0269] 5.3.3.7 Ports In one form of the present technology, the patient interface 3000, 6000, 9000 includes one or more ports that allow access to the volume within the cavity 3101. 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 cavity 3101 to be measured directly.

[0270] 5.3.4 Full face mask cushion 5.3.4.1 First illustrative example 39-50 , a patient interface 14000 includes a cushion assembly 14105 with a seal-forming structure 14100. The seal-forming structure 14100 is configured to seal around the patient's nares and mouth individually (i.e., an oral-nasal cushion assembly or a miniature full face mask). The cushion assembly 14105 is at least partially formed by the seal-forming structure 14100 and a plenum chamber 14200 attached to the plenum chamber according to an example of the present technology.

[0271] 51-56, a cushion assembly 31105 is illustrated. The cushion assembly 31105 is similar to the cushion assembly 14105 and has a seal-forming structure 31100. The seal-forming structure 31100 is configured to separately seal around the patient's nares and mouth (i.e., an oral-nasal cushion assembly or a miniature full face mask). The cushion assembly 31105 is at least partially formed by the seal-forming structure 31100 and a plenum chamber 31200 attached to the plenum chamber according to an example of the present technology.

[0272] The cushion assembly 31105 includes a nose region 31101, nose region holes 31103, a mouth region 31102, a mouth region hole 31104, a cavity 31001, a support structure 31120, a sealing portion 31130, and a vent portion 31400, which are similar to the features shown in Figures 39-50 and will not be discussed separately. A pair of plenum chamber holes are configured to receive airflow.

[0273] As mentioned above, Figures 54-56 show grip pads 31150 on the surface of the textile membrane.

[0274] Plenum Chamber The plenum chamber 14200 has edges shaped to complement the surface contours of an average human face in the area where a seal is formed in use. In use, the peripheral edges of the plenum chamber 14200 are positioned in close proximity to the adjacent surface of the face. Actual contact with the face is provided by the seal-forming structure 14100. The seal-forming structure 14100 may extend around the entire edge of the plenum chamber 14200 in use.

[0275] In certain forms of the present technology, the plenum chamber 14200 is constructed from a relatively rigid material (e.g., polycarbonate) compared to the seal-forming structure. In another example, the plenum chamber 14200 may be 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.

[0276] In certain forms of the present technology, the plenum chamber 14200 is constructed from a translucent material that can make the patient interface less intrusive and help improve compliance with treatment.

[0277] The plenum chamber 14200 according to embodiments of the present technology may include a plenum chamber hole on each side. The plenum chamber holes may provide pneumatic communication between the conduit connector 14800 (described in more detail below) and the cavity 14001. A connecting rim around each plenum chamber hole may facilitate a mechanical connection (e.g., a snap or friction fit) with the respective conduit connector. The plenum chamber 14200 may be constructed of a sufficiently rigid material to provide auditory and / or tactile feedback to the patient when the conduit connector 14800 is connected to or disconnected from the plenum chamber 14200.

[0278] The seal-forming structure 14100 may be sealingly connected to the plenum chamber 14200. The connection may be permanent or the seal-forming structure 14100 may be removable from the plenum chamber 14200. The seal-forming structure 14100 may be overmolded onto the plenum chamber 14200. The seal-forming structure 14100 and the plenum chamber 14200 may be joined by a mechanical interlock. In the mechanical connection, no chemical bond is formed between the plenum chamber 14200 and the seal-forming structure 14100.

[0279] Seal formation structure 39-50, the seal-forming structure 14100 may include a nose portion 14101 having a pair of nose portion openings 14103 for sealing against a patient's nares. In the illustrated embodiment, two separate openings 14103 are provided, each corresponding to one of the patient's nares, to provide airflow to both of the patient's nares. A bridge portion 14106 may be provided between the nostril openings 14103. In another example, a single opening may be used to provide pressurized flow to both of the patient's nares.

[0280] The seal-forming structure 14100 may include a mouth region 14102 having a mouth region aperture 14104 for sealing with the patient's mouth.

[0281] The seal-forming structure 14100 may at least partially form a cavity 14001 that is pressurized by the air flow. The plenum chamber 14200 may join with the seal-forming structure 14100 to further form the cavity 14001.

[0282] The seal-forming structure 14100 can include a support structure 14120 that provides support to a sealing portion 14130 (e.g., a fabric membrane). The sealing portion is configured to sealingly engage with the patient's face. Depending on the size and contour of the patient's nose, the support structure can also sealingly engage with the patient's face.

[0283] The support structure 14120 may include a wall structure having at least two regions of different thickness (e.g., portions of the support structure adjacent to or connected to the plenum chamber 14200. These portions may be thicker than portions of the support structure adjacent to or connected to the sealing portion 14130, thereby providing structural stability in connection with the plenum chamber 14200 and flexibility in interfacing with the patient). FIG. 84 illustrates an example in which portion (d1) of the support structure may be thicker than portion (d2) of the support structure. For example, portion (d1) may be adjacent to or connect to the plenum chamber, and portion (d2) may be adjacent to or connect to the sealing portion, thereby providing structural stability in connection with the plenum chamber and flexibility in interfacing with the patient. Alternatively, thicker lateral support regions 3122 may be positioned (e.g., directly connected to the fabric membrane) in the corners of the nasal and / or mouth regions of the seal-forming structure, for example, to ensure proper sealing in the lowest alar and / or mouth regions of the patient's face.

[0284] As described above, the seal-forming structure 14100 may be sealingly connected to the plenum chamber 14200. The support structure 14120 may be less rigid than the plenum chamber 14200 and may be constructed from silicone, foam (e.g., polyurethane foam), polyurethane solid material, thermoplastic elastomer (e.g., thermoplastic polyurethane), suitable plastic, or other suitable material as described below. Additionally, the sealing portion 14130 may be less rigid than the support structure 14120 and may be constructed from a woven material (e.g., nylon, polyester, nylon and polyester blends, microfiber, or polyurethane, for example, as described in more detail below).

[0285] The support structure 14120 may have an aperture formed therein, thereby providing an inner edge of the support structure along which a sealing portion 14130 (e.g., an outer periphery of the sealing portion) is attached to the support structure, extending radially inward of the seal-forming structure (beyond or further than the support structure), as shown, for example, in FIGS. 43-46. For example, the sealing portion may be molded around the inner edge of the support structure, or may be connected to the support structure in other suitable ways, as described below.

[0286] In the example of FIG. 49, the support structure 14120 can extend into the cavity 14001, forming a base cushion 14121 that provides support to the sealing portion 14130. The base cushion 14121 and the sealing portion 14130 can form a double-wall structure around the sealing portion. In another example, a second or third base cushion layer can be provided to form a triple- or quadruple-wall structure. In the example of FIG. 49, the base cushion is constructed of a foam material (e.g., polyurethane foam). In another example, the base cushion 14122 can be constructed of silicone, as shown in FIG. 50. However, it will be appreciated that the base cushion can be constructed of other suitable materials (e.g., fabric).

[0287] It should also be noted that one or more aspects of the present technology may be combined with one or more aspects of U.S. Provisional Application No. 62 / 609,909 (filed December 22, 2017) or WO2019 / 119058 (filed December 21, 2018), both entitled "Conduit Headgear Connector for Patient Interface," each of which is incorporated herein by reference in its entirety. For example, the conduit and positioning and stabilizing structure of the present technology may be identical to the conduit and positioning and stabilizing structure in any of the embodiments of the '909 or '058 applications. Furthermore, the cushion assembly (seal-forming structure and plenum chamber) and seal-forming structure in any of the patient interfaces disclosed in the '909 or '058 applications may be used in place of the cushion assembly and seal-forming structure disclosed herein.

[0288] 5.3.4.1.1 Positioning and stabilizing structures The seal-forming structure 14100 of the patient interface 14000 of the present technology may be held in a sealed position by the positioning and stabilizing structure 14300 in use.

[0289] In one form, the positioning and stabilizing structure 14300 provides at least enough holding force to overcome the effect of positive pressure in the cavity 14001 to lift off the face.

[0290] In one form, the positioning and stabilizing structure 14300 provides a holding force sufficient to overcome the attractive force on the patient interface 14000.

[0291] In one form, the positioning and stabilizing structure 14300 provides a holding force as a safety margin to eliminate the possibility of destructive action on the patient interface 14000 (e.g., due to tube drag or accidental interference with the patient interface).

[0292] In one form of the present technology, there is provided a positioning and stabilizing structure 14300 configured to be worn by a patient while sleeping. In one example, the positioning and stabilizing structure 14300 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 14300 includes at least one strap having a rectangular cross-section. In one example, the positioning and stabilizing structure 14300 includes at least one flat strap.

[0293] In one form of the present technology, a positioning and stabilizing structure 14300 is provided that is configured so that it does not have an excessively large or bulky size that would interfere with a patient sleeping in a supine sleep position with the posterior region of the patient's head resting on a pillow.

[0294] In one form of the present technology, a positioning and stabilizing structure 14300 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.

[0295] In one form of the present technology, the positioning and stabilizing structure 14300 comprises a decoupling site located between an anterior section of the positioning and stabilizing structure 14300 and a posterior section of the positioning and stabilizing structure 14300. The decoupling site does not resist compression and can be a flexible or flimsy strap, for example. The decoupling site is constructed and positioned such that when a patient lies with their head on a pillow, the presence of the decoupling site prevents forces from being transmitted along the positioning and stabilizing structure 3300 to the posterior section, disrupting the seal.

[0296] In one form of the present technology, the positioning and stabilizing structure 14300 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.

[0297] In certain forms of the present technology, the positioning and stabilizing structure 14300 includes an extensible (e.g., elastically extensible) strap. For example, the strap can be configured to be tensioned in use to direct a force that urges the seal-forming structure into contact with a portion of the patient's face. In one example, the strap can be configured as a tie.

[0298] In one form of the present technology, the positioning and stabilizing structure may include a first tie (e.g., upper strap 14302 (FIG. 41)) constructed and arranged such that in use at least a portion of its lower edge passes over and moves to the superior-ear-base point of the patient's head.

[0299] In one form of the present technology that is suitable for a full face mask, the positioning and stabilizing structure includes a second tie (e.g., lower strap 14303 (FIG. 41)) that is constructed and arranged such that, in use, at least a portion of its upper edge passes under the inferior ear base point on the underside of the patient's head and covers or rests under the occipital bone of the patient's head.

[0300] 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 (e.g., strap connector 14304 (FIG. 39)) constructed and arranged to interconnect the first tie and second tie in a manner that reduces the tendency of the first tie and second tie to move apart.

[0301] In certain forms of the present technology, the positioning and stabilizing structure 14300 includes straps that are bendable, for example, non-rigid. An advantage of this embodiment is that the straps are more comfortable when the patient lies down to sleep.

[0302] In a particular form of the present technology, the positioning and stabilizing structure 14300 includes straps configured to be breathable to allow water vapor to pass therethrough.

[0303] In certain forms of the present technology, a system is provided that includes more than one positioning and stabilizing structure 14300. Each positioning and stabilizing structure is configured to provide a holding force to accommodate a different size and / or shape range. For example, the system may include one form of positioning and stabilizing structure 14300 that is suitable for large sized heads but not small sized heads, and another form of positioning and stabilizing structure 14300 that is suitable for small sized heads but not large sized heads.

[0304] The positioning and stabilizing structure 14300 may include a clip 14301 for securing each tie to the conduit connector 14800, for example as shown in Figure 39. The clip 14301 and the conduit connector 14800 each have magnets disposed thereon with opposite polarities to facilitate connection therebetween.

[0305] 5.3.4.1.2 Ventilation In one form, the patient interface 14000 includes a vent 14400 constructed and arranged to allow for the expulsion of exhaled gases (eg, carbon dioxide), as shown in FIG.

[0306] In certain forms, the vent 14400 is configured to allow continuous vent flow from the interior of the plenum chamber 14200 to atmosphere when the pressure in the plenum chamber is positive relative to atmosphere. The vent 14400 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 in the plenum chamber in use.

[0307] Ventilation portion 14400 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).

[0308] The vent 3400 may be located within the plenum chamber 14200, as shown in Figure 47. Alternatively, the vent 14400 may be located within a decoupling structure (e.g., a swivel).

[0309] 39 shows an example of a vent 14400 located on a connection port 14600 (eg, a swivel elbow). In variations of these examples, the vent 14400 may be eliminated from the connection port 14600.

[0310] The conduit connector 14800, described in more detail below, may also include a venting feature.

[0311] 5.3.4.1.3 Decoupling Structures (Singular or Plural) In one form, the patient interface 14000 includes at least one decoupling structure (eg, a swivel or a bulb).

[0312] 5.3.4.1.4 Connection Port The connection port 14600 allows for connection to the air circuit 4170. The connection port 14600 in accordance with one embodiment of the present technology may be connected to a connection port housing 14903. The connection port 14600 may be swivelable relative to the connection port housing 14903, and the connection to the air circuit 4170 may also be swivelable.

[0313] The connection port 14600 and connection port housing 14903 may be positioned above the patient's head during use.

[0314] 5.3.4.1.5 Forehead support The example patient interface of the present technology shown in Figures 39-50 does not include a forehead support. Variations of the patient interface of the present technology may include a forehead support.

[0315] 5.3.4.1.6 Conduit A patient interface 14000 according to embodiments of the present technology may include a conduit 14900 for supplying pressurized air flow from the connection port 14600 to a cavity 14001 in the plenum chamber 14200. The conduit 14900 may be joined above the patient's head at the connection port housing 14903 and may pass along the lateral side of the patient's head between corresponding ones of the patient's eyes and ears. The conduit 14900 may be connected to the cushion assembly 14105 (e.g., plenum chamber 14200) via a conduit connector 14800 to provide pressurized air flow to the cavity 14001, as described below.

[0316] The conduit 14900 may also allow for stabilization and positioning of the seal-forming structure 14100 on the patient's face. Thus, the conduit 14900 may function similarly to a tie for the positioning and stabilizing structure 14300. Thus, the mechanical connection from the conduit 14900 to the conduit connector 14800 may be sufficient to transfer tensile forces in the conduit 3900 through the conduit connector 14800 to the seal-forming structure 14100.

[0317] The conduit 14900 may include features of similar conduits disclosed in International Application Publication No. WO 2017 / 124155 A1, which is incorporated by reference in its entirety. For example, the conduit 14900 of the present technology may include features of the headgear tube 3350 described in Figures 3A-3L and related description herein.

[0318] The conduit 14900 may be provided with a sleeve 14901 to cushion the patient's face from the conduit 14900. The sleeve 14901 may be removable. The sleeve 14901 may be constructed from a breathable material.

[0319] The conduit 14900 may also include a tie connector 14902 to facilitate connection with a tie of the positioning and stabilizing structure 14300.

[0320] 5.3.4.1.7 Conduit Connectors The patient interface 14000, according to an embodiment of the present technology, may include conduit connectors 14800 that connect the conduit 14900 to the cushion assembly 14105 to provide a flow of pressurized air to the cavity 14001. The conduit connectors 14800 may each be formed with a conduit connector housing 14801. The conduit connectors 14800 may provide other functions as described below (e.g., venting the plenum chamber 14200, connection to the positioning and stabilizing structure 14300, and preventing asphyxiation through the inclusion of an anti-asphyxiation valve 14850).

[0321] 43-50 show several views of a conduit connector 14800 of a patient interface 14000 in accordance with an embodiment of the present technology.

[0322] 39-50, the conduit connectors 14800 are shown attached to the plenum chamber 14200 at the plenum chamber apertures. As can be appreciated, one conduit connector 14800 is provided on each lateral side of the cushion assembly 14105, with each conduit connector 14800 connected to a plenum chamber aperture on a corresponding lateral side of the cushion assembly 14105. The conduit connectors 14800 can each include a conduit connector mounting structure for connecting the respective conduit connectors 14800 to their respective plenum chamber apertures at a connecting rim (not shown). This connection can be mechanical (e.g., a snap fit or a friction fit). This connection can also be detachable. The materials of the conduit connectors 14800 and the plenum chamber 14200 can each be selected to facilitate the desired connection features. For example, the material of the conduit connector 14800 and the material of the plenum chamber 14200 may each be relatively rigid to allow for auditory and / or tactile feedback in conjunction with the snap fit. The material of the conduit connector 14800 and the material of the plenum chamber 14200 may be different in at least one embodiment, or the materials may be the same. The conduit connector 14800 may be permanently connected to the plenum chamber at the plenum chamber hole. For example, the conduit connector 14800 may be ultrasonically welded to the plenum chamber 14200. The connection between the conduit connector 14800 and the plenum chamber 14200 may be removable or permanent and may also be designed to be robust enough to transmit tension from the conduit 14900 to the plenum chamber 14200 (without disturbing the connection). This is because, as described above, the conduit connector 14800 may facilitate positioning and stabilization of the seal-forming structure 14100 on the patient's head.

[0323] The conduit connector 14800 may be attached to a lateral side of the plenum chamber 14200 to improve the aesthetics of the patient interface 14000. As noted above, constructing the plenum chamber 14200 from a transparent or translucent material may allow for visibility of the patient's facial features. For example, by providing the conduit connector 14800 on the side of the plenum chamber as shown in the illustrated embodiment, greater visibility of the patient's face is achieved, and this arrangement allows for improved aesthetics of the patient interface 14000. This contrasts with alternative designs where the elbow and air circuit may be joined to the center of the plenum chamber 14200, thereby obstructing the patient's face.

[0324] Each conduit connector 14800 may also include a conduit connection end 14802 that connects to a respective conduit 14900. The connection between the conduit 14900 and the conduit connector 14800 at the conduit connection end 14802 may be removable or permanent. A conduit connector inlet hole 14803 may be formed in the conduit connector housing 14801 at the conduit connection end 14802 to receive a flow of pressurized air. The conduit connector 14800 may include structure (e.g., an undercut) to facilitate a removable snap-fit ​​connection with the corresponding conduit 14900. Each conduit 14900 may include a relatively rigid structure at its end that connects to the conduit connector 14800 to facilitate such a connection. The conduit connector 14800 may mate to the conduit 14900 by a friction fit. Again, as described above, the conduit 14900 provides positioning and stabilizing functions for placing the seal-forming structure at a therapeutically effective sealing position on the patient's face, thereby ensuring a connection between the conduit 14900 and the conduit connector 14800 at the conduit connection end 14802 that is sufficiently reliable to allow the transmission of tensile forces from the conduit 14900 to the conduit connector 14800 (without interfering with the connection between the conduit 14900 and the conduit connector 14800 at the conduit connection end 14802).

[0325] The conduit connector 14800 may also provide a venting function for the patient interface 14000. The conduit connector housing 14801 may include a vent inlet that is in pneumatic communication with the cavity 14001 when the patient interface 14000 is assembled. The conduit connector housing 14801 may also include at least one conduit connector vent 14831. As can be seen in the illustrated embodiment, each conduit connector housing 14801 includes multiple conduit connector vents 14831. This allows for proper mixing of newly introduced air with the air already in the plenum chamber 14200, which can improve carbon dioxide displacement and increase the amount of fresh air provided to the patient for breathing.

[0326] As shown in FIGS. 39-41 , the conduit connector 3800 may also provide connection to the ties of the positioning and stabilizing structure 3300. The lower tie may be joined to the conduit connector 3800 by a clip 14301. The clip 14301 and the conduit connector 14800 may include magnets of opposite polarity to facilitate the connection. The connection between the tie of the positioning and stabilizing structure 14300 and the conduit connector 14800 may be releasable. Tension from the lower tie of the positioning and stabilizing structure 14300 may urge a lower portion of the seal-forming structure 14100 into sealing engagement with the patient's face (e.g., around the mouth). Alternatively, the connection structure to the clip 14301 may be formed directly on the conduit connector housing 14801.

[0327] 5.3.4.1.8 Anti-asphyxiation valves In one form, the patient interface 14000 includes an anti-asphyxiation valve. As best seen in FIGS. 47 and 48 , each conduit connector 14800 may include an anti-asphyxiation valve assembly 14850. Thus, the patient interface 14000 may include two anti-asphyxiation valve assemblies 14850. Each anti-asphyxiation valve assembly 14850 may operate independently of the other (i.e., in response to cessation of pressurized air flow). For example, if the patient is sleeping on their side and the pressurized air flow is stopped and one anti-asphyxiation valve assembly 14850 is blocked (e.g., by a pillow), the other anti-asphyxiation valve assembly 14850 can function to prevent the patient from asphyxiating.

[0328] 5.3.4.1.9 Port In one form of the present technology, the patient interface 14000 includes one or more ports that allow access to the volume within the plenum chamber 4200. 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 14200 to be directly measured.

[0329] 5.3.4.2 Second illustration example 57-66 show a patient interface 30000 in accordance with another example of the present technology. The patient interface 30000 includes a cushion assembly 30105 with a seal-forming structure 30100. The seal-forming structure 30100 is configured to seal around the patient's nares and mouth individually (i.e., an oral-nasal cushion assembly or a miniature full face mask). The cushion assembly 30105 is formed at least in part by the seal-forming structure 30100 attached to a plenum chamber and a plenum chamber (or shell) 30200 in accordance with an example of the present technology.

[0330] The cushion assembly 30105 includes a nose region 30101, nose region holes 30103, a mouth region 30102, a mouth region hole 30104, a cavity 30001, a support structure 30120, and a sealing portion 30130, which are similar to the features shown in Figures 39-56 and will not be discussed separately. An inlet port 30240 is formed in the plenum chamber and configured to receive air flow for the air circuit.

[0331] 5.3.4.2.1 Positioning and stabilizing structures 57-66 show a patient interface 30000 in accordance with an example of the present technology. The patient interface 30000 has a positioning and stabilizing structure 30300 and a plenum chamber 30200 with a seal-forming structure 30100. In this example, the positioning and stabilizing structure 30300 includes a frame 30350 and a number of headgear straps connected to the frame 30350.

[0332] The plenum chamber 30200 of the patient interface 30000 is connected to the frame 30350. The plenum chamber 30200 may connect to the frame 30350 via a snap-fit ​​connection. In other examples, the plenum chamber may form a different type of removable connection to the frame, a snap-fit, a removable press fit, or other, or may be permanently connected to the frame.

[0333] The positioning and stabilizing structure 30300 may include multiple straps or strap sections that connect to the frame 30350 and pass around the patient's head to support the plenum chamber in a sealed position against the patient's face. It is understood that a single "strap" may be formed from multiple lengths of material that are cut or formed separately to create longer lengths and then joined at the ends, or the single "strap" may be a single length of material.

[0334] In the example shown in Figures 57-66, the positioning and stabilizing structure 30300 includes a pair of upper straps 30310, each configured to pass between a patient's eyes and ears. The positioning and stabilizing structure further includes a pair of lower straps 30320 configured to be positioned over the patient's cheeks, below the patient's cheekbones. In this example, the plenum chamber is held in place via a four-point connection to the headgear straps via the frame 30350.

[0335] The frame is shown in isolation in FIGS. 63-64. The frame includes a frame inlet connection port 30354. The frame inlet connection port 30354 can be configured to connect to a source of pressurized breathable gas (e.g., air). In one example, the frame inlet connection port 30354 can be configured to allow connection to a swivel elbow assembly 30610 that provides a connection port 30600 for connection to the air circuit 4170. In this example, the frame inlet connection port includes a connecting rim 30355. The connecting rim 30355 can include a radially outwardly extending flange. The swivel elbow assembly 30610 can form a releasable snap fit with the connecting rim, thereby creating a fluid connection between the swivel elbow assembly and the frame. The opposite side of the frame inlet connection port 30354 is configured to fluidly connect to a plenum chamber. As such, the frame 30350 allows for fluid communication between the swivel elbow assembly 30610 and the interior of the plenum chamber 30200.

[0336] The frame 30350 also includes a pair of opposing upper strap connection points 30315 to which the upper straps 30310 connect. In this example, each upper strap connection point includes an aperture formed in the frame. Each upper strap 30310 can connect to each upper strap connection point 30315 by passing through the aperture, looping back on itself, and then securing to itself. Each upper strap can be secured to itself via hook and loop material configured to releasably couple upon contact. In another example, each upper strap 30310 can be secured to itself with a band, clip, or the like after passing through a respective aperture and looping back on itself. In yet another example, the upper straps can connect to the frame via a side release buckle connection.

[0337] The frame 30350 also includes a pair of opposing lower strap connection points 30325 to which the lower straps 30320 connect. In this example, each lower strap connection point includes a magnet. Each lower strap includes a lower strap clip 30326 that includes a magnet or material that is attached to the magnet at the lower strap connection point 30325. In this example, each lower strap clip 30326 includes an aperture through which the end of each lower strap 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 may connect to the frame via a side release buckle connection, onto a hook, or any other suitable connection.

[0338] In one example, the frame 30350 and upper strap connection points 30315 are constructed and arranged to direct the force / tension provided by the upper straps 30310 into a partially upward and partially backward force vector that is applied to the plenum chamber 30200. Specifically, this partially upward and partially backward force vector causes the nasal portion 30101 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.

[0339] Each of the upper straps 30310 may be selectively adjustable. For example, the effective length of each upper strap may be changed by changing the amount of the upper strap that loops back on itself after passing through the aperture at each upper strap connection point 30315. Increasing the amount of upper strap that passes through the aperture effectively reduces the length of the upper strap, thereby allowing for alteration of the force vector and adjustment of the fit of the patient interface.

[0340] In one example, the frame 30350 and lower strap connection points 30325 are constructed and arranged to direct the force / tension provided from the lower straps 30320 into a partially posterior and partially downward force vector that is applied to the plenum chamber. Specifically, the partially posterior and partially downward force vector causes the mouth region 30102 to make sealing contact with the patient's face around the periphery of the patient's mouth. The partially downward force applied from the lower straps to the frame can balance the partially upward force applied from the upper straps and any downwardly directed force that may be applied from the patient's nose to the seal-forming structure.

[0341] The lower straps 30320 may be selectively adjustable. For example, the effective length of each lower strap may be changed by changing the amount of each lower strap that loops back on itself after passing through an aperture in each lower strap clip 30326. Increasing the amount of each lower strap that passes through the aperture effectively reduces the length of the lower strap, thereby allowing for alteration of the force vector and adjustment of the fit of the patient interface.

[0342] The positioning and stabilizing structure 30300 may also include one or more of a parietal coronal strap 30330, a pair of lateral parietal coronal straps 30332, and a neck strap 30334. In the example shown in FIGS. 57-66, the upper strap 30310 and the lower strap 30320 are connected to ends of the parietal coronal strap 30330. The parietal coronal strap is configured to pass around the patient's head and be positioned against surfaces facing upward and backward. The parietal coronal strap 30330 may be configured to be positioned on the parietal bone of the patient's skull. Each end of the parietal coronal strap is also connected to a respective upper strap 30310 and a respective pair of lateral parietal coronal straps 30332. Each lateral parietal coronal strap is connected between the upper and lower straps on each side of the patient's head. The lower ends of the lateral parietal coronal straps 30332 are interconnected by the neck strap 30334. The neck strap 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 may be positioned above or below the occipital bone of the patient's skull.

[0343] The length of the coronal strap 30330 can be selectably adjusted. The coronal strap 30330 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 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 threaded through the link can be varied to adjust the length of the coronal strap 30330 and thus the fit of the positioning and stabilizing structure.

[0344] After all headgear straps have been adjusted and the desired fit of the patient interface 30000 has been achieved, the magnetic clip connections provided by the lower strap clips 30326 allow the lower straps 30320 to be quickly disengaged from the lower strap connection points 30325 on the frame 30350, thereby allowing the patient interface 30000 to be removed from the patient without strap adjustments. Similarly, when the patient is ready to put the patient interface back on, the lower strap clips can be quickly disengaged at the lower strap connection points to allow the patient interface 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.

[0345] In certain forms of the present technology, a system is provided that includes more than one positioning and stabilizing structure, each configured to provide a holding force to accommodate a range of different sizes and / or shapes. For example, the system may include one form of positioning and stabilizing structure that is suitable for large heads but not for small heads, and another form that is suitable for small heads but not for large heads.

[0346] Furthermore, one or more aspects of the present technology may be combined with one or more aspects of the following: PCT / AU2019 / 050278 (filing date: March 28, 2019, title: "Patient Interface"), which is hereby incorporated by reference in its entirety.

[0347] 5.3.4.2.2 Ventilation In one form, the patient interface 30000 includes a vent 30400 constructed and arranged to allow for the expulsion of exhaled gases (eg, carbon dioxide).

[0348] In certain forms, the vent 30400 is configured to allow continuous vent flow from the interior of the plenum chamber 30200 to atmosphere when the pressure within the plenum chamber is positive relative to atmosphere. The vent 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.

[0349] The ventilation part in one embodiment according to the present technology includes a plurality of holes (for example, about 20 to about 80 holes, or about 40 to about 60 holes, or about 45 to about 55 holes).

[0350] The vent 30400 can be located within the plenum chamber. Alternatively, the vent is located within the decoupling structure (e.g., a swivel).

[0351] In the example shown in Figures 57-66, the patient interface 30000 includes a vent 30400. In this example, the vent includes passages within the frame and swivel elbow assembly. These passages allow air to flow from the interior of the plenum chamber to the surroundings. As shown in Figure 59, air flows into the swivel elbow assembly 30610 and then to the surroundings through external holes in the swivel elbow assembly that form part of the vent 30400. The swivel elbow assembly 30610 may be substantially similar to that described in International Publication No. WO2017 / 049357A1, which is incorporated herein by reference in its entirety.

[0352] 5.3.4.2.3 Decoupling Structures (Singular or Plural) In one form, the patient interface 30000 includes at least one decoupling structure (eg, a swivel or a bulb).

[0353] 5.3.4.2.4 Connection Port The connection port 30600 allows connection to the air circuit 4170 .

[0354] 5.3.4.2.5 Forehead support In one form, the patient interface 30000 includes a forehead support 3700 as shown in Figure 3A. In other examples, the patient interface may exclude a forehead support portion. Additionally, the patient interface 30000 may be configured to not contact the patient's forehead at all.

[0355] 5.3.4.2.6 Anti-asphyxiation valves In one form, the patient interface 30000 includes an anti-asphyxiation valve.

[0356] 5.3.4.2.7 Ports In one form of the present technology, the patient interface 30000 includes one or more ports that allow access to the volume within the plenum chamber. In one form, this allows a clinician to provide supplemental oxygen. In one form, this allows a characteristic of the gas (e.g., pressure) within the plenum chamber 302000 to be directly measured.

[0357] 5.3.4.3 Third illustrative example 67-77 show a patient interface 16000 in accordance with another embodiment of the present technology. The patient interface includes a frame assembly 16100, a cushion assembly 16175 including a seal-forming structure 16200, an air delivery connector (e.g., elbow assembly 16600), and a positioning and stabilizing structure (e.g., headgear 16800 including upper side straps 16802, lower side straps 16804, and a crown strap 16806). In use, one form of the seal-forming structure 16200 is positioned to surround the entrance to the airways of the patient 1000 to facilitate the delivery of air at positive pressure to the airways. In the example shown in FIGS. 46-56, the patient interface is a full-face / oronasal interface type that includes the seal-forming structure 16200 configured to form a seal around the mouth of the patient's nose. However, embodiments of the present technology may be adapted for use with other suitable types of interfaces (e.g., nasal interfaces, nasal prongs, pillows).

[0358] The seal-forming structure 16200 may also be commonly referred to as a cushion. Figures 67 and 68 are exemplary views of the patient interface 16000 with attached arm covers 16750 for the upper arms 16134 of the frame assembly 16100. Figure 69 is an exemplary view of the patient interface 16000 with the headgear 16800 and arm covers 16750 removed.

[0359] In this example, the cushion assembly 16175 connects to the frame assembly 16100 (via a first retention feature on the frame assembly) independently from the elbow assembly 16600, and the elbow assembly 16600 connects to the frame assembly 16100 (via a second retention feature on the frame assembly) independently from the cushion assembly 16175. That is, the retention connections of the cushion assembly 16175 and elbow assembly 16600 to the frame assembly 16100 are separate and distinct from one another, allowing for independent engagement / disengagement.

[0360] In the example patient interface 16000, a first seal for the air flow path is formed between the elbow assembly 16600 and the frame assembly 16100, and a separate second seal is formed between the frame assembly 16100 and the cushion assembly 16175. In this example, the frame assembly 16100 is disposed in the air flow path; that is, the elbow assembly 16600 is structured to establish a hard-to-hard connection and dynamic seal with the frame assembly 16100, and the cushion assembly 16175 is structured to establish a separate hard-to-hard connection and static seal with the frame assembly 16100.

[0361] Also, in the example patient interface 16000, the frame assembly 16100 includes a lockout feature along the opening 16105 that is constructed and arranged to prevent direct connection or insertion of the air circuit 4170 (e.g., air delivery tubing). With this arrangement, interconnection of the frame assembly 16100 and the air circuit 4170 requires the use of the elbow assembly 16600, thereby ensuring that the elbow assembly 16600 (and its vent and anti-asphyxiation valve (AAV)) is present in the system. Frame Assembly

[0362] 67-77, the frame assembly 16100 includes a shroud or wall member 16110, a pair (i.e., right and left) upper headgear connector arms 16134 (each including two flexible portions 16140 and 16145) extending from each side of the upper portion of the shroud 16110, and a pair (i.e., right and left) lower headgear connector arms 16154 extending from each side of the lower portion of the shroud 16110. Each lower headgear connector arm 16154 includes a magnetic connector 16155 (including a receptacle magnet). The magnetic connectors 16155 are structured to position and connect a provided headgear clip 16160 (including a receptacle magnet) to each lower headgear strap 16804 of the headgear.

[0363] In the illustrated example, opening 16105 in shroud 16110 (eg, constructed from a relatively rigid plastic material such as polycarbonate) is bounded by outer and inner annular flanges.

[0364] Cushion Assembly & Elbow Assembly 67-77, the cushion assembly 16175 includes a body, chassis, plenum chamber, or shell 16180 that is connected or otherwise provided to the seal-forming structure or cushion 16200 (see FIGS. 70 and 71). The shell 16180 may be permanently connected to the cushion 16200 (e.g., by integral molding, overmolding), or may be removably connected to the cushion 16200 (e.g., by a mechanical connection). In an example, the cushion 16200 is constructed of a relatively flexible or compliant material, and the shell 16180 is constructed of a relatively rigid material (e.g., polycarbonate). The shell 16180 and cushion 16200 cooperate to form a cavity 16500 (e.g., FIGS. 70, 71, and 73). The shell 16180 includes an opening 16305 for delivery of breathable gas to the cavity 16500. The opening 16305 is bounded by an annular flange 16310. The annular flange 16310 is adapted to connect to the frame assembly 16100.

[0365] The shell 6180 has multiple functions. For example, it at least partially forms a cavity for pressurized gas delivery to the entrance of the patient's airways. The shell 6180 is a rigid structure that directs a force onto the seal-forming structure for sealing against the patient's face. This force is achieved by tension from tightening the headgear straps. These forces are transferred from a pair of upper and lower headgear straps to corresponding upper and lower arms. In an example, the upper and lower arms comprise a frame assembly such that headgear tension is applied to the shell 16180.

[0366] The shell 16180 of the cushion assembly 16175 is repeatably engageable with and removably disengageable from the shroud 16110 of the frame assembly 16100 via a mechanical connection (e.g., a snap-fit ​​connection). An inner annular flange of the shroud 16110 extends through an opening 16305 in the shell 16180, and tabs or catches on the flange engage with or interlock onto the rear side of the annular flange 16310 of the shell 16180 to releasably connect the frame assembly 16100 to the cushion assembly 16175. Such a connection provides a sealed, hard-to-hard connection while maintaining ease of use and minimizing rocking motion between the components, reducing its impact on stability. Such a connection also provides an appropriate force vector on the cushion assembly 16175 for sealing while stably holding the cushion assembly 16175 in place.

[0367] 67 , the elbow assembly 16600 includes a first end 16610 and a second end 16620. The first end 16610 releasably engages (and together forms a swivel connection with) the frame assembly 16100 by a pinch arm 16650. The second end 16620 is adapted to connect to the air circuit 4170 (e.g., via a swivel connector 16625). The elbow assembly 16600 is structured to establish a rigid connection and seal with the frame assembly 16100.

[0368] In this example, the first end 16610 includes an inner radial wall and an outer radial wall that define radial channels that lead to a plurality of vents 16700 to allow the exit of exhaled gases from the patient interface.

[0369] It should also be understood that one or more aspects of the present technology may be combinable with one or more aspects of U.S. Patent Application Publication No. 2018 / 0250486 (filed March 12, 2018, entitled "Patient Interface"), which is incorporated herein by reference in its entirety. For example, the cushion assembly 16175 disclosed herein may be substituted for the cushion assembly in any of the patient interface embodiments disclosed in the '486 publication. Furthermore, the seal-forming structure 16200 disclosed herein may be substituted for the seal-forming structure in any of the patient interfaces disclosed in the '486 publication.

[0370] Seal formation structure As described above, the shell 16180 is sealingly connected or otherwise provided to a seal-forming structure or cushion 16200 , and the shell 16180 and cushion 16200 cooperate to form a cavity 16500 .

[0371] The cushion 16200 may include a support structure 16220 that provides support to a sealing portion 16230 (e.g., a fabric membrane). The sealing portion is configured to sealingly engage the patient's face.

[0372] The support structure 16220 may include a wall structure having at least two regions of different thickness (e.g., the portion of the support structure adjacent to or connected to the shell 16180 may be thicker than the portion of the support structure adjacent to or connected to the sealing portion 16230, thereby providing structural stability in connection with the shell 16180 and flexibility in interface with the patient). FIG. 84 illustrates an example in which portion (d1) of the support structure may be thicker than portion (d2) of the support structure. For example, portion (d1) may be adjacent to or connected to the plenum chamber, and portion (d2) may be adjacent to or connected to the sealing portion, thereby providing structural stability in connection with the frame and flexibility in interface with the patient. Alternatively, the thicker lateral support regions 3122 may be positioned, for example, in the lower cheek region of the seal-forming structure (e.g., directly connected to the fabric membrane), thereby ensuring proper sealing in the lower cheek region of the patient's face.

[0373] The support structure 16220 may be less rigid than the shell 16180 and may be constructed from silicone, foam (e.g., polyurethane foam), polyurethane solid material, thermoplastic elastomer (e.g., thermoplastic polyurethane), suitable plastic, or other suitable material as described below. Additionally, the sealing portion 16230 may be less rigid than the support structure 16220 and may be constructed from a woven material (e.g., nylon, polyester, nylon and polyester blends, microfiber, or polyurethane, for example, as described in more detail below).

[0374] The support structure 16220 may have an aperture formed therein, thereby providing an inner edge of the support structure along which a sealing portion 16230 (e.g., an outer periphery of the sealing portion) is attached to the support structure, extending radially inward of the seal-forming structure (beyond or further than the support structure), as shown, for example, in FIGS. 71 and 73-77. For example, the sealing portion may be molded around the inner edge of the support structure, or may be connected to the support structure in other suitable ways, as described below.

[0375] The support structure 16220 can extend into a cavity 16500 that forms a base cushion 16221 that provides support to the sealing portion 16230, as shown in FIGS. 73 and 77. The base cushion 16221 and sealing portion 16230 can form a double-wall structure around the sealing portion. In another example, a second or third base cushioning layer can be provided to form a triple- or quadruple-wall structure. The base cushion can be constructed of materials similar to those of the support structure or can be constructed of other suitable materials (e.g., fabric).

[0376] 5.3.4.3.1 Positioning and stabilizing structures The seal-forming structure of the patient interface of the present technology may be held in a sealed position in use by the positioning and stabilizing structure.

[0377] In one form of the present technology, there is provided a positioning and stabilizing structure configured to be worn by a patient while sleeping. In one embodiment, the positioning and stabilizing structure has a low profile or cross-sectional thickness to reduce the perceived or actual bulk of the device. In one embodiment, the positioning and stabilizing structure includes at least one strap having a rectangular cross-section. In one embodiment, the positioning and stabilizing structure includes at least one flat strap.

[0378] 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.

[0379] In certain forms of the present technology, the positioning and stabilizing structure includes an extensible (e.g., elastically extensible) strap. For example, the strap can be configured to be tensioned in use to direct a force that seals the cushion against a portion of the patient's face. In one example, the strap can be configured as a tie.

[0380] In certain forms of the present technology, the positioning and stabilizing structures include 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.

[0381] In certain forms of the present technology, the positioning and stabilizing structures provide a holding force configured to accommodate a particular head size and / or face shape. For example, one form of the positioning and stabilizing structures provides a holding force appropriate for a large head size but not a small head size. In another example, one form of the positioning and stabilizing structures provides a holding force appropriate for a small head size but not a large head size.

[0382] 5.3.4.3.2 Ventilation In one form, the patient interface includes a vent constructed and arranged to allow for the expulsion of exhaled gases (e.g., carbon dioxide).

[0383] The ventilation part in one embodiment according to the present technology includes a plurality of holes (for example, about 20 to about 80 holes, or about 40 to about 60 holes, or about 45 to about 55 holes).

[0384] The vent may be located within the plenum chamber or shell, or the vent may be located within the decoupling structure (e.g., a swivel).

[0385] 5.3.4.3.3 Decoupling Structures (Singular or Plural) In one form, the patient interface includes at least one decoupling structure (eg, a swivel or a bulb).

[0386] 5.3.4.3.4 Connection Port The connection port allows connection to an air circuit.

[0387] 5.3.4.3.5 Forehead support In the illustrated example, the frame assembly 6100 is provided without a forehead support.

[0388] In another aspect, the patient interface may include a forehead support. For example, the frame assembly may include a forehead support.

[0389] 5.3.4.3.6 Anti-asphyxiation valves In one form, the patient interface includes an anti-asphyxiation valve.

[0390] 5.3.4.3.7 Ports In one form of the present technology, the patient interface includes one or more ports that allow access to the volume within the cavity. In one form, this allows a clinician to provide supplemental oxygen. In one form, this allows direct measurement of the properties of the gas (e.g., pressure) within the cavity.

[0391] 5.3.5 Supporting structure and sealing arrangement The support structures and sealing portions of the above examples can have a number of different configurations and arrangements.

[0392] In use, sealing contact between the sealing portion (e.g., textile membrane) and the patient's face can be maintained by: 1) tension (e.g., low tension) in the textile membrane and / or the resilient elongation properties (e.g., elasticity) of the sealing portion's material (e.g., textile material, air impermeable layer material, and / or textile membrane composite); 2) reaction stress of the support structure; 3) the pre-formed state of the textile membrane, which is untensioned and formed as a substantially constant surface without leakage that would cause obstructions in the textile membrane (e.g., wrinkles, folds, buckling, or fine wrinkles); and / or 4) air pressure within the cavity against the inner surface of the sealing portion. Each of these factors can contribute to maintaining constant tension in the sealing portion so that the sealing portion conforms to the anthropometric contours of the patient's face, thereby minimizing wrinkles or ruptures and maximizing the contact area of ​​the sealing portion.

[0393] In some examples, the sealing portion may comprise a relatively thin, compliant, and extensible elastic material (e.g., a woven membrane comprising a suitable woven material (e.g., nylon, polyester, nylon and polyester blends, microfiber, or polyurethane)). Before and during use, the sealing portion may be held taut by the support structure. The sealing portion may be molded or otherwise attached (e.g., by gluing or adhesive) to the support structure so that the sealing portion is pre-tensioned (slightly stretched) and wrinkles in the sealing portion material are eliminated. This may be advantageous because it ensures that the sealing portion forms a smooth, continuous seal on the patient's face (without any folded sections that could cause air leaks). Furthermore, the sealing portion may be shaped or imparted with a curvature, for example, by heat molding, so that the sealing portion retains its shape. The support structure may also impart a curvature to the sealing portion.

[0394] For example, as shown in Figures 11-17 and 23-37, the sealing portion may have a concave curved profile (e.g., positive curvature in the left-right direction) from one lateral side (right) to the opposite lateral side (left) so as to cradle the patient's nose.

[0395] In some configurations, as shown in FIGS. 10-66, for example, the patient's nose is not intended to be received within the cavity formed by the plenum chamber and seal-forming structure. Instead, in contrast to conventional masks, the patient's nose is intended to press against the fabric membrane, so that the fabric membrane conforms to the contours of the patient's face and comfortably forms a reliable seal with the patient's airway. In this manner, the fabric membrane may stretch to accommodate the patient's face. Bridge regions 3104 and 1406 extending between the nostril openings may help maintain the fabric membrane taut before and / or during use. The bridge regions may also function to help eliminate a central opening in the fabric membrane, providing a sealing area that presses against the patient's nose instead of receiving it within the cavity. This may also provide a different sealing experience compared to conventional masks. Such a sealing experience may provide greater comfort due to contact with a compliant textile membrane than conventional masks made of stiffer materials (where the sealing has a smaller contact area around the nose and / or mouth) or conventional sealing arrangements.

[0396] The sealing portion may be constructed from a single or multiple layers of material (e.g., a woven material). The woven membrane (and / or the woven material of the woven membrane) may exhibit a low spring constant (i.e., be highly compliant in both the warp and weft). With conventional masks (e.g., silicone sealing membranes), fixed cushions can cause discomfort to the patient's skin during effective seal formation. In contrast to conventional masks, the present woven membrane may have a material spring constant and spring length (i.e., the amount of material available for stretching) such that the present woven membrane is more compliant than the patient's skin and therefore more easily conforms to the patient's facial features. This may improve mask comfort and reduce the formation of localized pressure "hot spots."

[0397] Compared to conventional silicone membranes and compressed foam seals, the sealing portion of the present technology has a more flexible structural rigidity, resulting in dynamic springback characteristics, which allows the sealing portion to recover more quickly (when disturbed by external forces). Furthermore, due to the lower structural rigidity, less sealing force is required, making the sealing portion more comfortable and reducing facial scarring during use.

[0398] The woven membrane may exhibit variable tension across the material (e.g., lower tension near holes or more stretched material). In some forms, the surface of the sealing material that contacts the patient's face may advantageously have low friction characteristics (e.g., a low friction finish), which may lead to improved material conformance with the patient's face while improving patient comfort.

[0399] The woven membrane may also include at least one layer that exhibits substantially air-tight properties while maintaining the resilient elongation properties necessary for comfort and minimal pressure points. That is, the addition of a membrane layer or laminate film layer (e.g., a polymer (e.g., silicone, polyurethane, thermoplastic polyurethane (TPU), polyester, nylon)) to the woven material results in a substantially airtight material. In another example, a closely woven woven fabric results in a substantially air-tight material.

[0400] In some embodiments, the thickness of the fabric material of the sealing portion can be within a range of 0.275 mm (e.g., 0.275 to 0.075 mm, 0.275 to 0.175 mm, 0.25 mm or less, 0.225 mm or less, 0.225 to 0.09 mm, 0.225 to 0.095 mm, 0.225 mm, or 0.25 mm) or less. The thickness of the membrane layer can be within a range of 0.03 to 0.01 mm (e.g., 0.015, 0.02 mm, or 0.025 mm). The overall composite thickness of the woven fabric material of the sealing portion can be within a range of 0.305 mm or less (e.g., 0.305 to 0.085 mm, 0.305 to 0.185 mm, 0.28 mm or less, 0.255 mm or less, 0.255 to 0.10 mm, 0.255 to 0.105 mm, 0.25 mm, or 0.275 mm). In an example, a woven fabric composite including a microfiber fabric and a polyurethane film layer can have these dimensions.

[0401] In another example, the thickness of the fabric material of the sealing portion may be within a range of 0.15 mm to 0.5 mm (e.g., 0.2 mm to 0.4 mm, or 0.3 mm to 0.4 mm, or 0.25 mm, or 0.3 mm, or 0.4 mm), and the thickness of the membrane layer may be within a range of 0.03 mm to 0.125 mm (e.g., 0.05 mm to 0.1 mm, or 0.075 mm to 0.1 mm, or 0.05 mm to 0.075 mm, or 0.05 mm, or 0.075 mm, or 0.1 mm). The overall composite thickness of the fabric material of the sealing portion with the membrane layer can be in the range of 0.18 mm to 0.625 mm (e.g., 0.25 mm to 0.6 mm, or 0.25 mm to 0.5 mm, or 0.3 mm to 0.5 mm, or 0.35 mm to 0.45 mm, or 0.3 mm, or 0.35 mm, or 0.4 mm, or 0.45 mm, or 0.5 mm). In an example, a fabric composite including a nylon or nylon and polyester blend fabric and a silicone film layer can have these dimensions.

[0402] The stiffness and resilience of the support structure may transfer tension forces to the sealing portion. The support structure may be formed from a variety of materials, such as silicone, foam (e.g., polyurethane foam), solid polyurethane material, thermoplastic elastomer (TPE) (e.g., thermoplastic polyurethane (TPU)), and suitable plastic materials. The support structure may be configured to produce several different cushion configurations, including a single air-assisted sealing portion (e.g., a woven membrane) and a sealing portion with an underlying cushion support layer(s), such as a dual air-assisted sealing portion (e.g., a dual woven membrane), a sealing portion with a compression support (e.g., open-cell foam, polyurethane foam, gel), a sealing portion with a TPU, TPE, or silicone support, or a dual air-assisted sealing portion with additional support (e.g., a dual woven membrane with an inner membrane provided with a foam laminate layer (e.g., open-cell, polyurethane) or a TPU, TPE, polyurethane, or silicone molded layer).

[0403] The underlying cushioning layer(s) can help optimize the contact surface area of ​​the sealing portion with the patient's face. Additionally, in instances where the sealing portion is constructed from a breathable material (e.g., a breathable fabric), the underlying cushioning layer(s) can provide sufficient contact area behind the sealing portion to properly seal with the patient's face and avoid leakage.

[0404] In use, engagement of the patient's face 1000 with the sealing portion 10130 generates a temporary deflection force that attempts to pull the walls of the support structure 10120 toward each other, as shown in FIG. 81. The support structure 10120 responds to this deflection force with a counter force that pulls it outward. The counter force causes the more compliant sealing portion to preferentially stretch, transferring more tension to the sealing portion 10130 by applying the spring force generated within the sealing portion to the patient's face.

[0405] In some examples, the support structure may include a biasing section that uses internal air pressure to dynamically support the support structure and sealing section, which may advantageously provide additional support for the sealing section under dynamic loads (e.g., pipe drag).

[0406] The air pressure within the cavity and its action on the inner surface of the sealing portion may also enable the surface of the fabric membrane to be maintained without wrinkles, wrinkles, buckles, or creases when presented to the patient's face (e.g., by generating tension in the sealing portion), allowing the sealing portion to substantially fill and press against the contours of the patient's face (e.g., around the sides of the nose). As a result, the compliant sealing portion may enable a larger sealing contact area to be formed on the patient's face. The tension in the sealing portion generated by the air pressure within the cavity may also be advantageous in providing a continuous seal even when the mask is partially displaced from its optimal position on the patient's face because the sealing portion may partially expand (due to an opposing force from the internal air pressure) (i.e., the "hovercraft effect").

[0407] Even in instances where the fabric membrane is not under constant tension (e.g., is inelastic), because the sealing portion is thinner and less stiff than the supporting structure, the sealing portion may be maintained in sealing contact with the patient's face by air pressure within the cavity, forming an improved air-assisted seal against the patient's face that dynamically adapts to changes / movements (i.e., the "hovercraft effect").

[0408] The sealing portion can be integrated with the support structure by molding the sealing portion to the inner edge of the support structure or otherwise attaching the sealing portion to the inner edge of the support structure. Thus, for example, when the periphery of the sealing portion is attached to the inner edge of the support structure, the sealing portion can extend radially inward of the seal-forming structure, extending beyond or wider than the support structure. The inner edge of the support structure can be curved, so that the sealing portion is angled slightly inward toward the interior of the mask. Attaching the sealing portion along the inner edge of the support structure eliminates the need to crease or cut the sealing portion to fit around the corners of the support structure. This can advantageously reduce the occurrence of protruding folds or wrinkles in the sealing portion (which could lead to leakage), thereby improving sealing performance.

[0409] As previously mentioned, the seal-forming structure may be removably connected to the plenum chamber or fixedly attached. In some configurations, the sealing portion may have a removable or modular structure. For example, the sealing portion may be circumferentially attached to a support frame structure. The support frame may be removably attached to the support structure as modules. The sealing portion may be attached to the support frame in a manner that reduces the occurrence of folds or wrinkles protruding from the fabric surface. The modular arrangement may also substantially simplify the manufacturing of the sealing portion (e.g., a fabric sealing portion) by allowing complex joints to be made in a simple, stress-free manner. While it may be possible to engineer the sealing portion to be substantially self-cleaning, the use of a modular sealing portion may provide a cheaper and more hygienic alternative.

[0410] The support frame can be preformed to have a flat shape or a three-dimensional shape (e.g., an arcuate shape) (to impart a curved shape to the sealing portion). The support frame can form an airtight seal with the support structure. In some examples, the support frame can engage with the support structure via connectors (e.g., male / female locating pins / holes, tongue and grooves).

[0411] The sealing portion may have an underlying cushion support layer(s) (e.g., a second, third, or subsequent cushion layer) therein. The underlying cushion support layer(s) may provide additional flexibility, making the cushion suitable for use with most patient faces (e.g., one size fits most). For example, the sealing portion may be constructed as a dual air-assisted sealing portion (e.g., a dual woven membrane), a sealing portion including a compression support layer(s) (e.g., open-cell foam, polyurethane foam, gel), a sealing portion with a TPU, TPE, or silicone support layer(s), or a dual air-assisted sealing portion with additional support layer(s) (e.g., a dual woven membrane with an inner membrane provided with a foam laminate layer (e.g., open-cell, polyurethane) or a TPU, TPE, polyurethane, or silicone molded layer).

[0412] In some instances, the support layer may be supported by a rigid structure (eg, a plastic (eg, polypropylene (PP), polycarbonate (PC), polyamide (PA), or polyethylene terephthalate (PET))).

[0413] In some examples, 3D printing the sealing portion, support layer, and / or support structure as a "skeleton" can lead to a reduction in structural thickness, which can also reduce mask weight. Also, different layers of the mask can be printed with different stiffness, hardness, or thickness. For example, the "skeleton" member can be formed using silicone, foam (e.g., polyurethane foam), polyurethane (e.g., polyurethane solid material), or any suitable plastic material. In some examples, biasing portions can be formed that can enable dynamic support during use.

[0414] 5.3.5.1 Textile membrane According to an example of the technology of the present disclosure, the seal-forming structure may include a woven membrane comprising a woven material. The woven material may be coated or otherwise applied with an airtight membrane / film or layer to obtain an air-retaining woven composite. The woven composite may be cut (e.g., die-cut, ultrasonic, laser, or RF) into a desired shape and then attached to a support structure. The resulting woven sealing portion (or woven membrane) may be attached to a support structure (e.g., silicone, TPE) by, for example, overmolding or injection molding. In another example, the woven sealing portion may be heat-welded at its edge (periphery) onto the support structure material (e.g., silicone, TPE).

[0415] A textile is a material comprising at least one natural or artificial fiber (e.g., spun or sewing yarn). The fiber may be a filament (mono- or poly), strand, sewing thread, or twisted yarn. The fiber(s) may include animal-based materials (e.g., wool or silk), plant-based materials (e.g., linen and cotton), and synthetic materials (e.g., polyester and rayon). Textiles may be formed by a variety of techniques (e.g., weaving, knitting, crocheting, knotting, tatting, bonding, felting, tufting, or braiding), and include, for example, woven and nonwoven materials (e.g., by interlacing or interlacing one or more of the above fibers).

[0416] In one example, the woven material is a knitted material. Knitted materials may be preferred because they can provide elasticity (e.g., extensibility) in woven fabrics (especially compared to woven materials). This can be advantageous because it provides comfort for the patient, as described below. Elasticity can be provided in all directions (e.g., four-way stretch / elasticity (e.g., substantially equal elasticity in all directions)), at least in the left-right lateral direction of the woven membrane. The woven material may have, for example, a weft-knitted or warp-knitted structure. Weft-knitted structures are more preferred because weft-knitted fabrics have higher elasticity than warp-knitted fabrics.

[0417] Figure 113 shows the weft knit fabric's fabric 70, or the direction in which loops of one yarn are joined to loops of another yarn. The path 80, or direction, of loops from a single yarn is shown in Figure 114. In the basic closed-loop warp knit 90 shown in Figure 115, the fabric and path run parallel to each other. In the weft knit 100 shown in Figure 116, the fabric 70 runs perpendicular to the path 80.

[0418] 5.3.5.1.1 Manufacturing In an example, an overmolding process can be used to construct a seal-forming structure having, for example, a flexible support structure (eg, silicone) attached to a textile membrane.

[0419] In step 10, an airtight woven composite may be formed by combining the woven material with an impermeable material, as shown in Figure 117. A thermal process may be used to attach the impermeable layer to the woven material, as shown in Figure 78. The woven composite may have a flat shape (e.g., a sheet shape).

[0420] In step 12, the woven composite may be cut into the desired shape according to the particular cushion assembly to be used.

[0421] In step 14, a support structure (e.g., silicone) may be overmolded onto the woven composite to form a seal-forming structure with the woven membrane. When the woven composite is held in place by vacuum, the woven composite has a non-flat, predefined shape during the overmolding process. That is, overmolding the flat woven composite with the support structure imparts curvature to the woven composite to form a woven membrane that may have a curvature (without creating wrinkles, folds, wrinkles, and / or buckling in the woven membrane). As can be seen in FIG. 33-1 , the woven membrane may extend from the front side of the seal-forming structure to the back side of the seal-forming structure along a curved portion 35. In one embodiment, as shown in FIG. 33-1 , both the support structure and the woven membrane may have a radius of curvature (e.g., the same or similar radii of curvature) along the curved portion 35. The woven membrane can be imparted with a predefined curvature, so that the portion of the woven membrane not directly supported by the support structure extends along a curved portion 35 (FIGS. 33-2-33-4). As noted above, the woven membrane can also have, for example, dome-shaped and saddle-shaped curvatures in other regions of the woven membrane. The woven membrane has a concave curved profile (e.g., a positive curvature in the left-right direction) from one lateral side (right) to the opposite lateral side (left), which is imparted during the overmolding process and maintained by the connection to the support structure (see, e.g., FIGS. 11-17, 23-27, and 33-37). In another example, the woven membrane can have a negative curvature in the downward / upward direction (which can be imparted during the overmolding process) and maintained by the connection to the support structure (see, e.g., FIGS. 18-22).

[0422] The support structure may be molded onto the woven composite such that the outer surface of the seal-forming structure is smooth and seamless at the transition from the support structure to the woven membrane (see Figure 33-4). The support structure may be bonded to the impermeable material of the woven membrane. The outer surface of the seal-forming structure may be smooth and seamless, but may also have a step on the inner surface of the seal-forming structure (where the thickness of the support structure is different (e.g., larger) than the thickness of the impermeable layer).

[0423] The overmolding process creates a seal-forming structure that imparts curvature to the woven membrane without causing any wrinkles, creases, creases and / or buckling in the woven membrane.

[0424] 5.3.5.1.2 Example of a woven membrane Exemplary properties and structural configurations of woven composites used as materials for woven membranes are described below.

[0425] 5.3.5.1.2.1 Textile composite structure Various combinations of textile materials and membrane / film layers can be used.In one example, a three-layer configuration is used, in which a thermoplastic polyurethane (TPU) film is placed between two textile layers (for example, nylon, a mixture of nylon and polyester, a mixture of nylon and spandex, a mixture of polyester and spandex, or a mixture of nylon / polyester / spandex).An additional textile layer is required to protect the TPU film from damage (for example, during cleaning).

[0426] In another example, a two-layer configuration is used that includes a fabric (e.g., nylon, a blend of nylon and polyester, a blend of nylon and spandex, a blend of polyester and spandex, or a blend of nylon / polyester / spandex) with a silicone layer (e.g., deposited as a coating). This composite material can be less expensive than the three-layer configuration described above because only one layer of fabric is required.

[0427] In another example, a woven material (eg, a microfiber or polyurethane material) may be coated with a polyurethane film to form a two-layer arrangement.

[0428] 5.3.5.1.2.2 Textile materials As noted above, multiple woven materials can be used to form the sealing portion (e.g., nylon, polyester, spandex, blends of nylon and polyester, blends of nylon and spandex, blends of polyester and spandex, blends of nylon / polyester / spandex, microfiber, or polyurethane).

[0429] In one example, a nylon material is used. Nylon is softer than polyester, which can provide comfort benefits to the patient. Nylon is also stronger than polyester, which can provide increased longevity and durability. Additionally, nylon has a higher melting temperature compared to polyester, allowing it to withstand higher temperature manufacturing conditions.

[0430] In another example, a nylon and polyester blend material is used. This material is more desirable because it is less irritating to the patient due to lower moisture absorption caused by the addition of polyester. The nylon and polyester blend is also less expensive than nylon.

[0431] 5.3.5.1.2.3 Fabric material thickness In one embodiment, the thickness of the fabric material of the sealing portion may be within a range of 0.15 mm to 0.5 mm (e.g., 0.2 mm to 0.4 mm, or 0.3 mm to 0.4 mm, or 0.25 mm, or 0.3 mm, or 0.4 mm). Such a thickness may be suitable for nylon materials or nylon and polyester blend materials.

[0432] In another embodiment, the thickness of the woven material of the sealing portion can be within a range of 0.275 mm (e.g., 0.275 to 0.075 mm, 0.275 to 0.175 mm, 0.25 mm or less, 0.225 mm or less, 0.225 to 0.09 mm, 0.225 to 0.095 mm, 0.225 mm, or 0.25 mm) or less. Such thicknesses can be compatible with microfiber woven materials or polyurethane woven materials.

[0433] 5.3.5.1.2.4 Air impermeable layer thickness In instances where silicone is used as the membrane / film layer, the thickness of the silicone can be in the range of 0.03 mm to 0.125 mm (e.g., 0.05 mm, 0.05 mm to 0.1 mm, or 0.05 mm to 0.075 mm, or 0.075 mm to 0.1 mm, or 0.1 mm). A thinner silicone layer (e.g., 0.05 mm) may be more desirable because it can result in a lighter product and also provide greater extensibility than a thicker silicone layer (e.g., 0.1 mm). However, a thicker silicone layer (e.g., 0.1 mm) is more durable than a thinner layer (e.g., 0.05 mm).

[0434] In another example, a polyurethane film is used as the membrane layer, and the thickness of the polyurethane film can be 0.03 to 0.01 mm (eg, 0.015, 0.02 mm, or 0.025 mm).

[0435] 5.3.5.1.2.5 Overall thickness of the fabric composite In instances where a textile material is coated with a silicone membrane / film layer, the thickness of the overall composite can be in the range of 0.18 mm to 0.625 mm (e.g., 0.25 mm to 0.6 mm, or 0.25 mm to 0.5 mm, or 0.3 mm to 0.5 mm, or 0.35 mm to 0.45 mm, or 0.3 mm, or 0.35 mm, or 0.4 mm, or 0.45 mm, or 0.5 mm).

[0436] Thicker woven membrane thicknesses (e.g., 0.5 mm) can be stronger and leave less residue. These woven membranes can be easier to handle during manufacturing because they are less likely to flap.

[0437] A mid-level thickness (e.g., 0.35 mm to 0.45 mm) may result in a flexible, lightweight structure that is relatively easy to handle during manufacturing and may provide greater comfort to the patient than thicker woven membranes.

[0438] Thinner woven membranes may result in a very lightweight construction and provide a soft, comfortable feel to the patient, but may be less durable than thicker woven membranes.

[0439] In instances where a textile material is coated with a polyurethane film, the thickness of the overall composite can be within the range of 0.305 mm or less (e.g., 0.305 to 0.085 mm, 0.305 to 0.185 mm, 0.28 mm or less, 0.255 mm or less, 0.255 to 0.10 mm, 0.255 to 0.105 mm, 0.25 mm, or 0.275 mm).

[0440] 5.3.5.1.2.6 Knitting structure The textile material of the textile membrane can have, for example, a weft-knitted or warp-knitted construction. Weft-knitted textiles are preferred because they provide a more elastic material than warp-knitted textiles. The knitted textiles stretch when the patient's face engages the textile membrane, thereby reducing the force exerted by the textile membrane on the patient's face and providing greater comfort to the patient.

[0441] In one example, the weft direction (the direction of path 80) may extend across the width of the woven fabric membrane, as the weft direction may have higher elasticity or extensibility, or the weft direction may extend across the length of the nose (up and down).

[0442] Additionally, weft knitting is better suited to producing relatively thin materials, such as those disclosed herein, and is generally less expensive than warp knitting.

[0443] However, in some instances warp knitting is more desirable because it shrinks less than weft knitted materials.

[0444] 5.3.5.1.2.7 Knitting machines Weft-knitted textile materials can have a single jersey knit construction, providing technical and back technical faces with different appearances. The single jersey knit can be formed by a single set of needles, providing a knit stitch on the technical face (front) and a purl stitch on the back technical face. In one example, the technical face can form the outer surface of a textile membrane, and an air-impermeable membrane can be attached to the back technical face. Alternatively, the technical face can be oriented toward the inner surface of the textile membrane, to which the membrane is attached.

[0445] In one example where the woven membrane comprises an air impermeable membrane sandwiched between two woven layers, a technical aspect of each woven material may form the exposed surface of the woven membrane.

[0446] 5.3.5.1.2.8 Fabric weight The weight of the woven material is in the range of 95 grams per square meter (gsm) to 130 gsm (e.g., 105 gsm to 120 gsm, or 110 gsm to 115 gsm, or 105 gsm, or 110 gsm, or 120 gsm). In the case of a heavier woven fabric (e.g., 120 gsm), the high weight / thickness can provide a desirable, comfortable woven feel even after being coated with a laminate layer. A lower weight woven fabric (e.g., 105 gsm) is more desirable because it allows for a lighter product.

[0447] 5.3.5.1.2.9 Mechanical Gauges The machine gauge (i.e., stitches per inch) of the woven material can vary. For example, the machine gauge can be in the range of 35GG to 70GG (e.g., 44GG to 60GG, or 50GG to 55GG, or 55GG to 60GG, or 44GG, or 50GG, or 55GG, or 60GG).

[0448] Using a relatively larger gauge material (e.g., 44GG) is desirable because it allows for more options for mélange materials, but using a finer gauge material (e.g., 60GG) is desirable because this softer material may lead to improved patient comfort.

[0449] 5.3.5.1.2.10 Aesthetics Woven materials can have a solid color aesthetic or a mélange aesthetic. Mélange materials can be considered materials made with more than one color of fabric / textile / yarn, either made with different colored fabrics / textiles / yarns or with different fabrics / textiles / yarns that are then dyed individually. Mélange materials are desirable because they have a greater ability to hide dirt or grime, which more easily improves product cleanliness. Mélange materials can also be useful during manufacturing, because it is easier to visually align the woven structure accurately during cutting and / or overmolding.

[0450] However, solid color materials are desirable because they provide increased options for finer gauge materials (eg, 55GG+) that are softer and therefore more comfortable for the patient.

[0451] 5.3.5.2 Illustrated examples of support and sealing arrangements 81-112 illustrate several different cushion assembly configurations, including various support structure and sealing portion arrangements and / or processes. Note that these examples may be applied to any of the patient interfaces and / or cushion assemblies described in this disclosure. Additionally, any feature of any example may be applied to a different example and / or used with different features. The plenum chamber, support structure, and sealing portion shown in these figures may be constructed from any of the suitable materials described above. Note also that components, such as the support structure, may include more than one material. For example, the underlying cushion of the support structure may include a different material than the support structure.

[0452] 83 , the support structure 10120 is removably connected to the plenum chamber 10200 via a clip 10126 on the support structure and a connector 10210 on the plenum chamber to form a cavity 10001. In some examples, the clip 10126 may be formed from polyurethane, polypropylene (PP), or polyethylene terephthalate (PET). The plenum chamber 10200 may be constructed from a stiffer material than the clip (e.g., polycarbonate or polyurethane with a higher Shore A hardness than the clip). The support structure 10120 and sealing portion 10130 are configured in a cushion arrangement with a single air-assisted sealing portion 10130 (e.g., a woven membrane).

[0453] The connection between the outer periphery (or outer edge) of the textile membrane and the inner edge of the support structure can be formed in several different ways. As shown in Figures 83 and 85, this connection can form a lap joint where the edge of the textile membrane overlaps the edge of the support structure. In an example, the attachment site 10122 of the support structure forms a recess that receives the sealing portion 10130, resulting in a smooth outer surface for the support structure and sealing portion, as shown in Figure 83. This overlap can be minimal and provided for manufacturing purposes only (i.e., necessary for attachment of the sealing portion and support structure (e.g., by overmolding and / or injection molding)). In conventional arrangements, the overlap region may be arranged to provide additional support (e.g., stiffness) to the sealing portion due to the presence of the support structure (as opposed to the above, as in such arrangements, this overlap may vary around the perimeter of the seal-forming structure to provide varying levels of support or stiffness (e.g., less overlap, less support, more flexibility, less tension in the sensitive nose bridge region).

[0454] In contrast to the lap joint described above, the connection between the textile membrane and the support structure may form an end-to-end joint (e.g., a butt joint), as shown in Figure 84. Due to manufacturing techniques (e.g., overmolding, injection molding), the end-to-end joint may have some overlap, but such overlap is negligibly small and constant around the sealing portion at the connection with the support structure. In other words, as noted above, any overlap of the support structure and textile membrane is not designed to adjust stiffness, tension, flexibility, or support in different areas of the face (e.g., reduced overlap, reduced support, increased flexibility, reduced tension in the sensitive nose bridge area).

[0455] Instead, whether a lap joint or an end-to-end joint is provided, the present arrangement allows the compliant fabric membrane to properly accommodate the patient's facial features, i.e., the seal-forming structure is designed so that the patient's facial features (e.g., nose) are recessed into the fabric membrane, which compliantly receives the patient's face.

[0456] The sealing portion may be glued, molded (e.g., overmolded or injection molded) onto the support structure, or otherwise attached to the support structure. In another example, as shown in FIG. 84, the recess may be eliminated and the sealing portion 10130 and support structure 10120 may be attached end-to-end using attachment sites 10122. Additionally, FIG. 84 illustrates that the portion of the support structure 10120 adjacent to or connecting to the plenum chamber 10200 (d1) may be thicker than the portion of the support structure 10120 adjacent to or connecting to the sealing portion 10130 (d2), thereby providing structural stability at the connection with the plenum chamber and flexibility at the interface with the patient.

[0457] 85, the support structure 10120 includes an underlying cushion 10121. The support structure also includes a sealing lip 10124 that seals the interface between the plenum chamber 10200 and the support structure 10120. The attachment site 10122 of the support structure can be configured to sandwich an end of the sealing portion between opposing portions of the attachment site 10122.

[0458] 86, the plenum chamber 11200 can have an underlying cushion 11121 attached thereto. Thus, the underlying cushion 11121 can be permanently attached to the plenum chamber 11200, while the support structure 10120 and sealing portion 10130 can be removably connected to the plenum chamber via the clips 10126 and connectors 10210.

[0459] 87 and 88 , the support structure 10120 can have an external biasing portion 10140 or an internal biasing portion 10140′. The external biasing portion 10140 or internal biasing portion 10140′ can utilize internal air pressure in the cavity to dynamically support the support structure and sealing portion 10130. The support structure 10120 can include an inwardly curved end 10142, thereby forming an air-assisted support region 10144. The air-assisted support region 10144 acts on the support structure and sealing portion by optimizing the force due to air pressure in the cavity to urge the sealing portion into sealing contact with the patient's face.

[0460] 89, the support structure 12120 includes an underlying cushion 12121. The support structure and / or the underlying cushion may be formed, for example, from molded polyurethane. In this example, the sealing portion 10130 is adhered to the support structure by adhesive 10150 (e.g., heat-activated polyurethane, tape, bonding adhesive).

[0461] In FIG. 90A, the support structure 15120 is removably connected to the plenum chamber 10200. The support structure includes an underlying cushion 15121. In this example, the support structure is formed from foam (e.g., molded polyurethane foam), but may also be formed from TPE, TPU, or any other suitable material. As shown in FIG. 90A-1, the sealing portion 10130 may have a membrane layer or film laminate layer 10131 that provides a substantially airtight material. Alternatively, the support structure 15120 may be glued, bonded, or otherwise attached to the plenum chamber 10200.

[0462] Figure 90B shows an example similar to that of Figure 90A, except that the sealing portion 10130 in Figure 90B may be directly connected to the plenum chamber 10200 to form a seamless cover over the underlying cushion 15121. The sealing portion 10130 and underlying cushion 15121 may be glued or otherwise joined to the plenum chamber 10200. Alternatively, the sealing portion 10130 and / or the underlying cushion 15121 may be removably connected to the plenum chamber.

[0463] 91 , the support structure 17120 includes a first portion 17123 and an underlying cushion 17121. The first portion 17123 may connect to a plenum chamber and may be constructed of a stiffer material than the material of the underlying cushion 17121. For example, the first portion 17123 and the underlying cushion may both be constructed of polyurethane, but the polyurethane material of the first portion may be stiffer than the material of the underlying cushion. A reinforcing member 17125 may extend along the periphery of the cushion spanning the intersection between the first portion 17123 and the underlying cushion 17121 to provide structural support.

[0464] As shown in FIG. 92 , the support structure 23120 can include an underlying cushion 23121 (e.g., constructed of TPU) having a U-shape or hook-shape. The underlying cushion can include a clip 23126 for releasable connection to the cushion (e.g., a frame, plenum chamber, or other portion of the support structure). Alternatively, the sealing portion 10130 can be attached to the support structure 23120 as a removable module and releasably connected to the cushion (e.g., a frame, plenum chamber, or other portion of the support structure) as a unit. The sealing portion 10130 can be attached to the underlying cushion 23121 by, for example, thermoforming. The underlying cushion can also be formed by thermoforming.

[0465] The support structure 24120 may include rigid clips 24126 that support the underlying cushion 24121, as shown in FIG. 93. The underlying cushion 24121 may include an outer fabric layer 10132 and an inner layer (e.g., constructed of foam) encapsulated by the fabric layers and clips. The support structure 24120 may be removably connectable to the cushion (e.g., a frame, plenum chamber, or other portion of the support structure). Alternatively, the sealing portion 10130 may be attached to the support structure 24120 as a removable module and removably connectable as a unit to the cushion (e.g., a frame, plenum chamber, or other portion of the support structure). The sealing portion 10130 may be connected to the underlying cushion 24121, for example, by thermoforming. The underlying cushion may also be formed by thermoforming.

[0466] 94, the support structure 18120 may include a rigid clip 18126 that supports an underlying cushion 18121 (e.g., constructed of foam). The support structure 18120 may be removably connectable to the cushion (e.g., a frame, plenum chamber, or other portion of the support structure). Alternatively, the sealing portion 10130 may be attached to the support structure 18120 as a removable module and removably connected to the cushion (e.g., a frame, plenum chamber, or other portion of the support structure) as a unit. The sealing portion 10130 may be attached to the underlying cushion 18121 by, for example, thermoforming. The underlying cushion may also be formed by thermoforming.

[0467] 95, the support structure 19120 includes a first section 19123 and an underlying cushion 19121. The first section 19123 may be connected to a plenum chamber and may be constructed of a material that is more rigid than the material of the underlying cushion 19121. For example, the first section may be constructed of polyurethane and the underlying cushion may be constructed of foam.

[0468] 96 , the support structure 20120 includes a first portion 20123 and an underlying cushion 20121. The first portion 20123 may connect to a plenum chamber and may be constructed of a material that has a different stiffness or Shore A hardness than the material of the underlying cushion. For example, the first portion 20123 and the underlying cushion 20121 may both be constructed of polyurethane, while the first portion 20123 may have a lower or higher stiffness or a higher or lower Shore A hardness than the underlying cushion 20121. In another example, the first portion 20123 and the underlying cushion 20121 may be constructed of the same material and have the same stiffness or Shore A hardness.

[0469] The support structure 21120 of Figure 97 includes a first portion 21123 and an underlying cushion 21121, similar to the support structure 20120 described above, except that the cushion includes a second sealing layer (e.g., fabric layer 10132) that forms a dual-ply fabric membrane. The underlying cushion 21121 may be molded or otherwise attached to the underside of the fabric layer 10132.

[0470] Referring to FIG. 98, the support structure 22120 includes a first portion 22123 and an underlying cushion 22121, and is similar to the support structure 21120 described above, except that the underlying cushion 22121 is a laminated foam layer or is otherwise attached to the underside of the fabric layer 10132.

[0471] 99, the illustrated cushion assembly includes a dual ceiling structure without an underlying cushion support. The cushion assembly includes a first fabric layer 10130 and a second fabric layer 10132 connected to a support structure 10120.

[0472] The cushion assembly in FIG. 100 is similar to the cushion assembly in FIG. 99 , except that a first fabric layer 10130 and a second fabric layer 10132 extend from a support section 10135 at the sealing portion. The support section 10135 may be constructed of, for example, TPU or foam (e.g., polyurethane foam molding). The support section 10135 may impart resiliency to the sealing portion and allow the fabric layers to rebound more quickly from external forces. The support section 10135 may be removably connected to the support structure 10120 as a modular unit with the fabric layers. In another example, the support section 10135 is removably connected to a plenum chamber.

[0473] 101 and 102, the sealing portion modular assembly 26400 may be permanently or removably connected (e.g., by mechanical clips) to the support structure 26120 (or to the plenum chamber 10200). The sealing portion modular assembly may include a skeletal support frame 26450 to which the sealing portion 10130 is attached. The sealing portion 10130 may be heat formed or insert molded, for example, to attach the sealing portion to the support frame 26450. The heat forming or molding process and / or the support frame itself may form and hold the sealing portion in a curved or three-dimensional shape. The support structure 26120 may be constructed, for example, from insert molded polyurethane.

[0474] In the example of Fig. 103, the woven membrane 10130 and / or the support structure may be configured to be removable or modular. As shown in Fig. 103, the woven membrane 10130 may be attached at its periphery to a modular support structure 26480. The modular support structure 26480 may then be removably engaged to the plenum chamber as a module. The modular construction may advantageously reduce the protrusion of folds or wrinkles in the surface of the woven membrane.

[0475] In some forms, the fabric membrane may be a sleeve or sock adapted to cover and be held over a plenum chamber or support structure.

[0476] Modular woven membrane seals may also substantially simplify manufacturing, as complex joints may all be made in a simple, stress-free manner. While some fabrics may be engineered to have substantially self-cleaning properties, modular woven membranes may advantageously provide a cheaper and more hygienic alternative. In some configurations, the woven membrane or support structure may be a removable and / or replaceable subassembly that is attached to the plenum chamber, support structure, or frame assembly.

[0477] In configurations where the woven membrane is attached to the support frame of the modular support structure 26480, the support frame may be preformed flat (as shown in FIG. 103) or may be preformed as a 3D structure such as an arc.

[0478] In some forms, the modular support structure 26480 can engage with the plenum chamber through corresponding male / female locating pins / holes. In some forms, the modular support structure can form an effective airtight seal with the plenum chamber using a tongue and groove arrangement around the peripheral sides of the structure. The modular support structure 26480 can be formed, for example, from a plastic material, polyurethane, or similar material.

[0479] 104-106, a process for insert molding a sealing portion (e.g., a textile material) as an in-mold decoration (IMD) is illustrated. As shown in FIGS. 104 and 105, contacting a first mold 26500 with a second mold 26550 may impart a curvature to the sealing portion while attaching the sealing portion 10130 to a support frame 26450. This molding process may also stretch the sealing portion 10130, so that its attachment to the support frame 26450 keeps it taut prior to use.

[0480] 107 and 108, a "one size fits all" cushion assembly 27105 is illustrated. The cushion assembly 27105 may include a sealing portion 10130 attached to an upper support frame portion 27202 and a lower support frame portion 27204. The upper support frame portion 27202 is spaced from the lower support frame portion 27204 to form an elastic region 27108. In the elastic region 27108, the sealing portion may stretch to space the upper support frame portion 27202 and the lower support frame portion 27204 to accommodate patients with a range of face sizes.

[0481] As shown in FIG. 109 and FIG. 110, a patient's face may be scanned to generate a custom mask. To obtain a three-dimensional profile, the facial scan may be used to generate a cushion assembly 28105 that includes a sealing portion 10130 attached to a support frame 28200. The support frame 28200 may include a relatively rigid support element (e.g., a polyurethane molded piece) and a cushioning element (e.g., foam) between the support element and the sealing portion. As shown in FIG. 84, the cushion assembly may be configured to stretch to accommodate patients with different face sizes.

[0482] In some examples of nasal cushions, such as those shown in FIGS. 111 and 112, the support structure 3120 may actually be configured to deform inward at specific folds or pivot points. For example, thinner regions of the support structure may be designed to create the folds or pivot points. In examples, the lower central portion of the support structure 3120 (e.g., the nasal base region 3112) may be relatively thin, so that when stress is applied to the walls of the support structure by engagement with the patient's face, the lower central portion of the support structure creates a pivot point, which may allow the left and right lateral sides of the support structure to deform inward to cradle the patient's face (e.g., nose) and accommodate the patient's engagement. The upper anterior region 3109 may also be thin compared to the lateral support regions 3122, so that the folds or pivot points are created.

[0483] Thus, in the example of FIGS. 111 and 112 , the support structure 3120 may have three regions with different stiffness (e.g., by having different thicknesses). The thickness of the upper anterior region 3109 may be the same as or greater than the thickness of the nose base region 3112. The thickness of the lateral support region 3122 may be greater than the thicknesses of the upper anterior region 3109 and the nose base region 3112. Thus, the lateral support region may be stiffer than the upper anterior region 3109, which may be stiffer than the nose base region 3112. Note that both the plenum chamber and the support structure may be formed from a flexible material (e.g., silicone) and may be molded into a one-piece structure (e.g., integrally molded). This may assist in flexing / folding / pivoting of the cushion assembly to accommodate the patient's facial features. In one embodiment, the seal-forming structure may be an extension of the plenum chamber or may be formed as part of the plenum chamber such that the plenum chamber includes the seal-forming structure. In such an example, the support structure and the fabric membrane may be considered part of the plenum chamber.

[0484] 5.4 RPT Device An RPT device 4000 according to one aspect of the present technology includes mechanical, pneumatic, and / or electrical components and is configured to execute one or more algorithms 4300 (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.

[0485] 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.

[0486] 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.

[0487] 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 capable of supplying air at positive pressure (e.g., a blower 4142), an outlet muffler 4124) and one or more transducers 4270 (e.g., a pressure sensor 4272 and a flow sensor 4274).

[0488] One or more of the air path items may be disposed within a removable, unitary structure referred to as a pneumatic block 4020. The pneumatic block 4020 may be disposed within the outer housing 4010. In one form, the pneumatic block 4020 is supported by or formed as part of the chassis 4016.

[0489] 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, one or more protection circuits, memory, a transducer, a data communication interface, and one or more output devices. The electrical components 4200 can be mounted on a single printed circuit board assembly (PCBA) 4202. In one alternative, the RPT device 4000 can include more than one PCBA 4202.

[0490] 5.5 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.

[0491] 5.5.1 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).

[0492] 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.

[0493] 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), which may differ from the humidity outside the room where the patient is sleeping.

[0494] In another example, the ambient pressure may be the pressure immediately surrounding or external to the body.

[0495] 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.

[0496] 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.

[0497] 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).

[0498] Flow Rate: The instantaneous amount (or mass) of air delivered per unit time. Flow rate can refer to an instantaneous quantity. Sometimes, when referring to flow rate, it refers to a scalar quantity (i.e., a quantity that has only magnitude). In other cases, when referring to flow rate, it refers to a vector quantity (i.e., a quantity that has both magnitude and direction). Flow rate may be given the symbol Q. "Flow rate" may also be called "flow" or "airflow" for shorthand.

[0499] In the example of a patient's breathing, the flow rate may be nominally positive for the inspiratory portion of the patient's breathing cycle, and therefore negative for the expiratory portion of the patient's breathing cycle. Total flow rate Qt is the flow rate of air exiting the RPT device. Vent flow rate Qv is the flow rate of air exiting the vent to allow for the outflow of exhaled gases. Leakage flow rate Ql is the flow rate of leakage from the patient interface system or elsewhere. Respiratory flow rate Qr is the flow rate of air received into the patient's respiratory system.

[0500] 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.

[0501] 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.

[0502] 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.

[0503] 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.

[0504] Ventilation noise (acoustic): In this document, ventilation noise refers to the noise generated by airflow through any ventilation (eg, vents in the patient interface).

[0505] Patient: A person with or without a respiratory disease.

[0506] Pressure: Force per unit area. Pressure can be expressed in a variety of units (e.g., cmH2O, gf / cm 2 , and hectopascals). 1 cmH2O is equal to 1 g-f / cm2, or approximately 0.98 hectopascals. In this specification, pressures are given in units of cmH2O unless otherwise specified.

[0507] 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.

[0508] Respiratory Pressure Therapy (RPT): The application to the airway entrance of an air supply at therapeutic pressure, typically positive pressure relative to atmosphere.

[0509] Ventilator: A mechanical device that provides pressure support to a patient while they perform some or all of the work of breathing.

[0510] 5.5.1.1 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.

[0511] Polycarbonate: A thermoplastic polymer of bisphenol A carbonate.

[0512] 5.5.1.2 Mechanical properties Resilience: The ability of a material to absorb energy during elastic deformation and to release the energy upon unloading.

[0513] Resilient: Releases substantially all of its energy upon unloading. Examples include certain silicone and thermoplastic elastomers.

[0514] 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 are not easily deformed under finger pressure, for example.

[0515] 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.

[0516] 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.

[0517] 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.

[0518] 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.

[0519] 5.5.2 Respiratory 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.

[0520] Respiratory rate: The patient's spontaneous breathing rate, usually measured in breaths per minute.

[0521] Duty cycle: The ratio of inspiration time Ti to total breathing time Ttot.

[0522] Exercise (Respiration): Respiratory effort is said to refer to the movement made by the spontaneous breathing of a person trying to breathe.

[0523] Expiratory portion of the respiratory cycle: the period from the start of expiratory flow to the start of inspiratory flow.

[0524] 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.

[0525] Flow-limited inspiration waveform types: (ii) 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. (ii) Chair-like: A single local peak occurs at the rising edge, followed by a relatively flat region. (ii) Inverted chair: A relatively flat region is followed by a single local peak, which occurs at the trailing edge.

[0526] 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: (ii) 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.

[0527] Hyperventilation: An increase in flow to a level higher than normal.

[0528] 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.

[0529] 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).

[0530] Positive end-expiratory pressure (PEEP): The pressure above atmosphere in the lungs that exists at the end of expiration.

[0531] Peak flow (Qpeak): The maximum value of flow during the inspiratory portion of the respiratory flow waveform.

[0532] 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.

[0533] Tidal volume (Vt): The volume of air inhaled or exhaled during normal breathing without extra effort. In principle, the inhaled volume Vi (volume of air inhaled) is equal to the exhaled volume Ve (volume of air exhaled), so a single tidal volume Vt can be defined as equal to either volume. In practice, the tidal volume Vt is estimated as some combination (e.g., the average of the inhaled volume Vi and the exhaled volume Ve).

[0534] (Inspiration) Time (Ti): The duration of the inspiratory portion of the respiratory flow waveform.

[0535] (Expiratory) Time (Te): The duration of the expiratory portion of the respiratory flow waveform.

[0536] (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.

[0537] 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 centered).

[0538] 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).

[0539] 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 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.

[0540] 5.5.3 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).

[0541] Backup Rate: A ventilator parameter that establishes the minimum respiratory rate (typically in breaths per minute) that will be delivered to the patient by the ventilator (when not triggered by spontaneous breathing efforts).

[0542] 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.

[0543] Expiratory Positive Airway Pressure (EPAP): The base pressure to which varying pressures are added within a breath to produce the desired mask pressure that the ventilator attempts to achieve at a given moment.

[0544] 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.

[0545] Inspiratory Positive Airway Pressure (IPAP): The maximum desired mask pressure that the ventilator attempts to achieve during the inspiratory portion of the breath.

[0546] 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 c...

Claims

1. A patient interface for delivering a flow of air at a positive pressure relative to ambient air pressure in a continuously sealed manner to an entrance to a patient's airways, including at least the entrance to the patient's nostrils, said patient interface maintaining a therapeutic pressure in use in the range of about 4 cmH2O to about 30 cmH2O above ambient air pressure throughout the patient's breathing cycle while the patient is sleeping; The patient interface is configured to ameliorate sleep-disordered breathing, the patient interface comprising: a plenum chamber at least partially defining a cavity pressurizable to a therapeutic pressure of at least 6 cm H2O above ambient air pressure, the plenum chamber including a plenum chamber inlet port sized and configured to receive a flow of air at the therapeutic pressure for breathing by a patient; a seal-forming structure having a textile membrane constructed and arranged to form a pressure-assisted seal with an area of ​​the patient's face surrounding an entrance to the patient's airway, the textile membrane having at least one hole formed therein to allow a flow of air at the therapeutic pressure to be delivered to at least an entrance to the patient's nares, the seal-forming structure constructed and arranged to, in use, maintain the therapeutic pressure within the cavity throughout the patient's respiratory cycle; the textile membrane comprises a textile material to which a membrane layer is added to render the textile material air impermeable, the textile material being a weft knitted fabric; the seal-forming structure includes a flexible support structure for supporting the textile membrane, the support structure being connected to the plenum chamber, the support structure being more rigid than the textile membrane; the textile membrane is attached to the support structure along a periphery of the textile membrane such that it extends radially inward beyond the support structure; In use, the textile membrane is configured to be pressed against the patient's face such that the patient's nose is not received in the cavity; 1. A patient interface comprising: a woven fabric membrane having a dome shape at corner regions of the woven fabric membrane configured to seal against the patient's alar lowest regions; and a saddle shape at a lower central region of the woven fabric membrane configured to seal against the patient's under-nose.

2. A patient interface as described in claim 1, wherein, in use, the treatment pressure within the cavity directs the woven membrane toward the patient's face, assisting the woven membrane in forming a seal with the patient's face.

3. At least one hole portion of the woven membrane includes two hole portions, and a bridge portion is disposed between the two hole portions of the woven membrane; 3. A patient interface according to claim 1 or 2, wherein the bridge region buckles with excess material, allowing the textile membrane to expand to accommodate different sized noses.

4. A patient interface as described in any one of claims 1 to 3, wherein the support structure comprises silicone and the woven membrane is molded to the inner edge of the support structure.

5. A patient interface as described in any one of claims 1 to 4, wherein the plenum chamber comprises silicone and is formed in one piece with the support structure.

6. A patient interface as described in any one of claims 1 to 5, wherein the woven membrane is attached to the support structure in a manner such that the woven membrane is in a taut state prior to use.

7. A patient interface as described in any one of claims 1 to 6, wherein a first region of the woven membrane is in a taut state before use and a second region of the woven membrane is in an untensioned state before use.

8. A patient interface described in any one of claims 1 to 7, wherein the woven membrane has elasticity in four directions.

9. A patient interface described in any one of claims 1 to 7, wherein the woven membrane has a first elasticity in the left-right lateral direction and a second different elasticity in the up-down direction, the elasticity in the first direction being higher than the elasticity in the second direction.

10. A patient interface described in any one of claims 1 to 9, wherein the membrane layer comprises silicone.

11. A patient interface as described in any one of claims 1 to 10, wherein the woven material comprises nylon, spandex, or polyester.

12. A patient interface as described in any one of claims 1 to 11, wherein the plenum chamber and the seal-forming structure form an oral-nasal cushion assembly.

13. A patient interface as described in any one of claims 1 to 12, wherein the plenum chamber and the seal-forming structure form a nasal cushion.

14. A treatment system for use in treating sleep-disordered breathing, comprising: A patient interface according to any one of claims 1 to 10; A respiratory pressure therapy (RPT) device that delivers breathable gas at positive pressure; and A treatment system including an air delivery tube for passing breathable gas from the RPT device to the patient interface.

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