Woven Patient Interface Seal with Silicone Layer - Patent application

Abstract

To provide medical devices used in the diagnosis, amelioration, treatment or prevention of respiratory disorders, improved in one or more of comfort, cost, efficacy, ease of use, and manufacturability.SOLUTION: A patient interface includes a cushion assembly including a textile membrane. The textile membrane includes an air impermeable silicone layer applied to a textile material. The textile material comprises 1) nylon and / or polyester, and 2) elastane. A yarn count of the nylon and / or polyester is in a range of 20 to 80 denier, and the textile material has stretchability in both a direction of the wales and a direction of the course.SELECTED DRAWING: Figure 118

Description

[Technical field]

[0001] 1 CROSS-REFERENCE TO RELATED APPLICATIONS Not applicable. [Background technology]

[0002] 2. Technology 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 contain a series of branching tubes that become narrower, shorter and more numerous the deeper they go into the lungs. The primary function of the lungs is gas exchange, allowing oxygen to enter the venous blood from the air and carbon dioxide to leave. The trachea divides into right and left main bronchi, which further divide into terminal bronchioles. The bronchi constitute the conducting airways and do not participate in gas exchange. The airways further divide into respiratory bronchioles and finally into alveoli. Gas exchange occurs in the alveolar region of the lungs, which is called the respiratory region. See: "Respiratory Physiology", by John B. West, Lippincott Williams & Wilkins, 9th edition published 2012.

[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 closure or obstruction of the upper airway during sleep. It is the result of an abnormally small upper airway combined with the normal loss of muscle tone in the region of the tongue, soft palate and posterior oropharyngeal wall during sleep. The condition causes affected patients to pause in breathing, typically for 30-120 seconds, sometimes as many as 200-300 times per night. This results in excessive daytime sleepiness, which can lead to cardiovascular disease and brain damage. The condition is common, especially in middle-aged, overweight men, but patients are asymptomatic. See U.S. Pat. No. 4,944,310 (Sullivan).

[0008] Cheyne-Stokes respiration (CSR) is another form of sleep-disordered breathing. CSR is a disease of the patient's respiratory regulator, followed by alternating periods of waxing and waning of ventilation, known as the CSR cycle. CSR is characterized by repeated deoxygenation and reaeration of arterial blood. Because of the repeated hypoxia, CSR can be harmful. In some patients, CCR is accompanied by recurrent sleep arousals that cause severe insomnia, increased sympathetic activity, and increased afterload. See U.S. Patent No. 6,532,959 (Berthon-Jones).

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

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

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

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

[0013] Neuromuscular diseases (NMD) is a broad term that encompasses numerous diseases and illnesses that impair muscle function directly through intrinsic muscle pathology or indirectly through neuropathology. Some NMD patients are characterized by progressive muscle damage, resulting in inability to walk, wheelchair confinement, difficulty swallowing, respiratory muscle weakness, and ultimately death due to respiratory failure. Neuromuscular disorders can be classified as rapidly and slowly progressive: (i) rapidly progressive disorders, characterized by muscle damage that worsens over months and leads to death within a few years (e.g., amyotrophic lateral sclerosis (ALS) and Duchenne muscular dystrophy (DMD) in teenagers); (ii) variable or slowly progressive disorders, characterized by muscle damage that worsens over years and only slightly reduces life expectancy (e.g., limb-girdle, facioscapulohumeral, and myotonic muscular dystrophies). Symptoms of respiratory failure in NMD include: increasing generalized weakness, difficulty swallowing, dyspnea on exertion and at rest, fatigue, drowsiness, morning headache, and difficulty concentrating and mood changes.

[0014] Chest wall disorders are a group of thoracic deformities that result in ineffective connections between the respiratory muscles and the rib cage. These disorders are primarily characterized by restrictive defects and share the potential for long-term hypercapnic respiratory insufficiency. Scoliosis and / or kyphoscoliosis can lead to severe respiratory insufficiency. Symptoms of respiratory insufficiency include: dyspnea on exertion, peripheral edema, orthopnea, recurrent chest infections, morning headache, fatigue, poor quality of sleep, and loss of appetite.

[0015] A range of treatments are available to treat or ameliorate such conditions, and otherwise healthy individuals may also benefit from preventative treatments for respiratory disease, but these suffer from a number of deficiencies.

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

[0017] Continuous positive airway pressure (CPAP) therapy has been used in the treatment of obstructive sleep apnea (OSA). Its mechanism of action is that CPAP therapy acts as a pneumatic splint, for example by pushing the soft palate and tongue forward or backward against the posterior oropharyngeal wall, which may prevent the upper airway from closing. Because the treatment of OSA with CPAP therapy may be voluntary, patients may choose not to comply with the treatment if they perceive one or more of the following from the device used to deliver the treatment: uncomfortable, difficult to use, expensive, or aesthetically unappealing.

[0018] Non-invasive ventilation (NIV) provides ventilatory support to a patient through the upper airway to assist in breathing by performing some or all of the respiratory functions and / or to maintain adequate oxygen levels in the body. Ventilatory support is provided through a non-invasive patient interface. NIV is used to treat forms of CSR and respiratory failure such as OHS, COPD, NMD, and chest wall disorders. In some forms, it may improve the comfort and effectiveness of these treatments.

[0019] Invasive ventilation (IV) provides ventilatory support to patients who can no longer breathe effectively on their own and may be provided using a tracheotomy tube. In some forms, the comfort and effectiveness of these treatments may be improved.

[0020] 2.2.3 Treatment system These therapies may be provided by a therapeutic system or device. Such systems and devices may also be used to screen, diagnose, or monitor a disease without treating it.

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

[0024] Certain other mask systems may be functionally inadequate in the field, for example masks that are purely decorative may not be able to maintain adequate pressure, mask systems used for underwater swimming or diving may be configured to protect against water intrusion from higher external pressures and not maintain internal air at pressures higher than ambient.

[0025] Certain masks may be clinically unsuitable for use with this technology (eg, if the mask blocks airflow through the nose and only allows airflow through the mouth).

[0026] In certain masks, where the patient must insert part of the mask structure into their mouth and create and maintain a seal via the lips, this may be uncomfortable or impractical in the art.

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

[0028] There are several challenges in designing a patient interface: The face has a complex three-dimensional shape. The size and shape of the nose and head vary greatly between individuals. Because the head contains bone, cartilage and soft tissue, different regions of the face respond differently to mechanical forces; i.e., the chin or mandible may move relative to other bones of the skull. The entire head may move throughout the respiratory treatment period.

[0029] These challenges may result in one or more of the following: some masks may be intrusive, aesthetically undesirable, costly, poor fit, difficult to use, and uncomfortable, especially if the wear time is long or the patient is unfamiliar with the system. If the wrong size mask is used, this may lead to poor compliance, poor comfort, and poor patient outcomes. While masks designed specifically for aviators, as part of personal protective equipment (e.g., filter masks), SCUBA masks, or masks for anesthesia administration may be tolerable for their intended use, such masks may be undesirably uncomfortable to wear for extended periods of time (e.g., several hours). Such discomfort may result in poor patient compliance with the treatment. This is especially true if the mask must be worn while sleeping.

[0030] CPAP therapy is highly effective in treating certain respiratory diseases if the patient complies with the therapy. If the mask is uncomfortable or difficult to use, the patient may not comply with the therapy. Because patients are often encouraged to clean their masks regularly, if the mask is difficult to clean (e.g., difficult to assemble or disassemble), the patient may not be able to clean the mask, which may affect patient compliance.

[0031] Masks for other uses (e.g., for aviators) may be unsuitable for use in treating sleep-disordered breathing, and masks designed for use in treating sleep-disordered breathing may be suitable for other uses.

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

[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 will fit, be comfortable, and be 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-produced patient interface, one or both must be adapted to form a seal, which may 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. The seal-forming structure may include an air or fluid filled cushion, or may include a molded or formed surface of a resilient sealing element comprised of an elastomer such as rubber. With this type of seal-forming structure, if the fit is improper, a gap will form between the seal-forming structure and the face, and additional force will be required to press the patient interface against the face to achieve a seal.

[0039] Another type of seal-forming structure uses a thin flap seal located around the periphery of the mask to provide a self-sealing action against the patient's face when positive pressure is applied within the mask. As with the previous type of seal-forming portion, if the fit between the face and the mask is poor, additional force may be required to achieve a seal or the mask may leak. Additionally, if the shape of the seal-forming structure does not match the shape of the patient, the seal-forming portion may fold or buckle during use, causing leakage.

[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. Some patients find it inconvenient to constantly apply and remove adhesives from their face.

[0043] A range of patient interface seal forming structures are disclosed in the following patent applications (assigned to ResMed Limited: WO1998 / 004,310; WO2006 / 074,513; WO2010 / 135,785).

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

[0045] ResMed Limited manufactures the following products that use nasal pillows: SWIFT® Nasal Pillows Mask, SWIFT® II Nasal Pillows Mask, SWIFT® LT Nasal Pillows Mask, SWIFT® FX Nasal Pillows Mask and MIRAGELIBERTY® Full Face Mask. Embodiments of nasal pillows masks are described in the following patent applications assigned to ResMed Limited: International Patent Application WO 2004 / 073,778 (which describes, among other things, aspects of ResMed Limited's SWIFT® nasal pillows); U.S. Patent Application No. 2009 / 0044808 (which describes, among other things, aspects of ResMed Limited's SWIFT® LT nasal pillows); International Patent Applications WO 2005 / 063,328 and WO 2006 / 130,903 (which describe, among other things, aspects of ResMed Limited's MIRAGE LIBERTY® full face mask); and International Patent Application WO 2009 / 052,560 (which describes, among other things, aspects of ResMed Limited's SWIFT® FX nasal pillows).

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

[0047] In one technique, adhesives are used, see, for example, U.S. Patent Application Publication US2010 / 0000534, but adhesives can be uncomfortable.

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

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

[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., medical equipment reliability requirements, size requirements, and weight requirements). 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 of 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 breathing support for patients for a range of conditions (including, but not limited to, NMD, OHS, and COPD).

[0054] ResMed Elis Accessory Taiguée® 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 provide volumetric and pressure ventilation modes with single or dual limb circuits. RPT devices typically include a pressure generator (e.g., a motorized 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 to a patient interface as described above via an air circuit.

[0055] A device designer may be presented with a myriad of choices. Often, design criteria conflict, making certain design choices unconventional or unavoidable. Furthermore, the comfort and effectiveness of a particular embodiment 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 drying of the airway. When a humidifier is used with the RPT device and patient interface, humidified gas is produced, minimizing drying of the nasal mucosa and increasing comfort of the patient airway. Additionally, in cooler climates, the application of warm air to the facial area surrounding the patient interface generally provides more comfort than cool air.

[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 the air stream relative to the ambient air when necessary. Bedside medical humidifiers may be small. Medical humidifiers may be configured to only humidify and / or heat the air stream delivered to the patient, and not the patient's surroundings. For example, room-based systems (e.g., saunas, air conditioners, or evaporative coolers) may also humidify the air breathed into the patient's body, but 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 a number of medical humidifiers are known, such medical humidifiers may suffer from one or more deficiencies, i.e., some of such medical humidifiers provide inadequate humidification and others 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 treatment is "compliant" (e.g., whether the patient complies with one or more "compliance rules" with their RPT device). One example of a compliance rule for CPAP treatment may require a patient to use the RPT device for at least 4 hours per night for at least 21 days out of 30 consecutive days to be considered compliant. To determine patient compliance, a provider of the RPT device (e.g., a healthcare provider) may manually obtain data describing the patient's treatment with the RPT device, calculate a usage rate over a period of time, and compare this to the compliance rules. Once the healthcare provider determines that the patient has used their RPT device in accordance with the compliance rules, the healthcare provider may notify a third party that the patient is compliant.

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

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

[0063] 2.2.3.5 Ventilation technology Some forms of treatment systems may include a vent to push out exhaled carbon dioxide, which may allow gas flow from an interior space of the patient interface (e.g., a plenum chamber) to an exterior of the patient interface (e.g., the surroundings).

[0064] The vent may include an orifice through which gas may flow when the mask is in use. Many such vents are noisy. Others may become blocked when in use, resulting in insufficient pumping. Some vents may disrupt sleep for the patient 1000 and bed companion 1100, for example, due to noise or airflow concentration.

[0065] ResMed Limited has developed several improved mask ventilation technologies, see International Patent Application Publication No. WO1998 / 034,665; International Patent Application Publication No. WO2000 / 078,381; U.S. Patent No. 6,581,594; U.S. Patent Application Publication No. US2009 / 0050156; U.S. Patent Application Publication No. 2009 / 0044808.

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

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

[0068] The sound pressure values ​​of various objects are listed below. [Table 3]

[0069] 2.2.4 Screening, diagnostic and surveillance systems Polysomnography (PSG) is a conventional system for diagnosing and monitoring cardiopulmonary diseases, which typically requires expert clinical staff for system application. In PSG, typically 15-20 contact sensors are placed on the human body to record various body signals (e.g., electroencephalography (EEG), electrocardiography (ECG), electrooculography (EOG), electromyography (EMG)). For PSG of sleep-disordered breathing, patients need to be observed for two nights in a specialized hospital; the first night is purely for diagnosis, and the second night is required for titration of treatment parameters by the clinician. Therefore, PSG is expensive and inconvenient. Screening / diagnosis / monitoring of sleep-disordered breathing is particularly unsuitable at home.

[0070] 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. Different clinical experts may have different opinions about the patient's condition. Furthermore, a clinical expert may apply different criteria at different times. Summary of the Invention [Means for solving the problem]

[0071] 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.

[0072] A first aspect of the present technology relates to a device for use in the diagnosis, amelioration, treatment or prevention of respiratory disease.

[0073] Another aspect of the present technology relates to methods for use in the diagnosis, amelioration, treatment or prevention of respiratory disorders.

[0074] One aspect of certain forms of the present technology is to provide methods and / or devices that improve patient compliance with respiratory treatment.

[0075] Another aspect of the present technology relates to a seal-forming structure for a patient interface, the seal-forming structure including a woven membrane.

[0076] In one form, the woven membrane is air impermeable.

[0077] Another aspect of the present technology relates to a manufacturing process for a patient interface using a flat woven composite to produce a contoured woven membrane.

[0078] Another aspect of the present technology relates to a seal-forming structure of a patient interface, the seal-forming structure including a woven membrane, the seal-forming structure having no (or minimal) buckling or wrinkling.

[0079] Another aspect of the present technology relates to a patient interface that includes a textile membrane that includes a knitted textile material.

[0080] One form of knitted textile material is warp knit.

[0081] One form of knitted textile material is weft knitting.

[0082] In one form, the woven membrane is compliant (eg, equally compliant) in both the vertical and horizontal directions.

[0083] In one form, the woven membrane is more extensible in the horizontal direction than in the vertical direction.

[0084] Another aspect of the present technology relates to a wide range of patient interfaces.

[0085] 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, including a woven material) that is held taut prior to use.

[0086] Another aspect of the present technology relates to a seal-forming structure for a patient interface, the seal-forming structure including a non-tensioned woven membrane that has no wrinkles, creases, creases or buckles on an outer surface of the woven membrane.

[0087] 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.

[0088] Another aspect of the present technology relates to a cushion assembly that interfaces with a patient's airway, including at least the patient's nares. The cushion assembly is configured to maintain a therapeutic pressure higher than ambient air pressure in use throughout the patient's respiratory cycle while the patient is sleeping, such that sleep disordered breathing is improved. The cushion assembly may include: 1) a 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 therapeutic pressure for the patient's breathing; 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 airway below the nasal bridge area of ​​the patient's face, the textile membrane having holes formed therein whereby the airflow at 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 in the cavity throughout the patient's respiratory cycle in use.

[0089] In an example: (a) the woven membrane comprises a woven material adapted to contact the patient's face and an air impermeable silicone layer attached thereto, the woven material comprising 1) nylon and / or polyester and 2) elastane; (b) the nylon and / or polyester has a denier count in the range of 20-80; and (c) the woven membrane is extensible in both the weave direction and the track direction.

[0090] In further examples: (a) the nylon and / or polyester count is in the range of 20 to 50 denier; (b) the elastane count is in the range of 20 to 120D; (c) the coefficient of friction of the woven material is in the range of 0.7 to 5.0; (d) the average deviation of the surface roughness is in the range of 0.7 to 5.0; (e) the woven membrane has the same or similar elongation properties in both the weave direction and the process direction of the woven material; (f) the woven membrane has the same or similar tensile strength in both the weave direction and the process direction of the woven material; (g) the thickness of the woven membrane is in the range of 0.2 mm to 0.46 mm.

[0091] In further examples: (a) the textile material is an elastic weft knit; (b) the textile material comprises nylon, polyester, or a nylon / polyester composite; (c) the textile material comprises 1) 75% to 85% nylon, polyester, or a nylon / polyester composite, and 2) 15% to 25% elastane; (d) the thickness of the textile material is in the range of 0.18 mm to 0.32 mm; (e) the mechanical gauge of the textile material is in the range of 30GG to 6 (f) the weave weight of the woven material is in the range of 105 gsm to 160 gsm; (g) the woven membrane has the same or similar surface friction in both the weave direction and the process direction of the woven material; (h) the woven material has four-way elasticity; (i) the thickness of the air impermeable silicone layer is in the range of 0.04 mm to 0.125 mm; (j) the woven material has a mélange aesthetic; and (k) the woven material has a solid color aesthetic.

[0092] Another aspect of the present technology relates to a patient interface for delivering airflow 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 patient's nares. The patient interface may include: 1) a cushion assembly according to any of the above aspects; and 2) a positioning and stabilizing structure for providing a force to hold the seal-forming structure in a therapeutically effective position on the patient's head, the positioning and stabilizing structure including a tie, the tie constructed and arranged such that in use at least a portion of the tie rests on a region of the patient's head above the superior ear base point of the patient's head.

[0093] In examples: (a) the patient interface further includes a vent structure that allows 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; and (b) the plenum chamber and seal-forming structure form an oral-nasal cushion assembly or a nasal cushion.

[0094] Another aspect of the present technology relates to a method of forming a cushion assembly for a patient interface, the cushion assembly configured to interface with a patient's airway including at least the patient's nares. The cushion assembly is configured to maintain a therapeutic pressure in use above ambient air pressure throughout the patient's breathing cycle while the patient is sleeping to improve sleep disordered breathing. The method includes: 1) providing a woven material having a first side and a second side, the first side of the woven material configured to contact the patient's face in use to facilitate delivery of airflow at therapeutic pressure to the patient's airway; and 2) applying an air impermeable silicone layer to the woven material to form a woven membrane configured to form a pressure assisted seal with an area of ​​the patient's face surrounding an entrance to the patient's airway below a nasal bridge area of ​​the patient's face, the woven membrane having holes formed therein such that airflow at therapeutic pressure is delivered to at least the entrance to the patient's nares.

[0095] In an example: (a) the woven material comprises 1) nylon and / or polyester and 2) elastane; (b) the nylon and / or polyester has a denier count in the range of 20 to 80; and (c) the woven membrane has extensibility in both the weave direction and the machine direction.

[0096] In further examples: (a) the nylon and / or polyester count is in the range of 20-50 denier; (b) the elastane count is in the range of 20-120D; (c) the coefficient of friction of the woven material is in the range of 0.7-5.0; (d) the woven material comprises 1) 75%-85% nylon, polyester or a nylon / polyester composite and 2) 15%-25% elastane; (d) the woven material is an elastic weft knit.

[0097] Another aspect of the present technology relates to a patient interface for delivering airflow 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 nares. 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 of 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 holes formed therein such that an airflow 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.

[0098] 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; (b) the woven membrane is attached to the support structure along a periphery of the woven membrane in a manner such that the woven membrane is in a taut state prior to use.

[0099] Another aspect of the present technology relates to a patient interface for delivering airflow 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 nares. The patient interface is configured to maintain a therapeutic 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 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; 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 holes formed therein such that an airflow at the therapeutic pressure is delivered to at least an entrance to the patient's nares, the seal-forming structure constructed and arranged to maintain the therapeutic 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 stiffer than the textile membrane. In use, the textile membrane may be configured to be pressed against the patient's face such that the patient's nose is not received in the cavity. The textile membrane may extend radially inward beyond the support structure by being attached to the support structure along a periphery of the textile membrane.

[0100] In an embodiment, (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 textile membrane engages the patient's face such that the right and left lateral sides of the support structure deform inwardly 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 textile membrane is molded to an inner edge of the support structure; (e) the textile membrane has a dome shape at corner regions of the textile membrane; and (f) the textile membrane has a saddle shape at a lower central region of the textile membrane configured to seal under the patient's nose in use.

[0101] 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 thickness of the membrane layer is in 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 in the range of 105 gsm to 120 gsm; (f) the machine gauge of the woven material is in the range of 44GG to 60GG; (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; (l) the plenum chamber comprises silicone and is formed in one piece with the support structure.

[0102] In further embodiments, (a) the patient interface further comprises a positioning and stabilizing structure that provides a force to hold the seal-forming structure in a therapeutically effective position on the patient's head, the positioning and stabilizing structure including a tie, the tie constructed and arranged such that in use at least a portion of the positioning and stabilizing structure rests on a region of the patient's head above the superior ear-base point of the patient's head; (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 sized and shaped to maintain a therapeutic pressure within the cavity in use; (c) the plenum chamber and the seal-forming structure form an oral-nasal cushion assembly; and (d) the plenum chamber and the seal-forming structure form a nasal cushion.

[0103] Another aspect of the present technology relates to a patient interface for delivering airflow 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 nares. The patient interface is configured to maintain a therapeutic 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 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; 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 an airflow at the therapeutic pressure is delivered to at least an entrance to the patient's nares, the seal-forming structure constructed and arranged to maintain the therapeutic 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, the support structure being connected to the plenum chamber. At the transition region, the woven membrane may extend radially inwardly 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 a front side of the seal-forming structure to a front patient-facing side of the seal-forming structure.

[0104] 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 an inner edge of the woven membrane; (c) in use, the woven membrane is configured to be pressed against the patient's face such 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.

[0105] 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 knit; (d) the membrane layer comprises silicone; (e) the woven material comprises polyamide (e.g., 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.

[0106] Another aspect of the present technology relates to a patient interface for delivering airflow 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 nares. The patient interface is configured to maintain a therapeutic 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 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; 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 an airflow at the therapeutic pressure is delivered to at least an entrance to the patient's nares, the seal-forming structure constructed and arranged to maintain the therapeutic 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 stiffer than the textile membrane. The textile membrane may extend radially inward beyond the support structure by being attached to the support structure along the periphery of the textile membrane. In use, the textile membrane may be configured to be pressed against the patient's face such that the patient's nose is not received in the cavity. The textile membrane may have a dome shape at corner regions of the textile membrane configured to seal against the patient's alar nasal regions, and a saddle shape at a lower central region of the textile membrane configured to seal against the patient's undernose.

[0107] In embodiments, (a) during use, treatment pressure within the cavity directs the textile membrane toward the patient's face, assisting the textile membrane in forming a seal with the patient's face; (b) 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, and when the bridge portion buckles with excess material, the textile membrane can expand to accommodate different sized noses; (c) the support structure includes silicone, and the textile membrane is molded to an inner edge of the support structure; (d) the plenum chamber includes silicone and is formed in one piece with the support structure; (e) 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; (f) a first region of the textile membrane is in a taut state prior to use and a second region of the textile membrane is in an untensioned state prior to use.

[0108] In further embodiments, (a) the woven membrane has elasticity in four directions; (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-nose cushion assembly; and (f) the plenum chamber and seal-forming structure form a nasal cushion.

[0109] Another aspect of the present technology relates to a method of forming a cushion assembly for a patient interface configured to deliver airflow 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 nares, the cushion assembly configured to maintain 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 to improve sleep disordered breathing, the method comprising: 1) forming an airtight woven composite having a flat shape by adding an air impermeable material to a woven material, 2) cutting the woven composite to desired dimensions depending on the particular cushion assembly typology to be 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, imparting a curved, non-flat shape to the woven membrane, which does not form wrinkles, wrinkles, folds and / or buckles.

[0110] In an embodiment, (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 extends 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, 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 front 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.

[0111] 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 extending radially inwardly beyond the support structure by being attached to the support structure along an outer periphery of the sealing portion, and in use the sealing portion is configured to be pressed against the patient's face such that the patient's nose is not received in the cavity, and due to the reactive stress of the support structure and / or the elastic elongation properties of the fabric the sealing portion is brought into tension, thereby causing the sealing portion to apply a force against the patient's face.

[0112] According to a further aspect of the present technology, the sealing portion comprises a fabric. In a further embodiment, the patient interface comprises a plenum chamber, 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, 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 against an area of ​​the patient's face surrounding an entrance to the patient's airway, the sealing portion having a hole formed therein whereby an airflow at the therapeutic pressure is delivered to at least an entrance to the patient's nares, and the seal-forming structure is constructed and arranged to maintain the therapeutic pressure in the cavity during use throughout the patient's respiratory cycle. In a further embodiment, the support structure comprises silicone and / or a thermoplastic elastomer.

[0113] According to a further aspect of the present technology, a wall structure of the support structure between the sealing portion and the plenum chamber has a first member having a first thickness and a second member having a second thickness different from the first thickness.

[0114] 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.

[0115] According to a further aspect of the present technology, the sealing portion comprises a woven material. In a further embodiment, the patient interface comprises a plenum chamber, 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, 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 against an area of ​​the patient's face surrounding an entrance to the patient's airway, the sealing portion having a hole formed therein whereby an airflow at the therapeutic pressure is delivered to at least an entrance to the patient's nares, and the seal-forming structure is constructed and arranged to maintain the therapeutic pressure in the cavity during use throughout the patient's respiratory cycle. In a further embodiment, the support structure comprises silicone and / or a thermoplastic elastomer.

[0116] 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 woven material and attached to the support structure along a 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.

[0117] According to further aspects of the present technology, the support structure comprises silicone and / or thermoplastic elastomer, the patient interface comprises 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 further embodiments, the sealing portion is constructed and arranged to form a seal against an area of ​​the patient's face surrounding an entrance to the patient's airways, said sealing portion having holes formed therein whereby the airflow at the therapeutic pressure is delivered to at least an 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.

[0118] 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.

[0119] One aspect of the present disclosure is a method for manufacturing a device.

[0120] One aspect of certain forms of the present technology is a medical device that is easy to use, for example, by individuals without medical training, individuals with limited dexterity or insight, or individuals with limited experience in using medical devices of this type.

[0121] One aspect of one form of the present technology is a patient interface that is washable in the patient's home, for example with soapy water, without the need for special cleaning equipment.

[0122] Another aspect of the present technology relates to a treatment system for use in treating sleep disorder 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.

[0123] The described methods, systems, devices and apparatus may be implemented to enable improved functionality in a processor (e.g., a processor of a special purpose computer, a respiratory monitor and / or a respiratory treatment device). Additionally, the described methods, systems, devices and apparatus enable advances in the art of automated management, monitoring and / or treatment of respiratory conditions (e.g., sleep disordered breathing).

[0124] Of course, some of the above aspects may form sub-aspects of the present technology, and various one of the sub-aspects and / or aspects may be combined in various ways to form further aspects or sub-aspects of the present technology.

[0125] Other features of the present technology will become apparent in light of the information contained in the following detailed description, abstract, drawings, and claims. [Brief description of the drawings]

[0126] 4. Brief Description of the Drawings The present technology is illustrated by way of one non-limiting example in the accompanying drawings, in which like reference symbols include like elements: 4.1 Treatment system

[0127] [Figure 1A]The system is shown to include a patient 1000 wearing a patient interface 3000. The system takes the form of nasal pillows and receives air at positive pressure supplied by an RPT device 4000. The air from the RPT device 4000 is humidified by a humidifier 5000 and travels along an air circuit 4170 to the patient 1000. A bed companion 1100 is also shown. The patient is sleeping in a supine sleep position. [Figure 1B] A system is shown including a patient 1000 wearing a patient interface 3000. The system takes the form of a nasal mask and receives air at positive pressure supplied by an RPT device 4000. Air from the RPT device is humidified by a humidifier 5000 and travels along an air circuit 4170 to the patient 1000. [Figure 1C] The system includes a patient 1000 wearing a patient interface 3000. The patient interface 3000 takes the form of a full face mask and receives a positive pressure air supply from an RPT device 4000. Air from the RPT device is humidified by a humidifier 5000 and travels along an air circuit 4170 to the patient 1000. The patient is sleeping in a lateral sleep position. 4.2 Respiratory System and Facial Anatomy [Figure 2A] An outline of the human respiratory system is shown, including the nasal and oral cavities, larynx, vocal folds, esophagus, trachea, bronchi, lungs, alveolar sacs, heart and diaphragm. [Figure 2B] FIG. 1 is a diagram of the human upper respiratory tract including the nasal cavity, nasal bones, lateral nasal cartilages, greater alar cartilage, nostrils, upper lip, lower lip, larynx, hard palate, soft palate, oropharynx, tongue, epiglottis, vocal cords, esophagus, and trachea. [Figure 2C] FIG. 1 is a front view of a face including several features of the surface anatomy including upper lip, upper lip vermilion, lower lip vermilion, lower lip, mouth width, medial canthus, alae of the nose, nasolabial folds, and corners of the mouth. The directions of superior, inferior, radially inward, and radially outward are also given. [Figure 2D]FIG. 1 is a lateral view of the head including several features of the surface anatomy including the glabella, serion, nasal tip, subnasal point, upper lip, lower lip, supramenton, nasal ridge, alar crest, superior and inferior temporal points. The directions of superior and inferior, and anterior and posterior are also given. [Figure 2E] FIG. 1 is a further lateral view of the head, with the approximate locations of the Frankfort horizontal and nasolabial angle noted. The coronal plane is also noted. [Figure 2F] A bottom view of the nose including several features including nasolabial fold, lower lip, upper lip vermilion, nostrils, subnasal point, columella, nasal tip, nostril axis and midsagittal plane. [Figure 2G] FIG. 2 is a side view of the superficial features of the nose. [Figure 2H] Shown are the subcutaneous structures of the nose including the lateral nasal cartilages, nasal septum cartilage, greater alar cartilage, lesser alar cartilage, nasal sesamoid cartilage, nasal bones, epidermis, adipose tissue, frontal process of the maxilla and fibro-adipose tissue. [Figure 2I] The mid-nasal incision is shown approximately a few millimeters from the midsagittal plane, with particular attention to the nasal septum cartilage and the medial crus of the greater alar cartilage. [Figure 2J] FIG. 1 is a frontal bony view of the skull including the frontal, nasal and cheekbones, with the nasal turbinates shown along with the maxilla and mandible. [Figure 2K] Side view of the skull with the outline of the head surface and some muscles. The following bones are shown: frontal, sphenoid, nasal, zygomatic, maxilla, mandible, parietal, temporal and occipital. The mental protuberance is shown. The following muscles are shown: digastric, masseter, sternocleidomastoid and trapezius. [Figure 2L] 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 having a positive sign and a relatively large magnitude compared to the magnitude of curvature shown in 3C. [Figure 3C]3B is a schematic cross-sectional view of the structure cut at a point, with the outward normal at this point shown, and the curvature at this point having a positive sign and a relatively small magnitude compared to the magnitude of the curvature shown in FIG. [Figure 3D] 1 is a schematic cross-sectional view of a structure cut at a point, where the outward normal is shown and the curvature value at this point is zero. [Figure 3E] 3C is a schematic cross-sectional view of the structure cut at a point, where the outward normal is shown, and the curvature at this point has a negative sign and a relatively small magnitude compared to the magnitude of curvature shown in FIG. [Figure 3F] 3C is a schematic cross-sectional view of the structure cut at a point, where the outward normal is shown, and the curvature at this point has a negative sign and a relatively large magnitude compared to the magnitude of curvature shown in FIG. [Figure 3G] 1 shows a mask cushion including two pillows, the outer surface of the cushion is shown, the edge of the surface is shown, and the dome region and saddle region are shown. [Figure 3H] 1 shows a cushion for a mask. The outer surface of the cushion is illustrated. The edge of the surface is illustrated. The path on the surface between points A and B is illustrated. The straight line distance between A and B is illustrated. Two saddle regions and a dome region are illustrated. [Figure 3I] The surface of a structure is shown, with a one-dimensional hole drilled into it. The planar curves shown form the boundary of the one-dimensional hole. [Figure 3J] FIGURE 3D is a cross-sectional view through the structure of Figure 3I.The surfaces shown bound a two-dimensional hole in the structure of Figure 3I. [Figure 3K] 3I includes a two-dimensional hole and a one-dimensional hole, and the surfaces bounding the two-dimensional hole in the structure of FIG. [Figure 3L] 1 shows a mask with an inflatable bladder as a cushion. [Figure 3M] 3D is a cross-sectional view of the mask of FIG. 3L showing the inner surface of the bladder, which bounds the two-dimensional hole in the mask. [Figure 3N] 3D shows a further cross section through the mask of FIG. 3L, with the interior surface also shown. [Figure 3O] Demonstrates the left hand rule. [Figure 3P] Demonstrates the right-hand rule. [Figure 3Q] 1 shows the left ear including the left ear helix. [Figure 3R] 1 shows the right ear including the right ear helix. [Figure 3S] Shown is a right-handed spiral. [Figure 3T] FIG. 13 is a diagram of a mask including the signature of the twist of the space curve defined by the edges of the sealing membrane in different regions of the mask. [Figure 3U] A diagram of the plenum chamber 3200 showing the midsagittal plane and the central contact plane. [Figure 3V] A posterior view of the plenum chamber of Figure 3U. Directions in the figure are perpendicular to the central contact plane. In Figure 3V, the midsagittal plane bisects the plenum chamber into a left hand side and a right hand side. [Figure 3W] FIG. 3V is a cross-sectional view through the plenum chamber of FIG. 3V, where the cross-section is taken in the midsagittal plane shown in FIG. The "mid-contact" plane is illustrated. The mid-sagittal plane is perpendicular to the mid-sagittal plane. The orientation of the mid-sagittal plane corresponds to the orientation of the tendon 3210. The tendon 3210 rests on the mid-sagittal plane and only contacts the cushion of the plenum chamber at two points on the mid-sagittal plane (i.e., superior point 3220 and inferior point 3230). Depending on the geometry of the cushion in this region, the mid-contact plane may contact both the superior and inferior points. [Figure 3X] The plenum chamber 3200 of FIG. 3U is shown in a use position on the face. The mid-sagittal plane of the plenum chamber 3200 generally coincides with the mid-sagittal plane of the face when the plenum chamber is in the use position. The central contact plane generally corresponds to the "face of the face" when the plenum chamber is in the use position. In FIG. 3X, the plenum chamber 3200 is of a nasal mask, with the upper point 3220 resting approximately on the cerion and the lower point 3230 resting on the upper lip. 4.4 RPT Device [Figure 4A]4.5 Patient Interfaces According to the Present Technology [Diagram 5] FIG. 13 is a perspective view of a patient interface according to an embodiment of the present technology as worn by a patient. [Figure 6] FIG. 13 is a perspective view of a patient interface according to another embodiment of the present technology as 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. [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. [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. 13 is a front view of a cushion assembly positioned on a patient's face according to another embodiment of the present technology. [Figure 19] FIG. 19 is a top view of the cushion assembly of FIG. [Figure 20] FIG. 19 is a front view of the cushion assembly of FIG. [Figure 21] FIG. 19 is a bottom view of the cushion assembly of FIG. [Figure 22] FIG. 19 is a side perspective view of the cushion assembly of FIG. [Diagram 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. [Diagram 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. 13 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. [Diagram 30] FIG. 29 is a side perspective view of the cushion assembly of FIG. 28. [Diagram 31] FIG. 29 is a rear perspective view of the cushion assembly of FIG. 28. [Diagram 32] FIG. 29 is a bottom view of the cushion assembly of FIG. 28. [Diagram 33] FIG. 13 is a front perspective view of a cushion assembly according to another embodiment of the present technology. [Figure 33-1] FIG. 13 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] A cross-sectional view taken along line 33-3-33-3 in Figure 33-1. [Figure 33-4] This is an enlarged detail taken from Figure 33-2. [Diagram 34] FIG. 34 is a cross-sectional view of the cushion assembly of FIG. 33. [Diagram 35] FIG. 13 is a front perspective view of a cushion assembly with a grip pad disposed on a textile membrane in accordance with an example of the present technology. [Diagram 36] FIG. 13 is a front perspective view of a cushion assembly with a grip pad disposed on a textile membrane in accordance with an example of the present technology. [Figure 37]FIG. 13 is a front perspective view of a cushion assembly with a grip pad disposed on a textile membrane in accordance with an example of the present technology. [Figure 38] FIG. 13 is a perspective view of a patient interface according to another embodiment of the present technology as worn by a patient. [Figure 39] 1 is a perspective view of a patient interface according to another embodiment of the present technology. [Diagram 40] FIG. 40 is a perspective view of the patient interface of FIG. 39 as worn by a patient. [Diagram 41] FIG. 41 is a side view of the patient interface of FIG. [Diagram 42] FIG. 41 is a front perspective view of the patient interface of FIG. [Diagram 43] FIG. 40 is a front view of the cushion assembly of the patient interface of FIG. 39. [Diagram 44] FIG. 40 is a top view of the cushion assembly of FIG. 39. [Diagram 45] FIG. 40 is a bottom view of the cushion assembly of FIG. 39. [Diagram 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. 13 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. 13 is a front perspective view of a cushion assembly with a grip pad disposed on a textile membrane in accordance with an example of the present technology. [Figure 55] FIG. 13 is a front perspective view of a cushion assembly with a grip pad disposed on a textile membrane in accordance with an example of the present technology. [Figure 56] FIG. 13 is a front perspective view of a cushion assembly with a grip pad disposed on a textile membrane in accordance with an example of the present technology. [Figure 57] FIG. 30 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. [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. [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. [Figure 64] FIG. 58 is a rear view of the frame 30350 of FIG. [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 a strap of the positioning and stabilizing structure 30300 of the patient interface 30000 of FIG. 57. [Figure 67] FIG. 13 is a perspective view of a patient interface according to another embodiment of the present technology as worn by a patient. [Figure 68] FIG. 68 is a side view of the patient interface of FIG. [Figure 69] FIG. 68 is an exploded view of the patient interface shown in FIG. 67, illustrating 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. [Figure 72] FIG. 68 is a front view of the cushion assembly of the patient interface of FIG. [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. 2 is a schematic diagram of a patient's face being placed against a woven membrane having low tension prior to 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] 13 is a schematic diagram of tension applied to a sealing portion of a cushion assembly according to an embodiment of the present technology. [Figure 82] FIG. 13 is a schematic diagram illustrating the force exerted by the textile membrane on the patient's face due to air pressure within the cavity formed by the cushion assembly. [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] 13 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. [Figure 89] 1 is a partial cross-sectional view of a cushion assembly according to an embodiment of the present technology. [Figure 90A] 1 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] 1 is a partial cross-sectional view of a cushion assembly according to an embodiment of the present technology. [Figure 91] 1 is a partial cross-sectional view of a cushion assembly according to an embodiment of the present technology. [Figure 92] 1 is a partial cross-sectional view of a cushion assembly according to an embodiment of the present technology. [Figure 93] 1 is a partial cross-sectional view of a cushion assembly according to an embodiment of the present technology. [Figure 94] 1 is a partial cross-sectional view of a cushion assembly according to an embodiment of the present technology. [Figure 95] 1 is a partial cross-sectional view of a cushion assembly according to an embodiment of the present technology. [Figure 96] 1 is a partial cross-sectional view of a cushion assembly according to an embodiment of the present technology. [Figure 97] 1 is a partial cross-sectional view of a cushion assembly according to an embodiment of the present technology. [Figure 98] 1 is a partial cross-sectional view of a cushion assembly according to an embodiment of the present technology. [Figure 99] 1 is a partial cross-sectional view of a cushion assembly according to an embodiment of the present technology. [Figure 100] 1 is a partial cross-sectional view of a cushion assembly according to an embodiment of the present technology. [Figure 101]13 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] FIG. 1 is a perspective view of a modular support structure according to an embodiment of the present technology; [Figure 104] 14 illustrates a process for molding a sealing portion to a support structure according to an embodiment of the present technology. [Figure 105] 14 illustrates a process for molding a sealing portion to a support structure according to an embodiment of the present technology. [Fig. 106] FIG. 106 is a side view of a sealing portion modular assembly formed by the process shown in FIGS. 104 and 105. [Figure 107] 1 illustrates a "one size fits all" cushion assembly in accordance with an example of the present technology. [Figure 108] 1 illustrates a "one size fits all" cushion assembly in accordance with an example of the present technology. [Fig. 109] 13 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] 13 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. 13 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. [Figure 113] 1 shows the knitting process. [Fig. 114] 1 shows the knitting process. [Fig. 115] 1 shows a warp knitted fabric according to one embodiment of the present technology. [Fig. 116] 1 shows a weft knit fabric according to one embodiment of the present technology. [Fig. 117]FIG. 13 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. [Fig. 118] FIG. 13 is a schematic diagram of a sealing portion according to another example of the present technology. [Figure 119] FIG. 13 is a cross-sectional perspective view of a sealing portion according to an example of the present technology. [Figure 120] FIG. 120 is an enlarged cross-sectional view of the sealing portion of FIG. 119. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0128] 5 Detailed Description of the Embodiments of the Present Technology Before describing the present technology in further detail, it should be understood that the present technology is not limited to the specific embodiments described herein, which may vary. It should also be understood that the terminology used in the present disclosure is for the purpose of describing the specific embodiments described herein, and is not intended to be limiting.

[0129] The following description is provided in conjunction with various embodiments that may share one or more common characteristics and / or features. It should be understood that one or more features of any one embodiment may be combined with one or more features of another embodiment or other embodiments. In addition, any single feature or combination of features in any of these embodiments may constitute an additional embodiment.

[0130] 5.1 Treatment In one form, the present technology includes a method of treating a respiratory disorder, the method including the step of applying positive pressure to an entrance to the airways of a patient 1000.

[0131] 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.

[0132] In certain embodiments of the present technology, mouth breathing is restricted, limited or prevented.

[0133] 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).

[0134] 5.3 Patient Interface A non-invasive patient interface 3000 according to one aspect of the present technology includes the following functionalities: a seal-forming structure 3100, a plenum chamber 3200, a positioning and stabilizing structure 3300, a vent 3400, a form of connection port 3600 for connection to an air circuit 4170, and a forehead support 3700. In some forms, the functionalities may be provided by one or more physical components. In some forms, one physical component may provide one or more functionalities. In use, the seal-forming structure 3100 is positioned to surround an entrance to the patient's airway to facilitate the supply of air at positive pressure to the airway.

[0135] 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.

[0136] 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.

[0137] 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.

[0138] 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.

[0139] 5.3.1 Plenum chamber The plenum chamber has edges shaped to be complementary to the surface contours of an average human face in the area where a seal is formed in use. In use, the peripheral edges of the plenum chamber are positioned in close proximity to the adjacent surfaces of the face. Actual contact with the face is provided by the seal-forming structure. The seal-forming structure may extend around the entire perimeter 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. In examples, the plenum chamber may be constructed from a flexible material (e.g., silicone) and formed as a one-piece structure with the support structure (e.g., with any of the materials described herein as suitable for the support structure and / or plenum chamber). In examples, 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 examples, the support structure and the woven membrane may be considered as part of the plenum chamber.

[0140] 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 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).

[0141] In one form, the target seal-forming area is located on an exterior surface of the seal-forming structure 3100 .

[0142] In certain forms of the present technology, the seal-forming structure 3100 is constructed from a biocompatible material, such as liquid silicone rubber (LSR) (or "silicone").

[0143] A seal-forming structure 3100 in accordance with the present technology may be constructed from a material that is soft, flexible and resilient (eg, silicone).

[0144] In some configurations, such as those shown in Figures 5-77, the seal-forming structure has a sealing portion that includes a woven material. The woven material may cover all or a portion of the seal-forming structure. In some configurations, the woven material may include a material formed by a fiber network and adapted to be impermeable to air. For example, the woven material may have an air impermeable film on at least one surface thereof to form a woven membrane or woven sealing portion.

[0145] 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 mesh, the woven membrane can be stretchable in the longitudinal warp direction and / or the transverse weft direction across the woven membrane.In some embodiments, the woven membrane is constructed to be elastically stretchable to a range that exceeds the range that can be achieved by conventional silicone seal-forming structures.

[0146] In some configurations, 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 and transverse weft directions across the woven membrane.

[0147] 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.

[0148] In some forms, 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 forms, the woven membrane may include an air impermeable material 10131 formed on an inner surface of a woven material 10133. The air impermeable material may be laminated onto the woven material in some forms. In some forms, the air impermeable material and the woven material may be selected such that the resulting woven membrane may exhibit a predetermined overall elasticity or elastic resistance as desired. For example, the addition of an air impermeable material (or membrane layer) may provide elasticity (or extensibility) in the woven material, thereby increasing the extensibility of the resulting woven membrane.

[0149] In some configurations, the membrane may exhibit a low spring constant (i.e., high compliance) in both warp and weft directions. In such configurations, in contrast to conventional designs that may cause 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 with the woven membrane. This may advantageously improve mask comfort and reduce the formation of localized pressure "hot spots."

[0150] In some forms, the surface of the woven material that contacts the patient's face 1300 may have low friction characteristics. This may 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) may have a first coefficient of friction in a first direction. The first coefficient of friction is different (e.g., higher or lower) than the coefficient of friction in a second direction. In contrast, a higher friction woven material may cause the woven membrane to snag or rub in the contact area with the patient's face during use. Such friction or snagging may cause the woven membrane to warp or deform, which may lead to reduced sealing effectiveness and potential undesirable air leakage from the device.

[0151] In some embodiments, the overall thickness of the woven material of the woven membrane is 0.275 mm or less.

[0152] In certain forms of the present technology, a system is provided that includes more than one seal-forming structure 3100. Each seal-forming structure 3100 is configured to accommodate a different size and / or shape range. For example, the system may include one form of seal-forming structure 3100 suitable for large head sizes but not small head sizes, and another suitable for small head sizes but not large head sizes.

[0153] It should be noted that although reference may be made herein (e.g., using reference numbers) 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).

[0154] 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 to act on its underside to form a tight sealing engagement with a surface. The pressure-assisted mechanism can work in conjunction with elastic tension in the positioning and stabilizing structure.

[0155] In one form, the seal-forming structure 3100 includes a sealing flange and a support flange. The sealing flange includes a relatively thin member having a thickness of less than about 1 mm (e.g., about 0.25 mm to about 0.45 mm) that extends around the edge length of the plenum chamber 3200. The support flange may be relatively thicker than the sealing flange. The support flange is disposed between the sealing flange and the periphery of the plenum chamber 3200 and extends around at least a portion of the edge length. The support flange is or includes a spring-like element and functions to support the sealing flange against buckling in use.

[0156] In one form, a woven membrane (e.g., including nylon, polyester, a blend of nylon and polyester, microfiber, or polyurethane) is used as the face-contacting portion of a 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 a support structure prior to and / or during use. Prior to 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).

[0157] Alternatively, the woven fabric may be formed as a complex three-dimensional predetermined shape such that it is not under tension (e.g., loose, relaxed and / or wrinkle-free) prior to and / or during use, but is substantially free of leakage that would cause wrinkles. Due to manufacturing, the woven polymer may shrink, thus losing the inherent pre-tension in the woven membrane, but the woven membrane may remain substantially wrinkle-free.

[0158] FIG. 79 shows an example where 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, creases, or fine lines) in the woven material prior to contact between the patient's face 1300 and the seal-forming structure 3100. In some forms, this can be achieved by applying a light pre-tension or by shaping the woven membrane such that there are substantially no leaks that cause wrinkles in the woven membrane. This can be advantageous as it ensures that the woven membrane forms a smooth and continuous seal on and around the patient's face 1300. As a result, improved respiratory pressure therapy can be achieved by reducing the occurrence of creases or fine lines in the members of the seal-forming structure 3100 that can be sources of therapeutic air leakage. This may also be advantageous in ensuring that the fabric membrane is under a minimum threshold tension as it is forced against the patient's face 1300 (FIG. 80).

[0159] In some configurations, areas of the woven membrane can be pre-tensioned and stretched slightly while other areas of the woven membrane can remain relaxed. For example, in some configurations, the under-nose area can be pre-tensioned while the outside of the nose and / or the area cupping the patient's mouth can be held in untensioned (e.g., by excess material) to form a saddle 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 elements protrude longer distances into or into the cavity. In another example, the sides of the nose area and / or nose bridge area can remain untensioned and / or relaxed prior to use while providing additional material to accommodate the facial contours of these sensitive facial areas. In another example, a bridge region (e.g., bridge region 3104) that extends between the 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 woven membrane to expand (e.g., in the superior / inferior (height) direction to accommodate different sized noses.

[0160] In some configurations, instead of providing pre-tensioned regions, the woven membrane may be formed to be substantially free of leakage that can cause wrinkles. This may be advantageous because it may be difficult to form complex three-dimensional shapes that are substantially free of leakage from a relaxed woven membrane or from a woven membrane that includes material that is not overly tensioned. The use of a woven membrane that is not tensioned may also reduce pressure on the patient's face, which may increase comfort in some configurations.

[0161] In some forms, the woven membrane may be substantially tension-free and may be formed onto a support structure or directly onto the plenum chamber (so that it remains untensioned and / or relaxed). In examples, such woven membranes may still remain wrinkle-free to avoid leakage in the seal with the patient's face. In some forms, a untensioned and / or wrinkle-free woven membrane may utilize cushion support (e.g., an underlying cushion, a seal support area (e.g., a support structure) and / or air pressure within the cavity) to form an effective seal against the patient's face.

[0162] In some forms, the tensioned and / or wrinkle-free state of the textile membrane (see FIG. 80 and FIG. 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 disturbances in the woven membrane (e.g., wrinkles, folds, buckles, or wrinkles); 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 textile membrane); and d) Additional air pressure from within the cavity applied to the inner surface of the woven membrane: The internal air pressure can 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 can be stressed against the patient's face 1300 (e.g., creating a pressure assisted seal).

[0163] By continually maintaining the woven membrane under tensile stress and / or wrinkle-free state before and during use, the woven membrane can conform to the profile of the patient's face while minimizing wrinkling and / or rupture of the seal-forming structures. 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) in some forms.

[0164] In some forms, application of air pressure from within the plenum chamber may help maintain 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 may be sufficient to cause the woven membrane to elastically stretch in at least one dimension to form 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.

[0165] In some configurations, the woven membrane may be held under tension by a relatively stiff support structure. In various configurations, the support structure may be formed from, for example, any of silicone, PU foam, PU solid material, or another suitable material. In some configurations, the support structure may be relatively less stiff than the shell or frame of the plenum chamber.

[0166] In some configurations, the magnitude of the tensile stress may be varied across the seal-forming structural woven membrane as desired, for example, areas of stress concentration may exist adjacent one or more holes in the woven membrane as a passageway through which therapeutic application occurs in the more stretched material.

[0167] In some configurations, the seal-forming structure may use a number of 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.

[0168] 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.

[0169] In some configurations, the woven membrane can be configured to generate an effective seal over the patient's nasal tip, as shown, for example, in Fig. 58. In some configurations, the woven membrane can be configured to generate an effective seal against a subnasal area of ​​the patient's nose, such that the woven membrane does not engage the nasal tip, as shown, for example, in Fig. 40.

[0170] In some forms, stretching and / or maintaining the wrinkle-free state of the woven membrane (to conform to the patient's face 1300) during use may apply stress to the walls of the support structure. This stress may cause the walls of the support structure to be pulled inwardly toward one another during use. In some forms, the support structure may be adapted to withstand additional stress loads to avoid inward deformation. Thus, the stiffness of the support structure may apply additional stress to the woven membrane, which may result in elastic stretching of the woven membrane during use.

[0171] In some configurations, 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. In this manner, additional support may be advantageously provided to the textile membrane under dynamic loads (e.g., tube drag). In other configurations, the pleats, folds, or gussets may use internal air pressure to decouple dynamic loads (e.g., tube drag) from the seal-forming structure. In some configurations, the textile membrane substantially fills the compressed contours of the patient's face 1300 (e.g., around either side of the nose) as the air pressure in the cavity loads the textile membrane's inner surface, creating additional tensile stress. In some configurations, the elasticity of the textile membrane in combination 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. Doing so may, in some configurations, also be advantageous in providing a continuous seal even if the mask is partially displaced from its optimal interface with the patient's face, because the woven membrane may partially expand due to reaction forces from the internal air pressure (i.e., the "hovercraft effect").

[0172] In some configurations, such as those shown in Figures 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 on the grip pad 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 Figures 35, 37, 54, and 56), circular, square, etc.). In some configurations, the grip pads may be elongated (see Figures 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 take the form of dotted lines (see Figs. 35 and 54). In some forms, the grip pads forming the perimeter may take the form of solid lines (see Figs. 36 and 55). In some forms, the grip pads forming the perimeter may take 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 textile membrane.

[0173] In some configurations, the textile membrane may be integrated with the support structure by attaching (e.g., molding) the outer edge (e.g., perimeter) 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 way, the textile membrane may be free of a curved portion that curves 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, such as shown in FIGS. 11-17). This arrangement may be advantageous because the textile membrane does not need to be scored or cut 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 lead to leakage).

[0174] In some configurations, the textile membrane may 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 front side of the seal-forming structure to the rear face-contacting side (see, e.g., Figs. 33-1-33-4, 73, and 74). This may allow more of the textile membrane's surface (opposite the support structure) to be provided 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 (as described below) that may allow for the formation of a curved region without the occurrence of folds, wrinkles, creases, or buckling in the textile membrane surface. As will be appreciated, in some examples, at the transition region 36, both the support structure and the textile membrane may have a radius of curvature (e.g., the same or similar radius of curvature) along the curved portion 35 in the direction from the front side of the seal-forming structure to the rear side of the seal-forming structure (see, e.g., Figs. 33-1-33-4). The woven membrane may be given a predefined curvature so that the portion of the woven membrane that is 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 areas (e.g., lateral side 3250 and / or corner area 3252) of the woven membrane, which may assist in sealing the woven membrane against the contours of the patient's face (e.g., the nasal ala nasal area (i.e., the area where the ala terminates at the upper lip adjacent the nasolabial fold)) of the patient's face, 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 areas of the patient's face (e.g., the corners of the nose area). The woven membrane 29130 may have a saddle shape in the mid-subnasal point region 3260 configured to seal against the patient's subnasal point, so that it conforms to the saddle shape formed by the patient's nasolabial angle and upper lip, as shown in Figure 33-1. Similarly, the tip of the nose region 3270 may have a saddle shape configured to seal against a conforming profile presented at or below the patient's tip of the nose.The curvature (e.g., the magnitude of the curvature and / or 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-nasal tip region 3270 may have a different curvature in the direction of the curve 35 than the woven membrane in the mid-subnasal tip region 3260. In the example of FIG. 33-2, the woven membrane in the mid-nasal tip region 3270 may have a relatively larger (e.g., smaller radius) curvature (e.g., negative curvature in the downward / upward direction along the curve 35) than the curvature in the mid-subnasal tip region 3260 (e.g., negative curvature in the downward / upward direction along the curve 35). In one example, the curvature (e.g., the magnitude of the curvature and / or radius of curvature) of the woven membrane in the lateral side 3250 may be different from the curvature in the mid-nasal tip region 3270 and / or the mid-subnasal tip region 3260. The nasal regions of the cushion assemblies 14105, 30105, 31105 may have similar dome-like and saddle-like features, for example as shown in FIGS.

[0175] 73, the curvature of the woven membrane 16230 from the connection with the support structure 16220 (e.g., at the transition area) can be continuous 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.

[0176] 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 Figures 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 Figures 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 for Figure 33-1, so that, for example, the woven membrane 6130 of the cushion assembly 6105 may have more of a dome shape with more convexity from one lateral side to the other lateral side.

[0177] 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 adapts to changes / movements (i.e., a "hovercraft" effect), for example, due to the woven membrane being thinner and less structurally rigid than a silicone membrane.

[0178] In some forms, the woven 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 can be suitable for use with most patient faces (one size fits most). The second or third support layer can be formed using a woven membrane, a woven including a PU / Si membrane, a laminated open cell foam, a laminated PU foam, a PU molding, TPU / TPE or silicone. In some forms, the additional support layer itself can be supported by a structural / rigid plastic (e.g., PP / PC / PA / PET or other suitable material).

[0179] In some forms, 3D printing the woven membrane and / or cushion support section as a “skeleton” can reduce thickness and, therefore, mask weight.

[0180] In some configurations, multiple 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.

[0181] In some configurations, 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.

[0182] In one form, the seal-forming structure may include a compressive or gasket sealing portion that is constructed and arranged such that, in use, it is in a compressed state due to, for example, elastic tension in the positioning and stabilizing structure.

[0183] In one form the seal-forming structure includes a tension part which, in use, is held taut, for example by an adjacent region of a sealing flange.

[0184] In one form the seal-forming structure includes an area having a sticky or adhesive surface.

[0185] 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 bonding surface.

[0186] 5.3.2.2 Nasal bridge or nasal ridge area In one form, the non-invasive patient interface 3000 includes a seal-forming structure which, in use, forms a seal on the nasal bridge or nasal ridge region of the patient's face.

[0187] In one form, the seal-forming structure includes a saddle region constructed to form a seal over the nasal bridge or nasal ridge region of the patient's face in use.

[0188] 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 area (ie, upper lip) of the patient's face.

[0189] In one form, the seal-forming structure includes a saddle region constructed to form a seal over the upper lip region of the patient's face in use.

[0190] 5.3.2.4 Jaw area In one form, the non-invasive patient interface 3000 includes a seal-forming structure which, in use, forms a seal over the chin area of ​​the patient's face.

[0191] In one form, the seal-forming structure includes a saddle region constructed to form a seal over the chin region of the patient's face in use.

[0192] 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, hi such a form, the plenum chamber may cover the eye when in use.

[0193] 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.

[0194] A nasal pillow according to one aspect of the present technology includes a frustum of a cone. At least a portion of the frustum forms a seal over the underside of the patient's nose, the stalk, and a flexible region on the underside of the frustum, connecting the frustum to the stalk. Additionally, the structure to which the nasal pillows of the present technology are connected includes a flexible region adjacent the base of the stalk. The flexible region may function to facilitate a universal joint structure. The universal joint structure accommodates both the displacement and angle of the frustum of the cone and the relative movement of the structure to which the nasal pillows are connected. For example, the frustum of the cone may be displaced axially towards the structure to which the stalk is connected.

[0195] 5.3.3 Nasal cushion With reference to Figs. 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 according to 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 according to 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 according to a fourth embodiment of the present technology. With reference 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 in accordance with a sixth embodiment of the present technology.

[0196] 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.

[0197] The examples of the seal-forming structures 3100, 5100, 6100, 7100, 8100, 9100 described in the above paragraphs may be considered as nasal cradle cushions, intended to provide a flow of pressurized gas to the patient's nares by sealing at least the underside of the patient's nose. The example seal-forming structures engage the patient's face below the bridge of the nose, and in some examples may engage the patient's nose below the nasal tip depending on the size and shape of the patient's nose. The example seal-forming structures may also engage the patient's face at least above the upper vermilion lip. Thus, the example seal-forming structures may seal the patient's upper lip in use. Furthermore, the patient's mouth is left exposed by the seal-forming structures of the illustrated examples, so the patient may be able to breathe freely (i.e., directly to the atmosphere) without interference from the seal-forming structures. The under-nose nasal cradle may be configured to not have an aperture sized to receive the patient's nose within the 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 left-right width of the cushion from one lateral edge of the woven membrane to the other lateral edge of the woven membrane (see Figures 33 and 33-1).

[0198] An example of a nasal cradle cushion (e.g., an exemplary seal-forming structure disclosed herein) may include a superior saddle-shaped or concave region with a positive curvature across the cushion. Also, a nasal cradle cushion may be understood as having a single target seal-forming region or surface, while a pillow cushion may have two target seal-forming regions, 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 in the range of 90 degrees to 120 degrees.

[0199] Additionally, the exemplary seal-forming structure may be shaped and dimensioned such that, during use, no portion of the seal-forming structure enters the patient's nares.

[0200] Plenum Chamber 5-17, the plenum chamber 3200 has edges shaped to be complimentary to 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 proximate 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.

[0201] 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 such that the plenum chamber includes the seal-forming structure, or may be formed as part of the plenum chamber. In such an example, the support structure and the woven membrane may be considered as 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 aid in improved compliance with treatment. The use of a transparent material may aid the clinician in viewing the placement and function of the patient interface.

[0202] In certain forms of the present technology, the plenum chamber 3200 is constructed from a translucent material. The use of a translucent material can make the patient interface less intrusive and can help improve compliance with treatment.

[0203] 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.

[0204] 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 removable connection.

[0205] At each lateral side of the plenum chamber 3200, the plenum chamber lateral ends 3202 may be provided as hollow passages forming plenum chamber inlet ports sized and configured to receive airflow. A plenum chamber connector 3204 may also be provided at each lateral side of the plenum chamber 3200 outwardly of the plenum chamber lateral ends 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 is provided on the other side. In further examples, the connection between the plenum chamber connector 3204 and each end 3314 of the positioning and stabilizing structure 3300 may be permanent on both sides.

[0206] 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.

[0207] 32 illustrates how the ends 3314 of the positioning and stabilizing structure 3300 may be connected to the plenum chamber lateral ends 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.

[0208] The third, fourth and fifth plenum chambers 3200 of the present technology substantially as shown in Figures 18-32 may be similar or identical to the plenum chambers of Figures 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 the following: 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 herein by reference in its entirety. For example, the plenum chamber of the present technology may be identical to the plenum chamber in any 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.

[0209] In the example of Figures 28-32, the plenum chamber 13200 has the plenum chamber lateral 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). It is noted that in any of the other examples, a vent insert may be provided (e.g., the vent 3400 in the plenum chamber 3200 of Figures 10-27 may be provided by a vent insert 13400, such as shown in Figures 28-32).

[0210] 38, the frame 9200 may include a centrally located connection for the air circuit 4170. The frame may also include headgear attachment sites on the lateral sides of the frame 9210 itself. 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.

[0211] 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 textile 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 Figures 5-27, the support structure may also sealingly engage the patient's face.

[0212] The exemplary seal-forming structures 3100, 5100, 6100, 7100, 8100, 9100, 29100, differ in various aspects further described below, but may each include a support structure having at least two regions (e.g., two, three, or four regions) of different thickness (e.g., the seal-forming structure 3100 includes a support structure 3120 (having a wall structure with a lateral support region 3122 of greater thickness relative to other portions of the wall structure). For example, as shown in FIG. 59, a portion (d1) of the support structure may be thicker than a 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 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 a fabric membrane) to ensure proper sealing in the lowest alar region of the patient's face.

[0213] Further, in the embodiment shown, 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.

[0214] In some forms, as described above, the seal-forming structure 3100 may 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 may include openings through which the support structures are sealingly joined to the plenum chamber 3200.

[0215] The support structure may be less rigid than the plenum chamber 3200 and may be constructed from silicone, foam (e.g., polyurethane foam) (see Figures 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 portions described in any of the examples of this disclosure may be referred to as woven sealing portions or woven membranes and may include woven materials having an air impermeable material laminated, coated, or otherwise added thereto.

[0216] The support structure may have an aperture formed therein, resulting in an inner edge of the support structure along which the sealing portion (e.g., the outer periphery of the sealing portion) is attached to the support structure such that the sealing portion extends radially inward of the seal-forming structure (beyond or further than the support structure), as shown, for example, in Figures 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 of Figures 28-32, the sealing portion 8130 may be laminated (e.g., foam) onto the support structure 8120.

[0217] 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. At the lateral most sides of each seal-forming structure 3100, the lateral support regions 3122 may be provided. The seal-forming structure 3100 may include two lateral support regions 3122. Each of the two lateral support regions 3122 is spaced distally from a plane that bisects the seal-forming structure 3100, the plane being parallel to a sagittal plane of the patient in use. 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 sleeps with their head on their side and presses a pillow laterally against the seal-forming structure) and providing 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.

[0218] 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 (ala, 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).

[0219] 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 configured to contract and the sealing portion 5130 to expand, such that the sealing portion 5130 engages the alar-lowest region of the patient's face in use. As a result, the seal-forming structure 5100 may be more flexible and compliant such that it can more easily conform to the contours of the patient's face.

[0220] 18-22, the seal-forming structure in this example is arranged to provide a larger cavity 3101 such that the sealing portion 6130 protrudes further from the plenum chamber in the direction towards the patient's face in use due to increased tension in the sealing portion, causing the sealing portion to balloon outwardly. In use, the patient's nose can be pressed against the sealing portion 6130 in the direction towards the cavity 3101 and plenum chamber 3200, causing the sealing portion 6130 to stretch and invert, as shown in FIG. 18, such that the space created by the cavity 3101 receives the patient's nose and the sealing portion 6130 seals above the patient's nose tip. In contrast, the sealing portions 3130 and 5130 seal below the patient's nose tip, as shown in FIG.

[0221] 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 serion along the bridge of the nose.

[0222] 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 connection openings 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 patient's facial contours through compression of the support structure 8120.

[0223] 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 rear portion of the plenum chamber 3200 and is configured to engage the patient's upper lip in use.

[0224] 33-37, cushion assembly 29105 is similar to cushion assembly 3105, but may extend further in the left-right lateral direction. 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 membrane 29105 formed such that the woven membrane forms a portion of the seal-forming structure that extends curvilinearly from the front side of the seal-forming structure to the rear face-contacting side, as described above.

[0225] As mentioned above, Figures 35-37 show grip pads 29150 on the surface of the textile membrane.

[0226] In the example of Figure 38, the sealing portion 9130 is positioned to seal above the patient's nasal tip.

[0227] 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.

[0228] In one form, the positioning and stabilizing structure 3300, 9300 provides at least sufficient retention to overcome the effect of positive pressure in the cavity 3101 to lift off the face.

[0229] In one form, the positioning and stabilising structure provides a retaining force sufficient to overcome the attractive force on the patient interface.

[0230] In one form, the positioning and stabilizing structure provides a retention force as a safety margin to eliminate potentially destructive effects on the patient interface (e.g., due to tube drag or inadvertent interference with the patient interface).

[0231] In one form of the present technology, a positioning and stabilizing structure 3300, 9300 is provided that is 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.

[0232] In one form of the present technology, a positioning and stabilizing structure is provided that is configured to not be of 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.

[0233] In one form of the present technology, a positioning and stabilizing structure is provided that is configured to not be of an excessively large or bulky size that would interfere with a patient sleeping in a lateral sleep position with the side region of the patient's head resting on a pillow.

[0234] In one form of the present technology, the positioning and stabilizing structure 3300, 9300 includes 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 down with their head on a pillow, the presence of the decoupling site prevents forces from being transferred along the positioning and stabilizing structure to the posterior portion, disrupting the seal.

[0235] In one form of the present technology, the 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.

[0236] In certain forms of the present technology, the positioning and stabilizing structure includes an expandable (e.g., elastically expandable) strap. For example, the strap may 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 may be configured as a tie.

[0237] In one form of the present technology, the positioning and stabilizing structure includes a first tie constructed and arranged such that, in use, at least a portion of its lower edge passes over and moves to a superior-temporal point on the patient's head to cover a portion of the parietal bone without covering the occipital bone.

[0238] In one form of the present technology, suitable for a nasal only or full face mask, the positioning and stabilizing structure includes a second tie constructed and arranged such that, in use, at least a portion of its upper edge passes under the lower ear base point on the underside of the patient's head and covers or rests under the occipital bone of the patient's head.

[0239] In one form of the present technology, suitable for a nasal only or full face mask, the positioning and stabilizing structure includes a third tie constructed and arranged to interconnect the first tie and the second tie in a manner that reduces the tendency of the first tie and the second tie to move apart relative to one another.

[0240] 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.

[0241] 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.

[0242] In certain forms of the present technology, a system is provided that includes 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, the system may include one form of positioning and stabilizing structure that is suitable for a large sized head but not a small sized head and another that is suitable for a small sized head but not a large sized head.

[0243] 5.3.3.1.1 Positioning and stabilization 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 to move more freely (without becoming entangled with the air circuit 4170).

[0244] The positioning and stabilizing structure 3300 may be constructed from silicone. For example, the side portions 3302, upper portion 3304, hub 3306 and lateral ends 3314 may be constructed or molded from a single piece of silicone.

[0245] 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 a corresponding portion 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.

[0246] 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 since it reduces the shape and size variability of the sides of the patient's head.

[0247] The ends 3314 may connect to each plenum chamber lateral end 3202. As described above, the plenum chamber lateral ends 3202 receive the pressurized gas flow from the positioning and stabilizing structure 3300. This pressurized gas flow 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.

[0248] The positioning and stabilizing structure 3300 may be constructed and arranged to direct the force / tension provided from the lateral portions 3302 into a partially superior and partially posterior force vector applied to the plenum chamber 3200. In particular, this partially superior and partially posterior force vector causes the textile membrane of the seal-forming structure 3100 to make sealing contact below the patient's nose (e.g., at or below the nasal tip and at least above the vermilion of the upper lip).

[0249] Additionally, each side portion 3302 may include a tab 3308 that receives a rear strap end 3311 of the rear strap 3310. The rear strap 3310 may be length adjustable, 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 hook material on the exterior and the other has loop material on the exterior. In this manner, the rear strap 3310 is length adjustable 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).

[0250] The side portions 3302 may also include sleeves 3312 to provide cushioning protection for the patient's face from the side portions 3302. The sleeves 3312 may be constructed of a soft feeling, breathable woven material.

[0251] 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 of 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.

[0252] In some forms, the woven tube 6350 may be formed with a first side configured to contact the patient, which may be referred to as the inner layer 6352. The woven conduit may also include a second side, which may be attached to the inner layer but facing away from the patient, which may be referred to as the outer layer 6354. The inner and outer layers may be secured together along the edges of the inner and outer layers, 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 may be joined using various techniques that impart specific attributes to the seams or joints. For example, in some forms, the seams are formed using ultrasonic welding, radio frequency welding, and cutting and welding techniques. The application of heat to certain areas activates the thermosetting or thermoplastic materials used in the tube 6350. This heat may be used to heat form layers, such as the outer layer 6354, as well as to bond the layers together. Additionally, in some configurations, the layers can be joined together using adhesion, such as stitching or adhesives. In some configurations, stitching is not used. In further configurations, no material beyond the material disposed within the layers is used in joining the inner and outer layers of the tube. For example, in some configurations, the inner and outer layers can be formed such that no additional material, such as adhesives or stitching, is required in joining the inner and outer layers.

[0253] The inner and outer layers may 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 configurations including a single sheet, the inner surface is the surface of the sheet that is disposed inwardly or toward itself.

[0254] In some configurations, the sheet or tube sheet may include an air impermeable layer or membrane. In some configurations, 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 configurations, 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 formed to allow a predetermined velocity or air movement and a particular pressure.

[0255] The membrane may be formed of a thermoplastic or thermosetting material such that when exposed to a particular temperature, the membrane material may be molded or formed into a particular shape and then cured or solidified or cooled to solidify. In some forms, the membrane may be formed of silicone or polyurethane. In some forms, the outer layer 6354 is preformed such that in an unpressurized or supported state, the outer layer 6354 is prepositioned and preformed to extend away from the inner layer 6352 between the opposing joints 6312. That is, the outer layer 6354 may support its own weight such 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.

[0256] 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.

[0257] As shown in Figure 7, and particularly as shown in Figure 8, the inner layer 6352 includes a textile sheet 6360 with a membrane 6362. The textile sheet 6360 may be formed from a felt, a foam material, a woven, knitted, or nonwoven material or other fiber network.

[0258] The outer layer 6354 includes a tube sheet 6364 and an outer covering 6366. In some configurations, 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.

[0259] 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 the same as 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.

[0260] 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. The sides may include holes or other connectors for connection to headgear attachment sites 9210 of the frame 9200. The positioning and stabilizing structure 9300 also includes a rear 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.

[0261] 5.3.3.2 Ventilation In one form, the patient interface 3000, 6000, 9000 includes a vent 3400 constructed and arranged to allow for the expulsion of exhaled gases (eg, carbon dioxide), as shown, for example, in FIG.

[0262] 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 with respect to atmosphere. The vent 3400 is configured such that the magnitude of the vent flow is sufficient to reduce rebreathing of exhaled CO2 by the patient while maintaining a therapeutic pressure in the plenum chamber in use.

[0263] The ventilation section 3400 in one embodiment according to the present technology includes a plurality of holes (eg, about 20 to about 80 holes, or about 40 to about 60 holes, or about 45 to about 55 holes).

[0264] 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 of the vent 3400 may be divided into two laterally spaced groups. The axes of the flow paths through each of the holes of the vent 3400 may be parallel, thus avoiding cross-flow and further noise generation. The vents may be circular.

[0265] The radius of the holes in the vents 3400 may decrease from the inside to the outside of the plenum chamber 3200. Each vent hole is provided with 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, if the draft angle is large, the plenum chamber 3200 may be 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.

[0266] The vent 3400 holes 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 crowding.

[0267] The holes in the vent 3400 may be located at an optimal distance away from the centerline of the plenum chamber 3200. Locating the holes in the vent 3400 toward the centerline may be advantageous as it may reduce the likelihood of the vent becoming blocked when the patient is lying down. However, locating the holes 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 blocking of the holes during lying down while still allowing the middle member of the chassis to remain sufficiently strong.

[0268] The size of each vent and the number of vents can be optimized to achieve a balance between noise reduction while achieving the required carbon dioxide flushing even at extreme humidification. In the example described, the entire ventilation volume of the system may not be obtained from the vents of the vent 3400. The decoupling structure 3500 may include a decoupling structure vent 3402. The decoupling structure vent 3402 may include one hole or multiple holes through the decoupling structure 3500. The decoupling structure vent 3402 may function to bleed off excess pressure generated by the RPT device 4000 (before it reaches the patient), while the vent 3400 may function to flush out carbon dioxide exhaled by the patient during treatment.

[0269] 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.

[0270] 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 bulb).

[0271] The hub 3306 as described above is connected to the decoupling structure 3500 which is a rotatable elbow in these examples. The decoupling structure 3500 may be rotatable 360° within the hub 3306 in use. To remove the decoupling structure 3500 from the hub 3306, a button 3504 is manually pressed which releases a catch (not shown) from within the hub 3306.

[0272] The decoupling structure 3500 may also include a swivel 3502 that allows for a rotatable connection to the air circuit 4170.

[0273] The decoupling structure 3500 being rotatable, the decoupling structure 3500 being in the form of an elbow, and the swivel 3502 being rotatable on the decoupling structure 3500 can lead to increased degrees of freedom, resulting in reduced tube drag and torque on the patient interface 3000 due to connection to the air circuit 4170.

[0274] 5.3.3.4 Connection Ports The connection port 3600 allows connection to the air circuit 4170 .

[0275] 5.3.3.5 Forehead support In one form, the patient interface includes a forehead support 3700.

[0276] 5.3.3.6 Anti-asphyxiation valves In one form, the patient interface includes an anti-asphyxiation valve.

[0277] 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 characteristic of the gas (e.g., pressure) within the cavity 3101 to be directly measured.

[0278] 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 nares and mouth of a patient individually (i.e., an oral-nose 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 a plenum chamber according to an example of the present technology.

[0279] 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 nares and mouth of a patient (i.e., an oral-nose cushion assembly or a miniature full face mask). The cushion assembly 31105 is at least partially formed by the seal-forming structure 31100 attached to a plenum chamber and a plenum chamber 31200 according to an example of the present technology.

[0280] 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.

[0281] As mentioned above, Figures 54-56 show grip pads 31150 on the surface of the woven membrane.

[0282] Plenum Chamber The plenum chamber 14200 has edges shaped to be complimentary to 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 proximate 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.

[0283] 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.

[0284] In certain forms of the present technology, the plenum chamber 14200 is constructed from a translucent material. The use of a translucent material can make the patient interface less intrusive and can help improve compliance with treatment.

[0285] The plenum chamber 14200 according to embodiments of the present technology may include a plenum chamber hole on each side. The plenum chamber hole 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 mechanical connection (e.g., snap or friction fit) with each 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.

[0286] The seal-forming structure 14100 may be hermetically 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 a mechanical connection, no chemical bond is formed between the plenum chamber 14200 and the seal-forming structure 14100.

[0287] 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 the patient's nares. In the embodiment shown, 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.

[0288] The seal-forming structure 14100 may include a mouth site 14102 having a mouth site aperture 14104 for sealing with the patient's mouth.

[0289] 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.

[0290] The seal-forming structure 14100 can include a support structure 14120 that provides support to a sealing portion 14130 (e.g., a textile membrane). The sealing portion is configured to sealingly engage with a 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.

[0291] The wall structure that may be included in the support structure 14120 may include at least two regions of different thickness (e.g., portions of the support structure adjacent to or connected to the plenum chamber 14200, which may be thicker than portions of the support structure adjacent to or connected to the sealing portion 14130, thereby providing structural stability in the connection with the plenum chamber 14200 and flexibility in the interface with the patient). FIG. 84 illustrates an example where 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 the connection with the plenum chamber and flexibility in the interface with the patient. Alternatively, thicker lateral support regions 3122 may be positioned (e.g., directly connected to the fabric membrane), for example, in the corners of the nasal region of the seal-forming structure and / or in the mouth area, to ensure proper sealing in the nasal nadir region and / or mouth area of ​​the patient's face.

[0292] 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).

[0293] The support structure 14120 may have an aperture formed therein, resulting in 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 such that the sealing portion extends radially inward of the seal-forming structure (beyond or further than the support structure), as shown, for example, in Figures 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 manners, as described below.

[0294] In the example of FIG. 49, the support structure 14120 may 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 may form a double wall structure around the sealing portion. In another example, a second or third base cushion layer may 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 may be constructed of silicone as shown in FIG. 50. However, it will be appreciated that the base cushion may be constructed of other suitable materials (e.g., fabric).

[0295] 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 / 609,909, filed Dec. 22, 2017, or WO2019 / 119058, filed Dec. 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 the same as 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.

[0296] 5.3.4.1.1 Positioning and stabilizing structures

[0297] 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 stabilising structure 14300 in use.

[0298] In one form, the positioning and stabilizing structure 14300 provides at least enough retention to overcome the effect of positive pressure in the cavity 14001 to lift off the face.

[0299] In one form, the positioning and stabilising structure 14300 provides a retaining force sufficient to overcome the attractive force on the patient interface 14000.

[0300] In one form, the positioning and stabilizing structure 14300 provides a retaining force as a safety margin to eliminate the possibility of destructive action on the patient interface 14000 (e.g., due to tube drag or inadvertent interference with the patient interface).

[0301] In one form of the present technology, a positioning and stabilizing structure 14300 is provided that is configured to be worn by a patient while sleeping. In one embodiment, 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 embodiment, the positioning and stabilizing structure 14300 includes at least one strap having a rectangular cross-section. In one embodiment, the positioning and stabilizing structure 14300 includes at least one flat strap.

[0302] In one form of the present technology, a positioning and stabilizing structure 14300 is provided that is configured so as not to be excessively large or bulky in size that would interfere with a patient sleeping in a supine sleeping position with the posterior region of the patient's head resting on a pillow.

[0303] In one form of the present technology, a positioning and stabilizing structure 14300 is provided that is configured to not be excessively large or bulky in size that would interfere with a patient sleeping in a lateral sleep position with the side region of the patient's head resting on a pillow.

[0304] In one form of the present technology, the positioning and stabilizing structure 14300 comprises a decoupling site located between an anterior portion of the positioning and stabilizing structure 14300 and a posterior portion of the positioning and stabilizing structure 14300. The decoupling site does not resist compression and can be, for example, a flexible or flimsy strap. The decoupling site is constructed and positioned such that when a patient lies down with their head on a pillow, the presence of the decoupling site prevents forces from being transferred along the positioning and stabilizing structure 3300 to the posterior portion, disrupting the seal.

[0305] 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 a loop material that engages with a hook material portion.

[0306] In certain forms of the present technology, the positioning and stabilizing structure 14300 includes a stretchable (e.g., elastically stretchable) 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.

[0307] In one form of the present technology, the positioning and stabilizing structure can 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 a superior ear-base point of the patient's head.

[0308] In one form of the present technology suitable for a full face mask, the positioning and stabilizing structure includes a second tie (e.g., lower strap 14303 (FIG. 41)) constructed and arranged such that, in use, at least a portion of its upper edge passes under the lower ear base point of the underside of the patient's head and covers or rests under the occipital bone of the patient's head.

[0309] In one form of the present technology suitable for a nasal or full face mask, the positioning and stabilizing structure includes a third tie (e.g., a strap connector 14304 (FIG. 39)) constructed and arranged to interconnect the first and second ties in a manner that reduces the tendency of the first and second ties to move apart relative to one another.

[0310] In certain forms of the present technology, the positioning and stabilizing structure 14300 includes straps that are bendable, e.g., non-rigid. An advantage of this embodiment is that the straps are more comfortable when the patient lies down to sleep.

[0311] In a particular form of the present technology, the positioning and stabilizing structure 14300 includes a strap configured to be breathable to allow water vapor to pass therethrough.

[0312] 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 range of different sizes and / or shapes. For example, a system may include one form of positioning and stabilizing structure 14300 that is suitable for a large sized head but not a small sized head and another that is suitable for a small sized head but not a large sized head.

[0313] 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 Fig. 39. The clip 14301 and the conduit connector 14800 each have magnets disposed thereon with opposite polarities to facilitate connection therebetween.

[0314] 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.

[0315] In certain forms, the vent 14400 is configured to allow continuous vent flow from the interior of the plenum chamber 14200 to atmosphere when pressure in the plenum chamber is positive with respect 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 a therapeutic pressure in the plenum chamber in use.

[0316] The ventilation portion 14400 in one embodiment according to the present technology includes a plurality of holes (eg, about 20 to about 80 holes, or about 40 to about 60 holes, or about 45 to about 55 holes).

[0317] The vent 3400 may be disposed within the plenum chamber 14200 as shown in Figure 47. Alternatively, the vent 14400 is disposed within a decoupling structure (e.g., a swivel).

[0318] 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.

[0319] The conduit connector 14800, described in more detail below, may also include a venting feature.

[0320] 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).

[0321] 5.3.4.1.4 Connection Ports The connection port 14600 allows for connection to the air circuit 4170. The connection port 14600 according to one embodiment of the present technology can be connected to a connection port housing 14903. The connection port 14600 can be swivellable relative to the connection port housing 14903 and the connection to the air circuit 4170 can also be swivellable.

[0322] The connection port 14600 and the connection port housing 14903 may be positioned above the patient's head in use.

[0323] 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.

[0324] 5.3.4.1.6 Conduit A patient interface 14000 according to an embodiment of the present technology may include a conduit 14900 for providing pressurized air flow from a connection port 14600 to a cavity 14001 in a plenum chamber 14200. The conduit 14900 may be joined above the patient's head at a 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 a 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.

[0325] 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 in the positioning and stabilizing structure 14300. Thus, the mechanical connection from the conduit 14900 to the conduit connector 14800 may be sufficient to transfer pulling forces in the conduit 3900 through the conduit connector 14800 to the seal-forming structure 14100.

[0326] The conduit 14900 may include features of similar conduits disclosed in International Publication WO2017 / 124155A1, the entirety of which is incorporated herein by reference. For example, the conduit 14900 of the present technology may include features of the headgear tube 3350 described in Figures 3A-3L and related descriptions herein.

[0327] 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.

[0328] The conduit 14900 may also include a tie connector 14902 to facilitate connection with a tie of the positioning and stabilizing structure 14300.

[0329] 5.3.4.1.7 Conduit Connectors The patient interface 14000 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, according to an embodiment of the present technology. 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).

[0330] 43-50 show several views of a conduit connector 14800 of a patient interface 14000 in accordance with an embodiment of the present technology.

[0331] In Figs. 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 at each corresponding lateral side of the cushion assembly 14105. Each of the conduit connectors 14800 can include a conduit connector attachment structure for connecting each of the conduit connectors 14800 to a respective plenum chamber aperture at a connecting rim (not shown). This connection can be mechanical (e.g., snap-fit ​​or friction-fit). This connection can also be removable. The material of the conduit connector 14800 and the material of 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 stiff 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 disrupting 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.

[0332] 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, the plenum chamber 14200 may be constructed from a transparent or translucent material to allow for visibility of the patient's facial features. For example, by providing the conduit connector 14800 to the side of the plenum chamber as shown in the illustrated embodiment, a greater view of the patient's face is provided, and this arrangement allows for improved aesthetics of the patient interface 14000. This is in contrast to 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.

[0333] Each of the conduit connectors 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 may be 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 pressurized air flow. The conduit connector 14800 may include structure (e.g., undercuts) to facilitate a removable snap-fit ​​connection with the corresponding conduit 14900. Each of the conduits 14900 may include a relatively rigid structure at the end that connects to the conduit connector 14800 to facilitate such a connection. The conduit connectors 14800 may join to the conduits 14900 by a friction fit. Again, as described above, the conduit 14900 provides positioning and stabilizing functions for positioning a seal-forming structure at a therapeutically effective sealing position on the patient's face, such that the connection between the conduit 14900 and the conduit connector 14800 at the conduit connection end 14802 can be made sufficiently reliably to allow for 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).

[0334] 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 existing air in the plenum chamber 14200, which can improve the pushing out of carbon dioxide and increase the amount of fresh air provided to the patient for breathing.

[0335] As shown in Figures 39-41, the conduit connector 3800 may also provide a connection to the tie 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 with opposite polarity to facilitate 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.

[0336] 5.3.4.1.8 Anti-asphyxiation valves In one form, the patient interface 14000 includes an anti-asphyxiation valve. As best seen in Fig. 47 and Fig. 48, each of the conduit connectors 14800 may include an anti-asphyxiation valve assembly 14850. Thus, the patient interface 14000 may include two anti-asphyxiation valve assemblies 14850. Each of the anti-asphyxiation valve assemblies 14850 may operate independently of the other (i.e., in response to the cessation of pressurized air flow). For example, if the pressurized air flow is stopped while the patient is sleeping on his / her side and one of the anti-asphyxiation valve assemblies 14850 is blocked (e.g., by a pillow), the other anti-asphyxiation valve assembly 14850 may function to prevent the patient from asphyxiating.

[0337] 5.3.4.1.9 Ports 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 characteristic of the gas (e.g., pressure) within the plenum chamber 14200 to be directly measured.

[0338] 5.3.4.2 Second illustrative example 57-66 show a patient interface 30000 according to 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 nares and mouth of a patient individually (i.e. an oral-nose cushion assembly or a miniature full face mask). The cushion assembly 30105 is at least partially formed by the seal-forming structure 30100 attached to a plenum chamber and a plenum chamber (or shell) 30200 according to an example of the present technology.

[0339] The cushion assembly 30105 includes a nose region 30101, nose region holes 30103, mouth region 30102, mouth region holes 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.

[0340] 5.3.4.2.1 Positioning and stabilizing structures 57-66 show a patient interface 30000 according to an example of the present technology. The patient interface 30000 has a positioning and stabilizing structure 30300 and a plenum chamber 30200 having 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.

[0341] 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 otherwise, or may be permanently connected to the frame.

[0342] 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 by multiple lengths of material that are cut or formed separately to create longer lengths and then joined at the ends, or the single "strap" may be a single length of material.

[0343] In the example shown in Figures 57-66, the positioning and stabilizing structure 30300 includes a pair of upper straps 30310. Each upper strap is configured to pass between a respective eye and ear of the patient. Additionally, the positioning and stabilizing structure includes a pair of lower straps 30320 configured to be positioned on the patient's cheeks and 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.

[0344] 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 an air circuit 4170. In this example, the frame inlet connection port includes a connection rim 30355. The connection rim 30355 can include a flange extending radially outward. The swivel elbow assembly 30610 can form a releasable snap fit with the connection 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 a fluid connection between the swivel elbow assembly 30610 and the interior of the plenum chamber 30200.

[0345] 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 a hook and loop material configured to releasably join when they come into contact. In another example, each upper strap 30310 can be secured to itself by a band, clip, or the like after passing through a respective aperture and looping back on itself. In yet another example, the upper straps can connect to the frame via a side release buckle connection.

[0346] 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 points 30325. In this example, each lower strap clip 30326 includes an aperture through which an end of each lower strap can be passed and then looped back and secured to itself (e.g., by hook and loop material, straps, clips, etc.). In another example, the lower straps may connect to the frame via a side release buckle connection and onto a hook or any other suitable connection.

[0347] In one example, the frame 30350 and the upper strap connection points 30315 are constructed and arranged to direct the force / tension provided from the upper straps 30310 into a partially upward and partially backward force vector that is applied to the plenum chamber 30200. In particular, 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.

[0348] 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 the upper strap that passes through the aperture effectively reduces the length of the upper strap, which allows for altering the force vector and adjusting the fit of the patient interface.

[0349] In one example, the frame 30350 and the 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 inferior force vector applied to the plenum chamber. In particular, the partially posterior and partially inferior force vector causes the mouth region 30102 to be in sealing contact with the patient's face around the periphery of the patient's mouth. The partially inferior force applied from the lower straps to the frame can balance the partially superior 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.

[0350] The lower straps 30320 may be selectively adjustable. For example, the effective length of each lower strap may be altered 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.

[0351] The positioning and stabilizing structure 30300 may also include one or more of a parietal crown strap 30330, a pair of lateral crown 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 crown strap 30330. The parietal crown strap is configured to pass around the patient's head and to be positioned against opposing surfaces above and behind. The parietal crown strap 30330 may be configured to be positioned on the parietal bone of the patient's skull. Each end of the parietal crown strap also connects to a respective upper strap 30310 and to a respective pair of lateral crown straps 30332. Each lateral crown strap is connected between the upper strap and the lower strap on each side of the patient's head. The lower ends of the lateral crown straps 30332 are interconnected by the neck strap 30334. The neck strap may be configured to pass across the sagittal plane and be placed against a downward and / or backward facing surface of the patient's head or on the back of the patient's neck. The neck strap may be placed above or below the occipital bone of the patient's skull.

[0352] The length of the crown strap 30330 can be selectably adjusted. The crown 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 crown strap can loop back after passing through a respective aperture and be secured to itself, for example, via hook-and-loop material, additional clips, bands, and / or the like. The amount of each upper strap section that is routed through the link can be varied to adjust the length of the crown strap 30330 and thus the fit of the positioning and stabilizing structure.

[0353] After all headgear strap adjustments have been made and the desired fit of the patient interface 30000 has been achieved, the magnetic clip connection provided by the lower strap clips 30326 allows 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.

[0354] In certain forms of the present technology, a system is provided that includes more than one positioning and stabilizing structure. Each positioning and stabilizing structure is configured to provide a holding force to accommodate a range of different sizes and / or shapes. For example, the system may include one form of positioning and stabilizing structure that is suitable for large heads rather than small heads and another form that is suitable for small heads rather than large heads.

[0355] In addition, one or more aspects of the present technology may be combined with one or more aspects of the following: PCT / AU2019 / 050278 (filed March 28, 2019, entitled "Patient Interface"), the entirety of which is incorporated herein by reference.

[0356] 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).

[0357] In certain forms, the vent 30400 is configured to allow continuous vent flow from the interior of the plenum chamber 30200 to atmosphere when pressure in the plenum chamber is positive with respect 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 a therapeutic pressure in the plenum chamber in use.

[0358] 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).

[0359] The vent 30400 can be located within the plenum chamber. Alternatively, the vent is located within the decoupling structure (e.g., a swivel).

[0360] 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 the 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 may flow into the swivel elbow assembly 30610 and then to the surroundings through swivel elbow assembly exterior holes 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, the entirety of which is incorporated herein by reference.

[0361] 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 bulb).

[0362] 5.3.4.2.4 Connection Ports The connection port 30600 allows connection to the air circuit 4170 .

[0363] 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 the forehead support portion. Additionally, the patient interface 30000 may be configured to not contact the patient's forehead at all.

[0364] 5.3.4.2.6 Anti-asphyxiation valves In one form, the patient interface 30000 includes an anti-asphyxiation valve.

[0365] 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.

[0366] 5.3.4.3 Third illustrative example 67-77 show a patient interface 16000 according to 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 crown strap 16806). In use, one form of the seal-forming structure 16200 is positioned to surround the entrance of the airway of the patient 1000 to facilitate the delivery of air at positive pressure to the airway. In the example shown in Figs. 46-56, the patient interface is a full face / oronasal interface type that includes a seal-forming structure 16200 that is structured 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).

[0367] 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 an arm cover 16750 attached for the upper arm 16134 of the frame assembly 16100. Figure 69 is an exemplary view of the patient interface 16000 with the headgear 16800 and the arm cover 16750 removed.

[0368] 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.

[0369] In an example of the 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.

[0370] 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 tube). With this arrangement, the 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.

[0371] Frame Assembly 67-77, the frame assembly 16100 includes a shroud or wall member 16110 with 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 headgear clips 16160 (including a receptacle magnet) provided to respective lower headgear straps 16804 of the headgear.

[0372] In the illustrated example, the opening 16105 in the shroud 16110 (eg, constructed from a relatively rigid plastic material such as polycarbonate) is bounded by an outer annular flange and an inner annular flange.

[0373] 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 molding, overmolding) or may be removably connected to the cushion 16200 (e.g., by mechanical connection). In an example, the cushion 16200 is constructed of a relatively flexible or pliable material and the shell 16180 is constructed of a relatively rigid material (e.g., polycarbonate). The shell 16180 and the 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.

[0374] The shell 6180 has multiple functions. For example, it at least partially forms a cavity for pressurized gas delivery to the patient's airway entrance. The shell 6180 is a rigid structure and directs forces 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, so that headgear tension is applied to the shell 16180.

[0375] The shell 16180 of the cushion assembly 16175 is repeatably engageable to 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 the shell 16180 opening 16305 and a tab or catch on the flange engages or interlocks with a 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 rattling and rocking motion between the components, reducing impact on stability. Such a connection also provides a stable hold of the cushion assembly 16175 in place while providing an appropriate force vector on the cushion assembly 16175 for sealing.

[0376] 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.

[0377] 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.

[0378] It should also be understood that one or more aspects of the present technology may be combinable with one or more aspects of the following: 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 any of the cushion assemblies in the patient interface embodiments disclosed in the '486 publication. Furthermore, the seal-forming structure 16200 disclosed herein may be substituted for any of the seal-forming structures in the patient interface disclosed in the '486 publication.

[0379] Seal formation structure As described above, the shell 16180 is sealingly connected or otherwise attached to a seal-forming structure or cushion 16200 , and the shell 16180 and cushion 16200 cooperate to form a cavity 16500 .

[0380] The cushion 16200 may include a support structure 16220 that provides support to a sealing portion 16230 (e.g., a textile membrane). The sealing portion is configured to sealingly engage the patient's face.

[0381] 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 or connected to the shell 16180 may be thicker than the portion of the support structure adjacent or connected to the sealing portion 16230, thereby providing structural stability in connection with the shell 16180 and flexibility in the interface with the patient). FIG. 84 illustrates an example where the portion (d1) of the support structure may be thicker than the portion (d2) of the support structure. For example, the portion (d!) may be adjacent or connected to the plenum chamber, and the portion (d2) may be adjacent or connected to the sealing portion, thereby providing structural stability in connection with the frame and flexibility in the interface with the patient. Alternatively, the thicker lateral support region 3122 may be located, for example, in the lower cheek region of the seal-forming structure (e.g., directly connected to the textile membrane), thereby ensuring proper sealing in the lower cheek region of the patient's face.

[0382] The support structure 16220 may be less stiff 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 stiff 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).

[0383] The support structure 16220 may have an aperture formed therein, resulting in 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 such that the sealing portion extends radially inward of the seal-forming structure (beyond or further than the support structure), as shown, for example, in Figures 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 manners, as described below.

[0384] The support structure 16220 may extend into a cavity 16500 forming a base cushion 16221 that provides support to the sealing portion 16230, as shown in Figures 73 and 77. The base cushion 16221 and the sealing portion 16230 may form a double wall structure around the sealing portion. In another example, a second or third base cushioning layer may be provided to form a triple or quadruple wall structure. The base cushion may be constructed of similar materials to the support structure or may be constructed of other suitable materials (e.g., fabric).

[0385] 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 stabilising structure.

[0386] 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.

[0387] In one form of the present technology, the positioning and stabilizing structure 3300 includes a strap constructed from a laminate of a fabric patient-contacting layer, a foam material inner layer, and a fabric outer layer. In one form, the foam material is porous to allow moisture (e.g., sweat) to pass through the strap. In one form, the fabric outer layer includes a loop material that engages with a hook material portion.

[0388] 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.

[0389] 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.

[0390] In certain forms of the present technology, the positioning and stabilizing structures provide a retention force configured to accommodate a particular size head and / or face shape. For example, one form of the positioning and stabilizing structures provides a retention force suitable for a large size head but not for a small size head. In another example, one form of the positioning and stabilizing structures provides a retention force suitable for a small size head but not for a large size head.

[0391] 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 (eg, carbon dioxide).

[0392] 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).

[0393] 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).

[0394] 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).

[0395] 5.3.4.3.4 Connection Ports The connection port allows for connection to an air circuit.

[0396] 5.3.4.3.5 Forehead support In the illustrated example, the frame assembly 6100 is provided without a forehead support.

[0397] In another aspect, the patient interface may include a forehead support. For example, the frame assembly may include a forehead support.

[0398] 5.3.4.3.6 Anti-asphyxiation valves In one form, the patient interface includes an anti-asphyxiation valve.

[0399] 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 a property of the gas (e.g., pressure) within the cavity to be directly measured.

[0400] 5.3.5 Supporting structure and sealing arrangement The above example support structures and sealing portions can have a number of different configurations and arrangements.

[0401] In use, the 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 elastic stretch 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) preformed state of the textile membrane, untensioned and formed as a substantially constant surface, without leakage that would cause disturbances (e.g., wrinkles, folds, buckling, or fine wrinkles) in the textile membrane; and / or 4) air pressure in the cavity against the inner surface of the sealing portion. Each of these factors can contribute to maintaining a constant tension in the sealing portion so that the sealing portion conforms to the anthropometric contours of the patient's face, thereby minimizing fine wrinkles or ruptures and maximizing the contact area of ​​the sealing portion.

[0402] 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, adhesive) to the support structure so that the sealing portion is pre-tensioned (slightly stretched) and wrinkles in the material of the sealing portion are eliminated. This may be advantageous as it ensures that the sealing portion forms a smooth, continuous seal on the patient's face (without any folded sections that may cause air leakage). Additionally, the sealing portion may be shaped or imparted with a curvature, e.g., by heat molding, so that the sealing portion retains its shape. A curvature may also be imparted to the sealing portion from the support structure.

[0403] For example, as shown in Figures 11-17 and 23-37, the sealing portion can 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.

[0404] In some configurations, as shown in, for example, FIGS. 10-66, the patient's nose is not intended to be received within the cavity formed by the plenum chamber and the seal-forming structure. Instead, in contrast to conventional masks, the patient's nose is intended to be pressed against the textile membrane so that the textile membrane conforms to the contours of the patient's face to comfortably form a reliable seal with the patient's airway. In this manner, the textile membrane may stretch to conform to the patient's face. Bridge regions 3104 and 1406 extending between the nostril openings may help to keep the textile membrane taut before and / or during use. The bridge regions may also function to help provide a sealing portion that presses against the patient's nose instead of receiving it within the cavity by eliminating a central opening in the textile membrane. This also provides a different sealing experience in contrast to conventional masks. Such a sealing experience may be more comfortable due to contact with a compliant textile membrane than conventional masks made of stiffer materials (where the sealing area has a smaller contact area around the nose and / or mouth) or conventional sealing arrangements.

[0405] The sealing portion may be constructed from a single or multiple layers of material (e.g., woven material). The woven membrane (and / or the woven material of the woven membrane) may exhibit a low spring constant (i.e., very compliant in both warp and weft). In conventional masks (e.g., silicone sealing membranes), the fixed cushion may cause discomfort to the patient's skin during effective seal formation. In contrast to the 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."

[0406] Compared with conventional silicone membranes and compressed foam seals, the sealing part of the present technology has a more flexible structural rigidity and therefore has dynamic springback properties, which allows the sealing part to recover more quickly (when disturbed by external forces). Furthermore, due to the lower structural rigidity, less sealing force is required, making the sealing part more comfortable and reducing facial scarring during use.

[0407] Woven membranes may exhibit variable tension across the material (e.g., lower tension near holes or more stretched material). In some forms, the material surface of the sealing portion 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.

[0408] The woven membrane may also include at least one layer that exhibits substantially air-tight properties while maintaining the resilient stretch 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 air-tight material. In another example, the woven fibers are tightly woven to provide a substantially air-tight material.

[0409] In some embodiments, the thickness of the fabric material of the sealing portion can be within the range of 0.275 (e.g., 0.275-0.075 mm, 0.275-0.175 mm, 0.25 mm or less, 0.225 mm or less, 0.225-0.09 mm, 0.225-0.095 mm, 0.225 mm, or 0.25 mm) or less. The thickness of the membrane layer can be within the range of 0.03-0.01 mm (e.g., 0.015, 0.02 mm, or 0.025 mm). The total composite thickness of the woven fabric material of the sealing portion can be in the range of 0.305 mm or less (e.g., 0.305-0.085 mm, 0.305-0.185 mm, 0.28 mm or less, 0.255 mm or less, 0.255-0.10 mm, 0.255-0.105 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.

[0410] In another embodiment, the thickness of the fabric material of the sealing portion may be within the range of 0.15mm to 0.5mm (e.g., 0.2mm to 0.4mm, or 0.3mm to 0.4mm, or 0.25mm, or 0.3mm, or 0.4mm). The thickness of the membrane layer may be within the range of 0.03mm to 0.125mm (e.g., 0.05mm to 0.1mm, or 0.075mm to 0.1mm, or 0.05mm to 0.075mm, or 0.05mm, or 0.075mm, or 0.1mm). The total 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.

[0411] The stiffness and resilience of the support structure may transfer the tensile force to the sealing portion. The support structure may be formed from a variety of materials, such as silicone, foam (e.g., polyurethane foam), polyurethane solid material, thermoplastic elastomer (TPE) (e.g., thermoplastic polyurethane (TPU)), and suitable plastic materials. The support structure may be configured to generate several different cushion configurations, including a single air-assisted sealing portion (e.g., woven membrane) and a sealing portion with an underlying cushion support layer(s), such as a dual air-assisted sealing portion (e.g., 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., dual woven membrane with foam laminate layer (e.g., open cell, polyurethane) on inner membrane or TPU, TPE, polyurethane, or silicone molded layer on top).

[0412] The underlying cushioning layer(s) may 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) may provide sufficient contact area behind the sealing portion to properly seal with the patient's face and avoid leakage.

[0413] In use, engagement of the patient's face 1000 with the sealing portion 10130 creates a temporary distortion force that attempts to pull the walls of the support structure 10120 towards each other, as shown in Figure 81. The support structure 10120 responds to this distortion force with a reaction force that pulls it outward. The reaction 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.

[0414] In some examples, the support structure may include a biasing section using 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).

[0415] The air pressure in the cavity and the action on the inner surface of the sealing portion may also enable the surface of the woven membrane to be kept free of wrinkles, wrinkles, buckles or creases when presented to the patient's face (e.g., by tension generation in the sealing portion), so that the sealing portion can 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 in 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 the opposing force from the internal air pressure) (i.e., the "hovercraft effect").

[0416] Even in instances where the woven 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 the air pressure in the cavity, forming an improved air-assisted seal against the patient's face that dynamically adapts to changes / movements (i.e., the "hovercraft effect").

[0417] The sealing portion may 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 may extend radially inward of the seal-forming structure to extend beyond or wider than the support structure. The inner edge of the support structure may be curved, so that the sealing portion may be angled slightly inward toward the mask interior. By attaching the sealing portion along the inner edge of the support structure, it is not necessary to crease or cut the sealing portion to make it conform to the corners of the support structure. This may advantageously reduce the occurrence of protruding folds or wrinkles in the sealing portion (which may cause leakage), which may improve the sealing performance.

[0418] As mentioned above, the seal-forming structure may be removably connected or fixedly attached to the plenum chamber. 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 a module. The sealing portion may be attached to the support frame in a manner that reduces the occurrence of creases or wrinkles protruding from the fabric surface. The modular arrangement may also substantially simplify the manufacturing of the sealing portion (e.g., the fabric sealing portion) by allowing complex joints to be made in a simple stress-free manner. Although it may be possible to engineer the sealing portion to be substantially self-cleaning, the modular sealing portion may provide a cheaper and more hygienic alternative.

[0419] 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 by connectors (e.g., male / female locating pins / holes, tongue and grooves).

[0420] The sealing part may have an underlying cushion support layer(s) (e.g., a second cushion layer, a third cushion layer, or a subsequent cushion layer) inside. The underlying cushion 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 part may be constructed as: a dual air-assisted sealing part (e.g., a dual woven membrane), a sealing part with a compression support layer(s) (e.g., open cell foam, polyurethane foam, gel), a sealing part with a TPU, TPE, or silicone support layer(s), or a dual air-assisted sealing part with additional support layer(s) (e.g., a dual woven membrane with a foam laminate layer (e.g., open cell, polyurethane) on the inner membrane or a TPU, TPE, polyurethane, or silicone molded layer on top).

[0421] 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))).

[0422] In some examples, 3D printing the sealing portion, support layer and / or support structure as a "skeleton" can lead to a reduction in the thickness of the structure, which can also reduce the weight of the mask. 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, a biasing portion can be formed that can enable dynamic support during use.

[0423] 5.3.5.1 Textile membrane According to an example of the technology of the present disclosure, the sealing-forming structure may include a woven membrane including a woven material. The woven material may be coated or otherwise added 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).

[0424] A textile is a material that includes at least one natural or artificial fiber (e.g., spun or sewing yarn). The fiber may be a filament (mono or poly), a strand, a sewing yarn, or a twisted yarn. The fiber or fibers 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 materials (e.g., by interlacing or interlacing one or more of the above fibers) and nonwoven materials.

[0425] In one example, the woven material is a knitted material. Knitted materials may be preferred because they provide elasticity (e.g., extensibility) in woven fabrics (especially compared to woven materials). This may be advantageous because it provides comfort for the patient as described below. Elasticity may be provided in all directions (e.g., four-way stretch / elasticity (e.g., substantially equal elasticity in all directions)), at least in the left and right lateral directions of the woven membrane. Woven materials may have, for example, a weft-knitted or warp-knitted structure. Weft-knitted structures are more preferred because the elasticity of weft-knitted fabrics is higher than that of warp-knitted fabrics.

[0426] Fig. 113 shows the weft knit fabric fabric 70 or the direction in which the loops of one yarn are joined to the loops of another yarn. The path 80 or direction of the loops from a single sewing yarn is shown in Fig. 114. In the basic closed loop warp knit 90 shown in Fig. 115, the fabric and path run parallel to each other. In the weft knit 100 shown in Fig. 116, the fabric 70 runs perpendicular to the path 80.

[0427] 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.

[0428] In step 10, an airtight woven composite may be formed by combining the woven material with an impermeable material, as shown in Fig. 117. A thermal process may be used to attach the impermeable layer to the woven material, for example, as shown in Fig. 78. The woven composite may have a flat shape (e.g., a sheet shape).

[0429] In step 12, the woven composite may be cut into the desired shape according to the particular cushion assembly that is to be used.

[0430] 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, when the flat woven composite is overmolded with the support structure, a curvature is imparted to the woven composite to form a woven membrane that may have a curvature (without causing 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 rear side of the seal-forming structure along the 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 radius of curvature) along the curved portion 35. The woven membrane may be given a predefined curvature, so that the portion of the woven membrane that is not directly supported by the support structure extends along a curved portion 35 (FIGS. 33-2-33-4). As mentioned above, the woven membrane may 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., 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, for example, FIGS. 11-17, 23-27, and 33-37). In another example, the woven membrane may have a negative curvature in the down / up direction (which may be imparted during the overmolding process) and maintained by the connection to the support structure (see, for example, FIGS. 18-22).

[0431] 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 FIG. 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 (wherein the thickness of the support structure is different (e.g., larger) than the thickness of the impermeable layer).

[0432] The overmolding process creates a seal-forming structure that imparts curvature to the woven membrane without any wrinkles, creases, wrinkles and / or buckling in the woven membrane.

[0433] 5.3.5.1.2 Woven membrane example Exemplary properties and structural configurations of woven composites that can be used as materials for woven membranes are described below.

[0434] 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 (e.g., 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 (e.g., during cleaning).

[0435] In another example, a two-layer arrangement 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) having a silicone layer (e.g., deposited as a coating). This composite material can be less expensive than the three-layer arrangement described above because only one layer of fabric is required.

[0436] 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.

[0437] 5.3.5.1.2.2 Textile materials As noted above, a number of woven materials may 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).

[0438] In one example, a nylon material is used. Nylon is softer than polyester, which may provide comfort benefits to the patient. Nylon is also stronger than polyester, which may provide increased longevity and durability. Additionally, nylon has a higher melting temperature compared to polyester, which allows it to withstand higher temperature manufacturing conditions.

[0439] In another example, a nylon and polyester blend material is used, which is more desirable because it is less irritating to the patient due to the lower moisture absorption caused by the addition of polyester, and is also less expensive than nylon.

[0440] 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 the range of 0.15mm to 0.5mm (e.g., 0.2mm to 0.4mm, or 0.3mm to 0.4mm, or 0.25mm, or 0.3mm, or 0.4mm). Such thickness may be suitable for nylon material or nylon and polyester blend material.

[0441] In another embodiment, the thickness of the woven material of the sealing portion may be in the range of 0.275 (e.g., 0.275-0.075 mm, 0.275-0.175 mm, 0.25 mm or less, 0.225 mm or less, 0.225-0.09 mm, 0.225-0.095 mm, 0.225 mm, or 0.25 mm) or less. Such thickness may be suitable for microfiber woven material or polyurethane woven material.

[0442] 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 may 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 may result in a lighter product and may also provide greater extensibility than a thicker silicone layer (e.g., 0.1 mm). However, a thicker silicone layer (e.g., 0.1 mm) may be more durable than a thinner layer (e.g., 0.05 mm).

[0443] 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).

[0444] 5.3.5.1.2.5 Overall thickness of textile composite In instances where a textile material is coated with a silicone membrane / film layer, the thickness of the entire composite may 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).

[0445] Thicker woven membranes (e.g., 0.5 mm) can be more robust and have less traces. These woven membranes can be easier to handle during manufacturing because they are less likely to flap.

[0446] Intermediate thicknesses (e.g., 0.35 mm to 0.45 mm) can provide a flexible, lightweight structure that is relatively easy to handle during manufacturing and can provide greater comfort to the patient than thicker woven membranes.

[0447] 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.

[0448] In instances where a textile material is coated with a polyurethane film, the thickness of the overall composite material can be in the range of 0.305 mm or less (e.g., 0.305-0.085 mm, 0.305-0.185 mm, 0.28 mm or less, 0.255 mm or less, 0.255-0.10 mm, 0.255-0.105 mm, 0.25 mm, or 0.275 mm).

[0449] 5.3.5.1.2.6 Knitting structure The textile material of the textile membrane may have, for example, a weft-knitted or alternatively a warp-knitted structure, with weft-knitted textiles being more desirable since they provide a material with greater elasticity than warp-knitted textiles, which may provide greater comfort to the patient by stretching as the patient's face engages the textile membrane, thereby reducing the force exerted by the textile membrane on the patient's face.

[0450] In one example, the weft direction (the direction of path 80) may run across the width of the woven membrane nose since the weft direction may have higher elasticity or extensibility, or the weft direction may run across the length of the nose (up and down).

[0451] Additionally, weft knitting is better suited to producing relatively thin materials, such as those disclosed herein, and weft knitting is generally less expensive than warp knitting.

[0452] However, in some instances warp knitting is more desirable because it shrinks less than weft knitted materials.

[0453] 5.3.5.1.2.7 Knitting machines The weft knitted textile material may have a single jersey knit construction providing a technical face and a technical back face with different appearances. The single jersey knit may be formed by one set of needles, providing a knitted seam on the technical face (front) and a back stitch on the technical back face. In one example, the technical face may form the outer surface of a textile membrane, and an air impermeable membrane may be attached to the technical back face. Alternatively, the technical face may be oriented towards the inner surface of the textile membrane, to which the membrane is attached. In another example, the textile may be an interlock knit.

[0454] In one example where the woven membrane comprises an air impermeable membrane sandwiched between two woven layers, the technical aspects of each woven material may define the exposed surface of the woven membrane.

[0455] 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). A higher weight woven (e.g., 120 gsm) may provide a desirable, comfortable woven feel even after being coated with a laminate layer due to its high weight / thickness. A lower weight woven (e.g., 105 gsm) is more desirable as it allows for a lighter product.

[0456] 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). Note that the machine gauge can also be indicated by the letter "E" (e.g., E35 to E70).

[0457] A relatively larger gauge material (e.g., 44GG) is desirable because it provides more options for melange materials, but a finer gauge material (e.g., 60GG) is desirable because it provides greater material flexibility, which may lead to improved patient comfort.

[0458] 5.3.5.1.2.10 Aesthetics Woven materials can have a solid color aesthetic or a melange aesthetic. Melange materials can be considered as materials made with more than one color of fabric / textile / yarn, either made with different colored fabrics / textiles / yarns or made with different fabrics / textiles / yarns that are then dyed individually. Melange materials are desirable because they have a greater ability to hide dirt or grime, which makes it easier to improve the cleanliness of the product. Melange materials can also be useful during manufacturing, because it is easier to visually align the woven knit structure correctly when cutting and / or overmolding.

[0459] However, for solid color materials, the increased options for finer gauge materials (eg, 55GG+) which are softer and therefore more comfortable for the patient are desirable.

[0460] 5.3.5.1.3 Woven membrane with air-impermeable silicone layer In another example, an air impermeable silicone layer 32130-2, which may be included in the sealing portion 32130 (or woven membrane), is applied (eg, coated) to the woven material 32130-1, as shown in FIGS. 118-120.

[0461] The silicone layer 32130 may provide flexibility and extensibility to the sealing portion 32130 (while also providing an outer surface of the silicone layer that is smooth feeling and highly durable and abrasion resistant).

[0462] The sealing portion 32130 may have the same or similar extensibility / elasticity and tensile strength properties in both the fabric and machine directions to conform to a variety of facial features and achieve an effective and robust seal against the patient's face.

[0463] The overall thickness of the sealing portion 32130 may be in the range of 0.2 mm to 0.46 mm (e.g., 0.25 mm to 0.425 mm, 0.275 mm to 0.375 mm, 0.3 mm to 0.38 mm, 0.3 mm to 0.35 mm, 0.25 mm to 0.33 mm, or 0.275 mm to 0.3 mm).

[0464] It should be noted that the values ​​of any material property or properties described anywhere in this disclosure may be applicable to this example woven membrane (e.g., in addition to any properties or values ​​described in this section).

[0465] 5.3.5.1.3.1 Textile materials The woven material 32130-1 to which the silicone layer 32130-2 is applied can be an elastic knitted (eg, weft knitted) woven material.

[0466] The textile material may have a single jersey knit construction with a machine gauge in the range of 30-60GG (e.g. 35GG-55GG or 44GG-60GG or 40GG-50GG or 55GG-60GG or 44GG or 50GG or 55GG or 60GG). This single jersey knit construction provides a different appearance for the technical face and the technical back face. As mentioned above, the single jersey knit may be formed by one set of needles and may provide a knit stitch on the technical face (front) and a back stitch on the technical back face. In an example, the technical face may form the outer surface of the textile membrane that contacts the patient's skin and the silicone layer 32130-2 may be attached to the technical back face. Alternatively, the technical face may be oriented towards the inner surface of the textile membrane and a silicone layer may be added to the technical face. In another example, the textile material may have an interlock knit construction.

[0467] The woven material may be produced by dope dyeing, piece dyeing or yarn dyeing to obtain solid color or mélange fabrics.

[0468] The woven material 32130-1 may include nylon (e.g., nylon 6), polyester, spandex, leuca and / or lycra. For example, the woven material may include nylon (or polyester or nylon / polyester blends) and elastane (e.g., spandex (or leuca or lycra)). In examples, the woven material may include 75-95% (e.g., 80%, 85%, 90% or 95%) nylon (or polyester or nylon / polyester blends) and 5-25% (e.g., 5%, 10%, 15% or 20%) elastane (e.g., spandex (or leuca or lycra)). In other examples, the spandex (or leuca or lycra) may be greater than 25% and the nylon (or polyester or nylon / polyester blends) may be less than 75%.

[0469] The nylon count can be FDY (or DTY) 20-80D / 17-144F, where FDY is fully drawn yarn, DTY is drawn textured yarn, D is denier (i.e., the linear mass density of the yarn), and F is the number of filaments per yarn, as understood by those skilled in the art. The polyester yarn can be FDY (or DTY) (20-80D / 17-144F). The nylon / polyester blend count can be FDY (or DTY) (20-80D / 17-144F). In other examples, the denier of the nylon, polyester, and / or nylon / polyester blend can be, for example, 30-70D, 40-60D, 20-30D, 20-50D, 50-70D, 20D, 40D, 60D, or 80D. Further, in other examples, the filament count of nylon, polyester and / or nylon / polyester blends can be, for example, 20-130F, 40-110F, 60-90F or 70-80F. These yarns can be multifilament yarns as indicated by the filament counts listed above. Spandex (or Leuca or Lycra) can be 20-120D (e.g., 40-100D, 60-80D, 20-40D, 80-120D, 20D, 40D, 80D or 120D). The count (or denier) can at least in part determine the thickness, density, elasticity and / or hand of the woven fabric.

[0470] The fabric weight of the woven material can be in grams per square meter (gsm) of 95 to 170 gsm (e.g., 105 gsm to 160 gsm, 110 gsm to 150 gsm, 120 gsm to 140 gsm, 105 gsm, 110 gsm, 120 gsm, 130 gsm, 140 gsm, 150 gsm or 160 gsm), resulting in a relatively lightweight material for promoting patient comfort.

[0471] As discussed above, the woven material may be elastic in all directions (e.g., four-way stretch / elasticity (e.g., substantially equal elasticity in all directions (i.e., substantially equal extensibility / elasticity in the weave and process directions and at least in the left-right direction laterally of the woven membrane). The woven material is extensible without curvature at the weave edges. The extensibility / elasticity of the woven material facilitates the extensibility / elasticity of the woven membrane in all directions, which conforms (e.g., stretches to conform) to the contours of the patient's face without creating folds or wrinkles and without causing patient discomfort.

[0472] The textile material is prepared for silicone coating, molding or lamination and silicone flexibilizers are not added to the textile surface because the use of such agents can cause delamination and affect the bond strength of the textile.

[0473] It should be noted that the bond strength between the woven material 32130-1 and the silicone layer 32130-2 can be affected due to the surface texture or roughness of the yarn. A relatively rough surface allows for easier bonding and therefore a stronger bond. Additionally, multifilament yarns have a larger surface area compared to monofilament yarns, which allows for a stronger bond between the woven material and the silicone layer.

[0474] It should be noted that the use of a cross-linking agent may provide a chemical bond, however, in the examples no cross-linking agent is present and therefore only a physical bond is provided.

[0475] The textile material 32130-1 forming the patient contacting side of the sealing portion 32130 may have the same or similar surface friction and roughness in both the weave and track directions so that the bonding force of the silicone layer 32130-2 to the textile material is substantially uniform in all directions (i.e., across the entire surface of the textile material). This may result in the avoidance of thin spots from the textile material of the silicone layer 32130-2. The same or similar surface friction and roughness in the weave and track directions also results in a soft and smooth surface on the patient contacting side, which is comfortable for the patient. In an example, the average value of the coefficient of friction (MIU) in the weave and track directions may be 0.7 to 5.0 (e.g., 1.0 to 4.0, 1.5 to 3.5, 2.0 to 3.0, 1.0, 1.5, 2.5, 3.5 or 5.0). Additionally, the mean deviation of the surface roughness (SMD) in the weave and course direction can be from 0.7 to 5.0 (e.g., 1.0 to 4.0, 1.5 to 3.5, 2.0 to 3.0, 1.0, 1.5, 2.5, 3.5, or 5.0).

[0476] In one embodiment, the mean values ​​of the coefficient of friction (MIU) in the weave and course direction based on surface test method KES-FB4 on samples with dimensions of 200mm x 200mm may be between 0.3 and 2.0 (e.g., 0.5-1.8, 0.8-1.5, or 1.0-1.5, 0.5, 1.0, 1.5, or 2.0). Additionally, the mean deviation of the surface roughness (SMD) in the weave and course direction may be between 0.3 and 2.0 (e.g., 0.5-1.8, 0.8-1.5, 1.0-1.5, 0.5, 1.0, 1.5, or 2.0).

[0477] The woven material may have high pilling resistance and excellent snagging resistance (eg, both grade 5 (ie, little pilling and little snagging)).

[0478] The sealing portion 32130 may be made stronger in the fabric direction and more extensible in the track direction, thus providing the sealing portion with better dimensional stability during stretching.

[0479] The thickness of the woven material 32130-1 may be between 0.18 mm and 0.32 mm (e.g., between 0.2 mm and 0.3 mm, between 0.2 mm and 0.28 mm, or between 0.225 mm and 0.275 mm).

[0480] 5.3.5.1.3.2 Air-impermeable silicone layer The silicone layer 32130-2 may have a clear or transparent appearance.

[0481] The thickness of the silicone layer 32130-2 may be in the range of 0.04 mm to 0.125 mm (e.g., 0.05 mm to 0.1 mm, 0.06 mm to 0.09 mm, 0.07 mm to 0.08 mm, 0.05 mm, 0.075 mm, 0.1 mm, or 0.125 mm). This provides a durable, tough, air impermeable layer. However, it should be noted that the thickness of the silicone layer 32130-2 may not be uniform across the sealing portion 32130 due to the penetration of the silicone layer into the textile material upon curing.

[0482] 5.3.5.2 Illustrated examples of support and sealing arrangements 81-112 show several different cushion assembly configurations including various support structure and sealing portion arrangements and / or processes. It should be noted 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. It should also be noted 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.

[0483] 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).

[0484] The connection between the outer periphery (or edge) of the woven membrane and the inner edge of the support structure can be made in a number of different ways. As shown in Figures 83 and 85, the connection can form a lap joint where the edge of the woven membrane overlaps the edge of the support structure. In an example, the attachment site 10122 of the support structure forms a recess to receive the sealing portion 10130, so that the support structure and sealing portion form a smooth outer surface, 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 the case of 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, in such arrangements, the overlap may vary around the periphery 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 area).

[0485] In contrast to the lap joints 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 Fig. 84. Due to manufacturing techniques (e.g., overmolding, injection molding), the end-to-end joint may have a certain overlap, but such overlap is negligibly small and constant around the sealing portion at the connection with the support structure. In other words, as described above, all overlaps of the support structure and textile membrane are not designed to adjust stiffness, tension, flexibility or support in different areas of the face (e.g., less overlap, less support, more flexibility, less tension in the sensitive nose bridge area).

[0486] Instead, whether a lap joint or an end-to-end joint is provided, the present arrangement allows the compliant woven 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 woven membrane which compliantly receives the patient's face.

[0487] The sealing portion may be bonded, molded (e.g., overmolded or injection molded) to the support structure, or otherwise attached to the support structure. In another example, the recess may be eliminated and the sealing portion 10130 and the support structure 10120 may be attached end-to-end using the attachment sites 10122, as shown in FIG. 84. Additionally, FIG. 84 shows that the portion of the support structure 10120 adjacent or connecting to the plenum chamber 10200 (d1) may be thicker than the portion of the support structure 10120 adjacent or connecting to the sealing portion 10130 (d2), providing structural stability at the connection with the plenum chamber and flexibility at the interface with the patient.

[0488] 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.

[0489] 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.

[0490] 87 and 88, the support structure 10120 may have an external biasing portion 10140 or an internal biasing portion 10140'. The external biasing portion 10140 or the internal biasing portion 10140' may utilize the internal air pressure in the cavity to dynamically support the support structure and sealing portion 10130. The support structure 10120 may include an inwardly curved end 10142, thus 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 the air pressure in the cavity to bias the sealing portion into sealing contact with the patient's face.

[0491] 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 an adhesive 10150 (e.g., heat activated polyurethane, tape, bonding adhesive).

[0492] 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 of foam (e.g., polyurethane foam molding), but may be formed of 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.

[0493] Figure 90B shows an example similar to that of Figure 90A, but 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.

[0494] 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.

[0495] As shown in FIG. 92, the support structure 23120 may include an underlying cushion 23121 (e.g., constructed of TPU) having a U-shape or hook shape. The underlying cushion may include a clip 23126 for releasable connection to the cushion (e.g., frame, plenum chamber, or other portion of the support structure). Alternatively, the sealing portion 10130 may be attached to the support structure 23120 as a removable module and releasably connected to the cushion (e.g., frame, plenum chamber, or other portion of the support structure) as a unit. The sealing portion 10130 may be attached to the underlying cushion 23121, for example, by heat molding. The underlying cushion may also be formed by heat molding.

[0496] The support structure 24120 may include a rigid clip 24126 that supports 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 layer and clip. The support structure 24120 may be removably connected to the cushion (e.g., frame, plenum chamber, or other part of the support structure). Alternatively, the sealing portion 10130 may be attached to the support structure 24120 as a removable module and removably connected to the cushion (e.g., frame, plenum chamber, or other part of the support structure) as a unit. The sealing portion 10130 may be connected to the underlying cushion 24121, for example, by heat molding. The underlying cushion may also be formed by heat molding.

[0497] 94, the support structure 18120 may include a rigid clip 18126 that supports the underlying cushion 18121 (e.g., constructed of foam). The support structure 18120 may be removably connectable to the cushion (e.g., 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., 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, for example, by heat molding. The underlying cushion may also be formed by heat molding.

[0498] 95, the support structure 19120 includes a first portion 19123 and an underlying cushion 19121. The first portion 19123 may be connected to a plenum chamber and may be constructed of a stiffer material than the material of the underlying cushion 19121. For example, the first portion may be constructed of polyurethane and the underlying cushion may be constructed of foam.

[0499] 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 having 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.

[0500] 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.

[0501] 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.

[0502] 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.

[0503] The cushion assembly in FIG. 100 is similar to the cushion assembly in FIG. 99, except that the first fabric layer 10130 and the second fabric layer 10132 extend from the 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 provide elasticity to the sealing portion and allow the fabric layers to bounce back 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 the plenum chamber.

[0504] 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 skeleton support frame 26450 to which the sealing portion 10130 is attached. The sealing portion 10130 may be heat molded or insert molded, for example, to attach the sealing portion to the support frame 26450. The heat molding 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 of, for example, insert molded polyurethane.

[0505] In the example of Fig. 103, the woven membrane 10130 and / or the support structure may be configured as removable or modular. As shown in Fig. 103, the woven membrane 10130 may be attached to a modular support structure 26480 at the periphery. The modular support structure 26480 may then be removably engaged to the plenum chamber as a module. The modular formation may advantageously reduce the protrusion of folds or wrinkles in the woven membrane surface.

[0506] In some forms, the textile membrane may be a sleeve or sock, adapted to cover and be held over a plenum chamber or support structure.

[0507] The modular woven membrane seal may also substantially simplify manufacturing, as all of the complex joints may be made in a simple, stress-free manner. Some fabrics may be engineered to have substantially self-cleaning properties, but the modular woven membrane 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 and is attached to the plenum chamber, support structure, or frame assembly.

[0508] In the configuration in which 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 a circular arc.

[0509] In some forms, the modular support structure 26480 may engage with the plenum chamber through corresponding male / female locating pins / holes. In some forms, the modular support structure may 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 may be formed, for example, from a plastic material, polyurethane, or similar material.

[0510] 104-106, a process of 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 attachment of the sealing portion to the support frame 26450 keeps the sealing portion taut prior to use.

[0511] 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 apart to accommodate patients with a range of face sizes.

[0512] 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 face 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 arranged to stretch so that it can accommodate patients with different face sizes.

[0513] 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 inwardly at certain creases or pivot points. For example, thinner regions of the support structure may be designed to create the creases or pivot points. In an example, the lower central portion of the support structure 3120 (e.g., nose base region 3112) may be made relatively thin so that when stress is applied to the walls of the support structure by engagement with the patient's face, a pivot point is created by the lower central portion of the support structure, which may allow the left and right lateral sides of the support structure to deform inwardly to cradle the patient's face (e.g., nose) and accommodate the patient's engagement. The upper anterior region 3109 may also be made thin compared to the lateral support regions 3122, so that a crease or pivot point is created.

[0514] 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 thickness 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 of a flexible material (e.g., silicone) and may be molded (e.g., integrally molded) into a one-piece structure. This may assist in bending / 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 woven membrane may be considered as part of the plenum chamber.

[0515] 5.4 RPT Devices An RPT device 4000 according to one aspect of the present technology includes mechanical, pneumatic, and / or electrical components and is configured to execute one or more algorithms 4300 (e.g., any of the methods described herein, in whole or in part). The RPT device 4000 may be configured to generate an airflow that is delivered to a patient's airway for treatment of one or more of the respiratory conditions described anywhere herein, for example.

[0516] 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.

[0517] 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.

[0518] 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).

[0519] One or more of the pneumatic 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.

[0520] 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, a 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 an alternative, the RPT device 4000 can include more than one PCBA 4202.

[0521] 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.

[0522] 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 combinations of other breathable gases (e.g., oxygen-rich atmospheric air).

[0523] 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.

[0524] For example, the ambient humidity for a humidifier may be the humidity of the air immediately surrounding the humidifier (e.g., the humidity inside the room in which the patient sleeps). Such ambient humidity may differ from the humidity outside the room in which the patient sleeps.

[0525] In another example, the atmospheric pressure may be the pressure immediately surrounding or external to the body.

[0526] 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.

[0527] 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.

[0528] Continuous Positive Airway Pressure (CPAP) Therapy: Respiratory pressure therapy in which the therapeutic pressure is approximately constant throughout the patient's respiratory cycle. In some forms, the pressure at the entrance to the airway increases slightly during expiration and decreases slightly during inspiration. In some forms, the pressure varies during different respiratory cycles of the patient (e.g., increased in response to detection of an indication of partial upper airway obstruction and decreased in the absence of notification of partial upper airway obstruction).

[0529] Flow Rate: The instantaneous amount (or mass) of air delivered per unit time. Flow rate may refer to an instantaneous quantity. In some cases, references to flow rate refer to a scalar quantity (i.e., a quantity that has only magnitude). In other cases, references to flow rate refer 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.

[0530] In the example of a patient's breath, the flow rate may be nominally positive for the inhalation portion of the patient's breathing cycle, and therefore negative for the exhalation portion of the patient's breathing cycle. Total flow rate Qt is the flow rate of air exiting the RPT device. Ventilator 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.

[0531] Humidifier: The word "humidifier" is to be construed as meaning a humidification device constructed, arranged or configured with a physical structure capable of providing a therapeutically beneficial quantity of water (H2O) vapor to an air stream to improve the medical respiratory condition of a patient.

[0532] Leakage: The term "leakage" is taken as an unintended air flow. In one example, leakage may occur due to an imperfect seal between the mask and the patient's face. In another example, leakage may occur at the swivel elbow to the perimeter.

[0533] Noise Conduction (Acoustic): In this document, conducted noise refers to noise that is carried to the patient by the pneumatic pathway (e.g., the air circuit and the patient interface and the air therein). In one form, conducted noise can be quantified by measuring the sound pressure level at the end of the air circuit.

[0534] Noise Emission (Acoustic): In this document, radiated noise refers to noise that is carried by the surrounding air to the patient. In one form, radiated noise can be quantified by measuring the sound power / pressure level of the target according to ISO 3744.

[0535] Ventilation Noise (Acoustic): In this document, ventilation noise refers to the noise generated by airflow through any vents (eg, vents in a patient interface).

[0536] Patient: A person with or without respiratory disease.

[0537] Pressure: force per unit area. Pressure can be expressed in a variety of units (e.g., cmH2O, gf / cm 2 , and hectopascals). 1cmH2O is 1g-f / cm 2 which is approximately 0.98 hectopascals. In this specification, pressure is given in units of cmH2O unless otherwise specified.

[0538] The pressure in the patient interface is given the symbol Pm, and the therapeutic pressure, which represents the target value that the mask pressure Pm should achieve at this moment, is given the symbol Pt.

[0539] Respiratory Pressure Therapy (RPT): The application to the airway inlet of an air supply at therapeutic pressure, typically a positive pressure relative to the atmosphere.

[0540] Ventilator: A mechanical device that provides pressure support to a patient during some or all of the work of breathing.

[0541] 5.5.1.1 Materials Silicone or Silicone Elastomer: Synthetic rubber. In this specification, when silicone is mentioned, it refers to liquid silicone rubber (LSR) or compression molded silicone rubber (CMSR). One form of commercially available LSR is SILASTIC (in a family of products sold under this trademark) manufactured by Dow Corning. Another LSR manufacturer is Wacker. Unless otherwise specified to the contrary, exemplary forms of LSR have a Shore A (or Type A) indentation hardness of about 35 to about 45 as measured by ASTM D2240.

[0542] Polycarbonate: A thermoplastic polymer of bisphenol A carbonate.

[0543] 5.5.1.2 Mechanical properties Resilience: The ability of a material to absorb energy during elastic deformation and to release the energy when unloaded.

[0544] Elastic: Releases substantially all of the energy upon unloading. Examples include certain silicone and thermoplastic elastomers.

[0545] Hardness: The ability of a material to resist deformation within itself (as described, for example, by Young's Modulus or the indentation hardness scale measured over a standardized sample size). "Soft" materials may include silicone or thermoplastic elastomers (TPEs) and may easily deform under finger pressure, for example. "Hard" materials may include polycarbonate, polypropylene, steel or aluminum, and do not easily deform under finger pressure, for example.

[0546] 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.

[0547] 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.

[0548] Rigid Structure or Component: A structure or component that does not substantially change shape when subjected to loads typically encountered in use. An example of such an application may be setting up and maintaining a patient interface in a sealed manner against a patient airway entrance under a pressure load of, for example, approximately 20-30 cmH2O.

[0549] As one example, an I-beam may include a different bending stiffness (resistance to bending load) in a first direction compared to a second, orthogonal direction, hi another example, a structure or component may be floppy in a first direction and stiff in a second direction.

[0550] 5.5.2 Breathing cycle Apnea: According to some definitions, apnea is said to occur when flow below a certain threshold continues for a duration of, for example, 10 seconds. Obstructive apnea is said to occur when some airway obstruction does not allow airflow despite patient effort. Central apnea is said to refer to a condition in which apnea is detected due to reduced or absent respiratory effort despite a patent airway. Mixed apnea is said to refer to a condition in which reduced or absent respiratory effort occurs simultaneously with airway obstruction.

[0551] Respiratory Rate: The patient's spontaneous breathing rate, usually measured in breaths per minute.

[0552] Duty Cycle: The ratio of inspiration time Ti to total breathing time Ttot.

[0553] Effort (Respiration): Respiratory effort is said to refer to the movement made by a person's spontaneous breathing in an attempt to breathe.

[0554] Expiratory portion of the respiratory cycle: the period from the start of the expiratory flow to the start of the inspiratory flow.

[0555] Flow limitation: Flow limitation is understood to be a situation in a patient's breathing where an increase in effort by the patient does not cause a corresponding increase in flow rate. If the flow limitation occurs during the inspiratory portion of the respiratory cycle, the flow limitation may be referred to as inspiratory flow limitation. If the flow limitation occurs during the expiratory portion of the respiratory cycle, the flow limitation may be referred to as expiratory flow limitation.

[0556] Flow-limited inspiration waveform types: (ii) Flattening: An upswing is followed by a relatively flat area, then a downswing occurs. (ii) M-shaped: It 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 shape: A relatively flat area is followed by a single local peak, which occurs at the trailing edge.

[0557] Hypopnea: By some definitions, hypopnea refers to a reduction in flow, rather than an interruption of flow. In one form, hypopnea is said to occur when there is a sustained period of reduced flow below a threshold rate. When hypopnea is detected due to a reduction in respiratory effort, central hypopnea is said to occur. In one form in adults, hypopnea may be considered when any of the following occur: (ii) A 30% decrease in patient ventilation for at least 10 seconds plus an associated 4% desaturation; or (ii) A reduction in patient respiration (less than 50%) lasting for at least 10 seconds and associated with at least 3% desaturation or arousal occurs.

[0558] Hyperventilation: An increase in flow to a level higher than normal.

[0559] Inspiration portion of the respiratory cycle: The period from the start of the inspiratory flow to the start of the expiratory flow is taken as the inspiration portion of the respiratory cycle.

[0560] Patency (Airway): The degree to which the airway is open or the extent to which the airway is open. Airway patency is an opening. Airway patency may be quantified, for example, with a value of 1 indicating open and a value of 0 indicating closed (obstructed).

[0561] Positive end-expiratory pressure (PEEP): The pressure above atmosphere in the lungs that exists at the end of expiration.

[0562] Peak flow (Qpeak): The maximum value of flow during the inspiratory portion of the respiratory flow waveform.

[0563] 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.

[0564] Tidal volume (Vt): The volume of air inhaled or exhaled during normal breathing without extra effort. In principle, the inhaled volume V i (volume of inhaled air) is the expiratory volume V e (volume of exhaled air), so a single tidal volume V t can be defined as being equal to either quantity. In practice, the tidal volume V t is some combination (e.g., intake volume V i and expiratory volume V e It is estimated as the average of

[0565] (Inspiration) Time (Ti): The duration of the inspiratory portion of the respiratory flow waveform.

[0566] (Expiratory) Time (Te): The duration of the expiratory portion of the respiratory flow waveform.

[0567] (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.

[0568] Typical Recent Ventilation: The ventilation value around which the most recent values ​​of ventilationVent tend to cluster over a given time scale (i.e., the degree to which the most recent values ​​of ventilation tend to be central).

[0569] 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).

[0570] Vent: A measurement of the rate of gas exchange performed by a patient's respiratory system. Measurements of ventilation may include either or both inhaled and exhaled airflow per unit of time. When expressed as volume per minute, this amount is often referred to as "minute ventilation." Minute ventilation is sometimes simply given as volume and is understood as volume per minute.

[0571] 5.5.3 Ventilation Adaptive servo-ventilator (ASV): A servo-ventilator that does not have a fixed target ventilation, but rather is variable. The variable target ventilation can be learned from some characteristics of the patient (e.g., the patient's breathing characteristics).

[0572] Backup Rate: A ventilator parameter that establishes the minimum respiratory rate (typically in breaths per minute) that will be delivered from the ventilator to the patient (when not triggered by spontaneous breathing efforts).

[0573] 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.

[0574] Expiratory Positive Airway Pressure (EPAP): The base pressure to which varying pressure is added within a breath to produce the desired mask pressure the ventilator is attempting to achieve at a given time.

[0575] 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.

[0576] Inspiratory Positive Airway Pressure (IPAP): The maximum desired mask pressure that the ventilator attempts to achieve during the inspiratory portion of the breath.

[0577] Pressure Support: A number indicating the increase in pressure during ventilator inhalation followed by exhalation of the same ventilator, and generally refers to the pressure difference between the maximum inhalation pressure and the base pressure (e.g., PS=IPAP-EPAP). In some contexts, pressure support refers to the difference the ventilator tries to achieve (rather than the difference it actually achieves).

[0578] Servo-ventilator: a ventilator that has patient ventilation and has target ventilation, and adjusts the level of pressure support to approximate the patient ventilation to the target ventilation.

[0579] Spontaneous / Timed (S / T): A mode of a ventilator or other device that attempts to detect the onset of a breath in a spontaneously breathing patient. However, if the device fails to detect a breath within a predetermined period of time, the device automatically begins breath delivery.

[0580] Swing: A term equivalent to pressure assistance.

[0581] Triggered: When a ventilator delivers a breath of air to a spontaneously breathing patient, the ventilator is said to be triggered to deliver a breath when the patient himself initiates the breathing portion of the breathing cycle.

[0582] 5.5.4 Anatomy 5.5.4.1 Facial anatomy Ala: The outer wall or "wing" of each nostril (plural: alar)

[0583] Wing Angle:

[0584] Alare: The outermost point on the ala of the nose.

[0585] Alar curvature (or alar crest) point: The most posterior point on the curved baseline of each ala, found in the crease formed by the union of the ala and cheek.

[0586] Pinna: the entire visible part of the ear.

[0587] (Nasal) Skeleton: The nasal skeleton includes the nasal bones, the frontal process of the maxilla, and the nasal part of the frontal bone.

[0588] (Nasal) Cartilaginous folds: The nasal cartilaginous folds include the septal cartilage, lateral cartilage, greater cartilage and lesser cartilage.

[0589] Columella: The piece of skin that separates the nostrils and extends from the tip of the nose to the upper lip.

[0590] Columella angle: the angle between a line drawn through the midpoint of the nostrils and a line drawn perpendicular to the Frankfurt horizontal intersecting the subnasal point.

[0591] Frankfort horizontal plane: A line extending from the inferiormost point of the orbital rim to the left auricular point, which is the deepest point above the notch to the tragus of the pinna.

[0592] Glabellar: Located in the soft tissue, the most prominent point on the midsagittal portion of the forehead.

[0593] Lateral nasal cartilage: A generally triangular plate of cartilage whose upper margin is attached to the nasal bone and the frontal process of the maxilla and whose lower margin is connected to the greater alar cartilage.

[0594] Lip, lower side (lower lip: labrale inferius):

[0595] Lip, upper side (upper lip: labrale superius):

[0596] Alar cartilage: a plate of cartilage located below the lateral nasal cartilage. It curves around the anterior part of the nostril. Its posterior end is attached to the frontal process of the maxilla by a tough fibrous membrane containing three or four alar cartilages.

[0597] Nostrils (nose holes): roughly ellipsoidal alar openings that form the entrance to the nasal cavity. The singular form of nares is naris (nose hole). The nostrils are separated by the nasal septum.

[0598] Nasolabial fold or nasolabial crease: a fold or groove of skin that runs from each side of the nose to the corners of the mouth and separates the cheeks from the upper lip.

[0599] Nasolabial angle: the angle between the bridge of the nose and the upper lip, intersecting with the subnasal point.

[0600] Inferior ear fundus point: lowest point of attachment of the pinna to the facial skin.

[0601] Superior auricular point: the highest point of attachment of the pinna to the facial skin.

[0602] Nasal tip: the most prominent point or tip of the nose, which can be seen in a lateral view of the rest of the head section.

[0603] Philtrum: midline groove extending from the lower border of the nasal septum to the top of the lip in the upper lip area.

[0604] Pogonion: The most anterior midpoint of the jaw, located on the soft tissue.

[0605] (Nasal) ridge: The nasal ridge is the midline prominence of the nose, extending from the serion to the apex.

[0606] Sagittal Plane: A vertical plane running from anterior (front) to posterior (back). The midsagittal plane is the sagittal plane that divides the body into right and left halves.

[0607] Cerion: Located on the soft tissue, it is the most concave point on the area of ​​the frontonasal suture.

[0608] Septal cartilage (nose): The nasal septal cartilage is part of the septum, which divides the anterior part of the nasal cavity.

[0609] Nasal Alar Lowest Point: The point on the lower margin of the alar base where it joins with the skin of the upper (top) lip.

[0610] Subnasal point: located on the soft tissue where the columella joins the upper lip in the midsagittal direction.

[0611] Supramenton: The most concave point in the midline of the lower lip between the lower lip midpoint and the soft tissue pogonion.

[0612] 5.5.4.2 Skull anatomy Frontal bone: The frontal bone contains the large vertical portion, the scales frontalis, which correspond to the area known as the forehead.

[0613] Mandible: The mandible forms the lower jaw. The mental eminence is a bony protuberance in the jaw, forming the chin.

[0614] Maxilla: The maxilla forms the upper jaw and is l...

Claims

1. 1. A cushion assembly for interfacing with a patient's airway including at least the patient's nares, the cushion assembly configured to maintain a therapeutic pressure, in use, greater than ambient air pressure throughout the patient's respiratory cycle while the patient is sleeping, for ameliorating sleep disordered breathing, the cushion assembly comprising: At least 6 cmH above ambient air pressure ２ a plenum chamber at least partially forming a cavity pressurizable to an elevated therapeutic pressure, the plenum chamber including a plenum chamber inlet port sized and configured to receive an air flow at the therapeutic pressure for breathing by a patient; and a seal-forming structure having a textile membrane constructed and arranged to, in use, form a pressure assisted seal against an area of ​​the patient's face surrounding an entrance to the patient's airways below the nasal bridge area of ​​the patient's face, the textile membrane having holes formed therein whereby airflow at the therapeutic pressure is delivered to at least an entrance to the patient's nares, the seal-forming structure constructed and arranged, in use, to maintain the therapeutic pressure within the cavity throughout the patient's respiratory cycle; Including, the textile membrane is configured, in use, to be pressed against a patient's face such that the patient's nose is not received within the cavity; the seal-forming structure further comprises a silicone support structure for supporting the woven membrane, the woven membrane extending radially inward beyond the support structure; at a curved 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, such that in a cross-section of the transition region, both the support structure and the textile membrane extend along a curve in a direction from a front side of the seal-forming structure to a rear patient-facing side of the seal-forming structure; the textile membrane comprises a textile material adapted to contact the patient's face and an air impermeable silicone layer applied thereto, the textile material comprising: 1) nylon and / or polyester; and 2) elastane; A cushion assembly, wherein the air impermeable silicone layer has a thickness in the range of 0.04 mm to 0.125 mm.

2. 2. The cushion assembly of claim 1, wherein the nylon and / or polyester has a denier count in the range of 20 to 50.

3. 3. The cushion assembly according to claim 1, wherein the elastane has a thread count in the range of 20 to 120D.

4. The cushion assembly of any one of claims 1 to 3, wherein the coefficient of friction of the woven material is in the range of 0.7 to 5.

0.

5. The cushion assembly according to any one of claims 1 to 4, wherein the average deviation of the surface roughness is within a range of 0.7 to 5.

0.

6. The cushion assembly of any one of claims 1 to 5, wherein the woven membrane has the same or similar extensibility in both the weave direction and the course direction of the woven material.

7. The cushion assembly of any one of claims 1 to 6, wherein the woven membrane has the same or similar tensile strength in both the weave and process directions of the woven material.

8. The cushion assembly of any one of claims 1 to 7, wherein the thickness of the textile membrane is in the range of 0.2 mm to 0.46 mm.

9. The cushion assembly of any one of claims 1 to 8, wherein the textile material is an elastic weft knit.

10. The cushion assembly of any one of claims 1 to 9, wherein the woven material comprises nylon, polyester, or a nylon / polyester composite.

11. The cushion assembly of any one of claims 1 to 10, wherein the textile material comprises: 1) 75% to 85% nylon, polyester, or a nylon / polyester composite; and 2) 15% to 25% elastane.

12. The cushion assembly of any one of claims 1 to 11, wherein the thickness of the woven material is in the range of 0.18mm to 0.32mm.

13. The cushion assembly of any one of claims 1 to 12, wherein the mechanical gauge of the woven material is in the range of 30GG to 60GG.

14. The cushion assembly of any one of claims 1 to 13, wherein the woven material has a woven weight in the range of 105 gsm to 160 gsm.

15. The cushion assembly of any one of claims 1 to 14, wherein the woven membrane has the same or similar surface friction in both the weave and track directions of the woven material.

16. The cushion assembly of any one of claims 1 to 15, wherein the woven material has four-way elasticity.

17. The cushion assembly according to any one of claims 1 to 16, wherein the air impermeable silicone layer has a thickness in the range of 0.05 mm to 0.1 mm.

18. The cushion assembly of any one of claims 1 to 17, wherein the silicone support structure is overmolded onto the textile membrane.

19. 19. The cushion assembly of any one of claims 1 to 18, wherein the woven material is attached to the support structure along a periphery of the woven membrane such that the woven membrane extends radially inward beyond the support structure.

20. 1. 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 patient's nares, the patient interface comprising: A cushion assembly according to any one of claims 1 to 19; and a positioning and stabilising structure for providing a force to hold the seal-forming structure in a therapeutically effective position on the patient's head, the positioning and stabilising structure including a tie, the tie constructed and arranged such that in use at least a portion of the tie rests against a region of the patient's head above an upper ear-base point of the patient's head; a patient interface including

21. 21. The patient interface of claim 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 the therapeutic pressure within the cavity in use.

22. 22. The patient interface of claim 20 or 21, wherein the plenum chamber and seal-forming structure form an oral-nasal cushion assembly.

23. 22. The patient interface of claim 20 or 21, wherein the plenum chamber and seal-forming structure form a nasal cushion.

24. 1. A therapy system for use in treating sleep disordered breathing, comprising: A patient interface according to any one of claims 20 to 23; A respiratory pressure therapy (RPT) device that delivers breathable gas at positive pressure; and an air delivery tube for passing the breathable gas from the RPT device to the patient interface; A treatment system comprising:

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